S-4: Registration of securities issued in business combination transactions
Published on December 3, 2008
As
filed with the Securities and Exchange Commission on __________
Registration
No. __________
___________________________________________________________________________
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
____________________
FORM
S-4
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
___________________
ACCESS PHARMACEUTICALS,
INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
3841
|
83-0221517
|
||
|
(State
or other jurisdiction of
incorporation
or organization)
|
(Primary
Standard Industrial
Classification
Code Number)
|
(I.R.S.
Employer
Identification
Number)
|
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
(Address,
including zip code, and telephone number, including area code, of registrant’s
principal executive offices)
___________________
Jeffrey
B. Davis
Chief
Executive Officer
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
(Name,
address, including zip code, and telephone number, including area code, of agent
for service)
___________________
Copies
to:
|
|
David
P. Luci
|
|
|
President
and Chief Business Officer
|
|
|
MacroChem
Corporation
|
|
|
80
Broad Street, 22nd
Floor
|
|
|
New
York, NY 10004
|
|
(212)
514-8094
|
Approximate
date of commencement of proposed sale to the public: As soon as practicable
after the effectiveness of this registration statement and the satisfaction or
waiver of all other conditions under the merger agreement described
herein.
If the
securities being registered on this form are being offered in connection with
the formulation of a holding company and there is compliance with General
Instruction G, check the following box.
If this
form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering.
If this
form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering.
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
(Check one):
Larger accelerated
filer ¨ Accelerated
filer ¨
Non-accelerated filer ¨ Smaller
reporting company x
CALCULATION
OF REGISTRATION FEE
|
Title
of Each Class
of
securities to be registered
|
Amount
to be registered
|
Proposed
maximum offering price
per unit
|
Proposed
maximum aggregate offering price
|
Amount
of
registration
fee
|
|
Common
Stock, $0.01 par value
per
share
|
2,500,000
(1)
|
$1.00
(1)
|
$2,500,000
|
$98.25
|
(1)
Estimated solely for the purpose of calculating the registration fee pursuant to
Rule 457(c) under the Securities Act of 1933. For the purposes of this
table, we have used the average of the high and low prices as reported on the
OTC Bulletin Board on December 1, 2008.
_________________
The
registrant hereby amends the registration statement on such date or dates as may
be necessary to delay its effective date until the registrant shall file a
further amendment which specifically states that the registration statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933, as amended, or until the registration statement shall
become effective on such date as the Securities and Exchange Commission, acting
pursuant to said Section 8(a), may determine.
The
information in this information statement/prospectus is not complete and may be
changed. Access may not sell these securities until the registration statement
filed with the Securities and Exchange Commission, of which this document is a
part, is declared effective. This information statement/prospectus is not an
offer to sell and it is not soliciting an offer to buy these securities in any
jurisdiction where the offer, solicitation or sale is not permitted or would be
unlawful prior to registration or qualification under the securities laws of any
such jurisdiction. Any representation to the contrary is a criminal
offense.
MACROCHEM
CORPORATION
80
Broad Street, 22nd Floor
New
York, NY 10004
NOTICE
OF ACTION BY WRITTEN CONSENT
TO THE
STOCKHOLDERS OF MACROCHEM CORPORATION:
NOTICE IS
HEREBY GIVEN that on July 30, 2008, MacroChem Corporation, a Delaware
corporation, obtained written consent from stockholders holding a majority of
the outstanding shares of common stock of MacroChem entitled to vote on the
following actions:
|
1.
|
To
ratify and approve the agreement and plan of merger (“Merger Agreement”)
by and between MacroChem, MACM Acquisition Corp. and Access
Pharmaceuticals, Inc. (“Access”) and the transactions contemplated
thereby.
|
The
details of the foregoing action and other important information are set forth in
the accompanying information statement and a copy of the Merger Agreement is
attached as Appendix A. The board of directors of MacroChem (“ MacroChem Board
of Directors”) has unanimously approved the above action.
Under
Section 228 of the Delaware General Corporation Law (“DGCL”), action by
stockholders may be taken without a meeting, without prior notice, without a
vote, by written consent of the holders of outstanding capital stock having not
less than the minimum number of votes that would be necessary to authorize the
action at a meeting at which all shares entitled to vote thereon were present
and voted. On that basis, the stockholders holding a majority of the outstanding
shares of capital stock entitled to vote approved the foregoing actions. No
other vote or stockholder action is required. Under Delaware law, appraisal
rights are afforded to stockholders who properly dissent with the merger and
comply with the requirements set forth herein. If you do not comply with the
procedures governing appraisal rights set forth under Delaware law and explained
elsewhere in this information statement, you may not be entitled to payment for
your shares. In the event that holders of more than 5% of the
outstanding common stock of MacroChem exercise dissenter or appraisal rights,
Access shall not be required to close the Merger.
Please
read this information statement carefully and in its entirety. Although you will
not have an opportunity to vote on the approval of the Merger Agreement and the
merger, this information statement contains important information about these
actions.
WE
ARE NOT ASKING YOU FOR A PROXY AND YOU ARE REQUESTED NOT TO SEND MACROCHEM A
PROXY.
This
information statement is being mailed on or about _________, 2008 to all
stockholders of record as of ___________, 2008.
|
By
Order of the Board of Directors
|
|
|
/s/
Robert J. DeLuccia
|
|
|
Robert
J. DeLuccia, Chairman
|
|
Access
Pharmaceuticals, Inc.
|
MacroChem
Corporation
|
2,500,000
Access
Pharmaceuticals, Inc.
Common
Stock
PRELIMINARY
INFORMATION STATEMENT
WE
ARE NOT ASKING YOU FOR A PROXY AND
YOU
ARE REQUESTED NOT TO SEND MACROCHEM A PROXY.
GENERAL
INFORMATION
The
boards of directors of Access Pharmaceuticals, Inc., (“Access”), and MacroChem
Corporation, (“MacroChem”) have each approved the merger of MacroChem with a
wholly owned subsidiary of Access. If the proposed merger is completed, the
holders of MacroChem’s common stock and in-the-money warrants are expected to
receive approximately 0.05423180 of a share of Access common stock for each
share of MacroChem common stock they own immediately prior to completion of the
merger with such exchange not to exceed in the aggregate 2,500,000 shares of
Access common stock.
This
information statement is being furnished to MacroChem stockholders in connection
with the actions taken by MacroChem’s Board of Directors and the written consent
of the holders of a majority of MacroChem’s outstanding voting securities with
respect to the actions described below. On July 10, 2008, MacroChem’s Board of
Directors unanimously approved these actions, subject to stockholder
approval. In accordance with Section 228 of the DGCL, on or about
July 30, 2008, MacroChem received written consents in lieu of a
meeting from 5 stockholders (the “Majority Stockholders”) holding 28,715,565
shares of MacroChem’s common stock, representing approximately 63% of the
45,798,412 total shares of common stock issued and outstanding as of
July 30, 2008, the record date. A copy of the written consent
is attached hereto as Appendix
B. This information statement is being sent to MacroChem’s
stockholders to comply with the requirements of Section 14(c) of the Securities
Exchange Act of 1934, as amended (“Exchange Act”), and shall constitute notice
to MacroChem’s stockholders of action taken by written stockholder
consent.
Pursuant
to the Merger Agreement dated as of July 10, 2008, by and between MacroChem,
MACM Acquisition Corp. (“Merger Sub”) and Access, Merger Sub will merge with and
into MacroChem, with MacroChem being the surviving corporation and a
wholly-owned subsidiary of Access. The merger will become effective as of the
date and at such time as the Certificate of Merger is filed with the Secretary
of State of the State of Delaware with respect to the merger (the “Effective
Time”). In accordance with the terms of the Merger Agreement, at the Effective
Time, each share of MacroChem common stock and in-the-money warrants to purchase
MacroChem common stock (the “MacroChem Warrants”) outstanding immediately prior
to the Effective Time will be converted into the right to receive a
proportionate share of an aggregate of approximately 2,500,000 fully paid and
non-assessable shares of common stock, par value $0.01 per share, of Access,
subject to certain adjustments set forth in the Merger
Agreement. Access common stock currently trades on the OTC Bulletin
Board under the symbol ACCP. At the Effective Time, MacroChem common
stock will no longer be outstanding and shall automatically be cancelled and
retired and cease to exist, and each holder of MacroChem common stock shall
cease to have any rights with respect to the shares of MacroChem common stock,
except the right to receive the shares of Access common stock as described
above. No fractions of a share of Access common stock will be issued,
and in lieu of such issuance, a holder of MacroChem common stock or MacroChem
Warrants, as the case may be, who would otherwise be entitled to a fraction of a
share of Access common stock as a result of the exchange of shares contemplated
by the Merger Agreement will receive cash in lieu of such fractional share(s)
based on a formula set forth in the Merger Agreement. In addition, at
the Effective Time, by virtue of consummating the Merger, Access will have
assumed all of MacroChem’s liabilities.
We encourage you to read carefully
this information statement/prospectus including the section entitled “Risk
Factors” beginning on
page 16.
IN
CONNECTION WITH THE MERGER, YOU HAVE THE RIGHT TO EXERCISE DISSENTERS’ RIGHTS
UNDER THE DELAWARE GENERAL CORPORATION LAW AND OBTAIN THE FAIR VALUE” OF YOUR
SHARES OF THE COMPANY’S COMMON STOCK, PROVIDED THAT YOU COMPLY WITH THE
CONDITIONS ESTABLISHED UNDER APPLICABLE DELAWARE LAW. IF YOU DO NOT COMPLY WITH
THE PROCEDURES GOVERNING APPRAISAL RIGHTS SET FORTH UNDER DELAWARE LAW AND
EXPLAINED ELSEWHERE IN THIS INFORMATION STATEMENT, YOU MAY NOT BE ENTITLED TO
PAYMENT FOR YOUR SHARES. IN THE EVENT THAT HOLDERS OF MORE THAN 5% OF THE
OUTSTANDING COMMON STOCK OF MACROCHEM EXERCISE DISSENTERS OR APPRAISAL RIGHTS,
ACCESS SHALL HOT BE REQUIRED TO CLOSE THE MERGER.
FOR A
DISCUSSION REGARDING YOUR APPRAISAL RIGHTS, SEE THE SECTION TITLED “APPRAISAL
RIGHTS” AND APPENDIX C AND APPENDIX D TO THIS INFORMATION
STATEMENT.
Neither
of the Securities and Exchange Commission nor any state securities commission
has approved or disapproved of these securities or passed on the adequacy or
accuracy of this information statement/prospectus. Any representation
to the contrary is a criminal offense.
THIS IS
NOT A NOTICE OF A MEETING OF STOCKHOLDERS AND NO STOCKHOLDERS’ MEETING WILL BE
HELD TO CONSIDER ANY MATTER DESCRIBED HEREIN.
The
information in this prospectus is not complete and may be changed. We
may not sell these securities until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is
not an offer to sell these securities and it is not soliciting an offer to buy
these securities in any state where the offer or sale is not
permitted.
Preliminary
Prospectus Subject to completion _________
TABLE
OF CONTENTS
|
Page
|
|
|
QUESTIONS
AND ANSWERS ABOUT THE MERGER
|
1
|
|
SUMMARY
|
3
|
|
The
Companies
|
3
|
|
The
Merger
|
7
|
|
Access
Board of Directors After the Merger
|
7
|
|
Ownership
of Access After the Merger
|
8
|
|
Opinion
of Financial Advisor
|
8
|
|
Share
Ownership of Directors and Executive Officers
|
8
|
|
Interests
of Directors and Executive Officers of MacroChem in the
Merger
|
8
|
|
Dissenters’
or Appraisal Rights
|
8
|
|
Conditions
to Completion of the Merger
|
9
|
|
Regulatory
Matters
|
9
|
|
Reasonable
Best Efforts to Complete the Merger
|
9
|
|
Termination
of the Merger Agreement
|
9
|
|
Material
United States Federal Income Tax Consequences of the
Merger
|
10
|
|
Accounting
Treatment
|
10
|
|
Risk
Factors
|
10
|
|
Summary
Selected Historical Financial Data
|
10
|
|
Selected
Unaudited Pro Forma Condensed Combined Financial
Data
|
13
|
|
Comparative
Per Share Information
|
14
|
|
Comparative
Per Share Market Price Data
|
15
|
|
RISK
FACTORS
|
16
|
|
Risks
Relating to the Merger
|
16
|
|
Risks
Relating to the Business of Access
|
16
|
|
Risks
Relating to the Business of MacroChem
|
24
|
|
CAUTIONARY
STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS
|
32
|
|
THE
MERGER
|
33
|
|
General
|
33
|
|
Background
of the Merger
|
33
|
|
MacroChem’s
Reasons for the Merger and Recommendation
|
33
|
|
No
Independent Financial Advisor
|
34
|
|
Vote
Required
|
34
|
|
Completion
and Effectiveness of the Merger
|
34
|
|
Appraisal
Rights
|
34
|
|
THE
MERGER AGREEMENT
|
35
|
|
Structure
of the Merger and Conversion of MacroChem Common Stock and In The Money
MacroChem Warrants
|
35
|
|
General
|
35
|
|
Exchange
Ratios
|
35
|
|
Exchange
of MacroChem Common Stock for certificates representing shares of Access
Common Stock
|
35
|
|
Restriction
on Sales of Shares Held by holders of Access Common
Stock
|
35
|
|
Conditions
to the Merger
|
36
|
|
Conditions
to Access’ and MacroChem’s Obligations
|
36
|
|
Conditions
to Access’ Obligations
|
36
|
|
Conditions
to MacroChem Obligations
|
37
|
|
Termination
|
37
|
|
Conduct
of Business of MacroChem
|
37
|
|
Representations
and Warranties
|
38
|
|
Accounting
Treatment
|
40
|
|
Material
United States Federal Income Tax Consequences
|
40
|
|
Indemnification
and Insurance
|
41
|
|
Reasonable
Best Efforts to Complete the Merger
|
41
|
|
MacroChem
Prohibited from Soliciting Other Offers
|
41
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|
INFORMATION
ABOUT ACCESS
|
43
|
|
Business
|
43
|
|
Products
|
43
|
|
Approved
Products
|
44
|
|
Products
in Development Status
|
44
|
|
Drug
Development Strategy
|
47
|
|
Process
|
48
|
|
Scientific
Background
|
48
|
|
Core
Drug Delivery Technology Platforms
|
49
|
|
Synthetic
Polymer Targeted Drug Delivery Technology
|
49
|
|
Cobalamin-Mediated
Oral Delivery Technology
|
49
|
|
Cobalamin-Mediated
Targeted Delivery Technology
|
50
|
|
Angiolix
|
50
|
|
Prodrax
|
51
|
|
Alchemix
|
51
|
|
Other
Key Developments
|
52
|
|
Patents
|
53
|
|
Government
Regulation
|
54
|
|
Competition
|
55
|
|
Supplies
|
56
|
|
Employees
|
56
|
|
Web
Availability
|
56
|
|
DESCRIPTION
OF PROPERTY
|
57
|
|
LEGAL
PROCEEDINGS
|
57
|
|
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
|
58
|
|
Code
of Business Conduct and Ethics
|
60
|
|
EXECUTIVE
COMPENSATION
|
60
|
|
2005
Equity Incentive Plan
|
62
|
|
Outstanding
Equity Awards at December 31, 2007
|
63
|
|
Director
Compensation – 2007
|
65
|
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
|
66
|
|
SECURITIES
AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION
PLANS
|
67
|
|
The
2007 Special Stock Option Plan
|
68
|
|
Annual
Incentive
|
68
|
|
Stock
Option Plans
|
68
|
|
Section
162(m)
|
69
|
|
Section
16(a) Beneficial Ownership Reporting Compliance
|
69
|
|
TRANSACTIONS
WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL
PERSONS
|
70
|
|
MARKET
FOR COMMON STOCK
|
71
|
|
Price
Range of Common Stock and Dividend Policies
|
71
|
|
Holders
|
72
|
|
Options
and Warrants
|
72
|
|
Shares
Eligible for Future Shares
|
72
|
|
Dividends
|
72
|
|
DESCRIPTION
OF SECURITIES
|
73
|
|
Common
Stock
|
73
|
|
Preferred
Stock
|
73
|
|
Transfer
Agent and Registrar
|
74
|
|
Delaware
Law and Certain Charter and By-Law Provisions
|
74
|
|
Elimination
of Monetary Liability for Officers and Directors
|
74
|
|
Indemnification
of Officers and Directors
|
74
|
|
Disclosure
of Commission Position on Indemnification for Securities Act
Liabilities
|
74
|
|
EXPERTS
|
75
|
|
LEGAL
MATTERS
|
75
|
|
WHERE
YOU CAN FIND MORE INFORMATION
|
75
|
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS
OF
OPERATIONS
|
76
|
|
Overview
|
76
|
|
Products
|
76
|
|
Approved
Products
|
77
|
|
Products
in Development Status
|
77
|
|
Recent
Events
|
77
|
|
Results
of Operations
|
79
|
|
Liquidity
and Capital Resources
|
82
|
|
Critical
Accounting Policies and Estimates
|
83
|
|
Off-Balance
Sheet Transactions
|
85
|
|
Changes
and Disagreements with Accountants on Accounting and Financial
Disclosures
|
85
|
|
INDEX
TO ACCESS FINANCIAL STATEMENTS
|
F-1
|
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
F-2
|
|
ACCESS
AUDITED FINANCIAL STATEMENTS
|
|
|
Consolidated
Balance Sheets
|
F-3
|
|
Consolidated
Statements of Operations and Comprehensive Loss
|
F-4
|
|
Consolidated
Statements of Shareholders' Equity (Deficit)
|
F-5
|
|
Consolidated
Statements of Cash Flows
|
F-6
|
|
Notes
to Consolidated Financial Statements
|
F-7
|
|
ACCESS
UNAUDITED QUARTERLY FINANCIAL STATEMENTS
|
|
|
Condensed
Consolidated Balance Sheets
|
F-23
|
|
Condensed
Consolidated Statements of Operations
|
F-24
|
|
Condensed
Consolidated Statements of Cash Flows
|
F-25
|
|
Notes
to Condensed Consolidated Financial Statements
|
F-26
|
|
INDEX
TO SOMANTA FINANCIAL STATEMENTS
|
F-30
|
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
F-31
|
|
SOMANTA
AUDITED FINANCIAL STATEMENTS
|
|
|
Consolidated
Balance Sheet
|
F-32
|
|
Consolidated
Statements of Operations
|
F-33
|
|
Consolidated
Statements of Shareholders' Deficit
|
F-34
|
|
Consolidated
Statements of Cash Flows
|
F-36
|
|
Notes
to Consolidated Financial Statements
|
F-37
|
|
SOMANTA
UNAUDITED QUARTERLY FINANCIAL STATEMENTS
|
|
|
Condensed
Consolidated Balance Sheets
|
F-57
|
|
Condensed
Consolidated Statements of Operations
|
F-58
|
|
Condensed
Consolidated Statement of Stockholders’ Deficit
|
F-60
|
|
Condensed
Consolidated Statements of Cash Flows
|
F-64
|
|
Notes
to Condensed Consolidated Financial Statements
|
F-66
|
|
INFORMATION
ABOUT MACROCHEM
|
|
|
Business
|
86
|
|
Overview
|
86
|
|
Drug
Delivery Technology
|
87
|
|
Product
Candidates
|
88
|
|
Other
Product Candidates
|
90
|
|
Competition
|
91
|
|
Government
Regulation
|
92
|
|
Research
and Development
|
93
|
|
Patents,
Trademarks and License Agreements
|
93
|
|
Employees
|
94
|
|
Web
Availability
|
94
|
|
Manufacturing
|
94
|
|
DESCRIPTION
OF PROPERTY
|
94
|
|
LEGAL
PROCEEDINGS
|
94
|
|
SECURITIES
AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION
PLAN
|
94
|
|
MARKET
FOR COMMON STOCK
|
95
|
|
Dividend
Policy
|
95
|
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
|
|
|
AND
RELATED STOCKHOLDERS MATTERS FOR MACROCHEM PHARMACEUTICALS,
INC.
|
96
|
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS
OF
OPERATIONS
|
97
|
|
General
|
97
|
|
Critical
Accounting Policies and Estimates
|
99
|
|
Results
of Operations
|
100
|
|
Liquidity
and Capital Resources
|
101
|
|
Recent
Accounting Pronouncements
|
102
|
|
Mergers
|
103
|
|
Other
Events
|
103
|
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL
DISCLOSURE
|
103
|
|
INDEX
TO MACROCHEM FINANCIAL STATEMENTS
|
F-75
|
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
F-76
|
|
MACROCHEM
AUDITED FINANCIAL STATEMENTS
|
|
|
Consolidated
Balance Sheet
|
F-77
|
|
Consolidated
Statements of Operations and Comprehensive Loss
|
F-78
|
|
Consolidated
Statement of Stockholders' Deficit
|
F-79
|
|
Consolidated
Statements of Cash Flows
|
F-80
|
|
Notes
to Consolidated Financial Statements
|
F-82
|
|
MACROCHEM
UNAUDITED FINANCIAL STATEMENTS
|
|
|
Condensed
Consolidated Balance Sheets
|
F-94
|
|
Condensed
Consolidated Statements of Operations
|
F-95
|
|
Condensed
Consolidated Statements of Cash Flows
|
F-96
|
|
Notes
to Condensed Consolidated Financial Statements
|
F-97
|
| VIRIUM FINANCIAL STATEMENTS | |
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTANING FIRM
|
F-110 |
|
Balance
Sheets March 31, 2008 (Unaudited), December 31, 2007 and December 31,
2006
|
F-111 |
|
Statement
of Operations Three Months Ended March 31, 2008 (Unaudited), Years Ended
December 31, 2007
|
F-112 |
| and 2006 and Period from July 15, 1997 (Inception) to March 31, 2008 (Unaudited) | |
|
Statements
of Stockholders' Deficiency Years Ended December 31, 2007 and 2006, Three
Months Ended
|
F-113 |
| March 31, 2008 (Unaudited), Period from July 15, 1997 (Inception) to March 31, 2008 (Unaudited) | |
|
Statements
of Cash Flows Three Months Ended March 31, 2008 (Unaudited), Years Ended
December 31, 2007
|
F-114 |
| and 2006 and Period from July 15, 1997 (Inception) to March 31, 2008 (Unaudited) | |
|
Notes
to Financial Statements
|
F-115 |
|
UNAUDITED
PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS
|
F-126
|
|
Pro
Forma Condensed Combined Balance Sheet
|
F-127
|
|
Pro
Forma Condensed Combined Statements of Operations
|
F-128
|
|
Notes
to Pro Formas
|
F-130
|
|
COMPARISON
OF STOCKHOLDER RIGHTS AND CORPORATE GOVERNANCE
MATTERS
|
|
|
ADDITIONAL
INFORMATION
|
|
|
Experts
|
|
|
Householding
of Proxy Materials
|
|
|
Where
You Can Find More Information
|
|
|
Appendix
A Agreement and Plan of Merger
|
|
|
Appendix
B Written Consent to Action of a Majority-In-Interest of the Stockholders
of MacroChem Corporation
|
|
|
Appendix
C Notification of Appraisal Rights of MacroChem Corporation Pursuant to
Section 262 of the Delaware General Corporation Law
|
|
|
Appendix
D Section 262 of the Delaware General Corporation
Law
|
SUMMARY
TERM SHEET FOR THE MERGER
The
following is a summary of the principal terms of the merger. This summary does
not contain all information that may be important to you. Access and MacroChem
encourage you to read carefully this information statement, including the
appendices, in their entirety.
On July
10, 2008, MacroChem Corporation entered into the Merger Agreement with Access
Pharmaceuticals, Inc. In connection with the merger:
|
•
|
Each
issued and outstanding share of MacroChem common stock and all shares to
be issued in connection with the exercise or conversion of any and all
options to purchase shares of MacroChem common stock or warrants
(including, without limitation, in-the-money MacroChem warrants) to
purchase shares of MacroChem common stock, in the aggregate, shall be
converted into the right to receive an aggregate of approximately
2,500,000 shares of Access common stock, however, no fractional shares
will be issued and instead Access will pay cash in lieu of any fractional
shares;
|
|
|
•
|
Certain
of MacroChem’s convertible promissory notes outstanding at the Effective
Time will convert automatically into the right to receive a number of
shares of common stock of Access at the closing price of such shares on
July 10, 2008; all remaining convertible promissory notes of MacroChem
will be assumed by Access at the closing of the merger (the “Effective
Time”);
|
|
|
•
|
The
in-the-money MacroChem warrants will convert into the right to receive a
portion of the merger consideration (as described above) at the Effective
Time and shall no longer be outstanding and shall be cancelled, retired
and shall cease to exist following the Effective Time;
|
|
|
•
|
Any
MacroChem options and MacroChem warrants which are not exercised or
converted prior to the Effective Time shall not be assumed by Access and
all such securities either shall be exercised or terminated prior to the
Effective Time.
|
|
|
•
|
MacroChem’s
officers and directors will resign effective as of the Effective Time of
the merger, except that Jeffrey B. Davis, Access’ CEO and a director of
Access and MacroChem will remain as a director of MacroChem after the
merger . As of the Effective Time, Mr. Davis shall become an
officer of MacroChem.
|
Access
common stock trades on the OTC Bulletin Board under the symbol “ACCP.” On
November 24, 2008, the last reported sales price of Access common stock at the
end of regular trading hours, as reported on the OTC Bulletin Board, was
$1.00. MacroChem common stock trades on the OTC Bulletin Board under the
symbol “MACM”. On November 24, 2008, the last reported sales price of MacroChem
common stock at the end of regular trading hours, as reported on the OTC
Bulletin Board, was $0.025.
The
Access and MacroChem stockholders are not required to vote on the merger. The
obligations of Access and MacroChem to complete the merger are also subject to
the satisfaction or waiver of several other conditions to the merger. More
information about Access, MacroChem and the merger is contained in this
information statement/prospectus.
|
Sincerely,
|
|
|
|
/s/
Jeffrey B. Davis
|
/s/
David P. Luci
|
|
|
Jeffrey
B. Davis
|
|
David
P. Luci
|
|
Chief
Executive Officer
|
|
President
and Chief Business Officer
|
|
Access
Pharmaceuticals, Inc.
|
|
MacroChem
Corporation
|
This
information statement/prospectus is dated ________, 2008, and is being
mailed to stockholders of MacroChem on or about _______, 2008.
ADDITIONAL
INFORMATION
This
information statement/prospectus incorporates by reference important business
and financial information about Access and MacroChem from documents that are not
included in or delivered with this information statement/prospectus. For a more
detailed description of the information incorporated by reference into this
information statement/prospectus and how you may obtain it, see “Additional
Information—Where You Can Find More Information” beginning on page
75.
You can
obtain any of the documents incorporated by reference into this information
statement/prospectus from Access or MacroChem, as applicable, or from the
Securities and Exchange Commission, which is referred to as the SEC, through the
SEC’s website at www.sec.gov. Documents incorporated by reference are available
from Access and MacroChem without charge, excluding any exhibits to those
documents, unless the exhibit is specifically incorporated by reference as an
exhibit in this information statement/prospectus. Access stockholders and
MacroChem stockholders may request a copy of such documents by contacting the
applicable department at:
|
Access
Pharmaceuticals, Inc.
|
MacroChem
Corporation
|
|
2600
Stemmons Freeway, Suite 176
|
80
Broad Street, 22nd
Floor
|
|
Dallas,
Texas 75207
|
New
York, NY 10004
|
|
Attn:
Investor Relations
|
Attn:
Chief Business Officer
|
In
addition, you may obtain copies of the information relating to Access, without
charge, by sending an e-mail to akc@accesspharma.com or by calling (214)
905-5100.
You may
obtain copies of the information relating to MacroChem, without charge, by
sending an e-mail to dluci@macrochem.com or by calling (212)
514-8094.
We are
not incorporating the contents of the websites of the SEC, Access, MacroChem or
any other person into this document. We are only providing the information about
how you can obtain certain documents that are incorporated by reference into
this information statement/prospectus at these websites for your
convenience.
QUESTIONS
AND ANSWERS ABOUT THE MERGER
Following
are questions and related answers that address some of the questions you may
have regarding the pending merger (the “Merger”) transaction between MacroChem
Corporation (“MacroChem”), MACM Acquisition Corp. and Access Pharmaceuticals,
Inc. (“Access”). These questions and answers may not contain all of the
information relevant to you, do not purport to summarize all material
information relating to the Merger Agreement, or any of the other matters
discussed in this information statement, and are subject to, and are qualified
in their entirety by, the more detailed information contained in or attached to
this information statement. Therefore, please carefully read this information
statement, including the attached appendices, in its entirety.
Q.
WHY DID I RECEIVE THIS INFORMATION STATEMENT?
A.
Applicable requirements of Delaware law and the federal securities laws require
MacroChem to provide you with information regarding the Merger. As explained
more fully elsewhere in this information statement, since MacroChem has adopted
the Merger Agreement and the merger has been approved by the written consent of
the holders of a majority of MacroChem’s outstanding capital stock, your consent
to the Merger or the other actions in connection therewith, is not required and
is not requested. Nevertheless, this information statement contains important
information about the merger, and the other actions contemplated
thereby.
Q.
WHY AM I NOT BEING ASKED TO VOTE ON THE MERGER?
A. Five
of MacroChem’s stockholders, who currently own in the aggregate approximately
67.4% of the voting power of outstanding shares of MacroChem’s capital stock,
have executed a written consent dated July 30, 2008 approving the Merger and the
transactions contemplated by the Merger Agreement. This consent of
stockholders is sufficient to approve entering into the
transactions. Accordingly, the actions will not be submitted to our
other stockholders for a vote.
Q.
WHEN IS IT EXPECTED THAT THE MERGER WILL BE COMPLETE?
A.
MacroChem and Access signed the Merger Agreement on July 10,
2008. The holders of a majority of MacroChem’s capital stock approved
the merger by written consent dated July 30, 2008. The parties are
working toward completing the Merger as quickly as possible, and hope to
complete the Merger the first quarter of 2009; however, the exact timing cannot
be predicted. In order to complete the Merger, several conditions set forth in
the Merger Agreement must be met or waived. The Merger will become effective
when a certificate of merger is filed with the Secretary of State of the State
of Delaware.
Q.
WHAT WILL I RECEIVE IN THE MERGER?
A. The
holders of MacroChem common stock and in-the-money warrants as a group will
receive an aggregate approximately 2,500,000 shares of Access common
stock. This means that each share of MacroChem common stock will
convert into the right to receive approximately 0.05423180 shares of Access
common stock. Rather than issue fractional shares, Access will pay
cash in lieu of any fractional shares. After the Merger is completed,
it is expected that MacroChem’s pre-merger stockholders and warrant holders will
own approximately 2,500,000 shares of Access common stock, or approximately
12.6% of the outstanding shares on an as converted basis of the newly merged
company, subject to adjustment under the terms of the Merger
Agreement.
Q.
HAS SOMEONE DETERMINED THAT THE MERGER IS ADVISABLE FOR THE MACROCHEM
STOCKHOLDERS AND ACCESS STOCKHOLDERS?
A. Yes.
MacroChem’s Board of Directors and the Board of Directors of Access have
independently determined that the merger is advisable for their stockholders,
respectively. MacroChem’s Board of Directors and the Board of Directors of
Access have approved the merger and the Merger Agreement, and Access’ Board of
Directors has approved the issuance of their common stock in the merger, as well
as the other actions contemplated in connection with the merger. The number of
shares of Access common stock to be issued pursuant to the Merger Agreement was
determined by negotiation between MacroChem and Access. This
consideration does not necessarily bear any relationship to our asset value, net
worth or other established criteria of value and should not be considered
indicative of the actual value of MacroChem. Furthermore, neither
MacroChem nor Access have obtained either an appraisal of either
company or their respective securities or an opinion from any third party that
the merger is fair from a financial perspective.
Q.
DO I HAVE APPRAISAL OR DISSENTER’S RIGHTS?
A. Yes.
Under Delaware law, holders of MacroChem Common Stock are entitled to appraisal
rights in connection with the merger. You are urged to read the discussion of
appraisal rights commencing on page 34 and applicable Delaware law attached as
Appendix D to
this information statement for a more complete discussion of
appraisal rights. If you do not comply with the procedures governing
appraisal rights set forth under Delaware law and explained elsewhere in this
information statement, you may not be entitled to payment for your
shares. In the event that holders of more than 5% of the outstanding
common stock of MacroChem exercise dissenter or appraisal rights, Access shall
not be required to close the Merger.
1
Q.
WHAT WILL HAPPEN IF THE MERGER IS NOT COMPLETED?
A. If the
merger is not completed for any reason, MacroChem may be subject to a number of
other risks. MacroChem will have no operating business and will have incurred
the expenses associated with attempting to effectuate the merger and the
transactions contemplated by the merger. The failure to consummate the merger
would have an adverse impact on the financial condition of MacroChem and the
value of its equity interests.
Q.
WHO CAN ANSWER QUESTIONS REGARDING THE MERGER?
A. If you
would like additional copies of this information statement, or if you have
questions about the merger, amendments or the other matters discussed in this
document, you should contact:
MacroChem
Corporation
80 Broad
Street, 22nd
Floor
New York,
New York 10004
Attention:
Chief Business Officer
Q.
WHERE CAN I FIND MORE INFORMATION ABOUT THE COMPANY?
A.
MacroChem and Access file periodic reports and other information with the
Securities and Exchange Commission (“SEC”). You may read and copy this
information at the SEC’s public reference facilities. Please call the SEC at
1-800-SEC-0330 for information about these facilities. This information is also
available on the Internet site maintained by the SEC at http://www.sec.gov. For
further information, please refer to the section of this information statement
titled “AVAILABLE INFORMATION.”
2
SUMMARY
The
following is a summary that highlights information contained in this information
statement/prospectus. This summary may not contain all of the information that
may be important to you. For a more complete description of the merger agreement
and the merger contemplated by the merger agreement, we encourage you to read
carefully this entire information statement/prospectus, including the attached
appendices. In addition, we encourage you to read the information incorporated
by reference into this information statement/prospectus, which includes
important business and financial information about Access and MacroChem that has
been filed with the SEC. You may obtain the information incorporated by
reference into this information statement/prospectus without charge by following
the instructions in the section entitled “Additional Information—Where You Can
Find More Information” beginning on page 75.
The
Companies
Access
Access
Pharmaceuticals, Inc.
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
Access’
Business
Access
Pharmaceuticals, Inc. (“Access”) is a Delaware corporation. Access is an
emerging biopharmaceutical company focused on developing products based upon its
nanopolymer chemistry technologies. Access currently has one approved product,
two products in Phase 2 clinical trials and five products in pre-clinical
development. Access’ description of Access business, including Access’ list of
products and patents, takes into consideration Access’ acquisition of Somanta
Pharmaceuticals, Inc. which closed January 4, 2008.
|
·
|
MuGard™
is Access’ approved product for the management of oral mucositis, a
frequent side-effect of cancer therapy for which there is no established
treatment. The market for mucositis treatment is estimated to be in excess
of $1 billion world-wide. MuGard, a proprietary nanopolymer formulation,
has received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
|
|
·
|
Access’
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase 2
clinical trial being conducted in the EU in patients with ovarian cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in excess
of $2.0 billion.
|
|
·
|
Pre-clinical
development of Cobalamin™, Access’ proprietary nanopolymer oral drug
delivery technology based on the natural vitamin B12 uptake mechanism. We
are currently developing a product for the oral delivery of
insulin.
|
|
·
|
Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably breast,
ovarian and colorectal cancers.
|
|
·
|
Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
|
|
·
|
Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
|
|
·
|
Pre-clinical
development of Cobalamin-mediated targeted
delivery.
|
|
·
|
Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration
with MacroChem Corporation.
|
Products
Access
used its drug delivery technologies to develop the following products and
product candidates:
3
Access
Drug Portfolio
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage (1)
|
||||
|
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
Marketing
clearance received
|
||||
|
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
– U London
|
Synthetic
polymer
|
Cancer
|
Phase
2
|
||||
|
Phenylbutyrate
(PB)
|
National
Institute
of
Health
|
Small
molecule
|
Cancer
|
Phase
2
|
||||
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
|
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
|
Angiolix®
|
Immunodex,
Inc.
|
Humanized
monoclonal
antibody
|
Cancer
|
Pre-clinical
|
||||
|
Prodrax®
|
Univ
London
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Alchemix®
|
DeMontford
Univ
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Cobalamin-Targeted
Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Pre-clinical
|
||||
|
(1)
|
For
more information, see “Government Regulation” for description of clinical
stages.
|
|
(2)
|
Licensed
from the School of Pharmacy, The University of London. Subject to a 1%
royalty and milestone payments on
sales.
|
MacroChem
MacroChem
Corporation
80 Broad
Street, 22nd Floor
New York,
NY 10004
(212)
514-8094
MacroChem’s
Business
MacroChem
is a specialty pharmaceutical company that develops and seeks to commercialize
pharmaceutical products. Currently, MacroChem’s portfolio of proprietary product
candidates includes products based on MacroChem drug delivery technologies:
SEPA(R), MacroDerm(TM) and DermaPass(TM) as well as SR-9025 and certain other
early stage product candidates MacroChem acquired in the acquisition of Virium
Pharmaceuticals in April 2008.
MacroChem’s
SEPA topical drug delivery technology (SEPA is an acronym for “Soft Enhancement
of Percutaneous Absorption,” where “soft” refers to the reversibility of the
skin effect of the technology, and “percutaneous” means “through the skin”)
enhances the efficiency and rate of diffusion of drugs into and through the
skin. MacroChem’s composition of matter patent on the SEPA family of compounds
expired in November 2006. MacroChem owns six composition of matter and use
patents, with expiration dates ranging from 2015 to 2019, for the combination of
SEPA with numerous existing classes of drugs, including antifungals and human
sex hormones. MacroChem’s patented MacroDerm drug delivery technology
encompasses a family of low to moderate molecular weight polymers that impede
dermal drug or chemical penetration, which may be usable, for example, to
prevent chemicals in insect repellant from penetrating the skin. MacroChem owns
three patents covering the composition of matter and methods of use of MacroChem
MacroDerm polymers that expire in 2015. MacroChem has also filed a patent
application for MacroChem’s DermaPass family of transdermal absorption enhancers
that have a different drug delivery profile than SEPA, which MacroChem believes
could be used with a wider range of active pharmaceutical
ingredients.
One of
MacroChem’s lead product candidates is EcoNail, a topically applied SEPA-based
econazole lacquer for the treatment of onychomycosis, a condition commonly known
as nail fungus. Econazole, a commercially available topical antifungal agent
most commonly used to treat fungal skin infections, inhibits in vitro growth of
the fungi most commonly implicated in onychomycosis. When used in EcoNail, SEPA
works by allowing more rapid and complete release of econazole from the lacquer
into and through the nail plate. In a pre-clinical study using human cadaver
nails, EcoNail delivered through the nail more than 14,000 times the minimum
concentration of econazole needed to inhibit the fungi most commonly associated
with onychomycosis. Following MacroChem’s laboratory studies, MacroChem
conducted a randomized, double blind controlled Phase 1 tolerance/human exposure
trial of EcoNail in nineteen patients with onychomycosis of the toenails. In
this study, EcoNail was well tolerated, and investigators reported no serious
drug-related adverse events. Serum assays used to determine the level of drug in
the bloodstream showed no detectable levels of econazole, further supporting
EcoNail’s systemic safety profile. Full data from the 18-week trial was
presented in May 2005 at the annual meeting of the Society for Investigative
Dermatology. MacroChem has a composition of matter and use patent covering
EcoNail that will expire in 2019.
4
MacroChem
commenced a 48 week, blinded open label Phase 2 efficacy study of EcoNail in the
third quarter of 2006 which was completed in Q2 2008. This study was conducted
through a contract research organization with significant experience in
onychomycosis trials. The study protocol allowed for an interim review of the
data after all patients have completed 24 weeks of treatment. On November 6,
2007, MacroChem announced that clinical photographs of 37 patients were assessed
by an external expert panel, and 20 (54%) showed evidence of clinical
improvement, defined as an increase in uninvolved nail of onychomycosis. All
week 24 cultures were negative for dermatophyte growth, and the panel observed
no signs of local irritation related to the once-daily EcoNail treatment. In a
consensus clinical judgment by the external panel, 13 of 37 (32%) of patients
demonstrated greater than or equal to 25% clinical improvement. MacroChem
continues to actively seek partnering opportunities to maximize the commercial
potential of EcoNail.
At the
completion of the Phase 2 study, the final clinical data which was evaluated by
MacroChem expert panel showed that 24 patients (65%) demonstrated evidence of
clinical improvement, defined in the protocol as an increase in uninvolved
(clear) nail area. While none of the 37 patients reached all criteria of the
composite primary endpoint, the consensus judgment of the panel was that 15 of
37 patients (41%) demonstrated significant (greater than or equal to 25%)
clinical improvement. All patients had fungal culture-proven nail infections at
entry, but after 48 weeks of once-daily treatment with EcoNail, 100% of patients
had cultures that were negative for dermatophyte growth. Eight of the 37
patients (22%) achieved the secondary endpoint of negative mycology (negative
fugal culture plus negative KOH evaluation) at 48 weeks. The panel observed no
signs of local irritation related to the once-daily EcoNail treatment. During
the trial, no patient required interruption of dosing due to local
intolerability. Through 56 weeks of observation, no cutaneous adverse events
were attributed by the investigators to EcoNail.
MacroChem’s
other lead product is pexiganan, a novel, small peptide anti-infective for
treatment of patients with mild diabetic foot infection (DFI). In October 2007,
MacroChem acquired the exclusive worldwide license rights for drug uses of
pexiganan, from Genaera Corporation. Pexiganan is formulated as a cream and has
a novel mechanism of action based on its ability to disrupt the integrity of
bacterial cell membranes that cause DFI and has antimicrobial activity against
organisms that commonly infect skin and soft tissue. Pexiganan has a low
potential for induction of resistance and no cross-resistance with existing
therapeutic antibiotics as a consequence of its mechanism of action. In clinical
trials previously conducted by Genaera Corporation, over 1,000 human subjects
were exposed to pexiganan without safety concerns, including patients who
received pexiganan in two Phase 3 clinical trials submitted in a new drug
application to the U.S. Food and Drug Administration (FDA) in 1998. The primary
clinical endpoint (rates of clinical cure or improvement) of one of the two
Phase 3 trials was judged by the FDA to have been achieved. The other Phase 3
clinical trial, which did not meet its specified endpoint, provided strong
supportive data indicative of the clinical benefit of pexiganan. At the time of
this second Phase 3 study, the prior holder of the rights to pexiganan
experienced difficulties with the product’s Chemistry Manufacturing &
Controls (CMC) and an FDA request for one additional controlled trial precluded
approval. MacroChem believes that since that time, significant improvements have
been made in peptide manufacturing processes as well as in clinical trial design
and execution. MacroChem has initiated a program to address the previously
identified CMC issues and intend to resume formal dialogue with the FDA to
determine the appropriate clinical development path.
MacroChem’s
product candidate, SR-9025 or 4'-thio-beta-D-arabinofuranosylcytosine, is a new
generation nucleoside analogue which we acquired in the merger transaction with
Virium Pharmaceuticals in April 2008 and which was invented by Southern Research
Institute of Birmingham, Alabama. This compound is within a certain
class of anti-cancer drugs generally characterized as cytotoxic agents with
proven success in certain blood-borne cancers. In pre-clinical studies, SR-9025
has shown activity against leukemia, colon, lung, prostate, pancreatic, renal,
and breast cancers. There have been two dose-escalation Phase I clinical trials
completed in patients with advanced solid tumor malignancies, showing
encouraging results and MacroChem is in the process of developing its clinical
strategy to capitalize on these data.
MacroChem’s
product candidate, Opterone, is a topically applied SEPA-based testosterone
cream designed to treat male hypogonadism. Male hypogonadism is a condition in
which men have levels of circulating testosterone below the normal range and may
exhibit one or more associated symptoms, including low energy levels, decreased
sexual performance, loss of sex drive, increased body fat or loss of muscle
mass. In December 2005, we received a letter from the Division of Reproductive
and Urologic Products of the U.S. Food and Drug Administration, or FDA, in
response to questions posed by MacroChem regarding a proposed Phase 3 clinical
program for Opterone. In the letter, the FDA requested that we conduct
additional investigation into multiple dose safety and pharmacokinetics before
beginning any eventual Phase 3 protocol. The additional investigation and Phase
3 revisions will increase the time and expense associated with the development
of Opterone. The next step in the development process for Opterone is a Phase 2
trial. MacroChem is seeking a partner to advance development of this product
candidate. MacroChem may elect not to develop Opterone further if MacroChem
cannot find a partner. MacroChem has a composition of matter and use patent
covering Opterone that will expire in 2017.
In
addition to EcoNail, pexiganan and Opterone, MacroChem is evaluating several
earlier stage product candidates. MacroChem has developed and tested SEPA-based
formulations to deliver other active pharmaceutical ingredients including
topical anesthetic and topical non-steroidal anti-inflammatory drugs (NSAIDs).
MacroChem has also tested application of MacroChem MacroDerm polymers for use
with cosmetics, pharmaceuticals and consumer products like insect repellants and
sunscreens to decrease skin penetration and/or improve persistence on the skin.
For example, MacroChem’s laboratory data demonstrated that, when formulated with
the insect repellant DEET, increasing concentrations of MacroDerm reduces the
amount of DEET that is absorbed through human skin. MacroChem has performed
initial laboratory experiments to test the ability of DermaPass to improve
transdermal delivery of various active pharmaceutical ingredients.
5
Since
inception, MacroChem’s primary source of funding for MacroChem operations has
been the private and public sale of MacroChem securities. MacroChem’s ability to
continue as a going concern after MacroChem current capital resources are
exhausted depends on MacroChem ability to secure additional financing, to
consummate a strategic transaction, or to make alternative arrangements to fund
operations, which MacroChem cannot guarantee.
6
The
Merger (see page 33)
Access
and MacroChem have agreed to the acquisition of MacroChem by Access under the
terms of the merger agreement that is described in this information
statement/prospectus. In the merger, MACM Acquisition Corporation, a wholly
owned subsidiary of Access, will merge with MacroChem, with MacroChem surviving
as a wholly owned subsidiary of Access. We have attached the merger agreement to
this information statement/prospectus as Annex A. We encourage you to carefully
read the merger agreement in its entirety because it is the legal document that
governs the merger.
Merger
Consideration
If the
proposed merger is completed, the holders of MacroChem’s common stock and In The
Money Warrants outstanding immediately prior to the closing of the merger (the
“Effective Time”) are expected to receive approximately 0.05423180 of a share of
Access common stock for each share of MacroChem common stock or In The Money
Warrants they own immediately prior to completion of the merger not to exceed in
the aggregate 2,500,000 of Access common stock. For a full description of a
comparison of the rights of the Access common stock to the rights of the
MacroChem common stock, see “Comparison of Stockholder Rights and Corporate
Governance Matters” beginning on page 43. The merger is expected to qualify as a
“reorganization” under the Internal Revenue Code. See “Risk Factors—Risks
Relating to the Merger” beginning on page 16.
For a
full description of the merger consideration and the possible adjustment to the
merger consideration, see “The Merger Agreement—Exchange Ratios” beginning on
page 35.
Fractional
Shares
Access
will not issue fractional shares of Access common stock in the merger. As a
result, each MacroChem stockholder and holder of In The Money Warrants will
receive cash for any fractional share of Access common stock the stockholder or
In The Money Warrant holder, as applicable, would otherwise be entitled to
receive in the merger after aggregating all fractional shares to be received by
the stockholder or In The Money Warrant holder.
For a
full description of the treatment of fractional shares, see “The Merger
Agreement—General” beginning on page 35.
Treatment
of MacroChem Stock Options
Each
outstanding option to purchase MacroChem common stock will either convert upon
exercise to common stock of MacroChem before the merger or cease to exist after
the merger.
Treatment
of MacroChem In The Money Warrants
Each of
MacroChems’s outstanding In The Money Warrants will convert into Access common
stock equal to the number of shares of Access common stock that would be issued
in exchange for the number of shares of MacroChem common stock into which the In
The Money Warrants would otherwise be entitled to convert into had such warrant
been exercised immediately prior to the consummation of the Merger assuming a
cashless exercise of such In The Money Warrant.
Access
Board of Directors after the Merger
Upon
completion of the merger, the Access board of directors will be remain the same.
The directors of Access prior to the completion of the merger will continue to
serve as the directors of Access after the merger.
7
Ownership
of Access after the Merger
Based on
the number of shares of Access common stock and preferred stock and MacroChem
common stock outstanding on July 30, 2008 and without giving effect to any
further issuances of shares of stock by Access, holders of MacroChem common
stock are expected to hold approximately 12.6% of the fully diluted shares
of Access common stock on an as converted basis immediately after the
merger.
Access
stockholders will continue to own their existing shares, which will not be
affected by the merger. Access may issue additional shares of its equity
securities prior to the closing of the merger and MacroChem stockholders would
be diluted in the case of any such issuances.
Opinion
of Financial Advisor
MacroChem
The
MacroChem board of directors did not engage a financial advisor to assist in the
sale of MacroChem or to render a financial opinion as to the fairness, from a
financial point of view, of the consideration to be paid to the MacroChem
stockholders in the merger. The MacroChem board of directors determined that the
factors which weighed in favor of the merger, as discussed below, were
substantial in relation to the factors which weighed against the merger. The
board of directors also considered the cost of obtaining a fairness opinion as
prohibitively expensive in light of MacroChem’s financial
condition.
Share
Ownership of Directors and Executive Officers
At the
close of business on July 30, 2008, the MacroChem record date, directors and
executive officers of MacroChem and their affiliates beneficially owned and were
entitled to vote approximately 39,676,952 shares of MacroChem common stock
(on an as-converted basis and after the exercise of certain warrants held by
them), collectively representing approximately 74% of the shares of MacroChem
common stock (on an as-converted basis) outstanding on that date. SCO Capital
Partners LLC, and its affiliates, are represented on MacroChem’s Board of
Directors and collectively control approximately 63% of MacroChem’s common
stock). Lake End Capital, LLC are represented on MacroChem’s board of directors
and controls approximately 7% of MacroChem’s common stock. MacroChem has
received written consent from certain MacroChem stockholders representing
approximately 63% of MacroChem’s outstanding common stock under which the
parties, subject to certain limited exceptions, have voted their shares in favor
of the merger. A copy of the form of the Written Consent is attached as Annex
B.
No vote
is required by the shareholders of Access in order to complete the
merger.
Interests
of Directors and Executive Officers of MacroChem in the Merger (see page
70)
In
considering the recommendation of the MacroChem board of directors with respect
to the merger agreement and the merger contemplated by the merger agreement, you
should be aware that members of the MacroChem board of directors and MacroChem
executive officers have interests in the merger contemplated by the merger
agreement that may be different than, or in addition to, the interests of
MacroChem stockholders, generally. These interests include:
|
•
|
the
use of certain executive officers of MacroChem by Access upon completion
of the merger as consultants to
Access;
|
|
•
|
that
Jeffrey Davis is a director of both MacroChem and Access and that Mr.
Davis is also an affiliate of SCO Capital an entity that beneficially owns
approximately 63% of MacroChem’s common stock and approximately 71% of
Access’ common stock on an as converted basis as of November 24, 2008. Mr.
Davis is also a director of Access and Chief Executive Officer of
Access.
|
Each of
the MacroChem and Access boards of directors were aware of these interests and
considered them, among other matters, in making their
recommendations.
Dissenters’
or Appraisal Rights (see page 34)
Holders
of shares of MacroChem common stock who do not vote in favor of approval and
adoption of the merger agreement and approval of the merger and who properly
demand appraisal of their shares will be entitled to appraisal rights in
connection with the merger under Section 262 of the Delaware General Corporate
Law (“DGCL”). Under the DGCL, holders of shares of Access common stock are not
entitled to appraisal rights in connection with the merger.
Annex C
to this information statement/prospectus contains the full text of Section 262
of the DGCL, which relates to the rights of appraisal. We encourage you to read
these provisions carefully and in their entirety.
8
Conditions
to Completion of the Merger (see page 36)
A number
of conditions must be satisfied before the merger will be completed. These
include among others:
|
·
|
The
Form S-4 shall have become effective under the Securities Act of 1993, as
amended;
|
|
·
|
The
representations and warranties made by MacroChem in the Merger Agreement
are true and correct;
|
|
·
|
MacroChem
has performed, in all material respects, all obligations and complied with
all covenants required by the Merger Agreement to be performed or complied
with, in all material respects, by MacroChem prior to the Effective
Time;
|
|
·
|
Access
and Merger Sub shall have received evidence to its reasonable satisfaction
that such licenses, permits, consents, approvals, authorizations,
qualifications and orders of governmental authorities and other third
parties as are necessary in connection with the transactions contemplated
by the merger have been obtained, except where the failure to do so would
not, individually or in the aggregate, have a material adverse effect with
respect to the MacroChem;
|
|
·
|
There
shall be no pending third party litigation or pending or threatened
litigation with any governmental entity (i) challenging or seeking to
restrain or prohibit the consummation of the Merger or the transactions
contemplated thereby, or (ii) seeking to prohibit or limit the ownership
or operation by MacroChem of any material portion of the business or
assets of MacroChem, or (iii) seeking to impose limitations on the ability
of Access to acquire or hold any shares of common stock of the Surviving
Corporation;
|
|
·
|
All
outstanding MacroChem options and MacroChem warrants not exercised prior
to the Effective Time shall be terminated and the in-the-money MacroChem
warrants shall automatically convert into the right to receive the Merger
Consideration (Access Common Stock) as provided in the Merger Agreement;
and
|
|
·
|
Any
applicable period during which stockholders of MacroChem have the right to
exercise appraisal, dissenters’ or other similar rights under Section 262
of the DGCL or other applicable law shall have expired and stockholders of
MacroChem holding in the aggregate more than five percent of the
outstanding shares of MacroChem Common Stock shall not have exercised
appraisal, dissenters’ or similar rights under Section 262 of the DGCL or
other applicable law with respect to such shares by virtue of the
Merger.
|
|
·
|
The
representations and warranties made by Access and/or MACM Acquisition
Corp. in the Merger Agreement are true and
correct;
|
|
·
|
Access
has performed, in all material respects, all obligations and complied with
all covenants required by the Merger Agreement to be performed or complied
with, in all material respects, by it prior to the Effective
Time;
|
|
·
|
MacroChem
shall have received evidence to MacroChem’s reasonable satisfaction that
such licenses, permits, consents, approvals, authorizations,
qualifications and orders of governmental authorities and other third
parties as are necessary in connection with the transactions contemplated
by the merger have been obtained, except where the failure to do so would
not, individually or in the aggregate, have a material adverse effect with
respect to the Access; and
|
|
·
|
There
shall be no pending third party litigation or pending or threatened
litigation with any governmental entity challenging or seeking to restrain
or prohibit the consummation of the Merger or any of the other
transactions contemplated thereby.
|
Each of
Access, MACM Acquisition Corporation and MacroChem may waive the conditions to
the performance of its respective obligations under the merger agreement and
complete the merger even though one or more of these conditions has not been
met.
Regulatory
Matters (see page 40)
The
merger is not subject to antitrust laws or any federal or state regulatory
requirements.
Reasonable
Best Efforts to Complete the Merger (see page 41)
Each of
Access and MacroChem has agreed to cooperate fully with the other party and use
its reasonable best efforts to take, or cause to be taken, all actions
necessary, proper or advisable under applicable law and regulations to complete
the merger as promptly as practicable, but in no event later than October 31,
2008. As further described below, since this date has since passed, either
Access or MacroChem have the ability to terminate the Merger
Agreement.
Termination
of the Merger Agreement (see page 37)
Under
circumstances specified in the merger agreement, either Access or MacroChem may
terminate the merger agreement. Subject to the limitations set forth in the
merger agreement, the circumstances generally include, but are not limited to,
if:
|
·
|
The
merger has not been consummated by October 31, 2008, provided that the
party seeking to terminate the merger agreement is not then in breach of
the terms of the merger agreement;
|
|
·
|
By
mutual consent of Access and MacroChem;
and
|
|
·
|
By
either Access or MacroChem if MacroChem is unable to obtain stockholder
approval.
|
On August
27, 2008, after the Board’s approval of the merger agreement, MacroChem entered
into a Note Purchase Agreement with Access. Under the terms of the Note Purchase
Agreement, Access initially loaned MacroChem $225,000. Access, in its sole
discretion, may from time to time advance additional loan amounts to MacroChem.
All amounts loaned to MacroChem by Access are secured by substantially all of
the assets of MacroChem pursuant to the terms of the Note Purchase Agreement.
The Note bears interest at 10% and is repayable at the earlier of: (i) December
31, 2008, or (ii) the date of the termination of the Agreement and Plan of
Merger dated as of July 10, 2008 between MacroChem and Access. As of November
24, 2008 MacroChem had borrowed $504,000 from Access.
9
Material United States Federal Income
Tax Consequences of the Merger (see page 40)
MacroChem
expects the merger to qualify as a “reorganization” within the meaning of
Section 368(a) of the Internal Revenue Code. If the merger qualifies as a
“reorganization,” MacroChem stockholders generally will not recognize a gain or
loss for federal income tax purposes. No gain or loss will be recognized for
federal income tax purposes by MacroChem, Access, or Access stockholders as a
result of the merger.
Tax
matters are complicated, and the tax consequences of the merger to each
MacroChem stockholder will depend on the facts of each stockholder’s situation.
MacroChem stockholders are urged to read carefully the discussion in the section
entitled “The Merger—Material United States Federal Income Tax Consequences of
the Merger” and to consult their tax advisors for a full understanding of the
tax consequences of their participation in the merger.
Accounting
Treatment (see page 40)
Access
will account for the merger as a business combination under United States
generally accepted accounting principles.
Risk
Factors
In
evaluating the merger agreement and the merger, in the case of MacroChem
stockholders, or the issuance of shares of Access common stock in the merger,
you should carefully read this information statement/prospectus and especially
consider the factors discussed in the section entitled “Risk Factors” beginning
on page 16.
Summary
Selected Historical Financial Data
Access
and MacroChem are providing the following information to aid you in your
analysis of the financial aspects of the merger.
Access
The
following summary condensed consolidated financial information as of and for the
years ended December 31, 2007, 2006, 2005, 2004, and 2003 have been derived
from our audited financial statements. The financial information as of and for
the nine months ended September 30, 2008, and 2007 is derived from our unaudited
condensed financial statements. The summary condensed consolidated financial
information set forth below should be read in conjunction with “Management's
Discussion and Analysis of Financial Condition and Results of Operations” and
the financial statements and notes thereto included elsewhere in this
Prospectus.
|
For the Nine Months
Ended
September 30
|
For the Year Ended December
31,
|
|||||||
|
2008
|
2007
|
2007
|
2006
|
2005
|
2004
|
2003
|
||
|
(in
thousands, except per share
amounts)
|
||||||||
|
Consolidated
Statement of Operations and Comprehensive Loss Data:
|
||||||||
|
Total
revenues
|
$ | 217 | $ | 6 | $ | 57 | $ | - | $ | - | $ | - | $ | - | ||||||||||||||
|
Operating
loss
|
(15,460 | ) | (4,988 | ) | (6,900 | ) | (5,175 | ) | (9,622 | ) | (6,003 | ) | (5,426 | ) | ||||||||||||||
|
Interest
and miscellaneous income
|
167 | 72 | 125 | 294 | 100 | 226 | 279 | |||||||||||||||||||||
|
Interest
and other expense
|
(351 | ) | (3,277 | ) | (3,514 | ) | (7,436 | ) | (2,100 | ) | (1,385 | ) | (1,281 | ) | ||||||||||||||
|
Loss
on extinguishment of debt
|
- | - | (11,628 | ) | - | - | - | - | ||||||||||||||||||||
|
Unrealized
loss on fair value of warrants
|
- | - | - | (1,107 | ) | - | - | - | ||||||||||||||||||||
|
Income
tax benefit
|
- | - | 61 | 173 | 4,067 | - | - | |||||||||||||||||||||
|
Loss
from continuing operations
|
(15,644 | ) | (8,193 | ) | (21,856 | ) | (13,251 | ) | (7,555 | ) | (7,162 | ) | (6,428 | ) | ||||||||||||||
|
Preferred
stock dividends
|
(2,873 | ) | - | (14,908 | ) | |||||||||||||||||||||||
|
Discontinued
operations net of taxes
|
||||||||||||||||||||||||||||
|
($61
in 2007, $173 in 2006 and
$4,067
in 2005)
|
- | - | 112 | 377 | (5,855 | ) | (3,076 | ) | (507 | ) | ||||||||||||||||||
|
Net
loss
|
(18,517 | ) | (8,193 | ) | (36,652 | ) | (12,874 | ) | (1,700 | ) | (10,238 | ) | (6,935 | ) | ||||||||||||||
|
Common
Stock Data:
|
||||||||||||||||||||||||||||
|
Net
loss per basic and
diluted
common share
|
$ | (3.30 | ) | $ | (2.31 | ) | $ | (10.32 | ) | $ | (3.65 | ) | $ | (0.53 | ) | $ | (3.38 | ) | $ | (2.61 | ) | |||||||
|
Weighted
average basic and
diluted
common shares
outstanding
|
5,607 | 3,544 | 3,552 | 3,532 | 3,237 | 3,032 | 2,653 | |||||||||||||||||||||
10
|
September
30,
|
December
31,
|
|||||||
|
2008
|
2007
|
2007
|
2006
|
2005
|
2004
|
2003
|
||
|
(in
thousands)
|
||||||||
|
Consolidated
Balance Sheet Data:
|
||||||||
|
Cash,
cash equivalents and
short
term investments
|
$ | 4,618 | $ | 1,176 | $ | 6,921 | $ | 4,389 | $ | 474 | $ | 2,261 | $ | 2,587 | ||||||||||||||
|
Total
assets
|
5,754 | 3,500 | 9,149 | 6,426 | 7,213 | 11,090 | 11,811 | |||||||||||||||||||||
|
Deferred
revenue
|
2,450 | 1,167 | 978 | 173 | 173 | 1,199 | 1,184 | |||||||||||||||||||||
|
Convertible
notes, net of discount
|
5,500 | 16,906 | 5,564 | 8,833 | 7,636 | 13,530 | 13,530 | |||||||||||||||||||||
|
Total
liabilities
|
12,765 | 20,691 | 8,468 | 16,313 | 11,450 | 17,751 | 17,636 | |||||||||||||||||||||
|
Total
stockholders' equity (deficit)
|
(7,011 | ) | (17,191 | ) | 681 | (9,887 | ) | (4,237 | ) | (6,661 | ) | (5,825 | ) |
11
MacroChem
MACROCHEM
CORPORATION
|
Income
Statement Data:
|
Nine
Months
Ended
September
30,
2008
(Unaudited)
|
Year
Ended
December
31,
2007
|
||||||
|
Revenues
|
$ | 2,652 | $ | 0 | ||||
|
General
and Administrative Expenses
|
$ | 2,962,453 | $ | 3,717,994 | ||||
|
Interest
Expense (Income)
|
$ | 160,759 | $ | (84,595 | ) | |||
|
Net Loss
|
$ | (9,801,622 | ) | $ | (8,866,182 | ) | ||
|
Loss
Per Common Share
|
$ | (0.27 | ) | $ | (1.66 | ) | ||
|
Weighted
Average Shares Outstanding
|
36,604,749 | 7,635,313 | ||||||
|
|
September
30, 2008
(Unaudited)
|
December
31,
2007
|
| Balance Sheet Data: | ||||||||
| Cash | $ | 32,879 | 2,423,519 | |||||
|
Total
Current Assets
|
$ | 149,003 | $ | 3,313,813 | ||||
|
Total
Current Liabilities
|
$ | 3,045,508 | $ | 404,634 | ||||
|
Total
Stockholders' (Deficiency)
|
$ | (2,566,734 | ) | $ | (627,667 | ) |
12
Selected
Unaudited Pro Forma Condensed Combined Financial Data
The
following unaudited pro forma condensed combined financial statements are based
upon the historical condensed consolidated financial statements and notes
thereto (as applicable) of Access and MacroChem, which are included elsewhere in
this information statement/prospectus. The financial data gives pro forma effect
to the merger as if the merger had been completed on September 30, 2008, for the
unaudited pro forma condensed combined balance sheet and for the nine
months ended September 30, 2008, and the year ended December 31, 2007, for the
unaudited pro forma condensed combined statement of operations.
MacroChem
common stockholders are expected to receive approximately 2,500,000 shares of
Access common stock for MacroChem capital stock they own immediately prior
to the completion of the merger.
The pro
forma adjustments are based upon available information and certain assumptions
that Access believes are reasonable under the circumstances. A final
determination of fair values relating to the merger, which cannot be made prior
to the completion of the merger, may differ materially from the preliminary
estimates and will include management’s final valuation of the fair value of
assets acquired and liabilities assumed. This final valuation will be based on
the actual net tangible assets of MacroChem that exist as of the date of the
completion of the merger. The final valuation may change the allocations of the
purchase price, which could affect the fair value assigned to the assets and
liabilities and could result in a change to the unaudited pro forma condensed
combined financial data. These adjustments are more fully described in the
notes to the unaudited pro forma condensed combined financial statements under
the heading “Unaudited Pro Forma Condensed Combined Financial Statements.”
beginning on page F-126.
The
selected unaudited pro forma condensed combined financial data (i) have been
derived from and should be read in conjunction with the unaudited pro forma
condensed combined financial statements and accompanying notes included in
this informationstatement/prospectus as described under “Unaudited Pro
Forma Condensed Combined Financial Statements” beginning on page F-126, and (ii)
should be read in conjunction with the consolidated financial statements of
Access and MacroChem and other information filed by Access and MacroChem with
the SEC and incorporated by reference into this information
statement/prospectus. See “Additional Information—Where You Can Find More
Information” beginning on page 75.
|
Unaudited
Pro Forma Condensed Combined
Statement
of
Operations Data:
|
For
the Twelve
Months
Ended
December
31, 2007
|
For
the Nine
Months
Ended
September
30, 2008
|
||||
|
Total
revenues
|
$
|
63,304
|
$
|
220,978
|
||
|
Total
expenses
|
16,372,328
|
19,753,737
|
||||
|
Loss
from operations
|
(16,309,024)
|
(19,532,759)
|
||||
|
Interest
and miscellaneous income
|
206,595
|
193,097
|
||||
|
Interest
expense
|
(3,741,011)
|
(664,486)
|
||||
|
Loss
on extinguishment of debt
|
(11,628,000)
|
-
|
||||
|
Gain
(loss) in change in value of warrant liabilities
|
(5,119,000)
|
-
|
||||
|
Gain
on sale of equipment
|
106,000
|
6,466
|
||||
| Amortization of debt issuance costs | (117,302) | - | ||||
|
Loss
before discontinued operations
|
||||||
|
and before income tax benefit
|
(26,364,742)
|
(19,997,682)
|
||||
|
Income
tax benefit
|
56,000
|
-
|
||||
|
Loss
from continuing operations
|
(26,308,742)
|
(19,997,682)
|
||||
|
Beneficial
conversion feature
|
(3,223,929)
|
-
|
||||
|
Preferred
stock dividends
|
(15,504,017)
|
(2,873,000)
|
||||
|
Discontinued
operations, net of
taxes
of $61,000 and $0
|
112,000
|
|||||
|
Net
loss
|
$
|
(44,924,688)
|
$
|
(22,870,682)
|
||
13
|
Unaudited
Pro Forma Condensed Combined
Balance
Sheet Data:
|
As
of September 30, 2008
|
||||
|
Cash
and cash equivalents
|
$
|
233,879
|
|||
|
Short
term investments, at cost
|
4,417,000
|
||||
|
Receivables
|
105,000
|
||||
|
Prepaid
expenses and other current assets
|
226,124
|
||||
|
Total
current assets
|
$
|
4,982,003
|
|||
|
Property
and equipment, net
|
110,523
|
||||
|
Patents
net
|
1
,068,099
|
||||
|
Other
assets
|
62,900
|
||||
|
Total
assets
|
$
|
6,223,525
|
|||
|
Accounts
payable and accrued expenses
|
5,086,467
|
||||
|
Dividends
payable
|
1,799,000
|
||||
|
Accrued
interest payable
|
453,250
|
||||
|
Current
portion of deferred revenue
|
169,304
|
||||
|
Convertible
notes payable, net
|
791,487
|
||||
|
Long-term
debt
|
5,500,000
|
||||
|
Long-term
deferred revenue
|
2,311,469
|
||||
|
Total
liabilities
|
16,110,977
|
||||
| Preferred Stock | - | ||||
| Common Stock | 90,000 | ||||
|
Additional
paid-in capital
|
135,759,152
|
||||
| Less treasury stock, at cost | (4,000 | ) | |||
|
Notes
receivable from stockholders
|
(1,045,000
|
) | |||
|
Accumulated
deficit
|
(144,687,604
|
) | |||
|
Total
stockholders’ deficiciency
|
(9,887,452
|
) | |||
Comparative
Per Share Information
The
following tables set forth historical per share information of Access and
MacroChem and unaudited pro forma condensed combined per share information after
giving effect to the merger under the purchase method of accounting, based on an
average price per share of Access common stock of $3.19. The unaudited pro forma
condensed combined financial data are not necessarily indicative of the
financial position had the merger occurred on September 30, 2008, or operating
results that would have been achieved had the merger been in effect as of
January 1, 2007 and should not be construed as representative of future
financial position or operating results. The unaudited pro forma condensed
combined per share information is derived from, and should be read in
conjunction with, the unaudited pro forma condensed combined financial
statements and accompanying notes included in this information
statement/prospectus as described under “Unaudited Pro Forma Condensed Combined
Financial Statements” beginning on page F-110. The historical per share
information is derived from the audited financial statements as of and for the
years ended December 31, 2007 for Access and MacroChem and the unaudited
financial statements for the period ended September 30, 2008 .
|
Historical
Access
|
Historical
MacroChem
|
Pro
Forma
Combined
|
Pro
Forma
Equivalent
of
One
MacroChem
Share
(1)
|
||||||||||
|
Net
(loss) per share—basic and diluted:
|
|
|
|
||||||||||
|
Nine Months ended September 30, 2008
|
|
$
|
(3.30)
|
$
|
(0.27)
|
$
|
(3.49)
|
|
$
|
(0.19)
|
|||
|
Year ended December 31, 2007
|
|
(10.32)
|
(1.66)
|
(8.15)
|
|
(0.44)
|
|||||||
| Cash dividends declared per share (3) | - | - | - | ||||||||||
| Weighted average number of shares (in millions): | |||||||||||||
| Nine months ended September 30, 2008 | 5.6 | 36.6 | 8.1 | ||||||||||
| Year ended December 31, 2007 | 3.6 | 7.6 | 6.1 | ||||||||||
|
Book
value per share:
|
|
|
|
||||||||||
|
September 30, 2008 (2)
|
|
$
|
(1.08)
|
$
|
(0.05)
|
|
$
|
(1.04)
|
|
$
|
(0.06)
|
||
|
December 31, 2007 (2)
|
|
(0.19)
|
(0.03)
|
|
0.01
|
|
(0.00)
|
||||||
|
Outstanding
shares (in millions):
|
|
|
|
||||||||||
|
September 30, 2008 (2)
|
|
6.5
|
45.9
|
|
9.0
|
|
|||||||
|
December 31, 2007 (2)
|
|
3.6
|
22.5
|
|
6.1
|
|
|||||||
|
(1)
|
The
Pro Forma Equivalent of one MacroChem Share amounts were calculated by
applying the exchange ratio of 0.05423180 to the pro forma combined
net loss and book value per share. The actual exchange ratio in the merger
is subject to change.
|
|
(2)
|
As
of September 30, 2008 and December 31, 2008 for Access and
MacroChem.
|
| (3) | No dividends have been declared or paid for any period. |
14
This
information is only a summary and should be read in conjunction with the
financial statements and accompanying notes of Access and MacroChem contained in
the annual reports and other information that has been filed with the SEC and
incorporated by reference into this proxy statement/prospectus and with the
unaudited pro forma condensed combined financial statements referred to above.
See “Additional Information—Where You Can Find More Information” beginning on
page 75.
Comparative
Per Share Market Price Data
Access
common stock trades on the OTC Bulletin Board under the symbol “ACCP.” MacroChem
common stock trades on the OTC Bulletin Board under the symbol “MACM.” The
following table sets forth the closing prices for Access common stock and
MacroChem common stock as reported on the OTC Bulletin Board on July 9, 2008,
the last trading day before Access and MacroChem announced the merger,
and November 24, 2008 the latest practicable date before the date of
this information statement/ prospectus.
|
|
Access
Common Stock
|
MacroChem
Common Stock
|
Pro Forma Equivalent
Value
of
MacroChem Common Stock
|
||||||
|
July
9, 2008
|
|
$3.19
|
$0.25
|
$0.17
|
|||||
|
November
24, 2008
|
|
$1.00
|
$0.025
|
$0.05
|
|||||
The above
tables show only historical comparisons. These comparisons may not provide
meaningful information to MacroChem stockholders in determining whether to
approve and adopt the merger agreement and approve the merger contemplated by
the merger agreement. See “Additional Information—Where You Can Find More
Information” beginning on page 75.
15
RISK
FACTORS
You
should carefully consider the following factors, in addition to the other
information included elsewhere in this information statement and the other
documents that MacroChem and Access have filed with the SEC.
Additional risks and uncertainties not presently known to MacroChem or Access or
that you may not currently believe to be important to you, if they materialize,
also may adversely affect the merger and the value of MacroChem
stock.
Risks Relating to the
Proposed Merger:
There
may be adverse tax consequences as a result of the merger.
As a
general rule, Federal and state tax laws and regulations have a significant
impact upon the structuring of business combinations. MacroChem has evaluated
the possible tax consequences of any prospective business combination and
endeavored to structure the acquisition transaction so as to achieve the most
favorable tax treatment to MacroChem and MacroChem’s stockholders. There can be
no assurance that the Internal Revenue Service (“IRS”) or relevant state tax
authorities will ultimately assent to MacroChem tax treatment of a particular
consummated business combination. To the extent the IRS or any relevant state
tax authorities ultimately prevail in re-characterizing the tax treatment of a
business combination, there may be adverse tax consequences to MacroChem and
MacroChem’s stockholders. See “Certain U.S. Federal Tax
Considerations.”
There
was no independent valuation of MacroChem with respect to this
Merger.
The
number of shares of MacroChem’s Common Stock to be issued pursuant to the Merger
Agreement was determined by negotiation between MacroChem and Access. This
consideration does not necessarily bear any relationship to MacroChem’s asset
value, net worth or other established criteria of value and should not be
considered indicative of the actual value of MacroChem. Furthermore, MacroChem
has not obtained either an appraisal of any entity or their respective
securities or an opinion that the merger is fair from a financial perspective to
MacroChem stockholders.
Risks Relating to Access
Business:
Access
may be required to pay liquidated damages to certain investors if it does not
maintain an effective registration statement relating to common stock issuable
upon conversion of Series A Preferred stock or upon exercise of certain
warrants.
Pursuant
to issuing Series A Preferred Stock and warrants, Access entered into an
Investor Rights Agreement with the purchasers of Series A Preferred Stock. The
Investor Rights Agreement requires, among other things, that under certain
circumstances Access maintain an effective registration statement for common
stock issuable upon conversion of Series A Preferred Stock or upon exercise of
certain warrants. If Access fails to maintain such an effective registration
statement it may be required to pay liquidated damages to the holders of such
Series A Preferred Stock and warrants for the period of time in which an
effective registration statement was required to be in place but was not in
place. Access is required to accrue liquidated damages at a rate of 1% per
month, of the holders’ total investment amount with respect to securities that
are required to be registered but are not covered by an effective registration
statement and may not be sold pursuant to Rule 144. Such liquidated damages
shall continue to accrue until a registration statement is declared effective,
such securities are no longer required to be covered by a registration
statement, or until such damages reach the maximum amount of 10% of the holders’
total investment amount. A registration statement filed by Access relating to a
portion of such securities was declared effective on November 13,
2008.
Failure
to achieve and maintain effective internal controls could have a material
adverse effect on Access’ business.
Effective
internal controls are necessary for Access to provide reliable financial
reports. If Access cannot provide reliable financial reports, Access’ operating
results could be harmed. All internal control systems, no matter how well
designed, have inherent limitations. Therefore, even those systems determined to
be effective can provide only reasonable assurance with respect to financial
statement preparation and presentation.
As noted
in Form 10-Q, Item 4T for September 30, 2008, Access has determined that a
material weakness exists relating to the monitoring and review of work performed
by our Chief Financial Officer in connection with our internal control over
financial reporting. All of our financial reporting is carried out by our Chief
Financial Officer. This lack of accounting staff results in a lack of
segregation of duties and accounting technical expertise necessary for an
effective system of internal control.
While
Access continues to evaluate and improve its internal controls, Access cannot be
certain that these measures will ensure that Access implements and maintains
adequate controls over its financial processes and reporting in the future. Any
failure to implement required new or improved controls, or difficulties
encountered in their implementation, could result in our financial results being
misstated, could harm our operating results or cause Access to fail to meet its
reporting obligations.
Failure
to achieve and maintain an effective internal control environment could cause
investors to lose confidence in Access’ reported financial information, which
could have a material adverse effect on its stock price.
16
Without
obtaining adequate capital funding, Access may not be able to continue as a
going concern.
The
report of Access’ independent registered public accounting firm for the fiscal
year ended December 31, 2007 contained a fourth explanatory paragraph to reflect
its significant doubt about Access’ ability to continue as a going concern as a
result of Access’ history of losses and Access’ liquidity position. If Access is
unable to obtain adequate capital funding in the future, Access may not be able
to continue as a going concern, which would have an adverse effect on Access’
business and operations, and investors’ investment in Access may
decline.
Access
has experienced a history of losses, Access expects to incur future losses and
Access may be unable to obtain necessary additional capital to fund operations
in the future.
Access
has recorded minimal revenue to date and has incurred a cumulative operating
loss of approximately $18.5 million for the nine months ended September 30,
2008. Net losses for the years ended 2007 and 2006 were $36.7 million and $12.9
million, respectively. Access’ losses have resulted principally from costs
incurred in research and development activities related to Access’ efforts to
develop clinical drug candidates and from the associated administrative costs.
Access expects to incur additional operating losses over the next several years.
Access also expects cumulative losses to increase if Access expands research and
development efforts and preclinical and clinical trials. Access’ net cash burn
rate for the nine months ended September 30, 2008 was approximately $506,000 per
month. Access projects its net cash burn rate from operations for the next 13
months to be approximately $525,000 per month. Capital expenditures are
forecasted to be minor for the next 13 months.
Access
requires substantial capital for its development programs and operating
expenses, to pursue regulatory clearances and to prosecute and defend its
intellectual property rights. Access believes that its existing capital
resources, interest income, product sales, royalties, revenue and milestones
from possible licensing agreements and collaborative agreements will be
sufficient to fund its currently expected operating expenses and capital
requirements into the fourth quarter of 2009. Access will need to raise
substantial additional capital to support its ongoing operations.
If Access
does raise additional funds by issuing equity securities, further dilution to
existing stockholders would result and future investors may be granted rights
superior to those of existing stockholders. If adequate funds are not available
to Access through additional equity offerings, Access may be required to delay,
reduce the scope of or eliminate one or more of its research and development
programs or to obtain funds by entering into arrangements with collaborative
partners or others that require Access to issue additional equity securities or
to relinquish rights to certain technologies or drug candidates that Access
would not otherwise issue or relinquish in order to continue independent
operations.
Access
has issued and outstanding shares of Series A Preferred Stock with rights and
preferences superior to those of its common stock.
The
issued and outstanding shares of Series A Preferred Stock grants the holders of
such preferred stock anti-dilution, dividend and liquidations rights that are
superior to those held by the holders of our common stock. Should
Access issue additional shares of common stock for a price below $3.00 per
share, the conversion price of the Series A Preferred Stock shall be lowered to
the lowest issue price below $3.00 per share which will have the effect of
diluting the holders of our common stock.
Access
does not have operating revenue and it may never attain
profitability.
To date,
Access has funded its operations primarily through private sales of common
stock, preferred stock and convertible notes. Contract research payments and
licensing fees from corporate alliances and mergers have also provided funding
for its operations. Its ability to achieve significant revenue or profitability
depends upon its ability to successfully complete the development of drug
candidates, to develop and obtain patent protection and regulatory approvals for
Access’ drug candidates and to manufacture and commercialize the resulting
drugs. Access sold its only revenue producing assets to Uluru, Inc. in October
2005. Access is not expecting any revenues in the short-term from its other
assets. Furthermore, Access may not be able to ever successfully identify,
develop, commercialize, patent, manufacture, obtain required regulatory
approvals and market any additional products. Moreover, even if Access does
identify, develop, commercialize, patent, manufacture, and obtain required
regulatory approvals to market additional products, Access may not generate
revenues or royalties from commercial sales of these products for a significant
number of years, if at all. Therefore, its proposed operations are subject to
all the risks inherent in the establishment of a new business
enterprise. In the next few years, its revenues may be limited to
minimal product sales and royalties, any amounts that Access receives under
strategic partnerships and research or drug development collaborations that
Access may establish and, as a result, Access may be unable to achieve or
maintain profitability in the future or to achieve significant revenues in order
to fund its operations.
17
Although
Access expects that the acquisition of MacroChem will result in benefits to the
combined company the combined company may not realize those benefits because of
integration and other challenges.
Access’
ability to realize the anticipated benefits of the merger will depend, in part,
on the ability of Access to integrate the business of Somanta with the business
of Access. The combination of two independent companies is a complex, costly and
time-consuming process. This process may disrupt the business of either or both
of the companies, and may not result in the full benefits expected by Access and
Somanta. The difficulties of combining the operations of the companies include,
among others:
|
•
|
unanticipated
issues in integrating information, communications and other
systems;
|
|
•
|
retaining
key employees;
|
|
•
|
consolidating
corporate and administrative
infrastructures;
|
|
•
|
the
diversion of management’s attention from ongoing business concerns;
and
|
|
•
|
coordinating
geographically separate
organizations.
|
Access
may not successfully commercialize its drug candidates.
Access’
drug candidates are subject to the risks of failure inherent in the development
of pharmaceutical products based on new technologies, and its failure to develop
safe commercially viable drugs would severely limit its ability to become
profitable or to achieve significant revenues. Access may be unable to
successfully commercialize Access’ drug candidates because:
|
·
|
some
or all of its drug candidates may be found to be unsafe or ineffective or
otherwise fail to meet applicable regulatory standards or receive
necessary regulatory clearances;
|
|
·
|
its
drug candidates, if safe and effective, may be too difficult to develop
into commercially viable drugs;
|
|
·
|
it
may be difficult to manufacture or market its drug candidates on a large
scale;
|
|
·
|
proprietary
rights of third parties may preclude it from marketing its drug
candidates; and
|
|
·
|
third
parties may market superior or equivalent
drugs.
|
The
success of Access’ research and development activities, upon which Access
primarily focuses, is uncertain.
Access’
primary focus is on its research and development activities and the
commercialization of compounds covered by proprietary biopharmaceutical patents
and patent applications. Research and development activities, by their nature,
preclude definitive statements as to the time required and costs involved in
reaching certain objectives. Actual research and development costs, therefore,
could exceed budgeted amounts and estimated time frames may require extension.
Cost overruns, unanticipated regulatory delays or demands, unexpected adverse
side effects or insufficient therapeutic efficacy will prevent or substantially
slow Access’ research and development effort and Access’ business could
ultimately suffer. Access anticipates that it will remain principally engaged in
research and development activities for an indeterminate, but substantial,
period of time.
Access
may be unable to successfully develop, market, or commercialize its products or
its product candidates without establishing new relationships and maintaining
current relationships.
Access’
strategy for the research, development and commercialization of its potential
pharmaceutical products may require it to enter into various arrangements with
corporate and academic collaborators, licensors, licensees and others, in
addition to its existing relationships with other parties. Specifically, Access
may seek to joint venture, sublicense or enter other marketing arrangements with
parties that have an established marketing capability or Access may choose to
pursue the commercialization of such products on its own. Access may, however,
be unable to establish such additional collaborative arrangements, license
agreements, or marketing agreements as Access may deem necessary to develop,
commercialize and market Access’ potential pharmaceutical products on acceptable
terms. Furthermore, if Access maintains and establishes arrangements or
relationships with third parties, its business may depend upon the successful
performance by these third parties of their responsibilities under those
arrangements and relationships.
Access’
ability to successfully commercialize, and market Access’ product candidates
could be limited if a number of these existing relationships were
terminated.
Furthermore,
its strategy with respect to its polymer platinate program is to enter into a
licensing agreement with a pharmaceutical company pursuant to which the further
costs of developing a product would be shared with its licensing partner.
Although Access has had discussions with potential licensing partners with
respect to its polymer platinate program, to date Access has only entered into a
licensing arrangement for the ProLindac in the Greater China Region. Access may
be unable to execute its licensing strategy for polymer platinate.
18
Access
may be unable to successfully manufacture its products and its product
candidates in clinical quantities or for commercial purposes without the
assistance of contract manufacturers, which may be difficult for it to obtain
and maintain.
Access
has limited experience in the manufacture of pharmaceutical products in clinical
quantities or for commercial purposes and Access may not be able to manufacture
any new pharmaceutical products that Access may develop. As a result, Access has
established, and in the future intends to establish arrangements with contract
manufacturers to supply sufficient quantities of products to conduct clinical
trials and for the manufacture, packaging, labeling and distribution of finished
pharmaceutical products if any of its potential products are approved for
commercialization. If Access is unable to contract for a sufficient supply of
its potential pharmaceutical products on acceptable terms, its preclinical and
human clinical testing schedule may be delayed, resulting in the delay of its
clinical programs and submission of product candidates for regulatory approval,
which could cause its business to suffer. Its business could suffer if there are
delays or difficulties in establishing relationships with manufacturers to
produce, package, label and distribute its finished pharmaceutical or other
medical products, if any, market introduction and subsequent sales of such
products. Moreover, contract manufacturers that Access may use must adhere to
current Good Manufacturing Practices, as required by the FDA. In this regard,
the FDA will not issue a pre-market approval or product and establishment
licenses, where applicable, to a manufacturing facility for the products until
the manufacturing facility passes a pre-approval plant inspection. If Access is
unable to obtain or retain third party manufacturing on commercially acceptable
terms, Access may not be able to commercialize its products as planned. Its
potential dependence upon third parties for the manufacture of its products may
adversely affect its ability to generate profits or acceptable profit margins
and its ability to develop and deliver such products on a timely and competitive
basis.
ProLindac™
is manufactured by third parties for Access’ Phase 2 clinical trials.
Manufacturing is ongoing for the current clinical trials. Certain manufacturing
steps are conducted by the Company to enable significant cost savings to be
realized.
Access
is subject to extensive governmental regulation which increases its cost of
doing business and may affect its ability to commercialize any new products that
Access may develop.
The FDA
and comparable agencies in foreign countries impose substantial requirements
upon the introduction of pharmaceutical products through lengthy and detailed
laboratory, preclinical and clinical testing procedures and other costly and
time-consuming procedures to establish its safety and efficacy. All of its drugs
and drug candidates require receipt and maintenance of governmental approvals
for commercialization. Preclinical and clinical trials and manufacturing of its
drug candidates will be subject to the rigorous testing and approval processes
of the FDA and corresponding foreign regulatory authorities. Satisfaction of
these requirements typically takes a significant number of years and can vary
substantially based upon the type, complexity and novelty of the product. The
status of Access’ principal products is as follows:
|
·
|
A
mucoadhesive liquid technology product, MuGard™, has received marketing
approval by the FDA.
|
|
·
|
ProLindac™
is currently in a Phase 2 trial in
Europe.
|
|
·
|
ProLindac™
has been approved for an additional Phase 1 trial in the US by the
FDA.
|
|
·
|
Phenylbutrate
is in planning stage for a Phase 2 trial in the United
States.
|
|
·
|
Cobalamin™
mediated delivery technology is currently in the pre-clinical
phase.
|
|
·
|
Angiolix®
is currently in the pre-clinical
phase.
|
|
·
|
Prodrax®
is currently in the pre-clinical
phase.
|
|
·
|
Alchemix®
is currently in the pre-clinical
phase.
|
|
·
|
Access
also has other products in the preclinical
phase.
|
Due to
the time consuming and uncertain nature of the drug candidate development
process and the governmental approval process described above, Access cannot
assure you when Access, independently or with its collaborative partners, might
submit a NDA, for FDA or other regulatory review.
Government
regulation also affects the manufacturing and marketing of pharmaceutical
products. Government regulations may delay marketing of Access’ potential drugs
for a considerable or indefinite period of time, impose costly procedural
requirements upon its activities and furnish a competitive advantage to larger
companies or companies more experienced in regulatory affairs. Delays in
obtaining governmental regulatory approval could adversely affect Access’
marketing as well as its ability to generate significant revenues from
commercial sales. Access’ drug candidates may not receive FDA or other
regulatory approvals on a timely basis or at all. Moreover, if regulatory
approval of a drug candidate is granted, such approval may impose limitations on
the indicated use for which such drug may be marketed. Even if Access obtains
initial regulatory approvals for its drug candidates, Access’ drugs and its
manufacturing facilities would be subject to continual review and periodic
inspection, and later discovery of previously unknown problems with a drug,
manufacturer or facility may result in restrictions on the marketing or
manufacture of such drug, including withdrawal of the drug from the market. The
FDA and other regulatory authorities stringently apply regulatory standards and
failure to comply with regulatory standards can, among other things, result in
fines, denial or withdrawal of regulatory approvals, product recalls or
seizures, operating restrictions and criminal prosecution.
19
The
uncertainty associated with preclinical and clinical testing may affect Access’
ability to successfully commercialize new products.
Before
Access can obtain regulatory approvals for the commercial sale of any of its
potential drugs, the drug candidates will be subject to extensive preclinical
and clinical trials to demonstrate their safety and efficacy in
humans. Preclinical or clinical trials of any of its future drug
candidates may not demonstrate the safety and efficacy of such drug candidates
at all or to the extent necessary to obtain regulatory approvals. In this
regard, for example, adverse side effects can occur during the clinical testing
of a new drug on humans which may delay ultimate FDA approval or even lead it to
terminate its efforts to develop the drug for commercial use. Companies in the
biotechnology industry have suffered significant setbacks in advanced clinical
trials, even after demonstrating promising results in earlier trials. In
particular, polymer platinate has taken longer to progress through clinical
trials than originally planned. This extra time has not been related to concerns
of the formulations but rather due to the lengthy regulatory process. The
failure to adequately demonstrate the safety and efficacy of a drug candidate
under development could delay or prevent regulatory approval of the drug
candidate. A delay or failure to receive regulatory approval for any of Access’
drug candidates could prevent Access from successfully commercializing such
candidates and Access could incur substantial additional expenses in its
attempts to further develop such candidates and obtain future regulatory
approval.
Access
may incur substantial product liability expenses due to the use or misuse of its
products for which Access may be unable to obtain insurance
coverage.
Access’
business exposes it to potential liability risks that are inherent in the
testing, manufacturing and marketing of pharmaceutical products. These risks
will expand with respect to its drug candidates, if any, that receive regulatory
approval for commercial sale and Access may face substantial liability for
damages in the event of adverse side effects or product defects identified with
any of its products that are used in clinical tests or marketed to the public.
Access generally procures product liability insurance for drug candidates that
are undergoing human clinical trials. Product liability insurance for the
biotechnology industry is generally expensive, if available at all, and as a
result, Access may be unable to obtain insurance coverage at acceptable costs or
in a sufficient amount in the future, if at all. Access may be unable to satisfy
any claims for which Access may be held liable as a result of the use or misuse
of products which Access has developed, manufactured or sold and any such
product liability claim could adversely affect its business, operating results
or financial condition.
Access
may incur significant liabilities if it fails to comply with stringent
environmental regulations or if Access did not comply with these regulations in
the past.
Access’
research and development processes involve the controlled use of hazardous
materials. Access is subject to a variety of federal, state and local
governmental laws and regulations related to the use, manufacture, storage,
handling and disposal of such material and certain waste products. Although
Access believes that its activities and its safety procedures for storing,
using, handling and disposing of such materials comply with the standards
prescribed by such laws and regulations, the risk of accidental contamination or
injury from these materials cannot be completely eliminated. In the event of
such accident, Access could be held liable for any damages that result and any
such liability could exceed its resources.
Intense
competition may limit Access’ ability to successfully develop and market
commercial products.
The
biotechnology and pharmaceutical industries are intensely competitive and
subject to rapid and significant technological change. Access’ competitors in
the United States and elsewhere are numerous and include, among others, major
multinational pharmaceutical and chemical companies, specialized biotechnology
firms and universities and other research institutions.
The
following products may compete with polymer platinate:
•
Cisplatin, marketed by Bristol-Myers Squibb, the originator of the drug, and
several generic manufacturers;
•
Carboplatin, marketed by Bristol-Myers Squibb, the originator of the drug, and
several generic manufacturers;
•
Oxaliplatin, marketed exclusively by Sanofi-Aventis.
The
following companies are working on therapies and formulations that may be
competitive with Access’ polymer platinate:
• Antigenics
and Regulon are developing liposomal platinum formulations;
• Spectrum
Pharmaceuticals and GPC Biotech are developing oral platinum
formulations;
• Poniard
Pharmaceuticals is developing both i.v. and oral platinum
formulations;
• Nanocarrier
and Debio are developing micellar nanoparticle platinum formulations;
and
|
•
|
American
Pharmaceutical Partners, Cell Therapeutics, Daiichi, and Enzon are
developing anticancer drugs in combination with polymers and other drug
delivery systems.
|
Companies
working on therapies and formulations that may be competitive with Access’
vitamin mediated drug delivery system are Bristol-Myers Squibb, Centocor
(acquired by Johnson & Johnson), Endocyte, GlaxoSmithKline, Imclone and Xoma
which are developing targeted monoclonal antibody therapy.
Amgen,
Carrington Laboratories, , EUSA Pharma, Endo Pharmaceuticals, Eisai, Nuvelo,
Inc. and EKR Therapeutics, Inc are developing products to treat mucositis that
may compete with Access’ mucoadhesive liquid technology.
20
BioDelivery
Sciences International, Biovail Corporation, Cellgate, CIMA Labs, Inc., Depomed
Inc., Emisphere Technologies, Inc., Eurand, Flamel Technologies, Generex
Biotechnology, Nobex, Oramed Pharmaceuticals, and Xenoport are developing
products which compete with Access’ oral drug delivery system.
Companies
working on therapies and formulations that may be competitive with Access’
Sodium Phenylbutyrate are Medicis Pharmaceuticals currently sells Sodium
Phenylbutyrate (Buphenyl ®) for the treatment of a urea cycle disorder,
hyperuremia. We are aware of numerous products in development for brain cancers.
We are aware of several products being developed by academic and commercial
organizations targeting glioblastoma.
There are
several companies that are marketing or developing anti-angiogenesis compounds
for cancer therapy that might compete with Angiolix, Access’ monoclonal antibody
product, Angiolix has a unique mechanism of action which should differentiate it
from the other anti-angiogenesis compounds.
Companies
working on therapies and formulations that may be competitive with Access’
Prodrax are Novocea, Inc., which has exclusively licensed from KuDOS
Pharmaceuticals, a subsidiary of Astra Zeneca, a small molecule prodrug that is
selectively activated by low oxygen tumors that is similar to our
Prodrax.Threshold Pharmaceuticals is developing a small molecule prodrug that is
activated in hypoxia by a different mechanism to that of Prodrax.
We are
not aware of any other organization developing a drug similar to Alchemix.
Several groups are developing agents against p-glycoprotein, which is only one
of the identified mechanisms of drug resistance within cells, and other groups
are developing agents that have the potential to become chemosensitisers, which
means they will make cancer cells more sensitive to the effects of
chemotherapy.
Many of
these competitors have and employ greater financial and other resources,
including larger research and development, marketing and manufacturing
organizations. As a result, Access’ competitors may successfully develop
technologies and drugs that are more effective or less costly than any that
Access is developing or which would render Access’ technology and future
products obsolete and noncompetitive.
In
addition, some of Access’ competitors have greater experience than Access does
in conducting preclinical and clinical trials and obtaining FDA and other
regulatory approvals. Accordingly, Access’ competitors may succeed in obtaining
FDA or other regulatory approvals for drug candidates more rapidly than Access
does. Companies that complete clinical trials, obtain required regulatory agency
approvals and commence commercial sale of their drugs before their competitors
may achieve a significant competitive advantage. Drugs resulting from Access’
research and development efforts or from its joint efforts with collaborative
partners therefore may not be commercially competitive with its competitors'
existing products or products under development.
Access depends
on licenses from third parties and the maintenance of its licenses are
necessary for its success.
Access,
as a result of its acquisition of Somanta Pharmaceuticals, Inc.,
has obtained rights to some product candidates through license
agreements with various third party licensors as follows:
|
•
|
Exclusive
Patent and Know-how Sub-license Agreement between Somanta and
Immunodex, Inc. dated August 18, 2005, as amended;
|
|
|
•
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Patent
and Know-how Assignment and License Agreement between Somanta and De
Montfort University dated March 20, 2003;
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•
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Patent
and Know-how Assignment and License Option Agreement between Somanta
and The School of Pharmacy, University of London dated March 16,
2004, as amended on September 21, 2005; and
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•
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The
Phenylbutyrate Co-Development and Sublicense Agreement
between Somanta and Virium Pharmaceuticals, Inc. dated
February 16, 2005, as amended.
|
Access
is dependent upon these licenses for its rights to develop and
commercialize its product candidates. While Access believes it is
in compliance with its obligations under the licenses, certain licenses may be
terminated or converted to non-exclusive licenses by the licensor if Access
breaches the terms of the license. Access cannot guarantee you that the
licenses will not be terminated or converted in the future.
While Access
expects that it will be able to continue to identify licensable product
candidates or research suitable for licensing and commercialization by it, there
can be no assurance that this will occur. For example, Access is in
discussions with the National Institutes of Health to obtain licenses to certain
patents held by them that will be necessary for the manufacture of its
product candidate Angiolix. Unless Access obtains licenses on terms that
are acceptable to it, Access may not be able to manufacture and obtain
product registrations on Angiolix. On December 5, 2006, NIH provided
Access with proposed terms for a non-exclusive license. Access is in
discussion with NIH on those proposed terms and conditions. On May 15, 2007, NIH
terminated Access’ non-exclusive license application since it had not
accepted the terms and had not executed the proposed license
agreement.
21
Access’
ability to successfully develop and commercialize its drug candidates will
substantially depend upon the availability of reimbursement funds for the costs
of the resulting drugs and related treatments.
The
successful commercialization of, and the interest of potential collaborative
partners to invest in the development of its drug candidates, may depend
substantially upon reimbursement of the costs of the resulting drugs and related
treatments at acceptable levels from government authorities, private health
insurers and other organizations, including health maintenance organizations, or
HMOs. Limited reimbursement for the cost of any drugs that Access develops may
reduce the demand for, or price of such drugs, which would hamper its ability to
obtain collaborative partners to commercialize its drugs, or to obtain a
sufficient financial return on its own manufacture and commercialization of any
future drugs.
The
market may not accept any pharmaceutical products that Access successfully
develops.
The drugs
that Access is attempting to develop may compete with a number of
well-established drugs manufactured and marketed by major pharmaceutical
companies. The degree of market acceptance of any drugs developed by it will
depend on a number of factors, including the establishment and demonstration of
the clinical efficacy and safety of its drug candidates, the potential advantage
of its drug candidates over existing therapies and the reimbursement policies of
government and third-party payers. Physicians, patients or the medical community
in general may not accept or use any drugs that Access may develop independently
or with its collaborative partners and if they do not, its business could
suffer.
Trends
toward managed health care and downward price pressures on medical products and
services may limit its ability to profitably sell any drugs that Access may
develop.
Lower
prices for pharmaceutical products may result from:
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third-party
payers' increasing challenges to the prices charged for medical products
and services;
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the
trend toward managed health care in the United States and the concurrent
growth of HMOs and similar organizations that can control or significantly
influence the purchase of healthcare services and products;
and
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legislative
proposals to reform healthcare or reduce government insurance
programs.
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The cost
containment measures that healthcare providers are instituting, including
practice protocols and guidelines and clinical pathways, and the effect of any
healthcare reform, could limit Access’ ability to profitably sell any drugs that
Access may successfully develop. Moreover, any future legislation or regulation,
if any, relating to the healthcare industry or third-party coverage and
reimbursement, may cause its business to suffer.
Access
may not be successful in protecting its intellectual property and proprietary
rights.
Access’
success depends, in part, on its ability to obtain U.S. and foreign patent
protection for its drug candidates and processes, preserve its trade secrets and
operate its business without infringing the proprietary rights of third parties.
Legal standards relating to the validity of patents covering pharmaceutical and
biotechnological inventions and the scope of claims made under such patents are
still developing and there is no consistent policy regarding the breadth of
claims allowed in biotechnology patents. The patent position of a biotechnology
firm is highly uncertain and involves complex legal and factual questions.
Access cannot assure you that any existing or future patents issued to, or
licensed by, it will not subsequently be challenged, infringed upon, invalidated
or circumvented by others. As a result, although Access, together with its
subsidiaries, are either the owner or licensee to 17 U.S. patents and to 9 U.S.
patent applications now pending, and 5 European patents and 13 European patent
applications, Access cannot assure you that any additional patents will issue
from any of the patent applications owned by, or licensed to, it. Furthermore,
any rights that Access may have under issued patents may not provide it with
significant protection against competitive products or otherwise be commercially
viable.
Access’
patents for the following technologies expire in the years and during the date
ranges indicated below:
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Mucoadhesive
technology in 2021,
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ProLindac™
in 2021,
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Phenylbutyrate
between 2011 and 2016,
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Angiolix®
in 2015,
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Alchemix®
in 2015,
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Cobalamin
mediated technology between 2009 and
2019
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22
In
addition to issued patents, Access has a number of pending patent applications.
If issued, the patents underlying theses applications could extend the patent
life of its technologies beyond the dates listed above.
Patents
may have been granted to third parties or may be granted covering products or
processes that are necessary or useful to the development of Access’ drug
candidates. If Access’ drug candidates or processes are found to infringe upon
the patents or otherwise impermissibly utilize the intellectual property of
others, Access’ development, manufacture and sale of such drug candidates could
be severely restricted or prohibited. In such event, Access may be required to
obtain licenses from third parties to utilize the patents or proprietary rights
of others. Access cannot assure you that it will be able to obtain such licenses
on acceptable terms, if at all. If Access becomes involved in litigation
regarding its intellectual property rights or the intellectual property rights
of others, the potential cost of such litigation, regardless of the strength of
its legal position, and the potential damages that Access could be required to
pay could be substantial.
Access’
business could suffer if Access loses the services of, or fail to attract, key
personnel.
Access is
highly dependent upon the efforts of its senior management and scientific team,
including its Chief Executive Officer, Jeffrey B. Davis. The loss of the
services of one or more of these individuals could delay or prevent the
achievement of its research, development, marketing, or product
commercialization objectives. While Access has employment agreements with
Jeffrey B. Davis, David P. Nowotnik, PhD its Senior Vice President Research and
Development, and Stephen B. Thompson, its Vice President and Chief Financial
Officer, their employment may be terminated by them or Access at any time. Mr.
Davis’, Dr. Nowotnik's and Mr. Thompson’s agreements expire within one year and
are extendable each year on the anniversary date. Access does not have
employment contracts with its other key personnel. Access does not maintain any
"key-man" insurance policies on any of its key employees and Access does not
intend to obtain such insurance. In addition, due to the specialized scientific
nature of its business, Access is highly dependent upon its ability to attract
and retain qualified scientific and technical personnel. In view of the stage of
its development and its research and development programs, Access has restricted
its hiring to research scientists and a small administrative staff and Access
has made only limited investments in manufacturing, production, sales or
regulatory compliance resources. There is intense competition among major
pharmaceutical and chemical companies, specialized biotechnology firms and
universities and other research institutions for qualified personnel in the
areas of Access’ activities, however, and Access may be unsuccessful in
attracting and retaining these personnel.
An
investment in Access’ common stock may be less attractive because it is not
traded on a recognized public market.
Access’
common stock has traded on the OTC Bulletin Board, or OTCBB since June 5, 2006.
From February 1, 2006 until June 5, 2006 Access traded on the “Pink Sheets”
after its common stock was de-listed from trading on AMEX. The OTCBB and Pink
Sheets are viewed by most investors as a less desirable, and less liquid,
marketplace. As a result, an investor may find it more difficult to purchase,
dispose of or obtain accurate quotations as to the value of its common
stock.
Access’
common stock is subject to Rules 15g-1 through 15g-9 under the Exchange Act,
which imposes certain sales practice requirements on broker-dealers who sell its
common stock to persons other than established customers and "accredited
investors" (as defined in Rule 501(c) of the Securities Act). For transactions
covered by this rule, a broker-dealer must make a special suitability
determination for the purchaser and have received the purchaser's written
consent to the transaction prior to the sale. This rule adversely affects the
ability of broker-dealers to sell Access’ common stock and purchasers of its
common stock to sell their shares of Access’ common stock.
Additionally,
Access’ common stock is subject to SEC regulations applicable to "penny stock."
Penny stock includes any non-NASDAQ equity security that has a market price of
less than $5.00 per share, subject to certain exceptions. The
regulations require that prior to any non-exempt buy/sell transaction in a penny
stock, a disclosure schedule proscribed by the SEC relating to the penny stock
market must be delivered by a broker-dealer to the purchaser of such penny
stock. This disclosure must include the amount of commissions payable
to both the broker-dealer and the registered representative and current price
quotations for Access’ common stock. The regulations also require
that monthly statements be sent to holders of penny stock that disclose recent
price information for the penny stock and information of the limited market for
penny stocks. These requirements adversely affect the market
liquidity of Access’ common stock.
Ownership
of Access’ shares is concentrated in the hands of a few investors which could
limit the ability of Access’ other stockholders to influence the direction of
the company.
As
calculated by the SEC rules of beneficial ownership, SCO Capital Partners LLC
and affiliates, Larry N. Feinberg (Oracle Partners LP, Oracle Institutional
Partners LP and Oracle Investment Management Inc.), and Lake End Capital LLC
each beneficially owned approximately 71.5%, 28.5% and 20.3%, respectively, of
Access’ common stock as of November 24, 2008. Accordingly, they collectively may
have the ability to significantly influence or determine the election of all of
Access’ directors or the outcome of most corporate actions requiring stockholder
approval. They may exercise this ability in a manner that advances their best
interests and not necessarily those of Access’ other stockholders.
Provisions
of Access’ charter documents could discourage an acquisition of our company that
would benefit its stockholders and may have the effect of
entrenching, and making it difficult to remove, management.
23
Provisions
of Access’ Certificate of Incorporation, By-laws and Stockholders Rights Plan
may make it more difficult for a third party to acquire control of the Company,
even if a change in control would benefit Access stockholders. In particular,
shares of Access preferred stock may be issued in the future without further
stockholder approval and upon such terms and conditions, and having such rights,
privileges and preferences, as Access’ Board of Directors may determine,
including, for example, rights to convert into Access common stock. The rights
of the holders of Access common stock will be subject to, and may be adversely
affected by, the rights of the holders of any of Access’ preferred stock that
may be issued in the future. The issuance of Access preferred stock, while
providing desirable flexibility in connection with possible acquisitions and
other corporate purposes, could have the effect of making it more difficult for
a third party to acquire control of Access. This could limit the price that
certain investors might be willing to pay in the future for shares of Access
common stock and discourage these investors from acquiring a majority of Access
common stock. Further, the existence of these corporate governance provisions
could have the effect of entrenching management and making it more difficult to
change Access’ management.
Substantial
sales of Access common stock could lower its stock price.
The
market price for Access common stock could drop as a result of sales of a large
number of its presently outstanding shares or shares that Access may
issue or be obligated to issue in the future. All of the 6,515,791 shares of
Access common stock that are outstanding as of November 24, 2008, are
unrestricted and freely tradable or tradable pursuant to a resale registration
statement or under Rule 144 of the Securities Act or are covered by a
registration rights agreement.
Future
sales by our stockholders may adversely affect our stock price and our ability
to raise funds in new stock offerings.
Sales of
our common stock in the public market following this offering could lower the
market price of our common stock. Sales may also make it more difficult for us
to sell equity securities or equity-related securities in the future at a time
and price that our management deems acceptable or at all. Of the 6,515,791
shares of common stock outstanding as of November 24, 2008, 6,515,791 shares
are, or will be, freely tradable without restriction, unless held by our
“affiliates.” Some of these shares may be resold under Rule 144. The sale of the
10,809,539 shares issuable upon conversion of our preferred stock and 9,687,326
shares issuable upon exercise of outstanding warrants could also lower the
market price of our common stock.
Risks Relating to MacroChem
Business:
MacroChem
may not continue as a going concern if the merger with Access Pharmaceuticals is
not consummated.
MacroChem
signed the merger agreement with Access Pharmaceuticals on July 10, 2008
and expects to close the transaction in the fourth quarter of 2008 at which time
the Company would become a wholly-owned subsidiary of Access. If for any
reason the merger transaction is not consummated, MacroChem may not be able to
continue as a going concern because MacroChem no longer has any
significant cash resource to fund operations. If MacroChem cannot continue
as a going concern, you will lose all or a substantial portion of any investment
in MacroChem.
MacroChem
has a history of operating losses, expects to continue to incur losses and rely
extensively on external financing to maintain MacroChem operations. If MacroChem
is unable to obtain external financing, MacroChem would be required to further
limit, scale back or cease MacroChem operations entirely.
Since
1981, MacroChem has been engaged primarily in research and development and has
derived limited revenues from feasibility studies and the licensing of MacroChem
technology. MacroChem has not generated any material revenues from the sale of
any products. In addition, MacroChem has incurred net operating losses every
year since MacroChem began doing business and MacroChem anticipates that
MacroChem will continue to incur operating losses for the foreseeable future. As
of December 31, 2007, MacroChem had an accumulated deficit of approximately
$90,847,978. For the fiscal year ended December 31, 2007, MacroChem had net loss
of $8,866,182, however, such loss was partially the result of a non-cash
increase in a liability classified warrant caused by an increase in MacroChem
stock price. For the fiscal year ended December 31, 2006, MacroChem had a net
income of $1,951,279, however, such net income was the result of a non-cash
reduction in a liability classified warrant caused by a decline in MacroChem
stock price. For the fiscal year ended 2005, MacroChem had a net loss of
$5,760,475.
On August
31, 2005, due to MacroChem’s financial condition at the time and MacroChem
inability to raise sufficient capital to maintain operations, MacroChem
discontinued all research and development activities and terminated
substantially all of MacroChem non-management personnel. In December 2005 and
February 2006, MacroChem raised an aggregate of $8.25 million in a private
placement of MacroChem securities to investors. As a result of this private
placement, MacroChem resumed operations with a focus on advancing clinical
development of MacroChem’s lead product, EcoNail. In October 2007, MacroChem
raised an additional $3,535,000 in a subsequent private placement. In addition,
in October 2007, MacroChem acquired the exclusive worldwide license rights for
drug uses of pexiganan, a novel small peptide anti-infective for treatment of
patients with mild diabetic for infection (DFI), from Genaera Corporation. The
audit report of Vitale, Caturano & Company, Ltd., MacroChem’s independent
registered public accounting firm, on MacroChem 2007 financial statements
includes an explanatory paragraph concerning MacroChem’s ability to continue as
a going concern. The inclusion of this explanatory paragraph may materially and
adversely affect MacroChem’s ability to raise new capital. MacroChem’s
continuation as a going concern depends on its ability to secure additional
financing, to consummate a strategic transaction, or to make alternative
arrangements to fund operations, which MacroChem cannot guarantee.
24
Before
MacroChem or any of MacroChem potential licensees may market any of MacroChem
product candidates, significant additional development efforts and substantial
testing will be necessary. MacroChem will require substantial additional
financing to fund clinical studies on MacroChem product candidates. MacroChem
may not be able to secure financing on favorable terms or at all. If MacroChem
is unable to obtain external financing, MacroChem would have to reduce, delay or
eliminate MacroChem clinical studies.
MacroChem
product candidates are in the early stages of development and are subject to the
risk of failure inherent in the development of innovative
technologies.
Various
pharmaceutical companies have developed systems to enhance the topical delivery
of specific drugs, but relatively limited research has been conducted about
using topical delivery systems for a wider range of pharmaceutical products.
Topical delivery systems currently are used only in a limited number of
products. In addition, some topical delivery systems have demonstrated adverse
side effects for users, including skin irritation and delivery
difficulties.
MacroChem
product candidates are in the early stages of development and will require
significant further research, development, testing and regulatory clearances.
MacroChem product candidates are subject to the risks of failure inherent in the
development of products based on innovative technologies. These risks include
the possibilities that any or all of MacroChem product candidates may be found
to be ineffective or toxic, or otherwise may fail to receive necessary
regulatory clearances.
Even
if MacroChem succeeds with pre-clinical and clinical trials, MacroChem product
candidates must undergo a rigorous regulatory approval process, which includes
extensive review of pre-clinical and clinical testing, to demonstrate safety and
efficacy before MacroChem can market them. If the results of MacroChem
pre-clinical and clinical testing indicate that MacroChem product candidates are
not safe or effective, MacroChem’s business will suffer.
Each of
MacroChem product candidates, including EcoNail, pexiganan and Opterone, must
undergo a rigorous regulatory approval process, including significant
pre-clinical and clinical testing to demonstrate that they are safe and
effective for human use, before MacroChem can market them. Conducting clinical
trials is a lengthy, expensive and uncertain process. Completion of clinical
trials may take several years or more. In addition, MacroChem clinical trials
may be delayed by many factors, including:
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inability
to fund clinical trials;
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slow
or insufficient patient enrollment;
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failure
of the FDA to approve MacroChem clinical trial
protocols;
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inability
to manufacture significant amounts of MacroChem product candidates for use
in a trial;
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safety
issues; and
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government
or regulatory delays.
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In
addition, the results of pre-clinical studies and early clinical trials may not
accurately predict results that MacroChem will obtain in later testing. A number
of other companies in the pharmaceutical industry have suffered significant
setbacks in advanced clinical trials, even after they achieved promising results
in earlier trials. If MacroChem, the FDA or physicians do not believe that
MacroChem clinical trials demonstrate that MacroChem product candidates are safe
and effective, MacroChem’s business, financial condition and results of
operations will be materially adversely affected.
MacroChem’s
product candidates are subject to significant FDA supervision and may not
successfully complete the extensive regulatory approval process required prior
to the marketing of any pharmaceutical product.
MacroChem
activities are regulated by a number of government authorities in the United
States and other countries, including the FDA. The FDA regulates pharmaceutical
products, including their manufacture and labeling. Before obtaining regulatory
approval to market any product candidate under development, MacroChem must
demonstrate to the FDA that the product is safe and effective for use in each
proposed indication through, among other things, pre-clinical studies and
clinical trials. Data obtained from testing is subject to varying
interpretations which can delay, limit or prevent FDA approval.
On
October 11, 2002, the FDA advised MacroChem that further clinical trials of
MacroChem drugs containing SEPA had been placed on clinical hold pending review
of questions surrounding a 26-week transgenic-mouse (Tg.AC) carcinogenicity
study of SEPA MacroChem performed in 1999. On April 10, 2003, the FDA lifted
this clinical hold. In releasing the hold, the FDA requested additional
information on that 1999 study, which MacroChem have provided.
25
On
December 5, 2005, MacroChem received a response from the Division of
Reproductive and Urologic Products at the FDA to questions posed by MacroChem
regarding the proposed Phase 3 clinical program for Opterone, a topical cream
for male testosterone deficiency containing SEPA. In the response, the FDA
reiterated its safety concerns regarding the skin irritation potential of SEPA
related to pre-clinical studies of SEPA, including without limitation, the
26-week transgenic-mouse (Tg.AC) carcinogenicity study of SEPA. The FDA also
expressed concern regarding skin irritation observed in some patients in
recently completed Opterone clinical studies. To address these concerns as well
as other issues related to Opterone’s safety and efficacy program, the FDA
requested that MacroChem, if MacroChem intend to pursue clinical development of
Opterone, conduct additional investigation into multiple dose safety and
pharmacokinetics before beginning any eventual Phase 3 study. The FDA also
confirmed the requirement for other clinical pharmacology studies prior to any
NDA submission and requested that MacroChem revise MacroChem’s proposed Phase 3
protocol to include additional patients and to extend patient exposure and
safety follow-up. If MacroChem decides to pursue the clinical development of
Opterone, the additional investigation and Phase 3 revisions will increase the
time and expense associated with the development of Opterone and may materially
adversely affect MacroChem’s ability to find a partner to advance the
development of Opterone. Furthermore, there can be no assurance that the results
of the studies, if conducted, will address the FDA’s safety concerns or justify
further development of Opterone or that any SEPA-based product will be approved
by the FDA.
To date,
neither the FDA nor any of its international equivalents has approved any of
MacroChem technologies or product candidates for marketing. If the FDA does not
approve MacroChem product candidates for marketing, MacroChem will be materially
adversely affected.
MacroChem
face additional risks associated with the regulatory approval process,
including:
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Changes
in existing regulatory requirements could prevent or affect MacroChem
regulatory compliance. Federal and state laws, regulations and policies
may be changed with possible retroactive effect. In addition, how these
rules actually operate can depend heavily on administrative policies and
interpretations over which MacroChem have no control. MacroChem also may
lack the experience with these policies and interpretations to assess
their full impact upon MacroChem
business.
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Obtaining
FDA clearances is time-consuming and expensive and MacroChem cannot
guarantee that such clearances will be granted or, if granted, will not be
withdrawn.
|
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The
FDA review process may prevent MacroChem from marketing MacroChem product
candidates or may involve delays that significantly and negatively affect
MacroChem product candidates. MacroChem also may encounter similar delays
in foreign countries.
|
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Regulatory
clearances may place significant limitations on the uses for which any
approved products may be marketed.
|
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Any
marketed product and its manufacturer are subject to periodic review by
the FDA. Any discovery of previously unrecognized problems with a product
or a manufacturer could result in suspension or limitation of previously
obtained or new approvals.
|
Because
the regulatory approval process is complex, MacroChem cannot accurately predict
the regulatory approval timeline for MacroChem product candidates.
The laws
and regulations administered by the FDA are complex, and compliance with these
laws and regulations requires substantial time, effort and expense. Because of
this complexity, and because the regulatory approval path for MacroChem product
candidates has not yet been confirmed by the FDA, MacroChem cannot guarantee
that MacroChem’s efforts will be sufficient to ensure compliance with all
applicable laws and regulations, nor can MacroChem accurately predict the
regulatory approval timeline for MacroChem product candidates.
Federal
regulatory reforms may create additional burdens that would cause MacroChem to
incur additional costs and may adversely affect MacroChem’s ability to
commercialize MacroChem products.
From time
to time, legislation is drafted, introduced and passed in Congress that could
significantly change the statutory provisions governing the approval,
manufacturing and marketing of products regulated by the FDA. For example, on
September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (the
“FDAAA”) was enacted, giving the FDA enhanced post-market authority, including
the authority to require post-market studies and clinical trials, labeling
changes based on new safety information, and compliance with a risk evaluation
and mitigation strategy approved by the FDA. The FDA’s post-market authority
takes effect 180 days after the enactment of the law. Failure to comply with any
requirements under the FDAAA may result in significant penalties. The FDAAA also
authorizes significant civil money penalties for the dissemination of false or
misleading direct-to-consumer advertisements and allows the FDA to require
companies to submit direct-to-consumer television drug advertisements for FDA
review prior to public dissemination. Additionally, the new law expands the
clinical trial registry so that sponsors of all clinical trials, except for
Phase I trials, are required to submit certain clinical trial information for
inclusion in the clinical trial registry data bank. In addition to the FDAAA,
FDA regulations and guidance are often revised or reinterpreted by the agency in
ways that may significantly affect MacroChem’s business and MacroChem’s
products. It is impossible to predict whether further legislative changes will
be enacted, or FDA regulations, guidance or interpretations will change, and
what the impact of such changes, if any, may be.
26
If
MacroChem product candidates are not accepted by physicians and patients,
MacroChem may never generate profits from operations.
Even if
MacroChem product candidates receive regulatory approval, MacroChem may not be
able to market them effectively, they may be uneconomical to market or third
parties may market equivalent or superior products. MacroChem will need to
expend significant effort to educate physicians and patients regarding any
product candidate that receives regulatory approval. Consequently, unless
MacroChem product candidates obtain market acceptance, MacroChem may never be
profitable.
If
physicians or patients perceive that testosterone replacement therapies create
health risks, the viability of Opterone may be questioned, and MacroChem
business and the price of MacroChem stock may be negatively
affected.
Recent
studies of female hormone replacement therapy products have reported an
associated increase in health risks. As a result of these studies, some
companies that sell or develop female hormone replacement products have
experienced decreased sales of these products, and in some cases, a decline in
their stock. From time to time, publications have suggested potential health
risks associated with testosterone replacement therapy, including fluid
retention, sleep apnea, breast tenderness or enlargement, increased red blood
cells, development of clinical prostate disease, increased cardiovascular
disease risk and the suppression of sperm production. It is possible that
studies on the effect of testosterone replacement therapy could demonstrate
these or other adverse health risks. This, along with the negative publicity
surrounding hormone replacement therapy in general, could negatively impact
market acceptance of Opterone, which could adversely affect MacroChem’s business
and the price of MacroChem stock.
MacroChem
depends on patents to protect MacroChem technologies and if MacroChem’s current
patents are ineffective or MacroChem is unable to secure and maintain adequate
patent protection, MacroChem’s ability to compete with other pharmaceutical
companies may be negatively affected.
MacroChem
believes that patent protection of MacroChem technologies, processes and
products is important to MacroChem’s future operations. The success of
MacroChem’s product candidates depends, in part, on MacroChem’s ability to
secure and maintain adequate patent protection.
Although
MacroChem has filed and intend to file additional patent applications, the patent application
process is lengthy and expensive and there is no guarantee that a patent will be
issued or, if issued, that it will be of commercial benefit to MacroChem. In
addition, it is impossible to anticipate the breadth or degree of protection
that any patents MacroChem obtains may afford MacroChem. Further, products that
MacroChem’s develop could infringe patents held by third parties. In these
cases, MacroChem may have to obtain licenses from third parties, which may not
be available on commercially acceptable terms, if at all. MacroChem does not
maintain separate insurance to cover intellectual property
infringement.
MacroChem’s
composition of matter patent covering SEPA expired in November 2006. The
expiration of that patent will enable competitors to develop SEPA-based product
candidates covering applications for which MacroChem have not obtained
composition and use patents. As a result, MacroChem’s competitive position may
be adversely affected.
Currently,
MacroChem is not involved in any litigation, settlement negotiations or other
legal action regarding patent issues and are not aware of any patent litigation
threatened against MacroChem. MacroChem may, however, become involved in patent
litigation against third parties to enforce MacroChem’s patent rights, to
invalidate patents held by those third parties or to defend against claims of
those third parties. MacroChem intends to enforce MacroChem’s patent position
and defend MacroChem’s intellectual property rights vigorously. The cost to
MacroChem of any patent litigation or similar proceeding could be substantial
and it may absorb significant management time. In the event of an unfavorable
resolution of any infringement litigation against MacroChem, MacroChem may be
enjoined from manufacturing or selling any products without a license from a
third party.
If
MacroChem is not able to protect the confidentiality of MacroChem’s proprietary
information and know-how, the value of MacroChem’s technologies may be adversely
affected.
In
addition to patent protection, MacroChem utilizes significant unpatented
proprietary technology and rely on unpatented trade secrets and proprietary
know-how to protect certain aspects of MacroChem technologies. To the extent
that MacroChem relies on unpatented proprietary technology, MacroChem cannot
guarantee that others will not independently develop or obtain substantially
equivalent or superior technologies or otherwise gain access to MacroChem trade
secrets, that any obligation of confidentiality will be honored or that
MacroChem will be able to effectively protect MacroChem rights to MacroChem
proprietary technologies.
If
MacroChem is not able to retain MacroChem key personnel and/or recruit
additional key personnel in the future, MacroChem business may
suffer.
The
success of MacroChem business depends on MacroChem ability to attract, retain
and motivate qualified senior management personnel and qualified scientific
personnel. MacroChem considers Robert J. DeLuccia, Chairman of the Board, to be
a key employee and MacroChem have entered into an employment agreement with him.
MacroChem does not maintain key person life insurance on any of MacroChem
employees. In MacroChem’s industry, the competition for experienced personnel is
intense and can be expected to increase. From time to time MacroChem may face,
and in the past has faced, difficulties in attracting and retaining employees
with the requisite experience and qualifications. If MacroChem fails to retain
or attract this type of personnel, it could have a significant negative effect
on MacroChem’s ability to develop MacroChem technologies.
27
MacroChem
failures to identify pharmaceuticals that are compatible with MacroChem drug
delivery technologies or additional product candidates or technologies would
impair MacroChem ability to grow.
MacroChem’s
growth depends on MacroChem’s ability to identify drugs suitable for delivery
using MacroChem proprietary drug delivery technologies, MacroChem’s ability to
identify other product candidates or technologies, and MacroChem’s ability,
financially or otherwise, to obtain such product candidates and technologies.
Identifying suitable drugs or product candidates is a lengthy and complex
process. Even if identified, the drugs or product candidates may not be
available to MacroChem or MacroChem may otherwise be unable to enter into
licenses or other agreements for their use. Other companies, including those
with substantially greater financial, marketing and sales resources, may compete
with MacroChem for the licensing or acquisition of drugs and product candidates
and MacroChem may not be able to enter into licenses or other agreements on
acceptable terms, or at all. If MacroChem is unable to identify and license or
acquire drugs that are compatible with MacroChem drug delivery technologies or
additional product candidates or technologies, MacroChem’s ability to grow
MacroChem portfolio of product candidates and MacroChem prospects would be
adversely affected.
MacroChem
does not have any laboratory facilities or scientific personnel and depend on
third parties to conduct research and development activities for MacroChem
technologies and product candidates.
MacroChem
does not have laboratory facilities or scientific personnel capable of
conducting research and development activities for MacroChem technologies and
product candidates and currently MacroChem does not have plans to obtain such
facilities and personnel. Accordingly, MacroChem’s ability to conduct research
and development activities is and will be limited and MacroChem will depend to a
significant extent on third-party contractors for such research and development
activities. If any of MacroChem third-party contractors fails to perform its
obligations in a timely fashion or in accordance with applicable regulations, it
may adversely affect MacroChem’s business. If MacroChem decides to establish
internal research and development capabilities, MacroChem would need to hire and
retain significant additional personnel, locate and acquire appropriate
laboratory facilities, comply with extensive government regulations, and obtain
additional capital, which may not be available on acceptable terms, or at
all.
MacroChem
does not have any manufacturing facilities and depends on third parties to
manufacture MacroChem product candidates.
MacroChem
does not have facilities capable of manufacturing any of MacroChem’s product
candidates and MacroChem does not have plans to obtain these facilities.
Accordingly, MacroChem will depend on third-party contractors, licensees, or
corporate partners to manufacture MacroChem products. If any of MacroChem’s
third-party manufacturers fails to perform its obligations in a timely fashion
or in accordance with applicable regulations, it may delay clinical trials, the
commercialization of MacroChem product candidates or MacroChem’s ability to
supply MacroChem product candidates for sale. If MacroChem decides to establish
a commercial manufacturing facility, MacroChem would need to hire and retain
significant additional personnel, comply with extensive government regulations,
and obtain significant amounts of additional capital, which may not be available
on acceptable terms, or at all.
MacroChem
faces the risk of product liability claims, and MacroChem may not have
sufficient product liability insurance to cover such claims. It may be expensive
and difficult to obtain adequate insurance coverage.
The
design, development, manufacture and sale of MacroChem product candidates
involve risk of liability claims and associated adverse publicity. MacroChem has
product liability insurance coverage with an aggregate policy limit of
approximately $10,000,000 for claims related to MacroChem product candidates
that may arise from clinical trials conducted prior to November 1, 2002.
MacroChem also has product liability insurance coverage with aggregate policy
limits between approximately $3,000,000 and $5,000,000 for claims related to
MacroChem product candidates that may arise from clinical trials conducted after
September 25, 2003. In the event that MacroChem products receive regulatory
approval and become commercialized, MacroChem would need to acquire additional
coverage. Product liability insurance is expensive, may be difficult to obtain
and may not be available on acceptable terms, if at all. If MacroChem obtains
coverage, MacroChem cannot guarantee that the coverage limits of these insurance
policies will be adequate. A successful claim against MacroChem if MacroChem is
uninsured, or which is in excess of MacroChem’s insurance coverage, could have a
material adverse effect on MacroChem and MacroChem’s financial
condition.
MacroChem
relies on a third-party supplier for a non-active ingredient in some of
MacroChem product candidates and, in the event the supplier is unable to supply
MacroChem with adequate product, MacroChem’s business may be negatively affected
if MacroChem are not able to timely obtain a substitute ingredient.
MacroChem
relies on a third-party supplier, Seppic Inc., for a non-active ingredient that
is important to the formulation and production of some of MacroChem topical
product candidates. While MacroChem believes similar products are available from
other suppliers, if Seppic Inc. were unable or unwilling to supply its product
in sufficient quantities at a reasonable price, MacroChem’s results could
suffer, as MacroChem may encounter significant costs and delays in identifying
and measuring the efficacy of replacement third party products.
28
Risks
Related to MacroChem’s Industry
MacroChem’s
industry is highly competitive and MacroChem’s competitors have or may have
significantly more resources than MacroChem.
MacroChem
competes with a number of firms, many of which are large, multi-national
organizations with worldwide distribution. MacroChem believes that MacroChem’s
major competitors in the drug delivery sector of the health care industry
include Anacor Pharmaceuticals, Bentley Pharmaceuticals, Inc., Biosante
Pharmaceuticals, Inc., NexMed, Inc., Connetics Corporation, Antares Pharma, Inc.
and Barrier Therapeutics, Inc. Competitors with approved products in the
therapeutic areas that MacroChem clinical stage product candidates seek to
address include, with respect to onychomycosis:
|
·
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Novartis
AG, maker of Lamisil®,
an oral therapy;
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·
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Johnson
& Johnson, maker of Sporanox®,
an oral therapy; and
|
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·
|
Sanofi
Aventis (Dermik Laboratories), maker of Penlac, a topical nail
lacquer.
|
and with
respect to male hypogonadism:
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·
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Solvay
Pharmaceuticals, Inc., maker of Androgel®, a
topical gel therapy;
|
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·
|
Auxilium
Pharmaceuticals, Inc., maker of Testim®, a
topical gel therapy;
|
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·
|
Watson
Pharmaceuticals, Inc., maker of Androderm®, a
transdermal patch; and
|
|
·
|
Columbia
Laboratories, Inc., maker of Striant®, a
buccal film which is placed between the patient’s cheek and
gum;
|
A number
of companies, including NexMed, Inc./Novartis AG, IVREA/MediQuest Therapeutics,
Inc., and Schering-Plough/Anacor Pharmaceuticals, Inc. are also developing
topical therapies for onychomycosis. In addition, a number of other companies,
including Auxilium Pharmaceuticals, Inc., are also developing topical and/or
transmucosal testosterone products.
With
respect to mild diabetic foot infection (DFI), there is currently no topical
treatment approved by the FDA. In addition, MacroChem are not aware of any other
companies working on a topical treatment for mild diabetic foot
infection.
These
companies have or may have substantially greater capital resources, research and
development and technical staff, facilities and experience in obtaining
regulatory approvals, as well as in manufacturing, marketing and distributing
products, than MacroChem. Recent trends in this industry are toward further
market consolidation of large drug companies into a smaller number of very large
entities, further concentrating financial, technical and market strength and
increasing competitive pressure in the industry. Academic institutions,
hospitals, governmental agencies and other public and private research
organizations also are conducting research and seeking patent protection and may
develop competing products or technologies of their own through joint ventures
or other arrangements. In addition, recently developed technologies, or
technologies that may be developed in the future, may or could be the basis for
competitive products which may be more effective or less costly to use than any
products that MacroChem currently is developing.
MacroChem
expects any future products approved for sale to compete primarily on the basis
of product efficacy, safety, patient compliance, reliability, price and patent
position. Generally, the first pharmaceutical product to reach the market in a
therapeutic or preventive area often has a significant commercial advantage
compared with later entrants to the market. MacroChem’s competitive position
also will depend on MacroChem’s ability to resume research and development
activities, engage third parties to conduct research and development activities,
attract and retain qualified scientific and other personnel, develop effective
proprietary products, implement production and marketing plans, obtain patent
protection and secure adequate capital resources.
Government
and private initiatives to reduce health care costs could have a material
adverse effect on pharmaceutical pricing and on MacroChem
operations.
The
future revenues and profitability of, and availability of capital for,
biomedical and pharmaceutical companies may be affected by the continuing
efforts of governmental and private third-party payers to contain or reduce the
costs of health care through various means. Reimbursement by payors such as
government and managed care organizations has become an increasingly important
factor in the success of a drug, as has the listing of new products on large
formulary lists (as well as their designated “Tier” on such lists), including
those of managed care organizations, pharmaceutical benefit providers and group
buying organizations. Failure of a pharmaceutical product to be included on
formulary lists, to obtain a Tier position on such formulary lists which
provides for a sufficiently low patient cost, or to be reimbursed by government
or managed care organizations, could negatively impact the profitability of a
drug.
Furthermore,
in some foreign markets pricing or profitability of prescription pharmaceuticals
is subject to government control and to possible reform in the health care
system. Frequently, it is not possible to obtain pricing in foreign markets that
is as favorable as that obtainable in the U.S. In the U.S., there have been, and
MacroChem expects there will continue to be, a number of federal and state
proposals to impose similar governmental control. While MacroChem cannot predict
whether any of these legislative or regulatory proposals will be adopted, the
announcement or adoption of these proposals could have a material adverse effect
on MacroChem prospects.
29
If
MacroChem succeeds in bringing to market one or more of MacroChem’s product
candidates, MacroChem cannot assure you that these product candidates will be
cost effective or that reimbursement to the consumer will be available or will
be sufficient to allow MacroChem to sell these products on a profitable
basis.
Risks Related to the
Securities Market
MacroChem’s
stock price has been, and likely will continue to be, highly volatile, and as a
result, an investment in MacroChem stock is subject to substantial
risk.
The
market price of MacroChem stock has been, and will likely continue to be, highly
volatile due to the risks and uncertainties described in this section of this
document, as well as other factors, including:
|
·
|
the
lack of any significant trading volume in the trading of MacroChem shares
on the OTC.BB market;
|
|
·
|
the
discontinuance in August 2005 of all of MacroChem research and product
development activities and MacroChem dependence on additional external
funding in resuming such
activities;
|
|
·
|
the
results of MacroChem previously conducted clinical trials for MacroChem
SEPA-based formulations;
|
|
·
|
conditions
and publicity regarding the pharmaceutical industry generally as well as
the specific therapeutic areas MacroChem product candidates seek to
address;
|
|
·
|
price
and volume fluctuations in the stock market at large which do not relate
to MacroChem operating performance;
and
|
|
·
|
MacroChem’s
ability to raise additional
capital.
|
Over the
two-year period ending December 31, 2007, the closing price of MacroChem common
stock as reported on the Pink Sheets LLC and the OTC Bulletin Board ranged from
a high of $2.70 to a low of $0.26. On November 24, 2008, the closing price for
MacroChem common stock on the OTC Bulletin Board was $0.025. In the past,
companies that have experienced stock price volatility have sometimes been the
subject of securities class action litigation. If litigation were instituted on
this basis, it could result in substantial costs and a diversion of management’s
attention and resources. As a result of this volatility, an investment in
MacroChem stock is subject to substantial risk.
On
November 22, 2005, MacroChem common stock was delisted from the Nasdaq Capital
Market for failure to meet its listing standards. MacroChem common stock
currently is quoted on the OTC Bulletin Board, which investors may perceive as
less desirable and which could negatively affect the liquidity of an investment
in MacroChem common stock.
MacroChem’s
listing on The Nasdaq Capital Market was conditioned on MacroChem’s compliance
with Nasdaq’s continued listing requirements. The minimum standards for
continued listing on The Nasdaq Capital Market include stockholders’ equity of
$2.5 million or market capitalization of $35 million and a minimum bid price of
$1.00.
On
October 18, 2005, MacroChem received a Nasdaq Staff Determination indicating
that MacroChem securities were subject to delisting from The Nasdaq Capital
Market as MacroChem did not comply with the minimum bid price requirement for
continued listing. MacroChem requested a hearing before a Nasdaq Listing
Qualifications Panel to review the Staff Determination. On November 21, 2005,
MacroChem withdrew its appeal of the Nasdaq Staff Determination and MacroChem
common stock was delisted from quotation on the Nasdaq Capital Market effective
as of Tuesday, November 22, 2005. Immediately thereafter, MacroChem common stock
was quoted on the Pink Sheets LLC, and on December 22, 2005, MacroChem stock
became eligible for quotation on the OTC Bulletin Board and presently trades
under the symbol “MACM.OB.”
The
over-the-counter market is generally considered to be a less efficient system
than markets such as Nasdaq or other national exchanges because of lower trading
volumes, transaction delays and reduced security analyst and news media
coverage. These factors could contribute to lower prices and larger spreads in
the bid and ask prices for MacroChem common stock. Additionally, trading of
MacroChem common stock in an over-the-counter market may make MacroChem less
desirable to institutional investors and may, therefore, limit MacroChem future
equity funding options.
Together,
certain of MacroChem shareholders own a majority of MacroChem stock and could
ultimately control decisions regarding MacroChem.
A small
group of investors hold approximately 62.77% of the outstanding common stock of
the MacroChem. Because these investors currently own a large portion of
MacroChem voting stock, they may be able to generally determine or they will be
able to significantly influence the outcome of corporate actions requiring
shareholder approval. As a result, these parties may be in a position to control
matters affecting MacroChem, including amendments to MacroChem’s articles of
incorporation and bylaws; payment of dividends on MacroChem common stock; and
acquisitions, sales of all or substantially all of MacroChem’s assets, mergers
or similar transactions, including transactions involving a change of control.
As a result, some investors may be unwilling to purchase MacroChem common stock.
In addition, if the demand for MacroChem common stock is reduced because of
these shareholders’ control of the MacroChem, the price of MacroChem common
stock could be materially depressed. In addition, for so long as SCO Capital
Partners, LLC owns 20% of MacroChem outstanding common stock, it has the right
to designate two individuals to serve on the MacroChem board of
directors.
30
Certain
of MacroChem’s shareholders own large blocks of MacroChem common stock and
securities exercisable into shares of MacroChem common stock, and any exercises,
or sales by these shareholders could substantially lower the market price of
MacroChem common stock.
Several
of MacroChem’s shareholders own large blocks of MacroChem voting stock. The
resale of the shares of MacroChem common stock owned by these shareholders
(issuable to them upon exercise of outstanding warrants to purchase MacroChem
common stock) could substantially depress MacroChem’s stock price.
If
further material weaknesses are identified and reported as to the adequacy of
MacroChem internal controls over financial reporting as of December 31, 2008, as
required by Section 404 of the Sarbanes-Oxley Act of 2002, investors could lose
confidence in the reliability of MacroChem financial statements, which could
result in a decrease in the value of your investment.
As
directed by Section 404 of the Sarbanes-Oxley Act of 2002, the Securities and
Exchange Commission, or SEC, adopted rules requiring public companies to include
in their annual reports on Form 10-K a report of management on the MacroChem’s
internal controls over financial reporting, including management’s assessment of
the effectiveness of the MacroChem’s internal controls over financial reporting
as of MacroChem’s fiscal year end. In addition, the accounting
firm auditing MacroChem’s financial statements must also attest to, and report
on, the operating effectiveness of the MacroChem’s internal controls beginning
in 2009. As of December 31, 2007, Management concluded that
MacroChem’s internal control over financial reporting contained a material
weakness due to a lack of segregation of duties and ability to properly account
for complex and nonroutine transactions. Fiscal 2009 currently will
be the first year for which MacroChem must undergo the auditor attestation
process required by Section 404 and there is a risk that MacroChem may not
comply with all of its requirements. If MacroChem’s internal controls are not
designed or operating effectively as required by Section 404, MacroChem's
independent auditors may either disclaim an opinion as it relates to
management’s assessment of the effectiveness of its internal controls or may
issue an adverse opinion on the effectiveness of MacroChem’s internal
controls. If MacroChem is unable to remediate any material weaknesses by
December 31, 2009, MacroChem’s independent auditors will be required to issue an
adverse opinion on MacroChem’s internal controls. If MacroChem’s independent
auditors disclaim an opinion as to the effectiveness of MacroChem’s internal
controls or if they render an adverse opinion due to the material weaknesses in
MacroChem’s internal controls, then investors may lose confidence in the
reliability of MacroChem’s financial statements, which could cause the market
price of MacroChem’s common stock to decline and make it more difficult for
MacroChem to raise capital in the future.
31
CAUTIONARY
STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS
This
information statement/prospectus and the other documents incorporated by
reference into this information statement/prospectus contain or may contain
“forward-looking statements” intended to qualify for the safe harbor from
liability established by the Private Securities Litigation Reform Act of 1995.
These statements can be identified by the fact that they do not relate strictly
to historical or current facts. Access and MacroChem have based these
forward-looking statements on its current expectations about future events.
Further, statements that include words such as “may,” “will,” “project,”
“might,” “expect,” “believe,” “anticipate,” “intend,” “could,” “would,”
“estimate,” “continue” or “pursue,” or the negative of these words or other
words or expressions of similar meaning, may identify forward-looking
statements. These forward-looking statements are found at various places
throughout this information statement/prospectus and the other documents
incorporated by reference. These forward-looking statements, including, without
limitation, those relating to future actions, new projects, strategies, future
performance, the outcome of contingencies such as legal proceedings and future
financial results, in each case relating to Access or MacroChem, respectively,
wherever they occur in this information statement/prospectus or the other
documents incorporated by reference herein, are necessarily estimates reflecting
the best judgment of the respective management of Access and MacroChem and
involve a number of risks and uncertainties that could cause actual results to
differ materially from those suggested by the forward-looking statements. These
forward-looking statements should, therefore, be considered in light of various
important factors, including those set forth in this information
statement/prospectus and incorporated by reference into this information
statement/prospectus. In addition to the risk factors identified elsewhere,
important factors that could cause actual results to differ materially from
estimates or projections contained in the forward-looking statements include,
without limitation:
|
|
•
|
the
effects of local and national economic, credit and capital market
conditions on the economy in general, and on the pharmaceutical industry
in particular, and the effects of foreign exchange rates and interest
rates;
|
| • |
the
ability to obtain or meet the closing conditions in the merger agreement,
including applicable regulatory and tax requirements, and to otherwise
complete the merger in a timely
manner;
|
|
•
|
the
ability to timely and cost-effectively integrate the operations of Access
and MacroChem;
|
|
•
|
the
ability to realize the synergies and other perceived advantages resulting
from the merger;
|
|
•
|
access
to available and feasible financing on a timely
basis;
|
|
•
|
the
ability to retain key personnel both before and after the
merger;
|
|
•
|
the
ability of each company to successfully execute its business
strategies;
|
|
•
|
the
extent and timing of market acceptance of new products or product
indications;
|
|
•
|
the
ability of each company to procure, maintain, enforce and defend its
patents and proprietary rights;
|
|
•
|
changes
in laws, including increased tax rates, regulations or accounting
standards, third party relations and approvals, and decisions of courts,
regulators and governmental bodies;
|
|
•
|
litigation
outcomes and judicial actions, including costs and existing or additional
litigation associated with the merger, and legislative action, referenda
and taxation;
|
|
•
|
acts
of war or terrorist incidents; and
|
|
•
|
the
effects of competition, including locations of competitors and operating
and market competition.
|
You are
cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date of this information statement/prospectus or, in the
case of documents incorporated by reference, as of the date of those documents.
Neither Access nor MacroChem undertakes any obligation to publicly update or
release any revisions to these forward-looking statements to reflect events or
circumstances after the date of this information statement/prospectus or to
reflect the occurrence of unanticipated events, except as required by
law.
32
THE
MERGER
This section of the information
statement describes the merger and related transactions. Although MacroChem
believes that the description in this section covers the material terms of the
merger and the transactions, this summary may not contain all of the information
that is important to you. You must carefully read the entire information
statement and the other documents MacroChem refers to in this information
statement, including the Merger Agreement, for a more complete understanding of
the Merger Agreement and the transactions contemplated
thereby.
General
The
Merger Agreement provides that, at the Effective Time of the merger, MACM
Acquisition Corp., a Delaware corporation and a wholly-owned subsidiary of
Access, will merge with and into MacroChem, with MacroChem continuing in
existence as the surviving corporation. Each share of MacroChem
Common Stock issued and outstanding at the Effective Time will be converted into
approximately 0.05423180 shares of Access’ common stock with such exchange not
to exceed in aggregate 2,500,000 shares of Access common stock.
Outstanding
MacroChem warrants and options to purchase shares of MacroChem common stock
shall be treated as follows:
|
·
|
Any
in-the-money MacroChem warrants will convert into the right to receive a
portion of the merger consideration (as described above) at the Effective
Time and shall no longer be outstanding and shall be cancelled, retired
and shall cease to exist following the Effective
Time;
|
|
·
|
Any
MacroChem options and MacroChem warrants which are not exercised or
converted prior to the Effective Time shall not be assumed by Access and
all such securities either shall be exercised or terminated prior to the
Effective Time.
|
Certain
of MacroChem’s convertible promissory notes outstanding at the Effective Time
will convert automatically into the right to receive a number of shares of
common stock of Access at the closing price of such shares on July 10, 2008; all
remaining convertible promissory notes of MacroChem will be assumed by Access at
the Effective Time.
The
articles of incorporation and bylaws of MACM Acquisition Corp. will be MacroChem
articles of incorporation and bylaws from and after the Effective
Time.
MacroChem’s
officers and directors will resign effective as of the Effective Time of the
merger, except that Jeffrey B. Davis, Access’ CEO and a director of both Access
and MacroChem will remain a director of MacroChem after the
merger. As of the Effective Time, Mr. Davis shall become an officer
of MacroChem.
Background
of the Merger
Beginning
on or about June 16, 2008, members of MacroChem’s Board of Directors and the
Board of Directors of Access commenced dialogue about the possibility of merging
MacroChem with Access. The parties continued to consider the possibilities
throughout the week of June 16, 2008 including, without limitation, deal
structure and material terms. On June 26, 2008, MacroChem’s Board of Directors
met to discuss MacroChem’s cash flows and business development activities
recently conducted along with an update on third party discussions of the nature
of mergers and acquisitions. MacroChem’s Board of Directors engaged in a lengthy
discussion of MacroChem’s strategic focus and agreed management should continue
to pursue all ongoing business development and potential merger discussions on a
parallel track given MacroChem’s cash needs. Thereafter, management of MacroChem
and of Access continued to negotiate transaction terms. Further discussion
ensued during the week of June 30, 2008. During this period, Access and
MacroChem signed a Confidentiality Agreement on July 2, 2008 and each company’s
management team supplied the other company with corporate and other records,
agreements and documents for the purpose of performing due diligence on the
business and operations of the other company. Members of Access’ management and
Board of Directors requested a contract be drafted on the terms and provisions
then being considered in ongoing negotiations and MacroChem’s management
delivered a proposed merger agreement to Access during the week of June 30,
2008. On July 9, 2008, after each company had completed its due diligence
process, MacroChem’s Board of Directors and the Access Board of Directors each
approved entering into the definitive Merger Agreement, the merger and the
transactions contemplated thereby. On July 10, 2008, Access and
MacroChem executed the Merger Agreement.
MacroChem’s
Reasons for the Merger and Recommendation
In
reaching the decision to adopt the Merger Agreement and recommend it for
approval by the respective equity holders of the companies, MacroChem Board of
Directors and the Board of Directors of Access consulted with respective
management, as well as outside advisors. As discussed in greater detail below,
these consultations included discussions regarding Access’ strategic business
plan, the costs and risks of executing MacroChem’s business plan as a public
company, MacroChem’s cash position and prospects for raising more cash, its past
and current business operations, and its future prospects, the strategic
rationale for the potential transaction with Access and the terms and conditions
of the Merger Agreement.
33
MacroChem’s
Board of Directors determined that the merger is advisable and in the best
interest of MacroChem’s stockholders. In reaching its decision to approve the
Merger Agreement, MacroChem’s Board of Directors reviewed Access’ business
strategy and financial position and MacroChem management reviewed Access’ key
contracts and performed a due diligence investigation. MacroChem’s Board of
Directors identified and considered several factors in its assessment, which,
when taken as a whole, supported the decision to approve the merger and Merger
Agreement.
These
factors and potential benefits of the merger considered by MacroChem’s Board
included the following:
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•
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the
ability of the combined company to potentially secure investor capital and
financing for development of MacroChem product
portfolio;
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|
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•
|
the
cash reserve of Access positioning MacroChem products back in development
in the near term;
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•
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MacroChem’s
cash reserves were not sufficient for MacroChem to continue operations as
a going concern beyond the third quarter of 2008;
|
|
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•
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leveraging
Access’ existing research and development capabilities and general and
administrative infrastructure to further reduce MacroChem overhead
associated with ongoing development;
|
|
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•
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elimination
of certain contingent liabilities associated with MacroChem’s potential
financing efforts if MacroChem were to remain stand-alone rather than
merge with Access; and
|
|
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•
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The
remote likelihood that potential alternative transactions will be
available to MacroChem or if available if any such transactions would be
likely to close in sufficient time based on the MacroChem’s cash
position.
|
|
|
Access’
Board of Directors considered the following additional
factors:
|
||
|
•
|
access
to a rich pipeline of products including those in the late stages of
clinical development and attractive early stage oncology products;
and
|
|
|
•
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securing
a rich pipeline of products at an attractive price based upon the stage of
corporate development within which MacroChem is
situated.
|
|
Taking
into account all of the material facts, matters and information, including those
described above, MacroChem’s Board of Directors and the Board of Directors of
Access believe that the Merger Agreement is advisable and fair to and in the
best interests of each of MacroChem and Access and each company’s respective
equity holders.
No
Independent Financial Advisor
Neither
MacroChem nor Access has engaged an independent financial advisor to consult
with, or render an opinion on, the relative advantages and disadvantages of the
transactions.
Vote
Required
Section
228 of the DGCL provides that any action required or permitted to be taken at a
meeting of the stockholders may be taken without a meeting if, before or after
the action, a written consent is signed by stockholders holding at least a
majority of the voting power, except that if a different proportion of voting
power is required for such an action at a meeting, then that proportion of
written consents is required. In order to eliminate the costs and management
time involved in obtaining proxies and in order to effect the proposals as early
as possible in order to accomplish MacroChem purposes as described herein,
MacroChem’s Board of Directors decided to utilize, and did in fact obtain by
written consent dated July 30, 2008 of the Majority Stockholders, holding 63% of
MacroChem’s Common Stock, approving each of the actions.
Completion
and Effectiveness of the Merger
The
merger will be completed when all of the conditions to completion of the merger
are satisfied or waived. The merger will become effective upon the
filing of a certificate of merger with the Secretary of State of the State of
Delaware.
Appraisal
Rights
Under
Delaware law, MacroChem stockholders are entitled, after complying with certain
requirements of Delaware law, to dissent from the approval of the authority with
respect to the merger, pursuant to Section 262 of the DGCL (“Dissenters’ Law”)
and to be paid the “fair value” of their shares of MacroChem’s Common Stock in
cash by complying with the procedures set forth in the Dissenters’ Law. Set
forth below is a summary of the procedures relating to the exercise of appraisal
rights by MacroChem stockholders. This summary does not purport to be a complete
statement of the provisions of the Dissenters’ Law and is qualified in its
entirety by reference to such provisions, which are contained in Appendix D to this
information statement.
34
MacroChem
is sending a notice of appraisal rights to MacroChem stockholders with this
information statement, attached as Appendix C to this
information statement. Dissenting stockholders must, by no later than 20 days
following MacroChem’s mailing of the notice of appraisal rights demand in
writing from MacroChem or Access the appraisal of such holders’
shares.
THE
MERGER AGREEMENT
This
section summarizes the material provisions of the Merger Agreement. The
following is not a complete statement of all the provisions of the Merger
Agreement. Detailed terms and conditions are contained in the Merger Agreement,
a copy of which is attached to this information statement as Appendix A and is
incorporated into this information statement by reference. For a complete
presentation of this information, please read the full text of the Merger
Agreement.
Structure of the Merger and
Conversion of MacroChem Common Stock and In the Money MacroChem
Warrants
General
Pursuant
to the Merger Agreement, MACM Acquisition Corp. will merge with and into
MacroChem, with MacroChem being the surviving corporation and a wholly-owned
subsidiary of Access (“Parent”). The merger will become effective as
of the date and at such time as the Certificate of Merger is filed with the
Secretary of State of the State of Delaware (the “Effective
Time”). In accordance with the terms of the Merger Agreement, at the
Effective Time, each share of MacroChem common stock and in-the-money MacroChem
warrants outstanding immediately prior to the Effective Time will be converted
into the right to receive a proportional share of an aggregate of approximately
2,500,000 fully paid and non-assessable shares of Access common stock, par value
$0.01 per share (“Access Common Stock”), subject to certain adjustments under
the terms of the Merger Agreement. After the merger is completed, it is expected
that MacroChem pre-merger stockholders will own approximately 2,500,000 shares
of Access Common Stock or approximately 12.6% of the outstanding shares of the
combined company, subject to adjustment under the terms of the Merger
Agreement. At the Effective Time, shares of MacroChem common stock
will no longer be outstanding and shall automatically be cancelled and retired
and cease to exist, and each holder of MacroChem common stock shall cease to
have any rights with respect to the shares of MacroChem common stock, except the
right to receive the merger consideration (as described above).
No
fractions of a share of Access Common Stock will be issued, and in lieu of such
issuance, a holder of MacroChem Common Stock or In the Money MacroChem Warrants,
as the case may be, who would otherwise be entitled to a fraction of a share of
Access Common Stock as a result of the exchange of shares contemplated by the
Merger Agreement will receive from MacroChem cash in lieu of such fractional
share(s) based on a formula set forth in the Merger Agreement. In
addition, at the Effective Time, by virtue of consummating the Merger, Access
will have assumed all of MacroChem’s liabilities and other
obligations.
Exchange
Ratios
At the
Effective Time, Access will issue to the holders of MacroChem common stock and
in-the-money MacroChem warrants an aggregate of approximately 2,500,000 shares
of Access Common Stock. Each holder of MacroChem common stock at the
Effective Time will receive approximately 0.05423180 shares of Access Common
Stock for each share of MacroChem common stock. Each holder of
in-the-money MacroChem warrants will receive that number of shares of Access
Common Stock as would have been received had such holder converted such
in-the-money MacroChem warrants to shares of MacroChem common stock immediately
prior to the Effective Time in a cashless exercise, and then applying the same
exchange ratio as applied above to holders of MacroChem common stock at the
Effective Time.
Exchange
of MacroChem Common Stock for certificates representing shares of Access Common
Stock
When the
merger is completed, shares of MacroChem Common Stock will be canceled and the
former holders of MacroChem common stock will receive certificates representing
shares of Access Common Stock which constitute the number of full shares of
Access Common Stock to which they are entitled under the Merger Agreement. No
fractional shares will be issued and instead Access will pay cash in lieu of
issuance of any fractional shares as provided by the terms of the Merger
Agreement.
Restrictions
on Sales of Shares Held by holders of Access Common Stock
Shares of
Access Common Stock to be issued to holders of MacroChem common stock and
in-the-money MacroChem warrants in the merger will be registered by Access in a
registration statement on form S-4 prior to the Effective Time and shall not be
the subject of any stop order or proceedings seeking a stop
order. Certain of such shares shall be subject to the requirements of
Rule 144. Any material “blue sky” and other state securities laws applicable to
the registration and qualification of Access Common Stock issuable or required
to be reserved for issuance pursuant to the Merger Agreement will have been
complied with.
35
Conditions to the
Merger
Conditions
to Access’ and MacroChem’s Obligations
Neither
Access nor MacroChem are obligated to complete the merger unless various
conditions are satisfied or waiver, including without limitation the
following:
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No
temporary restraining order, preliminary or permanent injunction or other
order issued by any court of competent jurisdiction or other legal
restraint or prohibition preventing the consummation of the Merger shall
be in effect; provided, however, that the Access and MacroChem shall use
their reasonable best efforts to have any such injunction, order,
restraint or prohibition vacated;
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Other
than the filing of the Delaware Certificate of Merger, all authorizations,
consents, orders or approvals of, or declarations or filings with, or
expirations of waiting periods imposed by, any governmental entity in
connection with the Merger and the consummation of the other transactions
contemplated by the Merger Agreement, the failure of which to file, obtain
or occur is reasonably likely to have a Material Adverse Effect with
respect to Access or a Material Adverse Effect with respect to MacroChem,
shall have been filed, been obtained or occurred on terms and conditions
which would not reasonably be likely to have a Material Adverse Effect
with respect to Access or MacroChem;
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This
Form S-4 shall have become effective under the Securities Act and shall
not be the subject of any stop order or proceedings seeking a stop order,
and any material "blue sky" and other state securities laws applicable to
the registration and qualification of Access Common Stock issuable or
required to be reserved for issuance pursuant to this Merger Agreement
shall have been complied with;
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No
stop order suspending the use of the Information Statement shall have been
issued and no proceeding for that purpose shall have been initiated or
threatened in writing by the SEC or its staff;
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The
Merger and the Merger Agreement shall have been approved and adopted by
the requisite vote of the holders of shares of MacroChem Common Stock to
the extent required pursuant to the requirements of the certificate of
incorporation and the DGCL;
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Conditions
to Access’ Obligations
Access is
not obligated to complete the merger unless various conditions are satisfied or
waived, including without limitation the following:
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The
representations and warranties of MacroChem contained in the Merger
Agreement shall be true and correct in all material respects on and as of
the Closing Date, with the same force and effect as if made on and as of
the Closing Date, except for (i) changes contemplated by the Merger
Agreement or in the applicable disclosure schedules,
(ii) representations and warranties that are qualified by materiality
or Material Adverse Effect, in which case such representations and
warranties shall be true and correct in all respects, and
(iii) representations and warranties which address matters only as of
a particular date, in which case such representations and warranties
qualified as to materiality or Material Adverse Effect shall be true and
correct in all respects, and those not so qualified shall be true and
correct in all material respects, on and as of such particular
date;
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MacroChem
has performed, in all material respects, all obligations and complied with
all covenants required by the Merger Agreement to be performed or complied
with, in all material respects, by MacroChem prior to the Effective
Time;
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Access
and MACM Acquisition Corp. shall have received evidence to its reasonable
satisfaction that such licenses, permits, consents, approvals,
authorizations, qualifications and orders of governmental authorities and
other third parties as are necessary in connection with the transactions
contemplated by the merger have been obtained, except where the failure to
do so would not, individually or in the aggregate, have a material adverse
effect with respect to the MacroChem;
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There
shall be no pending third party litigation or pending or threatened
litigation with any governmental entity (i) challenging or seeking to
restrain or prohibit the consummation of the Merger or the transactions
contemplated thereby, (ii) seeking to prohibit or limit the ownership or
operation by MacroChem of any material portion of the business or assets
of MacroChem, or (iii) seeking to impose limitations on the ability of
Access to acquire or hold any shares of common stock of the Surviving
Corporation;
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MacroChem
shall have complied with the requirements of the 1994 Equity Incentive
Plana and the 2001 Incentive Plan and all outstanding MacroChem options
and MacroChem warrants not exercised prior to the Effective Time shall be
terminated and the in-the-money MacroChem warrants shall automatically
convert into the right to receive the Merger Consideration (Access Common
Stock) as provided in the Merger Agreement;
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As
of the Effective Time Access and MacroChem’s President & Chief
Business Officer shall have mutually agreed on terms to discharge the
MacroChem’s obligations and agree upon the terms of, if any, a consulting
and transition agreement;
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Since
the dated of the Merger Agreement, there shall not have occurred any
Material Adverse Effect or Material Adverse Change (in each case as
defined in the Merger Agreement) with respect to
MacroChem;
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Any
applicable period during which stockholders of MacroChem have the right to
exercise appraisal, dissenters’ or other similar rights under Section 262
of the DGCL or other applicable law shall have expired and stockholders of
MacroChem holding in the aggregate more than five percent of the
outstanding shares of MacroChem common stock shall not have exercised
appraisal, dissenters’ or similar rights under Section 262 of the DGCL or
other applicable law with respect to such shares by virtue of the Merger;
and
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The
directors and officers of MacroChem, in office immediately prior to the
Effective Time, shall have resigned as directors and officers of the
Surviving Corporation effective as of the Effective
Time.
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The
MacroChem shall have delivered a properly executed statement, dated as of
the Closing Date, in a form reasonably acceptable to Access, conforming to
the requirements of Treasury Regulations Section
1.1445-2(c)(3).
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Conditions
to MacroChem Obligations
MacroChem
is not obligated to complete the merger unless various conditions are satisfied
or waived, including, without limitation, the following:
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The
representations and warranties of Access contained in the Merger Agreement
shall be true and correct in all material respects on and as of the
Closing Date, with the same force and effect as if made on and as of the
Closing Date, except for (i) changes contemplated by the Merger
Agreement or in the applicable disclosure schedules,
(ii) representations and warranties that are qualified by materiality
or Material Adverse Effect, in which case such representations and
warranties shall be true and correct in all respects, and
(iii) representations and warranties which address matters only as of
a particular date, in which case such representations and warranties
qualified as to materiality or Material Adverse Effect shall be true and
correct in all respects, and those not so qualified shall be true and
correct in all material respects, on and as of such particular
date;
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Access
shall have performed, in all material respects, all obligations and
complied with all covenants required by the Merger Agreement to be
performed or complied with, in all material respects, by it prior to the
Closing Date;
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There
shall not be pending by any governmental entity or any other person or
solely with respect to any governmental entity, threatened by any suit,
action or proceeding, challenging or seeking to restrain or prohibit the
consummation of the Merger or any of the other transactions contemplated
by the Merger Agreement; and
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MacroChem
shall have received evidence to MacroChem’s reasonable satisfaction that
such licenses, permits, consents, approvals, authorizations,
qualifications and orders of governmental authorities and other third
parties as are necessary in connection with the transactions contemplated
by the merger have been obtained, except where the failure to do so would
not, individually or in the aggregate, have a material adverse effect with
respect to Access.
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Termination
Subject
to certain circumstances set forth in the Merger Agreement, either MacroChem or
Access may terminate the Merger Agreement since the Merger was not consummated
prior to October 31, 2008. With the exception of breaches of certain
covenants and breaches of confidentiality, if either party terminates the
agreement for this reason, then neither party shall have any further right or
obligation as against any other.
Conduct
of Business of MacroChem
In the
Merger Agreement, MacroChem agreed to conduct MacroChem businesses in the
ordinary course before the completion of the Merger and not to take various
actions that could affect MacroChem businesses without the prior consent of
Access. Until the termination of the Merger Agreement or completion of the
Merger, MacroChem will not, except as previously disclosed to Access take such
actions including, but not limited to the follow:
37
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declare
or pay any dividends or make other distributions or split, combine or
reclassify, purchase or redeem any capital stock of
MacroChem;
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authorize
for issuance, issue, deliver, sell, or pledge any capital stock or voting
securities of MacroChem or any Subsidiary;
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amend
its Certificate of Incorporation or Bylaws or other comparable charter or
organizational documents of MacroChem or any
Subsidiary;
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acquire
or agree to acquire by merging or consolidating with, or by purchasing all
or a substantial portion of the stock or assets of, or by any other
manner, any business or any corporation or other business organization or
division thereof;
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sell,
lease, license, mortgage or otherwise encumber any of the properties or
assets of MacroChem other than in the ordinary course of
business;
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incur
any indebtedness or guarantee any indebtedness of another person or entity
or amend, terminate or seek a waiver with respect to any existing
agreement of the MacroChem evidencing indebtedness of MacroChem or make
any loans, advances or capital contributions to, or investments in, any
other person;
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acquire
or agree to acquire any assets, other than inventory in the ordinary
course of business, or make or agree to make any capital
expenditures;
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pay,
discharge or satisfy any claims, liabilities or obligations, except for
payment of liabilities in the ordinary course of business consistent with
past practice and in accordance with their terms in effect on the date of
the Merger Agreement;
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adopt
a plan of complete or partial liquidation or resolutions providing for or
authorizing such liquidation or a dissolution, merger, consolidation,
restructuring, recapitalization or reorganization;
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change
any material accounting principle;
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settle
or compromise any litigation
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transfer
to any person any rights to its intellectual property;
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enter
into any agreement pursuant to which any other party is granted exclusive
marketing or other exclusive rights of any type with respect to its
products or technology; and
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make
any material tax election.
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Representations
and Warranties
The
Merger Agreement contains various representations and warranties of Access and
Merger Sub, including, among others, representations and warranties as to the
following:
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Access’
and Merger Sub’s valid existence and good standing and its corporate power
and authority to carry on its business;
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Access’
capitalization;
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Access’
and Merger Sub’s power and authority to enter into and perform its
obligations under the Merger Agreement;
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Access’
and Merger Sub’s power and authority to enter into and perform its
obligations under the Merger Agreement;
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the
accuracy of Access’ financial statements, and the absence of any material
liabilities and material claims not disclosed
therein;
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the
accuracy of information supplied by Access or Merger Sub included in its
Form S-4;
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the
absence of any Material Adverse Change with respect to Access since March
31, 2008;
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the
absence of any pending or threatened litigation against Access, its
properties and its business and Access’ compliance with all applicable
laws, rules and regulations;
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the
Merger Agreement has been approved by Access as the sole stockholder of
Merger Sub;
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the
accuracy and timely filing of tax returns by Access;
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the
absence of any brokers in the Merger transaction; and
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the
accuracy of statements included in certain certificates of officers of
Access.
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The
Merger Agreement also contains various representations and warranties of
MacroChem’s, including, among others, representations and warranties as to the
following:
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MacroChem’s
valid existence and good standing and MacroChem corporate power and
authority to carry on MacroChem business;
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MacroChem’s
ownership of subsidiaries;
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MacroChem’s
capitalization;
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MacroChem’s
power and authority to enter into and perform MacroChem obligations under
the Merger Agreement and related agreements;
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the
accuracy of MacroChem’s financial statements, reports filed with the SEC,
and the lack of any material liabilities and material claims not disclosed
therein;
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MacroChem’s
maintenance and effectiveness of disclosure controls and
procedures;
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the
accuracy of information supplied by MacroChem included in Access’ Form
S-4;
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the
absence of any Material Adverse Change with respect to Access since March
31, 2008;
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the
absence of any pending or threatened litigation against Access, its
properties and its business and Access’ compliance with all applicable
laws, rules and regulations;
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the
absence of any work stoppage or labor disputes;
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the
accuracy of disclosure relating to MacroChem’s employee benefit
plans;
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the
accuracy and timely filing of tax returns by MacroChem;
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MacroChem’s
ownership of good and marketable title to all properties and assets and
good and valid leasehold interests in all real property
leases;
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MacroChem’s
compliance with environmental laws;
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the
accuracy of information regarding MacroChem’s debts and contractual
obligations;
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the
absence of any brokers in the Merger transaction;
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MacroChem
ownership and rights in its intellectual property;
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MacroChem’s
compliance with regulatory requirements; and
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MacroChem
maintenance of insurance policies.
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39
Accounting
Treatment
The
merger, for accounting and financial reporting purposes, will be accounted for
as stock acquisition of MacroChem by Access. As such, Access will be
the surviving company in the merger.
Material United States
Federal Income Tax Consequences
The
following is a summary of certain material United States federal income tax
consequences of the merger. The following discussion is based upon the current
provisions of the Internal Revenue Code of 1986, as amended (the “Code”),
Treasury Regulations promulgated under the Code, Internal Revenue Service
(“IRS”) rulings and pronouncements, and judicial decisions now in effect, all of
which are subject to change at any time by legislative, judicial or
administrative action. Any such changes may be applied
retroactively.
Neither
MacroChem nor Access has sought and they will not seek any rulings from the IRS
or opinions from counsel with respect to the United States federal income tax
consequences discussed below. The discussion below does not in any way bind the
IRS or the courts or in any way constitute an assurance that the United States
federal income tax consequences discussed below will be accepted by the IRS or
the courts. The tax treatment of a stockholder may vary depending on such
stockholder’s particular situation or status. With respect to holders of
MacroChem Common Stock, this discussion is limited to holders of MacroChem
Common Stock who hold their MacroChem Common Stock as capital assets and it does
not address aspects of United States federal income taxation that may be
relevant to MacroChem holders of MacroChem Common Stock who are subject to
special treatment under United States federal income tax laws, such as dealers
in securities, financial institutions, insurance companies, tax-exempt entities,
persons holding MacroChem Common Stock as part of a hedge, straddle or other
risk reduction transaction, and persons that are subject to loss disallowance
rules with respect to their shares of MacroChem Common Stock. In
addition, the discussion does not consider the effect of any applicable foreign,
state, local or other tax laws, or estate or gift tax considerations or the
alternative minimum tax. MacroChem provides no assurance with respect to any
individual holder’s tax status or taxable position with respect to the Merger,
the Merger Agreement or the transactions contemplated thereby and holders are
encouraged to seek independent advice from the tax advisors.
HOLDERS
OF MACROCHEM COMMON STOCK SHOULD CONSULT THEIR OWN TAX ADVISORS AS TO THE
PARTICULAR TAX CONSEQUENCES TO THEM OF THE MERGER, INCLUDING THE APPLICABILITY
AND EFFECT OF ANY STATE, LOCAL OR FOREIGN TAX LAWS AND OF CHANGES IN APPLICABLE
TAX LAWS.
The
following notice is based on United States Treasury Regulations governing
practice before the IRS: (1) any United States federal tax advice contained in
this information statement is not intended or written to be used, and cannot be
used by any taxpayer, for the purpose of avoiding United States federal tax
penalties that may be imposed on the taxpayer, (2) any such advice is written to
support the promotion or marketing of the transactions described in this
memorandum, and (3) each taxpayer should seek advice based on the taxpayer’s
particular circumstances from an independent tax advisor.
MacroChem
has elected to be subject to tax as a “corporation” for federal income tax
purposes. As a result, the merger is intended to qualify for federal income tax
purposes as a “tax-free reorganization” within the meaning of Section 368(a) of
the Code. Assuming the merger qualifies as a tax-free reorganization, (i) no
gain or loss will be recognized for federal income tax purposes by the holders
of MacroChem Common Stock upon consummation of the merger, (ii) neither
MacroChem nor Access will recognize any gain or loss as a result of the merger,
(iii) the aggregate tax basis of the shares of Access Common Stock received in
the merger by all holders of MacroChem Common Stock will be the same as the
aggregate tax basis of the shares of MacroChem Common Stock held by such holders
prior to the Effective Time, and (iv) the holding period of the Common Stock
received in the merger will include the period for which the shares of MacroChem
Common Stock were held.
40
Indemnification
and Insurance
Under the
terms of the Merger Agreement, Access agreed, following completion of the
merger, to indemnify and hold harmless any person eligible for
indemnification pursuant to MacroChem’s certificate of incorporation or bylaws
or any agreement of indemnification, in each case as the same existed on July 9,
2008, the date of the Merger Agreement, for any claims arising out of (i) the
fact that such person was an officer, director or employee of MacroChem,
pertaining to matters existing on or prior to the Effective Date and (ii)
indemnified liabilities resulting from the transaction contemplated by the
Merger Agreement.
Reasonable Best Efforts to Complete
the Merger
Under the
terms of the merger agreement, each of Access and MacroChem has agreed to
cooperate fully with the other and use its reasonable best efforts to take all
actions, and to do all things necessary, proper or advisable to complete the
merger in the most expeditious manner possible, including:
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obtaining
all consents, approvals, waivers, licenses, permits or authorizations as
are required to be obtained in connection with the
merger;
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defending
any lawsuit or proceeding seeking to challenge the merger agreement or the
merger contemplated by the merger
agreement;
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accepting
and delivering any additional instruments necessary to consummate the
merger;
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satisfying
the conditions to closing set forth in the merger
agreement.
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MacroChem
Prohibited from Soliciting Other Offers
Under the
terms of the merger agreement, subject to certain exceptions described below,
MacroChem agreed that it will not, directly or indirectly:
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solicit,
initiate or take any action knowingly to facilitate the submission of
inquiries, proposals or offers from any person (other than Access or
MacroChem Acquisition Corporation) relating to an acquisition
proposal;
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enter
into or participate in any discussions or negotiations regarding any
acquisition proposal, or furnish to any other person any information with
respect to its business, properties or assets or any acquisition proposal,
or otherwise cooperate in any way with, or knowingly assist or participate
in, facilitate or encourage, any effort or attempt by any other person
(other than Access or MacroChem Acquisition Corporation) to do or seek any
acquisition proposal.
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In
addition, MacroChem agreed that it will not authorize or permit any of its
subsidiaries, directors, officers, employees, agents or representatives
(including any retained investment banker, attorney or accountant), to do any of
the foregoing.
For
purposes of the restrictions described above, an acquisition proposal is any
inquiry, proposal or offer, filing of any regulatory application or disclosure
of any intention relating to any of the following:
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the
direct or indirect acquisition by any person or group of equity securities
representing 33.3% or more of the consolidated assets or any class of
securities of MacroChem and/or its
subsidiaries;
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a
tender offer or exchange offer that would result in any person owning
33.3% or more of any class of equity securities of MacroChem or any of its
subsidiaries;
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any
merger, consolidation, business combination or similar transaction
involving MacroChem or any of its subsidiaries whose assets individually
or in the aggregate, constitute more than 33.3% of MacroChem's
consolidated assets, other than transactions specifically permitted under
the merger agreement; or
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any
transaction, the consummation of which would or could reasonably be
expected to impede, interfere with, prevent or materially delay the
merger.
|
Under the
merger agreement, MacroChem also agreed, and agreed to cause their subsidiaries,
affiliates, directors, officers, employees, agents and representatives
(including any retained investment banker, attorney or accountant),
to:
|
•
|
cease
all existing activities or negotiations with respect to any acquisition
proposal; and
|
|
•
|
not
release any third party from, or waive any provisions of, any existing
confidentiality or standstill agreement with respect to any acquisition
proposal.
|
41
Notwithstanding
the prohibitions described above, MacroChem may (either directly or indirectly
through advisors, agents or other intermediaries):
· furnish
information, pursuant to an appropriate confidentiality letter (a copy of which
is required to be provided to Access), concerning MacroChem and its businesses,
properties or assets to a third party who has made a bona fide transaction
proposal;
· engage
in discussions or negotiations with a third party who has made a bona fide
transaction proposal;
· following
receipt of a bona fide transaction proposal, make disclosure to its
stockholders;
· following
receipt of a bona fide transaction proposal, fail to make or withdraw or modify
the recommendation of its board of directors; and/or
· take
any action required to be taken by MacroChem pursuant to a non-appealable, final
order by any court of competent jurisdiction.
The
actions referred to above may be taken only to the extent that the board of
directors of MacroChem shall have concluded in good faith on the basis of advice
from outside counsel that such action is required in order to satisfy its
fiduciary duties to the stockholders of MacroChem under applicable law and not
until after prompt advance notice to Access with respect to such
action. The MacroChem board of directors is required to continue to
advise Access after taking such action, including disclosing the terms and
conditions of the acquisition proposal and the identity of the person making
it.
42
INFORMATION
ABOUT ACCESS
DESCRIPTION
OF BUSINESS
Business
Access
Pharmaceuticals, Inc. (together with our subsidiaries, “We”, “Access” or the
“Company”) is a Delaware corporation. We are an emerging biopharmaceutical
company focused on developing products based upon our nanopolymer chemistry
technologies. We currently have one approved product, two products in Phase 2
clinical trials and five products in pre-clinical development. Our description
of our business, including our list of products and patents, takes into
consideration our acquisition of Somanta Pharmaceuticals, Inc. which closed
January 4, 2008.
|
·
|
MuGard™
is our approved product for the management of oral mucositis, a frequent
side-effect of cancer therapy for which there is no established treatment.
The market for mucositis treatment is estimated to be in excess of US$1
billion world-wide. MuGard, a proprietary nanopolymer formulation, has
received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
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|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase 2
clinical trial being conducted in the EU in patients with ovarian cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in excess
of $2.0 billion.
|
|
·
|
Pre-clinical
development of Cobalamin™, our proprietary nanopolymer oral drug delivery
technology based on the natural vitamin B12 uptake mechanism. We are
currently developing a product for the oral delivery of
insulin.
|
|
·
|
Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably breast,
ovarian and colorectal cancers.
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|
·
|
Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
|
|
·
|
Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
|
|
·
|
Pre-clinical
development of Cobalamin-mediated targeted
delivery.
|
|
·
|
Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration with Virium
Pharmaceuticals.
|
Products
Access
used its drug delivery technologies to develop the following products and
product candidates:
Access
Drug Portfolio
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage (1)
|
||||
|
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
Marketing
clearance received
|
||||
|
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
– U London
|
Synthetic
polymer
|
Cancer
|
Phase
2
|
||||
|
Phenylbutyrate
(PB)
|
National
Institute
of
Health
|
Small
molecule
|
Cancer
|
Phase
2
|
||||
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
|
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
|
Angiolix®
|
Immunodex,
Inc.
|
Humanized
monoclonal
antibody
|
Cancer
|
Pre-clinical
|
||||
|
Prodrax®
|
Univ
London
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Alchemix®
|
DeMontford
Univ
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Cobalamin-Targeted
Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Pre-clinical
|
||||
43
|
(1)
|
For
more information, see “Government Regulation” for description of clinical
stages.
|
|
(2)
|
Licensed
from the School of Pharmacy, The University of London. Subject to a 1%
royalty and milestone payments on
sales.
|
|
|
|
Approved
Products
MuGard™ - Mucoadhesive
Liquid Technology (MLT)
Mucositis
is a debilitating condition involving extensive inflammation of mouth tissue
that affects annually an estimated 400,000 cancer patients in the United States
undergoing chemotherapy and radiation treatment. Any treatment that would
accelerate healing and/or diminish the rate of appearance of mucositis would
have a significant beneficial impact on the quality of life of these patients
and may allow for more aggressive chemotherapy. We believe the potential
addressable market for a mucositis product could be over $1 billion
world-wide.
Access’
MuGard is a viscous polymer solution which provides a coating for the oral
cavity. MuGard is dispensed in a ready to use form. A multi-site, randomized
clinical study was performed in the United States testing MuGard and MuGard
containing an anti-inflammatory drug to determine the effect of these products
on the prevention and treatment of mucositis. The data from this trial indicated
that the patients using MuGard displayed a lower incidence of mucositis than is
typically seen in the studied population with no additional benefit from the
drug.
The data
were retrospectively compared with two historical patient databases to evaluate
the potential advantages MuGard may represent in the prevention, treatment and
management of mucositis. The patient evaluation was conducted using the oral
mucositis assessment scale (OMAS), which qualifies the disease severity on a
scale of 0-5. Key highlights of the comparison with the historical patient
databases are as follows:
•
the average severity of the disease was reduced by approximately
40%;
•
the maximum intensity of the mucositis was approximately 35% lower;
and
•
the median peak intensity was approximately 50% lower.
These
data confirmed the fact that MuGard could represent an important advancement in
the management and prevention of mucositis. On September 20, 2006, we announced
that we had submitted a Premarket Notification 510(k) application to the United
States Food and Drug Administration (FDA) announcing the Company’s intent to
market MuGard. On December 13, 2006, we announced that we had received marketing
clearance for MuGard from FDA for the indication of the management of oral
wounds including mucositis, aphthous ulcers and traumatic ulcers.
Access is
currently seeking marketing partners to market MuGard in other territories
worldwide. In August 2007, we signed a definitive licensing agreement with
SpePharm Holding, B.V. under which SpePharm will market Access’ product MuGard
in Europe. In January 2008, we also signed a definitive licensing agreement with
RHEI Pharmaceuticals, Inc. under which RHEI will market Access’ product MuGard
in China and other Southeast Asian countries. In August 2008, we signed a
definitive licensing agreement with Milestone Biosciences, LLC under which
Milestone will market MuGard in the United States and Canada.
Products
in Development Status
ProLindac™ (Polymer
Platinate, AP5346) DACH Platinum
Chemotherapy,
surgery and radiation are the major components in the clinical management of
cancer patients. Chemotherapy serves as the primary therapy for some solid
tumors and metastases and is increasingly used as an adjunct to radiation and
surgery to improve their effectiveness. For chemotherapeutic agents to be
effective in treating cancer patients, however, the agent must reach the target
cells in effective quantities with minimal toxicity in normal
tissues.
The
current optimal strategy for chemotherapy involves exposing patients to the most
intensive cytotoxic regimens they can tolerate and clinicians attempt to design
a combination of chemotherapeutic drugs, a dosing schedule and a method of
administration to increase the probability that cancerous cells will be
destroyed while minimizing the harm to healthy cells. Notwithstanding
clinicians’ efforts, most current chemotherapeutic drugs have significant
shortcomings that limit the efficacy of chemotherapy. For example, certain
cancers are inherently unresponsive to chemotherapeutic agents. Alternatively,
other cancers may initially respond, but subgroups of cancer cells acquire
resistance to the drug during the course of therapy and the resistant cells may
survive and cause a relapse. Serious toxicity, including bone marrow
suppression, renal toxicity, neuropathy, or irreversible cardiotoxicity, are
some of the limitations of current anti-cancer drugs that can prevent their
administration in curative doses.
44
Oxaliplatin,
a formulation of DACH platinum, is a chemotherapeutic which was initially
approved in France and in Europe in 1999 for the treatment of colorectal cancer.
It is now also being marketed in the United States and generated worldwide sales
in excess of $2 billion in 2006. Carboplatin and Cisplatin, two other approved
platinum chemotherapy drugs, are not indicated for the treatment of metastatic
colorectal cancer. Oxaliplatin, in combination with 5-flurouracil and folinic
acid (known as the FOLFOX regime) is indicated for the first-line treatment of
metastatic colorectal cancer in Europe and the U.S. The colorectal cancer market
is a significant opportunity as there are over 940,000 reported new cases
annually worldwide, increasing at a rate of approximately three percent per
year, and 500,000 deaths.
Currently,
platinum compounds are one of the largest selling categories of chemotherapeutic
agents, with annual sales in excess of $3.0 billion in 2006. As is the case with
all chemotherapeutic drugs, the use of such compounds is associated with serious
systemic side effects. The drug development goal therefore is to enhance
delivery of the active drug to the tumor and minimize the amount of active drug
affecting normal organs in the body.
Utilizing
a biocompatible water-soluble polymer (HPMA) as a drug carrier, Access’ drug
candidate ProLindac, links DACH platinum to a polymer in a manner which permits
the selective release of active drug to the tumor by several mechanisms,
including taking advantage of the differential pH in tumor tissue compared to
healthy tissue. The polymer also capitalizes on the biological differences in
the permeability of blood vessels at tumor sites versus normal tissue. In this
way, tumor selective delivery and platinum release is achieved. The ability of
ProLindac to inhibit tumor growth has been evaluated in more than ten
preclinical models. Compared with the marketed product oxaliplatin, ProLindac
showed either marked superiority or superiority in most of these models.
Preclinical studies of the delivery of platinum to tumors in an animal model
have shown that, compared with oxaliplatin at equitoxic doses, ProLindac
delivers in excess of 16 times more platinum to the tumor. An analysis of tumor
DNA, which is the main target for anti-cancer platinum agents, has shown that
ProLindac delivers
approximately 14 times more platinum to tumor DNA than oxaliplatin. Results from
preclinical efficacy studies conducted in the B16 and other tumor models have
also shown that ProLindac is superior to oxaliplatin in inhibiting the growth of
tumors. An extensive preclinical package has been developed supporting the
development of ProLindac.
In 2005,
we completed a Phase 1 multi-center clinical study conducted in Europe, which
enrolled 26 patients. The study was reported in a journal publication, Cancer
Chemotherapy and Pharmacology, 60(4): 523-533 in 2007. The European trial
was designed to identify the maximum tolerated dose, dose limiting toxicities,
the pharmacokinetics of the platinum in plasma and the possible anti-tumor
activity of ProLindac. The open-label, non-randomized, dose-escalation Phase 1
study was performed at two European centers. ProLindac was administered as an
intravenous infusion over one hour, once a week on days 1, 8 and 15 of each
28-day cycle to patients with solid progressive tumors. We obtained results in
26 patients with a broad cross-section of tumor types, with doses ranging from
80-1,280 mg Pt/m2.
Of the 26
patients, 10 were not evaluable for tumor response, principally due to
withdrawal from the study prior to completing the required cycle. Of the 16
evaluable patients, 2 demonstrated a partial response, 1 experienced a partial
response based on a biomarker and 4 experienced stable disease. One of the
patients who attained a partial response had a melanoma with lung metastasis; a
CT scan revealed a tumor decrease of greater than 50%. The other patient who
responded had ovarian cancer; she had a reduction in lymph node metastasis and
remission of a liver metastasis. The patient who experienced a partial response
based on a biomarker was an ovarian cancer patient for whom Ca125 levels
returned to normal. Also of note, a patient with cisplatin resistant cervical
cancer showed a short lasting significant reduction in lung metastasis after 3
doses. However, due to toxicity, the patient could not be retreated to determine
whether the partial response could be maintained.
A Phase 2
clinical trial of ProLindac is underway in ovarian cancer patients who have
relapsed after first line platinum therapy. The primary aim of the study is to
determine the response rate of ProLindac monotherapy in this patient population.
The response rates for other platinum compounds in this indication are well
known, and will be used for comparison. Patients are dosed either once every 2
weeks or once every three weeks. As the Phase 1 study involved weekly dosing,
the initial phase of the ovarian cancer monotherapy study involves some dose
escalation to determine recommended doses using these dosing regimens.
Preliminary results from the dose ranging part of the study were presented at
AACR-NCI-EORTC conference in San Francisco in October 2007. Significantly, there
was a reduction of the Ca125 biomarker in five of the six patients in a cohort
receiving of ProLindac on a once every three week dosing schedule. The Ca125
biomarker has been demonstrated to be a reliable indicator of the clinical
progression of ovarian cancer
The
Company has submitted an IND application to the US Food and Drug Administration,
and has received clearance from the agency to proceed with a Phase 1 clinical
study of ProLindac in combination with fluorouracil and leucovorin. The study is
designed to evaluate the safety of the ProLindac in combination with two
standard drugs used to treat colorectal cancer and to establish a safe dose for
Phase 2 clinical studies of this combination in colorectal cancer. The company
is currently evaluating whether clinical development of ProLindac in this
indication might proceed more rapidly by utilizing an alternative clinical
strategy and/or conducting studies in the US and/or elsewhere in the
world.
45
|
Sodium
Phenylbutyrate
|
Sodium
Penylbutyrate, or PB, is a small molecule that was previously approved by the
FDA for sale as a treatment for a rare genetic disorder in infants known as
hyperuremia. PB has a number of additional mechanisms of action, including
the inhibition of histone deacetylase. Histone deacetylase is a class of
enzymes that remove acetyl groups from the amino acids in DNA. The
inhibition of histone deacetylase allows the body’s cancer suppressing genes to
work as intended. In addition, PB is not toxic to cells. These
characteristics make PB a good candidate to become a chemopotentiator; that is,
a substance that enhances the activity of a chemotherapeutic agent. As a
result, PB will ideally be administered in conjunction with radiation and/or
chemotherapy.
In
February 2005, we entered into a Phenylbutyrate Co-development and Sublicense
Agreement with Virium Pharmaceuticals, Inc., pursuant to which Virium granted us
an exclusive, worldwide sublicense to PB, excluding the U.S. and Canada, for the
treatment of cancer, autoimmune diseases and other clinical indications. We paid
Virium a license fee of $50,000. Virium has retained all rights with respect to
PB inside the U.S. and Canada. Access’ single largest stockholder, SCO
Capital Partners, LLC, is also the single largest stockholder of Virium
Pharmaceuticals, Inc. On April 18, 2008, Virium was acquired by
MacroChem and is currently a wholly-owned subsidiary of MacroChem. As a result
of the Merger any fees owed and paid by Access to Virium shall be treated as
intercompany receivables and payments.
Virium is
also a party to a sublicense agreement with VectraMed, Inc. for the rights to
develop and commercialize PB worldwide for the treatment of cancer, autoimmune
diseases and other clinical indications. VectraMed obtained its rights to the
product under an Exclusive Patent License Agreement dated May 25, 1995 with the
U.S. Public Health Service, representing the National Institutes of Health.
VectraMed subsequently assigned all its rights to PB to Virium pursuant to a
novation agreement dated May 10, 2005.
Pursuant
to our agreement with Virium, we are responsible for the conduct of clinical
trials and patent prosecution related to PB outside of the U.S. and Canada. The
Virium agreement also requires us to pay Virium a royalty on the sales of PB
products until such time as the patents covering such products
expire. These patents expire at various times between 2011 and 2016. Our
agreement with Virium expires upon the expiration of the last to expire of these
patents in 2016.
On
December 6, 2006, we signed a letter of intent (LOI) pertaining to a license and
collaboration agreement with Virium covering all formulations or drug
combinations where Phenylbutyrate is an active ingredient. Pursuant to the LOI,
in addition to current worldwide rights, excluding North America, involving the
current formulation of Phenylbutyrate, we would obtain a participation in any
revenue or royalties derived from sales in the U.S. and Canada. In return, we
would grant Virium a reciprocal participation in Europe. In the rest of the
world, Access and Virium would share revenues and royalties equally. The LOI’s
terms provide that both companies will, among other things, share data and
jointly undertake the necessary pre-clinical and clinical studies, seek
regulatory approvals and file for patent protection in all territories. It also
provides for the formation of a joint development committee to oversee all
aspects of the development and commercialization of Phenylbutyrate. Completion
of the transaction contemplated by the LOI remains subject to the negotiation
and execution of a definitive agreement.
Phenylbutyrate
has been the subject of numerous Phase 1 and Phase 2 clinical studies sponsored
by the National Cancer Institute and others demonstrating the safety and
efficacy of PB in cancer, both as a monotherapy and in combination with other
anticancer compounds. To date, we have not been involved in any capacity in the
conduct of any clinical trial related to PB.
We
believe that PB may be a candidate to become a biological-response modifier that
acts as a dose-dependent inhibitor of cancer cell proliferation, migration, and
invasiveness, possibly by inhibition of urokinase and c-myc pathways, which
means that it inhibits the protease activity that irreversibly induces
programmed cell death. In addition, we believe that PB shows potential for the
treatment of malignant gliomas, which are cancers of the brain. We are aware of
numerous products in development for brain cancers. We are aware of several
products being developed by academic and commercial organizations targeting
glioblastoma. Medicis Pharmaceuticals currently sells Sodium Phenylbutyrate
(Buphenyl ® ) for
the treatment of a urea cycle disorder, hyperuremia.
There are
thirteen key use patents related to PB which have been issued to the NIH and
licensed by us as follows:
|
•
|
A
patent covering a method of inhibiting rapid tumor growth issued in the
U.S. that expires on March 14, 2014 with foreign counterparts in
Austria, Australia, Canada, Germany, European Union, Spain, Israel, New
Zealand and South Africa;
|
|
•
|
A
patent covering a method of treating brain cancer, leukemia, prostate
cancer, breast cancer, skin cancer and non-small cell lung cancer issued
in the U.S. that expires on June 3, 2014 with foreign counterparts in
Austria, Australia, Canada, Germany, European Union, Spain, Israel, Japan,
New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of treating brain cancer, skin cancer, benign
enlarged prostate and a cervical infection issued in the U.S. that expires
on February 25, 2014 with foreign counterparts in Austria, Australia,
Canada, Germany, European Union, Spain, Israel, Japan, New Zealand,
Portugal and South Africa;
|
|
•
|
A
patent covering a method of inducing the production of TGF alpha (which
slows the growth of cancer cells) issued in the U.S. that expires on
January 13, 2015 with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal and
South Africa;
|
46
|
•
|
A
patent covering a pharmaceutical composition for treating or preventing a
cancerous condition issued in the U.S. that expires on January 20, 2015
with foreign counterparts in Austria, Australia, Canada, Germany, European
Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of inducing the differentiation of a cell issued
in the U.S. that expires on June 3, 2014 with foreign counterparts in
Austria, Australia, Canada, Germany, European Union, Spain, Israel, Japan,
New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of treating brain cancer, non-small cell lung
cancer, prostate cancer, skin cancer, brain tumors, cancers of the blood,
lung cancer and breast cancer issued in the U.S. that expires on August
26, 2014 with foreign counterparts in Austria, Australia, Canada, Germany,
European Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of inhibiting the growth of rapidly growing
nonmalignant or malignant tumor cells issued in the U.S. that expires on
March 2, 2016 with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal and
South Africa;
|
|
•
|
A
patent covering a method of sensitizing a subject to radiation therapy or
chemotherapy and a method of treating brain cancer, leukemia, non-small
cell lung cancer, skin cancer, cancers of the blood, lung cancer, or renal
cancer issued in the U.S. that expires on December 1, 2015 with foreign
counterparts in Austria, Australia, Canada, Germany, European Union,
Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of treating brain cancer, non-small cell lung
cancer, prostate cancer, skin cancer, cancers of the blood, breast cancer,
benign prostate enlargement, cervical infection, bladder cancer, kidney
cancer, colon cancer, or nose cancer issued in the U.S. that expires on
March 16, 2016 with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal and
South Africa;
|
|
•
|
A
patent covering a method of inducing the production of hemoglobin (blood)
and a method of treating a pathology associated with abnormal hemoglobin
(blood) activity issued in the U.S. that expires on January 27, 2015 with
foreign counterparts in Austria, Australia, Canada, Germany, European
Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of preventing prostate cancer, brain cancer, skin
cancer, cancers of the blood, breast cancer, non-small cell lung cancer,
or renal cancer issued in the U.S. that expires on August 5, 2014 with
foreign counterparts in Austria, Australia, Canada, Germany, European
Union, Spain, Israel, Japan, New Zealand, Portugal and South Africa;
and
|
|
•
|
A
patent covering a method of inhibiting the production of cancer in a cell
issued in the U.S. that expires on March 14, 2011, June 3, 2013 or March
7, 2014, depending on the subject matter disclosed in the priority
applications with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal and
South Africa.
|
Our
co-development partner, Virium advised us that it intends to initiate a Phase
1/2 clinical trial using PB to treat glioblastoma in the near future. We intend
to wait for the results of this Phase 1/2 clinical trial and the re-formulation
of the PB compound to a sustained release version before initiating our own
clinical trial related to PB in Europe. At this time, we do not know when
Virium will initiate such clinical trial, when it will be completed, or whether
it will be successful, nor do we know when Virium will have completed the
re-formulation of the PB compound to a sustained release version.
We also
believe that further studies should be considered to identify a subset of
patients that have tumors sensitive to PB, either as a single agent or in
combination with radiation therapy or other chemotherapeutic agents, and that we
should focus on this subset of patients in our future clinical trials related to
PB, subject to the successful completion of clinical trials by
Virium.
Research Projects, Products
and Products in Development
Drug
Development Strategy
A part of
our integrated drug development strategy is to form alliances with centers of
excellence in order to obtain alternative lead compounds while minimizing the
overall cost of research. The Company does not spend significant resources on
fundamental biological research but rather focuses on its chemistry expertise
and clinical development. For example, certain of our polymer platinate
technology has resulted in part from a research collaboration with The School of
Pharmacy, University of London.
47
Our
strategy is to focus on our polymer therapeutic program for the treatment of
cancer while continuing to develop technologies such as Cobalamin-mediated oral
drug delivery and Cobalamin-mediated tumor targeting which could provide us with
a revenue stream in the short term through commercialization or outlicensing to
fund our longer-term polymer and oncology drug development programs such as
Angiolix, Alchemix and Prodrax. To reduce financial risk and equity financing
requirements, we are directing our resources to the preclinical and early
clinical phases of development. Where the size of the necessary clinical studies
and cost associated with the later clinical development phases are significant,
we plan to co-develop with or to outlicense to marketing partners our
therapeutic product candidates. By forming strategic alliances with
pharmaceutical and/or biotech companies, we believe that our technology can be
more rapidly developed and successfully introduced into the
marketplace.
We will
continue to evaluate the most cost-effective methods to advance our programs. We
will contract certain research and development, manufacturing and manufacturing
scaleup, certain preclinical testing and product production to research
organizations, contract manufacturers and strategic partners. As appropriate to
achieve cost savings and accelerate our development programs, we will expand our
internal core capabilities and infrastructure in the areas of chemistry,
formulation, analytical methods development, clinical development, biology and
project management to maximize product opportunities in a timely manner.
Process
We begin
the product development effort by screening and formulating potential product
candidates, selecting an optimal active component, developing a formulation, and
developing the processes and analytical methods. Pilot stability, toxicity and
efficacy testing are conducted prior to advancing the product candidate into
formal preclinical development. Specialized skills are required to produce
these product candidates utilizing our technology. We have a limited core
internal development capability with significant experience in developing these
formulations, but also depend upon the skills and expertise of our
contractors.
Once the
product candidate has been successfully screened in pilot testing, our
scientists, together with external consultants, assist in designing and
performing the necessary preclinical efficacy, pharmacokinetic and toxicology
studies required for IND submission. External investigators and scaleup
manufacturing facilities are selected in conjunction with our consultants. The
initial Phase 1 and Phase 2 studies are conducted by institutions and
investigators supervised and monitored by our employees and contract research
organizations. We do not plan to have an extensive clinical development
organization as we plan to have the advance phases of this process conducted by
a development partner. Should we conduct Phase 3 clinical studies we expect to
engage a contract research organization to perform this work.
We
contract with third party contract research organizations (CROs) to complete our
large clinical trials and for data management of all of our clinical trials.
Currently, we have one Phase 2 trial in process continuing into 2008 and a new
Phase 2 trial planned for mid 2008 subject to preliminary findings in other
trials and our ability to fund such trials.
With all
of our product development candidates, we cannot assure you that the results of
the in vitro or animal studies are or will be indicative of the results that
will be obtained if and when these product candidates are tested in humans. We
cannot assure you that any of these projects will be successfully completed or
that regulatory approval of any product will be obtained.
We
expended approximately $2,602,000 and $2,053,000 on research and development
during the years 2007 and 2006, respectively.
Scientific
Background
Access
possesses a broad range of technologies and intellectual property in the areas
of drug delivery and oncology. Our core technologies rely on the use of
nanopolymers for use in the management of oral conditions such as mucositis, and
in drug delivery. In addition, we have small molecule and monoclonal antibody
programs which also embody the principals of drug delivery and drug
targeting.
The
ultimate criteria for effective drug delivery is to control and optimize the
localized release of the drug at the target site and rapidly clear the
non-targeted fraction. Conventional drug delivery systems such as controlled
release, sustained release, transdermal systems and others are designed for
delivering active product into the systemic circulation over time with the
objective of improving patient compliance. These systems do not address the
biologically relevant issues such as site targeting, localized release and
clearance of drug. The major factors that impact the achievement of this
ultimate drug delivery goal are the physical characteristics of the drug and the
biological characteristics of the disease target sites. The physical
characteristics of the drug affect solubility in biological systems, its
biodistribution throughout the body, and its interactions with the intended
pharmacological target sites and undesired areas of toxicity. The biological
characteristics of the diseased area impact the ability of the drug to
selectively interact with the intended target site to allow the drug to express
the desired pharmacological activity.
We
believe our drug delivery technologies are differentiated from conventional drug
delivery systems in that they seek to apply a disease-specific approach to
improve the drug delivery process with formulations to significantly enhance the
therapeutic efficacy and reduce toxicity of a broad spectrum of
products.
48
Core
Drug Delivery Technology Platforms
Our
current drug delivery technology platforms for use in cancer chemotherapy
are:
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Synthetic
Polymer Targeted Drug Delivery
Technology;
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Cobalamin™-Mediated
Oral Delivery Technology;
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Cobalamin™-Mediated
Targeted Delivery Technology;
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Angiolix®;
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Prodrax®;
and
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Alchemix®.
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Each
of these platforms is discussed below:
Synthetic
Polymer Targeted Drug Delivery Technology
In
collaboration with The School of Pharmacy, University of London, we have
developed a synthetic polymer technology, which utilizes
hydroxypropylmethacrylamide with platinum, designed to exploit enhanced
permeability and retention, or EPR, at tumor sites to selectively accumulate
drug and control drug release. This technology is employed in our lead clinical
program, ProLindac. Many solid tumors possess vasculature that is
hyperpermeable, or leaky, to macromolecules. In addition to this enhanced
permeability, tumors usually lack effective lymphatic and/or capillary drainage.
Consequently, tumors selectively accumulate circulating macromolecules,
including, for example, up to 10% of an intravenous dose in mice. This effect
has been termed EPR, and is thought to constitute the mechanism of action of
styrene-maleic/anhydride-neocarzinostatin, or SMANCS, which is in regular
clinical use in Japan for the treatment of hepatoma. These polymers take
advantage of endothelial permeability as the drug carrying polymers are trapped
in tumors and then taken up by tumor cells. Linkages between the polymer and
drug can be designed to be cleaved extracellularly or intracellularly. Utilizing
the principles of prodrugs, the drug is essentially inert while attached to the
polymer, but is released inside the tumor mass while polymer/drug not delivered
to tumors is cleared from the body via the kidneys. For example, ProLindac is
attached to a pH-sensitive linker which releases the platinum cytotoxic agent
much faster in the low pH environments found typically outside of hypoxic tumor
cells and within specific compartments inside of tumor cells. Data generated in
animal studies have shown that the polymer/drug complexes are far less toxic
than free drug alone and that greater efficacy can be achieved. Thus, these
polymer complexes have demonstrated significant improvement in the therapeutic
index of anti-cancer drugs, including, for example, platinum.
Cobalamin™-Mediated
Oral Delivery Technology
Oral
delivery is the preferred method of administration of drugs where either
long-term or daily use (or both) is required. However many therapeutics,
including peptide and protein drugs, are poorly absorbed when given orally. With
more and more peptide and protein based biopharmaceuticals entering the market,
there is an increasing need to develop an effective oral delivery system for
them, as well as for long-standing injected drugs such as insulin.
The
difficulty in administering proteins orally is their susceptibility to
degradation by digestive enzymes, their inability to cross the intestinal wall
and their rapid excretion by the body. Over the years, many different
methodologies for making protein drugs available orally have been attempted.
Most of the oral protein delivery technologies involve protecting the protein
degradation in the intestine. More recently, strategies have been developed that
involve coadministering the protein or peptide with permeation enhancers, which
assist in passive transit through the gut wall or by attaching the protein or
peptide to a molecule that transports the protein across the gut wall. However,
the field of oral drug delivery of proteins and peptides has yet to achieve
successful commercialization of a product (although positive results have been
achieved in early clinical trials for some products under
development).
Many
pharmaceutically active compounds such as proteins, peptides and cytotoxic
agents cannot be administered orally due to their instability in the
gastrointestinal tract or their inability to be absorbed and transferred to the
bloodstream. A technology that would allow many of these actives to be taken
orally would greatly enhance their acceptance and value. Several technologies
for the protection of sensitive actives in the gastro-intestinal tract and/or
enhancement of gastro-intestinal absorption have been explored and many have
failed.
Our
proprietary technology for oral drug delivery utilizes the body’s natural
vitamin B12 (VB12) transport system in the gut. The absorption of VB12 in the
intestine occurs by way of a receptor-mediated endocytosis. Initially, VB12
binds to intrinsic factor (IF) in the small intestine, and the VB12-IF complex
then binds to the IF receptor on the surface of the intestine. Receptor-mediated
endocytosis then allows the transport of VB12 across the gut wall. After binding
to another VB12-binding protein, transcobalamin II (TcII), VB12 is transferred
to the bloodstream.
49
Our
scientists discovered that Cobalamin (analogs of VB12) will still be transported
by this process even when drugs, macromolecules, or nanoparticles are coupled to
the Cobalamin. Thus Cobalamin serves as a carrier to transfer these
materials from the intestinal lumen to the bloodstream. For drugs and
macromolecules that are stable in the gastro-intestinal tract, the drug or
macromolecule can be coupled directly (or via a linker) to Cobalamin. If the
capacity of the Cobalamin transport system is inadequate to provide an effective
blood concentration of the active, transport can be amplified by attaching many
molecules of the drug to a polymer, to which Cobalamin is also attached. A
further option, especially for drugs and macromolecules that are unstable in the
intestine, is to formulate the drug in a nanoparticle which is then coated with
Cobalamin. Once in the bloodstream, the active is released by diffusion and/or
erosion of the nanoparticle. Utilization of nanoparticles also serves to
‘amplify’ delivery by transporting many molecules at one time due to the
inherently large nanoparticle volume compared with the size of the
drug.
Our
proprietary position in this technology involves the conjugation of Cobalamin
and/or folic acid and/or biotin (or their analogs) to a polymer to which is also
attached the drug to be delivered, or attached to a nanoparticle in which the
drug is incorporated. Since many molecules of the drug are attached to a single
polymer strand, or are incorporated in a single nanoparticle, disease targeting
is amplified compared to simpler conjugates involving one molecule of the
vitamin with one drug molecule. However, in situations when such a simple
conjugate might be preferred, our patents also encompass these vitamin-drug
conjugates.
Cobalamin™-Mediated
Targeted Delivery Technology
Most
drugs are effective only when they reach a certain minimum concentration in the
region of disease, yet are well distributed throughout the body contributing to
undesirable side effects. It is therefore advantageous to alter the natural
biodistribution of a drug to have it more localized where it is needed. Our
Cobalamin-mediated targeted delivery technology utilizes the fact that in many
diseases where there is rapid growth and/or cell division, the demand for
certain vitamins increases. By coupling the drug to a vitamin analog, the analog
serves as a carrier to increase the amount of drug at the disease site relative
to its normal distribution.
One
application of this technology is in tumor targeting. The use of cytotoxic drugs
is one of the most common methods for treating a variety of malignancies
including solid and non-solid tumors. The drawbacks of chemotherapeutic
treatments, which include tumor resistance, cancer relapse and toxicity from
severe damage to healthy tissues, has fuelled a scientific quest for novel
treatments that are specifically targeted to malignant cells thus reducing
damage to collateral tissues.
The
design of targeted therapies involves exploitation of the difference between the
structure and function of normal cells compared with malignant cells.
Differences include the increased levels of surface receptors on cancer cells,
which makes them more sensitive to treatment regimes that target these cell
surface receptors and differences in blood supply within and around tumor cells
compared with normal cells.
Two basic
types of targeting approaches are utilized, passive tumor targeting and active
tumor targeting.
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passive
tumor targeting involves transporting anti-cancer agents through the
bloodstream to tumor cells using a “carrier” molecule. Many different
carrier molecules, which can take a variety of forms (micelles,
nanoparticles, liposomes and polymers), are being investigated as each
provides advantages such as specificity and protection of the anti-cancer
drug from degradation due to their structure, size (molecular weights) and
particular interactions with tumor cells. Our polymer platinate program is
a passive tumor targeting technology.
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▪
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active
tumor targeting involves attaching an additional fragment to the
anticancer drug and the carrier molecule to create a new “targeted” agent
that will actively seek a complementary surface receptor to which it binds
(preferentially located on the exterior of the tumor cells). The theory is
that the targeting of the anti-cancer agent through active means to the
affected cells should allow more of the anti-cancer drug to enter the
tumor cell, thus amplifying the response to the treatment and reducing the
toxic effect on bystander, normal
tissue.
|
Examples
of active targeting fragments include antibodies, growth factors and vitamins.
Our scientists have specifically focused on using Cobalamin compounds (analogs
of vitamin B12), but we have also used and have certain intellectual property
protection for the use of folate and biotin which may more
effectively target anti-cancer drugs to certain solid tumors.
It has
been known for some time that vitamin B12 and folic acid are essential for tumor
growth and as a result, receptors for these vitamins are up-regulated in certain
tumors. Vitamin B12 receptor over-expression occurs in breast, lung, leukemic
cells, lymphoma cells, bone, thyroid, colon, prostate and brain cancers and some
other tumor lines, while folate receptor over-expression occurs in breast, lung,
ovarian, endometrial, renal, colon, brain and cancers of myeloid hemotopoietic
cells and methotrexate-sensitive tumors.
Angiolix®
Angiolix
(huMc-3 mAB) is a humanized monoclonal antibody targeting a protein known as
Lactadherin. Lactadherin promotes the growth of new blood vessels (angiogenesis)
to support tumor growth. Angiolix, by blocking Lactadherin, has the potential to
induce programmed cell death, or apoptosis, in blood vessels supporting tumors.
Angiolix was sublicensed from Immunodex, Inc., who licensed the product from
Cancer Research Institute of Contra Costa. Under that agreement, we are required
to meet certain development targets, and make certain payments including an
annual license maintenance fee and milestone payments.
50
We
believe that Angiolix has a large market potential in the treatment of cancer.
Avastin® is a marketed anti-angiogenesis monoclonal antibody that is effective
by using a similar mechanism to that of Angiolix, and is used in the treatment
of colorectal and other cancer types. Angiolix is unique in that it targets
a propriety gene product which is expressed by cancerous tumors. We are not
aware of any other organization developing similar products targeting this
protein. The key patent relating to Angiolix has been issued in the U.S.
and Australia. In general, it covers the composition of matter and various
aspects of the binding to applicable antigens as well as the manufacture of
Angiolix. We also have foreign counterparts to this patent pending in the
European Union and Canada.
Angiolix
is a humanized monoclonal antibody. Humanization is a process by which genetic
material from a mouse cell is made tolerable to humans, using a patented
technology developed by the National Institutes of Health. The NIH
previously granted to the Cancer Research Institute of Contra Costa a license to
the applicable humanization technology. Pursuant to the Immunodex agreement,
Immunodex and the Cancer Research Institute of Contra Costa are seeking to
obtain for us the NIH’s consent to a sublicense to us of the Cancer Research
Institute of Contra Costa right to use the NIH humanization
technology.
We have
an agreement with an academic investigator for the development of Angiolix. We
intend to complete preclinical development of Angiolix through the contributions
of this investigator and through a contract manufacturer and contract testing
laboratories, such that we are able to begin a Phase 1 clinical study of
Angiolix in 2009.
Prodrax®
Prodrax
is a prodrug technology whereby non-toxic small molecule anticancer drugs become
highly cytotoxic in low oxygen tumors by irreversible conversion to a form
capable of binding to the DNA in tumor cells. This binding of DNA can result in
tumor cell death. Prodrax molecules are di-N-oxides of
chloroalkylaminoanthraquinone derivatives. We have a license to this technology
from the University of London School of Pharmacy.
Prodrax
is inert in normally oxygenated cells and becomes toxic in low oxygen areas,
enabling it to kill tumor cells. Many solid tumors have a low oxygen area that
is resistant to radiation and conventional chemotherapy. These cells repopulate
the tumor with additional tumor cells that may be resisted to radiation- and
conventional chemotherapy. These cells are often referred to as
quiescent.
Prodrax
becomes irreversibly converted to its toxic form in low oxygen tumor cells where
it remains localized. When the surrounding oxygenated cells are killed by
radiotherapy or chemotherapy, these Prodrax-containing quiescent cells move
closer to the oxygen source and attempt to resume more active
replication. It is in this state that they are killed by Prodrax, through
potent DNA damage.
When
given in conjunction with radiotherapy or conventional chemotherapy we expect
Prodrax to result in significant improvement of tumor clearance and to reduce
the likelihood of tumor repopulation, improving disease free survival. It is
estimated that over 50% of all solid tumors exhibit clinically significant
hypoxia, or low oxygenation, and that over two million people in the U.S. and
Europe suffer from solid tumor cancers. If successful, Prodrax could improve the
prognosis for a significant number of cancer sufferers in a wide range of tumor
types.
In a
2-year research agreement with the University of Bradford in the UK, which
expired in March 2008, several Prodrax molecules were made and tested, two lead
compounds were identified. Additional testing is required in order to select a
primary lead which will be taken forward into clinical development. We expect to
identify the lead in the first half of 2009.
Alchemix®
Alchemix
is the name applied to a series of molecules which can bind to the DNA of tumor
by at least two mechanisms; intercelation and alkylation. Alchemix molecules are
intended to interrupt all phases of the cancer cell growth cycle to overcome
drug resistant tumors. We believe that Alchemix is toxic to cancer cells
due to its selective inhibition of many DNA processing enzymes and that it is as
well tolerated in animals as a number of classes of approved chemotherapeutic
drugs such as epirubicin and cisplatin, .
The
Alchemix platform technology is licensed from De Montfort University in the UK.
Although we are not obligated to make any royalty payments to De Montfort based
on the sale of any product that is based on Alchemix, we are obligated to pay De
Montfort certain milestone payments based on the achievement of agreed upon
clinical milestones. Our agreement with De Montfort expires in 2015, upon the
expiration of the last to expire of the Alchemix patents in 2015. The key patent
relating to Alchemix has been issued in the U.S, the European Union and in
Australia. In general, it covers composition of matter. We have prepared a
detailed pre-clinical and clinical development plan related to Alchemix. We plan
to manufacture, undertake pre-clinical studies and, initiate a Phase1/2 clinical
trial with respect to Alchemix within the next 24 months.
51
In August
2004, we entered into a Research Collaboration and License Agreement with
Advanced Cardiovascular Devices, LLC. Under this agreement, we granted Advanced
Cardiovascular Devices an exclusive, worldwide license to Alchemix solely for
use in the treatment of vascular disorders or proliferations using stents and
other medical devices. The term of this agreement expires when the underlying
patent expires in 2015. Pursuant to this agreement, Advanced Cardiovascular
Devices paid Somanta an upfront fee of $10,000. In addition, Advanced
Cardiovascular Devices is obligated to develop a product based on Alchemix
pursuant to an agreed upon timetable. If Advanced Cardiovascular Devices fails
to achieve any of the agreed upon milestones, we would then have the right to
terminate the agreement; provided, however, that Advanced Cardiovascular Devices
could prevent us from so terminating the agreement with respect to the
applicable failure by paying us a fee not to exceed $500,000 to reinstate its
rights under the agreement. In addition, Advanced Cardiovascular Devices is also
obligated to pay us a royalty based on net sales, if any, of products based on
Alchemix. Either party may terminate this agreement on thirty (30) days advance
notice for breach by the other party if the breach is not cured within such
thirty (30) day period. In addition, Advance Cardiovascular Devices may
terminate the agreement upon written notice to us and without any further
obligation to us if the licensed technology does not perform to the reasonable
satisfaction of Advanced Cardiovascular Devices or cannot be commercialized
because of safety or efficacy reasons or because Advanced Cardiovascular Devices
is unable to raise the funds necessary to develop a product based on the
licensed technology.
Other
Key Developments
On
September 3, 2008, we announced that we had retained Piper Jaffray to augment
ongoing business development efforts with the goal of establishing additional
strategic development and commercialization partnerships for our product
pipeline. The Piper Jaffray healthcare investment banking team will focus on
partnering opportunities for ProLindac, Angiolix and the Cobalamin
programs.
On August
27, 2008, we entered into a Note Purchase Agreement with MacroChem Corporation
in order for Access to loan MacroChem amounts to keep certain of their licenses
and vendors current. As of September 30, 2008, we loaned MacroChem
$225,000.
On August
18, 2008, we announced the signing of a definitive licensing agreement under
which Milestone Biosciences, LLC will market MuGard in the United States and
Canada.
On July
10, 2008, we announced the signing of a definitive merger agreement to acquire
MacroChem Corporation. Pursuant to the terms of the merger agreement,
MacroChem’s common shareholders and warrant holders will receive an aggregate of
2.5 million shares of Access common stock which would represent approximately 8%
of the combined company. The closing of the transaction is subject to numerous
conditions. There can be no assurance that the transaction will be consummated
or if consummated that it will be on the terms described above.
On June
4, 2008, we announced the signing of a definitive licensing agreement with
Jiangsu Aosaikang Pharmaeutical Co., Ltd (“ASK”). Under which agreement ASK will
manufacture, develop and commercialize our proprietary product ProLindac for the
Greater China Region which includes the People’s Republic of China, the Hong
Kong Special Administrative Region, the Macau Special Administrative Region and
Taiwan. Under the terms of the agreement ASK paid Access an upfront
fee and will pay subsequent milestone payments along with a royalty upon
commercialization of ProLindac. In addition, in cooperation with Access, ASK has
committed to fund two Phase 2 studies for ProLindac in colorectal cancer and one
other indication to be determined by both parties.
Steven H.
Rouhandeh was appointed as a director and Chairman of the Board effective as of
March 4, 2008.
On
February 4, 2008, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of
our preferred stock, designated “Series A Cumulative Convertible Preferred
Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the
“Series A Preferred Stock”) and agreed to issue warrants to purchase 499,594
shares of our common stock, which includes placement agent warrants to purchase
45,417 shares of our common stock, at an exercise price of $3.50 per share, for
an aggregate purchase price for the Series A Preferred Stock and Warrants of
$2,725,000. The shares of Series A Preferred Stock are convertible into common
stock at the initial conversion price of $3.00 per share.
On
January 14, 2008, we announced the signing of a definitive licensing agreement
under which RHEI Pharmaceuticals, Inc. will market and manufacture MuGard in the
Peoples Republic of China and certain Southeast Asian countries. RHEI will also
obtain the necessary regulatory approvals for MuGard in the
territory.
On
January 4, 2008, we closed our acquisition of Somanta Pharmaceuticals, Inc. In
connection with the acquisition, Access issued an aggregate of approximately 1.5
million shares of Access Pharmaceuticals, Inc. common stock to the common and
preferred shareholders of Somanta as consideration. In addition, Access
exchanged all outstanding warrants of Somanta for warrants to purchase 191,991
shares of Access common stock at exercise prices ranging between $18.55 and
$69.57 per share.
52
In
addition, $1,576,000 of Somanta Pharmaceuticals’ acquired accounts payable were
settled by issuing 538,508 shares of Access common stock and warrants to
purchase 246,753 shares of Access common stock at an exercise price of $3.50 per
share. The value of the shares and warrants issued was determined based on the
fair value of the accounts payable.
On
December 26, 2007, Jeffrey B. Davis, Chairman of the Board of Directors was
named Chief Executive Officer. Stephen R. Seiler resigned as President and Chief
Executive Officer and concurrently resigned from the Board of Directors
effective December 19, 2007.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
As a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and Oracle
Partners LP and affiliates, along with the other holders of an aggregate of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest for
437.3104 shares of the Series A Preferred Stock and were issued warrants to
purchase 728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving on our Board
of Directors. In connection with the exchange of the notes, all security
interests and liens relating thereto were terminated.
As a
condition to closing, we entered into an Investor Rights Agreement with each of
the investors purchasing shares of Series A Preferred Stock, and our Board of
Directors approved with respect to the shareholder rights plan any action
necessary under our shareholder rights plan to accommodate the issuance of the
Series A Preferred Stock and warrants without triggering the applicability of
the shareholder rights plan. The Investor Rights Agreement grants certain
registration and other rights to each of the investors.
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access.
On August
27, 2007, we signed a definitive licensing agreement with SpePharm Holding, B.V.
under which SpePharm will market Access’ product MuGard in Europe.
On August
1, 2007, we announced that Esteban Cvitkovic, a member of our board of directors
as Vice Chairman Europe, agreed to an expanded role as Senior Director, Oncology
Clinical R&D.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
Access
was incorporated in Wyoming in 1974 as Chemex Corporation, and in 1983 Access
changed its name to Chemex Pharmaceuticals, Inc. Access changed its state of
incorporation from Wyoming to Delaware on June 30, 1989. In 1996 Access merged
with Access Pharmaceuticals, Inc., a private Texas corporation, and changed its
name to Access Pharmaceuticals, Inc. Access’ principal executive office is
located at 2600 Stemmons Freeway, Suite 176, Dallas, Texas 75207; Access’
telephone number is (214) 905-5100.
Patents
We
believe that the value of technology both to us and to our potential corporate
partners is established and enhanced by our broad intellectual property
positions. Consequently, we have already been issued and seek to obtain
additional U.S. and foreign patent protection for products under development and
for new discoveries. Patent applications are filed with the U.S. Patent and
Trademark Office and, when appropriate, with the Paris Convention's Patent
Cooperation Treaty (PCT) Countries (most major countries in Western Europe and
the Far East) for our inventions and prospective products.
Two U.S.
patent applications and two European patent applications are under review for
our mucoadhesive liquid technology. Our patent applications cover a range of
products utilizing our mucoadhesive liquid technology for the management of the
various phases of mucositis.
Three
U.S. patents and two European patents have issued and one U.S. patent and two
European patent applications are pending for polymer platinum compounds. The two
patents and patent applications are the result in part of our collaboration with
The School of Pharmacy, University of London, from which the technology has been
licensed and include a synthetic polymer, hydroxypropylmethacrylamide
incorporating platinates, that can be used to exploit enhanced permeability and
retention in tumors and control drug release. The patents and patent
applications include a pharmaceutical composition for use in tumor treatment
comprising a polymer-platinum compound through linkages that are designed to be
cleaved under selected conditions to yield a platinum which is selectively
released at a tumor site. The patents and patent applications also include
methods for improving the pharmaceutical properties of platinum
compounds.
53
We have
two patented Cobalamin-mediated targeted therapeutic technologies:
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the
use of vitamin B12 to target the transcobalamin II receptor which is
upregulated in numerous diseases including cancer, rheumatoid arthritis,
certain neurological and autoimmune disorders with two U.S. patents and
three U.S. and four European patent applications;
and
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oral
delivery of a wide variety of molecules which cannot otherwise be orally
administered, utilizing the active transport mechanism which transports
vitamin B12 into the systemic circulation with six U.S. patents and two
European patents and one U.S. and one European patent
application.
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We also
have intellectual property in connection with the use of another B vitamin,
folic acid, for targeting of polymer therapeutics. Enhanced tumor delivery is
achieved by targeting folate receptors, which are upregulated in certain tumor
types. We have two U.S, and two European patent applications related to folate
polymer therapeutics
Our
patents for the following technologies expire in the years and during the date
ranges indicated below:
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Mucoadhesive
technology in 2021,
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ProLindac™
in 2021,
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Phenylbutyrate
between 2011 and 2016,
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Angiolix®
in 2015,
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Alchemix®
in 2015,
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·
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Cobalamin
mediated technology between 2008 and
2019
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In
addition to issued patents, we have a number of pending patent applications. If
issued, the patents underlying theses applications could extend the patent life
of our technologies beyond the dates listed above.
We have a
strategy of maintaining an ongoing line of patent continuation applications for
each major category of patentable carrier and delivery technology. By this
approach, we are extending the intellectual property protection of our basic
targeting technology and initial agents to cover additional specific carriers
and agents, some of which are anticipated to carry the priority dates of the
original applications.
Government
Regulation
We are
subject to extensive regulation by the federal government, principally by the
FDA, and, to a lesser extent, by other federal and state agencies as well as
comparable agencies in foreign countries where registration of products will be
pursued. Although a number of our formulations incorporate extensively tested
drug substances, because the resulting formulations make claims of enhanced
efficacy and/or improved side effect profiles, they are expected to be
classified as new drugs by the FDA.
The
Federal Food, Drug and Cosmetic Act and other federal, state and foreign
statutes and regulations govern the testing, manufacturing, safety, labeling,
storage, shipping and record keeping of our products. The FDA has the authority
to approve or not approve new drug applications and inspect research, clinical
and manufacturing records and facilities.
Among the
requirements for drug approval and testing is that the prospective
manufacturer's facilities and methods conform to the FDA's Code of Good
Manufacturing Practices regulations, which establish the minimum requirements
for methods to be used in, and the facilities or controls to be used during, the
production process. Such facilities are subject to ongoing FDA inspection to
insure compliance.
The steps
required before a pharmaceutical product may be produced and marketed in the
U.S. include preclinical tests, the filing of an IND with the FDA, which must
become effective pursuant to FDA regulations before human clinical trials may
commence, numerous phases of clinical testing and the FDA approval of a New Drug
Application (“NDA”) prior to commercial sale.
Preclinical
tests are conducted in the laboratory, usually involving animals, to evaluate
the safety and efficacy of the potential product. The results of preclinical
tests are submitted as part of the IND application and are fully reviewed by the
FDA prior to granting the sponsor permission to commence clinical trials in
humans. All trials are conducted under International Conference on
Harmonization, or ICH, good clinical practice guidelines. All investigator sites
and sponsor facilities are subject to FDA inspection to insure compliance.
Clinical trials typically involve a three-phase process. Phase 1 the initial
clinical evaluations, consists of administering the drug and testing for safety
and tolerated dosages and in some indications such as cancer and HIV, as
preliminary evidence of efficacy in humans. Phase 2 involves a study to evaluate
the effectiveness of the drug for a particular indication and to determine
optimal dosage and dose interval and to identify possible adverse side effects
and risks in a larger patient group. When a product is found safe, an initial
efficacy is established in Phase 2, it is then evaluated in Phase 3 clinical
trials. Phase 3 trials consist of expanded multi-location testing for efficacy
and safety to evaluate the overall benefit to risk index of the investigational
drug in relationship to the disease treated. The results of preclinical and
human clinical testing are submitted to the FDA in the form of an NDA for
approval to commence commercial sales.
54
The
process of forming the requisite testing, data collection, analysis and
compilation of an IND and an NDA is labor intensive and costly and may take a
protracted time period. In some cases, tests may have to be redone or new tests
instituted to comply with FDA requests. Review by the FDA may also take
considerable time and there is no guarantee that an NDA will be approved.
Therefore, we cannot estimate with any certainty the length of the approval
cycle.
We are
also governed by other federal, state and local laws of general applicability,
such as laws regulating working conditions, employment practices, as well as
environmental protection.
Competition
The
pharmaceutical and biotechnology industry is characterized by intense
competition, rapid product development and technological change. Competition is
intense among manufacturers of prescription pharmaceuticals and other product
areas where we may develop and market products in the future. Most of our
potential competitors are large, well established pharmaceutical, chemical or
healthcare companies with considerably greater financial, marketing, sales and
technical resources than are available to us. Additionally, many of our
potential competitors have research and development capabilities that may allow
such competitors to develop new or improved products that may compete with our
product lines. Our potential products could be rendered obsolete or made
uneconomical by the development of new products to treat the conditions to be
addressed by our developments, technological advances affecting the cost of
production, or marketing or pricing actions by one or more of our potential
competitors. Our business, financial condition and results of operation could be
materially adversely affected by any one or more of such developments. We cannot
assure you that we will be able to compete successfully against current or
future competitors or that competition will not have a material adverse effect
on our business, financial condition and results of operations. Academic
institutions, governmental agencies and other public and private research
organizations are also conducting research activities and seeking patent
protection and may commercialize products on their own or with the assistance of
major health care companies in areas where we are developing product candidates.
We are aware of certain development projects for products to treat or prevent
certain diseases targeted by us, the existence of these potential products or
other products or treatments of which we are not aware, or products or
treatments that may be developed in the future, may adversely affect the
marketability of products developed by us.
In the
area of advanced drug delivery, which is the focus of our early stage research
and development activities, a number of companies are developing or evaluating
enhanced drug delivery systems. We expect that technological developments will
occur at a rapid rate and that competition is likely to intensify as various
alternative delivery system technologies achieve similar if not identical
advantages.
Even if
our products are fully developed and receive required regulatory approval, of
which there can be no assurance, we believe that our products can only compete
successfully if marketed by a company having expertise and a strong presence in
the therapeutic area. Consequently, we do not currently plan to establish an
internal marketing organization. By forming strategic alliances with major and
regional pharmaceutical companies, management believes that our development
risks should be minimized and that the technology potentially could be more
rapidly developed and successfully introduced into the marketplace.
The
following products may compete with polymer platinate:
|
|
•
Cisplatin, marketed by Bristol-Myers Squibb, the originator of the drug,
and several generic manufacturers;
|
|
|
•
Carboplatin, marketed by Bristol-Myers Squibb in the US;
and
|
|
|
•
Oxaliplatin, marketed exclusively by
Sanofi-Aventis.
|
The
following companies are working on therapies and formulations that may be
competitive with Access’ polymer platinate:
|
•
|
Antigenics
and Regulon are developing liposomal platinum
formulations;
|
|
•
|
Spectrum
Pharmaceuticals and GPC Biotech are developing oral platinum
formulations;
|
|
•
|
Poniard
Pharmaceuticals is developing both i.v. and oral platinum
formulations;
|
|
•
|
Nanocarrier
and Debio are developing micellar nanoparticle platinum formulations;
and
|
|
▪
|
AmericanPharmaceutical
Partners, Cell Therapeutics, Daiichi, and Enzon are developing alternate
drugs in combination with polymers and other drug delivery
systems.
|
Companies
working on therapies and formulations that may be competitive with Access’
vitamin mediated drug delivery system are Bristol-Myers Squibb, Centocor
(acquired by Johnson & Johnson), Endocyte, GlaxoSmithKline, Imclone and Xoma
which are developing targeted monoclonal antibody therapy.
55
Amgen,
Carrington Laboratories, CuraGen Corporation, Cytogen Corporation, Endo
Pharmaceuticals, MGI Pharma, Nuvelo, Inc. and OSI Pharmaceuticals are developing
products to treat mucositis that may compete with Access’ mucoadhesive liquid
technology.
BioDelivery
Sciences International, Biovail Corporation, Cellgate, CIMA Labs, Inc., Cytogen
Corporation, Depomed Inc., Emisphere Technologies, Inc., Eurand, Flamel
Technologies, Nobex and Xenoport are developing products which compete with
Access’ oral drug delivery system.
Companies
working on therapies and formulations that may be competitive with Access’
Sodium Phenylbutyrate are Medicis Pharmaceuticals which currently sells Sodium
Phenylbutyrate (Buphenyl®) for the
treatment of a urea cycle disorder, hyperuremia. We are aware of numerous
products in development for brain cancers. We are aware of several products
being developed by academic and commercial organizations targeting
glioblastoma.
We are
targeting a propriety gene product which is expressed by cancerous
tumors. We are not aware of any other organization developing similar
products targeting this type of protein.
Companies
working on therapies and formulations that may be competitive with Access’
Prodrax are Novocea, Inc., which has exclusively licensed from KuDOS
Pharmaceuticals, a subsidiary of Astra Zeneca, a small molecule prodrug that is
selectively activated by low oxygen tumors that is similar to our Prodrax, and
Novocea is developing this small molecule prodrug in a similar fashion to
Prodrax.
We are
not aware of any other organization developing a drug similar to Alchemix.
Several groups are developing agents against p-glycoprotein, which is only one
of the identified mechanisms of drug resistance within cells, and other groups
are developing agents that have the potential to become chemosensitisers, which
means they will make cancer cells more sensitive to the effects of
chemotherapy.
Many of
these competitors have and employ greater financial and other resources,
including larger research and development, marketing and manufacturing
organizations. As a result, Access’ competitors may successfully develop
technologies and drugs that are more effective or less costly than any that
Access is developing or which would render Access’ technology and future
products obsolete and noncompetitive.
In
addition, some of Access’ competitors have greater experience than Access does
in conducting preclinical and clinical trials and obtaining FDA and other
regulatory approvals. Accordingly, Access’ competitors may succeed in obtaining
FDA or other regulatory approvals for drug candidates more rapidly than Access
does. Companies that complete clinical trials, obtain required regulatory agency
approvals and commence commercial sale of their drugs before their competitors
may achieve a significant competitive advantage. Drugs resulting from Access’
research and development efforts or from its joint efforts with collaborative
partners therefore may not be commercially competitive with its competitors'
existing products or products under development.
Suppliers
Some
materials used by Access are specialized. Access obtains materials from several
suppliers based in different countries around the world. If materials are
unavailable from one supplier Access has alternate suppliers
available.
Employees
As of
November 24, 2008, we had ten full time employees, five of whom have advanced
scientific degrees. We have never experienced employment-related work stoppages
and consider that we maintain good relations with our personnel. In addition, to
complement our internal expertise, we have contracts with scientific
consultants, contract research organizations and university research
laboratories that specialize in various aspects of drug development including
clinical development, regulatory affairs, toxicology, process scale-up and
preclinical testing.
Web
Availability
We make
available free of charge through our web site, www.accesspharma.com, our annual
reports on Form 10-K and Form 10-KSB, as applicable, and other reports required
under the Securities and Exchange Act of 1934, as amended, as soon as reasonably
practicable after such reports are filed with, or furnished to, the Securities
and Exchange Commission (the “SEC”). These documents are also available through
the SEC’s website at www.sec.gov certain
of our corporate governance policies, including the charters for the Board of
Directors’ audit, compensation and nominating and corporate governance
committees and our code of ethics, corporate governance guidelines and
whistleblower policy. The public may read and copy materials we file with the
Commission at the SEC’s Public Reading Room at 100 F Street, NE, Washington, DC
20549, on official business days during the hours of 10:00 am and 3:00 pm. The
public may obtain information on the operation of the Public Reading Room by
calling the Commission at 1-800-SEC-0330. We will provide to any person without
charge, upon request, a copy of any of the foregoing materials. Any such request
must be made in writing to Access Pharmaceuticals, Inc., 2600 Stemmons Freeway,
Suite 176, Dallas, TX 75207 attn: Investor Relations.
56
Access
maintains one facility of approximately 9,000 square feet for administrative
offices and laboratories in Dallas, Texas. Access has a lease agreement for the
facility, which terminates in December 2008. Access anticipates renewing its
current lease in
December 2008. Adjacent space may be available for expansion which
Access believes would accommodate growth for the foreseeable
future.
Access
believes that its existing properties are suitable for the conduct of its
business and adequate to meet its present needs.
LEGAL
PROCEEDINGS
The
Company is not currently subject to any material pending legal
proceedings.
57
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
The
following table sets forth the Directors, Executive Officers, and Key Employees
of Access along with their respective ages and positions and is as
follows:
|
Steven
H. Rouhandeh
|
51
|
Chairman
of the Board
|
|
Jeffrey
B. Davis
|
45
|
Chief
Executive Officer, Director
|
|
Esteban
Cvitkovic, M.D.
|
59
|
Vice
Chairman – Europe
|
|
Mark
J. Ahn, Ph.D.
|
46
|
Director
|
|
Mark
J. Alvino
|
41
|
Director
|
|
Stephen
B. Howell, M.D.
|
64
|
Director
|
|
David
P. Luci
|
42
|
Director
|
|
David
P. Nowotnik, Ph.D.
|
59
|
Senior
Vice President Research & Development
|
|
Phillip
S. Wise
|
50
|
Vice
President, Business Development & Strategy
|
|
Stephen
B. Thompson
|
55
|
Vice
President, Chief Financial Officer, Treasurer,
|
|
Secretary
|
No
director, officer, affiliate or promoter of Access has, within the past five
years, filed any bankruptcy petition, been convicted in or been the subject of
any pending criminal proceedings, or is any such person the subject or any
order, judgment or decree involving the violation of any state or federal
securities laws.
The
following is a brief account of the business experience during the past five
years of each director and executive officer of Access, including principal
occupations and employment during that period and the name and principal
business of any corporation or other organization in which such occupation and
employment were carried on.
Mr. Steven H. Rouhandeh
became a director and Chairman of the Board on March 4, 2008. He is a Chief Investment Officer
of SCO Capital Partners, L.P., a New York based life sciences fund. Mr.
Rouhandeh also is a founder of SCO Financial Group LLC, a highly successful
value-oriented healthcare group with an 11-year track record in this sector
(advisory, research, banking and investing). He possesses a diverse
background in financial services that includes experience in asset management,
corporate finance, investment banking and law. He has been active
throughout recent years as an executive in venture capital and as a founder of
several companies in the biotech field. His experience also includes
positions as Managing Director of a private equity group at Metzler Bank, a
private European investment firm and Vice President, Investment Banking at
Deutsche Morgan Grenfell. Mr. Rouhandeh was also a corporate attorney at
New York City-based Cravath, Swaine & Moore. Mr. Rouhandeh holds a J.D.,
from Harvard Law School, Harvard University and B.A. Government, Economics, from
Southern Illinois University.
Mr. Jeffrey B. Davis became a
director in March 2006. Mr. Davis became Chief Executive Officer of the Company
on December 26, 2007. Previously, Mr. Davis was Chairman of the Board and
Chairman of the Compensation Committee of the Board. Mr. Davis currently serves
as President of SCO Financial Group LLC and has been employed by SCO since 1997.
Previously, Mr. Davis served in senior management at a publicly traded
healthcare technology company. Prior to that, Mr. Davis was an investment banker
with various Deutsche Bank banking organizations, both in the U.S. and Europe.
Mr. Davis also served in senior marketing and product management positions at
AT&T Bell Laboratories, where he was also a member of the technical staff,
and at Philips Medical Systems North America. Mr. Davis is currently on
the board of MacroChem Corporation and Uluru, Inc., a private biotechnology
company. Mr. Davis holds a B.S. in biomedical engineering from Boston
University and an M.B.A. degree from the Wharton School, University of
Pennsylvania.
Dr. Esteban Cvitkovic became
a director in February 2007 as Vice Chairman (Europe) and is also a consultant
to the Company as Senior Director, Oncology Clinical Research & Development.
Recently, the oncology-focused CRO, Cvitkovic & Associés Consultants (CAC),
founded by Dr. Cvitkovic 11 years ago and which he developed from a small
oncology consultancy to a full-service CRO, was sold to AAIPharma to become
AAIOncology. Dr. Cvitkovic is currently a Senior Medical Consultant to
AAIOncology. In addition, he maintains a part-time academic practice including
teaching at the hospitals Beaujon and St. Louis in Paris. Dr. Cvitkovic is
Scientific President of the FNAB, a foundation devoted to the furthering of
personalized cancer treatments. Together with a small number of collaborators,
he has recently co-founded Oncoethix, a biotech company focused on licensing and
co-development of anti-cancer molecules. Dr. Cvitkovic has authored more than
200 peer-reviewed articles and 600 abstracts focused on therapeutic oncology
development. His international career includes staff and academic appointments
at Memorial Sloan Kettering Cancer Center (New York), Columbia Presbyterian (New
York), Instituto Mario Negri (Milan), Institut Gustave Roussy (Villejuif),
Hôpital Paul Brousse (Villejuif) and Hôpital St. Louis (Paris).
58
Dr. Mark J. Ahn became a
director in September 2006 and is a member of the Nominating & Corporate
Governance Committee. Dr. Ahn is Professor and Chair, Science & Technology
Faculties of Commerce & Administration Science at Victoria University of
Welling, New Zealand and has been in this position since September 2007. Dr. Ahn
was President and Chief Executive Officer and a member of the board of directors
of Hana Biosciences, Inc. from November 2003 to September 2007. Prior to joining
Hana, from December 2001 to November 2003, he served as Vice President,
Hematology and corporate officer at Genentech, Inc. where he was responsible for
commercial and clinical development of the Hematology franchise. From February
1991 to February 1997 and from February 1997 to December 2001, Dr. Ahn was
employed by Amgen and Bristol-Myers Squibb Company, respectively, holding a
series of positions of increasing responsibility in strategy, general
management, sales & marketing, business development, and finance. He has
also served as an officer in the U.S. Army. Dr. Ahn is a Henry Crown Fellow at
the Aspen Institute, founder of the Center for Non-Profit Leadership, a director
of TransMolecular, Inc., a privately held biotechnology company focused on
neuroncology, and a member of the Board of Trustees for the MEDUNSA (Medical
University of South Africa) Trust. Dr. Ahn received a B.A. in History and an
M.B.A. in Finance from Chaminade University. He was a graduate fellow in
Economics at Essex University, and has a Ph.D. in Business Administration from
the University of South Australia.
Mr. Mark J. Alvino became a
director in March 2006 initially as a designee of SCO Capital Partners LLC and
is a member of the Nominating and Corporate Governance Committee. Mr. Alvino is
currently Managing Director for Griffin Securities and has been in this position
since May 2007. Mr. Alvino was Managing Director for SCO Financial Group LLC
from July 2002 to May 2007. He is currently on the board of directors of
MacroChem Corporation. He previously worked at Feinstein Kean Healthcare, an
Ogilvy Public Relations Worldwide Company. There he was Senior Vice President,
responsible for managing both investor and corporate communications programs for
many private and public companies and acted as senior counsel throughout the
agency's network of offices. Prior to working at FKH, Mr. Alvino served as Vice
President of Investor Relations and managed the New York Office of Allen &
Caron, Inc., an investor relations agency. His base of clients included medical
devices, biotechnology, and e-healthcare companies. Mr. Alvino also spent
several years working with Wall Street brokerages including Ladenburg, Thallman
& Co. and Martin Simpson & Co.
Stephen B. Howell, M.D. has
served as one of Access’ directors since 1996. Dr. Howell is a member of the
Compensation Committee of the Board. Dr. Howell is a Professor of Medicine at
the University of California, San Diego, and director of the Cancer Pharmacology
Program of the UCSD Cancer Center. Dr. Howell is a recipient of the Milken
Foundation prize for his contributions to the field of cancer chemotherapy. He
has served on the National Research Council of the American Cancer Society and
is on the editorial boards of multiple medical journals. Dr. Howell founded
DepoTech, Inc. and served as a member of its board of directors from 1989 to
1999. Dr. Howell served on the board of directors of Matrix Pharmaceuticals from
2000 to 2002. Dr. Howell received his A.B. at the University of Chicago and his
M.D. from Harvard Medical School.
Mr. David P. Luci has served
as one of Access’ directors since January 2007 and is also chairman of the Audit
and Finance Committee and a member of the Compensation Committee. Mr. Luci is
currently President and Chief Business Officer of MacroChem Corporation. Mr.
Luci was Executive Vice President of Bioenvision, Inc. until August 2007. He has
also served as Bioenvision’s chief financial officer, general counsel and
corporate secretary since July 2004, after serving as director of finance,
general counsel and corporate secretary since July 2002. From September 1994 to
July 2002, Mr. Luci served as a corporate associate at Paul, Hastings, Janofsky
& Walker LLP (New York office). Prior to that, Mr. Luci served as a senior
auditor at Ernst & Young LLP (New York office). Mr. Luci is a certified
public accountant. He holds a Bachelor of Science in Business Administration
with a concentration in accounting from Bucknell University and a J.D. (cum
laude) from Albany Law School of Union University.
David P. Nowotnik, Ph.D. has
been Senior Vice President Research and Development since January 2003 and was
Vice President Research and Development from 1998. From 1994 until 1998, Dr.
Nowotnik had been with Guilford Pharmaceuticals, Inc. in the position of Senior
Director, Product Development and was responsible for a team of scientists
developing polymeric controlled-release drug delivery systems. From 1988 to 1994
he was with Bristol-Myers Squibb researching and developing technetium
radiopharmaceuticals and MRI contrast agents. From 1977 to 1988 he was with
Amersham International leading the project which resulted in the discovery and
development of Ceretec.
Mr. Phillip S. Wise has been
Access’ Vice President Business Development since June 2006. Mr. Wise was Vice
President of Commercial and Business Development for Enhance Pharmaceuticals,
Inc. and Ardent Pharmaceuticals, Inc. from 2000 until 2006. Prior to that time
he was with Glaxo Wellcome, from 1990 to 2000 in various
capacities.
Mr. Stephen B. Thompson has
been Vice President since 2000 and Access’ Chief Financial Officer since 1996.
From 1990 to 1996, he was Controller and Administration Manager of Access
Pharmaceuticals, Inc., a private Texas corporation. Previously, from 1989 to
1990, Mr. Thompson was Controller of Robert E. Woolley, Inc., a hotel real
estate company where he was responsible for accounting, finances and investor
relations. From 1985 to 1989, he was Controller of OKC Limited Partnership, an
oil and gas company, where he was responsible for accounting, finances and SEC
reporting. Between 1975 and 1985 he held various accounting and finance
positions with Santa Fe International Corporation.
59
Code
of Business Conduct and Ethics
In
October 2004, Access adopted a written Code of Business Conduct and Ethics for
Employees, Executive Officers and Directors, applicable to all employees,
management, and directors, designed to deter wrongdoing and promote honest and
ethical conduct, full, fair and accurate disclosure, compliance with laws,
prompt internal reporting and accountability to adherence to the Code of
Business Conduct and Ethics.
The
following executive compensation disclosure reflects compensation awarded to,
earned by or paid to Access’ Chief Executive Officer and each of Access’ other
executive officers listed below whose total compensation exceeded $100,000 for
the fiscal year ended December 31, 2007 and 2006. Access refers to Access’ Chief
Executive Officer and these other executive officers as Access’ "named executive
officers" elsewhere in this prospectus.
Summary
Compensation Table
|
Name and Principal Position
(8)
|
Year
|
Salary ($)
(1)
|
Bonus
($)
|
Stock
Awards
($) (2)
|
Option
Awards ($)
(3)
|
All Other
Compensation
(4)
|
Total ($)
|
|||||||||||||||||||||
|
Stephen
R. Seiler (5)
Former
President and CEO
|
2007
|
$ | 350,000 | $ | - | $ | - | $ | 270,000 | $ | 14,840 | $ | 634,840 | |||||||||||||||
|
Rosemary
Mazanet(6)
Former
Acting CEO
|
2007
2006
|
$
|
8,076 357,385 |
$
|
-
100,000
|
$
|
-
-
|
$
|
263,071 81,464 |
$
|
-
2,594
|
$
|
271,147 541,443 | |||||||||||||||
|
David
P. Nowotnik, Ph.D.
Senior
Vice President Research
and
Development
|
2007
2006
|
$
|
253,620 253,620 |
$
|
20,000 |
$
|
-
-
|
$
|
40,732 |
$
|
12,225 7,152 |
$
|
265,845 321,504 | |||||||||||||||
|
Phillip
S. Wise(7)
Vice
President, Business
Development
|
2007
2006
|
$
|
200,000 116,667 |
$
|
-
25,000
|
$
|
-
-
|
$
|
-
40,732
|
$
|
9,876
$ 358
|
$
|
209,876 182,757 | |||||||||||||||
|
Stephen
B. Thompson
Vice
President, Chief Financial
Officer
|
2007
2006
|
$
|
154,080 154,080 |
$
|
-
20,000
|
$
|
-
-
|
$
|
-
40,732
|
$
|
7,427 4,508 |
$
|
161,507 219,320 | |||||||||||||||
____________________
|
(1)
|
Includes
amounts deferred under our 401(k)
Plan.
|
|
(2)
|
There
were no stock awards grants in 2007 and 2006 and no restricted stock
outstanding at December 31, 2007 and
2006.
|
|
(3)
|
The
value listed in the above table represents the fair value of the options
granted in prior years that was recognized in 2007 and 2006 under FAS
123R. Fair value is calculated as of the grant date using a Black-Scholes
option-pricing model. The determination of the fair value of share-based
payment awards made on the date of grant is affected by our stock price as
well as assumptions regarding a number of complex and subjective
variables. Our assumptions in determining fair value are described in note
10 to our audited financial statements for the year ended December 31,
2007, included in our Annual Report on Form
10-K.
|
|
(4)
|
Amounts
reported for fiscal years 2007 and 2006 consist of: (i) amounts we
contributed to our 401(k) Plan with respect to each named individual, and
(ii) amounts we paid for group term life insurance for each named
individual.
|
|
(5)
|
Amounts
listed in 2007 for Mr. Seiler indicate compensation paid to him in
connection with his services as our President and CEO commencing on
January 1, 2007 and ending December 16,
2007.
|
|
(6)
|
Amounts
listed in 2007 and 2006 for Dr. Mazanet indicate compensation paid to her
in connection with her services as our Acting CEO commencing on May 11,
2005 and ending January 4, 2007.
|
|
(7)
|
Phillip
S. Wise became our Vice President Business Development June 1,
2006.
|
|
(8)
|
Jeffrey
B. Davis became our Chief Executive Officer effective December 26, 2007
and his employment agreement started January 4,
2008.
|
Employment
Agreements
President and Chief
Executive Officer
Access is
a party to an employment agreement, with Jeffrey B. Davis, who was named by the
Board as Access’ Chief Executive Officer, effective as of December 26, 2007. Mr.
Davis’ agreement was effective January 4, 2008 (the “Effective Date”) and was
amended April 9, 2008. Pursuant to the terms of his employment agreement, Mr.
Davis was paid an annual salary of $335,000 from the Effective Date through
March 31, 2008, and is currently paid an annual salary of $240,000 from April 1,
2008. Mr. Davis does not currently have any stock options resulting from his
employment with us. Mr. Davis was awarded stock options to purchase 600,000
shares of Common Stock. However, as of the Effective Date and pursuant to the
amended employment agreement, Mr. Davis has agreed to forgo any stock options
awarded under the terms of the original employment agreement. Mr. Davis is
entitled to similar employee benefits as Access’ other executive
officers.
60
Access
was a party to an employment arrangement with Stephen R. Seiler, who was named
by the Board as Access’ President and Chief Executive Officer and director,
effective as of January 4, 2007 (the "Effective Date"), and resigned from those
positions on December 16, 2007. Mr. Seiler was paid an annual salary of $350,000
and was granted stock options to purchase 500,000 shares of Common Stock with an
exercise price equal to the closing price of Common Stock on the day preceding
the Effective Date. Pursuant to a separation agreement with Mr. Seiler, 100,000
of his options vested on December 16, 2007, and such options shall remain
exercisable until March 12, 2010. The stock options were granted under Access’
2005 Equity Incentive Plan and the 2007 Special Stock Option Plan. Mr. Seiler
was entitled to similar employee benefits as Access’ other executive
officers.
Access
was a party to an employment arrangement with Rosemary Mazanet, Access’ former
Acting Chief Executive Officer. Dr. Mazanet reported directly to, and was
subject to the direction of, the Board. Dr. Mazanet salary was set at $25,000
monthly. Dr. Mazanet was granted a non-qualified stock option of 6,000 shares of
Common Stock, vesting over a six month period. In November 2005, Dr.
Mazanet was also granted 50,000 options under Access’ 2005 Equity Incentive
Plan. Of the options granted, 14,000 options vested on grant, the rest vest upon
attainment of preset milestones. Dr. Mazanet also received similar employee
benefits as Access’ other executive officers, D&O insurance coverage and
received a signing bonus of $30,000. The Board granted Dr. Mazanet an additional
200,000 options in 2006. Additionally, Dr. Mazanet was awarded a bonus of
$100,000 in April 2007.
Senior Vice
President
Access is
a party to an employment agreement with David P. Nowotnik, Ph.D., Access’ Senior
Vice President, Research and Development, which renews automatically for
successive one-year periods, with the current term extending until November 16,
2007. Under this agreement, Dr. Nowotnik is currently entitled to receive an
annual base salary of $253,620, subject to adjustment by the Board. Dr. Nowotnik
is eligible to participate in all of Access’ employee benefit programs available
to executives. Dr. Nowotnik is also eligible to receive:
|
·
|
a
bonus payable in cash and Common Stock related to the attainment of
reasonable performance goals specified by the
Board;
|
|
·
|
stock
options at the discretion of the
Board;
|
|
·
|
long-term
disability insurance to provide compensation equal to at least $60,000
annually; and
|
|
·
|
term
life insurance coverage of
$254,000.
|
Dr.
Nowotnik is entitled to certain severance benefits in the event that Access
terminates his employment without cause or if Dr. Nowotnik terminates his
employment following a change of control. In the event that Access terminates
the employment agreement for any reason, other than for cause, Dr. Nowotnik will
receive his salary for six months. Access will also continue benefits for such
period. In the event that Dr. Nowotnik's employment is terminated within six
months following a change in control or by Dr. Nowotnik upon the occurrence of
certain events following a change in control, Dr. Nowotnik will receive twelve
months salary and his stock options will become immediately exercisable. Access
will also continue payment of benefits for such period.
All Stock
options were approved by the Compensation Committee of the Board of Directors.
Stock options are priced at the market price of common stock the day of the
grant. Stock options generally vest over four years and can be exercised up to
ten years from grant date.
Vice President – Business
Development and Strategy
Phillip
S. Wise is entitled to an annual base salary of $200,000, subject to adjustment
by the Board. He is eligible to receive:
|
·
|
a
bonus payable in cash and Common Stock related to the attainment of
reasonable performance goals specified by the
Board;
|
|
·
|
stock
options at the discretion of the
Board;
|
|
·
|
long-term
disability insurance to provide compensation equal to at least $120,000
annually; and
|
|
·
|
term
life insurance coverage of
$200,000.
|
All Stock
options were approved by the Compensation Committee of the Board of Directors.
Stock options are priced at the market price of common stock the day of the
grant. Stock options generally vest over four years and can be exercised up to
ten years from grant date.
Vice President – Chief
Financial Officer
Access is
party to an employment agreement with Stephen B. Thompson, Access’ Vice
President and Chief Financial Officer, which renews automatically for successive
one-year periods. Mr. Thompson is entitled to an annual base salary of $154,080,
subject to adjustment by the Board. The employment agreement also grants Mr.
Thompson similar employee benefits as Access’ other executive officers. Mr.
Thompson is also eligible to receive:
61
|
·
|
a
bonus payable in cash and Common Stock related to the attainment of
reasonable performance goals specified by the
Board;
|
|
·
|
stock
options at the discretion of the
Board;
|
|
·
|
long-term
disability insurance to provide compensation equal to at least $90,000
annually; and
|
|
·
|
term
life insurance coverage of
$155,000.
|
Mr.
Thompson is entitled to certain severance benefits in the event that Access
terminates his employment without cause or if Mr. Thompson terminates his
employment following a change of control. In the event that Access terminates
the employment agreement for any reason, other than cause, Mr. Thompson will
receive salary for six months. Access will also continue benefits for such
period. In the event that Mr. Thompson's employment is terminated within six
months following a change of control or by Mr. Thompson upon the occurrence of
certain events following a change in control, Mr. Thompson will receive twelve
months salary and his stock options will become immediately exercisable. Access
will also continue payment of benefits for such period.
All Stock
options were approved by the Compensation Committee of the Board of Directors.
Stock options are priced at the market price of common stock the day of the
grant. Stock options generally vest over four years and can be exercised up to
ten years from grant date.
2005
Equity Incentive Plan
Access’
board of directors adopted and Access’ stockholders approved Access’ 2005 Equity
Incentive Plan (the “Plan”) in May 2005. As of September 30, 2008, there are
3,150,000 shares approved in the Plan. As of December 31, 2007, options to
purchase 926,386 shares of common stock were outstanding at a weighted average
exercise price of $1.59 per share and 748,614 shares remained available for
future grant.
Purpose. The
purpose of the Plan is to attract and retain the best available personnel for
positions of substantial responsibility and to provide additional incentive to
employees and directors of and advisers and consultants to the Company. The
purpose of the proposed amendment is to provide the Company with additional
capacity to award stock options to existing personnel and to attract qualified
new employees, directors, advisers and consultants through grants of stock
options.
Administration. The
Plan is administered by the Compensation Committee. The Compensation Committee
presently is composed of Jeffrey B. Davis, David P. Luci and Stephen B. Howell,
MD. Subject to the provisions of the Plan, the Compensation Committee has
discretion to determine when awards are made, which employees are granted
awards, the number of shares subject to each award and all other relevant terms
of the awards. The Compensation Committee also has broad discretion to construe
and interpret the Plan and adopt rules and regulations thereunder. The
Compensation Committee approved the 2007 Special Stock Option Plan and the grant
of 450,000 options to Mr. Seiler, the Company’s former President and Chief
Executive Officer.
Eligibility. Awards
may be granted to persons who are employees of the Company whether or not
officers or members of the Board and directors of or advisers or consultants to
the Company or of any of the Company’s subsidiaries. No election by
any such person is required to participate in the Plan.
Shares Subject to the
Plan. The shares issued or to be issued under the Plan
are shares of Common Stock, which may be newly issued shares or shares held in
the treasury or acquired in the open market. Currently, no more than 3,150,000
shares may be issued under the Plan. The foregoing limit is subject to
adjustment for stock dividends, stock splits or other changes in the Company’s
capitalization.
Stock
Options. The Compensation Committee in its discretion
may issue stock options which qualify as incentive stock options under the
Internal Revenue Code or non-qualified stock options. The Compensation Committee
will determine the time or times when each stock option becomes exercisable, the
period within which it remains exercisable and the price per share at which it
is exercisable, provided that no incentive stock option shall be exercised more
than 10 years after it is granted and no other options shall be exercised more
than 10 years and one day after it is granted, and further provided that the
exercise price of any incentive stock option shall not be less than the fair
market value of the Common Stock on the date of grant. The closing price of the
Common Stock on the OTC Bulletin Board on October 6, 2008 was $2.45 per
share.
Payment
for shares purchased upon exercise of an option must be made in full in cash or
check, by payment through a broker in accordance with Regulation T of the
Federal Reserve Board or by such other mode of payment as the Committee may
approve, including payment in whole or in part in shares of the Common Stock,
when the option is exercised. No option is transferable except by will or the
laws of descent and distribution or pursuant to a qualified domestic relations
order, as defined by the Code or in Title I of the Employee Retirement Income
Security Act of 1974, as amended.
Notwithstanding
any other provision of the Plan, each non-employee director is also entitled to
receive options to purchase 2,500 shares of Common Stock on the date of each
annual meeting of stockholders and options to purchase 25,000 shares of Common
Stock when he or she is first appointed as a director.
62
Tax
Considerations. The following is a brief and general
discussion of the federal income tax rules applicable to awards under the Plan.
With respect to an incentive stock option, an employee will generally not be
taxed at the time of grant or exercise, although exercise of an incentive option
will give rise to an item of tax preference that may result in an alternative
minimum tax. If the employee holds the shares acquired upon exercise of an
incentive stock option until at least one year after issuance and two years
after the option grant, he or she will have long-term capital gain (or loss)
based on the difference between the amount realized on the sale or disposition
and his or her option price. If these holding periods are not satisfied, then
upon disposition of the shares the employee will recognize ordinary income
equal, in general, to the excess of the fair market value of the shares at time
of exercise over the option price, plus capital gain in respect of any
additional appreciation. With respect to a non-qualified option, an employee
will not be taxed at the time of grant; upon exercise, he or she will generally
realize compensation income to the extent the then fair market value of the
stock exceeds the option price. The Company will generally have a tax deduction
to the extent that, and at the time that, an employee realizes compensation
income with respect to an award.
Any tax
deductions the Company may be entitled to in connection with awards under the
Plan may be limited by the $1 million limitation under Section 162(m) of the
Code on compensation paid to any of our chief executive officer or other named
officers. This limitation is further discussed in the Compensation Committee
Discussion on Executive Compensation.
For
purposes of this summary, we have assumed that no award will be considered
“deferred compensation” as that term is defined for purposes of the federal tax
rules governing nonqualified deferred compensation arrangements, Section 409A of
the Code, or, if any award were considered to any extent to constitute deferred
compensation, its terms would comply with the requirements of that legislation
(in general, by limiting any flexibility in the time of payment). For example,
the award of a non-qualified stock option with an exercise price which is less
than the market value of the stock covered by the option would constitute
deferred compensation. If an award includes deferred compensation, and its terms
do not comply with the requirements of these tax rules, then any deferred
compensation component of the award will be taxable when it is earned and vested
(even if not then payable) and the recipient will be subject to a 20% additional
tax.
In all
cases, recipients of awards should consult their tax advisors regarding the tax
treatment of any awards received by them.
401(k)
Plan
Access
maintains a defined contribution employee retirement plan, or 401(k) plan, for
Access’ employees. Access’ executive officers are also eligible to participate
in the 401(k) plan on the same basis as Access’ other employees. The plan is
intended to qualify as a tax-qualified plan under Section 401(k) of the Internal
Revenue Code. The plan provides that each participant may contribute up to the
statutory limit, which is $15,500 for calendar year 2008. Participants who are
50 years or older can also make "catch-up" contributions, which in calendar year
2008 may be up to an additional $5,000 above the statutory limit. Under the
plan, each participant is fully vested in his or her deferred salary
contributions, including any matching contributions by us, when contributed.
Participant contributions are held and invested by the participants in the
plan's investment options. The plan also permits Access to make discretionary
contributions and matching contributions, subject to established limits and a
vesting schedule. In 2006, Access matched 100% of participant contributions up
to the first two percent of eligible compensation. Access matched participant
contributions at the first four percent of eligible compensation in 2008 and
2007.
Outstanding
Equity Awards at December 31, 2007
The
following table sets forth certain information regarding outstanding equity
awards held by Access’ named executive officers at December 31, 2007. There were
no outstanding stock awards held by such officer at December 31,
2007:
Option
Awards
|
Name
|
Number
of Securities Underlying Unexercised Options (#)
Exercisable
|
Number
of
Securities
Underlying Unexercised
Options
(#) Unexercisable
|
Equity
Incentive
Plan
Awards: Number of
Securities
Underlying Unexercised Unearned
Options
(#)
|
Option
Exercise
Price
($) (1)
|
Option
Expiration
Date
|
|
Stephen
R. Seiler
|
100,000
|
-
|
-
|
2.90
|
03/12/10
|
|
Rosemary
Mazanet(2)
|
33,333
200,000
48,251
6,000
|
66,667
-
1,749
-
|
-
|
2.90
0.63
5.45
12.50
|
01/04/17
08/17/16
11/02/15
05/11/15
|
|
David
P. Nowotnik, Ph.D. (3)
|
100,000
6,000
5,000
7,000
10,000
10,000
10,000
10,000
|
-
2,000
-
-
-
-
-
-
|
-
|
0.63
11.60
29.25
10.10
18.65
12.50
10.00
15.00
|
08/17/16
05/23/15
01/23/14
01/30/13
03/22/12
03/01/10
07/20/09
11/16/08
|
63
|
Phillip
S. Wise
|
100,000
|
-
|
-
|
0.63
|
08/17/16
|
|
Stephen
B. Thompson (3)
|
100,000
3,750
3,000
4,000
6,000
9,000
4,000
4,000
|
-
1,250
-
-
-
-
-
-
|
-
|
0.63
11.60
29.25
10.10
18.65
12.50
10.00
15.00
|
08/17/16
05/23/15
01/23/14
01/30/13
03/22/12
03/01/10
07/20/09
06/18/08
|
____________________
|
(1)
|
On
December 31, 2007, the closing price of our Common Stock as quoted on the
OTC Bulletin Board was $3.25.
|
|
(2)
|
Options
listed for Dr. Mazanet include options paid to her in connection with her
services as our Acting CEO commencing on May 11, 2005 and ending on
January 4, 2007. Dr. Mazanet’s options stopped vesting when she retired
from the Board of Directors on May 21, 2008. The Board granted her the
right to exercise her vested options up to May 21,
2010.
|
|
(3)
|
Dr.
Nowotnik and Mr. Thompson’s options to purchase shares of common stock
will be fully vested in April 2009.
|
|
(4)
|
Jeffrey
B. Davis became our Chief Executive Officer effective December 26, 2007,
and his employment agreement became effective January 4, 2008. Mr. Davis
does not currently have any stock options resulting from his employment
with us.
|
Board
Committees
The Board
established an Audit and Finance Committee, a Compensation Committee and a
Nominating and Corporate Governance Committee. Each of the committees of the
Board acts pursuant to a separate written charter adopted by the Board. On
February 8, 2007, the Board also established an Executive Committee consisting
of Mr. Davis, Mr. Stephen R. Seiler and Dr. Ahn. The committee was dissolved on
February 12, 2008.
The Audit
and Finance Committee is currently comprised of David P. Luci (chairman) and
John J. Meakem, Jr. Mr. Luci is independent under applicable SEC rules relating
to Audit Committee member independence. Mr. Meakem is independent under
applicable SEC and AMEX rules and regulations. The Board has determined that Mr.
Luci, the chairman of the Audit and Finance Committee, is an “audit committee
financial expert,” under applicable SEC rules and regulations. The Audit and
Finance Committee’s responsibilities and duties are among other things to engage
the independent auditors, review the audit fees, supervise matters relating to
audit functions and review and set internal policies and procedure regarding
audits, accounting and other financial controls.
The
Compensation Committee is currently comprised of Mr. David P. Luci and Dr.
Stephen B. Howell. Mr. Luci is a non-employee director under applicable SEC
rules and “outside” under Internal Revenue Code Section 162(m). Mr. Luci and Dr.
Howell are not independent under applicable AMEX rules and
regulations.
The
Nominating and Corporate Governance Committee is currently comprised of John J.
Meakem, Jr. (chairman), Mark Ahn, PhD and Mark J. Alvino. All committee members
are independent under applicable AMEX rules and regulations. The Nominating and
Corporate Governance Committee is responsible for, among other things,
considering potential Board members, making recommendations to the full Board as
to nominees for election to the Board, assessing the effectiveness of the Board
and implementing Access’ corporate governance guidelines.
Compensation
of Directors
Each
director who is not also an Access employee receives a quarterly fee of $3,000
and $1,000 per quarter per committee (aggregate for all committees) in which
he/she is a member. The Chairman of the Board is paid an additional $1,000 per
quarter and the Chairman of each of the Audit and Finance and Compensation
Committee is paid an additional $500 per quarter. Each director will have $2,000
deducted from his or her fee if the director misses more than one Board meeting,
and $1,000 deducted per committee meeting not attended. In addition, Access
reimbursed each director, whether an employee or not, the expenses of attending
Board and committee meetings. Each non-employee director is also entitled to
receive options to purchase 2,500 shares of Common Stock on the date of each
annual meeting of stockholders and options to purchase 25,000 shares of Common
Stock when he/she is first appointed as a director.
64
Director Compensation
Table - 2007
The table
below represents the compensation paid to our outside directors during the year
ended December 31, 2007:
|
Name
|
Fees
earned or
Paid
in Cash ($)
|
Stock
Awards ($)
|
Option
Awards ($)(1)
|
All
Other Compensation ($)
|
Total
($)
|
|
|
Mark
J. Ahn, PhD (2)
|
16,000
|
-
|
2,000
|
-
|
18,000
|
|
|
Mark
J. Alvino
|
16,000
|
-
|
-
|
-
|
16,000
|
|
|
Esteban
Cvitkovic, MD (3)
|
11,000
|
-
|
256,000
|
153,000
|
420,000
|
|
|
Jeffrey
B. Davis
|
22,000
|
-
|
-
|
-
|
22,000
|
|
|
Stephen
B. Howell, MD (4)
|
15,000
|
-
|
2,000
|
67,000
|
84,000
|
|
|
David
P. Luci (5)
|
13,000
|
-
|
50,000
|
-
|
63,000
|
|
|
Rosemary
Mazanet, MD, PhD (6)
|
12,000
|
-
|
330,000
|
29,000
|
371,000
|
|
|
John
J. Meakem, Jr. (7)
|
18,000
|
-
|
2,000
|
-
|
20,000
|
|
___________________
|
|
(1)
|
|
The
value listed in the above table represents the fair value of the options
recognized as expense under FAS 123R during 2007, including unvested
options granted before 2007 and those granted in 2007. Fair value is
calculated as of the grant date using a Black-Scholes (“Black-Scholes”)
option-pricing model. The determination of the fair value of share-based
payment awards made on the date of grant is affected by our stock price as
well as assumptions regarding a number of complex and subjective
variables. Our assumptions in determining fair value are described in note
10 to our audited financial statements for the year ended December 31,
2007, included in our Annual Report on Form 10-K.
|
|
(2)
|
Represents
expense recognized in 2007 in respect of 25,000 options to purchase shares
based on a grant date fair value of $7,592.
|
||
|
(3)
|
Represents
expense recognized in 2007 in respect of 25,000 options to purchase shares
based on a grant date fair value of $157,027 and an additional 25,000
options to purchase shares based on a grant date fair value of $99,347.
Includes $153,000 Dr. Cvitkovic received for scientific consulting
services in 2007.
|
||
|
(4)
|
Represents
expense recognized in 2007 in respect of 25,000 options to purchase shares
based on a grant date fair value of $5,581. Includes $67,000 Dr. Howell
received for scientific consulting services in 2007.
|
||
|
(5)
|
Represents
expense recognized in 2007 in respect of 25,000 options to purchase shares
based on grant date fair value of $65,768.
|
||
|
(6)
|
Represents
expense recognized in 2007 in respect of 50,000 options to purchase shares
based on a grant date fair value of $147,737; 200,000 options to purchase
shares based on a grant date fair value of $81,464; and an additional
100,000 options to purchase shares based on a grant date fair value of
$263,071. Includes $29,000 Dr. Mazanet received for scientific consulting
services in 2007.
|
||
|
(7)
|
Represents
expense recognized in 2007 in respect of 25,000 options to purchase shares
based on a grant date fair value of
$5,581.
|
65
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Based
solely upon information made available to Access, the following table sets forth
certain information with respect to the beneficial ownership of Access’ Common
Stock as of November 24, 2008 (i) each person who is known by Access to
beneficially own more than five percent of Access’ Common Stock; (ii) each of
Access’ directors; (iii) each of Access’ named executive officers; and (iv) all
Access’ executive officers and directors as a group. Beneficial ownership as
reported in the following table has been determined in accordance with Rule
13d-3 under the Securities Exchange Act of 1934, as amended. The address of each
holder listed below, except as otherwise indicated, is c/o Access
Pharmaceuticals, Inc., 2600 Stemmons Freeway, Suite 176, Dallas, Texas
75207.
|
Title
of Class
|
Name
and Address of Beneficial Owner
|
Amount
and Nature of Beneficial Ownership
|
Percent
of Class
|
|
|
Common Stock
(1)
|
||||
|
Steven
H. Rouhandeh(2)
|
-
|
*
|
||
|
Jeffery
B. Davis (3)
|
31,000
|
*
|
||
|
Mark
J. Ahn, Ph. D. (4)
|
86,525
|
*
|
||
|
Mark
J. Alvino (5)
|
156,000
|
1.3%
|
||
|
Esteban
Cvitkovic, M.D. (6)
|
156,000
|
2.3%
|
||
|
Stephen
B. Howell, M.D. (7)
|
56,422
|
*
|
||
|
David
P. Luci (8)
|
35,167
|
*
|
||
|
David
P. Nowotnik, Ph.D. (9)
|
166,852
|
2.5%
|
||
|
Phillip
S. Wise (10)
|
100,000
|
1.5%
|
||
|
Stephen
B. Thompson (11)
|
140,103
|
2.1%
|
||
|
SCO
Capital Partners LLC, SCO
Capital
Partners LP, and Beach
Capital
LLC (12)
|
6,973,818
|
55.4%
|
||
|
Larry
N. Feinberg (13)
|
1,025,333
|
14.2%
|
||
|
Lake
End Capital LLC (14)
|
844,720
|
11.6%
|
||
|
Perceptive
Life Sciences (15)
|
666,666
|
10.23%
|
||
|
All
Directors and Executive
Officers
as a group
(consisting
of 10 persons) (16)
|
802,889
|
11.1%
|
||
|
Preferred
Stock
|
||||
|
Steven
H. Rouhandeh(2)
|
-
|
*
|
||
|
Jeffery
B. Davis (3)
|
-
|
*
|
||
|
David
P. Luci (8)
|
8,333
|
*
|
||
|
SCO
Capital Partners LLC, SCO
Capital
Partners LP, and Beach
Capital
LLC (12)
|
7,077,100
|
65.5%
|
||
|
Larry
N. Feinberg (13)
|
1,457,699
|
13.5%
|
||
|
Lake
End Capital LLC (14)
|
793,067
|
7.3%
|
||
|
All
Directors and Executive
Officers
as a group
(consisting
of 10 persons) (16)
|
8,333
|
*
|
||
* - Less
than 1%
|
(1)
|
Includes
Access’ outstanding shares of Common Stock held plus all shares of Common
Stock issuable upon exercise of options, warrants and other rights
exercisable within 60 days of November 24,
2008.
|
|
(2)
|
Steven
H. Rouhandeh is Chairman of SCO Securities LLC. a wholly-owned subsidiary
of SCO Financial Group LLC. His address is c/o SCO Capital Partners LLC,
1285 Avenue of the Americas, 35th Floor, New York, NY 10019. SCO
Securities LLC and affiliates (SCO Capital Partners LP and Beach Capital
LLC) are known to beneficially own an aggregate of 787,796 shares of
Access’ Common Stock, warrants to purchase an aggregate of 6,032,514
shares of Access’ Common Stock and 7,077,100 shares of Common Stock are
issuable to them upon conversion of Series A Preferred Stock. Mr.
Rouhandeh disclaims beneficial ownership of all such shares except to the
extent of his pecuniary interest
therein.
|
|
(3)
|
Includes
5,820 shares underlying warrants held directly by Mr. Davis and presently
exercisable options for the purchase of 25,000 shares of Access’ Common
Stock pursuant to the 2005 Equity Incentive Plan. Mr. Davis is President
of SCO Securities LLC, a wholly-owned subsidiary of SCO Financial Group
LLC. His address is c/o SCO Capital Partners LLC, 1285 Avenue of the
Americas, 35th Floor, New York, NY 10019. SCO Securities LLC and
affiliates (SCO Capital Partners LP and Beach Capital LLC) are known to
beneficially own 787,796 shares of Access’ Common Stock, warrants to
purchase an aggregate of 6,032,514 shares of Access’ Common Stock and
7,077,100 shares of Common Stock are issuable to them upon conversion of
Series A Preferred Stock. Mr. Davis disclaims beneficial ownership of all
such shares except to the extent of his pecuniary interest
therein.
|
66
|
(4)
|
Includes
presently exercisable options for the purchase of 31,000 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
|
(5)
|
Includes
55,525 shares of Common Stock underlying warrants held by Mr. Alvino and
presently exercisable options for the purchase of 31,000 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive Plan. Mr. Alvino is
Managing Director of Griffin Securities LLC. His address is c/o Griffin
Securities LLC, 17 State St., 3rd
Floor, New York, NY 10004. Mr. Alvino is a designated director of SCO
Securities LLC. SCO Securities LLC and affiliates (SCO Capital Partners LP
and Beach Capital LLC) are known to beneficially own 787,796 shares of
Access’ Common Stock, warrants to purchase an aggregate of 6,032,514
shares of Access’ Common Stock and 7,077,100 shares of Common Stock are
issuable to them upon conversion of Series A Preferred Stock. Mr. Alvino
disclaims beneficial ownership of all such shares except to the extent of
his pecuniary interest therein. Mr. Alvino disclaims beneficial ownership
of all such shares except to the extent of his pecuniary interest
therein.
|
|
(6)
|
Includes
presently exercisable options for the purchase of 56,000 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive Plan and a warrant to
purchase 50,000 shares of Access’ Common Stock at an exercise price of
$3.15 per share.
|
|
(7)
|
Includes
presently exercisable options for the purchase of 32,200 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive Plan, 12,500 shares of
Access’ Common Stock pursuant to the 1995 Stock Option Plan, and a warrant
to purchase 2,000 shares of Access’ Common Stock at an exercise price of
$24.80 per share.
|
|
(8)
|
Includes
warrants to purchase an aggregate of 4,167 shares of Access’ Common Stock,
8,333 shares of Common Stock are issuable to him upon conversion of Series
A Preferred Stock and presently exercisable options for the purchase of
31,000 shares of Access’ Common Stock pursuant to the 2005 Equity
Incentive Plan.
|
|
(9)
|
Includes
presently exercisable options for the purchase of 100,000 shares of
Access’ Common Stock pursuant to the 2005 Equity Incentive Plan and 59,167
shares of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
|
(10)
|
Includes
presently exercisable options for the purchase of 100,000 shares of
Access’ Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
|
(11)
|
Includes
presently exercisable options for the purchase of 100,000 shares of
Access’ Common Stock pursuant to the 2005 Equity Incentive Plan and 34,479
shares of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
|
(12)
|
SCO
Capital Partners LLC, SCO Capital Partner LP, Beach Capital LLC and SCO
Financial Group's address is 1285 Avenue of the Americas, 35th
Floor, New York, NY 10019. SCO Capital Partners LLC and affiliates (SCO
Capital Partners LP, Beach Capital LLC and SCO Financial Group) are known
to beneficially own an aggregate of 787,796 shares of Access’ Common
Stock, warrants to purchase an aggregate of 6,032,514 shares of Access’
Common Stock and 7,077,100 shares of Common Stock issuable to them upon
conversion of Series A Preferred Stock. Each of Mr. Rouhandeh. Mr. Davis
and Mr. Alvino, Access’ directors and Mr. Rouhandeh and Mr. Davis a
executives with SCO Capital Partners LLC, disclaim beneficial ownership of
such shares except to the extent of their pecuniary interest
therein.
|
|
(13)
|
Larry
N. Feinberg is a partner in Oracle Partners, L.P. His address is c/o
Oracle Partners, L.P., 200 Greenwich Avenue, 3rd
Floor, Greenwich, CT 06830. Oracle Partners, L.P. and affiliates (Oracle
Institutional Partners, L.P., Oracle Investment Management, Inc., Sam
Oracle Fund, Inc. and Mr. Feinberg) are known to beneficially own an
aggregate of 296,483 shares of Access’ Common Stock, warrants to purchase
an aggregate of 728,850 shares of Access’ Common Stock and Series A
Preferred Stock which may be converted into an aggregate of 1,457,699
shares of Access’ Common Stock.
|
|
(14)
|
Lake
End Capital LLC’s address is 1285 Avenue of the Americas, 35th
Floor, New York, NY 10019. Lake End Capital LLC is known to beneficially
own an aggregate of 67,694 shares of Access’ Common Stock, warrants to
purchase an aggregate of 777,027 shares of Access’ Common Stock and
793,067 shares of Common Stock issuable to them upon conversion of Series
A Preferred Stock.
|
|
(15)
|
Midsummer
Investment, Ltd.’s address is 295 Madison Ave., 38th
Fl., New York, NY 10017. Midsummer Investment is known to beneficially own
warrants to purchase an aggregate of 250,000 shares of Access’ Common
Stock and Series A Preferred Stock which may be converted into an
aggregate of 500,000 shares of Access’ Common
Stock.
|
|
(16)
|
Does
not include shares held by SCO Securities LLC and
affiliates.
|
SECURITIES
AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION PLANS
Access
adopted its 2005 Equity Incentive Plan in May 2005, as amended, authorizing
3,150,000 shares under the plan. Access issued 1,136,820 options or rights under
this plan as of September 30, 2008. The balance of the options
outstanding from other plans as of November 24, 2008 is 218,000.
Access adopted its 2001 Restricted Stock Plan in May 2001, authorizing 80,000
shares of its authorized but unissued common stock were reserved for issuance to
certain employees, directors, consultants and advisors. Access issued 27,182
shares and 52,818 shares are available for grant.
The
following table sets forth information as of December 31, 2007 about shares of
Common Stock outstanding and available for issuance under our equity
compensation plans existing as of such date.
67
|
Plan
Category
|
Number
of securities to
be
issued upon exercise
of
outstanding options warrants and rights
|
Weighted-average
exercise
price of
outstanding
options
warrants
and rights
|
Number
of securities
remaining
available
for
the issuance
under equity
compensation
plans
(excluding
securities
reflected
in column (a)
|
||
|
Equity
compensation plans
|
|||||
|
approved
by security holders
|
|||||
|
2005
Equity Incentive Plan
|
926,386
|
$
1.59
|
717.328
|
||
|
1995
Stock Awards Plan
|
162,417
|
15.53
|
-
|
||
|
2001
Restricted Stock Plan
|
-
|
-
|
52,818
|
||
|
Equity
compensation plans
|
|||||
|
not
approved by security holders
|
|||||
|
2007
Special Stock Option Plan
|
100,000
|
2.90
|
350,000
|
||
|
Total
|
1,188,803
|
$
3.60
|
1,120,146
|
The
2007 Special Stock Option Plan
The 2007
Special Stock Option Plan (the "Plan") was adopted by the Board in January 2007.
The Plan is not intended to be an incentive stock option plan within the meaning
of Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”).
The Plan allows for the issuance of up to 450,000 options to acquire Access’
stock of which 100,000 have been issued. The purpose of the Plan is to encourage
ownership of Common Stock by employees, consultants, advisors and directors of
Access and its affiliates and to provide additional incentive for them to
promote the success of Access’ business. The Plan provides for the grant of
non-qualified stock options to employees (including officers, directors,
advisors and consultants). The Plan will expire in January 2017, unless earlier
terminated by the Board. The granted options in the Plan expire in March 12,
2010.
Annual
Incentive
Each
year, the Compensation Committee evaluates the performance of the Company as a
whole, as well as the performance of each individual executive. Factors
considered include Company development, performance against objectives,
advancement of our research and development programs, commercial operations,
product acquisition, and in-licensing and out-licensing agreements. The
Compensation Committee does not utilize formalized mathematical formulas, nor
does it assign weightings to these factors. The Compensation Committee, in its
sole discretion, determines the amount, if any, of incentive payments to be
awarded to each executive based on an individual’s targeted incentive payment.
The Compensation Committee believes that analysis of our corporate growth
requires subjectivity on the part of the Compensation Committee when determining
incentive payments. The Compensation Committee believes that specific formulas
restrict flexibility. Based on this criteria, for the 2007 fiscal year Mr.
Seiler was granted options to purchase 500,000 shares of Common Stock under the
2005 Equity Incentive Plan and the 2007 Special Stock Option Plan. Pursuant to
the terms of his separation agreement with us, 100,000 of these options vested
and will expire on March 12, 2010.
Stock
Option Plans
The Board
has adopted and our stockholders have approved our 2005 Equity Incentive Plan
and 1995 Stock Awards Plan. The 2005 Equity Incentive Plan currently provides
for the issuance of up to a maximum of 3,150,000 shares of our Common Stock to
our employees, directors and consultants or any of our subsidiaries. The 1995
Stock Awards Plan provided for the issuance of up to a maximum of 500,000 shares
of our Common Stock to our employees, directors and consultants or any of our
subsidiaries. A total of 128,000 options are outstanding under the 1995 Stock
Awards Plan. Options granted under both plans may be either incentive stock
options or options which do not qualify as incentive stock options. In 2007, the
Board adopted the 2007 Special Stock Option Plan and Agreement (the “2007
Plan”). The 2007 Plan provides for the award of options to purchase a maximum of
450,000 shares of our Common Stock.
The stock
option plans are administered by a committee of non-employee members of the
Board, chosen by the Board, and is currently administered by the Compensation
Committee. The Compensation Committee presently is composed of David P. Luci and
Stephen B. Howell, MD. The Compensation Committee has the authority to determine
those individuals to whom stock options are granted, the number of shares to be
covered by each option, the option price, the type of option, the option period,
the vesting restrictions, if any, with respect to exercise of each option, the
terms for payment of the option price and other terms and conditions of each
option.
68
Our
non-employee directors, who include certain members of the Compensation
Committee, are eligible to receive options under the 2005 Equity Incentive Plan.
Each non-employee director is entitled to receive options to purchase 2,500
shares of our Common Stock on the date of each annual meeting of stockholders
and options to purchase 25,000 shares of Common Stock when he/she is first
appointed as a director.
Access
was a party to an employment arrangement with Mr. Seiler. Mr. Seiler was granted
stock options to purchase 500,000 shares of Common Stock. Pursuant to a
separation agreement with Mr. Seiler, 100,000 of his options vested on December
16, 2007 and such options shall remain exercisable until March 12, 2010. The
stock options were granted under Access’ 2005 Equity Incentive Plan and the 2007
Special Stock Option Plan.
Dr.
Mazanet received options to purchase 6,000 shares of Common Stock in the 2005
fiscal year under the 1995 Stock Awards Plan and options to purchase 50,000
shares of Common Stock in the 2005 fiscal year under the 2005 Equity Incentive
Plan. Dr. Mazanet also received options to purchase 200,000 shares of Common
Stock in the 2006 fiscal year under the 2005 Equity Incentive Plan.
We also
have a restricted stock plan, the 2001 Restricted Stock Plan under which 80,000
shares of our Common Stock have been reserved for issuance to certain employees,
directors, consultants and advisors. The restricted stock granted under the plan
generally vests over five years, 25% two years after the grant date with an
additional 25% vesting on the next three anniversary dates. All stock is vested
after five years. At December 31, 2007, there were 27,182 shares granted and
52,818 shares available for grant under the 2001 Restricted Stock
Plan.
Section
162(m)
Section
162(m) of the Internal Revenue Code of 1986, as amended, currently imposes a $1
million limitation on the deductibility of certain compensation paid to each of
our five highest paid executives. Excluded from this limitation is compensation
that is “performance based.” For compensation to be performance based it must
meet certain criteria, including being based on predetermined objective
standards approved by stockholders. In general, we believe that compensation
relating to options granted under the 1995 Stock Awards Plan and 2000 Plan
should be excluded from the $1 million limitation calculation. Compensation
relating to our incentive compensation awards do not currently qualify for
exclusion from the limitation, given the discretion that is provided to the
Compensation Committee in establishing the performance goals for such awards.
The Compensation Committee believes that maintaining the discretion to evaluate
the performance of our management is an important part of its responsibilities
and inures to the benefit of our stockholders. The Compensation Committee,
however, intends to take into account the potential application of Section
162(m) with respect to incentive compensation awards and other compensation
decisions made by it in the future.
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) (“Section 16(a)”) of the Securities Exchange Act of 1934, as amended,
requires our directors, executive officers and holders of more than ten percent
of our Common Stock to file with the SEC initial reports of ownership and
reports of changes in ownership of such securities. Directors, officers and 10%
holders are required by SEC rules to furnish us with copies of all of the
Section 16(a) reports they file.
Based
solely on a review of reports furnished to us during the 2007 fiscal year or
written representations from our directors and executive officers, none of our
directors, executive officers and 10% holders failed to file on a timely basis
reports required by Section 16(a) during the 2007 fiscal year or in prior years,
except for Esteban Cvitkovic and David P. Luci who each filed one late Form 4,
reporting one transaction.
69
TRANSACTIONS
WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL PERSONS
On
occasion we may engage in certain related party transactions. Our policy is that
all related party transactions are reviewed and approved by the Board of
Directors or Audit Committee prior to the Company entering into any related
party transactions.
On
February 12, 2008, the Board of Directors of the Company elected Steven H.
Rouhandeh as director and Chairman of the Board effective as of March 4,
2008.
David P.
Luci, one of our directors, participated in the February 2008 sale of our
preferred stock. Mr. Luci purchased 2.5 preferred shares for $25,000 and
warrants to purchase 4,167 shares of our common stock. In addition, Mr. Luci is
the President & Chief Business Officer of MacroChem, with which we expect to
merge pursuant to the Merger Agreement dated July 9, 2008.
Dr.
Esteban Cvitkovic, one of our directors, also serves as a consultant as Senior
Director, Oncology Clinical Research & Development to the Company since
August 2007. Dr. Cvitkovic currently receives $20,000 per month plus $2,500 for
office expenses. Dr. Cvitkovic received warrants to purchase 200,000 shares of
our Common Stock at $3.15 per share that can be exercised until January 4, 2012.
The warrants vest over two years in 50,000 blocks with vesting on July 4, 2008,
January 4, 2009, July 4, 2009 and the remaining shares on January 4, 2010.
During 2007 Dr. Cvitkovic received $153,000. Dr. Cvitkovic received warrants to
purchase 25,000 shares of our Common Stock at $4.35 per share with 12,500
options immediately in August 2007 and 12,500 options will vest in March 2008
based on the completion of certain defined tasks.
In the
event SCO Capital Partners LLC (“SCO”) and its affiliates were to convert all of
their shares of Series A Preferred Stock and exercise all of their warrants,
they would own approximately 71.0% of the voting securities of Access. During
2007 SCO and affiliates were paid $240,000 in placement agent fees relating to
the issuance of preferred stock and 100,000 warrants to purchase our common
stock. SCO and affiliates also were paid $150,000 in investor relations fees in
2007. During 2006 SCO and affiliates were paid $415,000 in fees relating to the
issuance of convertible notes and were paid $131,000 in investor relations fees.
Pursuant to a management consulting agreement with SCO, SCO provides certain
consulting services to the Company in exchange for a monthly fee of
$12,500.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
On
November 7, 2007, as a condition to closing our sale of Series A Preferred
Stock, SCO Capital Partners LLC and affiliates, along with the other holders of
an aggregate of $6,000,000 Secured Convertible Notes, also exchanged their notes
and accrued interest for an additional 1,836.0512 shares of Series A Preferred
Stock and were issued warrants to purchase 1,122,031 shares of our common stock
at an exercise price of $3.50 per share, and Oracle Partners LP and affiliates,
along with the other holders of an aggregate of $4,015,000 Convertible Notes
also exchanged their notes and accrued interest for 437.3104 shares of the
Series A Preferred Stock and were issued warrants to purchase 728,850 shares of
our common stock at an exercise price of $3.50 per share. SCO Capital
Partners LLC currently has two designees serving on our Board of
Directors. In connection with the exchange of the notes, all security
interests and liens relating thereto were terminated.
On
November 7, 2007, as a condition to closing our sale of Series A Preferred
Stock, we entered into an Investor Rights Agreement with each of the investors
purchasing shares of Series A Preferred Stock and our Board of Directors
approved with respect to the shareholder rights plan any action necessary under
our shareholder rights plan to accommodate the issuance of the Series A
Preferred Stock and warrants without triggering the applicability of the
shareholder rights plan. In addition, we entered into an Investor Rights
Agreement with the holders of Series A Preferred Stock. The Investor Rights
Agreement grants certain registration and other rights to each of the
investors.
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access.
Lake End
Capital LLC is known to beneficially own warrants to purchase an aggregate of
1,195,717 shares of Access’ Common Stock and Series A Preferred Stock which may
be converted into an aggregate of 793,067 shares of Access’ Common Stock. Lake
End Capital LLC and Mr. Davis are known to beneficially own warrants and options
to purchase an aggregate of 1,832,357 shares of Access’ Common Stock and 793,067
shares of Common Stock issuable upon conversion of Series A Preferred Stock.
Jeffrey B. Davis, in his capacity as managing member of Lake End Capital LLC,
has the power to direct the vote and disposition of the shares owned by Lake End
Capital LLC. Mr. Davis is President of SCO Securities LLC, a wholly-owned
subsidiary of SCO Financial Group LLC.
70
Dr.
Howell, one of our directors, also served as a scientific consultant to the
Company pursuant to a consulting agreement that provides for a minimum of two
days consulting during 2007 at a rate of $5,880 per month plus expenses. Dr.
Howell received warrants to purchase 2,000 shares of our Common Stock at $24.80
per share that can be exercised until January 1, 2009. During 2006, Dr. Howell
was paid $69,000 in consulting fees; during 2005, Dr. Howell was paid $79,000 in
consulting fees; and during 2004 Dr. Howell was paid $58,000 in consulting fees.
Dr. Howell’s agreement with us expired March 1, 2008.
On
January 20, 2006, Board approved the payment of a fee of $140,000 to J. Michael
Flinn, our former Chairman of the Board, for services as Chairman of the Board
for fiscal 2005. The $140,000 fee was paid on the completion of a financing. The
Board also approved the grant of options to purchase 20,000 shares of Common
Stock at an exercise price of $3.15 per share to J. Michael Flinn for services
as Chairman of the Board. In May 2006, the Board also approved the payment of a
fee of $43,333 to Mr. Flinn for services as Chairman of the Board for 2006. The
Board also approved the grant of options to purchase 4,836 shares of Common
Stock at an exercise price of $3.15 per share to Messrs. Duty and Meakem,
members of the then existing Merger and Acquisitions Committee of the Board, for
services in connection therewith. The Board also approved the grant of options
to purchase 1,200 shares of Common Stock at an exercise price of $3.15 per share
to each member of the Board, for services as members of the Board.
In August
2006, the Board approved the grant of options to purchase 25,000 shares of
Common Stock at an exercise price of $0.63 per share to each member of the
Board.
On
October 12, 2000, the Board authorized a restricted stock purchase program.
Under the program, our executive officers were given the opportunity to purchase
shares of Common Stock in an individually designated amount per participant
determined by our Compensation Committee. A total of 36,000 shares were
purchased by such officers at $27.50 per share, the fair market value of the
Common Stock on October 12, 2000, for an aggregate consideration of $990,000.
The purchase price was paid through the participant’s delivery of a 50%-recourse
promissory note payable to us. Each note bears interest at 5.87% compounded
semi-annually and has a maximum term of ten years. The notes are secured by a
pledge to us of the purchased shares. We recorded the notes receivable of
$990,000 from participants in this program as a reduction of equity in the
Consolidated Balance Sheet. As of December 31, 2007, principal and interest on
the notes was: Mr. Gray - $857,000; Dr. Nowotnik - $428,000; and Mr. Thompson -
$257,000. In accordance with the Sarbanes-Oxley Act of 2002, we no longer make
loans to our executive officers.
MARKET
FOR COMMON STOCK
Price
Range of Common Stock and Dividend Policies
Access’
common stock has traded on the OTC Bulletin Board, or OTCBB, under the trading
symbol ACCP since June 5, 2006. From February 1, 2006, until June 5, 2006,
Access traded on the “Pink Sheets” under the trading symbol AKCA. From March 30,
2000, until January 31, 2006, Access traded on the American Stock Exchange, or
AMEX, under the trading symbol AKC.
The
following table sets forth, for the periods indicated, the high and low closing
prices as reported by OTCBB, the Pink Sheets and AMEX for Access’ common stock
for fiscal years 2007 and 2006 and as the most recent date of the first quarter
2008. The OTCBB and Pink Sheet quotations reflect inter-dealer prices, without
retail mark-up, mark-down or commission and may not represent actual
transactions.
All per
share information reflect a one for five reverse stock split effected June 5,
2006.
|
Common
Stock
|
||||
|
High
|
Low
|
|||
|
Period
Ended
|
||||
|
First
quarter March 31, 2008
|
$ 3.50
|
$ 1.35
|
||
|
Second
quarter June 30, 2008
|
3.30
|
1.40
|
||
|
Third
quarter September 30, 2008
|
3.49
|
2.50
|
||
|
Fourth
quarter thru November 24, 2008
|
2.75
|
1.00
|
||
|
Fiscal
Year Ended December 31, 2007
|
||||
|
First
quarter
|
$ 10.66
|
$ 2.50
|
||
|
Second
quarter
|
6.75
|
4.30
|
||
|
Third
quarter
|
5.16
|
2.10
|
||
|
Fourth
quarter
|
4.48
|
2.10
|
||
71
|
Fiscal
Year Ended December 31, 2006
|
||||
|
First
quarter
|
$ 2.65
|
$ 0.80
|
||
|
Second
quarter
|
1.50
|
0.10
|
||
|
Third
quarter
|
1.30
|
0.45
|
||
|
Fourth
quarter
|
3.00
|
1.05
|
||
Holders
The
number of record holders of Access common stock at November 24, 2008, was
approximately 3,000. On November 24, 2008, the closing price for the common
stock as quoted on the OTCBB was $1.00. There were 6,515,791 shares of common
stock outstanding at November 24, 2008. The number of record holders
of Access preferred stock on November 24, 2008 was approximately
21. There were 10,809,539 shares of Series A Preferred Stock
outstanding on November 24, 2008.
Options
and Warrants
There are
9,687,326 outstanding warrants and 1,354,820 outstanding options to purchase
Access’ common equity as of November 24, 2008.
Shares
Eligible for Future Sales
Access
has issued 6,515,791 shares of its common stock as of November 24, 2008. Of
these shares, 6,448,032 are unrestricted and held by non-affiliates, and are
freely tradable without restriction under the Securities Act. The
remaining shares may be sold without restriction provided such sale is by a
non-affiliate pursuant to Rule 144 of the Securities Act. In general,
under Rule 144 as currently in effect, a person (or persons whose shares are
aggregated) who has beneficially owned restricted shares for at least six months
(including the holding period of any prior owner or affiliate) would be entitled
to sell such shares without restrictions or limitations.
Dividends
Access
never declared or paid any cash dividends on its preferred stock or common stock
and Access does not anticipate paying any cash dividends in the foreseeable
future on its common stock. The payment of dividends on common stock, if any, in
the future is within the discretion of Access’ Board of Directors and will
depend on its earnings, capital requirements and financial condition and other
relevant facts. Access currently intends to retain all future earnings, if any,
to finance the development and growth of its business.
The
holders of Series A Preferred Stock are entitled to receive dividends of 6% per
annum on their shares Series A Preferred Stock. The dividends are payable by
Access semi-annually and may be paid by Access either in cash, or if certain
conditions are met, at Access’ option, in shares of Access’ common stock. To be
eligible to pay dividends in shares of common stock, among other things, there
must be in place a registration statement pursuant to which the holders of the
Series A Preferred Stock are permitted to utilize the prospectus thereunder to
resell all of the shares of common stock issuable in relation to the Series A
Preferred Stock.
72
DESCRIPTION
OF SECURITIES
Access’
certificate of incorporation authorizes the issuance of 100,000,000 shares of
its common stock, $.01 par value per share, and 2,000,000 shares of preferred
stock, $.01 par value per share, which may be issued in one or more series.
Currently, 4,000 shares of preferred stock are designated as Series A Preferred
Stock. As of November 6, 2008, there were 6,515,791 shares of Access’
common stock outstanding and held of record by approximately 3,000 stockholders,
and there were 3,242.8617 shares of its preferred stock outstanding convertible
into 10,809,539 shares of common stock.
Common
Stock
Holders
of Access’ common stock are entitled to one vote for each share held on all
matters submitted to a vote of stockholders and have the right to vote
cumulatively for the election of directors. This means that in the voting at
Access’ annual meeting, each stockholder or his proxy, may multiply the number
of his shares by the number of directors to be elected then cast the resulting
total number of votes for a single nominee, or distribute such votes on the
ballot among the nominees as desired. Holders of Access’ common stock are
entitled to receive ratably such dividends, if any, as may be declared by
Access’ Board of Directors out of funds legally available therefor, subject to
any preferential dividend rights for Access’ outstanding preferred stock. Upon
Access’ liquidation, dissolution or winding up, the holders of Access’ common
stock are entitled to receive ratably Access’ net assets available after the
payment of all debts and other liabilities and subject to the prior rights of
any of Access’ outstanding preferred stock. Holders of Access’ common stock have
no preemptive, subscription, redemption or conversion rights. The outstanding
shares of Access’ common stock are, and the shares offered by the selling
stockholders in this offering will be, fully paid and nonassessable. The rights,
preferences and privileges of holders of Access’ common stock are subject to,
and may be adversely affected by, the rights of the holders of shares of any
series of Access’ preferred stock which Access may designate and issue in the
future.
Preferred
Stock
Access’
Board of Directors is authorized, subject to certain limitations prescribed by
law, without further stockholder approval, to issue from time to time up to an
aggregate of 2,000,000 shares of preferred stock in one or more series and to
fix or alter the designations, preferences, rights and any qualifications,
limitations or restrictions of the shares of each such series thereof, including
the dividend rights, dividend rates, conversion rights, voting rights and terms
of redemption of shares constituting any series or designations of such series.
The issuance of preferred stock may have the effect of delaying, deferring or
preventing a change of control. The fact that Access’ board of
directors has the right to issue preferred stock without stockholder approval
could be used to institute a “poison pill” that would work to dilute the stock
ownership of a potential hostile acquirer, effectively preventing acquisitions
that have not been approved by Access’ board of directors.
Access’
Board of Directors has designated 4,000 shares of preferred stock as Series A
Preferred Stock. The shares of Series A Preferred are convertible at
the option of the holder into shares of our common stock at a conversion price
of $3.00 per share of common stock.
The
Series A Preferred Stock is entitled to a liquidation preference equal to
$10,000 per share and is entitled to a dividend of 6% per annum, payable
semi-annually in cash or if certain conditions are met, in common stock, at the
option of the Company at time of payment. Our ability to pay
dividends in shares of common stock is limited by among other things a
requirement that (i) there is an effective registration statement on the shares
of common stock, issuable to the holders of Series A Preferred Stock, in the 20
day period immediately prior to such dividend or (ii) that such shares of common
stock referred to in (i) may be sold without restriction pursuant to Rule 144(k)
during the 20 day period immediately prior to such dividend.
The
Company has the right, but not the obligation, to force conversion of all, and
not less than all, of the outstanding Series A Preferred Stock into common stock
(i) as long as the closing price of our common stock exceeds $7.00 for at least
20 of the 30 consecutive trading days immediately prior to the conversion and
the average daily trading volume is greater than 100,000 shares per day for at
least 20 of the 30 consecutive trading days immediately prior to such
conversion, in each case, immediately prior to the date on which we gives notice
of such conversion or (ii) if we close a sale of common stock in which the
aggregate proceeds are equal to or greater than $10,000,000. Our
ability to cause a mandatory conversion is subject to certain other conditions,
including that a registration statement covering the common stock issuable upon
such mandatory conversion is in effect and able to be used.
The
conversion price of the Series A Preferred Stock is subject to a price
adjustment upon the issuance of additional shares of common stock for a price
below $3.00 per share and equitable adjustment for stock splits, dividends,
combinations, reorganizations and the like.
The
Series A Preferred Stock will vote together with the common stock on an
as-if-converted basis.
Holders
of Series A Preferred Stock are entitled to purchase their pro rata share of
additional stock issuances in certain future financings.
73
Transfer
Agent and Registrar
The
transfer agent and registrar of our common stock is American Stock Transfer
& Trust Company, New York, New York.
Delaware
Law and Certain Charter and By-Law Provisions
Certain anti-takeover
provisions.
We are
subject to the provisions of Section 203 of the General Corporation Law of
Delaware. Section 203 prohibits certain publicly held Delaware corporations from
engaging in a "business combination" with an "interested stockholder," for a
period of three years after the date of the transaction in which the person
became an "interested stockholder", unless the business combination is approved
in a prescribed manner. A "business combination" includes mergers, asset sales
and other transactions resulting in a financial benefit to the interested
stockholder. Subject to certain exceptions, an "interested stockholder" is a
person or entity who, together with affiliates and associates, owns (or within
the preceding three years, did own) 15% or more of the corporation's voting
stock. The statute contains provisions enabling a corporation to avoid the
statute's restrictions if the stockholders holding a majority of the
corporation's voting stock approve our Certificate of Incorporation provides
that our directors shall be divided into three classes, with the terms of each
class to expire on different years.
In
addition, our Certificate of Incorporation, in order to combat "greenmail,"
provides in general that any direct or indirect purchase by us of any of our
voting stock or rights to acquire voting stock known to be beneficially owned by
any person or group which holds more than five percent of a class of our voting
stock and which has owned the securities being purchased for less than two years
must be approved by the affirmative vote of at least two-thirds of the votes
entitled to be cast by the holders of voting stock, subject to certain
exceptions. The prohibition of "greenmail" may tend to discourage or foreclose
certain acquisitions of our securities which might temporarily increase the
price of our securities. Discouraging the acquisition of a large block of our
securities by an outside party may also have a potential negative effect on
takeovers. Parties seeking control of us through large acquisitions of its
securities will not be able to resort to "greenmail" should their bid fail, thus
making such a bid less attractive to persons seeking to initiate a takeover
effort.
We are a
party to a Rights Agreement pursuant to which we agree to provide holders of our
common stock with the right to buy shares of preferred stock should a party
acquire or beneficially own more than 15% of our common stock without first
being exempted by us. Such shares of preferred stock will entitle to
the holder to certain voting, dividend and liquidation preferences and is
designed to discourage take-over attempts not previously approved by our Board
of Directors.
Elimination
of Monetary Liability for Officers and Directors
Our
Certificate of Incorporation incorporates certain provisions permitted under the
General Corporation Law of Delaware relating to the liability of directors. The
provisions eliminate a director's liability for monetary damages for a breach of
fiduciary duty, including gross negligence, except in circumstances involving
certain wrongful acts, such as the breach of director's duty of loyalty or acts
or omissions, which involve intentional misconduct or a knowing violation of
law. These provisions do not eliminate a director's duty of care. Moreover,
these provisions do not apply to claims against a Director for certain
violations of law, including knowing violations of federal securities law. Our
Certificate of Incorporation also contains provisions to indemnify the
directors, officers, employees or other agents to the fullest extent permitted
by the General Corporation Law of Delaware. We believe that these provisions
will assist us in attracting and retaining qualified individual to serve as
directors.
Indemnification
of Officers and Directors
Our
Certificate of Incorporation also contains provisions to indemnify the
directors, officers, employees or other agents to the fullest extent permitted
by the General Corporation Law of Delaware. These provisions may have the
practical effect in certain cases of eliminating the ability of shareholders to
collect monetary damages from directors. We believe that these provisions will
assist us in attracting or retaining qualified individuals to serve as our
directors.
Disclosure
of Commission Position on Indemnification For Securities Act
Liabilities
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may
be permitted to directors, officers and controlling persons of the Registrant
pursuant to the foregoing provisions, or otherwise, the Registrant has been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act and
is, therefore, unenforceable.
74
EXPERTS
The
consolidated financial statements for Access Pharmaceuticals, Inc. for the years
ended December 31, 2007 and 2006 included in this prospectus, and included in
the Registration Statement, were audited by Whitley Penn LLP, an independent
registered public accounting firm, as stated in their report appearing with the
consolidated financial statements herein and incorporated in this Registration
Statement, and are included in reliance upon the report of such firm given upon
their authority as experts in accounting and auditing.
The
consolidated financial statements for Somanta Pharmaceuticals, Inc. for the
years ended April 30, 2006, and April 30, 2007, included in this prospectus, and
included in the Registration Statement, were audited by Stonefield Josephson,
Inc., an independent registered public accounting firm, as stated in their
report appearing with the consolidated financial statements herein and
incorporated in this Registration Statement, and are included in reliance upon
the report of such firm given upon their authority as experts in accounting and
auditing.
The
consolidated financial statements for MacroChem Corporation for the years ended
December 31, 2007 and 2006 included in this prospectus, and included in the
Registration Statement, were audited by Vitale, Caturano & Company, Ltd., an
independent registered public accounting firm, as stated in their report
appearing with the consolidated financial statements herein and incorporated in
this Registration Statement, and are included in reliance upon the report of
such firm given upon their authority as experts in accounting and
auditing.
The
financial statements of Virium Pharmaceuticals, Inc. as of December 31, 2007 and
2006 and for the years then ended and for the period from July 15, 1997 (date of
inception) through December 31, 2007, as such amounts relate to the period from
July 15, 1997 (date of inception) through March 31, 2008, included in this
registration statement, have been included herein in reliance on the report,
which includes an explanatory paragraph relating to Virium Pharmaceuticals,
Inc.'s ability to continue as a going concern, of J.H. Cohn LLP, an independent
registered public accounting firm, given on the authority of that firm as
experts in accounting and auditing.
None of
the independent public registered accounting firms named above have any interest
in the prospectus.
LEGAL
MATTERS
Bingham
McCutchen LLP will pass upon the validity of the shares of common stock offered
hereby. Several partners and attorneys of Bingham McCutchen LLP are
also shareholders of Access.
WHERE
YOU CAN FIND MORE INFORMATION
We have
filed with the Securities and Exchange Commission, Washington, D.C. 20549, under
the Securities Act of 1933, a registration statement on Form S-4 relating to the
shares of common stock offered hereby. This Prospectus does not contain all of
the information set forth in the registration statement and the exhibits and
schedules thereto. For further information with respect to our company and the
shares we are offering by this Prospectus you should refer to the registration
statement, including the exhibits and schedules thereto. You may inspect a copy
of the registration statement without charge at the Public Reference Section of
the Securities and Exchange Commission at Room 1024, 450 Fifth Street, N.W.,
Washington, D.C. 20549. The public may obtain information on the operation of
the Public Reference Room by calling the Securities and Exchange Commission. The
Securities and Exchange Commission also maintains an Internet site that contains
reports, proxy and information statements and other information regarding
registrants that file electronically with the Securities and Exchange
Commission. The Securities and Exchange Commission's World Wide Web address is
http://www.sec.gov.
We file
periodic reports, proxy statements and other information with the Securities and
Exchange Commission in accordance with requirements of the Exchange Act. These
periodic reports, proxy statements and other information are available for
inspection and copying at the regional offices, public reference facilities and
Internet site of the Securities and Exchange Commission referred to above. In
addition, you may request a copy of any of our periodic reports filed with the
Securities and Exchange Commission at no cost, by writing or telephoning us at
the following address:
Investor
Relations
Access
Pharmaceuticals, Inc.
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
Information
contained on our website is not a prospectus and does not constitute a part of
this Prospectus.
You
should rely only on the information contained in or incorporated by reference or
provided in this Prospectus. We have not authorized anyone else to provide you
with different information. We are not making an offer of these securities in
any state where the offer is not permitted. You should not assume the
information in this Prospectus is accurate as of any date other than the date on
the front of this Prospectus.
75
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The
following discussion should be read in conjunction with our consolidated
financial statements and related notes included in this Prospectus.
Overview
Access
Pharmaceuticals, Inc. (together with our subsidiaries, “We”, “Access” or the
“Company”) is a Delaware corporation. We are an emerging biopharmaceutical
company focused on developing products based upon our nanopolymer chemistry
technologies. We currently have one approved product, two products in Phase 2
clinical trials and five products in pre-clinical development. Our description
of our business, including our list of products and patents, takes into
consideration our acquisition of Somanta Pharmaceuticals, Inc. which closed
January 4, 2008.
|
·
|
MuGard™
is our approved product for the management of oral mucositis, a frequent
side-effect of cancer therapy for which there is no established treatment.
The market for mucositis treatment is estimated to be in excess of US$1
billion world-wide. MuGard, a proprietary nanopolymer formulation, has
received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
|
|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase 2
clinical trial being conducted in the EU in patients with ovarian cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in excess
of $2.0 billion.
|
|
·
|
Pre-clinical
development of Cobalamin™, our proprietary nanopolymer oral drug delivery
technology based on the natural vitamin B12 uptake mechanism. We are
currently developing a product for the oral delivery of
insulin.
|
|
·
|
Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably breast,
ovarian and colorectal cancers.
|
|
·
|
Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
|
|
·
|
Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
|
|
·
|
Pre-clinical
development of Cobalamin-mediated targeted
delivery.
|
|
·
|
Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration with Virium
Pharmaceuticals.
|
Products
Access
used its drug delivery technologies to develop the following products and
product candidates:
Access
Drug Portfolio
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage (1)
|
||||
|
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
Marketing
clearance received
|
||||
|
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
– U London
|
Synthetic
polymer
|
Cancer
|
Phase
2
|
||||
|
Phenylbutyrate
(PB)
|
National
Institute
of
Health
|
Small
molecule
|
Cancer
|
Phase
2
|
||||
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
|
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
|
Angiolix®
|
Immunodex,
Inc.
|
Humanized
monoclonal
antibody
|
Cancer
|
Pre-clinical
|
||||
|
Prodrax®
|
Univ
London
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Alchemix®
|
DeMontford
Univ
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Cobalamin-Targeted
Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Pre-clinical
|
||||
|
(1)
|
For
more information, see “Government Regulation” for description of clinical
stages.
|
|
(2)
|
Licensed
from the School of Pharmacy, The University of London. Subject to a 1%
royalty and milestone payments on
sales.
|
76
Approved
Products
MuGard™ - Mucoadhesive
Liquid Technology (MLT)
Access’
MuGard is a viscous polymer solution which provides a coating for the oral
cavity. MuGard is dispensed in a ready to use form. A multi-site, randomized
clinical study was performed in the United States testing MuGard and MuGard
containing an anti-inflammatory drug to determine the effect of these products
on the prevention and treatment of mucositis. The data from this trial indicated
that the patients using MuGard displayed a lower incidence of mucositis than is
typically seen in the studied population with no additional benefit from the
drug.
Access is
currently seeking marketing partners to market MuGard™ in the United States and
in other territories worldwide.
We have
signed the following definitive licensing agreements to market Access’ product
MuGard:
|
Territory
|
Partner
|
Date
|
|
|
United
States & Canada
|
Milestone
Biosciences, LLC
|
August
2008
|
|
|
Europe
|
SpePharm
IP BV
|
August
2007
|
|
|
China
(PRC), Hong Kong, Macau, Taiwan, Brunei, Cambodia, Laos, Malaysia,
Myanmar, Phillippines, Singapore, Thailand & Vietnam
|
RHEI,
Pharmaceuticals, Inc.
|
January
2008
|
|
Products
in Development Status
ProLindac™ (Polymer
Platinate, AP5346) DACH Platinum
We have
commenced a European Phase 2 ProLindac trial in ovarian cancer patients who have
relapsed after first line platinum therapy. The primary aim of the study is to
determine the response rate of ProLindac monotherapy in this patient population.
The response rates for other platinum compounds in this indication are well
known, and will be used for comparison.
We have
submitted an IND application to the US Food and Drug Administration, and have
received clearance from the agency to proceed with a Phase 2 clinical study of
ProLindac in combination with fluorouracil and leucovorin. The study is designed
to evaluate the safety of ProLindac in combination with two standard drugs used
to treat colorectal cancer and to establish a safe dose for further clinical
studies of this combination in colorectal cancer. We are currently evaluating
whether clinical development of ProLindac in this indication might proceed more
rapidly by utilizing an alternative clinical strategy and/or conducting studies
in the US and/or elsewhere in the world.
In June
2008, we signed a definitive licensing agreement with Jiangsu Aosaikang
Pharmaeutical Co., Ltd (“ASK”). Under which agreement ASK will manufacture,
develop and commercialize our proprietary product ProLindac for the Greater
China Region which includes the People’s Republic of China, the Hong Kong
Special Administrative Region, the Macau Special Administrative Region and
Taiwan. Under the terms of the agreement ASK paid Access an upfront
fee and will pay subsequent milestone payments along with a royalty upon
commercialization of ProLindac. In addition, in cooperation with Access, ASK has
committed to fund two Phase 2 studies for ProLindac in colorectal cancer and one
other indication to be determined by both parties.
Recent
Events
On
September 3, 2008, we announced that we had retained Piper Jaffray to augment
ongoing business development efforts with the goal of establishing additional
strategic development and commercialization partnerships for our product
pipeline. The Piper Jaffray healthcare investment banking team will focus on
partnering opportunities for ProLindac, Angiolix and the Cobalamin
programs.
77
On August
27, 2008, we entered into a Note Purchase Agreement with MacroChem Corporation
in order for Access to loan MacroChem amounts to keep certain of their licenses
and vendors current. As of September 30, 2008, we loaned MacroChem
$225,000.
On August
18, 2008, we announced the signing of a definitive licensing agreement under
which Milestone Biosciences, LLC will market MuGard in the United States and
Canada.
On July
10, 2008, we announced the signing of a definitive merger agreement to acquire
MacroChem Corporation. Pursuant to the terms of the merger agreement,
MacroChem’s common shareholders and warrant holders will receive an aggregate of
2.5 million shares of Access common stock which would represent approximately 8%
of the combined company. The closing of the transaction is subject to numerous
conditions. There can be no assurance that the transaction will be consummated
or if consummated that it will be on the terms described above.
On June
4, 2008, we announced the signing of a definitive licensing agreement with
Jiangsu Aosaikang Pharmaeutical Co., Ltd (“ASK”). Under which agreement ASK will
manufacture, develop and commercialize our proprietary product ProLindac for the
Greater China Region which includes the People’s Republic of China, the Hong
Kong Special Administrative Region, the Macau Special Administrative Region and
Taiwan. Under the terms of the agreement ASK paid Access an upfront
fee and will pay subsequent milestone payments along with a royalty upon
commercialization of ProLindac. In addition, in cooperation with Access, ASK has
committed to fund two Phase 2 studies for ProLindac in colorectal cancer and one
other indication to be determined by both parties.
Steven H.
Rouhandeh was appointed as a director and Chairman of the Board effective as of
March 4, 2008.
On
February 4, 2008, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of
our preferred stock, designated “Series A Cumulative Convertible Preferred
Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the
“Series A Preferred Stock”) and agreed to issue warrants to purchase 499,584
shares of our common stock, which includes placement agent warrants to purchase
45,417 shares of our common stock, at an exercise price of $3.50 per share, for
an aggregate purchase price for the Series A Preferred Stock and Warrants of
$2,725,000. Proceeds, net of issuance costs from the sale were $2,444,000. The
shares of Series A Preferred Stock are convertible into common stock at the
initial conversion price of $3.00 per share.
On
January 14, 2008, we announced the signing of a definitive licensing agreement
under which RHEI Pharmaceuticals, Inc. will market and manufacture MuGard in the
Peoples Republic of China and certain Southeast Asian countries. RHEI will also
obtain the necessary regulatory approvals for MuGard in the
territory.
On
January 4, 2008, we closed our acquisition of Somanta Pharmaceuticals, Inc. In
connection with the acquisition, Access issued an aggregate of approximately 1.5
million shares of Access Pharmaceuticals, Inc. common stock to the common and
preferred shareholders of Somanta as consideration. In addition, Access
exchanged all outstanding warrants of Somanta for warrants to purchase 191,991
shares of Access common stock at exercise prices ranging between $18.55 and
$69.57 per share.
In
addition, $1,576,000 of Somanta Pharmaceuticals’ acquired accounts payable were
settled by issuing 538,508 shares of Access common stock and warrants to
purchase 246,753 shares of Access common stock at an exercise price of $3.50 per
share. The value of the shares and warrants issued was determined based on the
fair value of the accounts payable.
On
December 26, 2007, Jeffrey B. Davis, Chairman of the Board of Directors was
named Chief Executive Officer. Stephen R. Seiler resigned as President and Chief
Executive Officer and concurrently resigned from the Board of Directors
effective December 19, 2007.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
As a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and Oracle
Partners LP and affiliates, along with the other holders of an aggregate of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest for
437.3104 shares of the Series A Preferred Stock and were issued warrants to
purchase 728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving on our Board
of Directors. In connection with the exchange of the notes, all security
interests and liens relating thereto were terminated.
78
As a
condition to closing, we entered into an Investor Rights Agreement with each of
the investors purchasing shares of Series A Preferred Stock, and our Board of
Directors approved with respect to the shareholder rights plan any action
necessary under our shareholder rights plan to accommodate the issuance of the
Series A Preferred Stock and warrants without triggering the applicability of
the shareholder rights plan. The Investor Rights Agreement grants certain
registration and other rights to each of the investors.
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access.
On August
27, 2007, we signed a definitive licensing agreement with SpePharm Holding, B.V.
under which SpePharm will market Access’ product MuGard in Europe.
On August
1, 2007, we announced that Esteban Cvitkovic, a member of our board of directors
as Vice Chairman Europe, agreed to an expanded role as Senior Director, Oncology
Clinical R&D.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
Results
of Operations
Comparison
of Third Quarter 2008 Compared To Third Quarter 2007
Our
licensing revenue for the third quarter of 2008 was $38,000 as compared to
$6,000 for the same period of 2007. We recognize licensing revenue over the
period of the performance obligation under our licensing agreements. We received
upfront licensing payments from SpePharm, RHEI, Milestone and ASK.
We have a
sponsored research and development agreement. Our revenue from this agreement
for the third quarter of 2008 was $9,000 as compared to no revenues for the same
period of 2007. We recognize revenue over the term of the agreement as services
are performed.
Total
research and development spending for the third quarter of 2008 was $1,284,000,
as compared to $596,000 for the same period in 2007, an increase of $688,000.
The increase in expenses was primarily due to:
·
costs for
product manufacturing for a new ProLindac clinical trial expected to start in
early 2009 ($259,000);
·
higher
salary and related cost due to the hiring of additional scientific staff
($113,000);
· costs for
studies with contract laboratories and universities
($96,000);
·
higher
scientific consulting expenses ($152,000); and
· other net
increases in research spending ($68,000).
Total
general and administrative expenses were $1,439,000 for the third quarter of
2008, an increase of $439,000 compared to 2007 expenses of $1,000,000. The
increase in spending was due primarily to the following:
·
possible
liquidated damages that may be due under the agreement with investors
($366,000);
·
higher
patent expenses and license fees ($243,000);
·
lower
salary related expenses due to stock option expenses ($126,000);
and
·
other net
decreases in general and administrative expenses
($44,000).
Depreciation
and amortization was $66,000 for the third quarter of 2008 as compared to
$61,000 for the same period in 2007. The increase in depreciation and
amortization was due to assets acquired in the Somanta acquisition and capital
expenditures.
Total
operating expenses for the third quarter of 2008 were $2,789,000 as compared to
total operating expenses of $1,657,000 for same quarter in 2007, an increase of
$1,132,000.
Interest
and miscellaneous income was $62,000 for the third quarter of 2008 as compared
to $12,000 for the same quarter of 2007, an increase of $50,000. The increase in
interest and miscellaneous income was due higher cash balances during the third
quarter of 2008 versus the same quarter in 2007 and miscellaneous income
received in the third quarter of 2008.
Interest
and other expense was $126,000 for the third quarter of 2008 as compared to
$318,000 in 2007, a decrease of $192,000. The decrease in interest and other
expense was due to $9,015,000 of convertible notes that were outstanding at
September 30, 2007, that were not outstanding at September 30, 2008. The
convertible notes were exchanged for preferred stock in November
2007.
Preferred
stock dividends of $523,000 were accrued for the third quarter of 2008.
Dividends are paid semi-annually in either cash or common stock. There was no
preferred stock outstanding at September 30, 2007.
79
Net loss
allocable to common stockholders for the third quarter of 2008 was $3,329,000,
or a $0.57 basic and diluted loss per common share, compared with a loss of
$1,957,000, or a $0.55 basic and diluted loss per common share for the same
period in 2007, an increased loss of $1,372,000.
Comparison
of Nine Months Ended September 30, 2008 Compared To Nine Months Ended September
30, 2007
Our
licensing revenue for the first nine months of 2008 was $77,000 as compared to
$6,000 for the same period of 2007. We recognize licensing revenue over the
period of the performance obligation under our licensing agreements. We received
upfront licensing payments from SpePharm, RHEI, Milestone and ASK.
We have a
sponsored research and development agreement. Our revenue from this agreement
for the first nine months of 2008 was $140,000 as compared to no revenues for
the same period of 2007. We recognize revenue over the term of the agreement as
services are performed.
Total
research and development spending for the first nine months of 2008 was
$12,108,000, as compared to $1,532,000 for the same period in 2007, an increase
of $10,576,000. The increase in expenses was primarily due to:
|
·
|
the
Somanta acquisition resulted in a one-time non-cash in-process research
and development expense in the first quarter of 2008
($8,879,000);
|
|
·
|
costs
for product manufacturing for a new ProLindac clinical trial
expected to start in early 2009
($1,047,000);
|
|
·
|
higher
scientific consulting expenses
($306,000);
|
|
·
|
higher
salary and related cost due to the hiring of additional scientific staff
($219,000); and
|
|
·
|
other
net increases in research spending
($125,000).
|
Total
general and administrative expenses were $3,372,000 for the first nine months of
2008, an increase of $120,000 over 2007 expenses of $3,252,000. The increase in
spending was due primarily to the following:
|
·
|
accrual
of liquidated damages that may be due under an investor rights agreement
with certain investors ($415,000);
|
|
·
|
higher
patent expenses and license fees
($391,000);
|
|
·
|
higher
general business consulting expenses
($69,000);
|
|
·
|
lower
salary related expenses due to stock option expenses
($467,000);
|
|
·
|
lower
salary and other salary related expenses ($213,000);
and
|
|
·
|
other
net decreases in general and administrative expenses
($75,000).
|
Depreciation
and amortization was $197,000 for the first nine months of 2008 as compared to
$210,000 for the same period in 2007 reflecting a decrease of $13,000. The
decrease in depreciation and amortization was due to certain assets becoming
fully depreciated.
Total
operating expenses for the first nine months of 2008 were $15,677,000 as
compared to total operating expenses of $4,994,000 for same period in 2007, an
increase of $10,683,000.
Interest
and miscellaneous income was $167,000 for the first nine months of 2008 as
compared to $72,000 for the same period of 2007, an increase of $95,000. The
increase in interest and miscellaneous income was due higher cash balances
during the third quarter of 2008 versus the same quarter in 2007.
Interest
and other expense was $351,000 for the first nine months of 2008 as compared to
$3,277,000 in 2007, a decrease of $2,926,000. The decrease in interest and other
expense was due to amortization of the discount on certain convertible notes and
the amortization of certain additional notes recognized in 2007. In addition,
the decrease in interest and other expense was due to $9,015,000 of convertible
notes that were outstanding at September 30, 2007, that were not outstanding at
September 30, 2008. The convertible notes were exchanged for preferred stock in
November 2007.
On
February 4, 2008, we issued 272.5 shares of our Series A Preferred Stock. The
shares are convertible into common stock at $3.00 per share. Based on the price
of our common stock on February 4, 2008, a new conversion price was calculated
for the Series A Preferred Stock and was considered to be “in the money” at the
time of the agreement to exchange the convertible notes for preferred stock.
This resulted in a beneficial conversion feature. The preferred stockholder has
the right at any time to convert all or any lesser portion of the Series A
Preferred Stock into common stock. This resulted in an intrinsic value of the
preferred stock. The difference between the implied value of the preferred stock
and the beneficial conversion feature was treated as preferred stock dividends
of $857,000.
An
additional $451,000 in preferred stock dividends was recorded in the first
quarter of 2008. The change was due to preferred stock dividends and the
beneficial conversion feature associated with the warrants issued in association
with the sale of preferred stock in November 2007.
80
Preferred
stock dividends of $1,565,000 were accrued for the first nine months of 2008.
Dividends are paid semi-annually in either cash or common stock. There was no
preferred stock outstanding at September 30, 2007.
Net loss
allocable to common stockholders for the first nine months of 2008 was
$18,517,000, or a $3.30 basic and diluted loss per common share, compared with a
loss of $8,193,000, or a $2.31 basic and diluted loss per common share for the
same period in 2007, an increased loss of $10,324,000.
Comparison
of Years Ended December 31, 2007 and 2006
Our
licensing revenue for the year ended December 31, 2007, was $23,000. We
recognize licensing revenue over the period of the performance obligation under
our licensing agreement. We received a $1.0 million upfront licensing payment in
August 2007 from SpePharm Holding, B.V. for marketing MuGard in Europe. We will
recognize the upfront licensing fee over 14 ¾ years, the license
term.
We have a
sponsored research and development agreement. Our revenue from this agreement
for the year ended December 31, 2007, was $34,000. We will recognize revenue
over the term of the agreement as services are performed.
Total
research spending for the year ended December 31, 2007, was $2,602,000, as
compared to $2,053,000 2006, an increase of $549,000. The increase in expenses
was primarily due to:
· costs for
product manufacturing for a new ProLindac clinical trial expected to start in
mid 2008 ($230,000);
· higher
salary and related cost due to the hiring of additional scientific staff
($225,000);
· higher
scientific consulting expenses ($179,000);
· higher
salary related expenses due to stock option expenses ($23,000); and
· other net
increases ($10,000).
The
increase in research spending was partially offset by lower clinical development
costs ($118,000). We incurred start-up costs for the clinical trial in early
2006.
Total
general and administrative expenses were $4,076,000 for the year ended December
31, 2007, an increase of $1,263,000 over 2006 expenses of $2,813,000. The
increase in spending was due primarily to the following:
· higher
salary related expenses due to stock option expenses ($785,000);
· higher
investor relations expenses ($476,000) due to our increased investor relations
efforts;
· higher
franchise taxes ($48,000);
· higher
travel expenses ($39,000) due to business development activities;
and
· other net
increases ($87,000).
The
increase in general and administrative spending was partially offset
by:
· lower
patent expenses ($43,000); and
· lower
professional fees ($129,000).
Depreciation
and amortization was $279,000 for the year ended December 31, 2007, as compared
to $309,000 for 2006 reflecting a decrease of $30,000. The decrease in
depreciation and amortization was due to assets becoming fully
depreciated.
Total
operating expenses for the year ended December 31, 2007, were $6,957,000 as
compared to total operating expenses of $5,175,000 for 2006, an increase of
$1,782,000.
Interest
and miscellaneous income was $125,000 for the year ended December 31, 2007, as
compared to $294,000 for 2006, a decrease of $169,000. The decrease in interest
income was due to accretion of the receivable due from Uluru that was recorded
in 2006.
Interest
and other expense was $3,514,000 for the year ended December 31, 2007 as
compared to $7,436,000 in 2006, a decrease of $3,922,000. The decrease in
interest and other expense was due to amortization of the discount on the Oracle
convertible notes and the amortization of the SCO notes recognized in
2006.
Convertible
notes payable of $10,015,000 and accrued interest of $1,090,000 were converted
from debt and accrued interest payable into preferred stock on November 10,
2007. A conversion of portion of the debt and interest resulted in a loss on the
extinguishment of debt of $11,628,000. The same transaction also resulted in a
beneficial conversion feature that was recorded as preferred stock dividends of
$14,648,000.
In 2006,
there was an unrealized loss on fair value of warrants of $1,107,000 due to the
warrants issued to SCO and affiliates. We changed our accounting for the
warrants in the fourth quarter of 2006 and there are no unrealized losses or
gains in 2007.
81
We
recognized deferred revenues of $173,000 from discontinued operations in
2007.
Net loss
allocable to common stockholders for the year ended December 31, 2007 was
$36,652,000, or a $10.32 basic and diluted loss per common share, compared with
a loss of $12,874,000, or a $3.65 basic and diluted loss per common share for
the same period in 2006, an increased loss of $23,778,000.
Over the
past two years we have not been materially affected by inflation to changing
prices.
Liquidity
and Capital Resources
We have
funded our operations primarily through private sales of common stock, preferred
stock, convertible notes and through licensing agreements. Our principal source
of liquidity is cash and cash equivalents. As of September 30, 2008, we had cash
and cash equivalents of $4,618,000. Our net cash burn rate for the nine months
ended September 30, 2008, was approximately $506,000 per month. As of September
30, 2008, our working capital was $79,000. Our working capital at September 30,
2008, represented a decrease of $6,160,000 as compared to our working capital as
of December 31, 2007, of $6,239,000. The decrease in working capital at
September 30, 2008 reflects the net capital raised in the February private
placement of $2,444,000 and new licensing agreements with RHEI, ASK and
Milestone, offset by operating expenses which included manufacturing product
scale-up for our new ProLindac trial and Somanta expenses. Also included in the
decrease are an estimated $1,799,000 in dividends due the Series A Preferred
Shareholders which we anticipate will paid in shares of Access common stock and
not in cash. As of September 30, 2008, we had one convertible note outstanding
in the principle amount of $5,500,000 which is due September 13,
2011.
As of
November 14, 2008, the Company did not have enough capital to achieve its
long-term goals. If we raise additional funds by selling equity securities, the
relative equity ownership of our existing investors would be diluted and the new
investors could obtain terms more favorable than previous investors. A failure
to obtain necessary additional capital in the future could jeopardize our
operations.
Since our
inception, we have devoted our resources primarily to fund our research and
development programs. We have been unprofitable since inception and to date have
received limited revenues from the sale of products. We cannot assure you that
we will be able to generate sufficient product revenues to attain profitability
on a sustained basis or at all. We expect to incur losses for the next several
years as we continue to invest in product research and development, preclinical
studies, clinical trials and regulatory compliance.
We have
generally incurred negative cash flows from operations since inception, and have
expended, and expect to continue to expend in the future, substantial funds to
complete our planned product development efforts. Since inception in 1989, our
expenses have significantly exceeded revenues, resulting in an accumulated
deficit as of September 30, 2008 of $132,841,000. We expect that our capital
resources will be adequate to fund our current level of operations into the
fourth quarter of 2009. However, our ability to fund operations over this time
could change significantly depending upon changes to future operational funding
obligations, acquisitions of products or companies or capital expenditures. As a
result, we will be required to seek additional financing sources within the next
twelve months. We cannot assure you that we will ever be able to generate
significant product revenue or achieve or sustain profitability.
We plan
to expend substantial funds to conduct research and development programs,
preclinical studies and clinical trials of potential products, including
research and development with respect to our acquired and developed technology.
Our future capital requirements and adequacy of available funds will depend on
many factors, including:
|
·
|
the
successful development and commercialization of ProLindac™, MuGard™ and
our other product candidates;
|
|
·
|
the
ability to convert, repay or restructure our outstanding convertible notes
and debentures;
|
|
·
|
the
ability to integrate Somanta Pharmaceuticals, Inc. assets and programs
with ours;
|
|
·
|
the
ability to establish and maintain collaborative arrangements with
corporate partners for the research, development and commercialization of
products;
|
|
·
|
continued
scientific progress in our research and development
programs;
|
|
·
|
the
magnitude, scope and results of preclinical testing and clinical
trials;the costs involved in filing, prosecuting and enforcing patent
claims;
|
|
·
|
the
costs involved in conducting clinical
trials;
|
|
·
|
competing
technological developments;
|
|
·
|
the
cost of manufacturing and scale-up;
|
|
·
|
the
ability to establish and maintain effective commercialization arrangements
and activities; and
|
|
·
|
successful
regulatory filings.
|
We have
devoted substantially all of our efforts and resources to research and
development conducted on our own behalf. The following table summarizes research
and development spending by project category (in thousands), which spending
includes, but is not limited to, payroll and personnel expense, lab supplies,
preclinical expense, development cost, clinical trial expense, outside
manufacturing expense and consulting expense:
82
|
(in
thousands)
|
Twelve
Months
ended
December
31,
|
Nine
Months
ended
September
30,
|
Inception
To
Date
(1)
|
|||||||||||||
|
Project
|
2007
|
2008
|
2008
|
|||||||||||||
|
Polymer
Platinate
(ProLindac™)
|
$ | 2,563 | $ | 2,043 | $ | 3,090 | $ | 25,307 | ||||||||
|
Mucoadhesive
Liquid
Technology
(MLT)
|
21 | 10 | - | 1,511 | ||||||||||||
|
Others
(2)
|
18 | - | 206 | 5,268 | ||||||||||||
|
Total
|
$ | 2,602 | $ | 2,053 | $ | 3,296 | $ | 32,086 | ||||||||
|
(1)
|
Cumulative
spending from inception of the Company or project through September 30,
2008.
|
|
(2)
|
Includes: Vitamin
Mediated Targeted Delivery, carbohydrate targeting and other related
projects.
|
Due to
uncertainties and certain of the risk factors described above, including those
relating to our ability to successfully commercialize our drug candidates, our
ability to obtain necessary additional capital to fund operations in the future,
our ability to successfully manufacture our products and our product candidates
in clinical quantities or for commercial purposes, government regulation to
which we are subject, the uncertainty associated with preclinical and clinical
testing, intense competition that we face, market acceptance of our products and
protection of our intellectual property, it is not possible to reliably predict
future spending or time to completion by project or product category or the
period in which material net cash inflows from significant projects are expected
to commence. If we are unable to timely complete a particular
project, our research and development efforts could be delayed or reduced, our
business could suffer depending on the significance of the project and we might
need to raise additional capital to fund operations, as discussed in the risk
factors above, including without limitation those relating to the uncertainty of
the success of our research and development activities and our ability to obtain
necessary additional capital to fund operations in the future. As
discussed in such risk factors, delays in our research and development efforts
and any inability to raise additional funds could cause us to eliminate one or
more of our research and development programs.
We plan
to continue our policy of investing any available funds in certificates of
deposit, money market funds, government securities and investment-grade
interest-bearing securities. We do not invest in derivative financial
instruments.
Critical
Accounting Policies and Estimates
The
preparation of our consolidated financial statements in conformity with
accounting principles generally accepted in the United State of America requires
us to make estimates and assumptions that affect the reported amounts of assets
and liabilities, disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amount of revenues and expenses during
the reported period. In applying our accounting principles, we must often make
individual estimates and assumptions regarding expected outcomes or
uncertainties. As you might expect, the actual results or outcomes are often
different than the estimated or assumed amounts. These differences are usually
minor and are included in our consolidated financial statements as soon as they
are known. Our estimates, judgments and assumptions are continually evaluated
based on available information and experience. Because of the use of estimates
inherent in the financial reporting process, actual results could differ from
those estimates.
Asset
Impairment
Our
intangible assets at December 31, 2007, consist primarily of patents
acquired in acquisitions and licenses which were recorded at fair value on the
acquisition date. We perform an impairment test on at least an annual basis or
when indications of impairment exist. At December 31, 2007, Management believes
no impairment of our intangible assets exists.
Based on
an assessment of our accounting policies and underlying judgments and
uncertainties affecting the application of those policies, we believe that our
consolidated financial statements provide a meaningful and fair perspective of
us. We do not suggest that other general factors, such as those discussed
elsewhere in this report, could not adversely impact our consolidated financial
position, results of operations or cash flows. The impairment test involves
judgment on the part of management as to the value of goodwill, licenses and
intangibles.
Stock
Based Compensation Expense
On
January 1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based Payment,” (“SFAS
123(R)”), which requires the measurement and recognition of all share-based
payment awards made to employees and directors including stock options based on
estimated fair values. SFAS 123(R) supersedes the Company’s previous accounting
under Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to
Employees” (“APB 25”), for periods beginning in fiscal year 2006. In
March 2005, the Securities and Exchange Commission issued Staff Accounting
Bulletin No. 107 (“SAB 107”) relating to SFAS 123(R). We applied the
provisions of SAB 107 in its adoption of SFAS 123(R).
83
We
adopted SFAS 123(R) using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006,
the first day of the Company’s 2006 fiscal year. Our consolidated financial
statements for the years ended December 31, 2007 and 2006, reflect the
impact of SFAS 123(R). In accordance with the modified prospective transition
method, our consolidated financial statements for prior periods have not been
restated to include the impact of SFAS 123(R). Stock-based compensation expense
recognized under SFAS 123(R) for the years ended December 31, 2007, and
2006 was approximately $1,048,000 and $284,000, respectively.
SFAS
123(R) requires companies to estimate the fair value of share-based payment
awards on the date of grant using an option-pricing model. The value of the
portion of the award that is ultimately expected to vest is recognized as
expense over the requisite service period in the company’s Statement of
Operations. Prior to the adoption of SFAS 123(R), we accounted for stock-based
awards to employees and directors using the intrinsic value method in accordance
with APB No. 25 as allowed under SFAS No. 123, “Accounting for Stock-Based
Compensation” (“SFAS 123”). Under the intrinsic value method, no
stock-based compensation expense for stock option grants was recognized because
the exercise price of our stock options granted to employees and directors
equaled the fair market value of the underlying stock at the date of grant.
There were no restricted stock awards granted in either 2006 or 2007
..
Stock-based
compensation expense recognized in the our Statement of Operations for the years
ended December 31, 2007, and 2006 includes compensation expense for share-based
payment awards granted prior to, but not yet vested as of December
31, 2005, based on the grant date fair value estimated in accordance with the
pro forma provisions of SFAS 123 and compensation expense for the share-based
payment awards granted subsequent to December 31, 2005, based on the grant date
fair value estimated in accordance with the provisions of SFAS 123(R).
Stock-based compensation expense recognized in the Company’s Statement of
Operations for the year ended December 31, 2007 and 2006 is based on awards
ultimately expected to vest and has been reduced for estimated forfeitures,
which currently is nil. SFAS 123(R) requires forfeitures to be estimated at the
time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates.
We used
the Black-Scholes option-pricing model (“Black-Scholes”) as our method of
valuation under SFAS 123(R) in fiscal years 2007 and 2006 and a single option
award approach. This fair value is then amortized on a straight-line basis over
the requisite service periods of the awards, which is generally the vesting
period. The fair value of share-based payment awards on the date of grant as
determined by the Black-Scholes model is affected by our stock price as well as
other assumptions. These assumptions include, but are not limited to the
expected stock price volatility over the term of the awards, and actual and
projected employee stock option exercise behaviors.
Recent
Accounting Pronouncements
In
June 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income
Taxes, an Interpretation of FASB Statement No. 109, Accounting for Income
Taxes (“FIN 48”), to create a single model to address accounting for
uncertainty in tax positions. FIN 48 clarifies the accounting for income taxes
by prescribing a minimum recognition threshold a tax position is required to
meet before being recognized in the financial statements. FIN 48 also provides
guidance on derecognition, measurement, classification, interest, and penalties,
accounting in interim periods, disclosure and transition. The Company adopted
FIN 48 as of January 1, 2007, and the adoption did not have a material
impact on the Company’s consolidated financial statements or effective tax rate
and did not result in any unrecognized tax benefits.
Interest
costs and penalties related to income taxes are classified as interest expense
and general and administrative costs, respectively, in the Company’s
consolidated financial statements. For the years ended December 31, 2007
and 2006, the Company did not recognize any interest or penalty expense related
to income taxes. It is determined not to be reasonably likely for the amounts of
unrecognized tax benefits to significantly increase or decrease within the next
12 months. The Company is currently subject to a three year statute of
limitations by major tax jurisdictions. The Company and its subsidiaries file
income tax returns in the U.S. federal jurisdiction.
In
September 2006, the FASB issued Statement of Financial Accounting Standard
(“SFAS”) No. 157, “Fair Value Measurements” (“SFAS 157”). SFAS 157 defines
fair value, establishes a market-based framework or hierarchy for measuring fair
value, and expands disclosures about fair value measurements. SFAS 157 is
applicable whenever another accounting pronouncement requires or permits assets
and liabilities to be measured at fair value. SFAS 157 does not expand or
require any new fair value measures; however the application of this statement
may change current practice. The requirements of SFAS 157 are first effective
for our fiscal year beginning January 1, 2008. However, in
February 2008 the FASB decided that an entity need not apply this standard
to nonfinancial assets and liabilities that are recognized or disclosed at fair
value in the financial statements on a nonrecurring basis until the subsequent
year. Accordingly, our adoption of this standard on January 1, 2008, is
limited to financial assets and liabilities. We do not believe the initial
adoption of SFAS 157 will have a material effect on our financial condition or
results of operations. However, we are still in the process of evaluating this
standard with respect to its effect on nonfinancial assets and liabilities and
therefore have not yet determined the impact that it will have on our financial
statements upon full adoption.
84
In
February 2007, FASB issued SFAS No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities — Including an Amendment of FASB Statement
No. 115. The fair value option permits entities to choose to measure
eligible financial instruments at fair value at specified election dates. The
entity will report unrealized gains and losses on the items on which it has
elected the fair value option in earnings. SFAS 159 is effective beginning in
fiscal year 2008. The Company is currently evaluating the effect of adopting
SFAS 159, but does not expect it to have a material impact on its consolidated
results of operations or financial condition.
Off-Balance
Sheet Transactions
None
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosures
None
85
FINANCIAL
STATEMENTS
ACCESS
PHARMACEUTICALS, INC.
|
PAGE
|
|
|
Report
of Independent Registered Public Accounting
Firm
|
F-2
|
|
Consolidated
Balance Sheets at December 31, 2007 and
2006
|
F-3
|
|
Consolidated
Statements of Operations and Comprehensive Loss for 2007 and
2006
|
F-4
|
|
Consolidated
Statement of Stockholders' Equity (Deficit) for 2007 and
2006
|
F-5
|
|
Consolidated
Statements of Cash Flows for 2007 and 2006
|
F-6
|
|
Notes
to Consolidated Financial Statements (Two years ended December 31,
2007)
|
F-7
|
|
Condensed
Consolidated Balance Sheets at September 30, 2008
(unaudited)
|
F-23
|
|
Condensed
Consolidated Statements of Operations for September 30, 2008 and 2007
(unaudited)
|
F-24
|
|
Condensed
Consolidated Statements of Cash Flows for September 30, 2008 and 2007
(unaudited)
|
F-25
|
|
Notes
to Condensed Consolidated Financial Statements (Nine Months Ended
September 30, 2008 and 2007) (unaudited)
|
F-26
|
F-1
Report
of Independent Registered Public Accounting Firm
To the
Board of Directors and Stockholders of Access Pharmaceuticals, Inc. and
Subsidiaries
We have
audited the accompanying consolidated balance sheets of Access Pharmaceuticals,
Inc. and Subsidiaries, as of December 31, 2007 and 2006, and the related
consolidated statements of operations, changes in stockholders’ equity
(deficit), and cash flows for the years then ended. These financial
statements are the responsibility of the Company’s management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. An audit includes consideration of internal
control over financial reporting as a basis for designing audit procedures that
are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position of Access
Pharmaceuticals, Inc. and Subsidiaries as of December 31, 2007 and 2006, and the
consolidated results of their operations and their cash flows for the years then
ended in conformity with accounting principles generally accepted in the United
States of America.
The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 2 to the
consolidated financial statements, the Company has had recurring losses from
operations, negative cash flows from operating activities and an accumulated
deficit. Management’s plans in regard to these matters are also described in
Note 2. These conditions raise substantial doubt about the Company’s ability to
continue as a going concern. These consolidated financial statements do not
include any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts and classification of
liabilities that may result from the outcome of this uncertainty.
/s/
WHITLEY PENN LLP
Dallas,
Texas
March 31,
2008
F-2
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
BALANCE SHEETS
|
ASSETS
|
December 31, 2007
|
December 31,
2006
|
|
Current
assets
Cash and cash
equivalents
Short
term investments, at cost
Receivables
Receivables due from Somanta
Pharmaceuticals
Prepaid
expenses and other current assets
|
$
|
159,000
6,762,000
35,000
931,000 410,000
|
$
|
1,194,000
3,195,000
359,000
-
283,000
|
||||
|
Total
current assets
|
8,297,000 | 5,031,000 |
|
Property
and equipment, net
|
130,000 | 212,000 | ||||||
|
Debt
issuance costs, net
|
- | 158,000 | ||||||
|
Patents,
net
|
710,000 | 878,000 | ||||||
|
Licenses,
net
|
- | 25,000 | ||||||
|
Other
assets
|
12,000 | 122,000 | ||||||
|
Total
assets
|
$ | 9,149,000 | $ | 6,426,000 | ||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|
Current
liabilities
Accounts
payable and accrued expenses
Accrued
interest payable
Current
portion of deferred revenue
Current
portion long-term debt, net of discount $0 at December 31,
2007
and
$2,062,000 at December 31, 2006
|
$
|
1,796,000
130,000
68,000
64,000
|
$
|
1,226,000
581,000 173,000
8,833,000
|
|
Total
current liabilities
|
2,058,000 | 10,813,000 | ||||||
| Long-term deferred revenue | 910,000 | - | ||||||
|
Long-term
debt
|
5,500,000 | 5,500,000 | ||||||
|
Total
liabilities
|
8,468,000 | 16,313,000 |
|
Commitments
and contingencies
|
|
Stockholders'
equity (deficit)
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
3,227.3617
issued at December 31, 2007; none issued at
December
31, 2006
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
3,585,458 at December 31, 2007; issued 3,535,108
at
December 31, 2006
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost – 163 shares
Accumulated
deficit
|
-
36,000
116,018,000
(1,045,000)
(4,000)
(114,324,000)
|
-
35,000
68,799,000
(1,045,000)
(4,000)
(77,672,000)
|
|
Total
stockholders' equity (deficit)
|
681,000
|
(9,887,000)
|
|
Total
liabilities and stockholders' equity (deficit)
|
$ | 9,149,000 | $ | 6,426,000 |
The
accompanying notes are an integral part of these consolidated
statements.
F-3
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
2007
|
2006
|
|||||||
|
Revenues
|
||||||||
|
License
revenues
|
$ | 23,000 | $ | - | ||||
|
Sponsored research and
development
|
34,000 | - | ||||||
|
Total revenues
|
57,000 | - | ||||||
|
Expenses
|
||||||||
|
Research and
development
|
2,602,000 | 2,053,000 | ||||||
|
General and
administrative
|
4,076,000 | 2,813,000 | ||||||
|
Depreciation and
amortization
|
279,000 | 309,000 | ||||||
|
Total expenses
|
6,957,000 | 5,175,000 | ||||||
|
Loss
from operations
|
(6,900,000 | ) | (5,175,000 | ) | ||||
|
Interest
and miscellaneous income
|
125,000 | 294,000 | ||||||
|
Interest
and other expense
|
(3,514,000 | ) | (7,436,000 | ) | ||||
|
Loss
on extinguishment of debt
|
(11,628,000 | ) | - | |||||
|
Unrealized
loss on fair value of warrants and beneficial
conversion
feature
|
- | (1,107,000 | ) | |||||
| (15,017,000 | ) | (8,249,000 | ) | |||||
|
Loss
before discontinued operations and before tax benefit
|
(21,917,000 | ) | (13,424,000 | ) | ||||
|
Income
tax benefit
|
61,000 | 173,000 | ||||||
|
Loss
from continuing operations
|
(21,856,000 | ) | (13,251,000 | ) | ||||
| Less preferred stock dividends | (14,908,000 | ) | - | |||||
| Loss from continuing operations allocable to common stockholders | (36,764,000 | ) | (13,251,000 | ) | ||||
|
Discontinued
operations, net of taxes of $61,000 in 2007 and $173,000
in 2006
|
112,000 | 377,000 | ||||||
|
Net
loss allocable to common stockholders
|
$ | (36,652,000 | ) | $ | (12,874,000 | ) | ||
|
Basic
and diluted loss per common share
|
||||||||
|
Loss
from continuing operations allocable to common
stockholders
|
$ | (10.35 | ) | $ | (3.76 | ) | ||
|
Discontinued
operations
|
0.03 | 0.11 | ||||||
|
Net
loss allocable to common stockholders
|
$ | (10.32 | ) | $ | (3.65 | ) | ||
|
Weighted
average basic and diluted common shares
outstanding
|
3,552,006 | 3,531,934 | ||||||
The
accompanying notes are an integral part of these consolidated
statements.
F-4
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
|
Common
Stock
|
Preferred
Stock
|
Additional
paid-in
capital
|
Notes
receivable from stockholders
|
Treasury
stock
|
Accumulated
deficit
|
|||
|
Shares
|
Amount
|
Shares
|
Amount
|
|||||
|
Balance,
December 31,
2005
|
3,528,000 | $ | 35,000 | - | $ | - | $ | 62,942,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (66,165,000 | ) | |||||||||||||||
|
Common
stock issued for
compensation
|
7,000 | - | - | - | 77,000 | - | - | - | ||||||||||||||||||||||||
|
Warrants
issued
|
- | - | - | - | 100,000 | - | - | - | ||||||||||||||||||||||||
|
Stock
option
compensation
expense
|
- | - | - | - | 248,000 | - | - | - | ||||||||||||||||||||||||
|
Issuance
of convertible
debt with
warrants
|
- | - | - | - | 5,432,000 | - | - | - | ||||||||||||||||||||||||
|
Cumulative
effect of
change
in accounting
principle
|
- | - | - | - | - | - | - | 1,367,000 | ||||||||||||||||||||||||
|
Net
loss
|
- | - | - | - | - | - | - | (12,874,000 | ) | |||||||||||||||||||||||
|
Balance,
December 31,
2006
|
3,535,000 | 35,000 | - | - | 68,799,000 | (1,045,000 | ) | (4,000 | ) | (77,672,000 | ) | |||||||||||||||||||||
|
Common
stock issued for
services
|
19,000 | - | - | - | 83,000 | - | - | - | ||||||||||||||||||||||||
|
Options
exercised
|
31,000 | 1,000 | - | - | 35,000 | - | - | - | ||||||||||||||||||||||||
|
Stock
option
compensation
expense
|
- | - | - | - | 1,048,000 | - | - | - | ||||||||||||||||||||||||
|
Preferred
stock issuances
|
- | - | 954.0001 | - | 5,560,000 | - | - | - | ||||||||||||||||||||||||
|
Warrants
issued with
preferred
stock
|
- | - | - | - | 3,980,000 | - | - | - | ||||||||||||||||||||||||
|
Costs
of stock issuances
|
(868,000 | ) | - | - | - | |||||||||||||||||||||||||||
|
Beneficial
conversion
Feature
|
- | - | - | - | 14,648,000 | - | - | - | ||||||||||||||||||||||||
|
Preferred
stock dividend
beneficial
conversion
feature
|
- | - | - | - | - | - | - | (14,648,000 | ) | |||||||||||||||||||||||
|
Conversion
of convertible
debt
into preferred stock
|
- | - | 2,273.3616 | - | 6,472,000 | - | - | - | ||||||||||||||||||||||||
|
Warrants
issued with
preferred
stock
|
- | - | - | - | 4,633,000 | - | - | - | ||||||||||||||||||||||||
|
Loss
on extinguishment
of
debt – preferred stock
|
- | - | - | - | 6,777,000 | - | - | - | ||||||||||||||||||||||||
|
Loss
on extinguishment
of
debt – warrants
|
- | - | - | - | 4,851,000 | - | - | - | ||||||||||||||||||||||||
|
Preferred
dividends
|
- | - | - | - | - | - | - | (260,000 | ) | |||||||||||||||||||||||
|
Net
loss
|
- | - | - | - | - | - | - | (21,744,000 | ) | |||||||||||||||||||||||
|
Balance,
December 31,
2007
|
3,585,000 | $ | 36,000 | 3,227.3617 | $ | - | $ | 116,018,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (114,324,000 | ) | |||||||||||||||
The
accompanying notes are an integral part of these consolidated
statements.
F-5
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
Year ended December
31,
|
||||||||
|
2007
|
2006
|
|||||||
| Cash flows from operating activities: | ||||||||
|
Net
loss
|
$ | (21,744,000 | ) | $ | (12,874,000 | ) | ||
|
Adjustments to
reconcile net loss to net cash used
|
||||||||
|
in operating
activities:
|
||||||||
|
Unrealized
loss
|
- | 1,107,000 | ||||||
|
Loss on
extinguishment of debt
|
11,628,000 | - | ||||||
|
Stock option
expense
|
1,048,000 | 248,000 | ||||||
|
Stock issued
for compensation/services
|
83,000 | 77,000 | ||||||
|
Depreciation and amortization
|
279,000 | 309,000 | ||||||
|
Amortization
of debt costs and
discounts
|
2,316,000 | 6,749,000 | ||||||
|
Loss (gain) on
sale of assets
|
2,000 | (550,000 | ) | |||||
|
Change in
operating assets and liabilities:
|
||||||||
|
Receivables
|
(607,000 | ) | 4,129,000 | |||||
|
Prepaid
expenses and other current assets
|
(127,000 | ) | 14,000 | |||||
|
Other
assets
|
14,000 | 127,000 | ||||||
|
Accounts
payable and accrued expenses
|
310,000 | (1,657,000 | ) | |||||
|
Accrued
interest payable
|
1,150,000 | 363,000 | ||||||
|
Deferred
revenues
|
805,000 | - | ||||||
| Net cash used in operating activities | 4,843,000 | (1,958,000 | ) | |||||
|
Cash
flows from investing activities:
|
||||||||
|
Capital
expenditures
|
(18,000 | ) | (3,000 | ) | ||||
|
Proceeds from
sale of equipment
|
13,000 | - | ||||||
|
Proceeds from
sale of oral/topical care assets
|
- | 550,000 | ||||||
|
Purchases of
short-term investments
|
||||||||
|
and
certificates of deposit, net
|
(3,567,000 | ) | (3,070,000 | ) | ||||
| Net cash used in investing activities | (3,572,000 | ) | (2,523,000 | ) | ||||
|
Cash
flows from financing activities:
|
||||||||
|
Payments of
notes payable
|
(1,327,000 | ) | (106,000 | ) | ||||
|
Proceeds from
secured convertible notes payable
|
- | 5,432,000 | ||||||
|
Exercise of
stock options
|
35,000 | - | ||||||
|
Proceeds from
preferred stock issuances, net of costs
|
8,672,000 | - | ||||||
| Net cash provided by financing activities | 7,380,000 | 5,326,000 | ||||||
| Net increase (decrease) in cash and cash equivalents | (1,035,000 | ) | 845,000 | |||||
| Cash and cash equivalents at beginning of year | 1,194,000 | 349,000 | ||||||
| Cash and cash equivalents at end of year | $ | 159,000 | $ | 1,194,000 | ||||
| Cash paid for interest | $ | 34,000 | $ | 315,000 | ||||
| Supplemental disclosure of noncash transactions | ||||||||
|
Common stock issued for SEDA
and
|
||||||||
|
Debt issuance
costs
|
- | 568,000 | ||||||
|
Accrued interest
capitalized
|
511,000 | 433,000 | ||||||
|
Warrants issued per
professional agreement
|
||||||||
|
of consulting
services
|
- | 100,000 | ||||||
|
Cumulative change of
accounting principle
|
- | 1,367,000 | ||||||
|
Issuance of convertible debt
with warrants
|
- | 5,432,000 | ||||||
|
Preferred stock
dividends
|
260,000 | - | ||||||
|
Debt exchanged for preferred
stock
|
10,015,000 | - | ||||||
|
Accrued interest exchanged for
preferred stock
|
1,090,000 | - | ||||||
The
accompanying notes are an integral part of these consolidated
statements.
F-6
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Two
years ended December 31, 2007
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Nature of
Operations
Access
Pharmaceuticals, Inc. is an emerging pharmaceutical company engaged in the
development of novel therapeutics for the treatment of cancer and supportive
care of cancer patients. This development work is based primarily on the
adaptation of existing therapeutic agents using the Company’s proprietary drug
delivery technology. Our efforts have been principally devoted to research and
development, resulting in significant losses since inception on February 24,
1988.
A summary
of the significant accounting policies applied in the preparation of the
accompanying consolidated financial statements follows.
Principles of
Consolidation
The
consolidated financial statements include the financial statements of Access
Pharmaceuticals, Inc. and our wholly-owned subsidiaries. All intercompany
balances and transactions have been eliminated in consolidation.
Use of
Estimates
In
preparing consolidated financial statements in conformity with accounting
principles generally accepted in the United States of America, management is
required to make estimates and assumptions that affect the reported amounts of
assets and liabilities, the disclosure of contingent assets and liabilities at
the date of the financial statements, and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from those
estimates.
We tested
intangible assets for impairment based on estimates of fair value. It is at
least reasonably possible that the estimates used by us will be materially
different from actual amounts. These differences could result in the impairment
of all or a portion of our intangible assets, which could have a materially
adverse effect on our results of operations.
Cash and Cash
Equivalents
We
consider all highly liquid instruments purchased with a maturity of three months
or less to be cash equivalents for purposes of the statements of cash flows.
Cash and cash equivalents consist primarily of cash in banks, money market funds
and short-term corporate securities. We invest any excess cash in government and
corporate securities. All other investments are reported as short-term
investments.
Short-term
Investments
Short-term
investments consist of certificates of deposit. All short term investments are
classified as held to maturity. The cost of debt securities is adjusted for
amortization of premiums and accretion of discounts to maturity. Such
amortization is included in interest income. The cost of securities sold is
based on the specific identification method.
Property and
Equipment
Property
and equipment are recorded at cost. Depreciation is provided using the
straight-line method over estimated useful lives ranging from three to seven
years. Expenditures for major renewals and betterments that extend the useful
lives are capitalized. Expenditures for normal maintenance and repairs are
expensed as incurred. The cost of assets sold or abandoned and the related
accumulated depreciation are eliminated from the accounts and any gains or
losses are recognized in the accompanying consolidated statements of operations
of the respective period.
F-7
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two
years ended December 31, 2007
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -
Continued
Research and Development
Expenses
Pursuant
to SFAS No. 2, “Accounting for Research and
Development Costs,” our research and development costs are expensed as
incurred. Research and development expenses include, but are not limited to,
payroll and personnel expense, lab supplies, preclinical, development cost,
clinical trial expense, outside manufacturing and consulting. The cost of
materials and equipment or facilities that are acquired for research and
development activities and that have alternative future uses are capitalized
when acquired.
Fair Value of Financial
Instruments
The
carrying value of cash, cash equivalents, short-term investments and accounts
payable approximates fair value due to the short maturity of these items. It is
not practical to estimate the fair value of the Company’s long-term debt because
quoted market prices do not exist and there were no available securities with
similar terms to use as a basis to value our debt.
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax
assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts of
existing assets and liabilities and their respective tax bases and operating
loss and tax credit carryforwards. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or
settled. The effect on deferred tax assets and liabilities of a
change in tax rates is recognized in income in the period that includes the
enactment date. A valuation allowance is provided for deferred tax assets to the
extent their realization is in doubt.
Loss Per
Share
We have
presented basic loss per share, computed on the basis of the weighted average
number of common shares outstanding during the year, and diluted loss per share,
computed on the basis of the weighted average number of common shares and all
dilutive potential common shares outstanding during the year. Potential common
shares result from stock options, vesting of restricted stock grants,
convertible notes and warrants. However, for all years presented, all
outstanding stock options, restricted stock grants, convertible notes and
warrants are anti-dilutive due to the losses for the periods. Anti-dilutive
common stock equivalents of 20,623,072 and 12,548,342 were excluded from the
loss per share computation for 2007 and 2006, respectively.
Intangible
Assets
We
expense internal patent and application costs as incurred because, even though
we believe the patents and underlying processes have continuing value, the
amount of future benefits to be derived therefrom are uncertain. Purchased
patents are capitalized and amortized over the life of the patent. We recognize
the purchase cost of licenses and amortize them over their estimated useful
lives.
The
Company operates in a single segment.
F-8
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two
years ended December 31, 2007
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES –
Continued
Intangible
assets consist of the following (in thousands):
|
December 31,
2007
|
December 31, 2006
|
|||||||||||||||
|
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
|||||||||||||
| Amortizable intangible assets | ||||||||||||||||
|
Patents
|
$ |
1,680
|
$ | 970 | $ | 1,680 | $ | 802 | ||||||||
|
Licenses
|
500 | 500 | 500 | 475 | ||||||||||||
|
Total
|
$ | 2,180 | $ | 1,470 | 2,180 | 1,277 | ||||||||||
Amortization
expense related to intangible assets totaled $193,000 and $218,000 for the years
ended December 31, 2007, and 2006, respectively. The aggregate estimated
amortization expense for intangible assets remaining as of December 31, 2007, is
as follows (in thousands):
| 2008 | $ |
168
|
| 2009 |
168
|
|
| 2010 |
168
|
|
| 2011 |
168
|
|
| Thereafter |
168
|
|
|
38
|
||
| Total | $ |
710
|
Revenues
We
recognize revenue, licensing and research and development revenues, over the
period of the performance obligation under our agreements.
Stock-Based
Compensation
On
January 1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based Payment,” (“SFAS
123(R)”), which requires the measurement and recognition of all share-based
payment awards made to employees and directors including stock options based on
estimated fair values. SFAS 123(R) supersedes the Company’s previous accounting
under Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to
Employees” (“APB 25”), for periods beginning in fiscal year 2006. In
March 2005, the Securities and Exchange Commission issued Staff Accounting
Bulletin No. 107 (“SAB 107”) relating to SFAS 123(R). We applied the
provisions of SAB 107 in its adoption of SFAS 123(R).
We
adopted SFAS 123(R) using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006,
the first day of the Company’s 2006 fiscal year. Our consolidated financial
statements for the years ended December 31, 2007 and 2006, reflect the
impact of SFAS 123(R). In accordance with the modified prospective transition
method, our consolidated financial statements for prior periods have not been
restated to include the impact of SFAS 123(R). Stock-based compensation expense
recognized under SFAS 123(R) for the year ended December 31, 2007, was
approximately $1,048,000 and $248,000 for the year ended December 31,
2006.
F-9
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two
years ended December 31, 2007
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES –
Continued
SFAS
123(R) requires companies to estimate the fair value of share-based payment
awards on the date of grant using an option-pricing model. The value of the
portion of the award that is ultimately expected to vest is recognized as
expense over the requisite service period in the company’s Statement of
Operations. Prior to the adoption of SFAS 123(R), we accounted for stock-based
awards to employees and directors using the intrinsic value method in accordance
with APB No. 25 as allowed under SFAS No. 123, “Accounting for Stock-Based
Compensation” (“SFAS 123”). Under the intrinsic value method, no
stock-based compensation expense for stock option grants was recognized because
the exercise price of our stock options granted to employees and directors
equaled the fair market value of the underlying stock at the date of grant.
There were no restricted stock awards granted in 2007 or 2006 and therefore no
stock compensation expense is recognized in 2007 or 2006.
We use
the Black-Scholes option-pricing model (“Black-Scholes”) as its method of
valuation under SFAS 123(R) in fiscal year 2007 and 2006 and a single option
award approach. This fair value is then amortized on a straight-line basis over
the requisite service periods of the awards, which is generally the vesting
period. The fair value of share-based payment awards on the date of grant as
determined by the Black-Scholes model is affected by our stock price as well as
other assumptions. These assumptions include, but are not limited to the
expected stock price volatility over the term of the awards, and actual and
projected employee stock option exercise behaviors.
During
2007 and 2006, 230,000 stock options and 753,872 stock options, respectively,
were granted under the 2005 Equity Incentive Plan. Assumptions for 2007 and 2006
are:
|
2007
|
2006
|
|
|
Expected
volatility assumption was based upon a combination of historical stock
price volatility measured on a twice a month basis and is a reasonable
indicator of expected volatility.
|
136%
|
127%
|
|
Risk-free
interest rate assumption is based upon U.S. Treasury bond interest rates
appropriate for the term of the Company’s employee stock
options.
|
4.65%
|
4.85%
|
|
Dividend
yield assumption is based on our history and expectation of dividend
payments.
|
None
|
None
|
|
Estimated
expected term (average of number years) is based on employee exercise
behavior.
|
5.7
years
|
1.6
years
|
F-10
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two
years ended December 31, 2007
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES –
Continued
At
December 31, 2007, the balance of unearned stock-based compensation to be
expensed in future periods related to unvested share-based awards, as adjusted
for expected forfeitures, is approximately $197,000. The period over which the
unearned stock-based compensation is expected to be recognized is approximately
three years. We anticipate that we will grant additional share-based awards to
employees in the future, which will increase our stock-based compensation
expense by the additional unearned compensation resulting from these grants. The
fair value of these grants is not included in the amount above, because the
impact of these grants cannot be predicted at this time due to the dependence on
the number of share-based payments granted. In addition, if factors change and
different assumptions are used in the application of SFAS 123(R) in future
periods, stock-based compensation expense recorded under SFAS 123(R) may
differ significantly from what has been recorded in the current
period.
Our
Employee Stock Option Plans have been deemed compensatory in accordance with
SFAS 123(R). Stock-based compensation relating to this plan was computed using
the Black-Scholes model option-pricing formula with interest rates, volatility
and dividend assumptions as of the respective grant dates of the purchase rights
provided to employees under the plan. The weighted-average fair value of options
existing under all plans during 2007 was $2.65.
The
following table summarizes stock-based compensation in accordance with SFAS
123(R) for the year ended December 31, 2007, and 2006 which was allocated as
follows (in thousands):
|
Year
ended
December 31, 2007
|
Year
ended
December 31, 2006
|
|||||||
|
Research
and development
|
$ | 91 | $ | 68 | ||||
|
General
and administrative
|
957 | 180 | ||||||
|
Stock-based
compensation expense included in operating expense
|
1,048 | 248 | ||||||
|
Total
stock-based compensation expense
|
1,048 | 248 | ||||||
|
Tax
benefit
|
- | - | ||||||
|
Stock-based
compensation expense, net of tax
|
$ | 1,048 | $ | 248 | ||||
Recent Accounting
Pronouncements
In
June 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income
Taxes, an Interpretation of FASB Statement No. 109, Accounting for Income
Taxes (“FIN 48”), to create a single model to address accounting for
uncertainty in tax positions. FIN 48 clarifies the accounting for income taxes
by prescribing a minimum recognition threshold a tax position is required to
meet before being recognized in the financial statements. FIN 48 also provides
guidance on derecognition, measurement, classification, interest, and penalties,
accounting in interim periods, disclosure and transition. The Company adopted
FIN 48 as of January 1, 2007, and the adoption did not have a material
impact on the Company’s consolidated financial statements or effective tax rate
and did not result in any unrecognized tax benefits.
Interest
costs and penalties related to income taxes are classified as interest expense
and general and administrative costs, respectively, in the Company’s
consolidated financial statements. For the years ended December 31, 2007
and 2006, the Company did not recognize any interest or penalty expense related
to income taxes. It is determined not to be reasonably likely for the amounts of
unrecognized tax benefits to significantly increase or decrease within the next
12 months. The Company is currently subject to a three year statute of
limitations by major tax jurisdictions. The Company and its subsidiaries file
income tax returns in the U.S. federal jurisdiction.
In
September 2006, the FASB issued Statement of Financial Accounting Standard
(“SFAS”) No. 157, “Fair Value Measurements” (“SFAS 157”). SFAS 157 defines
fair value, establishes a market-based framework or hierarchy for measuring fair
value, and expands disclosures about fair value measurements. SFAS 157 is
applicable whenever another accounting pronouncement requires or permits assets
and liabilities to be measured at fair value. SFAS 157 does not expand or
require any new fair value measures; however the application of this statement
may change current practice.
F-11
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
|
Two
years ended December 31, 2007
|
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES –
Continued
The
requirements of SFAS 157 are first effective for our fiscal year beginning
January 1, 2008. However, in February 2008 the FASB decided that an
entity need not apply this standard to nonfinancial assets and liabilities that
are recognized or disclosed at fair value in the financial statements on a
nonrecurring basis until the subsequent year. Accordingly, our adoption of this
standard on January 1, 2008, is limited to financial assets and
liabilities. We do not believe the initial adoption of SFAS 157 will have a
material effect on our financial condition or results of operations. However, we
are still in the process of evaluating this standard with respect to its effect
on nonfinancial assets and liabilities and therefore have not yet determined the
impact that it will have on our financial statements upon full
adoption.
In
February 2007, FASB issued SFAS No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities — Including an Amendment of FASB Statement
No. 115. The fair value option permits entities to choose to measure
eligible financial instruments at fair value at specified election dates. The
entity will report unrealized gains and losses on the items on which it has
elected the fair value option in earnings. SFAS 159 is effective beginning in
fiscal year 2008. The Company is currently evaluating the effect of adopting
SFAS 159, but does not expect it to have a material impact on its consolidated
results of operations or financial condition.
NOTE
2 – LIQUIDITY
The
accompanying consolidated financial statements have been prepared assuming that
the Company is a going concern. The Company incurred a net loss in the years
ended December 31, 2007 and 2006. As described in Note 13, the Company has
issued convertible preferred stock in February 2008 and entered into a license
in January 2008.
Management
believes that these additional funds should cover the Company’s expected burn
rate into the second quarter of 2009. The Company will require additional funds
to fund operations. These funds are expected to come from the future sales of
equity and/or license agreements.
NOTE
3 - RELATED PARTY TRANSACTIONS
Stephen
B. Howell, M.D., a Director, receives payments for consulting services and
reimbursement of direct expenses. Dr. Howell’s payments for consulting services
and expense reimbursements are as follows:
|
Consulting
|
Expense
|
|||||||
|
Year
|
Fees
|
|
Reimbursement
|
|||||
| 2007 | $ | 70,000 | $ | 2,000 | ||||
| 2006 | 69,000 | 5,000 | ||||||
Dr.
Esteban Cvitkovic, a Director, also serves as a consultant as Senior Director,
Oncology Clinical Research & Development to us since August 2007. Dr.
Cvitkovic receives payments for consulting expenses, office expenses and
reimbursement of direct expenses. Dr. Cvitkovic also received options to
purchase 25,000 shares of our Common Stock at $4.35 per share with 12,500
options immediately in August 2007 and 12,500 options will vest in March 2008
based on the completion of certain defined tasks. Dr. Cvitkovic’s payments for
consulting services and expense reimbursements are as follows:
|
Consulting
|
Office
|
Expense
|
Fair
Value
|
|||||||||||||
|
Year
|
Fees
|
Expenses
|
Reimbursement
|
of
Options
|
||||||||||||
| 2007 | $ | 153,000 | $ | 15,000 | $ | 12,000 | $ | 99,000 | ||||||||
Dr.
Rosemary Mazanet, a Director, receives payments for consulting services and
reimbursement of direct expenses. Dr. Mazanet’s payments for consulting services
and expense reimbursements are as follows:
|
Consulting
|
Expense
|
||||||||
|
Year
|
Fees
|
Reimbursement
|
|||||||
|
2007
|
$ | 29,000 | $ | 13,000 | |||||
F-12
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two
years ended December 31, 2007
NOTE
3 - RELATED PARTY TRANSACTIONS - Continued
In the
event SCO Capital Partners LLC (“SCO”) and its affiliates were to convert all of
their shares of Series A Preferred Stock and exercise all of their warrants,
they would own approximately 69.8% of the voting securities of Access. During
2007 SCO and affiliates were paid $240,000 in placement agent fees relating to
the issuance of preferred stock and 100,000 warrants to purchase our common
stock, valued at $250,000. SCO and affiliates also were paid $150,000 in
investor relations fees in 2007. During 2006 SCO and affiliates were paid
$415,000 in fees relating to the issuance of convertible notes and were paid
$131,000 in investor relations fees.
See Note
9 for a discussion of our Restricted Stock Purchase Program.
NOTE
4 - PROPERTY AND EQUIPMENT
| Property and equipment consists of the following: |
December
31,
|
|||||||
|
2007
|
2006
|
|||||||
| Laboratory equipment | $ | 824,000 | $ | 1,090,000 | ||||
| Laboratory and building improvements | 58,000 | 167,000 | ||||||
| Furniture and equipment | 40,000 | 134,000 | ||||||
| 922,000 | 1,391,000 | |||||||
| Less accumulated depreciation and amortization | 792,000 | 1,179,000 | ||||||
| Net property and equipment | $ | 130,000 | $ | 212,000 | ||||
Depreciation
and amortization on property and equipment was $86,000 and $91,000 for the years
ended December 31, 2007 and 2006, respectively.
NOTE
5 – 401(k) PLAN
We have a
tax-qualified employee savings and retirement plan (the “401(k) Plan”) covering
all our employees. Pursuant to the 401(k) Plan, employees may elect to reduce
their current compensation by up to the statutorily prescribed annual limit
($15,500 in 2007 and $15,000 in 2006) and to have the amount of such reduction
contributed to the 401(k) Plan. We have a 401(k) matching program whereby we
contribute for each dollar a participant contributes a like amount, with a
maximum contribution of 4% of a participant’s earnings in 2007 and 2% of a
participant’s earnings in 2006. The 401(k) Plan is intended to qualify under
Section 401 of the Internal Revenue Code so that contributions by employees or
by us to the 401(k) Plan, and income earned on 401(k) Plan contributions, are
not taxable to employees until withdrawn from the 401(k) Plan, and so that
contributions by us, if any, will be deductible by us when made. At the
direction of each participant, we invest the assets of the 401(k) Plan in any of
62 investment options. Company contributions under the 401(k) Plan were
approximately $50,000 in 2007 and $11,000 in 2006.
NOTE
6 – DEBT
$5,500,000 due on September
13, 2011. The note bears interest at 7.7% per annum with $423,500 of
interest due annually on September 13th. This
investor amended this note’s due date until 2011 and delayed his interest
payments which were due in 2005, 2006 and 2007 until September 13, 2008 or
earlier if the Company raised more than $5.0 million in funds. The capitalized
interest was $1,391,000 and interest on the capitalized interest was at 10%. We
raised $9,540,000 in November 2007, and entered into an agreement with the
investor to pay capitalized interest of $1,327,000 plus interest. At December
31, 2007 in addition to the note of $5,500,000 an additional $64,000 of
capitalized interest was due. Interest of $129,000 was due at December 31, 2007.
This note has a fixed conversion price of $27.50 per share of common stock and
may be converted by the note holder or us under certain circumstances as defined
in the note. If the notes are not converted we will have to repay the notes on
the due dates.
F-13
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two
years ended December 31, 2007
NOTE
6 – DEBT - Continued
$4,015,000 due on November
16, 2007 and $6,000,000 due on November 15, 2007 exchanged for
stock.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,000. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
As a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and Oracle
Partners LP and affiliates, along with the other holders of an aggregate of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest for
437.3104 shares of the Series A Preferred Stock and were issued warrants to
purchase 728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving
on our Board of Directors. In connection with the exchange of the
notes, all security interests and liens relating thereto were
terminated.
The
conversion of debt into equity resulted in a loss on extinguishment of debt of
$11,628,000. This represents the difference between the fair value of the equity
interest granted, based on recent sales of identical equity instruments, and the
carrying amount of the debt and interest settled.
$4,015,000 due on November
16, 2007. The investor’s notes were amended November 3, 2005, extending
the term and adjusting the conversion price from $27.50 to $5.00 per common
share. The amendment and modification resulted in us recording additional debt
discount of $2.1 million, which was accreted to interest expense to the revised
maturity date.
$6,000,000 due on November
15, 2007. The notes were sold in February 2006 in a private placement to
a group of accredited investors led by SCO Capital Partners LLC and affiliates.
We entered into a note and purchase agreement to which we sold and issued an
aggregate of $5 million of 7.5% convertible notes due November 15, 2007 and
warrants to purchase 3,863,634 shares of common stock of Access. Net proceeds to
Access were $4.5 million.
On
October 24, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible notes
due November 15, 2007 and warrants to purchase 386,364 shares of common stock of
Access. Net proceeds to Access were $450,000. On December 6, 2006, we entered
into a note and warrant purchase agreement pursuant to which we sold and issued
an aggregate of $500,000 of 7.5% convertible notes due November 15, 2007 and
warrants to purchase 386,364 shares of common stock of Access. Net proceeds to
Access were $450,000.
The
Secured Convertible Notes included warrants and a conversion feature. Until
September 30, 2006, we accounted for the warrants and conversion feature as
liabilities and recorded at fair value. From the date of issuance to September
30, 2006, the fair value of these instruments increased resulting in a net
unrealized loss of $1.1 million. On October 1, 2006, we adopted the
provisions of EITF 00-19-2, “Accounting for Registration Payment
Arrangements” (EITF 00-19-2), which requires that contingent obligations
to make future payments under a registration payment arrangement be recognized
and measured separately in accordance with SFAS No. 5, “Accounting for
Contingencies.” Under previous guidance, the fair value of the warrant
was recorded as a current liability in our balance sheet, due to a potential
cash payment feature in the warrant. Access may be required to pay in cash, up
to 2% per month, as defined, as liquidated damages for failure to file a
registration statement timely as required by an investor rights agreement. The
current liability was marked-to-market at each quarter end, using the
Black-Scholes option-pricing model, with the change being recorded to general
and administrative expenses. Under the new guidance in EITF 00-19-2, as we
believe the likelihood of such a
F-14
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two
years ended December 31, 2007
NOTE
6 – DEBT - Continued
cash
payment to not be probable, have not recognized a liability for such
obligations. Accordingly, a cumulative-effect adjustment of $1.4 million was
made as of October 1, 2006, to accumulated deficit, representing the
difference between the initial value of this warrant and its fair value as of
this date and recorded to equity.
Subsequent
to the adoption of EITF 00-19-2 on October 1, 2006, the Company has accounted
for the $6,000,000 notes under EITF Issue No. 00-27, Application of Issue No. 98-5 to
Certain Instruments. The value of the warrants was valued using a
Black-Scholes option-pricing model with the following assumptions with a
weighted average volatility of 120%, expected life of 6 years, expected yield of
0% and risk free rate of 5.0%. At December 31, 2006, approximately $1.6M of debt
discount related to the warrants and embedded conversion feature had not been
amortized to interest expense. This was amortized over the original remaining
life of the debt through March 31, 2007.
NOTE
7 – COMMITMENTS AND CONTINGENCIES
Future
maturities of the note payable and other obligations are as
follows:
|
Future
|
||
|
Maturities
|
Debt
|
|
| 2008 |
64,000
|
|
| 2011 |
5,500,000
|
Operating
Leases
At
December 31, 2007, we have commitments under non-cancelable operating leases for
office and research and development facilities until December 31, 2008, totaling
$77,000. Rent expense for the years ended December 31, 2007, and 2006 was
$94,000 and $94,000, respectively. We also have two other non-cancelable
operating leases – one lease for a fire alarm system totaling $5,000 ending in
2008 and one lease for a copier totaling $38,000 ending in 2011 (with $9,600
expensed each year).
Legal
The
Company is not currently subject to any material pending legal
proceedings.
NOTE
8 – PREFERRED STOCK
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
As a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and Oracle
Partners LP and affiliates, along with the other holders of an aggregate of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest for
437.3104 shares of the Series A Preferred Stock and were issued warrants to
purchase 728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving
on our Board of Directors. In connection with the exchange of the
notes, all security interests and liens relating thereto were
terminated.
F-15
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two
years ended December 31, 2007
NOTE
8 – PREFERRED STOCK - Continued
As a
condition to closing, we entered into an Investor Rights Agreement with each of
the investors purchasing shares of Series A Preferred Stock, and our Board of
Directors approved with respect to the shareholder rights plan any action
necessary under our shareholder rights plan to accommodate the issuance of the
Series A Preferred Stock and warrants without triggering the applicability of
the shareholder rights plan.
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access.
The
issued and outstanding shares of Series A Preferred Stock grants the holders of
such preferred stock anti-dilution, dividend and liquidations rights that are
superior to those held by the holders of our common stock. Should
Access issue additional shares of common stock for a price below $3.00 per
share, the conversion price of the Series A Preferred Stock shall be lowered to
the lowest issue price below $3.00 per share which will have the effect of
diluting the holders of our common stock.
In
connection with the preferred stock offering, we issued warrants for placement
agent fees, to purchase a total of 209,000 shares of common stock were issued.
All of the warrants are exercisable immediately and expire five years from date
of issue. The fair value of the warrants was $2.50 per share on the date of the
grant using the Black-Scholes pricing model with the following assumptions:
expected dividend yield 0.0%, risk-free interest rate 3.84%, expected volatility
114% and a term of 5 years.
Emerging
Issues Task Force (EITF) Issue 00-19, Accounting for Derivative Financial
Instruments Indexed to and Potentially Settled in, a Company’s Own Stock,
to determine whether the instruments should be accounted for as equity or
as liabilities.” EITF 00-19 requires the separation of single financial
instruments into components. For example, common stock issued with warrants
should be accounted for as equity, and the associated warrants could be
classified as either equity or liability. We determined that the warrants issued
along with the preferred stock and debt conversion are separate financial
instruments and separately exercisable and therefore, are within the scope of
EITF 00-19. Both the preferred stock and warrants were classified as equity. The
warrants were measured at their fair value.
The
conversion of debt into equity resulted in a loss on extinguishment of debt of
$11,628,000. This represents the difference between the fair value of the equity
interest granted, based on recent sales of identical equity instruments, and the
carrying amount of the debt and interest settled.
Based on
the loss on extinguishment of debt a new conversion price was calculated for the
preferred stock and considered to be “in the money” at the time of the agreement
to exchange the convertible notes for preferred stock. This resulted in a
beneficial conversion feature. The preferred stockholder has the right at any
time to convert all or any lesser portion of the Series A Preferred Stock into
Common Stock. This resulted in an intrinsic value of the preferred stock. The
difference between the implied value of the preferred stock and the beneficial
conversion option was treated as preferred stock dividends of
$14,648,000.
F-16
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two
years ended December 31, 2007
NOTE
9 - STOCKHOLDERS' EQUITY
Restricted Stock Purchase
Program
On
October 12, 2000, the Board of Directors authorized a Restricted Stock Purchase
Program. Under the Program, the Company’s executive officers and corporate
secretary were given the opportunity to purchase shares of common stock in an
individually designated amount per participant determined by the Compensation
Committee of the Board of Directors. A total of 38,000 shares were purchased
under the Program by four eligible participants at $27.50 per share, the fair
market value of the common stock on October 12, 2000, for an aggregate
consideration of $1,045,000. The purchase price was paid through the
participants’ delivery of a 50%-recourse promissory note payable to the Company
for three executive officer participants and a full-recourse promissory note
payable to the Company for one participant. Each note bears interest at 5.87%
compounded semi-annually and has a maximum term of ten years. The notes are
secured by a pledge of the purchased shares to the Company. The Company recorded
the notes receivable from participants in this Program of $1,045,000 as a
reduction of equity in the Consolidated Balance Sheet. Interest on the notes is
neither being collected nor accrued. The stock granted under the Program is
fully vested at December 31, 2007.
Warrants
There
were warrants to purchase a total of 8,476,397 shares of common stock
outstanding at December 31, 2007. All warrants were exercisable at December 31,
2007. The warrants had various prices and terms as follows:
|
Summary of Warrants
|
Warrants
Outstanding
|
Exercise
Price
|
Expiration
Date
|
||||||
| 2007 preferred stock offering (a) | 3,649,880 | $ | 3.50 |
11/10/13
|
|||||
| 2006 convertible note (b) | 3,863,634 | 1.32 |
2/16/12
|
||||||
| 2006 convertible note (b) | 386,364 | 1.32 |
10/24/12
|
||||||
| 2006 convertible note (b) | 386,364 | 1.32 |
12/06/12
|
||||||
| 2006 investor relations advisor (c) | 50,000 | 2.70 |
12/27/11
|
||||||
| 2004 offering (d) | 89,461 | 35.50 |
2/24/09
|
||||||
| 2004 offering (d) | 31,295 | 27.00 |
2/24/09
|
||||||
| 2003 financial advisor (e) | 14,399 | 19.50 |
10/30/08
|
||||||
| 2002 scientific consultant (f) | 2,000 | 24.80 |
2/01/09
|
||||||
| 2001 scientific consultant (g) | 3,000 | 15.00 |
1/1/08
|
||||||
|
Total
|
8,476,397 |
|
a)
|
In
connection with the preferred stock offering in November 2007, warrants to
purchase a total of 3,649,880 shares of common stock were issued. All of
the warrants are exercisable immediately and expire five years from date
of issue. The fair value of the warrants was $2.50 per share on the date
of the grant using the Black-Scholes pricing model with the following
assumptions: expected dividend yield 0.0%, risk-free interest rate 3.84%,
expected volatility 114% and a term of 5
years.
|
|
b)
|
In
connection with the convertible note offerings in 2006, warrants to
purchase a total of 4,636,362 shares of common stock were issued. All of
the warrants are exercisable immediately and expire six years from date of
issue.
|
|
c)
|
During
2006, an investor relations advisor received warrants to purchase 50,000
shares of common stock at an exercise price of $2.70 per share at any time
from December 27, 2006 until December 27, 2011, for investor relations
consulting services to be rendered in 2007. All of the warrants are
exercisable.
|
F-17
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE 9 -
STOCKHOLDERS' EQUITY - Continued
|
d)
|
In
connection with offering of common stock in 2004, warrants to purchase a
total of 120,756 shares of common stock were issued. All of the warrants
are exercisable and expire five years from date of
issuance.
|
|
e)
|
During
2003, financial advisors received warrants to purchase 14,399 shares of
common stock at any time until October 30, 2008, for financial consulting
services rendered in 2003 and 2004. All the warrants are
exercisable.
|
|
f)
|
During
2002, a director who is also a scientific advisor received warrants to
purchase 2,000 shares of common stock at an exercise price of $24.55 per
share at any time until February 1, 2009, for scientific consulting
services rendered in 2002.
|
|
g)
|
During
2001, a director who is also a scientific advisor received warrants to
purchase 3,000 shares of common stock at an exercise price of $15.00 per
share at any time until January 1, 2008, for scientific consulting
services rendered in 2001.
|
2001 Restricted Stock
Plan
We have a
restricted stock plan, the 2001 Restricted Stock Plan, as amended, under which
80,000 shares of our authorized but unissued common stock were reserved for
issuance to certain employees, directors, consultants and advisors. The
restricted stock granted under the plan generally vests, 25% two years after the
grant date with additional 25% vesting every anniversary date. All stock is
vested after five years. At December 31, 2007 there were 27,182 shares issued
and 52,818 shares available for grant under the 2001 Restricted Stock
Plan.
NOTE 10 - STOCK OPTION
PLANS
We have various stock-based employee
compensation plans described below:
2005 Equity Incentive
Plan
We have a
stock awards plan, (the “2005 Equity Incentive Plan”), under which 1,675,000
shares of our authorized but unissued common stock were reserved for issuance to
employees of, or consultants to, one or more of the Company and its affiliates,
or to non-employee members of the Board or of any board of directors (or similar
governing authority) of any affiliate of the Company. The 2005 Equity Incentive
Plan replaced the previously approved stock option plan (the 1995 Stock Awards
Plan").
For the
2005 Equity Incentive Plan, the fair value of options was estimated at the date
of grant using the Black-Scholes option pricing model with the following
weighted average assumptions used for grants in fiscal 2007: dividend yield of
0%; volatility of 136%; risk-free interest rate of 4.65%; and expected lives of
5.7 years. The weighted average fair value of options granted was $3.27 per
share during 2007. The assumptions for grants in fiscal 2006 were: dividend
yield of 0%; volatility of 127%; risk-free interest rate of 4.85%; and expected
lives of 1.6 years. The weighted average fair value of options granted was $0.36
per share during 2006.
F-18
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
10 - STOCK OPTION PLANS - Continued
Summarized
information for the 2005 Equity Incentive Plan is as follows:
|
Options
|
Weighted-
average
exercise
Price
|
|||||||
| Outstanding options at January 1, 2006 | 50,000 | $ | 5.45 | |||||
| Granted, fair value of $ 0.36 per share | 753,872 | 1.32 | ||||||
| Forfeited | (1,200 | ) | 3.15 | |||||
| Outstanding options at December 31, 2006 | 802,672 | 1.04 | ||||||
| Granted, fair value of $ 3.27 per share | 230,000 | 3.62 | ||||||
| Exercised | (31,286 | ) | 1.11 | |||||
| Forfeited | (75,000 | ) | 2.14 | |||||
| Outstanding options at December 31, 2007 | 926,386 | 1.59 | ||||||
| Exercisable at December 31, 2007 | 698,081 | 1.38 | ||||||
The
intrinsic value of options under this plan related to the outstanding and
exercisable options were $1,805,000 and $1,504,000, respectively, at December
31, 2007. The intrinsic value of options under this plan related to the
outstanding and exercisable options were $1,554,000 and $281,000, respectively,
at December 31, 2006.
The
total intrinsic value of options exercised during 2007 was $113,000.
Further information regarding options outstanding under the 2005 Equity Incentive Plan at December 31, 2006 is summarized below:
|
Number
of
|
Weighted
average
|
Number
of
|
Weighted average | |||||||||||||||||||||||
|
Range of exercise
prices
|
options
outstanding
|
Remaining
life in years
|
Exercise
price
|
options
excercisable
|
Remaining
life in years
|
Exercise
Price
|
||||||||||||||||||||
| $ |
0.63 -
0.63
|
666,750 | 9.0 | $ | 0.63 | 565,342 | 9.0 | $ | 0.63 | |||||||||||||||||
| $ | 2.90 - 7.23 | 259,636 | 9.4 | 4.06 | 132,739 | 9.2 | 4.67 | |||||||||||||||||||
| 926,386 | 698,081 | |||||||||||||||||||||||||
2007 Special Stock Option
Plan
In
January 2007 we adopted the 2007 Special Stock Option Plan and Agreement (the
“Plan”). The Plan provides for the award of options to purchase 450,000 shares
of the authorized but unissued shares of common stock of the Company. At
December 31, 2007, there were 350,000 additional shares available for grant
under the Plan.
Under the
2007 Special Stock Option Plan, 450,000 options were issued in 2007 and 350,000
were forfeited. 100,000 options were outstanding at December 31, 2007. 100,000
options in the 2007 Special Stock Option Plan were exercisable at December 31,
2007. All of the options had an exercise price of $2.90 per share and expire
March 12, 2010.
For the
2007 Special Stock Option Plan, the fair value of options was estimated at the
date of grant using the Black-Scholes option pricing model with the following
weighted average assumptions used for grants in fiscal 2007: dividend yield of
0%; volatility of 138%; risk-free interest rate of 4.66%; and expected lives of
5.0 years. The weighted average fair value of options granted was $2.70 per
share during 2007.
F-19
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
10 - STOCK OPTION PLANS – Continued
2000 Special Stock Option
Plan
In
February 2000 we adopted the 2000 Special Stock Option Plan and Agreement (the
“Plan”). The Plan provides for the award of options to purchase 100,000 shares
of the authorized but unissued shares of common stock of the Company. At
December 31, 2007, there were no additional shares available for grant under the
Plan and all of the options expired on June 30, 2007.
Under the
2000 Special Stock Option Plan, 100,000 options were issued in 2000 and were
outstanding at December 31, 2006. All of the options in the 2000 Special Stock
Option Plan were exercisable at December 31, 2006. All of the options expired on
June 30, 2007 and had an exercise price of $12.50 per share.
1995 Stock Awards
Plan
Under the
1995 Stock Awards Plan, as amended, 500,000 shares of our authorized but
unissued common stock were reserved for issuance to optionees including
officers, employees, and other individuals performing services for us. At
December 31, 2007, there were no additional shares available for grant under the
1995 Stock Awards Plan. A total of 162,417 options were outstanding under this
plan at December 31, 2007.
Options
granted under all the plans generally vest ratably over a four to five year
period and are generally exercisable over a ten-year period from the date of
grant. Stock options were generally granted with an exercise price equal to the
market value at the date of grant.
Summarized
information for the 1995 Stock Awards Plan is as follows:
|
Options
|
Weighted-
average
exercise
price
|
|||||||
| Outstanding options at January 1, 2006 | 430,271 | $ | 18.20 | |||||
| Forfeited | (69,354 | ) | 19.12 | |||||
| Outstanding options at December 31, 2006 | 18.03 | 18.03 | ||||||
| Forfeited | (198,500 | ) | 20.07 | |||||
| Exercisable at December 31, 2007 | 162,417 | 15.53 | ||||||
| Exercisable at December 31, 2007 | 157,337 | 15.64 | ||||||
There
was no intrinsic value related to outstanding or exercisable options under this
plan at December 31, 2007 or 2006.
Further
information regarding options outstanding under the 1995 Stock Awards Plan at
December 31, 2007 is summarized below:
|
Number
of
|
Weighted
average
|
Number
of
|
Weighted average | |||||||||||||||||||||||
|
Range of exercise
prices
|
options
outstanding
|
Remaining
life in years
|
Exercise
price
|
options
excercisable
|
Remaining
life in years
|
Exercise
Price
|
||||||||||||||||||||
|
$
|
10.00 - 12.50
|
85,140
|
5.3
|
$
|
11.42
|
80,238
|
5.1
|
$ |
11.41
|
|||||||||||||||||
|
14.05 -
18.65
|
48,717
|
3.3
|
16.33
|
48,717
|
3.3
|
16.33
|
||||||||||||||||||||
| $ | 20.25 – 29.25 |
28,560
|
6.1 | 26.42 |
28,382
|
6.1 | 26.41 | |||||||||||||||||||
| 162,417 | 157,337 | |||||||||||||||||||||||||
F-20
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
11 - INCOME TAXES
Income
tax expense differs from the statutory amounts as follows:
| 2007 | 2006 | |||||||
| Income taxes at U.S. statutory rate | $ | (7,393,000 | ) | $ | (4,378,000 | ) | ||
| Change in valuation allowance | 3,015,000 | 3,972,000 | ||||||
| Change in miscellaneous items | - | (130,000 | ) | |||||
| Benefit of foreign losses not recognized | 56,000 | 58,000 | ||||||
| Expenses not deductible | 3,957,000 | 240,000 | ||||||
| Expiration of net operating loss and general | ||||||||
|
business
credit carryforwards, net of
revisions
|
365,000 | 238,000 | ||||||
|
Total tax
expense
|
$ |
-
|
$ | - | ||||
Deferred
taxes are provided for the temporary differences between the financial reporting
bases and the tax bases of our assets and liabilities. The temporary
differences that give rise to deferred tax assets were as follows:
|
December
31,
|
||||||||
|
2007
|
2006
|
|||||||
| Deferred tax assets | ||||||||
|
Net operating
loss carryforwards
|
$ |
25,693,000
|
$ | 22,634,000 | ||||
|
General
business credit carryforwards
|
2,469,000 | 2,402,000 | ||||||
|
Property,
equipment and goodwill
|
87,000 | 46,000 | ||||||
| Gross deferred tax assets | 28,249,000 | 25,082,000 | ||||||
| Valuation allowance | (28,249,000 | ) | (25,082,000 | ) | ||||
|
|
||||||||
|
Net deferred
taxes
|
$ | - | $ | - | ||||
At
December 31, 2007, we had approximately $75,568,000 of net operating loss
carryforwards and approximately $2,469,000 of general business credit
carryforwards. These carryforwards expire as follows:
|
Net
operating
loss
carryforwards
|
General
business
credit
carryforwards
|
|||||||
| 2008 | $ | 4,004,000 | $ | 138,000 | ||||
| 2009 | 1,661,000 | 185,000 | ||||||
| 2010 | 2,171,000 | 140,000 | ||||||
| 2012 | 4,488,000 | 13,000 | ||||||
| 2013 | 4,212,000 | 77,000 | ||||||
| Thereafter | 59,032,000 | 1,916,000 | ||||||
| $ | 75,568,000 | $ | 2,469,000 | |||||
As a
result of a merger on January 25, 1996, a change in control occurred for federal
income tax purposes which limits the utilization of pre-merger net operating
loss carryforwards of approximately $3,100,000 to approximately $530,000 per
year.
F-21
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
12 – QUARTERLY FINANCIAL DATA (UNAUDITED)
Our
results of operations by quarter for the years ended December 31, 2007 and 2006
were as follows (in thousands, except per share amounts):
|
2007
Quarter Ended
|
||||
|
March 31
|
June 30
|
September 30
|
December 31
|
|||||||||||||
|
Loss
from continuing operations
|
$ | (4,127 | ) | $ | (2,109 | ) | $ | (1,957 | ) | $ | (13,663 | ) | ||||
| Preferred stock dividends | - | - | - | (14,908 | ) | |||||||||||
|
Discontinued
operations, net of tax
|
- | - | - | 112 | ||||||||||||
|
Net
loss allocable to common
stockholders
|
$ | (4,127 | ) | $ | (2,109 | ) | $ | (1,957 | ) | $ | (28,459 | ) | ||||
|
Basic
and diluted loss per
common
share
|
$ | (1.17 | ) | $ | (0.60 | ) | $ | (0.55 | ) | $ | (8.00 | ) | ||||
|
2006
Quarter Ended
|
||||||||||||||||
|
March
31
|
June
30
|
September 30
|
December 31
|
|||||||||||||
|
Loss
from continuing operations
|
$ | (4,856 | ) | $ | (3,331 | ) | $ | (2,015 | ) | $ | (3,049 | ) | ||||
|
Discontinued
operations, net of tax
|
- | - | - | 377 | ||||||||||||
|
Net
loss
|
$ | (4,856 | ) | $ | (3,331 | ) | $ | (2,015 | ) | $ | (2,672 | ) | ||||
|
Basic
and diluted loss per
common share
|
$ | (1.38 | ) | $ | (0.94 | ) | $ | (0.57 | ) | $ | (0.76 | ) | ||||
NOTE
13 – SUBSEQUENT EVENTS (UNAUDITED)
On
February 4, 2008, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of
our preferred stock, designated “Series A Cumulative Convertible Preferred
Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the
“Series A Preferred Stock”) and agreed to issue warrants to purchase 545,000
shares of our common stock, which includes placement agent warrants to purchase
90,883 shares of our common stock, at an exercise price of $3.50 per share, for
an aggregate purchase price for the Series A Preferred Stock and Warrants of
$2,700,000. The shares of Series A Preferred Stock are convertible into common
stock at the initial conversion price of $3.00 per share.
In
addition, due to the acquisition of Somanta, Access issued 538,508 shares of
Access common stock and 246,753 warrants to purchase Access common stock at an
exercise price of $3.50 per share to satisfy $1,576,000 of payables
due Somanta creditors.
On January 14, 2008, we announced the signing of a definitive licensing agreement under which RHEI Pharmaceuticals, Inc. will market and manufacture MuGard in the Peoples Republic of China and certain Southeast Asian countries. RHEI will also obtain the necessary regulatory approvals for MuGard in the territory.
On
January 4, 2008, we closed the acquisition of Somanta Pharmaceuticals, Inc. In
connection with the merger, Access issued an aggregate of approximately 1.5
million shares of Access Pharmaceuticals, Inc. common stock to the common and
preferred shareholders of Somanta as consideration. In addition, Access
exchanged all outstanding warrants of Somanta for warrants to purchase 191,991
shares of Access common stock at exercise prices ranging between $18.55 and
$69.57 per share.
F-22
Access
Pharmaceuticals, Inc. and Subsidiaries
Condensed
Consolidated Balance Sheets
|
ASSETS
|
September 30, 2008
(unaudited)
|
December 31,
2007
(audited)
|
|
|
Current
assets
Cash and cash
equivalents
Short
term investments, at cost
Receivables
Receivables due from Somanta
Pharmaceuticals
Prepaid
expenses and other current assets
|
$ 201,000
4,417,000
330,000
-
110,000
|
$ 159,000
6,762,000
35,000
931,000
410,000
|
|
|
Total
current assets
|
5,058,000
|
8,297,000
|
|
Property
and equipment, net
|
100,000
|
130,000
|
|
|
Patents,
net
|
584,000
|
710,000
|
|
|
Other
assets
|
12,000
|
12,000
|
|
|
Total
assets
|
$ 5,754,000
|
$ 9,149,000
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||
|
Current
liabilities
Accounts
payable and accrued expenses
Dividends
payable
Accrued
interest payable
Current
portion of deferred revenue
Current
portion of long-term debt
|
$ 2,571,000
1,799,000
445,000
164,000
-
|
$ 1,537,000
259,000
130,000
68,000
64,000
|
|
|
Total
current liabilities
|
4,979,000
|
2,058,000
|
|
|
Long-term
deferred revenue
Long-term
debt
|
2,286,000
5,500,000
|
910,000
5,500,000
|
|
|
Total
liabilities
|
12,765,000
|
8,468,000
|
|
|
Commitments
and contingencies
|
|||
|
Stockholders'
equity (deficit)
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
3,251.8617 issued at September
30, 2008; 3,227.3617 issued
at December 31,
2007
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
6,485,791 at September 30, 2008 and 3,585,458 at
December
31, 2007
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost – 163 shares
Accumulated
deficit
|
-
65,000
126,814,000
(1,045,000)
(4,000)
(132,841,000)
|
-
36,000
116,018,000
(1,045,000)
(4,000)
(114,324,000)
|
|
|
Total
stockholders' equity (deficit)
|
(7,011,000)
|
681,000
|
|
|
Total
liabilities and stockholders' equity (deficit)
|
$ 5,754,000
|
$ 9,149,000
|
The
accompanying notes are an integral part of these consolidated
statements.
F-23
Access
Pharmaceuticals, Inc. and Subsidiaries
Condensed
Consolidated Statements of Operations
(unaudited)
|
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
|||||||||||||||
|
2008
|
2007
|
2008
|
2007
|
|||||||||||||
|
Revenues
|
||||||||||||||||
|
License
revenues
|
$ | 38,000 | $ | 6,000 | $ | 77,000 | $ | 6,000 | ||||||||
|
Sponsored research and
development
|
9,000 | - | 140,000 | - | ||||||||||||
|
Total revenues
|
47,000 | 6,000 | 217,000 | 6,000 | ||||||||||||
|
Expenses
|
||||||||||||||||
|
Research and
development
|
1,284,000 | 596,000 | 12,108,000 | 1,532,000 | ||||||||||||
|
General and
administrative
|
1,439,000 | 1,000,000 | 3,372,000 | 3,252,000 | ||||||||||||
|
Depreciation and
amortization
|
66,000 | 61,000 | 197,000 | 210,000 | ||||||||||||
|
Total expenses
|
2,789,000 | 1,657,000 | 15,677,000 | 4,994,000 | ||||||||||||
|
Loss
from operations
|
(2,742,000 | ) | (1,651,000 | ) | (15,460,000 | ) | (4,988,000 | ) | ||||||||
|
Interest
and miscellaneous income
|
62,000 | 12,000 | 167,000 | 72,000 | ||||||||||||
|
Interest
and other expense
|
(126,000 | ) | (318,000 | ) | (351,000 | ) | (3,277,000 | ) | ||||||||
| (64,000 | ) | (306,000 | ) | (184,000 | ) | (3,205,000 | ) | |||||||||
|
Net
loss
|
(2,806,000 | ) | (1,957,000 | ) | (15,644,000 | ) | (8,193,000 | ) | ||||||||
|
Less
preferred stock dividends
|
523,000 | - | 2,873,000 | - | ||||||||||||
|
Net
loss allocable to common stockholders
|
$ | (3,329,000 | ) | $ | (1,957,000 | ) | $ | (18,517,000 | ) | $ | (8,193,000 | ) | ||||
|
Basic
and diluted loss per common share
Net
loss allocable to common shareholders
|
$ | (0.57 | ) | $ | (0.55 | ) | $ | (3.30 | ) | $ | (2.31 | ) | ||||
|
Weighted
average basic and diluted
common shares
outstanding
|
5,803,457 | 3,575,114 | 5,607,247 | 3,544,181 | ||||||||||||
The
accompanying notes are an integral part of these consolidated
statements.
F-24
Access
Pharmaceuticals, Inc. and Subsidiaries
Condensed Consolidated Statements of
Cash Flows
(unaudited)
|
Nine
Months ended September 30,
|
||||||||
|
2008
|
2007
|
|||||||
|
Cash
flows from operating activities:
|
||||||||
|
Net
loss
|
$ | (15,644,000 | ) | $ | (8,193,000 | ) | ||
|
Adjustments to
reconcile net loss to cash used
in
operating activities:
|
||||||||
|
Depreciation and
amortization
|
197,000 | 210,000 | ||||||
|
Stock option
expense
|
244,000 | 810,000 | ||||||
|
Stock issued for
services
|
307,000 | 44,000 | ||||||
|
Acquired in-process research
and development
|
8,879,000 | - | ||||||
|
Amortization of debt costs and
discounts
|
- | 2,316,000 | ||||||
|
Loss on sale of
asset
|
- | 2,000 | ||||||
|
Changes in operating assets and
liabilities:
|
||||||||
|
Receivables
|
(295,000 | ) | (502,000 | ) | ||||
|
Prepaid
expenses and other current assets
|
(85,000 | ) | (247,000 | ) | ||||
|
Other assets
|
- | 1,000 | ||||||
|
Accounts payable and accrued
expenses
|
30,000 | 369,000 | ||||||
|
Dividends
payable
|
(25,000 | ) | - | |||||
|
Accrued interest
payable
|
315,000 | 953,000 | ||||||
|
Deferred
revenue
|
1,472,000 | 994,000 | ||||||
|
Net cash used in operating
activities
|
(4,605,000 | ) | (3,243,000 | ) | ||||
|
Cash
flows from investing activities:
|
||||||||
|
Capital
expenditures
|
(28,000 | ) | (18,000 | ) | ||||
|
Somanta acquisition, net
of cash acquired
|
(65,000 | ) | - | |||||
|
Proceeds from sale of
asset
|
- | 13,000 | ||||||
|
Redemptions of short term
investments and
certificates of
deposit
|
2,345,000 | 2,680,000 | ||||||
|
Net cash provided by investing
activities
|
2,252,000 | 2,675,000 | ||||||
|
Cash
flows from financing activities:
|
||||||||
|
Payments
of notes payable
|
(64,000 | ) | - | |||||
|
Proceeds
from preferred stock issuances, net of costs
|
2,444,000 | - | ||||||
|
Proceeds
from exercise of common stock options
|
15,000 | 35,000 | ||||||
|
Net cash provided by financing
activities
|
2,395,000 | 35,000 | ||||||
|
Net
increase (decrease) in cash and cash equivalents
|
42,000 | (533,000 | ) | |||||
|
Cash
and cash equivalents at beginning of period
|
159,000 | 1,194,000 | ||||||
|
Cash
and cash equivalents at end of period
|
$ | 201,000 | $ | 661,000 | ||||
|
Supplemental
cash flow information:
|
||||||||
|
Cash
paid for interest
|
$ | 9,000 | $ | 5,000 | ||||
|
Supplemental
disclosure of noncash transactions:
|
||||||||
|
Shares issued for
payables
|
1,576,000 | - | ||||||
|
Preferred
stock dividends in dividends payable
|
1,799,000 | - | ||||||
|
Accrued
interest capitalized
|
- | 511,000 | ||||||
|
Beneficial
conversion feature –
February
2008 preferred stock dividends
November
2007 preferred stock dividends correction
|
857,000 451,000 | - - | ||||||
|
Preferred
stock issuance costs paid in cash
|
281,000 | - | ||||||
The
accompanying notes are an integral part of these consolidated
statements.
F-25
Access
Pharmaceuticals, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
Nine
Months Ended September 30, 2008 and 2007
(unaudited)
(1) Interim
Financial Statements
The
consolidated balance sheet as of September 30, 2008, and the consolidated
statements of operations and cash flows for the three and nine months ended
September 30, 2008, and 2007, were prepared by management without audit. In the
opinion of management, all adjustments, consisting only of normal recurring
adjustments, except as otherwise disclosed, necessary for the fair presentation
of the financial position, results of operations, and changes in financial
position for such periods, have been made.
Certain
information and footnote disclosures normally included in financial statements
prepared in accordance with accounting principles generally accepted in the
United States of America have been condensed or omitted. It is suggested that
these interim financial statements be read in conjunction with the consolidated
financial statements and notes thereto included in our Annual Report on Form
10-K for the year ended December 31, 2007. The results of operations for the
period ended September 30, 2008, are not necessarily indicative of the operating
results which may be expected for a full year. The consolidated balance sheet as
of December 31, 2007, contains financial information taken from the audited
financial statements as of that date.
The
report of our independent registered public accounting firm for the fiscal year
ended December 31, 2007, contained a fourth explanatory paragraph to reflect its
significant doubt about our ability to continue as a going concern as a result
of our history of losses and our liquidity position, as discussed herein and in
this Form 10-Q. We expect that our capital resources and expected receipts due
under our license agreements will be adequate to fund our current level of
operations into the fourth quarter of 2009. If we are unable to obtain adequate
capital funding in the future or enter into future license agreements for our
products, we may not be able to continue as a going concern, which would have an
adverse effect on our business and operations, and investors’ investment in us
may decline.
(2) Intangible Assets
Intangible
assets consist of the following (in thousands):
|
September
30, 2008
|
December
31, 2007
|
|||
|
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
Amortization
|
|
|
Amortizable
intangible assets
Patents
|
$ 1,680
|
$ 1,096
|
$ 1,680
|
$ 970
|
Amortization
expense related to intangible assets totaled $42,000 and $126,000 for each of
the three and nine months ended September 30, 2008, respectively, and totaled
$42,000 and $151,000 for each of the three and nine months ended September 30,
2007, respectively. The aggregate estimated amortization expense for intangible
assets remaining as of September 30, 2008, is as follows (in
thousands):
|
2008
|
$ 42
|
||
| 2009 |
168
|
||
| 2010 |
168
|
||
| 2011 |
168
|
||
| 2012 |
38
|
||
| Total |
$ 584
|
F-26
(3) Liquidity
The
Company incurred significant losses from losses allocable to common stockholders
of $18,517,000 for the nine months ended September 30, 2008, $36,652,000
for the year ended December 31, 2007, and $12,874,000 for the year ended
December 31, 2006. At September 30, 2008, our working capital was $79,000. We
expect that our capital resources and expected receipts due under our license
agreements will be adequate to fund our current level of operations into the
fourth quarter of 2009. However, our ability to fund operations over this time
could change significantly depending upon changes to future operational funding
obligations or capital expenditures. As a result we may be required to seek
additional financing sources and enter into future licensing agreements with our
products within the next twelve months.
(4) Somanta
Acquisition
On
January 4, 2008, we acquired all the outstanding shares of Somanta
Pharmaceuticals, Inc (“Somanta”). Somanta was engaged in the pharmaceutical
development business. We anticipate that the acquisition will add additional
product pipelines and complement our existing product pipelines. Total
consideration paid in connection with the acquisition included:
|
·
|
Approximately
1.5 million shares of Access common stock were issued to the common and
preferred shareholders of Somanta as consideration having a value of
approximately $4,650,000 (the value was calculated using Access’ stock
price on January 4, 2008, times the number of shares
issued);
|
|
·
|
exchange
of all outstanding warrants for Somanta common stock for warrants to
purchase 191,991 shares of Access common stock at exercise prices ranging
between $18.55 and $69.57 per share. The warrants were valued at
approximately $281,000. All of the warrants are exercisable immediately
and expire approximately four years from date of issue. The weighted
average fair value of the warrants was $1.46 per share on the date of the
grant using the Black-Scholes pricing model with the following
assumptions: expected dividend yield 0.0%, risk-free interest rate 3.26%,
expected volatility 114% and an expected term of approximately 4
years;
|
|
·
|
paid
an aggregate of $475,000 in direct transaction costs;
and
|
|
·
|
cancelled
receivable from Somanta of
$931,000.
|
The
following table summarizes the initial fair values of the assets acquired and
liabilities assumed at the date of the acquisition (in thousands) based on a
preliminary valuation. Subsequent adjustments may be recorded upon the
completion of the valuation and the final determination of the purchase price
allocation.
| Cash | $ | 1 | ||
| Prepaid expenses | 25 | |||
| Office equipment | 14 | |||
| Accounts payable | (2,582 | ) | ||
| In-process research & development | 8,879 | |||
| $ | 6,337 |
Approximately
$8,879,000 of the purchase price represents the estimated fair value of the
acquired in-process research and development projects that have no alternative
future use. Accordingly this amount was immediately expensed as
research and development in the consolidated statement of operations upon the
acquisition date.
Operating
results of Somanta have been included in our consolidated financial statements
since January 4, 2008.
The
following unaudited pro forma information presents the 2008 and 2007 results of
the Company as if the acquisition had occurred on January 1, 2007. The unaudited
pro forma results are not necessarily indicative of results that would have
occurred had the acquisition been in effect for the periods presented, nor are
they necessarily indicative of future results. Net loss for Somanta for the 2007
period is for the three and nine months ended October 31, 2007, based on its
fiscal year. Amounts are shown in thousands.
|
Three
months ended
September 30,
|
Nine
months ended
September 30,
|
|||||||||||||||
|
2008
|
2007
|
2008
|
2007
|
|||||||||||||
|
Net
loss
|
$ | (3,329 | ) | $ | (2,454 | ) | $ | (18,517 | ) | $ | (14,627 | ) | ||||
|
Net
loss per common shares (basic and diluted)
|
$ | (0.57 | ) | $ | (0.48 | ) | $ | (3.30 | ) | $ | (2.90 | ) | ||||
|
Weighted
average common shares outstanding
(basic
and diluted)
|
5,803 | 5,075 | 5,607 | 5,044 | ||||||||||||
F-27
(5) Equity
On
February 4, 2008, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 272.50 shares
of our preferred stock, designated “Series A Cumulative Convertible Preferred
Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the
“Series A Preferred Stock”) and agreed to issue warrants to purchase 454,167
shares of our common stock at an exercise price of $3.50 per share, for an
aggregate purchase price for the Series A Preferred Stock and Warrants of
$2,725,000. Proceeds, net of cash issuance costs from the sale were $2,444,000.
The shares of Series A Preferred Stock are convertible into common stock at the
initial conversion price of $3.00 per share.
In
connection with the preferred stock offering, we issued warrants for placement
agent fees to purchase a total of 45,417 shares of common stock. All of the
warrants are exercisable immediately and expire six years from the date of
issue. The fair value of the warrants was $2.29 per share on the date of grant
using the Black-Scholes pricing model with the following assumptions: expected
dividend yield 0.0%, risk-free interest rate 2.75%, expected volatility 110% and
an expected term of 6 years.
The
shares of Series A Preferred Stock are initially convertible into common stock
at $3.00 per share. Based on the price of our common stock on February 4, 2008,
a new conversion price was calculated for accounting purposes. As a result of
the change in conversion price for accounting purposes the preferred stock and
was considered to be “in the money”. This resulted in a beneficial conversion
feature. The preferred stockholder has the right at any time to convert all or
any lesser portion of the Series A Preferred Stock into common stock. This
resulted in an intrinsic value of the preferred stock. The difference between
the implied value of the preferred stock and the beneficial conversion option
was treated as preferred stock dividends of $857,000.
An
additional $451,000 in preferred stock dividends was recorded in the first
quarter of 2008 as a result of a prior year correction. The change was due to
preferred stock dividends and the beneficial conversion features associated with
the warrants issued in connection with the November 2007 preferred stock
agreement. The Company determined that the adjustment would have an immaterial
effect to the Company’s consolidated financial statements for the year ended
December 31, 2007, and the nine month period ended September 30, 2008, based on
management’s qualitative and quantitative analysis relative to its materiality
consistent with the applicable accounting guidance.
Pursuant
to the terms of an Investor Rights Agreement with the Purchasers of Series A
Preferred Stock, the Company is required to maintain an effective registration
statement as more fully described in Item 1A to this Form 10-Q. As of September
30, 2008, the Securities and Exchange Commission had not yet declared the
registration statement effective, and as a result, the Company accrued $415,000
in liquidated damages as of September 30, 2008. A registration statement filed
by Access relating to a portion of such securities was declared effective on
November 13, 2008.
During
the first quarter of 2008, $1,576,000 of Somanta Pharmaceuticals’ acquired
accounts payable were settled by issuing 538,508 shares of Access common stock
and warrants to purchase 246,753 shares of Access common stock at an exercise
price of $3.50 per share. The value of the shares and warrants issued was
determined based on the fair value of the accounts payable.
Preferred
stock dividends of $1,565,000 were accrued for the first nine months of 2008.
Dividends are required to be paid semi-annually in either cash or common
stock.
(6) Stock
Based Compensation
For the
three and nine months ended September 30, 2008, we recognized stock-based
compensation expense of $104,000 and $244,000, respectively, and $207,000 and
$810,000 for the three and nine months ended September 30, 2007,
respectively.
We
granted no stock options during the third quarter of 2008. For the second
quarter of 2008, we granted 305,000 stock options at a weighted average grant
price of $2.73 under the terms of our 2005 Equity Incentive Plan. We granted no
stock options during the first quarter of 2008.
F-28
The
following table summarizes stock-based compensation for the three and nine
months ended September 30, 2008, and 2007:
|
Three months
ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
|
2008
|
2007
|
2008
|
2007
|
|||||||||||||
|
Research
and development
|
$ | 39,000 | $ | 190,000 | $ | 78,000 | $ | 761,000 | ||||||||
|
General
and administrative
|
65,000 | 17,000 | 166,000 | 49,000 | ||||||||||||
|
Stock-based
compensation expense
|
104,000
|
|
207,000
|
244,000 | 810,000 | |||||||||||
|
included
in operating expense
|
||||||||||||||||
Our
weighted average Black-Scholes fair value assumptions used to value the 2008 and
2007 first nine months grants are as follows:
|
9/30/08
|
||||
|
Expected
life
|
6.2
|
yrs | ||
|
Risk
free interest rate
|
3.0
|
%
|
||
| Expected volatility(a) |
133
|
%
|
||
|
Expected
dividend yield
|
0.0
|
%
|
||
|
(a)
|
Reflects
movements in our stock price over the most recent historical period
equivalent to the expected life.
|
(7) Definitive
Merger Agreement and Loan
On July
10, 2008, we announced the signing of a definitive merger agreement to acquire
MacroChem Corporation. Pursuant to the terms of the merger agreement,
MacroChem’s common shareholders and warrant holders will receive an aggregate of
2.5 million shares of Access common stock which would represent approximately 8%
of the combined company. The closing of the transaction is subject to numerous
conditions. There can be no assurance that the transaction will be consummated
or if consummated that it will be on the terms described above.
On August
27, 2008, we entered into a Note Purchase Agreement with MacroChem Corporation
in order for Access to loan MacroChem amounts to keep certain of their licenses
and vendors current. As of September 30, 2008, we loaned MacroChem
$225,000.
F-29
INDEX
TO SOMANTA FINANCIAL STATEMENTS
SOMANTA
PHARMACEUTICALS, INC. AND SUBSIDIARIES
|
PAGE
|
|
|
Report
of Independent Registered Public Accounting Firm
|
F-31
|
|
Consolidated
Balance Sheet as of April 30, 2007
|
F-32
|
|
Consolidated
Statements of Operations for the years ended April 30, 2007 and 2006 and
for the period from inception of operations (April 19, 2001) to April 30,
2007
|
F-33
|
|
Consolidated
Statements of Stockholders’ Deficit for the period from inception of
operations (April 19, 2001) to April 30, 2007
|
F-34
|
|
Consolidated
Statements of Cash Flows for the years ended April 30, 2007 and 2006 and
for the period from inception of operations (April 19, 2001) to April 30,
2007
|
F-36
|
|
Notes
to Consolidated Financial Statements as of April 30, 2007
|
F-37
|
|
Condensed
Consolidated Balance Sheets at October 31, 2007
(unaudited)
|
F-57
|
|
Condensed
Consolidated Statements of Operations for the Three and Six Months Ended
October 31, 2007 and 2006 and for the Period from Inception of Operations
(April 19, 2001) to October 31, 2007 (unaudited)
|
F-58
|
|
Condensed
Consolidated Statement of Stockholders’ Deficit for the Period from
Inception of Operations (April 19, 2001) to October 31, 2007
(unaudited)
|
F-60
|
|
Condensed
Consolidated Statements of Cash Flows for the Six Months Ended October 31,
2007 and 2006 and for the Period from Inception of Operations (April 19,
2001) to October 31, 2007 (unaudited)
|
F-66
|
|
Notes
to Condensed Consolidated Financial Statements as of October 31,
2007
|
F-68
|
F-30
Report
of Independent Registered Public Accounting Firm
To the
Board of Directors of Somanta Pharmaceuticals, Inc.
Irvine,
California
We have
audited the accompanying consolidated balance sheet of Somanta Pharmaceuticals,
Inc., formerly Hibshman Optical Corp. (a development stage company) as of April
30, 2007, and the related consolidated statements of operations and consolidated
stockholders’ deficit and consolidated cash flows for the years ended April 30,
2007 and 2006, and for the period from inception of operations (April 19, 2001)
to April 30, 2007. These consolidated financial statements are the
responsibility of the Company’s management. Our responsibility is to express an
opinion on these consolidated financial statements based on our
audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement. The Company is not
required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audits included consideration of internal
control over financial reporting as a basis for designing audit procedures that
are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly, we express no such opinion. An audit includes examining,
on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles
used and significant estimates made by management, as well as evaluating the
overall financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Somanta Pharmaceuticals,
Inc. as of April 30, 2007, and the results of its operations and its cash flows
for the years ended April 30, 2007 and 2006, and for the period from inception
of operations (April 19, 2001) to April 30, 2007, in conformity with accounting
principles generally accepted in the United States of America.
The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 1 to the
consolidated financial statements, the Company’s operating losses, negative
working capital and stockholders’ deficit raise substantial doubt about its
ability to continue as a going concern. Management’s plans regarding those
matters also are described in Note 1. The consolidated financial statements do
not include any adjustments that might result from the outcome of this
uncertainty.
As
discussed in Note 2 to the consolidated financial statements, in 2006 the
Company adopted Statement of Financial Accounting Standards No. 123 (Revised
2004), Share-Based Payments.
|
/s/ STONEFIELD
JOSEPHSON, INC.
|
|
|
Irvine,
California
|
|
|
June
27, 2007
|
F-31
Somanta Pharmaceuticals,
Inc.
(Formerly Hibshman Optical
Corp.)
(A Development Stage
Company)
Consolidated Balance
Sheet
April 30,
2007
|
Assets
|
||||
|
Current
assets:
|
||||
|
Cash
|
$
|
5,385
|
||
|
Prepaid
expenses
|
43,308
|
|||
|
Total
current assets
|
48,693
|
|||
|
Office
equipment,
net of accumulated depreciation of $6,750
|
16,560
|
|||
|
Other
assets:
|
||||
|
Restricted
funds
|
2,000
|
|||
|
Deposits
|
73
|
|||
|
Total
other assets
|
2,073
|
|||
|
Total
assets
|
$
|
67,326
|
||
|
Liabilities and Stockholders’
Deficit
|
||||
|
Current
liabilities:
|
||||
|
Accounts
payable
|
$
|
774,022
|
||
|
Due
to related parties
|
241,874
|
|||
|
Accrued
expenses
|
811,539
|
|||
|
Accrued
research and development expenses
|
554,733
|
|||
|
Note
payable
|
33,462
|
|||
|
Liquidated
damages related to Series A preferred stock and warrants
|
35,200
|
|||
|
Deferred
revenue
|
7,143
|
|||
|
Warrant
liabilities
|
5,786,844
|
|||
|
Total
current liabilities
|
8,244,817
|
|||
|
Stockholders’
deficit:
|
||||
|
Preferred
stock,$0.001 par value, 20,000,000 shares authorized Series A Convertible
Preferred Stock, $0.001 par value, 2,000 shares designated, 591.6318
shares issued and outstanding
|
1
|
|||
|
Common
Stock, $0.001 par value, 100,000,000 shares authorized, 14,292,603 shares
issued and outstanding
|
14,293
|
|||
|
Additional
paid-in capital
|
7,604,360
|
|||
|
Deficit
accumulated during the development stage
|
(15,796,145
|
)
|
||
|
Total
stockholders’ deficit
|
(8,177,491
|
)
|
||
|
Total liabilities and
stockholders’ deficit
|
$
|
67,326
|
||
The accompanying notes are an integral part of these consolidated
financial statements.
F-32
Somanta Pharmaceuticals, Inc.
(Formerly Hibshman Optical Corp.)
(A Development Stage Company)
Consolidated Statements of
Operations
Years ended April 30, 2007 and
2006 and for the Period from Inception of Operations
(April 19, 2001) to April 30,
2007
|
From
Inception
of Operations(April 19,
2001)
to
April 30, 2007
|
||||||||||
|
Year ended April
30,
|
||||||||||
|
2007
|
2006
|
|||||||||
|
Revenue
|
$
1,429
|
$
1,428
|
$
2,857
|
|||||||
|
Operating
expenses:
|
||||||||||
|
General and
administrative
|
(3,312,660
|
) |
(2,845,634
|
) |
(7,337,118
|
) | ||||
|
Research and
development
|
(1,239,146
|
)
|
(1,264,225
|
)
|
(3,100,647
|
)
|
||||
|
Loss from
operations
|
(4,550,377
|
)
|
(4,108,431
|
)
|
(10,434,908
|
)
|
||||
|
Other income
(expense):
|
||||||||||
|
Interest
income
|
28,084
|
12,348
|
40,432
|
|||||||
|
Interest
expense
|
(54
|
)
|
(1,016,020
|
)
|
(1,016,074
|
)
|
||||
|
Liquidated
damages
|
(35,200
|
)
|
—
|
(35,200
|
)
|
|||||
|
Change in fair value of warrant
liabilities
|
(2,931,118
|
)
|
137,543
|
(2,793,575
|
)
|
|||||
|
Gain on settlement of
debt
|
—
|
5,049
|
5,049
|
|||||||
|
Currency translation
loss
|
(3,255
|
)
|
(30,241
|
)
|
(33,496
|
)
|
||||
|
Loss before income
taxes
|
(7,491,920
|
)
|
(4,999,752
|
)
|
(14,267,772
|
)
|
||||
|
Income
taxes
|
(3,717
|
)
|
(2,339
|
)
|
(6,056
|
)
|
||||
|
Net loss
|
(7,495,637
|
)
|
(5,002,091
|
)
|
(14,273,828
|
)
|
||||
|
Deemed dividends on convertible
preferred stock
|
—
|
(1,522,317
|
)
|
(1,522,317
|
)
|
|||||
|
Net loss applicable to common
shareholders
|
$
|
(7,495,637
|
)
|
$
|
(6,524,408
|
)
|
$
|
(15,796,145
|
)
|
|
|
Net loss per share—basic and
diluted
|
$
|
(0.56
|
)
|
$
|
(0.47
|
)
|
$
|
(1.24
|
)
|
|
|
Weighted average number of
shares outstanding—basic and diluted
|
14,278,247
|
14,274,365
|
13,247,052
|
|||||||
The
accompanying notes are an integral part of these consolidated financial
statements.
F-33
Somanta Pharmaceuticals, Inc.
(Formerly Hibshman Optical Corp.)
(A Development Stage Company)
Consolidated Statement of
Stockholders’ Deficit—(Continued)
For the Period from Inception of
Operations (April 19, 2001) to April 30, 2006
|
|
|
Peferred Stock
|
Common Stock
|
Additional
Paid-in
|
Shares
to be
|
Subscription
|
Deferred
Equity-
Based
|
Accumulated
Other
Comprehensive
Loss-foreign
Currency
|
Deficit
Accumulated
During
Development
|
Total
Stockholders'
Equity/
|
||||||||||||||||||||||||
|
Shares
|
Amount |
Shares
|
Amount |
Capital
|
Issued
|
Receivable
|
Expense
|
Translation
|
Stage
|
(Deficit)
|
||||||||||||||||||||||||
|
Balance
at April 19, 2001(Inception)
|
|
-
|
$
-
|
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
||||||||||||||||||||||
|
Shares
issued for cash at $.0326
|
4,299,860
|
4,300
|
135,680
|
|
(97,245)
|
|
|
|
42,735
|
|||||||||||||||||||||||||
|
Shares
issued for services at $.0139
|
514,674
|
515
|
11,801
|
|
|
(11,177)
|
|
|
1,139
|
|||||||||||||||||||||||||
|
Amortization
of deferred expense
|
521
|
|
|
521
|
||||||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
29,905
|
|
29,905
|
|||||||||||||||||||||||||||||||
|
Net
loss for the period from inception to April 30, 2002
|
(95,901)
|
(95,901)
|
||||||||||||||||||||||||||||||||
|
Balance
at April 30, 2002
|
—
|
—
|
4,814,534
|
4,815
|
147,481
|
—
|
(97,245)
|
(10,656)
|
29,905
|
(95,901)
|
(21,601)
|
|||||||||||||||||||||||
|
Shares
issued for cash at $1.0677
|
14,601
|
15
|
15,575
|
|
|
|
|
|
15,590
|
|||||||||||||||||||||||||
|
Shares
issued for services at $.0214
|
219,010
|
219
|
4,472
|
|
|
(3,127)
|
|
|
1,564
|
|||||||||||||||||||||||||
|
Amortization
of deferred expense
|
3,808
|
|
|
3,808
|
||||||||||||||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
91,517
|
|
|
|
91,517
|
|||||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
1,534
|
|
1,534
|
|||||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2003
|
(111,456)
|
(111,456)
|
||||||||||||||||||||||||||||||||
|
Balance
at April 30, 2003
|
—
|
—
|
5,048,145
|
5,049
|
167,528
|
—
|
(5,728)
|
(9,975)
|
31,439
|
(207,357)
|
(19,044)
|
|||||||||||||||||||||||
|
Shares
issued for cash at $1.2479
|
350,164
|
350
|
436,637
|
|
(81,464)
|
|
|
|
355,523
|
|||||||||||||||||||||||||
|
Shares
issued for services at $1.2587
|
22,233
|
22
|
27,962
|
|
|
(25,216
|
)
|
|
|
2,768
|
||||||||||||||||||||||||
|
Amortization
of deferred expense
|
7,691
|
|
|
7,691
|
||||||||||||||||||||||||||||||
|
Exchange
for loan payment and compensation
|
181,371
|
|
2,909
|
|
|
|
184,280
|
|||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
(51,651
|
)
|
|
(51,651
|
)
|
|||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2004
|
(439,453
|
)
|
(439,453
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2004
|
—
|
—
|
5,420,542
|
5,421
|
813,498
|
—
|
(84,283
|
)
|
(27,500
|
)
|
(20,212
|
)
|
(646,810
|
)
|
40,114
|
|||||||||||||||||||
|
Shares
issued for cash at $1.3218
|
374,073
|
374
|
494,069
|
|
|
|
|
|
494,443
|
|||||||||||||||||||||||||
|
Shares
issued for services at $1.2308
|
21,901
|
22
|
26,933
|
|
|
|
|
|
26,955
|
|||||||||||||||||||||||||
|
3,650
shares to be issued for service at $1.4973
|
5,465
|
|
|
|
|
5,465
|
||||||||||||||||||||||||||||
|
Amortization
of deferred expense
|
26,939
|
|
|
26,939
|
||||||||||||||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
84,283
|
|
|
|
84,283
|
|||||||||||||||||||||||||||||
|
Options
issued for services
|
257,515
|
|
|
|
|
|
257,515
|
|||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
(5,719
|
)
|
|
(5,719
|
)
|
|||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2005
|
(1,129,290
|
)
|
(1,129,290
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2005
|
—
|
—
|
5,816,516
|
5,817
|
1,592,015
|
5,465
|
—
|
(561
|
)
|
(25,931
|
)
|
(1,776,100
|
)
|
(199,295
|
)
|
|||||||||||||||||||
The
accompanying notes are an integral part of these consolidated financial
statements.
F-34
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated Statement of
Stockholders’ Deficit—(Continued)
For the Period from Inception of
Operations (April 19, 2001) to April 30, 2007
|
|
|
Preferred
|
Stock
|
Common
|
Stock
|
Additional
Paid-in
|
Shares
to
be
|
Subscription
|
Deferred
Equity
Based-
|
Accumulated
other
Comprehensive
Loss-Foreign
Currency
Translation
|
|
Deficit
Accumulated
During
Development
|
|
Total
Stockholders'
Equity
|
||||||||||||||||||||
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Issued
|
|
Receivable
|
|
Expense
|
|
Adjustments
|
Stage
|
(Deficit)
|
||||||||||||||
|
Write
off foreign currency translation adjustment
|
25,931
|
25,931
|
||||||||||||||||||||||||||||||||
|
Shares
issued for cash at $1.5656
|
12,669
|
13
|
19,821
|
19,834
|
||||||||||||||||||||||||||||||
|
Shares
issued for prior service
|
3,650
|
3
|
5,462
|
(5,465
|
) |
—
|
||||||||||||||||||||||||||||
|
Amortization
of deferred expense
|
561
|
561
|
||||||||||||||||||||||||||||||||
|
Options
issued for services
|
300,616
|
300,616
|
||||||||||||||||||||||||||||||||
|
Recapitalization
with Bridge Oncology
|
7,865,000
|
7,865
|
(92,335
|
) |
(84,470
|
) | ||||||||||||||||||||||||||||
|
Beneficial
conversion feature associated with convertible debt
financing
|
364,721
|
364,721
|
||||||||||||||||||||||||||||||||
|
Convertible
Series A Preferred Stock issued for cash at $10,000 (net of issuance costs
of $544,169)
|
464.0000
|
0.464
|
4,095,830
|
4,095,830
|
||||||||||||||||||||||||||||||
|
Convertible
Series A Stock issued on conversion of notes payable
|
128.6318
|
0.1286
|
1,286,318
|
1,286,318
|
||||||||||||||||||||||||||||||
|
Deemed
dividend on account of beneficial conversion feature associated with
issuance of Convertible Series A Preferred Stock
|
1,522,317
|
(1,522,317
|
)
|
—
|
||||||||||||||||||||||||||||||
|
Issuance
costs on warrants issued to placement agent in connection with the
Convertible Series A Preferred Stock
|
(429,757
|
)
|
(429,757
|
)
|
||||||||||||||||||||||||||||||
|
Discount
on warrant issued with Convertible Series A Preferred
Stock
|
(2,048,531
|
)
|
(2,048,531
|
)
|
||||||||||||||||||||||||||||||
|
Recapitalization
with Hibshman Optical Corp.
|
576,700
|
577
|
(7,708
|
)
|
(7,131
|
)
|
||||||||||||||||||||||||||||
|
Warrant
expense
|
92,689
|
92,689
|
||||||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2006
|
(5,002,091
|
)
|
(5,002,091
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2006
|
592.6318
|
$
|
0.5926
|
14,274,534
|
$
|
14,275
|
$
|
6,701,458
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(8,300,508
|
)
|
$
|
(1,584,775
|
)
|
||||||||||||
|
Options
issued for services
|
739,000
|
739,000
|
||||||||||||||||||||||||||||||||
|
Warrant
expense
|
163,920
|
163,920
|
||||||||||||||||||||||||||||||||
|
Conversion
of preferred stock
|
(1.000
|
)
|
(.0010
|
)
|
18,069
|
18
|
(18
|
)
|
—
|
|||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2007
|
(7,495,637
|
)
|
(7,495,637
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2007
|
591.6318
|
$
|
0.5916
|
14,292,603
|
$
|
14,293
|
$
|
7,604,360
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(15,796,145
|
)
|
$
|
(8,177,492
|
)
|
||||||||||||
F-35
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated Statements of Cash
Flows
Years ended April 30, 2007 and 2006
and for the Period from Inception of Operations
(April 19, 2001) to April 30,
2007
|
Year ended April
30,
|
From
Inception
of
operations
(April 19, 2001)
to
|
|||||||||
|
2007
|
2006
|
April 30,
2007
|
||||||||
|
Cash flows provided by (used
for) operating activities:
|
||||||||||
|
Net
loss
|
$
|
(7,495,637
|
)
|
$
|
(5,002,091
|
)
|
$
|
(14,273,828
|
)
|
|
|
Adjustments to reconcile net
loss to net cash provided by (used for) operating
activities:
|
||||||||||
|
Depreciation
|
5,462
|
1,496
|
6,994
|
|||||||
|
Gain
on sale of equipment
|
(622
|
)
|
—
|
(622
|
)
|
|
Amortization
of stock based expense
|
—
|
561
|
39,520
|
|||||||
|
Write
off foreign currency translation adjustment
|
—
|
25,931
|
25,931
|
|||||||
|
Change
in fair value of warrant liabilities
|
2,931,118
|
(137,543
|
)
|
2,793,575
|
|
|||||
|
Shares
issued for services and compensation
|
—
|
—
|
219,262
|
|||||||
|
Gain
on settlement of debts
|
—
|
(5,049
|
)
|
(5,049
|
)
|
|||||
|
Options
expense
|
739,000
|
300,616
|
1,297,131
|
|||||||
|
Warrant
expense
|
163,920
|
92,689
|
256,609
|
|||||||
|
Interest
expense related to beneficial conversion feature on convertible
note
|
—
|
364,721
|
364,721
|
|||||||
|
Interest
expense related to warrants issued on convertible note
|
—
|
514,981
|
514,981
|
|||||||
|
Changes in assets and
liabilities:
|
||||||||||
|
(Increase) decrease in
assets—
|
||||||||||
|
VAT
receivable
|
1,628
|
61,952
|
3,444
|
|||||||
|
Restricted
funds
|
150,048
|
(152,048
|
)
|
(2,000
|
)
|
|||||
|
Prepaid
expenses
|
47,767
|
(82,166
|
)
|
(43,037
|
)
|
|||||
|
Deposits
|
2,627
|
(2,700
|
)
|
(73
|
)
|
|||||
|
Increase (decrease) in
liabilities:
|
||||||||||
|
Accounts
payable
|
516,222
|
199,086
|
776,723
|
|||||||
|
Accrued
liabilities
|
1,052,994
|
137,846
|
1,354,412
|
|||||||
|
Liquidated
damages
|
35,200
|
—
|
35,200
|
|||||||
|
Deferred
revenue
|
(1,429
|
)
|
8,572
|
7,143
|
||||||
|
Due
to officer and related party
|
233,874
|
(186,263
|
)
|
95,980
|
||||||
|
Net
cash used for operating activities
|
(1,617,828
|
)
|
(3,859,409
|
)
|
(6,532,983
|
)
|
||||
|
Cash flows used for investing
activities:
|
||||||||||
|
Purchase
of equipment
|
—
|
(21,391
|
)
|
(24,824
|
)
|
|||||
|
Sale
of equipment
|
2,000
|
—
|
2,000
|
|||||||
|
Net
cash used for investing activities
|
2,000
|
(21,391
|
)
|
(22,824
|
)
|
|||||
|
Cash flows provided by
financing activities:
|
||||||||||
|
Loan
payable—related party
|
—
|
—
|
79,402
|
|||||||
|
Loan
payment—related party
|
—
|
—
|
(7,367
|
)
|
||||||
|
Proceeds
from convertible note-related party
|
—
|
1,250,000
|
1,250,000
|
|||||||
|
Proceeds
from note payable - related party
|
33,462
|
—
|
33,462
|
|||||||
|
Proceeds
from issuance of common stock
|
—
|
19,834
|
928,125
|
|||||||
|
Proceeds
from issuance of preferred stock
|
—
|
4,095,831
|
4,095,831
|
|||||||
|
Cash
received for subscription receivable
|
—
|
—
|
175,801
|
|||||||
|
Net
cash provided by financing activities
|
33,462
|
5,365,665
|
6,555,254
|
|||||||
|
Effect of exchange rate changes
on cash
|
—
|
—
|
5,938
|
|||||||
|
Increase (decrease) in
cash
|
(1,582,366
|
)
|
1,484,865
|
5,385
|
||||||
|
Cash,
beginning of year
|
1,587,750
|
102,885
|
—
|
|||||||
|
Cash,
end of year
|
$
|
5,385
|
$
|
1,587,750
|
$
|
5,385
|
||||
|
Supplemental disclosure of cash
flow information:
|
||||||||||
|
Interest
paid
|
54
|
$
|
1,016,020
|
$
|
1,016,074
|
|||||
|
Income
tax paid
|
$
|
3,717
|
$
|
2,339
|
$
|
6,056
|
||||
|
Supplemental disclosure of
non-cash operating and financing activities:
|
||||||||||
|
Loan
reduction with shares
|
$
|
—
|
$
|
—
|
$
|
2,909
|
||||
|
Issuance
of warrants in conjunction with convertible preferred
stock
|
$
|
—
|
$
|
2,341,785
|
$
|
2,341,785
|
||||
|
Deemed
dividends related to convertible preferred stock
|
$
|
—
|
$
|
1,522,317
|
$
|
1,522,317
|
||||
|
Conversion
of note and accrued interest
|
$
|
—
|
$
|
1,286,318
|
$
|
1,286,318
|
The
accompanying notes are an integral part of these consolidated financial
statements.
F-36
Somanta Pharmaceuticals,
Inc.
(Formerly Hibshman Optical
Corp.)
(A Development Stage
Company)
Notes to Consolidated Financial
Statements
1. ORGANIZATION,
BASIS OF PRESENTATION AND NATURE OF OPERATIONS
Organization
Somanta
Pharmaceuticals, Inc. is a Delaware corporation that was formed for the purpose
of effecting the reincorporation of Hibshman Optical Corp., a New Jersey
corporation, into the State of Delaware and for the purpose of consummating a
business combination via a reverse merger of Somanta Incorporated and Hibshman
Optical Corp. Pursuant to this reverse merger, Somanta Incorporated became
the wholly-owned subsidiary of Somanta Pharmaceuticals, Inc. and the sole
operating subsidiary of Somanta Pharmaceuticals, Inc. For financial
reporting purposes, this transaction has been reflected in the accompanying
financial statements as a recapitalization of Somanta Incorporated and the
financial statements of Somanta Pharmaceuticals, Inc. reflect the historical
financial information of Somanta Incorporated. References herein to the
“Company” or “Somanta” are intended to refer to each of Somanta Pharmaceuticals,
Inc. and its wholly owned subsidiary Somanta Incorporated, as well as Somanta
Incorporated’s wholly-owned subsidiary Somanta Limited.
Hibshman
Optical Corp. was originally incorporated in the State of New Jersey in 1991
under the name PRS Sub I, Inc. The name was subsequently changed to Service
Lube, Inc., then to Fianza Commercial Corp. and then to Hibshman Optical
Corp. The business plan since that time had been to seek to enter into a
business combination with an entity that had ongoing operations through a
reverse merger or other similar type of transaction.
Somanta
Incorporated was incorporated as Somantis Limited under the laws of England and
Wales on April 19, 2001. Somantis Limited changed its name to Somanta
Limited on March 14, 2005, and performed business as a United Kingdom
entity through the fiscal year ending April 30, 2005. On
August 22, 2005, Somanta Limited became a wholly owned subsidiary of Bridge
Oncology Products, Inc. (“BOPI”), a privately held Delaware corporation,
pursuant to a share exchange with BOPI.; however, Somanta Limited was deemed the
accounting acquirer in this share exchange transaction. On August 24,
2005, the name of BOPI was changed to Somanta Incorporated.
Somanta
Pharmaceuticals, Inc. is a development stage biopharmaceutical company engaged
in the development of products for the treatment of cancer. The Company has
in-licensed five product development candidates from academic and research
institutions in the United States and Europe designed for use in anti-cancer
therapy in order to advance them along the regulatory and clinical pathways
toward commercial approval. The Company intends to obtain approval from the
United States Food and Drug Administration (“FDA”) and from the European
Medicines Evaluation Agency (“EMEA”) for the products.
Somanta
is a development stage enterprise since the Company has not generated revenue
from the sale of its products, and its efforts have been principally devoted to
identification, licensing and clinical development of its products as well as
raising capital through April 30, 2007. Accordingly, the financial
statements have been prepared in accordance with the provisions of Statement of
Financial Accounting Standards (SFAS) No. 7, “Accounting and Reporting by
Development Stage Enterprises.”
Basis of
Presentation
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and accompanying
notes. Actual results could differ from those estimates. In the
opinion of management, all adjustments (consisting solely of normal recurring
adjustments) considered necessary for a fair presentation
have been included.
Going Concern
The
Company reported a net loss and net loss applicable to common shareholders of
$7,495,637 for the year ended April 30, 2007. The net loss from date of
inception, April 19, 2001 to April 30, 2007, totaled $14,273,828 (net
loss applicable to common shareholders of $15,796,145). The Company’s operating
activities
have used cash since its inception. These losses raise substantial doubt about
the Company’s ability to continue as a going
concern.
On April
18, 2007, the Company, Somanta Incorporated, a wholly-owned subsidiary of the
Company and Somanta Limited, a wholly-owned subsidiary of Somanta Incorporated,
and Access Pharmaceuticals, Inc. (“Access”) and Somanta Acquisition Corporation
(“Merger Sub”), a wholly-owned subsidiary of Access and a Delaware corporation,
entered into an Agreement and Plan of Merger (the “Merger Agreement”). Pursuant
to the terms and subject to the conditions set forth in the Merger Agreement,
Merger Sub will merge with and into Somanta, with Somanta continuing as the
surviving corporation and becoming a wholly-owned subsidiary of Access (the
“Merger”). The Board of Directors of Somanta has approved the Merger and the
Merger Agreement.
F-37
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the “Effective Time”) will be converted into
500,000 shares of Access common stock. No fractional shares of Access common
stock will be issued as a result of the Merger. In addition, all of Somanta’s
preferred stock, included accrued and unpaid dividends, that is outstanding at
the Effective Time of the Merger will be converted into 1,000,000 shares of
Access’ common stock. No shares of Access preferred stock will be issued as a
result of the Merger.
On April
26, 2007, the Company entered into a Note Purchase Agreement, a Security
Agreement, a Patent Collateral Assignment and Security Agreement and a Trademark
Collateral Security and Pledge Agreement (collectively, the “Loan Documents”)
with Access Pharmaceuticals, Inc. as more fully described in Note 15. Under the
terms of the Loan Documents, Access initially loaned the Company $33,462.
Access, in its sole discretion, may from time to time advance additional loan
amounts to the Company. All amounts loaned to the Company by Access are secured
by substantially all of the assets of the Company pursuant to the terms of the
Loan Documents. The Note bears interest at 10% and is repayable at the earlier
of: (i) August 31, 2007, or (ii) the date of the termination of the Agreement
and Plan of Merger dated as of August 18, 2007 between the Company and
Access.
If the
merger fails to close, the Company expects that it will no longer be able to
operate its business and will not have the resources to repay the
loan.
The
financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the amounts
and classification of liabilities that may result from the possible inability of
the Company to continue as a going concern.
Reclassifications
For
comparative purposes, prior periods’ consolidated financial statements have been
reclassified to conform with report classifications of the current
period.
2. Significant Accounting
Policies
Cash and Cash
Equivalents
The
Company considers all highly liquid financial instruments with a maturity of
three months or less when purchased to be cash equivalents. At April 30,
2007, there were no cash equivalents.
Office Equipment
Office
equipment is recorded at cost, net of accumulated depreciation. Depreciation on
equipment is calculated using the straight-line method over the estimated useful
lives of the assets, five years. The Company recorded depreciation expense for
the years ended April 30, 2007 and 2006 of $5,462 and $1,496,
respectively.
Intangible Assets—Patents and
Licenses
All
patent and license costs are charged to expense when incurred.
Revenue
Recognition
The
Company recognizes revenue from licensing its proprietary technology in
accordance with SEC staff Accounting Bulletin No. 104 (“SAB 104”). SAB 104
requires revenue to be recognized when all of the following criteria are met:
persuasive evidence of an arrangement exists, delivery has occurred or services
have been rendered, the price is fixed or determined, and collection is
reasonably assured. Licensing fees, including upfront payments upon execution of
a new agreement, are recognized ratably over the license term of such
agreement.
Research and
Development
All
research and development costs consist of expenditures for royalty payments,
licensing fees, contracted research by third parties and the fees and expense of
consultants to manage the research and development efforts.
F-38
Stock Based
Compensation
On
December 16, 2004, the FASB issued SFAS No. 123 (revised 2004),
“Share-Based Payment” (SFAS 123R). SFAS 123R eliminates the alternative of
applying the intrinsic value measurement provisions of APB 25 to stock
compensation awards issued to employees. Rather, the new standard requires
enterprises to measure the cost of employee services received in exchange for an
award of equity instruments based on the grant-date fair value of the award.
That cost will be recognized over the period during which an employee is
required to provide services in exchange for the award, known as the requisite
service period (usually the vesting period). On April 14, 2005, the
Securities and Exchange Commission announced the adoption of a rule that defers
the required effective date of SFAS 123R. The SEC rule provides that SFAS 123R
is now effective for registrants as of the beginning of the first fiscal year
beginning after June 15, 2005.
Effective May 1,
2006, the Company adopted SFAS 123R and accordingly has adopted the
modified prospective application method. Under this method, SFAS 123R is applied
to new awards and to awards modified, repurchased, or cancelled after the
effective date. Additionally, compensation cost for the portion of awards that
are outstanding as of the date of adoption for which the requisite service has
not been rendered (such as unvested options) is recognized over a period of time
as the remaining requisite services are rendered. The amounts recorded as
expense in the years ended April 30, 2007 and 2006 was $739,000 and $300,615,
respectively. As of April 30, 2007, there were 3,483,163 options
outstanding.
Prior
to May 1, 2006, the Company accounted for its employee stock option
plan in accordance with the provisions of SFAS No. 123, “Accounting for Stock-Based
Compensation,” and
SFAS No. 148, “Accounting for Stock-Based
Compensation - Transition and Disclosure.”
Translation of Foreign Currency in
Financial Statements
From
inception through the fiscal year ended April 30, 2005, the functional
currency of the Company was the United Kingdom pound and its reporting currency
was United States dollar.
Assets
and liabilities of foreign operations where the functional currency is other
than the U.S. dollar are translated at fiscal year-end rates of exchange, and
the related revenue and expense amounts are translated at the weighted average
rates of exchange during the fiscal year. Translation adjustments arising from
differences in exchange rates from these transactions are reported as
accumulated other comprehensive loss—foreign currency translation adjustment in
the statement of stockholders’ deficit. The currency exchange rate as of
April 30, 2005 was $1.9122.
On
August 22, 2005, the Company, then known as Somanta Limited, took part in a
share exchange with Bridge Oncology Products, Inc., a Delaware company, and
became a subsidiary of Bridge Oncology Products, Inc. (Note 10). As a
result of this transaction, Somanta Limited became a wholly owned subsidiary of
a U.S. entity and accordingly changed its functional currency to the U.S. dollar
as of the fiscal year beginning May 1, 2005.
Use of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities at the date of the consolidated financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual
results could differ from those estimates.
Income Taxes
Deferred
taxes are provided for on a liability method for temporary differences between
the financial reporting and tax basis of assets and liabilities that will result
in taxable or deductible amounts in the future. Deferred tax assets are reduced
by a valuation allowance when, in the opinion of management, it is more likely
than not that some portion or all of the deferred tax assets will be
realized.
Income
taxes are calculated in accordance with the tax laws of the United States for
the years ended April 30, 2007 and April 30, 2006. Since the Company
had net losses for the years ended April 30, 2007 and 2006, provisions for
income taxes in the financial statements include only state minimum taxes for
the year ended April 30, 2007.
Segment Reporting
The
Company has adopted SFAS No. 131, “Disclosures about Segments of an
Enterprise and Related Information.” Since the Company operates in one business
segment dedicated to development of therapeutic candidates for the treatment of
cancers, segment disclosure has not been presented.
F-39
Fair Value of Financial
Instruments
Statement
of Financial Accounting Standard No. 107, Disclosures about Fair Value of
Financial Instruments, requires that the company disclose estimated fair values
of financial instruments. The carrying amounts reported in the balance sheets
for current assets and current liabilities qualifying as financial instruments
are a reasonable estimate of fair value.
Basic and diluted net loss per
share
Net loss
per share is calculated in accordance with the Statement of Financial Accounting
Standards No. 128 (SFAS No. 128), Basic net loss per share is based
upon the weighted average number of common shares outstanding. Diluted net loss
per share is based on the assumption that all potential dilutive convertible
shares and stock options or warrants were converted or exercised. The
calculation of diluted net loss per share excludes potential common stock
equivalents if the effect is anti-dilutive. The Company’s weighted common shares
outstanding for basic and dilutive were the same since the effect of common
stock equivalents was anti-dilutive.
The
Company has the following dilutive convertible shares, stock options and
warrants as of April 30, 2007 and 2006 which were excluded from the
calculation since the effect is anti-dilutive.
|
2007
|
2006
|
|
|
Convertible
preferred stock
|
9,859,125
|
9,877,194
|
|
Stock
options
|
3,483,163
|
3,825,249
|
|
Warrants
|
7,102,838
|
6,952,838
|
|
Total
|
20,445,126
|
20,655,281
|
The
Company’s undeclared dividend on it’s Preferred Stock amounting to $115,604 was
included in the computation of net loss per share in accordance with SFAS
No. 129 for the year ended April 30, 2006.
The
Company’s undeclared dividends on its Preferred Stock amounting to $474,104 for
the year ended April 30, 2007 was included in the computation of net loss per
share in accordance with SFAS No. 129.
Aggregate
undeclared dividends on Preferred Stock amounting to $589,708 are included in
the computation of net loss per share for the period from inception (April 19,
2001) to April 30, 2007.
Recent Accounting
Pronouncements
In
February 2006, the FASB issued SFAS 155 “Accounting for Certain Hybrid
Financial Instruments,” an
amendment of FASB Statements No. 133 and in February 2006, the FASB issued
SFAS 155, “Accounting for Certain Hybrid Financial Instruments,” an amendment of
FASB Statements No. 133 and 140. This Statement amends FASB Statements
No. 133, “Accounting for Derivative Instruments and Hedging Activities,”
and No. 140, “Accounting for Transfers and Servicing of Financial Assets
and Extinguishments of Liabilities”. This Statement resolves issues addressed in
Statement 133 Implementation Issue No. D1, Application of Statement 133 to
Beneficial Interests in Securitized Financial Assets. This
Statement:
|
a.
|
Permits
fair value remeasurement for any hybrid financial instrument that contains
an embedded derivative that otherwise would require
bifurcation;
|
|
|
b.
|
Clarifies
which interest-only strips and principal-only strips are not subject to
the requirements of Statement
133;
|
|
c.
|
Establishes
a requirement to evaluate interests in securitized financial assets to
identify interests that are freestanding derivatives or that are hybrid
financial instruments that contain an embedded derivative requiring
bifurcation;
|
|
|
d.
|
Clarifies
that concentrations of credit risk in the form of subordination are not
embedded derivatives; and
|
|
|
e.
|
Amends
Statement 140 to eliminate the prohibition on a qualifying special-purpose
entity from holding a derivative financial instrument that pertains to a
beneficial interest other than another derivative financial
instrument.
|
This
Statement is effective for all financial instruments acquired or issued after
the beginning of an entity’s first fiscal year that begins after
September 15, 2006. The fair value election provided for in paragraph 4(c)
of this Statement may also be applied upon adoption of this Statement for hybrid
financial instruments that had been bifurcated under paragraph 12 of Statement
133 prior to the adoption of this Statement. Earlier adoption is permitted as of
the beginning of an entity’s fiscal year, provided the entity has not yet issued
financial statements, including financial statements for any interim period for
that fiscal year. Provisions of this Statement may be applied to instruments
that an entity holds at the date of adoption on an instrument-by-instrument
basis. The Company is currently evaluating the impact of SFAS
155.
F-40
In March
2006, the FASB issued SFAS No. 156 (“FAS 156”), “Accounting for Servicing
of Financial Assets-An Amendment of
FASB Statement No. 140.” Among
other requirements, FAS 156 requires a company to recognize a servicing asset or
servicing liability when it undertakes an obligation to service a financial
asset by entering into a servicing contract under certain situations. Under FAS
156 an election can also be made for subsequent fair value measurement of
servicing assets and servicing liabilities by class, thus simplifying the
accounting and providing for income statement recognition of potential
offsetting changes in the fair value of servicing assets, servicing liabilities
and related derivative instruments. The Statement will be effective beginning
the first fiscal year that begins after September 15, 2006. The Company
does not expect the adoption of FAS 156 will have a material impact on the
financial position or results of operations.
In June
2006, the FASB issued FASB Interpretation (FIN) No. 48, “Accounting for Uncertainty
in
Income Taxes” that
provides guidance on the accounting for uncertainty in income taxes recognized
in financial statements. The interpretation will be adopted by us on May 1,
2007. We are currently evaluating the impact of adopting FIN 48; however, we do
not expect the adoption of this provision to have a material effect on our
financial position, results of operations or cash flows.
In July
2006, the FASB issued FASB Staff Position (FSP) No. FAS 13-2, “Accounting for a Change or Projected
Change in the Timing of Cash Flows Relating to Income Taxes Generated by a
Leveraged
Lease Transaction,” that
provides guidance on how a change or a potential change in the timing of cash
flows relating to income taxes generated by a leveraged lease transaction
affects the accounting by a lessor for the lease. This staff position will be
adopted by us on May 1, 2007. The Company is currently evaluating the
impact of adopting this FSP; however, the Company does not expect the adoption
of this provision to have a material effect on the financial position, results
of operations or cash flows.
In
September 2006, the FASB issued Statement No. 157, “Fair Value
Measurements” (SFAS
157). This Statement defines fair value, establishes a framework for measuring
fair value in generally accepted accounting principles (GAAP), and expands
disclosures about fair value measurements. This Statement applies under other
accounting pronouncements that require or permit fair value measurements, the
Board having previously concluded in those accounting pronouncements that fair
value is the relevant measurement attribute. Accordingly, this Statement does
not require any new fair value measurements. However, for some entities, the
application of this Statement will change current practice. This Statement is
effective for financial statements issued for fiscal years beginning after
November 15, 2007, and interim periods within those fiscal years. The
Company does not expect the adoption of SFAS No. 157 to have a material
impact on the consolidated financial statements.
In
September 2006, the FASB issued Statement No. 158, “Employers’ Accounting for Defined
Benefit Pension and Other Postretirement Plans—an amendment of FASB Statements
No. 87, 88, 106, and 132(R)” (SFAS
158). This Statement improves financial reporting by requiring an employer to
recognize the over funded or under funded status of a defined benefit
postretirement plan (other than a multiemployer plan) as an asset or liability
in its statement of financial position and to recognize changes in that funded
status in the year in which the changes occur through comprehensive income of a
business entity or changes in unrestricted net assets of a not-for-profit
organization. This Statement also improves financial reporting by requiring an
employer to measure the funded status of a plan as of the date of its year-end
statement of financial position, with limited exceptions. This Statement is
effective as of the end of the fiscal year ending after December 15, 2006.
The Company does not have any defined benefit plans, or other post-retirement
plans. Therefore, the Company does not expect SFAS No. 158 to have any
impact on the consolidated financial statements.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial
Assets and Financial Liabilities”. The
objective of this statement is to improve financial reporting by providing
entities with the opportunity to mitigate volatility in reported earnings caused
by measuring related assets and liabilities differently without having to apply
complex hedge accounting provisions. This Statement is expected by the Board to
expand the use of fair value measurement, consistent with the Board’s long-term
measurement objectives for accounting for financial instruments. This statement
is effective for fiscal years beginning after November 15, 2007. The Company is
currently evaluating the impact of adopting this statement; however, the Company
does not expect the adoption of this provision to have a material effect on its
financial position, results of operations or cash flow.
F-41
3. ACCRUED EXPENSES
Accrued
expenses consist of the following at April 30, 2007:
|
Payroll
& vacation
|
$
|
472,014
|
||
|
Accounting
& legal
|
326,325
|
|||
|
Consultant
|
13,200
|
|||
|
$
|
811,539
|
4. WARRANT
LIABILITIES
The
Company issued 6,792,852 warrants in conjunction with convertible note (Note 10)
and private placement (Note 11). These warrants have registration rights for the
underlying shares. EITF 00-19 provides that contracts that include any provision
that could require net-cash settlement cannot be accounted for as equity of the
Company. The warrant agreements require net cash settlement, at the option of
the holders, in the event the Company fails to issue and deliver common stock on
exercise of the warrants within three business days of receipt of a written
exercise notice by a holder. Pursuant to EITF 00-19, the fair value of the
warrants revalued at April 30, 2007 was recorded as a warrant liability
amounting $5,786,844. The change in fair value of warrant liabilities from April
30, 2006 to April 30, 2007 in the amount of $2,931,118 was recorded as other
expense in the consolidated statements of operations for the year ended April
30, 2007. The change in fair value from the issuance date to April 30, 2006 in
the amount of $137,543 was recorded as other income in the consolidated
statements of operations for the year ended April 30, 2006.
In the
year ended April 30, 2007, the Company issued warrants to non-employees to
purchase up to 150,000 common shares over a period of six years at a price of
$.01. The Company recorded $163,920 to permanent equity as, pursuant to EITF
00-19, no criteria were met requiring liability classification.
5. RELATED PARTY
TRANSACTIONS
Fees Paid to Related
Parties
Pursuant
to a financial advisory agreement dated March 2005 between Bridge Oncology and
SCO Financial Group LLC (SCO), which the Company has assumed, the Company
compensates SCO with a monthly fee of $12,500 and an annual grant of warrants
(Note 4) to purchase 150,000 shares of Company common stock at an exercise price
of $.01 for the term of the agreement for financial advisory services.
The
Company recorded advisory service fees totaling $150,000 and $112,500 to SCO for
the years ended April 30, 2007 and 2006, respectively. The Company recorded
non-cash advisory service fees to SCO related to the warrant grants totaling
$163,920 (Note 4) and $88,734 for the years ended April 30, 2007 and 2006,
respectively.
The
Company recorded board of director fees of $76,000 and $38,187 for the years
ended April 30, 2007 and 2006, respectively.
Agreement with Related
Party
Virium Pharmaceuticals,
Inc.
The
Company entered into an exclusive co-development and sublicense agreement in
February 2005 with a related entity, Virium Pharmaceuticals, Inc. These two
entities share a common director and their largest single shareholder, SCO
Capital Partners LLC. On May 19, 2005, the Company paid $50,000 to this
related party to in-license phenylbutyrate and expensed this
amount.
6. LEASES
The lease
on the Company’s London office space of approximately 500 sq. ft. for its United
Kingdom operations is an operating lease which expired on May 16, 2007.
Lease expense for the years ended April 30, 2007 and 2006 were $22,370 and
$26,724, respectively.
7. INCOME TAXES
The
significant components of the Company’s income tax provision (benefit) at
April 30, 2007 and April 30, 2006 are as follows:
F-42
|
April 30,
2007
|
April 30,
2006
|
||||||
|
Current
Taxes:
|
|||||||
|
Federal
|
$
|
—
|
$
|
—
|
|||
|
State
|
3,717
|
2,339
|
|||||
|
Foreign
|
—
|
—
|
|||||
|
Total
|
$
|
3,717
|
$
|
2,339
|
|||
|
Deferred
Taxes:
|
|||||||
|
Federal
|
—
|
—
|
|||||
|
State
|
—
|
—
|
|||||
|
Foreign
|
—
|
—
|
|||||
|
Total
|
—
|
—
|
The
principal components of the Company’s deferred tax assets at April 30, 2007
and April 30, 2006 are as follows:
|
April 30,
2007
|
April 30,
2006
|
||||||
|
US
Net Operating Loss Carryforwards at statutory rate
|
$
|
2,602,000
|
$
|
1,107,000
|
|
UK
Net Operating Loss Carryforwards at statutory rate
|
703,000
|
703,000
|
|
Total
|
3,305,000
|
1,810,000
|
|
Less
Valuation Allowance
|
(3,305,000
|
)
|
(1,810,000
|
)
|
|
Net
Deferred Tax assets
|
$
|
—
|
$
|
—
|
A
reconciliation of the provision (benefit) for income taxes to the amount
computed by applying the statutory income tax rate to the loss before income
taxes is as follows:
|
April 30,
2007
|
April 30,
2006
|
||||||
|
Income
tax (benefit) expense at statutory rate
|
$
|
(2,549,000
|
)
|
(1,701,000
|
)
|
|
Non
Deductible Expenses at statutory rate
|
1,050,000
|
335,000
|
|
Other
|
4,000
|
18,000
|
|
Change
in valuation allowance at statutory rate
|
1,495,000
|
1,348,000
|
|||||
| $ | - | $ |
The
Company has established a valuation allowance against its deferred tax asset,
due to the uncertainty of the realization of the asset. Management periodically
evaluates the recoverability of the deferred tax asset. At such time as it is
determined that it is more likely than not that deferred tax assets are
realizable, the valuation allowance will be reduced.
At
April 30, 2007 and 2006, the Company had US net operating loss
carryforwards of approximately $7,652,000 and $3,256,000 respectively, which may
be available to offset future taxable income for tax purposes. These net
operating loss carryforwards expire through 2026. At April 30, 2007 and
2006, the Company also had UK net operating loss carryforwards of approximately
$2,696,000.
The
Internal Revenue Code limits the availability of net operating losses that arose
prior to certain cumulative changes in a corporation’s ownership resulting in a
change of control of the Company. The Company’s use of $167,000 of its prior net
operating loss carryforwards will be significantly limited, because the Company
underwent “ownership changes” during the fiscal year ended April 30, 2006.
Further, the use of UK net operating loss carryforwards may be
limited.
8. STOCKHOLDERS’
TRANSACTIONS
Common
Stock
From
inception through April 30, 2003, the Company financed its operations
through the sale of 4,314,461 shares of common stock to individual investors at
prices in United Kingdom Pounds translated into US Dollars ranging from
approximately $0.03, to $1.10, for a total of $155,570. Of this total, $5,728
remained unpaid at the end April 30, 2003 and was recorded as subscription
receivable. In addition, 733,684 shares were issued at $0.03 for the services of
consultants, for a total of $17,007. Of this total, $9,975 was recorded to
deferred equity-based expense, because some services were performed in the
subsequent years. The services were accounted for at the fair value of the
common stock issued, measured at the dates the commitments for service were
reached with the contractors. The fair value of these shares was determined
as equal to the value at which shares were being sold to unaffiliated investors
at the times of the commitments for service.
For the
year ending April 30, 2004, the Company completed additional sales of
350,164 shares of common stock at approximately $1.23 for a total of $436,987.
At the end of April 30, 2004, the amount remaining unpaid for all prior
equity sales was $84,283 and was recorded as subscription receivable. The
Company issued 22,233 shares of common stock at approximately $1.23 for the
services of a consultant, for a total of $27,985. Of this total, $25,216
was recorded as deferred equity-based expense. During the year ended
April 30, 2004, 146,007 issued shares were purchased by the President and
Chief Executive Officer of the Company from an individual who had not paid for
the shares. The fair value of these shares was determined as equal to the
value at which shares were being sold to all other unaffiliated investors at the
time of this share purchase. The Company recorded the difference between the
purchase price and the fair value of the shares as compensation expense
amounting to $181,371.
F-43
For the
year ending April 30, 2005, the Company sold 374,074 shares to individual
investors at approximately $1.33, for a total of $494,443. In this period,
21,901 shares of common stock were issued at approximately $1.23 per share for
the services of a consultant, for a total of $26,955.
During
the year ended April 30, 2006, the Company sold 12,669 shares to an
individual investor at approximately $1.57, for a total of $19,834. In this
period, 3,650 shares of common stock were issued at approximately $1.50 in
satisfaction of the shares to be issued at April 30, 2005 for a balance of
$5,465.
Stock-Based
Compensation
The Board
of Directors adopted and the stockholders approved the 2005 Equity Incentive
Plan in June 2005. The plan was adopted to recognize the contributions made
by the Company’s employees, officers, consultants, and directors, to provide
those individuals with additional incentive to devote themselves to its future
success, and to improve the Company’s ability to attract, retain and motivate
individuals upon whom the Company’s growth and financial success
depends. Under the plan, stock options may be granted as approved by the
Board of Directors or the Compensation Committee. There are 8,000,000
shares reserved for grants of options under the plan, of which 2,204,701 have
been issued as substitutions with the exact same terms for the 2,204,701
previously issued options outstanding as of April 30, 2005. Stock options
vest pursuant to individual stock option agreements. No options granted
under the plan are exercisable after the expiration of ten years (or less in the
discretion of the Board of Directors or the Compensation Committee) from the
date of the grant. The plan will continue in effect until terminated or
amended by the Board of Directors or until expiration of the plan on
August 31, 2015.
On April
13, 2007, the Company’s Board of Directors approved a merger agreement with
Access Pharmaceuticals, Inc, as more fully described in Note 15. Under the terms
of that agreement Access will not assume, or provide a substitute option, for
any of the Company’s stock options. Rather, all of the outstanding options
to purchase Company common stock issued pursuant to the Company’s 2005 Equity
Incentive Plan will be cancelled prior to the closing of the transaction in
accordance with Section 11.3(d) of the Equity Incentive Plan. As a result,
pursuant to the terms of Section 11.3(d) of the Equity Incentive Plan, the
Company’s Board of Directors has resolved to: (i) allow the immediate and
accelerated vesting of all of the options granted, and (ii) allowed the exercise
of the option in whole or in part until May 31, 2007. Based on FAS 123(R), no
incremental expense was recorded for these options with accelerated vesting as
the fair value of the modified options was less than the fair value of the
original options calculated immediately before the terms were modified. None of
the options were exercised thru May 31, 2007. Additional expenses of $507,284
was due to the acceleration of the vesting.
FAS
123(R) requires the use of a valuation model to calculate the fair value of each
stock-based award. Since May 1, 2003, the Company has used the
Black-Scholes model to estimate the fair value of stock options granted. For the
valuation of stock-based awards granted in the years ended April 30, 2007 and
2006, respectively, the Company used the following significant
assumptions:
Compensation Amortization
Period. All
stock-based compensation is amortized over the requisite service period of the
options, which is generally the same as the vesting period of the options. For
all stock options, the Company amortizes the fair value on a straight-line basis
over the service periods.
Expected Term or
Life. The
expected term or life of stock options granted or stock purchase rights issued
represents the expected weighted average period of time from the date of grant
to the estimated date that the stock option would be fully exercised. To
calculate the expected term, the Company used the total of one-half of the
option term and one-half of the vesting periods.
Expected
Volatility.
Expected volatility is a measure of the amount by which the Company’s stock
price is expected to fluctuate. The Company’s stock is currently traded on the
over-the -counter bulletin board under the trading symbol “SMPM”. The Company
estimated the expected volatility of the stock options at grant date using the
daily stock price of three comparable companies over a recent historical period
equal to the Company’s expected term.
Risk-Free Interest Rate.
The
risk-free interest rate used in determining the fair value of our stock-based
awards is based on the implied yield on U.S. Treasury zero-coupon issues with
remaining terms equivalent to the expected term of our stock-based
awards.
F-44
Expected Dividends.
The
Company has never paid any cash dividends on common stock and does not
anticipate paying any cash dividends in the foreseeable future. Consequently,
the Company used an expected dividend yield of zero in valuation
models.
Expected Forfeitures.
As
stock-based compensation expense recognized in the consolidated statements of
operations for year ended April 30, 2007 is based on awards that are ultimately
expected to vest, it should be reduced for estimated forfeitures.
FAS 123(R) requires forfeitures to be estimated at the time of grant and
revised, if necessary, in subsequent periods if actual forfeitures differ from
those estimates. Pre-vesting forfeitures were estimated to be 0% for stock
options granted for the year ended April 30, 2007 based upon historical
forfeitures.
Summary of Significant Assumptions
of the Valuation of Stock-Based Awards. The
weighted-average estimated fair value of stock options granted during the year
ended April 30, 2007 and 2006 was $0.43 and $0.42 per share, respectively. The
fair value for these stock options was estimated at the date of grant with the
following weighted-average assumptions for the years ended April 30, 2007 and
April 30, 2006, respectively:
|
Year ended
April
30,
|
||
|
2007
|
2006
|
|
|
Expected
volatility
|
80.17
to 81.38%
|
101.80%
|
|
Weighted-average
volatility
|
80.41%
|
101.80%
|
|
Expected
dividend yield
|
0%
|
0%
|
|
Expected
term in years
|
6.0
|
6.0
to 7.0
|
|
Risk-free
interest rate
|
4.8%
to 5.1%
|
4.1%
to 4.6%
|
During
the years ended April 30, 2007 and 2006, the Company recognized compensation
costs related to stock options of $739,000 and $300,615,
respectively.
F-45
The
following table summarizes activity for stock options issued to employees,
consultants and directors for the years ended April 30, 2007 and
2006:
|
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
|
Outstanding
at April 30, 2005
|
2,204,701
|
$
|
1.23
|
7.6
|
$
|
44,094
|
|||||||
|
Granted
|
1,781,170
|
0.60
|
|||||||||||
|
Exercised
|
—
|
||||||||||||
|
Forfeited
|
(160,622
|
)
|
1.23
|
||||||||||
|
Expired
|
—
|
||||||||||||
|
Outstanding
at April 30, 2006
|
3,825,249
|
0.94
|
7.9
|
$
|
65,696
|
||||||||
|
Granted
|
122,500
|
0.60
|
|||||||||||
|
Exercised
|
—
|
||||||||||||
|
Forfeited
|
(339,417
|
)
|
0.60
|
||||||||||
|
Expired
|
(125,169
|
)
|
1.15
|
||||||||||
|
Outstanding
at April 30, 2007
|
3,483,163
|
$
|
0.95
|
0.1
|
$
|
1,040,399
|
|||||||
|
Exercisable
at April 30, 2007
|
3,483,163
|
$
|
0.95
|
0.1
|
$
|
1,040,399
|
|||||||
The
aggregate intrinsic value represents the difference between the stock price on
the last day of the fiscal year, April 30, 2007, which was $1.25, and the
exercise price multiplied by the number of options outstanding.
The
following table summarizes information about non-vested Company stock options as
of April 30, 2007 (unaudited):
|
Shares
|
Weighted
Average
Grant Date Fair
Value
|
||||||
|
Non-vested
at April 30, 2006
|
1,849,128
|
$
|
0.43
|
|
Granted
|
122,500
|
$
|
0.43
|
||||
|
Vested
|
(1,632,211
|
)
|
$
|
0.48
|
|||
|
Forfeited
|
(339,417
|
)
|
$
|
0.18
|
|||
|
Non-vested
at April 30, 2007
|
-0-
|
Stock
Warrants
Through
the year ended April 30, 2005, the Company issued no warrants. During the
year ended April 30, 2006, the Company issued warrants to non-employees to
purchase up to 6,952,838 common shares over periods ranging from 5 to 7 years at
prices ranging from $0.01 to $2.25. Included in the warrants issued were
warrants to a non-employee to purchase up to 9,987 common shares over a five
year period at a price of $2.25. In the year ended April 30, 2007, the Company
issued warrants to non-employees to purchase up to 150,000 common shares over a
period of six years at a price of $.01 (Note 4). In accordance with EITF 96-18,
the Company determined that the fair value of the equity instrument issued was
more reliably measured because it was difficult to determine the value of the
services performed. In accordance with FASB Statement No. 123R, the Company
has expensed the fair value of all the warrants issued during the year. The fair
value was estimated using the Black-Scholes valuation method. The assumptions
utilized in the valuation model were a dividend yield of zero, volatility
factors ranging from 76.5 to 97.2%, the risk-free interest rates prevailing at
the warrant issuance dates, which ranged from 4.1 to 4.9%, and expected warrant
lives ranging from 2.5 to 3.5 years. The fair market value of the warrants used
in the Black-Scholes valuation model was equal to the most recent value at which
shares were being sold to unaffiliated investors.
F-46
The
following table summarizes the activity for warrants issued during the years
ended April 30, 2007 and 2006.
|
Shares
|
Wtd.
Avg.
Exercise
Price
|
||||||
| Outstanding April 30, 2005 |
—
|
||||||
|
Granted
|
6,952,838
|
$
|
.62
|
||||
|
Exercised
|
—
|
| Forfeited |
—
|
||||||
|
Expired
|
—
|
||||||
|
Outstanding
April 30, 2006
|
6,952,838
|
$
|
.62
|
||||
|
Granted
|
150,000
|
$
|
.01
|
||||
|
Exercised
|
—
|
||||||
|
Forfeited
|
—
|
||||||
|
Expired
|
—
|
||||||
|
Outstanding
April 30, 2007
|
7,102,838
|
$
|
.61
|
The
following table summarizes information about warrants outstanding as of
April 30, 2007:
|
Warrants
Outstanding
|
Warrants
Exercisable
|
||||
|
Exercise
Prices
|
Number
Outstanding
|
Wtd.
Avg
Remaining
Contr.
Life
|
Wtd.
Avg
Exercise
Price
|
Number
Exercisable
|
Wtd.
Avg
Exercise
Price
|
|||||||||||
|
$0.01
|
1,166,534
|
5.8
years
|
$
|
0.01
|
1,166,534
|
$
|
0.01
|
|||||||||
|
$0.60
|
987,720
|
4.8
years
|
$
|
0.60
|
987,720
|
$
|
0.60
|
|||||||||
|
$0.75
|
4,938,597
|
4.8
years
|
$
|
0.75
|
4,938,597
|
$
|
0.75
|
|||||||||
|
$2.25
|
9,987
|
3.1
years
|
$
|
2.25
|
9,987
|
$
|
2.25
|
9. SHARE EXCHANGE AGREEMENT AND PLAN OF
MERGER AGREEMENT
On
August 22, 2005, Somanta Limited, a company organized under the laws of
England and Wales, became a wholly-owned subsidiary of Bridge Oncology Products,
Inc. (“BOPI”), a privately held Delaware corporation pursuant to a share
exchange with BOPI. BOPI was formed in February 2005, and its only
operation was to in-license a product development candidate for development
outside the United States and Canada.
Under the
terms of a Share Exchange Agreement by and among BOPI, Somanta Limited, and the
shareholders and option holders of Somanta Limited, BOPI (i) issued
5,832,834 shares of BOPI to the twenty-five holders of 79,898,686 ordinary
shares of Somanta Limited and (ii) issued substitute options to purchase
2,032,166 shares of BOPI to the eleven holders of Somanta Limited options
covering 27,836,800 ordinary shares of Somanta Limited. The exchange ratio in
the share exchange was 1 share of BOPI for each 13.698 shares of Somanta
Limited. As a result of this share exchange, the shareholders of Somanta Limited
owned 50% of the fully diluted ownership of BOPI, and the holders of BOPI owned
the remaining 50%.
Somanta
Limited options were all priced at 5 pence pursuant to Somanta Limited’s Board
resolution dated May 18, 2005. These option grant prices were converted
into US dollars at the exchange rate on June 13, 2005, to $0.09 per
share. After the exchange ratio from the share exchange was applied, these
options now have an exercise price of $1.232828 per share for each BOPI option
issued in the share exchange.
The
acquisition was accounted for as a recapitalization, as described in FASB 141,
17-3. This transaction is treated as a capital transaction in substance, rather
than a business combination. That is, the transaction is equivalent to Somanta
Limited issuing stock for the net monetary assets of BOPI, accompanied by a
recapitalization. The assets of BOPI were recorded at the historical value. The
intangible asset on BOPI’s books was written off to the income statement on the
date of the acquisition (August 22, 2005). Accordingly, the historical
financial statements of Somanta Limited became the historical financial
statements of BOPI after this transaction. In accounting for this transaction,
since Somanta Limited is deemed to be the purchaser and surviving company, its
net assets have been included in the consolidated balance sheets at their
historical book values.
On
August 24, 2005, the name of BOPI was changed to Somanta Incorporated
(“SI”).
F-47
On
September 7, 2005, SI entered into a letter of intent to effect a merger
with Hibshman Optical Corp (“Hibshman”), a New Jersey corporation, and a public
reporting company that did not have a market for its common stock. Hibshman
was formed in 1991 under the name PRS Sub I, Inc., as a subsidiary of People
Ridesharing Systems, Inc.
(“PRS”), a public corporation that had filed for Bankruptcy in 1989. In March
1992, the name of PRS Sub I was changed to Service Lube, Inc., in anticipation
of becoming an operating business. In April 1992 the name was changed to Fianza
Commercial Corp. Again in April 1992 the name was changed to Hibshman. Hibshman
never had an operating business, its stock never traded publicly, and its
shareholders never received stock certificates.
On
September 27, 2005, Hibshman, pursuant to an action taken by the written
consent of its board and shareholders, adopted an Agreement and Plan of Merger
to effect the reincorporation of Hibshman into Delaware prior to the merger with
SI. Hibshman formed a new Delaware corporation which was a wholly owned
subsidiary of Hibshman (“Delaware NewCo”). At the closing of the
reincorporation, Hibshman merged into Delaware NewCo and each outstanding
Hibshman share was exchanged for .01305340 of Delaware NewCo shares with each
registered holder of a fractional share being issued 50 Delaware NewCo shares in
lieu of such fractional share. Delaware NewCo was the surviving entity and
the successor issuer under the Exchange Act and had 576,700 outstanding
shares. Delaware NewCo was named “Somanta Pharmaceuticals,
Inc.”
On
January 31, 2006, pursuant to an Agreement and Plan of Merger by and among
Delaware NewCo, SI, and Somanta Merger Sub (“Merger Sub”), a wholly-owned
subsidiary of Delaware NewCo, SI merged with Merger Sub and became a
wholly-owned subsidiary of Delaware NewCo. In connection with this merger
transaction, Delaware NewCo issued to the holders of SI capital stock an
aggregate of 13,697,834 shares of Delaware NewCo common stock and assumed the SI
2005 Equity Incentive Plan and all options outstanding thereunder which options
became options to purchase 3,831,864 shares of Delaware NewCo common stock. As a
result, (i) the shareholders and optionholders of SI owned approximately
97% of the total outstanding common stock of Delaware NewCo on a fully diluted
basis, (ii) Delaware NewCo assumed the SI 2005 Equity Incentive Plan and
reserved 8,000,000 common shares for issuance under the Plan, and
(iii) Delaware NewCo changed its name to Somanta Pharmaceuticals,
Inc.
The
acquisition was accounted for as a recapitalization, as described in FASB 141,
17-3. This transaction is treated as a capital transaction in substance, rather
than a business combination. That is, the transaction is equivalent to Somanta
Incorporated issuing stock for the net monetary assets of Hibshman Optical
Corp., accompanied by a recapitalization. Accordingly, the historical financial
statements of Somanta Incorporated became the historical financial statements of
Hibshman Optical Corp. after this transaction. In accounting for this
transaction, since Somanta Incorporated is deemed to be the purchaser and
surviving company, its net assets have been included in the consolidated balance
sheets at their historical book values. Somanta Pharmaceuticals, Inc., elected
to change the fiscal year end from December 31 to April 30 of Somanta
Incorporated.
10. CONVERTIBLE NOTE
On
August 23, 2005, Bridge Oncology Products, Inc. (“BOPI”) issued a
$1,000,000 secured convertible note to SCO Capital Partners LLC
(“SCO”). The note was secured by BOPI’s assets, carries an annual interest
rate of 7.5%, and was due at the earlier of (i) BOPI’s completion of a
qualified equity financing of at least $10,000,000 or (ii) August 23,
2006. SCO had the option to be repaid in cash or to convert the debt into
the shares of a qualified equity financing at the lowest price paid by
institutional investors.
On
November 7, 2005, SCO agreed to expand its secured convertible note to SI
from $1,000,000 up to $1,250,000. Under the terms of the revised arrangement
with SI, the security and interest rate remained unchanged. The terms were
amended to require repayment at the earlier of (i) SI’s completion of an
equity financing of at least $5,000,000 or (ii) February 28,
2006. Consistent with the secured convertible note above, SCO had the
option to be repaid in cash or to convert the debt into the shares of a
qualified equity financing at the lowest price paid by institutional
investors.
In
addition, for each $50,000 borrowed on the additional $250,000 line of credit,
the Company agreed to issue a six-year warrant to purchase 173,307 shares of
common stock in the amount of 1% of the Company’s fully diluted common shares
outstanding at an exercise price of $0.01 per share. SI has drawn an
additional $250,000 under this arrangement, for a total amount outstanding of
$1,250,000 and has issued warrants to purchase a total of 866,534 shares of
common stock to SCO. These warrants are immediately exercisable upon issuance
and expire on November 8, 2012. The fair market value of these warrants, as
discussed further below, was estimated to be $0.59 per share at the issuance
date and re-measured at $0.59 as of April 30, 2006. The assumptions used in
the Black-Scholes model were risk-free interest rate of 4.5% at the time of
issuance and 4.95% at April 30, 2006, volatility factors of 97.24% at the
issuance and 76.63% at April 30, 2006, calculated as the weighted average
of the stock price volatility of ranked comparable public companies, and
contractual terms equal to the exercise periods of the respective warrants. The
fair value of the common stock as used in this calculation was $.60 per share,
as negotiated between the Company and the Series A Convertible Preferred Stock
investors. None of these warrants have been exercised as of April 30,
2007.
F-48
These
warrants have registration rights for the underlying shares. The investor rights
agreement for the warrant requires the Company pay a penalty in cash as
liquidated damages if the underlying shares are not registered in a Registration
Statement and such Registration Statement is not declared effective on or prior
to the 90th day
following the initial closing date. The Company will be required to pay, in
cash, liquidated damages for such failure, equal to 1% of the holder’s
subscription amount. Pursuant to Emerging Issues Task Force (EITF) No.
00-19, Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company’s Own
Stock, the
fair value of the warrants at the issuance was recorded as a warrant liability,
as 1) the shares are required to be registered and 2) net cash settlement could
occur. EITF 00-19 provides that contracts that include any
provision that could require net-cash settlement cannot be accounted for as
equity of the Company. The warrant agreements require net cash settlement, at
the option of the holders, in the event the Company fails to issue and deliver
common stock on exercise of the warrants within three business days of receipt
of a written exercise notice by a holder and the holder purchases shares of
common stock to deliver in satisfaction of a sale of the shares of warrants
stock which the holder anticipated to receive upon exercise.
In
accordance with Statement of Financial Accounting Standards No. 133,
Accounting for Derivative
Instruments and Hedging Activities, (“FASB
133”), the Company determined that the conversion feature of the notes did not
meet the criteria for bifurcation of the conversion option, as the debt met the
definition of “conventional convertible debt”, as defined under EITF 00-19, and
therefore the conversion feature of the debt did not need to be bifurcated and
accounted for as a derivative.
In
accordance with EITF No. 00-27, Application of Issue No. 98-5
to Certain Convertible Instruments, which
provides guidance on the calculation of a beneficial conversion feature on a
convertible instrument, the Company has determined that the convertible note
payable had a non-cash beneficial conversion feature of $364,721, which was
determined once the qualified equity financing was finalized. The beneficial
conversion feature was calculated on the note commitment date but recognized
when the contingency of conversion was resolved and was determined based on the
difference between the calculated conversion value after the allocation of the
full fair value of the warrants of $514,981 to the debt as debt discount and the
fair value of the Company’s common stock of $0.60 per share. The value of
the Company’s common stock of $0.60 per share was based on the value of common
stock obtained through negotiation for independent sales of common stock to
unaffiliated investors. After the allocation of proceeds between the debt
and warrants are made, conversion price of $0.425 was calculated based on the
allocated amount to debts divided by 2,083,333, the total number of shares into
which the note is convertible. The calculated amount of $0.175, the difference
of the fair value of the common stock of $0.60 and the effective conversion
price of $0.425, represents the beneficial value per share. This beneficial
value was applied to the total shares into which the note is convertible, to
calculate the beneficial conversion feature. The proceeds of $1,250,000 on the
note were recorded net of the discount of $364,721 on account of the beneficial
conversion feature and discount of $514,981 on account of the full fair value of
the warrants. In conjunction with the private placement (Note 12), the debt and
accrued interest was converted into 128.6318 shares of Series A Convertible
Preferred Stock. The discounts on account of the beneficial conversion feature
and fair value of the warrants have been recognized as additional interest
expense on conversion.
11. PRIVATE PLACEMENT
On
January 31, 2006, Somanta Pharmaceuticals, Inc. completed a private
placement of 592.6318 shares of its Series A Convertible Preferred
Stock (“Series A Preferred”) at a price of $10,000 per share, including six-year
warrants to purchase an additional 4,938,598 shares of its common
stock. The Series A Preferred shares consisted of 464 shares purchased by
investors which are convertible into 7,733,333 shares of common stock and
128.6318 shares that gave effect to the conversion amount of $1,286,318,
representing the value of the converted note of $1,250,000 (Note 11) and the
associated accrued interest of $36,318. The total 592.6318 preferred shares
are convertible into 9,877,197 common shares. Gross proceeds to Somanta were
$4,640,000, including $3,671,209 in cash, payments to various vendors amounting
$968,791, which included cash payment of $624,105 to SCO Securities, LLC, its
placement agent.
The
Series A Preferred is initially convertible into 9,877,197 shares of the
Company’s common stock at a conversion price of $0.60 per share. The conversion
value is subject to adjustment. The exercise price for the warrants is $0.75 per
share and they are immediately exercisable upon issuance. The fair market value
of these warrants, as discussed further below, was estimated to be $0.41 per
share at the issuance date. The warrants expire on January 31,
2012. None of the warrants have been exercised as of April 30,
2007.
Holders
of the Series A Preferred stock are entitled to receive dividends at 8% per
annum. Dividends will accrue and will be cumulative from the date of issuance,
whether or not earned or declared by the Board of Directors. Dividends can be
paid at the Company’s option either in cash or shares of the Company’s common
stock on April 30 and October 31 of each year. The holders of the
Series A Preferred stock have full voting rights and powers, subject to the
Beneficial Ownership Cap, equal to the voting rights and powers of the Common
stock holders.
F-49
The
Series A Preferred stockholders have a liquidation preference, in the event of
any voluntary or involuntary liquidation, dissolution or winding up of the
Corporation, senior to the holders of common stock in an amount equal to $10,000
per share of preferred stock plus any accumulated and unpaid dividends on the
preferred stock. In the alternative, the holders of the Series A Preferred
may elect to receive the amount per share that would be distributed among the
holders of the preferred stock and common stock pro rata based on the number of
shares of the common stock held by each holder assuming conversion of all
preferred stock, if such amount is greater than the amount such holder would
receive pursuant to the liquidation preference. A change of Control of the
Corporation will not be deemed a liquidation.
The
Series A Preferred Stock is not redeemable for cash. The holder of any
share or shares of Series A Preferred can, at the holder’s option, at any time
convert all or any lesser portion of such holder’s shares of Series A Preferred
stock into such number of shares of common stock as is determined by dividing
the aggregate liquidation preference of the shares of preferred stock to be
converted plus accrued and unpaid dividends thereon by the conversion value then
in effect for such Preferred Stock (“Conversion Value”). The Company can, on the
occurrence of a conversion triggering event, elect to convert all of the
outstanding preferred stock into common stock. A conversion triggering event is
(i) a time when the registration statement covering the shares of common
stock into which the Series A Preferred is convertible is effective and sales
may be made pursuant thereto or all of the shares of common stock into which the
Series A Preferred is convertible may be sold without restriction pursuant to
Rule 144(k) promulgated by the SEC and the daily market price of the common
stock, after adjusting for stock splits, reverse splits, stock dividends and the
like is $5 or more for a period of 30 of the immediately preceding 60
consecutive trading days and the volume of common stock traded on the applicable
stock exchange on each such trading day is not less than 100,000 shares, or
(ii) a time when the Company consummates a sale of common stock in a firm
commitment underwritten public offering in which the offering price before
deduction of expenses of the common stock is greater than 200% of the Conversion
Value and the aggregate gross proceeds of the offering to the Company are
greater than $25 million.
All the
outstanding preferred stock will be automatically converted to common stock upon
an occurrence of a qualified change of control provided that upon consummation
of a qualified change of control the holders of the shares issuable on automatic
conversion shall be entitled to receive the same per share consideration as the
qualified change of control transaction consideration. The holders of the Series
A Preferred may require the Company to redeem the shares upon the Company’s
failure or refusal to convert any shares of Preferred Stock in accordance with
the terms of issue, or by providing a written notice to that
effect.
The
Series A Preferred has been classified as equity, as the Series A Preferred
stock is not redeemable. In accordance with EITF No. 00-27, Application of Issue No. 98-5
to Certain Convertible Instruments, the
Company has determined that the Series A Preferred had a beneficial conversion
feature of $1,522,317 as of the date of issuance. As such, the Company recorded
a non-cash deemed dividend of $1,522,317 resulting from the difference between
the conversion price determined after allocation of the full fair value of the
warrants of $0.41 at the issuance date, revalued at $0.78 as of April 30,
2007, and the fair value of common stock of $0.60. The carrying value of the
Series A Preferred of $5,926,318 was recorded net of the deemed dividend of
$1,522,317 and a discount of $2,048,531 at the issuance date. The change in fair
value of the warrants was recorded as other income in the consolidated statement
of operations for the year ended April 30, 2007.
The
holders of the Series A Preferred and warrants have registration rights which
obligate the Company to file a registration statement with the Securities and
Exchange Commission (“SEC”) covering the resale of the common stock issuable
upon conversion of the Series A Preferred and the common stock issuable upon
exercise of the warrants (as well as certain other securities of the Company)
within 30 days after the closing of the private placement. In the event the
registration statement is not filed within such thirty day period or if the
registration statement is not effective within 120 days after the date it is
filed, or a registration statement, once declared effective ceases to remain
effective during the period that the securities covered by the agreement are not
sold, the Company will be required to pay, in cash, liquidated damages for such
failure, equal to 1% of the holders of the Series A Preferred investment amount
for each thirty day period in which the registration statement is not filed or
effective, or maintained effective, as the case may be. This penalty obligation
expired on January 31, 2007 since the SEC declared the Registration
Statement effective on August 10, 2006.
In
accordance with EITF Issue 05-4, The Effect of a Liquidated Damages
Clause on a Freestanding Financial Instrument Subject to Issue No.
00-19, the
Company believes that the effect of the liquidated damages should be treated
under the first view (View A), which states that a registration rights agreement
should be treated as a combined unit together with the underlying financial
instruments, warrants and derivative debenture and evaluated as a single
instrument under EITF Issue 00-19 and FAS 133. The Company concluded that this
view is the most appropriate for the transaction. The Registration Rights
Agreement and the financial instruments to which it pertains (the warrants and
the preferred stock) were considered a combined instrument and accounted for
accordingly. The SEC declared the Registration Statement effective on
August 10, 2006. As a result, during the quarter ended July 31, 2006,
the Company accrued a liability of liquidated damages of $120,502. During the
quarter ended October 31, 2006 an agreement was reached with SCO on the
liquidated damages matter. The agreement concluded that since the securities
owned by SCO Capital Partners,
LLC were not registered because SCO voluntarily withdrew them from the
Registration because of the resale restrictions required by the SEC, the Company
is not obligated for any liquidated damages pertaining specifically to SCO
Capital Partners, LLC. Accordingly, the Company reversed out $85,302 of
liquidated damages in the prior quarter ended October 31,
2006.
F-50
The
Company also issued six year warrants to its placement agent to purchase 987,720
common shares at $0.60 per share to SCO Securities LLC, as part of the success
fees of 10% of the aggregate value of the transaction at sales price of common
stock. These warrants are immediately exercisable upon issuance. The fair value
of these warrants at the date of issuance was estimated to be $0.44 per share
and revalued at $0.41 as of April 30, 2006 and has been recorded as
issuance costs and offset against the proceeds of the Series A Preferred. On
February 27, 2007, the Company issued a six year warrant to SCO Financial Group
to purchase 150,000 common shares at $.01 per share.
The fair
value of warrants issued in connection with the issue of convertible debt and
convertible preferred stock, including the agent warrants, was estimated at the
date of grant and revalued at April 30, 2007 using a Black Scholes option
pricing model with the following assumptions: a risk free interest rate of
approximately 4.5% at the issuance date and 4.6% on April 30, 2007, no dividend
yield, volatility factors of 81.89% to 97.24% at the issuance date
and 50.89% to 60.56% at April 30, 2007, contractual terms of 6 and 7 years
and expected terms based upon the formula prescribed in SEC Staff Accounting
Bulletin 107 of 3 years and 3.5 years. These assumptions use the interest
rate prevailing at the time of issuance, volatility factors calculated as the
weighted average of the stock price volatility of ranked comparable public
companies, and contractual terms equal to the exercise periods of the respective
warrants. The fair value of the common stock as used in this calculation was
$.60 per share at the issuance date, as negotiated between the Company and
unaffiliated third party Series A investors, and $1.25 on April 30, 2007. The
change in fair value of the warrants for the year ended April 30, 2007 of
$2,931,118 was reported in other expense and disclosed in the financial
statements.
The fair
value of the above warrants has been classified as a liability pursuant to EITF
00-19 as described in Note 4 for the years ended April 30, 2007.
The fair
value of the warrants was reassessed at the end of the fiscal year 2007 with
changes in fair value recorded in other income (expense) and disclosed in the
financial statements.
The
holders of the Series A Preferred Stock are entitled to receive, when, if and as
declared by the Board, dividends at 8% per annum cumulative from the date
of issuance of the shares of Preferred Stock. The board did not declare the
dividends as of April 30 2007. Therefore, a dividend of $589,708 and
$115,604 for the year ended April 30, 2007 and 2006, respectively,
on the Preferred Stock has not been recorded in the consolidated financial
statements, but in accordance with SFAS No. 129, the dividend amount has
been included in the calculation of net loss per share.
12. SECURED NOTE
On April
26, 2007, the Company entered into a Note Purchase Agreement, a Security
Agreement, a Patent Collateral Assignment and Security Agreement and a Trademark
Collateral Security and Pledge Agreement (collectively, the “Loan Documents”)
with Access Pharmaceuticals, Inc. (“Access”). Under the terms of the Loan
Documents, Access initially loaned the Company $33,462. Access, in its sole
discretion, may from time to time advance additional loan amounts to the
Company. All amounts loaned to the Company by Access are secured by
substantially all of the assets of the Company pursuant to the terms of the Loan
Documents. The Note bears interest at 10% and is repayable at the earlier of:
(i) August 31, 2007, or (ii) the date of the termination of the Agreement and
Plan of Merger dated as of August 18, 2007 between the Company and
Access.
13. COMMITMENTS—EMPLOYMENT AND CONSULTING
AGREEMENTS
In
January 2006, the Company entered into employment agreements with the Company’s
President and Chief Executive Officer (“CEO”), and with the Company’s Executive
Chairman, for one year terms. These agreements were automatically renewed for an
additional on year term on January 31, 2007. Under these agreements, the
President and Executive Chairman are to be paid annual base salaries of $275,000
and $248,000, respectively. Both officers are eligible to receive annual bonuses
and additional stock option grants at the discretion of the Company’s board of
directors. In July 2006, the Company’s CEO and Executive Chairman agreed to
defer 50% of their base salaries until the completion of the Company’s next fund
raising at which time the deferred amounts would be repaid and the deferrals
would cease. Effective October 1, 2006, the Company’s CEO and Executive
Chairman agreed to defer 100% of their base salaries until the completion of the
Company’s next fund raising, or the completion of a merger or other
consolidation with another company, at which time the deferred amounts would be
repaid and the deferrals would cease. Effective June 30, 2006, our
Executive Chairman was appointed by our Board to be our Chief Financial Officer,
Secretary and Treasurer.
F-51
In
January 2006, the Company entered into an employment agreement with the
Company’s Chief Financial Officer (“CFO”). Under the agreement, the CFO was
to be paid an annual base salary of $215,000 and also entitled to receive an
annual bonus and additional stock option grants at the discretion of the
Company’s board of directors. In June 2006, the Company’s CFO resigned. The
Company is not obligated to pay him any severance or other payments as the
result of his departure; however, the board agreed to amend the terms of his
stock option agreement to immediately vest him in twenty five percent
(25%) of the shares covered by the option, or 101,668 shares, and enable
him to exercise such option until June 30, 2007. Based on FAS 123R, no
incremental expense was recorded for these options with accelerated vesting as
the fair value of the modified options was less than the fair value of the
original options calculated immediately before the terms were
modified.
In
November 2005, the Company entered into two consulting agreements: (i) a
Service Provision Agreement with Pharma Consultancy Limited, a UK company
controlled by Luiz Porto, one of the Company’s stockholders pursuant to which
the Company will pay Dr. Porto approximately $278,000 per year, for
services rendered by Dr. Porto to the Company as an independent consultant
in connection with the management of the Company’s clinical activities, that
will terminate on December 31, 2006 unless extended by a mutual written
agreement of the parties and may be terminated, with or without cause, by giving
the other party thirty (30) days’ prior written notice; and (ii) a
Service Provision Agreement with Gary Bower pursuant to which the Company
will pay Mr. Bower approximately $156,000 per year for services rendered by
Mr. Bower to the Company as an independent consultant in connection with
the pre-clinical activities related to the manufacturing of the Company’s
product candidates, that will terminate on December 31, 2006 unless
extended by a mutual written agreement of the parties and that may be
terminated, with or without cause, by giving the other party thirty
(30) days’ prior written notice.
The
agreement with Mr. Bower was amended in April 2006 to include GTE
Consultancy Limited, a company organized under the laws of United Kingdom and
owned by Mr. Bower, as the service provider pursuant to the agreement. With
the approval of the Company’s board of directors, both Dr. Porto and
Mr. Bower may also be granted cash bonuses and stock options in the future.
In July 2006, Pharma Consultancy Limited and GTE Consultancy Limited amended
their agreements to reduce, effective September 1, 2006, their consulting
services to the Company by 33%, which in turn, will reduce the Company’s
payments by approximately $91,000 and $51,000, respectively, on an annualized
basis. Both agreements expired by there terms on December 31, 2006 and were not
renewed.
The
Company’s former CFO resigned in August 2005, in connection with the closing of
the share exchange agreement with Bridge Oncology. In January 2006, he
entered into a consulting arrangement with the Company under which he is paid
$5,000 per month retroactive to June 2005. Effective June 1, 2006, the
former CFO agreed to modify his consulting arrangement to provide his services
for $100 per hour in lieu of a fixed retainer and was granted options to acquire
25,000 of the Company’s common stock at $.60 per share vesting quarterly over
twenty four months. Those options expired as of May 31, 2007.
14. SIGNIFICANT CONTRACTS AND
LICENSES
IN-LICENSING
AGREEMENTS
De Montfort
University
In
November 2001, the Company entered into a Patent and Know-how Assignment and
License Agreement with De Montfort University of Leicester, England, pursuant to
which De Montfort University agreed to assign to the Company the key patent
related to chloroethylaminoanthraquinone, a cytotoxic small molecule and to
exclusively license to the Company certain know-how related to this molecule for
use in field of the treatment of cancer. In March 2003, the Company amended and
restated that agreement to extend the time period in which the assignment and
license would be triggered. In October 2005, De Montfort University formally
assigned the patent that covers the molecule to the Company. Pursuant to the
agreement with De Montfort University, the Company paid De Montfort an initial
assignment fee of $42,815 in March 2004 and issued 219,010 shares of common
stock to De Montfort valued at $4,677 in December 2001. The Company is not
obligated to make any royalty payments to De Montfort based on the sale of any
product that is based on this small molecule, but it is obligated to pay De
Montfort certain milestone payments based on the achievement of agreed upon
clinical milestones. If the Company successfully achieves each of these
milestones, it would be obligated to pay De Montfort a total aggregate amount of
milestone payments of GBP 250,000, or approximately $500,000. The Company is
obligated to use its commercial best efforts to achieve these agreed upon
clinical milestones. The Company has the right to terminate its agreement with
De Montfort on 90 days advance notice, and either party has the right to
terminate the agreement for breach by the other party upon 90 days advance
notice (60 days for payment failures), if such breach is not cured within the
notice period.
F-52
Immunodex,
Inc.
On
January 25, 2002, the Company entered into a Patent Know-How and License
Option Agreement with Immunorex, Inc. (later renamed Immunodex, Inc.) giving it
a worldwide, exclusive sublicense, with the right to further sublicense, to all
human radioimmunotherapy applications of certain patents on BrE3 and Mc3
monoclonal antibodies for use in breast cancer and other types of cancer.
Pursuant to this agreement, the Company paid Immunodex an initial license fee of
$10,000 and sold 292,012 shares of common stock to Immunodex for $5,638. On
August 16, 2005, the Company entered into a Patent and Know-how Exclusive
Sublicense Agreement with Immunodex, Inc. which had essentially the same terms
and conditions as the 2002 agreement and which superseded that agreement. It
also superseded prior agreements dated March 1, 2002 and September 17,
2002 related to the same subject matter. Pursuant to this August 2005 agreement,
the Company paid Immunodex an initial license fee of $300,000. In addition, the
Company is obligated to pay Immunodex $150,000 upon the delivery by Immunodex of
each cell line that is necessary to manufacture each of the BrE3 and Mc3
monoclonal antibodies. The Company is further obligated to pay Immunodex annual
license maintenance fees and all costs and expenses associated with the
prosecution and maintenance of each of the patents licensed to the Company under
the agreement. The Company’s obligation to pay this fee is reduced at such time
as it begins to sell a product based on either of the antibodies, and terminates
in its entirety at such time as the Company is selling products based on both
antibodies. As noted below, on November 3, 2006 we terminated our license with
respect on one of the monoclonal antibodies (huBrE-3 mAb), and continue to
develop on Angiolix.
Assuming
that we begin to sell products based on Angiolix fifteen (15) years after the
date of the August 2005 agreement, or August 2020, which is our anticipated
development timetable, we would have to pay to Immunodex an additional
$2,600,000 in maintenance fees during that time period. In addition, we are
obligated to pay Immunodex a royalty based on the net sales, if any, of products
based on Angiolix. Further, we are obligated to develop Angiolix on an agreed
upon timetable. If we fail to achieve any of the agreed upon clinical
development and regulatory milestones, Immunodex would then have the right to
terminate the August 2005 agreement, and if such a termination occurs, we would
be obligated to pay Immunodex a termination fee of up to $500,000. We are also
entitled to terminate the agreement with respect to Angiolix upon ninety (90)
days advance notice to Immunodex. If we do so without cause, we would also be
required to pay a termination fee of up to $500,000. Notwithstanding the
foregoing, we do not have to pay a termination fee with respect to Angiolix if
the agreement is terminated due to: (i) negative results of toxicity testing for
the applicable drug candidate that the FDA indicates would preclude further
testing of such drug candidate, (ii) a third party being granted orphan drug
status by the FDA for a drug that would preclude us from receiving orphan drug
status with respect to the applicable drug candidate, or (iii) our inability to
achieve commercially viable yields with respect to the manufacture of the
applicable drug candidate.
If we
sublicense our rights with respect to Angiolix, we would be obligated to pay to
Immunodex a sublicensing fee not to exceed $1,000,000 for each such sublicense
granted based on payments received from each such sublicensee.
The term
of the August 2005 agreement expires on the latter to occur of: (i) the
expiration of the last to expire licensed patent, or (ii) fifteen (15) years
after the first commercial sale of a product covered by the licensed patents.
The August 2005 agreement superseded prior agreements with Immunodex dated
January 25, 2002, March 1, 2002 and September 17, 2002, in each case
related to the same subject matter.
In
February 2006, the Company made a deposit of $150,000 into an escrow account
pursuant to the agreement. This amount was released on November 7,
2006.
Effective
November 3, 2006, the Company entered into a Side Amendment to Patent and
Know-how Exclusive Sublicense Agreement with Immunodex and the Cancer Research
Institute of Contra Costa (“CRICC”) (the “Side Amendment”). Pursuant to the
Side Amendment, the Company has agreed with Immunodex and CRICC to reduce the
amount of the annual maintenance fee under the License Agreement from $250,000
to $200,000 and to defer the annual maintenance fee that was due in August 2006
until the earlier of (i) the closing of a fundraising resulting in gross
proceeds to us of at least $5,000,000, or (ii) January 31, 2007 (the
“2006 Annual Maintenance Fee”). If the Company is unable to timely pay the 2006
Annual Maintenance Fee, the annual maintenance fee due under the License
Agreement would revert to $250,000.
The
Company has retained its rights with respect to huMc-3 mAb and its product
candidate Angiolix; however, the Company has agreed to suspend the development
of Angiolix until such time as the Company has paid the 2006 Annual Maintenance
Fee. In addition, each of the product development milestones with respect to
Angiolix set forth in the License Agreement has been reset to begin at such time
as we make the 2006 Annual Maintenance Fee payment.
In
addition, the Company agreed to reimburse Immunodex for certain out of pocket
expenses in the aggregate amount of approximately $21,000, which amount was
payable upon the execution of the Side Amendment.
On
January 18, 2007 the Company entered into an Amendment to the Side Amendment
which defers the amounts due on January 31, 2007, including the 2006 Annual
Maintenance Fee, until July 31, 2007. In consideration for the deferral, the
Company will pay $12,000 for each month of the deferral. In addition, the
Company paid $2,050 of patent annuity payments.
F-53
On
November 8, 2006, the Company made application to the National Institutes
of Health for a non-exclusive license to certain patents held by NIH related to
the humanization of Angiolix (huMc-3 mAb). On December 5, 2006 NIH
provided the Company with proposed terms for a non-exclusive license. On May 15,
2007, the NIH terminated Somanta’s non-exclusive license application since
Somanta had not accepted the terms and had not executed the proposed license
agreement.
The School of Pharmacy, University
of London (SOP)
In March
2004, the Company entered into a Patent and Know-how Assignment and License
Option Agreement with The School of Pharmacy, University of London. The
Agreement granted to the Company an option to acquire the rights to the key
patent application related to di-N-oxides of chloroethylaminoanthraquinone as a
bioreductive prodrug and an exclusive worldwide license to the related know-how
for development and commercialization in the field of the treatment of cancer.
Pursuant to this agreement, the Company paid an initial option fee of $44,575
and issued 131,505 shares of common stock valued at $2,630 to The School of
Pharmacy. In September 2005, The School of Pharmacy formally assigned to the
Company the rights to the key patent application and the relevant know-how in
the field of the treatment of cancer. The Agreement obligate the Company to pay
The School of Pharmacy certain milestone payments based on the achievement of
agreed upon clinical milestones with respect to the prodrug. If the Company
successfully achieve each of these milestones, it would be obligated to pay The
School of Pharmacy a total aggregate amount of milestone payments of
GBP 275,000, or approximately $550,000. The Company is obligated to use its
commercial best efforts to achieve these agreed upon clinical milestones. If the
Company fails to achieve any of these agreed upon clinical milestones, The
School of Pharmacy would have the right to terminate the know-how license under
the agreement. In addition, the Company is obligated to pay The School of
Pharmacy a royalty on net sales, if any, of products based on the prodrug. The
Company has the right to terminate the agreement with the The School of Pharmacy
on 90 days advance notice, and either party has the right to terminate the
agreement for breach by the other party upon 90 days advance notice (60 days for
payment failures), if such breach is not cured within the notice period. In
February, 2006, SOP waived the condition in the agreement that the Company
assign the patent back to SOP if the Company was unable to complete a
substantial funding by December 31, 2005.
Virium Pharmaceuticals, Inc.
(Virium)
In
February 2005, Bridge Oncology Products, Inc. (BOPI), entered into a
Phenylbutyrate Co-development and Sublicense Agreement with Virium
Pharmaceuticals, Inc. covering the worldwide rights, excluding the United States
and Canada, for the treatment of cancer, autoimmune diseases and other clinical
indications. BOPI paid an upfront license fee of $50,000. As a result of the
exchange agreement with BOPI, the Company has succeeded to the rights and
obligations under this Agreement. The Company’s single largest stockholder, SCO
Capital Partners, LLC, is also the single largest stockholder of Virium
Pharmaceuticals, Inc., and the companies share a common director.
Virium is
also a party to a sublicense agreement with VectraMed, Inc. for the rights to
develop and commercialize PB worldwide for the treatment of cancer, autoimmune
diseases and other clinical indications. In turn, VectraMed has obtained its
rights to the product under an Exclusive Patent License Agreement dated
May 25, 1995 with the U.S. Public Health Service (“PHS”) representing the
National Institutes of Health. VectraMed subsequently assigned all its rights to
PB to Virium pursuant to a novation agreement dated May 10, 2005. Virium is
in the process of obtaining PHS approval for this agreement.
The
Company is responsible for the conduct of clinical trials and patent prosecution
outside the United States and Canada and payment of royalties to Virium on net
product sales until such time as the patents covering such products
expire. These patents expire at various times between 2011 and
2016.
The
Company’s agreement with Virium does not fully comply with the sublicensing
requirements set forth in Virium’s agreement with the National Institutes of
Health because it does not expressly incorporate by reference all of the
relevant sections of Virium’s license with NIH. The Company is currently
seeking to amend its agreement with Virium to bring it into full compliance with
such sublicensing requirements and to permit the Company to become a direct
licensee of the NIH, should Virium default on its license with the
NIH.
On
October 20, 2006, NIH conditionally consented to the sublicense to the
Company. However, the NIH conditions include an amendment to the Virium license
to reflect an updated Virium development plan and milestones, the payment of
$216,971 in past due patent expenses and the payment of a $5,000 sublicense
royalty. Based on the information provided by NIH, it appears that about
$200,000 relates to foreign patent expenses for calendar 2005 which would be the
Company’s responsibility under its license agreement
with Virium. Of that amount, approximately $12,000 relates to foreign patent
maintenance fees and $197,000 largely relates to foreign patent legal
expenses. Somanta accrued an additional approximately $38,700 as patent
annuity and legal expense for the year ended April 30, 2007. Virium advised
Somanta that they satisfied two of the three conditions to obtaining final NIH
approval for Somanta’s sublicense. Virium is in the process of negotiating an
installment payment plan with respect to the past due patent
expenses.
F-54
On
December 6, 2006, the Company signed a letter of intent (LOI) pertaining to a
license and collaboration agreement with Virium covering all formulations or
drug combinations where Phenylbutyrate is an active ingredient. Pursuant
to the LOI, in addition to current worldwide rights, excluding North America,
involving the current formulation of Phenylbutyrate, Somanta would obtain a
participation in any revenue or royalties derived from sales in North
America. In return, we would grant Virium a reciprocal participation in
Europe. In the rest of the world, Somanta and Virium would share revenues
and royalties equally. The LOI’s terms provide that both companies will, among
other things, share data and jointly undertake the necessary pre-clinical and
clinical studies, seek regulatory approvals and file for patent protection in
all territories. It also provides for the formation of a joint development
committee to oversee all aspects of the development and commercialization of
Phenylbutyrate. Completion of the transaction contemplated by the LOI remains
subject to the negotiation and execution of a definitive agreement.
COLLABORATIONS
Cancer Research Institute of Contra
Costa (CRICC)
In August
2005, the Company entered into an Agreement Regarding Academic Clinical Study
with the Cancer Research Institute of Contra Costa to provide financial support
for an on-going Phase I-II clinical trial of patients with recurrent, metastatic
breast cancer using the humanized monoclonal antibody BrE-3, labeled with
Yttrium-90. In this trial, the antibody is being administered to patients in
combination with the chemotherapeutic drug, Xeloda®. This
agreement superseded a similar agreement signed in October 2003, which related
to the same subject matter. Pursuant to this agreement, the Company is obligated
to reimburse the Cancer Research Institute of Contra Costa over the twenty-four
moths after the date of the agreement for the costs associated with the
treatment of at least 10 patients with recurrent, metastatic breast cancer that
are enrolled in the current Phase I/II clinical trial of Phoenix, which is being
conducted at New York University/Bellevue Hospital. The Company does not expect
these reimbursement payments to exceed $300,000 in the aggregate.
Effective
November 3, 2006, the Company entered into a Side Amendment to Patent and
Know-how Exclusive Sublicense Agreement with Immunodex and the Cancer Research
Institute of Contra Costa (“CRICC”) (the “Side Amendment”). Pursuant to the
Side Amendment, the Company elected to terminate the License Agreement with
respect to huBrE-3 mAb product candidate. As a result, the Company has
terminated all development activities with respect to huBrE-3 mAb and returned
the related cell lines to Immunodex. In connection therewith, the Company has
terminated its financial support of the clinical trial currently being conducted
at New York University with respect to huBrE-3 mAB (the “huBrE-3 mAb Clinical
Trial”). The Company has agreed to pay a total of $31,400 to CRICC for the two
patients that were dosed in the huBrE-3 mAb Clinical Trial, which amount shall
become due and payable at the time the Company becomes obligated to make the
2006 Annual Maintenance Fee payment.
University of Bradford
(“UoB”)
On
March 1, 2006, the Company entered into an agreement with the University of
Bradford, Leeds, United Kingdom for the Company to fund a two-year research and
development project staffed by UoB scientists to evaluate di-N-oxides of
chloroethylaminoanthraquinones as a bioreductive prodrug and to evaluate and
provide data on chloroethylaminoanthraquinones to support the requirements to
initial clinical trials. The Company paid $84,835 and accrued $180,000 for
project costs based on this agreement as of April 30, 2007. In May 2007, UoB
threaten suit for non-payment of the amounts owed.
Imperial College of Science,
Technology and Medicine (“Imperial College”)
On
July 27, 2006, the Company entered into an agreement with Imperial College
and a post-graduate student for the Company to fund a three-year pre-clinical
research project staffed by Imperial College scientists to evaluate Angiolix
(huMc-3 mAb) for anti-vascular cancer therapy. The Company has accrued $10,000
for the project costs in the year ended April 30, 2007.
F-55
OUT-LICENSING
AGREEMENT
Advanced Cardiovascular Devices LLC
(ACD)
On
August 31, 2004, the Company entered into a research collaboration and
license agreement with ACD. Under the agreement Somanta granted to ACD an
exclusive license to use Somanta’s intellectual property, including the licensed
patent and know-how related to chloroethlylaminoanthraquinone (see De Montfort
University), a cytotoxic small molecule, in the field of vascular disorders
using stents and devices in that field. The term of this agreement expires when
the underlying patent expires in 2015. ACD agreed to pay Somanta a licensing fee
at such time as ACD had received funding, plus milestones, and royalties on
future product sales. In August, 2005, ACD paid the Company a non-refundable
licensing fee of $10,000. In addition, ACD is obligated to develop a product
based on the small molecule pursuant to an agreed-upon timetable. If ACD fails
to achieve any of the agreed upon milestones, the Company would have the right
to terminate the agreement; provided, however, that ACD could prevent the
Company from so terminating the agreement with respect to the applicable failure
by paying the Company a fee not to exceed $500,000 to reinstate its rights under
the agreement. In addition, ACD is also obligated to pay the Company a royalty
based on net sales, if any, of products based on the small molecule. Either
party may terminate this agreement on 30 days advance notice for breach by the
other party if the breach is not cured within such 30 day period. In addition,
ACD may terminate the agreement upon written notice to the Company and without
any further obligation if the licensed technology does not perform to the
reasonable satisfaction of ACD or cannot be commercialized because of safety or
efficacy reasons or because ACD is unable to raise the funds necessary to
develop a product based on the licensed technology.
15. MERGER
AGREEMENT
On April
18, 2007, the Company, Somanta Incorporated, a wholly-owned subsidiary of the
Company and Somanta Limited, a wholly-owned subsidiary of Somanta
Incorporated, and Access Pharmaceuticals, Inc. (“Access”) and Somanta
Acquisition Corporation (“Merger Sub”), a wholly-owned subsidiary of Access and
a Delaware corporation, entered into an Agreement and Plan of Merger (the
“Merger Agreement”). Pursuant to the terms and subject to the conditions set
forth in the Merger Agreement, Merger Sub will merge with and into Somanta, with
Somanta continuing as the surviving corporation and becoming a wholly-owned
subsidiary of Access (the “Merger”). In addition, Access has received voting
agreements with certain executive officers, directors and affiliates of Somanta
representing approximately 81% of Somanta’s outstanding common and approximately
60% of its outstanding preferred shares under which the parties, subject to
certain limited exceptions, have granted an irrevocable proxy to Access to vote
their shares in favor of the merger.
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the “Effective Time”) will be converted into
500,000 shares of Access common stock. No fractional shares of Access common
stock will be issued as a result of the Merger. In addition, all of Somanta’s
preferred stock, including accrued and unpaid dividends, that is outstanding at
the Effective Time of the Merger will be converted into 1,000,000 shares of
Access’ common stock. No shares of Access preferred stock will be issued as a
result of the Merger.
As of
April 18, 2007, there were (i) 15,459,137 shares of Somanta’s common stock
outstanding, including 1,166,534 shares issuable upon the exercise of warrants
that are expected to be exercised prior to the Effective Time, and (ii) 591.6
shares of Somanta’s preferred stock outstanding. Also as of April 18, 2007,
there were outstanding warrants to purchase 5,936,304 shares of Somanta’s common
stock that are not expected to be exercised prior to the Effective Time and are
expected to be converted into warrants to purchase approximately 192,000 shares
of Access’ common stock (subject to adjustment as provided in the Merger
Agreement).
The
completion of the Merger is subject to various conditions to closing, including,
without limitation, obtaining the approval of the Somanta stockholders. The
Merger is intended to qualify as reorganization for federal income tax
purposes.
F-56
Somanta Pharmaceuticals,
Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Condensed
Consolidated Balance Sheets
|
(Unaudited)
October
31, 2007
|
(Audited)
April
30,
2007
|
||||||
|
Assets
|
|||||||
|
Current
assets:
|
|||||||
|
Cash
|
$
|
1,424
|
$
|
5,385
|
|||
|
Prepaid
expenses
|
25,391
|
43,308
|
|||||
|
Total
current assets
|
26,815
|
48,693
|
|||||
|
Office equipment, net of
accumulated depreciation of $9,441 and $6,750 for the period ended October
31, 2007 and April 30, 2007, respectively
|
13,870
|
16,560
|
|||||
|
Other
assets:
|
|||||||
|
Restricted
funds
|
—
|
2,000
|
|||||
|
Deposits
|
73
|
73
|
|||||
|
Total
other assets
|
73
|
2,073
|
|||||
|
Total
assets
|
$
|
40,758
|
$
|
67,326
|
|||
|
Liabilities
and Stockholders’ Deficit
|
|||||||
|
Current
liabilities:
|
|||||||
|
Accounts
payable
|
$
|
1,027,819
|
$
|
774,022
|
|||
|
Due
to related parties
|
281,335
|
241,874
|
|||||
|
Accrued
expenses
|
969,121
|
811,539
|
|||||
|
Accrued
research and development expenses
|
354,733
|
554,733
|
|||||
|
Note
payable
|
822,712
|
33,462
|
|||||
|
Liquidated
damages related to Series A preferred stock and warrants
|
35,200
|
35,200
|
|||||
|
Deferred
revenue
|
6,429
|
7,143
|
|||||
|
Warrant
liabilities
|
117,636
|
5,786,844
|
|||||
|
Total
current liabilities
|
3,614,985
|
8,244,817
|
|||||
|
Stockholders’
deficit:
|
|||||||
|
Preferred
stock - $0.001 par value, 20,000,000 shares authorized Series A
Convertible Preferred Stock, $0.001 par value, 2,000 shares designated,
591.6318 issued and outstanding as of October 31, 2007 and April 30,
2007
|
1
|
1
|
|||||
|
Common
stock, $0.001 par value, 100,000,000 shares authorized, 15,459,137 shares
issued and outstanding as of October 31, 2007 and April 30,
2007
|
15,460
|
14,293
|
|||||
|
Additional
paid-in capital
|
7,614,859
|
7,604,360
|
|||||
|
Deficit
accumulated during development stage
|
(11,204,549
|
)
|
(15,796,145
|
)
|
|||
|
Total
stockholders’ deficit
|
(3,574,229
|
)
|
(8,177,491
|
)
|
|||
|
Total
liabilities and stockholders’ deficit
|
$
|
40,756
|
$
|
67,326
|
|||
The
accompanying notes to condensed consolidated financial statements are an
integral part of these statements.
F-57
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Three
Months and Six Months Ended October 31, 2007 and 2006 and for the
Period
from
Inception of Operations
(April
19, 2001) to October 31, 2007
(Unaudited)
|
From Inception
of
Operations
(April 19, 2001) to
October 31,
2007
|
||||||||||||||||
|
Three
Months Ended
October 31,
|
Six
Months Ended
October 31,
|
|||||||||||||||
|
2007
|
2006
|
2007
|
2006
|
|||||||||||||
|
Revenue
|
$
|
357
|
$
|
357
|
$
|
714
|
$
|
714
|
$
|
3,571
|
||||||
|
Operating
expenses:
|
||||||||||||||||
|
General
and administrative
|
(293,809
|
)
|
(874,810
|
)
|
(726,685
|
)
|
(1,700,359
|
)
|
(8,063,803
|
)
|
||||||
|
Research
and development
|
(269,688
|
)
|
(583,318
|
)
|
(321,827
|
)
|
(901,352
|
)
|
(3,422,474
|
)
|
||||||
|
Loss
from operations
|
(563,140
|
)
|
(1,457,771
|
)
|
(1,047,798
|
)
|
(2,600,997
|
)
|
(11,482,706
|
)
|
||||||
|
Other
income (expense):
|
||||||||||||||||
|
Interest
income
|
—
|
11,475
|
5
|
28,554
|
40,437
|
|||||||||||
|
Interest
expense
|
(20,181
|
)
|
—
|
(27,316
|
)
|
—
|
(1,043,390
|
)
|
||||||||
|
Liquidated
damages
|
—
|
85,302
|
—
|
(35,200
|
)
|
(35,200
|
)
|
|||||||||
|
Change
in fair value of warrant liabilities
|
88,157
|
119,762
|
5,669,206
|
394,324
|
2,875,631
|
|||||||||||
|
Gain
on settlement of debt
|
—
|
—
|
—
|
—
|
5,049
|
|||||||||||
|
Currency
translation loss
|
(589
|
)
|
(768
|
)
|
(710
|
)
|
(2,002
|
)
|
(34,206
|
)
|
||||||
|
Income
(loss) before income taxes
|
(495,753
|
)
|
(1,242,000
|
)
|
4,593,387
|
(2,215,321
|
)
|
(9,674,385
|
)
|
|||||||
|
Income
taxes
|
(1,600
|
)
|
—
|
(1,791
|
)
|
(250
|
)
|
(7,847
|
)
|
|||||||
|
Net
income (loss)
|
(497,353
|
)
|
(1,242,000
|
)
|
4,591,596
|
(2,215,571
|
)
|
(9,682,232
|
)
|
|||||||
F-58
|
Deemed
dividends on convertible preferred stock
|
—
|
—
|
—
|
—
|
(1,522,317
|
)
|
||||||||||
|
Net
income (loss) applicable to common shareholders
|
$
|
(497,353
|
)
|
$
|
(1,242,000
|
)
|
$
|
4,591,596
|
$
|
(2,215,571
|
)
|
$
|
(11,204,549
|
)
|
||
|
Net
income (loss) per share-basic
|
$
|
(0.03
|
)
|
$
|
(0.09
|
)
|
$
|
0.31
|
$
|
(0.16
|
)
|
$
|
(0.84
|
)
|
||
|
Weighted
average number of shares outstanding—basic
|
14,630,402
|
14,274,534
|
14,630,402
|
14,274,534
|
13,364,892
|
|||||||||||
|
Net
income (loss) per share-diluted
|
$
|
(0.03
|
)
|
$
|
(0.09
|
)
|
$
|
0.19
|
$
|
(0.16
|
)
|
$
|
(0.84
|
)
|
||
|
Weighted
average number of shares outstanding—diluted
|
14,630,402
|
14,274,534
|
23,889,527
|
14,274,534
|
13,364,892
|
The
accompanying notes to condensed consolidated financial statements are an
integral part of these statements.
F-59
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
For
the Period from Inception of Operations (April 19, 2001) to October 31, 2007
(Unaudited)
|
Preferred
Stock
|
Common Stock
|
|||||||||||||||||||||||
|
Shares
|
Amount
|
Shares | Amount |
Additional
Paid-in
Capital
|
Shares
to
be
Issued
|
|||||||||||||||||||
|
Balance
at April 19, 2001 (Inception)
|
— | $ | — | — | $ | — | $ | — | $ | — | ||||||||||||||
|
Shares
issued for cash at $.0326
|
4,299,860 | 4,300 | 135,680 | — | ||||||||||||||||||||
|
Shares
issued for services at $.0139
|
514,674 | 515 | 11,801 | |||||||||||||||||||||
|
Amortization
of deferred expense
|
||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
||||||||||||||||||||||||
|
Net
loss for the period from inception to April 30, 2002
|
||||||||||||||||||||||||
|
Balance
at April 30, 2002
|
— | — | 4,814,534 | 4,815 | 147,481 | — | ||||||||||||||||||
|
Shares
issued for cash at $1.0677
|
14,601 | 15 | 15,575 | |||||||||||||||||||||
|
Shares
issued for services at $.0214
|
219,010 | 219 | 4,472 | |||||||||||||||||||||
|
Amortization
of deferred expense
|
||||||||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2003
|
||||||||||||||||||||||||
|
Balance
at April 30, 2003
|
— | — | 5,048,145 | 5,049 | 167,528 | — | ||||||||||||||||||
|
Shares
issued for cash at $1.2479
|
350,164 | 350 | 436,637 | |||||||||||||||||||||
|
Shares
issued for services at $1.2587
|
22,233 | 22 | 27,962 | |||||||||||||||||||||
|
Amortization
of deferred expense
|
||||||||||||||||||||||||
|
Exchange
for loan payment and compensation
|
181,371 | |||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2004
|
||||||||||||||||||||||||
|
Balance
at April 30, 2004
|
— | — | 5,420,542 | 5,421 | 813,498 | — | ||||||||||||||||||
|
Shares
issued for cash at $1.3218
|
374,073 | 374 | 494,069 | |||||||||||||||||||||
|
Shares
issued for services at $1.2308
|
21,901 | 22 | 26,933 | |||||||||||||||||||||
|
3,650
shares to be issued for service at $1.4973
|
5,465 | |||||||||||||||||||||||
|
Amortization
of deferred expense
|
||||||||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
||||||||||||||||||||||||
|
Options
issued for services
|
257,515 | |||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2005
|
||||||||||||||||||||||||
|
Balance
at April 30, 2005
|
— | — | 5,816,516 | 5,817 | 1,592,015 | 5,465 | ||||||||||||||||||
|
Write
off foreign currency translation adjustment
|
||||||||||||||||||||||||
|
Shares
issued for cash at $1.5656
|
12,669 | 13 | 19,821 | |||||||||||||||||||||
|
Shares
issued for prior service
|
3,650 | 3 | 5,462 | (5,465 | ) | |||||||||||||||||||
|
Amortization
of deferred expense
|
||||||||||||||||||||||||
|
Options
issued for services
|
300,616 | |||||||||||||||||||||||
|
Recapitalization
with Bridge Oncology
|
7,865,000 | 7,865 | (92,335 | ) | ||||||||||||||||||||
F-60
|
Beneficial
conversion feature associated with convertible debt
financing
|
364,721 | ||||||||||||||||||||
|
Convertible
Series A Preferred shares issued for cash at $10,000
(net
of issuance costs of $544,169)
|
464 | 0.464 | 4,095,830 | ||||||||||||||||||
|
Convertible
Series A Shares issued on conversion of notes payable
|
128.6318 | 0.1286 | 1,286,318 | ||||||||||||||||||
|
Deemed
dividend on account of beneficial conversion feature associated with
issuance of Convertible Series A Preferred Shares
|
1,522,317 | ||||||||||||||||||||
|
Issuance
costs on warrants issued to placement agent in connection with the
Convertible Series A Preferred stock
|
(429,757 |
)
|
|||||||||||||||||||
|
Discount
on warrant issued with Convertible Series A Preferred
stock
|
(2,048,531 |
)
|
|||||||||||||||||||
|
Recapitalization
with Hibshman Optical Corp.
|
576,700 | 577 | (7,708 |
)
|
|||||||||||||||||
|
Warrant
expense
|
92,689 | ||||||||||||||||||||
|
Net
loss for the year ended April 30, 2006
|
|||||||||||||||||||||
|
Balance
at April 30, 2006
|
592.6318 | .5926 | 14,274,535 | 14,275 | 6,701,458 | — | ||||||||||||||||||
|
Options
issued for services
|
739,000 | |||||||||||||||||||||||
|
Warrant
expense
|
163,920 | |||||||||||||||||||||||
|
Conversion
of preferred stock
|
(1.000 | ) | (.0010 | ) | 18,069 | 18 | (18 | ) | ||||||||||||||||
|
Net
loss for the year ended April 30, 2007
|
||||||||||||||||||||||||
|
Balance
at April 30, 2007
|
591.6318 | .5916 | 14,292,604 | 14,293 | 7,604,360 | |||||||||||||||||||
|
Conversion
of warrants
|
1,166,534 | 1,167 | 10,499 | |||||||||||||||||||||
|
Net
income for the six months ended October 31, 2007
|
||||||||||||||||||||||||
|
Balance
at October 31, 2007 (unaudited)
|
591.6318 | $ | .5916 | 15,459,138 | $ | 15,460 | $ | 7,614,859 | — | |||||||||||||||
F-61
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Condensed
Consolidated Statement of Stockholders’ Deficit
For
the Period from Inception of Operations
(April
19, 2001) to October 31, 2007 (Unaudited)
|
Subscription
Receivable
|
Deferred
Equity-
Based
Expense
|
Accumulated
Other
Comprehensive
Loss
- Foreign
Currency
Translation
Adjustment
|
Deficit
Accumulated
During
Development
Stage
|
Total
Stockholders’
Equity/(Deficit)
|
||||||||||||||||
|
Balance
at April 19, 2001(Inception)
|
$ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||
|
Shares
issued for cash at $.0326
|
(97,245 | ) | — | — | — | 42,735 | ||||||||||||||
|
Shares
issued for services at $.0139
|
(11,177 | ) | 1,139 | |||||||||||||||||
|
Amortization
of deferred expense
|
521 | 521 | ||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
29,905 | 29,905 | ||||||||||||||||||
|
Net
loss for the period from inception to April 30, 2002
|
(95,901 | ) | (95,901 | ) | ||||||||||||||||
|
Balance
at April 30, 2002
|
(97,245 | ) | (10,656 | ) | 29,905 | (95,901 | ) | (21,601 | ) | |||||||||||
|
Shares
issued for cash at $1.0677
|
15,590 | |||||||||||||||||||
|
Shares
issued for services at $.0214
|
(3,127 | ) | 1,564 | |||||||||||||||||
|
Amortization
of deferred expense
|
3,808 | 3,808 | ||||||||||||||||||
|
Receipt
of cash for subscription
Receivable
|
91,517 | 91,517 | ||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
1,534 | 1,534 | ||||||||||||||||||
|
Net
loss for the year ended April 30, 2003
|
(111,456 | ) | (111,456 | ) | ||||||||||||||||
|
Balance
at April 30, 2003
|
(5,728 | ) | (9,975 | ) | 31,439 | (207,357 | ) | (19,044 | ) | |||||||||||
|
Shares
issued for cash at $1.2479
|
(81,464 | ) | 355,523 | |||||||||||||||||
|
Shares
issued for services at $1.2587
|
(25,216 | ) | 2,768 | |||||||||||||||||
|
Amortization
of deferred expense
|
7,691 | 7,691 | ||||||||||||||||||
|
Exchange
for loan payment and compensation
|
2,909 | 184,280 | ||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
(51,651 | ) | (51,651 | ) | ||||||||||||||||
|
Net
loss for the year ended April 30, 2004
|
(439,453 | ) | (439,453 | ) | ||||||||||||||||
F-62
|
Balance
at April 30, 2004
|
(84,283 | ) | (27,500 | ) | (20,212 | ) | (646,810 | ) | 40,114 | |||||||||||
|
Shares
issued for cash at $1.3218
|
494,443 | |||||||||||||||||||
|
Shares
issued for services at $1.2308
|
26,955 | |||||||||||||||||||
|
3,650
shares to be issued for service at $1.4973
|
5,465 | |||||||||||||||||||
|
Amortization
of deferred expense
|
26,939 | 26,939 | ||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
84,283 | 84,283 | ||||||||||||||||||
|
Options
issued for services
|
257,515 | |||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
(5,719 | ) | (5,719 | ) | ||||||||||||||||
|
Net
loss for the year ended April 30, 2005
|
(1,129,290 | ) | (1,129,290 | ) | ||||||||||||||||
|
Balance
at April 30, 2005
|
— | (561 | ) | (25,931 | ) | (1,776,100 | ) | (199,295 | ) | |||||||||||
|
Write
off foreign currency translation adjustment
|
25,931 | 25,931 | ||||||||||||||||||
|
Shares
issued for cash at $1.5656
|
19,834 | |||||||||||||||||||
|
Shares
issued for prior service
|
— | |||||||||||||||||||
|
Amortization
of deferred expense
|
561 | 561 | ||||||||||||||||||
|
Options
issued for services
|
300,616 | |||||||||||||||||||
|
Recapitalization
with Bridge Oncology
|
(84,470 | ) | ||||||||||||||||||
|
Beneficial
conversion feature associated with convertible debt
financing
|
364,721 | |||||||||||||||||||
|
Convertible
Series A Preferred shares issued for cash at $10,000 (net of issuance
costs of $544,169)
|
4,095,830 | |||||||||||||||||||
|
Convertible
Series A Shares issued on conversion of notes payable
|
1,286,318 | |||||||||||||||||||
|
Deemed
dividend on account of beneficial conversion feature associated with
issuance of Convertible Series A Preferred Shares
|
(1,522,317 | ) | — | |||||||||||||||||
|
Issuance
costs on warrants issued to placement agent in connection with the
Convertible Series A Preferred stock
|
(429,757 | ) | ||||||||||||||||||
|
Discount
on warrant issued with Convertible Series A Preferred
stock
|
(2,048,531 | ) | ||||||||||||||||||
|
Recapitalization
with Hibshman Optical Corp.
|
(7,131 | ) | ||||||||||||||||||
|
Warrant
expense
|
92,689 | |||||||||||||||||||
|
Net
loss for the year ended April 30, 2006
|
(5,002,091 | ) | (5,002,091 | ) | ||||||||||||||||
|
Balance
at April 30, 2006
|
— | — | — | (8,300,508 | ) | (1,584,775 | ) | |||||||||||||
|
Options
issued for services
|
739,000 | |||||||||||||||||||
|
Warrant
expense
|
163,920 | |||||||||||||||||||
|
Conversion
of preferred stock
|
— | |||||||||||||||||||
|
Net
loss for the year ended April 30, 2007
|
(7,495,637 | ) | (7,495,637 | ) | ||||||||||||||||
|
Balance
at April 30, 2007
|
— | — | — | (15,796,145 | ) | (8,177,492 | ) | |||||||||||||
|
Conversion
of warrants
|
11,666 | |||||||||||||||||||
|
Net
income for the six months ended October 31, 2007
|
4,591,596 | 4,591,596 | ||||||||||||||||||
|
Balance
at October 31, 2007 (unaudited)
|
$ | — | $ | — | — | $ | (11,204,549 | ) | $ | (3,574,229 | ) | |||||||||
The
accompanying notes to condensed consolidated financial statements are an
integral part of these statements.
F-63
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Six
Months Ended October 31, 2007 and 2006 and for the Period from Inception of
Operations
(April
19, 2001) to October 31, 2007
(Unaudited)
|
From
Inception of
Operations
(April
19, 2001) to
October
31, 2007
|
||||||||||
|
Six
Months Ended October 31,
|
||||||||||
|
2007
|
2006
|
|||||||||
|
Cash
flows provided by (used for) operating activities:
|
||||||||||
|
Net
income (loss)
|
|
4,591,596
|
|
(2,215,571
|
)
|
|
(9,682,232
|
)
|
||
|
Adjustments
to reconcile net loss to net cash provided by (used for) operating
activities:
|
||||||||||
|
Depreciation
|
2,690
|
2,770
|
9,684
|
|||||||
|
Gain
on sale of equipment
|
—
|
(622
|
)
|
(622
|
)
|
|||||
|
Amortization
of stock based expense
|
—
|
—
|
39,520
|
|||||||
|
Write
off foreign currency translation adjustment
|
—
|
—
|
25,931
|
|||||||
|
Change
in fair value of warrant liabilities
|
(5,669,206
|
)
|
(394,324
|
)
|
(2,875,631
|
)
|
||||
|
Shares
issued for services and compensation
|
—
|
—
|
219,262
|
|||||||
|
Gain
on settlement of debts
|
—
|
—
|
(5,049
|
)
|
||||||
|
Options
expense
|
—
|
124,376
|
1,297,131
|
|||||||
|
Warrants
expense
|
—
|
—
|
256,609
|
|||||||
|
Interest
expense related to beneficial conversion feature on convertible
note
|
—
|
—
|
364,721
|
|||||||
|
Interest
expense related to warrants issued on convertible note
|
—
|
—
|
514,981
|
|||||||
|
Changes
in assets and liabilities:
|
||||||||||
|
(Increase)
decrease in assets -
|
||||||||||
|
VAT
receivable
|
—
|
1,628
|
3,444
|
|||||||
|
Other
receivable
|
—
|
(22,509
|
)
|
—
|
||||||
|
Restricted
funds
|
2,000
|
(2,269
|
)
|
—
|
||||||
|
Prepaid
expenses
|
17,917
|
33,093
|
(25,120
|
)
|
||||||
|
Deposits
|
—
|
—
|
(73
|
)
|
||||||
|
Increase
(decrease) in liabilities:
|
||||||||||
|
Accounts
payable
|
229,784
|
214,931
|
1,012,445
|
|||||||
|
Accrued
liabilities
|
(42,418
|
)
|
783,221
|
1,311,994
|
||||||
|
Liquidated
damages
|
—
|
35,200
|
35,200
|
|||||||
|
Deferred
revenue
|
(714
|
)
|
(714
|
)
|
6,429
|
|||||
|
Due
to officers and related parties
|
75,140
|
152,003
|
171,120
|
|||||||
|
Net
cash used for operating activities
|
(793,211
|
)
|
(1,288,787
|
)
|
(7,320,256
|
)
|
||||
|
Cash
flows used for investing activities:
|
||||||||||
|
Purchase
of equipment
|
—
|
—
|
(24,824
|
)
|
||||||
|
Proceeds
from sale of equipment
|
—
|
2,000
|
2,000
|
|||||||
|
Net
cash used for investing activities
|
—
|
2,000
|
(22,824
|
)
|
||||||
|
Cash
flows provided by financing activities:
|
||||||||||
|
Loan
payable—related party
|
—
|
—
|
79,402
|
|||||||
|
Loan
payment-related party
|
—
|
—
|
(7,367
|
)
|
||||||
|
Proceeds
from convertible note-related party
|
—
|
—
|
1,250,000
|
|||||||
|
Proceeds
from note payable
|
789,250
|
—
|
822,712
|
|||||||
|
Proceeds
from issuance of common stock
|
—
|
—
|
928,125
|
|||||||
|
Proceeds
from issuance of preferred stock
|
—
|
—
|
4,095,831
|
|||||||
|
Cash
received for subscription receivable
|
—
|
—
|
175,801
|
|||||||
F-64
|
Net
cash provided by financing activities
|
789,250
|
—
|
7,344,504
|
|||||||
|
Effect
of exchange rate changes on cash
|
—
|
—
|
—
|
|||||||
|
Increase
(decrease) in cash
|
(3,961
|
)
|
(1,286,787
|
)
|
1,424
|
|||||
|
Cash, beginning of
period
|
5,385
|
1,587,751
|
—
|
|||||||
|
Cash, end of
period
|
1,424
|
|
300,964
|
|
1,424
|
|||||
|
Supplemental
disclosure of cash flow information:
|
||||||||||
|
Interest
paid
|
|
—
|
|
—
|
|
—
|
||||
|
Income
tax paid
|
|
—
|
|
—
|
|
—
|
||||
|
Supplemental
disclosure of non-cash operating and financing activities:
|
||||||||||
|
Loan
reduction with shares
|
|
—
|
|
—
|
|
2,909
|
||||
|
Receivable
from issuance of convertible stock
|
|
—
|
|
—
|
|
—
|
||||
|
Issuance
of warrants in conjunction with convertible preferred
stock
|
|
—
|
|
—
|
|
2,341,785
|
||||
|
Deemed
dividends related to convertible preferred stock
|
|
—
|
|
—
|
|
1,522,317
|
||||
|
Conversion
of note and accrued interest
|
|
—
|
|
—
|
|
1,286,318
|
||||
|
Accrued
issuance costs related to convertible stock
|
|
—
|
|
—
|
|
—
|
||||
The
accompanying notes to condensed consolidated financial statements are an
integral part of these statements.
F-65
SOMANTA
PHARMACEUTICALS, INC. AND SUBSIDIARIES
(Unaudited)
|
1.
|
ORGANIZATION,
BASIS OF PRESENTATION, AND NATURE OF OPERATIONS
|
Organization
Somanta
Pharmaceuticals, Inc. is a Delaware corporation that was formed for the purpose
of effecting the reincorporation of Hibshman Optical Corp., a New Jersey
corporation, into the State of Delaware and for the purpose of consummating a
business combination via a reverse merger of Somanta Incorporated and Hibshman
Optical Corp. Pursuant to this reverse merger, Somanta Incorporated became the
wholly-owned subsidiary of Somanta Pharmaceuticals, Inc. and the sole operating
subsidiary of Somanta Pharmaceuticals, Inc. For financial reporting purposes,
this transaction has been reflected in the accompanying financial statements as
a recapitalization of Somanta Incorporated and the financial statements of
Somanta Pharmaceuticals, Inc. reflect the historical financial information of
Somanta Incorporated. References herein to the “Company” or “Somanta” are
intended to refer to each of Somanta Pharmaceuticals, Inc. and its wholly owned
subsidiary Somanta Incorporated, as well as Somanta Incorporated’s wholly-owned
subsidiary Somanta Limited.
Hibshman
Optical Corp. was originally incorporated in the State of New Jersey in 1991
under the name PRS Sub I, Inc. The name subsequently changed to Service Lube,
Inc., then to Fianza Commercial Corp. and then to Hibshman Optical Corp. The
business plan since that time had been to seek to enter into a business
combination with an entity that had ongoing operations through a reverse merger
or other similar type of transaction.
Somanta
Incorporated was incorporated as Somantis Limited under the laws of England and
Wales on April 19, 2001. Somantis Limited changed its name to Somanta Limited on
March 14, 2005, and performed business as a United Kingdom entity through the
fiscal year ending April 30, 2005. On August 22, 2005, Somanta Limited became a
wholly owned subsidiary of Bridge Oncology Products, Inc. (“BOPI”), a privately
held Delaware corporation, pursuant to a share exchange with BOPI; however,
Somanta Limited was deemed the accounting acquirer in this share exchange
transaction. On August 24, 2005, the name of BOPI was changed to Somanta
Incorporated.
Somanta
Pharmaceuticals, Inc. is a development stage biopharmaceutical company engaged
in the development of products for the treatment of cancer. The Company has
in-licensed four product development candidates from academic and research
institutions in the United States and Europe designed for use in anti-cancer
therapy in order to advance them along the regulatory and clinical pathways
toward commercial approval. The Company intends to obtain approval from the
United States Food and Drug Administration (“FDA”) and from the European
Medicines Evaluation Agency (“EMEA”) for the products.
Somanta
is a development stage enterprise since the Company has not generated revenue
from the sale of its products, and its efforts have been principally devoted to
identification, licensing and clinical development of its products as well as
raising capital through October 31, 2007. Accordingly, the financial statements
have been prepared in accordance with the provisions of Statement of Financial
Accounting Standards (SFAS) No. 7, “Accounting and Reporting by Development
Stage Enterprises.”
Basis
of Presentation
The
accompanying unaudited condensed interim consolidated financial statements have
been prepared in accordance with accounting principles generally accepted in the
United States of America for interim financial information and with the
instructions to Form 10-QSB and Article 10 of Regulation S-X. Accordingly, they
do not include all of the information and footnotes required by accounting
principles generally accepted in the United States of America for complete
financial statements. These condensed consolidated financial statements should
be read in conjunction with the consolidated financial statements and notes for
the years ended April 30, 2007 and 2006.
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and accompanying notes.
Actual results could differ from those estimates. In the opinion of management,
all adjustments (consisting solely of normal recurring adjustments) considered
necessary for a fair presentation have been included. Operating results for the
six months ended October 31, 2007 are not necessarily indicative of the results
that may be expected for the full fiscal year ending April 30,
2008.
The
Company reported a net income and net income applicable to common stockholders
of $4,591,596 for the six month period ended October 31, 2007. The net loss from
date of inception, April 19, 2001 to October 31, 2007, totaled $9,682,232 (net
loss applicable to common stockholders of $11,204,549). The Company’s operating
activities have used cash since its inception. These losses raise substantial
doubt about the Company’s ability to continue as a going concern.
F-66
On
April 18, 2007, the Company, Somanta Incorporated, a wholly-owned subsidiary of
the Company and Somanta Limited, a wholly-owned subsidiary of Somanta
Incorporated, and Access Pharmaceuticals, Inc. (“Access”) and Somanta
Acquisition Corporation (“Merger Sub”), a wholly-owned subsidiary of Access and
a Delaware corporation, entered into an Agreement and Plan of Merger (the
“Merger Agreement”). Pursuant to the terms and subject to the conditions set
forth in the Merger Agreement, Merger Sub will merge with and into Somanta, with
Somanta continuing as the surviving corporation and becoming a wholly-owned
subsidiary of Access (the “Merger”). The Board of Directors of Somanta has
approved the Merger and the Merger Agreement. On August 17, 2007 the Company’s
stockholders approved the merger.
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the “Effective Time”) will be converted into
500,000 shares of Access common stock. No fractional shares of Access common
stock will be issued as a result of the Merger. In addition, all of Somanta’s
preferred stock, included accrued and unpaid dividends, that are outstanding at
the Effective Time of the Merger will be converted into 1,000,000 shares of
Access’ common stock. No shares of Access preferred stock will be issued as a
result of the Merger.
On
April 26, 2007, the Company entered into a Note Purchase Agreement, a Security
Agreement, a Patent Collateral Assignment and Security Agreement and a Trademark
Collateral Security and Pledge Agreement (collectively, the “Loan Documents”)
with Access Pharmaceuticals, Inc. as more fully described in Note 7. Under the
terms of the Loan Documents, Access initially loaned the Company $33,462
($822,712 at October 31, 2007). Access, in its sole discretion, may from time to
time advance additional loan amounts to the Company. All amounts loaned to the
Company by Access are secured by substantially all of the assets of the Company
pursuant to the terms of the Loan Documents. The Note bears interest at 10% and
is repayable at the earlier of: (i) August 31, 2007, or (ii) the date of the
termination of the Agreement and Plan of Merger dated as of August 18, 2007
between the Company and Access. No demand for repayment has been made by Access.
To date the Merger has not closed since the Company has not been able to meet
one of the key closing conditions.
If the
merger fails to close, the Company expects that it will no longer be able to
operate its business and will not have the resources to repay the
loan.
The
financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the amounts
and classification of liabilities that may result from the possible inability of
the Company to continue as a going concern.
Reclassifications
For
comparative purposes, prior periods’ consolidated financial statements have been
reclassified to conform with report classifications of the current period. The
Company has reclassified certain expenses related to the in-licensing of product
candidates, milestone and license maintenance payments and patent expense from
general and administrative expense to research and development
expense.
Share-Based
Compensation
On
December 16, 2004, the FASB issued SFAS No. 123 (revised 2004), “Share-Based
Payment” (SFAS 123R). SFAS 123R eliminates the alternative of applying the
intrinsic value measurement provisions of APB 25 to stock compensation awards
issued to employees. Rather, the new standard requires enterprises to measure
the cost of employee services received in exchange for an award of equity
instruments based on the grant-date fair value of the award. That cost will be
recognized over the period during which an employee is required to provide
services in exchange for the award, known as the requisite service period
(usually the vesting period). On April 14, 2005, the Securities and Exchange
Commission announced the adoption of a rule that defers the required effective
date of SFAS 123R. The SEC rule provides that SFAS 123R is now effective for
registrants as of the beginning of the first fiscal year beginning after June
15, 2005.
Effective
May 1, 2006, the Company adopted SFAS 123R and accordingly has adopted the
modified prospective application method. Under this method, SFAS 123R is applied
to new awards and to awards modified, repurchased, or cancelled after the
effective date. Additionally, compensation cost for the portion of awards that
are outstanding as of the date of adoption for which the requisite service has
not been rendered (such as unvested options) is recognized over a period of time
as the remaining requisite services are rendered.
Prior to
May 1, 2006, the Company accounted for its employee stock option plan in
accordance with the provisions of SFAS No. 123, “Accounting for Stock-Based
Compensation,” and SFAS No. 148, “Accounting for Stock-Based
Compensation – Transition and Disclosure.”
Fair
Value of Financial Instruments
Statement
of Financial Accounting Standard No. 107, Disclosures About Fair Value of
Financial Instruments, requires that the company disclose estimated fair values
of financial instruments. The carrying amounts reported in the balance sheets
for current assets and current liabilities qualifying as financial instruments
are a reasonable estimate of fair value.
Basic
and diluted net income (loss) per share
Net
income (loss) per share is calculated in accordance with the Statement of
Financial Accounting Standards No. 128 (SFAS No. 128). Basic net income (loss)
per share is based upon the weighted average number of common shares
outstanding. Diluted net income (loss) per share is based on the assumption that
all potential dilutive convertible shares and stock options or warrants were
converted or exercised.
F-67
The
Company has the following dilutive convertible shares, stock options and
warrants as of October 31, 2007 and 2006 which were excluded from the
calculation for the six months ended October 31, 2007 and from inception to date
since the effect is anti-dilutive. For the six months ended October 31, 2007,
the convertible preferred stock have been included.
|
2007
|
||||||||||
|
Three
Months
Ended
October 31
|
Six
Months
Ended
October 31
|
2006
|
||||||||
|
Convertible
preferred stock
|
9,859,125
|
9,859,125
|
9,877,194
|
|||||||
|
Stock
options
|
—
|
—
|
3,642,747
|
|||||||
|
Warrants
|
5,936,304
|
7,102,838
|
6,952,838
|
|||||||
|
Total
|
15,795,429
|
16,961,963
|
20,472,779
|
|||||||
The
Company’s undeclared dividends on its Preferred Stock amounting to $115,605 for
the three months ended October 31, 2007 are included in the computation of net
income per share for the period ended October 31, 2007 in accordance with SFAS
No. 129.
Aggregate
undeclared dividends on Preferred Stock amounting to $820,918 are included in
the computation of net loss per share for the period from inception (April 19,
2001) to October 31, 2007.
Recent
Accounting Pronouncements
In
February 2006, the FASB issued SFAS 155 “Accounting for Certain Hybrid Financial
Instruments,” an amendment of FASB Statement No. 133 and in February 2006, the
FASB issued SFAS 155, “Accounting for Certain Hybrid Financial Instruments,” an
amendment of FASB Statements No. 133 and 140. This Statement amends FASB
Statements No. 133, “Accounting for Derivative Instruments and Hedging
Activities,” and No. 140, “Accounting for Transfers and Servicing of Financial
Assets and Extinguishments of Liabilities”. This Statement resolves issues
addressed in Statement 133 Implementation Issue No. D1, Application of Statement
133 to Beneficial Interests in Securitized Financial Assets. This
Statement:
|
a.
|
Permits
fair value remeasurement for any hybrid financial instrument that contains
an embedded derivative that otherwise would require
bifurcation;
|
|
|
b.
|
Clarifies
which interest-only strips and principal-only strips are not subject to
the requirements of Statement 133;
|
|
|
c.
|
Establishes
a requirement to evaluate interests in securitized financial assets to
identify interests that are freestanding derivatives or that are hybrid
financial instruments that contain an embedded derivative requiring
bifurcation;
|
|
|
d.
|
Clarifies
that concentrations of credit risk in the form of subordination are not
embedded derivatives; and
|
|
|
e.
|
Amends
Statement 140 to eliminate the prohibition on a qualifying special-purpose
entity from holding a derivative financial instrument that pertains to a
beneficial interest other than another derivative financial
instrument.
|
F-68
This
Statement is effective for all financial instruments acquired or issued after
the beginning of an entity’s first fiscal year that begins after September 15,
2006. The fair value election provided for in paragraph 4(c) of this Statement
may also be applied upon adoption of this Statement for hybrid financial
instruments that had been bifurcated under paragraph 12 of Statement 133 prior
to the adoption of this Statement. Earlier adoption is permitted as of the
beginning of an entity’s fiscal year, provided the entity has not yet issued
financial statements, including financial statements for any interim period for
that fiscal year. Provisions of this Statement may be applied to instruments
that an entity holds at the date of adoption on an instrument-by-instrument
basis. The Company has no new instruments impacted by SFAS 155.
In March
2006, the FASB issued SFAS No. 156 (“FAS 156”), “Accounting for Servicing of
Financial Assets-An Amendment of FASB Statement No. 140.” Among other
requirements, FAS 156 requires a company to recognize a servicing asset or
servicing liability when it undertakes an obligation to service a financial
asset by entering into a servicing contract under certain situations. Under FAS
156 an election can also be made for subsequent fair value measurement of
servicing assets and servicing liabilities by class, thus simplifying the
accounting and providing for income statement recognition of potential
offsetting changes in the fair value of servicing assets, servicing liabilities
and related derivative instruments. The Statement will be effective beginning
the first fiscal year that begins after September 15, 2006. The Company does not
expect the adoption of FAS 156 will have a material impact on the financial
position or results of operations.
In June
2006, the FASB issued FASB Interpretation (FIN) No. 48, “Accounting for
Uncertainty in Income Taxes,” that provides guidance on the accounting for
uncertainty in income taxes recognized in financial statements. The
interpretation was adopted by us on May 1, 2007. Because of the Company’s
operating losses, adoption of this provision does not have material effect on
the financial position, results of operations or cash flows.
In July
2006, the FASB issued FASB Staff Position (FSP) No. FAS 13-2, “Accounting for a
Change or Projected Change in the Timing of Cash Flows Relating to Income Taxes
Generated by a Leveraged Lease Transaction,” that provides guidance on how a
change or a potential change in the timing of cash flows relating to income
taxes generated by a leveraged lease transaction affects the accounting by a
lessor for the lease. This staff position was adopted by us on May 1, 2007. The
Company does not expect the adoption of this provision to have a material effect
on the financial position, results of operations or cash flows.
In
September 2006, the FASB issued Statement No. 157, “Fair Value Measurements”
(SFAS 157). This Statement defines fair value, establishes a framework for
measuring fair value in generally accepted accounting principles (GAAP), and
expands disclosures about fair value measurements. This Statement applies under
other accounting pronouncements that require or permit fair value measurements,
the Board having previously concluded in those accounting pronouncements that
fair value is the relevant measurement attribute. Accordingly, this Statement
does not require any new fair value measurements. However, for some entities,
the application of this Statement will change current practice. This Statement
is effective for financial statements issued for fiscal years beginning after
November 15, 2007, and interim periods within those fiscal years. The Company
does not expect the adoption of SFAS No. 157 to have a material impact on the
consolidated financial statements.
In
September 2006, the FASB issued Statement No. 158, “Employers’ Accounting for Defined
Benefit Pension and Other Postretirement Plans—an amendment of FASB Statements
No. 87, 88, 106, and 132(R)” (SFAS 158). This Statement improves
financial reporting by requiring an employer to recognize the over funded or
under funded status of a defined benefit postretirement plan (other than a
multiemployer plan) as an asset or liability in its statement of financial
position and to recognize changes in that funded status in the year in which the
changes occur through comprehensive income of a business entity or changes in
unrestricted net assets of a not-for-profit organization. This Statement also
improves financial reporting by requiring an employer to measure the funded
status of a plan as of the date of its year-end statement of financial position,
with limited exceptions. This Statement is effective as of the end of the fiscal
year ending after December 15, 2006. The Company does not have any defined
benefit plans, or other post-retirement plans. Therefore, the Company does not
expect SFAS No. 158 to have any impact on the consolidated financial
statements.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial
Assets and Financial Liabilities”. The objective of this statement is to
improve financial reporting by providing entities with the opportunity to
mitigate volatility in reported earnings caused by measuring related assets and
liabilities differently without having to apply complex hedge accounting
provisions. This Statement is expected by the Board to expand the use of fair
value measurement, consistent with the Board’s long-term measurement objectives
for accounting for financial instruments. This statement is effective for fiscal
years beginning after November 15, 2007. The Company is currently evaluating the
impact of adopting this statement; however, the Company does not expect the
adoption of this provision to have a material effect on its financial position,
results of operations or cash flow.
In
December 2007, the FASB issued SFAS No. 141 (Revised 2007), “Business Combinations”. The
objective of this statement will significantly change the accounting for
business combinations. Under Statement 141R, an acquiring entity will be
required to recognize all the assets acquired and liabilities assumed in a
transaction at the acquisition –date fair value will limited exceptions.
Statement 141 applies prospectively to business combinations for which the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008. The Company does not expect the
adoption of SFAS No. 141R to have a material impact on the consolidated
financial statements.
F-69
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements-An Amendment of ARB No. 51". The
objective of this statement is to establish new accounting and reporting
standards for the Noncontrolling interest in a subsidiary and for the
deconsolidation of a subsidiary.. Statement 160 is effective for fiscal years,
and interim periods within those fiscal years, beginning on or after December
15, 2008. The Company does not expect the adoption of SFAS No. 160 to have a
material impact on the consolidated financial statements.
In late
2007, the Emerging Issues Task Force (“EITF”) added two new issues to their
agenda. These include EITF Issue No. 07-1, “Accounting for Collaborative
Arrangements Relating to the Development and Commercialization of Intellectual
Property”, and EITF Issue No. 07-3, “Accounting for Nonrefundable
Payments for Goods or Services to be Used in Future Research and Development
Activities”. The Company expects that its activities will be subject to
the EITF’s determination on these matter.
|
2.
|
PRIVATE
PLACEMENT
|
On
January 31, 2006, Somanta Pharmaceuticals, Inc. completed a private placement of
592.6318 shares of its Series A Convertible Preferred Stock (“Series A
Preferred”) at a price of $10,000 per share, including six-year warrants to
purchase an additional 4,938,598 shares of its common stock. The Series A
Preferred shares consisted of 464 shares purchased by investors which are
convertible into 7,733,333 shares of common stock and 128.6318 shares that gave
effect to the conversion amount of $1,286,318, representing the value of the
converted note of $1,250,000 and the associated accrued interest of $36,318. The
total 592.6318 preferred shares are convertible into 9,877,197 common shares.
Gross proceeds to Somanta were $4,640,000, including $3,671,209 in cash,
payments to various vendors amounting $968,791, which included cash payment of
$624,105 to SCO Securities, LLC, its placement agent.
The
Series A Preferred is initially convertible into 9,877,197 shares of the
Company’s common stock at a conversion price of $0.60 per share. The conversion
value is subject to adjustment. The exercise price for the warrants is $0.75 per
share and they are immediately exercisable upon issuance. The fair market value
of these warrants, as discussed further below, was estimated to be $0.41 per
share. The warrants expire on January 31, 2012. None of the warrants have been
exercised as of October 31, 2007.
Holders
of the Series A Preferred stock are entitled to receive dividends at 8% per
annum. Dividends will accrue and will be cumulative from the date of issuance,
whether or not earned or declared by the Board of Directors. Dividends can be
paid at the Company’s option either in cash or shares of the Company’s common
stock on April 30 and October 31 of each year. The holders of the Series A
Preferred stock have full voting rights and powers, subject to the Beneficial
Ownership Cap, equal to the voting rights and powers of the Common stock
holders. The Board of Directors did not declare the dividends as of October 31,
2007. Therefore, a dividend of $115,605 for the quarter ended October 31, 2007,
and $820,918 for the period from inception (April 19, 2001) to October 31, 2007
on the Preferred Stock have not been recorded in the consolidated financial
statements, but in accordance with SFAS No. 129, the dividend amount has been
included in the calculation of the net income per share.
The
Series A Preferred stockholders have a liquidation preference, in the event of
any voluntary or involuntary liquidation, dissolution or winding up of the
Corporation, senior to the holders of common stock in an amount equal to $10,000
per share of preferred stock plus any accumulated and unpaid dividends on the
preferred stock. In the alternative, the holders of the Series A Preferred may
elect to receive the amount per share that would be distributed among the
holders of the preferred stock and common stock pro rata based on the number of
shares of the common stock held by each holder assuming conversion of all
preferred stock, if such amount is greater than the amount such holder would
receive pursuant to the liquidation preference. A change of control of the
Corporation will not be deemed a liquidation.
The
Series A Preferred Stock is not redeemable for cash. The holder of any share or
shares of Series A Preferred can, at the holder’s option, at any time convert
all or any lesser portion of such holder’s shares of Series A Preferred Stock
into such number of shares of common stock as is determined by dividing the
aggregate liquidation preference of the shares of preferred stock to be
converted plus accrued and unpaid dividends thereon by the conversion value then
in effect for such Preferred Stock (“Conversion Value”). The Company can, on the
occurrence of a conversion triggering event, elect to convert all of the
outstanding preferred stock into common stock. A conversion triggering event is
(i) a time when the registration statement covering the shares of common stock
into which the Series A Preferred is convertible is effective and sales may be
made pursuant thereto or all of the shares of common stock into which the Series
A Preferred is convertible may be sold without restriction pursuant to Rule
144(k) promulgated by the SEC and the daily market price of the common stock,
after adjusting for stock splits, reverse splits, stock dividends and the like
is $5 or more for a period of 30 of the immediately preceding 60 consecutive
trading days and the volume of common stock traded on the applicable stock
exchange on each such trading day is not less than 100,000 shares, or (ii) a
time when the Company consummates a sale of common stock in a firm commitment
underwritten public offering in which the offering price before deduction of
expenses of the common stock is greater than 200% of the Conversion Value and
the aggregate gross proceeds of the offering to the Company are greater than $25
million.
All the
outstanding preferred stock will be automatically converted to common stock upon
an occurrence of a qualified change of control provided that upon consummation
of a qualified change of control the holders of the shares issuable on automatic
conversion shall be entitled to receive the same per share consideration as the
qualified change of control transaction consideration. The holders of the Series
A Preferred may require the Company to redeem the shares upon the Company’s
failure or refusal to convert any shares of Preferred Stock in accordance with
the terms of issue, or by providing a written notice to that
effect.
F-70
The
Series A Preferred has been classified as equity, as the Series A Preferred
stock is not redeemable. In accordance with EITF No. 00–27, Application of Issue No. 98–5 to
Certain Convertible Instruments, the Company has determined that the
Series A Preferred had a beneficial conversion feature of $1,522,317 as of the
date of issuance. As such, the Company recorded a non-cash deemed dividend of
$1,522,317 resulting from the difference between the conversion price determined
after allocation of the full fair value of the warrants of $0.41 and the fair
value of common stock of $0.60. The carrying value of the Series A Preferred of
$5,926,318 was recorded net of the deemed dividend of $1,522,317 and a discount
of $2,048,531 on account of the full fair value of the warrants at the issuance
date.
The fair
value of the above warrants has been classified as a liability pursuant to EITF
00-19.
|
3.
|
LIQUIDATED
DAMAGES AND WARRANT LIABILITIES
|
In
connection with the additional $250,000 line of credit drawn pursuant to a
convertible note which was converted into Series A Preferred on January 31, 2006
(Note 4), the Company issued warrants to purchase a total of 866,534 shares of
common stock at an exercise price of $0.01 per share to SCO. The warrants are
immediately exercisable upon issuance and expire on November 8, 2012. The fair
market value of these warrants, as discussed further below, was estimated to be
$0.59 per share. The assumptions used in the Black-Scholes model were risk-free
interest rate of 4.5% at the time of issuance, volatility factors of 97.24%
calculated as the weighted average of the stock price volatility of ranked
comparable public companies, and contractual terms equal to the exercise periods
of the respective warrants. The fair value of the common stock as used in this
calculation was $.60 per share, as negotiated between the Company and the Series
A Convertible Preferred Stock investors. These warrants were exercised on August
20, 2007 by a partial forgiveness of $11,666 of debt owed by the Company to SCO
Financial Group.
The
holders of the Series A Preferred and warrants have registration rights which
obligate the Company to file a registration statement with the Securities and
Exchange Commission (“SEC”) covering the resale of the common stock issuable
upon conversion of the Series A Preferred and the common stock issuable upon
exercise of the warrants (as well as certain other securities of the Company)
within 30 days after the closing of the private placement. In the event the
registration statement is not filed within such thirty day period or if the
registration statement is not effective within 120 days after the date it is
filed, or a registration statement, once declared effective ceases to remain
effective during the period that the securities covered by the agreement are not
sold, the Company will be required to pay, in cash, liquidated damages for such
failure, equal to 1% of the holders of the Series A Preferred investment amount
for each thirty day period in which the registration statement is not filed or
effective, or maintained effective, as the case may be. The SEC declared the
Registration Statement effective on August 10, 2006.
In
accordance with EITF Issue 05-4, The Effect of a Liquidated Damages
Clause on a Freestanding Financial Instrument Subject to Issue No. 00-19,
the Company believes that the effect of the liquidated damages should be treated
under the first view (View A), which states that a registration rights agreement
should be treated as a combined unit together with the underlying financial
instruments, warrants and derivative debenture and evaluated as a single
instrument under EITF Issue 00-19 and FAS 133. The Company concluded that this
view is the most appropriate for the transaction. The Registration Rights
Agreement and the financial instruments to which it pertains (the warrants and
the preferred stock) were considered a combined instrument and accounted for
accordingly. The SEC declared the Registration Statement effective on August 10,
2006. As a result, during the quarter ended July 31, 2006, the Company accrued a
liability of liquidated damages of $120,502. During the quarter ended October
31, 2006 an agreement was reached with SCO on the liquidated damages matter. The
agreement concluded that since the securities owned by SCO Capital Partners, LLC
were not registered because SCO voluntarily withdrew them from the Registration
because of the resale restrictions required by the SEC, the Company is not
obligated for any liquidated damages pertaining specifically to SCO Capital
Partners, LLC. Accordingly, the Company reversed out $85,302 of liquidated
damages in the prior quarter ended October 31, 2006.
The
Company also issued six year warrants to its placement agent to purchase 987,720
common shares at $0.60 per share to SCO Securities LLC, as part of the success
fees of 10% of the aggregate value of the transaction at sales price of common
stock. These warrants are immediately exercisable upon issuance. The fair value
of these warrants at the date of issue was estimated to be $0.44 per share and
has been recorded as issuance costs and offset against the proceeds of the
Series A Preferred.
The fair
value of warrants issued in connection with the issue of convertible debt and
convertible preferred stock, including the agent warrants, was estimated at the
date of grant and revalued at October 31, 2007 using a Black Scholes option
pricing model with the following assumptions: a risk free interest rate of
approximately 4.5% at the issuance date and 3.94% on October 31, 2007, no
dividend yield, volatility factors of 81.89% to 97.24% at the issuance date and
53.6% at October 31, 2007, contractual terms of 6 and 7 years and expected terms
based upon the formula prescribed in SEC Staff Accounting Bulletin 107 of 2.1
years and years. These assumptions use the interest rate prevailing at the time
of issuance, volatility factors calculated as the weighted average of the stock
price volatility of ranked comparable public companies, and contractual terms
equal to the exercise periods of the respective warrants. The fair value of the
common stock as used in this calculation was $.60 per share at the issuance
date, as negotiated between the Company and unaffiliated third party Series A
investors, and $0.17 on October 31, 2007. The change in fair value of the
warrants for the three months ended October 31, 2007 of $88,157, was reported in
other income and disclosed in the financial statements.
F-71
The
following table summarizes the activity for warrants issued during the six month
period ended October 31, 2007.
On
August 20, 2007, SCO Capital Partners LLC exercised warrants on 1,166,534 shares
of common stock at $.01 per share by forgiving $11,666 owed by the Company to
SCO Financial Group LLC.
|
Number
of
shares
|
Weighted
Average
Exercise
Price
|
||||||
|
Balance—April
30, 2007
|
7,102,838
|
0.61
|
|||||
|
Granted
|
—
|
—
|
|||||
|
Exercised
|
1,166,534
|
0.001
|
|||||
|
Forfeited
|
—
|
—
|
|||||
|
Expired
|
—
|
—
|
|||||
|
Balance—October
31, 2007
|
5,936,304
|
0.61
|
|||||
The
following table summarizes information about warrants outstanding as of October
31, 2007.
|
Warrants
Outstanding
|
Warrants
Exercisable
|
|||||||||||||||||
|
Exercise
Prices
|
Number
Outstanding
|
Wtd.
Avg
Remaining
Contr.
Life
|
Wtd.
Avg
Exercise
Price
|
Number
Exercisable
|
Wtd.
Avg
Exercise
Price
|
|||||||||||||
|
$
|
0.60
|
987,720
|
4.2
years
|
$
|
0.60
|
987,720
|
$
|
0.60
|
||||||||||
|
$
|
0.75
|
4,938,597
|
4.2
years
|
$
|
0.75
|
4,938,597
|
$
|
0.75
|
||||||||||
|
$
|
2.25
|
9,987
|
2.5
years
|
$
|
2.25
|
9,987
|
$
|
2.25
|
||||||||||
|
4.
|
EMPLOYMENT
AND CONSULTING AGREEMENTS
|
In
January 2006, the Company entered into employment agreements with the Company’s
President and Chief Executive Officer (“CEO”), and with the Company’s Executive
Chairman, for one year terms. These agreements were automatically renewed for an
additional oneyear term on January 31, 2007. Under these agreements, the
President and Executive Chairman are to be paid annual base salaries of $275,000
and $248,000, respectively. Both officers are eligible to receive annual bonuses
and additional stock option grants at the discretion of the Company’s board of
directors. In July 2006, the Company’s CEO and Executive Chairman agreed to
defer 50% of their base salaries until the completion of the Company’s next fund
raising at which time the deferred amounts would be repaid and the deferrals
would cease. Effective October 1, 2006, the Company’s CEO and Executive Chairman
agreed to defer 100% of their base salaries until the completion of the
Company’s next fund raising, or the completion of a merger or other
consolidation with another company, at which time the deferred amounts would be
repaid and the deferrals would cease. Effective June 30, 2006, our Executive
Chairman was appointed by our Board to be our Chief Financial Officer, Secretary
and Treasurer.
F-72
|
5.
|
STOCK-
BASED COMPENSATION
|
The Board
of Directors adopted and the stockholders approved the 2005 Equity Incentive
Plan in June 2005. The plan was adopted to recognize the contributions made by
the Company’s employees, officers, consultants, and directors, to provide those
individuals with additional incentive to devote themselves to its future
success, and to improve the Company’s ability to attract, retain and motivate
individuals upon whom the Company’s growth and financial success depends. Under
the plan, stock options may be granted as approved by the Board of Directors or
the Compensation Committee. There are 8,000,000 shares reserved for grants of
options under the plan, of which 2,204,701 have been issued as substitutions
with the exact same terms for the 2,204,701 previously issued options
outstanding as of April 30, 2005. Stock options vest pursuant to individual
stock option agreements. No options granted under the plan are exercisable after
the expiration of ten years (or less in the discretion of the Board of Directors
or the Compensation Committee) from the date of the grant. The plan will
continue in effect until terminated or amended by the Board of Directors or
until expiration of the plan on August 31, 2015.
On April
13, 2007, the Company’s Board of Directors approved a merger agreement with
Access Pharmaceuticals, Inc, as more fully described in Note 15. Under the terms
of that agreement Access will not assume, or provide a substitute option, for
any of the Company’s stock options. Rather, all of the outstanding options to
purchase Company common stock issued pursuant to the Company’s 2005 Equity
Incentive Plan will be cancelled prior to the closing of the transaction in
accordance with Section 11.3(d) of the Equity Incentive Plan. As a result,
pursuant to the terms of Section 11.3(d) of the Equity Incentive Plan, the
Company’s Board of Directors has resolved to: (i) allow the immediate and
accelerated vesting of all of the options granted, and (ii) allowed the exercise
of the option in whole or in part until May 31, 2007. Based on FAS 123(R), no
incremental expense was recorded for these options with accelerated vesting as
the fair value of the modified options was less than the fair value of the
original options calculated immediately before the terms were modified. None of
the options were exercised thru May 31, 2007. Additional expense of $507,284 was
recorded in the year ended April 30, 2007 due to the acceleration of the
vesting. There is no stock-based compensation expense for the three months ended
October 31, 2007.
|
6.
|
RELATED
PARTY TRANSACTIONS
|
Fees
Paid to Related Parties
Pursuant
to a financial advisory agreement dated March 2005 between Bridge Oncology and
SCO Financial Group LLC (SCO), which the Company has assumed, the Company
compensates SCO with a monthly fee of $12,500 and an annual grant of warrants to
purchase 150,000 shares of Company common stock at an exercise price of $.01 for
the term of the agreement for financial advisory services. The Company recorded
advisory service fees totaling $75,000 and $75,000 to SCO for the six months
ended October 31, 2007 and 2006, respectively.
Agreement
with Related Party
Virium
Pharmaceuticals, Inc.
The
Company entered into an exclusive co-development and sublicense agreement in
February 2005 with a related entity, Virium Pharmaceuticals, Inc. These two
entities share a common director and their largest single shareholder, SCO
Capital Partners LLC. On May 19, 2005, the Company paid $50,000 to this related
party to in-license phenylbutyrate and expensed this amount.
|
7.
|
SECURED
NOTE
|
On April
26, 2007, the Company entered into a Note Purchase Agreement, a Security
Agreement, a Patent Collateral Assignment and Security Agreement and a Trademark
Collateral Security and Pledge Agreement (collectively, the “Loan Documents”)
with Access Pharmaceuticals, Inc. (“Access”). Under the terms of the Loan
Documents, Access initially loaned the Company $33,462 ($822,712 at October 31,
2007). Access, in its sole discretion, may from time to time advance additional
loan amounts to the Company. All amounts loaned to the Company by Access are
secured by substantially all of the assets of the Company pursuant to the terms
of the Loan Documents. The Note bears interest at 10% and is repayable at the
earlier of: (i) August 31, 2007, or (ii) the date of the termination of the
Agreement and Plan of Merger dated as of August 18, 2007 between the Company and
Access. To date the Merger has not closed since the Company has not been able to
meet one of the key closing conditions. No demand for repayment has been
received from Access.
F-73
|
8.
|
MERGER
AGREEMENT
|
On
April 18, 2007, the Company, Somanta Incorporated, a wholly-owned subsidiary of
the Company and Somanta Limited, a wholly-owned subsidiary of Somanta
Incorporated, and Access Pharmaceuticals, Inc. (“Access”) and Somanta
Acquisition Corporation (“Merger Sub”), a wholly-owned subsidiary of Access and
a Delaware corporation, entered into an Agreement and Plan of Merger (the
“Merger Agreement”). Pursuant to the terms and subject to the conditions set
forth in the Merger Agreement, Merger Sub will merge with and into Somanta, with
Somanta continuing as the surviving corporation and becoming a wholly-owned
subsidiary of Access (the “Merger”). In addition, Access has received voting
agreements with certain executive officers, directors and affiliates of Somanta
representing approximately 81% of Somanta’s outstanding common and approximately
60% of its outstanding preferred shares under which the parties, subject to
certain limited exceptions, have granted an irrevocable proxy to Access to vote
their shares in favor of the merger.
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the “Effective Time”) will be converted into
500,000 shares of Access common stock. No fractional shares of Access common
stock will be issued as a result of the Merger. In addition, all of Somanta’s
preferred stock, including accrued and unpaid dividends, that is outstanding at
the Effective Time of the Merger will be converted into 1,000,000 shares of
Access’ common stock. No shares of Access preferred stock will be issued as a
result of the Merger.
As of
April 18, 2007, there were (i) 15,459,137 shares of Somanta’s common stock
outstanding, including 1,166,534 shares issuable upon the exercise of warrants
that are expected to be exercised prior to the Effective Time, and (ii) 591.6
shares of Somanta’s preferred stock outstanding. Also as of April 18, 2007,
there were outstanding warrants to purchase 5,936,304 shares of Somanta’s common
stock that are not expected to be exercised prior to the Effective Time and are
expected to be converted into warrants to purchase approximately 192,000 shares
of Access’ common stock (subject to adjustment as provided in the Merger
Agreement). On August 17, 2007, the Company’s stockholders approved the Merger.
On August 20, 2007, SCO Capital Partners LLC exercised warrants on 1,166,534
shares of common stock at $.01 per share by forgiving $11,622 owed by the
Company to SCO Financial Group LLC
The
completion of the Merger is subject to various conditions to closing, including,
without limitation, obtaining the approval of the Somanta stockholders. The
Merger is intended to qualify as reorganization for federal income tax purposes.
To date the Merger has not closed since the Company has not been able to meet
one of the key closing conditions.
|
9.
|
SUBSEQUENT
EVENTS
|
As of December 19, 2007, the Company had borrowed $856,064 from Access
under the Secured Note (Footnote 7)
F-74
INFORMATION
ABOUT MACROCHEM
DESCRIPTION
OF BUSINESS
Overview
MacroChem
is a specialty pharmaceutical company that develops and seeks to commercialize
pharmaceutical products. Currently, MacroChem’s portfolio of proprietary product
candidates includes products based on MacroChem drug delivery technologies:
SEPA(R), MacroDerm(TM) and DermaPass(TM) as well as SR-9025 and certain other
early stage product candidates MacroChem acquired in the acquisition of Virium
Pharmaceuticals in April 2008. When MacroChem acquired Virium in April 2008,
Virium was a non-public, development stage company whose business was developing
and commercializing novel therapeutics with a focus in oncology. Virium has
in-licensed opportunities for the development and commercialization of several
oncology-related compounds and technologies in order to advance them along the
regulatory and clinical pathways toward commercial approval. These opportunities
involved compounds that Virium believed to show promising late-stage,
pre-clinical or early clinical data.
MacroChem’s
SEPA topical drug delivery technology (SEPA is an acronym for “Soft Enhancement
of Percutaneous Absorption,” where “soft” refers to the reversibility of the
skin effect of the technology, and “percutaneous” means “through the skin”)
enhances the efficiency and rate of diffusion of drugs into and through the
skin. MacroChem’s composition of matter patent on the SEPA family of compounds
expired in November 2006. MacroChem owns six composition of matter and use
patents, with expiration dates ranging from 2015 to 2019, for the combination of
SEPA with numerous existing classes of drugs, including antifungals and human
sex hormones. MacroChem’s patented MacroDerm drug delivery technology
encompasses a family of low to moderate molecular weight polymers that impede
dermal drug or chemical penetration, which may be usable, for example, to
prevent chemicals in insect repellant from penetrating the skin. MacroChem owns
three patents covering the composition of matter and methods of use of MacroChem
MacroDerm polymers that expire in 2015. MacroChem has also filed a patent
application for MacroChem’s DermaPass family of transdermal absorption enhancers
that have a different drug delivery profile than SEPA, which MacroChem believes
could be used with a wider range of active pharmaceutical
ingredients.
One of
MacroChem’s lead product candidates is EcoNail, a topically applied SEPA-based
econazole lacquer for the treatment of onychomycosis, a condition commonly known
as nail fungus. Econazole, a commercially available topical antifungal agent
most commonly used to treat fungal skin infections, inhibits in vitro growth of
the fungi most commonly implicated in onychomycosis. When used in EcoNail, SEPA
works by allowing more rapid and complete release of econazole from the lacquer
into and through the nail plate. In a pre-clinical study using human cadaver
nails, EcoNail delivered through the nail more than 14,000 times the minimum
concentration of econazole needed to inhibit the fungi most commonly associated
with onychomycosis. Following MacroChem’s laboratory studies, MacroChem
conducted a randomized, double blind controlled Phase 1 tolerance/human exposure
trial of EcoNail in nineteen patients with onychomycosis of the toenails. In
this study, EcoNail was well tolerated, and investigators reported no serious
drug-related adverse events. Serum assays used to determine the level of drug in
the bloodstream showed no detectable levels of econazole, further supporting
EcoNail’s systemic safety profile. Full data from the 18-week trial were
presented in May 2005 at the annual meeting of the Society for Investigative
Dermatology. MacroChem has a composition of matter and use patent covering
EcoNail that will expire in 2019.
MacroChem
commenced a 48 week, blinded open label Phase 2 efficacy study of EcoNail in the
third quarter of 2006 which was completed in Q2 2008. This study was conducted
through a contract research organization with significant experience in
onychomycosis trials. The study protocol allowed for an interim review of the
data after all patients have completed 24 weeks of treatment. On November 6,
2007, MacroChem announced that clinical photographs of 37 patients were assessed
by an external expert panel, and 20 (54%) showed evidence of clinical
improvement, defined as an increase in uninvolved nail of onychomycosis. All
week 24 cultures were negative for dermatophyte growth, and the panel observed
no signs of local irritation related to the once-daily EcoNail treatment. In a
consensus clinical judgment by the external panel, 13 of 37 (32%) of patients
demonstrated greater than or equal to 25% clinical improvement. MacroChem
continues to actively seek partnering opportunities to maximize the commercial
potential of EcoNail.
At the
completion of the Phase 2 study, the final clinical data which was evaluated by
MacroChem expert panel showed that 24 patients (65%) demonstrated evidence of
clinical improvement, defined in the protocol as an increase in uninvolved
(clear) nail area. While none of the 37 patients reached all criteria of the
composite primary endpoint, the consensus judgment of the panel was that 15 of
37 patients (41%) demonstrated significant (greater than or equal to 25%)
clinical improvement. All patients had fungal culture-proven nail infections at
entry, but after 48 weeks of once-daily treatment with EcoNail, 100% of patients
had cultures that were negative for dermatophyte growth. Eight of the 37
patients (22%) achieved the secondary endpoint of negative mycology (negative
fugal culture plus negative KOH evaluation) at 48 weeks. The panel observed no
signs of local irritation related to the once-daily EcoNail treatment. During
the trial, no patient required interruption of dosing due to local
intolerability. Through 56 weeks of observation, no cutaneous adverse events
were attributed by the investigators to EcoNail.
86
MacroChem’s
other lead product is pexiganan, a novel, small peptide anti-infective for
treatment of patients with mild diabetic foot infection (DFI). In October 2007,
MacroChem acquired the exclusive worldwide license rights for drug uses of
pexiganan, from Genaera Corporation. Pexiganan is formulated as a cream and has
a novel mechanism of action based on its ability to disrupt the integrity of
bacterial cell membranes that cause DFI and has antimicrobial activity against
organisms that commonly infect skin and soft tissue. Pexiganan has a low
potential for induction of resistance and no cross-resistance with existing
therapeutic antibiotics as a consequence of its mechanism of action. In clinical
trials previously conducted by Genaera Corporation, over 1,000 human subjects
were exposed to pexiganan without safety concerns, including patients who
received pexiganan in two Phase 3 clinical trials submitted in a new drug
application to the U.S. Food and Drug Administration (FDA) in 1998. The primary
clinical endpoint (rates of clinical cure or improvement) of one of the two
Phase 3 trials was judged by the FDA to have been achieved. The other Phase 3
clinical trial, which did not meet its specified endpoint, provided strong
supportive data indicative of the clinical benefit of pexiganan. At the time of
this second Phase 3 study, the prior holder of the rights to pexiganan
experienced difficulties with the product’s Chemistry Manufacturing &
Controls (CMC) and an FDA request for one additional controlled trial precluded
approval. MacroChem believes that since that time, significant improvements have
been made in peptide manufacturing processes as well as in clinical trial design
and execution. MacroChem has initiated a program to address the previously
identified CMC issues and intend to resume formal dialogue with the FDA to
determine the appropriate clinical development path.
MacroChem’s
product candidate, SR-9025 or 4'-thio-beta-D-arabinofuranosylcytosine, is a new
generation nucleoside analogue which we acquired in the merger transaction with
Virium Pharmaceuticals in April 2008 and which was invented by Southern Research
Institute of Birmingham, Alabama. This compound is within a certain
class of anti-cancer drugs generally characterized as cytotoxic agents with
proven success in certain blood-borne cancers. In pre-clinical studies, SR-9025
has shown activity against leukemia, colon, lung, prostate, pancreatic, renal,
and breast cancers. There have been two dose-escalation Phase I clinical trials
completed in patients with advanced solid tumor malignancies, showing
encouraging results and the MacroChem is in the process of developing its
clinical strategy to capitalize on these data expeditiously.
MacroChem’s
product candidate, Opterone, is a topically applied SEPA-based testosterone
cream designed to treat male hypogonadism. Male hypogonadism is a condition in
which men have levels of circulating testosterone below the normal range and may
exhibit one or more associated symptoms, including low energy levels, decreased
sexual performance, loss of sex drive, increased body fat or loss of muscle
mass. In December 2005, we received a letter from the Division of Reproductive
and Urologic Products of the U.S. Food and Drug Administration, or FDA, in
response to questions posed by MacroChem regarding a proposed Phase 3 clinical
program for Opterone. In the letter, the FDA requested that we conduct
additional investigation into multiple dose safety and pharmacokinetics before
beginning any eventual Phase 3 protocol. The additional investigation and Phase
3 revisions will increase the time and expense associated with the development
of Opterone. The next step in the development process for Opterone is a Phase 2
trial. MacroChem is seeking a partner to advance development of this product
candidate. MacroChem may elect not to develop Opterone further if MacroChem
cannot find a partner. MacroChem has a composition of matter and use patent
covering Opterone that will expire in 2017.
In
addition to EcoNail, pexiganan and Opterone, MacroChem is evaluating several
earlier stage product candidates. MacroChem has developed and tested SEPA-based
formulations to deliver other active pharmaceutical ingredients including
topical anesthetic and topical non-steroidal anti-inflammatory drugs (NSAIDs).
MacroChem has also tested application of MacroChem MacroDerm polymers for use
with cosmetics, pharmaceuticals and consumer products like insect repellants and
sunscreens to decrease skin penetration and/or improve persistence on the skin.
For example, MacroChem’s laboratory data demonstrated that, when formulated with
the insect repellant DEET, increasing concentrations of MacroDerm reduces the
amount of DEET that is absorbed through human skin. MacroChem has performed
initial laboratory experiments to test the ability of DermaPass to improve
transdermal delivery of various active pharmaceutical ingredients.
Since
inception, MacroChem’s primary source of funding for MacroChem operations has
been the private and public sale of MacroChem securities. MacroChem’s ability to
continue as a going concern after MacroChem current capital resources are
exhausted depends on MacroChem ability to secure additional financing, to
consummate a strategic transaction, or to make alternative arrangements to fund
operations, which MacroChem cannot guarantee.
Drug
Delivery Technologies
To be
effective, drugs must reach an intended site in the body, at an effective
concentration, and for an appropriate length of time. Currently, the vast
majority of drugs are administered either orally or by injection. However, there
are numerous drugs for which these modes of administration are not well suited.
For example, oral administration of certain drugs may result in irritation of
the gastro-intestinal tract or undesirable rapid first pass metabolism. First
pass metabolism, which refers to the chemical breakdown of compounds in the
liver and gastro-intestinal tract, can result in a significant reduction in the
amount of drug reaching its intended site of activity in the body. In some
cases, liver damage may occur due to the toxicities associated with the
breakdown of a particular drug. In the case of injectable drugs, administration
may be painful and in many cases requires frequent and costly office visits to
treat chronic conditions.
One
alternative method of administering drugs is topical delivery. Topical delivery
works by either introducing drugs into the skin (dermal delivery) for the
treatment of dermatologic or localized conditions and diseases, or through the
skin (transdermal delivery) and into the bloodstream for the treatment of
systemic conditions and diseases. Topical drug delivery has several advantages.
For example, topical drug delivery:
87
|
·
|
helps
to avoid inactivation of a drug caused by first pass metabolism in the
liver and gastro-intestinal tract;
|
|
·
|
can
provide local delivery of appropriate concentrations of a drug to the
intended site of action without systemic
exposure;
|
|
·
|
helps
avoid gastro-intestinal distress caused by ingesting a drug;
and
|
|
·
|
simplifies
drug administration to patients who have difficulty swallowing oral dosage
forms or who do not wish to endure the discomfort of
injections.
|
SEPA Drug Delivery
Technology
Delivering
drug molecules through the skin is challenging. The skin naturally serves as the
primary barrier that prevents outside organisms, chemicals and toxins from
easily entering the body. Human skin is made up of two layers: the outer layer
or epidermis (which includes the stratum corneum) and the inner layer or dermis.
The stratum corneum acts as the main barrier to drug delivery. The stratum
corneum consists of corneocytes, which are dead, flattened skin cells filled
with keratin, and a lipid matrix, which is made up of multi-layered oily
molecules that hold the corneocytes together in a sheet.
MacroChem’s
SEPA drug delivery technology is a family of compounds that can enhance the
transport, penetration and controlled delivery of a wide range of drugs through
the skin. MacroChem has chosen SEPA 0009, a member of the SEPA family, for
clinical development. SEPA enhances transdermal drug delivery by temporarily and
reversibly disrupting the alignment of the lipid bilayer within the lipid matrix
in the stratum corneum. This disruption renders the skin temporarily permeable,
allowing a drug to diffuse through the stratum corneum in the epidermis, and
then into and through the dermis, where it can enter the bloodstream through the
capillaries.
SEPA
possesses the following attributes:
|
·
|
Reversible: The
alignment of the lipid bilayer within the lipid matrix in the stratum
corneum reverts back to normal after SEPA has diffused through it without
causing permanent changes to the
skin.
|
|
·
|
Rapidly metabolized:
The human body rapidly metabolizes SEPA into ethylene glycol and decanoic
acid, two metabolites well understood by regulatory
agencies.
|
|
·
|
Chemically
non-reactive: SEPA does not react chemically with most other
organic molecules and, as a result, is compatible with a wide range of
active pharmaceutical ingredients.
|
|
·
|
Versatile: The
rate and amount of drug absorbed by the skin or body in a SEPA-based
formulation can be controlled by varying the components in the
formulation.
|
SEPA,
when properly combined with active pharmaceutical ingredients, may provide for a
variety of convenient and easy-to-apply formulations, including creams, gels,
ointments, lacquers and solutions for the treatment of a wide range of systemic
and localized conditions. MacroChem believes that products incorporating SEPA
may allow selected drugs to be administered more effectively and with improved
patient compliance compared to alternative methods of drug administration, such
as ingestion and injection.
MacroDerm Drug Delivery
Technology
For
chemicals that penetrate the skin too readily or that can be toxic if
significantly absorbed into the bloodstream, it may be desirable to retard the
rate of drug absorption to achieve an optimal delivery profile. For these
chemicals, MacroChem has developed MacroChem second drug delivery technology,
called MacroDerm, encompassing a series of low to moderate molecular weight
polymers that impede drug penetration through the skin. MacroChem believes
MacroDerm may have uses in cosmetics, personal care products and selected
pharmaceuticals. Potential applications include their formulation with
sunscreens, moisturizers and insect repellents to decrease skin penetration and
improve persistence on the skin. MacroChem has synthesized MacroDerm prototypes
and MacroChem is seeking strategic partners to evaluate, manufacture and market
specific MacroDerm products.
New Transdermal Drug
Delivery Technology
MacroChem
has also filed a patent application for DermaPass, a new family of enhancers
that MacroChem believes can be used with a wider variety of active
pharmaceutical ingredients than SEPA. MacroChem has performed initial laboratory
experiments to test the ability of DermaPass to improve transdermal delivery of
various active pharmaceutical ingredients.
Product
Candidates:
EcoNail for
Onychomycosis
Onychomycosis,
a fungal infection of the nail, is predominantly an infection of the toe nail
bed and nail plate underlying the surface of a nail. Typical symptoms of
onychomycosis can include:
|
·
|
nail
discoloration;
|
|
·
|
nail
thickening;
|
|
·
|
cracking
and fissuring of the nail plate;
and
|
|
·
|
in
severe cases, inflammation, pain and secondary infection of the nail bed
and adjacent skin.
|
88
According
to Fitzpatrick’s Dermatology
in General Medicine (Sixth Edition), onychomycosis is a common disease,
the prevalence of which varies by geographic region and ranges from
approximately 2% to 18% of the worldwide population, with up to 48% of the
population experiencing onychomycosis at least once by age 70. According to an
article published in 2000 in the Journal of the American Academy of
Dermatology, a large scale study found that the prevalence of
onychomycosis in the normal population of North America was approximately
14%.
Current
Treatments and Their Shortcomings
Current
treatment options for onychomycosis include oral drugs, debridement (filing,
trimming and scraping), nail avulsion (surgical or chemical excision of the
infected nail plate) and topical drug therapies. There are two oral therapies
marketed for the treatment of onychomycosis in the U.S.: Lamisil (terbinafine)
and Sporanox (itraconazole). The leading oral treatment, Lamisil, has a complete
cure rate of approximately 38%, but also has a 15% relapse rate. Sporanox has a
complete cure rate of approximately 14%. Complete cure refers to mycological
cure, or simultaneous occurrence of a negative KOH (a potassium hydroxide
staining method for direct microscopic examination of nail scrapings) and a
negative fungal culture, plus clinical cure, or clearance of all signs of
infection. One risk associated with each of the oral treatments, both of which
undergo substantial first pass metabolism by the liver, is liver disease. As a
result, patients must continually monitor their liver function for signs of
failure, including fatigue, anorexia, nausea and/or vomiting, jaundice, dark
urine or pale stools. Such monitoring typically requires blood tests and
associated office visits, which can impact patient compliance. In the rare case
that liver failure occurs, it can result in death or the need for a liver
transplant. Mechanical debridement, which is a traditional podiatric approach to
onychomycosis that reduces the thickness of the nail, is not a cure for
onychomycosis and requires time, specialized instruments and experience. Nail
avulsion, which requires surgical or chemical removal of the nail plate causes
discomfort and traumatizes the nail bed.
Topical
Administration
The only
topical onychomycosis drug currently marketed in the U.S. is Penlac®
(ciclopirox), a nail lacquer which has a complete cure rate of less than 10% and
requires up to 48 weeks of treatment, including periodic removal of any
unattached infected nail by a health care professional.
The EcoNail
Approach
Topically
delivered lacquer formulations, like EcoNail, have specific advantages over
other existing oral treatments because they are applied like nail polish, treat
fungal nail infections locally, and facilitate close and extended contact
between an antifungal drug and the outer, or dorsal, nail surface. Developers of
topical nail lacquers for onychomycosis face two major challenges. First,
lacquers with acceptable hardness, durability and drying time tend not to
release antifungal drugs from the lacquer matrix readily. Second, most
antifungal drugs do not penetrate into the deep, or ventral, nail plate
adequately when applied to the outer, or dorsal, nail surface, which results in
insufficient antifungal concentrations at the site of infection.
EcoNail
is a topically applied lacquer formulation containing econazole and SEPA for the
topical treatment of onychomycosis. Econazole, a topical antifungal agent,
effectively inhibits in
vitro growth of the fungi most commonly implicated in onychomycosis. In
contrast to SEPA’s action in disrupting the lipid bilayer of the skin, SEPA as
used in EcoNail works to soften the lacquer in which econazole is contained,
thereby allowing for more rapid and complete release of econazole from the
lacquer into and through the nail. A 14-day study of lacquers containing
radioactively labeled econazole on human non-diseased cadaver nails demonstrated
that EcoNail delivered approximately seven times more econazole to the ventral
nail and 200 times more econazole to the nail bed than a similar lacquer without
SEPA. In this study, EcoNail delivered to the ventral nail more than 14,000
times the minimum concentration of econazole needed to inhibit the two most
common fungi associated with onychomycosis. In addition, MacroChem believes that
EcoNail, as a locally applied lacquer, will have a reduced risk of systemic side
effects compared with oral treatments for onychomycosis.
Clinical
Development
Following
MacroChem laboratory studies, MacroChem conducted a Phase 1 tolerance/human
exposure clinical trial of EcoNail in patients with onychomycosis and released
six week safety and tolerance data from that trial in November 2004. The trial
was a randomized, double-blind, controlled Phase 1 trial conducted at two U.S.
clinical sites. Nineteen patients with onychomycosis of the toenails completed
the safety-tolerability segment of the study, in which all fingernails and
toenails were treated twice daily for six weeks with either EcoNail or a control
nail lacquer. The six week safety-tolerability segment was followed by an
open-label segment of the trial in which all patients received EcoNail applied
once daily to all nails for an additional 12 weeks to extend patient exposure
experience.
The main
objectives of this Phase 1 study were to test the safety and local tolerability
of EcoNail in patients with onychomycosis and to determine systemic exposure to
econazole. In this study, EcoNail was well tolerated, and investigators reported
no serious drug-related adverse events. Serum assays showed no detectable levels
of econazole, further supporting EcoNail’s systemic safety profile. Full data
from the 18 week trial were presented in May 2005 at the annual meeting of the
Society for Investigative Dermatology.
89
MacroChem
commenced a 48 week, blinded open label Phase 2 efficacy study of EcoNail in the
third quarter of 2006. This study is being conducted through a contract research
organization with significant experience in onychomycosis trials. The study
protocol allows for an interim review of the data after all patients have
completed 24 weeks of treatment. On November 6, 2007, MacroChem announced that
clinical photographs of 37 patients were assessed by an external expert panel,
and 20 (54%) showed evidence of clinical improvement, defined as an increase in
uninvolved nail of onychomycosis. All week 24 cultures were negative for
dermatophyte growth, and the panel observed no signs of local irritation related
to the once-daily EcoNail treatment. In a consensus clinical judgment by the
external panel, 13 of 37 (32%) of patients demonstrated greater than or equal to
25% clinical improvement.
Pexiganan for mild diabetic
foot infections
Acquisition
On
October 3, 2007, MacroChem announced it took a step to broaden its product
portfolio by acquiring exclusive worldwide rights for drug uses of pexiganan, a
novel, small peptide anti-infective for topical treatment of patients with mild
diabetic foot infection (DFI) from Genaera.
Acquiring
license rights to pexiganan represents the first product under MacroChem’s
previously stated strategy to seek such opportunities to complement its
proprietary products based on its transdermal drug delivery
technologies.
Pexiganan
Approach
There
continues to be a very large and growing incidence of diabetes, approximately 20
million diabetics in the U.S. alone, and as a result a growing number of
diabetic foot infections in the U.S. There is also a lack of effective topical
anti-infectives to treat diabetic foot infection. MacroChem believes that
pexiganan could fill an important unmet medical need for a topical
anti-infective treatment and, provide a significant commercial opportunity with
an addressable market of approximately 3.5 million diabetic foot infections
annually.
Clinical
Development
Clinical
trials previously conducted by Genaera include two Phase 3 trials submitted in a
New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in
1998. At that time, outstanding issues with CMC (Chemistry, Manufacturing and
Controls) and an FDA request for one additional controlled trial precluded
approval. In recent years there have been many advances in the manufacturing of
peptides, a better understanding of the treatment of diabetic foot infection,
improvements in clinical trial design and execution, more clarity concerning
regulatory requirements for topical anti-infectives and the potential market is
even more attractive than before.
Other
Product Candidates:
Opterone for
Hypogonadism
Hypogonadism
is a condition in which the testes produce insufficient amounts of testosterone,
a hormone responsible for normal growth and development of the male sex organs
and for maintenance of secondary male sex characteristics. Hypogonadism is
generally characterized by serum testosterone levels of less than 300 nanograms
per deciliter together with one or more of the following signs or
symptoms:
|
·
|
low
energy levels;
|
|
·
|
decreased
sexual performance;
|
|
·
|
loss
of sex drive;
|
|
·
|
increased
body fat;
|
|
·
|
loss
of muscle mass;
|
|
·
|
reduced
bone density; and
|
|
·
|
mild
depression.
|
According
to the Endocrine Society, this disorder affects an estimated four to five
million men in the United States, approximately 200,000 of whom receive hormone
replacement therapy. According to a 2001 article published in The Journal of Clinical
Endocrinology & Metabolism, the incidence of hypogonadal testosterone
levels in U.S. males increases from approximately 20% in men over the age of 60
to approximately 50% in men over the age of 80.
90
Diagnosis
of testosterone-deficiency often occurs when a patient seeks treatment for other
conditions or symptoms. Routine testing of testosterone levels has become a more
common part of men’s health evaluations by specialists, although testosterone
testing is still relatively new among the majority of primary care
physicians.
The Opterone
Approach
Opterone
is MacroChem topically applied cream formulation of 1% testosterone and SEPA. To
the best of MacroChem knowledge, Opterone is the first and only clinical
development stage testosterone cream in the U.S. In both laboratory and clinical
settings, MacroChem demonstrated that SEPA enhances the absorption of
testosterone through the skin. In vitro studies using human
cadaver skin showed that MacroChem enhanced cream formulation delivered two to
three times more testosterone transdermally over a 24-hour period when compared
to equivalent doses of the currently marketed gel products. These in vitro studies also
suggested that MacroChem enhanced cream formulation may deliver comparable
amounts of testosterone in smaller dose volumes than currently marketed gel
products. In addition, MacroChem believes that the creamy texture and
consistency, the non-oily feel and the other physical attributes of Opterone
cream will provide a more cosmetically pleasing application than available gel
treatments.
Clinical
Development
On
December 5, 2005, MacroChem received a response from the Division of
Reproductive and Urologic Products at the FDA to questions posed by MacroChem
regarding the proposed Phase 3 clinical program for Opterone. In the response,
the FDA reiterated its concerns regarding the skin irritation potential of SEPA
related to pre-clinical studies of SEPA, including without limitation, a 26-week
transgenic-mouse (Tg.AC) carcinogenicity study of SEPA. To address these
concerns as well as other issues related to Opterone’s safety and efficacy
program, the FDA requested that MacroChem conduct additional investigation into
multiple dose safety and pharmacokinetics before beginning any eventual Phase 3
study. The FDA also requested that MacroChem revise its proposed Phase 3
protocol to include additional patients and to extend patient exposure and
safety follow-up. The additional investigation and Phase 3 revisions will
increase the time and expense associated with the development of Opterone.
Accordingly, the next step in the development process for Opterone is a Phase 2
trial. MacroChem is seeking a partner to advance development of this product
candidate. MacroChem may elect not to develop Opterone further if MacroChem
cannot find a partner.
Earlier Stage
Product
Candidates
MacroChem
has also tested a number of formulations containing MacroChem proprietary drug
delivery technologies combined with various active pharmaceutical ingredients.
As MacroChem continues to build MacroChem product candidate portfolio, MacroChem
reviews its pre-clinical-stage product opportunities to identify those that show
sufficient promise to be advanced into clinical development. MacroChem evaluates
each new product candidate on its potential for success based on both scientific
and commercialization criteria. These criteria include:
|
·
|
technical
feasibility (formulation, product stability and laboratory
results);
|
|
·
|
likelihood
of laboratory results translating into a meaningful clinical
benefit;
|
|
·
|
expected
clinical studies needed and the regulatory pathway required to obtain
marketing approval;
|
|
·
|
determination
of the product candidate’s expected competitive advantage in the
marketplace;
|
|
·
|
duration
of development timeline leading to
commercialization;
|
|
·
|
financial
investment needed for development and availability of necessary financial
resources; and
|
|
·
|
expected
sales and profitability.
|
Competition
MacroChem
competes with a number of companies, many of which are large, multi-national
organizations with worldwide distribution. MacroChem believes that its major
competitors in the drug delivery sector of the health care industry include
Bentley Pharmaceuticals, Inc., Biosante Pharmaceuticals, Inc., NexMed, Inc.,
Antares Pharma, Inc. and Barrier Therapeutics, Inc. Established competitors in
the therapeutic areas that MacroChem clinical stage product candidates seek to
address include, with respect to onychomycosis, Novartis AG, Johnson &
Johnson and Sanofi Aventis (Dermik Laboratories), and with respect to male
hypogonadism, Solvay Pharmaceuticals, Inc., Auxilium Pharmaceuticals, Inc.,
Watson Pharmaceuticals, Inc. and Columbia Laboratories, Inc. Compared with
MacroChem, these companies have or may have substantially greater capital
resources, research and development and technical staff, facilities and
experience in obtaining regulatory approvals, as well as in manufacturing,
marketing and distribution of products.
With
respect to mild diabetic foot infection (DFI), there is currently no topical
treatment approved by the FDA. In addition, MacroChem is not aware of any other
companies working on a topical treatment for mild diabetic foot
infection.
With
respect to onychomycosis, Novartis AG and Johnson & Johnson each offer an
orally administered antifungal therapy and Sanofi Aventis (Dermik Laboratories)
offers a topical nail lacquer therapy for treating fungal infections of the
nail. A number of other companies, including Nexmed, Inc./Novartis AG,
Schering-Plough/Anacor Pharmaceuticals, Inc. and Ivrea/MediQuest Therapeutics,
Inc., are also developing topical therapies for these infections.
91
With
respect to male hypogonadism, Solvay Pharmaceuticals, Inc. and Auxilium
Pharmaceuticals, Inc. each offer a topically administered testosterone gel,
Watson Pharmaceuticals, Inc. offers a testosterone patch, and Columbia
Laboratories, Inc. offers a testosterone buccal film product. A number of other
companies are also developing topical testosterone products.
MacroChem
expects any products approved for sale to compete primarily on the basis of
efficacy, safety, patient compliance, reliability, convenience, price and patent
position. Generally, the first pharmaceutical product to reach the market in a
therapeutic or preventive area often has a significant commercial advantage
compared with later entrants to the market. MacroChem’s competitive position
will also depend on MacroChem ability to attract and retain qualified scientific
and other personnel, develop effective proprietary products, implement
production and marketing plans, obtain patent protection and secure adequate
capital resources.
Government
Regulation
The
production and marketing of MacroChem’s drug delivery systems and pharmaceutical
products are subject to regulation for safety, efficacy and quality by numerous
federal, state and local agencies and comparable agencies in foreign
countries.
In the
United States, the Federal Food, Drug and Cosmetics Act, the Public Health
Service Act, the Controlled Substances Act and other federal statutes and
regulations govern or influence the testing, manufacture, safety, labeling,
storage, record keeping, approval, advertising and promotion of MacroChem
proposed products and technologies.
Non-compliance
with applicable requirements can result in fines and other judicially imposed
sanctions including recalls and criminal prosecutions based on violation of
statutory requirements by products, promotional practices, clinical practices or
manufacturing practices. In addition, administrative remedies can involve
voluntary recalls or cessation of sale of products, administrative detention,
public notice, voluntary changes in labeling, manufacturing or promotional
practices, as well as refusal of the government to approve New Drug Applications
(NDAs). The FDA also has the authority to withdraw approval of drugs in
accordance with statutory procedures.
The FDA
approval procedure involves completion of certain pre-clinical and
manufacturing/stability studies and the submission of the results of these
studies to the FDA in an Investigational New Drug (IND) application in support
of performing clinical trials. IND allowance is then followed by performance of
human clinical trials, and additional pre-clinical and manufacturing quality
control studies, supporting safety, efficacy and manufacturing quality control.
The safety, chemistry, manufacturing and stability and clinical studies
developed under the IND are generally compiled into an NDA or Abbreviated New
Drug Application (ANDA) and submitted to the FDA for approval to
market.
Pre-clinical
studies involve laboratory evaluation of product characteristics and animal
studies to assess the efficacy and safety of the product. Human clinical trials
are typically conducted in three sequential phases, but the phases may overlap.
Phase 1 trials typically consist of testing of the product in a small number of
normal volunteers primarily for safety. In Phase 2, in addition to safety, the
efficacy of the product is typically evaluated in a small patient population.
Phase 3 trials typically involve multicenter testing for safety and clinical
efficacy in an expanded population of patients at geographically dispersed test
sites. A clinical plan, or “protocol,” accompanied by the identification of the
institutions participating in the trials, must be submitted to the FDA prior to
commencement of each clinical trial. The FDA may order the temporary or
permanent discontinuation of a clinical trial at any time if adverse events that
endanger patients in the trials are observed. In addition, the FDA may request
Phase 4 clinical trials, to be performed after marketing approval, to resolve
any lingering questions.
A 30-day
waiting period after the filing of each IND application is required by the FDA
prior to the commencement of clinical testing in human subjects. If the FDA does
not comment on or question the IND application within 30 days, initial clinical
studies may begin. However, any FDA comments or questions must be answered to
the satisfaction of the FDA before initial clinical testing can begin. In some
instances, this process can result in substantial delay and
expense.
The
results of the pre-clinical and clinical studies on new drugs are submitted to
the FDA in the form of NDAs for approval to commence commercial sales. Following
extensive review, the FDA may grant marketing approval, require additional
testing or information, or deny the application. All products must continue to
comply with all FDA requirements and the conditions in an approved application,
including product specifications, manufacturing process and labeling
requirements. Failure to comply, or the occurrence of unanticipated adverse
events during commercial marketing, could lead to the need for labeling changes,
product recall, seizure, injunctions against distribution or other FDA-initiated
action, which could delay further marketing until the products are brought into
compliance.
In
certain cases, an ANDA may be filed in lieu of filing an NDA. An ANDA relies on
bioequivalency tests that compare the applicant’s drug with an already approved
reference drug, rather than on clinical trials. For example, an ANDA may be
available for a new topical formulation of a drug which has already been
approved by the FDA in other topical dosage forms.
92
The NDA
itself is a complicated and detailed document and must include the results of
extensive animal, clinical and other testing, the cost of which is substantial.
Although the FDA is required to review applications within 180 days of filing,
in the process of reviewing applications the FDA frequently requests that
additional information be submitted and restarts the 180-day regulatory review
period when the requested additional information is submitted. The effect of
such requests and subsequent submissions can significantly extend the time for
the NDA review process. Until an NDA is actually approved, no assurance can be
given that the information requested and submitted will be considered adequate
by the FDA to justify approval.
In
addition, packaging and labeling of MacroChem proposed products are subject to
FDA regulation. MacroChem must get FDA approval for all labeling and packaging
prior to marketing of a regulated product.
Whether
or not FDA approval has been obtained, approval of a product by a comparable
regulatory authority must be obtained in most foreign countries before marketing
of the product in that country. The approval procedure varies from country to
country and may involve additional testing, and the time required may differ
from that required for FDA approval. Although some procedures for unified
filings exist for certain European countries, in general each country has its
own procedure and requirements, many of which are time consuming and expensive.
Thus, substantial delays in obtaining required approvals from foreign regulatory
authorities can result after the relevant applications are filed. After such
approvals are obtained, further delays may be encountered before the products
become commercially available. Moreover, differing reimbursement regulations in
various foreign countries may affect pricing of MacroChem drug
candidates.
MacroChem
cannot guarantee that any required FDA or other governmental approval will be
granted or, if granted, will not be withdrawn. Governmental regulation may
prevent or substantially delay the marketing of MacroChem proposed products,
cause MacroChem to undertake costly procedures and furnish a competitive
advantage to the more substantially capitalized companies with which MacroChem
plan to compete. In addition, MacroChem cannot predict the extent of potentially
adverse government regulations that may arise from future administrative action
or legislation.
Research
and Development
In August
2005, at the direction of MacroChem’s board of directors, MacroChem discontinued
all research and development activities and terminated substantially all of its
non-management personnel. Following this staff reduction, in order to conduct
research and development activities, including stability studies, tests of
MacroChem’s unique formulations and the design of manufacturing processes for
MacroChem drug delivery technologies, MacroChem has contracted and will continue
to contract with third parties to perform this work. MacroChem believes that
there are numerous third party contractors who would be able to perform such
research and development activities.
Prior to
the staff reduction in August 2005, MacroChem conducted MacroChem research and
development activities through its own staff and facilities, and also through
collaborative arrangements with universities, contract research organizations
and independent consultants. Research and developmental
expenditures were $2,291,721, $679,759 and $2,135,393 during the years ended
December 31, 2005, 2006 and 2007, respectively. MacroChem also relies upon third
parties to conduct clinical studies and to obtain FDA and other regulatory
approvals.
Patents,
Trademarks and License Rights
MacroChem’s
composition of matter patent on the SEPA family of compounds expired in November
2006. MacroChem owns six composition of matter and use patents, with expiration
dates ranging from 2015 to 2019, for the combination of SEPA with numerous
existing classes of drugs, including antifungals and human sex hormones. The
patent for SEPA combined with antifungals covers the combination of SEPA and
econazole in EcoNail, and the patent for SEPA combined with human sex hormones
covers the combination of SEPA and testosterone in Opterone.
With
respect to MacroChem MacroDerm technology, MacroChem has three U.S. patents
covering the chemical composition and use of the MacroDerm polymers, which
expire in 2015.
On
October 3, 2007, MacroChem announced it took a step to broaden its product
portfolio by acquiring exclusive worldwide rights for drug uses of pexiganan, a
novel, small peptide anti-infective for topical treatment of patients with mild
diabetic foot infection (DFI) from Genaera. Under the terms of the license
agreement, MacroChem has paid Genaera an initial fee of $1 million through
February 1, 2008. The deal terms also include payments of $7 million to Genaera
upon the achievement of certain clinical and regulatory milestones through
approval, sales-based milestones of up to $35 million, and 10% royalty payments
on net sales. In addition, MacroChem assumed all clinical
development, manufacturing and regulatory activities for pexiganan.
MacroChem
intends to seek other composition of matter and use patents regarding various
formulations based on its drug delivery technologies and for new technologies.
In 2007, MacroChem did not file any new U.S. patent applications.
In
addition to the patent activity, MacroChem has trademarks for the marks SEPA and
Opterone. MacroChem also have pending trademark applications for the marks
MacroDerm and EcoNail.
93
MacroChem
believes that patent protection of its technologies, processes and products is
important to MacroChem’s future operations. The success of MacroChem’s proposed
products may depend, in part, upon its ability to obtain patent and trademark
protection. MacroChem intends to enforce MacroChem patent position and
intellectual property rights vigorously. The cost of enforcing MacroChem patent
rights in lawsuits, if necessary, may be significant and could interfere with
MacroChem’s operations.
Employees
As of
November 24, 2008, MacroChem had four full time employees, none of whom are
dedicated to research and development or regulatory affairs. None of MacroChem’s
employees are covered by a collective bargaining agreement, and MacroChem
consider relations with MacroChem employees to be good.
Web
Availability
We make
available free of charge through our web site, www.macrochem.com, our annual
reports on Form 10-K and Form 10-KSB, as applicable, and other reports required
under the Securities and Exchange Act of 1934, as amended, as soon as reasonably
practicable after such reports are filed with, or furnished to, the Securities
and Exchange Commission (the “SEC”). These documents are also available through
the SEC’s website at www.sec.gov certain
of our corporate governance policies, including the charters for the Board of
Directors’ audit, compensation and nominating and corporate governance
committees and our code of ethics, corporate governance guidelines and
whistleblower policy. The public may read and copy materials we file with the
Commission at the SEC’s Public Reading Room at 100 F Street, NE, Washington, DC
20549, on official business days during the hours of 10:00 am and 3:00 pm. The
public may obtain information on the operation of the Public Reading Room by
calling the Commission at 1-800-SEC-0330. We will provide to any person without
charge, upon request, a copy of any of the foregoing materials. Any such request
must be made in writing to MacroChem Corporation, 80 Board Street, 22nd Floor,
New York, New York 10004, attn: Investor Relations.
Manufacturing
In order
to manufacture MacroChem’s product candidates for clinical trials and for
commercial distribution following FDA approval, MacroChem will need to contract
with a third party manufacturer to produce the product. MacroChem believes that
there are numerous third party manufacturers who would be able to manufacture
MacroChem’s product candidates for clinical trial purposes and on a commercial
scale.
DESCRIPTION
OF PROPERTY
We
currently occupy approximately 3,975 square feet of office space under a lease
which terminates in April 2010. This space is located at 80 Broad
Street, 22nd Floor,
New York, New York 10004. We believe that this facility is adequate
to meet our current requirements. We also believe that suitable alternative
locations are readily available.
LEGAL
PROCEEDINGS
MacroChem
is not currently subject to any material pending legal proceedings.
SECURITIES
AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION PLANS
The
following table details our equity compensation plans at December 31,
2007:
|
EQUITY
COMPENSATION PLAN INFORMATION
|
|||
|
(a)
|
(b)
|
(c)
|
|
|
Plan
Category
|
Number of
securities to be issued upon exercise of outstanding options and rights
|
Weighted-average exercise price of outstanding options and rights | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) |
|
Equity compensation
plans approved by security holders
|
110,693 | $ 79.84 |
1,296,654
|
|
Equity
compensation plans
not
approved by
security
holders
|
2,646,904(1)
|
$ 1.18 | None |
|
Total
|
2,757,597
|
$ 4.33 |
1,296,654
|
94
|
Date
|
Grantee
|
Number
of Shares
|
|
June
20, 2003
|
Mr. DeLuccia
|
11,904
|
|
February
14, 2006
|
Mr.
DeLuccia
|
350,000
|
|
Mr.
Patriacca
|
175,000
|
|
|
Mr.
Deegan
|
150,000
|
|
|
February
22, 2006
|
Dr.
Zabriskie
|
45,000
|
|
Dr.
Davis
|
45,000
|
|
|
Mr.
Davis
|
45,000
|
|
|
Mr.
Martin
|
45,000
|
|
|
Mr.
Echenberg
|
45,000
|
|
|
Mr.
Fischer
|
45,000
|
|
| February 22, 2007 | Mr. DeLuccia |
400,000
|
| Mr. Patriacca |
300,000
|
|
| Mr. Davis |
45,000
|
|
| Dr. Davis |
45,000
|
|
| Mr. Martin |
45,000
|
|
| Mr. Fischer |
45,000
|
|
| Mr. Echenberg |
45,000
|
|
| Mr. Zabriskie |
45,000
|
|
|
September
5, 2007
|
Mr.
DeLuccia
|
300,000
|
|
Mr.
Patriacca
|
150,000
|
|
|
Mr.
Zabriskie
|
45,000
|
|
|
Dr.
Davis
|
45,000
|
|
|
Mr.
Davis
|
45,000
|
|
|
Mr.
Martin
|
45,000
|
|
|
Mr.
Echenberg
|
45,000
|
|
|
Mr.
Alvino
|
45,000
|
Since
December 31, 2007, Mr. Patriacca, Dr. Zabriskie, Dr. Davis, Mr. Echenberg, Mr.
Martin, Mr. Echenberg and Mr. Fischer have resigned from our Board of Directors
or left employment with us.
MARKET
FOR COMMON STOCK
Our
common stock is traded on the OTC Bulletin Board under the symbol "MACM.OB.”
Prior to February 10, 2006, our common stock was traded on the OTC Bulletin
Board under the symbol "MCMP.OB.” Between November 24, 2003 and November 21,
2005, our common stock was traded on The Nasdaq Capital Market under the symbol
"MCHM” and, prior to November 24, 2003, it was traded on The Nasdaq National
Market under the symbol "MCHM.”
The
following chart shows the high and low closing prices for our common stock for
the periods indicated:
|
Common
Stock
MACM
|
||
|
Year
Ended
|
High
|
Low
|
|
December
31, 2006
|
||
|
First
Quarter
|
$2.70
|
$1.08
|
|
Second
Quarter
|
1.60
|
0.70
|
|
Third
Quarter
|
0.85
|
0.26
|
|
Fourth
Quarter
|
0.54
|
0.30
|
|
December
31, 2007
|
||
|
First
Quarter
|
$0.75
|
$0.31
|
|
Second
Quarter
|
1.15
|
0.40
|
|
Third
Quarter
|
0.84
|
0.55
|
|
Fourth
Quarter
|
0.90
|
0.45
|
|
December
31, 2008
|
||
|
First
Quarter
|
$0.50
|
$0.30
|
|
Second
Quarter
|
0.32
|
0.17
|
|
Third
Quarter
|
0.25
|
0.17
|
|
Fourth
Quarter Thru November 24, 2008
|
0.13
|
0.025
|
95
These
prices are between dealers and do not reflect retail markups, markdowns or
commissions and may not necessarily represent actual transactions. As of
November 24, 2008, there were 660 holders of record of our common stock. On
November 24, 2008, our common stock closed at $0..025 per share.
We have
never paid cash dividends on our common stock and our Board of Directors does
not contemplate declaring any dividends in the foreseeable future. We intend to
retain any earnings to finance research, development, and expansion of our
business.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The
following table sets forth, as of November 5, 2008 (except as noted),
information concerning ownership of our voting securities by (1) each person
known by us to be the beneficial owner of more than five percent (5%) of our
voting securities, (2) each of our directors, (3) each of the executive officers
and (4) all directors and executive officers as a group. Except as
otherwise indicated, the stockholders listed in the table have sole voting and
investment powers with respect to the shares indicated. There were a total of
45,873,412 shares of our common stock outstanding on November 5,
2008.
The
aggregate market value of common stock held by non-affiliates of MacroChem has
been computed as if Steven H. Rouhandeh is the only “affiliate” listed on the
table of Five Percent Stockholders and the table of Directors and Officers each
set below are all “affiliates”, but we do not state whether each such listed
stockholders are an affiliate.
In our
2006 private placement, unless an investor elected otherwise, its ability to
exercise warrants is restricted to the extent that such exercise would result in
the holder owning more than 4.95% of our issued and outstanding common stock.
SCO Capital Partners LLC, Beach Capital LLC, SCO Capital Partners L.P. and
Perceptive Life Sciences Master Fund Ltd. Perceptive elected not to be governed
by these restrictions, and we have entered into an agreement with Perceptive
whereby Perceptive's ability to exercise warrants will be subject to a
beneficial ownership cap of 9.95% instead of 4.95%. In the 2007
private placement, the investors were given the option to elect a similar
restriction, whereby an electing investor's ability to exercise warrants is
restricted to the extent that such exercise would result in the holder owning
more than 4.99% of our issued and outstanding common stock.
We have
determined the number of shares beneficially owned by each stockholder under
rules promulgated by the SEC. The information is not necessarily
indicative of beneficial ownership for any other purpose. Under these rules,
beneficial ownership includes any shares as to which the individual or entity
has sole or shared voting or investment power and any shares as to which the
individual or entity has the right to acquire beneficial ownership within 60
days after November 5, 2008, through the exercise of any stock option, warrant
or other right. The inclusion in the following table of those shares,
however, does not constitute an admission that the named stockholder is a direct
or indirect beneficial owner.
|
Class
of Stock
|
Name and Address
of
Beneficial Owner
|
Number
of shares
Beneficially
Owned
|
Percentage of Class | ||
|
FIVE
PERCENT STOCKHOLDERS
|
|||||
|
Common Stock
|
Steven H. Rouhandeh(1)
|
36,056,000
|
66.8%
|
||
|
Common Stock
|
Joseph Edelman(2)
|
5,372,780 |
9.95%
|
||
|
Common Stock
|
Franklin Resources,
Inc.(3)
|
2,925,000
|
6.3%
|
||
|
Common Stock
|
Whalehaven Capital Fund Limited
(4)
|
2,687,921
|
4.95%
|
||
|
DIRECTORS
AND EXECUTIVE OFFICERS
|
|||||
|
Common Stock
|
Robert
J. DeLuccia(5)(7)
|
808,900
|
1.8%
|
||
|
Common Stock
|
Jeffrey
Davis (5)(6)(7)(8)(9)
|
2,199,867
|
4.7%
|
||
|
Common Stock
|
Mark
J. Alvino(5)(10)
|
355,916
|
*
|
||
|
Common Stock
|
David
P. Luci(5)
|
676,667
|
1.5% | ||
|
Common Stock
|
All
directors and officers as a group (5 persons)(7)
|
4,041,350
|
8.8%
|
||
------------------
* Less
than one percent (1%).
|
(1)
|
SCO
Capital Partners LLC is the record owner of 15,891,304 shares of common
stock, Beach Capital LLC is the record owner of 1,979,078 shares of common
stock and SCO Capital Partners, L.P. is the record owner of 993,941 shares
of common stock. Mr. Rouhandeh, as Chairman and managing member of SCO
Capital Partners LLC, managing member of Beach Capital LLC, and managing
member of the general partner of SCO Capital Partners, L.P., has sole
dispositive and voting power with respect to all shares listed in the
table. The shares of common stock listed as beneficially owned by Mr.
Rouhandeh include 8,075,498 shares of common stock issuable upon the
exercise of warrants exercisable within 60 days. The Steven H. Rouhandeh
Family Trust, of which Mr. Rouhandeh is a Trustee, is the record owner of
500,000 shares of common stock. The address of SCO
Capital Partners LLC, Beach Capital LLC, SCO Capital Partners,
L.P., The Steven H. Rouhandeh Family Trust and Mr. Rouhandeh is 1285
Avenue of the Americas, 35th Floor, New York, New
York10019.
|
96
|
(2)
|
According
to a Schedule 13G/A dated November 16, 2007, Mr. Edelman has sole
dispositive and voting power with respect to the shares listed in the
table. 2,366,780 shares reported as beneficially owned by Mr.
Edelman are held of record by Perceptive Life Sciences Master
Fund Ltd., a Cayman Islands company of which the investment manager is
Perceptive Advisors LLC, a Delaware limited liability company of which Mr.
Edelman is the managing member and 6,000 shares are held by
First New York Trading LLC. These warrants beneficially owned
by Mr. Edelman are subject to restrictions on their exercise, such that as
a result of their exercise, Mr. Edelman, together with his affiliates,
cannot hold more than 9.95% of the issued and outstanding common stock of
the Company. The address of Mr. Edelman is c/o First New York
Securities, LLC, 850 Third Avenue, 8th Floor, New York, NY
10022.
|
|
(3)
|
According
to a Schedule 13G dated December 11, 2006, Franklin Resources, Inc. has
sole voting and dispositive power with respect to the shares listed in the
table, as investment manager for investment management clients. The
address of Franklin Resources, Inc. is One Franklin Parkway, San Mateo, CA
94403-1906.
|
|
(4)
|
The
address of Whalehaven Capital Fund Limited is FWS Capital Ltd., Management
for Whalehaven Capital, 160 Summit Avenue, Montvale, NJ
07645. The shares of common stock listed as
beneficially owned by Whalehaven Capital Fund Limited include 1,187,921
shares of common stock beneficially owned by Whalehaven Capital Fund
Limited. 1,500,000 warrants held by Whalehaven Capital Fund
Limited are subject to restrictions on their exercise such that as a
result of their exercise, Whalehaven Capital Fund Limited, together with
its affiliates, cannot hold more than 4.95% of the issued and outstanding
common stock of the Company.
|
|
(5)
|
The
address of Messrs. DeLuccia and Luci is c/o MacroChem Corporation, 80
Broad Street, Suite 2210, New York, New
York 10004.
|
|
(6)
|
The
address of Mr. Davis is 1285 Avenue of the Americas, 35th Floor, New York,
New York 10019.
|
|
(7)
|
Includes
the following numbers of shares issuable upon the exercise of stock
options and/or warrants exercisable within 60 days: Mr.
DeLuccia 516,668 shares; Mr. Davis 1,335,165 shares; Mr. Luci 635,000
shares; and Mr. Alvino 355,916
shares.
|
|
(8)
|
Lake
End Capital LLC is the record owner of the securities listed in the
table. Mr. Jeffrey Davis, as managing member of Lake End
Capital LLC, has sole dispositive and voting power with respect to all
shares held of record by Lake End Capital LLC. The shares of
common stock listed as beneficially owned by Jeffrey Davis include
1,139,773 shares of common stock issuable upon exercise of the warrants
held by Lake End Capital LLC within 60 days and 60,000 shares of common
stock issuable upon the exercise of options held by Mr. Davis within 60
days. The warrants held by Lake End Capital LLC are subject to
restrictions on their conversion and exercise such that as a result of
their exercise, Lake End Capital LLC, together with
its affiliates, cannot hold more than 4.95% of the
issued and outstanding common stock of the Company. The address
of Lake End Capital LLC is 33 Tall Oaks Drive, Summit, New Jersey
07501.
|
|
(9)
|
Includes
1,139,773 shares of common stock issuable upon the exercise of a warrant
held of record by Lake End Capital LLC as described in Note 9 above that
is exercisable within 60 days.
|
|
(10)
|
The
address of Mr. Alvino is c/o Griffin Securities, Inc., 17 State Street,
3rd floor, New York, NY 10004.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The
following discussion should be read in conjunction with our consolidated
financial statements and related notes included in this Information
Statement/Prospectus.
We are a
specialty pharmaceutical company that develops and seeks to commercialize
pharmaceutical products. As of September 30, 2008, our portfolio of
proprietary product candidates are based on our drug delivery technologies:
SEPA, MacroDerm and DermaPass. Our SEPA topical drug delivery technology (SEPA
is an acronym for “Soft Enhancement of Percutaneous Absorption,” where “soft”
refers to the reversibility of the skin effect, and “percutaneous” means
“through the skin”) enhances the efficiency and rate of diffusion of drugs into
and through the skin. Our patented MacroDerm drug delivery technology
encompasses a family of low to moderate molecular weight polymers that impede
dermal drug or chemical penetration. We have also filed a patent application for
our DermaPass family of transdermal absorption enhancers that have a different
drug delivery profile than SEPA, which we believe could be used with a wider
range of active pharmaceutical ingredients. Our product candidates include two
clinical stage investigational new drugs: EcoNail, for the treatment of fungal
infections of the nails and pexiganan, for the treatment of mild diabetic foot
infection (DFI). We believe that products incorporating our drug delivery
technologies may allow selected drugs to be administered more effectively and
with improved patient compliance compared to alternative methods of drug
administration, such as ingestion and injection.
Since
inception, we have been engaged primarily in research and development. We have
not generated any meaningful revenues from operations and we have sustained
significant operating losses. We anticipate that we will continue to incur
significant losses for the foreseeable future. We cannot guarantee that we will
be successful in commercializing our products, or that we will ever become
profitable. As of September 30, 2008, we had an accumulated deficit of
$100,649,600. Our product candidates are in discovery or developmental stages
and must undergo a rigorous regulatory approval process, which includes costly
and extensive pre-clinical and clinical testing, to demonstrate safety and
efficacy before we can market any resulting product. To date, neither the FDA
nor any of its international equivalents has approved any of our product
candidates for marketing.
97
Our
results of operations can vary significantly from year-to-year and
quarter-to-quarter, and depend, among other factors, on:
|
|
the
progress of clinical trials we conduct;
|
|
|
|
the
degree of our research, marketing and administrative
efforts;
|
|
|
|
our
ability to raise additional capital;
|
|
|
|
the
signing of licenses and product development agreements;
|
|
|
|
the
timing of revenues recognized pursuant to license agreements;
and
|
|
|
|
the
achievement of milestones by
licensees.
|
We expect
to continue spending funds on developing and seeking regulatory approval of our
lead product candidates, EcoNail and pexiganan. Ultimately, if we receive
regulatory approval for either product, significant expenses will be incurred in
connection with its commercialization. In addition, we also plan to identify and
develop, internally, through in-licensing, or through other collaborative
arrangements, additional product candidates and technologies that fit within our
growth strategy. If we identify potential product candidates, we will incur
additional costs in connection with testing and seeking regulatory approval of
those product candidates.
On
October 10, 2007, the Company entered into a Securities Purchase Agreement,
pursuant to which the Company issued in a private placement 5,891,667 shares of
its common stock and five-year warrants to purchase 1,767,500 shares of the
Company’s common stock at an exercise price of $0.60 per share, for aggregate
proceeds of $3,535,000. In connection with the private placement, all of the
752.25 then outstanding shares of the Company’s Series C Cumulative
Convertible Preferred Stock were converted into a total of 12,571,850 shares of
common stock. In addition, outstanding warrants to purchase 8,648,102 shares of
common stock previously issued with the Series C Preferred have been reset
to purchase 17,885,848 shares of common stock at an exercise price of $0.60 per
share, pursuant to anti-dilution provisions of those warrants.
In
connection with the private placement, the Company entered into a Director
Designation Agreement dated as of October 1, 2007 with SCO Capital
Partners, LLC (“SCO”), a current stockholder and a purchaser in the private
placement, pursuant to which, for so long as SCO holds 20% of the Company’s
outstanding common stock, SCO has the right to designate two individuals to
serve on the Company’s board of directors. SCO previously held the right to
designate two individuals to serve on the Company’s board of directors for so
long as it held 20% of the Company’s outstanding Series C
Preferred.
The
Company entered into an agreement and plan of merger with Access
Pharmaceuticals, Inc. on July 10, 2008. As of September 30, 2008,
our existing cash, cash equivalents and short term investments totaled $32,879.
The Company’s continuation as a going concern depends on its ability to obtain
additional financing, to consummate a strategic transaction or to make
alternative arrangements to fund its operations, which cannot be guaranteed.
There can be no assurance that the Company will be able to obtain additional
financing, to consummate a strategic transaction, or to make alternative
arrangements to fund its operations. The Company’s cash requirements may vary
materially from those now planned because of changes in the focus and direction
of its research and development programs, identification of additional product
candidates and technologies, competitive and technical advances, patent
developments or other developments related to the status of fund
raising.
Research and Development
Expenses. Research and development expenses consist of:
|
|
payments
to consultants, investigators, contract research organizations and
manufacturers in connection with
our
|
pre-clinical
and clinical trials;
|
|
costs
associated with conducting our clinical trials;
|
|
|
|
costs
of developing and obtaining regulatory
approvals
|
allocable
costs, including occupancy and depreciation.
Because a
significant portion of our research and development expenses (including
laboratory supplies, travel, dues and subscriptions, temporary help costs,
consulting costs and allocable costs such as occupancy and depreciation) benefit
multiple projects or our drug delivery technologies in general, we do not track
these expenses by project.
98
For the
nine-month period ended September 30, 2008, we spent $916,940 on research
and development including $614,700 in costs associated with a clinical trial for
Econail, $295,110 in costs associated with the in-licensing of pexiganan acetate
from Geneara, and $7,130 in costs not specifically tracked to a project.
Opterone was not in clinical trial in 2008. For the nine months ended
September, 2007 we spent $1,047,187 on research and development, including
$592,742 in costs associated with a clinical trial for Econail and $314,824 in
costs associated with the in licensing of Suponex (pexignan acetate) and
$140,861 in costs not specifically tracked to a project.
Each of
our research and development programs is subject to risks and uncertainties,
including the requirement to seek regulatory approval, that are outside of our
control. Moreover, the product candidates identified in these research and
development programs, which currently are in developmental stages, must overcome
significant technological, manufacturing and marketing challenges before they
can be successfully commercialized. As a result of these risks and
uncertainties, we are unable to predict with any certainty the period in which
material net cash inflows from these projects could be expected to commence or
the completion date of these programs. For example, we are seeking a partner to
advance development of our Opterone product candidate. We cannot predict whether
our efforts to find a partner will be successful nor can we predict the manner
and timing in which any eventual partner may elect to pursue development of
Opterone. In addition, these risks and uncertainties also prevent us from
estimating with any certainty the specific timing and future costs of our
clinical development programs, although historical trends at similarly situated
companies indicate that research and development expenses tend to increase in
later stages of clinical development. Our failure to obtain requisite
governmental approvals timely or at all will delay or preclude us from licensing
or marketing our products or limit the commercial use of our products, which
could adversely affect our business, financial condition and results of
operations.
Marketing, General and
Administrative Expenses. Marketing, general and administrative expenses
consist primarily of salaries and other related costs for personnel, marketing
and promotion, professional fees and facilities costs. Assuming we are able to
raise sufficient capital, we anticipate that marketing, general and
administrative expenses will increase over the next several years as we begin,
when appropriate, to license, partner, or market our product candidates if and
when they receive regulatory approval.
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations are
based on our financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States of America. The
preparation of these financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenues and
expenses. The following is a brief discussion of the more significant accounting
policies and methods that affect the judgments and estimates used in the
preparation of our condensed consolidated financial statements.
Research and Development.
Research and development costs are expensed as incurred.
Patent Assets. We defer costs
and expenses incurred in connection with pending patent applications. We
amortize costs related to successful patent applications over the estimated
useful lives of the patents using the straight-line method. We charge
accumulated patent costs and deferred patent application costs related to
patents that are considered to have limited future value to operations.
Estimates we use to determine the future value of deferred patent costs include
analysis of potential market size, time and cost to complete clinical trials,
anticipated interest in our products and potential value for licensing or
partnering opportunities.
Deferred Taxes. As part of
the process of preparing our financial statements we are required to estimate
our income taxes in each of the jurisdictions in which we operate. This process
involves estimating our actual current tax exposure together with assessing
temporary differences resulting from differing treatments of items for tax and
accounting purposes. We have recorded a valuation allowance to fully offset
against these otherwise recognizable net deferred tax assets due to the
uncertainty surrounding the timing of the realization of the tax benefit. In the
event that we determine in the future that we will be able to realize all or a
portion of the net deferred tax benefit, an adjustment to deferred tax valuation
allowance would increase net income in the period in which such a determination
is made. The utilization of net operating loss carryforwards and credits
available to be used in any given year may be limited in the event of
significant changes in ownership interest, as defined.
Warrant Liability. Based on
certain terms in the warrants that we issued in connection with the sale of our
Series C Cumulative Convertible Preferred Stock, we determined that the
warrants should be classified as a liability and valued at fair market value
each reporting period, with the changes in fair value recorded in earnings, in
accordance with EITF 00-19, “Accounting for Derivative Financial Investments
Indexed to, and Potentially Settled in, a Company’s Own Stock.” We will
continue to evaluate the warrants under EITF 00-19 to determine when, if ever,
they meet certain criteria under EITF 00-19 for permanent equity.
99
Stock-Based Compensation.
On January 1, 2006, the Company adopted Statement of Financial
Accounting Standards (“SFAS”) No. 123(R), “Share-Based Payment,” using the
modified prospective method, which requires measurement of compensation cost for
all stock awards at fair value on the date of grant and recognition of
compensation over the requisite service period for awards expected to vest. The
fair value of stock options is estimated using the Black-Scholes valuation
model, and the fair value of restricted stock units is determined based on the
number of shares granted and the quoted price of the Company’s common stock on
the date of grant. Such value is recognized as expense over the requisite
service period, net of estimated forfeitures, using the straight-line
attribution method. The estimate of awards that will ultimately vest requires
significant judgment, and to the extent actual results or updated estimates
differ from the Company’s current estimates, such amounts will be recorded as a
cumulative adjustment in the period estimates are revised. The Company considers
many factors when estimating expected forfeitures, including types of awards,
employee class and historical employee attrition rates. Actual results, and
future changes in estimates, may differ substantially from the Company’s current
estimates.
Results
of Operations
Comparison
of Nine Months Ended September 30, 2008 and 2007
We had
$2,652 and no revenues for the nine- month periods ended September 30, 2008
and 2007, respectively. The increases in revenue is due to the recognition of an
up-front fee of $50,000 assumed from Virium merger. This fee is being recognized
over life of the agreement. For the year ending December 31, 2008 and the
foreseeable future, we do not expect to have any meaningful
revenues.
For the
nine- month period ended September 30, 2008, research and development costs
decreased by $130,247, or 12 % to $916,940 from $1,047,187 in the nine- month
period ended September 30, 2007. This decrease is primarily attributable to
the decrease in spending on clinical trials as well as a decrease in general
research and development consulting costs.
For the
nine- month period ended September 30, 2008, marketing, general and
administrative costs increased by $208,266, or 8% to $2,962,453 from $2,754,187
in the nine- month period ended September 30, 2007. The increase is
primarily attributable to an increase in stock based compensation of $242,389,
severance payments of $158,786, financial advisory services of $101,804 and rent
expense of $114,489. This increase was partially offset by decreases in public
relations fees of $237,390, patent search fees of $119,642 and franchise tax
fees of $42,260.
Other
income and expense increased by $4,798,719 due to a gain of $3,731,913 in the
nine- month period ended September 30, 2008 compared with a loss of
$1,066,806 in the nine- month period ended September 30, 2007. The increase
is primarily attributable to an increase in the gain associated with the change
in value of the warrant liability of $3,886,206 for the nine month period ended
September 30, 2008. Interest expense increased by $186,856 in the nine-
month period ended September 30, 2008 from $0 in the nine- month period
ended September 30, 2007. The increase in interest expense is payments due
to debt holders assumed from the Virium merger agreement.
In-process
research and development costs of $9,656,794 are attributed to the acquisition
of Virium Pharmaceuticals Inc. in April of 2008. The acquisition costs are
comprised of $6,869,618 related to the calculated value of 22,899,206 shares of
the Company’s stock issued to Virium shareholders valued at $.30 per share,
$2,403,916 of net liabilities and assets assumed as part of the merger, $143,020
related to the calculated value of 670,408 warrants issued to Virium
shareholders and $240,240 in transaction costs.
For the
reasons described above, the Company’s condensed consolidated financial
statements for the nine- month period ended September 30, 2008,
reflect a net loss of $9,801,622 compared with a net loss of $4,868,180 for the
nine- months ended September 30, 2007.
100
Comparison
of Years Ended December 31, 2007 and 2006
The
Company had no revenues for the years ended December 31, 2007 and 2006,
respectively. For the year ending December 31, 2008, we do not expect to have
any revenues.
Research
and development costs for 2007 increased by $1,455,634 from $679,759 in 2006 to
$2,135,393 in 2007, a 214.1% increase. The increase is attributable to the in
licensing costs of the pexiganan acetate product of $1,222,123 and an increase
in the costs for the EcoNail clinical trial of $133,900 and an increase in
general costs of $99,611. Current operating plans call for the Company to spend
approximately $1,000,000 on research and development in the year ending December
31, 2008.
Marketing,
general and administrative costs for 2007 increased by $1,988 or less then 1% to
$3,714,994, from $3,713,006 in 2006. The increase was attributable to increases
of $129,498 in legal and accounting fees associated with certain SEC filings,
$239,119 in patent and research fees and $223,636 in consulting and investor
relations expenses. The above increases were offset by decreases of $286,379 in
stock based compensation, $12,836 in payroll and related expenses, $40,934 in
insurance premiums, $84,778 in filing and registration fees, $56,504 in rent and
office related expenses, a reduction of the Delaware state franchise tax of
$52,590 and a decrease in travel, conference and related expenses of $56,129.
The current operating plan calls for the Company to spend up to approximately
$1,200,000 in marketing, general and administrative expenses in the year ending
December 31, 2008.
For the
year ended December 31, 2007, other income was a loss of $3,015,795 compared to
a gain of $6,344,044 for the year ended December 31, 2006. This loss is
primarily a non-cash decrease as a result of a change in the valuation of
warrants in accordance with EITF 00-19, Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in a Company’s Own Stock” to
reflect a decline in the exercise price of warrants outstanding which increases
the value of the warrant liability. As a result, the fair value of the warrant
liability increased by $3,206,390. Interest income for the year December 31,
2007 decreased by $158,834 to $84,595 compared to interest income of $243,429
for the year ended December 31, 2006. The decrease in interest income is due to
the smaller amounts of cash available for investing purposes and lower interest
rate returns available for the cash that is invested.
For the
reasons described above, the Company’s financial statements reflect a net loss
of $8,866,182 for the year ended December 31, 2007, compared to net income of
$1,951,279 for the year ended December 31, 2006.
Comparison
of Years Ended December 31, 2006 and2005
The
Company had no revenues for the years ended December 31, 2006 and 2005,
respectively.
Research
and development costs for 2006 decreased by $1,611,962 from $2,291,721 in 2005
to $679,759 in 2006, a 70.3% decrease. The decrease is primarily attributable to
the temporary cessation of research and development activities in August 2005,
resulting in a reduction in payroll and employee related expenses of $692,824
and a reduction in lab operating expenses of $674,166 for the year ended
December 31, 2006. In addition, there was a decrease in clinical development
costs of $244,320.
Marketing,
general and administrative costs for 2006 increased by $724,914, or 24.3% to
$3,713,006, from $2,988,092 in 2005. The increase was primarily attributable to
the Company’s adoption of SFAS No. 123(R), which requires the expensing of stock
options granted to employees based on the fair value on the date of the grant,
resulting in an expense of $941,127. In addition, expenses related to
conferences and investor meetings increased by approximately $265,311. The
effect of these amounts on marketing, general and administrative expenses for
the year 2006 was partially offset by savings attributable to a staff reduction
in August 2005 which resulted in a reduction of salary and related expenses of
approximately $603,428 during the year ended December 31, 2006.
For the
year ended December 31, 2006, other income increased by $6,278,494 to $6,344,044
compared to $65,550 for the year ended December 31, 2005. This gain is primarily
a non-cash increase as a result of a change in the valuation of warrants in
accordance with EITF 00-19, Accounting for Derivative Financial Instruments
Indexed to, and Potentially Settled in a Company’s Own Stock” to reflect a
decline in price of our common stock for which the warrants are exercisable. As
a result, the fair value of the warrant liability decreased by $6,100,615.
Interest income for the year December 31, 2006 increased by $177,879 to $243,429
compared to interest income of $65,550 for the year ended December 31, 2005. The
increase in interest income is due to the higher amounts of cash available for
investing purposes and higher interest rate returns available for the cash that
is invested.
For the
reasons described above, the Company’s financial statements reflect a net income
of $1,951,279 for the year ended December 31, 2006 compared to a net loss of
$(5,760,475) for the year ended December 31, 2005.
Liquidity
and Capital Resources
Since
inception, our primary source of funding for our operations has been the private
and public sale of our securities, and, to a lesser extent, the licensing of our
proprietary technology and products, research collaborations, feasibility
studies, government grants and the limited sales of products and test
materials.
101
At
September 30, 2008, working capital was approximately $(2,896,505),
compared to $1,613,120 at September 30, 2007. The decrease in our working
capital reflects use of funds for operations.
On
October 10, 2007, the Company entered into a Securities Purchase Agreement,
pursuant to which the Company issued in a private placement 5,891,667 shares of
its common stock and five-year warrants to purchase 1,767,500 shares of the
Company’s common stock at an exercise price of $0.60 per share, for gross
proceeds of $3,535,000 ($3,046,245 net of issuance costs). In connection with
the private placement, all of the 752.25 then outstanding shares of the
Company’s Series C Cumulative Convertible Preferred Stock were converted
into a total of 12,571,850 shares of common stock. In addition, outstanding
warrants to purchase 8,648,102 shares of common stock previously issued with the
Series C Preferred have been reset to purchase 17,885,848 shares of common
stock at an exercise price of $0.60 per share, pursuant to anti-dilution
provisions of those warrants.
In
connection with the private placement, the Company entered into a Director
Designation Agreement dated as of October 1, 2007 with SCO Capital
Partners, LLC (“SCO”), a current stockholder and a purchaser in the private
placement, pursuant to which, for so long as SCO holds 20% of the Company’s
outstanding common stock, SCO has the right to designate two individuals to
serve on the Company’s board of directors. SCO previously held the right to
designate two individuals to serve on the Company’s Board of Directors for so
long as it held 20% of the Company’s outstanding Series C
Preferred.
Until
such time as we obtain agreements with third-party licensees or partners to
provide funding for our anticipated business activities, or otherwise generate
revenue from the commercialization of our products, we will use our working
capital to fund our operating activities.
As of
September 30, 2008, we had $32,879 in cash, cash equivalents and short-term
investments. On July 10, 2008, the Company entered into an agreement and
plan of merger with Access Pharmaceuticals Inc. The Company’s continuation as a
going concern depends on its ability to obtain additional financing, to
consummate a strategic transaction or to make alternative arrangements to fund
its operations, which cannot be guaranteed. Our cash requirements may vary
materially from those now planned because of changes in the focus and direction
of our research and development programs, competitive and technical advances,
patent developments or other developments. To continue to operate, the Company
will require significant additional funding. The Company is assessing
opportunities to raise capital and expects to continue financing operations
through sales of securities, strategic alliances and other financing vehicles,
if any, that might become available to the Company on terms that it deems
acceptable. The Company cannot assure that sufficient funds will be available to
the Company, if they are available at all, to enable the Company to continue to
operate. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
We do not
enter into financial instrument transactions for trading or speculative
purposes. We do not intend to establish any special purpose entity and do not
have any material off balance sheet financing transactions. We do not believe
that inflation will have any significant effect on the results of our
operations.
Recent
Accounting Pronouncements
In
September 2006, the FASB issued FAS No. 157, “Fair Value Measurements”
(“SFAS 157”). SFAS 157 establishes a common definition of fair value to be used
whenever GAAP requires (or permits) assets or liabilities to be measured at fair
value, and does not expand the use of fair value in any new circumstances. It
also requires expanded disclosure about the extent to which companies measure
assets and liabilities at fair value, the information used to measure fair
value, and the effect of fair value measurements on earnings. On
February 12, 2008, the FASB issued proposed FASB Staff Position
No. SFAS No. 157-2, “Effective Date of FASB Statement No. 157”
which defers the effective date for all nonfinancial assets and nonfinancial
liabilities, except those that are recognized or disclosed at fair value in the
financial statements on a recurring basis (that is, at least annually) to fiscal
years beginning after November 15, 2008. The Company adopted SFAS 157 for
all financial assets and liabilities required to be measured at fair value on a
recurring basis, prospectively from January 1, 2008. The application of
SFAS 157 did not have a significant impact on the Company’s financial position,
results of operations or cash flows.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option
for Financial Assets and Financial Liabilities – including an amendment of FASB
115” (“SFAS 159”), which allows an entity to choose to measure certain financial
instruments and liabilities at fair value. Subsequent measurements for the
financial instruments and liabilities an entity elects to fair value will be
recognized in earnings and this election is irrevocable. SFAS 159 also
establishes additional disclosure requirements. SFAS 159 is effective for the
Company beginning January 1, 2008. The Company has not elected to apply the
fair value option to any of its financial instruments.
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), “Business
Combinations” (“SFAS 141R”). SFAS 141R establishes principles and requirements
for how an acquirer recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed, any non controlling
interest in the acquiree and the goodwill acquired. SFAS 141R also establishes
disclosure requirements to enable the evaluation of the nature and financial
effects of the business combination. SFAS 141R is effective beginning
January 1, 2009. The Company is currently evaluating the potential impact
of the adoption of SFAS 141R on its financial position, results of operations or
cash flows.
102
In
December 2007, the FASB issued SFAS No. 160, “Non Controlling
Interests in Consolidated Financial Statements-an amendment of Accounting
Research Bulletin No. 51” (“SFAS 160”). SFAS 160 establishes accounting and
reporting standards for ownership interests in subsidiaries held by the parties
other than parent, the amount of the consolidated net income attributable to the
parent and to the non controlling interest, changes in parent’s ownership
interest, and the valuation of retained non controlling equity investments when
a subsidiary is deconsolidated. SFAS 160 also establishes disclosure
requirements that clearly identify and distinguish between the interests of the
parent and interests of the non controlling owners. SFAS 160 is effective for
the Company beginning January 1, 2009. The Company is currently evaluating
the potential impact of the adoption of SFAS 160 on its financial position,
results of operations or cash flows.
In
March 2008, the FASB issued SFAS No.161, “Disclosures about Derivative
Instruments and Hedging Activities-an amendment of FASB Statement No.133” (“SFAS
161”). SFAS161 enhances disclosures about the Company’s derivative and hedging
activities and thereby improves the transparency of financial reporting. SFAS
161 is effective for financial statements issued for fiscal years and interim
periods beginning after November 15, 2008. The Company is currently
evaluating the potential impact of the adoption of SFAS 161 on its financial
position, results of operations or cash flows.
On
October 10, 2008, the FASB issued FSP No. SFAS 157-3, “Determining the
Fair Value of a Financial Asset When the Market for That Asset Is Not Active.”
FSP SFAS 157-3 clarifies the application of SFAS No. 157, “Fair Value
Measurements,” in a market that is not active and provides an example to
illustrate key considerations in determining the fair value of a financial asset
when the market for that financial asset is not active. FSP SFAS 157-3 is
effective immediately, including prior periods for which financial statements
have not been issued. The Company is currently evaluating the potential impact
of the adoption of SFAS 157-3 on its financial position, results of operations
or cash flows.
Mergers.
On
April 18, 2008, the Company acquired Virium Pharmaceuticals Inc.
(“Virium”), a privately held biotechnology company focused primarily on oncology
based technology, pursuant to the terms of an Agreement and Plan of Merger (the
“Merger Agreement”) dated as of April 18, 2008 (the “Effective Time”) by
and among the Company, VRM Acquisition, LLC, a Delaware limited liability
company and a direct wholly-owned subsidiary of the Company (“VRM Acquisition”),
Virium and Virium Holdings, Inc., a non-public Delaware corporation
(“Holdings”) and the parent of Virium. On the Effective Date, VRM
Acquisition merged with and into Virium with Virium continuing as the surviving
company and a wholly-owned subsidiary of the Company (the “Merger”).
Pursuant to the Merger Agreement, each share of Virium common stock
outstanding at the Effective Time was converted into the right to receive
0.89387756 shares of the Company’s common stock (the “Merger Consideration”)
resulting in an aggregate of 22,899,206 shares of MacroChem common stock being
issued in the Merger. The fair value of the shares issued on the closing
date to the stockholders of Virium was $6,869,618.
Virium
has a pipeline of oncology products that target a variety of niche cancer
indications. Virium’s product pipeline included a next generation
nucleoside analogue (small molecule) which it had licensed from the Southern
Research Institute in August 2007. This class of compounds has
demonstrated proven efficacy in certain hematological cancer
indications.
On
July 10, 2008, Access Pharmaceuticals, Inc. (OTC BB: ACCP.OB) announced
it had signed an agreement and plan of merger with MacroChem pursuant to which
MacroChem is expected to be merged with and into a wholly-owned subsidiary of
Access. The merger transaction is expected to close in the fourth quarter of
2008. Holders of MacroChem common shares and in- the- money MacroChem
warrants will receive an aggregate of 2,500,000 shares of common stock of Access
Pharmaceuticals as merger consideration. All other options and warrants of
MacroChem which are unexercised at the Effective Time of the merger shall
automatically be cancelled and void.
Other
Events.
On
August 27, 2008, we entered into a Note Purchase Agreement with Access,
pursuant to which Access has loaned us an initial loan amount of $225,000 and
agreed to loan additional funds to us as required to operate our business.
The note is due upon the earlier of December 31, 2008 or the date of termination
of the agreement and plan of the merger transaction. We have agreed to pay
interest to Access at the rate of 10% per annum.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
On
April 24, 2008, the Company dismissed our independent registered public
accounting firm Vitale, Caturano and Company, Ltd. (“Vitale”).
The
dismissal was recommended by management based in part on expected efficiency
gains from appointing a new accountant and was approved by the Audit
Committee. Expected efficiency gains associated with the appointment of JH
Cohn LLP as the Company’s new accountant include JH Cohn LLP’s prior service as
accountant for Virium Pharmaceuticals Inc., which the Company recently
acquired.
103
Vitale’s
reports relating to the financial statements of MacroChem for the years ended
December 31, 2006 and December 31, 2007 did not contain an adverse
opinion or a disclaimer of opinion, and was not qualified or modified as to
audit scope or accounting principles, except that the December 31, 2007
report contained an explanatory paragraph relating to our ability to continue as
a going concern.
During
our fiscal years ended December 31, 2006 and December 31, 2007 through
April 24, 2008, the date on which Vitale was dismissed, we had no
disagreement with Vitale on any matter of accounting principles or practices,
financial statement disclosure, or auditing scope or procedure, which, if not
resolved to Vitale’s satisfaction, would have caused Vitale to make reference to
the subject matter of the disagreement in connection with its reports for such
periods. During our fiscal years ended December 31, 2006 and
December 31, 2007, and through April 24, 2008, there were no
reportable events as defined in Item 304(a)(1)(v) of Regulation
S-K.
On
April 24, 2008 and effective the same date, we engaged JH Cohn LLP as its
independent registered public accounting firm to audit our financial statements
as of and for the fiscal year ending December 31, 2008 and to perform
procedures related to the financial statements included in our quarterly
reportsbeginning with quarter ended March 31, 2008. The appointment
of JH Cohn LLP was recommended by management and approved by the Audit
Committee.
During
the two most recent fiscal years and through April 24, 2008, we had not
consulted with JH Cohn LLP regarding any matter which was the subject of any
disagreement or any reportable event as defined in Regulation S-K Item
304(a)(1)(iv) and Regulation S-K Item 304(a)(1)(v), respectively, or on the
application of accounting principles to a specified transaction, either
completed or proposed, or the type of audit opinion that might be rendered on
our financial statements, relating to which either a written report was provided
to us or oral advice was provided that JH Cohn LLP concluded was an important
factor considered by us in reaching a decision as to the accounting, auditing or
financial reporting issue.
On
January 24, 2006, Deloitte & Touche LLP (“Deloitte”) resigned as our
independent registered public accounting firm.
Deloitte’s
report relating to the financial statements of the Company for the year ended
December 31, 2004 did not contain an adverse opinion or a disclaimer of opinion,
and was not qualified or modified as to audit scope or accounting principles,
except the report contained an explanatory paragraph relating to the Company’s
ability to continue as a going concern.
During
the Company’s fiscal year ended December 31, 2004, and through January 24, 2006,
the date which Deloitte resigned, the Company had no disagreement with Deloitte
on any matter of accounting principles or practices, financial statement
disclosure, or auditing scope or procedure, which, if not resolved to Deloitte’s
satisfaction, would have caused Deloitte to make reference to the subject matter
of the disagreement in connection with its report for such period. During the
Company’s fiscal year ended December 31, 2004, and through January 24, 2006,
there were no reportable events as defined in Item 304(a)(1)(v) of Regulation
S-K.
On
February 14, 2006 and effective the same date, on the recommendation of the
Company’s Audit Committee, the Company engaged Vitale, Caturano & Company,
Ltd. (“Vitale”) as its independent registered public accounting firm to audit
the Company’s financial statements as of and for the fiscal year ending December
31, 2005 and to perform procedures related to the financial statements included
in the Company’s quarterly reports on Form 10-Q, beginning with quarter ended
March 31, 2006.
During
the two most recent fiscal years and through February 14, 2006, the Company had
not consulted with Vitale on any matter which was the subject of any
disagreement or any reportable event as defined in Regulation S-K
Item 304(a)(1)(iv) and Regulation S-K Item 304(a)(1)(v), respectively, or on the
application of accounting principles to a specified transaction, either
completed or proposed, or the type of audit opinion that might be rendered on
the Company’s financial statements, relating to which either a written report
was provided to the Company or oral advice was provided that Vitale concluded
was an important factor considered by the Company in reaching a decision as to
the accounting, auditing or financial reporting issue.
104
FINANCIAL
STATEMENTS
MACROCHEM
CORPORATION
|
PAGE
|
|
|
Report
of Independent Registered Public Accounting
Firm
|
F-76
|
|
Consolidated
Balance Sheets at December 31, 2007 and
2006
|
F-77
|
|
Consolidated
Statements of Operations and Comprehensive Loss for 2007 and
2006
|
F-78
|
|
Consolidated
Statement of Stockholders' Equity (Deficit) for 2007 and
2006
|
F-79
|
|
Consolidated
Statements of Cash Flows for 2007 and
2006
|
F-80
|
|
Notes
to Consolidated Financial Statements (Two years ended December 31,
2007)
|
F-82
|
|
Condensed
Consolidated Balance Sheets at September 30, 2008 (unaudited) and December
31, 2007
|
F-94
|
|
Condensed
Consolidated Statements of Operations for the nine months ended September
30, 2008 and 2007 (unaudited)
|
F-95
|
|
Condensed
Consolidated Statements of Cash Flows for the nine months ended September
30, 2008 and 2007 (unaudited)
|
F-96
|
|
Notes
to Condensed Consolidated Financial
Statements (unaudited)
|
F-97
|
F-75
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors and Stockholders of MacroChem Corporation:
We have
audited the accompanying balance sheets of MacroChem Corporation (the “Company”)
as of December 31, 2007 and 2006, and the related statements of operations,
stockholders’ deficit/equity, and cash flows for each of the years in the
three-year period ended December 31. 2007. These financial statements are the
responsibility of the Company’s management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We
conducted our audits in accordance with the auditing standards of the Public
Company Accounting Standards Board (United States). Those standards require that
we plan and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement. The Company is not
required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audits included consideration of internal
control over financial reporting as a basis for designing audit procedures that
are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, the accompanying financial statements referred to above present fairly,
in all material respects, the financial position of the Company as of December
31, 2007 and 2006, and the results of its operations and its cash flows for each
of the years in the three-year period ended December 31, 2007 in conformity with
accounting principles generally accepted in the United States of
America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1 to the financial
statements of December 31, 2007, the Company’s recurring losses and need to
obtain additional financing raise substantial doubt about its ability to
continue as a going concern. Management’s plans concerning these matters are
also described in Note 1. The financial statements do not include any
adjustments that might result from the outcome of the uncertainty.
As
discussed in Note 1 to the financial statements, effective January 1, 2006, the
Company adopted the provisions of Statement of Financial Accounting Standard No.
123R "Share Based Payment”.
/s/
VITALE, CATURANO & COMPANY, LTD.
Boston,
Massachusetts
March 12,
2008
F-76
MACROCHEM
CORPORATION
BALANCE
SHEETS
|
December
31,
|
|||||||
|
2007
|
2006
|
||||||
|
ASSETS
|
|||||||
|
Current
assets:
|
|||||||
|
Cash
and cash equivalents
|
$
|
2,423,519
|
$
|
738,264
|
|||
|
Short-term
investments
|
759,247
|
4,157,038
|
|||||
|
Prepaid
expenses and other current assets
|
131,047
|
153,660
|
|||||
|
Total
current assets
|
3,313,813
|
5,048,962
|
|||||
|
Property
and equipment, net
|
22,042
|
37,391
|
|||||
|
Patents,
net
|
517,600
|
567,604
|
|||||
|
Total
assets
|
$
|
3,853,455
|
$
|
5,653,957
|
|||
|
LIABILITIES
|
|||||||
|
Current
liabilities:
|
|||||||
|
Accounts
payable
|
$
|
94,439
|
$
|
85,473
|
|||
|
Accrued
expenses and other liabilities
|
310,195
|
183,362
|
|||||
|
Total
current liabilities
|
404,634
|
268,835
|
|||||
|
Warrants
liability
|
4,076,488
|
870,098
|
|||||
|
Total
liabilities
|
4,481,122
|
1,138,933
|
|||||
|
Commitments
and contingencies (Note 6)
|
|||||||
|
Preferred
stock, $.01 par value, 6,000,000 shares authorized; liquidation value of
$0 and $8,053,400, 0 and 805 shares Series C Convertible issued and
outstanding at December 31, 2007 and December 31, 2006, respectively (Note
5)
|
——
|
333,783
|
|||||
|
STOCKHOLDERS’
(DEFICIT) EQUITY
|
|||||||
|
Common
stock, $.01 par value, 100,000,000 shares authorized;
22,500,026
and 2,620,679 shares issued at December 31, 2007 and December 31, 2006,
respectively
|
225,000
|
26,206
|
|||||
|
Additional
paid-in capital
|
90,054,421
|
85,599,924
|
|||||
|
Accumulated
deficit
|
(90,847,978
|
)
|
(81,385,779
|
)
|
|||
|
Less
treasury stock, at cost, 529 shares at December 31, 2007 and December 31,
2006
|
(59,110
|
)
|
(59,110
|
)
|
|||
|
Total
stockholders’ (deficit) equity
|
(627,667
|
)
|
4,181,241
|
||||
|
Total
liabilities and stockholders’ (deficit) equity
|
$
|
3,853,455
|
$
|
5,653,957
|
|||
See notes
to financial statements.
F-77
MACROCHEM
CORPORATION
STATEMENTS
OF OPERATIONS
|
Fiscal
Year Ended December 31,
|
||||||||||
|
2007
|
2006
|
2005
|
||||||||
|
REVENUES:
|
$
|
——
|
$
|
——
|
$
|
——
|
||||
|
OPERATING
EXPENSES:
|
||||||||||
|
Research
and development
|
2,135,393
|
679,759
|
2,291,721
|
|||||||
|
Marketing,
general and administrative
|
3,714,994
|
3,713,006
|
2,988,092
|
|||||||
|
Costs
associated with staff reduction and transition
agreements
|
——
|
——
|
546,212
|
|||||||
|
TOTAL
OPERATING EXPENSES
|
5,850,387
|
4,392,765
|
5,826,025
|
|||||||
|
LOSS
FROM OPERATIONS
|
(5,850,387
|
)
|
(4,392,765
|
)
|
(5,826,025
|
)
|
||||
|
OTHER
INCOME (LOSS):
|
||||||||||
|
Interest
income
|
84,595
|
243,429
|
65,550
|
|||||||
|
(Loss)
Gain on change in value of warrant liability
|
(3,206,390
|
)
|
6,100,615
|
——
|
||||||
|
Gain
on sale of equipment
|
106,000
|
——
|
——
|
|||||||
|
TOTAL
OTHER INCOME (LOSS) (NOTES 1 and 5)
|
(3,015,795
|
)
|
6,344,044
|
65,550
|
||||||
|
NET
(LOSS) INCOME
|
$
|
(8,866,182
|
)
|
$
|
1,951,279
|
$
|
(5,760,475
|
)
|
||
|
BENEFICIAL
CONVERSION FEATURE (NOTE 5)
|
$
|
(3,223,929
|
)
|
$
|
(11,895
|
)
|
$
|
(330,243
|
)
|
|
|
DIVIDEND
ON SERIES C CUMULATIVE PREFERRED STOCK
|
$
|
(596,017
|
)
|
$
|
(752,066
|
)
|
$
|
——
|
||
|
NET
(LOSS) INCOME ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(12,686,128
|
)
|
$
|
1,187,318
|
$
|
(6,090,718
|
)
|
||
|
BASIC
NET (LOSS) INCOME PER COMMON SHARE
|
$
|
(1.66
|
)
|
$
|
0.84
|
$
|
(6.25
|
)
|
||
|
DILUTED
NET (LOSS) INCOME
PER
COMMON SHARE
|
$
|
(1.66
|
)
|
$
|
0.24
|
$
|
(6.25
|
)
|
||
|
WEIGHTED
AVERAGE SHARES USED TO COMPUTE BASIC NET (LOSS) INCOME PER COMMON
SHARE
|
7,635,313
|
1,423,665
|
974,367
|
|||||||
|
WEIGHTED
AVERAGE SHARES USED TO COMPUTE DILUTED NET (LOSS) INCOME PER COMMON
SHARE
|
7,635,313
|
8,260,510
|
974,367
|
|||||||
See notes
to financial statements.
F-78
MACROCHEM
CORPORATION
STATEMENTS
OF STOCKHOLDERS’ (DEFICIT) EQUITY
|
Common
Stock Shares
|
Common
Stock
|
Additional
Paid-In
Capital
|
Accumulated
Deficit
|
Subtotal
|
Cost
of
Treasury
Stock
|
Total
Stockholders’
(Deficit)
Equity
|
|||||||||||||||||
|
Issued
|
Treasury
|
||||||||||||||||||||||
|
BALANCE,
DECEMBER 31, 2004
|
926,285
|
(1,482
|
)
|
$
|
9,263
|
$
|
83,320,908
|
$
|
(76,824,517
|
)
|
$
|
6,505,654
|
$
|
(169,150
|
)
|
$
|
6,336,504
|
||||||
|
Exercise
of warrants
|
6,012
|
——
|
60
|
87,440
|
——
|
87,500
|
——
|
87,500
|
|||||||||||||||
|
Stock
issued to 401(k) trust
|
——
|
953
|
——
|
(94,431
|
)
|
——
|
(94,431
|
)
|
110,040
|
15,609
|
|||||||||||||
|
Issuance
of common stock, net
|
65,141
|
——
|
651
|
417,430
|
——
|
418,081
|
——
|
418,081
|
|||||||||||||||
|
Issuance
of warrants in connection with sale of common stock
|
——
|
——
|
——
|
183,260
|
——
|
183,260
|
——
|
183,260
|
|||||||||||||||
|
Net
loss
|
——
|
——
|
——
|
——
|
(5,760,475
|
)
|
(5,760,475
|
)
|
——
|
(5,760,475
|
)
|
||||||||||||
|
BALANCE,
DECEMBER 31, 2005
|
997,438
|
(529
|
)
|
$
|
9,974
|
$
|
83,914,608
|
$
|
(82,584,992
|
)
|
$
|
1,339,590
|
$
|
(59,110
|
)
|
$
|
1,280,480
|
||||||
|
Non-cash
dividend on preferred stock
|
1,429,700
|
——
|
14,297
|
737,769
|
(752,066
|
)
|
——
|
——
|
——
|
||||||||||||||
|
Stock-based
compensation expense
|
——
|
——
|
——
|
941,127
|
——
|
941,127
|
——
|
941,127
|
|||||||||||||||
|
Conversion
of preferred stock to common
|
193,541
|
——
|
1,935
|
6,420
|
——
|
8,355
|
——
|
8,355
|
|||||||||||||||
|
Net
income
|
——
|
——
|
——
|
——
|
$
|
1,951,279
|
$
|
1,951,279
|
——
|
$
|
1,951,279
|
||||||||||||
|
BALANCE,
DECEMBER 31, 2006
|
2,620,679
|
(529
|
)
|
$
|
26,206
|
$
|
85,599,924
|
$
|
(81,385,779
|
)
|
$
|
4,240,351
|
$
|
(59,110
|
)
|
$
|
4,181,241
|
||||||
|
Non-cash
dividend on preferred stock
|
899,437
|
——
|
8,995
|
587,022
|
(596,017
|
)
|
——
|
——
|
——
|
||||||||||||||
|
Stock-basedcompensation
expense
|
——
|
——
|
——
|
654,747
|
——
|
654,747
|
——
|
654,747
|
|||||||||||||||
|
Conversion
of preferred stock to common
|
13,050,744
|
——
|
130,507
|
203,275
|
——
|
333,782
|
——
|
333,782
|
|||||||||||||||
|
Sale
of common stock, net of issuance costs
|
5,891,666
|
——
|
58,917
|
2,987,328
|
——
|
3,046,245
|
——
|
3,046,245
|
|||||||||||||||
|
Exercise
of warrants
|
37,500
|
——
|
375
|
22,125
|
——
|
22,500
|
——
|
22,500
|
|||||||||||||||
|
Net
loss
|
——
|
——
|
——
|
——
|
(8,866,182
|
)
|
(8,866,182
|
)
|
——
|
(8,866,182
|
)
|
||||||||||||
|
BALANCE,
DECEMBER 31, 2007
|
22,500,026
|
(529
|
)
|
$
|
225,000
|
$
|
90,054,421
|
$
|
(90,847,978
|
)
|
$
|
(568,557
|
)
|
$
|
(59,110
|
)
|
$
|
(627,667
|
)
|
||||
|
|
See
notes to financial statements.
|
F-79
MACROCHEM
CORPORATION
STATEMENTS
OF CASH FLOWS
|
Year
Ended December 31,
|
||||||||||
|
2007
|
2006
|
2005
|
||||||||
|
|
||||||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
||||||||||
|
Net (loss) income
|
$
|
(8,866,182
|
)
|
$
|
1,951,279
|
$
|
(5,760,475
|
)
|
||
|
Adjustments
to reconcile net (loss) income to net cash used by operating
activities:
|
||||||||||
|
Depreciation
and amortization
|
65,352
|
87,031
|
175,024
|
|||||||
|
Stock-based
compensation
|
654,747
|
941,127
|
——
|
|||||||
|
401(k)
contributions in company common stock
|
——
|
——
|
15,610
|
|||||||
|
Deferred
rent
|
——
|
——
|
(5,509
|
)
|
||||||
|
Loss
(Gain) on change in value of warrant liability
|
3,206,390
|
(6,100,615
|
)
|
——
|
||||||
|
Change
in assets and liabilities:
|
||||||||||
|
Prepaid
expenses and other current assets
|
22,613
|
(46,900
|
)
|
222,147
|
||||||
|
Accounts
payable and accrued expenses
|
135,799
|
(106,195
|
)
|
(392,821
|
)
|
|||||
|
Net
cash used in operating activities
|
(4,781,281
|
)
|
(3,274,272
|
)
|
(5,746,024
|
)
|
||||
|
CASH FLOWS FROM INVESTING
ACTIVITIES:
|
||||||||||
|
Sales
of short-term investments
|
3,397,791
|
——
|
1,185,406
|
|||||||
|
Purchases
of short-term investments
|
——
|
(4,157,038
|
)
|
——
|
||||||
|
Expenditures
for property and equipment
|
——
|
——
|
(14,519
|
)
|
||||||
|
Additions
to patents
|
——
|
(40,770
|
)
|
(105,080
|
)
|
|||||
|
Net
cash provided by (used in) investing activities
|
3,397,791
|
(4,197,808
|
)
|
1,065,807
|
||||||
|
CASH FLOWS FROM FINANCING
ACTIVITIES:
|
||||||||||
|
Net
proceeds from issuance of Series C
Cumulative
Convertible Preferred Stock
|
——
|
5,186,908
|
2,125,943
|
|||||||
|
Net
proceeds from sale of common stock
|
3,046,245
|
——
|
601,342
|
|||||||
|
Proceeds
from exercise of warrants
|
22,500
|
——
|
87,500
|
|||||||
|
Net
cash provided by financing activities
|
$
|
3,068,745
|
$
|
5,186,908
|
$
|
2,814,785
|
||||
See notes
to financial statements. (Continued)
F-80
MACROCHEM
CORPORATION
STATEMENTS
OF CASH FLOWS (Continued)
|
Years
Ended December 31,
|
||||||||||
|
2007
|
2006
|
2005
|
||||||||
|
NET
CHANGE IN CASH
AND
CASH EQUIVALENTS
|
$
|
1,685,255
|
$
|
(2,285,172
|
)
|
$
|
(1,865,432
|
)
|
||
|
CASH
AND CASH EQUIVALENTS,
BEGINNING
OF YEAR
|
738,264
|
3,023,436
|
4,888,868
|
|||||||
|
CASH
AND CASH EQUIVALENTS,
END
OF YEAR
|
$
|
2,423,519
|
$
|
738,264
|
$
|
3,023,436
|
||||
SUPPLEMENTAL
DISCLOSURES OF CASH FLOW INFORMATION:
|
Cash
paid for taxes
|
$
|
——
|
$
|
——
|
$
|
——
|
||||
|
Cash
paid for interest
|
$
|
——
|
$
|
——
|
$
|
——
|
||||
|
Non-cash
dividend to Series C Preferred stockholders
|
$
|
596,017
|
$
|
752,066
|
$
|
——
|
||||
|
Beneficial
conversion feature associated with Series C Preferred
Stock
|
$
|
3,223,929
|
$
|
11,895
|
$
|
330,243
|
||||
|
Conversion
of Series C Preferred Stock to Common Stock
|
$
|
333,782
|
$
|
8,355
|
$
|
——
|
See notes to financial statements.
F-81
MACROCHEM
CORPORATION
NOTES
TO FINANCIAL STATEMENTS
|
1.
|
Nature
of Business and Summary of Significant Accounting
Policies.
|
MacroChem
Corporation (the “Company”) is a specialty pharmaceutical company that develops
and seeks to commercialize pharmaceutical products using its proprietary drug
delivery technologies.
The
Company has been engaged primarily in research and development since its
inception in 1981 and has derived limited revenues from the commercial sale of
its products, licensing of certain technology and feasibility studies. The
Company has had no revenues relating to the sale of any products currently under
development. The Company has incurred losses from operations every year since
its inception and the Company anticipates that operating losses may continue for
the foreseeable future. At December 31, 2007 and 2006, the Company’s accumulated
deficit was approximately $90.8 million and $81.4 million, respectively . The
audit report of Vitale, Caturano & Company, Ltd., our independent registered
public accounting firm, on our 2007 financial statements includes an explanatory
paragraph concerning our ability to continue as a going concern. The inclusion
of this explanatory paragraph may materially and adversely affect our ability to
raise new capital. To continue to operate, the Company will require significant
additional funding. The Company is assessing opportunities to raise capital and
expects to continue financing operations through sales of securities, strategic
alliances and other financing vehicles, if any, that might become available to
the Company on terms that it deems acceptable. The Company cannot assure that
sufficient funds will be available to the Company, if they are available at all,
to enable the Company to continue to operate. The financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
The Company believes that its existing cash, cash equivalents and short-term
investments will be sufficient to fund current operations under the Company’s
current plan into the fourth quarter of 2008. The Company’s cash requirements
may vary materially from those now planned because of changes in the focus and
direction of its research and development programs, competitive and technical
advances, patent developments or other developments.
The
Company organizes itself as one segment reporting to the chief executive
officer. Products and services consist primarily of research and development
activities in the pharmaceutical industry.
Accounting Estimates
– The preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. The primary estimates underlying the
Company’s financial statements include the fair market value of warrants
included in liabilities, the carrying value and useful lives of the Company’s
patents and property and equipment, the valuation allowance established for the
Company’s deferred tax assets, and the underlying assumptions to apply the
pricing model to value stock options under SFAS No. 123(R). Management bases its
estimates on certain assumptions, which it believes are reasonable in the
circumstances, and while actual results could differ from those estimates,
management does not believe that any change in those assumptions in the near
term would have a significant effect on the financial position or the results of
operations.
Fair Value of Financial
Instruments – The carrying amounts of cash, cash equivalents, short-term
investments, accounts payable and accrued expenses approximate their fair value
because of their short-term nature.
Cash and Cash
Equivalents – Cash and cash equivalents at December 31, 2007 and 2006 are
primarily comprised of highly liquid investments with a maturity of three months
or less when purchased. Short-term investments are liquid
certificates of deposit with a carrying value of $759,247 at December 31, 2007
and $4,157,038 at December 31, 2006.
Property and
Equipment – Property and equipment are stated at cost. Depreciation and
amortization are provided on the straight-line method over the estimated useful
lives of the related assets, which range from three to ten years.
Patents – The Company
has filed applications for United States and foreign patents covering aspects of
its technology. Costs and expenses incurred in connection with pending patent
applications are deferred. Costs related to successful patent applications are
amortized over the estimated useful lives of the patents, not exceeding 20
years, using the straight-line method. Accumulated patent costs and deferred
patent application costs related to patents that are considered to have limited
future value are charged to expense. Accumulated amortization aggregated
approximately $426,231 and $376,228, respectively, at December 31, 2007 and
2006. On an on-going basis, the Company evaluates the recoverability of the net
carrying value of various patents by reference to the patent’s expected use in
drug and other research activities as measured by outside interest in the
Company’s patented technologies and management’s determination of potential
future uses of such technologies.
Long-lived Assets –
The Company reviews its long-lived assets for impairment when events or changes
in circumstances indicate that the carrying amount of a long-lived asset may not
be recoverable. Recoverability of such assets to be held and used is measured by
a comparison of the carrying amount of the asset to future undiscounted net cash
flows expected to be generated by the asset. If such assets are considered to be
impaired, the impairment to be recognized is measured by the amount by which the
carrying amount of the assets exceeds the fair value of the assets.
F-82
Research and
Development – Research and development costs are charged to operations as
incurred. Such costs include proprietary research and development activities and
expenses associated with research and development contracts, whether performed
by the Company or contracted with independent third parties.
Stock Based
Compensation – Adoption
of SFAS 123(R)
Prior to
January 1, 2006, the Company accounted for stock-based compensation issued
to employees using the intrinsic value method, which follows the recognition and
measurement principles of Accounting Principles Board (“APB”) Opinion
No. 25, “Accounting for Stock Issued to Employees,” and Financial
Accounting Standards Board (“FASB”) Interpretation (‘‘FIN’’) No. 44,
‘‘Accounting for Certain Transactions Involving Stock Compensation.’’ Generally,
no stock-based employee compensation cost related to stock options was reflected
in net income, as all options granted under stock-based compensation plans had
an exercise price equal to the market value of the underlying common stock on
the grant date. Compensation cost related to restricted stock units granted to
non-employee directors and certain key employees was reflected as an expense as
services were rendered.
On
January 1, 2006, the Company adopted Statement of Financial Accounting
Standards (“SFAS”) No. 123(R), “Share-Based Payment,” using the modified
prospective method, which requires measurement of compensation cost for all
stock awards at fair value on the date of grant and recognition of compensation
over the requisite service period for awards expected to vest. The fair value of
stock options is estimated using the Black-Scholes valuation model, and the fair
value of restricted stock units is determined based on the number of shares
granted and the quoted price of the Company’s common stock on the date of grant.
Such value is recognized as expense over the requisite service period, net of
estimated forfeitures, using the straight-line attribution method. The estimate
of awards that will ultimately vest requires significant judgment, and to the
extent actual results or updated estimates differ from the Company’s current
estimates, such amounts will be recorded as a cumulative adjustment in the
period estimates are revised. The Company considers many factors when estimating
expected forfeitures, including types of awards, employee class and historical
employee attrition rates. Actual results, and future changes in estimates, may
differ substantially from the Company’s current estimates.
Stock
based compensation expense for the years ended December 31, 2007, 2006 and 2005
is as follows:
|
Year
Ended December 31,
|
||||||||||
|
2007
|
2006
|
2005
|
||||||||
|
Research
and development
|
$
|
——
|
$
|
——
|
$
|
——
|
||||
|
Marketing,
general and administrative
|
654,747
|
941,127
|
——
|
|||||||
|
$
|
654,747
|
$
|
941,127
|
$
|
——
|
|||||
On
November 10, 2005, the Financial Accounting Standards Board (“FASB”) issued FASB
Staff Position SFAS 123(R)-3 “Transition Election Related to Accounting for Tax
Effects of Share-Based Payment Awards.” The Company has elected to adopt the
alternative transition method provided the FASB Staff Position for calculating
the tax effects (if any) of stock-based compensation expense pursuant to SFAS
123(R). The alternative transition method includes simplified methods to
establish the beginning balance of the additional paid-in capital pool related
to the tax effects of employee stock-based compensation, and to determine the
subsequent impact to the additional paid-in capital pool and the consolidated
statements of operations and cash flows of the tax effects of employee
stock-based compensation awards that are outstanding upon adoption of SFAS
123(R).
Income Taxes – The
Company recognizes deferred tax assets and liabilities for the expected future
tax consequences of events that have been included in the Company’s financial
statements or tax returns. Deferred tax assets and liabilities are determined
based upon the difference between the financial reporting basis and the tax
basis of existing assets and liabilities using enacted tax rates expected to be
in effect in the year(s) in which the differences are expected to reverse. A
valuation allowance is provided against deferred tax assets if it is more likely
than not that such assets will not be realized.
Reverse Stock Split -
On December 30, 2005, the Company implemented a 1-for-7 reverse stock split of
its common stock and on February 9, 2006, the Company implemented a subsequent
1-for-6 reverse stock split of its common stock. Unless otherwise noted, data
used throughout the Financial Statements have been adjusted to reflect these
reverse splits.
F-83
Basic and Diluted (Loss)
Income Per Share – Basic earnings per share is computed using the
weighted average number of common shares outstanding during each year. Diluted
earnings per common share for the year ended December 31, 2006 reflect the
effect of the Company’s outstanding Series C Convertible Preferred shares,
options and warrants, except where such items would be anti-dilutive. For the
years ended December 31, 2007 and 2005, potential common shares are not included
in the per share calculations for diluted EPS, because the effect of their
inclusion would be anti-dilutive. Anti-dilutive potential shares from stock
options and warrants not included in per share calculations under the treasury
stock method for 2007, 2006 and 2005 were 18,000, 9,769,170 and 2,807,673
shares, respectively.
|
Basic
and Diluted Income (Loss) Per Share
|
Year
Ended December 31,
|
|||||||||
|
2007
|
2006
|
2005
|
||||||||
|
Basic
net (loss) income attributable to common stockholders
|
$
|
(12,686,128
|
)
|
$
|
1,187,318
|
$
|
(6,090,718
|
)
|
||
|
Dividend
on Series C Cumulative Preferred Stock
|
$
|
——
|
$
|
752,066
|
$
|
——
|
||||
|
Net
(loss) income used to compute diluted net (loss) income per common
share
|
$
|
(12,686,128
|
)
|
$
|
1,939,384
|
$
|
(6,090,718
|
)
|
||
|
Basic
net (loss) income per common share
|
$
|
(1.66
|
)
|
$
|
0.84
|
$
|
(6.25
|
)
|
||
|
Diluted
net (loss) income per common share
|
$
|
(1.66
|
)
|
$
|
0.24
|
$
|
(6.25
|
)
|
||
|
Weighted
average shares used to compute basic net (loss) income per common
share
|
7,635,313
|
1,423,665
|
974,367
|
|||||||
|
Weighted
average shares used to compute diluted net (loss) income per common
share
|
7,635,313
|
8,260,510
|
974,367
|
|||||||
Recent Accounting
Pronouncement –
In September 2006, the FASB issued FAS No. 157, “Fair Value
Measurements” (“FAS 157”). FAS 157 establishes a common definition of fair value
to be used whenever GAAP requires (or permits) assets or liabilities to be
measured at fair value, and does not expand the use of fair value in any new
circumstances. It also requires expanded disclosure about the extent to which
companies measure assets and liabilities at fair value, the information used to
measure fair value, and the effect of fair value measurements on earnings. In
addition, in February 2007, the FASB issued FAS No. 159, “The Fair Value Option
for Financial Assets and Financial Liabilities-including an amendment of FASB
Statement No. 115” (“FAS 159”). FAS 159 expands the use of fair value accounting
but does not affect existing standards that require assets or liabilities to be
carried at fair value. Under FAS 159, a company may elect to use fair value to
measure most financial assets and liabilities and any changes in fair value are
recognized in earnings. The fair value election is irrevocable and generally
made on an instrument-by-instrument basis, even if a company has similar
instruments that it elects not to measure based on fair value. Both FAS 157 and
FAS 159 will be effective for the Company on January 1, 2008. On February 12,
2008, the FASB issued proposed FASB Staff Position No. FAS No. 157-2, “Effective
Date of FASB Statement No. 157” which defers the effective date for all
nonfinancial assets and nonfinancial liabilities, except those that are
recognized or disclosed at fair value in the financial statements on a recurring
basis (that is, at least annually) to fiscal years beginning after November 15,
2008. The Company does not expect the adoption of FAS 157 and FAS 159 will have
a material impact on its financial statements upon adoption.
In
December 2007, the FASB issued FAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements-an amendment of Accounting Research Bulletin
No. 51” (“FAS 160”). FAS 160 clarifies the classification in a company’s
consolidated balance sheet and the accounting for and disclosure of transactions
between the company and holders of noncontrolling interests. FAS 160 is
effective for the Company January 1, 2009. Early adoption is not permitted. The
Company does not expect the adoption of FAS 160 to have a material impact on its
financial statements upon adoption.
2. Property
and Equipment.
Property
and equipment consists of the following as of December 31:
F-84
|
2007
|
2006
|
||||||
|
Laboratory
equipment
|
$
|
1,069,282
|
$
|
1,139,249
|
|||
|
Office
equipment
|
489,459
|
489,459
|
|||||
|
Leasehold
improvements
|
250,049
|
250,049
|
|||||
|
Total
|
1,808,790
|
1,878,757
|
|||||
|
Less: accumulated
depreciation
|
(1,786,748
|
)
|
(1,841,366
|
)
|
|||
|
Property
and equipment, net
|
$
|
22,042
|
$
|
37,391
|
3. Accrued
Expenses.
Accrued
expenses and other liabilities consists of the following as of December
31:
|
2007
|
2006
|
||||||
|
Accrued
professional fees
|
$
|
143,279
|
$
|
98,300
|
|||
|
Accrued
vacation
|
54,504
|
31,103
|
|||||
|
Accrued
other
|
112,412
|
53,959
|
|||||
|
$
|
310,195
|
$
|
183,362
|
4. Stock-Based
Compensation
Stock Incentive Plans
– The Company has granted options to purchase the Company’s common stock to
employees and directors under various stock incentive plans. Under the plans,
employees and non-employee directors are eligible to receive awards of various
forms of equity-based incentive compensation, including stock options,
restricted stock, and performance awards, among others. The plans are
administered by the Board of Directors or the Compensation Committee of the
Board of Directors, which determine the terms of the awards granted. Stock
options are generally granted with an exercise price equal to the market value
of a share of common stock on the date of grant, have a term of ten years or
less, and vest over terms of two to three years from the date of
grant.
Stock Option Plans –
The Company has two stock option plans, the 1994 Equity Incentive
Plan (1994 Plan) and the 2001 Incentive Plan (the 2001 Plan).
Under the
terms of the 1994 Plan, the Company may no longer award any options. All options
previously granted under the 1994 Plan may be exercised at any time up to ten
years from the date of award.
Under the
terms of the 2001 Plan, the Company may grant options to purchase up to a
maximum of 2,373,809 shares of common stock to certain employees, directors and
consultants. On April 9, 2007, at the Company’s Annual Meeting of Stockholders,
the Company’s stockholders approved an amendment to the Company’s 2001 Incentive
Plan to increase the number of shares of Common Stock authorized for issuance
under the Incentive Plan by 1,000,000 from 1,373,809, resulting in a maximum of
2,373,809 shares of Common Stock that may be granted as options. The options may
be awarded as incentive stock options (employees only) and non-incentive stock
options (certain employees, directors and consultants).
The 2001
Plan and the 1994 Plan state that the exercise price of options shall not be
less than fair market value at the date of grant. The 2001 Plan has a total of
2,373,809 shares reserved for issuance. As of December 31, 2007, there were
outstanding options to purchase 3,020,249 shares of common stock with 238,669
shares remaining available for future grants.
Stock-Based
Compensation
–Effective January 1, 2006, the Company adopted FAS No. 123(R),
“Accounting for Stock-Based Compensation,” (“FAS 123(R)”) using the modified
prospective method, which results in the provisions of FAS 123(R) being applied
to the financial statements on a going-forward basis. FAS 123(R) requires
companies to recognize stock-based compensation awards granted to its employees
as compensation expense on a fair value method. Under the fair value recognition
provisions of FAS 123(R), stock-based compensation cost is measured at the grant
date based on the fair value of the award and is recognized as expense over the
service period, which generally represents the vesting period. The grant date
fair value of stock options is calculated using the Black-Scholes option-pricing
model and the grant date fair value of restricted stock is based on intrinsic
value. The expense recognized over the service period is required to include an
estimate of the awards that will be forfeited.
All
stock-based awards to non-employees are accounted for at their fair market value
in accordance with FAS 123(R) and Emerging Issues Task Force No. 96-18,
“Accounting for Equity Instruments That Are Issued to Other Than Employees for
Acquiring, or in Conjunction with Selling, Goods or Services.” Under this
method, the equity-based instrument was valued at either the fair value of the
consideration received or the equity instrument issued on the date of grant. The
resulting compensation cost was recognized and charged to operations over the
service period, which was usually the vesting period.
F-85
For
purposes of recording stock based compensation expense as required by Statement
No. 123(R), the fair values of each stock option granted under the
Company’s stock option plan for the fiscal years ended December 31, 2007
and 2006, respectively, were estimated as of the date of grant using the
Black-Scholes option-pricing model.
The fair
values of all stock option grants issued were determined using the following
assumptions:
|
Year Ended December 31,
|
||
|
2007
|
2006
|
|
|
Risk-free
interest rate
|
3.66%
|
4.86%
|
|
Expected
life of option grants
|
6
years
|
6
years
|
|
Expected
volatility of underlying stock
|
115%
|
102%
|
|
Expected
dividend payment rate, as a percentage of the stock price on the date of
grant
|
0%
|
0%
|
The
dividend yield assumption is based on the Company’s history and expectation of
future dividend payouts. The Company estimated stock price volatility using the
historical volatility in the market price of its common stock for the expected
term of the options. The risk-free interest rate assumption is based upon the
U.S. Treasury yield curve in effect at the time of grant for periods
corresponding with the expected life of the option.
As
share-based compensation expense is recognized based on awards ultimately
expected to vest, it must be reduced for estimated forfeitures. FAS 123(R)
requires forfeitures to be estimated at the time of grant and revised, if
necessary, in subsequent periods if actual forfeitures differ from those
estimates. Forfeiture rates are calculated based on actual historical
forfeitures.
The
expected life of employee stock options represents the weighted-average period
the stock options are estimated to remain outstanding. The expected life of
employee stock options is, in part, a function of the options’ remaining
contractual life and the extent to which the option is in-the-money (i.e., the
average stock price during the period is above the strike price of the stock
option).
F-86
SFAS No.
123 requires the presentation of pro forma information for the comparative
periods prior to the adoption as if all of the Company’s employee stock options
had been accounted for under the fair value method of the original
SFAS No. 123. The following table illustrates the effect on net loss
and loss per share if the Company had applied the fair value recognition
provisions of SFAS No. 123 to stock-based employee compensation for
the year ended December 31, 2005:
|
2005
|
||||
|
Net
loss attributable to common stockholders as reported
|
$
|
(6,090,718
|
)
|
|
|
Add:
Stock-based employee compensation expense included in reported net
loss
|
——
|
|||
|
Deduct:
Total stock-based employee compensation measured using the fair value
method
|
(733,414
|
)
|
||
|
Pro
forma net loss
|
$
|
(6,824,132
|
)
|
|
|
Basic
and diluted net loss per share - as reported
|
$
|
(6.25
|
)
|
|
|
Basic
and diluted net loss per share - pro forma
|
$
|
(7.00
|
)
|
For
purposes of determining the disclosures required by SFAS No. 123, the
fair values of each stock option granted in the fiscal year ended
December 31, 2005 under the Company’s stock option plan were estimated on
the date of grant using the Black-Scholes option-pricing model. The Company
granted 9,142 options under its Stock Option Plans for the year ended
December 31, 2005.
The
Company uses the Black-Scholes option-pricing model to estimate the fair value
of the options at the grant date. The weighted average grant date fair value of
all stock option grants issued for the year ended December 31, 2005 was
$91,907, using the following assumptions:
|
Year
Ended
December
31, 2005
|
|
|
Risk-free
interest rate
|
4.25%
|
|
Expected
dividend yield
|
0
|
|
Volatility
|
100%
|
|
Forfeiture
rate
|
10%
|
|
Expected
life of option grants (years)
|
6
years
|
Stock
Option Activity –
During the year ended December 31, 2007, the Company granted stock
options to existing employees and Directors, as part of the Company’s yearly
review process. All such options were granted with exercise prices equal to the
current market value of the underlying common stock on the date of grant. Stock
option activity was as follows:
|
Number
of
Shares
|
Weighted
Average
Exercise
Price
Per
Share
|
Weighted-Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
|
||||||||
|
Balance,
January 1, 2005
|
51,223
|
167.16
|
|||||||||
|
Granted
|
39,319
|
12.67
|
|||||||||
|
Exercised
|
——
|
——
|
|||||||||
|
Canceled
|
(17,153
|
)
|
29.85
|
||||||||
|
Balance,
December 31, 2005
|
118,600
|
132.24
|
|||||||||
|
Granted
|
988,000
|
1.58
|
|||||||||
|
Exercised
|
——
|
——
|
|||||||||
|
Canceled
|
(39,003
|
)
|
136.04
|
||||||||
|
Balance,
December 31, 2006
|
1,067,597
|
$
|
10.21
|
||||||||
|
Granted
|
2,095,000
|
0.63
|
|||||||||
|
Exercised
|
——
|
||||||||||
|
Canceled
|
(142,348
|
)
|
$
|
2.55
|
|||||||
|
Outstanding
at, December 31, 2007
|
3,020,249
|
$
|
3.90
|
8.97
|
$
|
——
|
|||||
|
Exercisable,
December 31, 2007
|
753,391
|
$
|
13.29
|
8.73
|
$
|
——
|
|||||
|
Exercisable,
December 31, 2006
|
408,436
|
$
|
23.43
|
8.69
|
$
|
——
|
|||||
|
Exercisable,
December 31, 2005
|
88,360
|
$
|
153.81
|
3.72
|
$
|
——
|
|||||
F-87
The
following table summarizes information relating to currently outstanding and
exercisable options as of December 31, 2007 as follows:
|
Outstanding
|
Weighted
|
Weighted
|
|||
|
Weighted-Average
|
Average
|
Exercisable
|
Average
|
||
|
Number
of
|
Remaining
|
Exercise
|
Number
|
Exercise
|
|
|
Exercise Price
|
Shares
|
Contractual Life (in Yrs)
|
Price
|
of Shares
|
Price
|
|
$0.45
- $10.50
|
2,953,350
|
9.00
|
$0.95
|
688,158
|
$1.60
|
|
$17.22
- $48.30
|
31,181
|
5.98
|
$34.82
|
31,181
|
$34.82
|
|
$53.34
- $76.44
|
8,696
|
5.67
|
$70.65
|
7,030
|
$70.97
|
|
$106.30
– $246.75
|
9,616
|
3.10
|
$188.62
|
9,616
|
$188.62
|
|
$254.94
- $532.90
|
17,406
|
2.21
|
$313.86
|
17,406
|
$313.86
|
As of
December 31, 2007, there was $1,037,090 of total expected unrecognized
compensation cost related to unvested stock options granted under the Company’s
stock-based compensation plans. That cost is expected to be recognized over a
period of up to three years.
Stock and Stock Option
Issuances to Non-Employees – During 2007 and 2006, there were no options
granted to non-employees or consultants.
Stock and Stock Option
Issuances Outside the Stock Option Plans – During 2006, options to
purchase an aggregate of 945,000 shares of common stock were granted to
executive officers and directors of the Company. One third of the options vested
on the date of grant and the remaining options vest over a two year period with
an exercise price of $1.62. On the date of grant, the per share fair value of
these options was $1.62. As of December 31, 2007, 95,000 of these options have
canceled.
During
2003, 11,904 shares of restricted stock were granted to Robert J. DeLuccia, the
Company’s Chief Executive Officer, of which 3,571 shares vested immediately,
with the remainder vesting over two years, with an exercise price of $44.52 per
share.
During
2006, 75,000 shares of restricted stock were granted to Robert J. DeLuccia, the
Company’s Chief Executive Officer. The restricted stock vests if and when the
Company’s common stock trades at or above $4.00 per share for thirty consecutive
trading days.
5. Stockholders’
Equity.
Authorized Capital
Stock –
Authorized capital stock consists of 100,000,000 shares of $.01 par value common
stock of which 22,500,026 shares are issued (22,499,497 are outstanding) and
23,278,733 are reserved for issuance upon exercise of common stock options and
warrants at December 31, 2007. Authorized preferred stock totals 6,000,000
shares, of which 500,000 shares have been designated Series A Preferred Stock,
600,000 shares have been designated Series B Preferred Stock and 1,500 shares
have been designated Series C Cumulative Convertible Preferred Stock. On
December 31, 2006 there were 805 shares of Series C Cumulative Preferred Stock
outstanding. The Series C Preferred Stock has a liquidation value of $10,000 per
share, is entitled to a dividend of 10% per annum, payable in cash or shares of
our common stock at our option, which dividend rate is subject to increase to
14% upon the occurrence of certain events. The Series C Preferred Stock is
redeemable at the holder’s election in the event the Company fails or refuses to
convert any shares of Series C Preferred Stock in accordance with the terms of
the Certificate of Designation, Rights and Preferences of the Series C Preferred
Stock. The number of shares of common stock into which each share of Series C
Preferred Stock is convertible is determined by dividing the liquidation value
per share plus all accrued and unpaid dividends thereon by $1.05. On October 10,
2007, all of the 752.25 then outstanding shares of Series C Preferred Stock were
converted into a total of 12,571,850 shares of common stock. As a result of a
anti-dilutive provision in the Preferred Stock, the conversion price was reduced
to $0.60 from the original $1.05 convertible value resulting in a beneficial
conversion charge to common shareholders of $3,223,929. During 1998, the
Company’s Board of Directors authorized the repurchase of up to 23,809 shares of
common stock at market price. The Company repurchased no shares in 2005, 2006
and 2007. At December 31, 2007, 529 repurchased shares remain available for
future use and 16,180 shares are available to be repurchased.
Series C Convertible
Preferred Stock –
On December 23, 2005, pursuant to the terms of a Preferred Stock and
Warrant Purchase Agreement (the “Purchase Agreement”), the Company completed the
first closing of a private placement (the “Series C Financing”) in which
institutional investors (the “Purchasers”) acquired 250 shares of Series C
Cumulative Convertible Preferred Stock (the “Series C Preferred Stock”) and
six-year warrants (the “Warrants”) to purchase 2,380,951 shares of common stock
at an exercise price of $1.26 per share, for an aggregate purchase price of $2.5
million (the “First Closing”). The net proceeds from the First Closing were
$2,125,943. In the second closing of the Series C Financing, on February 13,
2006, the Company issued to institutional investors 575.5 shares of Series C
Preferred Stock and six-year warrants to purchase 5,480,961 shares of the
Company’s common stock at an exercise price of $1.26 per share, for an aggregate
purchase price of approximately $5.75 million (the “Second
Closing”). The net proceeds from the Second Closing were $5,186,908.
The terms of the Series C Preferred Stock and Warrants issued in the First
Closing and the Second Closing were identical. On October 10, 2007,
the Company entered into a Securities Purchase Agreement, pursuant to which the
Company issued in a private placement 5,891,667 shares of its common stock and
five-year warrants to purchase 1,767,500 shares of the Company’s common stock at
an exercise price of $0.60 per share, for aggregate gross proceeds of
$3,535,000. In connection with the private placement, all of the 752.25 then
outstanding shares of the Company’s Series C Cumulative Convertible Preferred
Stock were converted into a total of 12,571,850 shares of common stock. In
addition, outstanding warrants to purchase 8,648,102 shares of common stock
previously issued with the Series C Preferred have been reset to purchase
17,885,848 shares of common stock at an exercise price of $0.60 per share,
pursuant to anti-dilution provisions of those warrants.
F-88
Relevant Material
Terms: The terms
and provisions of the Series C Preferred Stock are set forth in the Certificate
of Designations, Rights and Preferences of Series C Cumulative Convertible
Preferred Stock (the “Certificate of Designations”). Certain material terms of
the Series C Preferred Stock relevant to this response are summarized
below:
Obligations to
Register Shares: When issued, the securities offered and sold
to the Purchasers in the Series C Financing were not registered under the
Securities Act of 1933, as amended (the “Securities Act”) and were sold in
reliance upon the exemption from securities registration afforded by Regulation
D under the Securities Act. All of the Purchasers represented to MacroChem that
they were “accredited investors”, as defined in Rule 501 of Regulation D. In
connection with the Series C Financing, MacroChem entered into an Investor
Rights Agreement with the Purchasers, pursuant to which MacroChem was required
to file a registration statement with the Securities and Exchange Commission
covering the resale of the common stock issuable upon conversion of the Series C
Preferred Stock, issuable as payment of dividends on the Series C Preferred
Stock and issuable upon exercise of the Warrants and the warrants issued to the
placement agent, no later than March 27, 2006, and to use its best efforts
to cause the registration statement to become effective within a specified time
period. The registration statement became effective on April 18,
2006.
Dividends: The Series C
Preferred Stock accrues dividends at the rate of 10% of the stated price
annually, payable quarterly in cash or common stock. The first dividend payment
date was March 31, 2006.
Liquidation: Upon liquidation,
dissolution or winding up, the holders of Series C Preferred Stock are
entitled, before any distributions are made to the holders of the common stock,
or any other class or series of capital stock of the Company ranking junior to
the Series C Preferred Stock as to such distributions, to be paid an amount
equal to $10,000 per share and any unpaid dividends thereon, subject to
adjustment.
Voting: The Certificate of
Designations contains a provision that restricts a holder of Series C Preferred
Stock from (i) converting Series C Preferred Stock into common stock to the
extent that such conversion would result in the holder owning more than 4.95% of
the issued and outstanding common stock of the Company or (ii) voting together
with the common stock on an as-if-converted to common stock basis in respect of
more than 4.95% of the issued and outstanding common stock of the Company. The
Warrants issued pursuant to the purchase agreement contain a similar restriction
(collectively, the “Beneficial Ownership Cap”). A holder of Series C Preferred
Stock or a Warrant may elect, subject to certain conditions, to be exempt from
the Beneficial Ownership Cap. Subject to the Beneficial Ownership Cap
restrictions, as of the date of the second closing of the private placement
financing in February 2006 (the “Second Closing”), the Series C Preferred Stock
acquired by the purchasers was convertible into 4,057,885 shares of common stock
and the holders of the Series C Preferred Stock vote on an as-converted basis
with the holders of our common stock, and therefore held approximately 80.28% of
the voting power of our outstanding securities.
Redemption: If the Company
fails or refuses to convert any shares of Series C Preferred Stock in accordance
with the terms of the Series C Preferred Stock, the holders of the Series C
Preferred Stock are entitled to elect to require the Company to redeem their
Series C Preferred Stock. In the event of a redemption, the redemption price per
share of Series C Preferred Stock is an amount in cash equal to the greater of
(1) all accrued but unpaid dividends as of the date the holder makes the demand
for redemption with respect to each share to be redeemed plus the $10,000
liquidation preference per share or (2) the total number of shares of common
stock into which such Series C Preferred Stock is convertible multiplied by the
then-current market price of the common stock.
Given
that the redemption provision described above does not embody an unconditional
obligation requiring the Company to redeem the instrument at a specified or
determinable date or upon an event certain to occur, the Series C Preferred
Stock is not a mandatorily redeemable financial instrument. Therefore, the
Company determined that the guidance in FAS 150, Accounting for Certain Financial
Instruments with Characteristics of both Liabilities and Equity, which
requires liability classification for mandatorily redeemable financial
instruments, does not apply.
Rule
5-02.28 of Regulation S-X requires securities with redemption features that are
not solely within the control of the issuer to be classified outside of
permanent equity. The holders of the Series C Preferred Stock control a majority
of the voting power of the Company’s common stock and, as a result of this
control, could directly or indirectly influence the triggering of the redemption
provision by, for example, refusing to approve an increase in the authorized but
unissued shares of common stock of the Company if, in the future, such increase
were necessary to effect the conversion of the Series C Preferred Stock.
Accordingly, the redemption provision is not solely within the Company’s
control, and thus the Series C Preferred Stock is not permanent
equity.
F-89
Because
the Series C Preferred Stock did not qualify for treatment as a liability or as
permanent equity as described above, the Company recorded the portion of the
proceeds attributable to the Series C Preferred Stock as mezzanine equity
pursuant to EITF Topic D-98, Classification and Measurement of Redeemable
Securities. Because the Company has a substantial amount of authorized but
unissued common stock (in excess of 95 million shares), the occurrence of a
redemption event is not considered probable, and thus the carrying value of the
Series C Preferred Stock is not being accreted to its redemption
value.
Conversion: The
Company evaluated whether the embedded conversion feature in the Series C
Preferred Stock required bifurcation and determined, in accordance with
paragraph 12 of SFAS 133, that the economic characteristics and risks of the
embedded conversion feature in the Series C Preferred Stock were clearly and
closely related to the underlying common stock. In conducting this evaluation,
the Company recognized that the cumulative fixed dividend and the potential
redemption requirement of the Series C Preferred Stock are characteristics of
debt. The Company also recognized, however, that the Series C Preferred Stock
had the following equity like characteristics: the Series C Preferred Stock
clearly gives the stockholders both existing and ongoing rights of ownership
(i.e., a residual interest), as the holders of Series C Preferred Stock are
entitled to vote on an as-converted basis with the holders of our common stock;
the dividend, while fixed, is payable quarterly in cash or common stock at the
Company’s election, and, to date, the Company’s Board of Directors has declared
each quarterly dividend to be paid in shares of common stock; the redemption
rights of the Series C preferred stock are perpetual and do not have a stated
maturity or redemption date, unlike debt instruments; and the right of the
holders of the Series C Preferred stock to receive payments, including the
liquidation preference, is not secured by any collateral. Consequently, when all
of the economic characteristics and risks of the Series C Preferred Stock are
considered as a whole, the Company concluded that the Series C Preferred Stock
is more akin to equity than to debt and, as a result, the Company concluded that
bifurcation was not required under SFAS 133.
Pursuant
to the guidance in paragraph 5 of EITF 00-27, Application of Issue No. 98-5
to Certain Convertible Instruments, the Company allocated the proceeds
from the Series C financing between the Series C Preferred Stock and the
warrants based upon their estimated fair values as of the closing date. The Company then calculated the intrinsic value of the
beneficial conversion feature embedded in the Series C Preferred Stock. As the
amount of the beneficial conversion feature exceeded the value
allocated to the Series C Preferred Stock, the amount of the beneficial conversion feature recorded was limited to the proceeds
allocated to the Series C Preferred Stock. The beneficial conversion value was
recognized as an additional discount on the Series C Preferred Stock which
amount was immediately accreted and treated as a deemed dividend to the holder
of the shares of Series C Preferred Stock as all of the Series C Preferred Stock
was eligible for conversion upon issuance.
Stock Sales
– On October 10, 2007, the Company entered into a Securities Purchase
Agreement, pursuant to which the Company issued in a private placement 5,891,667
shares of its common stock and five-year warrants to purchase 1,767,500 shares
of the Company’s common stock at an exercise price of $0.60 per share, for
aggregate gross proceeds of $3,535,000. In connection with the private
placement, all of the 752.25 then outstanding shares of the Company’s Series C
Cumulative Convertible Preferred Stock were converted into a total of 12,571,850
shares of common stock. In addition, outstanding warrants to purchase 8,648,102
shares of common stock previously issued with the Series C Preferred have been
reset to purchase 17,885,848 shares of common stock at an exercise price of
$0.60 per share, pursuant to anti-dilution provisions of those
warrants.
In
connection with the private placement, the Company entered into a Director
Designation Agreement dated as of October 1, 2007 with SCO Capital Partners, LLC
(“SCO”), a current stockholder and a purchaser in the private placement,
pursuant to which, for so long as SCO holds 20% of the Company’s outstanding
common stock, SCO has the right to designate two individuals to serve on the
Company’s board of directors. SCO previously held the right to designate two
individuals to serve on the Company’s board of directors for so long as it held
20% of the Company’s outstanding Series C Preferred.
Warrants
– On October 10, 2007, in connection with the conversion of its
Series C Preferred Stock to shares of common stock, warrants to purchase
8,648,102 shares of common stock previously issued with the Series C Preferred
Stock have been reset to purchase 17,885,847 shares with an exercise price of
$.60 per share pursuant to anti-dilution provisions in the warrants. On February
13, 2006, the Company closed a private placement in which institutional
investors received six-year warrants to purchase 11,510,018 shares of the
Company’s common stock at an exercise price of $0.60 per share (“Investor
Warrants”). As of December 31, 2007, none of the $0.60 Investor Warrants had
been exercised. The placement agent in the transaction received a warrant to
purchase approximately 959,166 shares of common stock at a purchase price of
$0.60 for a period of six years (“Placement Agent Warrants”). As of December 31,
2007, none of these $0.60 Placement Agent Warrants had been exercised. On
December 23, 2005, the Company closed a private placement in which institutional
investors received warrants to purchase 4,999,997 shares of common stock at an
exercise price of $0.60 per share for a period of six years (“Investor
Warrants”). As of December 31, 2007, 37,500 of these $0.60 Investor Warrants had
been exercised. The placement agent in this transaction received a warrant to
purchase approximately 416,666 shares of common stock at a purchase price of
$0.60 for a period of six years (“Placement Agent Warrants”). As of December 31,
2007, none of the $0.60 Placement Agent Warrants had been exercised. In
accordance with EITF 00-19, “Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company’s Own
Stock,: the Investor Warrants and the Placement Agent Warrants are
included as a liability and valued at fair market value until the Company meets
the criteria under EITF 00-19 for permanent equity. Changes in the fair value of
such warrants are recorded as a charge or credit to operations each reporting
period. The Company valued the Investor Warrants and the Placement Agent
Warrants at $4,076,488 on December 31, 2007 using the Black-Scholes model with
the following assumptions: a risk-free interest rate of 3.05%, volatility of
114% and a dividend yield of 0%.
F-90
On
October 10, 2007, the Company closed a private placement in which institutional
investors received warrants to purchase approximately 1,767,500 shares of common
stock for a period of five years. The exercise price of the warrants is $0.60
per share. The placement agent also received warrants to purchase 589,166 shares
of common stock for a period of five years. The exercise price of these warrants
is $0.60. At December 31, 2007, none of these warrants had been
exercised.
On April
19, 2005, the Company closed a private placement in which institutional
investors and certain executive officers and directors of the Company received
warrants to purchase approximately 32,520 shares of common stock for a period of
five years. The exercise price of the warrants is $14.70 per share for the
institutional investors and $21.84 for the participating executive officers and
directors. As of December 31, 2007, approximately 6,012 of the $14.70 warrants
issued to the institutional investors had been exercised and none of the $21.84
warrants issued to participating executive officers and directors had been
exercised. The placement agent in this transaction received a warrant to
purchase approximately 1,190 shares of common stock at a purchase price of
$14.70 for a period of five years. As of December 31, 2007, none of the $14.70
warrants issued to the placement agent had been exercised.
During
2004, the Company conducted a private placement in which primarily institutional
investors received warrants to purchase an aggregate of 25,723 shares of common
stock at a purchase price of $87.78 per share for a period of five years. As of
December 31, 2007, none of the $87.78 warrants had been exercised.
Shareholder Rights
Plan – The Company has adopted a shareholder rights plan. The Company
declared a dividend consisting of one Right for each share of common stock
outstanding on September 10, 1999. Stock issued after that date will be issued
with an attached Right.
Each
Right entitles the holder, upon the occurrence of certain events, to purchase
42/100th of a
share of Series B Preferred Stock of the Company at an initial exercise price of
$2,100.00, subject to adjustments for stock dividends, splits and similar
events. The Rights are exercisable only if a person or group acquires 20% or
more of the Company’s outstanding common stock, or announces an intention to
commence a tender or exchange offer, the consummation of which would result in
ownership by such person or group of 20% or more of the Company’s outstanding
common stock.
On
December 23, 2005, the shareholder rights plan was amended to provide that the
acquisition of the Company’s Series C Cumulative Convertible Preferred Stock and
warrants to acquire shares of its common stock by the purchasers in the
Company’s recent private placement, and any subsequent acquisition by the
purchasers of common stock upon the conversion or exercise of those securities,
would not result in the Rights becoming exercisable.
The Board
of Directors may, at its option after the occurrence of one of the events
described above, exchange all of the then outstanding and exercisable Rights for
shares of common stock at an exchange ratio of one share of common stock per
Right.
The Board
of Directors may redeem the Rights at the redemption price of $0.01 per Right at
any time prior to the expiration of the rights plan on August 13, 2009.
Distribution of the Rights is not a taxable event to shareholders.
The Board
of Directors has authorized 600,000 shares of Series B Preferred
Stock.
6. Commitments
and Contingencies.
At
December 31, 2007, the Company had no long-term contractual
obligations.
7. Income
Taxes.
No income
tax provision or benefit has been provided for federal or state income tax
purposes as the Company has incurred losses in all periods reported and
recoverability of these losses in future tax filings is uncertain. As of
December 31, 2007, the Company has available net operating loss carryforwards of
approximately $77,284,666 for federal income tax purposes, expiring through 2027
and $34,476,179 for state income tax purposes, expiring through 2012. In
addition, the Company has unused investment and research and development tax
credits for federal and state income tax purposes aggregating $1,521,990 and
$870,953, respectively. The use of the federal net operating loss may also be
restricted due to changes in ownership in accordance with definitions as stated
in the Internal Revenue Code.
F-91
Income
taxes computed using the federal statutory income tax rate differs from the
Company’s effective tax rate primarily due to the following:
|
2007
|
2006
|
2005
|
|||
|
Statutory
U.S. federal tax rate
|
(34.0%)
|
(34.0%)
|
(34.0%)
|
||
|
State
taxes, net of federal tax benefit
|
(6.2%)
|
(6.2%)
|
(6.2%)
|
||
|
Federal
research and development credits
|
(0.2%)
|
(0.5%)
|
(1.5%)
|
||
|
Valuation
allowance on deferred tax assets
|
40.4%
|
40.7%
|
41.7%
|
||
|
---%
|
---%
|
---%
|
The net
tax effect of differences in the timing of certain revenue and expense items and
the related carrying amounts of assets and liabilities for financial reporting
and tax purposes are not material and, accordingly, are not displayed in the
table below. The components of the Company’s deferred tax assets as of December
31, 2007 and 2006 are as follows:
|
2007
|
2006
|
||||||
|
Deferred
Tax Assets:
|
|||||||
|
Net
operating loss carryforwards
|
$
|
27,930,000
|
$
|
25,920,000
|
|||
|
Tax
credit carryforwards
|
2,393,000
|
2,475,000
|
|||||
|
30,323,000
|
28,395,000
|
||||||
|
Valuation
allowance
|
(30,323,000
|
)
|
(28,395,000
|
)
|
|||
|
Deferred
tax asset, net
|
$
|
——
|
$
|
——
|
For the
year ended December 31, 2007 the valuation allowance increased by approximately
$1,928,000 and for the year ended December 31, 2006 decreased by approximately
$423,000, respectively, due to the uncertainty of future realization of
currently generated net operating loss and tax credit
carryforwards. During 2007, the adoption of FASB Interpretation No.
48, “Accounting for Uncertainty in Income Taxes” did not have a material impact
on the financial statements.
8. Employee
Benefit Plan.
The
Company sponsors a qualified 401(k) Retirement Plan (the “Plan”) under which
employees are allowed to contribute certain percentages of their pay, up to the
maximum allowed under Section 401(k) of the Internal Revenue Code. Company
contributions to the Plan are at the discretion of the Board of Directors. The
Company did not make any matching contributions for the year ended December 31,
2007 and 2006, respectively. The Company contributed 953 shares of common stock
in 2005, valued at $15,610. The Company also contributed $42,539 in cash to the
Plan in 2005.
F-92
9. Selected
Quarterly Financial Data (Unaudited)
The
quarters ended March 31, June 30 and September 30, 2006 have been restated.
|
First
|
Second
|
Third
|
Fourth
|
||||||||||
|
2007
Quarters
|
|||||||||||||
|
Revenues
|
$
|
——
|
$
|
——
|
$
|
——
|
$
|
——
|
|||||
|
Loss
from Operations
|
(1,302,760
|
)
|
(1,155,902
|
)
|
(1,342,713
|
)
|
(2,049,012
|
)
|
|||||
|
Net
(Loss)
|
(1,528,093
|
)
|
(2,600,293
|
)
|
(739,795
|
)
|
(3,998,001
|
)
|
|||||
|
Net
(Loss) Attributable to Common Stockholders
|
(1,720,792
|
)
|
(2,793,393
|
)
|
(929,403
|
)
|
(7,242,540
|
)
|
|||||
|
Basic
Net (Loss) per Common Share
|
$
|
(0.62
|
)
|
$
|
(0.86
|
)
|
$
|
(0.25
|
)
|
$
|
(0.35
|
)
|
|
|
Diluted
Net (Loss) per Common Share
|
$
|
(0.62
|
)
|
$
|
(0.86
|
)
|
$
|
(0.25
|
)
|
$
|
(0.35
|
)
|
|
|
2006
Quarters
|
|||||||||||||
|
Revenues
|
$
|
——
|
$
|
——
|
$
|
——
|
$
|
——
|
|||||
|
Loss
from Operations
|
(1,207,109
|
)
|
(1,066,803
|
)
|
(1,160,767
|
)
|
(958,086
|
)
|
|||||
|
Net
Income (Loss)
|
(1,991,360
|
)
|
4,410,432
|
685,163
|
(1,152,956
|
)
|
|||||||
|
Net
Income (Loss) Attributable to Common Stockholders
|
(2,142,907
|
)
|
4,205,008
|
481,164
|
(1,355,947
|
)
|
|||||||
|
Basic
Net Income (Loss) per Common Share
|
$
|
(1.98
|
)
|
$
|
3.86
|
$
|
0.33
|
$
|
(0.64
|
)
|
|||
|
Diluted
Net Income (Loss) per Common Share
|
$
|
(1.98
|
)
|
$
|
0.57
|
$
|
0.08
|
$
|
(0.12
|
)
|
|||
F-93
MACROCHEM
CORPORATION
|
September 30, 2008
|
December 31, 2007
|
||||||
|
(Unaudited)
|
(Note 1)
|
||||||
|
ASSETS
|
|||||||
|
Current
assets:
|
|||||||
|
Cash
and cash equivalents
|
$
|
32,879
|
$
|
2,423,519
|
|||
|
Short-term
investments
|
—
|
759,247
|
|||||
|
Prepaid
expenses and other current assets
|
116,124
|
131,047
|
|||||
|
Total
current assets
|
149,003
|
3,313,813
|
|||||
|
Property
and equipment, net
|
10,523
|
22,042
|
|||||
|
Other
assets
|
50,900
|
—
|
|||||
|
Patents,
net
|
484,099
|
517,600
|
|||||
|
Total
assets
|
$
|
694,525
|
$
|
3,853,455
|
|||
|
LIABILITIES
|
|||||||
|
Current
liabilities:
|
|||||||
|
Accounts
payable
|
$
|
1,428,488
|
$
|
94,439
|
|||
|
Accrued
expenses and other liabilities
|
586,979
|
310,195
|
|||||
|
Deferred
revenue
|
5,304
|
—
|
|||||
|
Accrued
interest on notes payable
|
8,250
|
—
|
|||||
|
Note
payable - related party
|
225,000
|
||||||
|
Convertible
notes payable, net
|
791,487
|
—
|
|||||
|
Total
current liabilities
|
3,045,508
|
404,634
|
|||||
|
Warrants
liability (Note 4)
|
190,282
|
4,076,488
|
|||||
|
Deferred
revenue
|
25,469
|
—
|
|||||
|
Total
liabilities
|
3,261,259
|
4,481,122
|
|||||
|
Commitments
and contingencies (Note 3)
|
|||||||
|
STOCKHOLDERS’
DEFICIT
|
|||||||
|
Cumulative
preferred stock, $.01 par value, 6,000,000 shares authorized, none
issued
|
—
|
—
|
|||||
|
Common
stock, $.01 par value, 100,000,000 shares authorized; 45,873,412 issued
and 45,872,883 outstanding as of September 30, 2008 and 22,500,026 shares
issued and outstanding as of December 31, 2007
|
458,734
|
225,000
|
|||||
|
Additional
paid-in capital
|
97,683,242
|
90,054,421
|
|||||
|
Accumulated
deficit
|
(100,649,600)
|
(90,847,978
|
)
|
||||
|
Less
treasury stock, at cost, 529 shares at September 30, 2008 and
December 31, 2007
|
(59,110)
|
(59,110
|
)
|
||||
|
Total
stockholders’ deficit
|
(2,566,734)
|
(627,667
|
)
|
||||
|
Total
liabilities and stockholders’ deficit
|
$
|
694,525
|
$
|
3,853,455
|
|||
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
F-94
MACROCHEM
CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
For the
nine months ended September 30, 2008 and 2007
(Unaudited)
|
For the Nine Months Ended
September 30,
|
|||||||
|
2008
|
2007
|
||||||
|
Other
Income
|
$
|
2,652
|
—
|
||||
|
TOTAL
OTHER INCOME
|
2,652
|
||||||
|
OPERATING
EXPENSES:
|
|||||||
|
Research
and development
|
916,940
|
1,047,187
|
|||||
|
Marketing,
general and administrative
|
2,962,453
|
2,754,187
|
|||||
|
In-
process research and development
|
9,656,794
|
—
|
|||||
|
TOTAL
OPERATING EXPENSES
|
13,536,187
|
3,801,374
|
|||||
|
LOSS
FROM OPERATIONS
|
(13,533,535
|
)
|
(3,801,374
|
)
|
|||
|
OTHER
(EXPENSE) INCOME:
|
|||||||
|
Interest
income (expense), net
|
(160,759
|
)
|
59,590
|
||||
|
Gain
(loss) on change in value of warrant liability
|
3,886,206
|
(1,194,396
|
)
|
||||
|
Gain
on sale of equipment
|
6,466
|
68,000
|
|||||
|
TOTAL
OTHER INCOME (EXPENSE)
|
3,731,913
|
(1,066,806
|
)
|
||||
|
NET
LOSS
|
(9,801,622
|
)
|
(4,868,180
|
)
|
|||
|
DIVIDEND
ON SERIES C CUMULATIVE PREFERRED STOCK
|
—
|
(575,407
|
)
|
||||
|
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(9,801,622
|
)
|
$
|
(5,443,587
|
)
|
|
|
BASIC
NET LOSS PER COMMON SHARE
|
$
|
(0.27
|
)
|
$
|
(1.63
|
)
|
|
|
DILUTED
NET LOSS PER COMMON SHARE
|
$
|
(0.27
|
)
|
$
|
(1.63
|
)
|
|
|
WEIGHTED
AVERAGE SHARES USED TO COMPUTE BASIC NET LOSS PER COMMON
SHARE
|
36,604,749
|
3,334,612
|
|||||
|
WEIGHTED
AVERAGE SHARES USED TO COMPUTE DILUTED NET LOSS PER COMMON
SHARE
|
36,604,749
|
3,334,612
|
|||||
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
F-95
MACROCHEM
CORPORATION
For the
nine months ended September 30, 2008 and 2007
(Unaudited)
|
2008
|
2007
|
||||||
|
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|||||||
|
Net
loss
|
$
|
(9,801,622
|
)
|
$
|
(4,868,180
|
)
|
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
|
In-process
research and development
|
9,656,794
|
—
|
|||||
|
Depreciation
and amortization
|
48,202
|
50,295
|
|||||
|
Stock-based
compensation
|
654,871
|
456,482
|
|||||
|
Stock
issued for services
|
120,000
|
—
|
|||||
|
(Gain)/loss
on change in value of warrant liability
|
(3,886,206
|
)
|
1,194,396
|
||||
|
Changes
in operating assets and liabilities, net of acquisition:
|
|||||||
|
Prepaid
expenses and other current assets
|
(35,977
|
)
|
(20,478
|
)
|
|||
|
Accounts
payable and accrued expenses
|
287,473
|
55,144
|
|||||
|
Net
cash used in operating activities
|
(2,956,465
|
)
|
(3,132,342
|
)
|
|||
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
|
Sales
of short-term investments
|
759,247
|
2,652,192
|
|||||
|
Addition
to patents
|
(42
|
)
|
—
|
||||
|
Expenditures
for property and equipment
|
(3,140
|
)
|
—
|
||||
|
Payments
for acquisition of Virium, net of cash acquired
|
(240,240
|
)
|
—
|
||||
|
Net
cash provided by investing activities
|
515,825
|
2,652,192
|
|||||
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
|
Proceeds
from debt issuance
|
400,000
|
—
|
|||||
|
Proceeds
from note payable - related party
|
225,000
|
—
|
|||||
|
Repayment
of debt
|
(575,000
|
)
|
—
|
||||
|
Net
cash provided by financing activities
|
50,000
|
—
|
|||||
|
Net
change in cash and cash equivalents
|
(2,390,640
|
)
|
(480,150
|
)
|
|||
|
Cash
and cash equivalents at beginning of period
|
2,423,519
|
738,264
|
|||||
|
Cash
and cash equivalents at end of period
|
$
|
32,879
|
$
|
258,114
|
|||
The
Company did not pay any cash for income taxes during the three and nine month
periods ended September 30, 2008 and 2007.
SUPPLEMENTAL
DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
See Note
7 for the acquisition of Virium Pharmaceuticals, Inc and consideration
(principally shares, warrants and assumption of $1,000,000 debt) issued
/assumed.
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
F-96
MACROCHEM
CORPORATION
|
|
(1) Basis of Presentation
and Operations
|
|
|
|
The
unaudited condensed consolidated financial statements included herein have been
prepared by MacroChem Corporation (“MacroChem” or the “Company”) without audit,
pursuant to the rules and regulations of the Securities and Exchange
Commission. Certain information and footnote disclosures normally included in
financial statements prepared in accordance with accounting principles generally
accepted in the United States of America have been condensed or omitted pursuant
to such rules and regulations. In the opinion of management, the
accompanying unaudited condensed consolidated financial statements include all
adjustments (consisting only of normal recurring adjustments) necessary to
present fairly the financial position, results of operations and cash flows of
the Company at the dates and for the periods indicated. The results disclosed in
the condensed consolidated statement of operations for the nine months ended
September 30, 2008 are not necessarily indicative of the results to be
expected for the full year. The unaudited condensed consolidated financial
statements included herein should be read in conjunction with the audited
financial statements and the notes thereto included in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2007.
The condensed consolidated balance sheet as of December 31, 2007 has been
derived from the audited financial statements included in the Company’s
Form 10-K for that year.
The
Company has been engaged primarily in research and development since its
inception in 1981 and has derived limited revenues from the commercial sale of
its products, licensing of certain technology and feasibility studies. The
Company has incurred losses from operations every year since its inception and
the Company anticipates that losses will continue for the foreseeable future. At
September 30, 2008, the Company’s accumulated deficit was $100,649,600. On
July 10, 2008, the Company entered into an agreement and plan of merger
with Access Pharmaceuticals, Inc.(“Access”). However, management believes that
our continuation as a going concern depends on our ability to obtain additional
financing, to consummate a strategic transaction or to make alternative
arrangements to fund our operations. There can be no assurance that the
Company will be able to obtain additional financing, to consummate a strategic
transaction, or to make alternative arrangements to fund our operations. The
Company’s cash requirements may vary materially from those now planned because
of changes in the focus and direction of its research and development programs,
identification of additional product candidates and technologies, competitive
and technical advances, patent developments or other developments related to the
status of fund raising. These matters raise substantial doubt about the
Company’s ability to continue as a going concern. The accompanying
financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
|
|
(2) Stock-Based
Compensation
|
Stock
Incentive Plans
The
Company has granted options to purchase the Company’s common stock to employees
and directors under various stock incentive plans. Under the plans,
employees
F-97
and
non-employee directors are eligible to receive awards of various forms of
equity-based incentive compensation, including stock options, restricted stock,
and performance awards, among others. The plans are administered by the Board of
Directors or the Compensation Committee of the Board of Directors, which
determine the terms of the awards granted. Stock options are generally granted
with an exercise price equal to the market value of a share of common stock on
the date of grant, have a term of ten years or less, and vest over terms of two
to three years from the date of grant.
Stock
Option Plans
The
Company has three stock option plans, the 1994 Equity Incentive Plan (the “1994
Plan”) and the 2001 Incentive Plan (the “2001 Plan”) and the 2008 Stock
Incentive Plan ( the “2008 Plan”).
Under the
terms of the 1994 Plan, the Company may no longer award any options. All options
previously granted under the 1994 Plan may be exercised at any time up to ten
years from the date of award.
Under the
terms of the 2001 Plan, the Company may grant options to purchase up to a
maximum of 2,373,809 shares of common stock to certain employees, directors and
consultants. The options may be awarded as incentive stock options (employees
only) and non-incentive stock options (certain employees, directors and
consultants).
Under the
terms of the 2008 Plan, the Company may grant options to purchase up to a
maximum of 8,500,000 shares of future grants of options.
The 2008
Plan, 2001 Plan and the 1994 Plan state that the exercise price of options shall
not be less than fair market value at the date of grant. As of
September 30, 2008, there were outstanding options under all plans to
purchase 5,651,988 shares of common stock with 6,003,545 shares remaining
available for future grants under the 2001 and 2008 Plan.
Stock-Based
Compensation
Effective
January 1, 2006, the Company adopted SFAS No. 123(R), “Accounting for
Stock-Based Compensation,” (“SFAS 123(R)”) using the modified prospective
method, which results in the provisions of SFAS 123(R) being applied to the
financial statements on a going-forward basis. SFAS 123(R) requires
companies to recognize stock-based compensation awards granted to its employees
as compensation expense on a fair value method. Under the fair value recognition
provisions of SFAS 123(R), stock-based compensation cost is measured at the
grant date based on the fair value of the award and is recognized as expense
over the service period, which generally represents the vesting period. The
grant date fair value of stock options is calculated using the Black-Scholes
option-pricing model and the grant date fair value of restricted stock is based
on fair value on the date of grant. The expense recognized over the
service period is required to include an estimate of the awards that will be
forfeited.
All
stock-based awards to non-employees are accounted for at their fair market value
in accordance with SFAS 123(R) and Emerging Issues Task Force
No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than
Employees for Acquiring, or in Conjunction with Selling, Goods or Services.”
Under this method, the equity-based instrument was valued at either the fair
value of the consideration received or the equity instrument issued on the date
of grant. The resulting compensation cost was recognized and charged to
operations over the service period, which was usually the vesting
period.
F-98
For
purposes of recording stock-based compensation expense as required by
SFAS 123(R), the fair values of each stock option granted under the
Company’s stock option plan for the three and nine months ended
September 30, 2008 were estimated as of the date of grant using the
Black-Scholes option-pricing model.
The fair
values of all stock option grants issued were determined using the following
assumptions:
|
Nine
Months Ended
September 30,
|
|||||
|
2008
|
2007
|
||||
|
Risk-free
interest rate
|
2.00%
|
4.16%
|
|||
|
Expected
life of option grants
|
6
years
|
6
years
|
|||
|
Expected
volatility of underlying stock
|
110%
|
113%
|
|||
|
Expected
dividend yield
|
0%
|
0%
|
|||
The
dividend yield assumption is based on the Company’s history and expectation of
future dividend payouts. The Company estimated the stock price volatility using
the historical volatility in the market price of its common stock for the
expected term of the options. The risk-free interest rate assumption is based
upon the U.S. Treasury yield curve in effect at the time of grant for periods
corresponding with the expected life of the option.
As
share-based compensation expense is recognized based on awards ultimately
expected to vest, it must be reduced for estimated forfeitures. SFAS
123(R) requires forfeitures to be estimated at the time of grant and
revised, if necessary, in subsequent periods if actual forfeitures differ from
those estimates. Forfeiture rates are calculated based on actual historical
forfeitures.
The
expected life of employee stock options represents the weighted-average period
the stock options are estimated to remain outstanding. The expected term of the
options represents the estimated period of time until exercise and is based on
historical experience of similar awards. The expected life of employee stock
options is, in part, a function of the options’ remaining contractual life and
the extent to which the option is in-the-money (i.e., the average stock price
during the period is above the strike price of the stock option).
F-99
Stock
Option Activity
Stock
option activity for the nine months ended September 30, 2008 was as
follows:
|
Number of
Shares
|
Weighted Average
Exercise Price
Per Share
|
Weighted-Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
|
||||||||
|
Outstanding December 31,
2007
|
3,020,249
|
$
|
3.90
|
8.97
|
$
|
—
|
|||||
|
Granted
|
4,840,000
|
$
|
0.19
|
9.56
|
$
|
—
|
|||||
|
Exercised
|
—
|
$
|
—
|
—
|
$
|
—
|
|||||
|
Cancelled
or expired
|
(2,208,261
|
)
|
$
|
0.73
|
8.94
|
$
|
—
|
||||
|
Outstanding, September 30,
2008
|
5,651,988
|
$
|
2.05
|
8.96
|
$
|
—
|
|||||
|
Exercisable,
September 30, 2008
|
2,352,940
|
$
|
5.78
|
8.95
|
$
|
—
|
|||||
As of
September 30, 2008 there was $800,768 of total expected unrecognized
compensation cost related to unvested stock options granted under the Company’s
stock- based compensation plans. The cost is to be recognized over a period of
up to three years.
Restricted Stock
Activity
On
March 7, 2008, the Company issued 400,000 shares of common stock to a
consultant to the Company for services to be performed in the first three
quarters of 2008. The common shares vested immediately and were not
subject to forfeiture. The common shares had a fair value of $120,000 on
the grant date.
On
April 22, 2008, the Company issued 75,000 shares of common stock to the
Company’s Chairman Robert DeLuccia. The common shares vested immediately and
were not subject to forfeiture. The common shares had a fair value of
$22,500.
|
|
(3) Commitments and
Contingencies
|
|
|
|
Lease
Commitments
The
Company has the following commitments as of September 30,
2008:
|
Payments
Due in
|
|||||||||||||
|
Total
|
2008
|
2009
|
2010
|
||||||||||
|
Occupancy
Leases
|
$
|
213,988
|
$
|
33,788
|
$
|
135,150
|
$
|
45,050
|
|||||
|
Total
|
$
|
213,988
|
$
|
33,788
|
$
|
135,150
|
$
|
45,050
|
|||||
Other Commitments and
Contingencies
RAI
Merger
On
April 17, 2008, the REIT Americas Inc. (“RAI”) and Virium
Pharmaceuticals agreed to terminate the Merger Agreement that had been entered
into on May 25, 2007 by and among RAI and Virium Pharmaceuticals. Upon
completion of a qualified financing, the Company will be obligated to pay RAI
$535,000 in consideration for agreeing to terminate the Merger
Agreement.
F-100
|
|
(4) Stockholders’
Equity
|
|
|
|
Authorized
Capital Stock
Authorized
capital stock consists of 100,000,000 shares of $.01 par value common stock of
which 45,873,412 shares are issued (45,872,883 are outstanding) and 29,942,508
are reserved for issuance upon exercise of common stock options and warrants at
September 30, 2008. Authorized preferred stock totals 6,000,000 shares, of
which 500,000 shares have been designated Series A Preferred Stock, 600,000
shares have been designated Series B Preferred Stock and 1,500 shares have
been designated Series C Cumulative Convertible Preferred Stock. On
September 30, 2008, there were no shares of Series A, B or C
Cumulative Preferred Stock outstanding.
Stock
Sales
On
October 10, 2007, the Company entered into a Securities Purchase Agreement,
pursuant to which the Company issued in a private placement 5,891,667 shares of
its common stock and five-year warrants to purchase 1,767,500 shares of the
Company’s common stock at an exercise price of $0.60 per share, for aggregate
gross proceeds of $3,535,000. In connection with the private placement, all of
the 752.25 then outstanding shares of the Company’s Series C Cumulative
Convertible Preferred Stock were converted into a total of 12,571,850 shares of
common stock. In addition, outstanding warrants to purchase 8,648,102 shares of
common stock previously issued with the Series C Preferred have been reset
to purchase 17,885,848 shares of common stock at an exercise price of $0.60 per
share, pursuant to anti-dilution provisions of those warrants.
In
connection with the private placement, the Company entered into a Director
Designation Agreement dated as of October 1, 2007 with SCO Capital
Partners, LLC (“SCO”), a current stockholder and a purchaser in the private
placement, pursuant to which, for so long as SCO holds 20% of the Company’s
outstanding common stock, SCO has the right to designate two individuals to
serve on the Company’s Board of Directors. SCO previously held the right to
designate two individuals to serve on the Company’s Board of Directors for so
long as it held 20% of the Company’s outstanding Series C
Preferred.
Warrants
On
October 10, 2007, in connection with the conversion of its Series C
Preferred Stock to shares of common stock, warrants to purchase 8,648,102 shares
of common stock previously issued with the Series C Preferred Stock have
been reset to purchase 17,885,847 shares with an exercise price of $.60 per
share pursuant to anti-dilution provisions in the warrants. On February 13,
2006, the Company closed a private placement in which institutional investors
received six-year warrants to purchase 11,510,018 shares of the Company’s common
stock at an exercise price of $0.60 per share (“Investor Warrants”). As of
September 30, 2008, none of the $0.60 Investor Warrants had been exercised.
The placement agent in the transaction received a warrant to purchase
approximately 959,166 shares of common stock at a purchase price of $0.60 for a
period of six years (“Placement Agent Warrants”). As of September 30, 2008,
none of these $0.60 Placement Agent Warrants had been exercised. On
December 23, 2005, the Company closed a private placement in which
institutional investors received warrants to purchase 4,999,997
shares
F-101
of common
stock at an exercise price of $0.60 per share for a period of six years
(“Investor Warrants”). As of September 30, 2008, 37,500 of these $0.60
Investor Warrants had been exercised. The placement agent in this transaction
received a warrant to purchase approximately 416,666 shares of common stock at a
purchase price of $0.60 for a period of six years (“Placement Agent
Warrants”). As of September 30, 2008, none of the $0.60 Placement
Agent Warrants had been exercised. In accordance with EITF 00-19, “Accounting
for Derivative Financial Instruments Indexed to, and Potentially Settled in, a
Company’s Own Stock” (“EITF 00-19”), the Investor Warrants and the Placement
Agent Warrants are included as a liability and valued at fair market value until
the Company meets the criteria under EITF 00-19 for permanent equity due to a
put option in the agreement. Changes in the fair value of such warrants are
recorded as a charge or credit to operations each reporting period. The Company
valued the Investor Warrants and the Placement Agent Warrants at $190,282 on
September 30, 2008 using the Black-Scholes model with the following
assumptions: a risk-free interest rate of 2.00%, volatility of 110%, expected
life of 1 year and a dividend yield of 0%.
On
October 10, 2007, the Company closed a private placement in which
institutional investors received warrants to purchase 1,767,500 shares of common
stock for a period of five years. The exercise price of the warrants is $0.60
per share. The placement agent also received warrants to purchase 589,166 shares
of common stock for a period of five years. The exercise price of these warrants
is $0.60. At September 30, 2008, none of these warrants had been
exercised.
On
April 19, 2005, the Company closed a private placement in which
institutional investors and certain executive officers and directors of the
Company received warrants to purchase 32,520 shares of common stock for a period
of five years. The exercise price of the warrants is $14.70 per share for the
institutional investors and $21.84 for the participating executive officers and
directors. As of September 30, 2008, 6,012 of the $14.70 warrants issued to
the institutional investors had been exercised and none of the $21.84 warrants
issued to participating executive officers and directors had been exercised. The
placement agent in this transaction received a warrant to purchase 1,190 shares
of common stock at a purchase price of $14.70 for a period of five years. As of
September 30, 2008, none of the $14.70 warrants issued to the placement
agent had been exercised.
During
2004, the Company conducted a private placement in which primarily institutional
investors received warrants to purchase an aggregate of 25,723 shares of common
stock at a purchase price of $87.78 per share for a period of five years. As of
September 30, 2008, none of the $87.78 warrants had been
exercised.
On
June 23, 2008, the Company entered into a $400,000 Convertible Note
agreement with new holders of convertible promissory notes whose notes mature on
December 6, 2008, subject to certain conditions. The note holders received
warrants to purchase 100,000 shares of common stock at an exercise price of $.01
per share for a period of five years These warrants were valued at $24,000 using
the Black Scholes model and are being amortized over the term of the debt. As of
September 30, 2008, none of the warrants had been exercised.
|
|
(5) Basic and Diluted
(Loss) Income Per Share-
|
|
|
|
The
Company presents “basic” earnings (loss) per share and, if applicable,
“diluted” earnings per share pursuant to the provisions of Statement of
Financial Accounting Standards No. 128, “Earnings per Share”. Basic
earnings (loss) per share is calculated by dividing net income or loss by
the weighted average number of common shares outstanding during each period. The
calculation of diluted earnings per share is similar to that of basic earnings
per share, except that the denominator is increased to include the number of
additional common shares that would have been outstanding if all potentially
dilutive common shares, such as those issuable upon the exercise of outstanding
stock options and warrants were issued during the
F-102
period
and the treasury stock method had been applied to the proceeds from the exercise
of the options and warrants and net income or loss was adjusted for changes in
warrant liabilities.
As of
September 30, 2008, there were options and warrants outstanding for the
purchase of shares of common stock. However, diluted per share amounts
presented in the accompanying condensed consolidated statements of operations
for the nine months ended September 30, 2008 and 2007 are the same as basic
per share amounts because the assumed effects of the exercise of the Company’s
options and warrants that were outstanding during all or part of the period
would have been anti-dilutive due to the Company being in a net loss
position.
F-103
|
|
(6) Recent Accounting
Pronouncements
|
In
September 2006, the FASB issued SFAS No. 157, “Fair Value
Measurements” (“SFAS 157”). SFAS 157 establishes a common definition of fair
value to be used whenever GAAP requires (or permits) assets or liabilities to be
measured at fair value, and does not expand the use of fair value in any new
circumstances. It also requires expanded disclosure about the extent to which
companies measure assets and liabilities at fair value, the information used to
measure fair value, and the effect of fair value measurements on earnings. On
February 12, 2008, FASB issued proposed FASB Staff Position No. SFAS
No. 157-2, “Effective Date of FASB Statement No. 157” which defers the
effective date for all nonfinancial assets and nonfinancial liabilities, except
those that are recognized or disclosed at fair value in the financial statements
on a recurring basis (that is, at least annually) to fiscal years beginning
after November 15, 2008. The Company adopted SFAS 157 for all
financial assets and liabilities required to be measured at fair value on a
recurring basis, prospectively from January 1, 2008. The application of
SFAS 157 did not have a significant impact on the Company’s financial position,
results of operations or cash flows.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option
for Financial Assets and Financial Liabilities — including an amendment of FASB
115” (“SFAS 159”) which allows an entity to choose to measure certain financial
instruments and liabilities at fair value. Subsequent measurements for the
financial instruments and liabilities an entity elects to fair value will be
recognized in earnings and this election is irrevocable. SFAS 159 also
establishes additional disclosure requirements. SFAS 159 is effective for the
Company beginning Jnuary 1, 2008. The Company has not elected to apply the
fair value option to any of its financial instruments.
In
December 2007, the FASB issued SFAS No.141 (revised 2007), “Business
Combinations” (“SFAS 141R”). SFAS 141R establishes principles and requirements
for how an acquirer recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed, any non controlling
interest in the acquiree and the goodwill acquired. SFAS 141R also establishes
disclosure requirements to enable the evaluation of the nature and financial
effects of the business combination. SFAS 141R is effective beginning
January 1, 2009. The Company is currently evaluating the potential impact
of the adoption of SFAS 141R on its financial position, results of operations or
cash flows.
In
December 2007, the FASB issued SFAS No.160, “Non Controlling Interests in
Consolidated Financial Statements-an amendment of Accounting Research
Bulletin
F-104
No. 51”
(“SFAS 160”). SFAS 160 establishes accounting and reporting standards for
ownership interests in subsidiaries held by the parties other than parent, the
amount of the consolidated net income attributable to the parent and to the non
controlling interest, changes in parent’s ownership interest, and the valuation
of retained non controlling equity investments when a subsidiary is
deconsolidated. SFAS 160 also establishes disclosure requirements that
clearly identify and distinguish between the interests of the parent and
interests of the non controlling owners. SFAS 160 is effective for the Company
beginning January 1, 2009. The Company is currently evaluating the
potential impact of the adoption of FAS 160 on its financial position, results
of operations or cash flows.
In
March 2008, the FASB issued SFAS No. 161 “Disclosures about Derivative
Instruments and Hedging Activities-an amendment of FASB Statement No. 133”
(“SFAS 161”). SFAS 161 enhances disclosures about the Company’s derivative and
hedging activities and thereby improves the transparency of financial reporting.
SFAS 161 is effective for financial statements issued for fiscal years and
interim periods beginning after November 15, 2008. The Company is currently
evaluating the potential impact of the adoption of SFAS 161 on its financial
position, results of operations or cash flows.
On
October 10, 2008, the FASB issued FSP No. SFAS 157-3, ”Determining the Fair
Value of a Financial Asset When the Market for That Asset Is Not Active.” (“FSP
SFAS 157-3”) clarifies the application of SFAS No. 157, “Fair Value
Measurements,” in a market that is not active and provides an example to
illustrate key considerations in determining the fair value of a financial asset
when the market for that financial asset is not active. FSP SFAS 157-3 is
effective immediately, including prior periods for which financial statements
have not been issued. The Company is currently evaluating the potential impact
of the adoption of FSP SFAS 157-3 on its financial position, results of
operations or cash flows.
|
|
(7) Mergers
|
A. Virium Pharmaceuticals,
Inc
On
April 18, 2008, the Company acquired Virium Pharmaceuticals Inc.
(“Virium”), a privately held biotechnology company focused primarily on oncology
based technology, pursuant to the terms of an Agreement and Plan of Merger (the
“Merger Agreement”) dated as of April 18, 2008 by and among the Company,
VRM Acquisition, LLC, a Delaware limited liability company and a direct
wholly-owned subsidiary of the Company (“VRM Acquisition”), Virium and Virium
Holdings, Inc., a non-public Delaware corporation (“Holdings”) and the
parent of Virium. On the Effective Date, VRM Acquisition merged with and
into Virium with Virium continuing as the surviving company and a wholly-owned
subsidiary of the Company (the “Merger”). Pursuant to the Merger
Agreement, each share of Virium common stock outstanding at the Effective Time
was converted into the right to receive 0.89387756 shares of the Company’s
common stock (the “Merger Consideration”) resulting in an aggregate of
22,899,206 shares of MacroChem common stock being issued in the Merger. The
fair value of the shares issued on the closing date to the stockholders of
Virium was $6,869,618.
Virium
has a pipeline of oncology products that target a variety of niche cancer
indications. Virium’s product pipeline included a next generation
nucleoside analogue (small molecule) which it had licensed from the Southern
Research Institute in August 2007. This class of compounds has
demonstrated proven efficacy in certain hematological cancer indications.
Upon completing the merger, management has commenced a process of conducting a
strategic evaluation of each drug candidate in the Company’s newly constituted
product portfolio.
In
addition, all outstanding warrants to purchase shares of Virium common stock
were converted into warrants to purchase MacroChem common
stock. After giving effect to the Merger, these vested warrants,
which expire at various dates from 2012 to 2013, are exercisable to
purchase 446,938 shares of MacroChem common stock at an exercise price
of $0.671 and 223,469 shares of MacroChem common stock at an exercise price
of $1.119 per share. As described in more detail below, MacroChem also
assumed convertible notes of Virium.
F-105
On
April 23, 2008, MacroChem assumed all obligations under the convertible
promissory note in the aggregate principal amount of $500,000 issued to
Strategic Capital Resources, Inc. by Virium on May 30, 2007 (the
“First Convertible Note”). The First Convertible Note was due to mature on
April 25, 2008. The First Convertible Note had a 12% annual interest
rate until November 30, 2007, which increased to 15% thereafter.
MacroChem paid to Strategic Capital Resources, Inc. $44,726 in cash which
represents all accrued and unpaid interest on such note through the date of
consummation of the Merger plus $10,000. MacroChem made this payment in
consideration of Strategic Capital Resources, Inc.’s prior agreement with
Virium to extend the maturity date on its note from March 26, 2008 to
April 25, 2008. Upon closing of MacroChem’s next round of
equity financing, if any, the principal amount of the First Convertible Note and
all accrued interest may be converted into MacroChem common stock at the
discretion of each First Convertible Note holder such that each holder will be
entitled to acquire shares of MacroChem common stock at $0.8950 per share,
subject to anti-dilution adjustments.
On
June 6, 2008, the Company repaid a principal amount of $400,000 to the
holder of the First Convertible Note together with accrued and unpaid interest
thereon. Further, on June 23, 2008, the Company repaid the unpaid
principal balance of $100,000 together with accrued and unpaid interest thereon
to the remaining holder of the First Convertible Note. Additionally,
the First Convertible Note was repaid, in part, with funds from new holders of
convertible promissory notes whose notes mature on December 6, 2008. The
new promissory notes have a principal amount of $400,000 and a warrant to
purchase 100,000 shares of common stock at $.01. The fair value of the
warrants issued of $24,000 is recorded as debt discount and are being amortized
to interest expense over the term of the debt. The notes have a 12% interest
rate with accrued interest due on or prior to the 5 th day of each
calendar month. These notes are due to mature on the earlier of 1) closing
of the next financing by the Company or 2) December 6, 2008.
MacroChem
also assumed on the Effective Date all obligations under convertible promissory
notes in the aggregate principal amount of $500,000 issued by Virium on
December 12, 2007 (the “Second Convertible Notes”). The Second
Convertible Notes were to mature on the earlier of (a) the closing of any
equity financing by MacroChem or (b) June 12, 2008. The
Second Convertible Notes have a 12% annual interest rate with all accrued
interest due at maturity. Upon closing of MacroChem’s next round of equity
financing, if any, the principal amount of the Second Convertible Notes and all
accrued interest thereon will be automatically converted into MacroChem common
stock such that each Second Convertible Note holder will be entitled to
acquire shares of MacroChem Common Stock at $0.8950 per share. Additionally,
upon written consent to the borrower, simultaneously with the next round of
financing, the holders have the ability to convert the entire outstanding
principal and all accrued interest into shares. The conversion price will be
equal to 50% of the qualified offering price.
In
June 2008, a principal amount of $425,000 of the Second Convertible Notes
were rolled forward to a maturity of December 31, 2008, subject to certain
conditions and the Company repaid holders of the Second Convertible Notes a
principal amount of $75,000 and accrued interest of $4,568. To induce the
holders to extend the maturity, the Company issued 212,500 warrants to purchase
common stock at $.01. The fair value of the warrants issued of $51,053 is
recorded as debt discount and will be amortized to interest expense over the
term of the debt.
Prior to
the merger agreement,, SCO Capital Partners, LLC (“SCO LLC”) together with its
affiliates Beach Capital LLC, SCO Securities LLC and SCO Capital Partners, L.P.
(collectively with SCO LLC, “SCO”) was the owner of the outstanding common stock
of MacroChem, including warrants to purchase certain shares, and also held a
majority of the outstanding stock of Holdings and warrants to purchase 112,500
shares of Virium common stock. Pursuant to a Director Designation Agreement
dated as of October 1, 2007 between MacroChem and SCO LLC, SCO LLC has the
right to designate two individuals to serve on MacroChem’s board of directors
for so long as SCO holds 20% of MacroChem’s outstanding common stock. The
current SCO director designees are Jeffrey B. Davis and Mark J. Alvino.
Mr. Davis is currently the president of SCO Securities LLC and Chief
Executive Officer of Access Pharmaceuticals, Inc. Prior to the Effective Date,
Mr. Davis was a director of Virium. Mr. Alvino is a former Managing
Director of SCO Financial Group LLC and currently an officer of Griffin
Securities, Inc. SCO Securities LLC acted as placement agent in
connection with MacroChem’s 2006 private placement.
F-106
Pursuant
to the terms of the Merger Agreement, at the Effective Time , all members
of the Special Committee, namely, John L. Zabriskie, Michael A. Davis, Paul S.
Echenberg, and Peter G. Martin resigned from the board of directors of
MacroChem.
Immediately
following these resignations, David P. Luci and Dr. James Pachence were
appointed to the board of directors of MacroChem. Dr. Pachence and
Mr. Luci will be entitled to the standard compensation payable to our
directors which as of April 22, 2008, is now applicable to all directors
and includes compensation of $12,000 annually, $1,000 per regular board meeting
attended, $500 for each special, telephone or committee meeting attended and the
stock option grants that our Compensation Committee from time to time deems
appropriate. On June 26, 2008, Dr. James Pachence resigned from the office of
Chief Executive Officer of the Company and resigned from his position as a
member of our board of directors, in each case, effective
immediately.
The
acquisition of Virium on April 18, 2008 was accounted for by the Company
under the purchase method of accounting in accordance with Statement of
Financial Accounting Standards No. 141 “ Business Combinations”. Under the
purchase method, assets acquired and liabilities assumed by the Company were
recorded at their estimated fair values at the date of acquisition and the
results of operations of the acquired company were consolidated with those of
the Company from the date of acquisition
The total
purchase price of $9,656,794, has been primarily allocated to in-process
research and development and is comprised of $6,869,618 related to the
calculated value of the Company’s common stock issued of $0.30 per share,
$2,441,696 of liabilities the Company assumed in addition to $143,020 of
warrants issued to certain debt holders. Additionally, the Company incurred
$240,240 in professional fees and gained $37,780 in assets.
The
components of the purchase price, which the Company has preliminarily allocated
to in-process research and development, are summarized as follows:
|
Common
stock issued
|
$
|
6,869,618
|
||
|
Liabilities
and assets assumed, net
|
2,403,916
|
|||
|
Warrants
related to debt assumed
|
143,020
|
|||
|
Transaction
costs
|
240,240
|
|||
|
Total
purchase price
|
$
|
9,656,794
|
||
The
following unaudited pro forma information presents the 2008 and 2007 results of
the Company as if the acquisition had occurred on January 1, 2007. The unaudited
pro forma results are not necessarily indicative of results that would have
occurred had the acquisition been in effect for the periods presented, nor are
they necessarily indicative of future results.
|
Nine Months Ended September 30,
|
|||||||
|
2008
|
2007
|
||||||
|
Net
income (loss)
|
$
|
(10,125,596)
|
$
|
(15,151,486)
|
|
||
|
Net
income (loss) per common share (basic and diluted)
|
$
|
(0.22)
|
$
|
(0.58)
|
|
||
|
Weighted
average common shares outstanding (basic and diluted)
|
45,714,287
|
26,233,818
|
|||||
(8) Merger
- -Access Pharmaceuticals, Inc.
On
July 10, 2008, Access Pharmaceuticals, Inc. (OTC BB: ACCP.OB)
announced it had signed an agreement and plan of merger with MacroChem, pursuant
to which MacroChem is expected to be merged with and into a wholly-owned
subsidiary of Access Pharmaceuticals Inc. The merger transaction is expected to
close in the fourth quarter of 2008. Holders of MacroChem common shares
and inthe money MacroChem warrants will receive an aggregate of 2,500,000 shares
of common stock of Access as merger consideration at the closing of the merger.
All other options and warrants of MacroChem which are unexercised at the
Effective Time of the merger shall automatically be cancelled and
void.
F-107
(9) Note
Purchase Agreement
On August
27, 2008, the Company entered into a Note Purchase Agreement with Access,
pursuant to which Access has loaned us an initial loan amount of $225,000 and
agreed to loan additional funds to us as required to operate our business upon
the earlier of December 31, 2008 or the date of termination of the agreement and
plan of the merger transaction. We have agreed to pay interest to
Access at the rate of 10% per annum.
F-108
VIRIUM
PHARMACEUTICALS, INC.
(A
DEVELOPMENT STAGE COMPANY)
|
Page
|
|
|
Report
of Independent Registered Public Accounting Firm
|
F-110
|
|
Balance
SheetsMarch 31, 2008 (Unaudited), December 31, 2007 and
December 31, 2006
|
F-111
|
|
Statements
of Operations Three Months Ended March 31, 2008 (Unaudited), Years
Ended December 31, 2007 and 2006 and Period from July 15,
1997(Inception) to March 31, 2008 (Unaudited)
|
F-112 |
|
Statements
of Stockholders’ DeficiencyYears Ended December 31, 2007 and
2006Three Months Ended March 31, 2008 (Unaudited), Period from
July 15, 1997(Inception) to March 31,
2008(Unaudited)
|
F-113
|
|
Statements
of Cash FlowsThree Months Ended March 31, 2008 (Unaudited), Years
Ended December 31, 2007 and 2006 and Period from July 15,
1997(Inception) to March 31, 2008 (Unaudited)
|
F-114
|
|
Notes
to Financial Statements
|
F-115
|
F-109
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We have
audited the accompanying balance sheets of Virium Pharmaceuticals, Inc. (a
development stage company) as of December 31, 2007 and 2006, and the
related statements of operations, stockholders’ deficiency and cash flows for
the years then ended and for the period from July 15, 1997 (Date of
Inception) through December 31, 2007, as such amounts relate to the amounts
for the period from July 15, 1997 (Date of Inception) through
March 31, 2008. These financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on
these financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform an audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An audit
also includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, assessing the accounting principles
used and significant estimates made by management, as well as evaluating the
overall financial statement presentation. We believe that our audits
provide a reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Virium Pharmaceuticals, Inc.
as of December 31, 2007 and 2006, and its results of operations and cash
flows for the years then ended and for the period from July 15, 1997 (Date
of Inception) to December 31, 2007, as such amounts relate to the amounts
for the period from July 15, 1997 (Date of Inception) through
March 31, 2008, in conformity with accounting principles generally accepted
in the United States of America.
The
accompanying financial statements have been prepared assuming that Virium
Pharmaceuticals, Inc. will continue as a going concern. As
discussed in Note 1 to the financial statements, Virium
Pharmaceuticals, Inc. suffered losses from operations and has a working
capital deficiency, which raises substantial doubt about its ability to continue
as a going concern. Management’s plans regarding those matters are
also described in Note 1. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
/s/ J.H.
Cohn LLP
Roseland,
New Jersey
March 13,
2008 except for Note 3, as to which the date is April 17,
2008
F-110
VIRIUM
PHARMACEUTICALS, INC
(A
DEVELOPMENT STAGE COMPANY)
BALANCE
SHEETS
|
March 31,
|
December 31,
|
December 31,
|
||||||||
|
2008
|
2007
|
2006
|
||||||||
|
(unaudited)
|
(audited)
|
(audited)
|
||||||||
|
A S S E T S
|
||||||||||
|
CURRENT
ASSETS:
|
||||||||||
|
Cash
|
$
|
10,175
|
$
|
117,394
|
$
|
59,992
|
||||
|
Total
current assets
|
10,175
|
117,394
|
59,992
|
|||||||
|
Security
deposit
|
5,850
|
4,810
|
2,250
|
|||||||
|
Debt
issuance costs, net
|
26,873
|
81,381
|
13,750
|
|||||||
|
Total
assets
|
$
|
42,898
|
$
|
203,585
|
$
|
75,992
|
||||
|
L I A B I L I T I E S A N D
STOCKHOLDERS’ DEFICIENCY
|
||||||||||
|
CURRENT
LIABILITIES:
|
||||||||||
|
Accounts
payable and accrued expenses
|
$
|
1,084,128
|
$
|
1,058,772
|
$
|
682,075
|
||||
|
Other
current liabilities
|
227,845
|
227,845
|
227,845
|
|||||||
|
Deferred
revenue
|
5,304
|
5,304
|
5,304
|
|||||||
|
Accrued
interest on notes payable
|
350,502
|
8,292
|
—
|
|||||||
|
Convertible
notes payable
|
775,000
|
775,000
|
||||||||
|
Accrued
interest on notes payable - related party
|
36,082
|
305,017
|
144,607
|
|||||||
|
Convertible
notes payable - related party
|
1,499,500
|
1,499,500
|
1,327,000
|
|||||||
|
Total
current liabilities
|
3,978,361
|
3,879,730
|
2,386,831
|
|||||||
|
Deferred
revenue
|
28,121
|
29,447
|
34,751
|
|||||||
|
Total
liabilities
|
4,006,482
|
3,909,177
|
2,421,582
|
|||||||
|
Commitments
and contingencies
|
||||||||||
|
STOCKHOLDERS’
DEFICIENCY:
|
||||||||||
|
Preferred
stock - $0.001 par value; 1,000,000 shares authorized; No shares issued
and outstanding as of March 31, 2008, December 31, 2007 and
2006
|
—
|
—
|
—
|
|||||||
|
Common
stock - $0.001 par value; 50,000,000 shares authorized; 23,941,900 issued
and outstanding as of March 31, 2008 and December 31, 2007,
13,916,900 issued and outstanding as of December 31,
2006
|
23,942
|
23,942
|
13,917
|
|||||||
|
Additional
paid-in capital
|
695,518
|
695,518
|
522,595
|
|||||||
|
Deficit
accumulated during the development stage
|
(4,683,044
|
)
|
(4,425,052
|
)
|
(2,882,102
|
)
|
||||
|
Total
stockholders’ deficiency
|
(3,963,584
|
)
|
(3,705,592
|
)
|
(2,345,590
|
)
|
||||
|
Total
liabilities and stockholders’ deficiency
|
$
|
42,898
|
$
|
203,585
|
$
|
75,992
|
||||
SEE
ACCOMPANYING NOTES TO THE FINANCIAL STATEMENTS
F-111
VIRIUM
PHARMACEUTICALS, INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF OPERATIONS
|
For
the Three
Months
Ended
March 31,
2008
(unaudited)
|
Year
Ended
December 31,
2007
(audited)
|
Year
Ended
December 31,
2006
(audited)
|
Period
from
July 15,
1997
(date
of
inception)
to
March 31,
2008
(unaudited)
|
||||||||||
|
REVENUE
|
|||||||||||||
|
License
revenue
|
$
|
1,326
|
$
|
5,304
|
$
|
5,304
|
$
|
16,575
|
|||||
|
Total
revenue
|
1,326
|
5,304
|
5,304
|
16,575
|
|||||||||
|
OPERATING
COSTS
|
|||||||||||||
|
Research
and development
|
(115,830
|
)
|
316,465
|
714,449
|
1,854,523
|
||||||||
|
General
and administrative
|
247,365
|
914,476
|
314,001
|
1,939.143
|
|||||||||
|
Total
operating costs
|
131,535
|
1,230,941
|
1,028,450
|
3,793,666
|
|||||||||
|
Loss
from operations
|
(130,209
|
)
|
(1,225,637
|
)
|
(1,023,146
|
)
|
(3,777,091
|
)
|
|||||
|
OTHER
EXPENSES
|
|||||||||||||
|
Interest
expense
|
73,275
|
200,011
|
106,318
|
417,893
|
|||||||||
|
Amortization
of debt issuance costs
|
54,508
|
117,302
|
165,000
|
488,060
|
|||||||||
|
Total
other expenses
|
127,783
|
317,313
|
271,318
|
905,953
|
|||||||||
|
Net
loss
|
$
|
(257,992
|
)
|
$
|
(1,542,950
|
)
|
$
|
(1,294,464
|
)
|
$
|
(4,683,044
|
)
|
|
SEE
ACCOMPANYING NOTES TO THE FINANCIAL STATEMENTS
F-112
VIRIUM
PHARMACEUTICALS, INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF STOCKHOLDERS’ DEFICIENCY
|
Common
Stock
|
Additional
|
Deficit
Accumulated
During
the
Development
|
|||||||||||||
|
Shares
|
Amount
|
Paid-in
Capital
|
Stage
|
Totals
|
|||||||||||
|
Issuance
of shares of common stock
|
10,000,000
|
$
|
10,000
|
$
|
(9,990
|
)
|
—
|
$
|
10
|
||||||
|
Net
loss
|
—
|
—
|
—
|
(50,000
|
)
|
(50,000
|
)
|
||||||||
|
Balance
at December 31, 2004
|
10,000,000
|
10,000
|
(9,990
|
)
|
(50,000
|
)
|
(49,990
|
)
|
|||||||
|
Repurchase
of outstanding common stock from sole stockholder
|
(10,000,000
|
)
|
(10,000
|
)
|
9,999
|
—
|
(1
|
)
|
|||||||
|
Issuance
of shares of common stock
|
10,000,000
|
10,000
|
(9.999
|
)
|
—
|
1
|
|||||||||
|
Issuance
of common stock under license agreement
|
1,500,000
|
1,500
|
98,500
|
—
|
100,000
|
||||||||||
|
Warrant
issued with convertible note
|
—
|
—
|
330,000
|
—
|
330,000
|
||||||||||
|
Net
loss
|
—
|
—
|
—
|
(1,537,638
|
)
|
(1,537,638
|
)
|
||||||||
|
Balance
at December 31, 2005
|
11,500,000
|
11,500
|
418,510
|
(1,587,638
|
)
|
(1,157,628
|
)
|
||||||||
|
Warrant
issued for settlement of accrued consulting services
|
—
|
—
|
102,632
|
—
|
102,632
|
||||||||||
|
Warrant
for consulting services exercised
|
2,391,900
|
2,392
|
—
|
—
|
2,392
|
||||||||||
|
Issuance
of common stock under license agreement
|
25,000
|
25
|
1,453
|
—
|
1,478
|
||||||||||
|
Net
loss
|
—
|
—
|
—
|
(1,294,464
|
)
|
(1,294,464
|
)
|
||||||||
|
Balance
at December 31, 2006
|
13,916,900
|
13,917
|
522,595
|
(2,882,102
|
)
|
(2,345,590
|
)
|
||||||||
|
Exercise
of warrant
|
10,000,000
|
10,000
|
90,000
|
—
|
100,000
|
||||||||||
|
Issuance
of common stock under license agreement
|
25,000
|
25
|
5,615
|
—
|
5,640
|
||||||||||
|
Warrants
issued with convertible notes
|
—
|
—
|
77,308
|
—
|
77,308
|
||||||||||
|
Net
loss
|
—
|
—
|
—
|
(1,542,950
|
)
|
(1,542,950
|
)
|
||||||||
|
Balance
at December 31, 2007
|
23,941,900
|
23,942
|
695,518
|
(4,425,052
|
)
|
(3,705,592
|
)
|
||||||||
|
Unaudited:
|
|||||||||||||||
|
Net
loss for the three months ended March 31, 2008
|
—
|
—
|
—
|
(257,992
|
)
|
(257,992
|
)
|
||||||||
|
Balance
at March 31, 2008
|
23,941,900
|
$
|
23,942
|
$
|
695,518
|
$
|
(4,683,044
|
)
|
$
|
(3,963,584
|
)
|
||||
SEE
ACCOMPANYING NOTES TO THE FINANCIAL STATEMENTS
F-113
VIRIUM
PHARMACEUTICALS, INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS
|
For
the Three
Months
Ended
March 31,
2008
(unaudited)
|
For
the Year
Ended
December 31,
2007
(audited)
|
For
the Year
Ended
December 31,
2006
(audited)
|
Period
from
July 15,
1997
(date
of
inception)
to
March 31,
2008
(unaudited)
|
||||||||||
|
OPERATING
ACTIVITIES:
|
|||||||||||||
|
Net
loss
|
$
|
(257,992
|
)
|
$
|
(1,542,950
|
)
|
$
|
(1,294,464
|
)
|
$
|
(4,683,044
|
)
|
|
|
Adjustments
to reconcile net loss to cash used in operating
activities:
|
|||||||||||||
|
Common
stock issued for acquired technologies
|
—
|
5,640
|
1,478
|
107,118
|
|||||||||
|
Liabilities
assumed with acquired technologies
|
—
|
—
|
—
|
260,167
|
|||||||||
|
Warrant
issued for services
|
—
|
—
|
105,024
|
105,024
|
|||||||||
|
Amortization
of debt issuance costs
|
54,508
|
117,302
|
165,000
|
488,060
|
|||||||||
|
Changes
in operating assets and liabilities:
|
|||||||||||||
|
Accounts
payable, accrued expenses and other liabilities
|
25,356
|
376,697
|
166,914
|
1,051,806
|
|||||||||
|
Accrued
interest on convertible notes
|
73,275
|
168,702
|
106,318
|
386,584
|
|||||||||
|
Deferred
revenue
|
(1,326
|
)
|
(5,304
|
)
|
(5,304
|
)
|
33,425
|
||||||
|
Security
deposit
|
(1,040
|
)
|
(2,560
|
)
|
—
|
(5,850
|
)
|
||||||
|
Net
cash used in operating activities
|
(107,219
|
)
|
(882,473
|
)
|
(755,034
|
)
|
(2,256,710
|
)
|
|||||
|
FINANCING
ACTIVITIES:
|
|||||||||||||
|
Common
stock issuance
|
—
|
—
|
—
|
10
|
|||||||||
|
Advances
under convertible note
|
—
|
939,875
|
750,000
|
2,266,875
|
|||||||||
|
Net
cash provided by financing activities
|
—
|
939,875
|
750,000
|
2,266,885
|
|||||||||
|
Net
increase (decrease) in cash
|
(107,219
|
)
|
57,402
|
(5,034
|
)
|
10,175
|
|||||||
|
Cash,
beginning of period
|
117,394
|
59,992
|
65,026
|
—
|
|||||||||
|
Cash,
end of period
|
$
|
10,175
|
$
|
117,394
|
$
|
59,992
|
$
|
10,175
|
|||||
|
Supplemental
disclosure of non cash transactions:
|
|||||||||||||
|
Warrant
issued and exercised for settlement of accrued consulting
services
|
$
|
—
|
$
|
—
|
$
|
105,024
|
$
|
105,024
|
|||||
|
Warrants
issued with convertible notes
|
—
|
77,308
|
—
|
407,308
|
|||||||||
|
Warrants
exercised by reduction in note payable
|
—
|
100,000
|
—
|
100,000
|
|||||||||
|
Supplemental
disclosure of cash flow data:
|
|||||||||||||
|
Interest
paid
|
$
|
—
|
$
|
31,309
|
$
|
31,309
|
|||||||
SEE
ACCOMPANYING NOTES TO THE FINANCIAL STATEMENTS
F-114
VIRIUM
PHARMACEUTICALS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
(Unaudited
with respect to March 31, 2008 and the three months then
ended)
Note
1 — Business, Basis of Presentation and Nature of Operations:
Business:
Virium
Pharmaceuticals, Inc. (the “Company”) is a development stage
biopharmaceutical company based in Princeton, New Jersey that in-licenses novel
therapeutics and develops such therapeutics for the treatment of
cancer. The Company’s development strategy is structured around the
development of novel and proprietary small molecule inhibitors targeting enzymes
involved primarily in oncology.
Basis
of Presentation:
The
Company is a development stage enterprise since it has not yet generated any
continuing revenue from the sale of products or royalties and, through
March 31, 2008, its efforts have been principally devoted to identifying
and acquiring, by license or other wise, drug candidates for the treatment of
cancer. Accordingly, the accompanying financial statements have been
prepared in accordance with the provisions of Statement of Financial Accounting
Standards (“SFAS”) No. 7, “Accounting and Reporting by Development Stage
Enterprises.” The Company has reported a net loss of $1,542,950 and
negative cash flows from operating activities of $882,473 for the year ended
December 31, 2007. The net loss from date of inception, July 15,
1997, to March 31, 2008 amounted to $4,683,044. Management believes
that the Company will continue to incur net losses and negative net cash flows
from operating activities through at least 2011.
The
accompanying unaudited financial statements have been prepared in accordance
with accounting principles generally accepted in the United States of America
for interim financial information. Accordingly, the financial statements do
not include all information and footnotes required by accounting principles
generally accepted in the United States of America for complete annual financial
statements. In the opinion of management, the accompanying unaudited financial
statements reflect all adjustments, consisting of only normal recurring
adjustments, considered necessary for a fair presentation. Interim operating
results are not necessarily indicative of results that may be expected for the
year ending December 31, 2008 or for any subsequent
period.
Going
Concern:
The
Company’s continued operations will depend on its ability to raise additional
funds through various potential sources such as equity and debt
financing. Through March 31, 2008, a significant portion of its
financing has been through the issuance of convertible notes. Given the
current and desired pace of clinical development of its three primary product
candidates and the costs of maintaining the general operations of the business,
the Company will need additional funding in 2008. The Company is currently
in negotiations to raise additional capital, the Company will likely be forced
to curtail or cease desired development activities and the general operations of
the business. There can be no assurance that such capital will be
available on favorable terms or at all. The Company will need additional
financing thereafter until it can achieve profitability, if ever.
The
financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the amounts
and classification of liabilities that may result if the Company is unable to
continue as a going concern.
Note
2 — Significant Accounting Policies:
The
significant accounting policies followed in the preparation of these financial
statements are as follows:
F-115
Use
of Estimates:
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect certain reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of expenses for the periods
presented. Accordingly, actual results could differ from those
estimates.
Initial
Capitalization and Stock Split
On
January 4, 2005, the Company purchased all the outstanding shares of the
Company’s stock for $1 from the Company’s sole stockholder. On
January 5, 2005, the Company issued 10,000,000 shares for $1, and SCO
Capital Partners, LLC, considered the Company’s Majority Stockholder, received
8,500,000 of these initial shares.
On
July 16, 2006, the Company decreased the par value of the Company’s common
stock from $0.01 to $0.001, increased the number of shares authorized for
issuance to 51,000,000 (50,000,000 authorized as common stock and 1,000,000
authorized as preferred stock), and effected a 100,000 — for - 1 stock split for
all shares outstanding as of July 16, 2006. All share and per
share information has been retroactively adjusted to reflect the change in par
value and stock split.
Fair
Value of Financial Instruments:
For
financial instruments consisting of cash and accounts payable included in the
Company’s balance sheets, the carrying amounts reasonably approximate the fair
values due to their short maturities. It is not practical to estimate the fair
value of the Company’s debt because quoted market prices do not exist and there
were no available securities with similar terms to use as a basis to value the
debt.
Property
and Equipment:
The
Company has not acquired any property and equipment to date. Property
and equipment purchases will be recorded at cost and depreciated over estimated
useful lives using the straight-line method. Leasehold improvements will be
recorded at cost and depreciated over the shorter of their useful lives or the
term of the lease by use of the straight-line method. Maintenance and repair
costs will be charged to operations as incurred.
Revenue
Recognition:
The
Company expects to generate revenue principally from collaborative research and
development arrangements, technology licenses, and government grants and
eventually through the sales of products. Revenue is recognized when
the four basic criteria of revenue recognition are met: (1) a contractual
agreement exists; (2) transfer of technology has been completed or services
have been rendered; (3) the fee is fixed or determinable; and
(4) collectability is reasonably assured. Revenue arrangements
with multiple components are divided into separate units of accounting if
certain criteria are met, including whether the delivered component has
stand-alone value to the customer, and whether there is objective and reliable
evidence of the fair value of the undelivered items. Consideration received is
allocated among the separate units of accounting based on their respective fair
values, and the applicable revenue recognition criteria are then applied to each
of the units. Where an item in a revenue arrangement with multiple deliverables
does not constitute a separate unit of accounting and for which delivery has not
occurred, the Company defers revenue until the delivery of the item is
completed.
Upfront,
non-refundable license fees and other fees received in connection with research
and development collaboration are recorded as deferred revenue and recognized
ratably over their relevant periods specified in the agreements, generally the
research term or life of the relevant patents. The
Company has one sublicense agreement under which it has received an up-front
non-refundable fee of $50,000. The Company deferred the revenue
recognition of the fee because the sublicense requires continuing obligations
around the development activities. The Company is recognizing the
deferred revenue over the life of the agreement which is based on the life of
the licensed patents.
F-116
Research
and Development:
Research
and development costs are charged to operations as incurred. Research and
development expenses include license fees charged to in-process research and
development, fees paid to development consultants, including our clinical
program management and outside service providers for laboratory development,
legal expenses resulting from intellectual property protection, and other
expenses relating to the acquiring, design, development, testing, and
enhancement of our development programs. The Company accrues for
costs incurred as the services are being provided by monitoring the status of
the services being provided and the invoices received from external service
providers. As actual costs become known, the Company adjusts its accruals in the
period when actual costs become known.
Concentration
of Risk:
Financial
instruments, which potentially subject the Company to concentrations of credit
risk, principally consist of cash. The Company currently does not
have any investments in excess of its cash balances. The Company
currently maintains all of its cash balances in an account with one financial
institution. The Company will adopt an investment policy that includes
guidelines related to diversification and maturities to maintain safety and
liquidity should the Company accumulate significant cash balances. Accordingly,
the Company does not believe it is exposed to any significant credit
risk.
Equity
Transactions:
Under
SFAS No. 123 (revised 2004), “Share-Based Payment” (“SFAS 123(R)”), the
Company is required to measure and recognize all share-based payment awards made
to employees and directors including stock options based on estimated fair
values. SFAS 123(R) supersedes the Company’s previous
accounting under Accounting Principles Board (“APB”) Opinion No. 25,
“Accounting for Stock Issued to Employees” (“APB 25”), for periods beginning in
fiscal year 2006.
In
accordance with the provisions of SFAS 123(R) and EITF No. 96-18, all
issuances of common stock or other equity instruments to non-employees
(including consultants) as the consideration for goods or services received by
the Company are accounted for based on the fair value of the equity instruments
issued unless the fair value of the consideration received can be more reliably
measured. The fair value of any warrants issued to non-employees is
recorded in expense and additional paid-in capital in stockholders’ deficiency
or current liabilities over the applicable service periods using variable
accounting through the vesting date based on the fair value of the warrants at
the end of each period.
Income
Taxes:
Deferred
income taxes are recognized for differences between the bases of assets and
liabilities for financial statement and income tax purposes. The deferred tax
assets and liabilities represent the future tax return consequences of those
differences, which will either be deductible or taxable when the assets and
liabilities are recovered or settled. Deferred income taxes are also
recognized for net operating loss carryforwards and tax credits that are
available to offset future taxable income. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply to taxable
income in the year in which the temporary differences are expected to be
reversed. Changes to enacted tax rates would result in either increases or
decreases in the provision for income taxes in the period of
change. Valuation allowances are established when necessary to reduce
deferred tax assets to the amount expected to be realized.
The
realization of deferred tax assets is primarily dependent on future earnings.
Any reduction in estimated forecasted results may require that the Company
record valuation allowances against deferred tax assets. Once a valuation
allowance has been established, it will be maintained until there is sufficient
positive evidence to conclude that it is more likely than not that the deferred
tax assets will be realized. A pattern of sustained profitability will generally
be considered as sufficient positive evidence to reverse a valuation allowance.
If the allowance is reversed in a future period, the income tax provision will
be correspondingly reduced. Accordingly, the increase and decrease of valuation
allowances could have a significant negative or positive impact on future
earnings.
F-117
In
July 2006, the Financial Accounting Standards Board (“FASB”) issued FASB
interpretation No. 48 (“FIN 48”), “Accounting for Uncertainty in Income
Taxes-an interpretation of FASB Statement No. 109”. FIN 48 prescribes a
recognition threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected to be taken in a
tax return. FIN 48 also provides guidance on de-recognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. FIN 48 is effective for fiscal years beginning
after December 15, 2007 and the Company’s implementation of FIN 48 as of
January 1, 2008 is not expected to have any impact on the Company’s results
of operations or financial position.
Warrants
Issued with Debt Instruments:
The debt
discount attributable to the value of warrants issued with the convertible
promissory note are amortized to other expense over the terms of the related
debt instrument on a straight-line basis, which approximates the effective
interest method.
Recently
Issued Accounting Standards:
In
September 2006, the FASB issued SFAS No. 157, “Fair Value
Measurements” (“SFAS 157”), which addresses how companies should measure fair
value when they are required to use a fair value measure for recognition or
disclosure purposes under U.S. generally accepted accounting principles
(“GAAP”). As a result of SFAS 157, there is now a common definition of fair
value to be used throughout GAAP which is expected to make the measurement of
fair value more consistent and comparable. SFAS 157 is effective for fiscal
years beginning after November 15, 2007 and interim periods within those
fiscal years. The Company adopted FAS 157 for all financial assets and
liabilities required to be measured at fair value on a recurring basis,
prospectively from January 1, 2008. The application of FAS 157 did
not have a significant impact on the Company’s financial position, results of
operations or cash flows.
On
February 15, 2007, FASB issued SFAS No. 159, “The Fair Value Option
for Financial Assets and Financial Liabilities”, (“SFAS 159”). SFAS 159 provides
companies with an option to report selected financial assets and liabilities at
fair value. SFAS 159 also establishes presentation and disclosure requirements
to facilitate comparisons between companies using different measurement
attributes for similar types of assets and liabilities. SFAS 159 is effective as
of the beginning of the first fiscal year that begins after November 15,
2007. Earlier adoption is permitted provided the Company also elects to apply
the provisions of SFAS 159. We are currently evaluating the impact that SFAS 159
may have on our financial statements.
In
June 2007, the FASB ratified EITF Issue No. 07-03, “Accounting for
Nonrefundable Advance Payments for Goods and Services Received for Use in Future
Research and Development Activities” (“EITF 07-03”). EITF 07-03
requires companies to defer nonrefundable advance payments for goods and
services and to expense advance payments as the goods are delivered or services
are rendered. If the Company does not expect to have the goods delivered or
services performed, the advance should be expensed. EITF 07-03 is effective for
fiscal years beginning after December 15, 2007. We are currently evaluating
the impact of adopting EITF 07-03 on our results of operations and financial
condition.
In
September 2007, the FASB ratified EITF Issue No. 07-1 “Collaborative
Arrangements” (“EITF 07-1”). EITF 07-1 addresses the accounting for
arrangements in which two companies work together to achieve a commercial
objective, without forming a separate legal entity. The nature and purpose
of a company’s collaborative arrangements are required to be disclosed, along
with the accounting policies applied and the classification and amounts for
significant financial activities related to the arrangements. EITF 07-1 is
effective for fiscal years beginning after December 15, 2008. The
Company is currently assessing the impact EITF 07-1 will have on its results of
operations and financial position.
The FASB
and the Securities and Exchange Commission (the “SEC”) had issued certain other
accounting pronouncements as of March 31, 2008 that will become effective
in subsequent periods; however, the Company does not believe that any of those
pronouncements would have significantly affected our financial accounting
measurements or disclosures had they been in effect during the three months
ended March 31, 2008 and for the years ended December 31, 2007 and
2006 or that they will have a significant effect at the time they become
effective.
F-118
VIRIUM
PHARMACEUTICALS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
(Unaudited
with respect to March 31, 2008 and the three months then
ended)
Note
3 — RAI Merger
The
Company entered into an Agreement and Plan of Merger on May 25, 2007, (the
“Merger Agreement”) by and among REIT Americas, Inc. (“RAI”), the Company,
Virium Pharmaceuticals, Inc., a newly formed Delaware corporation and
direct, wholly-owned subsidiary of RAI (“Pharmaceuticals”) and Virium Merger
Sub, Inc., a newly formed Delaware corporation and direct,
wholly-owned subsidiary of Pharmaceuticals (“Merger Sub”). Pursuant to the terms
and conditions of the Merger Agreement, the Company will merge with and into
Merger Sub with the Company as the surviving corporation (the “Merger”). As a
result of the Merger, each share of common stock, par value $0.001 per share, of
the Company held by the Virium stockholders will be exchanged for one
newly-issued share of common stock, par value $0.01 per share, of
Pharmaceuticals, on the terms and conditions set forth in the Merger Agreement.
The consummation of the Merger is subject to certain conditions, including
obtaining the approval of the RAI’s stockholders of a 23.06062-to-1 reverse
stock split (the “Reverse Stock Split”), obtaining the approval of the RAI’s
stockholders of a merger of RAI with and into Pharmaceuticals, with
Pharmaceuticals as the surviving entity (the “Reincorporation Merger”),
effecting the reverse stock split and consummating the Reincorporation Merger,
and the obtaining of at least $2 million of funding through the sale of equity
in Pharmaceuticals following the Merger. The Merger Agreement may be terminated
by mutual consent or by either party after August 31, 2007, assuming the
terminating party is not responsible for the delay in closing.
On
August 31, 2007, the parties entered into an amendment to the Merger
Agreement which changed the date from which either party may terminate the
Merger Agreement from August 31, 2007 to November 2, 2007. In
October 2007, the parties entered into an additional amendment to allow the
Company to raise additional funding prior to the closing of the Merger through
the issuance of additional convertible notes. In December 2007, the
parties amended the Merger Agreement to extend the date by which either party
may terminate the Merger Agreement to March 31, 2008. On April 17,
2008, the parties agreed to terminate the Merger Agreement. Upon completion of a
qualified financing, the Company will be obligated to pay RAI $535,000 in
consideration for agreeing to terminate the Merger Agreement.
Note
4 — Accounts Payable Accrued Expenses and Other Liabilities:
Accounts
payable and accrued expenses at March 31, 2008, December 31,
2007 and 2006 consist of the following:
|
March 31,
2008
|
2007
|
2006
|
||||||||
|
Licensing
fees and development costs
|
$
|
489,329
|
$
|
489,329
|
$
|
388,027
|
||||
|
Other
professional fees
|
436,849
|
323,623
|
—
|
|||||||
|
Consulting
fees
|
70,200
|
38,800
|
15,000
|
|||||||
|
Patent
costs
|
75,000
|
206,830
|
272,303
|
|||||||
|
Other
|
12,750
|
190
|
6,745
|
|||||||
|
Total
|
$
|
1,084,128
|
$
|
1,058,772
|
$
|
682,075
|
||||
The
Company also has other current liabilities of $227,845 as of March 31,
2008, December 31, 2007 and 2006 which were acquired liabilities related to
a licensing agreement.
F-119
VIRIUM
PHARMACEUTICALS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
(Unaudited
with respect to March 31, 2008 and the three months then
ended)
Note
4 — Debt
Convertible Promissory Note
and Warrants — Related Party
In
February 2005, the Company issued a convertible promissory note (the
“Note”) and warrant to the Company’s Majority Stockholder. The Note
is structured as a line of credit and is secured by our assets. The
Note carries an annual interest rate of 12% with all accrued interest due at
maturity, and was due at the earlier of (i) our completion of an equity
financing of at least $5,000,000 or (ii) March 31, 2008 (as
amended). The warrant issued in connection with the Note was for
10,000,000 shares of the Company’s common stock at $0.01 per share, and expires
seven years from the date of grant. The Note’s conversion feature was at the
option of the Note holder, at a conversion rate based on the next offering of
equity securities. The Company accounts for the intrinsic value of
beneficial conversion rights arising from the issuance of convertible debt
instruments with non-detachable conversion rights that are in-the-money at the
commitment date pursuant to the consensus of EITF Issue No. 98-5,
“Accounting for Convertible Securities with Beneficial Conversion Features or
Contingently Adjustable Conversion Ratios” and EITF Issue No. 00-27 (“EITF
00-27”), “Application of Issue No. 98-5 to Certain Convertible
Instruments.” Such values are determined by first allocating an appropriate
portion of the proceeds received from the debt instruments to the warrants
included in the exchange based on the fair values of the warrants and the debt
instruments as explained above. The intrinsic value of the beneficial conversion
rights at the commitment date may also be recorded as additional paid-in capital
or liabilities and debt discount as of that date or, if the terms of the debt
instrument are contingently adjustable, may only be recorded if a triggering
event occurs and the contingency is resolved. Because the conversion
price of the Note was to be determined in the future based on the value of any
future equity offering by the Company, without any discount, the beneficial
conversion feature of the Note is considered a contingent beneficial conversion
feature. The Company will recognize any impact from beneficial
conversion feature when the contingency no longer exists.
In
May 2007, the Company and the Majority Stockholder entered into an
agreement that called for the discharge of the remaining principal and interest
due under the Note contingent on the Company completing the RAI Merger as
described in Note 3. The Company’s outstanding principal due on the Note
was $1,274,500, $1,274,500 and $1,327,000 as of March 31, 2008,
December 31, 2007 and 2006, respectively, with accrued interest of
$342,177, $303,500 and $144,600 as of March 31, 2008,
December 31, 2007 and 2006, respectively.
In
addition to the Note, the Majority Stockholder acquired $225,000 of the Second
Bridge Notes described below.
Other Convertible Promissory
Note and Warrants
On
May 30, 2007, the Company issued a convertible promissory note (“First
Bridge Note”) for $500,000 and a warrant to acquire 250,000 shares of the
Company’s common stock. The First Bridge Note was due to mature on the
earlier of 1) the closing of any equity financing by the Company, or 2)
November 26, 2007. Until November 30, 2007, the First Bridge
Note had a 12% interest rate with all accrued interest due at maturity, with
principal and all accrued interest convertible into shares of the Company’s
common stock at $0.80 per share at the discretion of the note holder. On
November 26, 2007, the Company amended the First Bridge Note to extend the
maturity date to March 26, 2008 and issued and additional warrant to
acquire 250,000 shares of the Company’s common stock. Under the amendment,
the interest rate was increased to 15% beginning December 1, 2007 and
interest accrued through November 30, 2007 was due and paid by
December 10, 2007. The interest accrued from December 1, 2007 through
March 26, 2008 was due and paid by April 22, 2008.
F-120
On
December 12, 2007, the Company issued $500,000 in additional convertible
promissory notes (“Second Bridge Notes” and together with the First Bridge Note,
the “Bridge Notes”) and a warrant to acquire 250,000 shares of the Company’s
common stock. The Second Bridge Notes mature on the earlier of 1) the
closing of any equity financing by the Company, or 2) June 12, 2008.
The Second Bridge Notes have a 12% interest rate with all accrued interest due
at maturity, and the principal and all accrued interest may be converted into
shares of the Company’s common stock at $0.80 per share at the discretion of the
note holder.
Because
the conversion price of the Bridge Notes is higher than the fair value of the
common stock as determined by the Company at the date of issuance, and the
future possible beneficial conversion associated with the warrants’ conversion
feature under the Merger Agreement is a contingent conversion feature, the
Company will recognize any impact from the conversion feature when the
contingency no longer exists.
All of
the warrants issued in connection with the Bridge Notes are convertible into
750,000 shares of the Company’s common stock at $1.00 per share, and expire five
years from the date of grant. Like the Bridge Notes, the warrants allow
the holder to convert into shares of Pharmaceuticals without being adjusted like
the Company’s existing shares. The Company accounted for the value of the
warrants arising from the issuance of debt instruments pursuant to EITF 00-27,
by allocating the proceeds first to the fair value of warrants, and then any
residual amounts to the debt instruments. The assumptions utilized in the
valuation model were a dividend yield of zero, a volatility factor of 90%, the
risk-free interest rate in place at the time of issuance which were 4.67% and
3.39%, and an expected warrant life of 5 years. The fair value of the
common stock used in the Black-Scholes valuation model was $0.2256 which was
determined based on valuation procedures. The fair value of the warrants
was determined to be $77,308 and this amount was allocated to additional paid-in
capital and deferred debt issuance costs. The debt issuance costs are
being expensed over the term of the bridge notes and the extension
period.
Note
6 — Common Stock:
Majority
Shareholder
In
May 2007, the Company and our Majority Stockholder entered into an
agreement under which the Majority Shareholder exercised its warrant for
10,000,000 shares of common stock for $100,000 which was satisfied as a
reduction in the amount outstanding under the Note.
The
Company has also paid advisory fees to the Company’s Majority Stockholder of
$37,500, $150,000, $150,000, and $462,500 for the three months ended
March 31, 2008 and for the years ended December 31, 2007 and 2006 and
from inception, respectively.
Chairman
Services
In
November 2004, the Company entered in a consulting services agreement for
the performance of chairman of the board services for the
Company. Our chairman is an officer of the Majority
Stockholder. Under the original agreement, our chairman was to
receive a warrant representing 8% of the Company’s common stock
shares. The agreement also called for a monthly consulting fee of
$12,500 per month. The Company did not issue any equity instruments
or pay any consulting fee under the original agreement.
In
August 2006, the consulting agreement was amended and under the amendment,
the Company issued a warrant to purchase 2,391,900 shares of the Company’s
common stock. The Company had accrued consulting expense from
November 2004 through August 2006 for these consulting
services. The Company used valuation procedures to determine the fair
value of the warrant. The warrant had a strike price of $0.001 per
share, and the total exercise price was considered satisfied by the services
rendered when the warrant was exercised in August 2006. The
assumptions utilized in the valuation model were a dividend yield of zero, a
volatility factor of 90%, the risk-free interest rate of 4.86% which was the
prevailing rate at the warrant issuance date, and expected warrant life of 5
years. The fair value of the warrant was determined to be
$102,632. The Company reversed the previous accrued consulting fees
to the value of the warrant and credited the adjusted amount to additional
paid-in capital when the warrant was granted.
F-121
UMDNJ
Shares
In
November 2006, the Company issued 25,000 shares of common stock as part of
the consideration provided for under a license agreement with the University of
Medicine and Dentistry of New Jersey (See “UMDNJ License” under Note
7). The Company used a valuation model to determine the fair value of
the shares. The fair value was determined to be $0.059 per share, and
the $1,478 value was considered part of the initial license fee and charged to
research and development as licensed in-process research and development in
2006.
SRI
Shares
In
August 2007, the Company issued 25,000 shares of common stock as part of
the consideration provided for under a license agreement with the Southern
Research Institute (See “SRI License” under Note 7). The Company used a
valuation model to determine the fair value of the shares. The fair value was
determined to be $0.2256 per share, and the $5,640 value was considered part of
the initial license fee and charge to research and development as licensed
in-process research and development in 2007.
Warrants:
As of
March 31, 2008 , outstanding and fully vested warrants to purchase the
Company’s common stock are as follows:
|
Warrant
Right
|
Exercise
Price
|
Expiration
Date
|
|||
|
250,000
|
$1.00
|
May 30,
2012
|
|||
|
250,000
|
$1.00
|
November 30,
2012
|
|||
|
250,000
|
$1.00
|
December 11,
2012
|
Note
7 — Licenses:
Phenylbutyrate License and
Sublicense
In
January 2005, the Company entered into an exclusive license agreement with
VectraMed, Inc. (“VectraMed”) and subsequently a novation agreement with
VectraMed and the National Institute of Health (“NIH”) for the exclusive
worldwide rights to certain amino acid derivative compounds with potential
therapeutic use as anti-cancer agents commonly known as Phenylbutyrate
(“PB”). VectraMed acquired the exclusive license rights from a former
licensee through a transfer agreement in June 2003 and a subsequent
novation agreement between VectraMed, NIH and the former
licensee. Under the agreement with VectraMed, the Company paid a
one-time license fee of $250,000, assumed $260,167 in liabilities the majority
of which were due to the former licensee, and agreed to issue 1,500,000 shares
of the Company’s common stock to VectraMed. The total consideration
paid under the agreement was expensed as acquired technology in
2005.
The
license, transfer and novation agreements provide the Company with the
exclusive worldwide rights to develop, make, use, and sell products derived from
the licensed technology, and continues for the life of the last-to-expire
patent. The licensed technology has produced thirteen issued patents, the last
of which is due to expire in June 2014. Under the
agreements, the Company is obligated to make certain royalty and milestone
payments to the NIH and the former licensee. Future milestone
payments include approximately $3 million of pre-commercialization milestones
and an additional $3.2 million of milestones based on various product approvals
and cumulative gross sales levels.
In
addition to milestone payments, there is an annual minimum royalty of $5,000 due
the NIH, and additional royalties based on net sales of any commercialized
products, as well as a portion of any sub-license revenue received by the
Company. The Company is obligated to use its best efforts
to advance the development of PB as outlined under a development program as
amended from time to time by the Company and NIH. The Company is also
required to reimburse certain patent and patent prosecution costs incurred by
NIH.
F-122
VIRIUM
PHARMACEUTICALS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
(Unaudited
with respect to March 31, 2008 and the three months then
ended)
In
February 2005, the Company entered into a sublicense agreement with Bridge
Oncology Products, Inc. (now known as Somanta Pharmaceuticals, Inc.,
“Somanta”) providing Somanta with rights to PB for markets outside the United
States and Canada. The Company’s Majority Stockholder is also the
largest stockholder of Somanta. Under the terms of the agreement, Somanta paid
an up-front non-refundable sublicense fee of $50,000, and will pay a royalty
based on all direct product sales and the parties will split evenly any
marketing right sublicense payments received by Somanta. Somanta is
also responsible for all patent and patent prosecution costs related to their
territory rights. The agreement also calls for the cooperation
by the parties under a co-development plan for PB under which the parties will
provide each other with development and clinical information. Each
party is responsible for their own development and regulatory costs, and neither
party has any obligation to further develop the technology under the
sublicense.
The
Somanta agreement also requires them to reimbursement the Company (or NIH
directly) for patent costs related to their territory
rights. If Somanta does not pay these patent reimbursement
costs, the Company is still required to reimburse NIH for these costs under its
license agreement. We have accrued certain patent prosecution costs
related to Somanta’s territories. We will reverse these accruals when
we receive confirmation that Somanta has paid outstanding patent reimbursement
costs due under the license agreement with NIH. Somanta paid to NIH
$95,000 of patent costs for the year ended December 31, 2007.
On
December 6, 2006, the Company signed a letter of intent (“LOI”) pertaining
to a license and collaboration agreement with Somanta covering all formulations
or drug combinations where PB is an active ingredient. Pursuant to
the LOI, the Company would provide Somanta with participation in any revenue or
royalties derived from sales in North America in return for a portion of revenue
or royalties derived from Europe. In the rest of the world, the
Company and Somanta would share revenues and royalties equally. The LOI’s terms
provide that both companies will, among other things, share data and jointly
undertake the necessary pre-clinical and clinical studies, seek regulatory
approvals and file for patent protection in all territories. It also provides
for the formation of a joint development committee to oversee all aspects of the
development and commercialization of PB. Completion of the transaction
contemplated by the LOI remains subject to the negotiation and execution of a
definitive agreement. On January 4, 2008, Somanta was acquired by
Access Pharmaceuticals, Inc (“Access”). Access has continued to pay for
the amounts due under the Somanta agreement.
UMDNJ
License
In
November 2006, the Company exercised an option to license the exclusive
worldwide rights to a certain class of anti-cancer drugs generally characterized
as tubulin binding agents from the University of Medicine and Dentistry of New
Jersey (“UMDNJ”). Under the license agreement, the Company was
obligated to pay $75,000 as an initial license fee, $17,267 as reimbursement for
past patent expenses, and to issue 25,000 shares of the Company’s common stock
to UMDNJ. We also accrued the initial milestone of $200,000 which is
due within 36 months from the date of the agreement based on the initial
development plan goal of submitting an Investigational New Drug (IND)
application to the Food and Drug Administration. This initial
milestone is due even if the Company fails to submit an IND application in the
designated time. The total consideration paid or accrued under the
agreement was expensed as acquired technology in 2006.
The
Company is obligated to pay an annual minimum maintenance payment of $25,000
until the first commercial sale of products as well as royalties based on
product sales and certain milestone payments totaling up to $14.7 million, of
which $1.7 million are for pre-approval events, $5 million are related to market
approvals and first commercial sales in various countries, and $8 million are
associated with cumulative sale milestones. The Company is obligated
to use its best efforts to advance the development of licensed technology as
outlined under a development program that may be amended from time to time by
the Company and UMDNJ. The Company is also obligated to reimburse
UMDNJ for all patent costs, and those reimbursements can be credited against
annual minimum royalties and milestones due.
F-123
SRI
License
On
August 8, 2007, the Company entered into a license agreement (“SRI
License”) for the exclusive worldwide rights to a nucleoside analogue
(4’thioβ-D-arabinofuranosylcytosine)
from the Southern Research Institute (“SRI”). This compound is within a
certain class of anti-cancer class of anti-cancer drugs generally characterized
as cytotoxic agents. Under the license agreement, the Company was
obligated to pay $200,000 as an initial license fee of which $50,000 is
due within 30 days and $150,000 is due on August 8, 2008, and to issue
25,000 shares of the Company’s common stock.
The
Company is obligated to make royalty payments based on product sales as well as
additional milestone payments totaling up to $16.5 million, of which $1 million
is for pre-approval events, $2 million is related to market approvals and first
commercial sales, and $13.5 million is associated with cumulative sales
milestones. In addition, the Company is obligated to issue additional
shares of its common stock of up to 75,000 shares based on the attainment of
certain one-time milestones, and pay an annual minimum maintenance beginning in
year four of the agreement to the extent it has not yet made royalty payments
related to certain clinical indications. The Company is obligated to use
its best efforts to advance the development of licensed technology as outlined
under a development program that may be amended from time to time by the Company
and SRI. The Company is also obligated to reimburse SRI for all patent and
patent prosecution costs.
Note
8 — Income Taxes:
Income
tax expense differs from the statutory amounts as follows:
|
March 31,
2008
|
2007
|
2006
|
||||||||
|
Income
taxes at U.S. statutory rate
|
$
|
(88,000
|
)
|
$
|
(525,000
|
)
|
$
|
(440,000
|
)
|
|
|
State
income tax benefit
|
(15,000
|
)
|
(92,000
|
)
|
(78,000
|
)
|
||||
|
Change
in valuation allowance
|
103,000
|
617,000
|
518,000
|
|||||||
|
Total
tax expense
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
Deferred
taxes are provided for the temporary differences between the financial reporting
basis and the tax basis of our assets and liabilities. The temporary differences
that give rise to deferred tax assets were as follows:
|
March 31,
2008
|
2007
|
2006
|
||||||||
|
Deferred
tax assets
|
||||||||||
|
Net
operating loss carryforwards
|
$
|
956,000
|
889,000
|
$
|
455,000
|
|||||
|
Intangible
assets
|
354,000
|
383,000
|
327,000
|
|||||||
|
Deferred
revenue
|
13,000
|
14,000
|
16,000
|
|||||||
|
Accrued
interest and debt issuance expenses
|
305,000
|
253,000
|
184,000
|
|||||||
|
Other
deferred expenses
|
246,000
|
231,000
|
171,000
|
|||||||
|
Total
deferred tax assets
|
1,874,000
|
1,770,000
|
1,153,000
|
|||||||
|
Less
valuation allowance
|
(1,874,000
|
)
|
(1,770,000
|
)
|
(1,153,000
|
)
|
||||
|
Net
deferred tax assets
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
At
March 31, 2008, we had approximately $2,390,000 of net operating loss
carry-forwards. These net loss carryforwards begin expiring in 2011
and 2017 for state and federal purposes, respectively.
F-124
VIRIUM
PHARMACEUTICALS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
(Unaudited
with respect to March 31, 2008 and the three months then
ended)
The
Company has established a valuation allowance against its deferred tax assets,
due to the uncertainty of the realization of those assets. Management
periodically evaluates the recoverability of the deferred tax assets. At such
time as it is determined that it is more likely than not that deferred tax
assets are realizable, the valuation allowance will be reduced.
F-125
The
following unaudited pro forma condensed combined financial statements apply to
the merger between MacroChem and Access, by which MacroChem is expected to
become a wholly owned subsidiary of Access, and are based upon the historical
condensed consolidated financial statements and notes thereto (as applicable) of
Access and MacroChem, which are included in this Form S-4. The unaudited pro
forma condensed combined balance sheet gives pro forma effect to the merger as
if the merger had been completed on September 30, 2008 and combines Access’s
September 30, 2008 unaudited consolidated balance sheet with
MacroChem’s September 30, 2008 unaudited consolidated balance sheet.
The unaudited pro forma condensed combined statement of operations gives pro
forma effect to the merger as if it had been completed on January 1, 2007 and
combines Access’ audited consolidated statement of operations for the year
ended December 31, 2007, with Somanta, MacroChem and Virium
Pharmaceutical’s audited consolidated statement of operations for the year ended
December 31, 2007 and combines Access’ unaudited consolidated statement of
operations for the nine months ended September 30, 2007, with MacroChem and
Virium.
On
January 4, 2008, Access Pharmaceuticals, Inc. closed the acquisition of Somanta
Pharmaceuticals, Inc. In connection with the merger, Access issued an aggregate
of 1.5 million shares of Access Pharmaceuticals' common stock to the
shareholders of Somanta as consideration. In addition, Access exchanged all
outstanding warrants of Somanta for warrants to purchase 191,991 shares of
Access common stock at exercise prices ranging between $18.55 and $69.57 per
share. The total purchase price of $6,337,000 has been preliminarily allocated
to in-process research and development.
On
April 18, 2008, Macrochem acquired Virium Pharmaceuticals Inc., a privately
held biotechnology company focused primarily on oncology based technology,
pursuant to the terms of an Agreement and Plan of Merger dated as of
April 18, 2008. Pursuant to the Merger Agreement, each share of
Virium common stock outstanding was converted into the right to receive
0.89387756 shares of the MacroChem’s common stock resulting in an aggregate of
22,899,206 shares of MacroChem common stock being issued in the merger. The fair
value of the shares issued on the closing date to the stockholders of Virium was
$6,869,618. The total purchase price of $9,656,794, has been preliminarily
allocated to in-process research and development ("IPRD") and is comprised
of $6,869,618 related to the calculated value of the Company’s common stock
issued of $0.30 per share, $2,441,696 of liabilities the Company assumed in
addition to $143,020 of warrants issued to certain debt holders. Additionally,
the Company incurred $240,240 in professional fees and acquired $37,780 in
assets.
The pro
forma adjustments are based upon available information and certain assumptions
that Access believes are reasonable under the circumstances.
Total
consideration paid in connection with the acquisition is expected to
include:
|
·
|
Approximately
2.5 million shares of Access common stock will be issued to the common
shareholders and in-the-money warrant holders of MacroChem as
consideration having a value of approximately $7,975,000 (the value was
calculated using Access’ five day average stock price from July 8, 2008 to
July 14, 2008, times the shares
issued);
|
|
·
|
an
aggregate of $500,000 in direct transaction costs; and
|
|
·
|
cancelled
receivable from MacroChem of
$225,000.
|
The
entire preliminary purchase price represents the estimated fair value of
the acquired in-process research and development projects that have no
alternative future use. Accordingly, this amount was immediately expensed and
for the purposes of this pro forma is included as an increase in additional
paid-in capital and an increase to accumulated deficit. However, if the merger
should occur after December 31, 2008 the transaction will be accounted for under
FASB 141(R) “Business Combinations”, whereby the total amount of IPRD would
be capitalized and subject to impairment testing. Additionally, under FASB
141(R) any estimated transaction costs would be expensed.
The
following table summarizes the initial estimated fair values of the assets
acquired and liabilities assumed at the date of the acquisition (in thousands)
based on a estimated purchase price allocation. Subsequent adjustments may be
recorded upon the completion of the valuation and the final determination of the
purchase price allocation.
|
Common
stock issued
|
$ | 7,975,000 | ||
|
Liabilities
assumed
|
2,845,977 | |||
| Liability forgiven | 225,000 | |||
|
Assets
acquired
|
(694,525 | ) | ||
|
Warrants
related to debt assumed
|
995,152 | |||
|
Estimated
transaction costs
|
500,000 | |||
|
Total
purchase price
|
$ | 11,846,604 |
These
unaudited pro forma condensed combined financial statements should be read in
conjunction with the historical consolidated financial statements and related
notes contained in the annual, quarterly and other reports filed by Access,
MacroChem, Somanta and Virium with the Securities and Exchange
Commission.
F-126
UNAUDITED
PRO FORMA FINANCIAL STATEMENTS
UNAUDITED
PRO FORMA CONDENSED COMBINED BALANCE SHEET
AS OF
SEPTEMBER 30, 2008
|
Historical
|
|||||||||||||
|
Access
Pharmaceuticals
|
Macrochem
Corp.
|
Pro
Forma adjustments
|
Pro
Forma combined
|
||||||||||
|
A S S E T S
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
|||||||||
|
CURRENT
ASSETS:
|
|||||||||||||
|
Cash
and cash equivalents
|
$
|
201,000
|
$
|
32,879
|
$
|
233,879
|
|||||||
|
Short-term
investments, at cost
|
4,417,000
|
-
|
4,417,000
|
||||||||||
|
Receivables
|
330,000
|
-
|
(225,000)
|
(d)
|
105,000
|
||||||||
|
Prepaid
expenses and other current assets
|
110,000
|
116,124
|
226,124
|
||||||||||
|
Total
current assets
|
5,058,000
|
149,003
|
(225,000)
|
4,982,003
|
|||||||||
|
OTHER
ASSETS:
|
|||||||||||||
|
Patents,
net
|
584,000
|
484,099
|
1,068,099
|
||||||||||
|
Property
and equipment, net
|
100,000
|
10,523
|
110,523
|
||||||||||
|
Other
assets
|
12,000
|
50,900
|
62,900
|
||||||||||
|
Total
other assets
|
696,000
|
545,522
|
|
1,241,522
|
|||||||||
|
Total assets
|
$
|
5,754,000
|
$
|
694,525
|
(225,000)
|
$
|
6,223,525
|
||||||
|
CURRENT
LIABILITIES:
|
|||||||||||||
|
Accounts
payable and other liabilities
|
$
|
2,571,000
|
$
|
2,015,467
|
$500,000
|
(c)
|
$
|
5,086,467
|
|||||
|
Dividends
payable
|
1,799,000
|
-
|
1,799,000
|
||||||||||
|
Accrued
interest payable
|
445,000
|
8,250
|
453,250
|
||||||||||
|
Convertible
notes payable, net
|
-
|
791,487
|
791,487
|
||||||||||
|
Current
portion of deferred revenue
|
164,000
|
5,304
|
169,304
|
||||||||||
|
Note
payable-related party
|
-
|
225,000
|
(225,000)
|
(d)
|
-
|
||||||||
|
Total
current liabilities
|
4,979,000
|
3,045,508
|
275,000
|
8,299,508
|
|||||||||
|
NON
CURRENT LIABILITIES
|
|||||||||||||
|
Warrants
liability
|
-
|
190,282
|
(190,282) | (e) |
-
|
||||||||
|
Long
term debt
|
5,500,000
|
-
|
5,500,000
|
||||||||||
|
Deferred
revenue
|
2,286,000
|
25,469
|
|
2,311,469
|
|||||||||
|
Total
non current liabilities
|
7,786,000
|
215,751
|
(190,282) |
7,811,469
|
|||||||||
|
Total
liabilities
|
12,765,000
|
3,261,259
|
84,718
|
16,110,977
|
|||||||||
|
STOCKHOLDERS’
(DEFICIENCY)
|
|||||||||||||
|
Preferred
stock
|
-
|
-
|
-
|
-
|
|||||||||
|
Common
stock
|
65,000
|
458,734
|
(458,734)
|
(b)
|
|
||||||||
|
25,000
|
(a)
|
90,000
|
|||||||||||
|
Additional
paid-in-capital
|
126,814,000
|
97,683,242
|
(97,683,242)
|
(b)
|
-
|
||||||||
|
7,950,000
|
(a)
|
||||||||||||
|
995,152
|
(a)
|
135,759,152
|
|||||||||||
|
Notes
receivable from stockholders
|
(1,045,000)
|
-
|
(1,045,000)
|
||||||||||
|
Accumulated
deficit
|
(132,841,000)
|
(100,649,600
|
)
|
100,649,600
|
(b)
|
||||||||
|
(11,846,604)
|
(a)
|
|
|||||||||||
|
|
144,687,604 | ||||||||||||
|
Less
treasury stock, at cost
|
(4,000)
|
(59,110)
|
59,110
|
(b)
|
(4,000)
|
||||||||
|
Total
stockholders’ (deficiency)
|
(7,011,000)
|
(2,566,734)
|
(309,718)
|
(9,887,452)
|
|||||||||
|
Total liabilities and stockholders’ (deficiency)
|
$
|
5,754,000
|
$
|
694,525
|
(225,000)
|
(c) |
$
|
6,223,525
|
|||||
See Notes to the Pro Forma Condensed Balance
Sheet and Statement of Operations
F-127
UNAUDITED
PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS
FOR THE
NINE MONTHS ENDED SEPTEMBER 30, 2008
(unaudited)
|
(in
thousands except per share amounts)
|
Access
Pharmaceuticals
Inc.
|
MacroChem
Corp
|
Virium
Pharmaceuticals Inc.
|
Pro
Forma
Adjustments
|
MacroChem
and Virium Combined
|
Pro
Forma
Adjustments
|
Access
and MacroChem Combined
|
|
REVENUE
|
$ 217
|
$ 3
|
$ 1
|
$ 4
|
$ 221
|
||
|
OPERATING
EXPENSES
|
15,677
|
13,536
|
197
|
(9,657) (f)
|
4,076
|
19,753
|
|
|
LOSS
FROM
OPERATIONS
|
(15,460)
|
(13,533)
|
(196)
|
9,657
|
(4,072)
|
(19,532)
|
|
|
OTHER
(EXPENSE)
INCOME
|
|||||||
|
Interest
and
miscellaneous
income
|
167
|
26
|
-
|
26
|
193
|
||
|
Interest
and other
expenses
|
(351)
|
(187)
|
(127)
|
(314)
|
(665)
|
||
|
Gain
on change in
value
of warrant
liability
|
-
|
3,886
|
-
|
3,886
|
(3,886) (e)
|
-
|
|
|
Gain
on sale of
equipment
|
-
|
6
|
-
|
6
|
6
|
||
|
TOTAL
OTHER
(EXPENSE)
INCOME
|
(184)
|
3,731
|
(127)
|
3,604
|
(3,886)
|
(466)
|
|
|
NET
LOSS
|
(15,644)
|
(9,802)
|
(323)
|
9,657
|
(468)
|
(3,886)
|
(19,998)
|
|
LESS
PREFERRED
STOCK
DIVIDENDS
|
2,873
|
-
|
-
|
-
|
2,873
|
||
|
NET
LOSS
ATTRIBUTABLE
TO
COMMON
STOCKHOLDERS
|
$ (18,517)
|
$ (9,802)
|
$ (323)
|
$ 9,657
|
$ (468)
|
$ (3,886)
|
$ (22,871)
|
|
LOSS
PER SHARE,
BASIC
AND DILUTED
|
$ 3.30
|
$ (0.27)
|
$ (2.82)
|
||||
|
WEIGHTED
AVERAGE
NUMBER
OF
SHARES
|
5,607
|
36,605
|
8,107
|
F-128
FOR THE
YEAR ENDED DECEMBER 31, 2007
(unaudited)
|
(in
thousands except per share amounts)
|
Access
|
Somanta
|
Pro
Forma
Adjustments
|
Access
and
Somanta
Combined
|
MacroChem
|
Virium
|
Pro
Forma
Adjustments
|
MacroChem
and
Virium
Combined
|
Pro
Forma
Adjustments
|
Access
and MacroChem Combined
|
|
REVENUE
|
$ 57
|
$ 1
|
$ 58
|
-
|
$ 5
|
$ 5
|
$ 63
|
|||
|
OPERATING
EXPENSES
|
6,957
|
2,334
|
9,291
|
5,850
|
1,231
|
7,081
|
16,372
|
|||
|
LOSS
FROM
OPERATIONS
|
(6,900)
|
(2,333)
|
(9,233)
|
(5,850)
|
(1,226)
|
(7,076)
|
(16,309)
|
|||
|
OTHER
(EXPENSE)
INCOME
|
||||||||||
|
Interest
and
miscellaneous
income
|
125
|
(3)
|
122
|
84
|
-
|
84
|
206
|
|||
|
Interest
and other
expenses
|
(3,514)
|
(27)
|
(3,541)
|
-
|
(200)
|
(200)
|
(3,741)
|
|||
|
Amortization
of
debt
issuance
costs
|
-
|
-
|
-
|
-
|
(117)
|
(117)
|
(117)
|
|||
|
Loss
on
extinguishment
of debt
|
(11,628)
|
-
|
(11,628)
|
-
|
-
|
-
|
(11,628)
|
|||
|
Loss
on change in
value
of warrant
liability
|
-
|
5,119
|
5,119
|
(3,206)
|
-
|
(3,206)
|
3,206 (e)
|
5,119
|
||
|
Currency
translation
loss
|
-
|
(1)
|
(1)
|
-
|
-
|
-
|
(1)
|
|||
|
Gain
on sale of
equipment
|
-
|
-
|
-
|
106
|
-
|
106
|
106
|
|||
|
TOTAL
OTHER
(EXPENSE)
INCOME
|
(15,017)
|
5,088
|
(9,929)
|
(3,016)
|
(317)
|
(3,333)
|
3,206
|
(10,056)
|
||
|
NET
LOSS BEFORE
DISCONTINUED
OPERATIONS
AND
BEFORE
INCOME
TAX
BENEFIT
|
(21,917)
|
(2,755)
|
(19,162)
|
(8,866)
|
(1,543)
|
(10,409)
|
3,206
|
(26,365)
|
||
|
INCOME
TAX
BENEFIT
|
61
|
(5)
|
56
|
-
|
-
|
-
|
56
|
|||
|
NET
INCOME
FROM
CONTINUING
OPERATIONS
|
(21,856)
|
2,750
|
(19,106)
|
(8,866)
|
(1,543)
|
(10,409)
|
3,206
|
(26,309)
|
||
|
BENEFICIAL
CONVERSION
FEATURE
|
-
|
-
|
-
|
(3,224)
|
-
|
(3,224)
|
(3,224)
|
|||
|
LESS
PREFERRED
STOCK
DIVIDENDS
|
(14,908)
|
-
|
(14,908)
|
(596)
|
-
|
(596)
|
(15,504)
|
|||
|
NET INCOME
(LOSS)
FROM
CONTINUING
OPERATIONS
ATTRIBUTABLE
TO
COMMON
STOCKHOLDERS
|
(36,764)
|
2,750
|
(34,014)
|
(12,686)
|
(1,543)
|
(14,229)
|
3,206
|
(45,037)
|
||
|
DISCONTINUED
OPERATIONS
NET
OF TAXES
|
112
|
-
|
112
|
-
|
-
|
-
|
112
|
|||
|
NET INCOME
(LOSS)
ATTRIBUTABLE
TO
COMMON
STOCKHOLDERS
|
$(36,652)
|
$ 2,750
|
$ (33,902)
|
$ (12,686)
|
$ (1,543)
|
$ (14,229)
|
3,206
|
$ (44,925)
|
||
|
EARNINGS
(LOSS) PER SHARE, BASIC
AND
DILUTED
|
$
(10.32)
|
$ 0.19
|
$ (6.73)
|
$ (1.66)
|
$ (0.47)
|
$ (7.42)
|
||||
|
WEIGHTED
AVERAGE
NUMBER
OF
SHARES
|
3,552
|
14,630
|
5,052
|
7,635
|
30,534
|
6,052
|
See Notes to the Pro Forma Condensed Balance Sheet and Statement of Operations
F-129
Notes
to Pro Forma Condensed Combined Balance Sheet and Statments of
Operations
|
a)
|
To
record the exchange, for accounting purposes, by Macrochem shareholders of
their common stock for 2,500,000 shares of Access. The fair value of the
shares issued on the five day average closing price between July 8, 2008
and July 14, 2008 to the stockholders of Macrochem was
$7,975,000. Additionally, to record the exchange
of Macrochem warrants for Access
warrants.
|
The
Merger will be accounted for as purchase by the Company under accounting
principles generally accepted in the United States
of America. Under the purchase method of accounting, the
liabilities of Macrochem will be recorded as of the acquisition date,
at their respective fair values, and combined with those of the Company. The
reported financial condition and results of operations of the Company after
completion of the Merger will reflect these values, but will not be restated
retroactively to reflect the historical financial position or results of
operations of Macrochem. The estimated purchase price has been preliminarily
allocated to Acquired In Process Research and Development. These
unaudited pro forma statements were prepared under the assumption that the
merger would occur prior to January 1, 2009. However, if the transaction does
occur after December 31, 2008 the amount allocated to IPRD will be capitalized
and subject to impairment testing. Additionally, under FASB 141(R), any
estimated transaction costs would be expensed.
The
components of the preliminary purchase price, which we anticipate will be
charged to IPRD, are summarized as follows:
|
Common
stock issued
|
$ | 7,975,000 | ||
|
Liabilities
assumed
|
2,845,977 | |||
| Liability forgiven | 225,000 | |||
|
Assets
acquired
|
(694,525 | ) | ||
|
Warrants
related to debt assumed
|
995,152 | |||
|
Estimated
transaction costs
|
500,000 | |||
|
Total
purchase price
|
$ | 11,846,604 |
|
b)
|
To
eliminate the stockholders’ deficiency section of Macrochem in connection
with the merger.
|
|
c)
|
To
reflect estimated transaction
costs.
|
|
d)
|
To
eliminate receivable/payable between two merger companies. The note is due
upon the earlier of December 31, 2008 or the date of termination of the
agreement and plan of the merger transaction. MacroChem agreed to pay
interest to Access at the rate of 10% per annum. As of September 30, 2008
there was $0 interest recorded.
|
|
e)
|
To
eliminate gain or loss in MacroChem warrant
liability.
|
|
f)
|
To
eliminate Virium in-process research and development of
$9,656,794.
|
After the
consummation of the transactions described herein, Access had 100,000,000 common
shares authorized of which 8,985,791 shares are issued and outstanding; par
value of $0.01 per share. Additionally, the Company had 2,000,000 preferred
stock authorized of which 3,242.8617 shares are issued and outstanding
convertible into 10,809,539 shares of common stock.
F-130
COMPARISON
OF STOCKHOLDER RIGHTS AND CORPORATE GOVERNANCE MATTERS
Both
Access and MacroChem are incorporated under the laws of the State of Delaware
and, accordingly, the rights of the stockholders of each are governed by the
DGCL. Before the completion of the merger, the rights of MacroChem stockholders
are also governed by the MacroChem certificate of incorporation, and the
MacroChem bylaws. Upon completion of the merger, MacroChem stockholders will
receive Access common stock in exchange for their shares of MacroChem common
stock. As a result, upon completion of the merger, the rights of MacroChem
stockholders who become Access stockholders in the merger will be governed by
the DGCL, the Access certificate of incorporation, and the Access
bylaws.
The
following is a summary of material differences between the current rights of
Access stockholders and the current rights of MacroChem stockholders. While we
believe that this summary covers the material differences between the two, this
summary may not contain all of the information that is important to you. This
summary is not intended to be a complete discussion of the respective rights of
Access and MacroChem stockholders and it is qualified in its entirety by
reference to the various documents of Access and MacroChem to which we refer in
this summary. We urge you to carefully read this entire information
statement/prospectus, the relevant provisions of the DGCL and the other
documents to which we refer in this information statement/prospectus for a more
complete understanding of the differences between being an Access stockholder
and being a MacroChem stockholder. Access and MacroChem have filed with the SEC
their respective documents referenced in this summary of stockholder rights and
will send copies of these documents to you, without charge, upon your request.
See “Additional Information—Where You Can Find More Information” beginning on
page 75.
|
Provision
|
Access
Common Stock and
Preferred
Stock
|
MacroChem
Common Stock and Preferred Stock
|
|
ELECTIONS;
VOTING PROCEDURAL MATTERS
|
||
|
Authorized
Capital Stock
|
Access’
certificate of incorporation authorizes the issuance of up to 102,000,000
shares, each with a par value of $0.01 per share. Of the total authorized
shares, 100,000,000 shares shall be common stock and 2,000,000 shares
shall be preferred stock.
|
MacroChem’s
certificate of incorporation authorizes the issuance of up to 106,000,000
shares, each with a par value of $0.01 per share. Of the total authorized
shares, 100,000,000 shares shall be common stock and 6,000,000 shares
shall be preferred stock.
|
|
Number
of Directors
|
Access’
bylaws provide that the board of directors shall consist of between five
(5) and fifteen (15) directors, and unless otherwise provided in the
certificate of incorporation, the board of directors shall have the
exclusive power to establish the size of the board of directors.
Currently there are 12 members on the board of
Access.
|
MacroChem’s
bylaws provide that the board of directors shall have the exclusive power
to establish the size of the board of directors. Currently there are
[six (6)] members on the board of MacroChem.
|
|
Stockholder
Nominations and Proposals
|
Access’
most recent proxy statement dated April 22, 2008, provides that the 2009
annual meeting of stockholders is expected to be held on or about May 13,
2009. The Access board will make provisions for the presentation of
proposals submitted by eligible stockholders who have complied with the
relevant rules and regulations of the SEC. Proposals must be received by
Access no later than December 12, 2008 to be considered for inclusion on
the Access proxy statement and form of proxy relating to that meeting, and
no later than March 13, 2009 for all other
proposals.
|
MacroChem’s
bylaws provide that, in order for a stockholder to make a director
nomination or propose business at an annual meeting of the stockholders,
the stockholder must give timely written notice to MacroChem’s secretary
not less 60 nor more than 90 days prior to the anniversary date of the
immediately preceding annual meeting (with certain adjustments if the date
of the annual meeting is 30 or more days before or after such anniversary
date).
|
|
Classified
Board of Directors
|
Except
as otherwise provided in Access’ bylaws or in its certificate of
incorporation, the board of directors shall be divided into three (3)
classes as nearly equal in number as possible. Each director will be
elected at the appropriate annual meeting and will hold officer for a term
of three (3) years and until his successor is elected and qualified or
until his earlier resignation or removal.
|
MacroChem’s
certificate of incorporation and bylaws do not provide for the division of
the board of directors into classes.
|
|
Removal
of Directors
|
Access’
certificate of incorporation provides that any director of the entire
board of directors may be removed from office at any time, but only for
cause and only upon the affirmative vote of the holders of at least 66
2/3% of the shares entitled to vote in the election of
directors.
|
Under
MacroChem’s bylaws, subject to the certificate of incorporation, the board
of directors or any individual director may be removed from office at any
time without cause by the affirmative vote of the holders of at least a
majority of the outstanding shares entitled to vote on such
removal.
|
|
Special
Meetings of Stockholders
|
Access’
bylaws provide that a special meeting of the board of directors or any
committee designated by the board may be called at any time by the
chairman of the board, if any, by the president or by a majority of the
members of the board of directors or any such committee as the case may
be.
|
MacroChem’s
bylaws provide that a special meeting of the stockholders may be called by
the chairman of the board, the president, a majority of the board of
directors, or by stockholders holding a majority of the issued and
outstanding capital stock of MacroChem.
|
|
Cumulative
Voting
|
Access’
bylaws provide that every stockholder entitled to vote for the election of
directors shall have the right to vote the number of shares owned by him
for as many persons as there are directors to be elected and cumulative
voting in the election of such directors shall be
permitted.
|
All
elections shall be determined by a plurality vote.
|
|
Vacancies
|
Access’
bylaws provide that, any vacancy or newly created directorships on the
board of directors will be filled by the affirmative vote of a majority of
the directors in office, although less than a quorum.
|
MacroChem’s
bylaws provide that any vacancy or newly created directorships on the
board of directors will be filled by the affirmative vote of a majority of
the directors in office even if less than a
quorum.
|
|
Voting
Stock
|
Under
Access’ certificate of incorporation, each stockholder of common stock
shall have one vote for each share of stock standing in his name on the
books of Access and entitled to vote.
Under
Access’ certificate of designation, a holder of Access Series A preferred
stock (none of which is currently outstanding) would be entitled to 100
votes, for each share of Series A preferred stock held, on all matters
submitted to a vote of the stockholders of Access, voting together with
the common as a single class.
The
number of shares a holder of Series A preferred stock would be entitled to
vote is subject to adjustment for any dividends on common stock which are
paid in common stock or combination or consolidation of the outstanding
shares of common stock by reclassification or otherwise into a greater or
lesser number of shares of common stock.
|
Under
MacroChem’s bylaws and certificate of incorporation the holders of common
stock have the right to one vote per share of common stock.
Under
MacroChem’s certificate of designations, each holder of outstanding Series
A and Series C preferred stock shall be entitled to cast the number of
votes equal to the number of shares of common stock into which the Series
A and Series C preferred stock is convertible. Except as provided in
certain provisions in the certificate of designation with respect to the
Series C preferred stock, the Series C preferred stock shall vote together
with the holders of common stock as single class.
|
||
|
Stockholder
Action by Written Consent
|
Access
bylaws provide that, any action required to be taken at a meeting of
stockholders, or any action which may be taken at a meeting of
stockholders, may be taken without a meeting, without prior notice and
without a vote, if a consent in writing setting for the action so taken,
shall be signed by the holders of outstanding stock having not less than
the minimum number of votes that would be necessary to authorize or take
such action at a meeting at which all shares entitled to vote thereon were
present and voted.
|
MacroChem’s
bylaws provide that, any action to be taken at any annual meeting of the
stockholders, may be taken without a meeting, if a consent in
writing, setting forth the action, is signed by the holders of outstanding
stock having not less that the minimum number of votes that would be
necessary to take such action at a meeting at which all shares entitled to
vote were present and voted.
|
||
|
Notice
of Meetings
|
Under
Access bylaws, written notice of each stockholder meeting must include the
date, time and place of such meeting. Notice will be given not less
than 10 nor more than 60 days prior to the date of the meeting to each
stockholder entitled to vote at such meeting.
|
Under
MacroChem’s bylaws, written notice of each stockholder meeting must
include the date, time and place of such meeting. Notice will be
given not less than 10 nor more than 60 days prior to the date of the
meeting to each stockholder entitled to vote at such meeting. In the
case of a special meeting the purpose or purposes of the meeting shall be
provided.
|
||
|
Stockholders
Rights Plan
|
Access
is a party to a stockholder rights agreement under which holders of
Access common stock as of a certain date are entitled to the right to
purchase Access Series A preferred stock. The right will become
exercisable only if a person or group other than SCO Capital Partners LLC,
together with its affiliates (a) acquires 15% (20% in the case of
Heartland Advisors, Inc, or 45% in the case of Oracle Partners LP) or more
of Access’ common stock or (b) announces a tender offer that would result
in ownership of 15% (20% in the case of Heartland Advisors, Inc, or 45% in
the case Oracle Partners LP) or more of the common stock. Each right may
entitle its holder (other than the 15% person or group) to receive upon
exercise of the right, a one one-hundredth of a share of Series A
preferred Stock. Holders of such Series A preferred stock shall be
entitled to certain rights including a minimum quarterly dividend
payments, voting rights, and consideration upon a change in control of
Access.
|
MacroChem
is a party to a stockholder rights agreement pursuant to which holders of
MacroChem common stock as of a certain date are entitled to the right to
purchase MacroChem Series B preferred stock of the Company at an initial
exercise price of $2,100.00, subject to adjustments for stock dividends,
splits and similar events. The Rights are exercisable only if a person or
group acquires 20% or more of the Company’s outstanding common stock, or
announces an intention to commence a tender or exchange offer, the
consummation of which would result in ownership by such person or group of
20% or more of the Company’s outstanding common stock.
On
December 23, 2005, the shareholder rights plan was amended to provide that
the acquisition of the Company’s Series C Cumulative Convertible Preferred
Stock and warrants to acquire shares of its common stock by the purchasers
in the Company’s recent private placement, and any subsequent acquisition
by the purchasers of common stock upon the conversion or exercise of those
securities, would not result in the Rights becoming
exercisable.
The
Board of Directors may, at its option after the occurrence of one of the
events described above, exchange all of the then outstanding and
exercisable Rights for shares of common stock at an exchange ratio of one
share of common stock per Right.
The
Board of Directors may redeem the Rights at the redemption price of $0.01
per Right at any time prior to the expiration of the rights plan on August
13, 2009. Distribution of the Rights is not a taxable event to
shareholders.
The
Board of Directors has authorized 600,000 shares of Series B Preferred
Stock.
The
stockholder rights agreement shall have been terminated prior to
consummation of the merger with Access.
|
||
|
Conversion
Rights and Protective Provisions
|
Under
Access’ certificate of designation, each share of Series A preferred stock
(none of which is currently outstanding) would be convertible into 100
shares of Access common stock subject to adjustment for any dividends on
common stock which are paid in common stock or combination or
consolidation of the outstanding shares of common stock by
reclassification or otherwise into a greater or lesser number of shares of
common stock.
|
Holders
of Series A convertible preferred stock shall have the right to convert
each shares of Series A convertible preferred stock into two shares of
common stock and one common stock purchase warrant. Such common
stock purchase warrant shall be at an exercise price of $1.50 per share
and expires on December 31, 1993
Under
MacroChem’s certificate of designations, each share of Series C
convertible preferred stock is convertible, at the option of the holder
thereof at any time and shall convert at MacroChem’s election upon a
Conversion Triggering Event (as defined in the certificate of
designation)
MacroChem’s
certificate of designations provides that, upon certain terms and
conditions, the holders of MacroChem Series C convertible preferred stock
shall have a right to participate with respect to the issuance or possible
issuance by MacroChem of any future equity or equity linked
securities.
MacroChem’s
Series C certificate of designations provides that upon a change in
control (as defined in the certificate of designations) the successor
corporation shall expressly assume the due and punctual observance and
performance of each and every covenant and condition contained in the
certificate of designations.
In
accordance with the certificate of designations of MacroChem’s Series C
convertible preferred stock, holders of a majority of the Series C
convertible preferred stock of MacroChem have acknowledged and agreed that
if the stockholders of MacroChem approve the merger agreement and the
transactions contemplated thereby, then each share of preferred stock will
be exchanged for common stock of Access and all the rights, preferences
and privileges associated with such Series A preferred stock will cease to
exist as of the closing of the merger.
|
||
|
INDEMNIFICATION
OF OFFICERS AND DIRECTORS AND ADVANCEMENT OF EXPENSES; LIMITATION ON
PERSONAL LIABILITY
|
||
|
Indemnification
|
Access’
certificate of incorporation provides that Access shall indemnify all
persons to the extent and in the manner permitted by the provisions of the
DGCL, subject to any permissible expansion or limitation of such
indemnification as may be set forth in the bylaws or any stockholder or
director resolution or by contract. Additionally, no director of
Access shall be liable to Access or its stockholders for monetary damages
for a breach of fiduciary duty as a director, except for liability for:
(i) breach of the director’s duty of loyalty, (ii) acts or omissions not
in good faith or which involve intentional misconduct, (iii) unlawful
payment of dividends or unlawful repurchases or redemptions, or (iv) any
transaction from which the directors derived an improper personal
benefit.
|
MacroChem’s
bylaws provide that MacroChem shall indemnify any director or officer and
shall have the power to indemnify any employee or agent, to the
fullest extent not prohibited by applicable law.
|
|
Advancement
of Expenses
|
MacroChem’s
bylaws provide that MacroChem shall advance expenses to any person who was
or is made a party or is threatened to be made a party to or is otherwise
involved in any action, suit or proceeding, whether civil, criminal,
administrative or investigative, by reason of being or having been a
director or officer, of MacroChem, or is or was serving at the request of
MacroChem as a director or officer of another corporation, partnership,
joint venture, trust or other enterprise, provided, however, that if
applicable law so requires, such advancement of expenses shall be made
only upon delivery to MacroChem of any undertaking by such person to repay
all amounts so advanced if there is a final judgment that such person is
not entitled to be indemnified for such expenses.
|
|
|
DIVIDENDS
|
||
|
Declaration
and Payment of Dividends
|
Access’
bylaws provide that dividends shall be declared and paid out of any
surplus or net profits for the fiscal year in which the dividend is
declared, and/or the preceding fiscal year as often and at such times as
the board of directors may determine. If the capital of Access is
diminished by depreciation of property, or by losses, or otherwise, to an
amount less than the aggregate amount of the capital represented by the
issued and outstanding stock; the board of directors shall not declare and
pay out of net profits any dividends upon any shares of its capital stock
until the deficiency in the amount of capital represented by issued and
outstanding stock shall have been repaired.
While
dividends will accrue on outstanding shares of preferred stock, subject to
the provisions of Access’ certificate of designation, Access shall be
under no obligation to pay such accruing dividends, provided, however,
that Access shall not declare, pay or set aside any dividends on any other
shares of capital stock of Access unless the holders of preferred stock
then outstanding shall first receive the dividend to which they are
entitled pursuant to the terms of Access’ certificate of
designation.
|
MacroChem’s
Series A convertible preferred stock certificate of designation provides
that when and if determined by the board of directors, the holders of
Series A preferred stock shall be entitled to a dividend of $0.06 per
shares of Series A preferred stock.
MacroChem’s
Series C convertible preferred stock certificate of designation provides
that subject to the preferential dividend rights of the preferred stock,
dividends may be paid on the common stock from funds lawfully available
for such purpose. Dividends on Series C convertible preferred stock
are cumulative and are payable when and if declared by the board of
directors. The dividend rate on Series C convertible preferred
stock is 10% per annum. If at any time a Breach Event (as
defined in the Series C convertible preferred stock certificate of
designation) occurs, then such dividend rate shall be increased to 14% per
annum.
MacroChem
shall not declare, pay or set aside any dividends on any other shares of
capital stock of MacroChem unless the holders of Series C convertible
preferred stock then outstanding shall first receive the dividends to
which they are entitled pursuant to the terms of MacroChem’s certificate
of designation.
|
|
AMENDMENTS
TO ARTICLES OF INCORPORATION, CERTIFICATE OF DESIGNATION OR
BYLAWS
|
||
|
General
Provisions
|
Access’
certificate of incorporation provides that Access reserves the right to
amend or repeal any provision of the certificate of incorporation.
Certain provision of the certificate of incorporation may not be altered
or amended without the affirmative vote of the holders of at least 66-2/3%
of the shares entitled to vote.
Access’
bylaws provide that subject to repeal or change by action of the
stockholders in accordance with the certificate of incorporation, the
board of directors may amend, supplement or repeal the
bylaws.
|
MacroChem’s
certificate of incorporation provides that MacroChem reserves the right to
amend or repeal any provision of the certificate of incorporation.
Certain provision of the certificate of incorporation may not be altered
or amended without the affirmative vote of the holders of at least 66-2/3%
of the voting power of all the then outstanding shares of capital
stock of MacroChem entitled to vote, voting together as a single
class.
MacroChem’s
certificate of designation provides that the certificate may be amended,
altered or repealed upon the affirmative vote of the holders of at least a
majority of the shares of preferred stock outstanding. Currently,
MacroChem does not have any shares of preferred stock
outstanding.
MacroChem’s
certificate of incorporation provides that MacroChem’s board of directors
is expressly empowered to adopt, amend or repeal the bylaws. The
stockholders shall also have the power to adopt, amend or repeal the
bylaws. Any adoption, amendment or repeal of the bylaws by the
stockholders shall require, in addition to any vote of the holders of any
class of series of stock of MacroChem required to vote, the affirmative
vote of 66-2/3% of the voting power of all the then outstanding
shares of capital stock of MacroChem entitled to vote, voting together as
a single class.
|
ADDITIONAL
INFORMATION
Householding
of Proxy Materials
The SEC
has adopted rules that permit companies and intermediaries (e.g. brokers) to
satisfy the delivery requirements for proxy statements and annual reports to two
or more stockholders sharing the same address by delivering a single proxy
statement addressed to those stockholders. This process, which is commonly
referred to as "householding," potentially means extra convenience for
stockholders and cost savings for companies.
This
year, a number of brokers with account holders who are our stockholders will be
"householding" our proxy materials. A single proxy statement will be delivered
to multiple stockholders sharing an address unless contrary instructions have
been received from affected stockholders. Once you have received notice from
your broker that they will be "householding" communications to your address,
"householding" will continue until you are notified otherwise or until you
revoke your consent. If, at any time, you no longer wish to participate in
"householding" and would prefer to receive a separate proxy statement and annual
report, please notify your broker, and direct your written request to MacroChem
Pharmaceuticals, Inc., 19200 Von Karman Avenue, Suite 400, Irvine, California or
call MacroChem at (949) 477-8090. Stockholders who currently receive multiple
copies of the proxy statement at their address and would like to request
"householding" of their communications should contact their broker.
Where
You Can Find More Information
Access
and MacroChem file annual, quarterly and current reports, proxy statements and
other information with the SEC. You may read and copy these reports, statements
or other information filed by either Access or MacroChem at the SEC’s Public
Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549. Please call
the SEC at 1-800-SEC-0330 for further information on the public reference rooms.
The SEC filings of Access and MacroChem are also available to the public from
commercial document retrieval services and at the website maintained by the SEC
at www.sec.gov.
Access
has filed a registration statement on Form S-4 to register with the SEC the
Access common stock to be issued to MacroChem stockholders in the merger. This
information statement/prospectus is a part of that registration statement and
constitutes a prospectus of Access, in addition to being a proxy statement of
MacroChem for MacroChem’s special meeting. The registration statement, including
the attached annexes, exhibits and schedules, contains additional relevant
information about Access, Access common stock and MacroChem. As allowed by SEC
rules, this information statement/prospectus does not contain all the
information you can find in the registration statement or the exhibits to the
registration statement.
Access
and MacroChem incorporate by reference the agreement and plan of merger attached
to this information statement/prospectus as Annex A.
Access
has supplied all information contained in or incorporated by reference into this
information statement/prospectus relating to Access and MacroChem has supplied
all information contained in or incorporated by reference into this information
statement/prospectus relating to MacroChem.
You may
obtain copies of the information relating to Access, without charge, by sending
an e-mail to akc@accesspharma.com or by calling (214) 905-5100.
You may
obtain copies of the information relating to MacroChem, without charge, by
sending an e-mail to dluci@macrochem.com or by calling (212)
514-8094.
IN
ORDER FOR YOU TO RECEIVE TIMELY DELIVERY OF THE DOCUMENTS, ACCESS OR MACROCHEM,
AS APPLICABLE, SHOULD RECEIVE YOUR REQUEST NO LATER THAN _________,
2008.
We have
not authorized anyone to give any information or make any representation about
the merger or the companies that is different from, or in addition to, that
contained in this information statement/prospectus or in any of the materials
that are incorporated into this information statement/prospectus. Therefore, if
anyone does give you information of this sort, you should not rely on it. If you
are in a jurisdiction where offers to exchange or sell, or solicitations of
offers to exchange or purchase, the securities offered by this information
statement/prospectus or the solicitation of proxies is unlawful, or if you are a
person to whom it is unlawful to direct these types of activities, then the
offer presented in this information statement/prospectus does not extend to you.
The information contained in this information statement/prospectus is accurate
only as of the date of this document unless the information specifically
indicates that another date applies.
APPENDIX
A
Agreement
and Plan of Merger, Dated July 9, 2008, by and among MacroChem, MACM Acquisition
Corp. and Access Pharmaceuticals, Inc.
TABLE OF
CONTENTS
|
Page
|
|||
|
ARTICLE
I
|
THE
MERGER
|
||
|
1.01
|
The
Merger
|
||
|
1.02
|
Closing
|
||
|
1.03
|
Effective
Time of the Merger
|
||
|
1.04
|
Effects
of the Merger
|
||
|
1.05
|
Certificate
of Incorporation; By-Laws; Purposes
|
||
|
1.06
|
Directors
|
||
|
1.07
|
Officers
|
||
|
ARTICLE
II
|
EFFECT
OF THE MERGER ON THE CAPITAL STOCK AND MEMBERSHIP UNITS OF THE CONSTITUENT
COMPANIES
|
||
|
2.01
|
Effect
on Capital Stock and Membership Units
|
||
|
2.02
|
Exchange
of Certificates
|
||
|
2.03
|
Treatment
of Company Warrants
|
||
|
2.04
|
Company
Notes
|
||
|
2.05
|
Withholding
Rights
|
||
|
ARTICLE
III
|
REPRESENTATIONS
AND WARRANTIES
|
||
|
3.01
|
Representations
and Warranties of the Company
|
||
|
3.02
|
Representations
and Warranties of Parent and Merger Sub
|
||
|
ARTICLE
IV
|
ADDITIONAL
AGREEMENTS
|
||
|
4.01
|
Company
Financial Statements
|
||
|
4.02
|
Access
to Information; Confidentiality
|
||
|
4.03
|
Reasonable
Best Efforts
|
||
|
4.04
|
Indemnification
of Company Directors and Officers
|
||
|
4.05
|
Public
Announcements
|
||
|
4.06
|
Shareholder
Rights Plan
|
||
|
4.07
|
Tax
Free Reorganization Treatment
|
||
|
ARTICLE
V
|
CONDITIONS
PRECEDENT
|
||
|
5.01
|
Conditions
to each Party’s Obligation to Effect the Merger
|
||
|
5.02
|
Conditions
to Obligations of Parent and Merger Sub
|
||
|
5.03
|
Conditions
to Obligations of the Company
|
||
|
ARTICLE
VI
|
TERMINATION,
AMENDMENT, AND WAIVER
|
||
|
6.01
|
Termination
|
||
|
6.02
|
Effect
of Termination
|
||
|
6.03
|
Amendment
|
||
|
6.04
|
Extension;
Waiver
|
||
|
6.05
|
Procedure
for Termination, Amendment, Extension or Waiver
|
||
|
ARTICLE
VII
|
GENERAL
PROVISIONS
|
||
|
7.01
|
Nonsurvival
of Representations and Warranties
|
||
|
7.02
|
Notices
|
||
|
7.03
|
Definitions
|
||
|
7.04
|
Interpretation
|
||
|
7.05
|
Counterparts
|
||
|
7.06
|
Entire
Agreement; No Third-Party Beneficiaries
|
||
|
7.07
|
Governing
Law; Consent to Jurisdiction; Waiver of Jury Trial
|
||
|
7.08
|
Assignment
|
||
|
7.09
|
Remedies
|
||
EXECUTION
COPY
AGREEMENT
AND PLAN OF MERGER (this “Agreement”),
dated as of July 9, 2008, by and among Access Pharmaceuticals, Inc. (“Parent”),
MACM Acquisition Corp., a Delaware corporation and a direct wholly-owned
subsidiary of Parent (“Merger
Sub”) and MacroChem Corporation, a Delaware corporation (the “Company”). Certain
capitalized terms used herein are defined in Section 7.03
of this Agreement.
WHEREAS,
each of the respective Boards of Directors of Parent, Merger Sub and the Company
has (i) determined it advisable and in the best interests of each
corporation and their respective stockholders that Parent acquire the Company
upon the terms and subject to the conditions set forth in this Agreement and
(ii) approved this Agreement and the transactions contemplated hereby on
the terms and subject to the conditions set forth herein;
WHEREAS,
the acquisition of the Company shall be effected through the merger (the “Merger”)
of Merger Sub with and into the Company, upon the terms and subject to the
conditions set forth in this Agreement and in accordance with the Delaware
General Corporation Law (the “DGCL”),
as a result of which the Company shall become a wholly-owned Subsidiary of
Parent;
WHEREAS,
Parent, Merger Sub and the Company desire to make certain representations,
warranties, covenants and agreements in connection with the Merger and also to
prescribe various conditions to the Merger; and
WHEREAS,
for federal income Tax purposes, it is intended that the Merger shall qualify as
a reorganization under the provisions of Section 368(a) of the
Internal Revenue Code of 1986, as amended (the “Code”)
and this Agreement is intended to be a “plan of reorganization” within the
meaning of the regulations promulgated under Section 368 of the
Code.
NOW,
THEREFORE, in consideration of the representations, warranties, covenants and
agreements contained in this Agreement, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
Parent, Merger Sub and the Company agree as follows:
ARTICLE
I.
THE
MERGER
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1.01 The
Merger. Upon the terms and subject to the conditions set
forth in this Agreement, and in accordance with the DGCL, Merger Sub shall
be merged with and into the Company at the Effective Time. Upon the
Effective Time, the separate existence of Merger Sub shall cease, and the
Company shall continue as the surviving corporation and a wholly-owned
Subsidiary of Parent (the “Surviving
Corporation”).
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1.02
Closing.
Unless this Agreement shall have been terminated and the transactions
herein contemplated shall have been abandoned pursuant to
Section 7.01, and subject to the satisfaction or waiver of the
conditions set forth in Article VI, the closing of the Merger (the
“Closing”) shall
take place at 10:00 a.m. (New York time) on a date to be specified by
the parties hereto, such date to be no later than the second business day
following satisfaction or waiver of all of the conditions set forth in
Article VI capable of satisfaction prior to Closing (the “Closing
Date”), at the offices of Bingham McCutchen, LLP, 399 Park Avenue,
New York, New York 10019, unless another date, time or place is agreed to
in writing by the parties hereto.
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1.03 Effective
Time. Upon the Closing, the parties shall file with the
Secretary of State of the State of Delaware a certificate of merger (the
“Certificate
of Merger”) in such form as required by, and executed and
acknowledged in accordance with, the relevant provisions of the DGCL and
shall, in each case, make all other filings or recordings required
thereby. The Merger shall become effective at such time as the
Certificate of Merger is duly filed with the Secretary of State of the
State of Delaware, or at such other time as is permissible in accordance
with the DGCL and as Merger Sub and the Company shall agree should be
specified in the Certificate of Merger (the time the Merger becomes
effective being the “Effective
Time”).
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1.04 Effects of the
Merger. The Merger shall have the effects set forth in the
applicable provisions of the DGCL. Without limiting the
generality of the foregoing, and subject thereto, at the Effective Time,
all the properties, rights, privileges, powers and franchises of the
Company and Merger Sub shall vest in the Surviving Corporation, and all
debts, liabilities and duties of the Company and Merger Sub shall become
the debts, liabilities and duties of the Surviving
Corporation.
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1.05 Certificate of
Incorporation; By-Laws;
Purposes.
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(a)
At the Effective Time, and without any further action on the part of the
Company or Merger Sub, the certificate of incorporation of Merger Sub as
in effect at the Effective Time shall be the certificate of incorporation
of the Surviving Corporation until thereafter amended as provided therein
or by applicable law.
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(b) At
the Effective Time, and without any further action on the part of the
Company or Merger Sub, the by-laws of Merger Sub as in effect at the
Effective Time shall be the by-laws of the Surviving Corporation until
thereafter changed or amended as provided therein or by applicable
law.
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1.06 Directors.
From and after the Effective Time, the directors of the Surviving
Corporation shall be Jeffrey B. Davis and David P. Luci, until the earlier
of their respective resignation or removal or until their successors are
duly elected and qualified, as the case may
be.
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1.07
Officers.
From and after the Effective Time, the officer of the Surviving
Corporation shall be Jeffrey B. Davis and David Luci, until the earlier of
their resignation or removal or until their respective successors are duly
elected or appointed and qualified, as the case may
be.
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ARTICLE
II.
EFFECT OF
THE MERGER ON THE CAPITAL STOCK OF THE CONSTITUENT COMPANIES
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2.01
Effect on
Capital Stock and Company Notes. As of the Effective Time, by
virtue of the Merger and without any action on the part of the Company,
Merger Sub or any holder of any shares of Company Common Stock, Company
Notes, Company Warrants, In the Money Company Warrants or any common stock
of Merger Sub:
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(a) Common Stock of Merger
Sub. Each share of common stock of Merger Sub outstanding
immediately prior to the Effective Time shall be converted into one share
of the common stock, par value $0.001 per share, of the Surviving
Corporation.
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(b)
Cancellation of
Treasury Stock and Parent-Owned Company Stock. Each share of
Company Common Stock that is owned by the Company, and each share of
Company Common Stock that is owned by Parent, Merger Sub or any other
Subsidiary of Parent shall automatically be cancelled and retired and
shall cease to exist, and no cash, Parent Capital Stock or other
consideration shall be delivered or deliverable in exchange
therefor.
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(c) Conversion of Company
Common Stock and In the Money Company
Warrants.
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(i) Each
issued and outstanding share of Company Common Stock (excluding shares
cancelled pursuant to Section 2.01(b)
and any Dissenting Shares to the extent provided in Section 2.04
but including all shares of Company Common Stock issued upon exercise of
Company Options or Company Warrants occurring after the date of this
Agreement and including all shares issuable upon conversion of any of the
In the Money Company Warrants) shall be converted into the right to
receive a number of shares of Parent Common Stock equal to: (A)
2,500,000, divided by (B) the sum of (1) the total number of shares of
Company Common Stock outstanding at the Effective Time, and (2) the total
number of shares of Company Common Stock issuable upon conversion of the
In the Money Company Warrants assuming a cashless conversion at the
closing price of Company Common Stock on the date of this Agreement, such
quotient to be carried out to eight decimal points (the “Common
Stock Exchange Ratio”); provided, however, that in no event shall
Parent be required to issue more than an aggregate of 2,500,000 shares of
Parent Common Stock as consideration for the Merger and the transactions
contemplated thereby;
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(ii) The
total number of shares of Parent Common Stock issuable in exchange for the
Company Common Stock and shares underlying the In the Money Company
Warrants shall be referred to herein collectively as the “Merger
Consideration.” In no event shall the aggregate number of
shares of Parent Common Stock to be issued or issuable hereunder in
exchange for Company Common Stock and/or In the Money Company Warrants
exceed, in the aggregate, 2,500,000 (or such lesser number if decreased in
accordance with Section
2.04). Except as set forth in this Article II, no
other amounts shall be payable with respect to such Company Common Stock
or In the Money Company Warrants.
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(d) Cancellation and
Retirement of Company Common Stock. As of the Effective Time,
all shares of Company Common Stock issued and outstanding immediately
prior to the Effective Time shall no longer be outstanding and shall
automatically be cancelled and retired and shall cease to exist, and each
holder of a certificate representing any such shares of Company Common
Stock (collectively, the “Certificates”)
shall, to the extent such Certificate represents such shares, cease to
have any rights with respect thereto, except the right to receive the
Merger Consideration (and cash in lieu of fractional shares of Parent
Common Stock) to be issued or paid in consideration therefor upon
surrender of such Certificate in accordance with Section 2.02.
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(e)
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Cancellation and
Retirement of In the Money Company Warrants. As of the
Effective Time, all of the In the Money Company Warrants outstanding
immediately prior to the Effective Time shall no longer be outstanding and
shall be cancelled and retired and shall cease to exist, and each holder
of an In the Money Warrant shall cease to have any rights with respect
thereto, except the right to receive the Merger Consideration (and cash in
lieu of fractional shares of Parent Common Stock) to be issued or paid in
consideration therefor upon surrender of such In the Money Warrant in
accordance with Section
2.02.
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(f)
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Company Notes.
At the Effective Time, Parent shall assume the due and punctual
performance of all of the terms and conditions of each outstanding Company
Note and each such Company Note shall, unless the conversion rights
thereunder have previously expired, become convertible into the number of
New Securities (as defined in the Company Notes) of Parent and at such
Conversion Price (as defined in the Company Notes) as set forth therein.
The “Company
Notes” shall be the convertible promissory notes made by the
Company listed in Section 2.01(f)
of the Company Disclosure Schedule. The parties acknowledge that certain
of the Company Notes automatically will convert, at the closing price of
Parent Common Stock on the date hereof, to the right to receive Parent
Common Stock at the Effective Time.
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2.02
Exchange of
Certificates.
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(a)
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Exchange
Agent. As of the Effective Time, Parent shall enter into an
agreement with such bank or trust company as may be designated by Parent
(the “Exchange
Agent”) which shall provide that Parent shall deposit with the
Exchange Agent, for the benefit of the holders of Certificates and In the
Money Company Warrants, for exchange in accordance with this Article II,
certificates representing the shares of Parent Common Stock (such shares
of Parent Common Stock, together with any dividends or distributions with
respect thereto with a record date after the Effective Time and any cash
payable in lieu of any fractional shares of Parent Common Stock being
hereinafter referred to as the “Exchange
Fund”) issuable pursuant to Section 2.01 in
exchange for outstanding shares of Company Common Stock and In the Money
Company Warrants.
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(i)
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Exchange
Procedures. Promptly after the Effective Time, the Exchange
Agent shall mail to each holder of record of Certificates and In the Money
Company Warrants immediately prior to the Effective Time whose shares of
Company Common Stock and/or In the Money Company Warrants were converted
into shares of Parent Common Stock pursuant to Section 2.01(c)
a letter of transmittal (which shall specify that delivery shall be
effected, and risk of loss and title to the Certificates and/or In the
Money Company Warrants shall pass only upon delivery of the Certificates
and/or In the Money Company Warrants, as applicable, to the Exchange
Agent, and which shall be in such form and have such other provisions as
Parent may reasonably specify) and (ii) instructions for use in effecting
the surrender of the Certificates and/or In the Money Company Warrants in
exchange for certificates representing shares of Parent Common
Stock. Upon surrender of a Certificate and/or In the Money
Company Warrants for cancellation (or indemnity reasonably satisfactory to
Parent and the Exchange Agent, if any of such Certificates and/or In the
Money Company Warrants are lost, stolen or destroyed) to the Exchange
Agent together with such letter of transmittal, duly executed, the holder
of such Certificate and/or In the Money Company Warrants shall be entitled
to receive in exchange therefor a certificate representing that number of
whole shares of Parent Common Stock which such holder has the right to
receive in respect of all Certificates and/or In the Money Company
Warrants surrendered by such holder pursuant to the provisions of this
Article II (after taking into account all shares of Company Common Stock
than held by such holder either directly or upon conversion of the In the
Money Company Warrants in a cashless conversion), and the Certificates
and/or In the Money Company Warrants, as applicable, so surrendered shall
forthwith be cancelled. In the event of a transfer of ownership
of shares of Company Common Stock and/or In the Money Company Warrants
which is not registered in the transfer records of the Company, a
certificate representing the proper number of shares of Parent Common
Stock may be issued to a transferee if the Certificate and/or In the Money
Company Warrants, as applicable, is presented to the Exchange Agent,
accompanied by all documents required to evidence and effect such transfer
and by evidence that any applicable stock transfer Taxes have been
paid. Until surrender as contemplated by this Section
2.02(b), subject to the provisions of Section 6.02(h)
(Dissenters Rights) each Certificate and In the Money Company Warrants, in
each case, shall be deemed at any time after the Effective Time to
represent only the Parent Common Stock into which the shares of Company
Common Stock represented by such Certificate or In the Money Company
Warrants have been converted as provided in this Article II and the right
to receive upon such surrender cash in lieu of any fractional shares of
Parent Common Stock as contemplated by this Section
2.02(b).
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(ii)
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Distributions with
Respect to Unexchanged Shares. No dividends or other
distributions with respect to Parent Common Stock with a record date after
the Effective Time shall be paid to the holder of any unsurrendered
Certificate with respect to the shares of Parent Common Stock represented
thereby, and no cash payment in lieu of fractional shares shall be paid to
any such holder pursuant to this Section 2.02
until the surrender of such Certificate and/or In the Money Company
Warrants, as applicable, in accordance with this Article
II. Subject to the effect of applicable laws, following
surrender of any such Certificate and/or In the Money Company Warrants, as
applicable, there shall be paid to the holder of the certificate
representing the whole shares of Parent Common Stock issued in exchange
therefor without interest, (i) at the time of such surrender, the amount
of any cash payable in lieu of any fractional share of Parent Common Stock
to which such holder is entitled pursuant to this Section 2.02
and the amount of any dividends or other distributions with a record date
after the Effective Time and a payment date subsequent to such surrender
payable with respect to such whole shares of Parent Common
Stock.
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(iii)
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No further Ownership
Rights in Company Common Stock. All shares of Parent
Common Stock issued upon conversion of shares of Company Common Stock and
In the Money Company Warrants in accordance with the terms hereof, and all
cash paid pursuant to this Section 2.02 in
lieu of fractional shares, shall be deemed to have been issued in full
satisfaction of all rights pertaining to such Company Common Stock and/or
In the Money Company Warrants, and there shall be no further registration
of transfers on the stock transfer books of the Surviving Corporation of
the Company Common Stock and In the Money Company Warrants which were
outstanding prior to the Effective Time. If, after the
Effective Time, Certificates are presented to the Surviving Corporation
for any reason, they shall be cancelled and exchanged as provided in this
Article II.
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(iv)
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No Fractional
Shares. (i) No certificate or scrip representing
fractional shares of Parent Common Stock shall be issued upon the
surrender for exchange of Certificates and/or In the Money Company
Warrants, and such fractional share interests shall not entitle the owner
thereof to vote or to any rights of a stockholder of Parent. In
lieu of such issuance of fractional shares, Parent shall pay each holder
of Certificates and In the Money Company Warrants an amount in cash equal
to the product obtained by multiplying (a) the fractional share interest
to which such holder would otherwise be entitled (after taking into
account all shares of Company Common Stock held immediately prior to the
Effective Time by such holder) by (b) the average of the closing sale
prices for a share of Parent Common Stock on the OTC Bulletin Board for
the ten trading days immediately preceding the date of the Effective
Time.
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(b)
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As
soon as reasonably practicable after the determination of the amount of
cash, if any, to be paid to holders of Certificates and/or In the Money
Company Warrants, as applicable, with respect to any fractional share
interests, the Exchange Agent shall make available such amounts to such
holders of Certificates and/or In the Money Company Warrants, subject to
and in accordance with the terms of this Section
2.02.
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(c)
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Termination of
Exchange Fund. Any portion of the Exchange Fund
deposited with the Exchange Agent pursuant to this Section 2.02
which remains undistributed to the holders of the Certificates and/or In
the Money Company Warrants six months after the Effective Time shall be
delivered to Parent, upon demand, and any holders of Certificates and/or
In the Money Company Warrants who have not theretofore complied with this
Article II shall thereafter look only to Parent and only as general
creditors thereof for payment of their claim for Parent Common Stock, cash
in lieu of fractional shares of Parent Common Stock and any dividends or
distributions with respect to Parent Common Stock to which such holders
may be entitled pursuant to this Article
II.
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(d)
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No
Liability. None of Parent, Merger Sub, the Company or
the Exchange Agent shall be liable to any Person in respect of any shares
of Parent Common Stock (or dividends or distributions with respect
thereto) or cash from the Exchange Fund delivered to a public official
pursuant to any applicable abandoned property, escheat or similar
law. If any Certificates and/or In the Money Company Warrants
shall not have been surrendered prior to three years after the Effective
Time of the Merger, or immediately prior to such earlier date on which any
Merger Consideration, any cash in lieu of fractional shares of Parent
Common Stock or any dividends or distributions with respect to Parent
Common Stock would otherwise escheat to or become the property of any
Governmental Entity, any such Merger Consideration or cash shall, to the
extent permitted by applicable law, become the property of the Surviving
Corporation, free and clear of all claims or interest of any Person
previously entitled thereto.
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(e)
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Investment of Exchange
Fund. The Exchange Agent shall invest any cash included
in the Exchange Fund, as directed by Parent on a daily basis. Any interest
and other income resulting from such investments shall be paid to
Parent.
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(f)
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Adjustment
Provisions. In the event Parent changes (or establishes
a record date for changing) the number of shares of Parent Common Stock
issued and outstanding prior to the Effective Time as a result of,
including, without limitation, a forward or reverse stock split, stock
dividend, recapitalization or similar transaction with respect to the
outstanding Parent Common Stock and the record date therefor shall be
prior to the Effective Time, the Common Stock Exchange Ratio shall be
proportionately adjusted. If between the date hereof and the
Effective Time, Parent shall merge, be acquired or consolidated with, by
or into any other corporation (a “Business Combination”) and the terms
thereof shall provide that Parent Common Stock shall be converted into or
exchanged for the shares of any other corporation or entity, then
provision shall be made as part of the terms of such Business Combination
so that security holders of the Company who would be entitled to receive
shares of Parent Common Stock pursuant to this Agreement shall be entitled
to receive, in lieu of each share of Parent Common Stock issuable to such
security holders as provided herein, the same kind and amount of
securities or assets as shall be distributable upon such Business
Combination with respect to one share of Parent Common Stock (provided
that nothing herein shall be construed so as to release the acquiring
entity in any such Business Combination from its obligations under this
Agreement as the successor to
Parent).
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2.03
Treatment
of Company Options and Company Warrants. Parent shall
not assume any options to purchase shares of Company Common Stock (the “Company
Options”), even if such Company Options are outstanding immediately prior
to the Effective Time and are fully vested and exercisable immediately prior to
the Effective Time. All Company Options shall have been exercised or
terminated prior to the Closing Date. The Company shall have taken
all necessary action to implement and carry out the provisions of this Section
2.03, including, without limitation, taking the actions described in
Section
6.02(e).
Section
2.03 of the Company Disclosure Letter sets forth a list of the
outstanding “in the money” warrants to purchase shares of Company Common Stock
(the “In the
Money Company Warrants”). At the Effective Time, the In the
Money Company Warrants shall automatically convert into the right to receive a
portion of the Merger Consideration as provided in Section
2.01 above. Except for the obligation to grant a portion of
the Merger Consideration to holders of the In the Money Company Warrants, Parent
shall not assume either the In the Money Company Warrants or the warrants to
purchase shares of Company Common Stock (the “Company
Warrants”), even if such Company Warrants are outstanding immediately
prior to the Effective Time and are fully vested and exercisable immediately
prior to the Effective Time. The Company shall have taken all
necessary action to implement and carry out the provisions of this Section
2.03, including, without limitation, taking the actions described in
Section
6.02(e).
2.04 Dissenting
Shares.
(a) Subject
to the provisions of Section
6.02(g) and notwithstanding any provision of this Agreement to the
contrary, the shares of any holder of Company Common Stock who has demanded and
perfected appraisal rights of such shares in accordance with Delaware Law and
who, as of the Effective Time of the Merger, has not effectively withdrawn or
lost such appraisal rights ("Dissenting
Shares") shall not be converted into or represent a right to receive
Parent Common Stock pursuant to Section
2.01(c), but the holder thereof shall only be entitled to such rights as
are granted by Delaware Law, and the total number of shares of Parent Common
Stock issuable as Merger Consideration as provided in Section 2.01(c)
shall be proportionately decreased.
(b) Notwithstanding
the foregoing, if any holder of shares of Company Common Stock who demands
appraisal of such shares under Delaware Law shall effectively withdraw the right
to appraisal, then, as of the later of the Effective Time and the occurrence of
such event, such holder's shares shall automatically be converted into and
represent only the right to receive Parent Common Stock, without interest
thereon, upon surrender of the Certificate representing such shares as provided
in Section
2.01(c), and the total number of shares of Parent Common Stock issuable
as Merger Consideration as provided in Section 2.01(c)
shall be proportionally increased to the extent such number was previously
decreased pursuant to Section 2.05(a)
above with respect to such shares.
(c) The
Company shall give Parent (i) prompt notice of any written demands for appraisal
of any shares of Company Common Stock, withdrawals of such demands, and any
other instruments served pursuant to Delaware Law and received by the Company
which relate to any such demand for appraisal and (ii) the opportunity to
participate in all negotiations and proceedings which take place prior to the
Effective Time with respect to demands for appraisal under Delaware
Law. The Company shall not, except with the prior written consent of
Parent or as may be required by applicable law, voluntarily make any payment
with respect to any demands for appraisal of the Company Common Stock or offer
to settle or settle any such demands.
2.05 Withholding
Rights. Each of Parent and the Surviving Corporation shall be
entitled to deduct and withhold from the consideration otherwise payable
pursuant to this Agreement to any holder of Company Common Stock such amounts as
it is required to deduct and withhold with respect to the making of such payment
under the Code, or any provision of state, local or foreign Tax
law. To the extent that amounts are so withheld by Parent or the
Surviving Corporation, as the case may be, such withheld amounts shall be
treated for all purposes of this Agreement as having been paid to such holder in
respect of which such deduction and withholding was made by Parent or the
Surviving Corporation, as the case may be.
ARTICLE
III.
REPRESENTATIONS
AND WARRANTIES
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3.01 Representations and
Warranties of the Company and its Subsidiaries. Except as may be
set forth in a disclosure letter (to the extent each disclosure item
therein is clearly marked to indicate the section, paragraph or
subparagraph of this Agreement to which such disclosure is an exception,
referencing the same section, paragraph and subparagraph as used in this
Agreement, in each case, except to the extent that any such disclosure is
reasonably discernable to apply to more than one section, paragraph or
subparagraph of this Agreement) delivered by the Company to Parent and
Merger Sub at the time of execution of this Agreement (the “Company
Disclosure Letter”), the Company hereby represents and warrants to
Parent and Merger Sub as follows:
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(a) Organization; Standing
and Corporate Power. The Company is duly organized, validly
existing and in good standing under the laws of the State of Delaware and
has the requisite corporate power and authority to carry on its business
as it is now being conducted. The Company is duly qualified or
licensed to do business and is in good standing in each jurisdiction
(domestic or foreign) in which the nature of its business or the ownership
or leasing of its properties makes such qualification or licensing
necessary, other than in such jurisdictions where the failure to be so
qualified or licensed (individually or in the aggregate) would not have a
Material Adverse Effect with respect to the Company. The Company has
delivered to Parent complete and correct copies of each of (i) the
certificate of incorporation (including any Certificate of Designations
thereto) (the “Company
Certificate”) and by-laws (the “Company By-laws”)
of the Company, in each case as amended and as currently in effect and
(ii) the minute books of the Company which contain records of all
meetings held of, and other corporate actions taken by, its stockholders,
board of directors and any committees appointed by its board of
directors.
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(b) Subsidiaries.
Except as set forth in Section 3.01(b)
of the Company Disclosure Letter, the Company does not own, directly or
indirectly, any capital stock or other ownership interest in any
Person.
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(c)
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Capital
Structure. The authorized capital stock of the Company
consists of (x) 100,000,000 shares of Company Common Stock and
(y) 6,000,000 shares of Company Preferred Stock. As of the date
hereof, there were: (i) 45,798,412 shares of Company Common Stock
issued and outstanding; (ii) 0 shares of Company Preferred Stock issued and
outstanding, (iii) 299 shares of Company Common Stock held in the treasury
of the Company; (iv) 1,784,584 shares of Company Common Stock reserved for
issuance upon exercise of options available for grant pursuant to the Company’s
stock option plans; (v) 7,376,488 shares of Company Common Stock issuable
upon exercise of awarded but unexercised stock options; and (vi) warrants
representing the right to purchase 20,445,984 shares of Company Common
Stock. Except as set forth above, as of the date hereof, there were no
shares of capital stock or other equity securities of the Company issued,
reserved for issuance or outstanding. All outstanding shares of capital
stock of the Company are, and all shares which may be issued as described above
will be, when issued, duly authorized, validly issued, fully paid and
nonassessable and not subject to preemptive rights. The shares of Company
Common Stock to be issued in connection with the Merger (x) will, when
issued, be duly authorized, validly issued, fully paid and nonassessable and not
subject to preemptive rights and (y) will be issued in compliance in all
material respects with all applicable federal and state securities laws and
applicable rules and regulations promulgated thereunder. Except as
set forth above and in (i) Section
3.01(c) of the Company Disclosure Letter and (ii) the Rights Agreement
dated as of August 13, 1999, between the Company and American Stock
Transfer & Trust Company as Rights Agent (the “Shareholder
Rights Plan”), there are no outstanding securities, options, warrants,
calls, rights, commitments, agreements, arrangements or undertakings of any kind
to which the Company is a party or by which it is bound obligating the Company
to issue, deliver or sell, or cause to be issued, delivered or sold, additional
shares of capital stock or other equity or voting securities of the Company or
obligating the Company to issue, grant, extend, accelerate the vesting of or
enter into any such security, option, warrant, call, right, commitment,
agreement, arrangement or undertaking. There are no outstanding
contractual obligations, commitments, understandings or arrangements of the
Company to repurchase, redeem or otherwise acquire or make any payment in
respect of any shares of capital stock of the Company. As of the date
hereof, all of the issued and outstanding shares of common stock in Virium
Pharmaceuticals Inc., a Subsidiary of the Company, are owned by the Company,
free and clear of any Lien, and as of the Closing Date, all of the common stock
of Virium Pharmaceuticals Inc. will be owned by the Company free and clear of
any Lien.
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(d) Authority;
Noncontravention. The Company has the requisite corporate power and
authority to enter into this Agreement and to consummate the transactions
contemplated hereby. The execution and delivery of this Agreement by
the Company and the consummation by the Company of the transactions
contemplated hereby have been duly authorized by all necessary corporate
action on the part of the Company. This Agreement has been duly
executed and delivered by the Company and (assuming due authorization,
execution and delivery by Parent and Merger Sub) constitutes a legal,
valid and binding obligation of the Company, enforceable against the
Company in accordance with its terms, subject to the effects of
bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium
and other similar laws affecting creditors’ rights generally and general
equitable principles (whether considered in a proceeding in equity or at
law). The execution and delivery of this Agreement does not, and the
consummation by the Company of the transactions contemplated by this
Agreement and compliance by the Company with the provisions hereof will
not, conflict with, or result in any breach or violation of, or any
default (with or without notice or lapse of time, or both) under, or give
rise to a right of termination, cancellation or acceleration of, or a
“put” right with respect to any obligation under, or to a loss of a
material benefit under, or result in the creation of any pledge, claim,
lien, charge, encumbrance or security interest of any kind or nature
whatsoever except for a Permitted Lien (collectively, “Liens”) upon
any of the properties or assets of the Company under, (i) the Company
Certificate or Company By-laws, (ii) any agreement, contract,
license, loan or credit agreement, note, note purchase agreement, bond,
mortgage, indenture, lease or other agreement, instrument, permit,
concession, franchise or license applicable to the Company or its
properties or assets or (iii) subject to the governmental filings and
other matters referred to in the last sentence of this
Section 3.01(d), any judgment, order, decree, statute, law,
ordinance, rule, regulation or arbitration award applicable to the Company
or its properties or assets. Each Lien of the Company in excess of $5,000
is set forth in Section 3.01(d) of the Company Disclosure
Letter. No consent, approval, order or authorization of, or registration,
declaration or filing with, or notice to, any federal, state or local
government or any court, administrative agency or commission or other
governmental authority or agency, domestic or foreign (a “Governmental
Entity”) is required by or with respect to the Company in
connection with the execution and delivery of this Agreement by the
Company or the consummation by the Company of any of the transactions
contemplated hereby or the performance by the Company of its obligations
hereunder, except for the filing of the Delaware Certificate of Merger
with the Secretary of State of the State of Delaware and appropriate
documents with the relevant authorities of other states in which the
Company is qualified to do
business.
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(e)
Company SEC
Documents; Undisclosed Liabilities. Since January 1,
2005, the Company has filed with the SEC all reports, schedules, forms,
statements and other documents required pursuant to the Securities Act and
the Exchange Act (collectively, and in each case including all exhibits
and schedules thereto and documents incorporated by reference therein, the
“Company
SEC Documents”). As of their respective dates, the Company
SEC Documents complied in all material respects with the requirements of
the Securities Act or the Exchange Act, as the case may be, and the
rules and regulations of the SEC promulgated thereunder applicable to
such Company SEC Documents. Except to the extent that information
contained in any Company SEC Document has been revised or superseded by a
later filed Company SEC Document, none of the Company SEC Documents
(including any and all Company SEC Financial Statements included therein)
contains any untrue statement of a material fact or omits to state a
material fact required to be stated therein or necessary in order to make
the statements therein, in the light of the circumstances under which they
were made, not misleading. The financial statements of Company
included in the Company SEC Documents (the “Company
SEC Financial Statements”) comply as to form in all material
respects with applicable published accounting requirements and the
published rules and regulations of the SEC with respect thereto, have
been prepared in accordance with GAAP, applied on a consistent basis
during the periods involved (except as may be indicated in the notes
thereto) and fairly present the financial position of the Company as of
the dates thereof and the results of its operations and cash flows for the
periods then ended (subject, in the case of unaudited quarterly
statements, to normal recurring year-end audit adjustments). The
Company has no liabilities or obligations of any nature (whether accrued,
absolute, contingent or otherwise) required by GAAP to be recognized or
disclosed on a balance sheet of the Company or in the notes thereto,
except (i) liabilities reflected in the audited balance sheet of the
Company as of March 31, 2008, (ii) liabilities incurred since
March 31, 2008, in the ordinary course of business consistent with
past practice and (iii) liabilities that would not be reasonably
likely to have a Material Adverse Effect with respect to the
Company.
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(f) Disclosure Controls
and Procedures. The Company maintains disclosure controls and
procedures required by Rule 13a-15 and 15d-15 under the Exchange
Act. Such disclosure controls and procedures are designed to ensure
that all material information relating to the Company is made known to the
Company’s chief executive officer and chief financial officer by others
within the Company, particularly during the period in which the Company’s
applicable Exchange Act report is being prepared, and effective, in that
they provide reasonable assurance that information required to be
disclosed by the Company in the reports that it files or submits under the
Exchange Act is recorded, processed, summarized and reported within the
time periods specified in the SEC’s rules and forms. The
Company’s management assessment was that disclosure controls and
procedures were effective as of March 31,
2008.
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(g)
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Information
Supplied. None of the information supplied or to be
supplied by the Company in writing for inclusion or incorporation by
reference in (i) the registration statement on Form S-4 to be filed with
the SEC by Parent in connection with the issuance of Parent Common Stock
in the Merger (the “Form
S-4”) shall, at the time the Form S-4 becomes effective under the
Securities Act, contain any untrue statement of a material fact or omit to
state anymaterial fact required to be stated therein or necessary to make
the statements therein not misleading or (ii) the Information Statement
shall, at (A) the date it is first mailed to the Company's stockholders
and/or (B) at the time of the Stockholder Meeting, contain any untrue
statement of a material fact or omit to state any material fact required
to be stated therein or necessary in order to make the statements therein,
in the light of the circumstances under which they are made, not
misleading. The Information Statement shall comply as to form
in all material respects with the requirements of the Exchange Act and the
rules and regulations promulgated thereunder, except that no
representation is made by the Company with respect to statements made or
incorporated by reference therein based on information supplied in writing
by Parent or Merger Sub specifically for inclusion or incorporation by
reference therein.
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(h) Absence of Certain
Changes or Events. Since March 31, 2008, there is not and has
not been: (i) any Material Adverse Change with respect to the
Company; (ii) any condition, event or occurrence which, individually
or in the aggregate, could reasonably be expected to have a Material
Adverse Effect or give rise to a Material Adverse Change with respect to
the Company; (iii) any condition, event or occurrence which,
individually or in the aggregate, could reasonably be expected to prevent
or materially delay the ability of the Company to consummate the
transactions contemplated by this Agreement or perform its obligations
hereunder.
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(i)
Litigation;
Labor Matters; Compliance with
Laws.
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(i)
Except as set forth in Section 3.01(i)(i) of
the Company Disclosure Letter, there is no suit, action, claim, charge,
arbitration, investigation or proceeding pending before or, to the
knowledge of the Company, threatened by, a Governmental Entity, in each
case with respect to the Company that, individually or in the aggregate,
could reasonably be expected to have a Material Adverse Effect with
respect to the Company or prevent or materially delay the ability of the
Company to consummate the transactions contemplated by this Agreement or
to perform its obligations hereunder. There is no judgment, decree,
citation, injunction, rule or order of any Governmental Entity or
arbitrator outstanding against the Company which, individually or in the
aggregate, could reasonably be expected to have a Material Adverse Effect
with respect to the Company.
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(ii)
Except as set forth in Section 3.01(i)(ii) of
the Company Disclosure Letter (1) the Company is not a party to, or
bound by, any collective bargaining agreement, contract or other agreement
or understanding with a labor union or labor organization; (2) the
Company is not the subject of any strike, grievance or other proceeding
asserting that the Company has committed an unfair labor practice or
seeking to compel it to bargain with any labor organization as to wages or
conditions of employment; (3) there is no strike, work
stoppage or other labor dispute involving the Company or, to its
knowledge, threatened; (4) no grievance is pending or, to the
knowledge of the Company, threatened against the Company which,
individually or in the aggregate, could reasonably be expected to have a
Material Adverse Effect with respect to the Company; (5) the Company
is in material compliance with all applicable laws (domestic and foreign),
agreements, contracts and policies relating to employment, employment
practices, wages, hours, immigration matters and terms and conditions of
employment; (6) the Company has paid in full to all employees of the
Company all wages, salaries, commissions, bonuses, benefits and other
compensation due and payable to such employees under any policy, practice,
agreement, plan, program, statute or other law; (7) the Company is
not liable for any severance pay or other payments to any employee or
former employee arising from the termination of employment under any
benefit or severance policy, practice, agreement, plan or program of the
Company, nor will the Company have any liability which exists or arises,
or may be deemed to exist or arise, under any applicable law, contract or
otherwise, as a result of or in connection with the transactions
contemplated hereunder or as a result of the termination by the Company of
any Persons employed by the Company on or prior to the Effective Time; and
(8) the Company is in compliance with its obligations pursuant to the
Worker Adjustment and Retraining Notification Act of 1988 (“WARN”)
and any similar state or local laws, and all other employee notification
and bargaining obligations arising under any statute or
otherwise.
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(iii)
The business of the Company is not being conducted in violation of any law
(domestic or foreign), ordinance or regulation of any Governmental Entity
in any material respect.
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(j) Employee Benefit
Plans.
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(i) Section 3.01(j)(i) of
the Company Disclosure Letter contains a true and complete list of each
“employee benefit plan” (within the meaning of Section 3(3) of
ERISA) (including, without limitation, multiemployer plans within the
meaning of Section 3(37) of ERISA or any of its foreign
equivalents)), stock purchase, stock option, severance, employment,
change-in-control, fringe benefit, collective bargaining, bonus,
incentive, deferred compensation and all other employee benefit plans,
agreements, programs, policies or other arrangements relating to
employment, benefits or entitlements, whether or not subject to ERISA
(including any funding mechanism therefor now in effect or required in the
future as a result of the transactions contemplated by this Agreement or
other activities taken by the Company on or prior to the date of this
Agreement), sponsored by the Company or any other entity such as a
co-employer, whether formal or informal, oral or written, legally binding
or not under which any employee or former employee of the Company has any
present or future right to benefits based on such employee’s employment
with the Company and under which the Company has any present or future
liability. All such plans, agreements, programs, policies and
arrangements are herein collectively referred to as the “Company
Plans.”
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(ii) With
respect to each Company Plan, the Company has delivered to the Parent a
current, accurate and complete copy (or, to the extent no such copy
exists, an accurate description) thereof and, to the extent applicable,
(A) any related trust agreement, annuity contract or other funding
instrument; (B) the most recent determination letter issued by the
IRS; (C) any summary plan description and other material written
communications (or a description of any material oral communications) by
the Company to its employees concerning the extent of the benefits
provided under a Company Plan; and (D) for the three most recent
years (I) the Form 5500 and attached schedules;
(II) audited financial statements; (III) actuarial valuation
reports; and (IV) attorney’s response to an auditor’s request for
information.
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(iii) (A) Neither
the Company nor any member of its Controlled Group has or shall have, as
of the Effective Time, any obligation to any multiemployer plan (within
the meaning of 4001(a)(3) of ERISA) or any collective bargaining
agreement; (B) neither the Company nor any member of its Controlled
Group has incurred any material withdrawal liability under Title IV of
ERISA; and (C) neither the Company nor any member of its Controlled
Group has engaged in a transaction which could subject it to liability
under ERISA Section 4212(c).
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(iv) (A) Each
Company Plan which is intended to meet the requirements for Tax-favored
treatment under Subchapter B of Chapter 1 of Subtitle A of the Code meets
such requirements; and (B) the Company has received a favorable
determination from the IRS with respect to any trust intended to be
qualified within the meaning of Code
Section 501(c)(9).
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(v) The
Company has complied and currently complies in all material respects with
the applicable continuation requirements for its welfare benefit plans,
including Section 4980B of the Code and Sections 601 through 608,
inclusive, of ERISA and any applicable state statutes maintaining health
insurance continuation coverage for employees and
beneficiaries.
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(vi) Except
as otherwise disclosed in Section 3.01(j)(vi) of
the Company Disclosure Letter, none of the terms of the Company Plans
provides that the consummation of the transactions contemplated by this
Agreement will, either alone or in combination with another event,
(A) entitle any of the Company’s employees or current or former
officers or directors to severance pay, unemployment compensation or any
other payment, except as expressly provided in this Agreement, or
(B) accelerate the time of payment or vesting, or increase the amount
of compensation due any such employee or
officer.
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(vii) Except
as otherwise disclosed in Section 3.01(j)(vii) of
the Company Disclosure Letter, no payment that is owed or may become
due to any director, officer, employee or agent of the Company will be
non-deductible or subject to tax under Section 280G,
Section 4999 or Section 162(m) of the Code; nor will the
Company be required to “gross up” or otherwise compensate any such person
because of the imposition of any excise tax on a payment to such
person.
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(viii) Each
Company Plan is amendable and terminable at the sole discretion of the
sponsor thereof without notice to any participant or
beneficiary.
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(ix)
There is no suit, action, claim, charge, arbitration, investigation or
proceeding (except with respect to benefits payable in the normal
operation of Company Plans and qualified domestic relations orders)
against or involving any Company Plan or asserting any rights or claims to
benefits under any Company Plan that could give rise to any material
liability.
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(x)
Except as disclosed in Section 3.01(j)(x) of
the Company Disclosure Letter, there are no obligations or potential
liability under any Company Plan for providing welfare benefits after
termination of employment to any employee (or any beneficiary of an
employee), including, but not limited to, retiree health and life
insurance coverage, but excluding continuation of health coverage required
to be continued under Section 4980B of the Code or other applicable
law and insurance conversion privileges under state law. The assets of
each Company Plan which is funded are reported on their fair market value
on the books and records of such Company
Plan.
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(xi) No
individuals are currently providing, or have ever provided, services to
the Company pursuant to a leasing arrangement or similar type of
arrangement. The Company has no obligation to provide benefits under any
Company Plan maintained for its employees to or for the benefit of any
individual who has been treated as an independent contractor by the
Company.
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(k)
Taxes.
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(i) The
Company has timely filed with the appropriate Governmental Entity all Tax
Returns required to be filed by it, each such Tax Return has been prepared
in compliance with all applicable laws and regulations and all such Tax
Returns are true, accurate and complete in all material respects. The
Company has (A) timely paid in full all Taxes required to have been
paid by it (whether or not such Taxes were shown to be due on such Tax
Returns); and (B) made adequate provision for all accrued Taxes not
yet due. The Company has made accruals for Taxes on the Company
SEC Financial Statements that are adequate to cover any Tax liability of
the Company determined in accordance with GAAP through the date of the
applicable Company SEC Financial Statements, and any Taxes of the Company
arising after the date of the most recent Company SEC Financial Statements
and at or before the Effective Time have been or will be incurred in the
ordinary course of the Company’s
business.
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(ii)
As of the date of this Agreement, no federal, state, local or foreign
audits, suits or other administrative proceedings or court proceedings are
presently pending with regard to any Taxes or Tax Returns of Parent, and
the Company has not received a written notice of any material pending or
proposed claims, audits or proceedings with respect to Taxes. The Company
has not granted any outstanding extensions of the time in which any Tax
may be assessed or collected by any Tax authority. There is no
action, suit, proceeding or audit with respect to any Tax or, to the
knowledge of the Company, threatened against or with respect to the
Company. The Company has not received any notice of deficiency
or assessment from any Governmental Entity for any amount of Tax that has
not been fully settled or satisfied, and to the knowledge of the Company
no such deficiency or assessment is
proposed.
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(iii)
No claim has been made in writing by any Governmental Entity in a
jurisdiction where the Company does not file Tax Returns that any such
entity is, or may be, subject to taxation by that
jurisdiction.
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(l) Properties. The
Company (i) has good and marketable title to all the properties and
assets (A) reflected in the Company Financial Statements as being
owned by the Company (other than any such properties or assets sold or
disposed of since such date in the ordinary course of business consistent
with past practice) or (B) acquired after March 31, 2008 which are
material to the Company’s business, free and clear of all Liens. The
Company has good and valid leasehold interests in all real property
leases, subleases and occupancy agreements to which the Company is a party
(the “Company
Leases”) and is in sole possession of the properties purported to
be leased thereunder. Section 3.01(l) of
the Company Disclosure Letter lists and describes briefly all Company
Leases. Each Company Lease is in full force and effect and
constitutes a legal, valid and binding obligation of, and is legally
enforceable against, the respective parties thereto. There is no uncured
breach, and no default exists, on the part of landlord under any of
the Company Leases, and the Company has no knowledge of breach or default
or any event, condition or state of facts, which with the giving of notice
or the passage of time, or both, would constitute a breach or default by
the Company under any Company Lease. There is no suit, action, arbitration
or other proceeding with respect to the Company Leases or the premises
leased under the Company Leases. The Company has not received notice and
does not otherwise have knowledge of any pending, threatened or
contemplated condemnation proceeding affecting any premises leased by the
Company or any part thereof or of any sale or other disposition of
any such leased premises or any part thereof in lieu of condemnation.
The real property leased to the Company under the Company Leases
encompasses all real property used by the Company, and the Company does
not own any real property and does not have any options to purchase real
property. The landlord under each of the Company Leases has performed all
initial improvements required to be performed by it under such Company
Lease and all tenant improvements allowances have been paid to the Company
as tenant under such Company Lease. All insurance required to be
maintained by the Company under each of the Company Leases is in full
force and effect.
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(m) Environmental
Matters.
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(i) The
Company holds and is in compliance in all material respects with all
Environmental Permits and the Company is, and has been, otherwise in
compliance with all Environmental Laws in all material respects and, to
the knowledge of the Company, there are no conditions that might prevent
or interfere with such compliance in the
future.
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(ii) The
Company has not received any Environmental Claim, and to the knowledge of
the Company there is no threatened Environmental
Claim.
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(iii) The
Company has not entered into any consent decree, order or agreement under
any Environmental Law.
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(iv) There
are no (A) underground storage tanks, (B) polychlorinated
biphenyls, (C) friable asbestos or asbestos-containing materials,
(D) sumps, (E) surface impoundments, (F) landfills or
(G) sewers or septic systems present at any facility currently
leased, operated or otherwise used by the Company that could reasonably be
expected to give rise to liability of the Company under any Environmental
Laws.
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(v) There
are no past (including, without limitation, with respect to assets or
businesses formerly owned, leased or operated by the Company) or present
actions, activities, events, conditions or circumstances, including,
without limitation, the release, threatened release, emission, discharge,
generation, treatment, storage or disposal of Hazardous Materials, that
could reasonably be expected to give rise to liability of the Company
under any Environmental Laws.
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(vi)
No modification, revocation, reissuance, alteration, transfer or amendment
of the Environmental Permits, or any review by, or approval of, any third
party of the Environmental Permits is required in connection with the
execution or delivery of this Agreement or the consummation of the
transactions contemplated hereby or the continuation of the business of
the Company following such
consummation.
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(vii) Hazardous
Materials have not been generated, transported, treated, stored, disposed
of, arranged to be disposed of, released or threatened to be released at,
on, from or under any of the properties or facilities currently leased or
otherwise used by the Company, in violation of or so as could result in
liability under, any Environmental
Laws.
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(viii)
The Company has not contractually assumed any liabilities or obligations
under any Environmental Laws.
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(n) Contracts; Debt
Instruments.
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(i)
The Company is not, and has not received any notice and has no knowledge
that any other party is, in default in any material respect under any
contract, agreement, commitment, arrangement, lease, policy or other
instrument to which it is a party or by which it is bound; and, to the
knowledge of the Company, there has not occurred any event that with the
lapse of time or the giving of notice or both would constitute such a
default.
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(ii)
The Company has delivered to Parent and Merger Sub (x) true, complete
and correct copies of all loan or credit agreements, notes, bonds,
mortgages, indentures and other agreements and instruments pursuant to
which any Indebtedness of the Company is outstanding and (y) accurate
information regarding the respective principal amounts currently
outstanding thereunder.
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(iii) The
Company has delivered to Parent and Merger Sub true, complete and correct
copies of all other contracts, agreements, commitments, arrangements,
leases, policies or other instruments that are material to the business of
the Company, including, without limitation, any non-compete agreement or
any other agreement requiring expenditures above
$25,000.
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(o) No
Brokers. No broker, investment banker, financial advisor or
other Person (including, without limitation, SCO Capital Partners LLC
and/or its affiliates) is entitled to any broker’s finder’s, financial
advisor’s or other similar fee or commission in connection with the
transactions contemplated by this Agreement based upon arrangements made
by or on behalf of the Company.
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(p) Intellectual
Property.
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(i)
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Section 3.01(p)(i) of
the Company Disclosure Letter sets forth all Intellectual Property owned
by the Company, which is registered or filed with, or has been submitted
to, any Governmental Entity, and all Intellectual Property licensed from
third parties by the Company, and the nature of the Company’s rights
therein.
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(ii) The
Company owns or has the right to use all Intellectual Property necessary
for the Company to conduct its business as it is currently conducted and
consistent with past practice.
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(iii) All
of the Intellectual Property used by the Company is subsisting and
unexpired, free of all Liens, has not been abandoned and, to the knowledge
of the Company, does not infringe the intellectual property rights of any
third party. None of the Intellectual Property to the extent used by the
Company is the subject of any license, security interest or other
agreement to which the Company is a party granting rights therein to any
third party. No judgment, decree, injunction, rule or order has been
rendered by any U.S. federal or state or foreign Governmental Entity which
would limit, cancel or question the validity of, or the Company’s rights
in and to any Intellectual Property in any material respect. The Company
has not received notice of any pending or threatened suit, action or
proceeding that seeks to limit, cancel or question the validity of, or the
Company’s rights in and to any Intellectual Property. The Company takes
reasonable steps to protect, maintain and safeguard its Intellectual
Property, including any Intellectual Property for which improper or
unauthorized disclosure would impair its value or validity, and have
executed appropriate agreements and made appropriate filings and
registrations in connection with the
foregoing.
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(q) Government Licenses;
Compliance With FDC Act and Other Regulatory
Requirements.
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(i) The
Company holds all material authorizations, consents, approvals,
franchises, licenses and permits required under applicable law or
regulation for the operation of the business of the Company as presently
operated (the “Company
Permits”). All the Company Permits have been duly issued or
obtained and are in full force and effect, and the Company is in material
compliance with the terms of all the Company Permits. The Company
has not engaged in any activity that would cause revocation or suspension
of any such Company Permits. Neither the execution, delivery nor
performance of this Agreement shall adversely affect the status of any of
the Company Permits.
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(ii) Without
limiting the generality of the representations and warranties made in
sub-paragraph (i) above, the Company represents and warrants that
(i) all Pharmaceutical Products that are subject to the jurisdiction
of the United States Food and Drug Administration (the “FDA”) are being developed, labelled,
stored, tested and distributed directly by the Company in substantial
compliance with all applicable requirements under the Federal Food, Drug
and Cosmetic Act of 1938 (the “FDCA”), the Public Health Service Act
of 1944 (the “PHSA”) and all applicable similar
state and foreign Legal Requirements, including those relating to
investigational use, premarket clearance and applications or abbreviated
applications to market a new Pharmaceutical Product. “Pharmaceutical
Products” shall mean
all biological and drug candidates, compounds or products being
researched, tested, developed, manufactured or distributed by the Company,
(ii) all preclinical studies and clinical trials conducted by the
Company have been, and are being, conducted in substantial compliance with
the requirements of Good Laboratory Practice and Good Clinical Practice
and all requirements relating to protection of human subjects contained in
Title 21, Parts 50, 54, and 56 of the United States Code of Federal
Regulations (“C.F.R.”), in each case, to the extent
required by applicable law and regulations, (iii) no Pharmaceutical
Product has been recalled, suspended, or discontinued as a result of any
action by the FDA or any other similar foreign Governmental Entity by the
Company, or (iv) since December 31, 2005, neither the Company
nor, to the knowledge of the Company, any of its officers, key employees
or agents has been convicted of any crime or engaged in any conduct that
has resulted, or would reasonably be expected to result, in debarment
under 21 U.S.C. Section 335a or any similar state law or
regulation under 42 U.S.C.
Section 1320a-7.
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(r) Insurance. The
Company maintains insurance policies (each, a “Company
Insurance Policy”) with reputable insurance carriers against all
risks of a character and in such amounts as are usually insured against by
similarly situated companies in the same or similar businesses. Each
Company Insurance Policy is in full force and effect and is set forth in
Section 3.01(q) of
the Company Disclosure Letter.
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(s) Disclaimer of Other
Representations and Warranties. The representations and
warranties contained in this Section 3.01,
and in the Officer’s Certificate and Secretary’s Certificate to be
delivered by the Company under this Agreement, do not contain any untrue
statement of material fact or omit to state any material fact necessary in
order to make the statements and information contained therein not
misleading. Parent and Merger Sub acknowledge and agree that the
Company has made no representation or warranty in connection with this
Agreement or the transactions contemplated hereby other than as set forth
in this Section 3.01.
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3.02 Representations and
Warranties of Parent and Merger Sub. Except as set forth in
the disclosure letter (to the extent each disclosure item therein is
clearly marked to indicate the section, paragraph or subparagraph of this
Agreement to which such disclosure is an exception, referencing the same
section, paragraph and subparagraph as used in this Agreement, in each
case, except to the extent that any such disclosure is reasonably
discernable to apply to more than one section, paragraph or subparagraph
of this Agreement) delivered by Parent and Merger Sub to Holdings and the
Company at the time of execution of this Agreement (the “Parent
Disclosure Letter”) or in the Parent SEC Documents filed on or
after January 1, 2007, Parent and Merger Sub represent and warrant to
Holdings and the Company as
follows:
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(a)
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Organization, Standing
and Corporate Power. Each of Parent and Merger Sub is
duly organized, validly existing and in good standing under the laws of
the jurisdiction in which it is organized and has the requisite corporate
power and authority to carry on its business as now being
conducted. Each of Parent and Merger Sub is duly qualified or
licensed to do business and is in good standing in each jurisdiction
(domestic or foreign) in which the nature of its business or the ownership
or leasing of its properties makes such qualification or licensing
necessary, other than in such jurisdictions where the failure to be so
qualified or licensed (individually or in the aggregate) would not have a
Material Adverse Effect with respect to Parent. Parent has made
available to the Company complete and correct copies of its certificate of
incorporation and by-laws and the certificate of incorporation and by-laws
of Merger Sub.
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(b)
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Capital
Structure. As of the date of this Agreement, the
authorized capital stock of Parent consists of (i) 100,000,000,000 shares
of Parent Common Stock and (ii) 2,000,000 shares of Parent Preferred
Stock. As of the close of business on June 30, 2008, there
were: (i) 5,648,781 shares of Parent Common Stock issued and outstanding,
(ii) 11,666,195 shares of Parent Common Stock issuable upon conversion of
3,227.3617 shares of Parent Preferred Stock, (iii) 163 shares of Parent
Common Stock held in the treasury of Parent; (iv) 52,818 shares of Parent
Common Stock reserved for issuance pursuant to Parent's stock option plans
(collectively, the "Parent
Stock Plans"); (v) 1,293,820 shares of Parent Common Stock issuable
upon exercise of awarded but unexercised stock options; and (vi) warrants
representing the right to purchase 9,461,725 shares of Parent Common
Stock; Except as set forth above, as of the close of business
on June 30, 2008 there were no shares of capital stock or other equity
securities of Parent issued, reserved for issuance or
outstanding. All outstanding shares of capital stock of Parent
are, and all shares which may be issued as described above shall be, when
issued, duly authorized, validly issued, fully paid and nonassessable and
not subject to preemptive rights. The shares of Parent Common
Stock to be issued in connection with the Merger (x) shall, when
issued, be duly authorized, validly issued, fully paid and nonassessable
and not subject to preemptive rights, and (y) shall be issued in
compliance in all material respects with all applicable federal and state
securities laws and applicable rules and regulations promulgated
thereunder. As of the Effective Time of the Merger, the Board
of Directors of Parent shall have reserved for issuance a number of shares
of Parent Common Stock as is required by the Company Warrants to be
assumed by Parent pursuant to Section
2.03. Except as set forth above and in the Rights
Agreement, dated as of October 31, 2001, between Parent and the American
Stock Transfer & Trust Company, there are no outstanding securities,
options, warrants, calls, rights, commitments, agreements, arrangements or
undertakings of any kind to which Parent is a party or by which it is
bound obligating Parent to issue, deliver or sell, or cause to be issued,
delivered or sold, additional shares of capital stock or other equity or
voting securities of Parent or obligating Parent to issue, grant, extend,
accelerate the vesting of or enter into any such security, option,
warrant, call, right, commitment, agreement, arrangement or
undertaking. There are no outstanding contractual obligations,
commitments, understandings or arrangements of Parent to repurchase,
redeem or otherwise acquire or make any payment in respect of any shares
of capital stock of Parent.
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As
of the date hereof, the authorized capital stock of Merger Sub consists of 1,000
shares of common stock, par value $0.01 per share, 100 of which have been
validly issued, are fully paid and nonassessable and are owned by Parent, free
and clear of any Lien, and as of the Closing Date, all the issued and
outstanding shares of the common stock of Merger Sub shall be owned by Parent
free and clear of any Lien.
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(c)
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Authority;
Noncontravention. Parent and Merger Sub have all
requisite corporate power and authority to enter into this Agreement and
to consummate the transactions contemplated hereby. The
execution and delivery of this Agreement by Parent and Merger Sub and the
consummation by Parent and Merger Sub of the transactions contemplated
hereby have been duly authorized by all necessary corporate action on the
part of Parent and Merger Sub. This Agreement has been duly
executed and delivered by each of Parent and Merger Sub, as applicable,
and (assuming due authorization, execution and delivery by the Company)
constitute valid and binding obligations of Parent and Merger Sub, as
applicable, enforceable against them in accordance with their terms,
subject to the effects of bankruptcy, insolvency, fraudulent conveyance,
reorganization, moratorium and other similar laws affecting creditors'
rights generally, general equitable principles (whether considered in a
proceeding in equity or at law) and an implied covenant of good faith and
fair dealing. The execution and delivery of this Agreement does
not, and the consummation by Parent and Merger Sub of the transactions
contemplated by this Agreement and compliance by Merger Sub with the
provisions of this Agreement shall not, conflict with, or result in any
breach or violation of, or default (with or without notice or lapse of
time, or both) under, or give rise to a right of termination, cancellation
or acceleration of, or a "put" right with respect to any obligation under,
or to a loss of a material benefit under, or result in the creation of any
Lien upon any of the properties or assets of Parent or Merger Sub under
(i) the certificate of incorporation or by-laws of Parent or Merger Sub,
(ii) any loan or credit agreement, note, bond, mortgage, indenture,
lease or other agreement, instrument, permit, concession, franchise or
license applicable to Parent or Merger Sub or any of their respective
properties or assets or (iii) subject to the governmental filings and
other matters referred to in the following sentence, any judgment, order,
decree, statute, law, ordinance, rule, regulation or arbitration award
applicable to Parent or Merger Sub or their respective properties or
assets, other than, in the case of clauses (ii) and (iii), any such
conflicts, breaches, violations, defaults, rights, losses or Liens that
individually or in the aggregate would not have a Material Adverse Effect
with respect to Parent or prevent or materially delay the ability of
Parent and Merger Sub to consummate the transactions contemplated by this
Agreement or perform their respective obligations hereunder. No
consent, approval, order or authorization of, or registration, declaration
or filing with, or notice to, any Governmental Entity is required by or
with respect to Parent or Merger Sub in connection with the execution and
delivery of this Agreement by Parent and Merger Sub or the consummation by
Parent and Merger Sub of any of the transactions contemplated hereby,
except for (i) such filings, if any, may be required under the HSR Act and
the filing of any required applications, if any, by Parent and Merger Sub
pursuant to antitrust or similar laws in such foreign jurisdictions as
necessary, (ii) the filing with the SEC of (A) the Form S-4 and (B) such
reports under the Exchange Act as may be required in connection with this
Agreement and the transactions contemplated hereby, (iii) the filing of
the Certificate of Merger with the Secretary of State of the State of
Delaware and appropriate documents with the relevant authorities of other
states in which Parent is qualified to do business, (iv) such other
consents, approvals, orders, authorizations, registrations, declarations,
filings or notices as may be required under the "takeover" or "blue sky"
laws of various states and (v) such other consents, approvals, orders,
authorizations, registrations, declarations, filings or notices the
failure of which to make or obtain, individually or in the aggregate,
could not reasonably be expected to (x) prevent or materially delay
consummation of the Merger or the other transactions contemplated hereby
or performance of Parent's and Merger Sub's obligations hereunder or
(y) have a Material Adverse Effect with respect to
Parent.
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(d)
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Parent SEC Documents;
Undisclosed Liabilities. Parent has filed with the SEC
all reports, schedules, forms, statements and other documents required
pursuant to the Securities Act and the Exchange Act since January 1, 2005
(collectively, and in each case including all exhibits and schedules
thereto and documents incorporated by reference therein, the "Parent
SEC Documents"). As of their respective dates, the
Parent SEC Documents (other than the Parent SEC Financial Statements)
complied in all material respects with the requirements of the Securities
Act or the Exchange Act, as the case may be, and the rules and regulations
of the SEC promulgated thereunder applicable to such Parent SEC
Documents. Except to the extent that information contained in
any Parent SEC Document has been revised or superseded by a later filed
Parent SEC Document, none of the Parent SEC Documents (including any
Parent SEC Financial Statements included therein) contains any untrue
statement of a material fact or omits to state a material fact required to
be stated therein or necessary in order to make the statements therein, in
the light of the circumstances under which they were made, not
misleading. The consolidated financial statements of Parent
included in all Parent SEC Documents filed since January 1, 2005 (the
"Parent
SEC Financial Statements") comply as to form in all material
respects with applicable published accounting requirements and the
published rules and regulations of the SEC with respect thereto, have been
prepared in accordance with generally accepted accounting principles as
applied in the United States (except, in the case of unaudited
consolidated quarterly statements, as permitted by Form 10-Q of the SEC),
applied on a consistent basis during the periods involved (except as may
be indicated in the notes thereto) and fairly present the consolidated
financial position of Parent and its consolidated subsidiaries as of the
dates thereof and the consolidated results of their operations and cash
flows for the periods then ended (subject, in the case of unaudited
quarterly statements, to normal recurring year-end audit
adjustments). Neither Parent nor any of its Subsidiaries has
any liabilities or obligations of any nature (whether accrued, absolute,
contingent or otherwise) required by generally accepted accounting
principles as applied in the United States to be recognized or disclosed
on a consolidated balance sheet of Parent and its Subsidiaries or in the
notes thereto, except (i) liabilities reflected in the audited
consolidated balance sheet of Parent as of December 31, 2006 and (ii)
liabilities incurred since December 31, 2006, in the ordinary course of
business consistent with past
practice.
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(e)
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Information
Supplied. None of the information supplied or to be
supplied by Parent or Merger Sub in writing for inclusion or incorporation
by reference in (i) the Form S-4 shall, at the time the Form S-4 becomes
effective under the Securities Act, contain any untrue statement of a
material fact or omit to state any material fact required to be stated
therein or necessary to make the statements therein not misleading or (ii)
the Information Statement shall, (A) at the date it is first mailed to the
Company's stockholders and/or (B) at the time of the Stockholder Meeting,
contain any untrue statement of a material fact or omit to state any
material fact required to be stated therein or necessary to make the
statements therein, in the light of the circumstances under which they are
made, not misleading. The Form S-4 shall comply as to form in
all material respects with the requirements of the Securities Act and the
rules and regulations promulgated thereunder, except that no
representation is made by Parent or Merger Sub with respect to statements
made or incorporated by reference therein based on information supplied in
writing by the Company specifically for inclusion or incorporation by
reference therein.
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(f)
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Absence of Certain
Changes or Events. Since March 31, 2008, there is not
and has not been: (i) any Material Adverse Change with respect to Parent;
(ii) any condition, event or occurrence which, individually or in the
aggregate, could reasonably be expected to have a Material Adverse Effect
or give rise to a Material Adverse Change with respect to Parent; (iii)
any condition, event or occurrence which, individually or in the
aggregate, could reasonably be expected to prevent or materially delay the
ability of Parent and Merger Sub to consummate the transactions
contemplated by this Agreement or perform their respective obligations
hereunder.
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(g)
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Litigation; Compliance
with Laws.
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Except
as set forth on Schedule
3.02(g) of the Parent Disclosure Schedules, there is no suit, action,
claim, charge, arbitration, investigation or proceeding pending before a
Governmental Entity, and, to the knowledge of Parent, no suit, action, claim,
charge, arbitration, investigation or proceeding pending, in each case with
respect to Parent or any of its Subsidiaries that, individually or in the
aggregate, could reasonably be expected to have a Material Adverse Effect with
respect to Parent or prevent or materially delay the ability of Parent and
Merger Sub to consummate the transactions contemplated by this Agreement or to
perform their respective obligations hereunder, nor is there any judgment,
decree, citation, injunction, rule or order of any Governmental Entity or
arbitrator outstanding against Parent or any of its Subsidiaries which,
individually or in the aggregate, could reasonably be expected to have, a
Material Adverse Effect with respect to Parent. The businesses of
Parent and its Subsidiaries are not being conducted in violation of any law
(domestic or foreign), ordinance or regulation of any Governmental Entity,
except for possible violations which, individually or in the aggregate, do not
and would not have a Material Adverse Effect with respect to
Parent.
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(h)
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Interim Operations of
Merger Sub. Merger Sub was formed on July 10, 2008
solely for the purpose of engaging in the transactions contemplated
hereby, has engaged in no other business activities and has conducted its
operations only as contemplated
hereby.
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(i)
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Required
Vote. This Agreement has been approved by Parent, as the
sole stockholder of Merger Sub. No other vote of holders of any class or
series of securities of Parent or Merger Sub is necessary to approve this
Agreement, the Merger and the transactions contemplated
hereby.
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(j)
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Taxes. Parent
has timely filed all Tax Returns required to be filed by it, each such Tax
Return has been prepared in compliance with all applicable laws and
regulations, and all such Tax Returns are true, accurate and complete in
all respects. Parent has paid all Taxes shown to be due on such
Tax Returns. Parent has made accruals for Taxes on the Parent
SEC Financial Statements that are adequate to cover any Tax liability of
Parent determined in accordance with generally accepted accounting
principles through the date of the applicable Parent SEC Financial
Statements, and any Taxes of Parent arising after the date of the most
recent Parent SEC Financial Statements and at or before the Effective Time
of the Merger have been or will be incurred in the ordinary course of
Parent's business. Parent has timely withheld and timely paid
all Taxes that are required to have been withheld and paid by it in
connection with amounts paid or owing to any employee, independent
contractor, creditor or other person. No outstanding deficiency
or adjustment in respect of Taxes has been proposed, asserted or assessed
by any Tax authority against Parent. Parent has not granted any
outstanding extensions of the time in which any Tax may be assessed or
collected by any Tax authority. There is no action, suit,
proceeding, or audit with respect to any Tax now in progress, pending or,
to the knowledge of Parent, threatened against or with respect to
Parent. Neither Parent nor any of its Subsidiaries has ever
been a member of any affiliated group of corporations (as defined in
Section 1504(a) of the Code) other than a group of which Parent was the
common parent. Neither Parent nor any of its Subsidiaries has
ever filed or been included in a combined, consolidated or unitary Tax
Return other than with respect to a group of which Parent was the common
parent. Parent is neither a party to nor bound by any Tax
sharing agreement or Tax allocation agreement. Neither Parent
nor any of its Subsidiaries is presently liable, nor does Parent or any of
its Subsidiaries have any potential liability, for the Taxes of another
person (i) under Treasury Regulations Section 1.1502-6 or comparable
provision of state, local or foreign law, except with respect to a group
of which Parent was the common parent, (ii) as transferee or successor, or
(iii) by contract or indemnity or otherwise (other than pursuant to
contracts entered into with customers, vendors, real property lessors, or
other third parties the principal purpose of which is not to address Tax
matters). Parent has not participated, within the meaning of
Treasury Regulations Section 1.6011-4(c), in (i) any "reportable
transaction" within the meaning of Section 6011 of the Code and the
Treasury Regulations thereunder, (ii) any "confidential corporate tax
shelter" within the meaning of Section 6111 of the Code and the Treasury
Regulations thereunder, (iii) any "potentially abusive tax shelter" within
the meaning of Section 6112 of the Code and the Treasury Regulations
thereunder, or (iv) any transaction identified as a "transaction of
interest" within the meaning of proposed Treasury Regulations Section
1.6011-4(b)(6). Parent will not be required, as a result of a
change in method of accounting for any period ending on or before or
including the Effective Time of the Merger, to include any adjustment
under Section 481(c) of the Code (or any similar or corresponding
provision or requirement under any other Tax law) in Taxable income for
any period ending on or after the Effective Time of the
Merger. Parent will not be required to include any item of
income in Taxable income for any Taxable period (or portion thereof)
ending after the Closing Date as a result of any (i) prepaid amount
received on or prior to the Closing Date, or (ii) "closing agreement"
described in Section 7121 of the Code (or any similar or corresponding
provision of any other Tax law). Parent has never been either a
"distributing corporation" or a "controlled corporation" in connection
with a distribution of stock qualifying for Tax-free treatment, in whole
or in part, pursuant to Section 355 of the Code. Parent is not
and has not been a United States real property holding corporation within
the meaning of Code Section 897(c)(2), during the applicable period
specified in Code Section 897(c)(1)(A)(ii). For purposes of
this Section 3.02(j), references to Parent shall be deemed to include
Parent and all of its Subsidiaries except where the context indicates
otherwise.
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(k)
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No
Brokers. No broker, investment banker, financial advisor
or other Person (including, without limitation, SCO Capital Partners LLC
and its affiliates) is entitled to any broker's finder's, financial
advisor's or other similar fee or commission in connection with the
transactions contemplated by this Agreement based upon arrangements made
by or on behalf of Parent. Parent hereby indemnifies the
Company and holds the Company harmless from and against any and all
claims, liabilities or obligations with respect to any other fee,
commission or expense asserted by any Person on the basis of any act or
statement alleged to have been made by Parent or its
affiliates.
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(l)
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Disclaimer of Other
Representations and Warranties. The representations and
warranties contained in this Section 3.02,
and in the Officer’s Certificate and Secretary’s Certificate to be
delivered by the Parent under this Agreement, do not contain any untrue
statement of material fact or omit to state any material fact necessary in
order to make the statements and information contained therein not
misleading. The Company acknowledges and agrees that the Parent and
Merger Sub have made no representation or warranty in connection with this
Agreement or the transactions contemplated hereby other than as set forth
in this Section 3.02.
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ARTICLE
IV.
COVENANTS
RELATING TO CONDUCT OF BUSINESS PRIOR TO MERGER
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4.01
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Conduct of Business by
the Company.
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(a)
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During
the period from the date of this Agreement to the Effective Time (except
as otherwise expressly contemplated by the terms of this Agreement or
agreed to in writing by Parent), the Company shall, and shall cause its
Subsidiaries to, act and carry on their respective businesses in the
ordinary course of business consistent with past practice and use its and
their respective reasonable best efforts to preserve substantially intact
their current business organizations, keep available the services of their
current officers and employees and preserve their relationships with
customers, supplies, licensors, licensees, advertisers, distributors and
others having significant business dealings with them. Without
limiting the generality of the foregoing, during the period from the date
of this Agreement to the Effective Time, except as otherwise expressly
contemplated by the terms of this Agreement, the Company Disclosure
Schedule or agreed to in writing by Parent, the Company shall not, and
shall not permit any of its Subsidiaries
to:
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(i) (x)
declare, set aside or pay any dividends on, or make any other distributions in
respect of, any of its capital stock, other than dividends and distributions by
a direct or indirect wholly-owned domestic Subsidiary of the Company to its
parent, (y) split, combine or reclassify any capital stock of the Company or any
Subsidiary or issue or authorize the issuance of any other securities in respect
of, in lieu of or in substitution for shares of capital stock of the Company or
any Subsidiary, or (z) purchase, redeem or otherwise acquire any shares of
capital stock of the Company or any of its Subsidiaries or any other securities
thereof or any rights, warrants or options to acquire any such shares or other
securities;
(ii) authorize
for issuance, issue, deliver, sell, pledge or otherwise encumber any such shares
of its capital stock or the capital stock of any of its Subsidiaries, any other
voting securities or any securities convertible into, or any rights, warrants or
options to acquire, any shares, voting securities or convertible securities or
any other securities or equity equivalents (including, without limitation, stock
appreciation rights), other than the issuance of Company Common Stock upon (a)
the exercise of Company Stock Options awarded but unexercised on the date of
this Agreement in accordance with their present terms, or (b) the conversion of
the Company Warrants awarded but unexercised on the date of this Agreement in
accordance with their present terms;
(iii) amend
the Certificate of Incorporation, By-laws or other comparable charter or
organizational documents of the Company or any Subsidiary;
(iv)
acquire or agree to acquire by merging or consolidating with, or by purchasing a
substantial portion of the stock or assets of, or by any other manner, any
business or any corporation, partnership, joint venture, association or other
business organization or division thereof;
(v)
sell, lease, license, mortgage or otherwise encumber or subject to any Lien or
otherwise dispose of any of its properties or assets, except sales of inventory
and receivables in the ordinary course of business consistent with past
practice;
(vi) (A)
incur any Indebtedness or guarantee any Indebtedness of another Person or amend,
terminate or seek a waiver with respect to any existing agreement of the Company
evidencing Indebtedness of the Company, issue or sell any debt securities or
warrants or other rights to acquire any debt securities of the Company or any of
its Subsidiaries, guarantee any debt securities of another Person, enter into
any "keep well" or other agreement to maintain any financial statement condition
of another Person or enter to any arrangement having the economic effect of any
of the foregoing, except for intercompany Indebtedness between the Company and
its wholly-owned Subsidiaries or between such wholly-owned Subsidiaries, or (B)
make any loans, advances or capital contributions to, or investments in, any
other Person;
(vii) acquire
or agree to acquire any assets, other than inventory in the ordinary course of
business consistent with past practice, or make or agree to make any capital
expenditures;
(viii) pay,
discharge or satisfy any claims (including claims of stockholders), liabilities
or obligations (absolute, accrued, asserted or unasserted, contingent or
otherwise), except for the payment, discharge or satisfaction of (x) liabilities
or obligations in the ordinary course of business consistent with past practice
or in accordance with their terms as in effect on the date hereof or (y) claims
settled or compromised to the extent permitted by Section
4.01(a)(xii), or, except as set forth in the Company Disclosure Letter,
waive, release, grant, or transfer any rights of material value or modify or
change in any material respect any existing material license, lease, contract or
other document;
(ix) adopt
a plan of complete or partial liquidation or resolutions providing for or
authorizing such a liquidation or a dissolution, merger, consolidation,
restructuring, recapitalization or reorganization;
(x) enter
into or amend any collective bargaining agreement;
(xi)
change any material accounting principle used by it, except as required by
generally accepted accounting principles as applied in the United
States;
(xii) settle
or compromise any litigation (whether or not commenced prior to the date of this
Agreement);
(xiii)
engage in any transaction with, or enter into any agreement, arrangement, or
understanding with, directly or indirectly, any of the Company's affiliates
(other than Subsidiaries of the Company);
(xiv) transfer
to any Person any rights to its Intellectual Property;
(xv) enter
into or amend any agreement pursuant to which any other party is granted
exclusive marketing or other exclusive rights of any type or scope with respect
to any of its products or technology;
(xvi) make
any material Tax election or settle or compromise any material federal, state,
local or foreign Tax liability; or
(xvii) authorize,
or commit or agree to take, any of the foregoing actions.
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(b)
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Changes in Employment
Arrangements. Except as otherwise agreed to in writing
by Parent, neither the Company nor any of its Subsidiaries shall adopt or
amend (except as may be required by law) any bonus, profit sharing,
compensation, stock option, pension, retirement, deferred compensation,
employment or other employment benefit plan, agreement, trust, fund or
other arrangement for the benefit or welfare of any employee, director or
former director or employee or increase the compensation or fringe
benefits of any director, employee or former director or employee or pay
any benefit not required by any existing plan, arrangement or
agreement.
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(c)
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Severance. Except
as set forth in Section 3.01(i)(ii)
and/or 3.01(j)(vi) or (x) of the Company Disclosure Schedule,
neither the Company nor any of its Subsidiaries shall grant any new or
modified severance or termination arrangement or increase or accelerate
any benefits payable under its severance or termination pay policies in
effect on the date hereof.
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(d)
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WARN. Neither
the Company nor any of its Subsidiaries shall effectuate a "plant closing"
or "mass layoff," as those terms are defined in WARN, affecting in whole
or in part any site of employment, facility, operating unit or employee of
the Company or any Subsidiary, without notifying Parent in advance and
without complying with the notice requirements and other provisions of
WARN and any similar state or local
law.
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(e)
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Tax Free
Reorganization Treatment. The Company and Parent shall
not, and shall not permit any of their respective Subsidiaries to,
intentionally take or cause to be taken any action not otherwise
consistent with the transactions contemplated by this Agreement which
could reasonably be expected to prevent the Merger from qualifying as a
"reorganization" within the meaning of Section 368(a) of the
Code.
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(f)
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Other
Actions. Neither the Company nor Parent shall, or shall
permit any of its Subsidiaries to, intentionally take any action that
could reasonably be expected to result in any of its representations and
warranties set forth in this Agreement being or becoming untrue in any
material respect, or in any of the conditions to the Merger set forth in
Article VI not being satisfied; provided that the Company and its Board of
Directors shall not be required to take or be prohibited from taking any
action to the extent that such action is not required to be taken or is
permitted, as applicable, pursuant to Section 5.06 of
this Agreement. The Company and Parent shall promptly advise
the other party orally and in writing of (i) any representation or
warranty becoming untrue, (ii) the failure by such party to comply with
any covenant, condition or agreement hereunder and (iii) any event which
could reasonably be expected to cause the conditions set forth in Article
VI not being satisfied; provided, however, that no such notice shall
affect the representations, warranties, covenants and agreement of the
parties or the conditions to their obligations
hereunder.
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ARTICLE V.
ADDITIONAL
AGREEMENTS
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5.01 Preparation of Form
S-4 and Information Statement; Company Financial
Statements.
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(a)
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As
soon as practicable following the date of this Agreement, Parent and the
Company shall prepare the Information Statement and the Form S-4, and
Parent shall file with the SEC the Form S-4, in which the Information
Statement shall be included. Each party shall notify the other party
promptly upon the receipt of any comments from the SEC or its staff and of
any request by the SEC or its staff or any government officials for
amendments or supplements to the Form S-4 or the Information Statement, or
for any other filing or for additional information and shall supply the
other party with copies of all correspondence between such party or any of
its representatives, on the one hand, and the SEC, or its staff or any
other government officials, on the other hand, with respect to the Form
S-4, the Information Statement, the Merger or any other
filing. Parent and the Company shall each use its reasonable
best efforts to have the Form S-4 declared effective under the Securities
Act as promptly as practicable after such filing. The Company
shall use its reasonable best efforts to cause the Information Statement
to be mailed to the Company's stockholders as promptly as practicable
after the Form S-4 is declared effective under the Securities
Act. Parent shall also take any action (other than qualifying
to do business in any state in which it is not now so qualified or filing
a general consent to service of process) required to be taken under any
applicable state securities laws in connection with the registration and
qualification of the Parent Common Stock to be issued in the Merger, and
the Company shall furnish all information relating to the Company and its
stockholders as may be reasonably requested in connection with any such
action.
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(b)
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The
Company’s Board of Directors may withdraw or modify such recommendation if
the Board of Directors of the Company shall have concluded in good faith
on the basis of advice from outside counsel that such action is required
in order to satisfy its fiduciary duties to the stockholders of the
Company under applicable law. Any such recommendation shall be
included in the Information
Statement.
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(c)
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The
Company shall use its reasonable best efforts to promptly (i) prepare
all financial statements of the Company required for the Parent to timely
file with the SEC the financial statements required under Items 2.01 and
9.01 of Form 8-K including, without limitation, the Company Financial
Statements in compliance with Regulation S-X promulgated under the
Securities Act and (ii) obtain the consent of Vitale, Caturano &
Company, Ltd. and any other required consents of accountants to use their
opinion with respect to the Company Financial Statements in any SEC
filings that may be necessary in connection with the transactions
contemplated by this Agreement.
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5.02
Access to
Information;
Confidentiality.
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Each
of the Company and Parent shall, and shall cause its officers, employees,
counsel, financial advisors and other representatives to afford to the other
party and its representatives reasonable access during normal business hours,
during the period prior to the Effective Time to its properties, books,
contracts, commitments, personnel and records, and, during such period, each of
the Company and Parent shall, and shall cause its officers, employees and
representatives to furnish promptly to the other documents filed by it during
such period pursuant to the requirements of federal or state securities laws and
(ii) all other information concerning its business, properties, financial
condition, operations and personnel as such other party may from time to
time reasonably request. Each of the Company and Parent shall hold, and shall
cause its respective directors, officers, employees, accountants, counsel,
financial advisors and other representatives and Affiliates to hold, any
nonpublic information in confidence to the extent required by, and in accordance
with, the provisions of the confidentiality agreement between Parent and the
Company (the “Confidentiality
Agreement”). No investigation pursuant to this Section 5.02
shall affect any representations or warranties of the parties herein or the
conditions to the obligations of the parties hereto.
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5.03
Reasonable Best
Efforts. Upon the terms and subject to the conditions set forth in
this Agreement, each of the parties agrees to use its reasonable best
efforts to take, or cause to be taken, all actions, and to do, or cause to
be done, and to assist and cooperate with the other parties in doing, all
things necessary, proper or advisable under applicable laws and
regulations to consummate and make effective, in the most expeditious
manner practicable, the Merger and the other transactions contemplated by
this Agreement, including (i) obtaining all consents, approvals,
waivers, licenses, permits or authorizations as are required to be
obtained (or, which if not obtained, would result in an event of default,
termination or acceleration of any agreement or any put right under any
agreement) under any applicable law or regulation or from any Governmental
Entities or third parties in connection with the transactions contemplated
by this Agreement, (ii) defending any lawsuits or other proceedings
challenging this Agreement, (iii) accepting and delivering additional
instruments necessary to consummate the transaction contemplated by this
Agreement, and (iv) satisfying the conditions to closing set forth
under Article V hereof.
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5.04
Indemnification
of Company Directors and
Officers.
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(a)
From and after the Effective Time, Parent and the Surviving Corporation
shall jointly and severally indemnify, defend and hold harmless each
person who is now, or has been at any time prior to the date hereof or who
becomes prior to the Effective Time eligible for indemnification pursuant
to the Company Certificate and Company By-laws (or comparable
organizational documents) of the Company or any agreement of
indemnification with the Company, in each case as the same existed on the
date of this Agreement (the “Indemnified
Parties”) against (i) all losses, claims, fines, damages,
costs, expenses (including, without limitation, reasonable attorneys’
fees), liabilities or judgments, or amounts that are paid in settlement of
or in connection with any claim, action, suit, proceeding or investigation
(whether civil, criminal or administrative) based in whole or in
part on or arising in whole or in part out of the fact that such
person is or was a director, officer or employee of the Company,
pertaining to any matter existing or occurring at or prior to the
Effective Time, whether asserted or claimed prior to, or at or after, the
Effective Time (“Indemnified
Liabilities”) and (ii) all Indemnified Liabilities based in
whole or in part on, or arising in whole or in part out of, or
pertaining to this Agreement or the transaction contemplated hereby, in
each case to the extent the Company would have been permitted under the
Company Certificate and Company By-laws (or comparable organizational
documents) or any agreement of indemnification with the Company to
indemnify such person, in each case as the same existed on the date of
this Agreement. In the event any such claim, action, suit, proceeding or
investigation is brought against any Indemnified Parties (whether arising
before or after the Effective Time), (i) any counsel retained by the
Indemnified Parties for any period after the Effective Time shall be
reasonably satisfactory to Parent; (ii) after the Effective Time,
Parent or the Surviving Corporation shall pay all reasonable fees and
expenses of such counsel for the Indemnified Parties promptly as
statements therefor are received; and (iii) after the Effective Time,
Parent and the Surviving Corporation shall cooperate in the defense of any
such matter, provided that neither Parent nor the Surviving Corporation
shall be liable for any settlement of any claim effected without its
written consent, which consent shall not be unreasonably withheld. Any
Indemnified Party wishing to claim indemnification under this Section 5.04,
upon learning of any such claim, action, suit, proceeding or
investigation, shall notify Parent and the Surviving Corporation (but the
failure so to notify Parent and the Surviving Corporation shall not
relieve either from any liability which it may have under this Section 5.04
except to the extent such failure prejudices Parent and the Surviving
Corporation). Parent and the Surviving Corporation shall be liable for the
fees and expenses hereunder with respect to only one law firm to represent
the Indemnified Parties as a group with respect to each such matter unless
there is, under applicable standards of professional conduct, a conflict
between the positions of any two or more Indemnified Parties that would
preclude or render inadvisable joint or multiple representation of such
parties.
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(b)
If Parent or the Surviving Corporation or any of their respective
successors or assigns (i) shall consolidate with or merge into any
other corporation or entity and shall not be the continuing or surviving
corporation or entity of such consolidation or merger or (ii) shall
transfer all or substantially all of its properties and assets to any
individual, corporation or other entity, then, and in each such case,
proper provisions shall be made so that the successors and assigns of
Parent or the Surviving Corporation shall assume all of the obligations
set forth in this Section 5.04.
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(c) The
provisions of this Section 5.04
are intended to be for the benefit of, and shall be enforceable by, each
of the Indemnified Parties.
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(d) The
rights of the Indemnified Parties under this Section 5.04
shall be in addition to any rights such Indemnified Parties may have
under the Company Certificate or Company By-laws, or under any applicable
contracts or laws.
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(e) No Circular
Recovery. The obligations of the Parent and the Surviving
Corporation in this Section 5.04
are subject to the condition that each Indemnified Party will not make any
claim for indemnification against the Parent, the Surviving Corporation or
the Company by reason of the fact that such Indemnified Party was a
controlling person, director, employee or representative of the Company or
the Surviving Corporation or was serving as such for another Person at the
request of the Company (whether such claim is for losses of any kind or
otherwise and whether such claim is pursuant to any statute,
organizational document, contractual obligation or otherwise) with respect
to any claim brought by the Parent or its affiliates relating to this
Agreement that is finally and successfully adjudicated against such
Indemnified Party. With respect to any claim brought by the Parent or its
affiliates against any Indemnified Party relating to this Agreement that
is finally and successfully adjudicated against such Indemnified Party,
the obligations of the Parent and the Surviving Corporation in this Section 5.04
are subject to the condition that any right of subrogation, contribution,
advancement, indemnification or other claim against the Company with
respect to any amounts owed by any Indemnified Party shall not be
applicable.
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5.05 Public
Announcements. Neither Parent and Merger Sub, on the one hand, nor
the Company, on the other hand, shall issue any press release or public
statement with respect to the transactions contemplated by this Agreement,
including the Merger, without the other party’s prior consent (such
consent not to be unreasonably withheld or delayed), except as may be
required by applicable law, court process or by obligations pursuant to
any agreement with any securities exchange or quotation system on which
securities of the disclosing party are listed or quoted. In addition to
the foregoing, Parent, Merger Sub and the Company shall consult with each
other before issuing, and provide each other the opportunity to review and
comment upon, any such press release or other public statements with
respect to such transactions. The parties agree that the initial press
release or releases to be issued with respect to the transactions
contemplated by this Agreement shall be mutually agreed upon prior to the
issuance thereof.
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5.06
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No
Solicitation. The Company shall not (whether directly or
indirectly through advisors, agents or other intermediaries), nor shall
the Company authorize or permit any of its or their officers, directors,
agents, representatives or advisors to, (a) solicit, initiate or take any
action knowingly to facilitate the submission of inquiries, proposals or
offers from any Person (other than Merger Sub or Parent) relating to (i)
any acquisition or purchase of 33.33% or more of the assets of the Company
or of over 33.33% of any class of equity securities of the Company, (ii)
any tender offer (including a self tender offer) or exchange offer that if
consummated would result in any Person beneficially owning 33.33% or more
of any class of equity securities of the Company, (iii) any merger,
consolidation, business combination, sale of substantially all assets,
recapitalization, liquidation, dissolution or similar transaction
involving the Company whose assets, individually or in the aggregate,
constitute more than 33.33% of the consolidated assets of the Company
other than the transactions contemplated by this Agreement, or (iv) any
other transaction the consummation of which would or could reasonably be
expected to impede, interfere with, prevent or materially delay the Merger
(collectively, "Transaction
Proposals"), or agree to or endorse any Transaction Proposal, or
(b) enter into or participate in any discussions or negotiations regarding
any of the forgoing, or furnish to any other Person any information with
respect to its business, properties or assets or any of the foregoing, or
otherwise cooperate in any way with, or knowingly assist or participate
in, facilitate or encourage, any effort or attempt by any other Person
(other than Merger Sub or Parent) to do or seek any of the foregoing;
provided, however, that the foregoing shall not prohibit the Company
(either directly or indirectly through advisors, agents or other
intermediaries) from (i) furnishing information pursuant to an appropriate
confidentiality letter (which letter shall not be less favorable to the
Company in any material respect than the Confidentiality Agreement, a copy
of which shall be provided for informational purposes only to Parent)
concerning the Company and its businesses, properties or assets to a third
party who has made a bona fide Transaction Proposal, (ii) engaging in
discussions or negotiations with such a third party who has made a bona
fide Transaction Proposal, (iii) following receipt of a bona fide
Transaction Proposal, taking and disclosing to its stockholders a position
contemplated by Rule 14d-9 or Rule 14e-2(a) under the Exchange Act or
otherwise making disclosure to its stockholders, (iv) following receipt of
a bona fide Transaction Proposal, failing to make or withdrawing or
modifying its recommendation referred to in Section 3.01,
and/or (v) taking any action required to be taken by the Company pursuant
to a non-appealable, final order by any court of competent jurisdiction,
but in each case referred to in the foregoing clauses (i) through (iv)
only to the extent that the Board of Directors of the Company shall have
concluded in good faith on the basis of advice from outside counsel that
such action is required in order to satisfy its fiduciary duties to the
stockholders of the Company under applicable law; provided, further, that
the Board of Directors of the Company shall not take any of the foregoing
actions referred to in clauses (i) through (iv) until after prompt advance
notice to Parent (which notice shall in no event be given less than two
(2) business day prior to furnishing such information or entering into
such discussions) with respect to such action and that such Board of
Directors shall, to the extent consistent with its fiduciary duties,
continue to advise Parent after taking such action and, in addition, if
such Board of Directors receives a Transaction Proposal, then the Company
shall promptly inform Parent of the terms and conditions of such proposal
and the identity of the Person making it. The Company shall immediately
cease and cause its advisors, agents and other intermediaries to cease any
and all existing activities, discussions or negotiations with any parties
conducted heretofore with respect to any of the foregoing, and shall use
its reasonable best efforts to cause any such parties in possession of
confidential information about the Company that was furnished by or on
behalf of the Company to return or destroy all such information in the
possession of any such party or in the possession of any agent or advisor
of any such party.
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5.06 Shareholder Rights
Plan. The Parent shall take all action necessary to render the
Shareholder Rights Plan inapplicable to the execution, delivery and
performance of this Agreement and the transactions contemplated
hereby.
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5.07 Tax Free
Reorganization Treatment. The Company, Parent and Merger Sub shall
not intentionally take or cause to be taken any action not consistent with
the transactions contemplated by this Agreement or which could reasonably
be expected to prevent the Merger from qualifying as a “reorganization”
within the meaning of Section 368(a) of the
Code.
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5.08
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Termination of Company
Plans. Effective no later than the day immediately
preceding the Closing Date but contingent upon the Closing, the Company
shall terminate any and all Company Plans intended to include a Code
Section 401(k) arrangement (collectively, the "Terminated
Company Plans"). The Company shall provide Parent with
evidence that such Terminated Company Plan(s) have been terminated
(effective no later than the day immediately preceding the Closing Date)
in accordance with each such Terminated Company Plan’s respective
terms. The Company also shall take such other actions in
furtherance of terminating such Terminated Company Plan(s) as Parent may
reasonably require.
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ARTICLE VI.
CONDITIONS
PRECEDENT
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6.01
Conditions to
each Party’s Obligation to Effect the Merger. The respective
obligation of each party to effect the Merger is subject to the
satisfaction or waiver on or prior to the Closing Date of the following
conditions:
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(a) No Injunctions or
Restraints. No temporary restraining order, preliminary or
permanent injunction or other order issued by any court of competent
jurisdiction or other legal restraint or prohibition preventing the
consummation of the Merger shall be in effect; provided, however, that the
parties hereto shall use their reasonable best efforts to have any such
injunction, order, restraint or prohibition
vacated;
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(b)
Governmental
Approvals. Other than the filing of the Delaware Certificate of
Merger, all authorizations, consents, orders or approvals of, or
declarations or filings with, or expirations of waiting periods imposed
by, any Governmental Entity in connection with the Merger and the
consummation of the other transactions contemplated by this Agreement, the
failure of which to file, obtain or occur is reasonably likely to have a
Material Adverse Effect with respect to Parent or a Material Adverse
Effect with respect to the Company, shall have been filed, been obtained
or occurred on terms and conditions which would not reasonably be likely
to have a Material Adverse Effect with respect to Parent or a Material
Adverse Effect with respect to the
Company;
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(c)
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Form
S-4. The Form S-4 shall have become effective under the
Securities Act and shall not be the subject of any stop order or
proceedings seeking a stop order, and any material "blue sky" and other
state securities laws applicable to the registration and qualification of
Parent Common Stock issuable or required to be reserved for issuance
pursuant to this Agreement shall have been complied
with;
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(d)
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Information
Statement. No stop order suspending the use of the
Information Statement shall have been issued and no proceeding for that
purpose shall have been initiated or threatened in writing by the SEC or
its staff;
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(e)
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Flow of Funds
Memorandum. Parent and the Company shall have executed
and delivered a mutually agreeable Flow of Funds Memorandum setting forth
certain payments to be made by Parent concurrently with the Closing (the
“Flow
of Funds Memorandum”);
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(f)
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Stockholder
Approval. The Merger and this Agreement shall have been
approved and adopted by the requisite vote of the holders of shares of
Company Common Stock to the extent required pursuant to the requirements
of the certificate of incorporation and the
DGCL;
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6.02 Conditions to
Obligations of Parent and Merger Sub. The obligations of Parent and
Merger Sub to effect the Merger are further subject to the following
conditions:
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(a) Representations and
Warranties. The representations and warranties of the Company
contained in this Agreement shall be true and correct in all material
respects on and as of the Closing Date, with the same force and effect as
if made on and as of the Closing Date, except for (i) changes
contemplated by this Agreement or in the Company Disclosure Letter,
(ii) representations and warranties that are qualified by materiality
or Material Adverse Effect, in which case such representations and
warranties shall be true and correct in all respects, and
(iii) representations and warranties which address matters only as of
a particular date, in which case such representations and warranties
qualified as to materiality or Material Adverse Effect shall be true and
correct in all respects, and those not so qualified shall be true and
correct in all material respects, on and as of such particular date; and
Parent shall have received a certificate to such effect signed by the
president of the Company.
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(b) Performance of
Obligations of the Company. The Company shall have performed in all
material respects all obligations required to be performed by it under
this Agreement at or prior to the Closing Date. Parent shall have received
a certificate dated as of the Closing Date signed on behalf of the Company
by the president of the Company to the effect set forth in this
paragraph.
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(c) Consents, Etc.
Parent and Merger Sub shall have received evidence, in form and
substance reasonably satisfactory to Parent, that such licenses, permits,
consents, approvals, authorizations, qualifications and orders of
governmental authorities and other third parties as are necessary in
connection with the transactions contemplated hereby have been obtained,
except where the failure to obtain such licenses, permits, consents,
approvals, authorizations, qualifications and orders would not,
individually or in the aggregate with all other failures, have a Material
Adverse Effect with respect to the
Company.
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(d) No Litigation.
There shall not be pending by any Governmental Entity or any other
Person or solely with respect to any Governmental Entity, threatened by
any suit, action or proceeding, (i) challenging or seeking to
restrain or prohibit the consummation of the Merger or any of the other
transactions contemplated by this Agreement or seeking to obtain from any
party hereto or any of their Affiliates any damages that are material in
relation to the Company; (ii) seeking to prohibit or limit the
ownership or operation by the Company of any material portion of the
business or assets of the Company or to dispose of or hold separate any
material portion of the business or assets of the Company, as a result of
the Merger or any of the other transactions contemplated by this
Agreement; (iii) seeking to impose limitations on the ability of
Parent to acquire or hold, or exercise full rights of ownership of, any
shares of the common stock of the Surviving Corporation, including,
without limitation, the right to vote such common stock on all matters
properly presented to the stockholders of the Surviving Corporation; or
seeking to prohibit Parent or any of its Subsidiaries from effectively
controlling in any material respect the business or operations of the
Company.
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(e)
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Termination of Company
Options and certain Company Warrants. The Company shall
have complied with the requirements of the 1994 Equity Incentive Plan and
the 2001 Incentive Plan (together, the “Company
Option Plans”) in connection with offering holders of the Company
Options and Company Warrants (other than the In the Money Company
Warrants) the opportunity to exercise all such Company Options and Company
Warrants held by such holder prior to the Effective Time. At
the Effective Time, all outstanding Company Options and Company Warrants
not exercised (other than the In the Money Company Warrants) shall be
terminated and each such holder shall have no further rights thereunder to
purchase shares of Company Common Stock. At the Effective Time,
the In the Money Company Warrants shall automatically convert into the
right to receive Merger Consideration as provided in Article II
above.
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(f) Directors and
Officers. As of the Effective
Time:
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(i)
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Consulting and
Transition Agreement. Parent and the Company’s President &
Chief Business Officer shall have mutually agreed on terms to discharge
the Company’s obligations and agree upon the terms of that certain
Consulting and Transition Agreement, in the form attached as Exhibit
A hereto; and
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(g) No Material Adverse
Effect. Since the date of this Agreement, there shall not have
occurred any Material Adverse Effect or Material Adverse Change with
respect to the Company.
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(h) Dissenters’
Rights. Any applicable period during which stockholders
of the Company have the right to exercise appraisal, dissenters' or other
similar rights under Section 262 of the DGCL or other applicable law shall
have expired and stockholders of the Company holding in the aggregate more
than five percent (5%) of the outstanding shares of Company Common Stock
shall not have exercised appraisal, dissenters' or similar rights under
Section 262 of the DGCL or other applicable law with respect to such
shares by virtue of the Merger.
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(i) Resignation of
Directors and Officers. Except as set forth in Sections 1.06 and
1.07, the directors and officers of the Company, in office
immediately prior to the Effective Time shall have resigned as directors
and officers of the Surviving Corporation effective as of the Effective
Time.
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(f)
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FIRPTA
Certificate. The Company shall have delivered a properly
executed statement, dated as of the Closing Date, in a form reasonably
acceptable to Parent, conforming to the requirements of Treasury
Regulations Section 1.1445-2(c)(3).
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6.03 Conditions to
Obligations of the Company. The obligation of the Company to
effect the Merger is further subject to the following
conditions:
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(a) Representations and
Warranties. The representations and warranties of the Parent
and Merger Sub contained in this Agreement shall be true and correct in
all material respects on and as of the Closing Date, with the same force
and effect as if made on and as of the Closing Date, except for
(i) changes contemplated by this Agreement or in the Parent
Disclosure Letter, (ii) representations and warranties that are
qualified by materiality or Material Adverse Effect, in which case such
representations and warranties shall be true and correct in all respects,
and (iii) representations and warranties which address matters only
as of a particular date, in which case such representations and warranties
qualified as to materiality or Material Adverse Effect shall be true and
correct in all respects, and those not so qualified shall be true and
correct in all material respects, on and as of such particular date; and
the Company shall have received a certificate to such effect signed by an
authorized officer of Parent and Merger
Sub.
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(b) Performance of
Obligations of Parent and Merger Sub. Parent and Merger Sub
shall have performed in all material respects all obligations required to
be performed by each of them under this Agreement at or prior to the
Closing Date. Holdings and the Company shall have received a certificate
dated as of the Closing Date signed on behalf of Parent and Merger Sub by
an authorized officer of Parent and Merger Sub to the effect set forth in
this paragraph.
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(c) No Litigation.
There shall not be pending by any Governmental Entity or any other Person
or solely with respect to any Governmental Entity, threatened by any suit,
action or proceeding, challenging or seeking to restrain or prohibit the
consummation of the Merger or any of the other transactions contemplated
by this Agreement.
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(d) Parent Consents,
Etc. The Company shall have received evidence, in form and
substance reasonably satisfactory to the Company, that such licenses,
permits, consents, approvals, authorizations, qualifications and orders of
governmental authorities and other third parties as are necessary in
connection with the transactions contemplated hereby have been obtained,
except where the failure to obtain such licenses, permits, consents,
approvals, authorizations, qualifications and orders would not,
individually or in the aggregate with all other failures, have a Material
Adverse Effect with respect to the
Parent.
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ARTICLE
VII.
TERMINATION,
AMENDMENT, AND WAIVER
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7.01
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Termination. This
Agreement may be terminated and abandoned at any time prior to the
Effective Time:
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(a) by
mutual written consent of Parent and the Company;
(b) by
either Parent or the Company if any Governmental Entity shall have issued an
order, decree, or ruling or taken any other action permanently enjoining,
restraining, or otherwise prohibiting the Merger and such order, decree, ruling,
or other action shall have become final and nonappealable;
(c) by
either Parent or the Company if the Merger shall not have been consummated on or
before October 31, 2008 (other than due to the failure of the party seeking to
terminate this Agreement to perform in any material respect its obligations
under this Agreement required to be performed at or prior to the Effective
Time);
(d) by
either Parent or the Company if the Company Stockholder Approval shall not have
been obtained;
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(e)
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by
Parent, if the Company or its Board of Directors shall have (1) failed to
approve, withdrawn, modified, or amended in any respect adverse to Parent
its approval or recommendation of this Agreement or any of the
transactions contemplated herein; (2) failed as promptly as reasonably
practicable after the Form S-4 is declared effective to mail the
Information Statement to its stockholders or failed to include in such
statement such recommendation; (3) recommended any Transaction Proposal
from a Person other than Parent or any of its affiliates; (4) resolved to
do any of the foregoing; or (5) in response to the commencement of any
tender offer or exchange offer for more than 10% of the outstanding shares
of Company Common Stock, not recommended rejection of such tender offer or
exchange offer at the time of filing of the requisite Schedule 14d-9 with
the SEC;
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(f)
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by
the Company, if the Company has received a Superior Proposal, which the
Company’s Board of Directors determines in good faith (after consultation
with its financial advisors) continues to constitute a Superior
Proposal. For purposes of this Agreement, a “Superior Proposal”
is an Acquisition Proposal for 100% of the Company Common Stock that
involves consideration to the holders of shares of Company Common Stock
that is superior to the consideration offered to such holders pursuant to
the Merger and that otherwise represents a superior transaction to the
Merger in the reasonable discretion of the Company’s Board of
Directors;
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(g)
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by
Parent, upon a breach of any representation, warranty, covenant or
agreement on the part of the Company set forth in this Agreement, or if
any representation or warranty of the Company shall have become untrue, in
either case such that the conditions set forth in Section 6.02(a)
or Section
6.02(b) (other than with respect to the delivery of the officers'
certificates required thereunder) would not be satisfied at the time of
such breach or as of the time such representation or warranty shall have
become untrue; provided that if such inaccuracy in the Company's
representations and warranties or breach by the Company is curable by the
Company through the exercise of its commercially reasonable efforts within
ten (10) business days of the time such representation or warranty shall
have become untrue or such breach, Parent may not terminate this Agreement
under this Section 6.01(g)
during such ten-day period, provided Company continues to exercise such
commercially reasonable efforts; or
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(h)
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by
the Company, upon a breach of any representation, warranty, covenant or
agreement on the part of Parent or Merger Sub set forth in this Agreement,
or if any representation or warranty of Parent shall have become untrue,
in either case such that the conditions set forth in Section 6.03(a)
or Section
6.03(b) (other than with respect to the delivery of the officers'
certificates required thereunder) would not be satisfied at the time of
such breach or as of the time such representation or warranty shall have
become untrue; provided that if such inaccuracy in Parent's
representations and warranties or breach by Parent is curable by Parent
through the exercise of its commercially reasonable efforts within ten
(10) business days of the time such representation or warranty shall have
become untrue or such breach, the Company may not terminate this Agreement
under this Section 6.01(h)
during such ten-day period provided Parent continues to exercise such
commercially reasonable effort.
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7.02
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Effect of
Termination. In the event of termination of this
Agreement by either the Company or Parent as provided in Section 7.01,
this Agreement shall forthwith become void and have no effect, without any
liability or obligation on the part of Parent, Merger Sub, or the Company,
provided that (a) any such termination shall not relieve a party from
liability for any willful breach of this Agreement and (b) the last
sentence of Section
4.02(a), this Section 7.02,
Section
8.07 and the Confidentiality Agreement shall remain in full force
and effect and survive any such termination. Nothing contained in this
paragraph shall relieve any party for any breach of the covenants or
agreements set forth in this Agreement or the Confidentiality
Agreement.
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7.03
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Amendment. This
Agreement may be amended by the parties at any time before or after any
required approval of matters presented in connection with the Merger by
the stockholders of the Company; provided, however, that after any such
approval, there shall be made no amendment that by law requires further
approval by such stockholders without the further approval of such
stockholders. This Agreement may not be amended except by an instrument in
writing signed on behalf of each of the
parties.
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7.04
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Extension;
Waiver. At any time prior to the Effective Time, the
parties may (a) extend the time for the performance of any of the
obligations or other acts of the other parties; (b) waive any inaccuracies
in the representations and warranties contained in this Agreement or in
any document delivered pursuant to this Agreement; or (c) subject to the
provisions of Section 7.03,
waive compliance with any of the agreements or conditions contained in
this Agreement. Any agreement on the part of a party to any such extension
or waiver shall be valid only if set forth in an instrument in writing
signed on behalf of such party. The failure of any party to this Agreement
to assert any of its rights under this Agreement or otherwise shall not
constitute a waiver of such rights.
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7.05
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Procedure for
Termination, Amendment, Extension or Waiver. A
termination of this Agreement pursuant to Section 7.01,
an amendment of this Agreement pursuant to Section 7.03 or
an extension or waiver pursuant to Section 7.04
shall, in order to be effective, require in the case of any party hereto
an action by its Board of Directors or a duly-authorized designee of its
Board of Directors.
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VIII.
GENERAL
PROVISIONS
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8.01
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Nonsurvival of
Representations and Warranties. None of the
representations and warranties in this Agreement or in any instrument
delivered pursuant to this Agreement shall survive the Effective Time and
all such representations and warranties shall be extinguished on
consummation of the Merger and no party hereto nor any officer, director
or employee or stockholder of any of them shall be under any liability
whatsoever with respect to any such representation or warranty after such
time. This Section 8.01
shall not limit any covenant or agreement of the parties which by its
terms contemplates performance after Effective
Time.
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8.02
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Fees and
Expenses.
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Except
as set forth in this Section 8.02,
all fees and expenses incurred in connection with this Agreement and the
transactions contemplated hereby shall be paid by the party incurring such fees
and expenses, whether or not the Merger is consummated; provided however, that
the Company and Parent shall share equally all fees and expenses, other than
accountants' and attorneys' fees, incurred with respect to the printing, filing
and mailing of the S-4 and the Information Statement (including any related
preliminary materials) and any amendments or supplements thereto.
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8.03
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Notices. All
notices, requests, claims, demands and other communications under
this Agreement shall be in writing and
shall be deemed given if delivered personally or sent by overnight courier
(providing proof of delivery) to the parties at the following addresses
(or at such other address for a party as shall be specified by like
notice):
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(a)
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if
to Parent or Merger Sub, to
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Access
Pharmaceuticals, Inc.
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
Attention: Jeffrey
B. Davis
Telecopier
No.: (214) 905-5101
with
a copy to:
Bingham
McCutchen LLP
One
Federal Street
Boston,
MA 02110
Attention: John
J. Concannon III, Esq.
Telecopier
No.: (617) 951-8736
(b) if
to the Company or its Subsidiaries, to
MacroChem
Corporation
80
Broad Street, 22nd Floor
New
York, New York 10004
Attention: President
Telecopier
No.: (212) 514-8613
with
a copy to:
Hiscock
& Barclay LLP
258
Genesee Street, Suite 305
Utica,
New York 13502
Attention: John
A. Jadhon, Esq.
Telecopier
No.: (315) 624-7359
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8.04 Definitions.
For purposes of this Agreement:
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(a)
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“Acquisition
Proposal” means any solicitation, initiation, encouragements, discussions,
negotiations and communications regarding a similar transaction with any
third party involving:
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1. Any
acquisition or purchase from the Company by any person or “group” as defined
under Section 13(d) of the Exchange Act of more than a 20% interest in the
Company Common Stock or any tender offer or exchange offer that if consummated
would result in any person or “group” (as defined in Section 13(d) of the
Exchange Act) beneficially owning 20% or more of the total outstanding voting
securities of the Company;
2. any
consolidation, business combination, merger or similar transaction involving the
Company;
3. any
sale, lease, exchange, transfer, license, acquisition or disposition of assets
of the Company or its Subsidiaryfor consideration equal to 20% or more of the
market value of all of the outstanding shares of Company Common Stock on the
last trading day prior to the date of this Agreement; or
4. Any
recapitalization, restructuring, liquidation or dissolution of the
Company.
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(b)
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“Affiliate”
of any Person means another Person that directly or indirectly, through
one or more intermediaries, controls, is controlled by, or is under common
control with, such first Person;
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(c)
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“Agreement”
has the meaning set forth in the
preamble;
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(d)
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“Certificates”
shall have the meaning ascribed thereto in Section
2.01(d);
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(e)
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Certificate
of Merger” shall have the meaning ascribed thereto in Section
1.03;
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(f)
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“C.F.R.”
shall have meaning ascribed thereto in Section 3.01(p)(ii);
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(g)
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“Closing”
shall have meaning ascribed thereto in Section 1.02;
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(h)
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“Closing
Date” shall have meaning ascribed thereto in Section 1.02;
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(i)
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“Code”
shall have meaning ascribed thereto in the fourth recital to this
Agreement;
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(j)
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“Common
Stock Exchange Ratio” shall have meaning ascribed thereto in Section 2.01(c)(i);
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(k)
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“Company”
shall have meaning ascribed thereto in the preamble to this
Agreement;
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(l)
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“Company
By-laws” shall have the meaning set forth in Section
3.01(a);
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(m) “Company
Certificate” shall have meaning ascribed thereto in Section 3.01(a);
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(n) “Company
Common Stock” means the common stock, par value $0.001 per share, of the
Company;
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(o) “Company
Disclosure Letter” shall have meaning ascribed thereto in Section 3.01;
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(p) “Company
Financial Statements” shall have meaning ascribed thereto in Section 3.01(e);
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(q) “Company
Insurance Policy” shall have meaning ascribed thereto in Section 3.01(q);
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(r) “Company
Leases” shall have meaning ascribed thereto in Section 3.01(j);
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(s)
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“Company
Note” or “Company Notes” shall have the meaning ascribed thereto in Section
2.01(e);
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(t) “Company
Options” means the options to purchase shares of Company Common Stock
listed in Section 3.01(c)
of the Company Disclosure Letter;
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(u)
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“Company
Option Plans” shall have the meaning set forth in Section
6.02(e);
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(v)
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“Company
Plans” shall have the meaning set forth in Section
3.01(i)(i);
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(w) “Company
Permits” shall have meaning ascribed thereto in Section 3.01(p)(i);
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(x)
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“Company
SEC Documents” shall have the meaning ascribed thereto in Section
3.01(e);
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(y) “Company
Warrants” means warrants to purchase shares of Company Common Stock as
listed in Section 3.01(c) of
the Company Disclosure Letter;
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(z) “Confidentiality
Agreement” shall have meaning ascribed thereto in Section 4.02(a);
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(aa) “Controlled
Group” shall have meaning ascribed thereto in Section 3.01(h)(iii);
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(bb) “Delaware
Certificate of Merger” shall have meaning ascribed thereto in Section 1.03;
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(cc)
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“Dissenting
Shares” shall have the meaning set forth in Section
2.04;
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(dd) “DGCL”
shall have meaning ascribed thereto in the second recital to this
Agreement;
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(ee) “Effective
Time” shall have meaning ascribed thereto in Section 1.03;
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(ff) “Environmental
Claim” means any written or oral notice, claims, demand, action, suit,
complaint, proceeding or other communication by any Person alleging
liability or potential liability (including without limitation liability
or potential liability for investigatory costs, cleanup costs,
governmental response costs, natural resource damages, property damage,
personal injury, fines or penalties) arising out of, relating to, based on
or resulting from (A) the presence, discharge, emission, release or
threatened release of any Hazardous Materials at any location, whether or
not owned, leased or operated by the Company or Parent (as applicable) or
(B) circumstances forming the basis of any violation or alleged
violation of any Environmental Law or Environmental Permit or
(C) otherwise relating to obligations or liabilities under any
Environmental Laws;
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(gg) “Environmental
Permits” means all permits, licenses, registrations and other governmental
authorizations required under Environmental Laws for the Company or Parent
(as applicable) to conduct its operations and business on the date hereof
and consistent with past practices;
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(hh) “Environmental
Laws” means all applicable federal, state and local statutes, rules,
regulations, ordinances, orders, decrees and common law relating in any
manner to contamination, pollution or protection of the environment,
including, without limitation, the Comprehensive Environmental Response,
Compensation and Liability Act of 1980, the Solid Waste Disposal Act of
1976, the Clean Air Act, the Clean Water Act, the Toxic Substances Control
Act of 1976, the Occupational Safety and Health Act of 1970, the Emergency
Planning and Community-Right-to-Know Act, the Safe Drinking Water Act, all
as amended, and similar state laws;
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(ii) “ERISA”
shall mean the Employee Retirement Income Security Act of 1974 or any
successor law, and regulations and rules issued pursuant to that Act or
any successor law;
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(jj) “Exchange
Act” shall mean the Exchange Act of 1934, as
amended;
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(kk)
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“Exchange
Agent” shall have the meaning set forth in Section
2.02;
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(ll)
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“Exchange
Fund” shall have the meaning set forth in Section
2.02;
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(mm) “FDA”
shall have meaning ascribed thereto in Section 3.01(p)(ii);
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(nn) “FDCA”
shall have meaning ascribed thereto in Section 3.01(q)(ii);
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(oo)
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“Flow
of Funds” shall have the meaning set forth in Section
6.01(e);
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(pp)
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“Form
S-4” shall have the meaning set forth in Section
3.01(g);
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(qq) “GAAP”
shall have meaning ascribed thereto in Section 3.01(e);
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(rr) “Governmental
Entity” shall have meaning ascribed thereto in Section 3.01(d);
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(ss) “Hazardous
Materials” means all hazardous or toxic substances, wastes, materials or
chemicals, petroleum (including crude oil or any fraction thereof) and
petroleum products, friable asbestos and asbestos-containing materials,
pollutants, contaminants and all other materials, and substances regulated
pursuant to, or that could reasonably be expected to provide the basis of
liability under, any Environmental
Law;
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(tt) “Indebtedness”
means, with respect to any Person, without duplication, (A) all
obligations of such Person for borrowed money, (B) all obligations of
such Person evidenced by bonds, debentures, notes or similar instruments,
(C) all obligations of such Person under conditional sale or other
title retention agreements relating to property purchased by such Person,
(D) all obligations of such Person issued or assumed as the deferred
purchase price of property or services (excluding obligations of such
Person to creditors for raw materials, inventory, services and supplies
incurred in the ordinary course of such Person’s business), (E) all
capitalized lease obligations of such Person, (F) all obligations of
others secured by any Lien on property or assets owned or acquired by such
Person, whether or not the obligations secured thereby have been assumed,
(G) all obligations of such Person under interest rate or currency
hedging transactions (valued at the termination value thereof),
(H) all letters of credit issued for the account of such Person,
(I) all guarantees and arrangements having the economic effect of a
guarantee of such Person of any Indebtedness of any other Person and
(K) all obligations with respect to compensation or other employee
arrangements which become due or payable as a result of this Agreement or
the transactions contemplated
hereby;
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(uu) “Indemnified
Liabilities” shall have meaning ascribed thereto in Section 4.04(a);
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(vv) “Indemnified
Parties” shall have meaning ascribed thereto in Section 4.04(a);
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(ww) “Intellectual
Property” means all rights, privileges and priorities provided under
federal, state, foreign and multinational law relating to intellectual
property, including, without limitation, all (i)(a) inventions,
discoveries, processes, formulae, designs, methods, techniques,
procedures, concepts, developments, research, works, technology, new and
useful improvements thereof and know-how relating thereto, whether or not
patented or eligible for patent protection; (b) copyrights and
copyrightable works, including computer applications, programs, software,
databases and related items (except for off-the-shelf commercial
software); (c) trademarks, service marks, trade names, brand names,
corporate names, logos and trade dress, the goodwill of any business
symbolized thereby and all common-law rights relating thereto; and
(d) trade secrets and other confidential information; and
(ii) all registrations, applications, recordings and licenses or
other similar agreements related to the
foregoing;
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(xx)
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“In
the Money Company Warrants” shall have the meaning set forth in Section
2.03;
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(yy) “IRS”
shall mean the U.S. Internal Revenue
Service;
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(zz) “knowledge
of the Company” means the actual knowledge of any officer of the Company,
including James Pachence as President of the Company, assuming due
inquiry, or those facts which, taking into account the scope and nature of
the responsibilities of the individual in question, should have been known
to such individual;
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(aaa) “knowledge
of Parent” means the actual knowledge of any officer of Parent, assuming
due inquiry, or those facts which, taking into account the scope and
nature of the responsibilities of the individual in question, should have
been known to such individual;
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(bbb) “Licenses”
shall have meaning ascribed thereto in Section 3.01(o)(ii);
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(ccc) “Lien”
or “Liens” shall have meaning ascribed thereto in Section 3.01(d);
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(ddd) “Material
Adverse Change” or “Material Adverse Effect” means, when used in
connection with the Company or Parent, any change, effect, event or
occurrence that either individually or in the aggregate with all other
such changes, effects, events and occurrences has been or is reasonably
likely to be materially adverse to the business, properties, financial
condition or results of operations of the Company or Parent, as the case
may be, and its Subsidiaries taken as a whole, provided that (i) with
respect to Section 3.01(h)(i) and (ii), shall exclude any
material adverse change in the Company’s results of operations for any
fiscal period prior to the Closing Date that is directly attributable to a
disruption in the conduct of the Company’s business arising from the
transactions contemplated by this Agreement or the public announcement
thereof and (ii) with respect to Section 3.02(f)(i) and
(ii),
shall exclude any material adverse change in Parent’s results of
operations for any fiscal period prior to the Closing Date that is
directly attributable to a disruption in the conduct of Parent’s business
arising from the transactions contemplated by this Agreement or the public
announcement thereof; and provided, further, that Material Adverse Effect
and Material Adverse Change shall not be deemed to include the impact of
(a) any change in laws and regulations or interpretations thereof by
courts or governmental authorities generally applicable to the Company and
Parent, (b) any change in GAAP or regulatory accounting principles
generally applicable to the Company and Parent, (c) any change
arising or resulting from general industry, economic or capital market
conditions or conditions in markets relevant to the Company or Parent, as
applicable, that affects Parent or the Company, as applicable (or the
markets in which Parent or the Company, as applicable, compete) in a
manner not disproportionate to the manner in which such conditions affect
comparable companies in the industries or markets in which Company or
Parent, as applicable, compete, (d) any act or omission of the
Company taken with the prior written consent of Parent or (e) the
expenses reasonably incurred by the Company in entering into this
Agreement and consummating the transactions contemplated by this
Agreement;
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(eee) “Merger”
shall have meaning ascribed thereto in second recital to this
Agreement;
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(fff) “Merger
Consideration” shall have meaning ascribed thereto in Section 2.01(c)(ii);
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(ggg) “Merger
Sub” shall have meaning ascribed thereto in the preamble to this
Agreement;
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(hhh) “Parent”
shall have meaning ascribed thereto in the preamble to this
Agreement;
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(iii) “Parent
Common Stock” means the common stock, par value $0.01 per share, of
Parent;
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(jjj) “Parent
Disclosure Letter” shall have meaning ascribed thereto in Section 3.02;
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(kkk)
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“Parent
Capital Stock” means the Parent Common Stock and the Parent Preferred
Stock;
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(lll)
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“Parent
Common Stock” means the common stock, par value $0.01 per share, of
Parent;
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(mmm) “Parent
Preferred Stock” means the preferred stock, par value $0.01 per share, of
Parent;
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(nnn) “Parent
SEC Documents” shall have meaning ascribed thereto in Section 3.02(d);
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(ooo) “Parent
SEC Financial Statements” shall have meaning ascribed thereto in Section 3.02(d);
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(qqq) “Permitted
Lien” means statutory Liens securing payments not yet due and such Liens
as do not materially affect the use of the properties or assets subject
thereto or affected thereby or otherwise materially impair business
operations at such properties;
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(rrr) “Person”
means an individual, corporation, partnership, joint venture, association,
trust, unincorporated organization or other
entity;
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(sss) “Pharmaceutical
Products” shall have meaning ascribed thereto in Section 3.01(p)(ii);
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(ttt) “PHSA”
shall have meaning ascribed thereto in Section 3.01(p)(ii);
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(uuu)
“SEC” means the United States Securities and Exchange
Commission;
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(vvv) “Securities
Act” shall mean the Securities Act of 1933, as
amended;
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(www) “Shareholder
Rights Plan” shall have meaning ascribed thereto in Section 3.02(b);
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(xxx) “Subsidiary”
of any Person means another Person, who holds an amount of the voting
securities, other voting ownership or voting partnership interests which
is sufficient to elect at least a majority of its Board of Directors or
other governing body (or, if there are no such voting interests, 50% or
more of the equity interests of which) or is owned directly or indirectly
by such Person;
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(yyy)
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“Superior
Proposal” shall have the meaning ascribed thereto in Section
7.1(f);
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(zzz) “Surviving
Corporation” shall have meaning ascribed thereto in Section 1.01;
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(aaaa) “Tax”
or “Taxes” (and with correlative meaning, “Taxable” and “Taxing” and “Tax
Law”) means any United States federal, state or local, or non-United
States, income, gross receipts, franchise, estimated, alternative minimum,
add-on minimum, sales, use, transfer, registration, value added, excise,
natural resources, severance, stamp, withholding, occupation, premium,
windfall profit, environmental, customs, duties, real property, personal
property, capital stock, net worth, intangibles, social security,
unemployment, disability, payroll, license, employee or other tax or
similar levy, of any kind whatsoever, including any interest, penalties or
additions to tax in respect of the
foregoing;
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(bbbb) “Tax
Return” means any return, declaration, report, claim for refund,
information return or other document (including any related or supporting
estimates, elections, schedules, statements or information) filed or
required to be filed in connection with the determination, assessment or
collection of any Tax or the administration of any laws, regulations or
administrative requirements relating to any
Tax;
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(cccc) “Technology”
means all inventions, works, discoveries, innovations, know-how,
information (including ideas, research and development, know-how,
formulas, compositions, processes and techniques, data, designs, drawings,
specifications, customer and supplier lists, pricing and cost information,
business and marketing plans and proposals, documentation and manuals),
computer software, firmware, computer hardware, integrated circuits and
integrated circuit masks, electronic, electrical and mechanical equipment
and all other forms of technology, including improvements, modifications,
works in process, derivatives or changes, whether tangible or intangible,
embodied in any form, whether or not protectible or protected by patent,
copyright, mask work right, trade secret law or otherwise, and all
documents and other materials recording any of the
foregoing;
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(dddd) “WARN”
shall have meaning ascribed thereto in Section 3.01(i)(ii).
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8.05 Interpretation.
When reference is made in this Agreement to an Article or a
Section, such reference shall be to an Article or Section of
this Agreement, unless otherwise indicated. The table of contents,
table of defined terms and headings contained in this Agreement are for
convenience of reference only and shall not affect in any way the meaning
or interpretation of this Agreement. The language used in this
Agreement shall be deemed to be the language chosen by the parties hereto
to express their mutual intent, and no rule of strict construction
shall be applied against any party. Whenever the context may
require, any pronouns used in this Agreement shall include the
corresponding masculine, feminine or neuter forms, and the singular form
of nouns and pronouns shall include the plural, and vice versa. Any
reference to any federal, state, local or foreign statute or law shall be
deemed also to refer to all rules and regulations promulgated
thereunder, unless the context requires otherwise. Whenever the
words “include,” “includes” or “including” are used in this Agreement,
they shall be deemed to be followed by the words “without
limitation.” No summary of this Agreement prepared by any party
shall affect the meaning or interpretation of this
Agreement.
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8.06 Counterparts.
This Agreement may be executed in two or more counterparts, all of
which shall be considered one and the same agreement and shall become
effective when one or more counterparts have been signed by each of the
parties and delivered to the other parties. The delivery of a
signature page of this Agreement by one party to the other via
facsimile or other electronic transmission shall constitute the execution
and delivery of this Agreement by the transmitting
party.
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8.07 Entire Agreement; No
Third-Party Beneficiaries. This Agreement (including the
Company Disclosure Letter and the Parent Disclosure Letter, and the
Schedules and Exhibits attached hereto) and the other agreements and
instruments referred to herein constitute the entire agreement, and
supersede all prior agreements and understandings, both written and oral,
among the parties with respect to the subject matter of this Agreement.
This Agreement, other than Section 5.04 (with respect to which
the Indemnified Parties shall be third-party beneficiaries), is not
intended to confer upon any Person other than the parties any rights or
remedies.
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8.08 Governing Law; Consent
to Jurisdiction; Waiver of Jury Trial. This Agreement shall
be governed by, and construed in accordance with, the laws of the State of
New York, regardless of the laws that might otherwise govern under
applicable principles of conflicts of laws. Each of the parties to
this Agreement (a) consents to submit itself to the personal
jurisdiction of any state or federal court sitting in the State of New
York in any action in any action or proceeding arising out of or relating
to this Agreement or any of the transactions contemplated by this
Agreement, (b) agrees that all claims in respect of such action or
proceeding may be heard and determined in any such court, (c) agrees
that it shall not attempt to deny or defeat such personal jurisdiction by
motion or other request for leave from any such court and (d) agrees
not to bring any action or proceeding arising out of or relating to this
Agreement or any of the transaction contemplated by this Agreement in any
other court. Each of the parties hereto waives any defense of
inconvenient forum to the maintenance of any action or proceeding so
brought and waives any bond, surety or other security that might be
required of any other party with respect thereto. Any party hereto
may make service on another party by sending or delivering a copy of the
process to the party to be served at the address and in the manner
provided for the giving of notices in Section 7.02. Nothing in
this Section 7.07, however, shall affect the right of any party to
serve legal process in any other manner permitted by law. Each party hereto hereby irrevocably waives
all right to trial by jury in any action, proceeding or counterclaim
(whether based on contract, tort or otherwise) arising out of or relating
to this Agreement or the transactions contemplated hereby or the actions
of any party hereto in the negotiation, administration, performance and
enforcement of this
Agreement.
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8.09 Assignment.
Neither this Agreement nor any of the rights, interests or
obligations under this Agreement shall be assigned, in whole or in part,
by operation of law or otherwise by any of the parties without the prior
written consent of the other parties. Subject to the preceding
sentence, this Agreement shall be binding upon, inure to the benefit of
and be enforceable by the parties and their respective successors and
assigns.
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8.10 Remedies.
Except as otherwise provided herein, any and all remedies herein expressly
conferred upon a party shall be deemed cumulative with and not exclusive
of any other remedy conferred hereby, or by law or equity upon such party,
and the exercise by a party of any one remedy shall not preclude the
exercise of any other remedy. The parties hereto agree that
irreparable damage would occur in the event that any of the provisions of
this Agreement were not performed in accordance with their specific terms
or were otherwise breached. It is accordingly agreed that the
parties hereto shall be entitled to an injunction or injunctions to
prevent breaches of this Agreement and to enforce specifically the terms
and provisions of this Agreement, this being in addition to any other
remedy to which they are entitled at law or in
equity.
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[REMAINDER OF PAGE INTENTIONALLY LEFT
BLANK]
|
IN
WITNESS WHEREOF, the parties have caused this Agreement to be signed by their
respective officers thereunto duly authorized, all as of the date first written
above.
|
ACCESS
PHARMACEUTICALS, INC.
|
||||
|
By:
|
/s/ Jeffrey B. Davis | |||
|
Name:
|
Jeffrey
B. Davis
|
|||
|
Title:
|
Chief
Executive Officer
|
|||
|
MACM
ACQUISITION CORP.
|
||||
|
By:
|
/s/ Jeffrey B. Davis | |||
|
Name:
|
Jeffrey
B. Davis
|
|||
|
Title:
|
President
|
|||
|
MACROCHEM
CORPORATION
|
||||
|
By:
|
/s/ David P. Luci | |||
|
Name:
|
David
P. Luci
|
|||
|
Title:
|
President
& Chief Business Officer
|
|||
APPENDIX
B
Written
Consent of Stockholders of MacroChem Corporation
WRITTEN
CONSENT TO ACTION
OF
A
MAJORITY-IN-INTEREST
OF
THE
STOCKHOLDERS
OF
MACROCHEM
CORPORATION
____________________
The undersigned, being stockholders of
MacroChem Corporation, a Delaware corporation (the “Corporation”), holding a
majority-in-interest of the issued and outstanding shares of common stock, par
value $0.01 per share (the “Common Stock”) of the Corporation, do hereby adopt
the following preambles and resolutions by written consent, without a formal
meeting, pursuant to Section 228 of the Delaware General Corporation Law
(“DGCL”) and in lieu of a Special Meeting of the Stockholders, effective as of
the date specified herein:
|
I.
|
The
following preambles and Resolutions are adopted effective as of the date
hereof:
|
WHEREAS,
the Corporation’s board of directors having approved that certain Merger
Agreement, by and between Access Pharmaceuticals, Inc., a Delaware corporation
(“Parent”), MACM Acquisition Corp., a Delaware corporation and a wholly-owned
subsidiary of Parent (“Merger Sub”), and the Corporation, in the form annexed as
Exhibit A hereto (the “Merger Agreement”) and the transactions contemplated
thereby, which Merger Agreement is subject to the approval of the stockholders
of the Corporation;
NOW,
THEREFORE, it is
RESOLVED,
that the form, terms and provisions of the Merger Agreement, in the form annexed
as Exhibit A hereto, and the transactions contemplated thereby, is and hereby
are ratified and approved in all respects; and be it further
RESOLVED,
that the authorized officers of the Corporation are hereby authorized and
directed to do and perform all such acts to execute, deliver and perform under
the Merger Agreement and to execute, deliver, file and record, as the case may
be, any and all documents, instruments, certificates or instructions (however
characterized or described) as they or any of them may deem necessary or
advisable to carry into effect the purpose and intent of the foregoing
resolutions or the transactions contemplated therein or thereby, and all such
acts of the officers and directors of this Corporation, whether heretofore or
hereafter done or performed, in accordance with the purposes and intent of these
resolutions are hereby ratified, confirmed and approved, and the fact that such
acts are done and such expenses incurred, and the execution, delivery, filing
and recording, as the case may be, of such documents, instruments, certificates
or instructions, shall be conclusive evidence that such acts were
necessary.
This consent of a majority-in-interest
of the shares of Common Stock of the Corporation may be executed in one or more
counterparts, all of which together shall constitute one and the same document
and, when executed by stockholders of the Corporation holding a majority of the
issued and outstanding Common Stock of the Corporation, the foregoing
resolutions may be certified by the Secretary of the Corporation as and for the
act of the Stockholders of MacroChem Corporation effective July 30,
2008.
Signature
of
Stockholder Number
of Shares Held
/s/
Steven H.
Rouhandeh 22,428,035
____________________ ____________________
SCO
Capital Partners LLC
/s/ Lynn
A. Frielinghaus 446,947
____________________ ____________________
The
Steven H. Rouhandeh
Family
Trust
/s/
Steven H.
Rouhandeh 993,941
____________________ ____________________
SCO
Capital Partners, L.P.
/s/
Jeffrey B.
Davis 2,973,693
____________________ ____________________
Lake End
Capital LLC
/s/
Stephen H.
Rouhandeh 1,872,949
____________________ ____________________
Beach
Capital LLC
Total
Shares
Represented: 28,715,565
APPENDIX
C
Notification
of Appraisal Rights of MacroChem Corporation Pursuant to Section 262 of the
Delaware General Corporation Law
Appendix
C
NOTIFICATION
OF APPRAISAL RIGHTS OF MACROCHEM CORPORATION
PURSUANT
TO SECTION 262
OF
THE
DELAWARE
GENERAL CORPORATION LAW
If a
stockholder of MacroChem Corporation (the “Company”) has not approved the merger
between MacroChem Corporation (the “Company”), Access Pharmaceuticals, Inc.
(“Access”) and MACM Acquisition Corp. (“Merger Sub”), he, she or it is entitled
to certain appraisal rights.
This
notification of appraisal rights provides our stockholders with the right within
twenty (20) days of mailing hereof, to demand in writing from Access the
appraisal of such holders’ shares. The record date to determine
stockholders entitled to receive this notice and consider the exercise of
appraisal rights has been set for July 30, 2008.
A copy of
the appraisal rights provisions of the Delaware General Corporation Law (“DGCL”)
is attached as Appendix D to the
Information Statement to which this Appraisal Rights Notice is
attached.
MacroChem
Corporation
/s/ Robert J. DeLuccia
By: ____________________
Name: Robert J. DeLuccia
Title: Chairman
APPENDIX
D
SECTION
262 OF THE DELAWARE GENERAL CORPORATION LAW
Appraisal
Rights
(a) Any
stockholder of a corporation of this State who holds shares of stock on the date
of the making of a demand pursuant to subsection (d) of this section with
respect to such shares, who continuously holds such shares through the effective
date of the merger or consolidation, who has otherwise complied with subsection
(d) of this section and who has neither voted in favor of the merger or
consolidation nor consented thereto in writing pursuant to § 228 of this title
shall be entitled to an appraisal by the Court of Chancery of the fair value of
the stockholder's shares of stock under the circumstances described in
subsections (b) and (c) of this section. As used in this section, the word
"stockholder" means a holder of record of stock in a stock corporation and also
a member of record of a nonstock corporation; the words "stock" and "share" mean
and include what is ordinarily meant by those words and also membership or
membership interest of a member of a nonstock corporation; and the words
"depository receipt" mean a receipt or other instrument issued by a depository
representing an interest in one or more shares, or fractions thereof, solely of
stock of a corporation, which stock is deposited with the
depository.
(b)
Appraisal rights shall be available for the shares of any class or series of
stock of a constituent corporation in a merger or consolidation to be effected
pursuant to § 251 (other than a merger effected pursuant to § 251(g) of this
title), § 252, § 254, § 257, § 258, § 263 or § 264 of this title:
(1)
Provided, however, that no appraisal rights under this section shall be
available for the shares of any class or series of stock, which stock, or
depository receipts in respect thereof, at the record date fixed to determine
the stockholders entitled to receive notice of and to vote at the meeting of
stockholders to act upon the agreement of merger or consolidation, were either
(i) listed on a national securities exchange or (ii) held of record by more than
2,000 holders; and further provided that no appraisal rights shall be available
for any shares of stock of the constituent corporation surviving a merger if the
merger did not require for its approval the vote of the stockholders of the
surviving corporation as provided in subsection (f) of § 251 of this
title.
(2)
Notwithstanding paragraph (1) of this subsection, appraisal rights under this
section shall be available for the shares of any class or series of stock of a
constituent corporation if the holders thereof are required by the terms of an
agreement of merger or consolidation pursuant to §§ 251, 252, 254, 257, 258, 263
and 264 of this title to accept for such stock anything except:
a. Shares
of stock of the corporation surviving or resulting from such merger or
consolidation, or depository receipts in respect thereof;
b. Shares
of stock of any other corporation, or depository receipts in respect thereof,
which shares of stock (or depository receipts in respect thereof) or depository
receipts at the effective date of the merger or consolidation will be either
listed on a national securities exchange or held of record by more than 2,000
holders;
c. Cash
in lieu of fractional shares or fractional depository receipts described in the
foregoing subparagraphs a. and b. of this paragraph; or
d. Any
combination of the shares of stock, depository receipts and cash in lieu of
fractional shares or fractional depository receipts described in the foregoing
subparagraphs a., b. and c. of this paragraph.
(3) In
the event all of the stock of a subsidiary Delaware corporation party to a
merger effected under § 253 of this title is not owned by the parent corporation
immediately prior to the merger, appraisal rights shall be available for the
shares of the subsidiary Delaware corporation.
(c) Any
corporation may provide in its certificate of incorporation that appraisal
rights under this section shall be available for the shares of any class or
series of its stock as a result of an amendment to its certificate of
incorporation, any merger or consolidation in which the corporation is a
constituent corporation or the sale of all or substantially all of the assets of
the corporation. If the certificate of incorporation contains such a provision,
the procedures of this section, including those set forth in subsections (d) and
(e) of this section, shall apply as nearly as is practicable.
(d)
Appraisal rights shall be perfected as follows:
(1) If a
proposed merger or consolidation for which appraisal rights are provided under
this section is to be submitted for approval at a meeting of stockholders, the
corporation, not less than 20 days prior to the meeting, shall notify each of
its stockholders who was such on the record date for such meeting with respect
to shares for which appraisal rights are available pursuant to subsection (b) or
(c) hereof that appraisal rights are available for any or all of the shares of
the constituent corporations, and shall include in such notice a copy of this
section. Each stockholder electing to demand the appraisal of such stockholder's
shares shall deliver to the corporation, before the taking of the vote on the
merger or consolidation, a written demand for appraisal of such stockholder's
shares. Such demand will be sufficient if it reasonably informs the corporation
of the identity of the stockholder and that the stockholder intends thereby to
demand the appraisal of such stockholder's shares. A proxy or vote against the
merger or consolidation shall not constitute such a demand. A stockholder
electing to take such action must do so by a separate written demand as herein
provided. Within 10 days after the effective date of such merger or
consolidation, the surviving or resulting corporation shall notify each
stockholder of each constituent corporation who has complied with this
subsection and has not voted in favor of or consented to the merger or
consolidation of the date that the merger or consolidation has become effective;
or
(2) If
the merger or consolidation was approved pursuant to § 228 or § 253 of this
title, then either a constituent corporation before the effective date of the
merger or consolidation or the surviving or resulting corporation within 10 days
thereafter shall notify each of the holders of any class or series of stock of
such constituent corporation who are entitled to appraisal rights of the
approval of the merger or consolidation and that appraisal rights are available
for any or all shares of such class or series of stock of such constituent
corporation, and shall include in such notice a copy of this section. Such
notice may, and, if given on or after the effective date of the merger or
consolidation, shall, also notify such stockholders of the effective date of the
merger or consolidation. Any stockholder entitled to appraisal rights may,
within 20 days after the date of mailing of such notice, demand in writing from
the surviving or resulting corporation the appraisal of such holder's shares.
Such demand will be sufficient if it reasonably informs the corporation of the
identity of the stockholder and that the stockholder intends thereby to demand
the appraisal of such holder's shares. If such notice did not notify
stockholders of the effective date of the merger or consolidation, either (i)
each such constituent corporation shall send a second notice before the
effective date of the merger or consolidation notifying each of the holders of
any class or series of stock of such constituent corporation that are entitled
to appraisal rights of the effective date of the merger or consolidation or (ii)
the surviving or resulting corporation shall send such a second notice to all
such holders on or within 10 days after such effective date; provided, however,
that if such second notice is sent more than 20 days following the sending of
the first notice, such second notice need only be sent to each stockholder who
is entitled to appraisal rights and who has demanded appraisal of such holder's
shares in accordance with this subsection. An affidavit of the secretary or
assistant secretary or of the transfer agent of the corporation that is required
to give either notice that such notice has been given shall, in the absence of
fraud, be prima facie evidence of the facts stated therein. For purposes of
determining the stockholders entitled to receive either notice, each constituent
corporation may fix, in advance, a record date that shall be not more than 10
days prior to the date the notice is given, provided, that if the notice is
given on or after the effective date of the merger or consolidation, the record
date shall be such effective date. If no record date is fixed and the notice is
given prior to the effective date, the record date shall be the close of
business on the day next preceding the day on which the notice is
given.
(e)
Within 120 days after the effective date of the merger or consolidation, the
surviving or resulting corporation or any stockholder who has complied with
subsections (a) and (d) of this section hereof and who is otherwise entitled to
appraisal rights, may commence an appraisal proceeding by filing a petition in
the Court of Chancery demanding a determination of the value of the stock of all
such stockholders. Notwithstanding the foregoing, at any time within 60 days
after the effective date of the merger or consolidation, any stockholder who has
not commenced an appraisal proceeding or joined that proceeding as a named party
shall have the right to withdraw such stockholder's demand for appraisal and to
accept the terms offered upon the merger or consolidation. Within 120 days after
the effective date of the merger or consolidation, any stockholder who has
complied with the requirements of subsections (a) and (d) of this section
hereof, upon written request, shall be entitled to receive from the corporation
surviving the merger or resulting from the consolidation a statement setting
forth the aggregate number of shares not voted in favor of the merger or
consolidation and with respect to which demands for appraisal have been received
and the aggregate number of holders of such shares. Such written statement shall
be mailed to the stockholder within 10 days after such stockholder's written
request for such a statement is received by the surviving or resulting
corporation or within 10 days after expiration of the period for delivery of
demands for appraisal under subsection (d) of this section hereof, whichever is
later. Notwithstanding subsection (a) of this section, a person who is the
beneficial owner of shares of such stock held either in a voting trust or by a
nominee on behalf of such person may, in such person's own name, file a petition
or request from the corporation the statement described in this
subsection.
(f) Upon
the filing of any such petition by a stockholder, service of a copy thereof
shall be made upon the surviving or resulting corporation, which shall within 20
days after such service file in the office of the Register in Chancery in which
the petition was filed a duly verified list containing the names and addresses
of all stockholders who have demanded payment for their shares and with whom
agreements as to the value of their shares have not been reached by the
surviving or resulting corporation. If the petition shall be filed by the
surviving or resulting corporation, the petition shall be accompanied by such a
duly verified list. The Register in Chancery, if so ordered by the Court, shall
give notice of the time and place fixed for the hearing of such petition by
registered or certified mail to the surviving or resulting corporation and to
the stockholders shown on the list at the addresses therein stated. Such notice
shall also be given by 1 or more publications at least 1 week before the day of
the hearing, in a newspaper of general circulation published in the City of
Wilmington, Delaware or such publication as the Court deems advisable. The forms
of the notices by mail and by publication shall be approved by the Court, and
the costs thereof shall be borne by the surviving or resulting
corporation.
g) At the
hearing on such petition, the Court shall determine the stockholders who have
complied with this section and who have become entitled to appraisal rights. The
Court may require the stockholders who have demanded an appraisal for their
shares and who hold stock represented by certificates to submit their
certificates of stock to the Register in Chancery for notation thereon of the
pendency of the appraisal proceedings; and if any stockholder fails to comply
with such direction, the Court may dismiss the proceedings as to such
stockholder.
(h) After
the Court determines the stockholders entitled to an appraisal, the appraisal
proceeding shall be conducted in accordance with the rules of the Court of
Chancery, including any rules specifically governing appraisal proceedings.
Through such proceeding the Court shall determine the fair value of the shares
exclusive of any element of value arising from the accomplishment or expectation
of the merger or consolidation, together with interest, if any, to be paid upon
the amount determined to be the fair value. In determining such fair value, the
Court shall take into account all relevant factors. Unless the Court in its
discretion determines otherwise for good cause shown, interest from the
effective date of the merger through the date of payment of the judgment shall
be compounded quarterly and shall accrue at 5% over the Federal Reserve discount
rate (including any surcharge) as established from time to time during the
period between the effective date of the merger and the date of payment of the
judgment. Upon application by the surviving or resulting corporation or by any
stockholder entitled to participate in the appraisal proceeding, the Court may,
in its discretion, proceed to trial upon the appraisal prior to the final
determination of the stockholders entitled to an appraisal. Any stockholder
whose name appears on the list filed by the surviving or resulting corporation
pursuant to subsection (f) of this section and who has submitted such
stockholder's certificates of stock to the Register in Chancery, if such is
required, may participate fully in all proceedings until it is finally
determined that such stockholder is not entitled to appraisal rights under this
section.
(i) The
Court shall direct the payment of the fair value of the shares, together with
interest, if any, by the surviving or resulting corporation to the stockholders
entitled thereto. Payment shall be so made to each such stockholder, in the case
of holders of uncertificated stock forthwith, and the case of holders of shares
represented by certificates upon the surrender to the corporation of the
certificates representing such stock. The Court's decree may be enforced as
other decrees in the Court of Chancery may be enforced, whether such surviving
or resulting corporation be a corporation of this State or of any
state.
(j) The
costs of the proceeding may be determined by the Court and taxed upon the
parties as the Court deems equitable in the circumstances. Upon application of a
stockholder, the Court may order all or a portion of the expenses incurred by
any stockholder in connection with the appraisal proceeding, including, without
limitation, reasonable attorney's fees and the fees and expenses of experts, to
be charged pro rata against the value of all the shares entitled to an
appraisal.
(k) From
and after the effective date of the merger or consolidation, no stockholder who
has demanded appraisal rights as provided in subsection (d) of this section
shall be entitled to vote such stock for any purpose or to receive payment of
dividends or other distributions on the stock (except dividends or other
distributions payable to stockholders of record at a date which is prior to the
effective date of the merger or consolidation); provided, however, that if no
petition for an appraisal shall be filed within the time provided in subsection
(e) of this section, or if such stockholder shall deliver to the surviving or
resulting corporation a written withdrawal of such stockholder's demand for an
appraisal and an acceptance of the merger or consolidation, either within 60
days after the effective date of the merger or consolidation as provided in
subsection (e) of this section or thereafter with the written approval of the
corporation, then the right of such stockholder to an appraisal shall cease.
Notwithstanding the foregoing, no appraisal proceeding in the Court of Chancery
shall be dismissed as to any stockholder without the approval of the Court, and
such approval may be conditioned upon such terms as the Court deems just;
provided, however that this provision shall not affect the right of any
stockholder who has not commenced an appraisal proceeding or joined that
proceeding as a named party to withdraw such stockholder's demand for appraisal
and to accept the terms offered upon the merger or consolidation within 60 days
after the effective date of the merger or consolidation, as set forth in
subsection (e) of this section.
(l) The
shares of the surviving or resulting corporation to which the shares of such
objecting stockholders would have been converted had they assented to the merger
or consolidation shall have the status of authorized and unissued shares of the
surviving or resulting corporation. (8 Del. C. 1953, § 262; 56 Del. Laws, c. 50;
56 Del. Laws, c. 186, § 24; 57 Del. Laws, c. 148, §§ 27-29; 59 Del. Laws, c.
106, § 12; 60 Del. Laws, c. 371, §§ 3-12; 63 Del. Laws, c. 25, § 14; 63 Del.
Laws, c. 152, §§ 1, 2; 64 Del. Laws, c. 112, §§ 46-54; 66 Del. Laws, c. 136, §§
30-32; 66 Del. Laws, c. 352, § 9; 67 Del. Laws, c. 376, §§ 19, 20; 68 Del. Laws,
c. 337, §§ 3, 4; 69 Del. Laws, c. 61, § 10; 69 Del. Laws, c. 262, §§ 1-9; 70
Del. Laws, c. 79, § 16; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 299, §§ 2,
3; 70 Del. Laws, c. 349, § 22; 71 Del. Laws, c. 120, § 15; 71 Del. Laws, c. 339,
§§ 49-52; 73 Del. Laws, c. 82, § 21; 76 Del. Laws, c. 145, §§
11-16.)
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
20. Indemnification of Directors and Officers
Our
Certificate of Incorporation also contains provisions to indemnify the
directors, officers, employees or other agents to the fullest extent
permitted
by the General Corporation Law of Delaware. These provisions may have the
practical effect in certain cases of eliminating the ability
of
shareholders to collect monetary damages from directors. We believe that these
provisions will assist us in attracting or retaining qualified
individuals
to serve as our directors.
Item
21. Exhibits
The
following is a list of exhibits filed as a part of this registration
statement:
Exhibit
|
Number
|
Description of
Document
|
|
2.1
|
Amended
and Restated Agreement of Merger and Plan of Reorganization between Access
Pharmaceuticals, Inc. and Chemex Pharmaceuticals, Inc., dated as of
October 31, 1995 (Incorporated by reference to Exhibit A of the our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031)
|
|
2.2
|
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc., Somanta
Acquisition Corporation, Somanta Pharmaceuticals, Inc. Somanta
Incorporated and Somanta Limited, dated April 18, 2007. (Incorporated by
reference to Exhibit 2.1 to our Form 8-K dated April 18,
2007)
|
|
2.3
|
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc., MACM
Acquisition Corporation and MacroChem Corporation, dated July 9, 2008.
(Incorporated by reference to Exhibit 2.3 of our Form 10-Q for the quarter
ended June 30, 2008)
|
|
3.1
|
Certificate
of Incorporation (Incorporated by Reference to Exhibit 3(a) of our Form
8-B dated July 12, 1989, Commission File Number
9-9134)
|
3.2 Certificate
of Amendment of Certificate of Incorporation filed August 21, 1992
|
3.3
|
Certificate
of Merger filed January 25, 1996. (Incorporated by reference to Exhibit E
of our Registration Statement on Form S-4 dated December 21, 1995,
Commission File No. 33-64031)
|
|
3.4
|
Certificate
of Amendment of Certificate of Incorporation filed January 25, 1996.
(Incorporated by reference to Exhibit E of our Registration Statement on
Form S-4 dated December 21, 1995, Commission File No.
33-64031)
|
|
3.5
|
Certificate
of Amendment of Certificate of Incorporation filed July 18, 1996.
(Incorporated by reference to Exhibit 3.8 of our Form 10-K for the year
ended December 31, 1996)
|
|
3.6
|
Certificate
of Amendment of Certificate of Incorporation filed June 18, 1998.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the quarter
ended June 30, 1998
|
|
3.7
|
Certificate
of Amendment of Certificate of Incorporation filed July 31, 2000.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the quarter
ended March 31, 2001)
|
|
3.8
|
Certificate
of Designations of Series A Junior Participating Preferred Stock filed
November 7, 2001 (Incorporated by reference to Exhibit 4.1.h of our
Registration Statement on Form S-8, dated December 14, 2001, Commission
File No. 333-75136)
|
|
3.9
|
Amended
and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of our Form
10-Q for the quarter ended June 30,
1996)
|
|
3.10
|
Certificate
of Designation of Series A Cumulative Convertible Preferred Stock filed
November 9, 2007 (Incorporated by reference to Exhibit 3.10 to our Form
10-K for the year ended December 31,
2007)
|
|
3.11
|
Certificate
of Amendment to Certificate of Designations, Rights and Preferences of
Series A Cumulative Convertible Preferred Stock filed June 11, 2008
(Incorporated by reference to Exhibit 3.11 of our Form 10-Q for the
quarter ended June 30, 2008)
|
|
5.1
|
Opinion
of Bingham McCutchen LLP
|
|
10.1*
|
1995
Stock Option Plan (Incorporated by reference to Exhibit F of our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031
|
|
10.2*
|
Amendment
to 1995 Stock Option Plan (Incorporated by reference to Exhibit 10.25 of
our Form 10-K for the year ended December 31,
2001)
|
|
10.3
|
Lease
Agreement between Pollock Realty Corporation and us dated July 25, 1996
(Incorporated by reference to Exhibit 10.19 of our Form 10-Q for the
quarter ended September 30, 1996)
|
|
10.4
|
Platinate
HPMA Copolymer Royalty Agreement between The School of Pharmacy,
University of London and the Company dated November 19, 1996 (Incorporated
by reference to Exhibit 10.11 of our Form 10-K for the year ended December
31, 1996)
|
|
10.5*
|
Employment
Agreement of David P. Nowotnik, PhD (Incorporated by reference to Exhibit
10.19 of our Form 10-K for the year ended December 31,
1999)
|
|
10.6*
|
401(k)
Plan (Incorporated by reference to Exhibit 10.20 of our Form 10K for the
year ended December 31, 1999)
|
|
10.7
|
Form
of Convertible Note (Incorporated by reference to Exhibit 10.24 of our
Form 10-Q for the quarter ended September 30,
2000)
|
|
10.8
|
Rights
Agreement, dated as of October 31, 2001 between the us and American Stock
Transfer & Trust Company, as Rights Agent (incorporated by reference
to Exhibit 99.1 of our Current Report on Form 8-K dated October 19,
2001)
|
|
10.9
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between us and American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
|
10.10
|
Amendment
to Rights Agreement, dated as of November 9, 2007 between us and American
Stock Transfer & Trust Company as Rights
Agent
|
|
10.11*
|
2001
Restricted Stock Plan (Incorporated by reference to Appendix A of our
Proxy Statement filed on April 16,
2001)
|
|
10.12*
|
2005
Equity Incentive Plan (Incorporated by reference to Exhibit 1 of our Proxy
Statement filed on April 18, 2005
(2)
|
|
10.13*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen B.
Thompson (1)
|
10.14 Asset
Sale Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
|
10.15
|
Amendment
to Asset Sale Agreement, dated as of December 8, 2006, between us and
Uluru, Inc. (3)
|
10.16 License
Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
|
10.17
|
Form
of Warrant, dated February 16, 2006, issued by us to certain Purchasers
(2)
|
|
10.18
|
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
|
10.19
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
|
10.20*
|
2007
Special Stock Option Plan and Agreement, dated January 4, 2007, by and
between us and Stephen R. Seiler, President and Chief Executive Officer
(4)
|
|
10.21
|
Note
Purchase Agreement dated April 26, 2007 between us and Somanta
Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.42 of our
Form 10-Q for the quarter ended June 30,
2007)
|
|
10.22
|
Preferred
Stock and Warrant Purchase Agreement, dated November 7, 2007, between us
and certain Purchasers (5)
|
|
10.23
|
Investor
Rights Agreement, dated November 10, 2007, between us and certain
Purchasers (5)
|
|
10.24
|
Form
of Warrant Agreement dated November 10, 2007, between us and certain
Purchasers (5)
|
|
10.25
|
Board
Designation Agreement, dated November 15, 2007, between us and SCO Capital
Partners LLC (5)
|
|
10.26
|
Amendment
and Restated Purchase Agreement, dated February 4, 2008 between us and
certain Purchasers (5)
|
|
10.27
|
Amended
and Restated Investor Rights Agreement, dated February 4, 2008 between us
and certain Purchasers (5)
|
|
10.28*
|
Employment
Agreement, dated January 4, 2008 between us and Jeffrey B. Davis
(5)
|
23.1 Consent
of Whitley Penn LLP
23.2 Consent
of Stonefield Josephson, Inc.
23.3 Consent of Vitale,
Caturano & Company, Ltd.
23.4 Consent of JH Cohn
LLP
23.5 Consent
of Bingham McCutchen LLP (Included in Exhibit 5.1)
|
*
|
Management
contract or compensatory plan required to be filed as an Exhibit to this
Form pursuant to Item 15(c) of the
report.
|
|
(1)
|
Incorporated
by reference to our Form 10-K for the year ended December 31,
2005.
|
|
(2)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2006.
|
|
(3)
|
Incorporated
by reference to our Form 10-K for the year ended December 31,
2006.
|
|
(4)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2007.
|
|
(5)
|
Incorporated
by reference to our Form S-1,
333-149633.
|
Item
22. Undertakings
The
undersigned Registrant hereby undertakes:
|
(a)
|
(1)
To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration
statement:
|
(i) To
include any prospectus required by Section 10(a)(3) of the Securities Act of
1933;
(ii) To
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding the
foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than a 20 percent change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in the
effective registration statement.
(iii) To
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement.
(2) That,
for the purpose of determining any liability under the Securities Act of 1933,
as amended, each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
(3) To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
|
(b)
|
The
undersigned registrant hereby undertakes that, for purposes of determining
any liability under the Securities Act of 1933, each filing of the
registrant’s annual report pursuant to Section 13(a) or 15(d) of the
Securities Act of 1934 (and, where applicable, each filing of an employee
benefit plan’s annual report pursuant to Section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
|
|
(c)
|
(1)
The undersigned Registrant hereby undertakes as follows: that prior to any
public reoffering of the securities registered hereunder through use of a
prospectus which is a part of this registration statement, by any person
or party who is deemed to be an underwriter within the meaning of Rule
145(c), the issuer undertakes that such reoffering prospectus will contain
the information called for by the applicable registration form with
respect to reofferings by persons who may be deemed underwriters, in
addition to the information called for by the other items of the
applicable form.
|
(2) The
registrant undertakes that every prospectus: (i) that is filed pursuant to
paragraph (1) immediately preceding, or (ii) that purports to meet the
requirements of Section 10(a)(3) of the Securities Act of 1933 and is used in
connection with an offering of securities subject to Rule 415, will be filed as
a part of an amendment to the registration statement and will not be used until
such amendment is effective, and that, for purposes of determining any liability
under the Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
|
(d)
|
Insofar
as indemnification for liabilities arising under the Securities Act of
1933 may be permitted to directors, officers and controlling persons of
the registrant pursuant to the foregoing provisions, or otherwise, the
registrant has been advised that in the opinion of the Securities and
Exchange Commission such indemnification is against public policy as
expressed in the Act and is, therefore, unenforceable. In the event that a
claim for indemnification against such liabilities (other than the payment
by the registrant of expenses incurred or paid by a director, officer or
controlling person of the registrant in the successful defense of any
action, suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being registered, the
registrant will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against
public policy as expressed in the Act and will be governed by the final
adjudication of such issue.
|
|
(e)
|
The
undersigned registrant hereby undertakes to respond to requests for
information that is incorporated by reference into the prospectus pursuant
to Item 4, 10(b), 11, or 13 of this form, within one business day of
receipt of such request, and to send the incorporated documents by first
class mail or other equally prompt means. This includes
information contained in documents filed subsequent to the effective date
of the registration statement through the date of responding the
request.
|
|
(f)
|
The
undersigned registrant hereby undertakes to supply by means of a
post-effective amendment all information concerning a transaction, and the
company being acquired involved therein, that was not the subject of and
included in the registration statement when it became
effective.
|
|
(g)
|
Each
prospectus filed pursuant to Rule 424(b) as part of a registration
statement relating to an offering, other than registration statements
relying on Rule 430B or other than prospectuses filed in reliance on Rule
430A, shall be deemed to be part of and included in the registration
statement as of the date it is first used after effectiveness. Provided,
however, that no statement made in a registration statement or prospectus
that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the registration
statement or prospectus that is part of the registration statement will,
as to a purchaser with a time of contract of sale prior to such first use,
supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement or
made in any such document immediately prior to such date of first
use.
|
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the Registrant
has duly caused this Registration Statement on Form S-4 to be signed on its
behalf by the undersigned, thereunto duly authorized, in the City of Dallas,
State of Texas, on this 2nd day of December 2008.
ACCESS PHARMACEUTICALS,
INC.
Date
December 2,
2008 By: /s/ Jeffrey B.
Davis
Jeffrey B. Davis
Chief Executive Officer
(Principal Executive
Officer)
Date
December 2,
2008 By: /s/ Stephen B.
Thompson
Stephen B. Thompson
Vice President, Chief
Financial
Officer
and Treasurer
(Principal
Accounting Officer)
POWER
OF ATTORNEY
We, the
undersigned directors of Access Pharmaceuticals, Inc., hereby severally
constitute and appoint Jeffrey B. Davis and Stephen B. Thompson, and both or
either one of them, our true and lawful attorneys-in-fact and agents, with full
power of substitution and re-substitution in for him and in his name, place and
stead, and in any and all capacities, to sign any and all amendments (including
post-effective amendments) to this Registration Statement, and any subsequent
registration statements pursuant to Rule 462 of the Securities Act, and to file
the same, with all exhibits thereto and other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, and each of them, full power and authority to do
and perform each and every act and thing requisite and necessary to be done in
and about the premises, as fully to all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that each of said
attorneys-in-fact or his substitute or substitutes, may lawfully do or cause to
be done by virtue hereof.
In
accordance with the Securities and Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated:
Date
December 2,
2008 By: /s/ Jeffrey B.
Davis
Jeffrey B. Davis,
Director,
Chief Executive Officer
Date
December 2,
2008 By: /s/ Mark J.
Ahn
Mark J. Ahn, Director
Date
December 2,
2008 By: /s/ Mark J.
Alvino
Mark J. Alvino, Director
Date
December 2,
2008 By: /s/ Esteban
Cvitkovic
Esteban Cvitkovic,
Director
Date
December 2,
2008 By: /s/ Stephen B.
Howell
Stephen B. Howell,
Director
Date December 2,
2008
By: /s/ David P.
Luci
David P. Luci, Director
Date
December 2,
2008 By: /s/ Steven H.
Rouhandeh
Steven H. Rouhandeh, Chairman
of
the Board
Exhibit
|
Number
|
Description of
Document
|
|
|
Exhibit
Number
|
|
2.1
|
Amended
and Restated Agreement of Merger and Plan of Reorganization between Access
Pharmaceuticals, Inc. and Chemex Pharmaceuticals, Inc., dated as of
October 31, 1995 (Incorporated by reference to Exhibit A of the our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031)
|
|
2.2
|
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc., Somanta
Acquisition Corporation, Somanta Pharmaceuticals, Inc. Somanta
Incorporated and Somanta Limited, dated April 18, 2007. (Incorporated by
reference to Exhibit 2.1 to our Form 8-K dated April 18,
2007)
|
|
2.3
|
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc., MACM
Acquisition Corporation and MacroChem Corporation, dated July 9, 2008.
(Incorporated by reference to Exhibit 2.3 of our Form 10-Q for the quarter
ended June 30, 2008)
|
|
3.1
|
Certificate
of Incorporation (Incorporated by Reference to Exhibit 3(a) of our Form
8-B dated July 12, 1989, Commission File Number
9-9134)
|
3.2 Certificate
of Amendment of Certificate of Incorporation filed August 21, 1992
|
3.3
|
Certificate
of Merger filed January 25, 1996. (Incorporated by reference to Exhibit E
of our Registration Statement on Form S-4 dated December 21, 1995,
Commission File No. 33-64031)
|
|
3.4
|
Certificate
of Amendment of Certificate of Incorporation filed January 25, 1996.
(Incorporated by reference to Exhibit E of our Registration Statement on
Form S-4 dated December 21, 1995, Commission File No.
33-64031)
|
|
3.5
|
Certificate
of Amendment of Certificate of Incorporation filed July 18, 1996.
(Incorporated by reference to Exhibit 3.8 of our Form 10-K for the year
ended December 31, 1996)
|
|
3.6
|
Certificate
of Amendment of Certificate of Incorporation filed June 18, 1998.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the quarter
ended June 30, 1998
|
|
3.7
|
Certificate
of Amendment of Certificate of Incorporation filed July 31, 2000.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the quarter
ended March 31, 2001)
|
|
3.8
|
Certificate
of Designations of Series A Junior Participating Preferred Stock filed
November 7, 2001 (Incorporated by reference to Exhibit 4.1.h of our
Registration Statement on Form S-8, dated December 14, 2001, Commission
File No. 333-75136)
|
|
3.9
|
Amended
and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of our Form
10-Q for the quarter ended June 30,
1996)
|
|
3.10
|
Certificate
of Designation of Series A Cumulative Convertible Preferred Stock filed
November 9, 2007 (Incorporated by reference to Exhibit 3.10 to our Form
10-K for the year ended December 31,
2007)
|
|
3.11
|
Certificate
of Amendment to Certificate of Designations, Rights and Preferences of
Series A Cumulative Convertible Preferred Stock filed June 11, 2008
(Incorporated by reference to Exhibit 3.11 of our Form 10-Q for the
quarter ended June 30, 2008)
|
|
5.1
|
Opinion
of Bingham McCutchen LLP
|
|
10.1*
|
1995
Stock Option Plan (Incorporated by reference to Exhibit F of our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031
|
|
10.2*
|
Amendment
to 1995 Stock Option Plan (Incorporated by reference to Exhibit 10.25 of
our Form 10-K for the year ended December 31,
2001)
|
|
10.3
|
Lease
Agreement between Pollock Realty Corporation and us dated July 25, 1996
(Incorporated by reference to Exhibit 10.19 of our Form 10-Q for the
quarter ended September 30, 1996)
|
|
10.4
|
Platinate
HPMA Copolymer Royalty Agreement between The School of Pharmacy,
University of London and the Company dated November 19, 1996 (Incorporated
by reference to Exhibit 10.11 of our Form 10-K for the year ended December
31, 1996)
|
|
10.5*
|
Employment
Agreement of David P. Nowotnik, PhD (Incorporated by reference to Exhibit
10.19 of our Form 10-K for the year ended December 31,
1999)
|
|
10.6*
|
401(k)
Plan (Incorporated by reference to Exhibit 10.20 of our Form 10K for the
year ended December 31, 1999)
|
|
10.7
|
Form
of Convertible Note (Incorporated by reference to Exhibit 10.24 of our
Form 10-Q for the quarter ended September 30,
2000)
|
|
10.8
|
Rights
Agreement, dated as of October 31, 2001 between the us and American Stock
Transfer & Trust Company, as Rights Agent (incorporated by reference
to Exhibit 99.1 of our Current Report on Form 8-K dated October 19,
2001)
|
|
10.9
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between us and American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
|
10.10
|
Amendment
to Rights Agreement, dated as of November 9, 2007 between us and American
Stock Transfer & Trust Company as Rights
Agent
|
|
10.11*
|
2001
Restricted Stock Plan (Incorporated by reference to Appendix A of our
Proxy Statement filed on April 16,
2001)
|
|
10.12*
|
2005
Equity Incentive Plan (Incorporated by reference to Exhibit 1 of our Proxy
Statement filed on April 18, 2005
(2)
|
|
10.13*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen B.
Thompson (1)
|
10.14 Asset
Sale Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
|
10.15
|
Amendment
to Asset Sale Agreement, dated as of December 8, 2006, between us and
Uluru, Inc. (3)
|
10.16 License
Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
|
10.17
|
Form
of Warrant, dated February 16, 2006, issued by us to certain Purchasers
(2)
|
|
10.18
|
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
|
10.19
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
|
10.20*
|
2007
Special Stock Option Plan and Agreement, dated January 4, 2007, by and
between us and Stephen R. Seiler, President and Chief Executive Officer
(4)
|
|
10.21
|
Note
Purchase Agreement dated April 26, 2007 between us and Somanta
Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.42 of our
Form 10-Q for the quarter ended June 30,
2007)
|
|
10.22
|
Preferred
Stock and Warrant Purchase Agreement, dated November 7, 2007, between us
and certain Purchasers (5)
|
|
10.23
|
Investor
Rights Agreement, dated November 10, 2007, between us and certain
Purchasers (5)
|
|
10.24
|
Form
of Warrant Agreement dated November 10, 2007, between us and certain
Purchasers (5)
|
|
10.25
|
Board
Designation Agreement, dated November 15, 2007, between us and SCO Capital
Partners LLC (5)
|
|
10.26
|
Amendment
and Restated Purchase Agreement, dated February 4, 2008 between us and
certain Purchasers (5)
|
|
10.27
|
Amended
and Restated Investor Rights Agreement, dated February 4, 2008 between us
and certain Purchasers (5)
|
|
10.28*
|
Employment
Agreement, dated January 4, 2008 between us and Jeffrey B. Davis
(5)
|
23.1 Consent
of Whitley Penn LLP
23.2 Consent
of Stonefield Josephson, Inc.
23.3 Consent of Vitale,
Caturano & Company, Ltd.
23.4 Consent of JH Cohn
LLP
23.5 Consent
of Bingham McCutchen LLP (included in Exhibit 5.1)
|
*
|
Management
contract or compensatory plan required to be filed as an Exhibit to this
Form pursuant to Item 15(c) of the
report.
|
|
(6)
|
Incorporated
by reference to our Form 10-K for the year ended December 31,
2005.
|
|
(7)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2006.
|
|
(8)
|
Incorporated
by reference to our Form 10-K for the year ended December 31,
2006.
|
|
(9)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2007.
|
|
(10)
|
Incorporated
by reference to our Form S-1,
333-149633.
|