S-1/A: General form of registration statement for all companies including face-amount certificate companies
Published on October 8, 2008
As
filed with the Securities and Exchange Commission on __________
Registration
Number 333-149633
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-1/A
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
ACCESS PHARMACEUTICALS,
INC.
(Exact
Name of Registrant as Specified in its Charter)
|
Delaware
(State
or other jurisdiction of
incorporation
or organization)
|
3841
(Primary
Standard Industrial
Classification
Code Number)
|
83-0221517
(I.R.S.
Employer
Identification
No.)
|
||
|
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)
|
||||
|
Stephen
B. Thompson
Chief
Financial Officer
Access
Pharmaceuticals, Inc.
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)
|
||||
|
with
a copy to:
|
|
John
J. Concannon III, Esq.
Bingham
McCutchen LLP
150
Federal Street
Boston,
MA 02110
(617)
951-8000
|
Approximate
date of commencement of proposed sale to public:
As
soon as practicable after the effective date hereof.
If any of
the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act, check the
following box. þ
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(c) under the
Securities Act, check the following box and list the Securities Act registration
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
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
Security
|
Proposed
Maximum
Aggregate
Offering
Price
|
Amount
of
Registration
Fee
|
||||
|
Common
stock, $0.01 par value per share
|
7,577,868(1)
|
$2.50
(3)
|
$18,944,670
|
$745
(3)
|
||||
|
Common
stock, $0.01 par value per share
|
1,582,360
(2)
|
$2.50
(3)
|
$3,955,900
|
$155 (3)
|
||||
|
Total
common stock, $0.01 par value per share
|
9,160,228
|
$22,900,570
|
$900
(4)
|
|||||
(1) 7,577,868
shares are issuable to selling stockholders upon conversion of Series A
Preferred Stock.
(2) 1,582,360
shares of Common Stock that may be issued as dividends on the Series A Preferred
Stock.
(3) 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 October 6, 2008.
(4) The
registrant previously paid $1,436 of the registration fee in connection with the
filing of its Form S-1 Registration Statement filed with the Securities and
Exchange Commission on March 11, 2008.
Pursuant
to Rule 416, there are also being registered such additional securities as may
be issued to prevent dilution resulting from stock splits, stock dividends or
similar transactions as a result of the anti-dilution provisions contained in
the warrants and certificate of the Series A Preferred Stock.
THE REGISTRANT HEREBY AMENDS THIS
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 THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME
EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL
THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE
COMMISSION, ACTING PURSUANT TO SECTION 8(A), MAY
DETERMINE.
INFORMATION
CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A REGISTRATION STATEMENT
RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION. THESE SECURITIES MAY NOT BE SOLD UNTIL THE REGISTRATION STATEMENT
BECOMES EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL AND IS NOT A
SOLICITATION OF AN OFFER TO BUY IN ANY STATE IN WHICH AN OFFER, SOLICITATION, OR
SALE IS NOT PERMITTED.
SUBJECT
TO COMPLETION, DATED October 8, 2008
PROSPECTUS
ACCESS
PHARMACEUTICALS, INC.
9,160,228
Shares of Common Stock
This
Prospectus relates to the offer and sale of up to 9,160,228 shares of common
stock, $0.01 par value per share, of Access Pharmaceuticals, Inc. (“Access”) by
certain stockholders of Access, namely SCO Capital Partners LLC, (“SCO”) and
affiliates (SCO Capital Partners LP and Beach Capital LLC), Credit Suisse
Securities (USA) LLC, Enable Growth Partners LP, William G. Garrison, Edward and
Patricia Kelly, Dennis Lavalle, Lake End Capital LLC, David Luci, Midsummer
Investment, Ltd., Oracle Partners LP and affiliates (Oracle Institutional
Partners LP, Oracle Offshore Ltd., SAM Oracle Investments, Inc.), Perceptive
Life Sciences Master Fund Ltd., Rockmore Investment Master Fund Ltd., Brio
Capital LP, Catalytix LDC Life Science Hedge AC, Cobblestone Asset Management
LLC, Cranshire Capital LP, and Schroder & Co. Bank AG.
Access is
not selling any shares of common stock in this offering and therefore will not
receive any of the proceeds from this offering. All costs associated
with this registration will be borne by Access.
The
shares of common stock are being offered for sale by the selling stockholders at
prices established on the OTC Bulletin Board during the term of this offering.
On October 6, 2008, the last reported sale price of our common stock was $2.45
per share. Our common stock is presently listed on the OTC Bulletin Board under
the symbol “ACCP”. These prices will fluctuate based on the demand for the
shares of common stock.
Brokers
or dealers effecting transactions in these shares should confirm that the shares
are registered under the applicable state law or that an exemption from
registration is available.
No
underwriter or person has been engaged to facilitate the sale of shares of
common stock in this offering. None of the proceeds from the sale of stock by
the selling stockholders will be placed in escrow, trust or any similar
account.
These
securities are speculative and involve a high degree of risk.
You
should purchase securities only if you can afford a complete loss of your
investment.
See
“Risk factors” beginning on page 10.
These
securities have not been approved or disapproved by the Securities and Exchange
Commission or any state securities commission nor has the Securities and
Exchange Commission or any state securities commission passed upon the accuracy
or adequacy of this Prospectus. Any representation to the contrary is a criminal
offense.
THE DATE
OF THIS PROSPECTUS IS ________________, 2008.
| Page | ||
| PROSPECTUS SUMMARY | 1 | |
|
EXPLANATORY
NOTE
|
1 | |
|
ABOUT
ACCESS
|
1 | |
|
SUMMARY OF THE
OFFERING
|
5 | |
|
SUMMARY
CONDENSED CONSOLIDATED FINANCIAL INFORMATION
|
6 | |
| RISK FACTORS | 10 | |
| FORWARD-LOOKING STATEMENTS | 20 | |
| SELLING STOCKHOLDERS | 21 | |
| USE OF PROCEEDS | 32 | |
| PLAN OF DISTRIBUTION | 32 | |
| MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND | ||
|
RESULTS OF
OPERATIONS
|
35 | |
| DESCRIPTION OF BUSINESS | 46 | |
| DESCRIPTION OF PROPERTY | 63 | |
| DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS | 64 | |
| LEGAL PROCEEDINGS | 73 | |
| SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT | 73 | |
| TRANSACTIONS WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL PERSONS | 78 | |
| MARKET FOR OUR COMMON STOCK | 80 | |
| DESCRIPTION OF SECURITIES | 82 | |
| EXPERTS | 84 | |
| LEGAL MATTERS | 84 | |
| WHERE YOU CAN FIND MORE INFORMATION | 85 | |
| FINANCIAL STATEMENTS | F-1 |
WE
HAVE NOT AUTHORIZED ANY DEALER, SALESPERSON OR OTHER PERSON TO GIVE ANY
INFORMATION OR TO MAKE ANY REPRESENTATIONS NOT CONTAINED IN THIS PROSPECTUS OR
ANY PROSPECTUS SUPPLEMENT. YOU MUST NOT RELY ON ANY UNAUTHORIZED INFORMATION.
NEITHER THIS PROSPECTUS NOR ANY PROSPECTUS SUPPLEMENT IS AN OFFER TO SELL OR A
SOLICITATION OF AN OFFER TO BUY ANY OF THESE SECURITIES IN ANY JURISDICTION
WHERE AN OFFER OR SOLICITATION IS NOT PERMITTED. NO SALE MADE PURSUANT TO THIS
PROSPECTUS SHALL, UNDER ANY CIRCUMSTANCES, CREATE ANY IMPLICATION THAT THERE HAS
NOT BEEN ANY CHANGE IN OUR AFFAIRS SINCE THE DATE OF THIS
PROSPECTUS.
i
PROSPECTUS
SUMMARY
This
summary highlights selected information contained elsewhere in this Prospectus.
This summary does not contain all the information you should consider before
investing in shares of our common stock. You should read this entire Prospectus
carefully, including “Risk Factors” beginning on page 10 and our financial
statements and the notes to those financial statements beginning on F-1 before
making an investment decision.
EXPLANATORY
NOTE
Of the
9,160,228 shares being registered for sale in this offering:
|
(1)
|
1,457,699
of such shares relate to shares of common stock underlying Series A
Preferred Stock which were issued to Oracle and affiliates on November 13,
2007 in exchange for the cancellation of $4,015,000 of principal amount of
convertible promissory notes plus interest, as amended, originally issued
to Oracle on September 13, 2000. The Company had previously registered the
common stock underlying such convertible notes on a registration statement
on Form S-1 Registration Statement No. 333-135734 which was declared
effective on August 7, 2006.
|
|
(2)
|
6,120,169
of such shares relate to shares of common stock underlying Series A
Preferred Stock which were issued to Lake End Capital LLC and SCO and
affiliates on November 13, 2007 in exchange for the cancellation of
$6,000,000 of principal amount of convertible promissory notes plus
interest originally issued to Lake End Capital LLC and SCO and affiliates
on February 16, 2006 ($5,000,000), October 24, 2006 ($500,000) and
December 6, 2006, ($500,000). The Company had previously registered the
common stock underlying $5,000,000 of the convertible notes issued on a
registration statement on Form S-1 Registration Statement No. 333-135734,
which was declared effective on August 7,
2006.
|
|
(3)
|
1,582,360
of such shares relate to common stock dividends which may be paid on the
Series A Preferred Stock. The Series A Preferred Stock accrues
dividends at the rate of 6% per annum. Subject to certain
conditions being met, Access in its sole discretion may choose to pay
these dividends in shares of common stock rather than in cash. The common
stock dividend shares being registered represents anticipated dividends on
the Series A Preferred Stock over 2 years assuming a fixed market price of
$2.00 per share for Access’ common
stock.
|
ABOUT
ACCESS
Company
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.
|
1
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.
|
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 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.
2
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 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.
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.
(“Somanta”). 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.
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.
3
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.
On April
26, 2007, we entered into a Note Purchase Agreement with Somanta
Pharmaceuticals, Inc. in order for Access to loan Somanta amounts to keep
certain of their licenses and vendors current. As of September 30, 2007 we have
loaned Somanta $859,000.
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.
4
SUMMARY
OF THE OFFERING
This
offering relates to the sale of common stock by certain persons who are the
selling stockholders who intend to sell up to 9,160,228 shares of common stock,
consisting of (1) 7,577,868 shares are issuable to selling stockholders upon
conversion of Series A Preferred Stock and (2) 1,582,360 shares of Common Stock
that may be issued as dividends on the Series A Preferred Stock.
Our
registration of these shares does not necessarily mean that the selling
shareholders will convert any of these shares or sell any or all of the shares
of our common stock that we are registering.
|
Common
stock offered by Access:
|
None.
|
|
Common
stock offered by selling shareholders:
|
9,160,228
shares, which includes 7,577,868 shares issuable upon conversion of Series
A Preferred Stock, and 1,582,360 shares to be issued as dividends as
described above.
|
|
Common
stock outstanding:
|
As
of October 6, 2008, 6,475,447 shares of our common stock were issued and
outstanding.
|
|
Offering
Price:
|
To
be determined by the prevailing market price for the shares at the time of
the sale or in negotiated
transactions.
|
|
Proceeds
to Access:
|
We
will not receive proceeds from the resale of shares by the selling
shareholders.
|
|
Use
of proceeds:
|
We
will not receive any of the proceeds from the sale by any selling
shareholder of our common stock.
|
|
OTC
Bulletin Board Symbol:
|
ACCP:OB
|
5
SUMMARY
CONDENSED CONSOLIDATED FINANCIAL INFORMATION
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 six months ended June 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 theret
o included elsewhere in this Prospectus.
|
For the Six Months
Ended
June 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
|
$ | 170 | $ | - | $ | 57 | $ | - | $ | - | $ | - | $ | - | ||||||||||||||
|
Operating
loss
|
(12,718 | ) | (3,337 | ) | (6,900 | ) | (5,175 | ) | (9,622 | ) | (6,003 | ) | (5,426 | ) | ||||||||||||||
|
Interest
and miscellaneous income
|
105 | 60 | 125 | 294 | 100 | 226 | 279 | |||||||||||||||||||||
|
Interest
and other expense
|
(225 | ) | (2,959 | ) | (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
|
(12,838 | ) | (6,236 | ) | (21,856 | ) | (13,251 | ) | (7,555 | ) | (7,162 | ) | (6,428 | ) | ||||||||||||||
|
Preferred
stock dividends
|
(2,350 | ) | - | (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
|
(15,188 | ) | (6,236 | ) | (36,652 | ) | (12,874 | ) | (1,700 | ) | (10,238 | ) | (6,935 | ) | ||||||||||||||
|
Common
Stock Data:
|
||||||||||||||||||||||||||||
|
Net
loss per basic and
diluted
common share
|
$ | (2.76 | ) | $ | (1.76 | ) | $ | (10.32 | ) | $ | (3.65 | ) | $ | (0.53 | ) | $ | (3.38 | ) | $ | (2.61 | ) | |||||||
|
Weighted
average basic and
diluted
common shares
outstanding
|
5,508 | 3,537 | 3,552 | 3,532 | 3,237 | 3,032 | 2,653 | |||||||||||||||||||||
|
June 30,
|
December 31,
|
|||||||||||||||||||||||||||
|
2008
|
2007
|
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||||||||||||
|
(in
thousands)
|
||||||||||||||||||||||||||||
|
Consolidated
Balance Sheet Data:
|
|||||||||||||||||||||||||||||
|
Cash,
cash equivalents and
short
term investments
|
$ | 5,888 | $ | 1,900 | $ | 6,921 | $ | 4,389 | $ | 474 | $ | 2,261 | $ | 2,587 | |||||||||||||||
|
Total
assets
|
6,920 | 3,634 | 9,149 | 6,426 | 7,213 | 11,090 | 11,811 | ||||||||||||||||||||||
|
Deferred
revenue
|
2,047 | 173 | 978 | 173 | 173 | 1,199 | 1,184 | ||||||||||||||||||||||
|
Convertible
notes, net of discount
|
5,500 | 16,395 | 5,564 | 8,833 | 7,636 | 13,530 | 13,530 | ||||||||||||||||||||||
|
Total
liabilities
|
10,994 | 19,135 | 8,468 | 16,313 | 11,450 | 17,751 | 17,636 | ||||||||||||||||||||||
|
Total
stockholders' equity (deficit)
|
(4,074 | ) | (15,501 | ) | 681 | (9,887 | ) | (4,237 | ) | (6,661 | ) | (5,825 | ) | ||||||||||||||||
6
Somanta
Pharmaceuticals, Inc.
We have
derived the following historical information from Somanta’s audited consolidated
financial statements from inception through the fiscal year ended April 30,
2007, contained in Somanta’s annual reports on Form 10-KSB. The information
is only a summary and should be read in conjunction with Somanta’s consolidated
financial statements and accompanying notes, as well as management’s discussion
and analysis of results of operations and financial condition, all of which can
be found in publicly available documents, including those incorporated by
reference into this Registration Statement.
|
For
the Year Ended April 30,
|
||||||||||
|
2007
|
2006
|
2005
|
||||||||
|
(In
thousands, except per share amounts)
|
||||||||||
|
Consolidated
Statement of Operations and Comprehensive Loss Data
|
||||||||||
|
Total
revenues
|
$
|
1
|
$
|
1
|
$
|
-
|
||||
|
Operating
loss
|
(4,550
|
)
|
(4,108
|
)
|
(1,129
|
)
|
||||
|
Interest
and miscellaneous income
|
28
|
17
|
-
|
|||||||
|
Interest
and other expense
|
(2,969
|
)
|
(908
|
)
|
-
|
|||||
|
Income
tax
|
4
|
2
|
-
|
|||||||
|
Net
loss
|
(7,496
|
)
|
(5,002
|
)
|
(1,129
|
)
|
||||
|
Deemed
dividends on convertible preferred stock
|
-
|
(1,522
|
)
|
-
|
||||||
|
Net
loss applicable to common shareholders
|
(7,496
|
)
|
(6,524
|
)
|
(1,129
|
)
|
||||
|
Comprehensive
loss-foreign currency translation adjustment
|
-
|
-
|
(6
|
)
|
||||||
|
Comprehensive
loss
|
(7,496
|
)
|
(6,524
|
)
|
(1,135
|
)
|
||||
|
Common
Stock Data:
|
||||||||||
|
Net
loss per basic and diluted
common
share
|
$
|
(0.56
|
)
|
$
|
(0.47
|
)
|
$
|
(0.20
|
)
|
|
|
Weighted
average basic and
diluted
common shares
outstanding
|
14,278,247
|
14,274,365
|
5,576,845
|
|||||||
|
As
of April 30,
|
|||||||
|
2007
|
2006
|
||||||
|
(In
thousands)
|
|||||||
|
Consolidated Balance
Sheet Data
|
|||||||
|
Cash,
cash equivalents and short term investments
|
$
|
5
|
$
|
1,588
|
|||
|
Restricted
cash
|
2
|
152
|
|||||
|
Total
assets
|
67
|
1,859
|
|||||
|
Current
liabilities
|
8,245
|
3,443
|
|||||
|
Total
liabilities
|
8,245
|
3,443
|
|||||
|
Total
stockholders' equity (deficit)
|
(8,178
|
)
|
(1,585
|
)
|
|||
7
Selected
Unaudited Pro Forma Condensed Combined Financial Data
The
following unaudited pro forma condensed combined financial statements apply to
the merger between Somanta and Access, by which Somanta became a wholly owned
subsidiary of Access, and are based upon the historical condensed consolidated
financial statements and notes thereto (as applicable) of Access and Somanta,
which are incorporated by reference into this Form S-1/A. The unaudited pro
forma condensed combined balance sheet gives pro forma effect to the merger as
if the merger had been completed on December 31, 2007, and combines Access’s
December 31, 2007, audited consolidated balance sheet with
Somanta’s January 4, 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’s unaudited consolidated statement of
operations for the nine months ended October 31, 2007.
The pro
forma adjustments are based upon available information and certain assumptions
that Access believes are reasonable under the circumstances. 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-82.
Total
consideration paid in connection with the acquisition included:
|
·
|
Approximately
1.5 million shares of Access common stock was 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 shares issued);
|
|
·
|
exchange
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;
|
|
·
|
an
aggregate of $475,000 in direct transaction costs; and
|
|
·
|
cancelled
receivable from Somanta of
$931,000.
|
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 and for the
purposes of this pro forma is included in additional paid-in
capital.
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, net | 14 | |||
| Accounts payable | (2,582 | ) | ||
| In-process research & development | 8,879 | |||
| $ | 6,337 |
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
Registration Statement as described under “Unaudited Pro Forma Condensed
Combined Financial Statements” beginning on page F-82, and (ii) should be read
in conjunction with the consolidated financial statements of Access and Somanta
and other information filed by Access and Somanta with the SEC and incorporated
by reference into this Registration Statement.
8
|
Unaudited
Pro Forma Condensed Combined
Consolidated
Statement of Operations Data:
|
For
the Twelve
Months
Ended
December
31, 2006
|
For
the Twelve
Months
Ended
December
31, 2007
|
|||||
|
(in
thousands)
|
(in
thousands)
|
||||||
|
Total
revenues
|
$
|
1
|
$
|
58
|
|||
|
Total
expenses
|
9,727
|
9,791
|
|||||
|
Loss
from operations
|
(9,726
|
)
|
(9,233
|
)
|
|||
|
Interest
and miscellaneous income
|
322
|
122
|
|||||
|
Interest
and other expenses
|
(7,436
|
)
|
(3,541
|
)
|
|||
| Loss on extinguishment of debt | - | (11,628 | ) | ||||
|
Change
in fair value of warrant liabilities
|
(4,038
|
)
|
5,119
|
||||
|
Currency
translation loss
|
-
|
(1
|
)
|
||||
|
Loss
before discontinued
operations
and before tax benefit
|
(20,916
|
)
|
(19,162
|
)
|
|||
|
Income
tax benefit
|
169
|
56
|
|||||
|
Loss
from continuing operations
|
(20,747
|
)
|
(19,106
|
)
|
|||
| Less preferred stock dividends | - | (14,908 | ) | ||||
|
Loss
from continuing operations allocable
to common stockholders
|
(20,747
|
)
|
(34,014 | ) | |||
|
Discontinued
operations, net of
taxes
of $173,000 and $61,000
|
377
|
(112
|
)
|
||||
|
Net
loss allocable to common stockholders
|
$
|
(20,370
|
)
|
$
|
(33,902
|
)
|
|
Note 1:
The above statement gives effect to the merger of Access and Somanta, as if the
merger had occurred on January 1, 2006. Somanta statements used were for the
twelve months ended April 30, 2007 and the nine month period ended October 31,
2007.
|
Unaudited
Pro Forma Condensed Combined
Consolidated
Balance Sheet:
|
As
of December 31, 2007
|
||||
|
(in
thousands)
|
|||||
|
Cash
and cash equivalents
|
$
|
161
|
|||
|
Short
term investments, at cost
|
6,762
|
||||
|
Total
current assets
|
6,983
|
||||
|
Property
and equipment, net
|
144
|
||||
|
Patents
net
|
710
|
||||
|
Total
assets
|
7,849
|
||||
|
Accounts
payables and accrued expenses
|
3,969
|
||||
|
Current
portion of deferred revenue
|
68
|
||||
|
Current
portion of long-term debt net of discount
|
64
|
||||
|
Long-term
deferred revenue
|
910
|
||||
|
Long-term
debt
|
5,500
|
||||
|
Total
liabilities
|
10,641
|
||||
|
Additional
paid-in capital
|
120,774
|
||||
|
Notes
receivable from stockholders
|
(1,045
|
)
|
|||
|
Accumulated
deficit
|
(122,568
|
)
|
|||
|
Total
stockholders’ deficit
|
(2,792
|
)
|
|||
Note
1: Somanta statements used were for the period ended January 4, 2008
(unaudited).
9
RISK
FACTORS
Any
investment in our securities involves a high degree of risk. You should
carefully consider the risks described below, which we believe represent certain
of the material risks to our business, together with the information contained
elsewhere in this Prospectus, before you make a decision to invest in our
company.
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
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. As of June 18, 2008, the registration statement filed by Access relating
to such securities had not been declared effective. As such, 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. Such liquidated
damages shall continue to accrue until the 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.
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 our Form 10-Q at June 30, 2008, Item 4T, we have 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.
10
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 $15.2 million for the six months ended June 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 six months ended June 30, 2008 was approximately $556,000 per
month. Access projects its net cash burn rate from operations for the next 16
months to be approximately $525,000 per month. Capital expenditures are
forecasted to be minor for the next 16 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.
11
Although
Access expects that the acquisition of Somanta 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.
12
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 not entered into
any licensing arrangement. Access may be unable to execute its licensing
strategy for polymer platinate.
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.
|
13
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.
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.
14
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 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
|
|
• American
Pharmaceutical 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.
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 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.
15
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.
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;
|
|
|
•
|
Patent
and Know-how Assignment and License Agreement between Somanta and De
Montfort University dated March 20, 2003;
|
|
|
•
|
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
|
|
|
•
|
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.
16
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:
|
·
|
third-party
payers' increasing challenges to the prices charged for medical products
and services;
|
|
·
|
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
|
|
·
|
legislative
proposals to reform healthcare or reduce government insurance
programs.
|
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.
17
Access’
patents for the following technologies expire in the years and during the date
ranges indicated below:
|
·
|
Mucoadhesive
technology in 2021,
|
|
·
|
ProLindac™
in 2021,
|
|
·
|
Phenylbutyrate
between 2011 and 2016,
|
|
·
|
Angiolix®
in 2015,
|
|
·
|
Alchemix®
in 2015,
|
|
·
|
Cobalamin
mediated technology between 2008 and
2019
|
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.
18
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.), Lake End Capital LLC and
Midsummer Investment, Ltd. each beneficially owned approximately 71.0%, 28.7%,
20.4%, and 10.4%, respectively, of Access’ common stock as of October 6, 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.
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.
19
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 6,475,447 shares of
Access common stock that are outstanding as of October 6, 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 6,475,447
shares of common stock outstanding as of October 6, 2008, 6,475,447 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
10,849,528 shares issuable upon conversion of our preferred stock and 9,701,725
shares issuable upon exercise of outstanding warrants could also lower the
market price of our common stock.
The
selling stockholders intend to sell their shares of common stock in the market,
which sales may cause our stock price to decline.
The
selling stockholders intend to sell in the public market 9,160,228 shares of our
common stock being registered in this offering. That means that up to 9,160,228
shares may be sold pursuant to this registration statement. Such sales may cause
our stock price to decline. Our officers and directors and our shareholders who
are significant shareholders, as defined by the SEC, will continue to be subject
to the provisions of various insider trading and rule 144
regulations.
The
price you pay in this offering will fluctuate and may be higher or lower than
the prices paid by other people participating in this offering.
The price
in this offering will fluctuate based on the prevailing market price of our
common stock on the OTC Bulletin Board. Accordingly, the price you pay in this
offering may be higher or lower than the prices paid by other people
participating in this offering.
FORWARD-LOOKING
STATEMENTS
This
Prospectus contains “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended, and that involve risks and
uncertainties. These statements include, without limitation, statements relating
to uncertainties associated with research and development activities, clinical
trials, our ability to raise capital, the timing of and our ability to achieve
regulatory approvals, dependence on others to market our licensed products,
collaborations, future cash flow, the timing and receipt of licensing and
milestone revenues, the future success of our marketed products and products in
development, our sales projections, and the sales projections of our licensing
partners, our ability to achieve licensing milestones, our ability to continue
as a going concern, anticipated payments to be received from Uluru, anticipated
product approvals and timing thereof, product opportunities, clinical trials and
U.S. Food and Drug Administration (“FDA”) applications, as well as our drug
development strategy, our clinical development organization expectations
regarding our rate of technological developments and competition, our plan not
to establish an internal marketing organization, our expectations regarding
minimizing development risk and developing and introducing technology, the terms
of future licensing arrangements, our ability to secure additional financing for
our operations and our expected cash burn rate. These statements relate to
future events or our future financial performance. In some cases, you can
identify forward-looking statements by terminology such as “may,” “will,”
“should,” “expects,” “plans,” “could,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negative of such terms or other
comparable terminology. We intend the forward-looking statements to
be covered by the safe harbor for forward-looking statements in these sections.
The forward-looking information is based on various factors and was derived
using numerous assumptions.
Forward-looking
statements necessarily involve risks and uncertainties, and our actual results
could differ materially from those anticipated in the forward-looking statements
due to a number of factors, including those set forth above under “Risk Factors”
and elsewhere in this Prospectus. The factors set forth above under “Risk
Factors” and other cautionary statements made in this Prospectus should be read
and understood as being applicable to all related forward-looking statements
wherever they appear in this Prospectus. The forward-looking statements
contained in this Prospectus represent our judgment as of the date of this
Prospectus. We caution readers not to place undue reliance on such statements.
Except as required by law, we undertake no obligation to update publicly any
forward-looking statements for any reason, even if new information becomes
available or other events occur in the future.
20
SELLING
STOCKHOLDERS
The
following table presents information regarding the selling stockholders. The
selling shareholders are the entities who have assisted in or provided financing
to us. A description of each selling shareholder's relationship to us and how
each selling shareholder acquired the shares to be sold in this offering is
detailed in the information immediately following this table. The shares listed
in the table do not include the shares of common stock that may be paid as a
dividend on outstanding shares of Series A Preferred Stock.
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Percentage
of
Outstanding
Shares
Beneficially
Owned
Before
Offering
|
Shares
to
be Sold in the
Offering
(23)
|
Percentage
of
Outstanding
Shares
Beneficially
Owned
After
Offering
|
|
Beach
Capital LLC (2)
|
949,496
|
12.8%
|
514,299
|
6.3%
|
|
Brio
Capital LP (3)
|
75,000
|
1.1%
|
-
|
1.1%
|
|
Catalytix
LDC Life Science
Hedge
AC (4)
|
24,999
|
*
|
-
|
*
|
|
Cobblestone
Asset Mangement LLC (5)
|
155,450
|
2.4%
|
-
|
2.4%
|
|
Cranshire
Capital, LP (6)
|
183,333
|
2.8%
|
-
|
2.8%
|
|
Credit
Suisse Securities (USA) LLC (7)
|
500,000
|
7.2%
|
-
|
7.2%
|
|
Enable
Growth Partners LP (8)
|
249,999
|
3.7%
|
-
|
3.7%
|
|
William
G. Garrison (9)
|
66,667
|
1.0%
|
-
|
1.0%
|
|
Edward
and Patricia Kelly (10)
|
99,999
|
1.5%
|
-
|
1.5%
|
|
Lake
End Capital LLC (11)
|
1,637,788
|
20.4%
|
709,734
|
12.7%
|
|
Dennis
Lavalle (12)
|
45,000
|
*
|
-
|
*
|
|
David
P. Luci (13)
|
43,500
|
*
|
-
|
*
|
|
Midsummer
Investment, Ltd (14)
|
750,000
|
10.4%
|
-
|
10.4%
|
|
Oracle
Institutional Partners LP (15)
|
779,997
|
10.8%
|
493,221
|
4.3%
|
|
Oracle
Offshore Ltd. (16)
|
76,893
|
1.2%
|
47,924
|
*
|
|
Oracle
Partners, LP (17)
|
1,622,482
|
20.7%
|
916,554
|
10.2%
|
|
Perceptive
Life Sciences
Master
Fund Ltd (18)
|
666,666
|
9.3%
|
-
|
9.3%
|
|
Rockmore
Investment
Master
Fund Ltd (19)
|
249,999
|
3.7%
|
-
|
3.7%
|
|
Schroder
& Co. Bank AG, Zurich (20)
|
125,000
|
1.9%
|
-
|
1.9%
|
|
SCO
Capital Partners LLC (21)
|
11,947,915
|
67.8%
|
4,896,136
|
55.4%
|
|
SCO
Capital Partners LP (22)
|
999,999
|
13.4%
|
-
|
13.4%
|
|
Total:
|
21,250,182
|
7,577,868
|
--------------------
* - less
than 1%
|
(1)
|
Applicable
percentage of ownership is based on 6,475,447 shares of common stock
outstanding as of October 6, 2008, together with securities exercisable or
convertible into shares of common stock within 60 days of October 6, 2008,
for each stockholder. Beneficial ownership is determined in accordance
with Rule 13d-3(d) promulgated by the Commission under the Securities
and Exchange Act of 1934, as amended. Shares of common stock issuable
pursuant to options, warrants and convertible securities are treated as
outstanding for computing the percentage of the person holding such
securities but are not treated as outstanding for computing the percentage
of any other person. Unless otherwise noted, each person or group
identified possesses sole voting and investment power with respect to
shares, subject to community property laws where applicable. Shares not
outstanding but deemed beneficially owned by virtue of the right of a
person or group to acquire them within 60 days are treated as
outstanding only for purposes of determining the number of and percent
owned by such person or group. Unless a holder of Series A Cumulative
Convertible Preferred Stock either elected otherwise prior to the purchase
of such preferred stock or elects otherwise upon not less than 61 days
prior written notice, its ability to convert its Series A Cumulative
Convertible Preferred Stock into common stock or to vote on an
as-if-converted to common stock basis is restricted pursuant to
a beneficial ownership cap to the extent that such conversion would result
in the holder owning more than 4.99% of our issued and outstanding common
stock or voting together with the common stock on an as-if-converted to
common stock basis in respect of more than 4.99% of our issued and
outstanding common stock. The warrants issued in connection with the
Series A Cumulative Convertible Preferred Stock are subject to a similar
beneficial ownership cap restriction on their exercise. SCO Capital
Partners LLC, SCO Capital Partners, L.P. and Beach Capital LLC, have
elected not to be governed by these restrictions. For purposes of the
table, beneficial ownership has been calculated as if there were no such
beneficial ownership cap.
|
21
|
(2)
|
Beach
Capital LLC is known to directly beneficially own warrants to purchase an
aggregate of 435,197 shares of Access’ Common Stock and Series A Preferred
Stock which may be converted into an aggregate of 514,299 shares of
Access’ Common Stock. Beach Capital LLC and affiliates (SCO Capital
Partners LP and SCO Capital Partners 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 issuable to them upon conversion of Series A Preferred Stock. Steven
H. Rouhandeh, in his capacity as managing member of Beach Capital LLC has
the power to direct the vote and disposition of the shares owned by Beach
Capital LLC. Beach Capital LLC has opted out of the beneficial
ownership cap described above. Each of Mr. Davis and Mr. Alvino, Access’
directors and Mr. Davis an executive with SCO Capital Partners LLC,
disclaim beneficial ownership of such shares except to the extent of his
pecuniary interest therein.
|
|
(3)
|
Brio
Capital LP is known to beneficially own an aggregate of warrants to
purchase and aggregate of 25,000 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 50,000
shares of Access’ Common Stock.
|
|
(4)
|
Catalytix
LDC Life Science Hedge AC is known to beneficially own warrants to
purchase an aggregate of 8,333 shares of Access’ Common Stock and Series A
Preferred Stock which may be converted into an aggregate of 16,666 shares
of Access’ Common Stock.
|
|
(5)
|
Cobblestone
Asset Management LLC is known to beneficially own an aggregate of 30,450
shares of Access’ Common Stock, warrants to purchase an aggregate of
41,667 shares of Access’ Common Stock and Series A Preferred Stock which
may be converted into an aggregate of 83,333 shares of Access’ Common
Stock.
|
|
(6)
|
Cranshire
Capital, LP is known to beneficially own 50,000 shares of Access’ Common
Stock, warrants to purchase an aggregate of 83,333 shares of Access’
Common Stock and Series A Preferred Stock which may be converted into an
aggregate of 50,000 shares of Access’ Common Stock. Michael P. Koplin, the
president of Downsview Capital, Inc., the general partner of Cranshire
Capital, L.P., has sole voting control and investment discretion over
securities held by Cranshire Capital, L.P. Each of Michael P. Koplin and
Downsview Capital, Inc. disclaims beneficial ownership of shares held by
Cranshire Capital, L.P.
|
|
(7)
|
Credit
Suisse Securities (USA) LLC is known to beneficially own warrants to
purchase an aggregate of 166,667 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 333,333
shares of Access’ Common Stock.
|
|
(8)
|
Enable
Growth Partners LP is known to beneficially own 10,000 shares of Access’
Common Stock, warrants to purchase an aggregate of 83,333 shares of
Access’ Common Stock and Series A Preferred Stock which may be converted
into an aggregate of 156,666 shares of Access’ Common
Stock.
|
|
(9)
|
William
G. Garrison is known to beneficially own Series A Preferred Stock which
may be converted into an aggregate of 66,667 shares of Access’ Common
Stock.
|
|
(10)
|
Edward
and Patricia Kelly are known to beneficially own warrants to purchase an
aggregate of 33,333 shares of Access’ Common Stock and Series A Preferred
Stock which may be converted into an aggregate of 66,666 shares of Access’
Common Stock.
|
|
(11)
|
Lake
End Capital LLC is known to beneficially own 67,694 shares of Access’
Common Stock, warrants to purchase an aggregate of 777,027 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 67,694 shares of
Access’ Common Stock, warrants and options to purchase an aggregate of
807,847 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. Mr. Davis is a director of Access
designated by SCO Capital Partners LLC pursuant to an agreement between
SCO Capital Partners LLC and
Access.
|
|
(12)
|
Dennis
Lavalle is known to beneficially own warrants to purchase an aggregate of
15,000 shares of Access’ Common Stock and Series A Preferred Stock which
may be converted into an aggregate of 30,000 shares of Access’ Common
Stock.
|
|
(13)
|
David
P. Luci is known to beneficially own warrants and options to purchase an
aggregate of 35,167 shares of Access’ Common Stock and 8,333 shares of
Common Stock issuable upon conversion of Series A Preferred
Stock.
|
|
(14)
|
Midsummer
Investment, Ltd. is known to beneficially own 90,000 shares of Access’
Common Stock, 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 410,000 shares of Access’ Common
Stock.
|
22
|
(15)
|
Oracle
Institutional Partners LP is known to beneficially own an aggregate of
40,165 shares of Access’ Common Stock, warrants to purchase an aggregate
of 246,611 shares of Access’ Common Stock and Series A Preferred Stock
which may be converted into an aggregate of 493,221 shares of Access’
Common Stock. Larry N. Feinberg is a partner in Oracle Partners, L.P.
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.
|
|
(16)
|
Oracle
Offshore Ltd is known to beneficially own an aggregate of 5,007 shares of
Access’ Common Stock, warrants to purchase an aggregate of 23,962 shares
of Access’ Common Stock and Series A Preferred Stock which may be
converted into an aggregate of 47,924 shares of Access’ Common Stock.
Larry N. Feinberg is a partner in Oracle Partners, L.P. 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.
|
|
(17)
|
Oracle
Partners, LP is known to beneficially own an aggregate of 247,651 shares
of Access’ Common Stock, warrants to purchase an aggregate of 458,277
shares of Access’ Common Stock and Series A Preferred Stock which may be
converted into an aggregate of 916,554 shares of Access’ Common Stock.
Larry N. Feinberg is a partner in Oracle Partners, L.P. 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.
|
|
(18)
|
Perceptive
Life Sciences Master Fund Ltd is known to beneficially own 666,666 shares
of Access’ Common Stock.
|
|
(19)
|
Rockmore
Investment Master Fund Ltd is known to beneficially own warrants to
purchase an aggregate of 83,333 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 166,666
shares of Access’ Common Stock. Rockmore Capital, LLC (“Rockmore Capital”)
and Rockmore Partners, LLC (“Rockmore Partners”), each a limited liability
company formed under the laws of the State of Delaware, serve as the
investment manager and general partner, respectively, to Rockmore (US) LP,
a Delaware limited partnership, which invests all of its assets through
Rockmore Investment Master Fund Ltd., an exempted company formed under the
laws of Bermuda (“Rockmore Master Fund”). By reason of such relationships,
Rockmore Capital and Rockmore Partners may be deemed to share dispositive
power over shares of our common stock owned by Rockmore Master Fund.
Rockmore Capital and Rockmore Partners disclaim beneficial ownership of
such shares of our common stock. Rockmore Partners has delegated authority
to Rockmore Capital regarding portfolio management decisions with respect
to the shares of common stock owned by Rockmore Master Fund and, as of
December 10, 2007, Mr. Bruce T. Bernstein and Mr. Brian Daly, as officers
of Rockmore Capital, are responsible for the portfolio management
decisions of the shares of common stock owned by Rockmore Master Fund. By
reason of such authority, Messsrs. Bernstein and Daly may be deemed to
share dispositive power over the shares of our common stock owned by
Rockmore Master Fund. Messrs. Bernstein and Daly disclaim beneficial
ownership of such shares of our common stock and neither of such persons
has any legal right to maintain such authority. No other person has sole
or shared voting or dispositive power with respect to the shares of our
common stock as those terms are used for purposes under Regulation 13D-G
of the Securities Exchange Act of 1934, as amended. No person or “group”
(as that term is used in Section 13(d) of the Securities Act of 1934, as
amended, or the SEC’s Regulation 13D-G) controls Rockmore Master
Fund.
|
|
(20)
|
Schroder
& Co. Bank AG, Zurich is known to beneficially own warrants to
purchase an aggregate of 41,667 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 83,333
shares of Access’ Common Stock.
|
|
(21)
|
SCO
Capital Partners LLC is known to directly beneficially own 787,796 shares
of Access’ Common Stock, warrants to purchase an aggregate of 5,597,317
shares of Access’ Common Stock and Series A Preferred Stock which may be
converted into an aggregate of 5,562,802 shares of Access’ Common Stock.
SCO Capital Partners LLC and affiliates (SCO Capital Partners, L.P. 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 issuable to them
upon conversion of Series A Preferred Stock. Steven H. Rouhandeh, in his
capacity as chairman and managing member of SCO Capital Partners LLC, has
the power to direct the vote and disposition of the shares owned by SCO
Capital Partners LLC. SCO Capital Partners LLC has opted out of
the beneficial ownership cap described
above.
|
|
(22)
|
SCO
Capital Partners, L.P. is known to directly beneficially own warrants to
purchase an aggregate of 333,333 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 666,666
shares of Access’ Common Stock. SCO Capital Partners, L.P. and affiliates
(SCO Capital Partners LLC 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 issuable to them upon conversion of Series A Preferred
Stock. Steven H. Rouhandeh, in his capacity as managing member of the
entity that serves as general partner of SCO Capital Partners, L.P. has
the power to direct the vote and disposition of the shares owned by SCO
Capital Partners, L.P. SCO Capital Partners, L.P. has opted out of the
beneficial ownership cap described
above.
|
|
(23)
|
Access’
Common Stock registered in this offering consists of 7,577,868 shares of
common stock issued for previously outstanding convertible notes and
1,582,360 shares which will be issued as common stock dividends to holders
of the Series A Preferred Stock. Since, as of the date of this
filing, these dividends have not yet been issued, this table does not
include specific shares amounts for “Shares to be Sold in the Offering”
for certain of the Selling
Stockholders.
|
23
Excluding
shares held by the Selling Stockholders, as of October 6, 2008, there were
4,793,291 shares of our Common Stock issued and outstanding.
As of
October 6, 2008 we are not aware of any short positions in our stock held by the
Selling Stockholders.
The
following information contains a description of each selling shareholder's
relationship to us and how each selling shareholder acquired the shares to be
sold in this offering is detailed below. None of the selling stockholders have
held a position or office, or had any other material relationship, with us,
except as follows:
SCO Capital Partners LLC and
affiliates
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. Subsequently on February 4, 2008 we entered
into an Amended and Restated Purchase Agreement whereby we issued an additional
200 shares of Series A Preferred Stock and warrants to purchase 333,333 shares
of our common stock on substantially the same terms contained in the Purchase
Agreement and related transaction documents.
The
Series A Preferred Stock has a liquidation preference of $10,000 per share, is
entitled to a dividend of 6% per annum, payable in shares of our common stock at
our option. The number of shares of common stock into which each
share of Series A Preferred Stock is convertible is determined by dividing the
liquidation preference per share plus all accrued and unpaid dividends thereon
by $3.00. Unless a holder of Series A Preferred Stock either elected
otherwise prior to the purchase of such preferred stock or elects otherwise upon
not less than 61 days prior written notice, its ability to convert its Series A
Preferred Stock into common stock or to vote on an as-if-converted to common
stock basis is restricted pursuant to a beneficial ownership cap to the extent
that such conversion would result in the holder owning more than 4.99% of our
issued and outstanding common stock or voting together with the common stock on
an as-if-converted to common stock basis in respect of more than 4.99% of our
issued and outstanding common stock. The warrants issued in
connection with the Series A Preferred Stock are subject to a similar beneficial
ownership cap restriction on their exercise. SCO Capital Partners
LLC, SCO Capital Partners, L.P. and Beach Capital LLC have elected not to be
governed by these restrictions.
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. In
connection with the exchange of the notes, all security interests and liens
relating thereto were terminated.
In
connection with its sale and issuance of Series A Preferred Stock and warrants,
Access entered into an investor rights agreement whereby it granted registration
rights with respect to the shares of common stock of Access underlying the
Series A Preferred Stock and warrants. In addition, 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
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 notes and warrants were sold
in a private placement to a group of accredited investors led by SCO Capital
Partners LLC and affiliates. All of the principal and interest under these notes
were exchanged for shares of our Series A Preferred Stock and warrants as
described above. The warrants associated with the notes are currently
outstanding.
24
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. The notes and warrants were sold
in a private placement to a group of accredited investors led by SCO and
affiliates. All of the principal and interest under these notes were exchanged
for shares of our Series A Preferred Stock and warrants as described above. The
warrants associated with the notes are currently outstanding.
On
February 16, 2006, we entered into a note and warrant purchase agreement
pursuant to which we sold and issued an aggregate of $5,000,000 of 7.5%
convertible notes due November 15, 2007 and warrants to purchase an aggregate of
3,863,634 shares of common stock of Access. Net proceeds to Access were $4.5
million. The notes and warrants were sold in a private placement to a group of
accredited investors led by SCO and affiliates. All of the principal and
interest under these notes were exchanged for shares of our Series A Preferred
Stock and warrants as described above. The warrants associated with the notes
are currently outstanding.
Each
noteholder received a warrant to purchase a number of shares of common stock of
Access equal to 75% of the total number shares of Access common stock into which
such holder's note is convertible. Each warrant has an exercise price of $1.32
per share and is exercisable at any time prior to February 16, 2012, October 24,
2012 and December 6, 2012.
In
connection with its sale and issuance of notes and warrants, Access entered into
an investors rights agreement whereby it granted SCO the right to designate two
individuals to serve on the Board of Directors of Access while the notes are
outstanding, and also granted registration rights with respect to the shares of
common stock of Access underlying the notes and warrants. In connection with its
sale and issuance of notes and warrants, Access entered into an investor rights
agreement whereby it granted registration rights with respect to the shares of
common stock of Access underlying the notes and warrants. In
addition, pursuant to the purchase agreements in connection with each of the
note and warrant financings, Access granted SCO the right to designate two
individuals to serve on the Board of Directors of Access while the notes are
outstanding, and also granted. This right has now terminated in
accordance with its terms and as been replaced by a similar right pursuant to
the Director Designation Agreement described above.
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.
Mr. Steven H. Rouhandeh is a Chief Investment Officer
of SCO Capital Partners, L.P., a New York based life sciences
fund.
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. SCO
Capital Partners, 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 issuable to them upon conversion of Series
A Preferred Stock. Steven H. Rouhandeh, in his capacity as managing member of
the entity that serves as general partner of SCO Capital Partners, L.P. has the
power to direct the vote and disposition of the shares owned by SCO Capital
Partners, L.P. Steven H. Rouhandeh, in his capacity as Chairman of SCO Capital
Partners, LLC. has the power to direct the vote and disposition of the shares
owned by SCO Capital Partners, LLC.
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.
On
February 15, 2006 we entered into a Consulting Services Agreement with SCO
Financial Group LLC (“SCO Financial”) pursuant to which SCO Financial provides
certain consulting services to us in exchange for a monthly fee of $12,500. We
also pay SCO Financial a success fee of 7% (plus warrant coverage of 10% with
exercise price equal to purchaser’s warrants) of the aggregate value of any
proceeds received by us pursuant to our issuance of preferred
stock. SCO Financial agreed to waive its right to this 7% fee with
respect to any proceeds received by the us as a result of the efforts of other
placement agents.
25
Oracle Partners LP and
affiliates
As a
condition to the closing of the sale of the Series A Preferred Stock and
warrants, 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. Prior to the effectiveness of this registration
statement, we had previously registered an aggregate of 1,560,000 shares of
common stock for Partners, LP and affiliates of Oracle Partners,
LP.
Additional Tables and Information
Regarding Selling Stockholders.
As noted
in Table 1 and Table 1.A below, the total number of shares of common stock being
registered is 7,577,868. These shares represent shares of common
stock issuable upon conversion of Series A Preferred Stock which was issued to
certain selling stockholders in exchange for convertible notes held by those
Selling Stockholders. At the time of the exchange, the
convertible notes had an outstanding principal and accrued interest balance of
$21,468,927. We note that the total proceeds received by us,
including the exchanged convertible notes, in conjunction with our sale of
Series A Preferred Stock was $33,733,928.
In
addition, we note that the Series A Preferred Stock is subject to adjustment in
the event we issue or sell any shares of our common stock for a price below the
current Series A Preferred Stock conversion price; provided, however, that no
such adjustment will be made in connection with (i) shares of common stock
issued upon conversion of Series A Preferred Stock or the exercise of warrants
issued in connection with the issuance of Series A Preferred Stock, (ii) the
exercise of options, warrants or the conversion of convertible notes that were
outstanding on the date of issuance of the Series A Preferred Stock, (iii)
common stock issued pursuant to any stock-based compensation plans, (iv) common
stock issued pursuant to a stock split, combination or subdivision of the
outstanding common stock, and (v) shares of common stock issued in connection
with a bona-fide strategic transaction. As noted in Table 1 below,
the conversion price of the Series A Preferred Stock at the time of issuance was
$3.00 per share. As of the date hereof, we have not issued or sold,
and do not currently have any plans to issue or sell, any shares of our common
stock for a price below $3.00 per share.
As noted
in Table 1 below, we are also registering 1,582,360 shares of common stock which
may be issued by us in satisfaction of certain accrued dividends on our Series A
Preferred Stock. Although we have received adequate financing to pay
all required dividends over the next twelve month, in an effort to maximize the
amount of funds available for working capital, we anticipate issuing shares of
our common stock in lieu of cash dividends over the near term.
As noted
in Table 1.A below, we received proceeds of $11,351,451, net of placement agent
fees paid to Selling Stockholders, from our sale of Series A Preferred
Stock. Placement agent fees accounted for approximately 8% of the
private placement transaction.
TABLE
1 - Detail of Issuance of Series A Preferred Stock
(Including
Paid in Kind Dividends)
|
Event
Type
|
Form
of Consideration
|
Date
Acquired
|
Underlying
Common
Shares Acquired
|
Conversion/Exercise
Price
per Share
|
Consideration
Paid
|
Market
Price
|
Market
Value
|
Profit
(loss)
on
Conversion
|
||||||||||||||||||||||
|
Series
A Purchase
|
Cash
|
11/9/2007
|
3,179,996 | $ | 3.00 | $ | 9,540,001 | (3 | ) | $ | 3.11 | $ | 9,889,788 | 349,787 | ||||||||||||||||
|
Series
A Purchase/Exchange of Note
|
Exchange
of Note
|
11/9/2007
|
7,577,868 | $ | 3.00 | $ | 21,468,927 | (1 | ) | $ | 3.11 | $ | 23,567,169 | 2,098,242 | ||||||||||||||||
|
Series
A Purchase Warrant
|
Unexercised
Warrant
|
11/9/2007
|
3,649,880 | $ | 3.50 | N/A | (2 | ) | $ | 3.11 | $ | 11,351,127 | ||||||||||||||||||
|
Series
A Purchase
|
Cash
|
2/4/2008
|
908,331 | $ | 3.00 | $ | 2,725,000 | (3 | ) | $ | 2.80 | $ | 2,543,327 | (181,673 | ) | |||||||||||||||
|
Series
A Purchase - Warrant
|
Unexercised
Warrant
|
2/4/2008
|
499,584 | $ | 3.50 | N/A | (2 | ) | $ | 2.80 | $ | 1,398,835 | ||||||||||||||||||
|
Other
- Paid in Kind Dividends
|
Possible
dividends (value at time of dividend date equal to 20 day moving
average)
|
N/A | 1,582,360 | N/A | N/A | (4 | ) | N/A | N/A | N/A | ||||||||||||||||||||
|
Total
|
17,398,019 | $ | 33,733,928 | $ | 48,750,246 | (3) | $ | 2,266,356 | ||||||||||||||||||||||
Notes:
(1) - We
exchanged shares of our Series A Convertible Preferred Stock for outstanding
convertible notes. In this transaction we are registering 7,577,868 shares
of Common Stock underlying the Series A Preferred Stock issued in exchange for
the convertible notes.
(2) -
Includes placement agent warrants listed on Table 2.
(3) - We
received $12,265,001 of consideration in the form of cash. The
remainder is comprised of exchanged convertible notes and warrants.
(4) - We
are registering 1,582,360 shares of Common Stock which may be issued to the
Selling Stockholders in lieu of cash dividends.
26
TABLE
1.A - Proceeds Received of Private Placement Transaction
|
Event
Type
|
Form
of Consideration
|
Date
Acquired
|
|
Common
Shares
Acquired
|
Price
per
Share
|
Gross
Proceeds
Paid
to Issuer
|
Percentage
of Placement Agent Fees to Net Proceeds
|
||||||||
|
Series
A Purchase
|
Cash
|
11/9/2007
|
3,179,996 | $ | 3.00 | $ | 9,540,001 | ||||||||
|
Series
A Purchase
|
Cash
|
2/4/2008
|
908,331 | $ | 3.00 | $ | 2,725,000 | ||||||||
|
Sub-Total
Private Placement Transaction
|
4,088,327 | $ | 12,265,001 | ||||||||||||
|
Placement
Agent Fees (from Table 2)
|
$ | 913,550 | |||||||||||||
|
Net
Proceeds to Issuer
|
$ | 11,351,451 |
8.0%
|
||||||||||||
Note: The
total amount of Profit (loss) on Conversion and placement agent fees divided by
the Gross Proceeds to the Issuer is approximately 28.0%.
As noted
in Table 2 below, we paid certain selling stockholders “placement agent” fees in
the form of cash and warrants to purchase shares of our common
stock. The warrants have an exercise price of $3.50, and at the time
of issuance the underlying common stock was trading at $3.11 and $2.80 for
warrants granted on November 9, 2007, and February 4, 2008,
respectively.
Pursuant
to the terms of the Investor Rights Agreement, as amended, between the us and
the holders of our Series A Preferred Stock, we were required to file a
registration statement on Form S-1 with the Securities and Exchange Commission
on or before March 20, 2008, with such registration statement to become
effective on or before June 18, 2008. Since our registration
statement was not declared effective by June 18, 2008, we may incur additional
liquidated damages of 1% of the total Series A Preferred Stock proceeds for each
30 day period that the Registration Statement is not declared
effective. Potential liquidated damages are capped at 10% of the
total subscription amount. However, pursuant to the terms of the
Investor Rights Agreement, we may not be required to pay such liquidated damages
if such shares are saleable without restriction pursuant to Rule 144 of the
Securities Act of 1933.
Pursuant
to the rights and preferences of the Series A Preferred Stock, the Company is
required to pay semi-annually a dividend of 6% per annum on each outstanding
share of Series A Preferred Stock. In certain circumstances, or with
the approval of the holders owning a majority of the shares of Company’s Series
A Preferred Stock, we may pay these dividends in shares of our common
stock. In order for us to pay these dividends in shares of our common
stock, certain conditions must be met. These conditions include the requirement
that the shares to be issued as dividends are covered by an effective
Registration Statement.
27
TABLE
2 - Other Warrants and Placement Agent Fees
|
Stockholder
|
Date
Acquired
/ Amount Due
|
Common
Stock
Underlying
Placement
Agent
Warrants
|
Price
per
Share
|
Placement
Agent Fees Paid
|
Form
of
Consid-eration
|
Market
Price
at
Time
of
Sale
|
Market
Value
at
Time
of
Sale
|
|
SCO
Capital Partners LLC
|
2/16/2006
|
272,727
|
(1)
|
$
|
1.32
|
Warrant
|
$ |
1.05
|
$
|
286,363
|
||||||
|
Lake
End Capital Partners LLC
|
2/16/2006
|
90,909
|
(1)
|
$ |
1.32
|
Warrant
|
$ |
1.05
|
$
|
95,454
|
||||||
|
Howard
Fischer
|
2/16/2006
|
45,454
|
(1)
|
$ |
1.32
|
Warrant
|
$ |
1.05
|
$
|
47,727
|
||||||
|
Mark
Alvino
|
2/16/2006
|
45,454
|
(1)
|
$ |
1.32
|
Warrant
|
$ |
1.05
|
$ |
47,727
|
||||||
|
SCO
Capital Partners LLC
|
2/16/2006
|
$ |
400,000
|
Cash
|
$ |
400,000
|
||||||||||
|
SCO
Capital Partners LLC
|
10/24/2006
|
36,364
|
(1)
|
$ |
1.32
|
Warrant
|
$ |
1.20
|
$ |
43,637
|
||||||
|
Lake
End Capital Partners LLC
|
10/24/2006
|
9,091
|
(1)
|
$ |
1.32
|
Warrant
|
$ |
1.20
|
$ |
10,909
|
||||||
|
SCO
Capital Partners LLC
|
10/24/2006
|
$ |
40,000
|
Cash
|
$ |
40,000
|
||||||||||
|
SCO
Capital Partners LLC
|
12/6/2006
|
18,182
|
(1)
|
$ |
1.32
|
Warrant
|
$ |
1.80
|
$ |
32,728
|
||||||
|
Lake
End Capital Partners LLC
|
12/6/2006
|
9,091
|
(1)
|
$ |
1.32
|
Warrant
|
$
|
1.80
|
$ |
16,364
|
||||||
|
Howard
Fischer
|
12/6/2006
|
9,091
|
(1)
|
$ |
1.32
|
Warrant
|
$ |
1.80
|
$ |
16,364
|
||||||
|
Mark
Alvino
|
12/6/2006
|
9,091
|
(1)
|
$ |
1.32
|
Warrant
|
$ |
1.80
|
$ |
16,364
|
||||||
|
SCO
Capital Partners LLC
|
12/6/2006
|
$ |
40,000
|
Cash
|
$ |
40,000
|
||||||||||
|
SCO
Capital Partners LLC
|
11/9/2007
|
100,000
|
(2)
(4)
|
$ |
3.50
|
Warrant
|
$ |
3.11
|
$ |
311,000
|
||||||
|
SCO
Capital Partners LLC
|
11/9/2007
|
(2)
(4)
|
$ |
240,000
|
Cash
|
$ |
240,000
|
|||||||||
|
Rodman
& Renshaw LLC
|
11/9/2007
|
109,000
|
(2)
(3)
|
$ |
3.50
|
Warrant
|
$ |
3.11
|
$ |
338,990
|
||||||
|
Rodman
& Renshaw LLC
|
11/9/2007
|
(2)
(3)
|
$ |
482,800
|
Cash
|
$ |
482,800
|
|||||||||
|
SCO
Capital Partners LLC
|
2/4/2008
|
39,667
|
(2)
(4)
|
$ |
3.50
|
Warrant
|
$ |
2.80
|
$ |
111,068
|
||||||
|
SCO
Capital Partners LLC
|
2/4/2008
|
(2)
(4)
|
$ |
190,750
|
Cash
|
$ |
190,750
|
|||||||||
|
Lake
End Capital LLC
|
2/4/2008
|
5,750
|
(2)
(4)
|
$ |
3.50
|
Warrant
|
$ |
2.80
|
16,100
|
|||||||
|
Total
|
799,871
|
$ |
1,393,550
|
1,962,554
|
Notes:
(1) - In
connection with the convertible note stock offerings on 2/16/06, 11/24/06 and
12/6/06, we paid placement agent fees of 7% of the gross proceeds of the
placement plus we issued 6 year warrants to purchase our common stock at an
exercise price of $3.50 per share for 10% of the total warrants issued in the
placement.
(2) - In
connection with the preferred stock offering, we paid placement agent fees of 7%
of the gross proceeds of the placement plus we issued 6 year warrants to
purchase our common stock at an exercise price of $3.50 per share for 10% of the
total warrants issued in the placement.
(3) –
Rodman & Renshaw LLC is not a Selling Stockholder, however they are included
in this Table 3 as a result of receiving placement agent fees in connection with
our private placement transaction.
(4) Total fees paid (not including warrants) to Selling Stockholders
were $913,550. No discounts were received by the Selling Stockholders
pursuant to their purchase of Series A Preferred Stock.
Liquidated damages -
We may be
required to pay liquidated damages, pursuant to the terms of the Amended and
Restated Investor Rights Agreement dated February 4, 2008, to holders of Series
A Preferred Stock (some of whom also received placement agent fees) since an
effective registration was not in place by June 18, 2008. If required,
liquidated damages accrue at the rate of 1% per month, of the holders' total
Series A Preferred Stock investment amount until such time as the registration
statement is declared effective. Liquidated damages are capped at a
maximum amount of 10% of the holders' total Series A Preferred Stock investment
amount. Liquidated damages may also be waived by the investor. As of October 6,
2008, we accrued liquidated damages for (i) two of entities that received
placement agent fees and (ii) two affiliates of these entities that did not
receive placement agent fees, these accrual amounts are as follows:
SCO
Capital Partners LLC $310,273
Lake
End Capital LLC $38,136
Beach
Capital LLC $20,932
SCO
Capital Partners LP $74,000
Dividends -
We accrue
dividends on our Series A Preferred Stock at rate of 6% per year. As of October
6, 2008 we accrued preferred stock dividends for (i) two entities that received
placement agent fees and (ii) two affiliates of these entities that did not
receive placement agent fees, these accrual amounts are as follows:
SCO
Capital Partners LLC $956,262
Lake
End Capital LLC $128,901
Beach
Capital LLC $85,962
SCO
Capital Partners LP $111,429
28
As noted
in Table 3 below, certain of the Selling Stockholders and their affiliates held
warrants and options prior to our issuance of Series A Preferred
Stock. Table 3 below sets forth the warrants and options held by the
Selling Stockholders or their affiliates and certain other information,
including the profit(loss) on conversion of these securities:
Table
3 - Total Possible Profit for Selling Stockholders - Other Securities (Warrants
and Options)
|
Stockholder
|
Date
Acquired/
Amount
Due
|
Warrants/
Options
|
Exercise
Price
per
Share
|
Form
of
Consideration
|
Market
Price at
Time
of Sale
|
Combined
Market
Value
at
Time
of
Sale
|
Total
Possible
Profit
(Loss) at
Time
of Sale
|
|||||||||||||||
|
SCO Capital
Partners LLC
|
2/24/2004
|
18,949 | $ | 27.00 |
Warrant
|
$ | 27.70 | $ | 524,887 | $ | 13,264 | |||||||||||
|
Jeffrey
B. Davis
|
2/24/2004
|
5,820 | $ | 27.00 |
Warrant
|
$ | 27.70 | $ | 161,214 | $ | 4,074 | |||||||||||
|
Mark
Alvino
|
2/24/2004
|
980 | $ | 27.00 |
Warrant
|
$ | 27.70 | $ | 27,146 | $ | 686 | |||||||||||
|
SCO
Capital Partners LLC
|
2/16/2006
|
2,727,272 | $ | 1.32 |
Warrant
|
$ | 1.05 | $ | 2,863,636 | $ | (736,363 | ) | ||||||||||
|
Beach
Capital LLC
|
2/16/2006
|
340,909 | $ | 1.32 |
Warrant
|
$ | 1.05 | $ | 357,954 | $ | (92,045 | ) | ||||||||||
|
Lake
End Capital Partners LLC
|
2/16/2006
|
340,909 | $ | 1.32 |
Warrant
|
$ | 1.05 | $ | 357,954 | $ | (92,045 | ) | ||||||||||
|
SCO
Capital Partners LLC
|
2/16/2006
|
272,727 | $ | 1.32 |
Warrant
|
$ | 1.05 | $ | 286,363 | $ | (73,636 | ) | ||||||||||
|
Lake
End Capital Partners LLC
|
2/16/2006
|
90,909 | $ | 1.32 |
Warrant
|
$ | 1.05 | $ | 95,454 | $ | (24,545 | ) | ||||||||||
|
Howard
Fischer
|
2/16/2006
|
45,454 | $ | 1.32 |
Warrant
|
$ | 1.05 | $ | 47,727 | $ | (12,273 | ) | ||||||||||
|
Mark
Alvino
|
2/16/2006
|
45,454 | $ | 1.32 |
Warrant
|
$ | 1.05 | $ | 47,727 | $ | (12,273 | ) | ||||||||||
|
Jeffrey
B. Davis
|
8/16/2006
|
25,000 | $ | 0.63 |
Option
|
$ | 0.63 | $ | 15,750 | $ | - | |||||||||||
|
SCO
Financial Group
|
1/4/2008
|
39,722 | $ | 3.50 |
Warrant
|
$ | 3.10 | $ | 123,138 | $ | (15,889 | ) | ||||||||||
|
Jeffrey
B. Davis
|
1/4/2008
|
3,667 | $ | 3.50 |
Warrant
|
$ | 3.10 | $ | 11,368 | $ | (1,467 | ) | ||||||||||
| Total | 3,957,772 | $ | 4,920,318 | $ | (1,042,512 | ) | ||||||||||||||||
29
As noted
in Table 4 below, we have been a party to certain other security transactions
with the Selling Stockholders and their affiliates. Each of these
prior transactions are listed in the table below and are further described under
the heading “Selling Stockholders” above.
TABLE
4 - Prior Securities Transactions between Issuer and the Selling
Stockholders
* shares
adjusted to reflect reverse stock split, the current market price per share is
$2.45 on October 6, 2008.
|
Stockholder
|
Date
of
Transaction
|
Convertible
Notes
Principal
Amount
|
Common
Stock
k
to
be Issued
upon
the
Exercise
of
Warrants
|
Common
Stock
Underlying
Convertible
Notes
|
Market
Price per
Share (immediately
prior
to
transaction)*
|
Placement
Agent
Fees
Paid
|
||||||
|
Shares
Registered In Prior
Transactions
*
|
||||||||||||
|
Oracle
Institutional Partners LP
|
9/20/2000
|
698,500
|
(a)
|
25,400
|
||||||||
|
139,700
|
||||||||||||
|
Oracle
Offshore Ltd
|
9/20/2000
|
132,000
|
(a)
|
4,800
|
||||||||
|
26,400
|
||||||||||||
|
Oracle
Partners, LP
|
9/20/2000
|
2,524,500
|
(a)
|
91,800
|
||||||||
|
504,900
|
||||||||||||
|
SAM
Oracle Investments, Inc.
|
9/20/2000
|
660,000
|
(a)
|
24,000
|
||||||||
|
132,000
|
||||||||||||
|
4,015,000
|
(a)
|
949,000
|
||||||||||
|
SCO
Capital Partners LLC
|
2/24/2004
|
18,949
|
$ 27.00
|
|||||||||
|
Jeffrey
B. Davis
|
2/24/2004
|
5,820
|
$ 27.00
|
|||||||||
|
Mark
Alvino
|
2/24/2004
|
980
|
$ 27.00
|
|||||||||
|
SCO
Capital Partners LLC
|
2/24/2004
|
$ 560,000
|
(e)
|
|||||||||
|
25,749
|
$ 560,000
|
|||||||||||
|
SCO
Capital Partners LLC
|
2/16/2006
|
4,000,000
|
(b)
|
3,636,363
|
||||||||
|
Lake
End Capital LLC
|
2/16/2006
|
500,000
|
(b)
|
454,545
|
||||||||
|
Beach
Capital LLC
|
2/16/2006
|
500,000
|
(b)
|
454,545
|
||||||||
|
SCO
Capital Partners LLC
|
2/16/2006
|
2,727,272
|
$ 1.32
|
|||||||||
|
Lake
End Capital LLC
|
2/16/2006
|
340,909
|
$ 1.32
|
|||||||||
|
Beach
Capital LLC
|
2/16/2006
|
340,909
|
$ 1.32
|
|||||||||
|
SCO
Capital Partners LLC
|
2/16/2006
|
272,727
|
$ 1.32
|
|||||||||
|
Lake
End Capital LLC
|
2/16/2006
|
90,909
|
$ 1.32
|
|||||||||
|
Howard
Fischer
|
2/16/2006
|
45,454
|
$ 1.32
|
|||||||||
|
Mark
Alvino
|
2/16/2006
|
45,454
|
$ 1.32
|
|||||||||
|
SCO
Capital Partners LLC
|
2/16/2006
|
$ 400,000
|
(f)
|
|||||||||
|
5,000,000
|
3,863,634
|
4,545,453
|
$ 400,000
|
|||||||||
|
Sub-total
2/16/06 issue
|
8,409,087
|
|||||||||||
|
Total
Shares Previously Registered
|
3,889,383
|
5,494,453
|
||||||||||
|
Prior
Securities Transactions between Issuer and the Selling
Stockholders
|
||||||||||||
|
SCO
Capital Partners LLC
|
10/24/2006
|
400,000
|
(c)
|
363,636
|
||||||||
|
Lake
End Capital LLC
|
10/24/2006
|
100,000
|
(c)
|
90,909
|
||||||||
|
SCO
Capital Partners LLC
|
10/24/2006
|
272,727
|
$ 1.32
|
|||||||||
|
Lake
End Capital LLC
|
10/24/2006
|
68,182
|
$ 1.32
|
|||||||||
|
SCO
Capital Partners LLC
|
10/24/2006
|
36,364
|
$ 1.32
|
|||||||||
|
Lake
End Capital LLC
|
10/24/2006
|
9,091
|
$ 1.32
|
|||||||||
|
SCO
Capital Partners LLC
|
10/24/2006
|
$ 40,000
|
(f)
|
|||||||||
|
500,000
|
386,364
|
454,545
|
$ 40,000
|
|||||||||
|
SCO
Capital Partners LLC
|
12/6/2006
|
400,000
|
(d)
|
363,636
|
||||||||
|
Lake
End Capital LLC
|
12/6/2006
|
100,000
|
(d)
|
90,909
|
||||||||
|
SCO
Capital Partners LLC
|
12/6/2006
|
272,727
|
$ 1.32
|
|||||||||
|
Lake
End Capital LLC
|
12/6/2006
|
68,182
|
$ 1.32
|
|||||||||
|
SCO
Capital Partners LLC
|
12/6/2006
|
18,182
|
$ 1.32
|
|||||||||
|
Lake
End Capital LLC
|
12/6/2006
|
9,091
|
$ 1.32
|
|||||||||
|
Howard
Fischer
|
12/6/2006
|
9,091
|
$ 1.32
|
|||||||||
|
Mark
Alvino
|
12/6/2006
|
9,091
|
$ 1.32
|
|||||||||
|
SCO
Capital Partners LLC
|
12/6/2006
|
$ 40,000
|
(f)
|
|||||||||
|
500,000
|
386,364
|
454,545
|
$ 40,000
|
|||||||||
|
Total
Shares Not Previously Registered
|
772,728
|
909,090
|
||||||||||
|
Total
Prior Security Transactions
|
10,015,000
|
4,662,111
|
6,403,543
|
$ 1,040,000
|
||||||||
30
|
Stockholder
|
Registration
Statement
|
Total
Shares Registerd in Registration Statement *
|
Total
Common Shares Outstanding Prior to
Transaction
*
|
Total
Common Shares Held By Persons Other Than Selling Shareholder &
Affiliates *
|
Percentage
of Total & Outstanding Securities Issued/or Issuable in
Transaction
|
|
Shares Registered In Prior
Transactions *
|
|||||
|
S-3/A
File # 333-92210 – 7/15/03
|
146,000
|
2,520,696
|
2,327,598 | 5.8% | |
|
Oracle
Institutional Partners LP
|
S-1
File # 333-135734 – 7/13/06
|
803,000
|
3,530,908
|
2,837,555 | 22.7% |
|
Oracle
Offshore Ltd
|
|||||
|
Oracle
Partners, LP
|
|||||
|
SAM
Oracle Investments, Inc.
|
|||||
| Sub-total 9/20/00 issue |
949,000
|
||||
|
SCO
Capital Partners LLC
|
S-3
File # 333-113909 – 3/24/04
|
25,749
|
2,705,089
|
2,229,630 | 1.0% |
|
Jeffrey
B. Davis
|
|||||
|
Mark
Alvino
|
|||||
|
SCO
Capital Partners LLC
|
|||||
| Sub-total 2/24/04 issue |
25,749
|
||||
|
SCO
Capital Partners LLC
|
S-1
File # 333-135734 – 7/13/06
|
8,409,087
|
3,530,908
|
3,177,519 | 238.2% |
|
Lake
End Capital LLC
|
|||||
|
Beach
Capital LLC
|
|||||
|
Howard
Fischer
|
|||||
|
Mark
Alvino
|
|||||
| Sub-total 2/16/06 issue |
8,409,087
|
||||
|
|
|||||
|
Total
Shares Previously Registered
|
9,383,836
|
||||
|
Prior
Securities Transactions between Issuer and the Selling
Stockholders
|
|||||
|
SCO
Capital Partners LLC
|
|||||
|
Lake
End Capital LLC
|
|||||
| Sub-total 10/24/06 issue | 840,909 |
3,534,408
|
2,789,605 | 23.8% | |
|
SCO
Capital Partners LLC
|
|||||
|
Lake
End Capital LLC
|
|||||
|
Howard
Fischer
|
|||||
|
Mark
Alvino
|
|||||
| Sub-total 12/6/06 issue | 840,909 |
3,535,408
|
2,790,305 | 23.8% | |
|
Total Shares Not Previously
Registered
|
1,681,818 | ||||
|
Total
Prior Security Transactions
|
11,065,654
|
||||
(a)
Convertible note offering completed September 20, 2000. The notes originally had
a fixed conversion price of $27.50 per share in common stock. The note paid 7.0%
interest per annum for the first twelve months and thereafter adjusted to 7.7%
per annum. The notes were originally due September 13, 2005. In September 2005,
the notes were amended to a new maturity date of April 28, 2007, with the
conversion price being reduced from $5.50 per share (such price being the result
of a 1 for 5 reverse split which occurred in February 2006) to $1.00 per share.
The notes were again amended until they were exchanged for preferred
stock.
(b)
Convertible note offering completed February 16, 2006. The notes had a fixed
conversion price of $1.10 per share and converted into common stock. The note
paid 7.0% interest per annum. The notes were originally due April 27, 2007. The
notes were subsequently amended from time to time to extend the maturity date
thereon, and such notes were eventually exchanged for preferred stock on
November 9, 2007 (see Table 1).
(c)
Convertible note offering completed October 24, 2006. The notes had a fixed
conversion price of $1.10 per share in common stock. The note paid 7.0% interest
per annum. The notes were originally due April 27, 2007. The notes were
subsequently amended from time to time to extend the maturity date thereon, and
such notes were eventually exchanged for preferred stock on November 9, 2007
(see Table 1).
31
(d)
Convertible note offering completed December 6, 2006. The notes had a fixed
conversion price of $1.10 per share in common stock. The note paid 7.0% interest
per annum. The notes were originally due April 27, 2007. The notes were
subsequently amended from time to time to extend the maturity date thereon, and
such notes were eventually exchanged for preferred stock on November 9, 2007
(see Table 1).
(e)
Placement Agent fees paid to SCO Capital Partners, LLC in connection with a
closed private placement sale of the Company's common stock.
(f)
Placement Agent fees paid to SCO Capital Partners, LLC in connection with the
issuance of convertible notes.
Prior to
our sale of Series A Preferred Stock, we had an aggregate of 3,575,114 shares of
common stock outstanding. Of these 3,575,114 shares, 3,228,199 shares
were held by other than the Selling Stockholders, affiliates of the Company and
affiliates of the Selling Stockholders. Prior to the filing of this registration
statement on Form S-1/A, we previously registered 9,383,836 shares of
Common Stock for resale by the Selling Stockholders. Of these 9,383,836
shares, 3,889,383 shares are currently registered for resale and held by
the Selling Stockholders. We also note that no shares have been sold by the
Selling Shareholders or any affiliates of the selling shareholders in any
registered resale transactions.
The
Selling Stockholders are either themselves natural persons or are represented by
natural persons as follows:
|
Selling
Stockholder
|
Natural
Person or Persons who exercise sole or shared voting and/or dispositive
powers
|
|
|
Beach
Capital LLC
|
Steven
H. Rouhandeh
|
|
|
Brio
Capital LP
|
Shaye
Hirsch
|
|
|
Catalytix
LDC Life Science Hedge AC
|
Ken
Sorenson
|
|
|
Cobblestone
Asset Management LLC
|
Michael
J. Palazzi
|
|
|
Cranshire
Capital, LP
|
Lawrence
A. Pross or M. Kopin
|
|
|
Credit
Suisse Securities (USA) LLC
|
Greg
Grimaldi
|
|
|
Enable
Growth Partners LP
|
Brendan
O'Neil
|
|
|
William
G. Garrison
|
William
G. Garrison
|
|
|
Edward
W. Kelly and Patricia A. Kelly Jt Ten
|
Edward
W. Kelly or Patricia A. Kelly
|
|
|
Lake
End Capital LLC
|
Jeffrey
B. Davis
|
|
|
Dennis
Lavalle
|
Dennis
Lavalle
|
|
|
David
P. Luci
|
David
P. Luci
|
|
|
Midsummer
Investment, Ltd
|
Michael
Amsalem
|
|
|
Oracle
Institutional Partners LP
|
Larry
A. Feinberg
|
|
|
Oracle
Offshore Ltd
|
Larry
A. Feinberg
|
|
|
Oracle
Partners, LP
|
Larry
A. Feinberg
|
|
|
Perceptive
Life Sciences Master Fund Ltd
|
J.
Edelman
|
|
|
Rockmore
Investment Master Fund Ltd
|
Michael
Clateman
|
|
|
SAM
Oracle Investments, Inc.
|
Larry
A. Feinberg
|
|
|
Schroder
& Co Bank AG, Zurich
|
Schroder
& Co Bank AG
|
|
|
SCO
Capital Partners LP
|
Steven
H. Rouhandeh
|
|
|
SCO
Capital Partners LLC
|
Steven
H. Rouhandeh
|
USE
OF PROCEEDS
We will
not receive any proceeds from the sale of shares by the selling
stockholders.
PLAN
OF DISTRIBUTION
We are
registering the shares of common stock on behalf of the selling security
holders. Sales of shares may be made by selling security holders, including
their respective donees, transferees, pledgees or other successors-in-interest
directly to purchasers or to or through underwriters, broker-dealers or through
agents. Sales may be made from time to time on the OTC Bulletin Board, any other
exchange or market upon which our shares may trade in the future, in the
over-the-counter market or otherwise, at market prices prevailing at the time of
sale, at prices related to market prices, or at negotiated or fixed prices. The
shares may be sold by one or more of, or a combination of, the
following:
32
|
-
|
a
block trade in which the broker-dealer so engaged will attempt to sell the
shares as agent but may position and resell a portion of the block as
principal to facilitate the transaction (including crosses in which the
same broker acts as agent for both sides of the
transaction);
|
|
-
|
purchases
by a broker-dealer as principal and resale by such broker-dealer,
including resales for its account, pursuant to this
prospectus;
|
|
-
|
ordinary
brokerage transactions and transactions in which the broker solicits
purchases;
|
|
-
|
through
options, swaps or derivatives;
|
|
-
|
in
privately negotiated transactions;
|
|
-
|
in
making short sales or in transactions to cover short sales;
and
|
|
-
|
put
or call option transactions relating to the
shares.
|
-
through the writing or settlement of options or other hedging
transactions, whether through an options exchange or
otherwise;
- a
combination of any such methods of sale; or
- any
other method permitted pursuant to applicable law.
The
selling security holders may effect these transactions by selling shares
directly to purchasers or to or through broker-dealers, which may act as agents
or principals. These broker-dealers may receive compensation in the form of
discounts, concessions or commissions from the selling security holders and/or
the purchasers of shares for whom such broker-dealers may act as agents or to
whom they sell as principals, or both (which compensation as to a particular
broker-dealer might be in excess of customary commissions). The selling security
holders have advised us that they have not entered into any agreements,
understandings or arrangements with any underwriters or broker-dealers regarding
the sale of their securities.
The
selling security holders may enter into hedging transactions with broker-dealers
or other financial institutions. In connection with those transactions, the
broker-dealers or other financial institutions may engage in short sales of the
shares or of securities convertible into or exchangeable for the shares in the
course of hedging positions they assume with the selling security holders. The
selling security holders may also enter into options or other transactions with
broker-dealers or other financial institutions which require the delivery of
shares offered by this prospectus to those broker-dealers or other financial
institutions. The broker-dealer or other financial institution may then resell
the shares pursuant to this prospectus (as amended or supplemented, if required
by applicable law, to reflect those transactions).
The
selling security holders and any broker-dealers that act in connection with the
sale of shares may be deemed to be “underwriters” within the meaning of Section
2(11) of the Securities Act of 1933, and any commissions received by
broker-dealers or any profit on the resale of the shares sold by them while
acting as principals may be deemed to be underwriting discounts or commissions
under the Securities Act. The selling security holders may agree to indemnify
any agent, dealer or broker-dealer that participates in transactions involving
sales of the shares against liabilities, including liabilities arising under the
Securities Act. We have agreed to indemnify each of the selling security holders
and each selling security holder has agreed, severally and not jointly, to
indemnify us against some liabilities in connection with the offering of the
shares, including liabilities arising under the Securities Act.
The
selling security holders will be subject to the prospectus delivery requirements
of the Securities Act. We have informed the selling security holders that the
anti-manipulative provisions of Regulation M promulgated under the Securities
Exchange Act of 1934 may apply to their sales in the market.
Selling
security holders also may resell all or a portion of the shares in open market
transactions in reliance upon Rule 144 under the Securities Act, provided they
meet the criteria and conform to the requirements of Rule 144.
33
Upon
being notified by a selling security holder that a material arrangement has been
entered into with a broker-dealer for the sale of shares through a block trade,
special offering, exchange distribution or secondary distribution or a purchase
by a broker or dealer, we will file a supplement to this prospectus, if required
pursuant to Rule 424(b) under the Securities Act, disclosing:
|
-
|
the
name of each such selling security holder and of the participating
broker-dealer(s);
|
|
-
|
the
number of shares involved;
|
|
-
|
the
initial price at which the shares were
sold;
|
|
-
|
the
commissions paid or discounts or concessions allowed to the
broker-dealer(s), where applicable;
|
|
-
|
that
such broker-dealer(s) did not conduct any investigation to verify the
information set out or incorporated by reference in this prospectus;
and
|
|
-
|
other
facts material to the transactions.
|
In
addition, if required under applicable law or the rules or regulations of the
Commission, we will file a supplement to this prospectus when a selling security
holder notifies us that a donee or pledgee intends to sell more than 500 shares
of common stock.
We are
paying all expenses and fees customarily paid by the issuer in connection with
the registration of the shares. The selling security holders will bear all
brokerage or underwriting discounts or commissions paid to broker-dealers in
connection with the sale of the shares.
34
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
|
35
|
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
|
||||
|
(3)
|
For
more information, see “Government Regulation” for description of clinical
stages.
|
|
(4)
|
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)
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.
36
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.
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.
37
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.
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.
On April
26, 2007, we entered into a Note Purchase Agreement with Somanta
Pharmaceuticals, Inc. in order for Access to loan Somanta amounts to keep
certain of their licenses and vendors current. As of September 30, 2007 we have
loaned Somanta $859,000.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
Results
of Operations
Comparison
of Second Quarter 2008 Compared To Second Quarter 2007
Our
licensing revenue for the second quarter of 2008 was $22,000 as compared to no
revenues for the same period of 2007. We recognize licensing revenue over the
period of the performance obligation under our licensing agreement. We have
received upfront licensing payments from SpePharm Holding, B.V., RHEI and
ASK.
We have a
sponsored research and development agreement. Our revenue from this agreement
for the second quarter of 2008 was $110,000 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 second quarter of 2008 was $1,179,000,
as compared to $523,000 for the same period in 2007, an increase of $656,000.
The increase in expenses was primarily due to:
|
·
|
costs
for product manufacturing for a new ProLindac clinical trial expected to
start in mid 2008 ($513,000);
|
|
·
|
higher
scientific consulting expenses
($95,000);
|
|
·
|
higher
salary and related cost due to the hiring of additional scientific staff
($82,000);
|
|
·
|
lower
clinical trial costs this quarter ($58,000);
and
|
|
·
|
other
net increases in research spending
($24,000).
|
Total
general and administrative expenses were $1,044,000 for the second quarter of
2008, a decrease of $69,000 compared to 2007 expenses of $1,113,000. The
decrease in spending was due primarily to the following:
|
·
|
lower
salary related expenses due to stock option expenses
($237,000);
|
|
·
|
higher
patent expenses ($197,000); and
|
|
·
|
other
net decreases in general and administrative expenses
($29,000).
|
Depreciation
and amortization was $64,000 for the second quarter of 2008 as compared to
$74,000 for the same period in 2007 reflecting a decrease of $10,000. The
decrease in depreciation and amortization was due to assets becoming fully
depreciated.
Total
operating expenses for the second quarter of 2008 were $2,287,000 as compared to
total operating expenses of $1,710,000 for same quarter in 2007, an increase of
$577,000.
Interest
and miscellaneous income was $29,000 for the second quarter of 2008 as compared
to $25,000 for the same quarter of 2007, an increase of $4,000. The increase in
interest income was due to additional deposits.
38
Interest
and other expense was $117,000 for the second quarter of 2008 as compared to
$424,000 in 2007, a decrease of $307,000. The decrease in interest and other
expense was due to $9,015,000 of convertible notes that were outstanding at June
30, 2007 that were not outstanding at June 30, 2007. The convertible notes were
exchanged for preferred stock in November of 2007.
Preferred
stock dividends of $517,000 were accrued for the second quarter of 2008.
Dividends are paid semi-annually in either cash or common stock. There was no
preferred stock outstanding at June 30, 2007.
Net loss
allocable to common stockholders for the second quarter of 2008 was $2,760,000,
or a $0.49 basic and diluted loss per common share, compared with a loss of
$2,109,000, or a $0.60 basic and diluted loss per common share for the same
period in 2007, an increased loss of $651,000.
Comparison
of Six Months Ended June 30, 2008 Compared To Six Months Ended June 30,
2007
Our
licensing revenue for the first six months of 2008 was $39,000 as compared to no
revenues for the same period of 2007. We recognize licensing revenue over the
period of the performance obligation under our licensing agreement. We received
upfront licensing payments from SpePharm Holding, B.V., RHEI and
ASK.
We have a
sponsored research and development agreement. Our revenue from this agreement
for the first six months of 2008 was $131,000 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 six months of 2008 was
$10,824,000, as compared to $936,000 for the same period in 2007, an increase of
$9,888,000. 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 mid 2008 ($826,000);
|
|
·
|
higher
scientific consulting expenses
($154,000);
|
|
·
|
higher
salary and related cost due to the hiring of additional scientific staff
($114,000); and
|
|
·
|
other
net decreases in research spending
($85,000).
|
Total
general and administrative expenses were $1,933,000 for the first six months of
2008, a decrease of $319,000 over 2007 expenses of $2,252,000. The decrease in
spending was due primarily to the following:
| · | lower salary related expenses due to stock option expenses ($470,000); |
|
·
|
lower salary
and other salary related expenses
($49,000);
|
· higher
patent expenses ($148,000);
· higher
general business consulting expenses ($68,000); and
|
·
|
other
net decreases in general and administrative expenses
($16,000).
|
Depreciation
and amortization was $131,000 for the first six months of 2008 as compared to
$149,000 for the same period in 2007 reflecting a decrease of $18,000. The
decrease in depreciation and amortization was due to assets becoming fully
depreciated.
Total
operating expenses for the first six months of 2008 were $12,888,000 as compared
to total operating expenses of $3,337,000 for same period in 2007, an increase
of $9,551,000.
Interest
and miscellaneous income was $105,000 for the first six months of 2008 as
compared to $60,000 for the same period of 2007, an increase of $45,000. The
increase in interest income was due to additional deposits.
Interest
and other expense was $225,000 for the first six months of 2008 as compared to
$2,959,000 in 2007, a decrease of $2,734,000. 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 2007. In addition the
decrease in interest and other expense was due to $9,015,000 of convertible
notes that were outstanding at June 30, 2007 that were not outstanding at June
30, 2007. The convertible notes were exchanged for preferred stock in November
of 2007.
39
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.
Preferred
stock dividends of $1,042,000 were accrued for the first six months of 2008.
Dividends are paid semi-annually in either cash or common stock. There was no
preferred stock outstanding at June 30, 2007.
Net loss
allocable to common stockholders for the first six months of 2008 was
$15,188,000, or a $2.76 basic and diluted loss per common share, compared with a
loss of $6,236,000, or a $1.76 basic and diluted loss per common share for the
same period in 2007, an increased loss of $8,952,000.
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).
|
40
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.
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.
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 August 13, 2008, our cash and
cash equivalents and short-term investments were $5,401,000 and our net cash
burn rate for the six months ended June 30, 2008 was approximately $556,000 per
month. As of June 30, 2008 our working capital was $2,569,000. Our working
capital at June 30, 2008 represented a decrease of $3,670,000 as compared to our
working capital as of December 31, 2007 of $6,239,000. The decrease in working
capital at June 30, 2008 reflects the net capital raised in the February private
placement of $2,444,000 and new licensing agreements with RHEI and ASK, offset
by operating expenses which included manufacturing product scale-up for our new
ProLindac trial and Somanta expenses. As of June 30, 2008, we have one
convertible note outstanding in the principle amount of $5,5000,000 which is due
September 13, 2011.
As of
August 13, 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.
41
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 June 30, 2008 of $129,512,000. 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.
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.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
Currently,
one noteholder holding $5.5 million worth of 7.7% convertible notes has amended
their note to a new maturity date, September 13, 2011.
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 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.
|
42
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:
|
(in
thousands)
|
Twelve
Months ended
December 31,
|
Six
Months ended
June 30,
|
Inception
To
Date (1)
|
|||||||||||||
|
Project
|
2007
|
2006
|
2008
|
|||||||||||||
|
Polymer
Platinate
(ProLindac™)
|
$ | 2,563 | $ | 2,043 | $ | 1,944 | $ | 24,161 | ||||||||
|
Mucoadhesive
Liquid
Technology
(MLT)
|
21 | 10 | - | 1,511 | ||||||||||||
|
Others
(2)
|
18 | - | 68 | 5,130 | ||||||||||||
|
Total
|
$ | 2,602 | $ | 2,053 | $ | 2,012 | $ | 30,802 | ||||||||
|
(1)
|
Cumulative
spending from inception of the Company or project through June 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.
43
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).
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.
44
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.
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
45
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”).
|
|
·
|
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
|
||||
46
|
(5)
|
For
more information, see “Government Regulation” for description of clinical
stages.
|
|
(6)
|
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 agreement with Milestone Biosciences, LLC under which Milestone will
market MuGard in the United States and Canada,
47
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.
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.
48
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.
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.
49
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;
|
50
|
•
|
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;
|
|
•
|
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.
51
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.
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.
52
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
posseses 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.
Core
Drug Delivery Technology Platforms
Our
current drug delivery technology platforms for use in cancer chemotherapy
are:
|
·
|
Synthetic
Polymer Targeted Drug Delivery
Technology;
|
|
·
|
Cobalamin™-Mediated
Oral Delivery Technology;
|
|
·
|
Cobalamin™-Mediated
Targeted Delivery Technology;
|
|
·
|
Angiolix®;
|
|
·
|
Prodrax®;
and
|
|
·
|
Alchemix®.
|
Each
of these platforms is discussed below:
53
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.
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.
54
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.
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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.
55
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.
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 small molecule anticancer prodrug that is non-toxic in normally oxygenated
healthy tissue but becomes highly toxic in low oxygen tumors where it becomes
irreversibly converted to its toxic form which binds to the DNA in tumor cells,
resulting in tumor cell death. The chemical structure of Prodrax is a di-N-oxide
of chloroethylaminoanthraquinone. 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.
56
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 March
2006, we entered into a two year agreement with the University of Bradford to
perform pre-clinical studies. The Prodrax technology allows for the modification
of various drugs to make them inert until they are activated by a low oxygen
environment. Varieties of analogues have been developed and are being tested by
researchers at the University of Bradford for the purpose of enabling us to
select the lead compound to take forward into clinical development. We expect to
select a lead compound in 2008.
Alchemix®
Alchemix,
is a small molecule that is toxic to cancer cells. Alchemix attacks cancers
cells through at least two modes of action and is intended to interrupt all
phases of the cancer cell growth cycle o 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 entered into a
research and development collaboration with the University of Bradford. The
initial goal for this collaboration is to select one molecule for preclinical
development. We have prepared a detailed pre-clinical and clinical development
plan related to Alchemix. We intend to manufacture, undertake pre-clinical
studies and, based on the results of these studies, to initiate a Phase1/2
clinical trial with respect to Alchemix within the next 12-24
months.
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.
57
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 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.
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.
58
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.
On
November 7, 2007, as a condition to closing our 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
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.
On April
26, 2007, we entered into a Note Purchase Agreement with Somanta
Pharmaceuticals, Inc. in order for Access to loan Somanta amounts to keep
certain of their licenses and vendors current. As of December 31, 2007 we had
loaned Somanta $931,000.
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.
59
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.
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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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.
60
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.
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.
61
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:
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•
Cisplatin, marketed by Bristol-Myers Squibb, the originator of the drug,
and several generic manufacturers;
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•
Carboplatin, marketed by Bristol-Myers Squibb in the US;
and
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•
Oxaliplatin, marketed exclusively by
Sanofi-Aventis.
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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
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.
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.
62
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.
Employees
As of
October 6, 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.
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. 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.
63
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS ABD 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. | 58 |
Vice
Chairman – Europe
|
| Mark J. Ahn, Ph.D. | 46 | Director |
| Mark J. Alvino | 40 | Director |
| Stephen B. Howell, M.D. | 64 | Director |
|
David
P. Luci
|
41 |
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).
64
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.
65
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.
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 $100,000 for
the fiscal year ended December 31, 2007 and 2006. Access refers to Access’ Chief
Executive Officer and these other executive officers as Access’ "named executive
officers" elsewhere in this prospectus.
66
Summary
Compensation Table
|
Name and Principal
Position (8)
|
Year
|
Salary ($)
(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(5)
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-Sholes
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.
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.
67
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.
68
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:
|
·
|
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.
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.
69
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.
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 $5,000 above the statutory limit. Under the
plan, each participant is fully vested in his or her deferred salary
contributions, including any matching contributions by us, when contributed.
Participant contributions are held and invested by the participants in the
plan's investment options. The plan also permits Access to make discretionary
contributions and matching contributions, subject to established limits and a
vesting schedule. In 2006, Access matched 100% of participant contributions up
to the first two percent of eligible compensation. Access matched participant
contributions at the first four percent of eligible compensation in 2008 and
2007.
70
Outstanding
Equity Awards at December 31, 2007
The
following table sets forth certain information regarding outstanding equity
awards held by Access’ named executive officers at December 31, 2007. There were no outstanding
stock awards held by such officer at December 31, 2007:
Option
Awards
|
Name
|
Number
of Securities Underlying Unexercised Options (#)
Exercisable
|
Number
of Securities Underlying Unexercised Options (#)
Unexercisable
|
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned Options (#)
|
Option
Exercise Price ($)
|
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
|
|
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 vest over four years from the grant
date. Options to purchase 66,667 shares of common stock will be fully
vested in December 2010 and options to purchase 1,749 shares of common
stock will be fully vested in October
2009.
|
|
(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 started January 4, 2008. Mr. Davis does not
currently have any stock options resulting from his employment with
us.
|
71
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 $1,000 deducted per committee meeting not attended. In addition, Access
reimbursed each director, whether an employee or not, the expenses of attending
Board and committee meetings. Each non-employee director is also entitled to
receive options to purchase 2,500 shares of Common Stock on the date of each
annual meeting of stockholders and options to purchase 25,000 shares of Common
Stock when he/she is first appointed as a director.
Director
Compensation Table - 2007
The table
below represents the compensation paid to our outside directors during the year
ended December 31, 2007:
|
Name
|
Fees
earned or Paid in Cash ($)
|
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-Sholes (“Black-Sholes”)
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.
|
72
LEGAL
PROCEEDINGS
The
Company is not currently subject to any material pending legal
proceedings.
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 October 6, 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.
|
Common
Stock Beneficially Owned
|
||
|
Name
of Beneficial Owner
|
Number
of Shares(1)
|
% of Class
|
|
Steven
H. Rouhandeh(2)
|
-
|
*
|
|
Jeffery
B. Davis (3)
|
30,820
|
*
|
|
Mark
J. Ahn, Ph. D. (4)
|
31,000
|
*
|
|
Mark
J. Alvino (5)
|
86,525
|
1.3%
|
|
Esteban
Cvitkovic, M.D. (6)
|
106,000
|
1.6%
|
|
Stephen
B. Howell, M.D. (7)
|
56,422
|
*
|
|
David
P. Luci (8)
|
43,500
|
*
|
|
David
P. Nowotnik, Ph.D. (9)
|
176,682
|
2.7%
|
|
Phillip
S. Wise (10)
|
100,000
|
1.5%
|
|
Stephen
B. Thompson (11)
|
144,000
|
2.2%
|
|
SCO
Capital Partners LLC, SCO Capital Partners LP, and Beach Capital LLC (12)
|
13,897,410
|
71.0%
|
|
Larry
N. Feinberg (13)
|
2,483,032
|
28.7%
|
|
Lake
End Capital LLC (14)
|
1,637,788
|
20.4%
|
|
Midsummer
Investment, Ltd. (15)
|
750,000
|
10.4%
|
|
All
Directors and Executive
Officers
as a group
(consisting
of 10 persons) (16)
|
774,950
|
10.8%
|
* - Less
than 1%
|
(1)
|
Includes
Access’ outstanding shares of Common Stock held plus all shares of Common
Stock issuable upon conversion of Series A Preferred Stock, exercise of
options, warrants and other rights exercisable within 60 days of October
6, 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.
|
73
|
(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.
|
|
(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.
|
74
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 as of
September 30, 2008 is 228,000. 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.
|
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.
75
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.
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.
76
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.
77
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.
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.
78
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.
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.
79
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 October 6, 2008
|
2.75 | 2.45 | ||||||
|
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 | ||||||
|
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 October 6, 2008 was
approximately 3,000. On October 6, 2008, the closing price for the common stock
as quoted on the OTCBB was $2.45. There were 6,475,447 shares of common stock
outstanding at October 6, 2008.
Options
and Warrants
There are
9,701,725 outstanding warrants and 1,364,820 outstanding options to purchase
Access’ common equity as of October 6, 2008.
80
Shares
Eligible for Future Sales
Access
has issued 6,475,447 shares of its common stock as of October 6, 2008. Of these
shares, all shares are unrestricted and held by non-affiliates, and are freely
tradable without restriction under the Securities Act. These shares will be
eligible for sale in the public market, subject to certain volume limitations
and the expiration of applicable holding periods under Rule 144 under 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 one year (including the holding period of any prior owner or
affiliate) would be entitled to sell within any three-month period a number of
shares that does not exceed the greater of one percent (1%) of the number of
shares of common stock then outstanding or (2) the average weekly trading volume
of the common stock during the four calendar weeks preceding the filing of a
Form 144 with respect to such sale. Sales under Rule 144 are also subject to
certain manner of sale provisions and notice requirements and to the
availability of current public information about us. Under Rule 144(k), a person
who is not deemed to have been an affiliate of Access at any time during the
three months preceding a sale, and who has beneficially owned the shares
proposed to be sold for at least two years (including the holding period of any
prior owner except an affiliate), is entitled to sell such shares without
complying with the manner of sale, public information, volume limitation or
notice provisions of Rule 144.
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.
81
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 October 6, 2008 there were 6,475,447 shares of Access’
common stock outstanding and held of record by approximately 3,000 stockholders,
and there were 3,251.8617 shares of its preferred stock outstanding convertible
into 10,849,528 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.
82
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.
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.
83
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.
EXPERTS
The
consolidated financial statements 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 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.
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.
84
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-1 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.
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 March 31, 2008
(unaudited)
|
F-23
|
|
Condensed
Consolidated Statements of Operations for March 31, 2008 and 2007
(unaudited)
|
F-24
|
|
Condensed
Consolidated Statements of Cash Flows for March 31, 2008 and 2007
(unaudited)
|
F-25
|
|
Notes
to Condensed Consolidated Financial Statements (Three Months Ended March
31, 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 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
Licenses
Total
|
$ | 1,680 500 $ 2,180 | $ | 970 500 $1,470 | $ | 1,680 500 $ 2,180 | $ | 802 475 $ 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 | 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. 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.
F-11
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
|
|
Two
years ended December 31, 2007
|
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:
|
Year
|
Consulting
Fees
|
Expense
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:
|
Year
|
Consulting
Fee
|
Office
Expenses
|
Office
Reimbursement
|
Fair
Value
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:
|
Year
|
Consulting
Fees
|
Expense
Reimbursement
|
||||||
| 2007 | $ |
29,000
|
$ | $ 13,000 | ||||
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.
F-12
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
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 $136,000 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.
$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.
F-13
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
6 – DEBT - Continued
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 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.
F-14
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 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.
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.
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-15
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.
F-16
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
9 - STOCKHOLDERS' EQUITY - Continued
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.
|
|
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-17
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
9 - STOCKHOLDERS' EQUITY - Continued
|
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
|
June 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
Total
current assets
|
$ 96,000
5,792,000
105,000
-
165,000
6,158,000
|
$ 159,000
6,762,000
35,000
931,000
410,000
8,297,000
|
|
|
Property
and equipment, net
|
124,000
|
130,000
|
|
|
Patents,
net
|
626,000
|
710,000
|
|
|
Other
assets
|
12,000
|
12,000
|
|
|
Total
assets
|
$ 6,920,000
|
$ 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
Total
current liabilities
|
$ 1,832,000
1,276,000
339,000
142,000
-
3,589,000
|
$ 1,537,000
259,000
130,000
68,000
64,000
2,058,000
|
|
|
Long-term
deferred revenue
Long-term
debt
|
1,905,000
5,500,000
|
910,000
5,500,000
|
|
|
Total
liabilities
|
10,994,000
|
8,468,000
|
|
|
Commitments
and contingencies
|
|||
|
Stockholders'
equity (deficit)
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
3,499.8617 issued at June 30,
2008; 3,227.3617 issued
at December 31,
2007
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
5,648,781 at June 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
Total
stockholders' equity (deficit)
|
-
56,000
126,431,000
(1,045,000)
(4,000)
(129,512,000)
(4,074,000)
|
-
36,000
116,018,000
(1,045,000)
(4,000)
(114,324,000)
681,000
|
|
|
Total
liabilities and stockholders' equity (deficit)
|
$ 6,920,000
|
$ 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
June 30,
|
Six
months ended
June 30,
|
|||||||||||||||
|
2008
|
2007
|
2008
|
2007
|
|||||||||||||
|
Revenues
|
||||||||||||||||
|
License
revenues
|
$ | 22,000 | $ | - | $ | 39,000 | $ | - | ||||||||
|
Sponsored research and
development
|
110,000 | - | 131,000 | - | ||||||||||||
|
Total revenues
|
132,000 | - | 170,000 | - | ||||||||||||
|
Expenses
|
||||||||||||||||
|
Research and
development
|
1,179,000 | 523,000 | 10,824,000 | 936,000 | ||||||||||||
|
General and
administrative
|
1,044,000 | 1,113,000 | 1,933,000 | 2,252,000 | ||||||||||||
|
Depreciation and
amortization
|
64,000 | 74,000 | 131,000 | 149,000 | ||||||||||||
|
Total expenses
|
2,287,000 | 1,710,000 | 12,888,000 | 3,337,000 | ||||||||||||
|
Loss
from operations
|
(2,155,000 | ) | (1,710,000 | ) | (12,718,000 | ) | (3,337,000 | ) | ||||||||
|
Interest
and miscellaneous income
|
29,000 | 25,000 | 105,000 | 60,000 | ||||||||||||
|
Interest
and other expense
|
(117,000 | ) | (424,000 | ) | (225,000 | ) | (2,959,000 | ) | ||||||||
| (88,000 | ) | (399,000 | ) | (120,000 | ) | (2,899,000 | ) | |||||||||
|
Net
loss
|
(2,243,000 | ) | (2,109,000 | ) | (12,838,000 | ) | (6,236,000 | ) | ||||||||
|
Less
preferred stock dividends
|
517,000 | - | 2,350,000 | - | ||||||||||||
|
Net
loss allocable to common stockholders
|
$ | (2,760,000 | ) | $ | (2,109,000 | ) | $ | (15,188,000 | ) | $ | (6,236,000 | ) | ||||
|
Basic
and diluted loss per common share
Net
loss allocable to common shareholders
|
$ | (0.49 | ) | $ | (0.60 | ) | $ | (2.76 | ) | $ | (1.76 | ) | ||||
|
Weighted
average basic and diluted
common shares
outstanding
|
5,635,869 | 3,538,409 | 5,508,064 | 3,536,812 | ||||||||||||
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)
|
Six Months ended June
30,
|
||||||||
|
2008
|
2007
|
|||||||
|
Cash
flows from operating activities:
|
||||||||
|
Net
loss
|
$ | (12,838,000 | ) | $ | (6,236,000 | ) | ||
|
Adjustments to
reconcile net loss to cash used
in
operating activities:
|
||||||||
|
Depreciation and
amortization
|
132,000 | 149,000 | ||||||
|
Stock option
expense
|
140,000 | 603,000 | ||||||
|
Stock issued for
services
|
20,000 | - | ||||||
|
Acquired in-process research
and development
|
8,879,000 | - | ||||||
|
Amortization of debt costs and
discounts
|
- | 2,316,000 | ||||||
|
Changes in operating assets and
liabilities:
|
||||||||
|
Receivables
|
(70,000 | ) | 151,000 | |||||
|
Prepaid expenses and
other current assets
|
(140,000 | ) | (234,000 | ) | ||||
|
Other assets
|
- | 1,000 | ||||||
|
Accounts
payable and accrued expenses
|
(711,000 | ) | 124,000 | |||||
| Dividends payable | (25,000 | ) | - | |||||
|
Accrued
interest payable
|
209,000 | 636,000 | ||||||
|
Deferred revenues
|
1,069,000 | - | ||||||
|
Net cash used in operating
activities
|
(3,335,000 | ) | (2,490,000 | ) | ||||
|
Cash
flows from investing activities:
|
||||||||
|
Capital
expenditures
|
(28,000 | ) | (18,000 | ) | ||||
|
Somanta acquisition, net
of cash acquired
|
(65,000 | ) | - | |||||
|
Redemptions of short term
investments and
certificates of
deposit
|
970,000 | 1,465,000 | ||||||
|
Net cash provided by investing
activities
|
877,000 | 1,447,000 | ||||||
|
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 | 19,000 | ||||||
|
Net cash provided by financing
activities
|
2,395,000 | 19,000 | ||||||
|
Net
decrease in cash and cash equivalents
|
(63,000 | ) | (1,024,000 | ) | ||||
|
Cash
and cash equivalents at beginning of period
|
159,000 | 1,194,000 | ||||||
|
Cash
and cash equivalents at end of period
|
$ | 96,000 | $ | 170,000 | ||||
|
Supplemental
cash flow information:
|
||||||||
|
Cash
paid for interest
|
$ | 8,000 | $ | 8,000 | ||||
|
Supplemental
disclosure of noncash transactions::
|
||||||||
|
Shares issued for
payables
|
1,576,000 | - | ||||||
|
Preferred
stock dividends in accounts payable
|
1,042,000 | - | ||||||
|
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
Six
Months Ended June 30, 2008 and 2007
(unaudited)
(1) Interim
Financial Statements
The
consolidated balance sheet as of June 30, 2008 and the consolidated statements
of operations and cash flows for the three and six months ended June 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 June 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):
|
June
30, 2008
|
December
31, 2007
|
|||||||||||||||
|
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
Amortization
|
|||||||||||||
|
Amortizable
intangible assets
Patents
|
$ | 1,680 | $ | 1,054 | $ | 1,680 | $ | 970 | ||||||||
Amortization
expense related to intangible assets totaled $41,000 and $84,000 for each of the
three and six months ended June 30, 2008 and totaled $55,000 and $109,000 for
each of the three and six months ended June 30, 2007. The aggregate estimated
amortization expense for intangible assets remaining as of June 30, 2008 is as
follows (in thousands):
| 2008 | $ | 84 | ||
| 2009 | 168 | |||
| 2010 | 168 | |||
| 2011 | 168 | |||
| 2012 | 38 | |||
| Total | $ | 626 |
(3) Liquidity
The
Company incurred significant losses from losses allocable to common stockholders
of $15,188,000 for the six months ended June 30, 2008, $36,652,000 for the
year ended December 31, 2007 and $12,874,000 for the year ended December 31,
2006. At June 30, 2008, our working capital was $2,569,000. 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 within the next twelve months.
F-26
(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
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, net | 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 six months ended July 31, 2007 based on its
fiscal year. Amounts are shown in thousands.
|
Three months
ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
|
2008
|
2007
|
2008
|
2007
|
|||||||||||||
|
Net
loss
|
$ | (2,760 | ) | $ | (7,188 | ) | $ | (15,188 | ) | $ | (13,157 | ) | ||||
|
Net
loss per common shares (basic and diluted)
|
$ | (0.49 | ) | $ | (1.43 | ) | $ | (2.76 | ) | $ | (2.61 | ) | ||||
|
Weighted
average common shares outstanding
(basic
and diluted)
|
5,636 | 5,038 | 5,508 | 5,037 | ||||||||||||
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 date of issue.
The fair value of the warrants was $2.29 per share on 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 six month period ended June 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 June 30,
2008 the Securities and Exchange Commission had not yet declared the
registration statement effective, and as a result, the Company has accrued
$50,000 in liquidated damages as of June 30, 2008.
During
the prior quarter, $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 $1,042,000 were accrued for the first six months of 2008.
Dividends are paid semi-annually in either cash or common stock.
(6) Stock
Based Compensation
For the
three and six months ended June 30, 2008, we recognized stock-based compensation
expense of $83,000 and $140,000 in 2008 and $311,000 and $603,000 in 2007,
respectively.
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.
We
granted no stock options during the second quarter of 2007. We granted 205,000
stock options at a weighted average grant price of $3.30 under the terms of our
2005 Equity Incentive Plan and 450,000 stock options at a weighted average grant
price of $2.90, under the terms of our 2007 Special Stock Option Plan during the
first quarter of 2007.
F-28
The
following table summarizes stock-based compensation for the three and six months
ended June 30, 2008 and 2007:
|
Three
months ended
June 30,
|
Six
months ended
June 30,
|
|||||||||||||||
|
2008
|
2007
|
2008
|
2007
|
|||||||||||||
|
Research
and development
|
$ | 26,000 | $ | 17,000 | $ | 39,000 | $ | 33,000 | ||||||||
|
General
and administrative
|
57,000 | 294,000 | 101,000 | 570,000 | ||||||||||||
|
Stock-based
compensation expense
included
in operating expense
|
83,000 | 311,000 | 140,000 | 603,000 | ||||||||||||
Our
weighted average Black-Scholes fair value assumptions used to value the 2008 and
2007 first six months grants are as follows:
|
6/30/08
|
6/30/07
|
|||
|
Expected
life
|
6.2
yrs
|
4.3 yrs
|
||
|
Risk
free interest rate
|
3.0
|
%
|
4.7
|
%
|
|
Expected
volatility(a)
|
133
|
%
|
137
|
%
|
|
Expected
dividend yield
|
0.0
|
%
|
0.0
|
%
|
|
(a)
|
Reflects
movements in our stock price over the most recent historical period
equivalent to the expected life.
|
(7) Subsequent
Events
On July
10, 2008, we announced the signing of a definitive merger agreement to acquire
MacroChem Corporation. Pursuant to 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.
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-62
|
|
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-63
|
|
Condensed
Consolidated Statement of Stockholders’ Deficit for the Period from
Inception of Operations (April 19, 2001) to October 31, 2007
(unaudited)
|
F-65
|
|
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-69
|
|
Notes
to Condensed Consolidated Financial Statements as of October 31,
2007
|
F-71
|
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.
F-37
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.
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.
F-38
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.
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.
F-39
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.
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
|
F-40
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.
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.
F-41
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.
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
|
F-42
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.
F-43
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:
|
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.
F-44
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.
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:
F-45
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.
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-46
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-47
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.
F-48
On
August 24, 2005, the name of BOPI was changed to Somanta Incorporated
(“SI”).
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.
F-49
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.
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.
F-50
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-51
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-52
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-53
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.
F-54
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.
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.
F-55
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-56
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.
F-57
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.
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.
F-58
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.
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.
F-59
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.
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.
F-60
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-61
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
|
|||
F-62
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-63
|
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-64
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-65
|
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-66
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-67
|
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-68
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-69
|
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-70
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-71
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.
F-72
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.
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:
F-73
|
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 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.
F-74
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.
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.
F-75
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 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.
F-76
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.
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
|
|||||
F-77
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.
|
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.
F-78
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.
|
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.
As of
December 19, 2007, the Company had borrowed $856,064 from Access under the
Secured Note (Footnote 7).
|
9.
|
SUBSEQUENT
EVENTS
|
F-79
UNAUDITED
PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS
The
following unaudited pro forma condensed combined financial statements apply to
the merger between Somanta and Access, by which Somanta became a wholly owned
subsidiary of Access, and are based upon the historical condensed consolidated
financial statements and notes thereto (as applicable) of Access and Somanta,
which are incorporated by reference into this Form S-1/A. The unaudited pro
forma condensed combined balance sheet gives pro forma effect to the merger as
if the merger had been completed on December 31, 2007 and combines Access’s
December 31, 2007 audited consolidated balance sheet with Somanta’s January
4, 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’s unaudited consolidated statement of operations for the
nine months ended October 31, 2007.
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 included:
|
·
|
Approximately
1.5 million shares of Access common stock was 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 shares issued);
|
|
·
|
exchange
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;
|
|
·
|
an
aggregate of $475,000 in direct transaction costs; and
|
|
·
|
cancelled
receivable from Somanta of
$931,000.
|
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 and for the
purposes of this pro forma is included in additional paid-in
capital.
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, net | 14 | |||
| Accounts payable | (2,582 | ) | ||
| In-process research & development | 8,879 | |||
| $ | 6,337 |
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 and
Somanta with the Securities and Exchange Commission.
F-80
Pro
Forma Condensed Combined Balance Sheet
As
of December 31, 2007
(Unaudited)
Historical
|
Access
|
Somanta
|
Pro
Forma
Adjustments
|
Pro
Forma
Combined
|
||||||||||||
|
ASSETS
|
|||||||||||||||
|
Current
assets
|
|||||||||||||||
|
Cash
and cash equivalents
|
$
|
159,000
|
$
|
2,000
|
$
|
161,000
|
|||||||||
|
Short
term investments, at cost
|
6,762,000
|
6,762,000
|
|||||||||||||
|
Receivables
|
35,000
|
35,000
|
|||||||||||||
|
Receivables
from Somanta
|
931,000
|
(931,000
|
)
|
(d)
|
-
|
||||||||||
|
Prepaid
expenses and other current expenses
|
410,000
|
25,000
|
(410,000
|
)
|
(c)
|
25,000
|
|||||||||
|
Total
current assets
|
8,297,000
|
27,000
|
6,983,000
|
||||||||||||
|
Property
and equipment, net
|
130,000
|
14,000
|
144,000
|
||||||||||||
|
Patents
net
|
710,000
|
710,000
|
|||||||||||||
|
Other
assets
|
12,000
|
12,000
|
|||||||||||||
|
Total
assets
|
$
|
9,149,000
|
$
|
41,000
|
$
|
7,849,000
|
|||||||||
|
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
|||||||||||||||
|
Current
liabilities
|
|||||||||||||||
|
Accounts
payable and accrued expenses
|
$
|
1,796,000
|
$
|
2,583,000
|
(410,000
|
)
|
(c)
|
$
|
3,969,000
|
||||||
|
Accrued
interest payable
|
130,000
|
130,000
|
|||||||||||||
|
Current
portion of deferred revenue
|
68,000
|
68,000
|
|||||||||||||
|
Current
portion of long-term debt net of discount
|
64,000
|
856,000
|
(856,000
|
)
|
(d)
|
64,000
|
|||||||||
|
Total
current liabilities
|
2,058,000
|
3,439,000
|
4,231,000
|
||||||||||||
|
Long-term
deferred revenue
|
910,000
|
910,000
|
|||||||||||||
|
Long-term
debt
|
5,500,000
|
5,500,000
|
|||||||||||||
|
Total
liabilities
|
8,468,000
|
3,439,000
|
10,641,000
|
||||||||||||
|
Stockholders’
equity (deficit)
|
|||||||||||||||
|
Preferred
stock
|
-
|
-
|
-
|
||||||||||||
|
Common
stock
|
36,000
|
15,000
|
15,000
(15,000
|
)
|
(a)
(b)
|
51,000
|
|||||||||
|
Additional
paid-in capital
|
116,018,000
|
7,615,000
|
4,756,000
(7,615,000
|
)
|
(a)
(b)
|
120,774,000
|
|||||||||
|
Notes
receivable from stockholders
|
(1,045,000
|
)
|
(1,045,000
|
)
|
|||||||||||
|
Treasury
stock, at cost
|
(4,000
|
)
|
(4,000
|
)
|
|||||||||||
|
Accumulated
deficit
|
(114,324,000
|
)
|
(11,028,000
|
)
|
(4,771,000
|
)
|
(a)
|
(122,568,000
|
)
|
||||||
|
(3,398,000
11,028,000
(75,000
|
)
)
|
(b)
(b)
(d)
|
|||||||||||||
|
Total
stockholders’ equity (deficit)
|
681,000
|
(3,398,000
|
)
|
(2,792,000
|
)
|
||||||||||
|
Total
liabilities and stockholders’ equity (deficit)
|
$
|
9,149,000
|
$
|
41,000
|
$
|
7,849,000
|
|||||||||
See
accompanying Notes to Pro Forma Condensed Combined Balance Sheet
F-81
Notes
to Pro Forma Condensed Combined Balance Sheet
|
Note
1: The above statement gives effect to the following pro forma adjustments
necessary to reflect the merger of Access and Somanta, as if the
transaction had occurred January 1, 2007. Somanta statements used were as
of January 4, 2008 (unaudited).
|
|
a)
|
To
record the exchange, for accounting purposes, by Somanta shareholders of
their preferred and common stock (valued at $4,650,000) for 1,500,000
shares of Access (or 1,500,000 shares valued at the stock price of $3.10
per share) and record the exchange of Somanta warrants for Access warrants
valued at a fair value of $281,000. The value placed on the shares was
determined based on the Access stock price at January 4, 2008, the date of
the acquisition.
|
|
b)
|
To
eliminate the shareholders equity section and warrant liabilities of
Somanta in connection with the merger and credit the net equity to
combined deficit.
|
|
c)
|
Accrual
of $410,000 of legal, accounting and other professional fees relating to
the merger.
|
|
d)
|
Eliminate
intercompany notes receivable and payable of $856,000 and other Somanta
costs of $75,000 totaling $931,000.
|
After the
consummation of the transactions described herein, Access had 100,000,000 common
shares authorized, approximately 5,085,023 common shares issued and outstanding,
2,000,000 preferred shares authorized with approximately 3,227.3617 shares of
Series A cumulative Convertible Preferred Stock issued and
outstanding.
F-82
Pro
Forma Condensed Combined Statement of Operations
For
The Twelve Months Ended December 31, 2007
(Unaudited)
Historical
|
Access
|
Somanta
|
Pro
Forma
Combined
|
||||||||
|
Revenues
|
$
|
57,000
|
$
|
1,000
|
$
|
58,000
|
||||
|
Expenses
|
||||||||||
|
Research
and development
|
2,602,000
|
445,000
|
3,047,000
|
|||||||
|
General
and administrative
|
4,076,000
|
1,889,000
|
5,965,000
|
|||||||
|
Depreciation
and amortization
|
279,000
|
-
|
279,000
|
|||||||
|
Total
expenses
|
6,957,000
|
2,334,000
|
9,791,000
|
|||||||
|
Loss
from operations
|
(6,900,000
|
)
|
(2,333,000
|
)
|
(9,233,000
|
)
|
||||
|
Interest
and miscellaneous income
|
125,000
|
(3,000
|
) |
122,000
|
||||||
|
Interest
and other expenses
|
(3,514,000
|
)
|
(27,000
|
)
|
(3,541,000
|
)
|
||||
|
Loss
on extinguishment of debt
|
(11,628,000
|
)
|
(11,628,000
|
)
|
||||||
|
Change
in fair value of warrant liabilities
|
-
|
5,119,000
|
5,119,000
|
|||||||
|
Currency
translation loss
|
-
|
(1,000
|
)
|
(1,000
|
)
|
|||||
|
(15,017,000
|
)
|
5,088,000
|
(9,929,000
|
)
|
||||||
|
Loss
before discontinued operations and
before
income tax benefit
|
(21,917,000
|
)
|
2,755,000
|
(19,162,000
|
)
|
|||||
|
Income
tax benefit
|
61,000
|
(5,000
|
)
|
56,000
|
||||||
|
Loss
from continuing operations
|
(21,856,000
|
)
|
2,750,000
|
(19,106,000
|
)
|
|||||
|
Less
preferred stock dividends
|
(14,908,000
|
)
|
-
|
(14,908,000
|
)
|
|||||
|
Loss
from continuing operations allocable
to
common stockholders
|
(36,764,000
|
)
|
2,750,000
|
(34,014,000
|
)
|
|||||
|
Discontinued
operations, net of taxes of $61,000
|
112,000
|
-
|
112,000
|
|||||||
|
Net
loss allocable to common stockholders
|
$
|
(36,652,000
|
)
|
$
|
2,750,000
|
$
|
(33,902,000
|
)
|
||
|
Basic
and diluted loss per common share
Loss
from continuing operations allocable to
all
common stockholders
Discontinued
operations
Net
loss allocable to common stockholders
|
$
$
|
(10.35
0.03
(10.32
|
)
)
|
$
$
|
0.19
-
0.19
|
$
$
|
(6.73
0.02
(6.71
|
)
)
|
||
|
Weighted
average basic and diluted common shares outstanding
|
3,552,006
|
14,630,402
|
5,052,006
|
|||||||
Notes to
Pro Forma Condensed Combined Statement of Operations
Note 1:
The above statement gives effect to the merger of Access and Somanta, as if the
merger had occurred on January 1, 2006. Somanta statements used were for the
nine months ended October 31, 2007.
Note 2:
The pro forma combined-weighted average number of common outstanding shares is
based on the weighted average number of shares of common stock of Access during
the period plus those shares to be issued in conjunction with the merger. A
reconciliation between Access' historical weighted average shares outstanding
and pro forma weighted average shares outstanding and pro forma weighted average
shares outstanding is as follows:
|
Historical
|
3,552,006
|
|
|
Somanta
equivalent shares giving effect to the merger
|
1,500,000
|
|
|
Total
|
5,052,006
|
F-83
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
13. Other Expenses of Issuance and Distribution
Expenses
of the Registrant in connection with the issuance and distribution of the
securities being registered, are estimated as follows:
|
SEC
Registration Fee
|
$
|
1,324
|
|
|
Printing
and Engraving Expenses
|
$
|
2,500
|
|
|
Legal
Fees and Expenses
|
$
|
50,000
|
|
|
Accountants'
Fees and Expenses
|
$
|
25,000
|
|
|
Miscellaneous
Costs
|
$
|
2,176
|
|
|
Total
|
$
|
81,000
|
Item
14. Indemnification of Directors and Officers
Section 145
of the Delaware General Corporation law empowers a Delaware corporation to
indemnify its officers and directors and certain other persons to the extent and
under the circumstances set forth therein.
The
Registrant’s Certificate of Incorporation, as amended, and By-laws, as amended,
provide for indemnification of officers and directors of the Registrant and
certain other persons against liabilities and expenses incurred by any of them
in certain stated proceedings and under certain stated conditions.
The above
discussion of the Registrant's Certificate of Incorporation, as amended,
By-laws, as amended, and Section 145 of the Delaware General Corporation
Law is not intended to be exhaustive and is qualified in its entirety by such
Certificate of Incorporation, By-Laws and statute.
Item
15: Recent Sales of Unregistered Securities
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 “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 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.
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. The issuance of shares of our common stock
in settlement of these accounts was made pursuant to Section 4(2) and Rule 506
of the Securities Act of 1933, as amended.
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
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 notes and warrants were sold
in a private placement to a group of accredited investors led by SCO Capital
Partners LLC (“SCO”) and
affiliates.
II
- -1
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. The notes and warrants were sold
in a private placement to a group of accredited investors led by SCO and
affiliates.
On
February 16, 2006, the Registrant entered into a note and warrant purchase
agreement pursuant to which it sold and issued an aggregate of $5,000,000 of
7.5% convertible notes due November 15, 2007 and warrants to purchase an
aggregate of 3,863,634 shares of common stock of Access. Net proceeds to Access
were $4.557 million. The notes and warrants were sold in a private placement to
a group of accredited investors led by SCO and its affiliates.
All of
the above-described issuances were exempt from registration pursuant to
Section 4(2) of the Securities Act or Rule 506 of Regulation D
promulgated thereunder, as transactions not involving a public
offering.
Item
16. 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)
|
II
- -2
|
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 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.
|
II
- -3
Item
17. Undertakings
The
undersigned Registrant hereby undertakes:
(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 this Registration Statement or any material change to
such information in this Registration Statement.
(2) That,
for the purpose 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.
(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.
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 described in Item 24 above, 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.
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
Securities Act and will be governed by the final adjudication of such
issue.
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.
II
- -4
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the Registrant
has duly caused this Registration Statement on Form S-1/A to be signed on
its behalf by the undersigned, thereunto duly authorized, in the City of Dallas,
State of Texas, on this 7th day of October 2008.
ACCESS PHARMACEUTICALS,
INC.
Date
October 7,
2008 By: /s/ Jeffrey B.
Davis
Jeffrey B. Davis
Chief Executive
Officer
(Principal Executive Officer)
Date
October 7,
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
October 7,
2008 By: /s/ Jeffrey B.
Davis
Jeffrey
B. Davis, Director,
Chief
Executive Officer
Date
October 7,
2008 By: *
Mark J. Ahn, Director
Date
October 7,
2008 By: *
Mark J. Alvino, Director
Date
October 7,
2008 By: *
Esteban Cvitkovic, Director
Date
October 7,
2008 By: *
Stephen B. Howell, Director
Date October 7,
2008 By: *
David P. Luci, Director
Date
October 7,
2008 By: *
Steven H. Rouhandeh, Chairman of
the Board
* -
Executed October 7, 2008 by Stephen B. Thompson as attorney-in-fact under power
of attorney granted in Registration Statement previously filed on March 11,
2008.
II
- -5
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)
|
II
- -6
|
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 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.
|
II
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