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
One
Federal Street
Boston,
MA 02110
(617)
951-8000
|
|
||||||||
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)
|
|||||
|
TABLE
OF CONTENTS
|
||||||||
Page
|
||||||||
PROSPECTUS
SUMMARY
|
1
|
|||||||
ABOUT
THIS PROSPECTUS
|
1
|
|||||||
ABOUT
ACCESS
|
1
|
|||||||
SUMMARY
OF THE OFFERING
|
4 | |||||||
SUMMARY
CONDENSED CONSOLIDATED FINANCIAL INFORMATION
|
5
|
|||||||
RISK
FACTORS
|
6
|
|||||||
FORWARD-LOOKING
STATEMENTS
|
14
|
|||||||
SELLING
STOCKHOLDERS
|
15
|
|||||||
USE
OF PROCEEDS
|
27
|
|||||||
PLAN
OF DISTRIBUTION
|
27
|
|||||||
PRICE
RANGE OF OUR COMMON STOCK
|
29
|
|||||||
DIVIDEND
POLICY
|
31
|
|||||||
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
|
||||||||
RESULTS
OF OPERATIONS
|
32
|
|||||||
DESCRIPTION
OF BUSINESS
|
40
|
|||||||
DESCRIPTION
OF PROPERTY
|
54
|
|||||||
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
|
55 | |||||||
LEGAL
PROCEEDINGS
|
62
|
|||||||
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
|
62 | |||||||
TRANSACTIONS
WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL PERSONS
|
64
|
|||||||
DESCRIPTION
OF SECURITIES
|
65
|
|||||||
EXPERTS
|
68
|
|||||||
LEGAL
MATTERS
|
68
|
|||||||
WHERE
YOU CAN FIND MORE INFORMATION
|
68
|
|||||||
FINANCIAL
STATEMENTS
|
F-1
|
|
(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.
|
·
|
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 $1
billion world-wide. MuGard, a proprietary nanopolymer formulation, has
received marketing allowance in the U.S. from the Food & Drug
Administration (FDA). MuGard has been launched in Germany, Italy, UK,
Greece and the Nordic countries by our European commercial partner,
SpePharm. Our manufacturing of MuGard is underway as we expect to launch
MuGard in North America during the second quarter of 2010. We are working
with our partners in Korea and China for
marketing.
|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. We recently completed a Phase 2
clinical trial on ProLindac in the EU in patients with recurrent ovarian
cancer. The clinical study had positive safety and efficacy results. On
January 7, 2010, we announced that we are initiating a study of ProLindac
combined with Paclitaxel in second line treatment of platinum pretreated
advanced ovarian cancer patients. This multi-center study of up to 25
evaluable patients will be conducted in Europe. We are also currently
planning a number of combination trials, looking at combining ProLindac
with other cancer agents in solid tumor indications including colorectal
and 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.
|
·
|
Thiarabine,
or 4-thio Ara-C, is a next generation nucleoside analog licensed from
Southern Research Institute. Previously named SR9025 and OSI-7836, the
compound has been in two Phase 1/2 solid tumor human clinical trials and
was shown to have anti-tumor activity. We are working with leukemia and
lymphoma specialists at MD Anderson Cancer Center in Houston and intend to
initiate additional Phase 2 clinical trials in adult AML, ALL and other
indications.
|
·
|
Cobalamin™
is our proprietary preclinical nanopolymer oral drug delivery technology
based on the natural vitamin B12 oral uptake mechanism. We are currently
developing a product for the oral delivery of insulin, and have conducted
sponsored development of a product for oral delivery of human growth
hormone. We are in discussion with several companies regarding the
sponsored development of Cobalamin oral drug delivery formulations of
proprietary and non-proprietary
actives.
|
·
|
Cobalamin-mediated
cancer targeted delivery is a preclinical technology which makes use of
the fact that cell surface receptors for vitamins such as B12 are often
overexpressed by cancer cells. This technology uses nanopolymer constructs
to deliver more anti-cancer drug to tumors while protecting normal
tissues.
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage (1)
|
||||
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
(510k)
Marketing clearance received
|
||||
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
/
Univ
of
London
|
Synthetic
polymer
|
Cancer
|
Phase
2
|
||||
Thiarabine
(4-thio Ara-C) (3)
|
Southern
Research
Institute
|
Small
molecule
|
Cancer
|
Phase
1/2
|
||||
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
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.
|
(3)
|
Licensed
from Southern Research Institute of Birmingham,
Alabama.
|
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. As of April 23, 2010 1,366,820 shares of Common
Stock have been previously been issued as dividends to the Series A
Preferred Stock stockholders. There are 215,540 shares of Common Stock
remaining that may be issued as dividends on the Series A Preferred
Stock.
|
Common
stock outstanding:
|
As
of April 23, 2010, 15,382,755 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
|
(in
thousands, except per share amounts)
|
For
the Year
Ended
December 31,
|
|||||||
2009
|
2008
|
|||||||
Consolidated
Statements of Operations:
|
||||||||
Total
revenues
|
$ | 352 | $ | 291 | ||||
Loss
from operations
|
(9,676 | ) | (30,731 | ) | ||||
Interest
and miscellaneous income
|
29 | 211 | ||||||
Interest
and other expense
|
(539 | ) | (911 | ) | ||||
Loss
on change in fair value of derivative
|
(7,154 | ) | - | |||||
Net
loss
|
(17,340 | ) | (31,431 | ) | ||||
Preferred
stock dividends
|
(1,886 | ) | (3,358 | ) | ||||
Net
loss allocable to common stockholders
|
$ | (19,226 | ) | $ | (34,789 | ) | ||
Common
Stock Data:
|
||||||||
Net
loss per basic and
diluted
common share
|
$ | (1.63 | ) | $ | (4.16 | ) | ||
Weighted
average basic and
diluted
common shares outstanding
|
11,819 | 8,354 | ||||||
December 31,
|
||||||||
2009 | 2008 | |||||||
Consolidated
Balance Sheet Data:
|
||||||||
Cash
and cash equivalents
|
$ | 607 | $ | 2,677 | ||||
Total
assets
|
1,583 | 4,171 | ||||||
Deferred
revenue
|
5,077 | 2,409 | ||||||
Notes
payable
|
- | 825 | ||||||
Derivative
liability
|
9,708 | - | ||||||
Convertible
notes
|
5,500 | 5,500 | ||||||
Total
liabilities
|
28,572 | 15,357 | ||||||
Total
stockholders' deficit
|
(26,989 | ) | (11,186 | ) |
·
|
some
or all of our drug candidates may be found to be unsafe or ineffective or
otherwise fail to meet applicable regulatory standards or receive
necessary regulatory clearances;
|
·
|
our
drug candidates, if safe and effective, may be too difficult to develop
into commercially viable drugs;
|
·
|
it
may be difficult to manufacture or market our drug candidates on a large
scale;
|
·
|
proprietary
rights of third parties may preclude us from marketing our drug
candidates; and
|
·
|
third
parties may market superior or equivalent
drugs.
|
•
|
License
Agreement, dated as of August 8, 2007, by and between Virium
Pharmaceuticals, Inc.(a predecessor in interest to Access) and Southern
Research Institute; and
|
|
•
|
Exclusive
Patent and Know-how Sub-license Agreement between Somanta and
Immunodex, Inc. dated August 18, 2005, as
amended.
|
·
|
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.
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Percentage
of
Outstanding
Shares
Beneficially
Owned
Before
Offering
|
Shares
to
be Sold in the
Offering
(21)
|
Percentage
of
Outstanding
Shares
Beneficially
Owned
After
Offering
|
Beach
Capital LLC (2)
|
1,120,581
|
6.9%
|
514,299
|
3.7%
|
Brio
Capital LP (3)
|
150,000
|
*
|
-
|
*
|
Catalytix
LDC Life Science
Hedge
AC (4)
|
24,999
|
*
|
-
|
*
|
Cobblestone
Asset Mangement LLC (5)
|
41,667
|
*
|
-
|
*
|
Cranshire
Capital, LP (6)
|
210,001
|
1.4%
|
-
|
1.4%
|
Credit
Suisse Securities (USA) LLC (7)
|
166,667
|
1.1%
|
-
|
1.1%
|
Enable
Growth Partners LP (8)
|
83,333
|
*
|
-
|
*
|
William
G. Garrison (9)
|
66,667
|
*
|
-
|
*
|
Edward
and Patricia Kelly (10)
|
99,999
|
*
|
-
|
*
|
Lake
End Capital LLC (11)
|
1,852,668
|
11.0%
|
709,734
|
6.8%
|
Dennis
Lavalle (12)
|
45,000
|
*
|
-
|
*
|
David
P. Luci (13)
|
285,050
|
1.8%
|
-
|
1.8%
|
Midsummer
Investment, Ltd (14)
|
760,000
|
4.8%
|
-
|
4.8%
|
Oracle
Institutional Partners LP (15)
|
841,974
|
5.2%
|
493,221
|
2.2%
|
Oracle
Offshore Ltd. (16)
|
78,365
|
*
|
47,924
|
*
|
Oracle
Partners, LP (17)
|
1,759,803
|
10.5%
|
916,554
|
5.0%
|
Rockmore
Investment
Master
Fund Ltd (18)
|
473,333
|
3.0%
|
-
|
3.0%
|
Schroder
& Co. Bank AG, Zurich (19)
|
125,000
|
*
|
-
|
*
|
SCO
Capital Partners LLC (20)
|
15,491,606
|
56.2%
|
4,896,136
|
38.4%
|
Total:
|
23,676,713
|
7,577,868
|
(1)
|
Applicable
percentage of ownership is based on 15,382,755 shares of common stock
outstanding as of April 23, 2010, together with securities exercisable or
convertible into shares of common stock within 60 days of April 23, 2010,
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 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.
|
(2)
|
Beach
Capital LLC is known to beneficially own an aggregate of 171,085 of our
shares of Common Stock, warrants to purchase an aggregate of 435,197
shares of our Common Stock and Series A Preferred Stock which may be
converted into an aggregate of 514,299 shares of our Common Stock. Beach
Capital LLC and affiliate, SCO Capital Partners LLC, are known to
beneficially own 3,481,800 shares of our Common Stock, warrants to
purchase an aggregate of 6,053,287 shares of our Common Stock and
7,077,100 shares of Common Stock issuable to them upon conversion of
Series A Preferred Stock. Steven H. Rouhandeh, our chairman of the board
of directors, 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, our directors and
Mr. Davis, our CEO and 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 50,000 shares of
our Common Stock, warrants to purchase an aggregate of 50,000 shares of
our Common Stock and Series A Preferred Stock which may be converted into
an aggregate of 50,000 shares of ourCommon
Stock.
|
(4)
|
Catalytix
LDC Life Science Hedge AC is known to beneficially own warrants to
purchase an aggregate of 8,333 shares of our Common Stock and Series A
Preferred Stock which may be converted into an aggregate of 16,666 shares
of our Common Stock.
|
(5)
|
Cobblestone
Asset Management LLC is known to beneficially own warrants to purchase an
aggregate of 41,667 shares of our Common
Stock.
|
(6)
|
Cranshire
Capital, LP is known to beneficially own 83,334 shares of our Common
Stock, warrants to purchase an aggregate of 125,000 shares of our Common
Stock and Series A Preferred Stock which may be converted into an
aggregate of 1,667 shares of our 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 our Common
Stock.
|
(8)
|
Enable
Growth Partners LP is known to beneficially own warrants to purchase an
aggregate of 83,333 shares of our 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 our Common
Stock.
|
(10)
|
Edward
and Patricia Kelly are known to beneficially own warrants to purchase an
aggregate of 33,333 shares of our Common Stock and Series A Preferred
Stock which may be converted into an aggregate of 66,666 shares of our
Common Stock.
|
(11)
|
Lake
End Capital LLC is known to beneficially own 335,575 shares of our Common
Stock, warrants to purchase an aggregate of 724,026 shares of our Common
Stock and Series A Preferred Stock which may be converted into an
aggregate of 793,067 shares of our Common Stock. Lake End Capital LLC and
Mr. Davis are known to beneficially own 335,575 shares of our Common
Stock, warrants and options to purchase an aggregate of 749,026 shares of
our 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, our CEO, is also President of SCO Securities LLC, a wholly-owned
subsidiary of SCO Financial Group LLC. Mr. Davis is our director
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 our Common Stock and Series A Preferred Stock which may
be converted into an aggregate of 30,000 shares of our Common
Stock.
|
(13)
|
David
P. Luci is known to beneficially own 196,550 shares of our Common Stock,
warrants and options to purchase an aggregate of 80,167 shares of our
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 200,000 shares of our Common
Stock, warrants to purchase an aggregate of 350,000 shares of our Common
Stock and Series A Preferred Stock which may be converted into an
aggregate of 210,000 shares of Access’ Common
Stock.
|
(15)
|
Oracle
Institutional Partners LP is known to beneficially own an aggregate of
102,142 shares of our Common Stock, warrants to purchase an aggregate of
246,611 shares of our Common Stock and Series A Preferred Stock which may
be converted into an aggregate of 493,221 shares of our 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. and Mr. Feinberg) are known to beneficially
own an aggregate of 493,593 shares of our Common Stock, warrants to
purchase an aggregate of 728,850 shares of our 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 6,479 shares of
our Common Stock, warrants to purchase an aggregate of 23,962 shares of
our Common Stock and Series A Preferred Stock which may be converted into
an aggregate of 47,924 shares of our 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.
and Mr. Feinberg) are known to beneficially own an aggregate of 493,593
shares of Access’ Common Stock, warrants to purchase an aggregate of
728,850 shares of our Common Stock and Series A Preferred Stock which may
be converted into an aggregate of 1,457,699 shares of our Common
Stock.
|
(17)
|
Oracle
Partners, LP is known to beneficially own an aggregate of 384,972 shares
of our Common Stock, warrants to purchase an aggregate of 458,277 shares
of our Common Stock and Series A Preferred Stock which may be converted
into an aggregate of 916,554 shares of our 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.
and Mr. Feinberg) are known to beneficially own an aggregate of 493,593
shares of our Common Stock, warrants to purchase an aggregate of 728,850
shares of our Common Stock and Series A Preferred Stock which may be
converted into an aggregate of 1,457,699 shares of our Common
Stock.
|
(18)
|
Rockmore
Investment Master Fund Ltd is known to beneficially own an aggreagate of
200,000 shares of our Common Stock, warrants to purchase an aggregate of
183,333 shares of our Common Stock and Series A Preferred Stock which may
be converted into an aggregate of 90,000 shares of our 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 March 31,
2010, 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.
|
(19)
|
Schroder
& Co. Bank AG, Zurich is known to beneficially own warrants to
purchase an aggregate of 41,667 shares of our Common Stock and Series A
Preferred Stock which may be converted into an aggregate of 83,333 shares
of our Common Stock.
|
(20)
|
SCO
Capital Partners LLC is known to directly beneficially own 3,310,715
shares of our Common Stock, warrants to purchase an aggregate of 5,618,090
shares of our Common Stock and Series A Preferred Stock which may be
converted into an aggregate of 6,562,801 shares of our Common Stock. SCO
Capital Partners LLC and affiliate, Beach Capital LLC, are known to
beneficially own 3,481,800 shares of our Common Stock, warrants to
purchase an aggregate of 6,053,287 shares of our 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.
|
(21)
|
Our
Common Stock registered in this offering consists of 7,577,868 shares of
common stock 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. As of April 23, 2010
1,366,820 shares of Common Stock have been previously been issued as
dividends to the Series A Preferred Stock stockholders. There are 215,540
shares of Common Stock remaining that may be issued as dividends on the
Series A Preferred Stock.
|
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
|
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%
|
Stockholder
|
Date
Acquired / Amount Due
|
Common
Stock
Underlying
Placement
Agent Warrants
|
Price
per Share
|
Placement
Agent Fees Paid
|
Form
of Consideration
|
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
|
2,784,345
|
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 | ) |
Stockholder
|
Date
of Transaction
|
Convertible
Notes
Principal
Amount
|
Common
Stock
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
|
||||||||
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
|
2,709,210
|
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
|
3,535,108
|
2,790,305
|
23.8%
|
|
Total Shares Not Previously
Registered
|
1,681,818
|
||||
Total
Prior Security Transactions
|
11,065,654
|
||||
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
|
-
|
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.
|
-
|
throughthe
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
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.
|
Common Stock
|
||||||||
High
|
Low
|
|||||||
Fiscal Year 2010 Year-to
date
|
||||||||
First
quarter
|
$ | 3.29 | $ | 2.44 | ||||
Second
quarter (through April 22, 2010)
|
2.80 | 2.31 | ||||||
Fiscal Year Ended December 31,
2009
|
||||||||
First
quarter
|
$ | 1.85 | $ | 0.77 | ||||
Second
quarter
|
2.25 | 1.25 | ||||||
Third
quarter
|
4.70 | 1.84 | ||||||
Fourth
quarter
|
3.50 | 2.80 | ||||||
Fiscal Year Ended December 31,
2008
|
||||||||
First
quarter
|
$ | 3.50 | $ | 1.35 | ||||
Second
quarter
|
3.30 | 1.40 | ||||||
Third
quarter
|
3.49 | 2.50 | ||||||
Fourth
quarter
|
2.75 | 0.80 |
Number
of securities
|
||||||||||||
remaining
available
|
||||||||||||
for
future issuance
|
||||||||||||
Number
of securities to
|
Weighted-average
|
under
equity
|
||||||||||
be
issued upon exercise
|
exercise
price of
|
compensation
plans
|
||||||||||
of
outstanding options
|
outstanding
options
|
(excluding
securities
|
||||||||||
Plan Category
|
warrants
and rights
|
warrants
and rights
|
reflected
in column (a))
|
|||||||||
(a)
|
(b)
|
(c)
|
||||||||||
Equity
compensation plans
|
||||||||||||
approved
by security
|
||||||||||||
holders:
|
||||||||||||
2005
Equity Incentive Plan
|
1,435,237 | $ | 1.99 | 1,408,851 | ||||||||
1995
Stock Awards Plan
|
103,000 | 15.89 | - | |||||||||
2001
Restricted Stock Plan
|
- | - | 52,818 | |||||||||
Equity
compensation plans
|
||||||||||||
not
approved by security
|
||||||||||||
holders:
|
||||||||||||
2007
Special Stock Option Plan
|
100,000 | 2.9 | 350,000 | |||||||||
Total
|
1,638,237 | $ | 2.92 | 1,811,669 |
·
|
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 $1
billion world-wide. MuGard, a proprietary nanopolymer formulation, has
received marketing allowance in the U.S. from the Food & Drug
Administration (FDA). MuGard has been launched in Germany, Italy, UK,
Greece and the Nordic countries by our European commercial partner,
SpePharm. Our manufacturing of MuGard is underway as we expect to launch
MuGard in North America during the second quarter of 2010. We are working
with our partners in Korea and China for
marketing.
|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. We recently completed a Phase 2
clinical trial on ProLindac in the EU in patients with recurrent ovarian
cancer. The clinical study had positive safety and efficacy results. On
January 7, 2010, we announced that we are initiating a study of ProLindac
combined with Paclitaxel in second line treatment of platinum pretreated
advanced ovarian cancer patients. This multi-center study of up to 25
evaluable patients will be conducted in Europe. We are also currently
planning a number of combination trials, looking at combining ProLindac
with other cancer agents in solid tumor indications including colorectal
and 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.
|
·
|
Thiarabine,
or 4-thio Ara-C, is a next generation nucleoside analog licensed from
Southern Research Institute. Previously named SR9025 and OSI-7836, the
compound has been in two Phase 1/2 solid tumor human clinical trials and
was shown to have anti-tumor activity. We are working with leukemia and
lymphoma specialists at MD Anderson Cancer Center in Houston and intend to
initiate additional Phase 2 clinical trials in adult AML, ALL and other
indications.
|
·
|
Cobalamin™
is our proprietary preclinical nanopolymer oral drug delivery technology
based on the natural vitamin B12 oral uptake mechanism. We are currently
developing a product for the oral delivery of insulin, and have conducted
sponsored development of a product for oral delivery of human growth
hormone. We are in discussion with several companies regarding the
sponsored development of Cobalamin oral drug delivery formulations of
proprietary and non-proprietary
actives.
|
·
|
Cobalamin-mediated
cancer targeted delivery is a preclinical technology which makes use of
the fact that cell surface receptors for vitamins such as B12 are often
overexpressed by cancer cells. This technology uses nanopolymer constructs
to deliver more anti-cancer drug to tumors while protecting normal
tissues.
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage (1)
|
||||
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
(510k)
Marketing clearance received
|
||||
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
/
Univ
of
London
|
Synthetic
polymer
|
Cancer
|
Phase
2
|
||||
Thiarabine
(4-thio Ara-C) (3)
|
Southern
Research
Institute
|
Small
molecule
|
Cancer
|
Phase
1/2
|
||||
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
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.
|
(3)
|
Licensed
from Southern Research Institute of Birmingham,
Alabama.
|
·
|
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);
|
·
|
MacroChem’s
acquisition of Virium on April 18, 2008 which resulted in a one-time
non-cash in-process research and development expense
($9,657,000);
|
·
|
research
and development expenses incurred by MacroChem for the year ended December
31, 2008, which are no longer ongoing
($953,000);
|
·
|
lower
costs for product manufacturing due to the start of a new ProLindac
clinical trial ($753,000);
|
·
|
lower
salary and related expenses
($392,000);
|
·
|
lower
scientific consulting expenses
($266,000);
|
·
|
other
net decreases in research spending
($84,000);
|
·
|
offset
by higher expenses due to option grants ($303,000);
and
|
·
|
offset
by higher clinical costs due to the planned start of a new clinical trial
in 2010 ($103,000).
|
·
|
lower
general and administrative expenses incurred by MacroChem for the year
ended December 31, 2008 that are no longer ongoing
($2,943,000);
|
·
|
lower
accrual for liquidated damages
($493,000);
|
·
|
lower
director and officer insurance and lower director fees ($166,000) due to
lower insurance costs and directors taking options instead of fees in
2009;
|
·
|
lower
patent expenses ($117,000);
|
·
|
lower
legal and accounting expenses ($86,000);
and
|
·
|
other
net decreases in general and administrative expenses
($110,000);
|
·
|
offset
by higher shareholder consultant expenses ($2,348,000) to inform investors
about Access and to expand our shareholder
base;
|
·
|
higher
business professional expenses ($1,094,000);
and
|
·
|
higher
expenses due to the cost of option grants
($122,000).
|
·
|
the
successful development and commercialization of ProLindac™, MuGard™ and
our other product candidates;
|
·
|
the
ability to convert, repay or restructure our outstanding convertible note
and debentures;
|
·
|
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.
|
(in
thousands)
|
Twelve
Months ended
December 31,
|
Inception
To
Date (1)
|
||||||||||
Project
|
2009
|
2008
|
||||||||||
Polymer
Platinate
(ProLindac™)
|
$ | 2,507 | $ | 3,402 | $ | 28,126 | ||||||
Mucoadhesive
Liquid
Technology
(MLT)
|
107 | - | 1,618 | |||||||||
Others
(2)
|
43 | 332 | 5,437 | |||||||||
Total
|
$ | 2,657 | $ | 3,734 | $ | 35,181 | ||||||
(1)
|
Cumulative
spending from inception of the Company or project through December 31,
2009.
|
(2)
|
Includes: Vitamin
Mediated Targeted Delivery, carbohydrate targeting and other
projects.
|
·
|
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 $1
billion world-wide. MuGard, a proprietary nanopolymer formulation, has
received marketing allowance in the U.S. from the Food & Drug
Administration (FDA). MuGard has been launched in Germany, Italy, UK,
Greece and the Nordic countries by our European commercial partner,
SpePharm. Our manufacturing of MuGard is underway as we expect to launch
MuGard in North America during the second quarter of 2010. We are working
with our partners in Korea and China for
marketing.
|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. We recently completed a Phase 2
clinical trial on ProLindac in the EU in patients with recurrent ovarian
cancer. The clinical study had positive safety and efficacy results. On
January 7, 2010, we announced that we are initiating a study of ProLindac
combined with Paclitaxel in second line treatment of platinum pretreated
advanced ovarian cancer patients. This multi-center study of up to 25
evaluable patients will be conducted in Europe. We are also currently
planning a number of combination trials, looking at combining ProLindac
with other cancer agents in solid tumor indications including colorectal
and 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.
|
·
|
Thiarabine,
or 4-thio Ara-C, is a next generation nucleoside analog licensed from
Southern Research Institute. Previously named SR9025 and OSI-7836, the
compound has been in two Phase 1/2 solid tumor human clinical trials and
was shown to have anti-tumor activity. We are working with leukemia and
lymphoma specialists at MD Anderson Cancer Center in Houston and intend to
initiate additional Phase 2 clinical trials in adult AML, ALL and other
indications.
|
·
|
Cobalamin™
is our proprietary preclinical nanopolymer oral drug delivery technology
based on the natural vitamin B12 oral uptake mechanism. We are currently
developing a product for the oral delivery of insulin, and have conducted
sponsored development of a product for oral delivery of human growth
hormone. We are in discussion with several companies regarding the
sponsored development of Cobalamin oral drug delivery formulations of
proprietary and non-proprietary
actives.
|
·
|
Cobalamin-mediated
cancer targeted delivery is a preclinical technology which makes use of
the fact that cell surface receptors for vitamins such as B12 are often
overexpressed by cancer cells. This technology uses nanopolymer constructs
to deliver more anti-cancer drug to tumors while protecting normal
tissues.
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage (1)
|
||||
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
(510k)
Marketing clearance received
|
||||
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
/
Univ
of
London
|
Synthetic
polymer
|
Cancer
|
Phase
2
|
||||
Thiarabine
(4-thio Ara-C) (3)
|
Southern
Research
Institute
|
Small
molecule
|
Cancer
|
Phase
1/2
|
||||
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
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.
|
(3)
|
Licensed
from Southern Research Institute of Birmingham,
Alabama.
|
·
|
Synthetic
Polymer Targeted Drug Delivery
Technology;
|
·
|
Cobalamin™-Mediated
Oral Delivery Technology; and
|
·
|
Cobalamin™-Mediated
Targeted Delivery Technology.
|
●
|
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 ProLindac program uses a
passive tumor targeting technology.
|
●
|
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 binding 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.
|
-
|
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
|
-
|
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.
|
·
|
Mucoadhesive
technology in 2021,
|
·
|
ProLindac™
in 2021,
|
·
|
Thiarabine
in 2018, and
|
·
|
Cobalamin
mediated technology between 2010 and
2019
|
•
|
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 several generic
manufacturers, and
|
•
|
Oxaliplatin,
marketed exclusively by
Sanofi-Aventis.
|
•
|
Antigenics
and Regulon are developing liposomal platinum
formulations;
|
•
|
Poniard
Pharmaceuticals and Cell Therapeutics are developing both i.v. and oral
platinum formulations;
|
•
|
Nanocarrier
and Debio are developing micellar nanoparticle platinum formulations;
and
|
•
|
AmericanPharmaceutical
Partners, Cell Therapeutics, Daiichi, SynDevRx, and Enzon are developing
alternate drugs in combination with polymers and other drug
delivery
systems.
|
Name
|
Age
|
Title
|
||
Steven
H. Rouhandeh
|
53
|
Chairman
of the Board*
|
||
Jeffrey
B. Davis
|
47
|
Chief
Executive Officer, Director*
|
||
Esteban
Cvitkovic, M.D.
|
60
|
Vice
Chairman – Europe
|
||
Mark
J. Ahn, Ph.D.
|
47
|
Director
|
||
Mark
J. Alvino
|
41
|
Director
|
||
Stephen
B. Howell, M.D.
|
65
|
Director
|
||
David
P. Nowotnik, Ph.D.
|
61
|
Senior
Vice President Research & Development
|
||
Frank
A. Jacobucci
|
48
|
Vice
President, Sales and Marketing
|
||
Phillip
S. Wise
|
51
|
Vice
President, Business Development & Strategy
|
||
Stephen
B. Thompson
|
56
|
Vice
President, Chief Financial Officer, Treasurer,
|
||
Secretary
|
|
*
|
Appointed
to the board of directors by SCO Capital Partners LLC (“SCO”) pursuant to
a Director Designation Agreement between SCO and
Access.
|
Name and Principal Position
|
Year
|
Salary ($)
(1)
|
Option
Awards ($)
(2)
|
All Other
Compensation
(3)
|
Total ($)
|
|||||||||||||||
Jeffrey
B. Davis
Chief
Executive Officer
|
2009
2008
|
$
|
170,000
266,076
|
$
|
-
-
|
$
|
-
-
|
$
|
170,000 266,076 | |||||||||||
David
P. Nowotnik, Ph.D.
Senior
Vice President Research
and
Development
|
2009
2008
|
$
|
175,675
253,620
|
$
|
87,117
136,977
|
$
|
6,307
12,225
|
$
|
269,099 402,822 | |||||||||||
Phillip
S. Wise
Vice
President, Business
Development
|
2009
2008
|
$
|
200,000
200,000
|
$
|
-
136,977
|
$
|
5,209
9,876
|
$
|
205,209
346,853
|
|||||||||||
(1)
|
Includes
amounts deferred under our 401(k)
Plan.
|
(2)
|
The
value listed in the above table represents the fair value of the options
granted in prior years that was recognized in 2009 and 2008 under ASC 718.
Fair value is calculated as of the grant date using a Black-Scholes
option-pricing model. The determination of the fair value of share-based
payment awards made on the date of grant is affected by our stock price as
well as assumptions regarding a number of complex and subjective
variables. Our assumptions in determining fair value are described in note
11 to our audited financial statements for the year ended December 31,
2009, included in our Annual Report on Form
10-K.
|
(3)
|
Amounts
reported for fiscal years 2009 and 2008 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.
|
Name
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
|
Equity
Incentive
Plan
Awards:
Number
of
Securities
Underlying
Unexercised
Unearned
Options
(#)
|
Option
Exercise
Price
($)(1)
|
Option
Expiration
Date
|
Jeffrey
B. Davis (2)
|
25,000
|
-
|
-
|
0.63
|
08/17/16
|
David
P. Nowotnik, Ph.D. (3)
|
75,000
19,791
100,000
8,000
5,000
7,000
10,000
|
-
30,209
-
-
-
-
-
|
-
|
1.38
3.00
0.63
11.60
29.25
10.10
18.65
|
05/27/19
05/21/18
08/17/16
05/23/15
01/23/14
01/30/13
03/22/12
|
Phillip
S. Wise (4)
|
19,791
100,000
|
30,209
-
|
-
|
3.00
0.63
|
05/21/18
08/17/16
|
(1)
|
On
December 31, 2009, the closing price of our Common Stock as quoted on the
OTC Bulletin Board was $3.29.
|
(2)
|
Jeffrey
B. Davis’ employment agreement started January 4, 2008. The options
included in this table were granted to him as a director before he became
CEO. Mr. Davis does not have any stock options granted to him as
CEO.
|
(3)
|
Dr.
Nowotnik’s options to purchase 50,000 shares of common stock will be fully
vested in April 2012.
|
(4)
|
Mr.
Wise’s options to purchase 50,000 shares of common stock will be fully
vested in April 2012.
|
●
|
a
bonus payable in cash related to the attainment of reasonable performance
goals specified by the Board;
|
●
|
options
to purchase 200,000 shares of our Common Stock at an exercise price of
$2.79 per share, with one third options vesting on February 1, 2011 and
the remaining two thirds options vesting ratably on February 1, 2012 and
February 1, 2013;
|
●
|
stock
options issued from time to time at the discretion of the
Board;
|
|
disability
benefits up to six months; and
|
●
|
medical
insurance, term life insurance of $250,000 and long-term disability
insurance.
|
●
|
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 $254,000.
|
Name
|
Fees
earned or
Paid
in Cash ($)
|
Stock
Awards ($)
|
Option
Awards
($)(1)
|
All
Other
Compensation
($)
|
Total
($)
|
Mark
J. Ahn, PhD (2)
|
-
|
-
|
40,000
|
-
|
40,000
|
Mark
J. Alvino (3)
|
-
|
-
|
40,000
|
-
|
40,000
|
Esteban
Cvitkovic, MD (4)
|
-
|
-
|
115,000
|
132,000
|
247,000
|
Jeffrey
B. Davis (5)
|
-
|
-
|
-
|
-
|
-
|
Stephen
B. Howell, MD (6)
|
-
|
-
|
40,000
|
-
|
40,000
|
David
P. Luci (7)
|
-
|
265,000
|
52,000
|
83,000
|
400,000
|
Steven
H. Rouhandeh (8)
|
-
|
-
|
-
|
-
|
-
|
|
(1)
|
|
The
value listed represents the fair value of the options recognized as
expense under ASC 718 during 2009, including unvested options granted
before 2009 and those granted in 2009. Fair value is calculated as of the
grant date using a Black-Scholes (“Black-Scholes”) option-pricing model.
The determination of the fair value of share-based payment awards made on
the date of grant is affected by our stock price as well as assumptions
regarding a number of complex and subjective variables. Our assumptions in
determining fair value are described in note 11 to our audited financial
statements for the year ended December 31, 2009, included in our Annual
Report on Form 10-K.
|
(2)
|
Represents
expense recognized in 2009 in respect of options to purchase 35,000 shares
of our Common Stock based on a grant date fair value of $40,000. Dr. Ahn
has options to purchase 66,000 shares of our Common Stock at December 31,
2009.
|
||
(3)
|
Represents
expense recognized in 2009 in respect of options to purchase 35,000 shares
of our Common Stock based on a grant date fair value of $40,000. Mr.
Alvino has options to purchase 66,000 shares of our Common Stock at
December 31, 2009.
|
||
(4)
|
Represents
expense recognized in 2009 in respect of options to purchase 100,000
shares of our Common Stock based on a grant date fair value of $115,000.
Includes $132,000 Dr. Cvitkovic received for scientific consulting
services in 2009. Dr. Cvitkovic has options to purchase 156,000 shares of
our Common Stock and warrants to purchase 200,000 of our Common Stock at
December 31, 2009.
|
||
(5)
|
Mr.
Davis served as our CEO during 2009 and did not receive any compensation
for his services as our director. Mr. Davis’ salary and employment
agreement are discussed in the Summary Compensation Table and Compensation
Pursuant to Agreements and Plans – Employment Agreements – President and
Chief Executive Officer.
|
(6)
|
Represents
expense recognized in 2009 in respect of options to purchase 35,000 shares
of our Common Stock based on a grant date fair value of $40,000. Dr.
Howell has options to purchase 79,700 shares of our Common Stock at
December 31, 2009.
|
||
(7)
|
Represents
$265,000 of expense recognized in 2009 for stock awards: (a) in respect to
66,667 shares of Common Stock received on June 1, 2009 based on a fair
value of $181,000 per Mr. Luci’s consulting agreement and (b) in respect
to 60,000 shares of Common Stock received due to the termination of his
employment agreement with MacroChem Corporation based on a fair value of
$84,000. Represents expense recognized in 2009 in respect of options to
purchase 45,000 shares of our Common Stock based on a grant date fair
value of $52,000. Represents $83,000 of expense Mr. Luci received for
business consulting services in 2009. Mr. Luci has options to purchase
76,000 shares of our Common Stock at December 31, 2009. He also has
warrants to purchase 4,167 shares of our Common Stock at December 31,
2009. Mr. Luci resigned as director February 12, 2009.
|
||
(8)
|
Mr.
Rouhandeh does not have any options or warrants outstanding at December
31, 2009. See also the Security Ownership of Certain Beneficial Owners and
Management.
|
Name
and Address of Beneficial Owner
|
Amount
and
Nature
of
Beneficial
Ownership
Common
Stock
(1)
|
Percent
of Class
|
Amount
and
Nature
of
Beneficial
Ownership
Preferred
Stock
|
Percent
of Class
|
Amount
and
Nature
of
Beneficial
Ownership
All
Classes
of
Stock
|
Percent
of Class
|
||
Steven
H. Rouhandeh(2)
|
-
|
*
|
-
|
*
|
-
|
*
|
||
Jeffery
B. Davis (3)
|
36,000
|
*
|
-
|
*
|
36,000
|
*
|
||
Mark
J. Ahn, Ph. D. (4)
|
66,000
|
*
|
-
|
*
|
66,000
|
*
|
||
Mark
J. Alvino (5)
|
66,000
|
*
|
-
|
*
|
66,000
|
*
|
||
Esteban
Cvitkovic, M.D. (6)
|
356,000
|
2.3%
|
-
|
*
|
356,000
|
1.4%
|
||
Stephen
B. Howell, M.D. (7)
|
89,422
|
*
|
-
|
*
|
89,422
|
*
|
||
David
P. Nowotnik, Ph.D. (8)
|
245,436
|
1.6%
|
-
|
*
|
245,436
|
*
|
||
Phillip
S. Wise (9)
|
119,794
|
*
|
-
|
*
|
119,794
|
*
|
||
SCO
Capital Partners LLC, SCO Capital Partners LP, and Beach Capital LLC (10)
|
9,535,087
|
44.5%
|
7,077,100
|
71.1%
|
16,612,187
|
52.9%
|
||
Larry
N. Feinberg (11)
|
1,222,443
|
7.6%
|
1,457,699
|
14.7%
|
2,680,142
|
10.3%
|
||
Lake
End Capital LLC (12)
|
1,059,601
|
6.6%
|
793,067
|
8.0%
|
1,852,668
|
7.1%
|
||
All
Directors and Executive
Officers
as a group
(consisting
of 8 persons) (13)
|
978,652
|
6.0%
|
-
|
*
|
978,652
|
3.7%
|
(1)
|
Includes
our outstanding shares of Common Stock held plus all shares of Common
Stock issuable upon exercise of options, warrants and other rights
exercisable within 60 days of April 23,
2010.
|
(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, 1325 Avenue of the Americas, 27th 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 3,481,800 shares of our
Common Stock, warrants to purchase an aggregate of 6,053,287 shares of our
Common Stock and 7,077,100 shares of Common Stock issuable upon conversion
of Series A Cumulative Convertible Preferred Stock. Mr. Rouhandeh
disclaims beneficial ownership of all such shares except to the extent of
his pecuniary interest therein.
|
(3)
|
Mr.
Davis is known to beneficially own an aggregate of 7,333 shares of our
Common Stock, presently exercisable options for the purchase of 25,000
shares of our Common Stock pursuant to the 2005 Equity Incentive Plan and
3,667 shares of Common Stock underlying warrants held by Mr. Davis. 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, 1325 Avenue of the Americas, 27th Floor, New York, NY 10019. SCO
Securities LLC and affiliates (SCO Capital Partners LP and Beach Capital
LLC) are known to beneficially own 3,481,800 shares of our Common Stock,
warrants to purchase an aggregate of 6,053,287 shares of our Common Stock
and 7,077,100 shares of Common Stock issuable upon conversion of Series A
Cumulative Convertible 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 66,000 shares of our
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
(5)
|
Includes
presently exercisable options for the purchase of 66,000 shares of our
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. SCO Securities LLC and affiliates (SCO Capital
Partners LP and Beach Capital LLC) are known to beneficially own 3,481,800
shares of our Common Stock, warrants to purchase an aggregate of 6,053,287
shares of our Common Stock and 7,077,100 shares of Common Stock issuable
upon conversion of Series A Cumulative Convertible Preferred Stock. 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 156,000 shares of our
Common Stock pursuant to the 2005 Equity Incentive Plan and a warrant to
purchase 200,000 shares of our Common Stock at an exercise price of $3.15
per share.
|
(7)
|
Dr.
Howell is known to beneficially own an aggregate of 9,722 shares of our
Common Stock, presently exercisable options for the purchase of 67,200
shares of our Common Stock pursuant to the 2005 Equity Incentive Plan and
12,500 shares of our Common Stock pursuant to the 1995 Stock Option
Plan.
|
(8)
|
Dr.
Nowotnik is known to beneficially own an aggregate of 17,516 shares of our
Common Stock, presently exercisable options for the purchase of 197,920
shares of our Common Stock pursuant to the 2005 Equity Incentive Plan and
30,000 shares of our Common Stock pursuant to the 1995 Stock Option
Plan.
|
(9)
|
Includes
presently exercisable options for the purchase of 119,794 shares of our
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
(10)
|
SCO
Capital Partners LLC, SCO Capital Partner LP, Beach Capital LLC and SCO
Financial Group's address is 1325 Avenue of the Americas, 27th
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 3,481,800 shares of our Common Stock,
warrants to purchase an aggregate of 6,053,287 shares of our Common Stock
and 7,077,100 shares of Common Stock issuable upon conversion of Series A
Cumulative Convertible Preferred Stock. Each of Mr. Rouhandeh, Mr. Davis
and Mr. Alvino, directors of Access and Mr. Rouhandeh and Mr. Davis are
executives of SCO Capital Partners LLC and disclaim beneficial ownership
of such shares except to the extent of their pecuniary interest
therein.
|
(11)
|
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 493,593 shares of our Common Stock, warrants to purchase an
aggregate of 728,850 shares of our Common Stock and Series A Cumulative
Convertible Preferred Stock which may be converted into an aggregate of
1,457,699 shares of our Common
Stock.
|
(12)
|
Lake
End Capital LLC’s address is 1325 Avenue of the Americas, 27th
Floor, New York, NY 10019. Lake End Capital LLC is known to beneficially
own an aggregate of 335,575 shares of our Common Stock, warrants to
purchase an aggregate of 724,026 shares of our Common Stock and 793,067
shares of Common Stock issuable to them upon conversion of Series A
Cumulative Convertible Preferred
Stock.
|
(13)
|
Does
not include shares held by SCO Securities LLC and
affiliates.
|
|
Fair
Value
|
|||||||||||||||
of
exercisable
|
||||||||||||||||
Consulting
|
Office
|
Expense
|
Options
/
|
|||||||||||||
Year
|
Fees
|
Expenses
|
Reimbursement
|
Warrants
|
||||||||||||
2009
|
$ | 132,000 | $ | 18,000 | $ | 10,000 | $ | 86,000 |
PAGE
|
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
Consolidated
Balance Sheets at December 31, 2009 and 2008
|
F-3
|
Consolidated
Statements of Operations for 2009 and 2008
|
F-4
|
Consolidated
Statements of Stockholders' Equity (Deficit) for 2009 and 2008
|
F-5
|
Consolidated
Statements of Cash Flows for 2009 and 2008
|
F-6
|
Notes
to Consolidated Financial Statements (Two years ended December 31,
2009)
|
F-7
|
ASSETS
|
December 31, 2009
|
December 31, 2008
|
|
(See Note 12) | |||
Current
assets
Cash and cash
equivalents
Receivables
Prepaid expenses and other
current assets
|
$ 607,000
36,000
42,000
|
$ 2,677,000
147,000
175,000
|
|
Total current assets |
685,000
|
2,999,000
|
|
Property
and equipment, net
|
50,000
|
95,000
|
|
Patents,
net
|
787,000
|
999,000
|
|
Other
assets
|
61,000
|
78,000
|
|
Total
assets
|
$ 1,583,000
|
$ 4,171,000
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||
Current
liabilities
Accounts
payable
Accrued
expenses
Dividends
payable
Accrued
interest payable
Notes
payable
Current
portion of deferred revenue
|
$ 4,094,000
857,000
2,773,000
563,000
-
347,000
|
$ 3,287,000
1,295,000
1,896,000
145,000
825,000
164,000
|
|
Total current liabilities |
8,634,000
|
7,612,000
|
|
Derivative
liability
Long-term
deferred revenue
Long-term
convertible debt
|
9,708,000
4,730,000
5,500,000
|
-
2,245,000
5,500,000
|
|
Total
liabilities
|
28,572,000
|
15,357,000
|
|
Commitments
and contingencies
|
|||
Stockholders'
deficit
Convertible
preferred stock - $.01 par value; authorized 2,000,000
shares;
2,992.3617
issued at December 31, 2009; 3,242.8617 issued at
December
31, 2008
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
13,171,545 at December 31, 2009; issued 9,467,474
at
December 31, 2008
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost – 163 shares
|
-
132,000
215,735,000
(1,045,000)
(4,000)
|
-
95,000
225,753,000
(1,045,000)
(4,000)
|
|
Accumulated deficit | (241,807,000) | (235,985,000) | |
Total stockholders' deficit | (26,989,000) |
(11,186,000)
|
|
Total
liabilities and stockholders' deficit
|
$ 1,583,000
|
$ 4,171,000
|
December
31,
|
||||||||
2009
|
2008
|
|||||||
(See
Note 12)
|
||||||||
Revenues
|
||||||||
License
revenues
|
$ | 315,000 | $ | 118,000 | ||||
Royalties
|
37,000 | - | ||||||
Sponsored research and
development
|
- | 173,000 | ||||||
Total revenues
|
352,000 | 291,000 | ||||||
Expenses
|
||||||||
Research and
development
|
2,657,000 | 23,235,000 | ||||||
General and
administrative
|
7,112,000 | 7,463,000 | ||||||
Depreciation and
amortization
|
259,000 | 324,000 | ||||||
Total expenses
|
10,028,000 | 31,022,000 | ||||||
Loss
from operations
|
(9,676,000 | ) | (30,731,000 | ) | ||||
Interest
and miscellaneous income
|
29,000 | 211,000 | ||||||
Interest
and other expense
|
(539,000 | ) | (911,000 | ) | ||||
Loss
on change in fair value of derivative
|
(7,154,000 | ) | - | |||||
(7,664,000 | ) | (700,000 | ) | |||||
Net
loss
|
(17,340,000 | ) | (31,431,000 | ) | ||||
Less
preferred stock dividends
|
(1,886,000 | ) | (3,358,000 | ) | ||||
Net
loss allocable to common stockholders
|
$ | (19,226,000 | ) | $ | (34,789,000 | ) | ||
Basic
and diluted loss per common share
|
||||||||
Net
loss allocable to common stockholders
|
$ | (1.63 | ) | $ | (4.16 | ) | ||
Weighted
average basic and diluted common shares
outstanding
|
11,818,530 | 8,354,031 | ||||||
Common
Stock
|
Preferred
Stock
|
Notes | ||||||||||||||||||||||||||||||
Additional | receivable from | |||||||||||||||||||||||||||||||
Shares |
Amount
|
Shares
|
Amount
|
paid-in | stockholders | Treasury | Accumulated | |||||||||||||||||||||||||
capital
|
stock |
deficit
|
||||||||||||||||||||||||||||||
|
|
|
|
|
|
|||||||||||||||||||||||||||
Access-MacroChem
as if
combined
at January
1,
2008
|
6,085,000 | $ | 61,000 | 3,227.3617 | $ | - | $ | 213,782,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (199,892,000 | ) | |||||||||||||||
Common
stock issued for
services
|
10,000 | - | - | - | 27,000 | - | - | - | ||||||||||||||||||||||||
Warrants
issued for
services
|
- | - | - | - | 350,000 | - | - | - | ||||||||||||||||||||||||
Common
stock
issued
for cash exercise
of
options
|
25,000 | - | - | - | 15,000 | - | - | - | ||||||||||||||||||||||||
Stock
option
compensation
expense
|
- | - | - | - | 922,000 | - | - | - | ||||||||||||||||||||||||
Preferred
stock issuances
|
- | - | 272.5000 | - | 1,687,000 | - | - | - | ||||||||||||||||||||||||
Warrants
issued with
preferred
stock
|
- | - | - | - | 1,142,000 | - | - | - | ||||||||||||||||||||||||
Costs
of stock issuances
|
- | - | - | - | (385,000 | ) | - | - | - | |||||||||||||||||||||||
Preferred
stock dividend
beneficial
conversion
feature
|
- | - | - | - | 1,308,000 | - | - | (1,308,000 | ) | |||||||||||||||||||||||
Common
stock and
warrants
issued to
Somanta
shareholders
|
1,500,000 | 15,000 | - | - | 4,916,000 | - | - | - | ||||||||||||||||||||||||
Common
stock and
warrants
issued to
Somanta
creditors
|
538,000 | 5,000 | - | - | 1,571,000 | - | - | - | ||||||||||||||||||||||||
Preferred
stock converted
into
common stock
|
857,000 | 9,000 | (257.0000 | ) | - | (9,000 | ) | - | - | - | ||||||||||||||||||||||
Common
stock issued for
preferred
dividends
|
452,000 | 5,000 | - | - | 427,000 | - | - | - | ||||||||||||||||||||||||
Preferred
dividends
|
- | - | - | - | - | - | - | (3,358,000 | ) | |||||||||||||||||||||||
Net
loss
|
- | - | - | - | - | - | - | (31,427,000 | ) |
Balance,
December 31,
2008
|
9,467,000 | 95,000 | 3,242.8617 | - | 225,753,000 | (1,045,000 | ) | (4,000 | ) | (235,985,000 | ) | |||||||||||||||||||||
Cumulative
effect of a
change
in accounting
principle
(See Note 9)
|
- | - | - | - | (15,957,000 | ) | - | - | 13,404,000 | |||||||||||||||||||||||
Restricted
common stock
issued
for services
|
687,000 | 8,000 | - | - | 2,199,000 | - | - | - | ||||||||||||||||||||||||
Warrants
issued for
services
|
- | - | - | - | 796,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued
for
cash exercise
of
options
|
250,000 | 2,000 | - | - | 177,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued
for
cashless warrant
exercises
|
33,000 | - | - | - | - | - | - | - | ||||||||||||||||||||||||
Preferred
stock converted
into
common stock
|
836,000 | 9,000 | (250.5000 | ) | - | (9,000 | ) | - | - | - | ||||||||||||||||||||||
Common
stock issued
for
preferred dividends
|
915,000 | 9,000 | - | - | 918,000 | - | - | - | ||||||||||||||||||||||||
Stock
option
compensation
expense
|
- | - | - | - | 811,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued to
MacroChem
noteholders
for
notes and accrued
interest
|
859,000 | 8,000 | - | - | 851,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued to
former
MacroChem
executives
|
125,000 | 1,000 | - | - | 196,000 | - | - | - | ||||||||||||||||||||||||
Preferred
dividends
|
- | - | - | - | - | - | - | (1,886,000 | ) | |||||||||||||||||||||||
Net
loss
|
- | - | - | - | - | - | - | (17,340,000 | ) |
Balance,
December 31,
2009
|
13,172,000 | $ | 132,000 | 2,992.3617 | $ | - | $ | 215,735,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (241,807,000 | ) |
Year
ended December 31,
|
||||||||
2009
|
2008
|
|||||||
(See
Note 12)
|
||||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (17,340,000 | ) | $ | (31,431,000 | ) | ||
Adjustments
to reconcile net loss to net cash used
|
||||||||
in
operating activities:
|
||||||||
Stock
option compensation expense
|
811,000 | 922,000 | ||||||
Stock
and warrants issued for services
|
3,200,000 | 533,000 | ||||||
Acquired
in-process research & development
|
- | 18,540,000 | ||||||
Amortization
of debt discount and beneficial conversion feature
|
- | 263,000 | ||||||
Loss
on change in fair value of derivative
|
7,154,000 | - | ||||||
Depreciation
and amortization
|
259,000 | 317,000 | ||||||
Change
in operating assets and liabilities:
|
||||||||
Receivables
|
111,000 | (112,000 | ) | |||||
Prepaid
expenses and other current assets
|
133,000 | (19,000 | ) | |||||
Other
assets
|
17,000 | (66,000 | ) | |||||
Accounts
payable and accrued expenses
|
369,000 | 260,000 | ||||||
Dividends
payable
|
(82,000 | ) | 19,000 | |||||
Accrued
interest payable
|
452,000 | 15,000 | ||||||
Deferred
revenue
|
2,668,000 | 1,435,000 | ||||||
Net
cash used in operating activities
|
(2,248,000 | ) | (9,324,000 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Capital
expenditures
|
(2,000 | ) | (31,000 | ) | ||||
Proceeds
from sale of asset
|
1,000 | 13,000 | ||||||
Redemption
of short-term investments and certificate
|
||||||||
of
deposits
|
- | 759,000 | ||||||
Virium
acquisition by MacroChem, net of cash acquired
|
- | (240,000 | ) | |||||
Somanta
acquisition, net of cash acquired
|
- | (65,000 | ) | |||||
Net
cash provided by (used in) investing activities
|
(1,000 | ) | 436,000 | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from debt issuance
|
- | 400,000 | ||||||
Payments
of notes payable
|
- | (639,000 | ) | |||||
Proceeds
from exercise of stock options
|
179,000 | 15,000 | ||||||
Proceeds
from preferred stock issuances, net of costs
|
- | 2,444,000 | ||||||
Net
cash provided by financing activities
|
179,000 | 2,220,000 | ||||||
Net
decrease in cash and cash equivalents
|
(2,070,000 | ) | (6,668,000 | ) | ||||
Cash
and cash equivalents at beginning of year
|
2,677,000 | 9,345,000 | ||||||
Cash
and cash equivalents at end of year
|
$ | 607,000 | $ | 2,677,000 | ||||
Supplemental
cash flow information:
|
||||||||
Cash
paid for interest
|
$ | 1,000 | $ | 568,000 | ||||
Supplemental
disclosure of noncash transactions
|
||||||||
Shares
issued for payables, notes payable and accrued interest
|
859,000 | 1,576,000 | ||||||
Shares
issued for dividends on preferred stock
|
927,000 | 432,000 | ||||||
Warrants
issued for placement agent fees
|
- | 104,000 | ||||||
Preferred
stock dividends in dividends payable
|
1,886,000 | 3,358,000 | ||||||
Beneficial
conversion feature -
|
||||||||
February
2008 preferred stock dividends
|
- | 857,000 | ||||||
November
2007 preferred stock dividends
|
- | 451,000 | ||||||
Preferred
stock issuance costs paid in cash
|
- | 281,000 | ||||||
Debt
discount related to MacroChem convertible debt issuance
|
- | 93,000 |
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
|
|
Intangible
assets consist of the following (in
thousands):
|
December 31, 2009
|
December 31, 2008
|
|||||||||||||||
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
|||||||||||||
Amortizable
intangible
assets
- Patents
|
$ | 2,624 | $ | 1,837 | $ | 2,624 | $ | 1,625 |
2010
|
$ | 212 | ||
2011
|
212 | |||
2012
|
82 | |||
2013
|
44 | |||
2014
|
44 | |||
Thereafter
|
193 | |||
Total
|
$ | 787 |
2009
|
2008
|
|||
Expected
volatility assumption was based upon a combination of historical stock
price volatility measured on a weekly basis and is considered a reasonable
indicator of expected volatility.
|
115%
|
133%
|
||
Risk-free
interest rate assumption is based upon U.S. Treasury bond interest rates
appropriate for the term of the our employee stock options.
|
2.37%
|
2.97%
|
||
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 the simplified method
as prescribed by SAB 107/110 as we do not have sufficient information to
calculate an expected term.
|
5.5
years
|
6.2
years
|
Year
ended
December 31, 2009
|
Year
ended
December 31, 2008
|
|||||||
Research
and development
|
$ | 381 | $ | 108 | ||||
General
and administrative
|
430 | 814 | ||||||
Stock-based
compensation expense included in
operating
expense
|
811 | 922 | ||||||
Total
stock-based compensation expense
|
811 | 922 | ||||||
Tax
benefit
|
- | - | ||||||
Stock-based
compensation expense, net of tax
|
$ | 811 | $ | 922 | ||||
Fair
Value
|
|||||||||||||||||
of
exercisable
|
|||||||||||||||||
Consulting
|
Office
|
Expense
|
Options
/
|
||||||||||||||
Year
|
Fees
|
Expenses
|
Reimbursement
|
Warrants
|
|||||||||||||
2009
|
$ | 132,000 | $ | 18,000 | $ | 10,000 | $ | 86,000 | |||||||||
2008
|
$ | 320,000 | $ | 30,000 | $ | 71,000 | $ | 164,000 |
Consulting
|
Expense
|
||||||||
Year
|
Fees
|
Reimbursement
|
|||||||
2008
|
$ | 31,000 | $ | 3,000 |
Property
and equipment consists of the following:
|
December
31,
|
|||||||
2009
|
2008
|
|||||||
Laboratory
equipment
|
$ | 786,000 | $ | 831,000 | ||||
Laboratory
and building improvements
|
58,000 | 58,000 | ||||||
Furniture
and equipment
|
567,000 | 568,000 | ||||||
1,411,000 | 1,457,000 | |||||||
Less
accumulated depreciation and amortization
|
1,361,000 | 1,362,000 | ||||||
Net
property and equipment
|
$ | 50,000 | $ | 95,000 |
Future
|
|
|
Maturities
|
Debt
|
|
2011
|
5,500,000
|
·
|
Level
1 – Quoted prices in active markets for identical assets or
liabilities.
|
·
|
Level
2 – Observable inputs other than quoted prices included in Level 1, such
as quoted prices for similar assets and liabilities in active markets;
quoted prices for identical or similar assets and liabilities in markets
that are not active; or other inputs that are observable or can be
corroborated by observable market
data.
|
·
|
Level
3 – Unobservable inputs that are supported by little or no market activity
and that are significant to the fair value of the assets and liabilities.
This includes certain pricing models, discounted cash flow methodologies
and similar valuation techniques that use significant unobservable
inputs.
|
(in
thousands)
|
December
31, 2009
|
December
31, 2008
|
||||||||||||||||||||||
Level
1
|
Level
2
|
Total
|
Level
1
|
Level
2
|
Total
|
|||||||||||||||||||
Assets:
|
||||||||||||||||||||||||
Cash
|
$ | 607 | $ | - | $ | 607 | $ | 2,677 | $ | - | $ | 2,677 | ||||||||||||
Liabilities:
|
||||||||||||||||||||||||
Derivative
liability
|
$ | - | $ | 9,708 | $ | 9,708 | $ | - | $ | - | $ | - |
January 1, 2009
|
December 31, 2009
|
|||||||
Risk-free
interest rate
|
1.55 | % | 2.69 | % | ||||
Expected
volatility
|
116.31 | % | 117.43 | % | ||||
Expected
life (in years)
|
4.88 | 3.88 | ||||||
Dividend
yield
|
0.00 | % | 0.00 | % | ||||
Warrants
|
Exercise
|
Expiration
|
|||||||
Summary
of Warrants
|
Outstanding
|
Price
|
Date
|
||||||
2009
investor relations advisor (a)
|
30,000 | $ | 3.45 |
9/15/12
|
|||||
2009
business consultant (b)
|
150,000 | 2.07 |
7/23/14
|
||||||
2009
investor relations advisor (c)
|
50,000 | 6.00 |
8/27/12
|
||||||
2009
investor relations advisor (d)
|
60,000 | 1.85 |
7/14/12
|
||||||
2008
preferred stock offering (e)
|
499,584 | 3.50 |
2/24/14
|
||||||
2008
Somanta accounts payable (f)
|
246,753 | 3.50 |
1/04/14
|
||||||
2008
warrants assumed on acquisition (g)
|
191,991 | 18.55-69.57 |
6/9/10-1/31/12
|
||||||
2008
investor relations advisor (h)
|
50,000 | 3.15 |
1/3/13
|
||||||
2008
investor relations advisor (i)
|
40,000 | 3.00 |
9/1/13
|
||||||
2008
scientific consultant (j)
|
200,000 | 3.15 |
1/4/12
|
||||||
2007
preferred stock offering (k)
|
3,649,880 | 3.50 |
11/10/13
|
||||||
2006
convertible note (l)
|
3,853,634 | 1.32 |
2/16/12
|
||||||
2006
convertible note (l)
|
386,364 | 1.32 |
10/24/12
|
||||||
2006
convertible note (l)
|
377,273 | 1.32 |
12/06/12
|
||||||
2006
investor relations advisor (m)
|
50,000 | 2.70 |
12/27/11
|
||||||
Total
|
9,835,479 |
a)
|
During
2009, an investor relations advisor received warrants to purchase 30,000
shares of common stock at an exercise price of $3.45 per share at any time
until September 15, 2012, for investor relations consulting services
rendered from October 2009 through March 2010. 15,000 of the warrants were
exercisable on December 31, 2009 and 15,000 of the warrants will be
exercisable – 5,000 on January 31, 2010, 5,000 on February 28, 2010 and
5,000 on March 31, 2010. The fair value of the warrants was $1.55 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 1.43%, expected volatility 0.87% and a term of 3 years. The
expense recorded for the year ended December 31, 2009 was
$24,000.
|
b)
|
During
2009, a business consultant received warrants to purchase 150,000 shares
of common stock at an exercise price of $2.07 per share at any time until
July 23, 2014, for business consulting services rendered in 2009. 60,000
of the warrants were exercisable on December 31, 2009. The remaining
90,000 warrants may vest in 30,000 share increments with our stock price
reaching specified trading prices. The remaining warrants will expire July
23, 2010 if our stock does not reach these specified trading prices. The
expense recorded for the year ended December 31, 2009 was
$238,000.
|
c)
|
During
2009, an investor relations advisor received warrants to purchase 50,000
shares of common stock at an exercise price of $6.00 per share at any time
until August 27, 2012, for investor relations consulting services rendered
in 2009. All 50,000 of the warrants were exercisable at December 31, 2009.
The fair value of the warrants was $2.04 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 1.58%,
expected volatility 119% and a term of 3 years. The expense recorded for
the year ended December 31, 2009 was
$102,000.
|
d)
|
During
2009, an investor relations advisor received warrants to purchase 60,000
shares of common stock at an exercise price of $1.85 per share at any time
until July 14, 2012, for investor relations consulting services rendered
in 2009. All 60,000 of the warrants were exercisable on December 31, 2009.
The expense recorded for the year ended December 31, 2009 was
$233,000.
|
e)
|
In
connection with the preferred stock offering in February 2008, warrants to
purchase a total of 499,584 shares of common stock were issued. 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 the date of
the 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 a term of 6
years.
|
f)
|
In
connection with our acquisition of Somanta Pharmaceuticals, Inc. (Somanta)
we exchanged for $1,576,000 due to Somanta vendors, 538,508 shares of our
common stock and warrants to purchase 246,753 shares of common stock at
$3.50. The warrants expire January 4,
2014.
|
g)
|
We
assumed three warrants in the Somanta
acquisition:
|
-
|
Warrant#1
– 323 shares of our common stock at $69.57 per share and expires June 9,
2010.
|
-
|
Warrant
#2 – 31,943 shares of our common stock at $18.55 per share and expires
January 31, 2012.
|
-
|
Warrant
#3 – 159,725 shares of our common stock at $23.19 per share and expires
January 31, 2012.
|
h)
|
During
2008, an investor relations advisor received warrants to purchase 50,000
shares of common stock at an exercise price of $3.15 per share at any time
until January 3, 2013, for investor relations consulting services rendered
in 2008. 25,000 of the warrants were exercisable on July 3, 2008 and
25,000 of the warrants will be exercisable January 3, 2009. The fair value
of the warrants was $2.24 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 3.13%, expected volatility
127% and a term of 5 years.
|
i)
|
During
2008, an investor relations advisor received warrants to purchase 40,000
shares of common stock at an exercise price of $3.00 per share at any time
until September 1, 2013, for investor relations consulting services. All
of the warrants are exercisable. The fair value of the warrants was $2.61
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 2.37%, expected volatility 132% and a term of 5
years.
|
j)
|
During
2008, a director who is also a scientific advisor received warrants to
purchase 200,000 shares of common stock at an exercise price of $3.15 per
share at any time until January 4, 2012, for scientific consulting
services rendered in 2008. The warrants vest over two years in 50,000
share blocks with vesting on July 4, 2008, January 4, 2009, July 4, 2009
and the remaining shares on January 4, 2010. The fair value of the
warrants was $1.78 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 2.01%, expected volatility
92% and a term of 4 years.
|
k)
|
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 six 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 6
years.
|
l)
|
In
connection with the convertible note offerings in 2006, warrants to
purchase a total of 4,617,271 shares of common stock were issued. All of
the warrants are exercisable immediately and expire six years from date of
issue.
|
m)
|
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 rendered in 2007. All of the warrants are
exercisable.
|
Weighted-
|
||||||||
average
|
||||||||
exercise
|
||||||||
Options
|
price
|
|||||||
Outstanding
options at January 1, 2008
|
926,386 | $ | 1.59 | |||||
Granted,
fair value of $ 2.73 per share
|
305,000 | 3.00 | ||||||
Exercised
|
(25,250 | ) | 0.63 | |||||
Expired
|
(69,316 | ) | 3.17 | |||||
Outstanding
options at December 31, 2008
|
1,136,820 | 1.90 | ||||||
Granted,
fair value of $ 1.38 per share
|
565,000 | 1.38 | ||||||
Exercised
|
(249,916 | ) | 0.73 | |||||
Expired
|
(16,667 | ) | 3.00 | |||||
Outstanding
options at December 31, 2009
|
1,435,237 | 1.99 | ||||||
Exercisable at December 31, 2009 | 1,215,238 | 1.80 |
Number
of
|
Weighted
average
|
Number
of
|
Weighted-average
|
|||
options
|
Remaining
|
Exercise
|
options
|
Remaining
|
Exercise
|
|
Range
of exercise prices
|
outstanding
|
life in years
|
price
|
exercisable
|
life in years
|
price
|
$0.63
- 0.85
|
412,500
|
7.0
|
$0.64
|
412,500
|
7.0
|
$0.64
|
$1.38
|
460,000
|
10.0
|
$1.38
|
460,000
|
10.0
|
$1.38
|
$2.90
- 7.23
|
562,737
|
8.7
|
$3.47
|
342,738
|
8.2
|
$3.75
|
1,435,237
|
1,215,238
|
Weighted-
|
||||||||
average
|
||||||||
exercise
|
||||||||
Options
|
price
|
|||||||
Outstanding
options at January 1, 2008
|
162,417 | $ | 15.53 | |||||
Expired
|
(44,417 | ) | 16.57 | |||||
Outstanding
options at December 31, 2008
|
118,000 | 15.14 | ||||||
Expired
|
(15,000 | ) | 10.00 | |||||
Outstanding
options at December 31, 2009
|
103,000 | 15.89 | ||||||
Exercisable
at December 31, 2009
|
103,000 | 15.89 |
Number
of
|
Weighted
average
|
Number
of
|
Weighted-average
|
|||
options
|
Remaining
|
Exercise
|
options
|
Remaining
|
Exercise
|
|
Range
of exercise prices
|
outstanding
|
life in years
|
price
|
exercisable
|
life in years
|
price
|
$10.10
- 12.50
|
60,640
|
3.8
|
$11.74
|
60,640
|
3.8
|
$11.74
|
$14.05
- 18.65
|
22,800
|
2.8
|
$16.82
|
22,800
|
2.8
|
$16.82
|
$20.25
– 29.25
|
19,560
|
4.1
|
$26.58
|
19,560
|
4.1
|
$26.58
|
103,000
|
103,000
|
Access
Pharmaceuticals
|
MacroChem
Corporation
|
Combined
|
||||||||||
Current
assets
|
$ | 3,550,000 | $ | 84,000 | $ | 2,999,000 | ||||||
Total
assets
|
4,257,000 | 549,000 | 4,171,000 | |||||||||
Current
liabilities
|
4,906,000 | 3,346,000 | 7,612,000 | |||||||||
Long-term
deferred revenue
|
2,245,000 | 24,000 | 2,245,000 | |||||||||
Long-term
debt
|
5,500,000 | - | 5,500,000 | |||||||||
Stockholders’
deficit
|
(8,394,000 | ) | (2,925,000 | ) | (11,186,000 | ) |
For the year ended December 31,
2009
|
For the year ended December 31,
2008
|
|||||||||||||||||||||||
Access
Pharmaceuticals
|
MacroChem
Corporation
|
Combined
|
Access
Pharmaceuticals
|
MacroChem
Corporation
|
Combined
|
|||||||||||||||||||
Total
revenues
|
$ | 352,000 | $ | - | $ | 352,000 | $ | 291,000 | $ | - | $ | 291,000 | ||||||||||||
Expenses
|
||||||||||||||||||||||||
Research
and development
|
2,645,000 | 12,000 | 2,657,000 | 12,613,000 | 10,622,000 | 23,235,000 | ||||||||||||||||||
General
and administrative
|
6,932,000 | 180,000 | 7,112,000 | 4,340,000 | 3,123,000 | 7,463,000 | ||||||||||||||||||
Depreciation
and
amortization
|
207,000 | 52,000 | 259,000 | 253,000 | 71,000 | 324,000 | ||||||||||||||||||
Total
expenses
|
9,784,000 | 244,000 | 10,028,000 | 17,206,000 | 13,816,000 | 31,022,000 | ||||||||||||||||||
Loss
from operations
|
(9,432,000 | ) | (244,000 | ) | (9,676,000 | ) | (16,915,000 | ) | (13,816,000 | ) | (30,731,000 | ) | ||||||||||||
Interest
and miscellaneous
Income
|
29,000 | - | 29,000 | 178,000 | 33,000 | 211,000 | ||||||||||||||||||
Interest
and other expense
|
(513,000 | ) | (26,000 | ) | (539,000 | ) | ||||||||||||||||||
Change
in fair value of
derivative
|
(7,154,000 | ) | - | (7,154,000 | ) | (478,000 | ) | (433,000 | ) | (911,000 | ) | |||||||||||||
|
(7,638,000 | ) | (26,000 | ) | (7,664,000 | ) | (300,000 | ) | (400,000 | ) | (700,000 | ) | ||||||||||||
Loss
from operations
|
(17,070,000 | ) | (270,000 | ) | (17,340,000 | ) | (17,215,000 | ) | (14,216,000 | ) | (31,431,000 | ) | ||||||||||||
Less
preferred stock
Dividends
|
(1,886,000 | ) | - | (1,886,000 | ) | (3,358,000 | ) | - | (3,358,000 | ) | ||||||||||||||
Net
loss allocable to
common
stockholders
|
$ | (18,956,000 | ) | $ | (270,000 | ) | $ | (19,226,000 | ) | $ | (20,573,000 | ) | $ | (14,216,000 | ) | $ | (34,789,000 | ) | ||||||
Basic
and diluted loss per
common
share
|
||||||||||||||||||||||||
Net
loss allocable to
common
stockholders
|
- | - | $ | (1.63 | ) | - | - | $ | (4.16 | ) | ||||||||||||||
Weighted
average basic
and
diluted common
shares
outstanding
|
- | - | 11,818,530 | - | - | 8,354,031 |
·
|
Approximately
1.5 million shares of Access common stock were issued to the common and
preferred shareholders of Somanta as consideration having a value of
approximately $4,650,000 (the value was calculated using Access’ stock
price on January 4, 2008, times the number of shares
issued);
|
·
|
exchange
of all outstanding warrants for Somanta common stock for warrants to
purchase 191,991 shares of Access common stock at exercise prices ranging
between $18.55 and $69.57 per share. The warrants were valued at
approximately $281,000. All of the warrants are exercisable immediately
and expire approximately four years from date of issue. The weighted
average fair value of the warrants was $1.46 per share on the date of the
grant using the Black-Scholes pricing model with the following
assumptions: expected dividend yield 0.0%, risk-free interest rate 3.26%,
expected volatility 114% and an expected term of approximately 4
years;
|
·
|
paid
an aggregate of $475,000 in direct transaction costs;
and
|
·
|
cancelled
receivable from Somanta of
$931,000.
|
Cash
|
$ | 1 | ||
Prepaid
expenses
|
25 | |||
Office
equipment
|
14 | |||
Accounts
payable
|
(2,582 | ) | ||
In-process
research & development
|
8,879 | |||
$ | 6,337 |
Twelve
months ended
December
31, 2008
|
||||
Net
loss allocable to common stockholders
|
$ | (20,573 | ) | |
Net
loss per common shares (basic and diluted)
|
$ | (3.51 | ) | |
Weighted
average common shares outstanding
(basic and diluted)
|
5,854 |
Common
stock issued
|
6,870,000
|
||
Liabilities
assumed
|
2,404,000
|
||
Warrants
related to debt assumed
|
147,000
|
||
Transaction
costs
|
240,000
|
||
Total
purchase price
|
9,661,000
|
2008
|
||
(unaudited)
|
||
Net
income (loss)
|
(10,564,000)
|
|
Net
income (loss) per common share (basic and diluted)
|
(0.23)
|
|
Weighted
average common shares outstanding (basic and diluted)
|
45,754,492
|
2009
|
2008
|
|||||||
Income
taxes at U.S. statutory rate
|
$ | (6,537,000 | ) | $ | (10,477,000 | ) | ||
Change
in valuation allowance
|
5,182,000 | 6,987,000 | ||||||
Benefit
of foreign losses not recognized
|
57,000 | 59,000 | ||||||
Expenses
not deductible
|
623,000 | 2,874,000 | ||||||
Expiration
of net operating loss and general
|
||||||||
business
credit carryforwards, net of revisions
|
675,000 | 557,000 | ||||||
Total
tax expense
|
$ | - | $ | - |
December
31,
|
||||||||
2009
|
2008
|
|||||||
Deferred
tax assets
|
||||||||
Net
operating loss carryforwards
|
$ | 62,358,000 | $ | 59,939,000 | ||||
General
business credit carryforwards
|
2,371,000 | 2,472,000 | ||||||
State credits | 3,126,000 | 3,138,000 | ||||||
Property,
equipment and goodwill
|
51,000 | 54,000 | ||||||
Stock options | 773,000 | 497,000 | ||||||
Derivatives | 2,432,000 | - | ||||||
Deferred
revenue
|
748,000 | 324,000 | ||||||
Intangible assets | 383,000 | 383,000 | ||||||
Accrued interest | - | 253,000 | ||||||
Other
|
270,000 | 270,000 | ||||||
Gross
deferred tax assets
|
72,512,000 | 67,330,000 | ||||||
Valuation
allowance
|
(72,512,000 | ) | (67,330,000 | ) | ||||
Net
deferred taxes
|
$ | - | $ | - |
Net
operating
|
General
business
|
|||||||
loss
carryforwards
|
credit
carryforwards
|
|||||||
2010
|
$ | 2,171,000 | $ | 140,000 | ||||
2011
|
4,488,000 | 13,000 | ||||||
2012
|
4,212,000 | 77,000 | ||||||
2013
|
3,324,000 | 112,000 | ||||||
2014
|
3,306,000 | 95,000 | ||||||
Thereafter
|
165,903,000 | 1,934,000 | ||||||
$ | 183,404,000 | $ | 2,371,000 |
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 |
Number
|
Description of
Document
|
2.1
|
Amended
and Restated Agreement of Merger and Plan of Reorganization between the
Registrant and Chemex Pharmaceuticals, Inc., dated as of October 31, 1995
(Incorporated by reference to Exhibit A of our Registration
Statement on Form S-4 dated December 20, 1995, Commission File No.
33-64031)
|
2.2
|
Agreement
and Plan of Merger, by and among the Registrant, Somanta Acquisition
Corporation, Somanta Pharmaceuticals, Inc., Somanta Incorporated and
Somanta Limited, dated April 19, 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 the
Registrant, 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-K dated July 12, 1989, Commission File Number
9-9134)
|
3.2
|
Certificate
of Amendment of Certificate of Incorporation filed August 13, 1992
(Incorporated by reference to Exhibit 3.3 of our Form 10-K for year ended
December 31, 1995)
|
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 20, 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 20, 1995, Commission File No.
33-64031)
|
3.5
|
Certificate
of Amendment of Certificate of Incorporation filed July 18, 1996
(Incorporated by reference to Exhibit 3.7 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 2.1 of our Form
10-Q for the quarter ended June 30,
1996)
|
3.10
|
Certificate
of Designation, Rights and Preferences of Series A Cumulative Convertible
Preferred Stock filed November 9, 2007 (Incorporated by reference to
Exhibit 3.10 to our Form SB-2 filed on December 10,
2007.
|
3.11
|
Certificate
of Amendment to Certificate of Designations, Rights and Preferences of
Series A Cumulative Convertible Preferred Stock filed June 11, 2008
(Incorporated by reference to Exhibit 3.11 of our Form 10-Q for the
quarter ended June 30, 2008)
|
5.1
|
Opinion
of Bingham McCutchen LLP (Incorporated by reference to Exhibit 5.1 of our
Form S-1/A filed on October 8,
2008)
|
10.1*
|
1995
Stock Option Plan (Incorporated by reference to Exhibit F of our
Registration Statement on Form S-4 dated December 20, 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 the Registrant 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 Registrant dated November 19, 1996
(Incorporated by reference to Exhibit 10.9 of our Form 10-K for the year
ended December 31, 1996)
|
10.5*
|
401(k)
Plan (Incorporated by reference to Exhibit 10.20 of our Form 10-K for the
year ended December 31, 1999)
|
10.6
|
Form
of Convertible Note (Incorporated by reference to Exhibit 25 of our Form
10-Q for the quarter ended September 30,
2000)
|
10.7
|
Rights
Agreement dated as of October 31, 2001 between the Registrant 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 November
7, 2001)
|
10.8
|
Amendment
to Rights Agreement dated as of February 16, 2006 between the Registrant
and American Stock Transfer & Trust Company, as Rights Agent
(Incorporated by reference to Exhibit 10.33 of our Form 10-Q for the
quarter ended March 31, 2006)
|
10.9
|
Amendment
to Rights Agreement dated as of November 9, 2007 between the Registrant
and American Stock Transfer & Trust Company as Rights Agent
(incorporated by reference to Exhibit 10.9 of our Form 10-K for the year
ended December 31, 2009)
|
10.10*
|
2001
Restricted Stock Plan (Incorporated by reference to Exhibit 1 of our Proxy
Statement filed on April 16, 2001)
|
10.11*
|
2005
Equity Incentive Plan (Incorporated by reference to Exhibit 1 of our Proxy
Statement filed on April 18, 2005)
|
10.12
|
Asset
Sale Agreement dated as of October 12, 2005, between the Registrant and
Uluru, Inc. (Incorporated by reference to Exhibit 10.25 of our 10-K for
the year ended December 31, 2005)
|
10.13
|
Amendment
to Asset Sale Agreement dated as of December 8, 2006, between the
Registrant and Uluru, Inc. (Incorporated by reference to Exhibit 10.16 of
our Form 10-KSB filed on April 2,
2007)
|
10.14
|
License
Agreement dated as of October 12, 2005, between the Registrant and Uluru,
Inc. (Incorporated by reference to Exhibit 10.26 of our 10-K for the year
ended December 31, 2005)
|
10.15
|
Form
of Warrant dated February 16, 2006, issued by the Registrant to certain
Purchasers (Incorporated by reference to Exhibit 10.31 of our Form 10-Q
for the quarter ended March 31,
2006)
|
10.16
|
Form
of Warrant dated October 24, 2006, issued by the Registrant to certain
Purchasers (Incorporated by reference to Exhibit 10.27 of our Form 10-KSB
filed on April 2, 2007)
|
10.17
|
Form
of Warrant December 6, 2006, issued by the Registrant to certain
Purchasers (Incorporated by reference to Exhibit 10.32 of our Form 10-KSB
filed on April 2, 2007)
|
10.18*
|
2007
Special Stock Option Plan and Agreement dated January 4, 2007, by and
between the Registrant and Stephen R. Seiler, President and Chief
Executive Officer (Incorporated by reference to Exhibit 10.35 of our Form
10-QSB filed on May 15, 2007)
|
10.19
|
Note
Purchase Agreement dated April 26, 2007, between the Registrant and
Somanta Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.42
of our Form 10-Q filed on August 14,
2007)
|
10.20
|
Preferred
Stock and Warrant Purchase Agreement, dated November 7, 2007, between the
Registrant and certain Purchasers (Incorporated by reference to Exhibit
10.23 of our Form S-1 filed on March 11,
2008)
|
10.21
|
Investor
Rights Agreement dated November 10, 2007, between the Registrant and
certain Purchasers (Incorporated by reference to Exhibit 10.24 of our Form
S-1 filed on March 11, 2008)
|
10.22
|
Form
of Warrant Agreement dated November 10, 2007, between the Registrant and
certain Purchasers (Incorporated by reference to Exhibit 10.25 of our Form
S-1 filed on March 11, 2008)
|
10.23
|
Board
Designation Agreement dated November 15, 2007, between the Registrant and
SCO Capital Partners LLC (Incorporated by reference to Exhibit 10.26 of
our Form S-1 filed on March 11,
2008)
|
10.24
|
Amendment
and Restated Purchase Agreement, dated February 4, 2008 between the
Registrant and certain Purchasers (Incorporated by reference to Exhibit
10.27 of our Form S-1 filed on March 11,
2008)
|
10.25
|
Amended
and Restated Investor Rights Agreement, dated February 4, 2008, between
the Registrant and certain Purchasers (Incorporated by reference to
Exhibit 10.28 of our Form S-1 filed on March 11,
2008)
|
10.26*
|
Employment
Agreement dated January 4, 2008, between the Registrant and Jeffrey B.
Davis (Incorporated by reference to Exhibit 10.29 of our Form S-1 filed on
March 11, 2008)
|
10.27
|
Form
of Securities Purchase Agreement (Incorporated by reference to Exhibit
10.29 of our Form S-1 filed on January 15,
2010)
|
10.28
|
Form
of Warrant (Incorporated by reference to Exhibit 10.30 of our Form S-1
filed on January 15, 2010)
|
10.29*
|
Employment
Agreement of David P. Nowotnik, PhD (Incorporated by reference to Exhibit
10.31 of our Form 8-K February 8,
2010)
|
ACCESS
PHARMACEUTICALS, INC.
|
||||
Date
April 26, 2010
|
By:
|
/s/
Jeffrey B. Davis
|
||
Jeffrey
B. Davis
|
||||
Chief
Executive Officer
|
||||
(Principal
Executive Officer)
|
||||
Date
April 26, 2010
|
By:
|
/s/
Stephen B. Thompson
|
||
Stephen
B. Thompson
|
||||
Vice
President, Chief Financial
|
||||
Officer
and Treasurer
|
||||
(Principal
Accounting Officer)
|
Date
|
April
26, 2010
|
By:
|
/s/
Jeffrey B. Davis
|
|||||
Jeffrey
B. Davis, Director,
|
||||||||
Chief
Executive Officer
|
||||||||
Date
|
April
26, 2010
|
By:
|
* | |||||
Mark
J. Ahn, Director
|
||||||||
Date
|
April
26, 2010
|
By:
|
* | |||||
Mark
J. Alvino, Director
|
||||||||
Date
|
April
26, 2010
|
By:
|
* | |||||
Esteban
Cvitkovic, Director
|
||||||||
Date
|
April
26, 2010
|
By:
|
||||||
Stephen
B. Howell, Director
|
||||||||
Date
|
April
26, 2010
|
By:
|
* | |||||
Steven
H. Rouhandeh,
|
||||||||
Chairman
of the board
|
||||||||
Date
|
April
26, 2010
|
By:
|
/s/ Stephen B. Thompson
|
|||||
Stephen
B. Thompson
|
||||||||
Attorney-in-fact
|
Number
|
Description of
Document
|
Exhibit
Number
|
2.1
|
Amended
and Restated Agreement of Merger and Plan of Reorganization between the
Registrant and Chemex Pharmaceuticals, Inc., dated as of October 31, 1995
(Incorporated by reference to Exhibit A of our Registration
Statement on Form S-4 dated December 20, 1995, Commission File No.
33-64031)
|
2.2
|
Agreement
and Plan of Merger, by and among the Registrant, Somanta Acquisition
Corporation, Somanta Pharmaceuticals, Inc., Somanta Incorporated and
Somanta Limited, dated April 19, 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
the Registrant, 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-K dated July 12, 1989, Commission File Number
9-9134)
|
3.2
|
Certificate
of Amendment of Certificate of Incorporation filed August 13, 1992
(Incorporated by reference to Exhibit 3.3 of our Form 10-K for year ended
December 31, 1995)
|
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 20, 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 20, 1995, Commission File No.
33-64031)
|
3.5
|
Certificate
of Amendment of Certificate of Incorporation filed July 18, 1996
(Incorporated by reference to Exhibit 3.7 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 2.1 of our Form
10-Q for the quarter ended June 30,
1996)
|
3.10
|
Certificate
of Designation, Rights and Preferences of Series A Cumulative Convertible
Preferred Stock filed November 9, 2007 (Incorporated by reference to
Exhibit 3.10 to our Form SB-2 filed on December 10,
2007.
|
3.11
|
Certificate
of Amendment to Certificate of Designations, Rights and Preferences of
Series A Cumulative Convertible Preferred Stock filed June 11, 2008
(Incorporated by reference to Exhibit 3.11 of our Form 10-Q for the
quarter ended June 30, 2008)
|
5.1
|
Opinion
of Bingham McCutchen LLP (Incorporated by reference to Exhibit 5.1 of our
Form S-1/A filed on October 8,
2008)
|
10.1*
|
1995
Stock Option Plan (Incorporated by reference to Exhibit F of our
Registration Statement on Form S-4 dated December 20, 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 the Registrant 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 Registrant dated November 19, 1996
(Incorporated by reference to Exhibit 10.9 of our Form 10-K for the year
ended December 31, 1996)
|
10.5*
|
401(k)
Plan (Incorporated by reference to Exhibit 10.20 of our Form 10-K for the
year ended December 31, 1999)
|
10.6
|
Form
of Convertible Note (Incorporated by reference to Exhibit 25 of our Form
10-Q for the quarter ended September 30,
2000)
|
10.7
|
Rights
Agreement dated as of October 31, 2001 between the Registrant 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 November
7, 2001)
|
10.8
|
Amendment
to Rights Agreement dated as of February 16, 2006 between the Registrant
and American Stock Transfer & Trust Company, as Rights Agent
(Incorporated by reference to Exhibit 10.33 of our Form 10-Q for the
quarter ended March 31, 2006)
|
10.9
|
Amendment
to Rights Agreement dated as of November 9, 2007 between the Registrant
and American Stock Transfer & Trust Company as Rights
Agent (incorporated by reference to Exhibit 10.9 of our Form
10-K for the year ended December 31,
2009)
|
10.10*
|
2001
Restricted Stock Plan (Incorporated by reference to Exhibit 1 of our Proxy
Statement filed on April 16, 2001)
|
10.11*
|
2005
Equity Incentive Plan (Incorporated by reference to Exhibit 1 of our Proxy
Statement filed on April 18, 2005)
|
10.12
|
Asset
Sale Agreement dated as of October 12, 2005, between the Registrant and
Uluru, Inc. (Incorporated by reference to Exhibit 10.25 of our 10-K for
the year ended December 31, 2005)
|
10.13
|
Amendment
to Asset Sale Agreement dated as of December 8, 2006, between the
Registrant and Uluru, Inc. (Incorporated by reference to Exhibit 10.16 of
our Form 10-KSB filed on April 2,
2007)
|
10.14
|
License
Agreement dated as of October 12, 2005, between the Registrant and Uluru,
Inc. (Incorporated by reference to Exhibit 10.26 of our 10-K for the year
ended December 31, 2005)
|
10.15
|
Form
of Warrant dated February 16, 2006, issued by the Registrant to certain
Purchasers (Incorporated by reference to Exhibit 10.31 of our Form 10-Q
for the quarter ended March 31,
2006)
|
10.16
|
Form
of Warrant dated October 24, 2006, issued by the Registrant to certain
Purchasers (Incorporated by reference to Exhibit 10.27 of our Form 10-KSB
filed on April 2, 2007)
|
10.17
|
Form
of Warrant December 6, 2006, issued by the Registrant to certain
Purchasers (Incorporated by reference to Exhibit 10.32 of our Form 10-KSB
filed on April 2, 2007)
|
10.18*
|
2007
Special Stock Option Plan and Agreement dated January 4, 2007, by and
between the Registrant and Stephen R. Seiler, President and Chief
Executive Officer (Incorporated by reference to Exhibit 10.35 of our Form
10-QSB filed on May 15, 2007)
|
10.19
|
Note
Purchase Agreement dated April 26, 2007, between the Registrant and
Somanta Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.42
of our Form 10-Q filed on August 14,
2007)
|
10.20
|
Preferred
Stock and Warrant Purchase Agreement, dated November 7, 2007, between the
Registrant and certain Purchasers (Incorporated by reference to Exhibit
10.23 of our Form S-1 filed on March 11,
2008)
|
10.21
|
Investor
Rights Agreement dated November 10, 2007, between the Registrant and
certain Purchasers (Incorporated by reference to Exhibit 10.24 of our Form
S-1 filed on March 11, 2008)
|
10.22
|
Form
of Warrant Agreement dated November 10, 2007, between the Registrant and
certain Purchasers (Incorporated by reference to Exhibit 10.25 of our Form
S-1 filed on March 11, 2008)
|
10.23
|
Board
Designation Agreement dated November 15, 2007, between the Registrant and
SCO Capital Partners LLC (Incorporated by reference to Exhibit 10.26 of
our Form S-1 filed on March 11,
2008)
|
10.24
|
Amendment
and Restated Purchase Agreement, dated February 4, 2008 between the
Registrant and certain Purchasers (Incorporated by reference to Exhibit
10.27 of our Form S-1 filed on March 11,
2008)
|
10.25
|
Amended
and Restated Investor Rights Agreement, dated February 4, 2008, between
the Registrant and certain Purchasers (Incorporated by reference to
Exhibit 10.28 of our Form S-1 filed on March 11,
2008)
|
10.26*
|
Employment
Agreement dated January 4, 2008, between the Registrant and Jeffrey B.
Davis (Incorporated by reference to Exhibit 10.29 of our Form S-1 filed on
March 11, 2008)
|
10.27
|
Form
of Securities Purchase Agreement (Incorporated by reference to Exhibit
10.29 of our Form S-1 filed on January 15,
2010)
|
10.28
|
Form
of Warrant (Incorporated by reference to Exhibit 10.30 of our Form S-1
filed on January 15, 2010)
|
10.29*
|
Employment
Agreement of David P. Nowotnik, PhD (Incorporated by reference to Exhibit
10.31 of our Form 8-K February 8,
2010)
|
23.2
|
Consent
of Bingham McCutchen (included in Exhibit
5.1)
|