Delaware | 3841 | 83-0221517 | ||
(State
or other jurisdiction of
incorporation
or organization)
|
(Primary
Standard Industrial
Classification
Code Number)
|
(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
|
Proposed
maximum
aggregate offering price
|
Amount
of
registration
fee(1)
|
|||||
Units,
each unit consisting of ___ share of Common Stock, $0.01 par value, and
warrants to purchase ___ share of Common Stock
|
$
|
25,000,000
|
$
|
1,782.50
|
|
||
Common
Stock included in the Units
|
$
|
—
|
$
|
—
|
|
||
Warrants
included in the Units
|
$
|
—
|
—
|
(3)
|
|||
Common
Stock issuable upon exercise of the warrants included in the Units
(2)
|
$
|
—
|
—
|
(3)
|
|||
Warrants
issued to placement agent
|
$
|
—
|
—
|
(3)
|
|||
Common
Stock issuable upon exercise of placement agent warrants
|
$
|
—
|
—
|
(3)
|
|||
Series
A Junior Participating Preferred Stock Purchase Rights (4)
|
|||||||
Total
|
$
|
25,000,000
|
$
|
1,782.50
|
(5)
|
INFORMATION CONTAINED HEREIN IS
SUBJECT TO COMPLETION OR AMENDMENT. A REGISTRATION STATEMENT RELATING TO
THESE SECURITIES HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION. THESE SECURITIES MAY NOT BE SOLD UNTIL THE REGISTRATION
STATEMENT BECOMES EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL AND
IS NOT A SOLICITATION OF AN OFFER TO BUY IN ANY STATE IN WHICH AN OFFER,
SOLICITATION, OR SALE IS NOT
PERMITTED.
|
Per Unit | Total | ||
Offering Price per Unit | $ | $ | |
Placement Agent’s Fees | $ | $ | |
Offering Proceeds before expenses | $ | $ |
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
|
16
|
USE
OF PROCEEDS
|
17
|
DILUTION
|
18
|
PRICE
RANGE OF OUR COMMON STOCK
|
19
|
DIVIDEND
POLICY
|
21
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
|
|
RESULTS
OF OPERATIONS
|
22
|
DESCRIPTION
OF BUSINESS
|
33
|
DESCRIPTION
OF PROPERTY
|
48
|
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
|
49
|
LEGAL
PROCEEDINGS
|
57
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
|
57
|
TRANSACTIONS
WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL PERSONS
59
|
59
|
DESCRIPTION
OF SECURITIES
|
61
|
PLAN
OF DISTRIBUTION
|
65
|
EXPERTS
|
67
|
LEGAL
MATTERS
|
67
|
WHERE
YOU CAN FIND MORE INFORMATION
|
67
|
FINANCIAL
STATEMENTS
|
F-1
|
·
|
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 finished as we expect to launch
MuGard in North America during the third quarter of 2010. We are working
with our partners in Korea and China for registration and
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 have
initiated 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.
|
Securities
offered:
|
Up
to ___ units. Each unit will consist of __ shares of our common stock and
warrants to purchase up to an additional __ shares of our common stock.
Units may be issued and sold in one or more closings up to the termination
date .
|
Offering
Price:
|
$_____
per unit.
|
Description
of Warrants:
|
The
warrants will be exercisable at any time during the period commencing six
months after the date of closing and ending on the fifth anniversary of
the closing date at an exercise price of $__ per share. We and the
placement agent may, upon request of any investor in this offering, sell
units to such investors that exclude the warrants, provided that the sale
of units that exclude such warrants shall be at the same offering price
per unit as all other
investors. .
|
Common
stock outstanding prior to the offering:
|
__________
shares.
|
Common
stock outstanding after the offering:
|
__________
shares, which does not include ________ shares of common stock issuable
upon exercise of the warrants included in the offered units or the shares
of common stock issuable upon the exercise of the placement agent
warrants.
|
Over-allotment
option:
|
The
placement agent will have a 30-day option to arrange for the sale of up to
an additional __________ units (consisting of ___ shares and warrants to
purchase ____ shares of common stock) to cover
over-allotments.
|
Use
of proceeds:
|
We
expect to use the proceeds received from the offering to further develop
our products and product candidates and for general working capital
purposes.
|
OTC
BB Symbol:
|
ACCP.OB
|
Risk
Factors:
|
See
“Risk Factors” beginning on page 6 and the other information in this
prospectus for a discussion of the factors you should consider before you
decide to invest in the units.
|
·
|
3,208,971
shares of common stock reserved for future issuance under our equity
incentive plans. As of August 23, 2010, there were options to
purchase 1,883,617 shares of our common stock outstanding under our equity
incentive plans with a weighted average exercise price of $2.62 per
share;
|
·
|
10,966,243
shares of common stock issuable upon exercise of outstanding warrants as
of August 23, 2010 with exercise prices ranging from $1.32 per
share to $23.19 per share;
and
|
·
|
_______
shares of common stock that will be issued upon exercise of warrants at an
exercise price of $____ per share sold as part of the units in this
offering.
|
·
|
9,951,198
shares of our common stock initially issuable upon conversion of Series A
Cumulative Convertible Preferred Stock, subject to adjustment;
and
|
·
|
the
conversion of our currently outstanding Convertible
Note.
|
(in thousands, except per share
amounts)
|
For the Six Months
Ended
June 30,
|
For the Year
Ended
December 31,
|
||||||
2010
|
2009
|
2009
|
2008
|
|||||
Consolidated
Statement of Operations:
|
||||||||
Total
revenues
|
$ |
207
|
$ |
104
|
$ |
352
|
$ |
291
|
Loss
from operations
|
(3,583)
|
(4,051)
|
(9,676)
|
(30,731)
|
||||
Interest
and miscellaneous income
|
516
|
16
|
29
|
211
|
||||
Interest
and other expense
|
(292)
|
(262)
|
(539)
|
(911)
|
||||
Gain
(loss) on change in fair value of
derivative
|
6,238
|
-
|
(7,154)
|
-
|
||||
Net
income (loss)
|
2,879
|
(4,297)
|
(17,340)
|
(31,431)
|
||||
Preferred
stock dividends
|
(888)
|
(963)
|
(1,886)
|
(3,358)
|
||||
Net
income (loss) allocable to common
Stockholders
|
$
|
1,991
|
$
|
(5,260)
|
$
|
(19,226)
|
$
|
(34,789)
|
Common
Stock Data:
|
||||||||
Net
income (loss) per share
Basic
Diluted
|
$
|
0.13
0.11
|
$
|
(0.48)
(0.48)
|
$
|
(1.63)
(1.63)
|
$
|
(4.16)
(4.16)
|
Weighted
average of number common
shares
outstanding
Basic
Diluted
|
15,115
27,825
|
10,954
10,954
|
11,819
11,819
|
8,354
8,354
|
||||
June 30,
|
December 31,
|
|||||||
2010
|
2009
|
2009
|
2008
|
|||||
Consolidated
Balance Sheet Data:
|
||||||||
Cash
and cash equivalents
|
$ |
2,758
|
$ |
1,231
|
$ |
607
|
$ |
2,677
|
Total
assets
|
3,625
|
2,351
|
1,583
|
4,171
|
||||
Deferred
revenue
|
4,903
|
3,789
|
5,077
|
2,409
|
||||
Notes
payable
|
-
|
-
|
-
|
825
|
||||
Derivative
liability
|
3,470
|
-
|
9,708
|
-
|
||||
Convertible
notes
|
5,500
|
5,500
|
5,500
|
5,500
|
||||
Total
liabilities
|
21,604
|
16,177
|
28,572
|
15,357
|
||||
Total
stockholders' deficit
|
(17,979)
|
(13,826)
|
(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.
|
·
|
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.
|
We
will have immediate and broad discretion over the use of the net proceeds
from this offering.
|
·
|
3,208,971
shares of common stock reserved for future issuance under our equity
incentive plans. As of August 23, 2010, there were 1,883,617
options outstanding under our equity incentive plans with a weighted
average exercise price of $2.62 per
share;
|
·
|
10,966,243
shares of common stock issuable upon exercise of outstanding warrants as
of August 23, 2010, with exercise prices ranging from $1.32 per share to
$23.19 per share;
|
·
|
________
shares of common stock that will be issued upon exercise of warrants at an
exercise price of $____ per share sold as part of the units in this
offering; and
|
·
|
the
conversion of our currently outstanding Convertible
Note.
|
Common
Stock
|
||
High
|
Low
|
|
Fiscal Year 2010 Year-to
date
|
||
First
quarter
|
$ 3.29
|
$ 2.44
|
Second
quarter
|
2.80
|
1.96
|
Third
quarter (through August 23, 2010)
|
2.15
|
1.80
|
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
|
1,820,117
|
$ |
2.12
|
2,758,971
|
|||||
1995
Stock Awards Plan
|
63,500
|
16.79
|
-
|
||||||
2001
Restricted Stock Plan
|
-
|
-
|
52,818
|
||||||
Equity
compensation plans
|
|||||||||
not
approved by security
|
|||||||||
holders:
|
|||||||||
2007
Special Stock Option Plan
|
-
|
-
|
450,000
|
||||||
Total
|
1,883,617
|
$ |
2.62
|
3,261,789
|
·
|
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 finished as we expect to launch
MuGard in North America during the third quarter of 2010. We are working
with our partners in Korea and China for registration and
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 have
initiated 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
|
·
|
increased
stock compensation expense due to the calculated expense of options grants
($193,000);
|
·
|
increased
salary and related costs due to employees at full salary in the second
quarter of 2010 while employees were paid at a reduced salary in June 2009
($31,000);
|
·
|
other
net increases in research spending
($50,000);
|
·
|
offset
by lower costs for product manufacturing for ProLindac which were higher
in 2009 ($51,000);
|
·
|
offset
also by lower costs for clinical development ($36,000);
and
|
·
|
offset
by lower scientific consulting expenses
($36,000).
|
·
|
lower
general business consulting expenses due to reduction in use of outside
consultants ($295,000);
|
·
|
lower
license fees due to the termination of a license that was previously
accrued ($200,000);
|
·
|
lower
potential liquidated damages under an investor rights agreement with
certain investors ($159,000);
|
·
|
lower
general and administrative expenses incurred by MacroChem in
2010 ($57,000);
|
·
|
other
net decreases in other general and administrative expenses
($51,000);
|
·
|
offset
by higher investor relations expenses ($374,000);
and
|
·
|
offset
by higher salary and related costs due to the addition of two new
employees and due to existing employees at full salary in the second
quarter of 2010 while employees were paid at a reduced salary in June 2009
($134,000).
|
·
|
increased
stock compensation expense due to the calculated expense of options grants
($230,000);
|
·
|
increased
salary and related costs ($65,000);
|
·
|
increased
costs for our internal lab costs for various projects
($54,000);
|
·
|
increased
costs for our external lab costs for various projects
($41,000);
|
·
|
increased
costs for clinical development as we prepared to start our new ProLindac
combination therapy clinical
trial ($44,000);
|
·
|
other
net increases in research spending
($32,000);
|
·
|
offset
by lower costs for product manufacturing for ProLindac which were higher
in 2009 ($116,000); and
|
·
|
offset
by lower scientific consulting expenses
($100,000).
|
·
|
lower
general business consulting expenses due to reduction in use of outside
consultants ($405,000);
|
·
|
lower
potential liquidated damages under an investor rights agreement with
certain investors ($317,000);
|
·
|
lower
license fees due to the termination of a license that was previously
accrued ($200,000);
|
·
|
lower
general and administrative expenses incurred by MacroChem in
2010 ($196,000);
|
·
|
net
decreases in other general and administrative expenses
($26,000);
|
·
|
offset
by higher investor relations expenses ($395,000);
and
|
·
|
offset
by higher salary and related costs due to the addition of two new
employees ($146,000).
|
·
|
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 finished as we expect to launch
MuGard in North America during the third quarter of 2010. We are working
with our partners in Korea and China for registration and
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 have
initiated 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
|
·
|
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
|
•
|
American
Pharmaceutical 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.
|
48
|
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
|
52
|
Vice
President, Business Development & Strategy
|
|
Stephen
B. Thompson
|
57
|
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
|
$
|
175,67
5
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 board fees or
options. 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. Mr.
Davis has options to purchase 25,000 shares of our Common Stock at
December 31, 2009.
|
||
(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
expense recognized in 2009 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. Also represents expense recognized in 2009 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. Includes $83,000 Mr. Luci received for
business consulting services to Access 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)
|
6,000
|
*
|
-
|
*
|
6,000
|
*
|
||||||||
Esteban
Cvitkovic, M.D. (6)
|
356,000
|
2.2%
|
-
|
*
|
356,000
|
1.4%
|
||||||||
Stephen
B. Howell, M.D. (7)
|
118,422
|
*
|
-
|
*
|
118,422
|
*
|
||||||||
David
P. Nowotnik, Ph.D. (8)
|
252,726
|
1.6%
|
-
|
*
|
252,726
|
*
|
||||||||
Phillip
S. Wise (9)
|
130,210
|
*
|
-
|
*
|
130,210
|
*
|
||||||||
SCO
Capital Partners LLC, SCO Capital Partners LP, and Beach Capital LLC (10)
|
9,535,087
|
43.9%
|
7,077,100
|
71.3%
|
16,612,187
|
52.4%
|
||||||||
Larry
N. Feinberg (11)
|
1,222,443
|
7.5%
|
1,457,699
|
14.7%
|
2,680,142
|
10.2%
|
||||||||
Lake
End Capital LLC (12)
|
1,059,601
|
6.5%
|
793,067
|
8.0%
|
1,852,668
|
7.0%
|
||||||||
All
Directors and Executive
Officers
as a group
(consisting
of 8 persons) (13)
|
965,358
|
5.8%
|
-
|
*
|
965,358
|
3.6%
|
(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 August __,
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.
|
(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
11,500 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 205,210
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 130,210 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.
|
Year
|
Consulting
Fees
|
Office
Expenses
|
Expense
Reimbursement
|
Fair
Value
of exercisable
Options /
Warrants
|
||||
2009 | $ 132,000 |
$ 18,000
|
$ 10,000 | $ 86,000 | ||||
2008 | $ 320,000 | $ 30,000 | $ 71,000 | $ 164,000 |
Year |
Consulting
Fees
|
Expense
Reimbursement
|
||
2008 | $ 31,000 | $ 3,000 |
·
|
to
legal entities which are authorized or regulated to operate in the
financial markets or, if not so authorized or regulated, whose corporate
purpose is solely to invest in
securities;
|
·
|
to
any legal entity which has two or more of (1) an average of at least 250
employees during the last financial year; (2) a total balance sheet of
more than 43,000,000 euros; and (3) an annual net turnover of more than
50,000,000 euros, as shown in the last annual or consolidated accounts;
or
|
·
|
in
any other circumstances which do not require the publication by the Issuer
of a prospectus pursuant to Article 3 of the Prospectus
Directive.
|
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
|
Condensed
Consolidated Balance Sheets at June 30, 2010 (unaudited)
|
F-27
|
Condensed
Consolidated Statements of Operations for June 30, 2010 and 2009
(unaudited)
|
F-28
|
Condensed
Consolidated Statements of Stockholders’ Deficit for June 30, 2010
(unaudited)
|
F-29
|
Condensed
Consolidated Statements of Cash Flows for June 30, 2010 and 2009
(unaudited)
|
F-30
|
Notes
to Condensed Consolidated Financial Statements (Three and Six Months Ended
June 30, 2010 and 2009) (unaudited)
|
F-31
|
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:
|
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 |
|
June 30, 2010
|
December 31, 2009
|
|
ASSETS |
(unaudited)
|
||
Current
assets
Cash and cash
equivalents
Receivables
Prepaid expenses and other
current assets
|
$ 2,758,000
38,000
52,000
|
$ 607,000
36,000
42,000
|
|
Total current assets | 2,848,000 | 685,000 | |
Property
and equipment, net
|
44,000
|
50,000
|
|
Patents,
net
|
681,000
|
787,000
|
|
Other
assets
|
52,000
|
61,000
|
|
Total
assets
|
$ 3,625,000
|
$ 1,583,000
|
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||
Current
liabilities
Accounts
payable
Accrued
expenses
Dividends
payable
Accrued
interest payable
Current
portion of deferred revenue
|
$ 2,988,000
857,000
3,548,000
338,000
347,000
|
$ 4,094,000
857,000
2,773,000
563,000
347,000
|
|
Total current liabilities |
8,078,000
|
8,634,000
|
|
Derivative
liability
Long-term
deferred revenue
Long-term
debt
|
3,470,000
4,556,000
5,500,000
|
9,708,000
4,730,000
5,500,000
|
|
Total
liabilities
|
21,604,000
|
28,572,000
|
|
Commitments
and contingencies
|
|||
Stockholders'
deficit
Convertible
Series A preferred stock - $.01 par value; authorized
2,000,000
shares; 2,985.3617 shares issued at June 30, 2010
and
2,992.3617 shares issued at December 31, 2009
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
15,672,284 at June 30, 2010 and 13,171,545 at
December
31, 2009
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost – 163 shares
Accumulated
deficit
|
-
157,000
222,729,000
(1,045,000)
(4,000)
(239,816,000)
|
-
132,000
215,735,000
(1,045,000)
(4,000)
(241,807,000)
|
|
Total stockholders' deficit |
(17,979,000)
|
(26,989,000)
|
|
Total liabilities and
stockholders' deficit
|
$ 3,625,000
|
$ 1,583,000
|
Three
months ended
June 30,
|
Six
months ended
June 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Revenues
|
||||||||||||||||
License
revenues
|
$ | 87,000 | $ | 63,000 | $ | 174,000 | $ | 104,000 | ||||||||
Royalties
|
18,000 | - | 33,000 | - | ||||||||||||
Total revenues
|
105,000 | 63,000 | 207,000 | 104,000 | ||||||||||||
Expenses
|
||||||||||||||||
Research and
development
|
733,000 | 582,000 | 1,519,000 | 1,269,000 | ||||||||||||
General and
administrative
|
1,253,000 | 1,507,000 | 2,151,000 | 2,754,000 | ||||||||||||
Depreciation and
amortization
|
59,000 | 66,000 | 120,000 | 132,000 | ||||||||||||
Total expenses
|
2,045,000 | 2,155,000 | 3,790,000 | 4,155,000 | ||||||||||||
Loss
from operations
|
(1,940,000 | ) | (2,092,000 | ) | (3,583,000 | ) | (4,051,000 | ) | ||||||||
Interest
and miscellaneous income
|
512,000 | 2,000 | 516,000 | 16,000 | ||||||||||||
Interest
and other expense
|
(143,000 | ) | (118,000 | ) | (292,000 | ) | (262,000 | ) | ||||||||
Gain
on change in fair value of derivative
|
3,361,000 | - | 6,238,000 | - | ||||||||||||
3,730,000 | (116,000 | ) | 6,462,000 | (246,000 | ) | |||||||||||
Net
income (loss)
|
1,790,000 | (2,208,000 | ) | 2,879,000 | (4,297,000 | ) | ||||||||||
Less
preferred stock dividends
|
446,000 | 483,000 | 888,000 | 963,000 | ||||||||||||
Net
income (loss) allocable to
common
stockholders
|
$ | 1,344,000 | $ | (2,691,000 | ) | $ | 1,991,000 | $ | (5,260,000 | ) | ||||||
Net
income (loss) per share
|
||||||||||||||||
Basic
|
$ | 0.09 | $ | (0.24 | ) | $ | 0.13 | $ | (0.48 | ) | ||||||
Diluted
|
$ | 0.07 | $ | (0.24 | ) | $ | 0.11 | $ | (0.48 | ) | ||||||
Weighted
average basic and diluted
common shares
outstanding
|
||||||||||||||||
Basic
|
15,460,072 | 11,406,700 | 15,115,424 | 10,954,472 | ||||||||||||
Diluted
|
27,937,880 | 11,406,700 | 27,824,943 | 10,954,472 | ||||||||||||
Common Stock
|
Preferred Stock
|
|||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Additional
paid-in
capital
|
Notes
receivable from stockholders
|
Treasury
stock
|
Accumulated
deficit
|
|||||||||||||||||||||||||
Balance
December 31, 2009
|
13,172,000 | $ | 132,000 | 2,992.3617 | $ | - | $ | 215,735,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (241,807,000 | ) | |||||||||||||||
Restricted
common
stock
issued for services
|
73,000 | 1,000 | - | - | 17,000 | - | - | - | ||||||||||||||||||||||||
Warrants
issued for
services
|
- | - | - | - | 19,000 | - | - | - | ||||||||||||||||||||||||
Preferred
stock
converted
into common
stock
|
23,000 | - | (7.0000 | ) | - | - | - | - | - | |||||||||||||||||||||||
Stock
option
compensation
expense
|
- | - | - | - | 114,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued
for
cash exercise of
options
|
10,000 | - | - | - | 14,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued
for
cashless warrant
exercise
|
20,000 | - | - | - | - | - | - | - | ||||||||||||||||||||||||
Common
stock issued
$3.00
share, net of costs
|
2,083,000 | 21,000 | - | - | 5,827,000 | - | - | - | ||||||||||||||||||||||||
Preferred
dividends
|
- | - | - | - | - | - | - | (442,000 | ) | |||||||||||||||||||||||
Net
income
|
- | - | - | - | - | - | - | 1,089,000 | ||||||||||||||||||||||||
Balance
at March 31,
2010
|
15,381,000 | 154,000 | 2,985.3617 | - | 221,726,000 | (1,045,000 | ) | (4,000 | ) | (241,160,000 | ) | |||||||||||||||||||||
Restricted
common
stock
issued for services
|
106,000 | 1,000 | - | - | 248,000 | - | - | - | ||||||||||||||||||||||||
Stock
option
compensation
expense
|
- | - | - | - | 440,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued
for
cash exercise of
options
|
105,000 | 1,000 | - | - | 125,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued
for
preferred dividends
|
80,000 | 1,000 | - | - | 190,000 | - | - | - | ||||||||||||||||||||||||
Preferred
dividends
|
- | - | - | - | - | - | - | (446,000 | ) | |||||||||||||||||||||||
Net
income
|
- | - | - | - | - | - | - | 1,790,000 | ||||||||||||||||||||||||
Balance
at June 30,
2010
|
15,672,000 | $ | 157,000 | 2,985.3617 | $ | - | $ | 222,729,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (239,816,000 | ) | |||||||||||||||
Six Months ended June
30,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
income (loss)
|
$ | 2,879,000 | $ | (4,297,000 | ) | |||
Adjustments to
reconcile net income (loss) to cash used
in
operating activities:
|
||||||||
Gain on change in fair value of
derivative
|
(6,238,000 | ) | - | |||||
Gain on negotiated accounts payable | (509,000 | ) | - | |||||
Depreciation and
amortization
|
120,000 | 132,000 | ||||||
Stock option compensation
expense
|
554,000 | 308,000 | ||||||
Stock and warrants issued for
services
|
286,000 | 564,000 | ||||||
Change in operating assets and
liabilities:
|
||||||||
Receivables
|
(2,000 | ) | 132,000 | |||||
Prepaid expenses and other current assets
|
(10,000 | ) | 117,000 | |||||
Other assets
|
9,000 | 53,000 | ||||||
Accounts payable and accrued
expenses
|
(597,000 | ) | 60,000 | |||||
Dividends
payable
|
78,000 | (137,000 | ) | |||||
Accrued interest
payable
|
(225,000 | ) | 229,000 | |||||
Deferred
revenue
|
(174,000 | ) | 1,380,000 | |||||
Net cash used in operating
activities
|
(3,829,000 | ) | (1,459,000 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Capital
expenditures
|
(8,000 | ) | (2,000 | ) | ||||
Proceeds from sale of
asset
|
- | 1,000 | ||||||
Net cash used in investing
activities
|
(8,000 | ) | (1,000 | ) | ||||
Cash
flows from financing activities:
|
||||||||
Proceeds from exercise of
stock options
|
140,000 | 14,000 | ||||||
Proceeds
from common stock issuances, net of costs
|
5,848,000 | - | ||||||
Net cash provided by financing
activities
|
5,988,000 | 14,000 | ||||||
Net
decrease in cash and cash equivalents
|
(2,151,000 | ) | (1,446,000 | ) | ||||
Cash
and cash equivalents at beginning of period
|
607,000 | 2,677,000 | ||||||
Cash
and cash equivalents at end of period
|
$ | 2,758,000 | $ | 1,231,000 | ||||
Supplemental
cash flow information:
|
||||||||
Cash
paid for interest
|
$ | 440,000 | $ | - | ||||
Supplemental
disclosure of noncash transactions:
|
||||||||
Shares issued for payables,
notes payable and accrued interest
|
- | 859,000 | ||||||
Shares issued for dividends on
preferred stock
|
191,000 | 856,000 | ||||||
Preferred
stock dividends in dividends payable
|
888,000 | 963,000 | ||||||
June
30, 2010
|
December
31, 2009
|
|||||||||||||||
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
Amortization
|
|||||||||||||
Amortizable
intangible assets
Patents
|
$ | 2,624 | $ | 1,943 | $ | 2,624 | $ | 1,837 | ||||||||
·
|
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)
|
June
30, 2010
|
December
31, 2009
|
||||||||||||||||||||||
Level
1
|
Level
2
|
Total
|
Level
1
|
Level
2
|
Total
|
|||||||||||||||||||
Assets:
|
||||||||||||||||||||||||
Cash
|
$ | 2,758 | $ | - | $ | 2,758 | $ | 607 | $ | - | $ | 607 | ||||||||||||
Liabilities:
|
||||||||||||||||||||||||
Derivative
liability
|
$ | - | $ | 3,470 | $ | 3,470 | $ | - | $ | 9,708 | $ | 9,708 |
Three
months ended
June 30,
|
Six
months ended
June 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Research
and development
|
$ | 291,000 | $ | 99,000 | $ | 365,000 | $ | 135,000 | ||||||||
General
and administrative
|
149,000 | 153,000 | 189,000 | 173,000 | ||||||||||||
Stock-based
compensation expense
included
in operating expense
|
$ | 440,000 | $ | 252,000 | $ | 554,000 | $ | 308,000 |
6/30/10
|
6/30/09
|
|||
Expected
life (b)
|
5.7 yrs
|
5.5
yrs
|
||
Risk
free interest rate
|
2.4
|
%
|
2.4
|
%
|
Expected
volatility(a)
|
123
|
%
|
114
|
%
|
Expected
dividend yield
|
0.0
|
%
|
0.0
|
%
|
(a)
|
Reflects movements in our stock price over the most recent historical
period equivalent to the expected life.
|
(b) |
Based
on the simplified method.
|
(in
thousands, except per share amounts)
|
Three
months ended June 30,
|
Six
months ended June 30,
|
||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Basic
net income (loss) allocable to common shareholders
|
$ | 1,344 | $ | (2,691 | ) | $ | 1,991 | $ | (5,260 | ) | ||||||
Weighted
average shares outstanding
|
15,460 | 11,407 | 15,115 | 10,954 | ||||||||||||
Basic
net income (loss) per common share
|
$ | 0.09 | $ | (0.24 | ) | $ | 0.13 | $ | (0.48 | ) | ||||||
Basic
net income (loss) allocable to common shareholders
|
$ | 1,344 | $ | (2,691 | ) | $ | 1,991 | $ | (5,260 | ) | ||||||
Effect of dilutive securities | ||||||||||||||||
Preferred stock dividends | 446 | - | 888 | - | ||||||||||||
Interest related to dividends | 37 | - | 77 | - | ||||||||||||
Diluted net income | $ | 1,827 | $ | (2,691 | ) | $ | 2,956 | $ | (5,260 | ) | ||||||
Weighted
average shares outstanding
|
15,460 | 11,407 | 15,115 | 10,954 | ||||||||||||
Effect
of dilutive options, warrants and preferred stock
|
12,478 | - | 12,710 | - | ||||||||||||
Weighted
average shares outstanding assuming dilution
|
27,938 | 11,407 | 27,825 | 10,954 | ||||||||||||
Diluted
net income (loss) per common share
|
$ | 0.07 | $ | (0.24 | ) | $ | 0.11 | $ | (0.48 | ) | ||||||
(in
thousands, except per share amounts)
|
Three
months ended June 30,
|
Six
months ended June 30,
|
||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Warrants
|
6,175 | 9,564 | 6,150 | 9,564 | ||||||||||||
Stock
options
|
1,168 | 1,805 | 1,027 | 1,805 | ||||||||||||
Convertible
note
|
200 | 200 | 200 | 200 | ||||||||||||
Preferred
stock
|
- | 10,693 | - | 10,693 | ||||||||||||
Total
|
7,543 | 22,262 | 7,377 | 22,262 | ||||||||||||
SEC
Registration Fee
|
$
|
1,783
|
|
Printing
and Engraving Expenses
|
$
|
1,000
|
|
Legal
Fees and Expenses
|
$
|
15,000
|
|
Accountants'
Fees and Expenses
|
$
|
10,000
|
|
Miscellaneous
Costs
|
$
|
10,000
|
|
Total
|
$
|
37,783
|
Exhibit
|
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
|
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)
|
|
(1)
|
To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration
statement:
|
|
(ii)
|
To
reflect in the prospectus any facts or events arising after the effective
date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a
fundamental change in the information set forth in the registration
statement;
|
|
(iii)
|
To
include any material information with respect to the plan of distribution
not previously disclosed in the registration statement or any material
change to such information in the registration
statement;
|
(2)
|
That,
for the purpose of determining any liability under the Securities Act,
each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof.
|
(3)
|
To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
|
ACCESS
PHARMACEUTICALS, INC.
|
|||||
Date
August 24, 2010
|
By:
|
/s/ Jeffrey B. Davis |
|
||
Jeffrey
B. Davis
|
|||||
Chief
Executive Officer
|
|||||
(Principal
Executive Officer)
|
|||||
Date
August 24, 2010
|
By:
|
/s/
Stephen B. Thompson
|
|
||
Stephen
B. Thompson
|
|||||
Vice
President, Chief Financial
|
|||||
Officer
and Treasurer
|
|||||
(Principal
Accounting Officer)
|
ACCESS
PHARMACEUTICALS, INC.
|
|||||
Date
August 24, 2010
|
By:
|
/s/ Jeffrey B. Davis |
|
||
Jeffrey
B. Davis, Director
|
|||||
Chief
Executive Officer
|
|||||
|
|||||
Date
August 24, 2010
|
By:
|
*
|
|
||
Mark
J. Ahn, Director
|
|||||
|
|||||
Date
August 24, 2010
|
By:
|
* |
|
||
Mark
J. Alvino, Director
|
|||||
Date
August 24, 2010
|
By: | * | |||
Esteban Cvitkovic, Director | |||||
Date
August 24, 2010
|
By: | * | |||
Stephen B. Howell, Director | |||||
Date
August 24, 2010
|
By: | * | |||
Steven H. Rouhandeh, Chairman of | |||||
the Board |
Date
August 24, 2010
|
By: | /s/ Stephen B. Thompson | |||
Stephen B. Thompson | |||||
Attorney-in-fact |
Exhibit
|
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
|
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)
|