Per Unit | Total | |
Offering Price per Unit | $3.00 | $12,000,000 |
Placement Agent’s Fees | $0.18 | $ 720,000 |
Offering Proceeds before expenses | $3.82 | $11,280,000 |
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
|
7
|
FORWARD-LOOKING
STATEMENTS
|
18
|
USE
OF PROCEEDS
|
19
|
DILUTION
|
20
|
PRICE
RANGE OF OUR COMMON STOCK
|
21
|
DIVIDEND
POLICY
|
22
|
SELECTED
CONDENSED CONSOLIDATED FINANCIAL DATA
|
22
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
|
|
RESULTS
OF OPERATIONS
|
28
|
DESCRIPTION
OF BUSINESS
|
39
|
DESCRIPTION
OF PROPERTY
|
53
|
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
|
54
|
LEGAL
PROCEEDINGS
|
62
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
|
62
|
TRANSACTIONS
WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL PERSONS
65
|
|
DESCRIPTION
OF SECURITIES
|
66
|
PLAN
OF DISTRIBUTION
|
70
|
EXPERTS
|
73
|
LEGAL
MATTERS
|
73
|
WHERE
YOU CAN FIND MORE INFORMATION
|
73
|
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
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 ovarian cancer. The
clinical study had positive safety and efficacy results. We are currently
planning a number of combination trials, looking at combining ProLindac
with other cancer agents such as taxol and gemcitabine, in solid tumor
indications including colorectal and ovarian. The DACH-platinum
incorporated in ProLindac is the same active moiety as that in oxaliplatin
(Eloxatin; Sanofi-Aventis), which had worldwide sales in excess of $2.0
billion in 2008.
|
·
|
Thiarabine,
or 4-thio Ara-C, is a next generation nucleoside analog licensed from
Southern Research Institute. Previously named SR9025 and OSI-7836, the
compound has been in two Phase 1/2 solid tumor human clinical trials and
was shown to have anti-tumor activity. We are working with leukemia and
lymphoma specialists at MD Anderson Cancer Center in Houston and intend to
initiate additional Phase 2 clinical trials in adult AML, ALL and other
indications.
|
·
|
Cobalamin™
is our proprietary preclinical nanopolymer oral drug delivery technology
based on the natural vitamin B12 oral uptake mechanism. We are currently
developing a product for the oral delivery of insulin,, and are conducting
sponsored development of a product for oral delivery of human growth
hormone, in each case, based upon this
technology.
|
·
|
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.
|
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
½
|
||||
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
CobalaminTM-Targeted Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Pre-clinical
|
(1)
|
For
more information, see “Government Regulation” for description of clinical
stages. Some of these clinical development projects are subject
to funding.
|
(2)
|
Licensed
from the School of Pharmacy, The University of
London.
|
(3)
|
Licensed
from Southern Research Institute of Birmingham,
Alabama.
|
Securities
offered:
|
Up
to 4,000,000 units. Each unit will consist of 1 share of our common
stock and warrants to purchase up to an additional 0.5 shares of our
common stock.
|
Offering
Price:
|
$3.00
per unit.
|
Description
of Warrants:
|
The
warrants will include an exercise price of $3.00 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:
|
13,336,545
shares.
|
Common
stock outstanding after the offering:
|
17,336,545
shares, which does not include 2,240,000 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.
|
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 7 and the other information in this
prospectus for a discussion of the factors you should consider before you
decide to invest in the units.
|
·
|
1,748,935 shares
of common stock reserved for future issuance under our equity incentive
plans. As of January 14, 2010, there were options to
purchase 1,648,153 shares of our common stock outstanding under our
equity incentive plans with a weighted average exercise price of $2.93 per
share;
|
·
|
9,835,479
shares of common stock issuable upon exercise of outstanding warrants as
of January 14, 2010, with exercise prices ranging from $1.32 per share to
$69.57 per share; and
|
·
|
2,240,000
shares of common stock that will be issued upon exercise of warrants at an
exercise price of $3.00 per share sold as part of the units in this
offering including placement agent
warrants.
|
·
|
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 Nine Months
Ended
September 30,
|
For the Year
Ended
December 31,
|
||||||||||||||
2009
|
2008
|
2008
|
2007
|
|||||||||||||
Consolidated
Statement of Operations Data:
|
||||||||||||||||
Total
revenues
|
$ | 248 | $ | 217 | $ | 295 | $ | 57 | ||||||||
Operating
loss
|
(7,991 | ) | (28,996 | ) | (30,727 | ) | (12,750 | ) | ||||||||
Interest
and miscellaneous income
|
18 | 173 | 211 | 315 | ||||||||||||
Interest
and other expense
|
(395 | ) | (512 | ) | (911 | ) | (3,514 | ) | ||||||||
Loss
on extinguishment of debt
|
- | - | - | (11,628 | ) | |||||||||||
Income
tax benefit
|
- | - | - | 61 | ||||||||||||
Gain
on change in warrant liability
|
- | - | 3,972 | - | ||||||||||||
Loss
from continuing operations
|
(8,368 | ) | (29,335 | ) | (27,455 | ) | (30,722 | ) | ||||||||
Preferred
stock dividends
|
(1,434 | ) | (2,873 | ) | (3,358 | ) | (15,504 | ) | ||||||||
Beneficial conversion feature | - | - | - | (3,224) | ||||||||||||
Discontinued
operations, net of taxes of
$61
in 2007
|
- | - | - | 112 | ||||||||||||
Net
loss
|
$ | (9,802 | ) | $ | (32,208 | ) | $ | (30,813 | ) | $ | (49,338 | ) | ||||
Common
Stock Data:
|
||||||||||||||||
Net
loss per basic and
diluted
common share
|
$ | (0.86 | ) | $ | (3.97 | ) | $ | (3.69 | ) | $ | (8.15 | ) | ||||
Weighted
average basic and
diluted
common shares
outstanding
|
11,375 | 8,107 | 8,354 | 6,052 | ||||||||||||
September
30,
|
December
31,
|
|||||||||||||||
2009
|
2008
|
2008
|
2007
|
|||||||||||||
Consolidated
Balance Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents and
short
term investments
|
$ | 1,672 | $ | 4,651 | $ | 2,677 | $ | 10,014 | ||||||||
Total
assets
|
2,705 | 6,449 | 4,171 | 13,002 | ||||||||||||
Deferred
revenue
|
5,164 | 2,450 | 2,409 | 978 | ||||||||||||
Notes
payable
|
- | 791 | - | - | ||||||||||||
Convertible
notes
|
5,500 | 5,500 | 5,500 | 5,564 | ||||||||||||
Total
liabilities
|
18,304 | 15,582 | 15,357 | 12,949 | ||||||||||||
Total
stockholders' equity (deficit)
|
(15,599 | ) | (9,133 | ) | (11,186 | ) | 53 |
(in
thousands, except per share amounts)
|
|||||
2008
|
|||||
CONSOLIDATED
STATEMENT OF OPERATIONS DATA:
|
|||||
Total
revenues
|
$
|
4
|
|||
Operating
loss
|
(13,812)
|
||||
Interest
and other income
|
26
|
||||
Interest
and other expense
|
(433)
|
||||
Gain
on change in value of warrants liability
|
3,972
|
||||
Gain
on sale of equipment
|
7
|
||||
Net
loss
|
$
|
(10,240)
|
|||
Net
loss per basic and diluted common share
|
$
|
(0.26)
|
|||
Weighted
average basic and diluted common shares outstanding
|
38,934
|
||||
CONSOLIDATED
BALANCE SHEET DATA:
|
|||||
December
31,
|
|||||
Cash
and cash equivalents
|
$
|
14
|
|||
Total
assets
|
549
|
||||
Current
liabilities
|
3,346
|
||||
Total
liabilities
|
3,474
|
||||
Stockholders’
(deficit) equity
|
$
|
(2,925)
|
·
|
some
or all of its drug candidates may be found to be unsafe or ineffective or
otherwise fail to meet applicable regulatory standards or receive
necessary regulatory clearances;
|
·
|
its
drug candidates, if safe and effective, may be too difficult to develop
into commercially viable drugs;
|
·
|
it
may be difficult to manufacture or market its drug candidates on a large
scale;
|
·
|
proprietary
rights of third parties may preclude it from marketing its drug
candidates; and
|
·
|
third
parties may market superior or equivalent
drugs.
|
●
|
Amucoadhesive
liquid technology product, MuGard™, has received marketing approval by the
FDA.
|
●
|
ProLindac™
is currently in a Phase 2 trial in
Europe.
|
●
|
ProLindac™
has been approved for an additional Phase 1 trial in the US by the
FDA.
|
●
|
Thiarabine
™is currently in the planning stage for two additional Phase 2 trials in
the United States.
|
●
|
Cobalamin™
mediated delivery technology is currently in the pre-clinical
phase.
|
●
|
Access
also has other products in the preclinical
phase.
|
▪
|
American
Pharmaceutical Partners, Cell Therapeutics, Daiichi, and Enzon are
developing alternate drugs in combination with polymers and other
drug delivery systems.
|
•
|
License
Agreement, dated as of August 8, 2007, by and between Virium
Pharmaceuticals, Inc.(a predecessor in interest to Access) and Southern
Research Institute; and
|
|
•
|
Exclusive
Patent and Know-how Sub-license Agreement between Somanta and
Immunodex, Inc. dated August 18, 2005, as
amended.
|
·
|
third-party
payers' increasing challenges to the prices charged for medical products
and services;
|
·
|
the
trend toward managed health care in the United States and the concurrent
growth of HMOs and similar organizations that can control or significantly
influence the purchase of healthcare services and products;
and
|
·
|
legislative
proposals to reform healthcare or reduce government insurance
programs.
|
·
|
Mucoadhesive
technology in 2021,
|
·
|
ProLindac™
in 2021,
|
·
|
Thiarabine
in 2018,
|
·
|
Cobalamin
mediated technology between 2009 and
2019
|
Assumed
public offering price per unit
|
$ | 2.81 | ||
Net
tangible book value per share as of September 30, 2009
|
$ | (1.17 | ) | |
Increase
in net tangible book value per unit attributable to new
investors
|
$ | 0.89 | ||
Adjusted
net tangible book value per share as of September 30, 2009,
after
|
||||
giving
effect to the offering
|
$ | (0.28 | ) | |
Dilution
per unit to new investors in the offering
|
$ | 2.53 |
·
|
1,748,935 shares
of common stock reserved for future issuance under our equity incentive
plans. As of January 14 ,2010 there were 1,648,153 options
outstanding under our equity incentive plans with a weighted average
exercise price of $2.93 per share;
|
·
|
9,835,479
shares of common stock issuable upon exercise of outstanding warrants as
of January 14, 2010, with exercise prices ranging from $1.32 per share to
$69.57 per share;
|
·
|
2,240,000
shares of common stock that will be issued upon exercise of warrants at an
exercise price of $3.00 per share sold as part of the units in this
offering including placement agent warrants;
and
|
·
|
the
conversion of our currently outstanding Convertible
Note.
|
Common Stock
|
||||||||
High
|
Low
|
|||||||
Fiscal Year 2010 Year to
date
|
||||||||
First
quarter ( through January 14, 2010)
|
$ | 3.29 | $ | 3.11 | ||||
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 |
(in
thousands, except per share amounts)
|
For the Nine Months
Ended
September 30,
|
For the Year
Ended
December 31,
|
||||||||||||||
2009
|
2008
|
2008
|
2007
|
Consolidated
Statement of Operations Data:
|
||||||||||||||||
Total
revenues
|
$ | 248 | $ | 217 | $ | 295 | $ | 57 | ||||||||
Operating
loss
|
(7,991 | ) | (28,996 | ) | (30,727 | ) | (12,750 | ) | ||||||||
Interest
and miscellaneous income
|
18 | 173 | 211 | 315 | ||||||||||||
Interest
and other expense
|
(395 | ) | (512 | ) | (911 | ) | (3,514 | ) | ||||||||
Loss
on extinguishment of debt
|
- | - | - | (11,628 | ) | |||||||||||
Income
tax benefit
|
- | - | - | 61 | ||||||||||||
Gain
on change in warrant liability
|
- | - | 3,972 | - | ||||||||||||
Loss
from continuing operations
|
(8,368 | ) | (29,335 | ) | (27,455 | ) | (30,722 | ) | ||||||||
Preferred
stock dividends
|
(1,434 | ) | (2,873 | ) | (3,358 | ) | (15,504 | ) | ||||||||
Beneficial conversion feature | - | - | - | (3,224) | ||||||||||||
Discontinued
operations, net of taxes of
$61
in 2007
|
- | - | - | 112 | ||||||||||||
Net
loss
|
$ | (9,802 | ) | $ | (32,208 | ) | $ | (30,813 | ) | $ | (49,338 | ) | ||||
Common
Stock Data:
|
||||||||||||||||
Net
loss per basic and
diluted
common share
|
$ | (0.86 | ) | $ | (3.97 | ) | $ | (3.69 | ) | $ | (8.15 | ) | ||||
Weighted
average basic and
diluted
common shares
outstanding
|
11,375 | 8,107 | 8,354 | 6,052 | ||||||||||||
September 30,
|
December 31,
|
|||||||||||||||
2009
|
2008
|
2008
|
2007
|
Consolidated
Balance Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents and
short
term investments
|
$ | 1,672 | $ | 4,651 | $ | 2,677 | $ | 10,014 | ||||||||
Total
assets
|
2,705 | 6,449 | 4,171 | 13,002 | ||||||||||||
Deferred
revenue
|
5,164 | 2,450 | 2,409 | 978 | ||||||||||||
Notes
payable
|
- | 791 | - | - | ||||||||||||
Convertible
notes
|
5,500 | 5,500 | 5,500 | 5,564 | ||||||||||||
Total
liabilities
|
18,304 | 15,582 | 15,357 | 12,949 | ||||||||||||
Total
stockholders' equity (deficit)
|
(15,599 | ) | (9,133 | ) | (11,186 | ) | 53 |
(in
thousands, except per share amounts)
|
|||||
2008
|
|||||
CONSOLIDATED
STATEMENT OF OPERATIONS DATA:
|
|||||
Total
revenues
|
$
|
4
|
|||
Operating
loss
|
(13,812)
|
||||
Interest
and other income
|
26
|
||||
Interest
and other expense
|
(433)
|
||||
Gain
on change in value of warrants liability
|
3,972
|
||||
Gain
on sale of equipment
|
7
|
||||
Net
loss
|
$
|
(10,240)
|
|||
Net
loss per basic and diluted common share
|
$
|
(0.26)
|
|||
Weighted
average basic and diluted common shares outstanding
|
38,934
|
||||
CONSOLIDATED
BALANCE SHEET DATA:
|
|||||
December
31,
|
|||||
Cash
and cash equivalents
|
$
|
14
|
|||
Total
assets
|
549
|
||||
Current
liabilities
|
3,346
|
||||
Total
liabilities
|
3,474
|
||||
Stockholders’
(deficit) equity
|
$
|
(2,925)
|
·
|
Approximately
2.5 million shares of Access common stock was issued to the common
shareholders and the in-the-money warrant holders of MacroChem as
consideration having a value of approximately $3.5 million (the value was
calculated using Access’ stock price on February 25, 2009 times the shares
issued);
|
·
|
an
aggregate of $106,000 in direct transaction costs;
and
|
·
|
cancelled
receivable from MacroChem of
$635,000.
|
Access
|
MacroChem
|
Pro
Forma
Adjustments
|
Pro
Forma
Combined
|
|||||||||||||
ASSETS
|
||||||||||||||||
Current
assets
|
||||||||||||||||
Cash
and cash equivalents
|
$
|
2,663,000
|
$
|
14,000
|
$
|
2,677,000
|
||||||||||
Receivables
|
147,000
|
-
|
147,000
|
|||||||||||||
Receivables
due from MacroChem
|
635,000
|
-
|
(635,000
|
)
|
(f)
|
-
|
||||||||||
Prepaid
expenses and other current expenses
|
105,000
|
70,000
|
175,000
|
|||||||||||||
Total
current assets
|
3,550,000
|
84,000
|
2,999,000
|
|||||||||||||
Property
and equipment, net
|
87,000
|
8,000
|
95,000
|
|||||||||||||
Patents
net
|
542,000
|
457,000
|
999,000
|
|||||||||||||
Other
assets
|
78,000
|
-
|
78,000
|
|||||||||||||
Total
assets
|
$
|
4,257,000
|
$
|
549,000
|
$
|
4,171,000
|
||||||||||
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
||||||||||||||||
Current
liabilities
|
||||||||||||||||
Accounts
payable
|
$
|
1,970,000
|
$
|
1,317,000
|
106,000
|
(e)
|
$
|
3,393,000
|
||||||||
Accrued
expenses
|
748,000
|
547,000
|
1,295,000
|
|||||||||||||
Dividends
payable
|
1,896,000
|
-
|
1,896,000
|
|||||||||||||
Accrued
interest payable
|
128,000
|
17,000
|
(17,000
|
)
|
(b)
|
128,000
|
||||||||||
Current
portion of deferred revenue
|
164,000
|
5,000
|
(5,000
|
)
|
(d)
|
164,000
|
||||||||||
Notes
payable
|
-
|
825,000
|
(825,000
|
)
|
(b)
|
-
|
||||||||||
Payables
due Access
|
-
|
635,000
|
(635,000
|
)
|
(f)
|
-
|
||||||||||
Total
current liabilities
|
4,906,000
|
3,346,000
|
6,876,000
|
|||||||||||||
Long-term
deferred revenue
|
2,245,000
|
24,000
|
(24,000
|
)
|
(d)
|
2,245,000
|
||||||||||
Warrants
liability
|
-
|
104,000
|
(104,000
|
)
|
(d)
|
-
|
||||||||||
Long-term
debt
|
5,500,000
|
-
|
5,500,000
|
|||||||||||||
Total
liabilities
|
12,651,000
|
3,474,000
|
14,621,000
|
|||||||||||||
Stockholders’
equity (deficit)
|
||||||||||||||||
Preferred
stock
|
-
|
-
|
-
|
|||||||||||||
Common
stock
|
70,000
|
459,000
|
25,000
8,000
1,000
(459,000
|
)
|
(a)
(b)
(c)
(d)
|
104,000
|
||||||||||
Additional
paid-in capital
|
127,482,000
|
97,763,000
|
508,000
834,000
196,000
|
(a)
(b)
(c)
|
226,783,000
|
|||||||||||
Notes
receivable from stockholders
|
(1,045,000
|
)
|
(1,045,000
|
)
|
||||||||||||
Treasury
stock, at cost
|
(4,000
|
)
|
(59,000
|
)
|
59,000
|
(d)
|
(4,000
|
)
|
||||||||
Accumulated
deficit
|
(134,897,000
|
)
|
(101,088,000
|
)
|
(197,000
|
)
|
(c)
|
(236,288,000
|
)
|
|||||||
(106,000
|
)
|
(e)
|
||||||||||||||
Total
stockholders’ equity (deficit)
|
(8,394,000
|
)
|
(2,925,000
|
)
|
(10,450,000
|
)
|
||||||||||
Total
liabilities and stockholders’ equity (deficit)
|
$
|
4,257,000
|
$
|
549,000
|
$
|
4,171,000
|
|
Note
1: The above statement gives effect to the following pro forma adjustments
necessary to reflect the merger of Access and MacroChem, entities deemed
under common control, as if the transaction had occurred on December 31,
2008.
|
|
a)
|
To
record the exchange, for accounting purposes, by MacroChem shareholders of
their common stock and in-the-money warrants for 2,500,000 shares of
Access and the impact of pro-forma adjustments to additional paid-in
capital in the amount of $508,000.
|
b)
|
To
record Access common stock exchanged for notes payable of $825,000 and
accrued interest of $17,000.
|
c)
|
To
record Access common stock issued to former executives of MacroChem for
the settlement of employment
agreements.
|
d)
|
To
eliminate the common stock, treasury stock, warrant liabilities and
deferred revenue of MacroChem.
|
e)
|
To
record $106,000 in merger costs.
|
f)
|
To
eliminate intercompany notes payable/receivable of
$635,000.
|
|
Access
|
MacroChem
|
Pro
Forma
Combined
|
|||||||
Revenues
|
$
|
291,000
|
$
|
4,000
|
$
|
295,000
|
||||
Expenses
|
||||||||||
Research
and development
|
12,613,000
|
10,622,000
|
23,235,000
|
|||||||
General
and administrative
|
4,340,000
|
3,123,000
|
7,463,000
|
|||||||
Depreciation
and amortization
|
253,000
|
71,000
|
324,000
|
|||||||
Total
expenses
|
17,206,000
|
13,816,000
|
31,022,000
|
|||||||
Loss
from operations
|
(16,915,000
|
)
|
(13,812,000
|
)
|
(30,727,000
|
)
|
||||
Interest
and other income
|
178,000
|
33,000
|
211,000
|
|||||||
Interest
and other expenses
|
(478,000
|
)
|
(433,000
|
)
|
(911,000
|
)
|
||||
Change
in fair value of warrants liability
|
-
|
3,972,000
|
3,972,000
|
|||||||
(300,000
|
)
|
3,572,000
|
3,272,000
|
|||||||
Net
loss
|
(17,215,000
|
)
|
(10,240,000)
|
(27,455,000
|
)
|
|||||
Less
preferred stock dividends
|
(3,358,000
|
)
|
-
|
(3,358,000
|
)
|
|||||
Net
loss allocable to common stockholders
|
$
|
(20,573,000
|
)
|
$
|
(10,240,000
|
)
|
$
|
(30,813,000
|
)
|
|
Basic
and diluted loss per common share
Loss
from operations allocable to
all
common stockholders
|
$
|
(3.51
|
)
|
$
|
(0.26
|
)
|
$
|
(3.31
|
)
|
|
Weighted
average basic and diluted common shares outstanding
|
5,854,031
|
38,934,207
|
9,321,031
|
Historical
|
5,854,031
|
|
MacroChem
equivalent shares giving effect to the merger
|
2,500,000
|
|
Shares
issued to former MacroChem executives
|
125,000
|
|
Shares
issued for notes payable and interest
|
842,000
|
|
Total
|
9,321,031
|
·
|
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
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 ovarian cancer. The
clinical study had positive safety and efficacy results. We are currently
planning a number of combination trials, looking at combining ProLindac
with other cancer agents such as taxol and gemcitabine, in solid tumor
indications including colorectal and ovarian. The DACH-platinum
incorporated in ProLindac is the same active moiety as that in oxaliplatin
(Eloxatin; Sanofi-Aventis), which has sales in excess of $2.0
billion.
|
·
|
Thiarabine,
or 4-thio Ara-C, is a next generation nucleoside analog licensed from
Southern Research Institute. Previously named SR9025 and OSI-7836, the
compound has been in two Phase 1/2 solid tumor human clinical trials and
was shown to have anti-tumor activity. We are working with leukemia and
lymphoma specialists at MD Anderson Cancer Center in Houston and intend to
initiate additional Phase 2 clinical trials in adult AML, ALL and other
indications.
|
·
|
Cobalamin™
is our proprietary preclinical nanopolymer oral drug delivery technology
based on the natural vitamin B12 oral uptake mechanism. We are currently
developing a product for the oral delivery of insulin, and are conducting
sponsored development of a product for oral delivery of human growth
hormone.
|
·
|
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.
|
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
|
||||
CobalaminTM-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.
|
·
|
lower
costs for product manufacturing for a new ProLindac clinical trial in 2009
as some manufacturing is complete and a clinical trial has started
($444,000);
|
·
|
research
and development expenses incurred by MacroChem in the third quarter of
2008, which are no longer ongoing
($386,000);
|
·
|
lower
scientific consulting expenses
($149,000);
|
·
|
lower
salary and related expenses
($129,000);
|
·
|
other
net decreases in research spending ($92,000);
and
|
·
|
offset
by higher expenses due to the cost of option grants
($91,000).
|
·
|
higher
shareholder consultant expenses ($2,012,000) to inform investors about
Access and to expand our shareholder
base;
|
·
|
higher
business professional expenses
($371,000);
|
·
|
higher
expenses due to the cost of option grants
($89,000);
|
·
|
offset
by general and administrative expenses incurred by MacroChem in the third
quarter of 2008 that are no longer ongoing
($732,000);
|
·
|
lower
accrual of potential liquidated damages under an investor rights agreement
with certain investors ($205,000);
|
·
|
lower
director and officer insurance and lower director fees ($111,000) due to
lower insurance costs and directors taking options instead of fees in
2009;
|
·
|
lower
salary and related expenses ($83,000);
and
|
·
|
other
net decreases in general and administrative expenses
($50,000).
|
·
|
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 in the first nine months of
2008, which are no longer ongoing
($851,000);
|
·
|
lower
costs for product manufacturing due to the start of a new ProLindac
clinical trial ($1,038,000);
|
·
|
lower
salary and related expenses
($189,000);
|
·
|
lower
scientific consulting expenses
($210,000);
|
·
|
lower
travel expenses ($84,000);
|
·
|
other
net decreases in research spending ($130,000);
and
|
·
|
offset
by higher expenses due to option grants
($186,000).
|
·
|
general
and administrative expenses incurred by MacroChem in the first nine months
of 2008 that are no longer ongoing
($2,728,000);
|
·
|
lower
director and officer insurance and lower director fees ($137,000) due to
lower insurance costs and directors taking options instead of fees in
2009;
|
·
|
lower
salary and related expenses
($121,000);
|
·
|
lower
legal and accounting expenses
($93,000);
|
·
|
other
net decreases in general and administrative expenses
($58,000);
|
·
|
offset
by higher shareholder consultant expenses ($2,165,000) to inform investors
about Access and to expand our shareholder
base;
|
·
|
higher
business professional expenses ($737,000);
and
|
·
|
higher
expenses due to the cost of option grants
($162,000).
|
·
|
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);
|
·
|
costs
for product manufacturing for a new ProLindac clinical trial expected to
start in early 2009
($548,000);
|
·
|
higher
scientific consulting expenses ($278,000);
|
· | higher salary and related cost due to the hiring of additional scientific staff ($269,000); and |
·
|
other
net increases in research spending
($86,000);
|
·
|
partially
offset by lower clinical development costs ($49,000) due to the winding
down of the ProLindac Phase 2 clinical
trail.
|
·
|
accrual
of potential liquidated damages under an investor rights agreement with
certain investors ($675,000);
|
·
|
higher
patent expenses and license fees
($453,000);
|
·
|
higher
professional fees ($29,000);
|
·
|
lower
salary and other salary related expenses
($469,000);
|
·
|
lower
salary related expenses due to stock option expenses
($325,000);
|
·
|
lower
investor relations expenses ($148,000);
and
|
·
|
other
net increases in general and administrative expenses
($49,000).
|
·
|
the
successful development and commercialization of ProLindac™, MuGard™ and
our other product candidates;
|
·
|
the
ability to convert, repay or restructure our outstanding convertible notes
and debentures;
|
·
|
the
ability to integrate Somanta Pharmaceuticals, Inc. assets and programs
with ours;
|
·
|
the
ability to establish and maintain collaborative arrangements with
corporate partners for the research, development and commercialization of
products;
|
·
|
continued
scientific progress in our research and development
programs;
|
·
|
the
magnitude, scope and results of preclinical testing and clinical
trials;
|
·
|
the
costs involved in filing, prosecuting and enforcing patent
claims;
|
·
|
the
costs involved in conducting clinical
trials;
|
·
|
competing
technological developments;
|
·
|
the
cost of manufacturing and scale-up;
|
·
|
the
ability to establish and maintain effective commercialization arrangements
and activities; and
|
·
|
successful
regulatory filings.
|
·
|
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
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 ovarian cancer. The
clinical study had positive safety and efficacy results. We are currently
planning a number of combination trials, looking at combining ProLindac
with other cancer agents such as taxol and gemcitabine, in solid tumor
indications including colorectal and ovarian. The DACH-platinum
incorporated in ProLindac is the same active moiety as that in oxaliplatin
(Eloxatin; Sanofi-Aventis), which has sales in excess of $2.0
billion.
|
·
|
Thiarabine,
or 4-thio Ara-C, is a next generation nucleoside analog licensed from
Southern Research Institute. Previously named SR9025 and OSI-7836, the
compound has been in two Phase 1/2 solid tumor human clinical trials and
was shown to have anti-tumor activity. We are working with leukemia and
lymphoma specialists at MD Anderson Cancer Center in Houston and intend to
initiate additional Phase 2 clinical trials in adult AML, ALL and other
indications.
|
·
|
Cobalamin™
is our proprietary preclinical nanopolymer oral drug delivery technology
based on the natural vitamin B12 oral uptake mechanism. We are currently
developing a product for the oral delivery of insulin, and are conducting
sponsored development of a product for oral delivery of human growth
hormone.
|
·
|
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.
|
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
|
||||
CobalaminTM-Targeted
Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Pre-clinical
|
(1)
|
For
more information, see “Government Regulation” for description of clinical
stages.
|
(2)
|
Licensed
from the School of Pharmacy, The University of
London.
|
(3)
|
Licensed
from Southern Research Institute of Birmingham,
Alabama.
|
·
|
Synthetic
Polymer Targeted Drug Delivery
Technology;
|
·
|
Cobalamin™-Mediated
Oral Delivery Technology; and
|
Cobalamin™-Mediated Targeted Delivery Technology |
▪
|
passive
tumor targeting involves transporting anti-cancer agents through the
bloodstream to tumor cells using a “carrier” molecule. Many different
carrier molecules, which can take a variety of forms (micelles,
nanoparticles, liposomes and polymers), are being investigated as each
provides advantages such as specificity and protection of the anti-cancer
drug from degradation due to their structure, size (molecular weights) and
particular interactions with tumor cells. Our polymer platinate program is
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 means to the
affected cells should allow more of the anti-cancer drug to enter the
tumor cell, thus amplifying the response to the treatment and reducing the
toxic effect on bystander, normal
tissue.
|
-
|
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 2009 and
2019
|
•
|
American
Pharmaceutical Partners, Cell Therapeutics, Daiichi, and Enzon are
developing alternate drugs in combination with polymers and other drug
delivery systems.
|
Name
|
Age
|
Title
|
|
Steven
H. Rouhandeh
|
52
|
Chairman
of the Board*
|
|
Jeffrey
B. Davis
|
46
|
Chief
Executive Officer, Director*
|
|
Esteban
Cvitkovic
|
59
|
Vice
Chairman – Europe
|
|
Mark
J. Ahn, Ph.D.
|
47
|
Director
|
|
Mark
J. Alvino
|
41
|
Director
|
|
Stephen
B. Howell, M.D.
|
65
|
Director
|
|
David
P. Luci
|
42
|
Director
|
|
David
P. Nowotnik, Ph.D.
|
60
|
Senior
Vice President Research & Development
|
|
Frank A. Jacobucci | 47 | Vice President, Sales and Marketing | |
Phillip
S. Wise
|
51
|
Vice
President, Business Development & Strategy
|
|
Stephen
B. Thompson
|
56
|
Vice
President, Chief Financial Officer, Treasurer,
|
|
Secretary
|
*
|
Appointed
to the board of directors by SCO Capital Partners LLC (“SCO”) pursuant to
a Director Designation Agreement between SCO and
Access.
|
Name and Principal Position
|
Year
|
Salary ($)
(1)
|
Option Awards ($) (2)
|
All Other Compensation (3)
|
Total ($)
|
|||||||||||||||
Jeffrey
B. Davis (4)
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
2007
|
$
|
175,675 253,620 253,620 |
$
|
87,117 136,977 - |
$
|
6,307 12,225 12,225 |
$
|
269,099 402,822 265,845 | |||||||||||
Phillip
S. Wise
Vice
President, Business
Development
|
2009
2008
2007
|
$
|
200,000 200,000 200,000 |
$
|
-
136,977
-
|
$
|
5,209 9,876 9,876 |
$
|
205,209 346,853 209,876 | |||||||||||
Stephen
B. Thompson
Vice
President, Chief Financial Officer
|
2009
2008
2007
|
$
|
113,200 154,080 154,080 |
$
|
87,117 136,977 - |
$
|
4,107 7,612 7,427 |
$
|
204,424 298,669 161,507 |
(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, 2008 and 2007 under
FAS 123R. Fair value is calculated as of the grant date using a
Black-Scholes option-pricing model. The determination of the fair value of
share-based payment awards made on the date of grant is affected by our
stock price as well as assumptions regarding a number of complex and
subjective variables. Our assumptions in determining fair value are
described in note 10 to our audited financial statements for the year
ended December 31, 2008, included in our Annual Report on Form
10-K.
|
(3)
|
Amounts
reported for fiscal years 2009, 2008 and 2007 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.
|
(4)
|
Jeffrey
B. Davis became our Chief Executive Officer effective December 26, 2007
and his salary began to accrue as of the date of his employment agreement
which was January 4, 2008.
|
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
10,000
|
-
30,209
-
-
-
-
-
-
|
-
|
1.38
3.00
0.63
11.60
29.25
10.10
18.65
12.50
|
05/27/19
05/21/18
08/17/16
05/23/15
01/23/14
01/30/13
03/22/12
03/01/10
|
Phillip
S. Wise (5)
|
19,791
100,000
|
30,209
-
|
-
|
3.00
0.63
|
05/21/18
08/17/16
|
Stephen
B. Thompson (3)
|
75,000
19,791
100,000
5,000
3,000
4,000
6,000
9,000
|
-
30,209
-
-
-
-
-
-
|
-
|
1.38
3.00
0.63
11.60
29.25
10.10
18.65
12.50
|
05/27/19
05/21/18
08/17/16
05/23/15
01/23/14
01/30/13
03/22/12
03/01/10
|
(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 became our Chief Executive Officer effective December 26, 2007
and his 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.
|
(5)
|
Mr.
Wise’s options to purchase 50,000 shares of common stock will be fully
vested in April 2012.
|
(4)
|
Mr.
Thompson’s options to purchase 50,000 shares of common stock will be fully
vested in April 2012..
|
·
|
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.
|
·
|
a
bonus payable in cash and Common Stock related to the attainment of
reasonable performance goals specified by the
Board;
|
·
|
stock
options at the discretion of the
Board;
|
·
|
long-term
disability insurance to provide compensation equal to at least $90,000
annually; and
|
·
|
term
life insurance coverage of
$155,000.
|
Name
|
Fees
earned or Paid in Cash ($)
|
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)
|
-
|
-
|
116,000
|
132,000
|
248,000
|
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 FAS 123R 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 10 to our audited financial
statements for the year ended December 31, 2008, 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 $116,000.
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 35000 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.
|
||
(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.
|
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))
|
|||||||||
Equity
compensation plans
|
||||||||||||
approved
by security
|
||||||||||||
holders
|
||||||||||||
2005
Equity Incentive Plan
|
1,445,153 | $ | 2.01 | 1,398,935 | ||||||||
1995
Stock Awards Plan
|
103,000 | 15.89 | - | |||||||||
2001
Restricted Stock Plan
|
- | - | 52,818 | |||||||||
Equity
compensation plans
|
||||||||||||
not
approved by security
|
||||||||||||
holders
|
||||||||||||
2007
Special Stock Option Plan
|
100,000 | 2.90 | 350,000 | |||||||||
Total
|
1,648,153 | $ | 2.93 | 1,801,753 |
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)
|
101,454
|
*
|
-
|
*
|
101,454
|
*
|
|
Esteban
Cvitkovic, M.D. (6)
|
306,000
|
2.2%
|
-
|
*
|
306,000
|
1.3%
|
|
Stephen
B. Howell, M.D. (7)
|
89,422
|
*
|
-
|
*
|
89,422
|
*
|
|
David P.
Luci (8)
|
276,717
|
2.1%
|
8,333
|
*
|
285,050
|
1.2%
|
|
David P.
Nowotnik, Ph.D. (9)
|
252,310
|
1.9%
|
-
|
*
|
252,310
|
1.1%
|
|
Frank A. Jacobucci (10) | 128,125 | * | 128,125 | * | |||
Phillip
S. Wise (11)
|
119,794
|
*
|
-
|
*
|
119,794
|
*
|
|
Stephen
B. Thompson (12)
|
231,315
|
1.7%
|
-
|
*
|
231,315
|
*
|
|
SCO
Capital Partners LLC, SCO Capital Partners LP, and Beach Capital LLC (13)
|
9,535,087
|
49.2%
|
7,077,100
|
71.1%
|
16,612,187
|
56.6%
|
|
Larry N.
Feinberg (14)
|
1,222,443
|
8.7%
|
1,457,699
|
14.7%
|
2,680,142
|
11.2%
|
|
Lake End
Capital LLC (15)
|
1,059,601
|
7.5%
|
793,067
|
8.0%
|
1,852,668
|
7.7%
|
|
All
Directors and Executive
Officers
as a group
(consisting
of 10 persons) (16)
|
1,607,137
|
11.0%
|
8,333
|
*
|
1,487,345
|
6.1%
|
(1)
|
Includes
Access’ outstanding shares of Common Stock held plus all shares of Common
Stock issuable upon exercise of options, warrants and other rights
exercisable within 60 days of January 14,
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,
1285 Avenue of the Americas, 35th Floor, New York, NY 10019. SCO
Securities LLC and affiliates (SCO Capital Partners LP and Beach Capital
LLC) are known to beneficially own an aggregate of 3,481,800 shares of
Access’ Common Stock, warrants to purchase an aggregate of 6,053,287
shares of Access’ 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 Access’
Common Stock, presently exercisable options for the purchase of 25,000
shares of Access’ 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, 1285
Avenue of the Americas, 35th Floor, New York, NY 10019. SCO Securities LLC
and affiliates (SCO Capital Partners LP and Beach Capital LLC) are known
to beneficially own 3,481,800 shares of Access’ Common Stock, warrants to
purchase an aggregate of 6,053,287 shares of Access’ 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 Access’
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
(5)
|
Includes
35,454 shares of Common Stock underlying warrants held by Mr. Alvino and
presently exercisable options for the purchase of 66,000 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive Plan. Mr. Alvino is
Managing Director of Griffin Securities LLC. His address is c/o Griffin
Securities LLC, 17 State St., 3rd
Floor, New York, NY 10004. Mr. Alvino is a designated director of SCO
Securities LLC. SCO Securities LLC and affiliates (SCO Capital Partners LP
and Beach Capital LLC) are known to beneficially own 3,481,800 shares of
Access’ Common Stock, warrants to purchase an aggregate of 6,053,287
shares of Access’ Common Stock and 7,077,100 shares of Common Stock
issuable upon conversion of Series A Cumulative Convertible Preferred
Stock. Mr. Alvino disclaims beneficial ownership of all such shares except
to the extent of his pecuniary interest therein. Mr. Alvino disclaims
beneficial ownership of all such shares except to the extent of his
pecuniary interest therein.
|
(6)
|
Includes
presently exercisable options for the purchase of 156,000 shares of
Access’ Common Stock pursuant to the 2005 Equity Incentive Plan and a
warrant to purchase 150,000 shares of Access’ Common Stock at an exercise
price of $3.15 per share. Dr. Cvitkovic has also been granted an
additional warrant of 50,000 shares of Access’ Common Stock at an exercise
price of $3.15 that vests January 1,
2010.
|
(7)
|
Dr.
Howell is known to beneficially own an aggregate of 9,722 shares of
Access’ Common Stock, presently exercisable options for the purchase of
67,200 shares of Access’ Common Stock pursuant to the 2005 Equity
Incentive Plan and 12,500 shares of Access’ Common Stock pursuant to the
1995 Stock Option Plan.
|
(8)
|
Mr.
Luci is known to beneficially own an aggregate of 129,884 shares of
Access’ Common Stock, warrants to purchase an aggregate of 4,167 shares of
Access’ Common Stock, 8,333 shares of Common Stock issuable to him upon
conversion of Series A Cumulative Convertible Preferred Stock and
presently exercisable options for the purchase of 76,000 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive Plan. Mr. Luci has also
been granted 66,666 restricted shares of Access’ Common Stock that vests
on January 1, 2010 and 66,666 restricted shares of Access’ Common Stock
that vests on June 1, 2010.
|
(9)
|
Dr.
Nowotnik is known to beneficially own an aggregate of 17,516 shares of
Access’ Common Stock, presently exercisable options for the purchase of
193,752 shares of Access’ Common Stock pursuant to the 2005 Equity
Incentive Plan and 40,000 shares of Access’ Common Stock pursuant to the
1995 Stock Option Plan.
|
(10) | Includes presenty exercisable options for the purchase of 28,125 shares of Access' Common Stock pursuant to the 2005 Equity Incentive Plan |
(11)
|
Includes
presently exercisable options for the purchase of 118,752 shares of
Access’ Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
(12)
|
Mr.
Thompson is known to beneficially own an aggregate of 9,521 shares of
Access’ Common Stock, presently exercisable options for the purchase of
193,752 shares of Access’ Common Stock pursuant to the 2005 Equity
Incentive Plan and 27,000 shares of Access’ Common Stock pursuant to the
1995 Stock Option Plan.
|
(13)
|
SCO
Capital Partners LLC, SCO Capital Partner LP, Beach Capital LLC and SCO
Financial Group's address is 1285 Avenue of the Americas, 35th
Floor, New York, NY 10019. SCO Capital Partners LLC and affiliates (SCO
Capital Partners LP, Beach Capital LLC and SCO Financial Group) are known
to beneficially own an aggregate of 3,481,800 shares of Access’ Common
Stock, warrants to purchase an aggregate of 6,053,287 shares of Access’
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.
|
(14)
|
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 Access’ Common Stock, warrants to purchase
an aggregate of 728,850 shares of Access’ Common Stock and Series A
Cumulative Convertible Preferred Stock which may be converted into an
aggregate of 1,457,699 shares of Access’ Common
Stock.
|
(15)
|
Lake
End Capital LLC’s address is 1285 Avenue of the Americas, 35th
Floor, New York, NY 10019. Lake End Capital LLC is known to beneficially
own an aggregate of 335,575 shares of Access’ Common Stock, warrants to
purchase an aggregate of 724,026 shares of Access’ Common Stock and
793,067 shares of Common Stock issuable to them upon conversion of Series
A Cumulative Convertible Preferred
Stock.
|
(16)
|
Does
not include shares held by SCO Securities LLC and
affiliates.
|
·
|
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, 2008 and
2007
|
F-3
|
Consolidated
Statements of Operations for 2008 and
2007
|
F-4
|
Consolidated
Statements of Stockholders' Equity (Deficit) for 2008 and
2007
|
F-5
|
Consolidated
Statements of Cash Flows for 2008 and
2007
|
F-6
|
Notes
to Consolidated Financial Statements (Two years ended December 31,
2008)
|
F-7
|
Condensed
Consolidated Balance Sheets at September 30, 2009
(unaudited)
|
F-25
|
Condensed
Consolidated Statements of Operations for September 30, 2009 and 2008
(unaudited)
|
F-26
|
Condensed
Consolidated Statement of Stockholders’ Deficit for September 30, 2009
(unaudited)
|
F-27
|
Condensed
Consolidated Statements of Cash Flows for September 30, 2009 and 2008
(unaudited)
|
F-28
|
Notes
to Condensed Consolidated Financial Statements (Three Months Ended
September 30, 2009 and 2008) (unaudited)
|
F-29
|
ASSETS
|
December 31, 2008
|
December 31, 2007
|
Current
assets
Cash and cash
equivalents
Receivables
Receivables due from MacroChem
Corp.
Receivables due from Somanta
Pharmaceuticals, Inc.
Prepaid
expenses and other current assets
Total
current assets
|
$ 2,663,000
147,000
635,000
-
105,000
3,550,000
|
$ 6,921,000
35,000
-
931,000
410,000
8,297,000
|
Property
and equipment, net
|
87,000
|
130,000
|
Patents,
net
|
542,000
|
710,000
|
Other
assets
|
78,000
|
12,000
|
Total
assets
|
$ 4,257,000
|
$ 9,149,000
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||
Current
liabilities
Accounts
payable
Accrued
expenses
Dividends
payable
Accrued
interest payable
Current
portion of deferred revenue
Current
portion of convertible long-term debt
Total
current liabilities
|
$ 1,970,000
748,000
1,896,000
128,000
164,000
-
4,906,000
|
$ 1,506,000
30,000
260,000
130,000
68,000
64,000
2,058,000
|
Long-term
deferred revenue
Long-term
convertible debt
|
2,245,000
5,500,000
|
910,000
5,500,000
|
Total
liabilities
|
12,651,000
|
8,468,000
|
Commitments
and contingencies
|
||
Stockholders'
equity (deficit)
Convertible
preferred stock - $.01 par value; authorized 2,000,000
shares;
3,242.8617
issued at December 31, 2008; 3,227.3617 issued at
December
31, 2007
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
6,967,474 at December 31, 2008; issued 3,585,458
at
December 31, 2007
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost – 163 shares
Accumulated
deficit
Total
stockholders' equity (deficit)
|
-
70,000
127,482,000
(1,045,000)
(4,000)
(134,897,000)
(8,394,000)
|
-
36,000
116,018,000
(1,045,000)
(4,000)
(114,324,000)
681,000
|
Total
liabilities and stockholders' equity (deficit)
|
$ 4,257,000
|
$ 9,149,000
|
December
31,
|
||||||||
2008
|
2007
|
|||||||
Revenues
|
||||||||
License
revenues
|
$ | 118,000 | $ | 23,000 | ||||
Sponsored research and
development
|
173,000 | 34,000 | ||||||
Total revenues
|
291,000 | 57,000 | ||||||
Expenses
|
||||||||
Research and
development
|
12,613,000 | 2,602,000 | ||||||
General and
administrative
|
4,340,000 | 4,076,000 | ||||||
Depreciation and
amortization
|
253,000 | 279,000 | ||||||
Total expenses
|
17,206,000 | 6,957,000 | ||||||
Loss
from operations
|
(16,915,000 | ) | (6,900,000 | ) | ||||
Interest
and miscellaneous income
|
178,000 | 125,000 | ||||||
Interest
and other expense
|
(478,000 | ) | (3,514,000 | ) | ||||
Loss
on extinguishment of debt
|
- | (11,628,000 | ) | |||||
(300,000 | ) | (15,017,000 | ) | |||||
Loss
before discontinued operations and before tax benefit
|
(17,215,000 | ) | (21,917,000 | ) | ||||
Income
tax benefit
|
- | 61,000 | ||||||
Loss
from continuing operations
|
(17,215,000 | ) | (21,856,000 | ) | ||||
Less
preferred stock dividends
|
(3,358,000 | ) | (14,908,000 | ) | ||||
Loss
from continuing operations allocable to common
stockholders
|
(20,573,000 | ) | (36,764,000 | ) | ||||
Discontinued
operations, net of taxes of $0 in 2008 and
$61,000
in 2007
|
- | 112,000 | ||||||
Net
loss allocable to common stockholders
|
$ | (20,573,000 | ) | $ | (36,652,000 | ) | ||
Basic
and diluted loss per common share
|
||||||||
Loss
from continuing operations allocable to common
stockholders
|
$ | (3.51 | ) | $ | (10.35 | ) | ||
Discontinued
operations
|
- | 0.03 | ||||||
Net
loss allocable to common stockholders
|
$ | (3.51 | ) | $ | (10.32 | ) | ||
Weighted
average basic and diluted common shares
Outstanding
|
5,854,031 | 3,552,006 | ||||||
Notes
|
|||||||||||||||||||||||||||||||||
Additional | receivable | ||||||||||||||||||||||||||||||||
Common
Stock
|
Preferred Stock
|
paid-in
|
from
|
Treasury | Accumulated | ||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
capital
|
stockholders | stock |
deficit
|
Balance,
December 31,
2006
|
3,535,000 | $ | 35,000 | - | $ | - | $ | 68,799,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (77,672,000 | ) | ||||||||||||||||
Common
stock issued for
services
|
19,000 | - | - | - | 83,000 | - | - | - | |||||||||||||||||||||||||
Options
exercised
|
31,000 | 1,000 | - | - | 35,000 | - | - | - | |||||||||||||||||||||||||
Stock
option
compensation
expense
|
- | - | - | - | 1,048,000 | - | - | - | |||||||||||||||||||||||||
Preferred
stock issuances
|
- | - | 954.0001 | - | 5,560,000 | - | - | - | |||||||||||||||||||||||||
Warrants
issued with
preferred
stock
|
- | - | - | - | 3,980,000 | - | - | - | |||||||||||||||||||||||||
Costs
of stock issuances
|
(868,000 | ) | - | - | - | ||||||||||||||||||||||||||||
Beneficial
conversion
feature
|
- | - | - | - | 14,648,000 | - | - | - | |||||||||||||||||||||||||
Preferred
stock dividend
beneficial
conversion
feature
|
- | - | - | - | - | - | - | (14,648,000 | ) | ||||||||||||||||||||||||
Conversion
of convertible
debt
into preferred stock
|
- | - | 2,273.3616 | - | 6,472,000 | - | - | - | |||||||||||||||||||||||||
Warrants
issued with
preferred
stock
|
- | - | - | - | 4,633,000 | - | - | - | |||||||||||||||||||||||||
Loss
on extinguishment
of
debt – preferred stock
|
- | - | - | - | 6,777,000 | - | - | - | |||||||||||||||||||||||||
Loss
on extinguishment
of
debt – warrants
|
- | - | - | - | 4,851,000 | - | - | - | |||||||||||||||||||||||||
Preferred
dividends
|
- | - | - | - | - | - | - | (260,000 | ) | ||||||||||||||||||||||||
Net
loss
|
- | - | - | - | - | - | - | (21,744,000 | ) | ||||||||||||||||||||||||
Balance,
December 31,
2007
|
3,585,000 | 36,000 | 3,227.3617 | - | 116,018,000 | (1,045,000 | ) | (4,000 | ) | (114,324,000 | ) |
Common
stock issued for
services
|
10,000 | - | - | - | 27,000 | - | - | - | |||||||||||||||||||||||||
Warrants
issued for
services
|
- | - | - | - | 350,000 | - | - | - | |||||||||||||||||||||||||
Options
exercised
|
25,000 | - | - | - | 15,000 | - | - | - | |||||||||||||||||||||||||
Stock
option
compensation
expense
|
- | - | - | - | 415,000 | - | - | - | |||||||||||||||||||||||||
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
|
- | - | - | - | - | - | - | (2,050,000 | ) | ||||||||||||||||||||||||
Net
loss
|
- | - | - | - | - | - | - | (17,215,000 | ) |
Balance,
December 31,
2008
|
6,967,000 | $ | 70,000 | 3,242.8617 | $ | - | $ | 127,482,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (134,897,000 | ) |
Access
Pharmaceuticals, Inc. and Subsidiaries
|
||||||||
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
||||||||
Year
ended December 31,
|
||||||||
2008
|
2007
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (17,215,000 | ) | $ | (21,744,000 | ) | ||
Adjustments
to reconcile net loss to net cash used
|
||||||||
in
operating activities:
|
||||||||
Loss
on extinguishment of debt
|
- | 11,628,000 | ||||||
Stock
option expense
|
415,000 | 1,048,000 | ||||||
Stock
and warrants issued for services
|
377,000 | 83,000 | ||||||
Acquired
in-process research & development
|
8,879,000 | - | ||||||
Depreciation
and amortization
|
253,000 | 279,000 | ||||||
Amortization
of debt costs and discounts
|
- | 2,316,000 | ||||||
Loss
on sale of assets
|
- | 2,000 | ||||||
Change
in operating assets and liabilities:
|
||||||||
Receivables
|
(747,000 | ) | (607,000 | ) | ||||
Prepaid
expenses and other current assets
|
(80,000 | ) | (127,000 | ) | ||||
Other
assets
|
(66,000 | ) | 14,000 | |||||
Accounts
payable and accrued expenses
|
176,000 | 310,000 | ||||||
Dividends
payable
|
19,000 | - | ||||||
Accrued
interest payable
|
(2,000 | ) | 1,150,000 | |||||
Deferred
revenue
|
1,431,000 | 805,000 | ||||||
Net
cash used in operating activities
|
(6,560,000 | ) | (4,843,000 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Capital
expenditures
|
(28,000 | ) | (18,000 | ) | ||||
Somanta
acquisition, net of cash acquired
|
(65,000 | ) | - | |||||
Proceeds
from sale of asset
|
- | 13,000 | ||||||
Net
cash used in investing activities
|
(93,000 | ) | (5,000 | ) | ||||
Cash
flows from financing activities:
|
||||||||
Payments
of notes payable
|
(64,000 | ) | (1,327,000 | ) | ||||
Proceeds
from preferred stock issuances, net of costs
|
2,444,000 | 8,672,000 | ||||||
Proceeds
from exercise of stock options
|
15,000 | 35,000 | ||||||
Net
cash provided by financing activities
|
2,395,000 | 7,380,000 | ||||||
Net
increase (decrease) in cash and cash equivalents
|
(4,258,000 | ) | 2,532,000 | |||||
Cash
and cash equivalents at beginning of year
|
6,921,000 | 4,389,000 | ||||||
Cash
and cash equivalents at end of year
|
$ | 2,663,000 | $ | 6,921,000 | ||||
Supplemental
cash flow information:
|
||||||||
Cash
paid for interest
|
$ | 435,000 | $ | 34,000 | ||||
Supplemental
disclosure of noncash transactions
|
||||||||
Shares
issued for payables
|
1,576,000 | - | ||||||
Preferred
stock dividends in dividends payable
|
1,896,000 | 260,000 | ||||||
Accrued
interest capitalized
|
- | 511,000 | ||||||
Warrants
issued for placement agent fees
|
104,000 | 523,000 | ||||||
Beneficial
conversion feature -
|
||||||||
February
2008 preferred stock dividends
|
857,000 | - | ||||||
November
2007 preferred stock dividends
|
451,000 | 14,648,000 | ||||||
Preferred
stock issuance costs paid in cash
|
281,000 | 345,000 | ||||||
Debt
exchanged for preferred stock
|
- | 10,015,000 | ||||||
Accrued
interest exchanges for preferred stock
|
- | 1,090,000 | ||||||
Stock
issued for preferred dividends
|
432,000 | - | ||||||
The
accompanying notes are an integral part of these consolidated
statements.
|
December 31, 2008
|
December 31, 2007
|
|||
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
|
Amortizable
intangible assets - Patents
|
$ 1,680
|
$1,138
|
$ 1,680
|
$ 970
|
2009 |
$ 168
|
2010 |
168
|
2011 |
168
|
2012 |
38
|
Total |
$ 542
|
2008
|
2007
|
|
Expected
volatility assumption was based upon a combination of historical stock
price volatility measured on a twice a month basis and is a reasonable
indicator of expected volatility.
|
133%
|
136%
|
Risk-free
interest rate assumption is based upon U.S. Treasury bond interest rates
appropriate for the term of the Company’s employee stock
options.
|
2.97%
|
4.65%
|
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.
|
6.2
years
|
5.7
years
|
Year
ended
December 31, 2008
|
Year
ended
December 31, 2007
|
|||||||
Research
and development
|
$ | 108 | $ | 91 | ||||
General
and administrative
|
307 | 957 | ||||||
Stock-based
compensation expense included in operating expense
|
415 | 1,048 | ||||||
Total
stock-based compensation expense
|
415 | 1,048 | ||||||
Tax
benefit
|
- | - | ||||||
Stock-based
compensation expense, net of tax
|
$ | 415 | $ | 1,048 | ||||
Fair
Value
|
||||||||||||||||
of
exercisable
|
||||||||||||||||
Consulting
|
Office
|
Expense
|
Options
/
|
|||||||||||||
Year |
Fees
|
Expenses
|
Reimbursement |
Warrants
|
||||||||||||
2008 | $ | 320,000 | $ | 30,000 | $ | 71,000 | $ | 164,000 | ||||||||
2007 | $ | 153,000 | $ | 15,000 | $ | 12,000 | $ | 76,000 |
Consulting
|
Expense
|
|||||||
Year |
Fees
|
Reimbursement
|
||||||
2008 | $ | 31,000 | $ | 3,000 | ||||
2007 | $ | 70,000 | $ | 2,000 |
Property and equipment consists of the following: |
December
31,
|
|||||||
2008
|
2007
|
|||||||
Laboratory equipment | $ | 831,000 | $ | 824,000 | ||||
Laboratory and building improvements | 58,000 | 58,000 | ||||||
Furniture and equipment | 75,000 | 40,000 | ||||||
964,000 | 922,000 | |||||||
Less accumulated depreciation and amortization | 877,000 | 792,000 | ||||||
Net property and equipment | $ | 87,000 | $ | 130,000 |
Future
|
||
Maturities
|
Debt
|
|
2011
|
5,500,000
|
Warrants
|
Exercise
|
Expiration
|
|||||
Summary
of Warrants
|
Outstanding
|
Price
|
Date
|
||||
2008
preferred stock offering (a)
|
499,584
|
$
|
3.50
|
2/24/14
|
|||
2008
Somanta accounts payable (b)
|
246,753
|
3.50
|
1/04/14
|
||||
2008
Warrants assumed on acquisition (c)
|
191,991
|
18.55-69.57
|
6/9/10-1/31/12
|
||||
2008
investor relations advisor (d)
|
50,000
|
3.15
|
1/3/13
|
||||
2008
investor relations advisor (e)
|
40,000
|
3.00
|
9/1/13
|
||||
2008
scientific consultant (f)
|
200,000
|
3.15
|
1/4/12
|
||||
2007
preferred stock offering (g)
|
3,649,880
|
3.50
|
11/10/13
|
||||
2006
convertible note (h)
|
3,863,634
|
1.32
|
2/16/12
|
||||
2006
convertible note (h)
|
386,364
|
1.32
|
10/24/12
|
||||
2006
convertible note (h)
|
386,364
|
1.32
|
12/06/12
|
||||
2006
investor relations advisor (i)
|
50,000
|
2.70
|
12/27/11
|
||||
2004
offering (j)
|
89,461
|
35.5
|
2/24/09
|
||||
2004
offering (j)
|
31,295
|
27.00
|
2/24/09
|
||||
2002
scientific consultant (k)
|
2,000
|
24.80
|
2/01/09
|
||||
Total
|
9,687,326
|
a)
|
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.
|
b)
|
In
exchange for $1,576,000 due Somanta vendors, the vendors were given
538,508 shares of common stock and warrants to purchase 246,753 shares of
common stock at $3.50. The warrants expire January 4,
2014.
|
c)
|
We
assumed three warrants in the Somanta
acquisition:
|
|
-Warrant
#2 – 31,943 shares of our common stock at $18.55 per share and expires
January 31, 2012.
|
|
-Warrant
#3 – 159,725 shares of our common stock at $23.19 per share and expires
January 31, 2012.
|
d)
|
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 to be
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.
|
e)
|
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.
|
f)
|
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.
|
g)
|
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.
|
h)
|
In
connection with the convertible note offerings in 2006, warrants to
purchase a total of 4,636,362 shares of common stock were issued. All of
the warrants are exercisable immediately and expire six years from date of
issue.
|
i)
|
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.
|
j)
|
In
connection with offering of common stock in 2004, warrants to purchase a
total of 120,756 shares of common stock were issued. All of the warrants
are exercisable and expire five years from date of
issuance.
|
k)
|
During
2002, a director who is also a scientific advisor received warrants to
purchase 2,000 shares of common stock at an exercise price of $24.55 per
share at any time until February 1, 2009, for scientific consulting
services rendered in 2002.
|
Weighted-
|
||||||||
average
|
||||||||
exercise
|
||||||||
Options
|
price
|
|||||||
Outstanding
options at January 1, 2007
|
802,672 | $ | 1.04 | |||||
Granted,
fair value of $ 3.27 per share
|
230,000 | 3.62 | ||||||
Exercised
|
(31,286 | ) | 1.11 | |||||
Expired
|
(75,000 | ) | 2.14 | |||||
Outstanding
options at December 31, 2007
|
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 | ||||||
Exercisable
at December 31, 2008
|
859,112 | 1.53 |
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 | 641,500 | 8.0 | $ | 0.63 | 641,500 | 8.0 | $ | 0.63 | |||||||||||||||||
$ | 2.90 - 7.23 | 495,320 | 9.2 | $ | 3.53 | 217,612 | 8.5 | $ | 4.16 | |||||||||||||||||
1,136,820 | 859,112 |
Weighted-
|
||||||||
average
|
||||||||
exercise
|
||||||||
Options
|
price
|
|||||||
Outstanding
options at January 1, 2007
|
360,917 | $ | 18.03 | |||||
Expired
|
(198,500 | ) | 20.07 | |||||
Outstanding
options at December 31, 2007
|
162,417 | 15.53 | ||||||
Expired
|
(44,417 | ) | 16.57 | |||||
Outstanding
options at December 31, 2008
|
118,000 | 15.14 | ||||||
Exercisable
at December 31, 2008
|
116,558 | 15.18 |
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
|
||||||||||||||||||||
$ | 10.00 - 12.50 | 75,640 | 4.2 | $ | 11.39 | 74,198 | 4.1 | $ | 11.39 | |||||||||||||||||
$ | 14.05 - 18.65 | 22,800 | 3.9 | $ | 17.76 | 22,800 | 3.9 | $ | 17.76 | |||||||||||||||||
$ | 20.25 – 29.25 | 19,560 | 5.3 | $ | 26.58 | 19,560 | 5.3 | $ | 26.58 | |||||||||||||||||
118,000 | 116,558 |
·
|
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
|
2007
|
|||||||
Net
loss allocable to common stockholders
|
$ | (20,573 | ) | $ | (33,902 | ) | ||
Net
loss per common shares (basic and diluted)
|
$ | (3.51 | ) | $ | (6.71 | ) | ||
Weighted
average common shares outstanding
(basic
and diluted)
|
5,854 | 5,052 |
2008
|
2007
|
|||||||
Income
taxes at U.S. statutory rate
|
$ | (6,995,000 | ) | $ | (7,393,000 | ) | ||
Change
in valuation allowance
|
2,155,000 | 3,015,000 | ||||||
Change
in miscellaneous items
|
- | - | ||||||
Benefit
of foreign losses not recognized
|
59,000 | 56,000 | ||||||
Expenses
not deductible
|
4,224,000 | 3,957,000 | ||||||
Expiration
of net operating loss and general
|
||||||||
business
credit carryforwards, net of revisions
|
557,000 | 365,000 | ||||||
Total
tax expense
|
$ | - | $ | - |
December
31,
|
||||||||
2008
|
2007
|
|||||||
Deferred
tax assets
|
||||||||
Net
operating loss carryforwards
|
$ | 26,289,000 | $ | 25,693,000 | ||||
General
business credit carryforwards
|
3,217,000 | 2,469,000 | ||||||
Property,
equipment and goodwill
|
54,000 | 87,000 | ||||||
Deferred
revenue
|
310,000 | - | ||||||
Other
|
534,000 | - | ||||||
Gross
deferred tax assets
|
30,404,000 | 28,249,000 | ||||||
Valuation
allowance
|
(30,404,000 | ) | (28,249,000 | ) | ||||
Net
deferred taxes
|
$ | - | $ | - |
Net
operating
|
General
business
|
|||||||
loss
carryforwards
|
credit
carryforwards
|
|||||||
2009
|
$ | 1,661,000 | $ | 193,000 | ||||
2010
|
2,171,000 | 157,000 | ||||||
2012
|
4,488,000 | 30,000 | ||||||
2013
|
4,212,000 | 94,000 | ||||||
2014
|
3,324,000 | 129,000 | ||||||
Thereafter
|
61,464,000 | 2,614,000 | ||||||
$ | 77,320,000 | $ | 3,217,000 |
2008
Quarter Ended
|
||||||||||||||||
March 31
|
June 30
|
September 30
|
December 31
|
|||||||||||||
Loss
from continuing operations
|
$ | (10,595 | ) | $ | (2,243 | ) | $ | (2,806 | ) | $ | (1,571 | ) | ||||
Preferred
stock dividends
|
(1,833 | ) | (517 | ) | (523 | ) | (485 | ) | ||||||||
Net
loss allocable to common
Stockholder
|
$ | (12,428 | ) | $ | (2,760 | ) | $ | (3,329 | ) | $ | (2,056 | ) | ||||
Basic
and diluted loss per
common
share
|
$ | (2.31 | ) | $ | (0.49 | ) | $ | (0.57 | ) | $ | (0.31 | ) | ||||
2007
Quarter Ended
|
||||||||||||||||
March 31
|
June 30
|
September 30
|
December 31
|
|||||||||||||
Loss
from continuing operations
|
$ | (4,127 | ) | $ | (2,109 | ) | $ | (1,957 | ) | $ | (13,663 | ) | ||||
Preferred
stock dividends
|
- | - | - | (14,908 | ) | |||||||||||
Discontinued
operations, net
of
tax
|
- | - | - | 112 | ||||||||||||
Net
loss allocable to common
Stockholder
|
$ | (4,127 | ) | $ | (2,109 | ) | $ | (1,957 | ) | $ | (28,459 | ) | ||||
Basic
and diluted loss per
common
share
|
$ | (1.17 | ) | $ | (0.60 | ) | $ | (0.55 | ) | $ | (8.00 | ) |
ASSETS
|
September 30, 2009
|
December 31, 2008
|
|
(unaudited)
|
(unaudited)
(See
Note 4)
|
||
Current
assets
Cash and cash
equivalents
Receivables
Prepaid expenses and other
current assets
|
$ 1,672,000
23,000
45,000
|
$ 2,677,000
147,000
175,000
|
|
Total
current assets
|
1,740,000
|
2,999,000
|
|
Property
and equipment, net
|
59,000
|
95,000
|
|
Patents,
net
|
840,000
|
999,000
|
|
Other
assets
|
66,000
|
78,000
|
|
Total
assets
|
$ 2,705,000
|
$ 4,171,000
|
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||
Current
liabilities
Accounts
payable
Accrued
expenses
Dividends
payable
Accrued
interest payable
Notes
payable
Current
portion of deferred revenue
|
$ 3,692,000
1,208,000
2,294,000
446,000
-
352,000
|
$ 3,287,000
1,295,000
1,896,000
145,000
825,000
164,000
|
|
Total current liabilities |
7,992,000
|
7,612,000
|
|
Long-term
deferred revenue
Long-term
debt
|
4,812,000
5,500,000
|
2,245,000
5,500,000
|
|
Total
liabilities
|
18,304,000
|
15,357,000
|
|
Commitments
and contingencies
|
|||
Stockholders'
deficit
Convertible
Series A preferred stock - $.01 par value; authorized
2,000,000
shares; 2,992.3617 issued and outstanding at
September 30, 2009
and 3,242.8617 at December 31, 2008
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
13,111,545 at September 30, 2009 and 9,467,474 at
December
31, 2008
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost – 163 shares
Accumulated
deficit
|
-
131,000
231,106,000
(1,045,000)
(4,000)
(245,787,000)
|
-
95,000
225,753,000
(1,045,000)
(4,000)
(235,985,000)
|
|
Total stockholders' deficit |
(15,599,000)
|
(11,186,000)
|
|
Total
liabilities and stockholders' deficit
|
$ 2,705,000
|
$ 4,171,000
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
(See
Note 4)
|
(See
Note 4)
|
(See
Note 4)
|
||||||||||||||
Revenues
|
||||||||||||||||
License
revenues
|
$ | 124,000 | $ | 38,000 | $ | 228,000 | $ | 77,000 | ||||||||
Royalties
|
20,000 | - | 20,000 | - | ||||||||||||
Sponsored research and
development
|
- | 9,000 | - | 140,000 | ||||||||||||
Total revenues
|
144,000 | 47,000 | 248,000 | 217,000 | ||||||||||||
Expenses
|
||||||||||||||||
Research and
development
|
561,000 | 1,670,000 | 1,830,000 | 22,682,000 | ||||||||||||
General and
administrative
|
3,458,000 | 2,167,000 | 6,212,000 | 6,285,000 | ||||||||||||
Depreciation and
amortization
|
65,000 | 80,000 | 197,000 | 246,000 | ||||||||||||
Total expenses
|
4,084,000 | 3,917,000 | 8,239,000 | 29,213,000 | ||||||||||||
Loss
from operations
|
(3,940,000 | ) | (3,870,000 | ) | (7,991,000 | ) | (28,996,000 | ) | ||||||||
Interest
and miscellaneous income
|
2,000 | 32,000 | 18,000 | 173,000 | ||||||||||||
Interest
and other expense
|
(133,000 | ) | (183,000 | ) | (395,000 | ) | (512,000 | ) | ||||||||
(131,000 | ) | (151,000 | ) | (377,000 | ) | (339,000 | ) | |||||||||
Net
loss
|
(4,071,000 | ) | (4,021,000 | ) | (8,368,000 | ) | (29,335,000 | ) | ||||||||
Less
preferred stock dividends
|
471,000 | 523,000 | 1,434,000 | 2,873,000 | ||||||||||||
Net
loss allocable to common stockholders
|
$ | (4,542,000 | ) | $ | (4,544,000 | ) | $ | (9,802,000 | ) | $ | (32,208,000 | ) | ||||
Basic
and diluted loss per common share
Net
loss allocable to common shareholders
|
$ | (0.37 | ) | $ | (0.55 | ) | $ | (0.86 | ) | $ | (3.97 | ) | ||||
Weighted
average basic and diluted
common shares
outstanding
|
12,204,696 | 8,303,457 | 11,375,793 | 8,107,247 | ||||||||||||
Common Stock
|
Preferred Stock
|
Additional
paid-in
capital
|
Notes
receivable from
stockholders
|
Treasury
stock
|
Accumulated
deficit
|
|||
Shares
|
Amount
|
Shares
|
Amount
|
Access-MacroChem,
as
if combined at
December
31, 2008
(See
Note 4)
|
9,467,000 | $ | 95,000 | 3,242.8617 | $ | - | $ | 225,753,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (235,985,000 | ) | |||||||||||||||
Common
stock issued for
preferred
dividends
|
894,000 | 9,000 | - | - | 847,000 | - | - | - | ||||||||||||||||||||||||
Warrants
issued for
services
|
- | - | - | - | 24,000 | - | - | - | ||||||||||||||||||||||||
Stock
option
compensation
expense
|
- | - | - | - | 56,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued to
MacroChem
noteholders
for notes
and accrued
interest
|
859,000 | 8,000 | - | - | 851,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued to
former
MacroChem
executives
|
95,000 | 1,000 | - | - | 132,000 | - | - | - | ||||||||||||||||||||||||
Preferred
dividends
|
- | - | - | - | - | - | - | (480,000 | ) | |||||||||||||||||||||||
Net
loss
|
- | - | - | - | - | - | - | (2,089,000 | ) | |||||||||||||||||||||||
Balance at
March 31, 2009
|
11,315,000 | 113,000 | 3,242.8617 | - | 227,663,000 | (1,045,000 | ) | (4,000 | ) | (238,554,000 | ) | |||||||||||||||||||||
Warrants
issued for
services
|
- | - | - | - | 27,000 | - | - | - | ||||||||||||||||||||||||
Stock
option
compensation
expense
|
- | - | - | - | 252,000 | - | - | - | ||||||||||||||||||||||||
Preferred
stock converted
into
common stock
|
117,000 | 1,000 | (35.0000 | ) | - | (1,000 | ) | - | - | - | ||||||||||||||||||||||
Common
stock issued to
former
MacroChem
executives
|
30,000 | - | - | - | 64,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued
for
cash exercise of
options
|
25,000 | - | - | - | 14,000 | - | - | - | ||||||||||||||||||||||||
Restricted
common stock
issued
for services
|
127,000 | 2,000 | - | - | 314,000 | - | - | - | ||||||||||||||||||||||||
Preferred
dividends
|
- | - | - | - | - | - | - | (483,000 | ) | |||||||||||||||||||||||
Net
loss
|
- | - | - | - | - | - | - | (2,208,000 | ) | |||||||||||||||||||||||
Balance at
June 30, 2009
|
11,614,000 | 116,000 | 3,207.8617 | - | 228,333,000 | (1,045,000 | ) | (4,000 | ) | (241,245,000 | ) | |||||||||||||||||||||
Warrants
issued for
services
|
- | - | - | - | 503,000 | - | - | - | ||||||||||||||||||||||||
Stock
option
compensation
expense
|
- | - | - | - | 285,000 | - | - | - | ||||||||||||||||||||||||
Preferred
stock converted
into
common stock
|
719,000 | 8,000 | (215.5000 | ) | - | (8,000 | ) | - | - | - | ||||||||||||||||||||||
Common
stock issued for
preferred
dividends
|
21,000 | - | - | - | 71,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued
for
cash exercise of
options
|
210,000 | 2,000 | - | - | 142,000 | - | - | - | ||||||||||||||||||||||||
Common
stock issued
for
warrant exercises
|
33,000 | - | - | - | - | - | - | - | ||||||||||||||||||||||||
Restricted
common stock
issued
for services
|
515,000 | 5,000 | - | - | 1,780,000 | - | - | - | ||||||||||||||||||||||||
Preferred
dividends
|
- | - | - | - | - | - | - | (471,000 | ) | |||||||||||||||||||||||
Net
loss
|
- | - | - | - | - | - | - | (4,071,000 | ) | |||||||||||||||||||||||
Balance at
September 30, 2009
|
13,112,000 | $ | 131,000 | 2,992.3617 | $ | - | $ | 231,106,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (245,787,000 | ) | |||||||||||||||
Nine
Months ended September 30,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (8,368,000 | ) | $ | (29,335,000 | ) | ||
Adjustments to
reconcile net loss to net cash used
in
operating activities:
|
||||||||
Depreciation and
amortization
|
197,000 | 245,000 | ||||||
Stock option
expense
|
593,000 | 899,000 | ||||||
Stock and warrants issued for
services
|
2,852,000 | 427,000 | ||||||
Acquired in-process research
and development
|
- | 18,536,000 | ||||||
Change in operating assets and
liabilities:
|
||||||||
Receivables
|
124,000 | (295,000 | ) | |||||
Prepaid expenses and other current assets
|
130,000 | (121,000 | ) | |||||
Other assets
|
12,000 | - | ||||||
Accounts payable and accrued expenses
|
318,000 | 317,000 | ||||||
Dividends
payable
|
(109,000 | ) | (25,000 | ) | ||||
Accrued interest
payable
|
334,000 | 315,000 | ||||||
Deferred
revenue
|
2,755,000 | 1,475,000 | ||||||
Net cash used in operating
activities
|
(1,162,000 | ) | (7,562,000 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Capital
expenditures
|
(2,000 | ) | (31,000 | ) | ||||
Proceeds from sale of
asset
|
1,000 | - | ||||||
Redemptions of short-term
investments and certificate
of
deposits
|
- | 3,104,000 | ||||||
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 | ) | 2,768,000 | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds from debt
issuance
|
- | 625,000 | ||||||
Payments
of notes payable
|
- | (639,000 | ) | |||||
Proceeds from exercise of
common stock options
|
158,000 | 15,000 | ||||||
Proceeds
from preferred stock issuances, net of costs
|
- | 2,444,000 | ||||||
Net cash provided by financing
activities
|
158,000 | 2,445,000 | ||||||
Net
decrease in cash and cash equivalents
|
(1,005,000 | ) | (2,349,000 | ) | ||||
Cash
and cash equivalents at beginning of period
|
2,677,000 | 2,582,000 | ||||||
Cash
and cash equivalents at end of period
|
$ | 1,672,000 | $ | 233,000 | ||||
Supplemental
cash flow information:
|
||||||||
Cash
paid for interest
|
$ | - | $ | 9,000 | ||||
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 | - | ||||||
Preferred
stock dividends in dividends payable
|
1,434,000 | 2,873,000 | ||||||
Beneficial
conversion feature –
February
2008 preferred stock dividends
November
2007 preferred stock dividends correction
|
- - | 857,000 451,000 | ||||||
Preferred
stock issuance costs paid in cash
|
- | 281,000 | ||||||
Debt
discount related to MacroChem convertible debt issuance
|
- | 93,000 |
(1)
|
Interim
Financial Statements
|
September
30, 2009
|
December
31, 2008
|
|||
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
Amortization
|
|
Amortizable
intangible assets
Patents
|
$ 2,624
|
$ 1,784
|
$ 2,624
|
$1,625
|
2009 |
$ 53
|
|
2010 |
212
|
|
2011 |
212
|
|
2012 |
82
|
|
2013 |
44
|
|
over 5 years |
237
|
|
Total |
$ 840
|
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 nine months ended September 30,
2009
|
For the year ended December 31,
2008
|
|||||
Access
Pharmaceuticals
|
MacroChem
Corporation
|
Combined
|
Access
Pharmaceuticals
|
MacroChem
Corporation
|
Combined
|
Total
revenues
|
$ | 248,000 | $ | - | $ | 248,000 | $ | 291,000 | $ | 4,000 | $ | 295,000 | ||||||||||||
Expenses
|
||||||||||||||||||||||||
Research
and development
|
1,830,000 | - | 1,830,000 | 12,613,000 | 10,622,000 | 23,235,000 | ||||||||||||||||||
General
and administrative
|
6,020,000 | 192,000 | 6,212,000 | 4,340,000 | 3,123,000 | 7,463,000 | ||||||||||||||||||
Depreciation
and
amortization
|
156,000 | 41,000 | 197,000 | 253,000 | 71,000 | 324,000 | ||||||||||||||||||
Total
expenses
|
8,006,000 | 233,000 | 8,239,000 | 17,206,000 | 13,816,000 | 31,022,000 | ||||||||||||||||||
Loss
from operations
|
(7,758,000 | ) | (233,000 | ) | (7,991,000 | ) | (16,915,000 | ) | (13,812,000 | ) | (30,727,000 | ) | ||||||||||||
Interest
and miscellaneous
income
|
18,000 | - | 18,000 | 178,000 | 33,000 | 211,000 | ||||||||||||||||||
Interest
and other expense
|
(369,000 | ) | (26,000 | ) | (395,000 | ) | (478,000 | ) | (433,000 | ) | (911,000 | ) | ||||||||||||
Gain
on change in value of
warrant
liability
|
- | - | - | - | 3,972,000 | 3,972,000 | ||||||||||||||||||
(351,000 | ) | (26,000 | ) | (377,000 | ) | (300,000 | ) | 3,572,000 | 3,272,000 | |||||||||||||||
Loss
from operations
|
(8,109,000 | ) | (259,000 | ) | (8,368,000 | ) | (17,215,000 | ) | (10,240,000 | ) | (27,455,000 | ) | ||||||||||||
Less
preferred stock
dividends
|
(1,434,000 | ) | - | (1,434,000 | ) | (3,358,000 | ) | - | (3,358,000 | ) | ||||||||||||||
Net
loss allocable to
common
stockholders
|
$ | (9,543,000 | ) | $ | (259,000 | ) | $ | (9,802,000 | ) | $ | (20,573,000 | ) | $ | (10,240,000 | ) | $ | (30,813,000 | ) | ||||||
Basic
and diluted loss per
common
share
|
||||||||||||||||||||||||
Net
loss allocable to
common
stockholders
|
- | - | $ | (0.86 | ) | - | - | $ | (3.69 | ) | ||||||||||||||
Weighted
average basic
and
diluted common
shares
outstanding
|
- | - | 11,375,793 | - | - | 8,354,031 |
For the nine months ended September 30,
2008
|
For the three months ended September 30,
2008
|
|||||
Access
Pharmaceuticals
|
MacroChem
Corporation
|
Combined
|
Access
Pharmaceuticals
|
MacroChem
Corporation
|
Combined
|
Total
revenues
|
$ | 217,000 | $ | 3,000 | $ | 220,000 | $ | 47,000 | $ | 1,000 | $ | 48,000 | ||||||||||||
Expenses
|
||||||||||||||||||||||||
Research
and development
|
12,108,000 | 10,574,000 | 22,682,000 | 1,284,000 | 386,000 | 1,670,000 | ||||||||||||||||||
General
and administrative
|
3,372,000 | 2,913,000 | 6,285,000 | 1,439,000 | 728,000 | 2,167,000 | ||||||||||||||||||
Depreciation
and
amortization
|
197,000 | 49,000 | 246,000 | 66,000 | 14,000 | 80,000 | ||||||||||||||||||
Total
expenses
|
15,677,000 | 13,536,000 | 29,213,000 | 2,789,000 | 1,128,000 | 3,917,000 | ||||||||||||||||||
Loss
from operations
|
(15,460,000 | ) | (13,533,000 | ) | (28,993,000 | ) | (2,742,000 | ) | (1,127,000 | ) | (3,869,000 | ) | ||||||||||||
Interest
and miscellaneous
income
|
167,000 | 6,000 | 173,000 | 62,000 | - | 62,000 | ||||||||||||||||||
Interest
and other expense
|
(351,000 | ) | (161,000 | ) | (512,000 | ) | (126,000 | ) | (86,000 | ) | (212,000 | ) | ||||||||||||
Gain
(loss) on change in
warrant
value
|
- | 3,886,000 | 3,886,000 | - | 419,000 | 419,000 | ||||||||||||||||||
(184,000 | ) | 3,731,000 | 3,547,000 | (64,000 | ) | 333,000 | 269,000 | |||||||||||||||||
Loss
from operations
|
(15,644,000 | ) | (9,802,000 | ) | (25,446,000 | ) | (2,806,000 | ) | (794,000 | ) | (3,600,000 | ) | ||||||||||||
Less
preferred stock
dividends
|
(2,873,000 | ) | - | (2,873,000 | ) | (523,000 | ) | - | (523,000 | ) | ||||||||||||||
Net
loss allocable to
common
stockholders
|
$ | (18,517,000 | ) | $ | (9,802,000 | ) | $ | (28,319,000 | ) | $ | (3,329,000 | ) | $ | (794,000 | ) | $ | (4,123,000 | ) | ||||||
Basic
and diluted loss per
common
share
|
||||||||||||||||||||||||
Net
loss allocable to
common
stockholders
|
- | - | $ | (3.49 | ) | - | - | $ | (0.50 | ) | ||||||||||||||
Weighted
average basic
and
diluted common
shares
outstanding
|
- | - | 8,107,242 | - | - | 8,303,457 |
Three months
ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Research
and development
|
$ | 130,000 | $ | 39,000 | $ | 250,000 | $ | 78,000 | ||||||||
General
and administrative
|
155,000 | 187,000 | 343,000 | 821,000 | ||||||||||||
Stock-based
compensation expense
included
in operating expense
|
$ | 285,000 | $ | 226,000 | $ | 593,000 | $ | 899,000 |
9/30/09
|
9/30/08
|
|||
Expected
life
|
5.5
yrs
|
6.2
yrs
|
||
Risk
free interest rate
|
2.4
|
%
|
3.0
|
%
|
Expected
volatility(a)
|
114
|
%
|
133
|
%
|
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.
|
INDEX
|
||
Page No.
|
||
Report
of Independent Public Accounting Firm
|
F-35
|
|
Consolidated
Balance Sheet at December 31, 2008
|
F-36
|
|
Consolidated
Statement of Operations for Year Ended December 31, 2008
|
F-37
|
|
Consolidated
Statement of Stockholders’ Deficit for Year Ended December 31,
2008
|
F-38
|
|
Consolidated
Statement of Cash Flows Year ended December 31, 2008
|
F-39
|
|
Notes
to Consolidated Financial Statements
|
F-40
|
|
ASSETS
|
December 31, 2008
|
Current
assets
Cash and cash
equivalents
|
$ 14,000
|
Prepaid
expenses and other current assets
|
70,000
|
Total
current assets
|
84,000
|
Property
and equipment, net
|
8,000
|
Patents,
net
|
457,000
|
Total
assets
|
$ 549,000
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|
Current
liabilities
Accounts
payable
Accrued
expenses and other liabilities
Accrued
interest payable
Current
portion of deferred revenue
Note
payable – Access Pharmaceuticals, Inc.
Note
payable – related party
Notes
payable
|
$ 1,317,000
547,000
17,000
5,000
635,000
225,000
600,000
|
Total
current liabilities
|
3,346,000
|
Long-term
deferred revenue
Warrants
liability
|
24,000
104,000
|
Total
liabilities
|
3,474,000
|
Commitments
and contingencies
|
|
Stockholders'
deficit
Common
stock - $.01 par value; authorized 100,000,000 shares;
45,873,412
issued at December 31, 2008; 22,500,026 issued
at
December 31, 2007
Additional
paid-in capital
Treasury
stock, at cost – 529 shares
Accumulated
deficit
|
459,000
97,763,000
(59,000)
(101,088,000)
|
Total
stockholders' deficit
|
(2,925,000)
|
Total
liabilities and stockholders' deficit
|
$ 549,000
|
Year
Ended
December
31,
2008
|
||||
Revenues:
|
||||
License
revenues
|
$ | 4,000 | ||
Total revenues
|
4,000 | |||
Expenses:
|
||||
Research and
development
|
10,622,000 | |||
General and
administrative
|
3,123,000 | |||
Depreciation and
amortization
|
71,000 | |||
Total expenses
|
13,816,000 | |||
Loss
from operations
|
(13,812,000 | ) | ||
Interest
and other income
|
26,000 | |||
Interest
and other expense
|
(433,000 | ) | ||
Gain
on change in value of warrants liability
|
3,972,000 | |||
Gain
on sale of equipment
|
7,000 | |||
3,572,000 | ||||
Net
loss
|
$ | (10,240,000 | ) | |
Basic
and diluted loss per common share
|
$ | (0.26 | ) | |
Weighted
average basic and diluted common shares
outstanding
|
38,934,207 | |||
Common Stock Shares
|
||||||||||||||||||||||||||||
Issued
|
Treasury
|
Common
Stock
|
Additional
Paid-In
Capital
|
Accumulated
Deficit
|
Treasury
Stock,
at
cost
|
Total
Stockholders’
Deficit
|
||||||||||||||||||||||
Balance,
December
31, 2007
|
22,500,026 | (529 | ) | $ | 225,000 | $ | 90,054,000 | $ | (90,848,000 | ) | $ | (59,000 | ) | $ | (628,000 | ) | ||||||||||||
Common
stock and
warrants
issued to
Virium
shareholders
|
22,898,386 | - | 229,000 | 6,788,000 | - | - | 7,017,000 | |||||||||||||||||||||
Common
stock
issued
for services
|
400,000 | - | 4,000 | 116,000 | - | - | 120,000 | |||||||||||||||||||||
Warrants
issued with
debt
|
- | - | - | 75,000 | - | - | 75,000 | |||||||||||||||||||||
Warrants
issued for
services
|
- | - | - | 36,000 | - | - | 36,000 | |||||||||||||||||||||
Convertible
notes
beneficial
conversion
feature
|
- | - | - | 188,000 | - | - | 188,000 | |||||||||||||||||||||
Stock-based
compensation
expense
|
75,000 | - | 1,000 | 506,000 | - | - | 507,000 | |||||||||||||||||||||
Net
loss
|
- | - | - | - | (10,240,000 | ) | - | (10,240,000 | ) | |||||||||||||||||||
Balance,
December
31, 2008
|
45,873,412 | (529 | ) | $ | 459,000 | $ | 97,763,000 | $ | (101,088,000 | ) | $ | (59,000 | ) | $ | (2,925,000 | ) |
Year
ended December 31,
|
||
2008 | ||
Cash
flows from operating activities:
|
||
Net
loss
|
$
|
(10,240,000)
|
Adjustments
to reconcile net loss to net cash used
|
||
in
operating activities:
|
||
Stock
based compensation expense
|
507,000
|
|
Stock
and warrants issued for services
|
156,000
|
|
Acquired
in-process research and development
|
9,661,000
|
|
Depreciation
and amortization
|
71,000
|
|
Amortization
of debt discount and beneficial conversion feature
|
263,000
|
|
Gain
on change in value of warrants liability
|
(3,972,000)
|
|
Gain
on sale of equipment
|
(7,000)
|
|
Change
in operating assets and liabilities:
|
||
Prepaid
expenses and other current assets
|
61,000
|
|
Accounts
payable and accrued expenses
|
84,000
|
|
Accrued
interest payable
|
17,000
|
|
Net
cash used in operating activities
|
(3,399,000)
|
|
Cash
flows from investing activities:
|
||
Sales
of short-term investments
|
759,000
|
|
Expenditures
for property and equipment
|
(3,000)
|
|
Proceeds
from sale of asset
|
13,000
|
|
Payments
for acquisition of Virium, net of cash acquired
|
(240,000)
|
|
Net
cash provided by investing activities
|
529,000
|
|
Cash
flows from financing activities:
|
||
Proceeds
from debt issuance
|
400,000
|
|
Proceeds
from note payable – Access Pharmaceuticals, Inc.
|
635,000
|
|
Repayment
of debt
|
(575,000)
|
|
Net
cash provided by financing activities
|
460,000
|
|
Net
decrease in cash and cash equivalents
|
(2,410,000)
|
|
Cash
and cash equivalents at beginning of year
|
2,424,000
|
|
Cash
and cash equivalents at end of year
|
$
|
14,000
|
Supplemental
cash flow information:
|
||
Cash
paid for interest
|
$ |
133,000
|
1.
|
Nature
of Business and Summary of Significant Accounting
Policies.
|
Gross
carrying value
|
$ | 944,000 | ||
Accumulated
amortization
|
(487,000 | ) | ||
Net
asset value
|
$ | 457,000 |
2009
|
$ | 45 | ||
2010
|
45 | |||
2011
|
45 | |||
2012
|
45 | |||
2013
and thereafter
|
277 | |||
Total
|
$ | 457 |
Year
Ended
December
31,
2008
|
||||
General
and administrative
|
$
|
507,000
|
Basic
and Diluted Income (Loss) Per Share
|
Year
Ended
December
31,
2008
|
|||
Basic
net (loss) income attributable to common stockholders
|
$
|
(10,240,000
|
)
|
|
Basic
and diluted net (loss) income per common share
|
$
|
(0.26
|
)
|
|
Weighted
average shares used to compute basic and diluted net (loss) income per
common share
|
38,934,207
|
2.
|
Property
and Equipment.
|
2008
|
||||
Office
equipment
|
$ | 493,000 | ||
Less:
accumulated depreciation
|
(485,000 | ) | ||
Property
and equipment, net
|
$ | 8,000 | ||
3.
|
Accrued
Expenses and Other Liabilities.
|
Year
Ended
December
31,
2008
|
|
Risk-free
interest rate
|
2.96
%
|
Expected
life of option grants
|
6.0
years
|
Expected
volatility of underlying stock
|
111
%
|
Expected
dividend payment rate, as a percentage of the stock price on the date of
grant
|
0
%
|
Number
of
Shares
|
Weighted
Average
Exercise
Price
Per
Share
|
Weighted-Average
Remaining
Contractual
Term
|
||||||
Balance,
December 31, 2007
|
3,020,249
|
$
|
3.90
|
|||||
Granted
|
4,840,000
|
0.30
|
||||||
Exercised
|
——
|
|||||||
Canceled
|
(3,734,017
|
)
|
$
|
2.66
|
||||
Outstanding at,
December 31,
2008
|
4,126,232
|
$
|
0.58
|
8.92
|
||||
Exercisable,
December 31, 2008
|
1,939,417
|
$
|
2.58
|
8.63
|
Outstanding
|
Weighted
|
Weighted
|
|||
Weighted-Average
|
Average
|
Exercisable
|
Average
|
||
Number
of
|
Remaining
|
Exercise
|
Number
|
Exercise
|
|
Exercise Price
|
Shares
|
Contractual Life (in Yrs)
|
Price
|
of Shares
|
Price
|
$0.24
- $0.30
|
2,540,000
|
9.39
|
$0.29
|
927,498
|
$3.40
|
$0.60
- $1.62
|
1,575,000
|
8.18
|
$0.88
|
1,000,687
|
$1.60
|
$10.50
- $69.30
|
11,232
|
6.19
|
$22.76
|
11,232
|
$22.76
|
4,126,232
|
1,939,417
|
6.
|
Stockholders’
Equity.
|
7.
|
Commitments
and Contingencies.
|
8.
|
Virium
Pharmaceuticals, Inc. Acquisition.
|
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
|
9.
|
Income
Taxes.
|
2008
|
||||
Income
taxes at U.S. statutory rate
|
$ | (3,482,000 | ) | |
Change
in valuation allowance
|
4,832,000 | |||
Expenses
not deductible
|
(1,350,000 | ) | ||
Total
tax expense
|
$ | - |
December
31,
|
||||
2008
|
||||
Deferred
tax assets
|
||||
Net
operating loss carryforwards
|
$ | 33,650,000 | ||
State
credit
|
2,393,000 | |||
Intangible
assets
|
383,000 | |||
Accrued
interest
|
253,000 | |||
Deferred
revenue
|
14,000 | |||
Other
|
231,000 | |||
Gross
deferred tax assets
|
36,924,000 | |||
Valuation
allowance
|
(36,924,000 | ) | ||
Net
deferred taxes
|
$ | - |
10.
|
Employee
Benefit Plan.
|
11.
|
Subsequent
Event - Merger with Access Pharmaceuticals, Inc.
(Unaudited)
|
·
|
Approximately
2.5 million shares of Access common stock was issued to the common
shareholders and the in-the-money ($0.01) warrant holders of MacroChem as
consideration having a value of approximately $3.5 million (the value was
calculated using Access’ stock price on February 25, 2009 times the shares
issued);
|
·
|
an
aggregate of $106,000 in direct transaction costs;
and
|
·
|
cancelled
receivable from MacroChem of
$635,000.
|
Access
|
MacroChem
|
Pro
Forma
Adjustments
|
Pro
Forma
Combined
|
|||||||||||||
ASSETS
|
||||||||||||||||
Current
assets
|
||||||||||||||||
Cash
and cash equivalents
|
$
|
2,663,000
|
$
|
14,000
|
$
|
2,677,000
|
||||||||||
Receivables
|
147,000
|
-
|
147,000
|
|||||||||||||
Receivables
due from MacroChem
|
635,000
|
-
|
(635,000
|
)
|
(f)
|
-
|
||||||||||
Prepaid
expenses and other current expenses
|
105,000
|
70,000
|
175,000
|
|||||||||||||
Total
current assets
|
3,550,000
|
84,000
|
2,999,000
|
|||||||||||||
Property
and equipment, net
|
87,000
|
8,000
|
95,000
|
|||||||||||||
Patents
net
|
542,000
|
457,000
|
999,000
|
|||||||||||||
Other
assets
|
78,000
|
-
|
78,000
|
|||||||||||||
Total
assets
|
$
|
4,257,000
|
$
|
549,000
|
$
|
4,171,000
|
||||||||||
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
||||||||||||||||
Current
liabilities
|
||||||||||||||||
Accounts
payable
|
$
|
1,970,000
|
$
|
1,317,000
|
106,000
|
(e)
|
$
|
3,393,000
|
||||||||
Accrued
expenses
|
748,000
|
547,000
|
1,295,000
|
|||||||||||||
Dividends
payable
|
1,896,000
|
-
|
1,896,000
|
|||||||||||||
Accrued
interest payable
|
128,000
|
17,000
|
(17,000
|
)
|
(b)
|
128,000
|
||||||||||
Current
portion of deferred revenue
|
164,000
|
5,000
|
(5,000
|
)
|
(d)
|
164,000
|
||||||||||
Notes
payable
|
-
|
825,000
|
(825,000
|
)
|
(b)
|
-
|
||||||||||
Payables
due Access
|
-
|
635,000
|
(635,000
|
)
|
(f)
|
-
|
||||||||||
Total
current liabilities
|
4,906,000
|
3,346,000
|
6,876,000
|
|||||||||||||
Long-term
deferred revenue
|
2,245,000
|
24,000
|
(24,000
|
)
|
(d)
|
2,245,000
|
||||||||||
Warrants
liability
|
-
|
104,000
|
(104,000
|
)
|
(d)
|
-
|
||||||||||
Long-term
debt
|
5,500,000
|
-
|
5,500,000
|
|||||||||||||
Total
liabilities
|
12,651,000
|
3,474,000
|
14,621,000
|
|||||||||||||
Stockholders’
equity (deficit)
|
||||||||||||||||
Preferred
stock
|
-
|
-
|
-
|
|||||||||||||
Common
stock
|
70,000
|
459,000
|
25,000
8,000
1,000
(459,000
|
)
|
(a)
(b)
(c)
(d)
|
104,000
|
||||||||||
Additional
paid-in capital
|
127,482,000
|
97,763,000
|
508,000
834,000
196,000
|
(a)
(b)
(c)
|
226,783,000
|
|||||||||||
Notes
receivable from stockholders
|
(1,045,000
|
)
|
(1,045,000
|
)
|
||||||||||||
Treasury
stock, at cost
|
(4,000
|
)
|
(59,000
|
)
|
59,000
|
(d)
|
(4,000
|
)
|
||||||||
Accumulated
deficit
|
(134,897,000
|
)
|
(101,088,000
|
)
|
(197,000
|
)
|
(c)
|
(236,288,000
|
)
|
|||||||
(106,000
|
)
|
(e)
|
||||||||||||||
Total
stockholders’ equity (deficit)
|
(8,394,000
|
)
|
(2,925,000
|
)
|
(10,450,000
|
)
|
||||||||||
Total
liabilities and stockholders’ equity (deficit)
|
$
|
4,257,000
|
$
|
549,000
|
$
|
4,171,000
|
a)
|
To
record the exchange, for accounting purposes, by MacroChem shareholders of
their common stock and in-the-money warrants for 2,500,000 shares of
Access and $508,000 impact of pro-forma adjustments to additional paid-in
capital.
|
b)
|
To
record Access common stock exchanged for notes payable of $825,000 and
accrued interest of $17,000.
|
c)
|
To
record Access common stock issued to former executives of MacroChem for
the settlement of employment
agreements.
|
d)
|
To
eliminate the common stock, treasury stock, warrant liabilities and
deferred revenue of MacroChem.
|
e)
|
To
record $106,000 in merger costs.
|
f)
|
To
eliminate intercompany notes payable/receivable of
$635,000.
|
Access
|
MacroChem
|
Pro
Forma
Combined
|
||||||||
Revenues
|
$
|
291,000
|
$
|
4,000
|
$
|
295,000
|
||||
Expenses
|
||||||||||
Research
and development
|
12,613,000
|
10,622,000
|
23,235,000
|
|||||||
General
and administrative
|
4,340,000
|
3,123,000
|
7,463,000
|
|||||||
Depreciation
and amortization
|
253,000
|
71,000
|
324,000
|
|||||||
Total
expenses
|
17,206,000
|
13,816,000
|
31,022,000
|
|||||||
Loss
from operations
|
(16,915,000
|
)
|
(13,812,000
|
)
|
(30,727,000
|
)
|
||||
Interest
and other income
|
178,000
|
33,000
|
211,000
|
|||||||
Interest
and other expenses
|
(478,000
|
)
|
(433,000
|
)
|
(911,000
|
)
|
||||
Change
in fair value of warrants liability
|
-
|
3,972,000
|
3,972,000
|
|||||||
(300,000
|
)
|
3,572,000
|
3,272,000
|
|||||||
Net
loss
|
(17,215,000
|
)
|
(10,240,000)
|
(27,455,000
|
)
|
|||||
Less
preferred stock dividends
|
(3,358,000
|
)
|
-
|
(3,358,000
|
)
|
|||||
Net
loss allocable to common stockholders
|
$
|
(20,573,000
|
)
|
$
|
(10,240,000
|
)
|
$
|
(30,813,000
|
)
|
|
Basic
and diluted loss per common share
Loss
from operations allocable to
all
common stockholders
|
$
|
(3.51
|
)
|
$
|
(0.26
|
)
|
$
|
(3.31
|
)
|
|
Weighted
average basic and diluted common shares outstanding
|
5,854,031
|
38,934,207
|
9,321,031
|
Historical
|
5,854,031
|
|
MacroChem
equivalent shares giving effect to the merger
|
2,500,000
|
|
Shares
issued to former MacroChem executives
|
125,000
|
|
Shares
issued for notes payable and interest
|
842,000
|
|
Total
|
9,321,031
|