|
|
|
|
|
Delaware
|
|
3841
|
|
83-0221517
|
(State
or jurisdiction of
incorporation
or organization)
|
|
(Primary
Standard Industrial
Classification
Code Number)
|
|
(I.R.S.
Employer
Identification
Number)
|
Jack
Concannon, Esq.
|
Bingham
McCutchen LLP
|
150
Federal Street
|
Boston,
MA 02110
|
(617)
951-8000
|
Title
of Each Class
of
Securities Being Registered
|
Amount
Being Registered
|
Proposed
Maximum Offering Price Per Share
|
Proposed
Maximum Aggregate Offering Price
|
Amount
of
Registration
Fee
|
Common
Stock, $0.01 par value per share
|
9,298,170
(1)
|
$1.18
(2)
|
$10,971,840
|
$
1,173.99 (2)
|
|
|
(1)
|
86,083
shares and 3,863,634 shares are issuable to selling stockholders
upon
exercise of warrants for the purchase of shares of the Registrant’s Common
Stock and 5,348,453 shares of Common Stock are issuable to selling
stockholders upon conversion
of notes. All share numbers in this Registration Statement and the
accompanying prospectus reflect a one-for-five reverse stock split
of the
Company’s common Stock which was effected June 5, 2006.
|
|
|
(2)
|
The
registrant previously paid $1,173.99 of the registration fee in connection
with the filing of its Form S-1 Registration Statement filed with
the
Securities and Exchange Commission on July 12,
2006.
|
Page
|
|
|
|
|
|
Prospectus
Summary
|
1
|
|
Summary
Consolidated Financial Information
|
5
|
|
Risk
Factors
|
6
|
|
Forward-Looking
Statements
|
13
|
|
Use
of Proceeds
|
14
|
|
Determination
of Offering Price
|
14
|
|
Selling
Security Holders
|
14
|
|
Dilution
|
16
|
|
Plan
of Distribution
|
16
|
|
Management’s
Discussion and Analysis or Plan of Operations
|
18
|
|
Description
of Business
|
27
|
|
Description
of Property
|
38
|
|
Changes In and Disagreements with Accountants on Accounting and Financial Disclosure |
38
|
|
Directors
and Executive Officers
|
38
|
|
Executive
Compensation
|
41
|
|
Legal
Proceedings
|
46
|
|
Security
Ownership of Certain Beneficial Owners and Management
|
46
|
|
Securities
Authorized for Issuance Under Equity Compensation Plans
|
47
|
|
Certain
Relationships and Related Transactions
|
48
|
|
Market
for Common Equity and Related Stockholder Matters
|
49
|
|
Description
of Securities
|
50
|
|
Transfer
Agent
|
52
|
|
Indemnification
|
53
|
|
Experts
|
53
|
|
Legal
Matters
|
53
|
|
How
to Get More Information
|
53
|
|
Consolidated
Financial Statements
|
F-1
|
|
PART II
|
|
|
Item
24. Indemnification of Directors and
Officers
|
II-1
|
|
Item
25. Other Expenses of Issuance and Distribution
|
II-1
|
|
Item
26. Recent Sales of Unregistered Securities
|
II-1
|
|
Item
27. Exhibits
|
II-1
|
|
Item
28. Undertakings
|
II-3
|
|
Signatures
|
II-5
|
|
Power
of Attorney
|
II-5
|
|
Compound
|
|
Originator
|
|
Technology
|
|
Indication
|
|
FDA
Filing
|
|
Clinical
Stage
(1)
|
|
Cancer
|
|
|
|
|
|
|
|
|
|
|
|
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
510(k)
|
Marketing
clearance
|
||||||
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
|
Access
- U London
|
|
Synthetic
polymer
|
|
Cancer
|
|
Clinical
Development(3)
|
|
Phase
II
|
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Research
|
Pre-Clinical
|
||||||
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Research
|
Pre-Clinical
|
||||||
Cobalamin-Targeted
Therapeutics
|
|
Access
|
|
Cobalamin
|
|
Anti-tumor
|
|
Research
|
|
Pre-Clinical
|
|
|
|
|
|
|
|
|
|
|
|
For
the Year Ended December 31,
|
|||||||||
2006
|
2005
|
2004
|
2003
|
2002
|
|||||
(in thousands, except per share amounts)
|
|||||||||
Consolidated
Statement of Operations and Comprehensive Loss Data:
|
|||||||||
Total
revenues
|
$
-
|
$ -
|
$
-
|
$
-
|
$
89
|
||||
Operating
loss
|
(5,175)
|
(9,622)
|
(6,003)
|
(5,426)
|
(5,925)
|
||||
Interest
and miscellaneous income
|
294
|
100
|
226
|
279
|
594
|
||||
Interest
and other expense
|
(7,436)
|
(2,100)
|
(1,385)
|
(1,281)
|
(1,278)
|
||||
Unrealized
loss
|
(1,107)
|
-
|
-
|
-
|
-
|
||||
Income
tax benefit
|
173
|
4,067
|
-
|
-
|
-
|
||||
Loss
from continuing operations
|
(13,251)
|
(7,555)
|
(7,162)
|
(6,428)
|
(6,520)
|
||||
Discontinued
operations net of taxes
$173
in 2006 and $4,067 in 2005
|
377
|
5,855
|
(3,076)
|
(507)
|
(2,864)
|
||||
Net
loss
|
(12,874)
|
(1,700)
|
(10,238)
|
(6,935)
|
(9,384)
|
||||
Common
Stock Data: (2)
|
|||||||||
Net
loss per basic and diluted
common
share
|
$ (3.65)
|
$ (0.53)
|
$
(3.38)
|
$ (2.61)
|
$
(3.58)
|
||||
Weighted
average basic and
diluted
common shares
outstanding
|
3,532
|
3,237
|
3,032
|
2,653
|
2,621
|
|
December
31,
|
|||||||
|
2006
|
2005
|
2004
|
2003
|
2002
|
|||
(in
thousands)
|
||||||||
Consolidated
Balance Sheet Data:
|
|
|
|
|
||||
Cash,
cash equivalents and
short
term investments
|
$ 4,389
|
$
474
|
$
2,261
|
$
2,587
|
$
9,776
|
|||
Restricted
cash
|
-
|
103
|
1,284
|
649
|
468
|
|||
Total
assets
|
6,426
|
7,213
|
11,090
|
11,811
|
19,487
|
|||
Deferred
revenue
|
173
|
173
|
1,199
|
1,184
|
1,199
|
|||
Convertible
notes, net of discount
|
8,833
|
7,636
|
13,530
|
13,530
|
13,530
|
|||
Total
liabilities
|
16,313
|
11,450
|
17,751
|
17,636
|
18,998
|
|||
Total
stockholders' equity (deficit)
|
(9,887)
|
(4,237)
|
(6,661)
|
(5,825)
|
489
|
(1)
|
This
data has been adjusted for discontinued operations and sales of assets.
The discontinued operations relate to the sale of our oral care and
dermatology business to Uluru, Inc. and the closing and sale of the
our
Australian laboratory described more fully in “Management’s Discussion and
Analysis or Plan of Operations” appearing elsewhere in this
Prospectus.
|
(2)
|
All
shares and per share information reflect a one for five reverse stock
split effected June 5, 2006.
|
·
|
some
or all of our drug candidates may be found to be unsafe or ineffective
or
otherwise fail to meet applicable regulatory standards or receive
necessary regulatory clearances;
|
·
|
our
drug candidates, if safe and effective, may be too difficult to develop
into commercially viable drugs;
|
·
|
it
may be difficult to manufacture or market our drug candidates on
a large
scale;
|
·
|
proprietary
rights of third parties may preclude us from marketing our drug
candidates; and
|
·
|
third
parties may market superior or equivalent
drugs.
|
·
|
A
mucoadhesive liquid technology product, MuGard™, has received marketing
approval by the FDA.
|
·
|
ProLindac™
is currently in a Phase II trial in Europe and a Phase II trial in
the
US.
|
·
|
ProLindac™
has been approved for an additional Phase I trial in the US by the
FDA.
|
·
|
Cobalamin™
mediated delivery technology is currently in the pre-clinical
phase.
|
·
|
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,
|
·
|
Cobalamin
mediated technology between 2007 and
2019
|
Selling
Security Holder
|
Shares
Beneficially Owned Before Offering
|
Percentage
of Outstanding
Shares
Beneficially
Owned Before
Offering
|
Shares
to be Sold in the Offering
|
|
Shares
Beneficially Owned After Offering
|
Percentage
of Outstanding
Shares
Beneficially
Owned
After Offering (1)
|
SCO
Capital Partners, LLC
|
7,982,584
|
|
69.3
|
%
|
|
6,636,362
|
|
1,346,222
|
|
27.6
|
%
|
||
Beach
Capital LLC
|
795,454
|
|
18.4
|
%
|
|
795,454
|
|
-0-
|
|
-0-
|
%
|
||
Lake
End Capital LLC
|
1,222,728
|
|
25.7
|
%
|
|
886,363
|
|
336,365
|
|
8.7
|
%
|
||
Mark
J. Alvino
|
55,525
|
1.6
|
%
|
45,454
|
10,071
|
0.3
|
%
|
||||||
Jeffrey
B. Davis
|
5,820
|
0.2
|
%
|
-0-
|
5,820
|
0.2
|
%
|
||||||
Howard
Fisher
|
54,545
|
1.5
|
%
|
45,454
|
9,091
|
0.3
|
%
|
||||||
Cornell
Capital Partners, LP
|
86,083
|
2.4
|
%
|
86,083
|
-0-
|
-0-
|
%
|
||||||
Oracle
Partners, LP
|
646,000
|
15.5
|
%
|
504,900
|
141,100
|
3.8
|
%
|
||||||
Oracle
Institutional Partners, LP
|
176,680
|
4.8
|
%
|
139,700
|
36,980
|
1.0
|
%
|
||||||
Oracle
Associates LLC
|
136,824
|
3.7
|
%
|
-0-
|
136,824
|
3.7
|
%
|
||||||
Sam
Oracle Fund, Inc.
|
145,000
|
3.9
|
%
|
132,000
|
13,000
|
0.4
|
%
|
||||||
Oracle
Offshore, Ltd.
|
32,800
|
0.9
|
%
|
26,400
|
6,400
|
0.2
|
%
|
||||||
Larry
N. Feinberg
|
3,660
|
0.1
|
%
|
-0-
|
3,660
|
0.1
|
%
|
||||||
Total:
|
11,343,703
|
|
76.2
|
%
|
|
9,298,170
|
|
2,045,533
|
|
36.7
|
%
|
·
|
a
block trade in which the broker-dealer so engaged will attempt to
sell the
shares as agent but may position and resell a portion of the block
as
principal to facilitate the transaction (including crosses in which
the
same broker acts as agent for both sides of the
transaction);
|
·
|
purchases
by a broker-dealer as principal and resale by such broker-dealer,
including resales for its account, pursuant to this
prospectus;
|
·
|
ordinary
brokerage transactions and transactions in which the broker solicits
purchases;
|
·
|
through
options, swaps or derivatives;
|
·
|
in
privately negotiated transactions;
|
·
|
in
making short sales or in transactions to cover short sales;
and
|
·
|
put
or call option transactions relating to the
shares.
|
·
|
the
name of each such selling security holder and of the participating
broker-dealer(s);
|
·
|
the
number of shares involved;
|
·
|
the
initial price at which the shares were
sold;
|
·
|
the
commissions paid or discounts or concessions allowed to the
broker-dealer(s), where applicable;
|
·
|
that
such broker-dealer(s) did not conduct any investigation to verify
the
information set out or incorporated by reference in this prospectus;
and
|
·
|
other
facts material to the transactions.
|
·
|
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 merge with Somanta Pharmaceuticals, Inc. and integrate
their
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.
|
(in
thousands)
|
Twelve
Months ended
December
31,
|
Inception
To
Date
(1)
|
|||||||||
Project
|
2006
|
2005
|
|||||||||
Polymer
Platinate
(ProLindac™)
|
$
|
2,043
|
$
|
2,653
|
$
|
19,654
|
|||||
Mucoadhesive
Liquid
Technology
(MLT)
|
10
|
-
|
1,490
|
||||||||
Others
(2)
|
-
|
130
|
5,044
|
||||||||
Total
|
$
|
2,053
|
$
|
2,783
|
$
|
26,188
|
|||||
(1)
|
Cumulative
spending from inception of the Company or project through December
31,
2006.
|
(2)
|
The
following projects are among the ones included in this line item:
Vitamin
Mediated Targeted Delivery, carbohydrate targeting, amlexanox cream
and
gel and other related projects.
|
Payment
Due by Period
|
||||||||||||
|
Total
|
Less
Than 1 Year
|
1-4
Years
|
|||||||||
Long-Term
Debt
Obligations
|
$
|
16,395,000
|
$
|
10,895,000
|
$
|
5,500,000
|
||||||
Interest
|
2,422,000
|
1,151,000
|
1,271,000
|
|||||||||
Lease
Obligations
|
135,000
|
92,000
|
43,000
|
|||||||||
Total
|
$
|
18,952,000
|
$
|
12,138,000
|
$
|
6,814,000
|
Compound
|
|
Originator
|
|
Technology
|
|
Indication
|
|
FDA
Filing
|
|
Clinical
Stage
(1)
|
||
Cancer
|
|
|
|
|
|
|
|
|
|
|
||
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
510(k)
|
Marketing
clearance
|
|||||||
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
|
Access
- U London
|
|
Synthetic
polymer
|
|
Cancer
|
|
Clinical
Development(3)
|
|
Phase
II
|
||
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Research
|
Pre-Clinical
|
|||||||
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Research
|
Pre-Clinical
|
|||||||
Cobalamin-Targeted
Therapeutics
|
|
Access
|
|
Cobalamin
|
|
Anti-tumor
|
|
Research
|
|
Pre-Clinical
|
||
|
|
|
|
|
|
|
|
|
|
• |
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 molecule 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.
|
-
|
folate
conjugates of polymer therapeutics, to enhance tumor delivery by
targeting
folate receptors, which are upregulated in certain tumor types with
two
U.S. and two European patent
applications;
|
-
|
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,
|
·
|
Cobalamin
mediated technology between 2007 and
2019
|
Name | Age | Title | |||
Jeffrey B. Davis | 44 | Chairman of the Board | |||
Stephen R. Seiler | 51 | President, Chief Executive Officer, Director | |||
Rosemary Mazanet, M.D., Ph.D. | 51 | Vice Chairman | |||
Esteban Cvitkovic, M.D. | 57 | Vice Chairman - Europe | |||
Mark J. Ahn, Ph.D. | 44 | Director | |||
Mark J. Alvino | 39 | Director | |||
J. Michael Flinn | 73 | Director | |||
Stephen B. Howell, M.D. | 62 | Director | |||
David P. Luci | 40 | Director | |||
Herbert H. McDade, Jr. | 80 | Director | |||
John J. Meakem, Jr. | 70 | Director | |||
David P. Nowotnik, Ph.D. |
58
|
Senior Vice President Research & Development | |||
Phillip S. Wise | 48 | Vice President, Business Development & Strategy | |||
Stephen B. Thompson | 53 | Vice President, Chief Financial Officer, Treasurer, Secretary |
Stock
|
Option
|
All
Other
|
||||||||||||||||||||||
Name
and Principal Position (7)
|
Year |
Salary ($)
|
Bonus
|
Awards ($)
|
Awards ($)
|
Compensation |
Total ($)
|
|||||||||||||||||
|
(1)
|
($)
|
(2)
|
(3)
|
(4)
|
|
||||||||||||||||||
Rosemary
Mazanet(5)
Acting
CEO
|
2006
2005
|
$ |
357,385
217,500
|
$
|
100,000
30,000
|
$
|
-
-
|
$
|
81,464
168,468
|
$
|
2,594
1,297
|
$
|
541,443
248,797
|
|||||||||||
Kerry
P. Gray(6)
Former
President and CEO
|
2005
|
|
$
|
133,332
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
3,505
|
$
|
136,837
|
||||||||||
David
P. Nowotnik, Ph.D.
Senior
Vice President Research
and
Development
|
2006
2005
|
|
$
|
253,620
250,710
|
$
|
20,000
25,408
|
$
|
-
24,154
|
$
|
40,732
67,619
|
$
|
7,152
7,094
|
$
|
321,504
374,985
|
||||||||||
Phillip
S. Wise(7)
Vice
President, Business
Development
|
2006
|
$
|
116,667
|
$
|
25,000
|
$
|
-
|
$
|
40,732
|
$
|
358
|
$
|
182,757
|
|||||||||||
Stephen
B. Thompson
Vice
President,
Chief
Financial Officer
|
2006
2005
|
$
|
154,080
152,310
|
$
|
20,000
15,435
|
$
|
-
14,704
|
$
|
40,732
42,262
|
$
|
4,508
4,455
|
$
|
219,320
229,166
|
(1)
|
Includes
amounts deferred under our 401(k)
Plan.
|
(2)
|
There
were no stock awards grants in 2006 and no restricted stock outstanding
at
December 31, 2006.
|
(3)
|
The
value listed in the above table represents the fair value of the
options
granted in prior years that was recognized in 2006 under FAS 123R.
Fair
value is calculated as of the grant date using a Black-Sholes
option-pricing model. The determination of the fair value of share-based
payment awards made on the date of grant is affected by our stock
price as
well as assumptions regarding a number of complex and subjective
variables. Our assumptions in determining fair value are described
in note
10 to our audited financial statements for the year ended December
31,
2006, included in our Annual Report on Form
10-KSB.
|
(4)
|
Amounts
reported for fiscal years 2006 and 2005 consist of: (i) amounts we
contributed to our 401(k) Plan with respect to each named individual,
(ii)
amounts we paid for group term life insurance for each named individual,
and (iii) for Mr. Gray, premiums paid by us each year for life insurance
for Mr. Gray.
|
(5)
|
Amounts
listed in 2006 and 2005 for Dr. Mazanet indicate compensation paid
to her
in connection with her services as our Acting CEO commencing on May
11,
2005.
|
(6)
|
Amounts
listed in 2005 for Mr. Gray indicate compensation paid to him in
connection with his services as our President and CEO through May
10,
2005. In addition to such amounts listed in the table above, Mr.
Gray also
received a total of $333,333 and $488,335 per the terms of his Separation
Agreement in 2006 and 2005,
respectively.
|
(7)
|
Phillip
S. Wise became our Vice President Business Development June 1,
2006.
|
(8)
|
Stephen
R. Seiler became our President and Chief Executive Officer effective
January 1, 2007 and is not included in this
table.
|
·
|
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
$155,000.
|
Name |
Number
of
Securities
Underlying
Unexcersised
Options
(#)
Exercisable
|
Number
of
Securities
Underlying
Unexcersised
Options
(#)
Unexercisable
|
Equity
Incentive
Plan
Awards:
Number
of
Securities
Underlying
Unexercised
Unearned
Options
(#)
|
Option
Exercise
Price
($)
|
Option
Exercise
Date
|
||
Rosemary
Mazanet(2)
|
50,000
39,796
6,000
|
150,000
10,204
|
-
|
0.63
5.45
12.50
|
08/17/06
11/02/05
05/11/05
|
||
Kerry
P. Gray(3)
|
20,000
28,000
32,000
32,000
20,000
100,000
32,000
32,000
|
-
|
-
|
29.25
11.50
18.65
34.38
27.50
12.50
10.00
15.00
|
01/23/04
05/19/03
03/22/02
11/20/00
10/12/00
03/01/00
07/20/99
06/18/98
|
||
David
P. Nowotnik, Ph.D.
|
25,000
3,167
3,646
6,854
10,000
10,000
10,000
10,000
|
75,000
4,833
1,354
146
|
-
|
0.63
11.60
29.25
10.10
18.65
12.50
10.00
15.00
|
08/17/06
05/23/05
01/23/04
01/30/03
03/22/02
03/01/00
07/20/99
11/16/98
|
Phillip S. Wise |
25,000
|
75,000
|
-
|
0.63
|
08/17/06
|
||
Stephen
B. Thompson
|
25,000
1,979
2,187
3,917
6,000
9,000
4,000
4,000
|
75,000
3,021
813
83
|
-
|
0.63
11.60
29.25
10.10
18.65
12.50
10.00
15.00
|
08/17/06
05/23/05
01/23/04
01/30/03
03/22/02
03/01/00
07/20/99
06/18/98
|
||
(1)
|
On
December 31, 2006, the closing price of our Common Stock as quoted
on the
OTC Bulletin Board was $0.52.
|
(2)
|
Options
listed for Dr. Mazanet include options paid to her in connection
with her
services as our Acting CEO commencing on May 11,
2005.
|
(3)
|
Options
listed for Mr. Gray include options paid to him in connection with
his
services as our President and CEO through May 10,
2005.
|
Common
Stock Beneficially Owned
|
||||
Name
of Beneficial Owner
|
Number
of Shares(1)
|
%
of Class
|
||
Jeffery
B. Davis (2
|
30,820
|
*
|
||
Rosemary
Mazanet (3)
|
147,256
|
4.0%
|
||
Mark
Ahn (4)
|
25,000
|
*
|
|
|
Mark
J. Alvino (5)
|
80,525
|
2.2%
|
||
J.
Michael Flinn (6)
|
84,880
|
|
2.4%
|
|
Stephen
B. Howell, M.D. (7)
|
53,839
|
|
1.5%
|
|
Herbert
H. McDade, Jr. (8)
|
46,151
|
|
1.3%
|
|
John
J. Meakem, Jr.
(9)
|
53,536
|
|
1.5%
|
|
David
P. Nowotnik, Ph.D. (10)
|
122,682
|
|
3.4%
|
|
Phillip
S. Wise (11)
|
50,000
|
|
1.4%
|
|
Stephen
B. Thompson (12)
|
91,521
|
|
2.5%
|
|
Larry
N. Feinberg (13)
|
1,142,964
|
|
26.4%
|
|
Kerry
P. Gray (14)
|
355,136
|
|
9.3%
|
|
SCO
Capital Partners LLC (15)
|
4,682,040
|
|
57.0%
|
|
All
Directors and Executive Officers as a group
(consisting
of 12 persons) (16)
|
786,211
|
|
18.5%
|
(1)
|
Includes
our outstanding shares of Common Stock held plus all shares of Common
Stock issuable upon exercise of options, warrants and other rights
exercisable within 60 days of April 30, 2007.
|
(2)
|
Mr.
Davis is President of SCO Securities 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 LLC, Beach Capital LLC, Lake End Capital LLC, Howard Fischer,
Mr.
Davis and Mark J. Alvino) are known to beneficially own warrants
to
purchase an aggregate of 4,682,040 of our Common Stock and 5,454,544
shares of Common Stock issuable to them upon conversion of notes.
Mr.
Davis disclaims beneficial ownership of all such shares except to
the
extent of his pecuniary interest therein. Does not include any such
shares
other than 5,280 shares underlying warrants held directly by Mr.
Davis.
Includes presently exercisable options for the purchase of 25,000
shares
of our Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
(3)
|
Includes
presently exercisable options for the purchase of 141,256 shares
of our
Common Stock pursuant to the 2005 Equity Incentive Plan and 6,000
shares
of our Common Stock pursuant to the 1995 Stock Option
Plan.
|
(4)
|
Includes
presently exercisable options for the purchase of 25,000 shares of
our
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
(5)
|
Includes
55,525 shares of Common Stock underlying warrants held by Mr. Alvino.
Mr.
Alvino is Managing Director of SCO Securities 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 LLC, Beach Capital LLC, Lake End Capital LLC, Howard Fischer,
Jeffrey B. Davis and Mr. Alvino) are known to beneficially own warrants
to
purchase an aggregate of 4,682,040 of our Common Stock and 5,454,544
shares of Common Stock issuable to them upon conversion of notes.
Mr.
Alvino disclaims beneficial ownership of all such shares except to
the
extent of his pecuniary interest therein. Does not include any such
shares
other than 55,525 shares underlying warrants held directly by Mr.
Alvino.
Includes presently exercisable options for the purchase of 25,000
shares
of our Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
(6)
|
Includes
presently exercisable options for the purchase of 46,200 shares of
our
Common Stock pursuant to the 2005 Equity Incentive Plan and 16,500
shares
of our Common Stock pursuant to the 1995 Stock Option
Plan.
|
(7)
|
Includes
presently exercisable options for the purchase of 26,200 shares of
our
Common Stock pursuant to the 2005 Equity Incentive Plan, 12,917 shares
of
our Common Stock pursuant to the 1995 Stock Option Plan, a warrant
to
purchase 3,000 shares of our Common Stock at an exercise price of
$15.00
per share, and a warrant to purchase 2,000 shares of our Common Stock
at
an exercise price of $24.80 per
share.
|
(8)
|
Includes
presently exercisable options for the purchase of 26,200 shares of
our
Common Stock pursuant to the 2005 Equity Incentive Plan and 12,500
shares
of our Common Stock pursuant to the 1995 Stock Option
Plan.
|
(9)
|
Includes
presently exercisable options for the purchase of 31,036 shares of
our
Common Stock pursuant to the 2005 Equity Incentive Plan and 13,500
shares
of our Common Stock pursuant to the 1995 Stock Option
Plan.
|
(10)
|
Includes
presently exercisable options for the purchase of 50,000 shares of
our
Common Stock pursuant to the 2005 Equity Incentive Plan and 55,167
shares
of our Common Stock pursuant to the 1995 Stock Option
Plan.
|
(11)
|
Includes
presently exercisable options for the purchase of 50,000 shares of
our
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
(12)
|
Includes
presently exercisable options for the purchase of 50,000 shares of
our
Common Stock pursuant to the 2005 Equity Incentive Plan and 32,000
shares
of our Common Stock pursuant to the 1995 Stock Option
Plan.
|
(13)
|
Larry
N. Feinberg is a partner in Oracle Partners, L.P. His address is
c/o
Oracle Partners, L.P., 200 Greenwich Avenue, 3rd
Floor, Greenwich, CT 06830. Oracle Partners, L.P. and affiliates
(Oracle
Institutional Partners, L.P., Oracle Investment Management, Inc.,
Sam
Oracle Fund, Inc. and Mr. Feinberg) are known to beneficially own
an
aggregate of 339,964 shares of our Common Stock and convertible notes
which may convert into an aggregate of 803,000 shares of our Common
Stock.
|
(14)
|
Mr.
Gray's address is 4939 Stony Ford Dr., Dallas, Texas 75287. Includes
presently exercisable options for the purchase of 296,000 shares
of our
Common Stock pursuant to the 1995 Stock Option Plan and the 2000
Special
Stock Option Plan.
|
(15)
|
SCO
Capital Partners LLC's address is 1285 Avenue of the Americas,
35th
Floor, New York, NY 10019. SCO Capital Partners LLC and affiliates
(Beach
Capital LLC, Lake End Capital LLC, Howard Fisher, Jeffrey B. Davis
and
Mark J. Alvino) are known to beneficially own warrants to purchase
an
aggregate of 4,682,040 shares of our Common Stock and 5,454,544 shares
of
Common Stock issuable to them upon conversion of notes. Each of Mr.
Davis
and Mr. Alvino, our directors and executives with SCO Capital Partners
LLC, disclaims beneficial ownership of such shares except to the
extent of
his pecuniary interest therein.
|
(16)
|
Does
not include shares held by SCO Securities LLC and affiliates (other
than
shares underlying warrants held directly by Messrs. Davis and
Alvino).
|
Plan
Category
|
Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights
|
Weighted-average
exercise price of outstanding options, warrants
and rights
|
Number
of securities remaining available for future issuance under
equity
compensation
plans
(excluding
securities
reflected in
column (a))
|
|||||
(a)
|
(b)
|
(c)
|
||||||
Equity
compensation
plans
approved
by
security holders
2005
Equity Incentive Plan
1995
Stock Awards Plan
2001
Restricted Stock Plan
|
802,672
360,917
-
|
$
1.04
$18.03
-
|
197,328
-
52,818
|
|||||
Equity
compensation
plans
not approved
by
security holders
2000
Special Stock Option
Plan
|
100,000
|
$12.50
|
-
|
|||||
Total
|
1,263,589
|
$
6.80
|
250,146
|
Common
Stock
|
|||||||
High
|
Low
|
||||||
Quarter Ended | |||||||
First quarter March 31, 2007 | $ |
10.66
|
|
$
|
2.50
|
||
Second quarter April 30, 2007 | 6.75 |
4.75
|
|
Fiscal
Year Ended December 31, 2006
|
|||||||
First
quarter
|
$
|
2.65
|
$
|
0.80
|
|||
Second
quarter
|
1.50
|
0.10
|
|||||
Third
quarter
|
1.30
|
0.45
|
|||||
Fourth
quarter
|
3.00
|
1.05
|
|||||
Fiscal
Year Ended December 31, 2005
|
|||||||
First
quarter
|
$
|
18.30
|
$
|
11.00
|
|||
Second
quarter
|
15.05
|
8.80
|
|||||
Third
quarter
|
9.95
|
2.80
|
|||||
Fourth
quarter
|
8.65
|
2.60
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL
INFORMATION
|
Page
|
|
|
|
|
|
|
|
Report
of Registered Independent Registered Public Accounting
Firm
|
F-1
|
Report
of Registered Independent Registered Public Accounting
Firm
|
F-2
|
|
|
Consolidated
Balance
Sheets at December 31, 2006 and 2005
|
F-3
|
|
Consolidated
Statements
of Operations and Comprehensive Loss for 2006, 2005 and
2004
|
F-20
|
|
Consolidated
Statements
of Stockholders’ Equity (Deficit) for 2006,
2005 and 2004
|
F-21
|
|
Consolidated
Statements
of Cash Flows for 2006,
2005 and 2004
|
F-22
|
|
Notes
to Consolidated Financial Statements
|
F-24
|
|
|
|
ASSETS
|
December
31, 2006
|
December
31, 2005
|
|||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
1,194,000
|
$
|
349,000
|
|||
Short
term investments, at cost
|
3,195,000
|
125,000
|
|||||
Receivables
|
359,000
|
4,488,000
|
|||||
Prepaid
expenses and other current assets
|
283,000
|
197,000
|
|||||
Total
current assets
|
5,031,000
|
5,159,000
|
|||||
Property
and equipment, net
|
212,000
|
300,000
|
|||||
Debt
issuance costs, net
|
158,000
|
-
|
|||||
Patents,
net
|
878,000
|
1,046,000
|
|||||
Licenses,
ne
|
25,000
|
75,000
|
|||||
Restricted
cash and other assets
|
122,000
|
633,000
|
|||||
Total
assets
|
$
|
6,426,000
|
$
|
7,213,000
|
|||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable and accrued expenses
|
$
|
1,226,000
|
$
|
2,883,000
|
|||
Accrued
interest payable
|
581,000
|
652,000
|
|||||
Deferred
revenues
|
173,000
|
173,000
|
|||||
Current
portion long-term debt, net
of discount $2,062,000 in 2006
|
8,833,000
|
106,000
|
|||||
Total
current liabilities
|
10,813,000
|
3,814,000
|
|||||
Long-term
debt, net of discount $1,879,000 in 2005
|
5,500,000
|
7,636,000
|
|||||
Total
liabilities
|
16,313,000
|
11,450,000
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders'
deficit
|
|||||||
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
none
issued or outstanding
|
-
|
-
|
|||||
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
3,535,108 at December 31, 2006 and authorized
50,000,000
shares; issued 3,528,108 at December 31, 2005
|
35,000
|
35,000
|
|||||
Additional
paid-in capital
|
68,799,000
|
62,942,000
|
|||||
Notes
receivable from stockholders
|
(1,045,000
|
)
|
(1,045,000
|
)
|
|||
Treasury
stock, at cost - 163 shares
|
(4,000
|
)
|
(4,000
|
)
|
|||
Accumulated
deficit
|
(77,672,000
|
)
|
(66,165,000
|
)
|
|||
Total
stockholders' deficit
|
(9,887,000
|
)
|
(4,237,000
|
)
|
|||
Total
liabilities and stockholders' deficit
|
$
|
6,426,000
|
$
|
7,213,000
|
Year
ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Expenses
|
||||||||||
Research
and development
|
$
|
2,053,000
|
$
|
2,783,000
|
$
|
2,335,000
|
||||
General
and administrative
|
2,813,000
|
4,638,000
|
3,199,000
|
|||||||
Depreciation
and amortization
|
309,000
|
333,000
|
469,000
|
|||||||
Write
off of goodwill
|
-
|
1,868,000
|
-
|
|||||||
Total
expenses
|
5,175,000
|
9,622,000
|
6,003,000
|
|||||||
Loss
from operations
|
(5,175,000
|
)
|
(9,622,000
|
)
|
(6,003,000
|
)
|
||||
Interest
and miscellaneous income
|
294,000
|
100,000
|
226,000
|
|||||||
Interest
and other expense
|
(7,436,000
|
)
|
(2,100,000
|
)
|
(1,385,000
|
)
|
||||
Unrealized
loss on fair value of warrants and beneficial
conversion
feature
|
(1,107,000
|
)
|
-
|
-
|
||||||
(8,249,000
|
)
|
(2,000,000
|
)
|
(1,159,000
|
||||||
Loss
before discontinued operations and before tax benefit
|
(13,424,000
|
)
|
(11,622,000
|
)
|
(7,162,000
|
)
|
||||
Income
tax benefit
|
173,000 |
4,067,000
|
-
|
|||||||
Loss
from continuing operations
|
(13,251,000
|
)
|
(7,555,000
|
)
|
(7,162,000
|
)
|
||||
Discontinued
operations, net of taxes of $173,000 in 2006 and $4,067,000
in
2005
|
377,000
|
5,855,000
|
(3,076,000
|
)
|
||||||
Net
loss
|
$
|
(12,874,000
|
)
|
$
|
(1,700,000
|
)
|
$
|
(10,238,000
|
)
|
|
Basic
and diluted loss per common share
|
||||||||||
Loss
from continuing operations allocable to common
stockholders
|
$
|
(3.75
|
)
|
$
|
(2.34
|
)
|
$
|
(2.36
|
)
|
|
Discontinued
operations
|
0.11
|
1.81
|
(1.02
|
)
|
||||||
Net
loss allocable to common stockholders
|
$
|
(3.65
|
)
|
$
|
(0.53
|
)
|
$
|
(3.38
|
)
|
|
Weighted
average basic and diluted common shares
outstanding
|
3,531,934
|
3,237,488
|
3,032,451
|
|||||||
Net
loss
|
$
|
(12,874,000
|
)
|
$
|
(
1,700,000
|
)
|
$
|
(10,238,000
|
)
|
|
Other
comprehensive loss
Foreign
currency translation adjustment
|
-
|
3,000
|
(17,000
|
)
|
||||||
Comprehensive
loss
|
$
|
(12,874,000
|
)
|
$
|
(1,697,000
|
)
|
$
|
(10,255,000
|
)
|
Common
Stock
|
|||||||||||||||||||||||
Shares
|
Amount
|
Additional
paid in capital
|
Notes
receivable from stockholders
|
Unamortized
value
of restricted stock grants
|
Treasury
stock
|
Accumulated
other
comprehensive
income
(loss)
|
Accumulated
deficit
|
||||||||||||||||
Balance,
December 31, 2003
|
2,679,000
|
$
27,000
|
$49,704,000
|
(1,045,000)
|
$(294,000)
|
$(4,000)
|
$14,000
|
$(54,227,000)
|
|||||||||||||||
Common
stock issued
for
cash, net of offering
costs
|
359,000
|
4,000
|
9,012,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Common
stock issued for
cash
exercise of
warrants
and options
|
23,000
|
-
|
283,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Common
stock issued for cashless
exercise
of warrants
|
42,000
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Issuance
of restricted
stock
grants
|
2,000
|
-
|
135,000
|
-
|
(135,000)
|
-
|
-
|
-
|
|||||||||||||||
Other
comprehensive
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(17,000)
|
-
|
|||||||||||||||
Amortization
of restricted stock grants
|
-
|
-
|
-
|
-
|
120,000
|
-
|
-
|
-
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(10,238,000)
|
|||||||||||||||
Balance,
December 31, 2004
|
3,105,000
|
31,000
|
59,134
000
|
(1,045,000)
|
(309,000)
|
(4,000)
|
(3,000)
|
(64,465,000)
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||
Common
stock issued,
net
of offering costs
|
237,000
|
2,000
|
1,119,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Common
stock issued
for
payment of interest
|
190,000
|
2,000
|
616,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Other
comprehensive
income
|
-
|
-
|
-
|
-
|
-
|
-
|
3,000
|
-
|
|||||||||||||||
Discount
on convertible
note
extension
|
-
|
-
|
2,109,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Amortization
and
forfeiture
of restricted
stock
grants
|
(4,000)
|
-
|
(36,000)
|
-
|
309,000
|
-
|
-
|
-
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(1,700,000)
|
|||||||||||||||
Balance,
December 31, 2005
|
3,528,000
|
35,000
|
62,942,000
|
(1,045,000)
|
-
|
(4,000)
|
-
|
(66,165,000)
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||
Common
stock issued for
compensation
|
7,000
|
-
|
77,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Warrants
issued
|
-
|
-
|
100,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Stock
option
compensation
expense
|
-
|
-
|
248,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Issuance
of convertible
debt
with warrants
|
-
|
-
|
5,432,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Cumulative
effect of
change
in accounting
principle
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
1,367,000
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(12,874,000)
|
|||||||||||||||
Balance,
December 31, 2006
|
3,535,000
|
$
35,000
|
$
68,799,000
|
(1,045,000)
|
$
-
|
$
(4,000)
|
$
-
|
$(77,672,000)
|
Year
ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Cash
flows from operating activities
|
||||||||||
Net
loss
|
$
|
(12,874,000
|
)
|
$
|
(1,700,000
|
)
|
$
|
(10,238,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used
|
||||||||||
in
operating activities:
|
||||||||||
Unrealized
Loss
|
1,107,000
|
-
|
-
|
|||||||
Loss
on sale Australia assets
|
-
|
208,000
|
-
|
|||||||
Impairment
of investment
|
-
|
-
|
112,000
|
|||||||
Write
off of goodwill
|
-
|
1,868,000
|
-
|
|||||||
Amortization
of restricted stock grants
|
-
|
309,000
|
120,000
|
|||||||
Stock
option expense
|
248,000
|
-
|
-
|
|||||||
Stock
issued for compensation
|
77,000
|
42,000
|
-
|
|||||||
Stock
issued for interest
|
-
|
618,000
|
-
|
|||||||
Depreciation
and amortization
|
309,000
|
570,000
|
773,000
|
|||||||
Amortization
of debt costs and discounts
|
6,749,
000
|
695,000
|
183,000
|
|||||||
Gain
on sale of assets
|
(550,000)
|
(12,891,000
|
)
|
-
|
||||||
Change
in operating assets and liabilities:
|
||||||||||
Receivables
|
4,129,000
|
622,000
|
358,000
|
|||||||
Inventory
|
-
|
104,000
|
60,000
|
|||||||
Prepaid
expenses and other current assets
|
14,000
|
|
817,000
|
(195,000
|
)
|
|||||
Restricted
cash and other assets
|
127,000
|
-
|
-
|
|||||||
Accounts
payable and accrued expenses
|
(1,657,000
|
)
|
490,000
|
401,000
|
||||||
Accrued
interest payable
|
363,000
|
341,000
|
-
|
|||||||
Deferred
revenues
|
-
|
606,000
|
15,000
|
|||||||
Net
cash used in operating activities
|
(1,958,000
|
)
|
(7,301,000
|
)
|
(8,411,000
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Capital
expenditures
|
(3,000
|
)
|
(28,000
|
)
|
(221,000
|
)
|
||||
Proceeds
from sale of equipment
|
-
|
355,000
|
-
|
|||||||
Proceeds
from sale of patents
|
-
|
974,000
|
-
|
|||||||
Proceeds
from sale of oral/topical care assets
|
550,000
|
7,391,000
|
-
|
|||||||
Restricted
cash and other assets
|
|
684,000
|
(666,000
|
)
|
||||||
Redemptions
of short-term investments
|
||||||||||
and
certificates of deposit, net
|
(3,070,000
|
)
|
361,000
|
1,374,000
|
||||||
Net
cash provided by (used in) investing activities
|
(2,523,000
|
)
|
9,717,000
|
487,000
|
||||||
Cash
flows from financing activities:
|
||||||||||
Payments
of notes payable
|
(106,000
|
)
|
(407,000
|
)
|
(310,000
|
)
|
||||
Payment
of secured notes payable and convertible notes
|
-
|
(6,648,000
|
)
|
-
|
||||||
Proceeds
from secured notes payable
|
5,432,000
|
2,633,000
|
-
|
|||||||
Proceeds
from stock issuances, net of costs
|
-
|
577,000
|
9,299,000
|
|||||||
Net
cash provided by (used in) financing activities
|
5,326,000
|
(3,845,000
|
)
|
8,989,000
|
||||||
Net
increase (decrease) in cash and cash equivalents
|
845,000
|
(1,429,000
|
)
|
1,065,000
|
||||||
Effect
of exchange rate changes on cash and cash equivalents
|
-
|
3,000
|
(17,000
|
)
|
||||||
Cash
and cash equivalents at beginning of year
|
349,000
|
1,775,000
|
727,000
|
|||||||
Cash
and cash equivalents at end of year
|
$
|
1,194,000
|
$
|
349,000
|
$
|
1,775,000
|
||||
Cash
paid for interest
|
$
|
315,000
|
$
|
445,000
|
$
|
1,073,000
|
||||
Supplemental
disclosure of noncash transactions
|
||||||||||
Value
of restricted stock grants
|
-
|
-
|
135,000
|
|||||||
Assets
acquired under capital leases
|
-
|
-
|
59,000
|
|||||||
Common
stock issued for SEDA and
|
||||||||||
Secured
Convertible Notes
|
-
|
502,000
|
-
|
|||||||
Discount
on convertible note extension
|
-
|
2,109,000
|
-
|
|||||||
Debt
issuance costs
|
568,000
|
|||||||||
Accrued
interest capitalized
|
433,000
|
|||||||||
Warrants
issued per professional agreement of consulting
services
|
100,000
|
|||||||||
Cumulative
change of accounting principle
|
1,367,000
|
|||||||||
Issuance
of convertible debt with warrants
|
5,432,000
|
December
31, 2006
|
December
31, 2005
|
December
31, 2004
|
|||||||||||||||||
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
||||||||||||||
Amortizable
intangible assets
|
|||||||||||||||||||
Patents
|
$
|
1,680
|
$
|
802
|
$
|
1,680
|
$
|
634
|
$
|
3,179
|
$
|
864
|
|||||||
Licenses
|
500
|
475
|
500
|
425
|
500
|
375
|
|||||||||||||
Total
|
$
|
2,180
|
$
|
1,277
|
$
|
2,180
|
$
|
1,059
|
$
|
3,679
|
$
|
1,239
|
2007
|
$
|
193
|
||
2008
|
168
|
|||
2009
|
168
|
|||
2010
|
168
|
|||
2011
|
168
|
|||
Thereafter
|
38
|
|||
Total
|
$
|
903
|
· |
127%
- the 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.
|
· |
4.85%
(average) - the 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.
|
· |
None
- the dividend yield assumption is based on our history and expectation
of
dividend payments.
|
· |
1.6
years - the estimated expected term (average of 1.6 years) is
based on
employee exercise behavior.
|
|
|
Year ended
December 31,
2006
|
|
Research
and development
|
|
$
|
68
|
General
and administrative
|
|
|
180
|
|
|
|
|
Stock-based
compensation expense included in operating expenses
|
|
|
248
|
|
|
|
|
Total
stock-based compensation expense
|
|
|
248
|
Tax
benefit
|
|
|
—
|
|
|
|
|
Stock-based
compensation expense, net of tax
|
$
|
248
|
|
|
|
(in
thousands)
|
Year
Ended
December
31,
|
||||||
2006
|
2005
|
||||||
Net
loss, as reported under APB 25 for the prior period (1)
|
$
|
N/A
|
$
|
(1,700
|
)
|
||
Add
back stock based employee compensation expense in
reported
net loss, net of related tax effects
|
-
|
-
|
|||||
Subtract
total stock-based compensation expense determined
under
fair value-based method for all awards, net of related tax
effects(2)
|
(248
|
)
|
(750
|
)
|
|||
Net
loss including the effect of stock-based compensation expense(3)
|
$
|
(12,874
|
)
|
$
|
(2,450
|
)
|
|
Loss
per share:
|
|||||||
Basic
and diluted, as reported for the prior period(1)
|
$
|
(3.65
|
)
|
$
|
(0.53
|
)
|
|
Basic
and diluted, including the effect of stock-based
compensation
expense(3)
|
$
|
(3.65
|
)
|
$
|
(0.76
|
)
|
(1)
|
Net
loss and loss per share for periods prior to year 2006 does
not include
stock-based compensation expense under SFAS 123 because the
Company did
not adopt the recognition provisions of SFAS 123.
|
(2)
|
Stock-based
compensation expense for periods prior to year 2006 was calculated
based
on the pro forma application of SFAS 123.
|
(3)
|
Net
loss and loss per share for periods prior to year 2006 represent
pro forma
information based on SFAS 123.
|
Year
|
Consulting
Fees
|
Expense
Reimbursement
|
|||||
2006
|
$
|
69,000
|
$
|
5,000
|
|||
2005
|
79,000
|
5,000
|
|||||
2004
|
58,000
|
9,000
|
Property
and equipment consists of the following:
|
December
31,
|
||||||
2006
|
|
|
2005
|
||||
Laboratory
equipment
|
$
|
1,090,000
|
$
|
1,090,000
|
|||
Laboratory
and building improvements
|
167,000
|
167,000
|
|||||
Furniture
and equipment
|
134,000
|
138,000
|
|||||
|
1,391,000
|
1,395,000
|
|||||
Less
accumulated depreciation and amortization
|
1,179,000
|
1,095,000
|
|||||
Net
property and equipment
|
$
|
212,000
|
$
|
300,000
|
2006
|
2005
|
2004
|
||||||||
Revenues |
$
|
550,000
|
$
|
781,000
|
$
|
549,000
|
||||
|
||||||||||
Expenses | ||||||||||
Cost
of
product sales
|
|
(1,012,000
|
)
|
(239,000
|
)
|
|||||
Research
and
development
|
(2,501,000
|
)
|
(3,082,000
|
)
|
||||||
Depreciation
|
(237,000
|
)
|
(304,000
|
)
|
||||||
Total
expenses
|
-
|
(3,750,000
|
)
|
(3,625,000
|
)
|
|||||
|
||||||||||
Income/loss from discontinued operations |
550,000
|
(2,969,000
|
)
|
(3,076,000
|
)
|
|||||
|
||||||||||
Gain on sale of assets |
-
|
12,891,000
|
-
|
|||||||
Tax expense
|
(173,000
|
)
|
(4,067,000
|
)
|
-
|
|||||
Discontinued operations
|
$
|
377,000
|
$
|
5,855,000
|
$
|
(3,076,000
|
)
|
Future
Maturities
|
Debt
|
|
2007
|
10,895,000
|
|
2010
|
5,500,000
|
Summary of Warrants |
|
Outstanding
|
Exercise
Price
|
Expiration
Date
|
||||||||
2006
convertible note (a)
|
3,863,634
|
$
|
1.32
|
2/16/12
|
||||||||
2006
convertible note (a)
|
386,364
|
1.32
|
10/24/12
|
|||||||||
2006
convertible note (a)
|
386,364
|
1.32
|
12/06/12
|
|||||||||
2006
investor relations advisor (b)
|
50,000
|
2.70
|
12/27/11
|
|||||||||
2004
offering (c)
|
89,461
|
35.50
|
2/24/09
|
|||||||||
2004
offering (c)
|
31,295
|
27.00
|
2/24/09
|
|||||||||
2003
financial advisor (d)
|
14,399
|
19.50
|
10/30/08
|
|||||||||
2002
scientific consultant (e)
|
2,000
|
24.80
|
2/01/09
|
|||||||||
2001
scientific consultant (f)
|
3,000
|
15.00
|
1/1/08
|
|||||||||
Total
|
4,826,517
|
a) |
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.
|
b) |
During
2006, an investor relations advisor received warrants to purchase
50,000
shares of common stock at an exercise price of $2.70 per share
at any time
from December 27, 2006 until December 27, 2011, for investor
relations
consulting services to be rendered in 2007. All of the warrants
were
exercisable at December 31, 2006. The fair value of the warrants
was $2.00
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 4.58%, expected volatility 138% and a term of 2.5
years.
|
c) |
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.
|
d) |
During
2003, financial advisors received warrants to purchase 14,399
shares of
common stock at any time until October 30, 2008, for financial
consulting
services rendered in 2003 and 2004. All the warrants are exercisable.
The
fair value of the warrants was $14.10 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 2.9%, expected
volatility 92% and a term of 5 years.
|
e) |
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. The fair value of the warrants was
$18.50 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 3.90%, expected volatility 81% and a term of 7
years.
|
f) |
During
2001, a director who is also a scientific advisor received warrants
to
purchase 3,000 shares of common stock at an exercise price of
$15.00 per
share at any time until January 1, 2008, for scientific consulting
services rendered in 2001. The fair value of the warrants was
$13.70 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 5.03%, expected volatility 118% and a term of 7
years.
|
Weighted-
|
|||
average
|
|||
exercise
|
|||
Options
|
price
|
||
Outstanding
options at January 1, 2005
|
-
|
$
-
|
|
Granted,
fair value of $8.50 per share
|
50,000
|
5.45
|
|
Outstanding
options at December 31, 2005
|
50,000
|
5.45
|
|
Granted,
fair value of $ 0.36 per share
|
753,872
|
1.32
|
|
Forfeited
|
(1,200)
|
3.15
|
|
Outstanding
options at December 31, 2006
|
802,672
|
1.04
|
|
Exercisable
at December 31, 2005
|
14,000
|
5.45
|
|
Exercisable
at December 31, 2006
|
204,718
|
2.00
|
Number
of
|
Weighted
average
|
Number
of
|
Weighted
aververage
|
|||
|
options
|
Remaining
|
Exercise
|
options
|
Remaining
|
Exercise
|
Range
of excercise prices
|
outstanding
|
life
in years
|
price
|
exerciseable
|
life
in years
|
price
|
$0.63
- 0.85
|
717,000
|
9.6
|
$0.63
|
129,250
|
9.6
|
$0.63
|
$3.15
- 5.45
|
85,672
|
8.9
|
4.49
|
75,468
|
8.9
|
4.36
|
802,672
|
204,718
|
Weighted-
|
||
average
|
||
exercise
|
||
Options
|
price
|
|
Outstanding
options at January 1, 2004
|
410,725
|
$
17.25
|
Granted,
fair value of $10.90 per share
|
62,840
|
28.75
|
Exercised
|
(21,939)
|
11.90
|
Forfeited
|
(15,196)
|
21.05
|
Outstanding
options at December 31, 2004
|
436,430
|
18.80
|
Granted,
fair value of $6.45 per share
|
49,700
|
12.05
|
Forfeited
|
(55,859)
|
17.30
|
Outstanding
options at December 31, 2005
|
430,271
|
18.20
|
Forfeited
|
(69,354)
|
19.12
|
Outstanding
options at December 31, 2006
|
360,917
|
18.03
|
Exercisable
at December 31, 2004
|
334,232
|
18.20
|
Exercisable
at December 31, 2005
|
406,760
|
18.40
|
Exercisable
at December 31, 2006
|
349,990
|
18.12
|
Range
of
|
Number
of
|
Weighted
average
|
Number
of
|
Weighted
average
|
||
exercise
|
shares
|
Remaining
|
Exercise
|
shares
|
Remaining
|
Exercise
|
prices
|
outstanding
|
life
in years
|
price
|
exercisable
|
life
in years
|
Price
|
$10.00
- 12.50
|
147,640
|
3.6
|
$11.15
|
139,032
|
3.3
|
$11.12
|
$14.05
- 18.65
|
112,717
|
1.9
|
16.61
|
112,717
|
1.9
|
16.61
|
$20.25
- 34.38
|
100,560
|
2.1
|
29.73
|
98,241
|
2.0
|
29.74
|
|
|
|
|
|
|
|
|
360,917
|
|
|
349,990
|
|
|
2006
|
2005
|
2004
|
||||||||
Income
taxes at U.S. statutory rate
|
$
|
(4,378,000
|
)
|
$
|
(438,000
|
)
|
$
|
(3,442,000
|
)
|
|
Change
in valuation allowance
|
3,972,000
|
(2,051,000
|
)
|
895,000
|
||||||
Change
in miscellaneous items
|
(130,000) |
397,000
|
598,000
|
|||||||
Benefit
of foreign losses not recognized
|
58,000 |
304,000
|
-
|
|||||||
Expenses
not deductible
|
240,000 |
738,000
|
7,000
|
|||||||
Expiration
of net operating loss and general
|
||||||||||
business
credit carryforwards, net of revisions
|
238,000
|
1,050,000
|
1,942,000
|
|||||||
Total
tax expense
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
December
31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Deferred
tax assets (liabilities)
|
||||||||||
Net
operating loss carryforwards
|
$
22,634,000
|
$
20,261,000
|
$
20,808,000
|
|||||||
General
business credit carryforwards
|
2,402,000
|
2,261,000
|
2,094,000
|
|||||||
Deferred
gain on sale of oral/topical care assets
|
-
|
(1,490,000
|
)
|
-
|
||||||
Property,
equipment and goodwill
|
46,000
|
78,000
|
259,000
|
|||||||
Gross
deferred tax assets
|
25,082,000
|
21,110,000
|
23,161,000
|
|||||||
Valuation
allowance
|
(25,082,000
|
)
|
(21,110,000
|
)
|
(23,161,000
|
)
|
||||
Net
deferred taxes
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
|
Net
operating
loss
carryforwards
|
General
business
credit
carryforwards
|
|||||
2007
|
$
|
994,000
|
$
|
26,000
|
|||
2008
|
4,004,000
|
138,000
|
|||||
2009
|
1,661,000
|
185,000
|
|||||
2010
|
2,171,000
|
140,000
|
|||||
2011
|
4,488,000
|
13,000
|
|||||
Thereafter
|
53,251,000
|
1,900,000
|
|||||
$
|
66,569,000
|
$
|
2,402,000
|
2006
Quarter Ended
|
|||||||||||||
March
31
|
June
30
|
September
30
|
December
31
|
||||||||||
Loss
from operations
|
$
|
(4,856
|
)
|
$
|
(3,331
|
)
|
$
|
(2,015
|
)
|
$
|
(3,222
|
)
|
|
Discontinued
operations
|
-
|
-
|
-
|
550
|
|||||||||
Net
loss
|
$
|
(4,856
|
)
|
$
|
(3,331
|
)
|
$
|
(2,015
|
)
|
$
|
(2,672
|
)
|
|
Basic
and diluted income/loss per common share
|
$
|
(1.38
|
)
|
$
|
(0.94
|
)
|
$
|
(0.57
|
)
|
$
|
(0.76
|
)
|
|
|
2005
Quarter Ended
|
||||||||||||
|
March
31
|
|
|
June
30
|
|
|
September30
|
|
|
December31
|
|||
Loss
from operations
|
$
|
(1,616
|
)
|
$
|
(2,988
|
)
|
$
|
(1,612
|
)
|
$
|
(1,339
|
)
|
|
Discontinued
operations
|
(806
|
)
|
(798
|
)
|
(451
|
)
|
7,910
|
||||||
Net
loss/income
|
$
|
(2,422
|
)
|
$
|
(3,786
|
)
|
$
|
(2,063
|
)
|
$
|
6,571
|
||
Basic
and diluted loss per
common
share
|
$
|
(0.78
|
)
|
$
|
(1.21
|
)
|
$
|
(0.65
|
)
|
$
|
2.11
|
Type
of Expense
|
|
|
Amount
|
||
Securities
and Exchange Commission Registration Fee
|
|
$
|
1, | 174 |
|
Transfer
Agent Fees
|
|
|
2, | 500 |
|
Printing
and Engraving Expenses
|
|
|
15, | 000 |
|
Accounting
Fees and Expenses
|
|
|
5,
|
000 |
|
Legal
Fees and Expenses
|
|
|
6, | 326 |
|
Total
|
|
$
|
30, | 000 |
|
Exhibit
Number
|
Description of Document |
2.1 |
Amended
and Restated Agreement of Merger and Plan of Reorganization between
Access
Pharmaceuticals, Inc. and Chemex Pharmaceuticals, Inc., dated as
of
October 31, 1995 (Incorporated by reference toy Exhibit A of the
our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031)
|
2.2 | Agreement and Plan of Merger by and amoung us, Somanta Acquisition Corp., Somanta Pharmaceuticals, Inc., Somanta Inc. and Somanta Ltd. dated April 18, 2007 (incorporated by reference on our Form 8-K, Exhibit 2.1, dated April 19, 2007) |
3.0 |
Articles
of incorporation and bylaws:
|
3.1 |
Certificate
of Incorporation (Incorporated by Reference to Exhibit 3(a) of
our Form
8-B dated July 12, 1989, Commission File Number
9-9134)
|
3.2 |
Certificate
of Amendment of Certificate of Incorporation filed August 21,
1992
|
3.3 |
Certificate
of Merger filed January 25, 1996. (Incorporated by reference to
Exhibit E
of our Registration Statement on Form S-4 dated December 21, 1995,
Commission File No. 33-64031)
|
3.4 |
Certificate
of Amendment of Certificate of Incorporation filed January 25,
1996.
(Incorporated by reference to Exhibit E of our Registration Statement
on
Form S-4 dated December 21, 1995, Commission File No.
33-64031)
|
3.5 |
Certificate
of Amendment of Certificate of Incorporation filed July 18, 1996.
(Incorporated by reference to Exhibit 3.8 of our Form 10-K for
the year
ended December 31, 1996)
|
3.6 |
Certificate
of Amendment of Certificate of Incorporation filed June 18, 1998.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for
the quarter
ended June 30, 1998)
|
3.7 |
Certificate
of Amendment of Certificate of Incorporation filed July 31, 2000.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for
the quarter
ended March 31, 2001)
|
3.8 |
Certificate
of Designations of Series A Junior Participating Preferred Stock
filed
November 7, 2001 (Incorporated by reference to Exhibit 4.1.h of
our
Registration Statement on Form S-8, dated December 14, 2001, Commission
File No. 333-75136)
|
3.9 |
Amended
and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of
our Form
10-Q for the quarter ended June 30,
1996)
|
* |
10.1 |
1995
Stock Option Plan (Incorporated by reference to Exhibit F of our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031)
|
* |
10.2
|
Amendment
to 1995 Stock Option Plan (Incorporated by reference to Exhibit
10.25 of
our Form 10-K for the year ended December 31,
2001)
|
10.3
|
Lease
Agreement between Pollock Realty Corporation and us dated July
25, 1996
(Incorporated by reference to Exhibit 10.19 of our Form 10-Q for
the
quarter ended September 30, 1996)
|
10.4
|
Platinate
HPMA Copolymer Royalty Agreement between The School of Pharmacy,
University of London and the Company dated November 19, 1996 (Incorporated
by reference to Exhibit 10.19 of our Form 10-Q for the quarter
ended
September 30, 1996)
|
* |
10.5
|
Employment
Agreement of David P. Nowotnik, PhD (Incorporated
by reference to Exhibit 10.19 of our Form 10-K for the year ended
December
31, 1999)
|
* |
10.6
|
401(k)
Plan (Incorporated
by reference to Exhibit 10.20 of our Form 10K for the year ended
December
31, 1999)
|
* |
10.7
|
2000
Special Stock Option Plan and Agreement (Incorporated
by reference to Exhibit 10.24 of our Form 10-Q for the quarter
ended
September 30, 2000)
|
10.8
|
Form
of Convertible Note (Incorporated
by reference to Exhibit 10.24 of our Form 10-Q for the quarter
ended
September 30, 2000)
|
10.9 |
Rights
Agreement, dated as of October 31, 2001 between the us and American
Stock
Transfer & Trust Company, as Rights Agent (incorporated by reference
to Exhibit 99.1 of our Current Report on Form 8-K dated October
19,
2001)
|
10.10
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between us
and American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
* |
10.11
|
2001
Restricted Stock Plan (incorporated by reference to Appendix A
of our
Proxy Statement filed on April 16,
2001)
|
* |
10.12
|
2005
Equity Incentive Plan (incorporated by reference to Exhibit 1 of
our Proxy
Statement filed on April 18, 2005
|
* | 10.13 |
Agreement,
dated as of May 10, 2005 by and between us and Kerry P. Gray
(1)
|
* |
10.14
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen
B.
Thompson (1)
|
10.15 |
AssetSale
Agreement, dated as of October 12, 2005, between us and Uluru,
Inc.
(1)
|
10.16
|
Amendment to
Asset Sale Agreement, dated as December 8, 2006,
between us and Uluru,
Inc.
|
10.17 | License Agreement, dated as of October 12, 2005, between us and Uluru, Inc. (1) |
10.18
|
Amendment
to 7% (Subject to Adjustment) Convertible Promissory Notes
Due September
13, 2005, dated as of November 3, 2005, between us and Oracle
Partners LP,
Oracle Institutional Holders LP, SAM Oracle Investments Inc.
and Oracle
Offshore Ltd. (1)
|
10.19 |
Noteand
Warrant Purchase Agreement, dated February 16, 2006 between
us and certain
Secured Parties (3)
|
10.20
|
Security
Agreement, dated February 16, 2006, between us and certain
Secured Parties
(2)
|
10.21 |
Form
of 7.5% Secured Convertible Promissory Note, dated February
16, 2006,
issued by us and to certain Purchasers
(2)
|
10.22 |
Form
of Warrant, dated February 16, 2006, issued by us to certain
Purchasers
(2)
|
10.23 |
Investor
Rights Agreement, dated February 16, 2006, between us and
certain
Purchasers (2)
|
10.24 |
Note
and Warrant Purchase Agreement, dated October 24, 2006 between
us and
certain Secured Parties (3)
|
10.25
|
Security
Agreement, dated October 24, 2006, between us and certain
Secured Parties
(3)
|
10.26
|
Form
of 7.5% Secured Convertible Promissory Note, dated October
24, 2006,
issued by us and to certain Purchasers
(3)
|
10.27
|
Form
of Warrant, dated October 24, 2006, issued by us to certain
Purchasers
(3)
|
10.28
|
Investor
Rights Agreement, dated October 24, 2006, between us and
certain
Purchasers(3)
|
10.29
|
Note
and Warrant Purchase Agreement, dated December 6, 2006 between
us and
certain Secured Parties
(3)
|
10.30
|
Security
Agreement, dated December 6, 2006, between us and certain Secured
Parties
(3)
|
10.31
|
Form
of 7.5% Secured Convertible Promissory Note, dated December 6,
2006,
issued by us and to certain Purchasers
(3)
|
10.32
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
10.33
|
Investor
Rights Agreement, dated December 6, 2006, between us and certain
Purchasers (3)
|
21
|
Subsidiaries
of the registrant
|
23.1 |
Consent
of Whitley Penn LLP
|
23.2 |
Consent
of Grant Thornton LLP
|
23.3
|
Consent of Bingham McCutchen LLP (Previously
Filed)
|
24.1 | Power of Attorney (Previously Filed) |
*
|
Management
contract or compensatory plan required to be filed as an Exhibit
to this
Form pursuant to Item 15(c) of the
report.
|
(1) |
Incorporated
by reference to our Form 10-K for the year ended December 31,
2005
|
(2) |
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2006
|
(3) | Incorporated by reference to our Form 10-K for the year ended December 31, 2006. |
(i)
|
to
include any prospectus required by Section 10(a)(3) of the
Securities Act
of 1933.
|
(ii)
|
to
reflect in the prospectus any facts or events arising after
the effective
date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate,
represent a
fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease
in
volume of securities offered (if the total dollar value of
securities
offered would not exceed that which was registered) and any
deviation from
the low or high end of the estimated maximum offering range
may be
reflected in the form of prospectus filed with the Commission
pursuant to
Rule 424(b) if, in the aggregate, the changes in volume and
price
represent no more than a 20% change in the maximum aggregate
offering
price set forth in the “Calculation of Registration Fee” table in the
effective registration.
|
(iii)
|
to
include any material information with respect to the plan of distribution
not previously disclosed in this Registration Statement or any material
change to such information in this Registration
Statement.
|
|
|
|
|
|
|
|
|
In
accordance with the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe that
it
meets all of the requirements for filing on Form SB-2 and authorized
this
registration statement to be signed on our behalf by the undersigned
on
April 26, 2007.
|
|||
|
|
|
|
|
Access
Pharmaceuticals, Inc.
|
||
|
|
|
|
Date: May
1, 2007
|
By
|
/s/ Stephen
R. Seiler
|
|
|
Stephen
R. Seiler
|
|
|
|
Chief
Executive Officer and President
|
||
|
(Principal
Executive Officer)
|
||
|
|
|
|
Date: May
1, 2007
|
By
|
/s/ Stephen
B. Thompson
|
|
|
Stephen
B. Thompson
|
|
|
|
Chief
Financial Officer and Treasurer
|
||
|
(Principal
Financial and Accounting Officer)
|
Date:
May 1, 2007
|
/s/
Stephen R. Seiler
|
|
|
Stephen
R. Seiler, President and Chief Executive Officer,
Director
|
|
|
|
|
Date:
May 1, 2007
|
/s/
Mark J. Ahn
|
|
|
Mark
J. Ahn, Director
|
|
Date:
May 1, 2007
|
*
|
|
Mark
J. Alvino, Director
|
|
||
Date:
May 1, 2007
|
/s/
Esteban Cvitkovic, MD
|
|
Esteban
Cvitkovic, MD
|
||
Date:
May 1, 2007
|
*
|
|
|
Jeffrey
B. Davis, Director
|
|
|
|
|
Date:
May 1, 2007
|
*
|
|
|
J.
Michael Flinn, Director
|
|
Date:
May 1, 2007
|
*
|
|
Stephen
B. Howell, MD, Director
|
||
Date:
May 1, 2007
|
/s/
David P. Luci
|
|
David
P. Luci, Director
|
||
|
|
|
Date:
May 1, 2007
|
*
|
|
Herbert
H. McDade, Jr., Director
|
||
Date:
May 1, 2007
|
*
|
|
Rosemary
Mazanet, MD, PhD, Director
|
||
Date:
May 1, 2007
|
*
|
|
John
J. Meakem, Jr., Director
|
||
*
|
Executed
May 1, 2007 by Stephen B. Thompson as attorney-in-fact under power
of
attorney granted in Registration Statement previously filed on July
12,
2006.
|
2.1
|
Amended
and Restated Agreement of Merger and Plan of Reorganization
between Access
Pharmaceuticals, Inc. and Chemex Pharmaceuticals, Inc., dated
as of
October 31, 1995 (Incorporated by reference to Exhibit A of
the our
Registration Statement on Form S-4 dated December 21, 1995,
Commission
File No. 33-64031)
|
2.2 | Agreement and Plan of Merger by and amoung us, Somanta Acquisition Corp., Somanta Pharmaceuticals, Inc., Somanta Inc. and Somanta Ltd. dated April 18, 2007 (incorporated by reference on our Form 8-K, Exhibit 2.1, dated April 19, 2007) |
3.0 |
Articles
of incorporation and
bylaws:
|
3.1
|
Certificate
of Incorporation (Incorporated by Reference to Exhibit 3(a) of
our Form
8-B dated July 12, 1989, Commission File Number
9-9134)
|
3.2 |
Certificate
of Amendment of Certificate of Incorporation filed August 21,
1992
|
3.3 |
Certificate
of Merger filed January 25, 1996. (Incorporated by reference
to Exhibit E
of our Registration Statement on Form S-4 dated December 21,
1995,
Commission File No. 33-64031)
|
3.4
|
Certificate
of Amendment of Certificate of Incorporation filed January
25, 1996.
(Incorporated by reference to Exhibit E of our Registration
Statement on
Form S-4 dated December 21, 1995, Commission File No.
33-64031)
|
3.5
|
Certificate
of Amendment of Certificate of Incorporation filed July 18,
1996.
(Incorporated by reference to Exhibit 3.8 of our Form 10-K
for the year
ended December 31, 1996)
|
3.6
|
Certificate
of Amendment of Certificate of Incorporation filed June 18,
1998.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q
for the quarter
ended June 30, 1998)
|
3.7
|
Certificate
of Amendment of Certificate of Incorporation filed July 31,
2000.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q
for the quarter
ended March 31, 2001)
|
3.8 |
Certificate
of Designations of Series A Junior Participating Preferred
Stock filed
November 7, 2001 (Incorporated by reference to Exhibit 4.1.h
of our
Registration Statement on Form S-8, dated December 14, 2001,
Commission
File No. 333-75136)
|
3.9 |
Amended
and Restated Bylaws (Incorporated by reference to Exhibit 3.1
of our Form
10-Q for the quarter ended June 30,
1996)
|
* | 10.1 |
1995
Stock Option Plan (Incorporated by reference to Exhibit F of
our
Registration Statement on Form S-4 dated December 21, 1995,
Commission
File No. 33-64031)
|
* |
10.2
|
Amendment
to 1995 Stock Option Plan (Incorporated by reference to Exhibit
10.25 of
our Form 10-K for the year ended December 31,
2001)
|
10.3
|
Lease
Agreement between Pollock Realty Corporation and us dated July
25, 1996
(Incorporated by reference to Exhibit 10.19 of our Form 10-Q
for the
quarter ended September 30, 1996)
|
10.4
|
Platinate
HPMA Copolymer Royalty Agreement between The School of Pharmacy,
University of London and the Company dated November 19, 1996
(Incorporated
by reference to Exhibit 10.19 of our Form 10-Q for the quarter
ended
September 30, 1996)
|
* |
10.5
|
Employment
Agreement of David P. Nowotnik, PhD (Incorporated
by reference to Exhibit 10.19 of our Form 10-K for the year
ended December
31, 1999)
|
* |
10.6
|
401(k)
Plan (Incorporated
by reference to Exhibit 10.20 of our Form 10K for the year
ended December
31, 1999)
|
* |
10.7
|
2000
Special Stock Option Plan and Agreement (Incorporated
by reference to Exhibit 10.24 of our Form 10-Q for the quarter
ended
September 30, 2000)
|
10.8
|
Form
of Convertible Note (Incorporated
by reference to Exhibit 10.24 of our Form 10-Q for the quarter
ended
September 30, 2000)
|
10.9 |
Rights
Agreement, dated as of October 31, 2001 between the us and
American Stock
Transfer & Trust Company, as Rights Agent (incorporated by reference
to Exhibit 99.1 of our Current Report on Form 8-K dated October
19,
2001)
|
10.10
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between
us and American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
* | 10.11 |
2001
Restricted Stock Plan (incorporated by reference to Appendix
A of our
Proxy Statement filed on April 16,
2001)
|
* |
10.12
|
2005
Equity Incentive Plan (incorporated by reference to Exhibit 1
of our Proxy
Statement filed on April 18, 2005
|
* |
10.13
|
Agreement,
dated as of May 10, 2005 by and between us and Kerry P. Gray
(1)
|
* |
10.14
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen
B.
Thompson (1)
|
* |
10.15
|
Asset
Sale Agreement, dated as of October 12, 2005, between us and
Uluru, Inc.
(1)
|
10.16
|
Amendment
to Asset Sale Agreement, dated as December 8, 2006, between
us and Uluru,
Inc.
|
10.17
|
License
Agreement, dated as of October 12, 2005, between us and Uluru,
Inc.
(1)
|
10.18
|
Amendment
to 7% (Subject to Adjustment) Convertible Promissory
Notes Due September
13, 2005, dated as of November 3, 2005, between us and
Oracle Partners LP,
Oracle Institutional Holders LP, SAM Oracle Investments
Inc. and Oracle
Offshore Ltd. (1)
|
10.19
|
Note
and Warrant Purchase Agreement, dated February 16, 2006
between us and
certain Secured Parties (3)
|
10.20
|
Security
Agreement, dated February 16, 2006, between us and
certain Secured Parties
(2)
|
10.21
|
Form
of 7.5% Secured Convertible Promissory Note, dated February
16, 2006,
issued by us and to certain Purchasers
(2)
|
10.22
|
Form
of Warrant, dated February 16, 2006, issued by us to
certain Purchasers
(2)
|
10.23
|
Investor
Rights Agreement, dated February 16, 2006, between
us and certain
Purchasers (2)
|
10.24
|
Note
and Warrant Purchase Agreement, dated October 24, 2006
between us and
certain Secured Parties
(3)
|
10.25
|
Security
Agreement, dated October 24, 2006, between us and certain Secured
Parties
(3)
|
10.26
|
Form
of 7.5% Secured Convertible Promissory Note, dated October 24,
2006,
issued by us and to certain Purchasers
(3)
|
10.27
|
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
10.28
|
Investor
Rights Agreement, dated October 24, 2006, between us and certain
Purchasers (3)
|
10.29
|
Note
and Warrant Purchase Agreement, dated December 6, 2006 between
us and
certain Secured Parties (3)
|
10.30
|
Security
Agreement, dated December 6, 2006, between us and certain Secured
Parties
(3)
|
10.31
|
Form
of 7.5% Secured Convertible Promissory Note, dated December 6,
2006,
issued by us and to certain Purchasers
(3)
|
10.32
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
10.33
|
Investor
Rights Agreement, dated December 6, 2006, between us and certain
Purchasers (3)
|
21
|
Subsidiaries
of the registrant
|
23.1
|
Consent
of Whitley Penn LLP
|
23.2
|
Consent
of Grant Thornton LLP
|
23.3
|
Consent
of Bingham McCutchen LLP (Previously
Filed)
|
24.1 | Power of Attorney (Previously Filed) |
*
|
Management
contract or compensatory plan required to be filed as an Exhibit
to this
Form pursuant to Item 15(c) of the
report.
|
(4) |
Incorporated
by reference to our Form 10-K for the year ended December 31,
2005.
|
(5) |
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2006.
|
(6) |
Incorporated
by reference to our Form 10-K for the year ended December 31,
2006.
|