Delaware
|
83-0221517
|
||||
(State
or Other Jurisdiction
|
(I.R.S. Employer
Identification No.)
|
||||
of
Incorporation or Organization)
|
Item 1. | Condensed Consolidated Financial Statements: |
|
|
Condensed Consolidated Balance Sheets at | |||
September 30, 2007 (unaudited) and December 31, 2006 (audited) |
13
|
||
Condensed Consolidated Statements of Operations (unaudited) for the | |||
three and nine months ended September 30, 2007 and September 30, 2006 |
14
|
||
Condensed Consolidated Statements of Cash Flows (unaudited) for the | |||
nine months ended September 30, 2007 and September 30, 2006 |
15
|
||
Notes to Unaudited Condensed Consolidated Financial Statements |
16
|
||
Item 2. | Management's Discussion and Analysis or Plan of Operation |
2
|
|
Item 3. | Controls and Procedures |
8
|
|
Risk Factors |
9
|
Item
1.
|
Legal Proceedings |
10
|
|
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
10
|
|
Item 3. | Defaults Upon Senior Securities |
10
|
|
Item 4. | Submission of Matters to a Vote of Security Holders |
10
|
|
Item 5. | Other Information |
10
|
|
Item 6. | Exhibits |
10
|
|
SIGNATURES |
12
|
Compound
|
|
Originator
|
|
Technology
|
|
Indication
|
|
FDA
Filing
|
|
Clinical
Stage
(1)
|
|
|
|
|
|
|
|
|
|
|
|
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
|
· |
costs
for product manufacturing for a new ProLindac clinical trial expected
to
start in 2008 ($214,000);
|
· |
higher
salary and related cost due to the hiring of additional scientific
staff
($30,000); and
|
· |
other
net increases ($25,000).
|
· |
higher
investor relations expenses ($149,000) due to our increased investor
relations efforts;
|
· |
higher
salary related expenses due to stock option expenses ($156,000);
and
|
· |
higher
salary expenses ($65,000).
|
· |
lower
patent expenses ($90,000);
|
· |
lower
professional fees ($59,000); and
|
· |
other
net decreases ($21,000).
|
· |
lower
costs for product manufacturing for ProLindac ($198,000). Product
manufacturing was completed early in 2006 which we believe is adequate
to
supply drug product for our current ovarian cancer
trial;
|
· |
lower
costs of clinical trials for ProLindac
($170,000). We incurred start-up costs for the clinical trial in
early
2006; and
|
· |
other
net decreases ($53,000).
|
· |
higher
salary and related cost due to the hiring of additional scientific
staff
($121,000); and
|
· |
higher
scientific consulting costs ($63,000).
|
· |
higher
salary related expenses due mainly to stock option expenses
($580,000);
|
· |
higher
investor relations expenses ($368,000) due to our increased investor
relations efforts;
|
· |
higher
salary and related costs ($178,000); and
|
· |
higher
travel costs ($58,000).
|
· |
lower
patent expenses ($45,000); and
|
· |
other
net decreases ($16,000).
|
|
•
|
|
unanticipated
issues in integrating information, communications and other systems;
|
|
•
|
|
retaining
key employees;
|
|
•
|
|
consolidating
corporate and administrative infrastructures;
|
|
•
|
|
the
diversion of management’s attention from ongoing business concerns; and
|
|
•
|
|
coordinating
geographically separate organizations.
|
ITEM |
6 EXHIBITS
|
2.2 |
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc.,
Somanta
Acquisition Corporation, Somanta Pharmaceuticals, Inc., Somanta
Incorporated and Somanta Limited, dated April 18, 2007. (Incorporated
by
reference to Exhibit 2.1 to our Form 8-K dated April 18,
2007)
|
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)
|
10.43
|
Amendment
to 7.0% (Subject to Adjustment) Convertible Promissory Notes Due
November
16, 2007, dated October 24, 2007 by and between us and Oracle Partners
LP
and affiliates
|
10.44
|
Amendment
to Amended and Restated 7.5% Secured Convertible Promissory Notes
Due
November 15, 2007, dated October 24, 2007 by and between us and
SCO
Capital Partners LLC, Beach Capital LLC and Lake End Capital
LLC
|
31.1
|
Certification
of Chief Executive Officer of Access Pharmaceuticals, Inc. pursuant
to
Rule 13a-14(a)/15d-14(a)
|
31.2
|
Certification
of Chief Financial Officer of Access Pharmaceuticals, Inc. pursuant
to
Rule 13a-14(a)/15d-14(a)
|
32.1*
|
Certification
of Chief Executive Officer of Access Pharmaceuticals, Inc. pursuant
to 18
U.S.C. Section 1350
|
32.2*
|
Certification
of Chief Financial Officer of Access Pharmaceuticals, Inc. pursuant
to 18
U.S.C. Section 1350
|
Date:
|
November
14, 2007
|
By:
|
/s/
Stephen R. Seiler
|
Stephen
R. Seiler
|
|||
President
and Chief Executive Officer
|
|||
(Principal
Executive Officer)
|
|||
Date:
|
November
14, 2007
|
By:
|
/s/
Stephen B. Thompson
|
Stephen
B. Thompson
|
|||
Vice
President and Chief Financial Officer
|
|||
(Principal
Financial and Accounting Officer)
|
|||
|
September
30, 2007
|
December
31, 2006
|
|||||
ASSETS
|
(unaudited)
|
(audited)
|
|||||
Current
assets
Cash
and cash equivalents
Short
term investments, at cost
Receivables
Prepaid
expenses and other current assets
|
$
|
661,000
515,000
861,000
530,000
|
$
|
1,194,000
3,195,000
359,000
283,000
|
|||
Total
current assets
|
2,567,000
|
5,031,000
|
Property
and equipment, net
|
156,000
|
212,000
|
|||||
Debt
issuance costs, net
|
-
|
158,000
|
|||||
Patents,
net
|
752,000
|
878,000
|
|||||
Licenses,
net
|
-
|
25,000
|
|||||
Other
assets
|
25,000
|
122,000
|
|||||
Total
assets
|
$
|
3,500,000
|
$
|
6,426,000
|
|||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||||||
Current
liabilities
Accounts
payable and accrued expenses
Accrued
interest payable
Deferred
revenues
Current
portion of long-term debt, net of discount $0 at
September
30, 2007 and $2,062,000 at December 31, 2006
|
$
|
1,595,000
1,023,000
1,167,000
11,406,000
|
$
|
1,226,000
581,000
173,000
8,833,000
|
|
||
Total
current liabilities
|
15,191,000
|
10,813,000
|
|||||
Long-term
debt
|
5,500,000
|
5,500,000
|
|||||
Total
liabilities
|
20,691,000
|
16,313,000
|
|||||
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,
3,575,114 at September 30, 2007 and 3,535,108 at
December
31, 2006
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost - 163 shares
Accumulated
deficit
|
-
36,000
69,687,000
(1,045,000
(4,000
(85,865,000
|
)
)
)
|
-
35,000
68,799,000
(1,045,000
(4,000
(77,672,000
|
)
)
)
|
|||
Total
stockholders' deficit
|
(17,191,000
|
)
|
(9,887,000
|
)
|
|||
Total
liabilities and stockholders' deficit
|
$
|
3,500,000
|
$
|
6,426,000
|
Three
months ended
|
Nine
months ended
|
||||||||||||
September
30,
|
September
30
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Revenues
|
License
revenues
|
$
|
6,000
|
$
|
-
|
$ | 6,000 |
$
|
-
|
|||||
Expenses
|
|||||||||||||
Research
and development
|
596,000
|
379,000
|
1,532,000 |
1,769,000
|
|||||||||
General
and administrative
|
1,000,000
|
800,000
|
3,252,000 |
2,129,000
|
|||||||||
Depreciation
and amortization
|
61,000
|
77,000
|
210,000 |
231,000
|
|||||||||
Total
expenses
|
1,657,000
|
1,256,000
|
4,994,000 |
4,129,000
|
|||||||||
Loss
from operations
|
(1,651,000
|
)
|
(1,256,000
|
)
|
(4,988,000 | ) |
(4,129,000
|
)
|
|||||
Interest
and miscellaneous income
|
12,000
|
86,000
|
72,000 |
278,000
|
|||||||||
Interest
and other expense
|
(318,000
|
)
|
(1,976,000
|
)
|
(3,277,000 | ) |
(5,244,000
|
)
|
Unrealized
gain (loss) on fair value of
warrants
and conversion feature
|
-
|
|
1,131,000
|
|
-
|
|
(1,107,000
|
)
|
|||||
(306,000
|
) |
(759,000
|
) | (3,205,000 | ) |
(6,073,000
|
) | ||||||
Net
loss
|
$
|
(1,957,000
|
)
|
$
|
(2,015,000
|
)
|
$
|
(8,193,000
|
)
|
$
|
(10,202,000
|
)
|
|
Basic
and diluted loss per common share
Net
loss allocable to common
shareholders
|
$
|
(0.55
|
)
|
$
|
(0.57
|
)
|
|
|
|
$
|
(2.89
|
)
|
|
Weighted
average basic and diluted
common
shares outstanding
|
3,575,114
|
3,534,408
|
3,544,181
|
3,530,941
|
Nine
months ended September 30,
|
|||||||
2007
|
2006
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(8,193,000
|
)
|
$
|
(10,202,000
|
)
|
|
Adjustments
to reconcile net loss to cash used
in
operating activities:
|
|||||||
Depreciation
and amortization
|
210,000
|
230,000
|
|||||
Stock
option expense
|
810,000
|
171,000
|
|||||
Stock
compensation expense
|
-
|
69,000
|
|||||
Stock
issued for compensation
|
44,000
|
-
|
|||||
Amortization
of debt costs and discounts
|
2,316,000
|
4,192,000
|
|||||
Unrealized
loss on fair value of warrants and
conversion
feature
|
-
|
1,107,000
|
Loss on
sale of asset
|
2,000
|
|
-
|
||||
Change
in operating assets and liabilities:
|
|||||||
Receivables
|
(502,000
|
)
|
14,000
|
||||
Prepaid
expenses and other current assets
|
(247,000
|
)
|
143,000
|
||||
Other
assets
|
1,000
|
128,000
|
|||||
Accounts
payable and accrued expenses
|
369,000
|
(849,000
|
)
|
||||
Accrued
interest payable
|
953,000
|
805,000
|
|||||
Deferred
revenue
|
994,000
|
-
|
|||||
Net
cash used in operating activities
|
(3,243,000
|
)
|
(4,192,000
|
)
|
|||
Cash
flows from investing activities:
|
|||||||
Capital
expenditures
|
(18,000
|
)
|
(3,000
|
)
|
|||
Proceeds
from sale of asset
|
13,000
|
-
|
|||||
Redemptions
of short term investments and
certificates
of deposit, net
|
2,680,000
|
(98,000
|
)
|
||||
Net
cash provided by (used in) investing activities
|
2,675,000
|
(101,000
|
)
|
||||
Cash
flows from financing activities:
|
|||||||
Payments
of notes payable
|
-
|
(106,000
|
)
|
||||
Proceeds
from secured convertible notes payable
|
-
|
4,532,000
|
|||||
Exercise
of stock options
|
35,000
|
-
|
|||||
Net
cash provided by financing activities
|
35,000
|
4,426,000
|
|||||
Net
(decrease) increase in cash and cash equivalents
|
(533,000
|
)
|
133,000
|
||||
Cash
and cash equivalents at beginning of period
|
1,194,000
|
349,000
|
|||||
Cash
and cash equivalents at end of period
|
$
|
661,000
|
$
|
482,000
|
|||
Supplemental
cash flow information:
|
|||||||
Cash
paid for interest
|
$
|
5,000
|
$
|
5,000
|
|||
Accrued
interest capitalized
|
511,000 | - |
(1) |
Interim
Financial Statements
|
September
30, 2007
|
December
31, 2006
|
||||||||||||
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
||||||||||
Amortizable
intangible assets
Patents
Licenses
|
$
|
1,680
-
|
$
|
928
-
|
$
|
1,680
500
|
$
|
802
475
|
|||||
Total
|
$ | $1,680 |
$
|
928
|
$
|
2,180
|
$
|
1,277
|
2007 | $ | 42 | ||
2008 | 168 | |||
2009 | 168 | |||
2010 | 168 | |||
2011 | 168 | |||
Thereafter | 38 | |||
Total | $ | 752 |
|
|
9/30/07
|
|
|||
Expected
life
|
|
2.0
yrs.
|
|
|||
Risk
free interest rate
|
|
4.63
|
%
|
|||
Expected
volatility(a)
|
|
141
|
%
|
|||
Expected
dividend yield
|
|
0.0
|
%
|
|||
(a)
|
Reflects
movements in our stock price over the most recent historical period
equivalent to the expected life.
|
September
30,
2007
|
December
31,
2006
|
||||||
Convertible
note - Oracle and affiliates
|
$
|
4,015,000
|
$
|
4,015,000
|
|||
Convertible
note
|
5,500,000
|
5,500,000
|
|||||
Convertible
note
|
1,391,000
|
880,000
|
|||||
10,906,000
|
10,395,000
|
||||||
Discount
|
-
|
(456,000
|
)
|
||||
10,906,000
|
9,939,000
|
||||||
Convertible
note - SCO and affiliates
|
6,000,000
|
6,000,000
|
|||||
Discount
|
-
|
(1,606,000
|
)
|
||||
6,000,000
|
4,394,000
|
||||||
Total
|
$
|
16,906,000
|
$
|
14,333,000
|
|||
Short
term
|
$
|
11,406,000
|
$
|
8,833,000
|
|||
Long
term
|
5,500,000
|
5,500,000
|
|||||
Total
|
$
|
16,906,000
|
$
|
14,333,000
|
|||