ABEONA THERAPEUTICS INC. - Annual Report: 2007 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
x
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Annual
Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934 for the fiscal year ended December 31, 2007
or
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*
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Transition
Report pursuant to Section 13 or 15 (d) of the Securities Exchange Act of
1934 for the transition period from __________ to
__________
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Commission
File Number 0-9314
ACCESS PHARMACEUTICALS,
INC.
(Name of
Registrant as Specified in Its Charter)
Delaware
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83-0221517
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(State
of
Incorporation)
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(I.R.S.
Employer I.D. No.)
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2600 Stemmons Freeway, Suite 176, Dallas, TX |
75207
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(Address of Principal Executive Offices) |
(Zip
Code)
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Issuer's
telephone number, including area code: (214) 905-5100
Securities
registered pursuant to Section 12(b) of the Act:
None None
(Title
of
Class) (Name
of each exchange on which registered)
Securities
registered pursuant to Section 12(g) of the Act:
Common Stock, One Cent
($0.01) Par Value Per Share
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes ____ No P
Indicate
by check mark whether the issuer is not required to file reports pursuant to
Section 13 or Section 15(d) of the Exchange Act. Yes P No
____
Indicate
by check mark whether the issuer (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports) ,
and (2) has been subject to such filing requirements for the past 90
days. Yes
P No
____
Check if
disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not
contained herein, and will not be contained herein, to the best of
registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
(Check one):
Larger accelerated
filer ¨ Accelerated
filer ¨
Non-accelerated filer ¨ Smaller
reporting company x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes __ No
P
State
issuer’s revenues for the fiscal year ended December 31, 2007 was
$57,000.
State the
aggregate market value of the voting and non-voting common equity held by
non-affiliates computed by reference to the price at which the common equity was
sold, or the average bid and asked price of such common equity, as of the last
business day of the registrant’s most recently completed fiscal quarter.
$15,335,000 as of June 30, 2007.
As of
March 31, 2008 there were 5,623,781 shares of Access Pharmaceuticals, Inc.
Common Stock issued and outstanding. Also at March 31, 2008 there were
3,499.8617 shares of Series A Convertible Preferred Stock convertible into
11,666,195 shares of Common Stock.
DOCUMENTS INCORPORATED BY
REFERENCE: Portions of Registrant's Definitive Proxy Statement
to be filed with the Commission pursuant to Regulation 14A in connection with
the 2008 Annual Meeting are incorporated herein by reference into Part III of
this report.
TABLE
OF CONTENTS
Part I |
Page
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Item 1. | Description of Business |
2
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Item 2. | Description of Property |
28
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Item 3. | Legal Proceedings |
28
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Item 4. | Submission of Matters to a Vote of Security Holders |
28
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Part II | ||
Item
5.
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Market for Common Equity and Related Stockholder Matters |
30
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Item
7.
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Management’s Discussion and Analysis or Plan of Operation |
33
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Item
8.
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Financial Statements |
41
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Item 9.
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Changes In and Disagreements With Accountants on Accounting and Financial Disclosure |
41
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Item
9A(T)
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Controls and Procedures |
41
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Item 9B.
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Other Information |
41
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Part III | ||
Item 10. | Directors, Executive Officers, Promoters, Control Persons and Corporate Governance; | |
Compliance With Section 16(A) of the Exchange Act |
42
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Item 11. | Executive Compensation |
42
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Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related | |
Stockholder Matters |
42
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Item 13. | Certain Relationships and Related Transactions and Director Independence |
42
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Item 14. | Principal Accountant Fees and Services |
42
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Item 15. | Exhibits |
43
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Signatures |
45
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PART
I
ITEM
1. DESCRIPTION OF BUSINESS
This Form
10-K (including the information incorporated by reference) contains
forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended, that involve risks and uncertainties including, but not limited to
the uncertainties associated with research and development activities, clinical
trials, our ability to raise capital, the timing of and our ability to achieve
regulatory approvals, dependence on others to market our licensed products,
collaborations, future cash flow, the timing and receipt of licensing and
milestone revenues, the future success of our marketed products and products in
development, our sales projections, and the sales projections of our licensing
partners, our ability to achieve licensing milestones and other risks described
below as well as those discussed elsewhere in this 10-K, documents incorporated
by reference and other documents and reports that we file periodically with the
Securities and Exchange Commission. These statements include, without
limitation, statements relating to our ability to continue as a going concern,
anticipated payments to be received from Uluru, anticipated product approvals
and timing thereof, product opportunities, clinical trials and U.S. Food and
Drug Administration (“FDA”) applications, as well as our drug development
strategy, our clinical development organization, expectations regarding our rate
of technological developments and competition, our plan not to establish an
internal marketing organization, our expectations regarding minimizing
development risk and developing and introducing technology, the size of our
targeted markets, the terms of future licensing arrangements, our ability to
secure additional financing for our operations and our expected cash burn rate.
These statements relate to future events or our future financial performance. In
some cases, you can identify forward-looking statements by terminology such as
“may,” “will,” “should,” “expects,” “plans,” “could,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative of such terms
or other comparable terminology. These statements are only predictions and
involve known and unknown risks, uncertainties and other factors, including the
risks outlined under “Risk Factors,” that may cause our or our industry’s actual
results, levels of activity, performance or achievements to be materially
different from any future results, levels or activity, performance or
achievements expressed or implied by such forward-looking
statements.
Although
we believe that the expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee future results, levels of activity, performance
or achievements. We are under no duty to update any of the forward-looking
statements after the date of filing this Form 10-K to conform such statements to
actual results.
Business
Access
Pharmaceuticals, Inc. (together with our subsidiaries, “We”, “Access” or the
“Company”) is a Delaware corporation. We are an emerging biopharmaceutical
company focused on developing products based upon our nanopolymer chemistry
technologies. We currently have one approved product, two products in Phase 2
clinical trials and five products in pre-clinical development. Our description
of our business, including our list of products and patents, takes into
consideration our acquisition of Somanta Pharmaceuticals, Inc. which closed
January 4, 2008.
·
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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 US$1
billion world-wide. MuGard, a proprietary nanopolymer formulation, has
received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
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·
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Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase 2
clinical trial being conducted in the EU in patients with ovarian cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in excess
of $2.0 billion.
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·
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Pre-clinical
development of Cobalamin™, our proprietary nanopolymer oral drug delivery
technology based on the natural vitamin B12 uptake mechanism. We are
currently developing a product for the oral delivery of
insulin.
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·
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Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably breast,
ovarian and colorectal cancers.
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·
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Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
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·
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Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
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·
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Pre-clinical
development of Cobalamin-mediated targeted
delivery.
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·
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Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration with Virium
Pharmaceuticals.
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2
Products
Access
used its drug delivery technologies to develop the following products and
product candidates:
Access
Drug Portfolio
Compound
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Originator
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Technology
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Indication
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Clinical
Stage (1)
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MuGard™
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Access
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Mucoadhesive
liquid
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Mucositis
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Marketing
clearance received
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ProLindacTM
(Polymer
Platinate,
AP5346) (2)
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Access
– U London
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Synthetic
polymer
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Cancer
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Phase
2
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||||
Phenylbutyrate
(PB)
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National
Institute
of
Health
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Small
molecule
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Cancer
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Phase
2
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Oral
Insulin
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Access
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Cobalamin
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Diabetes
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Pre-clinical
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Oral
Delivery System
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Access
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Cobalamin
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Various
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Pre-clinical
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Angiolix®
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Immunodex,
Inc.
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Humanized
monoclonal
antibody
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Cancer
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Pre-clinical
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||||
Prodrax®
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Univ
London
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Small
molecule
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Cancer
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Pre-clinical
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||||
Alchemix®
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DeMontford
Univ
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Small
molecule
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Cancer
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Pre-clinical
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||||
Cobalamin-Targeted
Therapeutics
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Access
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Cobalamin
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Anti-tumor
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Pre-clinical
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||||
(1)
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For
more information, see “Government Regulation” for description of clinical
stages.
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(2)
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Licensed
from the School of Pharmacy, The University of London. Subject to a 1%
royalty and milestone payments on
sales.
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|
3
Approved
Products
MuGard™ - Mucoadhesive
Liquid Technology (MLT)
Mucositis
is a debilitating condition involving extensive inflammation of mouth tissue
that affects annually an estimated 400,000 cancer patients in the United States
undergoing chemotherapy and radiation treatment. Any treatment that would
accelerate healing and/or diminish the rate of appearance of mucositis would
have a significant beneficial impact on the quality of life of these patients
and may allow for more aggressive chemotherapy. We believe the potential
addressable market for a mucositis product could be over $1 billion
world-wide.
Access’
MuGard is a viscous polymer solution which provides a coating for the oral
cavity. MuGard is dispensed in a ready to use form. A multi-site, randomized
clinical study was performed in the United States testing MuGard and MuGard
containing an anti-inflammatory drug to determine the effect of these products
on the prevention and treatment of mucositis. The data from this trial indicated
that the patients using MuGard displayed a lower incidence of mucositis than is
typically seen in the studied population with no additional benefit from the
drug.
The data
were retrospectively compared with two historical patient databases to evaluate
the potential advantages MuGard may represent in the prevention, treatment and
management of mucositis. The patient evaluation was conducted using the oral
mucositis assessment scale (OMAS), which qualifies the disease severity on a
scale of 0-5. Key highlights of the comparison with the historical patient
databases are as follows:
•
the average severity of the disease was reduced by approximately
40%;
•
the maximum intensity of the mucositis was approximately 35% lower;
and
•
the median peak intensity was approximately 50% lower.
These
data confirmed the fact that MuGard could represent an important advancement in
the management and prevention of mucositis. On September 20, 2006, we announced
that we had submitted a Premarket Notification 510(k) application to the United
States Food and Drug Administration (FDA) announcing the Company’s intent to
market MuGard. On December 13, 2006, we announced that we had received marketing
clearance for MuGard from FDA for the indication of the management of oral
wounds including mucositis, aphthous ulcers and traumatic ulcers.
Access is
currently seeking marketing partners to market MuGard in the United States and
in other territories worldwide. In August 2007, we signed a definitive licensing
agreement with SpePharm Holding, B.V. under which SpePharm will market Access’
product MuGard in Europe. In January 2008 we also signed a definitive licensing
agreement with RHEI Pharmaceuticals, Inc. under which RHEI will market Access’
product MuGard in China and other Southeast Asian countries.
Products
in Development Status
ProLindac™ (Polymer
Platinate, AP5346) DACH Platinum
Chemotherapy,
surgery and radiation are the major components in the clinical management of
cancer patients. Chemotherapy serves as the primary therapy for some solid
tumors and metastases and is increasingly used as an adjunct to radiation and
surgery to improve their effectiveness. For chemotherapeutic agents to be
effective in treating cancer patients, however, the agent must reach the target
cells in effective quantities with minimal toxicity in normal
tissues.
The
current optimal strategy for chemotherapy involves exposing patients to the most
intensive cytotoxic regimens they can tolerate and clinicians attempt to design
a combination of chemotherapeutic drugs, a dosing schedule and a method of
administration to increase the probability that cancerous cells will be
destroyed while minimizing the harm to healthy cells. Notwithstanding
clinicians’ efforts, most current chemotherapeutic drugs have significant
shortcomings that limit the efficacy of chemotherapy. For example, certain
cancers are inherently unresponsive to chemotherapeutic agents. Alternatively,
other cancers may initially respond, but subgroups of cancer cells acquire
resistance to the drug during the course of therapy and the resistant cells may
survive and cause a relapse. Serious toxicity, including bone marrow
suppression, renal toxicity, neuropathy, or irreversible cardiotoxicity, are
some of the limitations of current anti-cancer drugs that can prevent their
administration in curative doses.
Oxaliplatin,
a formulation of DACH platinum, is a chemotherapeutic which was initially
approved in France and in Europe in 1999 for the treatment of colorectal cancer.
It is now also being marketed in the United States and generated worldwide sales
in excess of $2 billion in 2006. Carboplatin and Cisplatin, two other approved
platinum chemotherapy drugs, are not indicated for the treatment of metastatic
colorectal cancer. Oxaliplatin, in combination with 5-flurouracil and folinic
acid (known as the FOLFOX regime) is indicated for the first-line treatment of
metastatic colorectal cancer in Europe and the U.S. The colorectal cancer market
is a significant opportunity as there are over 940,000 reported new cases
annually worldwide, increasing at a rate of approximately three percent per
year, and 500,000 deaths.
4
Currently,
platinum compounds are one of the largest selling categories of chemotherapeutic
agents, with annual sales in excess of $3.0 billion in 2006. As is the case with
all chemotherapeutic drugs, the use of such compounds is associated with serious
systemic side effects. The drug development goal therefore is to enhance
delivery of the active drug to the tumor and minimize the amount of active drug
affecting normal organs in the body.
Utilizing
a biocompatible water-soluble polymer (HPMA) as a drug carrier, Access’ drug
candidate ProLindac, links DACH platinum to a polymer in a manner which permits
the selective release of active drug to the tumor by several mechanisms,
including taking advantage of the differential pH in tumor tissue compared to
healthy tissue. The polymer also capitalizes on the biological differences in
the permeability of blood vessels at tumor sites versus normal tissue. In this
way, tumor selective delivery and platinum release is achieved. The ability of
ProLindac to inhibit tumor growth has been evaluated in more than ten
preclinical models. Compared with the marketed product oxaliplatin, ProLindac
showed either marked superiority or superiority in most of these models.
Preclinical studies of the delivery of platinum to tumors in an animal model
have shown that, compared with oxaliplatin at equitoxic doses, ProLindac
delivers in excess of 16 times more platinum to the tumor. An analysis of tumor
DNA, which is the main target for anti-cancer platinum agents, has shown that
ProLindac delivers
approximately 14 times more platinum to tumor DNA than oxaliplatin. Results from
preclinical efficacy studies conducted in the B16 and other tumor models have
also shown that ProLindac is superior to oxaliplatin in inhibiting the growth of
tumors. An extensive preclinical package has been developed supporting the
development of ProLindac.
In 2005,
we completed a Phase 1 multi-center clinical study conducted in Europe, which
enrolled 26 patients. The study was reported in a journal publication, Cancer
Chemotherapy and Pharmacology, 60(4): 523-533 in 2007. The European trial
was designed to identify the maximum tolerated dose, dose limiting toxicities,
the pharmacokinetics of the platinum in plasma and the possible anti-tumor
activity of ProLindac. The open-label, non-randomized, dose-escalation Phase 1
study was performed at two European centers. ProLindac was administered as an
intravenous infusion over one hour, once a week on days 1, 8 and 15 of each
28-day cycle to patients with solid progressive tumors. We obtained results in
26 patients with a broad cross-section of tumor types, with doses ranging from
80-1,280 mg Pt/m2.
Of the 26
patients, 10 were not evaluable for tumor response, principally due to
withdrawal from the study prior to completing the required cycle. Of the 16
evaluable patients, 2 demonstrated a partial response, 1 experienced a partial
response based on a biomarker and 4 experienced stable disease. One of the
patients who attained a partial response had a melanoma with lung metastasis; a
CT scan revealed a tumor decrease of greater than 50%. The other patient who
responded had ovarian cancer; she had a reduction in lymph node metastasis and
remission of a liver metastasis. The patient who experienced a partial response
based on a biomarker was an ovarian cancer patient for whom Ca125 levels
returned to normal. Also of note, a patient with cisplatin resistant cervical
cancer showed a short lasting significant reduction in lung metastasis after 3
doses. However, due to toxicity, the patient could not be retreated to determine
whether the partial response could be maintained.
A Phase 2
clinical trial of ProLindac is underway in ovarian cancer patients who have
relapsed after first line platinum therapy. The primary aim of the study is to
determine the response rate of ProLindac monotherapy in this patient population.
The response rates for other platinum compounds in this indication are well
known, and will be used for comparison. Patients are dosed either once every 2
weeks or once every three weeks. As the Phase 1 study involved weekly dosing,
the initial phase of the ovarian cancer monotherapy study involves some dose
escalation to determine recommended doses using these dosing regimens.
Preliminary results from the dose ranging part of the study were presented at
AACR-NCI-EORTC conference in San Francisco in October 2007. Significantly, there
was a reduction of the Ca125 biomarker in five of the six patients in a cohort
receiving of ProLindac on a once every three week dosing schedule. The Ca125
biomarker has been demonstrated to be a reliable indicator of the clinical
progression of ovarian cancer
The
Company has submitted an IND application to the US Food and Drug Administration,
and has received clearance from the agency to proceed with a Phase 1 clinical
study of ProLindac in combination with fluorouracil and leucovorin. The study is
designed to evaluate the safety of the ProLindac in combination with two
standard drugs used to treat colorectal cancer and to establish a safe dose for
Phase 2 clinical studies of this combination in colorectal cancer. The company
is currently evaluating whether clinical development of ProLindac in this
indication might proceed more rapidly by utilizing an alternative clinical
strategy and/or conducting studies in the US and/or elsewhere in the
world.
5
|
Sodium
Phenylbutyrate
|
Sodium
Penylbutyrate, or PB, is a small molecule that was previously approved by the
FDA for sale as a treatment for a rare genetic disorder in infants known as
hyperuremia. PB has a number of additional mechanisms of action, including
the inhibition of histone deacetylase. Histone deacetylase is a class of
enzymes that remove acetyl groups from the amino acids in DNA. The
inhibition of histone deacetylase allows the body’s cancer suppressing genes to
work as intended. In addition, PB is not toxic to cells. These
characteristics make PB a good candidate to become a chemopotentiator; that is,
a substance that enhances the activity of a chemotherapeutic agent. As a
result, PB will ideally be administered in conjunction with radiation and/or
chemotherapy.
In
February 2005, we entered into a Phenylbutyrate Co-development and Sublicense
Agreement with Virium Pharmaceuticals, Inc., pursuant to which Virium granted us
an exclusive, worldwide sublicense to PB, excluding the U.S. and Canada, for the
treatment of cancer, autoimmune diseases and other clinical indications. We paid
Virium a license fee of $50,000. Virium has retained all rights with respect to
PB inside the U.S. and Canada. Access’ single largest stockholder, SCO
Capital Partners, LLC, is also the single largest stockholder of Virium
Pharmaceuticals, Inc.
Virium is
also a party to a sublicense agreement with VectraMed, Inc. for the rights to
develop and commercialize PB worldwide for the treatment of cancer, autoimmune
diseases and other clinical indications. VectraMed obtained its rights to the
product under an Exclusive Patent License Agreement dated May 25, 1995 with the
U.S. Public Health Service, representing the National Institutes of Health.
VectraMed subsequently assigned all its rights to PB to Virium pursuant to a
novation agreement dated May 10, 2005.
Pursuant
to our agreement with Virium, we are responsible for the conduct of clinical
trials and patent prosecution related to PB outside of the U.S. and Canada. The
Virium agreement also requires us to pay Virium a royalty on the sales of PB
products until such time as the patents covering such products
expire. These patents expire at various times between 2011 and 2016. Our
agreement with Virium expires upon the expiration of the last to expire of these
patents in 2016.
On
December 6, 2006, we signed a letter of intent (LOI) pertaining to a license and
collaboration agreement with Virium covering all formulations or drug
combinations where Phenylbutyrate is an active ingredient. Pursuant to the LOI,
in addition to current worldwide rights, excluding North America, involving the
current formulation of Phenylbutyrate, we would obtain a participation in any
revenue or royalties derived from sales in the U.S. and Canada. In return, we
would grant Virium a reciprocal participation in Europe. In the rest of the
world, Access and Virium would share revenues and royalties equally. The LOI’s
terms provide that both companies will, among other things, share data and
jointly undertake the necessary pre-clinical and clinical studies, seek
regulatory approvals and file for patent protection in all territories. It also
provides for the formation of a joint development committee to oversee all
aspects of the development and commercialization of Phenylbutyrate. Completion
of the transaction contemplated by the LOI remains subject to the negotiation
and execution of a definitive agreement.
Phenylbutyrate
has been the subject of numerous Phase 1 and Phase 2 clinical studies sponsored
by the National Cancer Institute and others demonstrating the safety and
efficacy of PB in cancer, both as a monotherapy and in combination with other
anticancer compounds. To date, we have not been involved in any capacity in the
conduct of any clinical trial related to PB.
We
believe that PB may be a candidate to become a biological-response modifier that
acts as a dose-dependent inhibitor of cancer cell proliferation, migration, and
invasiveness, possibly by inhibition of urokinase and c-myc pathways, which
means that it inhibits the protease activity that irreversibly induces
programmed cell death. In addition, we believe that PB shows potential for the
treatment of malignant gliomas, which are cancers of the brain. We are aware of
numerous products in development for brain cancers. We are aware of several
products being developed by academic and commercial organizations targeting
glioblastoma. Medicis Pharmaceuticals currently sells Sodium Phenylbutyrate
(Buphenyl ® ) for
the treatment of a urea cycle disorder, hyperuremia.
6
There are
thirteen key use patents related to PB which have been issued to the NIH and
licensed by us as follows:
•
|
A
patent covering a method of inhibiting rapid tumor growth issued in the
U.S. that expires on March 14, 2014 with foreign counterparts in
Austria, Australia, Canada, Germany, European Union, Spain, Israel, New
Zealand and South Africa;
|
•
|
A
patent covering a method of treating brain cancer, leukemia, prostate
cancer, breast cancer, skin cancer and non-small cell lung cancer issued
in the U.S. that expires on June 3, 2014 with foreign counterparts in
Austria, Australia, Canada, Germany, European Union, Spain, Israel, Japan,
New Zealand, Portugal and South
Africa;
|
•
|
A
patent covering a method of treating brain cancer, skin cancer, benign
enlarged prostate and a cervical infection issued in the U.S. that expires
on February 25, 2014 with foreign counterparts in Austria, Australia,
Canada, Germany, European Union, Spain, Israel, Japan, New Zealand,
Portugal and South Africa;
|
•
|
A
patent covering a method of inducing the production of TGF alpha (which
slows the growth of cancer cells) issued in the U.S. that expires on
January 13, 2015 with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal and
South Africa;
|
•
|
A
patent covering a pharmaceutical composition for treating or preventing a
cancerous condition issued in the U.S. that expires on January 20, 2015
with foreign counterparts in Austria, Australia, Canada, Germany, European
Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
•
|
A
patent covering a method of inducing the differentiation of a cell issued
in the U.S. that expires on June 3, 2014 with foreign counterparts in
Austria, Australia, Canada, Germany, European Union, Spain, Israel, Japan,
New Zealand, Portugal and South
Africa;
|
•
|
A
patent covering a method of treating brain cancer, non-small cell lung
cancer, prostate cancer, skin cancer, brain tumors, cancers of the blood,
lung cancer and breast cancer issued in the U.S. that expires on August
26, 2014 with foreign counterparts in Austria, Australia, Canada, Germany,
European Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
•
|
A
patent covering a method of inhibiting the growth of rapidly growing
nonmalignant or malignant tumor cells issued in the U.S. that expires on
March 2, 2016 with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal and
South Africa;
|
•
|
A
patent covering a method of sensitizing a subject to radiation therapy or
chemotherapy and a method of treating brain cancer, leukemia, non-small
cell lung cancer, skin cancer, cancers of the blood, lung cancer, or renal
cancer issued in the U.S. that expires on December 1, 2015 with foreign
counterparts in Austria, Australia, Canada, Germany, European Union,
Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
•
|
A
patent covering a method of treating brain cancer, non-small cell lung
cancer, prostate cancer, skin cancer, cancers of the blood, breast cancer,
benign prostate enlargement, cervical infection, bladder cancer, kidney
cancer, colon cancer, or nose cancer issued in the U.S. that expires on
March 16, 2016 with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal and
South Africa;
|
•
|
A
patent covering a method of inducing the production of hemoglobin (blood)
and a method of treating a pathology associated with abnormal hemoglobin
(blood) activity issued in the U.S. that expires on January 27, 2015 with
foreign counterparts in Austria, Australia, Canada, Germany, European
Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
•
|
A
patent covering a method of preventing prostate cancer, brain cancer, skin
cancer, cancers of the blood, breast cancer, non-small cell lung cancer,
or renal cancer issued in the U.S. that expires on August 5, 2014 with
foreign counterparts in Austria, Australia, Canada, Germany, European
Union, Spain, Israel, Japan, New Zealand, Portugal and South Africa;
and
|
•
|
A
patent covering a method of inhibiting the production of cancer in a cell
issued in the U.S. that expires on March 14, 2011, June 3, 2013 or March
7, 2014, depending on the subject matter disclosed in the priority
applications with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal and
South Africa.
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7
Our
co-development partner, Virium advised us that it intends to initiate a Phase
1/2 clinical trial using PB to treat glioblastoma in the near future. We intend
to wait for the results of this Phase 1/2 clinical trial and the re-formulation
of the PB compound to a sustained release version before initiating our own
clinical trial related to PB in Europe. At this time, we do not know when
Virium will initiate such clinical trial, when it will be completed, or whether
it will be successful, nor do we know when Virium will have completed the
re-formulation of the PB compound to a sustained release version.
We also
believe that further studies should be considered to identify a subset of
patients that have tumors sensitive to PB, either as a single agent or in
combination with radiation therapy or other chemotherapeutic agents, and that we
should focus on this subset of patients in our future clinical trials related to
PB, subject to the successful completion of clinical trials by
Virium.
Research Projects, Products
and Products in Development
Drug
Development Strategy
A part of
our integrated drug development strategy is to form alliances with centers of
excellence in order to obtain alternative lead compounds while minimizing the
overall cost of research. The Company does not spend significant resources on
fundamental biological research but rather focuses on its chemistry expertise
and clinical development. For example, certain of our polymer platinate
technology has resulted in part from a research collaboration with The School of
Pharmacy, University of London.
Our
strategy is to focus on our polymer therapeutic program for the treatment of
cancer while continuing to develop technologies such as Cobalamin-mediated oral
drug delivery and Cobalamin-mediated tumor targeting which could provide us with
a revenue stream in the short term through commercialization or outlicensing to
fund our longer-term polymer and oncology drug development programs such as
Angiolix, Alchemix and Prodrax. To reduce financial risk and equity financing
requirements, we are directing our resources to the preclinical and early
clinical phases of development. Where the size of the necessary clinical studies
and cost associated with the later clinical development phases are significant,
we plan to co-develop with or to outlicense to marketing partners our
therapeutic product candidates. By forming strategic alliances with
pharmaceutical and/or biotech companies, we believe that our technology can be
more rapidly developed and successfully introduced into the
marketplace.
We will
continue to evaluate the most cost-effective methods to advance our programs. We
will contract certain research and development, manufacturing and manufacturing
scaleup, certain preclinical testing and product production to research
organizations, contract manufacturers and strategic partners. As appropriate to
achieve cost savings and accelerate our development programs, we will expand our
internal core capabilities and infrastructure in the areas of chemistry,
formulation, analytical methods development, clinical development, biology and
project management to maximize product opportunities in a timely manner.
Process
We begin
the product development effort by screening and formulating potential product
candidates, selecting an optimal active component, developing a formulation, and
developing the processes and analytical methods. Pilot stability, toxicity and
efficacy testing are conducted prior to advancing the product candidate into
formal preclinical development. Specialized skills are required to produce
these product candidates utilizing our technology. We have a limited core
internal development capability with significant experience in developing these
formulations, but also depend upon the skills and expertise of our
contractors.
Once the
product candidate has been successfully screened in pilot testing, our
scientists, together with external consultants, assist in designing and
performing the necessary preclinical efficacy, pharmacokinetic and toxicology
studies required for IND submission. External investigators and scaleup
manufacturing facilities are selected in conjunction with our consultants. The
initial Phase 1 and Phase 2 studies are conducted by institutions and
investigators supervised and monitored by our employees and contract research
organizations. We do not plan to have an extensive clinical development
organization as we plan to have the advance phases of this process conducted by
a development partner. Should we conduct Phase 3 clinical studies we expect to
engage a contract research organization to perform this work.
8
We
contract with third party contract research organizations (CROs) to complete our
large clinical trials and for data management of all of our clinical trials.
Currently, we have one Phase 2 trial in process continuing into 2008 and a new
Phase 2 trial planned for mid 2008 subject to preliminary findings in other
trials and our ability to fund such trials.
With all
of our product development candidates, we cannot assure you that the results of
the in vitro or animal studies are or will be indicative of the results that
will be obtained if and when these product candidates are tested in humans. We
cannot assure you that any of these projects will be successfully completed or
that regulatory approval of any product will be obtained.
We
expended approximately $2,602,000 and $2,053,000 on research and development
during the years 2007 and 2006, respectively.
Scientific
Background
Access
posseses a broad range of technologies and intellectual property in the areas of
drug delivery and oncology. Our core technologies rely on the use of
nanopolymers for use in the management of oral conditions such as mucositis, and
in drug delivery. In addition, we have small molecule and monoclonal antibody
programs which also embody the principals of drug delivery and drug
targeting.
The
ultimate criteria for effective drug delivery is to control and optimize the
localized release of the drug at the target site and rapidly clear the
non-targeted fraction. Conventional drug delivery systems such as controlled
release, sustained release, transdermal systems and others are designed for
delivering active product into the systemic circulation over time with the
objective of improving patient compliance. These systems do not address the
biologically relevant issues such as site targeting, localized release and
clearance of drug. The major factors that impact the achievement of this
ultimate drug delivery goal are the physical characteristics of the drug and the
biological characteristics of the disease target sites. The physical
characteristics of the drug affect solubility in biological systems, its
biodistribution throughout the body, and its interactions with the intended
pharmacological target sites and undesired areas of toxicity. The biological
characteristics of the diseased area impact the ability of the drug to
selectively interact with the intended target site to allow the drug to express
the desired pharmacological activity.
We
believe our drug delivery technologies are differentiated from conventional drug
delivery systems in that they seek to apply a disease-specific approach to
improve the drug delivery process with formulations to significantly enhance the
therapeutic efficacy and reduce toxicity of a broad spectrum of
products.
Core
Drug Delivery Technology Platforms
Our
current drug delivery technology platforms for use in cancer chemotherapy
are:
·
|
Synthetic
Polymer Targeted Drug Delivery
Technology;
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·
|
Cobalamin™-Mediated
Oral Delivery Technology;
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·
|
Cobalamin™-Mediated
Targeted Delivery Technology;
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·
|
Angiolix®
|
·
|
Prodrax®
and
|
·
|
Alchemix®.
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Each
of these platforms is discussed below:
9
Synthetic
Polymer Targeted Drug Delivery Technology
In
collaboration with The School of Pharmacy, University of London, we have
developed a synthetic polymer technology, which utilizes
hydroxypropylmethacrylamide with platinum, designed to exploit enhanced
permeability and retention, or EPR, at tumor sites to selectively accumulate
drug and control drug release. This technology is employed in our lead clinical
program, ProLindac. Many solid tumors possess vasculature that is
hyperpermeable, or leaky, to macromolecules. In addition to this enhanced
permeability, tumors usually lack effective lymphatic and/or capillary drainage.
Consequently, tumors selectively accumulate circulating macromolecules,
including, for example, up to 10% of an intravenous dose in mice. This effect
has been termed EPR, and is thought to constitute the mechanism of action of
styrene-maleic/anhydride-neocarzinostatin, or SMANCS, which is in regular
clinical use in Japan for the treatment of hepatoma. These polymers take
advantage of endothelial permeability as the drug carrying polymers are trapped
in tumors and then taken up by tumor cells. Linkages between the polymer and
drug can be designed to be cleaved extracellularly or intracellularly. Utilizing
the principles of prodrugs, the drug is essentially inert while attached to the
polymer, but is released inside the tumor mass while polymer/drug not delivered
to tumors is cleared from the body via the kidneys. For example, ProLindac is
attached to a pH-sensitive linker which releases the platinum cytotoxic agent
much faster in the low pH environments found typically outside of hypoxic tumor
cells and within specific compartments inside of tumor cells. Data generated in
animal studies have shown that the polymer/drug complexes are far less toxic
than free drug alone and that greater efficacy can be achieved. Thus, these
polymer complexes have demonstrated significant improvement in the therapeutic
index of anti-cancer drugs, including, for example, platinum.
Cobalamin™-Mediated
Oral Delivery Technology
Oral
delivery is the preferred method of administration of drugs where either
long-term or daily use (or both) is required. However many therapeutics,
including peptide and protein drugs, are poorly absorbed when given orally. With
more and more peptide and protein based biopharmaceuticals entering the market,
there is an increasing need to develop an effective oral delivery system for
them, as well as for long-standing injected drugs such as insulin.
The
difficulty in administering proteins orally is their susceptibility to
degradation by digestive enzymes, their inability to cross the intestinal wall
and their rapid excretion by the body. Over the years, many different
methodologies for making protein drugs available orally have been attempted.
Most of the oral protein delivery technologies involve protecting the protein
degradation in the intestine. More recently, strategies have been developed that
involve coadministering the protein or peptide with permeation enhancers, which
assist in passive transit through the gut wall or by attaching the protein or
peptide to a molecule that transports the protein across the gut wall. However,
the field of oral drug delivery of proteins and peptides has yet to achieve
successful commercialization of a product (although positive results have been
achieved in early clinical trials for some products under
development).
Many
pharmaceutically active compounds such as proteins, peptides and cytotoxic
agents cannot be administered orally due to their instability in the
gastrointestinal tract or their inability to be absorbed and transferred to the
bloodstream. A technology that would allow many of these actives to be taken
orally would greatly enhance their acceptance and value. Several technologies
for the protection of sensitive actives in the gastro-intestinal tract and/or
enhancement of gastro-intestinal absorption have been explored and many have
failed.
Our
proprietary technology for oral drug delivery utilizes the body’s natural
vitamin B12 (VB12) transport system in the gut. The absorption of VB12 in the
intestine occurs by way of a receptor-mediated endocytosis. Initially, VB12
binds to intrinsic factor (IF) in the small intestine, and the VB12-IF complex
then binds to the IF receptor on the surface of the intestine. Receptor-mediated
endocytosis then allows the transport of VB12 across the gut wall. After binding
to another VB12-binding protein, transcobalamin II (TcII), VB12 is transferred
to the bloodstream.
Our
scientists discovered that Cobalamin (analogs of VB12) will still be transported
by this process even when drugs, macromolecules, or nanoparticles are coupled to
the Cobalamin. Thus Cobalamin serves as a carrier to transfer these
materials from the intestinal lumen to the bloodstream. For drugs and
macromolecules that are stable in the gastro-intestinal tract, the drug or
macromolecule can be coupled directly (or via a linker) to Cobalamin. If the
capacity of the Cobalamin transport system is inadequate to provide an effective
blood concentration of the active, transport can be amplified by attaching many
molecules of the drug to a polymer, to which Cobalamin is also attached. A
further option, especially for drugs and macromolecules that are unstable in the
intestine, is to formulate the drug in a nanoparticle which is then coated with
Cobalamin. Once in the bloodstream, the active is released by diffusion and/or
erosion of the nanoparticle. Utilization of nanoparticles also serves to
‘amplify’ delivery by transporting many molecules at one time due to the
inherently large nanoparticle volume compared with the size of the
drug.
10
Our
proprietary position in this technology involves the conjugation of Cobalamin
and/or folic acid and/or biotin (or their analogs) to a polymer to which is also
attached the drug to be delivered, or attached to a nanoparticle in which the
drug is incorporated. Since many molecules of the drug are attached to a single
polymer strand, or are incorporated in a single nanoparticle, disease targeting
is amplified compared to simpler conjugates involving one molecule of the
vitamin with one drug molecule. However, in situations when such a simple
conjugate might be preferred, our patents also encompass these vitamin-drug
conjugates.
Cobalamin™-Mediated
Targeted Delivery Technology
Most
drugs are effective only when they reach a certain minimum concentration in the
region of disease, yet are well distributed throughout the body contributing to
undesirable side effects. It is therefore advantageous to alter the natural
biodistribution of a drug to have it more localized where it is needed. Our
Cobalamin-mediated targeted delivery technology utilizes the fact that in many
diseases where there is rapid growth and/or cell division, the demand for
certain vitamins increases. By coupling the drug to a vitamin analog, the analog
serves as a carrier to increase the amount of drug at the disease site relative
to its normal distribution.
One
application of this technology is in tumor targeting. The use of cytotoxic drugs
is one of the most common methods for treating a variety of malignancies
including solid and non-solid tumors. The drawbacks of chemotherapeutic
treatments, which include tumor resistance, cancer relapse and toxicity from
severe damage to healthy tissues, has fuelled a scientific quest for novel
treatments that are specifically targeted to malignant cells thus reducing
damage to collateral tissues.
The
design of targeted therapies involves exploitation of the difference between the
structure and function of normal cells compared with malignant cells.
Differences include the increased levels of surface receptors on cancer cells,
which makes them more sensitive to treatment regimes that target these cell
surface receptors and differences in blood supply within and around
tumor cells compared with normal cells.
Two basic
types of targeting approaches are utilized, passive tumor targeting and active
tumor targeting.
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•
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.
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•
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.
|
Examples
of active targeting fragments include antibodies, growth factors and vitamins.
Our scientists have specifically focused on using Cobalamin compounds (analogs
of vitamin B12), but we have also used and have certain intellectual property
protection for the use of folate and biotin which may more
effectively target anti-cancer drugs to certain solid tumors.
It has
been known for some time that vitamin B12 and folic acid are essential for tumor
growth and as a result, receptors for these vitamins are up-regulated in certain
tumors. Vitamin B12 receptor over-expression occurs in breast, lung, leukemic
cells, lymphoma cells, bone, thyroid, colon, prostate and brain cancers and some
other tumor lines, while folate receptor over-expression occurs in breast, lung,
ovarian, endometrial, renal, colon, brain and cancers of myeloid hemotopoietic
cells and methotrexate-sensitive tumors.
11
Angiolix®
Angiolix
(huMc-3 mAB) is a humanized monoclonal antibody targeting a protein known as
Lactadherin. Lactadherin promotes the growth of new blood vessels (angiogenesis)
to support tumor growth. Angiolix, by blocking Lactadherin, has the potential to
induce programmed cell death, or apoptosis, in blood vessels supporting tumors.
Angiolix was sublicensed from Immunodex, Inc., who licensed the product from
Cancer Research Institute of Contra Costa Under that agreement, we
are required to meet certain development targets, and make certain payments
including an annual license maintenance fee and milestone payments.
We
believe that Angiolix has a large market potential in the treatment of cancer.
Avastin® is a
marketed anti-angiogenesis monoclonal antibody that is effective by using a
similar mechanism to that of Angiolix, and is used in the treatment of
colorectal and other cancer types. Angiolix is unique in that it targets a propriety
gene product which is expressed by cancerous tumors. We are not aware of
any other organization developing similar products targeting this
protein. The key patent relating to Angiolix has been issued in the U.S.
and Australia. In general, it covers the composition of matter and various
aspects of the binding to applicable antigens as well as the manufacture of
Angiolix. We also have foreign counterparts to this patent pending in the
European Union and Canada.
Angiolix
is a humanized monoclonal antibody. Humanization is a process by which genetic
material from a mouse cell is made tolerable to humans, using a patented
technology developed by the National Institutes of Health. The NIH
previously granted to the Cancer Research Institute of Contra Costa a license to
the applicable humanization technology. Pursuant to the Immunodex agreement,
Immunodex and the Cancer Research Institute of Contra Costa are seeking to
obtain for us the NIH’s consent to a sublicense to us of the Cancer Research
Institute of Contra Costa right to use the NIH humanization
technology.
We have
an agreement with an academic investigator for the development of Angiolix. We
intend to complete preclinical development of Angiolix through the contributions
of this investigator and through a contract manufacturer and contract testing
laboratories, such that we are able to begin a Phase 1 clinical study of
Angiolix in 2009.
Prodrax®
Prodrax
is a small molecule anticancer prodrug that is non-toxic in normally oxygenated
healthy tissue but becomes highly toxic in low oxygen tumors where it becomes
irreversibly converted to its toxic form which binds to the DNA in tumor cells,
resulting in tumor cell death. The chemical structure of Prodrax is a di-N-oxide
of chloroethylaminoanthraquinone. We have a license to this technology from the
University of London School of Pharmacy.
Prodrax
is inert in normally oxygenated cells and becomes toxic in low oxygen areas,
enabling it to kill tumor cells. Many solid tumors have a low oxygen area that
is resistant to radiation and conventional chemotherapy. These cells repopulate
the tumor with additional tumor cells that may be resisted to radiation- and
conventional chemotherapy. These cells are often referred to as
quiescent.
Prodrax
becomes irreversibly converted to its toxic form in low oxygen tumor cells where
it remains localized. When the surrounding oxygenated cells are killed by
radiotherapy or chemotherapy, these Prodrax-containing quiescent cells move
closer to the oxygen source and attempt to resume more active
replication. It is in this state that they are killed by Prodrax, through
potent DNA damage.
When
given in conjunction with radiotherapy or conventional chemotherapy we expect
Prodrax to result in significant improvement of tumor clearance and to reduce
the likelihood of tumor repopulation, improving disease free survival. It is
estimated that over 50% of all solid tumors exhibit clinically significant
hypoxia, or low oxygenation, and that over two million people in the U.S. and
Europe suffer from solid tumor cancers. If successful, Prodrax could improve the
prognosis for a significant number of cancer sufferers in a wide range of tumor
types.
In March
2006, we entered into a two year agreement with the University of Bradford to
perform pre-clinical studies. The Prodrax technology allows for the modification
of various drugs to make them inert until they are activated by a low oxygen
environment. Varieties of analogues have been developed and are being tested by
researchers at the University of Bradford for the purpose of enabling us to
select the lead compound to take forward into clinical development. We expect to
select a lead compound in 2008.
12
Alchemix®
Alchemix,
is a small molecule that is toxic to cancer cells. Alchemix attacks cancers
cells through at least two modes of action and is intended to interrupt all
phases of the cancer cell growth cycle o overcome drug resistant tumors. We
believe that Alchemix is toxic to cancer cells due to its selective inhibition
of many DNA processing enzymes and that it is as well tolerated in animals as a
number of classes of approved chemotherapeutic drugs such as epirubicin and
cisplatin, .
The
Alchemix platform technology is licensed from De Montfort University in the UK.
Although we are not obligated to make any royalty payments to De Montfort based
on the sale of any product that is based on Alchemix, we are obligated to pay De
Montfort certain milestone payments based on the achievement of agreed upon
clinical milestones. Our agreement with De Montfort expires in 2015, upon the
expiration of the last to expire of the Alchemix patents in 2015. The key patent
relating to Alchemix has been issued in the U.S, the European Union and in
Australia. In general, it covers composition of matter. We have entered into a
research and development collaboration with the University of Bradford. The
initial goal for this collaboration is to select one molecule for preclinical
development. We have prepared a detailed pre-clinical and clinical development
plan related to Alchemix. We intend to manufacture, undertake pre-clinical
studies and, based on the results of these studies, to initiate a Phase1/2
clinical trial with respect to Alchemix within the next 12-24
months.
In August
2004, we entered into a Research Collaboration and License Agreement with
Advanced Cardiovascular Devices, LLC. Under this agreement, we granted Advanced
Cardiovascular Devices an exclusive, worldwide license to Alchemix solely for
use in the treatment of vascular disorders or proliferations using stents and
other medical devices. The term of this agreement expires when the underlying
patent expires in 2015. Pursuant to this agreement, Advanced Cardiovascular
Devices paid Somanta an upfront fee of $10,000. In addition, Advanced
Cardiovascular Devices is obligated to develop a product based on Alchemix
pursuant to an agreed upon timetable. If Advanced Cardiovascular Devices fails
to achieve any of the agreed upon milestones, we would then have the right to
terminate the agreement; provided, however, that Advanced Cardiovascular Devices
could prevent us from so terminating the agreement with respect to the
applicable failure by paying us a fee not to exceed $500,000 to reinstate its
rights under the agreement. In addition, Advanced Cardiovascular Devices is also
obligated to pay us a royalty based on net sales, if any, of products based on
Alchemix. Either party may terminate this agreement on thirty (30) days advance
notice for breach by the other party if the breach is not cured within such
thirty (30) day period. In addition, Advance Cardiovascular Devices may
terminate the agreement upon written notice to us and without any further
obligation to us if the licensed technology does not perform to the reasonable
satisfaction of Advanced Cardiovascular Devices or cannot be commercialized
because of safety or efficacy reasons or because Advanced Cardiovascular Devices
is unable to raise the funds necessary to develop a product based on the
licensed technology.
Other
Key Developments
On
February 12, 2008, the Board of Directors of the Company elected Steven H.
Rouhandeh as director and Chairman of the Board effective as of March 4,
2008.
On
February 4, 2008, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of
our preferred stock, designated “Series A Cumulative Convertible Preferred
Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the
“Series A Preferred Stock”) and agreed to issue warrants to purchase 545,000
shares of our common stock, which includes placement agent warrants to purchase
90,883 shares of our common stock, at an exercise price of $3.50 per share, for
an aggregate purchase price for the Series A Preferred Stock and Warrants of
$2,700,000. The shares of Series A Preferred Stock are convertible into common
stock at the initial conversion price of $3.00 per share.
13
On
January 14, 2008, we announced the signing of a definitive licensing agreement
under which RHEI Pharmaceuticals, Inc. will market and manufacture MuGard in the
Peoples Republic of China and certain Southeast Asian countries. RHEI will also
obtain the necessary regulatory approvals for MuGard in the
territory.
On
January 4, 2008, we closed our acquisition of Somanta Pharmaceuticals, Inc. In
connection with the acquisition, Access issued an aggregate of approximately 1.5
million shares of Access Pharmaceuticals, Inc. common stock to the common and
preferred shareholders of Somanta as consideration. In addition, Access
exchanged all outstanding warrants of Somanta for warrants to purchase 191,991
shares of Access common stock at exercise prices ranging between $18.55 and
$69.57 per share.
On
December 26, 2007, Jeffrey B. Davis, Chairman of the Board of Directors was
named Chief Executive Officer. Stephen R. Seiler resigned as President and Chief
Executive Officer and concurrently resigned from the Board of Directors
effective December 19, 2007.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
On
November 7, 2007, as a condition to closing our Series A Preferred Stock, SCO
Capital Partners LLC and affiliates, along with the other holders of an
aggregate of $6,000,000 Secured Convertible Notes, also exchanged their notes
and accrued interest for an additional 1,836.0512 shares of Series A Preferred
Stock and were issued warrants to purchase 1,122,031 shares of our common stock
at an exercise price of $3.50 per share, and Oracle Partners LP and affiliates,
along with the other holders of an aggregate of $4,015,000 Convertible Notes
also exchanged their notes and accrued interest for 437.3104 shares of the
Series A Preferred Stock and were issued warrants to purchase 728,850 shares of
our common stock at an exercise price of $3.50 per share. SCO Capital
Partners LLC currently has two designees serving on our Board of
Directors. In connection with the exchange of the notes, all security
interests and liens relating thereto were terminated.
On
November 7, 2007, as a condition to closing our Series A Preferred Stock, we
entered into an Investor Rights Agreement with each of the investors purchasing
shares of Series A Preferred Stock, and our Board of Directors approved with
respect to the shareholder rights plan any action necessary under our
shareholder rights plan to accommodate the issuance of the Series A Preferred
Stock and warrants without triggering the applicability of the shareholder
rights plan.
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access.
On August
27, 2007, we signed a definitive licensing agreement with SpePharm Holding, B.V.
under which SpePharm will market Access’ product MuGard in Europe.
On August
1, 2007, we announced that Esteban Cvitkovic, a member of our board of directors
as Vice Chairman Europe, agreed to an expanded role as Senior Director, Oncology
Clinical R&D.
On April
26, 2007, we entered into a Note Purchase Agreement with Somanta
Pharmaceuticals, Inc. in order for Access to loan Somanta amounts to keep
certain of their licenses and vendors current. As of December 31, 2007 we had
loaned Somanta $931,000.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
Access
was incorporated in Wyoming in 1974 as Chemex Corporation, and in 1983 Access
changed its name to Chemex Pharmaceuticals, Inc. Access changed its state of
incorporation from Wyoming to Delaware on June 30, 1989. In 1996 Access merged
with Access Pharmaceuticals, Inc., a private Texas corporation, and changed its
name to Access Pharmaceuticals, Inc. Access’ principal executive office is
located at 2600 Stemmons Freeway, Suite 176, Dallas, Texas 75207; Access’
telephone number is (214) 905-5100.
14
Patents
We
believe that the value of technology both to us and to our potential corporate
partners is established and enhanced by our broad intellectual property
positions. Consequently, we have already been issued and seek to obtain
additional U.S. and foreign patent protection for products under development and
for new discoveries. Patent applications are filed with the U.S. Patent and
Trademark Office and, when appropriate, with the Paris Convention's Patent
Cooperation Treaty (PCT) Countries (most major countries in Western Europe and
the Far East) for our inventions and prospective products.
Two U.S.
patent applications and two European patent applications are under review for
our mucoadhesive liquid technology. Our patent applications cover a range of
products utilizing our mucoadhesive liquid technology for the management of the
various phases of mucositis.
Three
U.S. patents and two European patents have issued and one U.S. patent and two
European patent applications are pending for polymer platinum compounds. The two
patents and patent applications are the result in part of our collaboration with
The School of Pharmacy, University of London, from which the technology has been
licensed and include a synthetic polymer, hydroxypropylmethacrylamide
incorporating platinates, that can be used to exploit enhanced permeability and
retention in tumors and control drug release. The patents and patent
applications include a pharmaceutical composition for use in tumor treatment
comprising a polymer-platinum compound through linkages that are designed to be
cleaved under selected conditions to yield a platinum which is selectively
released at a tumor site. The patents and patent applications also include
methods for improving the pharmaceutical properties of platinum
compounds.
We have
two patented Cobalamin-mediated targeted therapeutic technologies:
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|
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
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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.
|
We also
have intellectual property in connection with the use of another B vitamin,
folic acid, for targeting of polymer therapeutics. Enhanced tumor delivery is
achieved by targeting folate receptors, which are upregulated in certain tumor
types. We have two U.S, and two European patent applications related to folate
polymer therapeutics
Our
patents for the following technologies expire in the years and during the date
ranges indicated below:
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Mucoadhesive
technology in 2021,
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ProLindac™
in 2021,
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Phenylbutyrate
between 2011 and 2016,
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Angiolix®
in 2015,
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Alchemix®
in 2015,
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·
|
Cobalamin
mediated technology between 2008 and
2019
|
In
addition to issued patents, we have a number of pending patent applications. If
issued, the patents underlying theses applications could extend the patent life
of our technologies beyond the dates listed above.
We have a
strategy of maintaining an ongoing line of patent continuation applications for
each major category of patentable carrier and delivery technology. By this
approach, we are extending the intellectual property protection of our basic
targeting technology and initial agents to cover additional specific carriers
and agents, some of which are anticipated to carry the priority dates of the
original applications.
15
Government
Regulation
We are
subject to extensive regulation by the federal government, principally by the
FDA, and, to a lesser extent, by other federal and state agencies as well as
comparable agencies in foreign countries where registration of products will be
pursued. Although a number of our formulations incorporate extensively tested
drug substances, because the resulting formulations make claims of enhanced
efficacy and/or improved side effect profiles, they are expected to be
classified as new drugs by the FDA.
The
Federal Food, Drug and Cosmetic Act and other federal, state and foreign
statutes and regulations govern the testing, manufacturing, safety, labeling,
storage, shipping and record keeping of our products. The FDA has the authority
to approve or not approve new drug applications and inspect research, clinical
and manufacturing records and facilities.
Among the
requirements for drug approval and testing is that the prospective
manufacturer's facilities and methods conform to the FDA's Code of Good
Manufacturing Practices regulations, which establish the minimum requirements
for methods to be used in, and the facilities or controls to be used during, the
production process. Such facilities are subject to ongoing FDA inspection to
insure compliance.
The steps
required before a pharmaceutical product may be produced and marketed in the
U.S. include preclinical tests, the filing of an IND with the FDA, which must
become effective pursuant to FDA regulations before human clinical trials may
commence, numerous phases of clinical testing and the FDA approval of a New Drug
Application (“NDA”) prior to commercial sale.
Preclinical
tests are conducted in the laboratory, usually involving animals, to evaluate
the safety and efficacy of the potential product. The results of preclinical
tests are submitted as part of the IND application and are fully reviewed by the
FDA prior to granting the sponsor permission to commence clinical trials in
humans. All trials are conducted under International Conference on
Harmonization, or ICH, good clinical practice guidelines. All investigator sites
and sponsor facilities are subject to FDA inspection to insure compliance.
Clinical trials typically involve a three-phase process. Phase 1 the initial
clinical evaluations, consists of administering the drug and testing for safety
and tolerated dosages and in some indications such as cancer and HIV, as
preliminary evidence of efficacy in humans. Phase 2 involves a study to evaluate
the effectiveness of the drug for a particular indication and to determine
optimal dosage and dose interval and to identify possible adverse side effects
and risks in a larger patient group. When a product is found safe, an initial
efficacy is established in Phase 2, it is then evaluated in Phase 3 clinical
trials. Phase 3 trials consist of expanded multi-location testing for efficacy
and safety to evaluate the overall benefit to risk index of the investigational
drug in relationship to the disease treated. The results of preclinical and
human clinical testing are submitted to the FDA in the form of an NDA for
approval to commence commercial sales.
The
process of forming the requisite testing, data collection, analysis and
compilation of an IND and an NDA is labor intensive and costly and may take a
protracted time period. In some cases, tests may have to be redone or new tests
instituted to comply with FDA requests. Review by the FDA may also take
considerable time and there is no guarantee that an NDA will be approved.
Therefore, we cannot estimate with any certainty the length of the approval
cycle.
We are
also governed by other federal, state and local laws of general applicability,
such as laws regulating working conditions, employment practices, as well as
environmental protection.
Competition
The
pharmaceutical and biotechnology industry is characterized by intense
competition, rapid product development and technological change. Competition is
intense among manufacturers of prescription pharmaceuticals and other product
areas where we may develop and market products in the future. Most of our
potential competitors are large, well established pharmaceutical, chemical or
healthcare companies with considerably greater financial, marketing, sales and
technical resources than are available to us. Additionally, many of our
potential competitors have research and development capabilities that may allow
such competitors to develop new or improved products that may compete with our
product lines. Our potential products could be rendered obsolete or made
uneconomical by the development of new products to treat the conditions to be
addressed by our developments, technological advances affecting the cost of
production, or marketing or pricing actions by one or more of our potential
competitors. Our business, financial condition and results of operation could be
materially adversely affected by any one or more of such developments. We cannot
assure you that we will be able to compete successfully against current or
future competitors or that competition will not have a material adverse effect
on our business, financial condition and results of operations. Academic
institutions, governmental agencies and other public and private research
organizations are also conducting research activities and seeking patent
protection and may commercialize products on their own or with the assistance of
major health care companies in areas where we are developing product candidates.
We are aware of certain development projects for products to treat or prevent
certain diseases targeted by us, the existence of these potential products or
other products or treatments of which we are not aware, or products or
treatments that may be developed in the future, may adversely affect the
marketability of products developed by us.
16
In the
area of advanced drug delivery, which is the focus of our early stage research
and development activities, a number of companies are developing or evaluating
enhanced drug delivery systems. We expect that technological developments will
occur at a rapid rate and that competition is likely to intensify as various
alternative delivery system technologies achieve similar if not identical
advantages.
Even if
our products are fully developed and receive required regulatory approval, of
which there can be no assurance, we believe that our products can only compete
successfully if marketed by a company having expertise and a strong presence in
the therapeutic area. Consequently, we do not currently plan to establish an
internal marketing organization. By forming strategic alliances with major and
regional pharmaceutical companies, management believes that our development
risks should be minimized and that the technology potentially could be more
rapidly developed and successfully introduced into the marketplace.
The
following products may compete with polymer platinate:
•
Cisplatin, marketed by Bristol-Myers Squibb, the originator of the drug, and
several generic manufacturers;
•
Carboplatin, marketed by Bristol-Myers Squibb in the US; and
•
Oxaliplatin, marketed exclusively by Sanofi-Aventis.
The
following companies are working on therapies and formulations that may be
competitive with Access’ polymer platinate:
• Antigenics
and Regulon are developing liposomal platinum formulations;
• Spectrum
Pharmaceuticals and GPC Biotech are developing oral platinum
formulations;
• Poniard
Pharmaceuticals is developing both i.v. and oral platinum
formulations;
• Nanocarrier
and Debio are developing micellar nanoparticle platinum formulations;
and
•
|
American
Pharmaceutical Partners, Cell Therapeutics, Daiichi, and Enzon are
developing alternate drugs in combination with
polymers and other drug delivery
systems.
|
Companies
working on therapies and formulations that may be competitive with Access’
vitamin mediated drug delivery system are Bristol-Myers Squibb, Centocor
(acquired by Johnson & Johnson), Endocyte, GlaxoSmithKline, Imclone and Xoma
which are developing targeted monoclonal antibody therapy.
Amgen,
Carrington Laboratories, CuraGen Corporation, Cytogen Corporation, Endo
Pharmaceuticals, MGI Pharma, Nuvelo, Inc. and OSI Pharmaceuticals are developing
products to treat mucositis that may compete with Access’ mucoadhesive liquid
technology.
BioDelivery
Sciences International, Biovail Corporation, Cellgate, CIMA Labs, Inc., Cytogen
Corporation, Depomed Inc., Emisphere Technologies, Inc., Eurand, Flamel
Technologies, Nobex and Xenoport are developing products which compete with
Access’ oral drug delivery system.
Companies
working on therapies and formulations that may be competitive with Access’
Sodium Phenylbutyrate are Medicis Pharmaceuticals which currently sells Sodium
Phenylbutyrate (Buphenyl®) for the
treatment of a urea cycle disorder, hyperuremia. We are aware of numerous
products in development for brain cancers. We are aware of several products
being developed by academic and commercial organizations targeting
glioblastoma.
We are
targeting a propriety gene product which is expressed by cancerous
tumors. We are not aware of any other organization developing similar
products targeting this type of protein.
17
Companies
working on therapies and formulations that may be competitive with Access’
Prodrax are Novocea, Inc., which has exclusively licensed from KuDOS
Pharmaceuticals, a subsidiary of Astra Zeneca, a small molecule prodrug that is
selectively activated by low oxygen tumors that is similar to our Prodrax, and
Novocea is developing this small molecule prodrug in a similar fashion to
Prodrax.
We are
not aware of any other organization developing a drug similar to Alchemix.
Several groups are developing agents against p-glycoprotein, which is only one
of the identified mechanisms of drug resistance within cells, and other groups
are developing agents that have the potential to become chemosensitisers, which
means they will make cancer cells more sensitive to the effects of
chemotherapy.
Many of
these competitors have and employ greater financial and other resources,
including larger research and development, marketing and manufacturing
organizations. As a result, Access’ competitors may successfully develop
technologies and drugs that are more effective or less costly than any that
Access is developing or which would render Access’ technology and future
products obsolete and noncompetitive.
In
addition, some of Access’ competitors have greater experience than Access does
in conducting preclinical and clinical trials and obtaining FDA and other
regulatory approvals. Accordingly, Access’ competitors may succeed in obtaining
FDA or other regulatory approvals for drug candidates more rapidly than Access
does. Companies that complete clinical trials, obtain required regulatory agency
approvals and commence commercial sale of their drugs before their competitors
may achieve a significant competitive advantage. Drugs resulting from Access’
research and development efforts or from its joint efforts with collaborative
partners therefore may not be commercially competitive with its competitors'
existing products or products under development.
Employees
As of
March 31, 2008, we had ten full time employees, five of whom have advanced
scientific degrees. We have never experienced employment-related work stoppages
and consider that we maintain good relations with our personnel. In addition, to
complement our internal expertise, we have contracts with scientific
consultants, contract research organizations and university research
laboratories that specialize in various aspects of drug development including
clinical development, regulatory affairs, toxicology, process scale-up and
preclinical testing.
Web
Availability
We make
available free of charge through our web site, www.accesspharma.com, our annual
reports on Form 10-K and Form 10-KSB, as applicable, and other reports required
under the Securities and Exchange Act of 1934, as amended, as soon as reasonably
practicable after such reports are filed with, or furnished to, the Securities
and Exchange Commission (the “SEC”). These documents are also available
through the SEC’s website at www.sec.gov certain
of our corporate governance policies, including the charters for the Board of
Directors’ audit, compensation and nominating and corporate governance
committees and our code of ethics, corporate governance guidelines and
whistleblower policy. The public may read and copy materials we file with the
Commission at the SEC’s Public Reading Room at 100 F Street, NE, Washington, DC
20549, on official business days during the hours of 10:00 am and 3:00 pm. The
public may obtain information on the operation of the Public Reading Room by
calling the Commission at 1-800-SEC-0330. We will provide to any person without
charge, upon request, a copy of any of the foregoing materials. Any such request
must be made in writing to Access Pharmaceuticals, Inc., 2600 Stemmons Freeway,
Suite 176, Dallas, TX 75207 attn: Investor Relations.
RISK
FACTORS
Without
obtaining adequate capital funding, Access may not be able to continue as a
going concern.
The
report of Access’ independent registered public accounting firm for the fiscal
year ended December 31, 2007 contained a fourth explanatory paragraph to reflect
its significant doubt about Access’ ability to continue as a going concern as a
result of Access’ history of losses and Access’ liquidity position. If Access is
unable to obtain adequate capital funding in the future, Access may not be able
to continue as a going concern, which would have an adverse effect on Access’
business and operations, and investors’ investment in Access may
decline.
18
Access
has experienced a history of losses, Access expects to incur future losses and
Access may be unable to obtain necessary additional capital to fund operations
in the future.
Access
has recorded minimal revenue to date and has incurred an accumulated deficit of
approximately $114.3 million through December 31, 2007. Net losses for the years
ended 2007 and 2006 were $36.7 million and $12.9 million, respectively. Access’
losses have resulted principally from costs incurred in research and development
activities related to Access’ efforts to develop clinical drug candidates and
from the associated administrative costs. Access expects to incur additional
operating losses over the next several years. Access also expects cumulative
losses to increase if Access expands research and development efforts and
preclinical and clinical trials. Access’ net cash burn rate for the year ended
December 31, 2007 was approximately $475,000 per month. Access projects its net
cash burn rate from operations for the next 15 months to be approximately
$450,000 per month. Capital expenditures are forecasted to be minor for the next
15 months.
Access
requires substantial capital for its development programs and operating
expenses, to pursue regulatory clearances and to prosecute and defend its
intellectual property rights. Access believes that its existing capital
resources, interest income, product sales, royalties and revenue from possible
licensing agreements and collaborative agreements will be sufficient to fund its
currently expected operating expenses and capital requirements into the second
quarter of 2009. Access will need to raise substantial additional capital to
support its ongoing operations.
If Access
does raise additional funds by issuing equity securities, further dilution to
existing stockholders would result and future investors may be granted rights
superior to those of existing stockholders. If adequate funds are not available
to Access through additional equity offerings, Access may be required to delay,
reduce the scope of or eliminate one or more of its research and development
programs or to obtain funds by entering into arrangements with collaborative
partners or others that require Access to issue additional equity securities or
to relinquish rights to certain technologies or drug candidates that Access
would not otherwise issue or relinquish in order to continue independent
operations.
Access
has issued and outstanding shares of Series A Preferred Stock with rights and
preferences superior to those of its common stock.
The
issued and outstanding shares of Series A Preferred Stock grants the holders of
such preferred stock anti-dilution, dividend and liquidations rights that are
superior to those held by the holders of our common stock. Should
Access issue additional shares of common stock for a price below $3.00 per
share, the conversion price of the Series A Preferred Stock shall be lowered to
the lowest issue price below $3.00 per share which will have the effect of
diluting the holders of our common stock.
Access
does not have operating revenue and it may never attain
profitability.
To date,
Access has funded its operations primarily through private sales of common
stock, preferred stock and convertible notes. Contract research payments and
licensing fees from corporate alliances and mergers have also provided funding
for its operations. Its ability to achieve significant revenue or profitability
depends upon its ability to successfully complete the development of drug
candidates, to develop and obtain patent protection and regulatory approvals for
Access’ drug candidates and to manufacture and commercialize the resulting
drugs. Access sold its only revenue producing assets to Uluru, Inc. in October
2005. Access is not expecting any revenues in the short-term from its other
assets. Furthermore, Access may not be able to ever successfully identify,
develop, commercialize, patent, manufacture, obtain required regulatory
approvals and market any additional products. Moreover, even if Access does
identify, develop, commercialize, patent, manufacture, and obtain required
regulatory approvals to market additional products, Access may not generate
revenues or royalties from commercial sales of these products for a significant
number of years, if at all. Therefore, its proposed operations are subject to
all the risks inherent in the establishment of a new business
enterprise. In the next few years, its revenues may be limited to
minimal product sales and royalties, any amounts that Access receives under
strategic partnerships and research or drug development collaborations that
Access may establish and, as a result, Access may be unable to achieve or
maintain profitability in the future or to achieve significant revenues in order
to fund its operations.
19
Although
Access expects that the acquisition of Somanta will result in benefits to the
combined company the combined company may not realize those benefits because of
integration and other challenges.
Access’
ability to realize the anticipated benefits of the merger will depend, in part,
on the ability of Access to integrate the business of Somanta with the business
of Access. The combination of two independent companies is a complex, costly and
time-consuming process. This process may disrupt the business of either or both
of the companies, and may not result in the full benefits expected by Access and
Somanta. The difficulties of combining the operations of the companies include,
among others:
•
|
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.
|
Access
may not successfully commercialize its drug candidates.
Access’
drug candidates are subject to the risks of failure inherent in the development
of pharmaceutical products based on new technologies, and its failure to develop
safe commercially viable drugs would severely limit its ability to become
profitable or to achieve significant revenues. Access may be unable to
successfully commercialize Access’ drug candidates because:
·
|
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.
|
The
success of Access’ research and development activities, upon which Access
primarily focuses, is uncertain.
Access’
primary focus is on its research and development activities and the
commercialization of compounds covered by proprietary biopharmaceutical patents
and patent applications. Research and development activities, by their nature,
preclude definitive statements as to the time required and costs involved in
reaching certain objectives. Actual research and development costs, therefore,
could exceed budgeted amounts and estimated time frames may require extension.
Cost overruns, unanticipated regulatory delays or demands, unexpected adverse
side effects or insufficient therapeutic efficacy will prevent or substantially
slow Access’ research and development effort and Access’ business could
ultimately suffer. Access anticipates that it will remain principally engaged in
research and development activities for an indeterminate, but substantial,
period of time.
Access
may be unable to successfully develop, market, or commercialize its products or
its product candidates without establishing new relationships and maintaining
current relationships.
Access’
strategy for the research, development and commercialization of its potential
pharmaceutical products may require it to enter into various arrangements with
corporate and academic collaborators, licensors, licensees and others, in
addition to its existing relationships with other parties. Specifically, Access
may seek to joint venture, sublicense or enter other marketing arrangements with
parties that have an established marketing capability or Access may choose to
pursue the commercialization of such products on its own. Access may, however,
be unable to establish such additional collaborative arrangements, license
agreements, or marketing agreements as Access may deem necessary to develop,
commercialize and market Access’ potential pharmaceutical products on acceptable
terms. Furthermore, if Access maintains and establishes arrangements or
relationships with third parties, its business may depend upon the successful
performance by these third parties of their responsibilities under those
arrangements and relationships.
20
Access’
ability to successfully commercialize, and market Access’ product candidates
could be limited if a number of these existing relationships were
terminated.
Furthermore,
its strategy with respect to its polymer platinate program is to enter into a
licensing agreement with a pharmaceutical company pursuant to which the further
costs of developing a product would be shared with its licensing partner.
Although Access has had discussions with potential licensing partners with
respect to its polymer platinate program, to date Access has not entered into
any licensing arrangement. Access may be unable to execute its licensing
strategy for polymer platinate.
Access
may be unable to successfully manufacture its products and its product
candidates in clinical quantities or for commercial purposes without the
assistance of contract manufacturers, which may be difficult for it to obtain
and maintain.
Access
has limited experience in the manufacture of pharmaceutical products in clinical
quantities or for commercial purposes and Access may not be able to manufacture
any new pharmaceutical products that Access may develop. As a result, Access has
established, and in the future intends to establish arrangements with contract
manufacturers to supply sufficient quantities of products to conduct clinical
trials and for the manufacture, packaging, labeling and distribution of finished
pharmaceutical products if any of its potential products are approved for
commercialization. If Access is unable to contract for a sufficient supply of
its potential pharmaceutical products on acceptable terms, its preclinical and
human clinical testing schedule may be delayed, resulting in the delay of its
clinical programs and submission of product candidates for regulatory approval,
which could cause its business to suffer. Its business could suffer if there are
delays or difficulties in establishing relationships with manufacturers to
produce, package, label and distribute its finished pharmaceutical or other
medical products, if any, market introduction and subsequent sales of such
products. Moreover, contract manufacturers that Access may use must adhere to
current Good Manufacturing Practices, as required by the FDA. In this regard,
the FDA will not issue a pre-market approval or product and establishment
licenses, where applicable, to a manufacturing facility for the products until
the manufacturing facility passes a pre-approval plant inspection. If Access is
unable to obtain or retain third party manufacturing on commercially acceptable
terms, Access may not be able to commercialize its products as planned. Its
potential dependence upon third parties for the manufacture of its products may
adversely affect its ability to generate profits or acceptable profit margins
and its ability to develop and deliver such products on a timely and competitive
basis.
ProLindac™
is manufactured by third parties for Access’ Phase 2 clinical trials.
Manufacturing is ongoing for the current clinical trials. Certain manufacturing
steps are conducted by the Company to enable significant cost savings to be
realized.
Access
is subject to extensive governmental regulation which increases its cost of
doing business and may affect its ability to commercialize any new products that
Access may develop.
The FDA
and comparable agencies in foreign countries impose substantial requirements
upon the introduction of pharmaceutical products through lengthy and detailed
laboratory, preclinical and clinical testing procedures and other costly and
time-consuming procedures to establish its safety and efficacy. All of its drugs
and drug candidates require receipt and maintenance of governmental approvals
for commercialization. Preclinical and clinical trials and manufacturing of its
drug candidates will be subject to the rigorous testing and approval processes
of the FDA and corresponding foreign regulatory authorities. Satisfaction of
these requirements typically takes a significant number of years and can vary
substantially based upon the type, complexity and novelty of the product. The
status of Access’ principal products is as follows:
·
|
A
mucoadhesive 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.
|
·
|
Phenylbutrate
is in planning stage for a Phase 2 trial in the United
States.
|
·
|
Cobalamin™
mediated delivery technology is currently in the pre-clinical
phase.
|
·
|
Angiolix®
is currently in the pre-clinical
phase.
|
·
|
Prodrax®
is currently in the pre-clinical
phase.
|
·
|
Alchemix®
is currently in the pre-clinical
phase.
|
·
|
Access
also has other products in the preclinical
phase.
|
21
Due to
the time consuming and uncertain nature of the drug candidate development
process and the governmental approval process described above, Access cannot
assure you when Access, independently or with its collaborative partners, might
submit a NDA, for FDA or other regulatory review.
Government
regulation also affects the manufacturing and marketing of pharmaceutical
products. Government regulations may delay marketing of Access’ potential drugs
for a considerable or indefinite period of time, impose costly procedural
requirements upon its activities and furnish a competitive advantage to larger
companies or companies more experienced in regulatory affairs. Delays in
obtaining governmental regulatory approval could adversely affect Access’
marketing as well as its ability to generate significant revenues from
commercial sales. Access’ drug candidates may not receive FDA or other
regulatory approvals on a timely basis or at all. Moreover, if regulatory
approval of a drug candidate is granted, such approval may impose limitations on
the indicated use for which such drug may be marketed. Even if Access obtains
initial regulatory approvals for its drug candidates, Access’ drugs and its
manufacturing facilities would be subject to continual review and periodic
inspection, and later discovery of previously unknown problems with a drug,
manufacturer or facility may result in restrictions on the marketing or
manufacture of such drug, including withdrawal of the drug from the market. The
FDA and other regulatory authorities stringently apply regulatory standards and
failure to comply with regulatory standards can, among other things, result in
fines, denial or withdrawal of regulatory approvals, product recalls or
seizures, operating restrictions and criminal prosecution.
The
uncertainty associated with preclinical and clinical testing may affect Access’
ability to successfully commercialize new products.
Before
Access can obtain regulatory approvals for the commercial sale of any of its
potential drugs, the drug candidates will be subject to extensive preclinical
and clinical trials to demonstrate their safety and efficacy in
humans. Preclinical or clinical trials of any of its future drug
candidates may not demonstrate the safety and efficacy of such drug candidates
at all or to the extent necessary to obtain regulatory approvals. In this
regard, for example, adverse side effects can occur during the clinical testing
of a new drug on humans which may delay ultimate FDA approval or even lead it to
terminate its efforts to develop the drug for commercial use. Companies in the
biotechnology industry have suffered significant setbacks in advanced clinical
trials, even after demonstrating promising results in earlier trials. In
particular, polymer platinate has taken longer to progress through clinical
trials than originally planned. This extra time has not been related to concerns
of the formulations but rather due to the lengthy regulatory process. The
failure to adequately demonstrate the safety and efficacy of a drug candidate
under development could delay or prevent regulatory approval of the drug
candidate. A delay or failure to receive regulatory approval for any of Access’
drug candidates could prevent Access from successfully commercializing such
candidates and Access could incur substantial additional expenses in its
attempts to further develop such candidates and obtain future regulatory
approval.
Access
may incur substantial product liability expenses due to the use or misuse of its
products for which Access may be unable to obtain insurance
coverage.
Access’
business exposes it to potential liability risks that are inherent in the
testing, manufacturing and marketing of pharmaceutical products. These risks
will expand with respect to its drug candidates, if any, that receive regulatory
approval for commercial sale and Access may face substantial liability for
damages in the event of adverse side effects or product defects identified with
any of its products that are used in clinical tests or marketed to the public.
Access generally procures product liability insurance for drug candidates that
are undergoing human clinical trials. Product liability insurance for the
biotechnology industry is generally expensive, if available at all, and as a
result, Access may be unable to obtain insurance coverage at acceptable costs or
in a sufficient amount in the future, if at all. Access may be unable to satisfy
any claims for which Access may be held liable as a result of the use or misuse
of products which Access has developed, manufactured or sold and any such
product liability claim could adversely affect its business, operating results
or financial condition.
22
Access
may incur significant liabilities if it fails to comply with stringent
environmental regulations or if Access did not comply with these regulations in
the past.
Access’
research and development processes involve the controlled use of hazardous
materials. Access is subject to a variety of federal, state and local
governmental laws and regulations related to the use, manufacture, storage,
handling and disposal of such material and certain waste products. Although
Access believes that its activities and its safety procedures for storing,
using, handling and disposing of such materials comply with the standards
prescribed by such laws and regulations, the risk of accidental contamination or
injury from these materials cannot be completely eliminated. In the event of
such accident, Access could be held liable for any damages that result and any
such liability could exceed its resources.
Intense
competition may limit Access’ ability to successfully develop and market
commercial products.
The
biotechnology and pharmaceutical industries are intensely competitive and
subject to rapid and significant technological change. Access’ competitors in
the United States and elsewhere are numerous and include, among others, major
multinational pharmaceutical and chemical companies, specialized biotechnology
firms and universities and other research institutions.
The
following products may compete with polymer platinate:
•
Cisplatin, marketed by Bristol-Myers Squibb, the originator of the drug, and
several generic manufacturers;
•
Carboplatin, marketed by Bristol-Myers Squibb in the US; and
•
Oxaliplatin, marketed exclusively by Sanofi-Aventis.
The
following companies are working on therapies and formulations that may be
competitive with Access’ polymer platinate:
• Antigenics and Regulon are developing liposomal
platinum formulations;
• Spectrum Pharmaceuticals and GPC Biotech are
developing oral platinum formulations;
• Poniard Pharmaceuticals is developing both i.v.
and oral platinum formulations;
• Nanocarrier and Debio are developing micellar
nanoparticle platinum formulations; and
|
• American
Pharmaceutical Partners, Cell Therapeutics, Daiichi, and Enzon are
developing alternate drugs in combination with polymers
and
|
other drug delivery systems |
Companies
working on therapies and formulations that may be competitive with Access’
vitamin mediated drug delivery system are Bristol-Myers Squibb, Centocor
(acquired by Johnson & Johnson), Endocyte, GlaxoSmithKline, Imclone and Xoma
which are developing targeted monoclonal antibody therapy.
Amgen,
Carrington Laboratories, CuraGen Corporation, Cytogen Corporation, Endo
Pharmaceuticals, MGI Pharma, Nuvelo, Inc. and OSI Pharmaceuticals are developing
products to treat mucositis that may compete with Access’ mucoadhesive liquid
technology.
BioDelivery
Sciences International, Biovail Corporation, Cellgate, CIMA Labs, Inc., Cytogen
Corporation, Depomed Inc., Emisphere Technologies, Inc., Eurand, Flamel
Technologies, Nobex and Xenoport are developing products which compete with
Access’ oral drug delivery system.
Companies
working on therapies and formulations that may be competitive with Access’
Sodium Phenylbutyrate are Medicis Pharmaceuticals currently sells Sodium
Phenylbutyrate (Buphenyl ®) for the
treatment of a urea cycle disorder, hyperuremia. We are aware of numerous
products in development for brain cancers. We are aware of several products
being developed by academic and commercial organizations targeting
glioblastoma.
We are
targeting a propriety gene product which is expressed by cancerous
tumors. We are not aware of any other organization developing similar
products targeting this type of protein.
Companies
working on therapies and formulations that may be competitive with Access’
Prodrax are Novocea, Inc., which has exclusively licensed from KuDOS
Pharmaceuticals, a subsidiary of Astra Zeneca, a small molecule prodrug that is
selectively activated by low oxygen tumors that is similar to our Prodrax, and
Novocea is developing this small molecule prodrug in a similar fashion to
Prodrax.
23
We are
not aware of any other organization developing a drug similar to Alchemix.
Several groups are developing agents against p-glycoprotein, which is only one
of the identified mechanisms of drug resistance within cells, and other groups
are developing agents that have the potential to become chemosensitisers, which
means they will make cancer cells more sensitive to the effects of
chemotherapy.
Many of
these competitors have and employ greater financial and other resources,
including larger research and development, marketing and manufacturing
organizations. As a result, Access’ competitors may successfully develop
technologies and drugs that are more effective or less costly than any that
Access is developing or which would render Access’ technology and future
products obsolete and noncompetitive.
In
addition, some of Access’ competitors have greater experience than Access does
in conducting preclinical and clinical trials and obtaining FDA and other
regulatory approvals. Accordingly, Access’ competitors may succeed in obtaining
FDA or other regulatory approvals for drug candidates more rapidly than Access
does. Companies that complete clinical trials, obtain required regulatory agency
approvals and commence commercial sale of their drugs before their competitors
may achieve a significant competitive advantage. Drugs resulting from Access’
research and development efforts or from its joint efforts with collaborative
partners therefore may not be commercially competitive with its competitors'
existing products or products under development.
Access depends
on licenses from third parties and the maintenance of its licenses are
necessary for its success.
Access,
as a result of its acquisition of Somanta Pharmaceuticals, Inc.,
has obtained rights to some product candidates through license
agreements with various third party licensors as follows:
•
|
Exclusive
Patent and Know-how Sub-license Agreement between Somanta and
Immunodex, Inc. dated August 18, 2005, as amended;
|
|
•
|
Patent
and Know-how Assignment and License Agreement between Somanta and De
Montfort University dated March 20, 2003;
|
|
•
|
Patent
and Know-how Assignment and License Option Agreement between Somanta
and The School of Pharmacy, University of London dated March 16,
2004, as amended on September 21, 2005; and
|
|
•
|
The
Phenylbutyrate Co-Development and Sublicense Agreement
between Somanta and Virium Pharmaceuticals, Inc. dated
February 16, 2005, as amended.
|
Access
is dependent upon these licenses for its rights to develop and
commercialize its product candidates. While Access believes it is
in compliance with its obligations under the licenses, certain licenses may be
terminated or converted to non-exclusive licenses by the licensor if Access
breaches the terms of the license. Access cannot guarantee you that the
licenses will not be terminated or converted in the future.
While Access
expects that it will be able to continue to identify licensable product
candidates or research suitable for licensing and commercialization by it, there
can be no assurance that this will occur. For example, Access is in
discussions with the National Institutes of Health to obtain licenses to certain
patents held by them that will be necessary for the manufacture of its
product candidate Angiolix. Unless Access obtains licenses on terms that
are acceptable to it, Access may not be able to manufacture and obtain
product registrations on Angiolix. On December 5, 2006, NIH provided
Access with proposed terms for a non-exclusive license. Access is in
discussion with NIH on those proposed terms and conditions. On May 15, 2007, NIH
terminated Access’ non-exclusive license application since it had not
accepted the terms and had not executed the proposed license
agreement.
24
Access’
ability to successfully develop and commercialize its drug candidates will
substantially depend upon the availability of reimbursement funds for the costs
of the resulting drugs and related treatments.
The
successful commercialization of, and the interest of potential collaborative
partners to invest in the development of its drug candidates, may depend
substantially upon reimbursement of the costs of the resulting drugs and related
treatments at acceptable levels from government authorities, private health
insurers and other organizations, including health maintenance organizations, or
HMOs. Limited reimbursement for the cost of any drugs that Access develops may
reduce the demand for, or price of such drugs, which would hamper its ability to
obtain collaborative partners to commercialize its drugs, or to obtain a
sufficient financial return on its own manufacture and commercialization of any
future drugs.
The
market may not accept any pharmaceutical products that Access successfully
develops.
The drugs
that Access is attempting to develop may compete with a number of
well-established drugs manufactured and marketed by major pharmaceutical
companies. The degree of market acceptance of any drugs developed by it will
depend on a number of factors, including the establishment and demonstration of
the clinical efficacy and safety of its drug candidates, the potential advantage
of its drug candidates over existing therapies and the reimbursement policies of
government and third-party payers. Physicians, patients or the medical community
in general may not accept or use any drugs that Access may develop independently
or with its collaborative partners and if they do not, its business could
suffer.
Trends
toward managed health care and downward price pressures on medical products and
services may limit its ability to profitably sell any drugs that Access may
develop.
Lower
prices for pharmaceutical products may result from:
·
|
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.
|
The cost
containment measures that healthcare providers are instituting, including
practice protocols and guidelines and clinical pathways, and the effect of any
healthcare reform, could limit Access’ ability to profitably sell any drugs that
Access may successfully develop. Moreover, any future legislation or regulation,
if any, relating to the healthcare industry or third-party coverage and
reimbursement, may cause its business to suffer.
Access
may not be successful in protecting its intellectual property and proprietary
rights.
Access’
success depends, in part, on its ability to obtain U.S. and foreign patent
protection for its drug candidates and processes, preserve its trade secrets and
operate its business without infringing the proprietary rights of third parties.
Legal standards relating to the validity of patents covering pharmaceutical and
biotechnological inventions and the scope of claims made under such patents are
still developing and there is no consistent policy regarding the breadth of
claims allowed in biotechnology patents. The patent position of a biotechnology
firm is highly uncertain and involves complex legal and factual questions.
Access cannot assure you that any existing or future patents issued to, or
licensed by, it will not subsequently be challenged, infringed upon, invalidated
or circumvented by others. As a result, although Access, together with its
subsidiaries, are either the owner or licensee to 17 U.S. patents and to 9 U.S.
patent applications now pending, and 5 European patents and 13 European patent
applications, Access cannot assure you that any additional patents will issue
from any of the patent applications owned by, or licensed to, it. Furthermore,
any rights that Access may have under issued patents may not provide it with
significant protection against competitive products or otherwise be commercially
viable.
25
Access’
patents for the following technologies expire in the years and during the date
ranges indicated below:
·
|
Mucoadhesive
technology in 2021,
|
·
|
ProLindac™
in 2021,
|
·
|
Phenylbutyrate
between 2011 and 2016,
|
·
|
Angiolix®
in 2015,
|
·
|
Alchemix®
in 2015,
|
·
|
Cobalamin
mediated technology between 2008 and
2019
|
In
addition to issued patents, Access has a number of pending patent applications.
If issued, the patents underlying theses applications could extend the patent
life of its technologies beyond the dates listed above.
Patents
may have been granted to third parties or may be granted covering products or
processes that are necessary or useful to the development of Access’ drug
candidates. If Access’ drug candidates or processes are found to infringe upon
the patents or otherwise impermissibly utilize the intellectual property of
others, Access’ development, manufacture and sale of such drug candidates could
be severely restricted or prohibited. In such event, Access may be required to
obtain licenses from third parties to utilize the patents or proprietary rights
of others. Access cannot assure you that it will be able to obtain such licenses
on acceptable terms, if at all. If Access becomes involved in litigation
regarding its intellectual property rights or the intellectual property rights
of others, the potential cost of such litigation, regardless of the strength of
its legal position, and the potential damages that Access could be required to
pay could be substantial.
Access’
business could suffer if Access loses the services of, or fail to attract, key
personnel.
Access is
highly dependent upon the efforts of its senior management and scientific team,
including its President and Chief Executive Officer, Jeffrey B. Davis. The loss
of the services of one or more of these individuals could delay or prevent the
achievement of its research, development, marketing, or product
commercialization objectives. While Access has employment agreements with
Jeffrey B. Davis, David P. Nowotnik, PhD its Senior Vice President Research and
Development, and Stephen B. Thompson, its Vice President and Chief Financial
Officer, their employment may be terminated by them or Access at any time. Mr.
Davis’, Dr. Nowotnik's and Mr. Thompson’s agreements expire within one year and
are extendable each year on the anniversary date. Access does not have
employment contracts with its other key personnel. Access does not maintain any
"key-man" insurance policies on any of its key employees and Access does not
intend to obtain such insurance. In addition, due to the specialized scientific
nature of its business, Access is highly dependent upon its ability to attract
and retain qualified scientific and technical personnel. In view of the stage of
its development and its research and development programs, Access has restricted
its hiring to research scientists and a small administrative staff and Access
has made only limited investments in manufacturing, production, sales or
regulatory compliance resources. There is intense competition among major
pharmaceutical and chemical companies, specialized biotechnology firms and
universities and other research institutions for qualified personnel in the
areas of Access’ activities, however, and Access may be unsuccessful in
attracting and retaining these personnel.
An
investment in Access’ common stock may be less attractive because it is not
traded on a recognized public market.
Access’
common stock has traded on the OTC Bulletin Board, or OTCBB since June 5, 2006.
From February 1, 2006 until June 5, 2006 Access traded on the “Pink Sheets”
after its common stock was de-listed from trading on AMEX. The OTCBB and Pink
Sheets are viewed by most investors as a less desirable, and less liquid,
marketplace. As a result, an investor may find it more difficult to purchase,
dispose of or obtain accurate quotations as to the value of its common
stock.
26
Access’
common stock is subject to Rules 15g-1 through 15g-9 under the Exchange Act,
which imposes certain sales practice requirements on broker-dealers who sell its
common stock to persons other than established customers and "accredited
investors" (as defined in Rule 501(c) of the Securities Act). For transactions
covered by this rule, a broker-dealer must make a special suitability
determination for the purchaser and have received the purchaser's written
consent to the transaction prior to the sale. This rule adversely affects the
ability of broker-dealers to sell Access’ common stock and purchasers of its
common stock to sell their shares of Access’ common stock.
Additionally,
Access’ common stock is subject to SEC regulations applicable to "penny stock."
Penny stock includes any non-NASDAQ equity security that has a market price of
less than $5.00 per share, subject to certain exceptions. The
regulations require that prior to any non-exempt buy/sell transaction in a penny
stock, a disclosure schedule proscribed by the SEC relating to the penny stock
market must be delivered by a broker-dealer to the purchaser of such penny
stock. This disclosure must include the amount of commissions payable
to both the broker-dealer and the registered representative and current price
quotations for Access’ common stock. The regulations also require
that monthly statements be sent to holders of penny stock that disclose recent
price information for the penny stock and information of the limited market for
penny stocks. These requirements adversely affect the market
liquidity of Access’ common stock.
Ownership
of Access’ shares is concentrated in the hands of a few investors which could
limit the ability of Access’ other stockholders to influence the direction of
the company.
As
calculated by the SEC rules of beneficial ownership, SCO Capital Partners LLC
and affiliates, Larry N. Feinberg (Oracle Partners LP, Oracle Institutional
Partners LP and Oracle Investment Management Inc.), Lake End Capital LLC,
Perceptive Life Sciences Master Fund Ltd and Midsummer Investment, Ltd. each
beneficially owned approximately 69.8%, 31.7%, 21.7%, 15.1% and 11.8%,
respectively, of Access’ common stock as of March 31, 2008. Accordingly, they
collectively may have the ability to significantly influence or determine the
election of all of Access’ directors or the outcome of most corporate actions
requiring stockholder approval. They may exercise this ability in a manner that
advances their best interests and not necessarily those of Access’ other
stockholders.
Access
may be required to pay liquidated damages to certain investors if it does not
maintain an effective registration statement relating to common stock issuable
upon conversion of Series A Preferred stock or upon exercise of certain
warrants.
Pursuant
to issuing Series A Preferred Stock and warrants, Access entered into an
Investor Rights Agreement with the purchasers of Series A Preferred
Stock. The Investor Rights Agreement requires, among other things,
that Access maintain an effective registration statement for common stock
issuable upon conversion of Series A Preferred Stock or upon exercise of certain
warrants. If Access fails to maintain such an effective registration
statement it may be required to pay liquidated damages to the holders of such
Series A Preferred Stock and warrants for the period of time in which an
effective registration statement was not in place.
Provisions
of Access’ charter documents could discourage an acquisition of our company that
would benefit its stockholders and may have the effect of entrenching, and
making it difficult to remove, management.
Provisions
of Access’ Certificate of Incorporation, By-laws and Stockholders Rights Plan
may make it more difficult for a third party to acquire control of the Company,
even if a change in control would benefit Access stockholders. In particular,
shares of Access preferred stock may be issued in the future without further
stockholder approval and upon such terms and conditions, and having such rights,
privileges and preferences, as Access’ Board of Directors may determine,
including, for example, rights to convert into Access common stock. The rights
of the holders of Access common stock will be subject to, and may be adversely
affected by, the rights of the holders of any of Access’ preferred stock that
may be issued in the future. The issuance of Access preferred stock, while
providing desirable flexibility in connection with possible acquisitions and
other corporate purposes, could have the effect of making it more difficult for
a third party to acquire control of Access. This could limit the price that
certain investors might be willing to pay in the future for shares of Access
common stock and discourage these investors from acquiring a majority of Access
common stock. Further, the existence of these corporate governance provisions
could have the effect of entrenching management and making it more difficult to
change Access’ management.
Substantial
sales of Access common stock could lower its stock price.
The
market price for Access common stock could drop as a result of sales of a large
number of its presently outstanding shares or shares that Access may
issue or be obligated to issue in the future. All of the 5,623,781 shares of
Access common stock that are outstanding as of March 31, 2008, are unrestricted
and freely tradable or tradable pursuant to a resale registration statement or
under Rule 144 of the Securities Act or are covered by a registration rights
agreement.
27
Failure
to achieve and maintain effective internal controls could have a material
adverse effect on Access’ business.
Effective
internal controls are necessary for Access to provide reliable financial
reports. If Access cannot provide reliable financial reports, Access’ operating
results could be harmed. All internal control systems, no matter how well
designed, have inherent limitations. Therefore, even those systems determined to
be effective can provide only reasonable assurance with respect to financial
statement preparation and presentation.
While
Access continues to evaluate and improve its internal controls, Access cannot be
certain that these measures will ensure that Access implements and maintains
adequate controls over its financial processes and reporting in the future. Any
failure to implement required new or improved controls, or difficulties
encountered in their implementation, could harm its operating results or cause
Access to fail to meet its reporting obligations.
Failure
to achieve and maintain an effective internal control environment could cause
investors to lose confidence in Access’ reported financial information, which
could have a material adverse effect on its stock price.
Future
sales by our stockholders may adversely affect our stock price and our ability
to raise funds in new stock offerings.
Sales of
our common stock in the public market following this offering could lower the
market price of our common stock. Sales may also make it more difficult for us
to sell equity securities or equity-related securities in the future at a time
and price that our management deems acceptable or at all. Of the 5,623,781
shares of common stock outstanding as of March 31, 2008, 5,623,781 shares are,
or will be, freely tradable without restriction, unless held by our
“affiliates.” Some of these shares may be resold under Rule 144. The sale of the
11,666,195 shares issuable upon conversion of our preferred stock and 9,269,734
shares issuable upon exercise of outstanding warrants could also lower the
market price of our common stock.
ITEM
2. DESCRIPTION OF PROPERTY
Access
maintains one facility of approximately 9,000 square feet for administrative
offices and laboratories in Dallas, Texas. Access has a lease agreement for the
facility, which terminates in December 2008. Adjacent space may be available for
expansion which Access believes would accommodate growth for the foreseeable
future.
Access
believes that its existing properties are suitable for the conduct of its
business and adequate to meet its present needs.
ITEM
3. LEGAL PROCEEDINGS
The
Company is not currently subject to any material pending legal
proceedings.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not
applicable.
28
EXECUTIVE
OFFICERS OF THE REGISTRANT
Mr.
Jeffrey B. Davis, 45 has been our Chief Executive Officer since December 26,
2007. Previously, Mr. Davis was Chairman of the Board, member of the Executive
Committee and a Chairman of the Compensation Committee of the Board. Mr. Davis
currently serves as President of SCO Financial Group LLC. Previously, Mr. Davis
served in senior management at a publicly traded healthcare technology company.
Prior to that, Mr. Davis was an investment banker with various Deutsche Bank
banking organizations, both in the U.S. and Europe. Mr. Davis also served in
senior marketing and product management positions at AT&T Bell Laboratories,
where he was also a member of the technical staff, and at Philips Medical
Systems North America. Mr. Davis is currently on the board of MacroChem
Corporation, Uluru, Inc. and Virium Pharmaceuticals, Inc., a private
biotechnology company.
David P.
Nowotnik, Ph.D., 59, has been Senior Vice President Research and Development
since January 2003 and had been Vice President Research and Development from
1998. From 1994 until 1998, Dr. Nowotnik had been with Guilford Pharmaceuticals,
Inc. in the position of Senior Director, Product Development and was responsible
for a team of scientists developing polymeric controlled-release drug delivery
systems. From 1988 to 1994 he was with Bristol-Myers Squibb researching and
developing technetium radiopharmaceuticals and MRI contrast agents. From 1977 to
1988 he was with Amersham International leading the project which resulted in
the discovery and development of Ceretec.
Mr.
Phillip S. Wise, 50, has been our Vice President Business Development since June
1, 2006. Mr. Wise was Vice President of Commercial and Business Development for
Enhance Pharmaceuticals, Inc. and Ardent Pharmaceuticals, Inc. from 2000 until
2006. Prior to that time he was with Glaxo Wellcome, from 1990 to 2000 in
various capacities.
Mr.
Stephen B. Thompson, 54, has been Vice President since 2000 and our Chief
Financial Officer since 1996. From 1990 to 1996, he was Controller and
Administration Manager of Access Pharmaceuticals, Inc., a private Texas
corporation. Previously, from 1989 to 1990, Mr. Thompson was Controller of
Robert E. Woolley, Inc. a hotel real estate company where he was responsible for
accounting, finances and investor relations. From 1985 to 1989, he was
Controller of OKC Limited Partnership, an oil and gas company where he was
responsible for accounting, finances and SEC reporting. Between 1975 and 1985 he
held various accounting and finance positions with Santa Fe International
Corporation.
29
PART
II
ITEM
5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
Price
Range of Common Stock and Dividend Policy
Our
common stock has traded on the OTC Bulletin Board, or OTCBB, under the trading
symbol ACCP since June 5, 2006. From February 1, 2006 until June 5, 2006 we
traded on the “Pink Sheets” under the trading symbol AKCA. From March 30, 2000
until January 31, 2006 we traded on the American Stock Exchange, or AMEX, under
the trading symbol AKC.
The
following table sets forth, for the periods indicated, the high and low closing
prices as reported by OTCBB, the Pink Sheets and AMEX for our common stock for
fiscal years 2007 and 2006. The OTCBB and Pink Sheet quotations reflect
inter-dealer prices, without retail mark-up, mark-down or commission and may not
represent actual transactions.
All per
share information reflect a one for five reverse stock split effected June 5,
2006.
Common Stock
|
||||||||
High
|
Low
|
|||||||
Fiscal Year Ended December 31,
2007
|
||||||||
First
quarter
|
$ | 10.66 | $ | 2.50 | ||||
Second
quarter
|
6.75 | 4.30 | ||||||
Third
quarter
|
5.16 | 2.10 | ||||||
Fourth
quarter
|
4.48 | 2.10 | ||||||
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 |
We have
never declared or paid any cash dividends on our preferred stock or common stock
and we do not anticipate paying any cash dividends in the foreseeable future.
The payment of dividends, if any, in the future is within the discretion of our
Board of Directors and will depend on our earnings, capital requirements and
financial condition and other relevant facts. We currently intend to retain all
future earnings, if any, to finance the development and growth of our
business.
The
number of record holders of Access common stock at March 31, 2008 was
approximately 3,800. On March 28, 2008, the closing price for the common stock
as quoted on the OTCBB was $1.49. There were 5,623,781 shares of common stock
outstanding at March 31, 2008.
Recent
Sales of Unregistered Securities
On
February 4, 2008, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of
our preferred stock, designated “Series A Cumulative Convertible Preferred
Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the
“Series A Preferred Stock”) and agreed to issue warrants to purchase 545,000
shares of our common stock, which includes placement agent warrants to purchase
90,883 shares of our common stock, at an exercise price of $3.50 per share, for
an aggregate purchase price for the Series A Preferred Stock and Warrants of
$2,700,000. The shares of Series A Preferred Stock are convertible into common
stock at the initial conversion price of $3.00 per share.
30
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
On
November 7, 2007, SCO Capital Partners LLC and affiliates, along with the other
holders of an aggregate of $6,000,000 Secured Convertible Notes, also exchanged
their notes and accrued interest for an additional 1,836.0512 shares of Series A
Preferred Stock and were issued warrants to purchase 1,122,031 shares of our
common stock at an exercise price of $3.50 per share, and Oracle Partners LP and
affiliates, along with the other holders of an aggregate of $4,015,000
Convertible Notes also exchanged their notes and accrued interest for 437.3104
shares of the Series A Preferred Stock and were issued warrants to purchase
728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving
on our Board of Directors. In connection with the exchange of the
notes, all security interests and liens relating thereto were
terminated.
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access. In addition, we entered into an Investor Rights Agreement with each of
the investors purchasing shares of Series A Preferred Stock, and our Board of
Directors approved with respect to the shareholder rights plan any action
necessary under our shareholder rights plan to accommodate the issuance of the
Series A Preferred Stock and warrants without triggering the applicability of
the shareholder rights plan.
31
Equity
Compensation Plan Information
The
following table sets forth information as of December 31, 2007 about shares of
Common Stock outstanding and available for issuance under our existing equity
compensation plans.
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
|
926,386 | $ | 1.59 | 717,328 | ||||||||
1995 Stock
Awards Plan
|
162,417 | 15.53 | - | |||||||||
2001
Restricted Stock Plan
|
- | - | 52,818 | |||||||||
Equity compensation plans | ||||||||||||
not approved
by security holders
|
||||||||||||
2007 Special
Stock Option Plan
|
100,000 | |||||||||||
Total | 1,188,803 | $ | 3.60 | 1,120,146 |
The
2007 Special Stock Option Plan
The 2007
Special Stock Option Plan (the "Plan") was adopted by the Board in January 2007.
The Plan is not intended to be an incentive stock option plan within the meaning
of Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”).
The Plan allows for the issuance of up to 450,000 options to acquire Access’
stock of which 100,000 have been issued. The purpose of the Plan is to encourage
ownership of Common Stock by employees, consultants, advisors and directors of
Access and its affiliates and to provide additional incentive for them to
promote the success of Access’ business. The Plan provides for the grant of
non-qualified stock options to employees (including officers, directors,
advisors and consultants). The Plan will expire in January 2017, unless earlier
terminated by the Board. The granted options in the Plan expire in March 12,
2010.
Issuer
Purchases of Equity Securities
None
32
ITEM
7.
|
MANAGEMENT'S
DISCUSSION AND ANALYSIS OR PLAN OF
OPERATIONS
|
The
following discussion should be read in conjunction with our consolidated
financial statements and related notes included in this Form 10-K.
Overview
Access
Pharmaceuticals, Inc. (“Access” or the “Company”) is a Delaware corporation. We
are an emerging biopharmaceutical company focused on developing products based
upon our nanopolymer chemistry technologies. We currently have one approved
product, two products in Phase 2 clinical trials and five products in
pre-clinical development.
·
|
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 US$1
billion world-wide. MuGard, a proprietary nanopolymer formulation, has
received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase 2
clinical trial being conducted in the EU in patients with ovarian cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in excess
of $2.0 billion.
|
·
|
Pre-clinical
development of Cobalamin™, our proprietary nanopolymer oral drug delivery
technology based on the natural vitamin B12 uptake mechanism. We are
currently developing a product for the oral delivery of
insulin.
|
·
|
Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably breast,
ovarian and colorectal cancers.
|
·
|
Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
|
·
|
Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
|
·
|
Pre-clinical
development of Cobalamin-mediated targeted
delivery.
|
·
|
Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration with Virium
Pharmaceuticals.
|
Products
Access is
using its drug delivery technologies to develop the following products and
product candidates:
Access
Drug Portfolio
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage (1)
|
||||
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
Marketing
clearance received
|
||||
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
– U London
|
Synthetic
polymer
|
Cancer
|
Phase
2
|
||||
Phenylbutyrate
(PB)
|
National
Institute
of
Health
|
Small
molecule
|
Cancer
|
Phase
2
|
||||
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
Angiolix®
|
Immunodex,
Inc.
|
Humanized
monoclonal
antibody
|
Cancer
|
Pre-clinical
|
||||
Prodrax®
|
Univ
London
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
Alchemix®
|
DeMontford
Univ
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
Cobalamin-Targeted
Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Pre-clinical
|
||||
(1)
|
For
more information, see “Government Regulation” for description of clinical
stages.
|
(2)
|
Licensed
from the School of Pharmacy, The University of London. Subject to a 1%
royalty and milestone payments on
sales.
|
33
Approved
Products
MuGard™ - Mucoadhesive
Liquid Technology (MLT)
Access’
MuGard is a viscous polymer solution which provides a coating for the oral
cavity. MuGard is dispensed in a ready to use form. A multi-site, randomized
clinical study was performed in the United States testing MuGard and MuGard
containing an anti-inflammatory drug to determine the effect of these products
on the prevention and treatment of mucositis. The data from this trial indicated
that the patients using MuGard displayed a lower incidence of mucositis than is
typically seen in the studied population with no additional benefit from the
drug.
Access is
currently seeking marketing partners to market MuGard™ in the United States and
in other territories worldwide.
In August
2007, we signed a definitive licensing agreement with SpePharm Holding, B.V.
under which SpePharm will market Access’ product MuGard in Europe.
Products
in Development Status
ProLindac™ (Polymer
Platinate, AP5346) DACH Platinum
We have
commenced a European Phase 2 ProLindac trial in ovarian cancer patients who have
relapsed after first line platinum therapy. The primary aim of the study is to
determine the response rate of ProLindac monotherapy in this patient population.
The response rates for other platinum compounds in this indication are well
known, and will be used for comparison.
We have
submitted an IND application to the US Food and Drug Administration, and have
received clearance from the agency to proceed with a Phase 2 clinical study of
ProLindac in combination with fluorouracil and leucovorin. The study is designed
to evaluate the safety of ProLindac in combination with two standard drugs used
to treat colorectal cancer and to establish a safe dose for further clinical
studies of this combination in colorectal cancer. We are currently evaluating
whether clinical development of ProLindac in this indication might proceed more
rapidly by utilizing an alternative clinical strategy and/or conducting studies
in the US and/or elsewhere in the world.
Recent
Events
On
February 12, 2008, the Board of Directors of the Company elected Steven H.
Rouhandeh as director and Chairman of the Board effective as of March 4,
2008.
On
February 4, 2008, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of
our preferred stock, designated “Series A Cumulative Convertible Preferred
Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the
“Series A Preferred Stock”) and agreed to issue warrants to purchase 545,000
shares of our common stock, which includes placement agent warrants to purchase
90,883 shares of our common stock, at an exercise price of $3.50 per share, for
an aggregate purchase price for the Series A Preferred Stock and Warrants of
$2,700,000. The shares of Series A Preferred Stock are convertible into common
stock at the initial conversion price of $3.00 per share.
On
January 14, 2008, we announced the signing of a definitive licensing agreement
under which RHEI Pharmaceuticals, Inc. will market and manufacture MuGard in the
Peoples Republic of China and certain Southeast Asian countries. RHEI will also
obtain the necessary regulatory approvals for MuGard in the
territory.
34
On
January 4, 2008, we closed our acquisition of Somanta Pharmaceuticals, Inc. In
connection with the acquisition, Access issued an aggregate of approximately 1.5
million shares of Access Pharmaceuticals, Inc. common stock to the common and
preferred shareholders of Somanta as consideration. In addition, Access
exchanged all outstanding warrants of Somanta for warrants to purchase 191,991
shares of Access common stock at exercise prices ranging between $18.55 and
$69.57 per share.
On
December 26, 2007, Jeffrey B. Davis, Chairman of the Board of Directors was
named Chief Executive Officer. Stephen R. Seiler resigned as President and Chief
Executive Officer and concurrently resigned from the Board of Directors
effective December 19, 2007.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
On
November 7, 2007, as a condition to closing our Series A Preferred Stock, SCO
Capital Partners LLC and affiliates, along with the other holders of an
aggregate of $6,000,000 Secured Convertible Notes, also exchanged their notes
and accrued interest for an additional 1,836.0512 shares of Series A Preferred
Stock and were issued warrants to purchase 1,122,031 shares of our common stock
at an exercise price of $3.50 per share, and Oracle Partners LP and affiliates,
along with the other holders of an aggregate of $4,015,000 Convertible Notes
also exchanged their notes and accrued interest for 437.3104 shares of the
Series A Preferred Stock and were issued warrants to purchase 728,850 shares of
our common stock at an exercise price of $3.50 per share. SCO Capital
Partners LLC currently has two designees serving on our Board of
Directors. In connection with the exchange of the notes, all security
interests and liens relating thereto were terminated.
On
November 7, 2007, as a condition to closing our Series A Preferred Stock, we
entered into an Investor Rights Agreement with each of the investors purchasing
shares of Series A Preferred Stock, and our Board of Directors approved with
respect to the shareholder rights plan any action necessary under our
shareholder rights plan to accommodate the issuance of the Series A Preferred
Stock and warrants without triggering the applicability of the shareholder
rights plan.
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access.
On August
27, 2007, we signed a definitive licensing agreement with SpePharm Holding, B.V.
under which SpePharm will market Access’ product MuGard in Europe.
On August
1, 2007, we announced that Esteban Cvitkovic, a member of our board of directors
as Vice Chairman Europe, agreed to an expanded role as Senior Director, Oncology
Clinical R&D.
On April
26, 2007, we entered into a Note Purchase Agreement with Somanta
Pharmaceuticals, Inc. in order for Access to loan Somanta amounts to keep
certain of their licenses and vendors current. As of December 31, 2007 we had
loaned Somanta $931,000.
35
Results
of Operations
Comparison
of Years Ended December 31, 2007 and 2006
Our
licensing revenue for the year ended December 31, 2007 was $23,000. We recognize
licensing revenue over the period of the performance obligation under our
licensing agreement. We received a $1.0 million upfront licensing payment in
August 2007 from SpePharm Holding, B.V. for marketing MuGard in Europe. We will
recognize the upfront licensing fee over 14 ¾ years, the license
term.
We have a
sponsored research and development agreement. Our revenue from this agreement
for the year ended December 31, 2007 was $34,000. We will recognize revenue over
the term of the agreement as services are performed.
Total
research spending for the year ended December 31, 2007 was $2,602,000, as
compared to $2,053,000 2006, an increase of $549,000. The increase in expenses
was primarily due to:
·
|
costs
for product manufacturing for a new ProLindac clinical trial expected to
start in mid 2008 ($230,000);
|
·
|
higher
salary and related cost due to the hiring of additional scientific staff
($225,000);
|
·
|
higher
scientific consulting expenses
($179,000);
|
·
|
higher
salary related expenses due to stock option expenses ($23,000);
and
|
·
|
other
net increases ($10,000).
|
The
increase in research spending was partially offset by lower clinical development
costs ($118,000). We incurred start-up costs for the clinical trial in early
2006.
Total
general and administrative expenses were $4,076,000 for the year ended December
31, 2007, an increase of $1,263,000 over 2006 expenses of $2,813,000. The
increase in spending was due primarily to the following:
·
|
higher
salary related expenses due to stock option expenses
($785,000);
|
·
|
higher
investor relations expenses ($476,000) due to our increased investor
relations efforts;
|
·
|
higher
franchise taxes ($48,000);
|
·
|
higher
travel expenses ($39,000) due to business development activities;
and
|
·
|
other
net increases ($87,000).
|
The
increase in general and administrative spending was partially offset
by:
·
|
lower
patent expenses ($43,000); and
|
·
|
lower
professional fees ($129,000).
|
Depreciation
and amortization was $279,000 for the year ended December 31, 2007 as compared
to $309,000 for 2006 reflecting a decrease of $30,000. The decrease in
depreciation and amortization was due to assets becoming fully
depreciated.
Total
operating expenses for the year ended December 31, 2007 were $6,957,000 as
compared to total operating expenses of $5,175,000 for 2006, an increase of
$1,782,000.
Interest
and miscellaneous income was $125,000 for the year ended December 31, 2007 as
compared to $294,000 for 2006, a decrease of $169,000. The decrease in interest
income was due to accretion of the receivable due from Uluru that was recorded
in 2006.
Interest
and other expense was $3,514,000 for the year ended December 31, 2007 as
compared to $7,436,000 in 2006, a decrease of $3,922,000. The decrease in
interest and other expense was due to amortization of the discount on the Oracle
convertible notes and the amortization of the SCO notes recognized in
2006.
36
Convertible
notes payable of $10,015,000 and accrued interest of $1,090,000 were converted
from debt and accrued interest payable into preferred stock on November 10,
2007. A conversion of portion of the debt and interest resulted in a loss on the
extinguishment of debt of $11,628,000. The same transaction also resulted in a
beneficial conversion feature that was recorded as preferred stock dividends of
$14,648,000.
In 2006,
there was an unrealized loss on fair value of warrants of $1,107,000 due to the
warrants issued to SCO and affiliates. We changed our accounting for the
warrants in the fourth quarter of 2006 and there are no unrealized losses or
gains in 2007.
We
recognized deferred revenues of $173,000 from discontinued operations in
2007.
Net loss
allocable to common stockholders for the year ended December 31, 2007 was
$36,652,000, or a $10.32 basic and diluted loss per common share, compared with
a loss of $12,874,000, or a $3.65 basic and diluted loss per common share for
the same period in 2006, an increased loss of $23,778,000.
Liquidity
and Capital Resources
We have
funded our operations primarily through private sales of common stock and
convertible notes and our principal source of liquidity is cash and cash
equivalents. Licensing fees provided minimal funding for operations during the
year ended December 31, 2007. As of March 28, 2008, our cash and cash
equivalents and short-term investments were $6,327,000 and our net cash burn
rate for the year ended December 31, 2007 was approximately $575,000 per month.
As of December 31, 2007 our working capital was $6,239,000. Our working capital
at December 31, 2007 represented an increase of $12,021,000 as compared to our
working capital deficit as of December 31, 2006 of $5,782,000. The increase in
working capital at December 31, 2007 reflects the capital raised in the November
private placement of $8,672,000, and approximately $10.0 million of debt and
$1.1 million of accrued interest that was converted to equity, offset by
operating expenses and $1.3 million in capitalized interest that was paid to a
convertible noteholder. As of December 31, 2007 we have one
convertible note outstanding in the principle amount of $5.5 million which is
due September 13, 2011.
As of
March 31, 2008, the Company did not have enough capital to achieve its long-term
goals. If we raise additional funds by selling equity securities, the relative
equity ownership of our existing investors would be diluted and the new
investors could obtain terms more favorable than previous investors. A failure
to obtain necessary additional capital in the future could jeopardize our
operations.
We have
generally incurred negative cash flows from operations since inception, and have
expended, and expect to continue to expend in the future, substantial funds to
complete our planned product development efforts. Since inception, our expenses
have significantly exceeded revenues, resulting in an accumulated deficit as of
December 31, 2007 of $114,324,000. We expect that our capital resources will be
adequate to fund our current level of operations into the second quarter of
2009. However, our ability to fund operations over this time could change
significantly depending upon changes to future operational funding obligations
or capital expenditures. As a result we may be required to seek additional
financing sources within the next twelve months. We cannot assure you that we
will ever be able to generate significant product revenue or achieve or sustain
profitability.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
Since our
inception, we have devoted our resources primarily to fund our research and
development programs. We have been unprofitable since inception and to date have
received limited revenues from the sale of products. We cannot assure you that
we will be able to generate sufficient product revenues to attain profitability
on a sustained basis or at all. We expect to incur losses for the next several
years as we continue to invest in product research and development, preclinical
studies, clinical trials and regulatory compliance.
We plan
to expend substantial funds to conduct research and development programs,
preclinical studies and clinical trials of potential products, including
research and development with respect to our acquired and developed technology.
Our future capital requirements and adequacy of available funds will depend on
many factors, including:
·
|
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;
|
37
·
|
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.
|
We have
devoted substantially all of our efforts and resources to research and
development conducted on our own behalf. The following table summarizes research
and development spending by project category (in thousands), which spending
includes, but is not limited to, payroll and personnel expense, lab supplies,
preclinical expense, development cost, clinical trial expense, outside
manufacturing expense and consulting expense:
(in
thousands)
|
Twelve
Months ended
December 31,
|
Inception
To
Date (1)
|
||||||||||
Project
|
2007
|
2006
|
||||||||||
Polymer
Platinate
(ProLindac™)
|
$ | 2,563 | $ | 2,043 | $ | 22,217 | ||||||
Mucoadhesive
Liquid
Technology
(MLT)
|
21 | 10 | 1,511 | |||||||||
Others
(2)
|
18 | - | 5,062 | |||||||||
Total
|
$ | 2,602 | $ | 2,053 | $ | 28,790 | ||||||
(1)
|
Cumulative
spending from inception of the Company or project through December 31,
2007.
|
(2)
|
Includes: Vitamin
Mediated Targeted Delivery, carbohydrate targeting, amlexanox cream and
gel and other related projects.
|
Due to
uncertainties and certain of the risk factors described above, including those
relating to our ability to successfully commercialize our drug candidates, our
ability to obtain necessary additional capital to fund operations in the future,
our ability to successfully manufacture our products and our product candidates
in clinical quantities or for commercial purposes, government regulation to
which we are subject, the uncertainty associated with preclinical and clinical
testing, intense competition that we face, market acceptance of our products and
protection of our intellectual property, it is not possible to reliably predict
future spending or time to completion by project or product category or the
period in which material net cash inflows from significant projects are expected
to commence. If we are unable to timely complete a particular
project, our research and development efforts could be delayed or reduced, our
business could suffer depending on the significance of the project and we might
need to raise additional capital to fund operations, as discussed in the risk
factors above, including without limitation those relating to the uncertainty of
the success of our research and development activities and our ability to obtain
necessary additional capital to fund operations in the future. As
discussed in such risk factors, delays in our research and development efforts
and any inability to raise additional funds could cause us to eliminate one or
more of our research and development programs.
We plan
to continue our policy of investing any available funds in certificates of
deposit, money market funds, government securities and investment-grade
interest-bearing securities. We do not invest in derivative financial
instruments.
38
Critical
Accounting Policies and Estimates
The
preparation of our consolidated financial statements in conformity with
accounting principles generally accepted in the United State of America requires
us to make estimates and assumptions that affect the reported amounts of assets
and liabilities, disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amount of revenues and expenses during
the reported period. In applying our accounting principles, we must often make
individual estimates and assumptions regarding expected outcomes or
uncertainties. As you might expect, the actual results or outcomes are often
different than the estimated or assumed amounts. These differences are usually
minor and are included in our consolidated financial statements as soon as they
are known. Our estimates, judgments and assumptions are continually
evaluated based on available information and experience. Because of the use of
estimates inherent in the financial reporting process, actual results could
differ from those estimates.
Asset
Impairment
Our
intangible assets at December 31, 2007 consist primarily of patents
acquired in acquisitions and licenses which were recorded at fair value on the
acquisition date. We perform an impairment test on at least an annual basis or
when indications of impairment exist. At December 31, 2007, Management believes
no impairment of our intangible assets exists.
Based on
an assessment of our accounting policies and underlying judgments and
uncertainties affecting the application of those policies, we believe that our
consolidated financial statements provide a meaningful and fair
perspective of us. We do not suggest that other general factors, such as those
discussed elsewhere in this report, could not adversely impact our consolidated
financial position, results of operations or cash flows. The impairment test
involves judgment on the part of management as to the value of goodwill,
licenses and intangibles.
Stock
Based Compensation Expense
On
January 1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based Payment,” (“SFAS
123(R)”), which requires the measurement and recognition of all share-based
payment awards made to employees and directors including stock options based on
estimated fair values. SFAS 123(R) supersedes the Company’s previous accounting
under Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to
Employees” (“APB 25”), for periods beginning in fiscal year 2006. In
March 2005, the Securities and Exchange Commission issued Staff Accounting
Bulletin No. 107 (“SAB 107”) relating to SFAS 123(R). We applied the
provisions of SAB 107 in its adoption of SFAS 123(R).
We
adopted SFAS 123(R) using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006,
the first day of the Company’s 2006 fiscal year. Our consolidated financial
statements for the years ended December 31, 2007 and 2006, reflect the
impact of SFAS 123(R). In accordance with the modified prospective transition
method, our consolidated financial statements for prior periods have not been
restated to include the impact of SFAS 123(R). Stock-based compensation expense
recognized under SFAS 123(R) for the years ended December 31, 2007 and 2006
was approximately $1,048,000 and $284,000, respectively.
SFAS
123(R) requires companies to estimate the fair value of share-based payment
awards on the date of grant using an option-pricing model. The value of the
portion of the award that is ultimately expected to vest is recognized as
expense over the requisite service period in the company’s Statement of
Operations. Prior to the adoption of SFAS 123(R), we accounted for stock-based
awards to employees and directors using the intrinsic value method in accordance
with APB No. 25 as allowed under SFAS No. 123, “Accounting for Stock-Based
Compensation” (“SFAS 123”). Under the intrinsic value method, no
stock-based compensation expense for stock option grants was recognized because
the exercise price of our stock options granted to employees and directors
equaled the fair market value of the underlying stock at the date of grant.
There were no restricted stock awards granted in either 2006 or 2007
.
Stock-based
compensation expense recognized in the our Statement of Operations for the years
ended December 31, 2007 and 2006 includes compensation expense for share-based
payment awards granted prior to, but not yet vested as of December
31, 2005, based on the grant date fair value estimated in accordance with the
pro forma provisions of SFAS 123 and compensation expense for the share-based
payment awards granted subsequent to December 31, 2005, based on the grant date
fair value estimated in accordance with the provisions of SFAS 123(R).
Stock-based compensation expense recognized in the Company’s Statement of
Operations for the year ended December 31, 2007 and 2006 is based on awards
ultimately expected to vest and has been reduced for estimated forfeitures,
which currently is nil. SFAS 123(R) requires forfeitures to be estimated at the
time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates.
39
We used
the Black-Scholes option-pricing model (“Black-Scholes”) as our method of
valuation under SFAS 123(R) in fiscal years 2007 and 2006 and a single option
award approach. This fair value is then amortized on a straight-line basis over
the requisite service periods of the awards, which is generally the vesting
period. The fair value of share-based payment awards on the date of grant as
determined by the Black-Scholes model is affected by our stock price as well as
other assumptions. These assumptions include, but are not limited to the
expected stock price volatility over the term of the awards, and actual and
projected employee stock option exercise behaviors.
Recent
Accounting Pronouncements
In
June 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income
Taxes, an Interpretation of FASB Statement No. 109, Accounting for Income
Taxes (“FIN 48”), to create a single model to address accounting for
uncertainty in tax positions. FIN 48 clarifies the accounting for income taxes
by prescribing a minimum recognition threshold a tax position is required to
meet before being recognized in the financial statements. FIN 48 also provides
guidance on derecognition, measurement, classification, interest, and penalties,
accounting in interim periods, disclosure and transition. The Company adopted
FIN 48 as of January 1, 2007, and the adoption did not have a material
impact on the Company’s consolidated financial statements or effective tax rate
and did not result in any unrecognized tax benefits.
Interest
costs and penalties related to income taxes are classified as interest expense
and general and administrative costs, respectively, in the Company’s
consolidated financial statements. For the years ended December 31, 2007
and 2006, the Company did not recognize any interest or penalty expense related
to income taxes. It is determined not to be reasonably likely for the amounts of
unrecognized tax benefits to significantly increase or decrease within the next
12 months. The Company is currently subject to a three year statute of
limitations by major tax jurisdictions. The Company and its subsidiaries file
income tax returns in the U.S. federal jurisdiction.
In
September 2006, the FASB issued Statement of Financial Accounting Standard
(“SFAS”) No. 157, “Fair Value Measurements” (“SFAS 157”). SFAS 157 defines
fair value, establishes a market-based framework or hierarchy for measuring fair
value, and expands disclosures about fair value measurements. SFAS 157 is
applicable whenever another accounting pronouncement requires or permits assets
and liabilities to be measured at fair value. SFAS 157 does not expand or
require any new fair value measures; however the application of this statement
may change current practice. The requirements of SFAS 157 are first effective
for our fiscal year beginning January 1, 2008. However, in
February 2008 the FASB decided that an entity need not apply this standard
to nonfinancial assets and liabilities that are recognized or disclosed at fair
value in the financial statements on a nonrecurring basis until the subsequent
year. Accordingly, our adoption of this standard on January 1, 2008 is
limited to financial assets and liabilities. We do not believe the initial
adoption of SFAS 157 will have a material effect on our financial condition or
results of operations. However, we are still in the process of evaluating this
standard with respect to its effect on nonfinancial assets and liabilities and
therefore have not yet determined the impact that it will have on our financial
statements upon full adoption.
In
February 2007, FASB issued SFAS No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities — Including an Amendment of FASB Statement
No. 115. The fair value option permits entities to choose to measure
eligible financial instruments at fair value at specified election dates. The
entity will report unrealized gains and losses on the items on which it has
elected the fair value option in earnings. SFAS 159 is effective beginning in
fiscal year 2008. The Company is currently evaluating the effect of adopting
SFAS 159, but does not expect it to have a material impact on its consolidated
results of operations or financial condition.
Off-Balance Sheet Transactions
None
Contractual
Obligations
The
Company’s contractual obligations as of December 31, 2007 are set forth
below.
Payment Due by Period
|
||||||||||||
Total
|
Less Than 1 Year
|
1-4 Years
|
||||||||||
Long-Term
Debt
Obligations
|
$ | 5,564,000 | $ | 64,000 | $ | 5,500,000 | ||||||
Interest
|
1,697,000 | 426,000 | 1,271,000 | |||||||||
Lease
Obligations
|
121,000 | 92,000 | 29,000 | |||||||||
Total
|
$ | 7,382,000 | $ | 582,000 | $ | 6,800,000 |
40
ITEM
8. FINANCIAL STATEMENTS
Financial
statements required by this Item are incorporated in this Form 10-K on pages F-1
through F-20. Reference is made to Item 15 of this Form -10-K.
ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
AND
FINANCIAL
DISCLOSURE
None
ITEM
9A.(T) CONTROLS AND PROCEDURES
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting, as such term is defined in
Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our internal control
system was designed to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external
purposes, in accordance with generally accepted accounting principles. Because
of inherent limitations, a system of internal control over financial reporting
may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate due to change in conditions, or that the degree of compliance with
the policies or procedures may deteriorate.
Our
management, including our principal executive officer and principal accounting
officer, conducted an evaluation of the effectiveness of our internal control
over financial reporting using the criteria set forth by the Committee of
Sponsoring Organizations of the Treadway Commission (COSO) in Internal
Control—Integrated Framework. Based on its evaluation, our management concluded
that there is a material weakness in our internal control over financial
reporting. A material weakness is a deficiency, or a combination of control
deficiencies, in internal control over financial reporting such that there is a
reasonable possibility that a material misstatement of the Company’s annual or
interim financial statements will not be prevented or detected on a timely
basis.
The
material weakness relates to the monitoring and review of work performed by our
Chief Financial Officer in the preparation of audit and financial statements,
footnotes and financial data provided to the Company’s registered public
accounting firm in connection with the annual audit. All of our financial
reporting is carried out by our Chief Financial Officer. This lack of accounting
staff results in a lack of segregation of duties and accounting technical
expertise necessary for an effective system of internal control.
In order
to mitigate this material weakness to the fullest extent possible, all financial
reports are reviewed by the Chief Executive Officer as well as the Chairman of
the Audit Committee for reasonableness. All unexpected results are investigated.
At any time, if it appears that any control can be implemented to continue to
mitigate such weaknesses, it is immediately implemented. As soon as our finances
allow, we will hire sufficient accounting staff and implement appropriate
procedures for monitoring and review of work performed by our Chief Financial
Officer.
This
annual report does not include an attestation report of the Company’s registered
public accounting firm regarding internal control over financial reporting.
Management’s report was not subject to attestation by the Company’s registered
public accounting firm pursuant to temporary rules of the SEC that permit the
Company to provide only management’s report in this annual report.
This
report shall not be deemed to be filed for purposes of Section 18 of the
Securities Exchange Act of 1934, or otherwise subject to the liabilities of that
section, and is not incorporated by reference into any filing of the Company,
whether made before or after the date hereof, regardless of any general
incorporation language in such filing.
Changes In Internal Control
Over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred
during the quarter ended December 31, 2007 that have materially affected,
or are reasonable likely to materially affect, our internal control over
financial reporting.
ITEM 9B. OTHER INFORMATION
None.
41
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS, CONTROL PERSONS
AND
CORPORATE GOVERNANCE;
COMPLIANCE WITH SECTION 16(A) OF THE
EXCHANGE ACT
Directors and Reports of Beneficial
Ownership. The information required by this item with respect
to directors (including with respect to the audit committee of our Board of
Directors) and reports of beneficial ownership will be contained in our
definitive Proxy Statement ("Proxy Statement") for our 2008 Annual Meeting of
Stockholders to be held on May 21, 2008 and is incorporated herein by reference.
We will file the Proxy Statement with the Securities and Exchange Commission not
later than April 29, 2008 (or will file an amendment to this Form 10-K to
include such information). Information relating to our executive officers is
contained in Part I of this report.
Code of Ethics. We
have adopted a Code of Business Conduct and Ethics (the “Code”) that applies to
all of our employees (including executive officers) and directors. The Code is
available on our website at www.accesspharma.com
under the heading “Investor Information”. We intend to satisfy the disclosure
requirement regarding any waiver of a provision of the Code applicable to any
executive officer or director, by posting such information on such
website. Access shall provide to any person without charge, upon
request, a copy of the Code. Any such request must be made in writing to Access,
c/o Investor Relations, 2600 Stemmons Freeway, Suite 176, Dallas,
TX 75207.
Our
corporate governance guidelines and the charters of the audit committee,
compensation committee and nominating and corporate governance committee of the
Board of Directors are available on our website at www.accesspharma.com
under the heading “Investor Information”. Access shall provide to any person
without charge, upon request, a copy of any of the foregoing materials. Any such
request must be made in writing to Access, c/o Investor Relations, 2600 Stemmons
Freeway, Suite 176, Dallas, TX 75207.
ITEM
11. EXECUTIVE COMPENSATION
The
information required by this item will be contained in the Proxy Statement and
is incorporated herein by reference.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
AND RELATED
STOCKHOLDER MATTERS
The
information required by this item will be contained in the Proxy Statement and
is incorporated herein by reference.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND
DIRECTOR
INDEPENDENCE
The
information required by this item will be contained in the Proxy Statement and
is incorporated herein by reference.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The
information required by this item will be contained in the Proxy Statement and
is incorporated herein by reference.
42
ITEM
15. EXHIBITS
Page
a.
|
Financial
Statements. The following financial statements are
submitted as part of this report:
|
Report of Registered
Independent Public Accounting Firm
|
F-1
|
Consolidated Balance Sheets at
December 31, 2007 and 2006
|
F-2
|
Consolidated Statements of
Operations for 2007 and 2006
|
F-3
|
Consolidated Statements of
Stockholders' Equity (Deficit) for 2007 and 2006
|
F-4
|
Consolidated Statements of
Cash Flows for 2007 and 2006
|
F-5
|
Notes to Consolidated
Financial Statements
|
F-6
|
b. Exhibits
|
Exhibit
Number
|
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 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)
|
3.10
|
Certificate
of Designation of Series A Cumulative Convertible Preferred Stock filed
November 9, 2007
|
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 10.11 of our Form 10-K for the year ended December
31, 1996)
|
43
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
|
Form
of Convertible Note (Incorporated by reference to Exhibit 10.24 of our
Form 10-Q for the quarter ended September 30,
2000)
|
10.8
|
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)
|
10.9
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between us and American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
10.10
|
Amendment
to Rights Agreement, dated as of November 9, 2007 between us and American
Stock Transfer & Trust Company as Rights
Agent
|
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
(2)
|
10.13*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen B.
Thompson (1)
|
10.14 Asset
Sale Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
10.15
|
Amendment
to Asset Sale Agreement, dated as of December 8, 2006, between us and
Uluru, Inc. (3)
|
10.16 License
Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
10.17
|
Form
of Warrant, dated February 16, 2006, issued by us to certain Purchasers
(2)
|
10.18
|
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
10.19
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
10.20*
|
2007
Special Stock Option Plan and Agreement, dated January 4, 2007, by and
between us and Stephen R. Seiler, President and Chief Executive Officer
(4)
|
10.21
|
Note
Purchase Agreement dated April 26, 2007 between us and Somanta
Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.42 of our
Form 10-Q for the quarter ended June 30,
2007)
|
10.22
|
Preferred
Stock and Warrant Purchase Agreement, dated November 7, 2007, between us
and certain Purchasers (5)
|
10.23
|
Investor
Rights Agreement, dated November 10, 2007, between us and certain
Purchasers (5)
|
10.24
|
Form
of Warrant Agreement dated November 10, 2007, between us and certain
Purchasers (5)
|
10.25
|
Board
Designation Agreement, dated November 15, 2007, between us and SCO Capital
Partners LLC (5)
|
10.26
|
Amendment
and Restated Purchase Agreement, dated February 4, 2008 between us and
certain Purchasers (5)
|
10.27
|
Amended
and Restated Investor Rights Agreement, dated February 4, 2008 between us
and certain Purchasers (5)
|
10.28*
|
Employment
Agreement, dated January 4, 2008 between us and Jeffrey B. Davis
(5)
|
21
|
Subsidiaries
of the registrant
|
23.1 Consent
of Whitley Penn LLP
31.1
|
Chief
Executive Officer Certification Pursuant to 18 U.S.C. Section 1350, as
Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
31.2
|
Chief
Financial Officer Certification Pursuant to 18 U.S.C. Section 1350, as
Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
32
|
Chief
Executive Officer Certification Chief Financial Officer Certification
Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002
|
*
|
[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.
|
(4)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2007.
|
(5)
|
Incorporated
by reference to our Form S-1,
333-149633.
|
44
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this Report to be signed on its behalf by
the undersigned, thereunto duly authorized.
ACCESS PHARMACEUTICALS,
INC.
Date March 31,
2008 By: /s/ Jeffrey B.
Davis
Jeffrey B.
Davis
Chief Executive
Officer
Principal Executive
Officer
Date March 31,
2008 By: /s/ Stephen B.
Thompson
Stephen B.
Thompson
Vice President, Chief
Financial
Officer and
Treasurer
Principal Financial
and Accounting Officer
Pursuant
to the requirements of the Securities Exchange Act of 1934, this Report has been
signed below by the following persons on behalf of the Company and in the
capacities and on the dates indicated.
Date
March 31,
2008 By: /s/ Mark J.
Ahn
Mark J. Ahn, Director
Date
March 31,
2008 By: /s/ Mark J.
Alvino
Mark J. Alvino,
Director
Date
March 31,
2008 By: /s/ Esteban
Cvitkovic
Esteban Cvitkovic,
Director
Date
March 31,
2008 By: /s/ Jeffrey B.
Davis
Jeffrey B. Davis,
Director,
Chief Executive
Officer
Date
March 31,
2008 By: /s/ Stephen B.
Howell
Stephen B. Howell,
Director
Date March 31,
2008 By: /s/ David P.
Luci
David P. Luci,
Director
Date
March 31,
2008 By: /s/ Rosemary
Mazanet
Rosemary Mazanet,
Director
Date
March 31,
2008 By:
John J. Meakem, Jr.,
Director
Date
March 31,
2008 By: /s/ Steven H.
Rouhandeh
Steven H. Rouhandeh,
Chairman of
the
Board
45
Report
of Independent Registered Public Accounting Firm
To the
Board of Directors and Stockholders of Access Pharmaceuticals, Inc. and
Subsidiaries
We have
audited the accompanying consolidated balance sheets of Access Pharmaceuticals,
Inc. and Subsidiaries, as of December 31, 2007 and 2006, and the related
consolidated statements of operations, changes in stockholders’ equity
(deficit), and cash flows for the years then ended. These financial
statements are the responsibility of the Company’s management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. An audit includes consideration of internal
control over financial reporting as a basis for designing audit procedures that
are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position Access Pharmaceuticals,
Inc. and Subsidiaries as of December 31, 2007 and 2006, and the consolidated
results of their operations and their cash flows for the years then ended in
conformity with accounting principles generally accepted in the United States of
America.
The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 2 to the
consolidated financial statements, the Company has had recurring losses from
operations, negative cash flows from operating activities and an accumulated
deficit. Management’s plans in regard to these matters are also described in
Note 2. These conditions raise substantial doubt about the Company’s ability to
continue as a going concern. These consolidated financial statements do not
include any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts and classification of
liabilities that may result from the outcome of this uncertainty.
/s/
WHITLEY PENN LLP
Dallas,
Texas
March 31,
2008
F-1
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
BALANCE SHEETS
ASSETS
|
December 31, 2007
|
December 31,
2006
|
Current
assets
Cash and cash
equivalents
Short
term investments, at cost
Receivables
Receivables due from Somanta
Pharmaceuticals
Prepaid
expenses and other current assets
|
$
|
159,000
6,762,000
35,000
931,000 410,000
|
$
|
1,194,000
3,195,000
359,000
-
283,000
|
||||
Total
current assets
|
8,297,000 | 5,031,000 |
Property
and equipment, net
|
130,000 | 212,000 | ||||||
Debt
issuance costs, net
|
- | 158,000 | ||||||
Patents,
net
|
710,000 | 878,000 | ||||||
Licenses,
net
|
- | 25,000 | ||||||
Other
assets
|
12,000 | 122,000 | ||||||
Total
assets
|
$ | 9,149,000 | $ | 6,426,000 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
Current
liabilities
Accounts
payable and accrued expenses
Accrued
interest payable
Current
portion of deferred revenue
Current
portion long-term debt, net of discount $0 at December 31,
2007
and
$2,062,000 at December 31, 2006
|
$
|
1,796,000
130,000
68,000
64,000
|
$
|
1,226,000
581,000 173,000
8,833,000
|
Total
current liabilities
|
2,058,000 | 10,813,000 | ||||||
Long-term deferred revenue | 910,000 | |||||||
Long-term
debt
|
5,500,000 | 5,500,000 | ||||||
Total
liabilities
|
8,468,000 | 16,313,000 |
Commitments
and contingencies
|
Stockholders'
equity (deficit)
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
3,227.3617
issued at December 31, 2007; none issued at
December
31, 2006
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
3,585,458 at December 31, 2007; issued 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
116,018,000
(1,045,000)
(4,000)
(114,324,000)
|
-
35,000
68,799,000
(1,045,000)
(4,000)
(77,672,000)
|
Total
stockholders' equity (deficit)
|
681,000
|
(9,887,000)
|
Total
liabilities and stockholders' equity (deficit)
|
$ | 9,149,000 | $ | 6,426,000 |
The
accompanying notes are an integral part of these consolidated
statements.
F-2
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
STATEMENTS OF OPERATIONS
2007
|
2006
|
|||||||
Revenues
|
||||||||
License
revenues
|
$ | 23,000 | $ | - | ||||
Sponsored research and
development
|
34,000 | - | ||||||
Total revenues
|
57,000 | - | ||||||
Expenses
|
||||||||
Research and
development
|
2,602,000 | 2,053,000 | ||||||
General and
administrative
|
4,076,000 | 2,813,000 | ||||||
Depreciation and
amortization
|
279,000 | 309,000 | ||||||
Total expenses
|
6,957,000 | 5,175,000 | ||||||
Loss
from operations
|
(6,900,000 | ) | (5,175,000 | ) | ||||
Interest
and miscellaneous income
|
125,000 | 294,000 | ||||||
Interest
and other expense
|
(3,514,000 | ) | (7,436,000 | ) | ||||
Loss
on extinguishment of debt
|
(11,628,000 | ) | - | |||||
Unrealized
loss on fair value of warrants and beneficial
conversion
feature
|
- | (1,107,000 | ) | |||||
(15,017,000 | ) | (8,249,000 | ) | |||||
Loss
before discontinued operations and before tax benefit
|
(21,917,000 | ) | (13,424,000 | ) | ||||
Income
tax benefit
|
61,000 | 173,000 | ||||||
Loss
from continuing operations
|
(21,856,000 | ) | (13,251,000 | ) | ||||
Less preferred stock dividends | (14,908,000 | ) | - | |||||
Loss from continuing operations allocable to common stockholders | (36,764,000 | ) | (13,251,000 | ) | ||||
Discontinued
operations, net of taxes of $61,000 in 2007 and $173,000
in 2006
|
112,000 | 377,000 | ||||||
Net
loss allocable to common stockholders
|
$ | (36,652,000 | ) | $ | (12,874,000 | ) | ||
Basic
and diluted loss per common share
|
||||||||
Loss
from continuing operations allocable to common
stockholders
|
$ | (10.35 | ) | $ | (3.76 | ) | ||
Discontinued
operations
|
0.03 | 0.11 | ||||||
Net
loss allocable to common stockholders
|
$ | (10.32 | ) | $ | (3.65 | ) | ||
Weighted
average basic and diluted common shares
outstanding
|
3,552,006 | 3,531,934 | ||||||
The
accompanying notes are an integral part of these consolidated
statements.
F-3
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
Common Stock
|
Preferred Stock
|
Additional
paid-in
capital
|
Notes
receivable from stockholders
|
Treasury
stock
|
Accumulated
deficit
|
|||
Shares
|
Amount
|
Shares
|
Amount
|
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 | ) | |||||||||||||||||||||
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 | ) |
The
accompanying notes are an integral part of these consolidated
statements.
F-4
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Year ended December
31,
|
||||||||
2007
|
2006
|
|||||||
Cash flows from operating activities: | ||||||||
Net
loss
|
$ | (21,744,000 | ) | $ | (12,874,000 | ) | ||
Adjustments to
reconcile net loss to net cash used
|
||||||||
in operating
activities:
|
||||||||
Unrealized
loss
|
- | 1,107,000 | ||||||
Loss on
extinguishment of debt
|
11,628,000 | - | ||||||
Stock option
expense
|
1,048,000 | 248,000 | ||||||
Stock issued
for compensation/services
|
83,000 | 77,000 | ||||||
Depreciation and amortization
|
279,000 | 309,000 | ||||||
Amortization
of debt costs and
discounts
|
2,316,000 | 6,749,000 | ||||||
Loss (gain) on
sale of assets
|
2,000 | (550,000 | ) | |||||
Change in
operating assets and liabilities:
|
||||||||
Receivables
|
(607,000 | ) | 4,129,000 | |||||
Prepaid
expenses and other current assets
|
(127,000 | ) | 14,000 | |||||
Other
assets
|
14,000 | 127,000 | ||||||
Accounts
payable and accrued expenses
|
310,000 | (1,657,000 | ) | |||||
Accrued
interest payable
|
1,150,000 | 363,000 | ||||||
Deferred
revenues
|
805,000 | - | ||||||
Net cash used in operating activities | 4,843,000 | (1,958,000 | ) | |||||
Cash
flows from investing activities:
|
||||||||
Capital
expenditures
|
(18,000 | ) | (3,000 | ) | ||||
Proceeds from
sale of equipment
|
13,000 | - | ||||||
Proceeds from
sale of oral/topical care assets
|
- | 550,000 | ||||||
Purchases of
short-term investments
|
||||||||
and
certificates of deposit, net
|
(3,567,000 | ) | (3,070,000 | ) | ||||
Net cash used in investing activities | (3,572,000 | ) | (2,523,000 | ) | ||||
Cash
flows from financing activities:
|
||||||||
Payments of
notes payable
|
(1,327,000 | ) | (106,000 | ) | ||||
Proceeds from
secured convertible notes payable
|
- | 5,432,000 | ||||||
Exercise of
stock options
|
35,000 | - | ||||||
Proceeds from
preferred stock issuances, net of costs
|
8,672,000 | - | ||||||
Net cash provided by financing activities | 7,380,000 | 5,326,000 | ||||||
Net increase (decrease) in cash and cash equivalents | (1,035,000 | ) | 845,000 | |||||
Cash and cash equivalents at beginning of year | 1,194,000 | 349,000 | ||||||
Cash and cash equivalents at end of year | $ | 159,000 | $ | 1,194,000 | ||||
Cash paid for interest | $ | 34,000 | $ | 315,000 | ||||
Supplemental disclosure of noncash transactions | ||||||||
Common stock issued for SEDA
and
|
||||||||
Debt issuance
costs
|
- | 568,000 | ||||||
Accrued interest
capitalized
|
511,000 | 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 | ||||||
Preferred stock
dividends
|
260,000 | - | ||||||
Debt exchanged for preferred
stock
|
10,015,000 | - | ||||||
Accrued interest exchanged for
preferred stock
|
1,090,000 | - |
The
accompanying notes are an integral part of these consolidated
statements.
F-5
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
Two years
ended December 31, 2007
|
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
|
Nature of
Operations
Access
Pharmaceuticals, Inc. is an emerging pharmaceutical company engaged in the
development of novel therapeutics for the treatment of cancer and supportive
care of cancer patients. This development work is based primarily on the
adaptation of existing therapeutic agents using the Company’s proprietary drug
delivery technology. Our efforts have been principally devoted to research and
development, resulting in significant losses since inception on February 24,
1988.
A summary
of the significant accounting policies applied in the preparation of the
accompanying consolidated financial statements follows.
Principles of
Consolidation
The
consolidated financial statements include the financial statements of Access
Pharmaceuticals, Inc. and our wholly-owned subsidiaries. All intercompany
balances and transactions have been eliminated in consolidation.
Use of
Estimates
In
preparing consolidated financial statements in conformity with accounting
principles generally accepted in the United States of America, management is
required to make estimates and assumptions that affect the reported amounts of
assets and liabilities, the disclosure of contingent assets and liabilities at
the date of the financial statements, and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from those
estimates.
We tested
intangible assets for impairment based on estimates of fair value. It is at
least reasonably possible that the estimates used by us will be materially
different from actual amounts. These differences could result in the impairment
of all or a portion of our intangible assets, which could have a materially
adverse effect on our results of operations.
Cash and Cash
Equivalents
We
consider all highly liquid instruments purchased with a maturity of three months
or less to be cash equivalents for purposes of the statements of cash flows.
Cash and cash equivalents consist primarily of cash in banks, money market funds
and short-term corporate securities. We invest any excess cash in government and
corporate securities. All other investments are reported as short-term
investments.
Short-term
Investments
Short-term
investments consist of certificates of deposit. All short term investments are
classified as held to maturity. The cost of debt securities is adjusted for
amortization of premiums and accretion of discounts to maturity. Such
amortization is included in interest income. The cost of securities sold is
based on the specific identification method.
Property and
Equipment
Property
and equipment are recorded at cost. Depreciation is provided using the
straight-line method over estimated useful lives ranging from three to seven
years. Expenditures for major renewals and betterments that extend the useful
lives are capitalized. Expenditures for normal maintenance and repairs are
expensed as incurred. The cost of assets sold or abandoned and the related
accumulated depreciation are eliminated from the accounts and any gains or
losses are recognized in the accompanying consolidated statements of operations
of the respective period.
F-6
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
|
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -
Continued
|
Research and Development
Expenses
Pursuant
to SFAS No. 2, “Accounting for Research and
Development Costs,” our research and development costs are expensed as
incurred. Research and development expenses include, but are not limited to,
payroll and personnel expense, lab supplies, preclinical, development cost,
clinical trial expense, outside manufacturing and consulting. The cost of
materials and equipment or facilities that are acquired for research and
development activities and that have alternative future uses are capitalized
when acquired.
Fair Value of Financial
Instruments
The
carrying value of cash, cash equivalents, short-term investments and accounts
payable approximates fair value due to the short maturity of these items. It is
not practical to estimate the fair value of the Company’s long-term debt because
quoted market prices do not exist and there were no available securities with
similar terms to use as a basis to value our debt.
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax
assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts of
existing assets and liabilities and their respective tax bases and operating
loss and tax credit carryforwards. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or
settled. The effect on deferred tax assets and liabilities of a
change in tax rates is recognized in income in the period that includes the
enactment date. A valuation allowance is provided for deferred tax assets to the
extent their realization is in doubt.
Loss Per
Share
We have
presented basic loss per share, computed on the basis of the weighted average
number of common shares outstanding during the year, and diluted loss per share,
computed on the basis of the weighted average number of common shares and all
dilutive potential common shares outstanding during the year. Potential common
shares result from stock options, vesting of restricted stock grants,
convertible notes and warrants. However, for all years presented, all
outstanding stock options, restricted stock grants, convertible notes and
warrants are anti-dilutive due to the losses for the periods. Anti-dilutive
common stock equivalents of 20,623,072 and 12,548,342 were excluded from the
loss per share computation for 2007 and 2006, respectively.
Intangible
Assets
We
expense internal patent and application costs as incurred because, even though
we believe the patents and underlying processes have continuing value, the
amount of future benefits to be derived therefrom are uncertain. Purchased
patents are capitalized and amortized over the life of the patent. We recognize
the purchase cost of licenses and amortize them over their estimated useful
lives.
The
Company operates in a single segment.
F-7
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
|
Two
years ended December 31, 2007
|
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES –
Continued
Intangible
assets consist of the following (in thousands):
December 31, 2007
|
December 31, 2006
|
|||||||||||||||
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
|||||||||||||
Amortizable
intangible assets
Patents
Licenses
Total
|
$ | 1,680 500 $ 2,180 | $ | 970 500 $1,470 | $ | 1,680 500 $ 2,180 | $ | 802 475 $ 1,277 |
Amortization
expense related to intangible assets totaled $193,000 and $218,000 for the years
ended December 31, 2007 and 2006, respectively. The aggregate estimated
amortization expense for intangible assets remaining as of December 31, 2007 is
as follows (in thousands):
2008 | $ | 168 | ||
2009 | 168 | |||
2010 | 168 | |||
2011 | 168 | |||
Thereafter | 38 | |||
Total | $ | 710 |
Revenues
We
recognize revenue, licensing and research and development revenues, over the
period of the performance obligation under our agreements.
Stock-Based
Compensation
On
January 1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based Payment,” (“SFAS
123(R)”), which requires the measurement and recognition of all share-based
payment awards made to employees and directors including stock options based on
estimated fair values. SFAS 123(R) supersedes the Company’s previous accounting
under Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to
Employees” (“APB 25”), for periods beginning in fiscal year 2006. In
March 2005, the Securities and Exchange Commission issued Staff Accounting
Bulletin No. 107 (“SAB 107”) relating to SFAS 123(R). We applied the
provisions of SAB 107 in its adoption of SFAS 123(R).
We
adopted SFAS 123(R) using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006,
the first day of the Company’s 2006 fiscal year. Our consolidated financial
statements for the years ended December 31, 2007 and 2006, reflect the
impact of SFAS 123(R). In accordance with the modified prospective transition
method, our consolidated financial statements for prior periods have not been
restated to include the impact of SFAS 123(R). Stock-based compensation expense
recognized under SFAS 123(R) for the year ended December 31, 2007 was
approximately $1,048,000 and $248,000 for the year ended December 31,
2006.
F-8
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
|
Two
years ended December 31, 2007
|
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES –
Continued
SFAS
123(R) requires companies to estimate the fair value of share-based payment
awards on the date of grant using an option-pricing model. The value of the
portion of the award that is ultimately expected to vest is recognized as
expense over the requisite service period in the company’s Statement of
Operations. Prior to the adoption of SFAS 123(R), we accounted for stock-based
awards to employees and directors using the intrinsic value method in accordance
with APB No. 25 as allowed under SFAS No. 123, “Accounting for Stock-Based
Compensation” (“SFAS 123”). Under the intrinsic value method, no
stock-based compensation expense for stock option grants was recognized because
the exercise price of our stock options granted to employees and directors
equaled the fair market value of the underlying stock at the date of grant.
There were no restricted stock awards granted in 2007 or 2006 and therefore no
stock compensation expense is recognized in 2007 or 2006.
We use
the Black-Scholes option-pricing model (“Black-Scholes”) as its method of
valuation under SFAS 123(R) in fiscal year 2007 and 2006 and a single option
award approach. This fair value is then amortized on a straight-line basis over
the requisite service periods of the awards, which is generally the vesting
period. The fair value of share-based payment awards on the date of grant as
determined by the Black-Scholes model is affected by our stock price as well as
other assumptions. These assumptions include, but are not limited to the
expected stock price volatility over the term of the awards, and actual and
projected employee stock option exercise behaviors.
During
2007 and 2006, 230,000 stock options and 753,872 stock options, respectively,
were granted under the 2005 Equity Incentive Plan. Assumptions for 2007 and 2006
are:
2007
|
2006
|
|
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.
|
136%
|
127%
|
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.
|
4.65%
|
4.85%
|
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 employee exercise
behavior.
|
5.7
years
|
1.6
years
|
F-9
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
|
Two
years ended December 31, 2007
|
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES –
Continued
At
December 31, 2007, the balance of unearned stock-based compensation to be
expensed in future periods related to unvested share-based awards, as adjusted
for expected forfeitures, is approximately $197,000. The period over which the
unearned stock-based compensation is expected to be recognized is approximately
three years. We anticipate that we will grant additional share-based awards to
employees in the future, which will increase our stock-based compensation
expense by the additional unearned compensation resulting from these grants. The
fair value of these grants is not included in the amount above, because the
impact of these grants cannot be predicted at this time due to the dependence on
the number of share-based payments granted. In addition, if factors change and
different assumptions are used in the application of SFAS 123(R) in future
periods, stock-based compensation expense recorded under SFAS 123(R) may
differ significantly from what has been recorded in the current
period.
Our
Employee Stock Option Plans have been deemed compensatory in accordance with
SFAS 123(R). Stock-based compensation relating to this plan was computed using
the Black-Scholes model option-pricing formula with interest rates, volatility
and dividend assumptions as of the respective grant dates of the purchase rights
provided to employees under the plan. The weighted-average fair value of options
existing under all plans during 2007 was $2.65.
The
following table summarizes stock-based compensation in accordance with SFAS
123(R) for the year ended December 31, 2007 and 2006 which was allocated as
follows (in thousands):
Year
ended
December
31, 2007
|
Year
ended
December 31,
2006
|
|||||||
Research
and development
|
$ | 91 | $ | 68 | ||||
General
and administrative
|
957 | 180 | ||||||
Stock-based
compensation expense included in operating expense
|
1,048 | 248 | ||||||
Total
stock-based compensation expense
|
1,048 | 248 | ||||||
Tax
benefit
|
- | - | ||||||
Stock-based
compensation expense, net of tax
|
$ | 1,048 | $ | 248 | ||||
Recent Accounting
Pronouncements
In
June 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income
Taxes, an Interpretation of FASB Statement No. 109, Accounting for Income
Taxes (“FIN 48”), to create a single model to address accounting for
uncertainty in tax positions. FIN 48 clarifies the accounting for income taxes
by prescribing a minimum recognition threshold a tax position is required to
meet before being recognized in the financial statements. FIN 48 also provides
guidance on derecognition, measurement, classification, interest, and penalties,
accounting in interim periods, disclosure and transition. The Company adopted
FIN 48 as of January 1, 2007, and the adoption did not have a material
impact on the Company’s consolidated financial statements or effective tax rate
and did not result in any unrecognized tax benefits.
Interest
costs and penalties related to income taxes are classified as interest expense
and general and administrative costs, respectively, in the Company’s
consolidated financial statements. For the years ended December 31, 2007
and 2006, the Company did not recognize any interest or penalty expense related
to income taxes. It is determined not to be reasonably likely for the amounts of
unrecognized tax benefits to significantly increase or decrease within the next
12 months. The Company is currently subject to a three year statute of
limitations by major tax jurisdictions. The Company and its subsidiaries file
income tax returns in the U.S. federal jurisdiction.
In
September 2006, the FASB issued Statement of Financial Accounting Standard
(“SFAS”) No. 157, “Fair Value Measurements” (“SFAS 157”). SFAS 157 defines
fair value, establishes a market-based framework or hierarchy for measuring fair
value, and expands disclosures about fair value measurements. SFAS 157 is
applicable whenever another accounting pronouncement requires or permits assets
and liabilities to be measured at fair value. SFAS 157 does not expand or
require any new fair value measures; however the application of this statement
may change current practice. The requirements of SFAS 157 are first effective
for our fiscal year beginning January 1, 2008. However, in
February 2008 the FASB decided that an entity need not apply this standard
to nonfinancial assets and liabilities that are recognized or disclosed at fair
value in the financial statements on a nonrecurring basis until the subsequent
year. Accordingly, our adoption of this standard on January 1, 2008 is
limited to financial assets and liabilities. We do not believe the initial
adoption of SFAS 157 will have a material effect on our financial condition or
results of operations. However, we are still in the process of evaluating this
standard with respect to its effect on nonfinancial assets and liabilities and
therefore have not yet determined the impact that it will have on our financial
statements upon full adoption.
In
February 2007, FASB issued SFAS No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities — Including an Amendment of FASB Statement
No. 115. The fair value option permits entities to choose to measure
eligible financial instruments at fair value at specified election dates. The
entity will report unrealized gains and losses on the items on which it has
elected the fair value option in earnings. SFAS 159 is effective beginning in
fiscal year 2008. The Company is currently evaluating the effect of adopting
SFAS 159, but does not expect it to have a material impact on its consolidated
results of operations or financial condition.
F-10
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
|
Two
years ended December 31, 2007
|
NOTE
2 – LIQUIDITY
The
accompanying consolidated financial statements have been prepared assuming that
the Company is a going concern. The Company incurred a net loss in the years
ended December 31, 2007 and 2006. As described in Note 13, the Company has
issued convertible preferred stock in February 2008 and entered into a license
in January 2008.
Management
believes that these additional funds should cover the Company’s expected burn
rate into the second quarter of 2009. The Company will require additional funds
to fund operations. These funds are expected to come from the future sales of
equity and/or license agreements.
NOTE
3 - RELATED PARTY TRANSACTIONS
Stephen
B. Howell, M.D., a Director, receives payments for consulting services and
reimbursement of direct expenses. Dr. Howell’s payments for consulting services
and expense reimbursements are as follows:
Year
|
Consulting
Fees
|
Expense
Reimbursement
|
||||||
2007 | $ | 70,000 | $ | 2,000 | ||||
2006 | 69,000 | 5,000 |
Dr.
Esteban Cvitkovic, a Director, also serves as a consultant as Senior Director,
Oncology Clinical Research & Development to us since August 2007. Dr.
Cvitkovic receives payments for consulting expenses, office
expenses and reimbursement of direct expenses. Dr. Cvitkovic also
received options to purchase 25,000 shares of our Common Stock at $4.35 per
share with 12,500 options immediately in August 2007 and 12,500 options will
vest in March 2008 based on the completion of certain defined tasks. Dr.
Cvitkovic’s payments for consulting services and expense reimbursements are as
follows:
Year
|
Consulting
Fee
|
Office
Expenses
|
Office
Reimbursement
|
Fair
Value
of Options
|
||||||||||||
2007 | $ | 153,000 | $ | 15,000 | $ | 12,000 | $ | 99,000 |
Dr.
Rosemary Mazanet, a Director, receives payments for consulting services and
reimbursement of direct expenses. Dr. Mazanet’s payments for consulting services
and expense reimbursements are as follows:
Year
|
Consulting
Fees
|
Expense
Reimbursement
|
||||||
2007 | $ |
29,000
|
$ | $ 13,000 |
In the
event SCO Capital Partners LLC (“SCO”) and its affiliates were to convert all of
their shares of Series A Preferred Stock and exercise all of their warrants,
they would own approximately 69.8% of the voting securities of Access. During
2007 SCO and affiliates were paid $240,000 in placement agent fees relating to
the issuance of preferred stock and 100,000 warrants to purchase our common
stock, valued at $250,000. SCO and affiliates also were paid $150,000 in
investor relations fees in 2007. During 2006 SCO and affiliates were paid
$415,000 in fees relating to the issuance of convertible notes and were paid
$131,000 in investor relations fees.
See Note
9 for a discussion of our Restricted Stock Purchase Program.
F-11
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
4 - PROPERTY AND EQUIPMENT
Property and equipment consists of the following: |
December 31,
|
|||||||
2007
|
2006
|
|||||||
Laboratory equipment | $ | 824,000 | $ | 1,090,000 | ||||
Laboratory and building improvements | 58,000 | 167,000 | ||||||
Furniture and equipment | 40,000 | 134,000 | ||||||
922,000 | 1,391,000 | |||||||
Less accumulated depreciation and amortization | 792,000 | 1,179,000 | ||||||
Net property and equipment | $ | 130,000 | $ | 212,000 |
Depreciation
and amortization on property and equipment was $86,000 and $91,000
for the years ended December 31, 2007 and 2006, respectively.
NOTE
5 – 401(k) PLAN
We have a
tax-qualified employee savings and retirement plan (the “401(k) Plan”) covering
all our employees. Pursuant to the 401(k) Plan, employees may elect to reduce
their current compensation by up to the statutorily prescribed annual limit
($15,500 in 2007 and $15,000 in 2006) and to have the amount of such reduction
contributed to the 401(k) Plan. We have a 401(k) matching program whereby we
contribute for each dollar a participant contributes a like amount, with a
maximum contribution of 4% of a participant’s earnings in 2007 and 2% of a
participant’s earnings in 2006. The 401(k) Plan is intended to qualify under
Section 401 of the Internal Revenue Code so that contributions by employees or
by us to the 401(k) Plan, and income earned on 401(k) Plan contributions, are
not taxable to employees until withdrawn from the 401(k) Plan, and so that
contributions by us, if any, will be deductible by us when made. At the
direction of each participant, we invest the assets of the 401(k) Plan in any of
62 investment options. Company contributions under the 401(k) Plan were
approximately $50,000 in 2007 and $11,000 in 2006.
NOTE
6 – DEBT
$5,500,000 due on September
13, 2011. The note bears interest at 7.7% per annum with $423,500 of
interest due annually on September 13th. This
investor amended this note’s due date until 2011 and delayed his interest
payments which were due in 2005, 2006 and 2007 until September 13, 2008 or
earlier if the Company raised more than $5.0 million in funds. The capitalized
interest was $1,391,000 and interest on the capitalized interest was at 10%. We
raised $9,540,000 in November 2007, and entered into an agreement with the
investor to pay capitalized interest of $1,327,000 plus interest. At December
31, 2007 in addition to the note of $5,500,000 an additional $64,000 of
capitalized interest was due. Interest of $136,000 was due at December 31,
2007. This note has a fixed conversion price of $27.50 per share of common stock
and may be converted by the note holder or us under certain circumstances as
defined in the note. If the notes are not converted we will have to repay the
notes on the due dates.
$4,015,000 due on November
16, 2007 and $6,000,000 due on November 15, 2007 exchanged for
stock.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,000. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
F-12
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
6 – DEBT - Continued
As a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and Oracle
Partners LP and affiliates, along with the other holders of an aggregate of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest for
437.3104 shares of the Series A Preferred Stock and were issued warrants to
purchase 728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving
on our Board of Directors. In connection with the exchange of the
notes, all security interests and liens relating thereto were
terminated.
The
conversion of debt into equity resulted in a loss on extinguishment of debt of
$11,628,000. This represents the difference between the fair value of the equity
interest granted, based on recent sales of identical equity instruments, and the
carrying amount of the debt and interest settled.
$4,015,000 due on November
16, 2007. The investor’s notes were amended November 3, 2005 extending
the term and adjusting the conversion price from $27.50 to $5.00 per common
share. The amendment and modification resulted in us recording additional debt
discount of $2.1 million, which was accreted to interest expense to the revised
maturity date.
$6,000,000 due on November
15, 2007. The notes were sold in February 2006 in a private placement to
a group of accredited investors led by SCO Capital Partners LLC and affiliates.
We entered into a note and purchase agreement to which we sold and issued an
aggregate of $5 million of 7.5% convertible notes due November 15, 2007 and
warrants to purchase 3,863,634 shares of common stock of Access. Net proceeds to
Access were $4.5 million.
On
October 24, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible notes
due November 15, 2007 and warrants to purchase 386,364 shares of common stock of
Access. Net proceeds to Access were $450,000. On December 6, 2006, we entered
into a note and warrant purchase agreement pursuant to which we sold and issued
an aggregate of $500,000 of 7.5% convertible notes due November 15, 2007 and
warrants to purchase 386,364 shares of common stock of Access. Net proceeds to
Access were $450,000.
The
Secured Convertible Notes included warrants and a conversion feature. Until
September 30, 2006 we accounted for the warrants and conversion feature as
liabilities and recorded at fair value. From the date of issuance to September
30, 2006, the fair value of these instruments increased resulting in a net
unrealized loss of $1.1 million. On October 1, 2006, we adopted the
provisions of EITF 00-19-2, “Accounting for Registration Payment
Arrangements” (EITF 00-19-2), which requires that contingent obligations
to make future payments under a registration payment arrangement be recognized
and measured separately in accordance with SFAS No. 5, “Accounting for
Contingencies.” Under previous guidance, the fair value of the warrant
was recorded as a current liability in our balance sheet, due to a potential
cash payment feature in the warrant. Access may be required to pay in cash, up
to 2% per month, as defined, as liquidated damages for failure to file a
registration statement timely as required by an investor rights agreement. The
current liability was marked-to-market at each quarter end, using the
Black-Scholes option-pricing model, with the change being recorded to general
and administrative expenses. Under the new guidance in EITF 00-19-2, as we
believe the likelihood of such a cash payment to not be probable, have not
recognized a liability for such obligations. Accordingly, a cumulative-effect
adjustment of $1.4 million was made as of October 1, 2006 to accumulated
deficit, representing the difference between the initial value of this warrant
and its fair value as of this date and recorded to equity.
Subsequent
to the adoption of EITF 00-19-2 on October 1, 2006, the Company has accounted
for the $6,000,000 notes under EITF Issue No. 00-27, Application of Issue No. 98-5 to
Certain Instruments. The value of the warrants was valued using a
Black-Scholes option-pricing model with the following assumptions with a
weighted average volatility of 120%, expected life of 6 years, expected yield of
0% and risk free rate of 5.0%. At December 31, 2006, approximately $1.6M of debt
discount related to the warrants and embedded conversion feature had not been
amortized to interest expense. This was amortized over the original remaining
life of the debt through March 31, 2007.
F-13
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
7 – COMMITMENTS AND CONTINGENCIES
Future
maturities of the note payable and other obligations are as
follows:
Future
Maturities
|
Debt
|
|
2008
|
64,000
|
|
2011
|
5,500,000
|
Operating
Leases
At
December 31, 2007, we have commitments under non-cancelable operating leases for
office and research and development facilities until December 31, 2008 totaling
$77,000. Rent expense for the years ended December 31, 2007 and 2006 was $94,000
and $94,000, respectively. We also have two other non-cancelable operating
leases – one lease for a fire alarm system totaling $5,000 ending in 2008 and
one lease for a copier totaling $38,000 ending in 2011 (with $9,600 expensed
each year).
Legal
The
Company is not currently subject to any material pending legal
proceedings.
NOTE
8 – PREFERRED STOCK
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
As a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and Oracle
Partners LP and affiliates, along with the other holders of an aggregate of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest for
437.3104 shares of the Series A Preferred Stock and were issued warrants to
purchase 728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving
on our Board of Directors. In connection with the exchange of the
notes, all security interests and liens relating thereto were
terminated.
As a
condition to closing, we entered into an Investor Rights Agreement with each of
the investors purchasing shares of Series A Preferred Stock, and our Board of
Directors approved with respect to the shareholder rights plan any action
necessary under our shareholder rights plan to accommodate the issuance of the
Series A Preferred Stock and warrants without triggering the applicability of
the shareholder rights plan.
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access.
The
issued and outstanding shares of Series A Preferred Stock grants the holders of
such preferred stock anti-dilution, dividend and liquidations rights that are
superior to those held by the holders of our common stock. Should
Access issue additional shares of common stock for a price below $3.00 per
share, the conversion price of the Series A Preferred Stock shall be lowered to
the lowest issue price below $3.00 per share which will have the effect of
diluting the holders of our common stock.
In
connection with the preferred stock offering, we issued warrants for placement
agent fees, to purchase a total of 209,000 shares of common stock were issued.
All of the warrants are exercisable immediately and expire five 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 5 years.
In
connection with the preferred stock offering, we issued warrants for placement
agent fees, to purchase a total of 209,000 shares of common stock were issued.
All of the warrants are exercisable immediately and expire five 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 5 years.
Emerging
Issues Task Force (EITF) Issue 00-19, Accounting for Derivative Financial
Instruments Indexed to and Potentially Settled in, a Company’s Own Stock,
to determine whether the instruments should be accounted for as equity or
as liabilities.” EITF 00-19 requires the separation of single financial
instruments into components. For example, common stock issued with warrants
should be accounted for as equity, and the associated warrants could be
classified as either equity or liability. We determined that the warrants issued
along with the preferred stock and debt conversion are separate financial
instruments and separately exercisable and therefore, are within the scope of
EITF 00-19. Both the preferred stock and warrants were classified as equity. The
warrants were measured at their fair value.
The
conversion of debt into equity resulted in a loss on extinguishment of debt of
$11,628,000. This represents the difference between the fair value of the equity
interest granted, based on recent sales of identical equity instruments, and the
carrying amount of the debt and interest settled.
Based on
the loss on extinguishment of debt a new conversion price was calculated for the
preferred stock and considered to be “in the money” at the time of the agreement
to exchange the convertible notes for preferred stock. This resulted in a
beneficial conversion feature. The preferred stockholder has the right at any
time to convert all or any lesser portion of the Series A Preferred Stock into
Common Stock. This resulted in an intrinsic value of the preferred stock. The
difference between the implied value of the preferred stock and the beneficial
conversion option was treated as preferred stock dividends of
$14,648,000.
NOTE
9 - STOCKHOLDERS' EQUITY
Restricted Stock Purchase
Program
On
October 12, 2000, the Board of Directors authorized a Restricted Stock Purchase
Program. Under the Program, the Company’s executive officers and corporate
secretary were given the opportunity to purchase shares of common stock in an
individually designated amount per participant determined by the Compensation
Committee of the Board of Directors. A total of 38,000 shares were purchased
under the Program by four eligible
participants at $27.50 per share, the fair market value of the common stock on
October 12, 2000, for an aggregate consideration of $1,045,000. The purchase
price was paid through the participants’ delivery of a 50%-recourse promissory
note payable to the Company for three executive officer participants and a
full-recourse promissory note payable to the Company for one participant. Each
note bears interest at 5.87% compounded semi-annually and has a maximum term of
ten years. The notes are secured by a pledge of the purchased shares to the
Company. The Company recorded the notes receivable from participants in this
Program of $1,045,000 as a reduction of equity in the Consolidated Balance
Sheet. Interest on the notes is neither being collected nor accrued. The stock
granted under the Program is fully vested at December 31, 2007.
F-14
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
9 - STOCKHOLDERS' EQUITY - Continued
Warrants
There
were warrants to purchase a total of 8,476,397 shares of common stock
outstanding at December 31, 2007. All warrants were exercisable at December 31,
2007. The warrants had various prices and terms as follows:
Summary of Warrants
|
Warrants
Outstanding
|
Exercise
Price
|
Expiration
Date
|
||||||
2007 preferred stock offering (a) | 3,649,880 | $ | 3.50 |
11/10/13
|
|||||
2006 convertible note (b) | 3,863,634 | 1.32 |
2/16/12
|
||||||
2006 convertible note (b) | 386,364 | 1.32 |
10/24/12
|
||||||
2006 convertible note (b) | 386,364 | 1.32 |
12/06/12
|
||||||
2006 investor relations advisor (c) | 50,000 | 2.70 |
12/27/11
|
||||||
2004 offering (d) | 89,461 | 35.50 |
2/24/09
|
||||||
2004 offering (d) | 31,295 | 27.00 |
2/24/09
|
||||||
2003 financial advisor (e) | 14,399 | 19.50 |
10/30/08
|
||||||
2002 scientific consultant (f) | 2,000 | 24.80 |
2/01/09
|
||||||
2001 scientific consultant (g) | 3,000 | 15.00 |
1/1/08
|
||||||
Total
|
8,476,397 |
a)
|
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 five 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 5
years.
|
b)
|
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.
|
c)
|
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 are
exercisable.
|
d)
|
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.
|
e)
|
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.
|
F-15
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
9 - STOCKHOLDERS' EQUITY - Continued
f)
|
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.
|
g)
|
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.
|
2001 Restricted Stock
Plan
We have a
restricted stock plan, the 2001 Restricted Stock Plan, as amended, under which
80,000 shares of our authorized but unissued common stock were reserved for
issuance to certain employees, directors, consultants and advisors. The
restricted stock granted under the plan generally vests, 25% two years after the
grant date with additional 25% vesting every anniversary date. All stock is
vested after five years. At December 31, 2007 there were 27,182 shares issued
and 52,818 shares available for grant under the 2001 Restricted Stock
Plan.
NOTE
10 - STOCK OPTION PLANS
We have various stock-based employee
compensation plans described below:
2005 Equity Incentive
Plan
We have a
stock awards plan, (the “2005 Equity Incentive Plan”), under which 1,675,000
shares of our authorized but unissued common stock were reserved for issuance to
employees of, or consultants to, one or more of the Company and its affiliates,
or to non-employee members of the Board or of any board of directors (or similar
governing authority) of any affiliate of the Company. The 2005 Equity Incentive
Plan replaced the previously approved stock option plan (the 1995 Stock Awards
Plan").
For the
2005 Equity Incentive Plan, the fair value of options was estimated at the date
of grant using the Black-Scholes option pricing model with the following
weighted average assumptions used for grants in fiscal 2007: dividend yield of
0%; volatility of 136%; risk-free interest rate of 4.65%; and expected lives of
5.7 years. The weighted average fair value of options granted was $3.27 per
share during 2007. The assumptions for grants in fiscal 2006 were: dividend
yield of 0%; volatility of 127%; risk-free interest rate of 4.85%; and expected
lives of 1.6 years. The weighted average fair value of options granted was $0.36
per share during 2006.
F-16
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
10 - STOCK OPTION PLANS - Continued
Summarized
information for the 2005 Equity Incentive Plan is as follows:
Options
|
Weighted-
average
exercise
Price
|
|||||||
Outstanding options at January 1, 2006 | 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 | ||||||
Granted, fair value of $ 3.27 per share | 230,000 | 3.62 | ||||||
Exercised | (31,286 | ) | 1.11 | |||||
Forfeited | (75,000 | ) | 2.14 | |||||
Outstanding options at December 31, 2007 | 926,386 | 1.59 | ||||||
Exercisable at December 31, 2007 | 698,081 | 1.38 |
The
intrinsic value of options under this plan related to the outstanding and
exercisable options were $1,805,000 and $1,504,000, respectively, at December
31, 2007. The intrinsic value of options under this plan related to the
outstanding and exercisable options were $1,554,000 and $281,000, respectively,
at December 31, 2006.
The total intrinsic value of options exercised during 2007 was $113,000.
Further information regarding options outstanding under the 2005 Equity Incentive Plan at December 31, 2006 is summarized below:
Number
of
|
Weighted
average
|
Number
of
|
Weighted average | |||||||||||||||||||||||
Range of exercise
prices
|
options
outstanding
|
Remaining
life in years
|
Exercise
price
|
options
excercisable
|
Remaining
life in years
|
Exercise
Price
|
||||||||||||||||||||
$ |
0.63 -
0.63
|
666,750 | 9.0 | $ | 0.63 | 565,342 | 9.0 | $ | 0.63 | |||||||||||||||||
$ | 2.90 - 7.23 | 259,636 | 9.4 | 4.06 | 132,739 | 9.2 | 4.67 | |||||||||||||||||||
926,386 | 698,081 | |||||||||||||||||||||||||
2007 Special Stock Option
Plan
In
January 2007 we adopted the 2007 Special Stock Option Plan and Agreement (the
“Plan”). The Plan provides for the award of options to purchase 450,000 shares
of the authorized but unissued shares of common stock of the Company. At
December 31, 2007, there were 350,000 additional shares available for grant
under the Plan.
Under the
2007 Special Stock Option Plan, 450,000 options were issued in 2007 and 350,000
were forfeited. 100,000 options were outstanding at December 31, 2007. 100,000
options in the 2007 Special Stock Option Plan were exercisable at December 31,
2007. All of the options had an exercise price of $2.90 per share and expire
March 12, 2010.
For the
2007 Special Stock Option Plan, the fair value of options was estimated at the
date of grant using the Black-Scholes option pricing model with the following
weighted average assumptions used for grants in fiscal 2007: dividend yield of
0%; volatility of 138%; risk-free interest rate of 4.66%; and expected lives of
5.0 years. The weighted average fair value of options granted was $2.70 per
share during 2007.
F-17
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
10 - STOCK OPTION PLANS – Continued
2000 Special Stock Option
Plan
In
February 2000 we adopted the 2000 Special Stock Option Plan and Agreement (the
“Plan”). The Plan provides for the award of options to purchase 100,000 shares
of the authorized but unissued shares of common stock of the Company. At
December 31, 2007, there were no additional shares available for grant under the
Plan and all of the options expired on June 30, 2007.
Under the
2000 Special Stock Option Plan, 100,000 options were issued in 2000 and were
outstanding at December 31, 2006. All of the options in the 2000 Special Stock
Option Plan were exercisable at December 31, 2006. All of the options expired on
June 30, 2007 and had an exercise price of $12.50 per share.
1995 Stock Awards
Plan
Under the
1995 Stock Awards Plan, as amended, 500,000 shares of our authorized but
unissued common stock were reserved for issuance to optionees including
officers, employees, and other individuals performing services for us. At
December 31, 2007, there were no additional shares available for grant under the
1995 Stock Awards Plan. A total of 162,417 options were outstanding under this
plan at December 31, 2007.
Options
granted under all the plans generally vest ratably over a four to five year
period and are generally exercisable over a ten-year period from the date of
grant. Stock options were generally granted with an exercise price equal to the
market value at the date of grant.
Summarized
information for the 1995 Stock Awards Plan is as follows:
Options
|
Weighted-
average
exercise
price
|
|||||||
Outstanding options at January 1, 2006 | 430,271 | $ | 18.20 | |||||
Forfeited | (69,354 | ) | 19.12 | |||||
Outstanding options at December 31, 2006 | 18.03 | 18.03 | ||||||
Forfeited | (198,500 | ) | 20.07 | |||||
Exercisable at December 31, 2007 | 162,417 | 15.53 | ||||||
Exercisable at December 31, 2007 | 157,337 | 15.64 |
There was no intrinsic value
related to outstanding or exercisable options under this plan at December 31,
2007 or 2006.
Further
information regarding options outstanding under the 1995 Stock Awards Plan at
December 31, 2007 is summarized below:
Number
of
|
Weighted
average
|
Number
of
|
Weighted average | |||||||||||||||||||||||
Range of exercise
prices
|
options
outstanding
|
Remaining
life in years
|
Exercise
price
|
options
excercisable
|
Remaining
life in years
|
Exercise
Price
|
||||||||||||||||||||
$
|
10.00 - 12.50
|
85,140
|
5.3
|
$
|
11.42
|
80,238
|
5.1
|
$ |
11.41
|
|||||||||||||||||
14.05 -
18.65
|
48,717
|
3.3
|
16.33
|
48,717
|
3.3
|
16.33
|
||||||||||||||||||||
$ | 20.25 – 29.25 |
28,560
|
6.1 | 26.42 |
28,382
|
6.1 | 26.41 | |||||||||||||||||||
162,417 | 157,337 |
F-18
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
11 - INCOME TAXES
Income
tax expense differs from the statutory amounts as follows:
2007 | 2006 | |||||||
Income taxes at U.S. statutory rate | $ | (7,393,000 | ) | $ | (4,378,000 | ) | ||
Change in valuation allowance | 3,015,000 | 3,972,000 | ||||||
Change in miscellaneous items | - | (130,000 | ) | |||||
Benefit of foreign losses not recognized | 56,000 | 58,000 | ||||||
Expenses not deductible | 3,957,000 | 240,000 | ||||||
Expiration of net operating loss and general | ||||||||
business
credit carryforwards, net of
revisions
|
365,000 | 238,000 | ||||||
Total tax
expense
|
$ |
-
|
$ | - | ||||
Deferred
taxes are provided for the temporary differences between the financial reporting
bases and the tax bases of our assets and liabilities. The temporary
differences that give rise to deferred tax assets were as follows:
December
31,
|
||||||||
2007
|
2006
|
|||||||
Deferred tax assets | ||||||||
Net operating
loss carryforwards
|
$ |
25,693,000
|
$ | 22,634,000 | ||||
General
business credit carryforwards
|
2,469,000 | 2,402,000 | ||||||
Property,
equipment and goodwill
|
87,000 | 46,000 | ||||||
Gross deferred tax assets | 28,249,000 | 25,082,000 | ||||||
Valuation allowance | (28,249,000 | ) | (25,082,000 | ) | ||||
|
||||||||
Net deferred
taxes
|
$ | - | $ | - | ||||
At
December 31, 2007, we had approximately $75,568,000 of net operating loss
carryforwards and approximately $2,469,000 of general business credit
carryforwards. These carryforwards expire as follows:
Net
operating
loss
carryforwards
|
General
business
credit
carryforwards
|
|||||||
2008 | $ | 4,004,000 | $ | 138,000 | ||||
2009 | 1,661,000 | 185,000 | ||||||
2010 | 2,171,000 | 140,000 | ||||||
2012 | 4,488,000 | 13,000 | ||||||
2013 | 4,212,000 | 77,000 | ||||||
Thereafter | 59,032,000 | 1,916,000 | ||||||
$ | 75,568,000 | $ | 2,469,000 |
As a
result of a merger on January 25, 1996, a change in control occurred for federal
income tax purposes which limits the utilization of pre-merger net operating
loss carryforwards of approximately $3,100,000 to approximately $530,000 per
year.
F-19
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Two years
ended December 31, 2007
NOTE
12 – QUARTERLY FINANCIAL DATA (UNAUDITED)
Our
results of operations by quarter for the years ended December 31, 2007 and 2006
were as follows (in thousands, except per share amounts):
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
stockholders
|
$ | (4,127 | ) | $ | (2,109 | ) | $ | (1,957 | ) | $ | (28,459 | ) | ||||
Basic
and diluted loss per
common
share
|
$ | (1.17 | ) | $ | (0.60 | ) | $ | (0.55 | ) | $ | (8.00 | ) | ||||
2006
Quarter Ended
|
March
31
|
June
30
|
September 30
|
December 31
|
|||||||||||||
Loss
from continuing operations
|
$ | (4,856 | ) | $ | (3,331 | ) | $ | (2,015 | ) | $ | (3,049 | ) | ||||
Discontinued
operations, net of tax
|
- | - | - | 377 | ||||||||||||
Net
loss
|
$ | (4,856 | ) | $ | (3,331 | ) | $ | (2,015 | ) | $ | (2,672 | ) | ||||
Basic
and diluted loss per
common share
|
$ | (1.38 | ) | $ | (0.94 | ) | $ | (0.57 | ) | $ | (0.76 | ) | ||||
NOTE
13 – SUBSEQUENT EVENTS (UNAUDITED)
On
February 4, 2008, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of
our preferred stock, designated “Series A Cumulative Convertible Preferred
Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the
“Series A Preferred Stock”) and agreed to issue warrants to purchase 545,000
shares of our common stock, which includes placement agent warrants to purchase
90,883 shares of our common stock, at an exercise price of $3.50 per share, for
an aggregate purchase price for the Series A Preferred Stock and Warrants of
$2,700,000. The shares of Series A Preferred Stock are convertible into common
stock at the initial conversion price of $3.00 per share.
In
addition, due to the acquisition of Somanta, Access issued 538,508 shares of
Access common stock and 246,753 warrants to purchase Access common stock at an
exercise price of $3.50 per share to satisfy $1,576,000 of payables
due Somanta creditors.
On January 14, 2008, we announced the signing of a definitive licensing agreement under which RHEI Pharmaceuticals, Inc. will market and manufacture MuGard in the Peoples Republic of China and certain Southeast Asian countries. RHEI will also obtain the necessary regulatory approvals for MuGard in the territory.
On
January 4, 2008 we closed the acquisition of Somanta Pharmaceuticals, Inc. In
connection with the merger, Access issued an aggregate of approximately 1.5
million shares of Access Pharmaceuticals, Inc. common stock to the common and
preferred shareholders of Somanta as consideration. In addition, Access
exchanged all outstanding warrants of Somanta for warrants to purchase 191,991
shares of Access common stock at exercise prices ranging between $18.55 and
$69.57 per share.
F-20