As Filed with the Securities and Exchange Commission on February 10, 2004
Registration No. 333-92210
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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PRE-EFFECTIVE AMENDMENT NO. 4
TO
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
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ACCESS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware 3841
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(State or Other Jurisdiction (Primary Standard Industrial
of Incorporation or Organization) Classification Code Number)
83-0221517
----------------
(I.R.S. Employer
Identification No.)
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2600 Stemmons Freeway, Suite 176
Dallas, Texas 75207 (214) 905-5100
(Address, including zip code, and telephone number,
including area code, of registrant's principal executive offices)
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Kerry P. Gray
President and Chief Executive Officer
Access Pharmaceuticals, Inc.
2600 Stemmons Freeway, Suite 176
Dallas, Texas 75207
(214) 905-5100
(Name, address, including zip code, and
telephone number, including area code, of agent for service)
-------------------------------
with copies to:
John J. Concannon III
Bingham McCutchen LLP
150 Federal Street
Boston, MA 02110
(617) 951-8000
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Approximate date of commencement of proposed sale to the public: As
soon as practicable after this Registration Statement is declared effective.
If the only securities being registered on this form are being offered
pursuant to dividend or interest reinvestment plans, please check the
following box. / /
If any of the securities being registered on this form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities
Act of 1933, other than securities offered only in connection with dividend
or interest reinvestment plans, check the following box. /x/
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement number of
the earlier effective registration statement for the same offering. / /
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. / /
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. / /
CALCULATION OF REGISTRATION FEE
Title of Securities to be Amount to be Registered Proposed Maximum
Registered Offering Price Per
Share(1)
- ------------------------- ----------------------- ---------------------
Common Stock $.01 par 1,525,584 shares (2) $3.36
value per share
Proposed Maximum
Aggregate Offering Amount of
Price (1) Registration Fee
- ------------------- -------------------
$5,125,962 $471.59 (3)
(1) Estimated solely for the purpose of determining the registration fee.
Calculated in accordance with Rule 457(c) under the Securities Act of
1933 based on the average of the high and low prices as reported by the
American Stock Exchange on July 5, 2002, with respect to the 65,584
shares included in the initial filing of this registration statement
on July 10, 2002 and based on the average of the high and low prices as
reported by the American Stock Exchange on July 9, 2003 with respect to
the 1,460,000 additional shares initially registered on Amendment No. 1
to this registration statement.
(2) Includes 25,000 shares issuable to certain selling stockholders upon
exercise of warrants for the purchase of shares of the Registrant's
Common Stock (see "Selling Stockholders").
(3) This amount is the total amount of the registration fee for all 1,525,584
shares being registered. $40.90 was previously paid to the Commission in
connection with the initial filing of this registration statement on July
10, 2002.
----------------------
The Registrant hereby amends this Registration Statement on such date or
dates as may be necessary to delay its effective date until the Registrant
shall file a further amendment which specifically states that this
Registration Statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933 or until the Registration
Statement shall become effective, on such date as the Commission, acting
pursuant to Section 8(a), may determine.
PROSPECTUS
Access Pharmaceuticals, Inc.
Subject to completion, February 10, 2004.
1,525,584 Shares of
Common Stock, $.01 par value per share
This prospectus relates to the sale by certain stockholders of ours, the
Selling Stockholders, of up to 1,525,584 shares of our common stock,
including 25,000 shares issuable upon the exercise of warrants and
1,460,000 shares issuable upon the conversion of outstanding convertible
notes previously issued by us. If the warrants are exercised, we will
receive the proceeds from such exercise if payment is made in cash.
On February 9, 2004, the last sale price of our Common Stock was
$6.06 per share, as reported by the American Stock Exchange, or AMEX,
under the symbol AKC.
Investing in the common stock involves risks. For a discussion of certain
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factors you should consider, see "Risk Factors" beginning on Page 2.
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Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or determined
if this prospectus is truthful or complete. Any representation to the
contrary is a criminal offense.
---------------------------
The date of this Prospectus is February 10, 2004
Table of Contents
Page
------
Access Pharmaceuticals, Inc. 2
Risk Factors 2
Forward Looking Statements 11
Use of Proceeds 11
Selling Stockholders 12
Plan of Distribution 12
Legal Matters 13
Experts 13
Where You Can Get More Information 13
Certain Information We Are Incorporating By Reference 14
2
ACCESS PHARMACEUTICALS, INC.
General
Access Pharmaceuticals is an emerging pharmaceutical company. We are
focused on developing both novel low development risk product candidates
and technologies with longer-term major product opportunities.
We were founded in Wyoming in 1974 as Chemex Corporation, and in
1983 we changed our name to Chemex Pharmaceuticals, Inc. We changed
our state of incorporation from Wyoming to Delaware on June 30, 1989.
In 1996 we merged with Access Pharmaceuticals, Inc., a private Texas
corporation, and changed our name to Access Pharmaceuticals, Inc. Our
principal executive office is located at 2600 Stemmons Freeway, Suite
176, Dallas, Texas 75207; our telephone number is (214) 905-5100.
Products
Milestone Payments And Royalties By Product
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The following table reflects aggregate milestone payments received to
September 30, 2003, aggregate possible milestone payments under
agreements signed as of September 30, 2003 and royalties received to
September 30, 2003.
Milestones Royalties
Received to Aggregate Possible Received to
Product 9/30/03 Milestones 9/30/03
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Aphthasol(R) $ 752,000 $ 5,891,000 $ 2,500,000
Zindaclin(R) $ 1,147,000 $ 1,010,000 $ 30,000
RISK FACTORS
This offering involves a high degree of risk. You should carefully
consider the risks described below and the other information in this
prospectus before purchasing our common stock.
We have experienced a history of losses and we expect to incur future losses.
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We have recorded minimal revenue to date and we have incurred a
cumulative operating loss of approximately $51.6 million through
September 30, 2003. Losses for the first nine months of 2003 were $4.3
million and for the years ended 2002, 2001 and 2000 were $9.4, $6.0 and
$5.4 million, respectively. Our losses have resulted principally from costs
incurred in research and development activities related to our efforts to
develop clinical candidates and from the associated administrative costs.
We expect to incur significant additional operating losses over the next
several years. We also expect cumulative losses to increase due to
expanded research and development efforts and preclinical and clinical
trials. Our net cash burn rate for the first nine months of 2003 was
$471,000 per month. We project our net cash burn rate for the next
twelve months to be approximately $500,000 per month. Capital
expenditures are forecasted to be minor for the next twelve months since
most of our new equipment is leased and the lease expense is included in
the calculation of the net cash burn rate.
We do not have significant operating revenue and we may never attain
profitability.
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To date, we have funded our operations primarily through private sales of
common stock and convertible notes. Contract research payments and
licensing fees from corporate alliances and mergers have also provided
funding for our operations. Our ability to achieve significant revenue or
profitability depends upon our ability to successfully complete the
development of drug candidates, to develop and obtain patent protection
and regulatory approvals for our drug candidates and to manufacture and
commercialize the resulting drugs. We have not received significant
royalties for sales of amlexanox or Zindaclin(R) products
3
to date and we may not receive significant revenues or profits from the sale
of these products in the future. Furthermore, we may not be able to ever
successfully identify, develop, commercialize, patent, manufacture, obtain
required regulatory approvals and market any additional products.
Moreover, even if we do identify, develop, commercialize, patent,
manufacture, and obtain required regulatory approvals to market additional
products, we may not receive revenues or royalties from commercial sales
of these products for a significant number of years, if at all. Therefore,
our proposed operations are subject to all the risks inherent in the
establishment of a new business enterprise. In the next few years, our
revenues may be limited to minimal royalties any amounts that we receive
under strategic partnerships and research or drug development
collaborations that we may establish and, as a result, we may be unable
to achieve or maintain profitability in the future or to achieve significant
revenues in order to fund our operations.
We may not successfully commercialize our drug candidates.
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Our drug candidates are subject to the risks of failure inherent in the
development of pharmaceutical products based on new technologies and
our failure to develop safe, commercially viable drugs would severely
limit our ability to become profitable or to achieve significant revenues.
We may be unable to successfully commercialize our drug candidates
because:
* some or all of our drug candidates may be found to be unsafe or
ineffective or otherwise fail to meet applicable regulatory standards or
receive necessary regulatory clearances;
* our drug candidates, if safe and effective, may be too difficult to
develop into commercially viable drugs;
* it will be difficult to manufacture or market our drug candidates on a
large scale;
* proprietary rights of third parties may preclude us from marketing our
drug candidates; and
* third parties may market superior or equivalent drugs.
The success of our research and development activities, upon which we
primarily focus, is uncertain.
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Our primary focus is on our 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 our
research and development effort and our business could ultimately suffer.
We anticipate that we will remain principally engaged in research and
development activities for an indeterminate, but substantial, period of
time.
We may be unable to obtain necessary additional capital to fund operations
in the future.
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We require substantial capital for our development programs and operating
expenses, to pursue regulatory clearances and to prosecute and defend our
intellectual property rights. Although we believe that our existing capital
resources, interest income, product sales, royalties and revenue from
possible licensing agreements and collaborative agreements will be
sufficient to fund our currently expected operating expenses and capital
requirements through September 2004, we will need to raise substantial
additional capital during that period to support our ongoing operations
because our actual cash requirements may vary materially from those now
planned and will depend upon numerous factors, including :
* the results of our research and development programs;
* the timing and results of preclinical and clinical trials;
* our ability to maintain existing and establish new collaborative
agreements with other companies to provide funding to us;
* technological advances; and
* activities of competitors and other factors.
4
If we do 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 us through additional equity offerings, we may be required to
delay, reduce the scope of or eliminate one or more of our research and
development programs or to obtain funds by entering into arrangements
with collaborative partners or others that require us to issue additional
equity securities or to relinquish rights to certain technologies or drug
candidates that we would not otherwise issue or relinquish in order to
continue independent operations.
We may be unable to successfully develop, market, or commercialize our
products or our product candidates without establishing new relationships
and maintaining current relationships.
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Our strategy for the research, development and commercialization of our
potential pharmaceutical products may require us to enter into various
arrangements with corporate and academic collaborators, licensors,
licensees and others, in addition to our existing relationships with other
parties. Specifically, if we successfully develop any commercially
marketable pharmaceutical products, we may seek to enter joint venture,
sublicense or other marketing arrangements with parties that have an
established marketing capability or we may choose to pursue the
commercialization of such products on our own. We may, however, be
unable to establish additional collaborative arrangements, license
agreements, or marketing agreements as we may deem necessary to
develop, commercialize and market our potential pharmaceutical products
on acceptable terms. Furthermore, if we maintain and establish
arrangements or relationships with third parties, our business may depend
upon the successful performance by these third parties of their
responsibilities under those arrangements and relationships. For our
commercialized products we currently rely upon the following
relationships in the following marketing territories:
* amlexanox 5% paste
o Strakan Ltd. - United Kingdom and Ireland manufacturing and marketing rights
o Zambon Group - France, Germany, Holland, Belgium, Luxembourg,
Switzerland, Brazil, Colombia and Italy manufacturing and marketing rights
o Laboratories Dr. Esteve SA - Spain, Portugal and Greece manufacturing
and marketing rights
o Meda, AB for Scandinavia, the Baltic states and Iceland marketing rights
o Mipharm SpA for Italy manufacturing and marketing rights
o Paladin Labs, Inc. for Canada manufacturing and marketing rights
* Zindaclin(R) and Residerm(R)
o Strakan Ltd. - worldwide manufacturing and marketing rights
o Fujisawa GmbH - sublicensed continental Europe marketing rights
o Taro - sublicensed Israel marketing rights
o Various companies for other smaller countries - sublicensed marketing
rights
Our ability to commercialize, and market our products and product
candidates could be limited if any of these existing relationships were
terminated.
Furthermore, our strategy with respect to our 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 our licensing partner. Although we have had discussions with
potential licensing partners with respect to our polymer platinate program,
to date we have not entered into any licensing arrangement. We may be
unable to execute our licensing strategy for polymer platinate.
We may be unable to successfully manufacture our products and our
product candidates in clinical quantities or for commercial purposes
without the assistance of contract manufacturers, which may be difficult
for us to obtain and maintain.
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We have no experience in the manufacture of pharmaceutical products in
clinical quantities or for commercial purposes and we may not be able to
manufacture any new pharmaceutical products that we
5
may develop. As a result, we have established, and in the future intend 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 our potential products are approved for commercialization. If we are
unable to contract for a sufficient supply of our potential pharmaceutical
products on acceptable terms, our preclinical and human clinical testing
schedule may be delayed, resulting in the delay of our submission of products
for regulatory approval and initiation of new development programs, which
could cause our business to suffer. Delays or difficulties in establishing
relationships with manufacturers to produce, package, label and distribute
our finished pharmaceutical or other medical products, if any, market
introduction and subsequent sales of such products could cause our
business to suffer. Moreover, contract manufacturers that we 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 after the manufacturing facility passes a pre-
approval plant inspection. If we are unable to obtain or retain third party
manufacturing on commercially acceptable terms, we may not be able to
commercialize our products as planned. Our potential dependence upon
third parties for the manufacture of our products may adversely affect our
profit margins and our ability to develop and deliver such products on a
timely and competitive basis.
Our amlexanox 5% paste is marketed in the US as Aphthasol(R). Block
Drug Company had manufactured the 5% amlexanox paste since the
product was approved by the FDA in 1996 in a facility certified by the
FDA for Good Manufacturing Practices. At such time we entered into a
Supply Agreement whereby Block Drug Company was to produce
Aphthasol(R) for us for a defined period of time at its Puerto Rico
facility. We were subsequently advised by Block Drug Company that it is
unable to comply with the terms of the Supply Agreement and that it
would not be able to produce Aphthasol(R) for us. Due to Block Drug
Company's production failure, we had sufficient product to supply
wholesalers only through June 2003. We do not anticipate further sales of
the product until the first quarter of 2004. We acquired the rights to
amlexanox 5% paste from Block Drug Company on July 22, 2002. We
have selected Contract Pharmaceuticals Ltd. Canada as our new
manufacturer of amlexanox 5% paste and it has produced initial qualifying
batches of the product. Full scale production is planned to commence in
the fourth quarter of 2003.
Amlexanox 5% paste was approved by regulatory authorities for sale in
the UK and is currently in the approval process in the remaining EU
countries. We licensed manufacturing rights to Strakan, Zambon, Esteve
and Mipharm for specific countries in Europe. Esteve is currently
preparing to manufacture the product and is obtaining the necessary
European approvals. Esteve has experience in the manufacture of other
commercial pharmaceutical products.
We licensed our patents for worldwide manufacturing and marketing for
Zindaclin(R) and the ResiDerm(R) technology to Strakan Ltd. for the
period of the patents. We receive a royalty on the sales of the product.
Strakan has a contract manufacturer for Zindaclin(R) in a European Union
approved facility. Zindaclin(R) was approved in the UK and seven
additional European Union countries and is currently under review for
approval in the remaining EU countries.
OraDisc(TM) is manufactured by a third party for our Phase III clinical
trials. Enough product was manufactured to cover the needs of the clinical
trials and testing. We are currently negotiating with a third party for
manufacturing if the product gains regulatory approval.
AP5280 and AP5346 are manufactured by a third party for our Phase I
clinical trials. Manufacturing is ongoing for the current clinical trials.
Some manufacturing may be completed by the Company if significant cost
savings can be achieved.
Our mucoadhesive technology is manufactured by a third party for our
clinical trials.
6
We are subject to extensive governmental regulation which increases our
cost of doing business and may affect our ability to commercialize any
new products that we may develop.
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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 their safety
and efficacy. All of our drug candidates will require governmental
approvals for commercialization, none of which have been obtained.
Preclinical and clinical trials and manufacturing of our 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 our principal products is as follows:
* 5% amlexanox paste is an approved product for sale in the US
(Aphthasol(R)); approved in the UK and Canada but not yet sold; and, in
the approval process in the EU.
* Zindaclin(R) is an approved product for sale in the UK and seven
additional European Union countries; in the approval process in the
remaining EU countries; and waiting for finalized plans and approval to
start a Phase III trial in the US.
* OraDisc(TM) has completed a Phase III clinical trial in the US.
* AP5280 is currently in a Phase I/II trial in Europe.
* AP5346 is currently in a Phase I trial in Europe.
* Mucoadhesive liquid technology is planned to start a Phase III trial in
the US in 2003.
* Vitamin mediated delivery technology is currently in the pre-clinical
phase.
* We also have other products in the preclinical phase.
Due to the time consuming and uncertain nature of the drug candidate
development process and the governmental approval process described
above, we cannot assure you when we, independently or with our
collaborative partners, might submit a New Drug Application, or "NDA",
for FDA or other regulatory review.
Government regulation also affects the manufacturing and marketing of
pharmaceutical products. Government regulations may delay marketing of
our potential drugs for a considerable or indefinite period of time, impose
costly procedural requirements upon our 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 our marketing as well as our ability to
generate significant revenues from commercial sales. Our 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 we obtain initial regulatory approvals for
our drug candidates, we, and our drugs and our 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
our ability to successfully commercialize new products.
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Before we can obtain regulatory approvals for the commercial sale of any
of our 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 our 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 or animals which may delay ultimate FDA
approval or even lead us to terminate our
7
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,
OraDisc(TM) and AP5280 have 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
our drug candidates could prevent us from successfully commercializing
such candidates and we could incur substantial additional expenses in our
attempts to further develop such candidates and obtain future regulatory
approval.
We may incur substantial product liability expenses due to the use or
misuse of our products for which we may be unable to obtain insurance
coverage.
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Our business exposes us to potential liability risks that are inherent in the
testing, manufacturing and marketing of pharmaceutical products. These
risks will expand with respect to our drug candidates, if any, that receive
regulatory approval for commercial sale and we may face substantial
liability for damages in the event of adverse side effects or product defects
identified with any of our products that are used in clinical tests or
marketed to the public. We generally procure 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, we may be unable able to obtain
insurance coverage at acceptable costs or in a sufficient amount in the
future, if at all. We may be unable to satisfy any claims for which we
may be held liable as a result of the use or misuse of products which we
have developed, manufactured or sold and any such product liability claim
could adversely affect our business, operating results or financial
condition.
We may incur significant liabilities if we fail to comply with stringent
environmental regulations or if we did not comply with these regulations
in the past.
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Our research and development processes involve the controlled use of
hazardous materials. We are 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 we believe that our activities and our 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, we could be held liable for any
damages that result and any such liability could exceed our resources.
Intense competition may limit our ability to successfully develop and
market commercial products.
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The biotechnology and pharmaceutical industries are intensely competitive
and subject to rapid and significant technological change. Our 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 platinum (AP5280)
and DACH platinum (AP5346):
* Cisplatin, marketed by Bristol-Myers-Squibb, the originator of the drug,
and several generic manufacturers;
* Carboplatin, marketed exclusively by Bristol-Myers-Squibb; and
* oxaliplatin, marketed exclusively by Sanofi-Synthelabo.
The following companies are working on therapies and formulations that
may be competitive with our polymer platinum (AP5280) and DACH
platinum (AP5346):
* Antigenics is developing liposomal formulations; and
8
* Cell Therapeutics, Daiichi, Enzon, Inhale and Pharmacia are developing
alternate drugs in combination with polymers.
The following products may compete with our Residerm(R) products:
* Benzamycin, marketed by a subsidiary of Aventis;
* Cleocin-T and a generic topical clindamycin, marketed by Pharmacia;
* Benzac, marketed by a subsidiary of L'Oreal; and
* Triaz, marketed by Medicis Pharmaceutical Corp.
Technology and prescription steroids such as Kenalog in OraBase,
developed by Bristol-Myers Squibb, may compete with our
commercialized Aphthasol(R) product. OTC products including Orajel
- -Del Laboratories and Anbesol-Wyeth Consumer Healthcare also
compete in the aphthous ulcer market.
Companies working on therapies and formulations that may be competitive
with our vitamin mediated drug delivery system are Bristol-Myers-Squibb,
Centocor (acquired by Johnson & Johnson), GlaxoSmithKline, Imclone
and Xoma who are developing targeted monoclonal antibody therapy.
RxKinetics, Human Genome Sciences, Endo Pharmaceuticals and Amgen
are developing products to treat mucositis that may compete with the
mucoadhesive liquid technology.
Emisphere Technologies, Inc., Biovail Corporation, CMA Labs, Inc. and
Flamel Technologies are developing products which compete with our oral
drug delivery system.
Many of these competitors have and employ greater financial and other
resources, including larger research and development staffs and more
effective marketing and manufacturing organizations, than us or our
collaborative partners. As a result, our competitors may successfully
develop technologies and drugs that are more effective or less costly than
any that we are developing or which would render our technology and
future products obsolete and noncompetitive.
In addition, some of our competitors have greater experience than we do
in conducting preclinical and clinical trials and obtaining FDA and other
regulatory approvals. Accordingly, our competitors may succeed in
obtaining FDA or other regulatory approvals for drug candidates more
rapidly than we do. 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 our research and development efforts or
from our joint efforts with collaborative partners therefore may not be
commercially competitive with our competitors' existing products or
products under development.
Our ability to successfully develop and commercialize our drug candidates
will substantially depend upon the availability of reimbursement funds for
the costs of the resulting drugs and related treatments.
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The successful commercialization of, and the interest of potential
collaborative partners to invest in, the development of our drug candidates
will 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. To date, the costs of our
marketed products Aphthasol(R) and Zindaclin(R) generally have been
reimbursed at acceptable levels, however, the amount of such
reimbursement in the United States or elsewhere may be decreased in the
future or may be unavailable for any drugs that we may develop in the
future. Limited reimbursement for the cost of any drugs that we develop
may reduce the demand for, or price of such drugs, which would hamper
our ability to obtain collaborative partners to commercialize our drugs, or
to obtain a sufficient financial return on our own manufacture and
commercialization of any future drugs.
9
The market may not accept any pharmaceutical products that we
successfully develop.
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The drugs that we are 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 us will depend on a number of factors, including the
establishment and demonstration of the clinical efficacy and safety of our
drug candidates, the potential advantage of our 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 we may develop independently or
with our collaborative partners and if they do not, our business could
suffer.
In 1996, the 5% amlexanox paste product was approved for sale in the
United States. To date, the product is not widely accepted in the
marketplace and its sales have not been significant. On July 22, 2002, we
acquired the rights to it from Block Drug Company and we intend to re-
launch it in the first quarter of 2004. The product has been approved in
the UK and Canada but has not been launched in any markets other than
the United States.
Trends toward managed health care and downward price pressures on
medical products and services may limit our ability to profitably sell any
drugs that we may develop.
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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 health care reform, could limit our ability to profitably sell
any drugs that we may successfully develop. Moreover, any future
legislation or regulation, if any, relating to the healthcare industry or
third-party coverage and reimbursement, may cause our business to suffer.
We may not be successful in protecting our intellectual property and
proprietary rights.
- ---------------------------------------------------------------------
Our success depends, in part, on our ability to obtain U.S. and foreign
patent protection for our drug candidates and processes, preserve our trade
secrets and operate our 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. We cannot assure you that
any existing or future patents issued to, or licensed by, us will not
subsequently be challenged, infringed upon, invalidated or circumvented
by others. As a result, although we, together with our subsidiaries, are
either the owner or licensee of technology to 23 U.S. patents and to 18
U.S. patent applications now pending, and 6 European and 15 European
patent applications, we cannot assure you that any additional patents will
issue from any of the patent applications owned by, or licensed to, us.
Furthermore, any rights that we may have under issued patents may not
provide us with significant protection against competitive products or
otherwise be commercially viable.
Our patents for the following technologies expire in the years and during
the date ranges indicated below:
* 5% amlexanox paste in 2011
10
* Zindaclin(R) and Residerm(R) between 2007 and 2011
* OraDisc(TM) in 2020
* AP5280 in 2016
* AP5346 in 2016
* Mucoadhesive technology, patents are pending
* Vitamin mediated technology between 2003 and 2019
In addition, 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 our drug candidates. If our drug candidates or processes
are found to infringe upon the patents or otherwise impermissibly utilize
the intellectual property of others, our development, manufacture and sale
of such drug candidates could be severely restricted or prohibited. In such
event, we may be required to obtain licenses from third parties to utilize
the patents or proprietary rights of others. We cannot assure you that we
will be able to obtain such licenses on acceptable terms, if at all. If we
become involved in litigation regarding our intellectual property rights or
the intellectual property rights of others, the potential cost of such
litigation, regardless of the strength of our legal position, and the potential
damages that we could be required to pay could be substantial.
Our business could suffer if we lose the services of, or fail to attract, key
personnel.
- -----------------------------------------------------------------------------
We are highly dependent upon the efforts of our senior management and
scientific team, including our President and Chief Executive Officer,
Kerry Gray. The loss of the services of one or more of these individuals
could delay or prevent the achievement of our research, development,
marketing, or product commercialization objectives. While we have
employment agreements with Mr. Gray and David Nowotnik our Senior
Vice President Research and Development, their employment may be
terminated by them or us at any time. Mr. Gray's and Dr. Nowotnik's
agreements expire within one year and are extendable each year on the
anniversary date. We do not have employment contracts with our other
key personnel. We do not maintain any "key-man" insurance policies on
any of our key employees and we do not intend to obtain such insurance.
In addition, due to the specialized scientific nature of our business, we are
highly dependent upon our ability to attract and retain qualified scientific
and technical personnel. In view of the stage of our development and our
research and development programs, we have restricted our hiring to
research scientists and a small administrative staff and we have made no
investment in manufacturing, production, marketing, product sales or
regulatory compliance resources. If we develop pharmaceutical products
that we will commercialize ourselves, however, we will need to hire
additional personnel skilled in the clinical testing and regulatory
compliance process and in marketing and product sales. 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 our activities, however,
and we may be unsuccessful in attracting and retaining these personnel.
Ownership of our shares is concentrated, to some extent, in the hands of
a few investors which could limit the ability of our other stockholders to
influence the direction of the company.
- ---------------------------------------------------------------------------
Heartland Advisors, Inc. and Larry N. Feinberg (Oracle Partners LP,
Oracle Institutional Partners LP and Oracle Investment Management Inc.)
each currently beneficially own approximately 13.9% of our common
stock as of February 9, 2004. Accordingly, they collectively may have
the ability to significantly influence or determine the election of all of our
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 our other stockholders.
Provisions of our charter documents could discourage an acquisition of
our company that would benefit our stockholders and may have the effect
of entrenching, and making it difficult to remove, management.
- ------------------------------------------------------------------------
Provisions of our Certificate of Incorporation, By-laws and Stockholders
Rights Plan may make it more difficult for a third party to acquire control
of our company, even if a change in control would benefit our
stockholders. In particular, shares of our preferred stock may be issued
in the future without further
11
stockholder approval and upon such terms and conditions, and having such
rights, privileges and preferences, as our Board of Directors may determine,
including, for example, rights to convert into our common stock. The rights
of the holders of our common stock will be subject to, and may be adversely
affected by, the rights of the holders of any of our preferred stock that
may be issued in the future. The issuance of our 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 us. This could limit the price that
certain investors might be willing to pay in the future for shares of our
common stock and discourage these investors from acquiring a majority of our
common stock. Further, the existence of these corporate governance provisions
could have the effect of entrenching management and making it more
difficult to change our management.
Substantial sales of our common stock could lower our stock price.
- ------------------------------------------------------------------
The market price for our common stock could drop as a result of sales of
a large number of our presently outstanding shares. All of the 13,441,299
shares of our common stock that are outstanding as of February 9, 2004
are unrestricted and freely tradable or tradable pursuant to a resale
registration statement or under Rule 144 of the Securities Act.
We are not currently in compliance with AMEX continued listing
requirements and may not be able to maintain our AMEX listing.
- --------------------------------------------------------------
Our common stock is presently listed on the American Stock Exchange
under the symbol "AKC". All companies listed on AMEX are required to
comply with certain continued listing standards, including maintaining
stockholders' equity at required levels. We are not in compliance with this
stockholders' equity standard as of September 30, 2003. However, we
have until November 2004 to become compliant with such equity standard.
If we are unable to remedy any listing standard noncompliance with
AMEX under its regulations, or otherwise regain compliance, we cannot
assure you that our common stock will continue to remain eligible for
listing on AMEX. In the event that our common stock is delisted from
AMEX its market value and liquidity could be materially adversely
affected.
FORWARD LOOKING STATEMENTS
This prospectus contains forward-looking statements that involve risks and
uncertainties. 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 this prospectus to
conform such statements to actual results.
USE OF PROCEEDS
We will not receive any proceeds from the sale of shares by the Selling
Stockholders.
12
SELLING STOCKHOLDERS
The following table sets forth certain information regarding the beneficial
ownership of our common stock as of February 9, 2004 and as adjusted
to reflect the sale of our common stock offered hereby, by the Selling
Stockholders.
The Selling Stockholders have not had any position, office or other
material relationship within the past three years with us or our affiliates.
In addition, we believe, based on information provided to us by the
Selling Stockholders, that each of the Selling Stockholders have sole
voting and investment power with respect to the shares beneficially
owned. For more information regarding the shares offered, see "Plan of
Distribution" below.
Shares Shares to be
Beneficially Beneficially
Owned Prior Shares Owned After
Name of Selling Stockholders to Offering Offered Offering
- ---------------------------- --------------- ------------- ------------
Philip Kaltenbacher 980,000 (2) 730,000 (2) 250,000 (2)
Oracle Partners LP 1,947,500 (2) 459,000 (2) 1,488,500 (2)
GroPep Limited 65,584 (1) 65,584 (1) -
Oracle Institutional Partners 1,947,500 (2) 127,000 (2) 1,820,500 (2)
SAM Oracle Investments Inc. 1,947,500 (2) 120,000 (2) 1,827,500 (2)
Oracle Offshore Ltd. 1,947,500 (2) 24,000 (2) 1,923,500 (2)
(1) These share amounts include shares issuable upon exercise of warrants
or options.
(2) These share amounts represent shares issuable upon conversion of
convertible notes.
PLAN OF DISTRIBUTION
The Selling Stockholders may sell or distribute the Shares directly to
purchasers as principals or through one or more underwriters, brokers,
dealers or agents as follows:
* from time to time in one or more transactions, which may involve block
transactions;
* on any exchange or in the over-the-counter market;
* in transactions otherwise than in the over-the-counter market; or
* through the writing of options, whether such options are listed on an
options exchange otherwise, on or settlement of short sales of, the Shares.
Any of these transactions may be effected at market prices at the time of
sale, at prices related to such prevailing market prices, at varying prices
determined at the time of sale or at negotiated or fixed price in each case
as determined by such Selling Stockholder or by agreement between such
Selling Stockholder and underwriters, brokers, dealers or agents, or
purchasers. If a Selling Stockholder effects such transactions by selling
Shares to or through underwriters, brokers, dealers or agents, the Selling
Stockholder may compensate these underwriters, brokers, dealers or
agents in the form of discounts, concessions or commissions from the
Selling Stockholder or commissions from purchasers of securities for
whom they may act as agent. These compensatory discounts, concessions
or commissions may be in excess of those customary in the types of
transactions involved as to particular underwriters, brokers, dealers or
agents. The Selling Stockholders and any brokers, dealers or agents that
participate in the
13
distribution of the Shares may be deemed to be
underwriters, and any profit on the sale of Shares by them and any
discounts, concessions or commissions received by any of these
underwriters, brokers, dealers or agents may constitute underwriting
discounts and commissions under the Securities Act of 1933.
Under the securities laws of certain states, the Shares may be sold in such
states only through registered or licensed brokers or dealers. In addition,
in certain states the Shares may not be sold unless the Shares have been
registered or qualified for sale in such state or an exemption from
registration or qualification is available and is complied with.
We will pay all of the expenses incident to the registration, offering and
sale of the Shares to the public hereunder, estimated at $17,000, other
than commissions, fees and discounts of underwriters, brokers, dealers
and agents. Those commissions, fees and discounts, if any, will be borne
by the respective Selling Stockholder. We have agreed to indemnify each
of the Selling Stockholders and any underwriters against certain liabilities
under the Securities Act. We will not receive any of the proceeds from the
sale of any of the Shares by the Selling Stockholders.
Certain of the underwriters, dealers, brokers or agents may have other
business relationships with us and our affiliates in the ordinary course.
LEGAL MATTERS
The validity of our common stock to be sold in this offering is being
passed upon for us by Bingham McCutchen LLP, 150 Federal Street,
Boston, Massachusetts 02110. Justin P. Morreale, David L. Engel and
John J. Concannon III, partners of Bingham McCutchen LLP, beneficially
own an aggregate of 269,533 shares of our common stock. Mr.
Concannon is our corporate Secretary.
EXPERTS
Our consolidated financial statements incorporated in this Prospectus by
reference to our Annual Report on Form 10-K for the period ended
December 31, 2002 have been so incorporated in reliance on the report
of Grant Thornton LLP, independent certified public accountants, given
on the authority of said firm as experts in accounting and auditing.
WHERE YOU CAN GET MORE INFORMATION
This prospectus constitutes a part of a registration statement on Form S-3
filed by us with the Securities and Exchange Commission, or SEC, under
the Securities Act of 1933. This prospectus does not contain all of the
information set forth in the Registration Statement, since we have omitted
some parts in accordance with the SEC's rules and regulations. The SEC
permits us to "incorporate by reference" the information we file with it,
which means that we can disclose important information to you by
referring you to those documents. The information incorporated by
reference is an important part of this prospectus, and information that we
file with the SEC will automatically update and supersede this
information. Access has filed a Registration Statement on Form S-3 under
the Securities Act of 1933 with the SEC with respect to common stock
being offered pursuant to this prospectus. This prospectus omits certain
information contained in the Registration Statement on Form S-3, as
permitted by the SEC. Refer to the Registration Statement on Form S-3,
including the exhibits, for further information about Access and the
common stock being offered pursuant to this prospectus. Statements in this
prospectus regarding provisions of certain documents filed with, or
incorporated by reference in, the Registration Statement are not
necessarily complete and each statement is qualified in all respects by that
reference. Copies of all or any part of the Registration Statement,
including the documents incorporated by reference or the exhibits, may be
obtained without charge at the offices of the SEC listed below.
14
We are subject to the reporting requirements of the Securities Exchange
Act of 1934 and we therefore file annual, quarterly and special reports,
proxy statements and other information with the SEC. You may read and
copy any document we file at the public reference facilities of the SEC
located at 450 Fifth Street N.W., Washington D.C. 20549. You may
obtain information on the operation of the SEC's public reference facilities
by calling the SEC at 1-800-SEC-0330. You can also access copies of
such material electronically on the SEC's home page on the World Wide
Web at http://www.sec.gov.
If you request a copy of any or all of the documents incorporated by
reference, then we will send to you the copies you requested at no charge.
However, we will not send exhibits to such documents, unless such
exhibits are specifically incorporated by reference in such documents. We
will also provide to each person to whom a copy of this prospectus has
been delivered, upon specific request and without charge, a copy of all
documents filed from time to time by us with the SEC pursuant to the
Securities Exchange Act of 1934. You should direct a request for such
copies to Access Pharmaceuticals, Inc., 2600 Stemmons Freeway, Suite
176, Dallas, Texas 75207, attention Chief Financial Officer. You may
direct telephone requests to the Chief Financial Officer at (214) 905-5100.
CERTAIN INFORMATION WE ARE INCORPORATING BY REFERENCE
We incorporate by reference the documents listed below (SEC File
Number 001-15771) and any future filings we make with the SEC under
Section 13(a), 13(c), 14 or 15(d) of the Securities and Exchange Act of
1934:
* Our Annual Report on Form 10-K for the fiscal year ended
December 31, 2002;
* Our Quarterly Report on Form 10-Q/A for the quarter ended
September 30, 2003;
* Our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2003;
* Our Quarterly Report on Form 10-Q for the quarter ended June
30, 2003;
* Our Quarterly Report on Form 10-Q for the quarter ended March
31, 2003;
* Our Current Report on Form 8-K dated May 16, 2003;
* Our Definitive Proxy Statement filed on April 16, 2003; and
* The description of the common stock contained in our Registration
Statement (No. 333-95413) filed with the SEC under Section 12(d)
of the Securities Exchange Act including any amendment or report
filed for the purpose of updating such description.
You may request a copy of these filings at no cost, by writing,
telephoning or e-mailing us at the following address:
Access Pharmaceuticals, Inc.
2600 Stemmons Freeway, Suite 176
Dallas, Texas 75207
Attention: Chief Financial Officer
(214) 905-5100
email: akc@accesspharma.com
This prospectus is part of a Registration Statement we filed with
the SEC. You should rely only on the information incorporated by
reference or provided in this prospectus. No one else is authorized to
provide you with different information. We are not making an offer of
these securities in any state where the offer is not permitted. You
should not assume that the information in this prospectus is accurate as
of any date other than the date on the front of this document.
- -----------------------------------------------------------------------------
We have not authorized any dealer, salesperson or
other person to give any information or to make any
representations not contained in this Prospectus or any
Prospectus Supplement. You must not rely on any
unauthorized information. Neither this Prospectus nor
any Prospectus Supplement is an offer to sell or a
solicitation of an offer to buy any of these securities in
any jurisdiction where an offer or solicitation is not
permitted. No sale made pursuant to this Prospectus
shall, under any circumstances, create any implication
that there has not been any change in the affairs of
Access since the date of this Prospectus.
----------------------
TABLE OF CONTENTS
Page
------
Access Pharmaceuticals, Inc. 2
Risk Factors 2
Forward Looking Statements 11
Use of Proceeds 11
Selling Stockholders 12
Plan of Distribution 12
Legal Matters 13
Experts 13
Where Can You Get More Information 13
Certain Information We Are Incorporating
By Reference 14
- -----------------------------------------------------------------------------
1,525,584 SHARES
[ LOGO ]
Access Pharmaceuticals, Inc.
COMMON STOCK
------------
PROSPECTUS
------------
February 10, 2004
- ----------------------------------------------------------------------------
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
- -------------------------------------------------------
Estimated expenses (other than underwriting discounts and commissions)
payable in connection with the sale of our common stock offer hereby are as
follows:
SEC registration fee $ 472
Printing and engraving expenses 0
Legal fees and expenses 10,000
Accounting fees and expenses 5,000
Blue Sky fees and expenses (including legal fees) 0
Transfer agent and registrar fees and expenses 0
Miscellaneous 1,528
--------
Total $17,000
========
Item 15. Indemnification of Directors and Officers
- ---------------------------------------------------
Section 145 of the Delaware General Corporation Law (the "DGCL")
empowers a Delaware corporation to indemnify any person who was or is, or is
threatened to be made, a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative
(other than an action by or in the right of such corporation) by reason of
the fact that such person is or was a director, officer, employee or agent
of such corporation, or is or was serving at the request of such corporation
as a director, officer, employee or agent of another corporation, partnership,
joint venture, trust or other enterprise, provided that such person acted in
good faith and in a manner that such person reasonably believed to be in or
not opposed to the best interests of the corporation, and, with respect to any
criminal action or proceeding, such person had no reasonable cause to believe
his conduct was unlawful. The indemnity may include expenses (including
attorneys' fees), judgments, fines and amounts paid in settlement actually
and reasonably incurred by such person in connection with such action, suit
or proceeding. A Delaware corporation may also indemnify such persons
against expenses (including attorneys' fees) in actions brought by or in the
right of the corporation to procure a judgment in its favor, subject to the
same conditions set forth in the immediately preceding sentences, except
that no indemnification is permitted in respect of any claim, issue or matter
as to which such person shall have been adjudged to be liable to the
corporation unless and to the extent the Court of Chancery of the State of
Delaware or the court in which such action or suit was brought shall
determine upon application that, in view of all the circumstances of the
case, such person is fairly and reasonably entitled to indemnity for such
expenses as the Court of Chancery or other such court shall deem proper.
To the extent such person has been successful on the merits or otherwise in
defense of any action to above, or in defense of any claim, issue or matter
therein, the corporation must indemnify such person against expenses
(including attorneys' fees) actually and reasonably incurred by such person in
connection therewith. The indemnification and advancement of expenses provided
for in, or granted pursuant to, Section 145 is not exclusive of any other
rights to which those seeking indemnification or advancement of expenses may
be entitled under any by-law, agreement, vote of stockholders or disinterested
directors or otherwise.
Section 145 of the DGCL also provides that a corporation may maintain
insurance against liabilities for which indemnification is not expressly
provided by the statute. The Registrant is insured against liabilities
which it may incur by reason of its indemnification obligations under its
Certificate of Incorporation, Bylaws and indemnification agreements.
Article X of the Registrant's Certificate of Incorporation provides that the
Registrant will indemnify, defend and hold harmless directors, officers,
employees and agents or the Registrant to the fullest extent currently
permitted under the DGCL.
In addition, Article X of the Registrant's Certificate of Incorporation,
provides that neither the Registrant nor its stockholders may recover
monetary damages from the Registrant's directors for a breach of their
fiduciary duty in the performance of their duties as directors of the
Registrant, unless such breach relates to (i) the director's duty of loyalty,
(ii) acts or omissions not in good faith or which involve intentional
misconduct or a knowing violation of law, (iii) unlawful payments of dividends
or unlawful stock repurchases or redemptions as provided in Section 174
of the DGCL or (iv) any transactions for which the director derived an
improper personal benefit. The By-Laws of the Registrant provide for
indemnification of the Registrant's directors, officers, employees and
agents on the terms permitted under Section 145 of the DGCL described above.
The Registrant has entered into indemnification agreements with certain of its
directors and executive officers. These agreements provide rights of
indemnification to the full extent allowed and provided for by Section
145 of the DGCL and the Certificate of Incorporation and Bylaws of Access.
Item 16. Exhibits
- --------------------
Exhibit Index
-------------
Exhibit Number Description
- -------------- --------------------------------------------------------------
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)
4.1 Certificate of Incorporation (Incorporated by Reference to Exhibit 3(a)
of our Form 8-B dated July 12, 1989, Commission File Number 9-9134)
4.2 Certificate of Amendment of Certificate of Incorporation filed
August 21, 1992
4.3 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)
4.4 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)
4.5 Amended and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of
our Form 10-Q for the quarter ended June 30, 1996)
4.6 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)
4.7 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)
4.8 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)
4.9 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)
5 Opinion of Bingham McCutchen LLP
23.1 Consent of Bingham McCutchen, LLP (included in Exhibit 5.1 and
Exhibit 5.2)
23.2 Consent of Grant Thornton LLP
26 Power of Attorney (Incorporated by reference to our Registration
Statement on Form S-3, dated July 10, 2002, Commission File No. 333-92210)
Item 17. Undertakings.
- ----------------------
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made
pursuant to this Registration Statement, a post-effective amendment to this
Registration
Statement to include any material information with respect to the plan of
distribution not previously disclosed in this Registration Statement or any
material change to such information in this Registration Statement;
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed to
be a new Registration Statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the termination
of the offering.
The undersigned registrant hereby undertakes that, for purposes of determining
any liability under the Securities Act of 1933, each filing of the registrant's
annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange
Act of 1934 (and, where applicable, each filing of an employee benefit plan's
annual report pursuant to Section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall
be deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling persons of
the Registrant pursuant to the foregoing provisions described in Item 15
above, or otherwise, the Registrant has been advised that in the opinion
of the Securities and Exchange Commission such indemnification is against
public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the Registrant of expenses incurred
or paid by a director, officer or controlling person of the Registrant in
the successful defense of any action, suit or proceeding) is asserted by
such director, officer or controlling person in connection with the securities
being registered, the Registrant will, unless in the opinion of its counsel
the matter has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such indemnification by it is
against public policy as expressed in the Securities Act and will be governed
by the final adjudication of such issue.
SIGNATURES
----------
Pursuant to the requirements of the Securities Act of 1933, the Registrant
has duly caused this Registration Statement to be signed on its behalf by
the undersigned, thereunto duly authorized, in the City of Dallas, Texas,
on this 10th day of February, 2004.
ACCESS PHARMACEUTICALS, INC.
By /s/ Kerry P. Gray
----------------------
Kerry P. Gray
President and Chief Executive Officer, Director
Pursuant to the requirements of the Securities Act of 1933, the Registration
Statement has been signed by the following person in the capacities and on
the dates indicated.
Signature Title Date
- ------------------------------ ----------------------------- ---------------
/s/ Kerry P. Gray
- ------------------------
Kerry P. Gray President and Chief Executive
Officer, Director February 10, 2004
- ------------------------
Stuart M. Duty Director
/s/ Herbert H. McDade, Jr.*
- ---------------------------
Herbert H. McDade, Jr. Director February 10, 2004
/s/ J. Michael Flinn*
- ---------------------------
J. Michael Flinn Director February 10, 2004
/s/ Stephen B. Howell*
- ---------------------------
Stephen B. Howell Director February 10, 2004
/s/ Max Link*
- ---------------------------
Max Link Director February 10, 2004
/s/ John J. Meakem, Jr.*
- ---------------------------
John J. Meakem, Jr. Director February 10, 2004
/s/ Stephen B. Thompson
- ---------------------------
Stephen B. Thompson Vice President, Chief Financial
Officer, Treasurer February 10, 2004
*By: Kerry P. Gray
- ----------------------------
Kerry P. Gray
Attorney-in-Fact February 10, 2004