As Filed with the Securities and Exchange Commission on April 26, 2000
Registration No. 333-95413
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PRE-EFFECTIVE AMENDMENT NO. 1
TO FORM SB-2
ON
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
ACCESS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware 3841
(State or Other Jurisdiction (Primary Standard Industrial
of Incorporation or Organization) Classification Code Number)
83-0221517
(I.R.S. Employer
Identification No.)
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)
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 Dana LLP
150 Federal Street
Boston, MA 02110
(617) 951-8000
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 Proposed Maximum
to be Registered Amount to be Registered Offering Price Per Share (1)
- ------------------- ------------------------- ----------------------------
Common Stock $.01 2,926,083 shares (2) $3.9375
par value per share
Proposed Maximum Aggregate
Offering Price (1) Amount of Registration Fee
- -------------------------- ------------------------------
$11,521,452 $3,041.66 (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 bid and ask prices reported in the
consolidated trading system of the National Association of Securities
Dealers, Inc. Automated Quotation System Over-the-Counter Bulletin
Board on January 20, 2000.
(2) Includes 265,722 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) Previously paid.
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.
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Table of Contents
<TABLE>
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Page
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<S> <C>
Where You Can Get More Information 2
Certain Information We Are Incorporating By Reference 3
Forward Looking Statements 3
Risk Factors 4
Access Pharmaceuticals, Inc. 10
Recent Developments 10
Use of Proceeds 11
Selling Stockholders 11
Plan of Distribution 13
Legal Matters 14
Experts 14
</TABLE>
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PROSPECTUS
Access Pharmaceuticals, Inc.
Information contained in this prospectus is subject to completion or
amendment. A registration statement relating to these securities has been
filed with the Securities and Exchange Commission. These securities may not
be sold until the registration statement becomes effective. This prospectus
is not an offer to sell and is not a soliciatation of an offer to buy these
securities in any state in which an offer, solicitation or sale is not
permitted.
Subject to completion, dated April 26, 2000.
2,926,083 Shares of
Common Stock, $.01 par value
This prospectus relates to the sale of up to 2,926,083 shares of our
common stock, or the Shares, $.01 par value per share, by certain
stockholders of ours, the Selling Stockholders, for their respective accounts.
We will not receive any proceeds from the sale of the Shares by the
Selling Stockholders. None of the Shares have been registered prior to
the filing of the Registration Statement of which this Prospectus is a part.
On April 25, 2000, the last sales price of our Common Stock was, as
reported by the American Stock Exchange, or AMEX, under the symbol
AKC, $4.94 per share.
The Selling Stockholders may sell the Shares in public or private
transactions, in or off the AMEX market, at prevailing market prices,
or at privately negotiated prices. The Selling Stockholders may sell
shares directly to purchasers or through brokers or dealers. Brokers or
dealers may receive compensation in the form of discounts, concessions
or commissions from the Selling Stockholders. For more information,
see "Plan of Distribution."
Investing in the common stock involves risks. For a discussion of
certain factors you should consider, see "Risk Factors" beginning on Page 4.
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 ___________, 2000
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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.
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
Frwy, Suite 176, Dallas, Texas 75207, attention Chief Financial Officer.
You may direct telephone requests to the Chief Financial Officer at (214)
905-5100.
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CERTAIN INFORMATION WE ARE INCORPORATING BY REFERENCE
We incorporate by reference the documents listed below 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:
* Annual Report on Form 10-K for the fiscal year ended December 31, 1999;
* Registration Statement on Form 8-A filed on March 29, 2000;
* The description of the common stock contained in Access'
Registration Statement 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: [email protected]
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.
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," "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.
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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.
We have recorded minimal revenue to date and we have incurred a
cumulative operating loss of approximately $26.5 million through
December 31, 1999. Our losses have resulted principally from costs
incurred in research and development activities related to our efforts to
develop target 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 substantially
due to expanded research and development efforts and preclinical and
clinical trials.
We do not have significant operating revenue and we may never attain
profitability.
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 our
amlexanox products 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, market and obtain required regulatory approvals for
any additional products. Moreover, even if we do identify, develop,
commercialize, patent, manufacture, market and obtain required
regulatory approvals for 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 any amounts that we receive under strategic partnerships and research
or drug development collaborations that we may establish and we cannot
assure you that we will be able to establish any such relationships on
terms acceptable to us. We cannot assure you that we will achieve or
maintain profitability in the future and our failure to receive significant
revenues or to achieve profitable operations would impair our ability to
sustain operations.
We may not successfully commercialize our drug candidates.
Our drug candidates are subject to the risks of failure inherent in the
development of pharmaceutical products based on new technologies.
These risks include the possibilities that some or all of our drug
candidates will be found to be unsafe or ineffective or otherwise fail to
meet applicable regulatory standards or receive necessary regulatory
clearances; that these drug candidates, if safe and effective will be
difficult to develop into commercially viable drugs or to manufacture on
a large scale or will be uneconomical to market; that proprietary rights
of third parties will preclude us from marketing such drugs; or that third
parties will market superior or equivalent drugs. Our failure to develop
safe, commercially viable drugs would have a material adverse effect on
our business, operating results and financial condition.
The success of our research and development activities, upon which we
primarily focus, is uncertain.
Our primary focus is on our research and development activities and the
commercialization of compounds covered by proprietary
biopharmaceutical patents. 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 the 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.
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We may be unable to obtain necessary additional capital to fund
operations in the future.
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 and revenue from possible
licensing agreements and collaborative agreements will be sufficient to
fund our currently expected operating expenses and capital requirements
for up to three years, we may need to raise substantial additional capital
during that period 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 and
collaboration programs, the timing and results of preclinical trials, our
ability to maintain existing and establish new collaborative agreements
with other companies to provide funding to us, the technological
advances and activities of competitors and other factors. We intend to
seek additional funding through additional equity offerings or
collaborative or other arrangements with corporate partners. We cannot
assure you, however, that any such equity offerings will occur, or that
additional financing will be available from any of these sources or, if
available, will be available on acceptable or affordable terms. If we do
raise additional funds by issuing equity securities, further dilution to
existing stockholders may result and future investors may be granted
rights superior to those of existing stockholders. Alternatively, we may
seek to raise additional funds through borrowing. As a non-revenue
producing company, however, we are unable to obtain standard credit
arrangements, and it is therefore likely that if we were to raise additional
funds through borrowing, we would be forced to accept unfavorable
terms. Furthermore, there can be no assurance that any credit
arrangement would be available at all. If adequate funds are not available
to us through additional equity offerings or borrowing, 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.
The success of our business may depend, in part, upon relationships with
other companies.
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 or license
agreements as we may deem necessary to develop and commercialize our
potential pharmaceutical products on acceptable terms, and our
collaborative arrangements or license agreements may be unsuccessful.
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.
We may depend upon contract manufacturers to assist us with the
commercialization of any new products that we may develop.
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 may develop,
so we 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
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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 U.S. Food and
Drug Administration, or 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.
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.
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. We cannot assure 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. We cannot assure you that the FDA or
other regulatory approvals for any drug candidates will be granted 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 initial
regulatory approvals for our drug candidates are obtained, we, or 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 regulatory standards are
applied stringently by the FDA and other regulatory authorities and
failure to comply can, among other things, result in fines, denial or
withdrawal of regulatory approvals, product recalls or seizures,
operating restrictions and criminal prosecution.
Our ability to successfully commercialize new products will be subject
to the uncertainty associated with preclinical and clinical testing.
Before obtaining 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. We cannot assure you that preclinical or clinical trials of any
future drug candidates will 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
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.
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 and could cause our business, operating results and
financial condition to suffer.
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We may incur substantial product liability expenses due to the use or
misuse of our products for which we may be unable to obtain complete
insurance coverage.
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 have product liability insurance for drug
candidates that are undergoing human clinical trials. Product liability
insurance for the biotechnology industry is generally expensive,
however, if available at all, and we cannot assure you that in the future
we will be able to obtain insurance coverage at acceptable costs or in a
sufficient amount, 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.
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. In addition, although we believe that we are in compliance
in all material respects with applicable environmental laws and
regulations and currently do not expect to make material capital
expenditures for environmental control facilities in the near-term, we
cannot assure you that we will not be required to incur significant costs
to comply with environmental laws and regulations in the future, or that
our operations, business or assets will not be materially adversely
affected by current or future environmental laws or regulations.
Intense competition may limit our ability to successfully develop and
market commercial products.
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. 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. We cannot assure
you that our competitors will not succeed in developing technologies and
drugs that are more effective or less costly than any which are being
developed by us or which would render our technology and future
products obsolete and noncompetitive.
In addition, some of our competitors have greater experience than us 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 us. 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. We cannot assure you that drugs resulting from our research
and development efforts or from our joint efforts with collaborative
partners will be able to compete successfully with our competitors'
existing products or products under development.
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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.
The successful commercialization of, and the interest of potential
collaborative partners to invest in, the development of our drug
candidates will depend substantially on 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. We cannot assure
you that reimbursement in the United States or elsewhere will be
available for any drugs that we may develop or, if available, will not be
decreased in the future, or that reimbursement amounts will not reduce
the demand for, or the price of, our drugs, thereby adversely affecting
our business. If reimbursement is not available or is available only to
limited levels, we cannot assure you that we will be able to obtain
collaborative partners to commercialize our drugs, or be able to obtain
a sufficient financial return on our own manufacture and
commercialization of any future drugs.
Any pharmaceutical products that we successfully develop may not be
accepted by the market.
The drugs that we are attempting to develop will 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.
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.
* 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. Although Access is either the owner or licensee
of technology to 13 U.S. patents and to 7 U.S. patent applications now
pending, we cannot assure you that any additional patents will issue from
any of the patent applications owned by, or licensed to, us.
Furthermore, we cannot assure you that any rights we may have under
issued patents will provide us with significant protection against
competitive products or otherwise be commercially viable. 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
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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. 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. The
loss of the services of one or more of these individuals could seriously
impede our success. 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 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 individual investors.
Howard P. Milstein and Richard Stone currently beneficially own
approximately 6.5% and 5.7% respectively, of our issued and
outstanding common stock. Mr. Milstein and Mr. Stone have signed
lock-up agreements for 71,922 and 81,877 shares, respectively, and have
agreed not to sell any of these shares of our common stock until July 20,
2000. The remainder of their shares are subject to Rule 144.
Provisions of our charter documents could discourage an acquisition of
our company that would benefit our stockholders.
Provisions of our Certificate of Incorporation and By-laws may make it
more difficult for a third party to acquire control of our company, even
if a change of in control would benefit our stockholders. In particular,
shares of our 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 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.
9
<PAGE>
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. Currently, a
significant percentage of the outstanding shares of our common stock are
unrestricted and freely tradable or tradable under Rule 144.
Shareholders holding approximately 650,000 shares of our common stock
will become eligible to sell such shares on January 11, 2001 and
additional shareholders holding approximately 533,000 shares of our
common stock will become eligible to sell such shares on July 20, 2000.
ACCESS PHARMACEUTICALS, INC.
Access Pharmaceuticals is a Delaware corporation in the development
stage. We are an emerging pharmaceutical company focused on
developing both novel low development risk product candidates and
technologies with longer-term major product opportunities. We have
proprietary patents or rights to five technology platforms: synthetic
polymers, bioerodible hydrogels, Residerm TM, carbohydrate targeting
technology, and agents for the prevention and treatment of viral disease,
including HIV. In addition, our partner Block Drug Company, or
Block, is marketing in the United States Aphthasol TM, the first FDA-
approved product for the treatment of canker sores. We are developing
new formulations and delivery forms to evaluate this product in
additional clinical indications. We have licensed the rights to amlexanox
for the treatment of canker sores from Block for certain countries
excluding the U.S. and the worldwide rights for certain additional
indications including mucositis and oral diseases.
Access was founded in 1974 as Chemex Corporation, a Wyoming
corporation, and in 1983 changed its name to Chemex Pharmaceuticals,
Inc. Chemex changed its state of incorporation from Wyoming to
Delaware on June 30, 1989. In connection with the merger of Access
Pharmaceuticals, Inc., a Texas corporation, with and into Chemex on
January 25, 1996, we changed our name to Access Pharmaceuticals, Inc.
Our principal executive office is at 2600 Stemmons Freeway, Suite 176,
Dallas, Texas 75207; our telephone number is (214) 905-5100.
RECENT DEVELOPMENTS
On March 28, 2000, our application for listing on the American Stock
Exchange, or AMEX was approved and we began trading on AMEX on
March 30, 2000 under the symbol AKC.
On March 1, 2000, with the assistance of an investment bank, we
completed the closing of a private offering, receiving gross proceeds of
$12.0 million, less issuance costs of approximately $89,500, at a per
share price of $2.50, from the private placement of 4,800,000 shares of
common stock. The placement agent for the offering received warrants
to purchase 459,806 shares of common stock at $2.50 per share, in
accordance with the offering terms and elected to receive approximately
520,000 shares of common stock in lieu of certain sales commissions and
expenses.
On February 25, 2000, we signed licensing agreements granting
Mipharm S.p.A. marketing and manufacturing rights for amlexanox for
numerous indications including the prevention and treatment of canker
sores and mucositis, oral lichen planus and atopic dermatitis. These
agreements cover Italy, Switzerland, Turkey and Lebanon. Under the
terms of these agreements, Mipharm will make an equity investment in
us, pay upfront licensing fees, make milestone payments and we will
receive a percentage of the product sales made in the territory. Mipharm
will have the option to license other product developments in the fields
of dermatology and gynecology in the territory.
On July 20, 1999, Access Holdings, a Delaware corporation and our
wholly-owned subsidiary, merged with and into Virologix Corporation,
a privately held Delaware corporation focused on the development of
product candidates for the prevention and treatment of viral diseases,
including HIV. Upon the consummation of the merger, the separate
existence of Access Holdings ceased, Virologix became our wholly-
owned subsidiary and each outstanding share of Virologix' common
stock was converted into 0.231047 shares of our common stock,
representing 999,963 shares of our common stock.
10
<PAGE>
USE OF PROCEEDS
We will not receive any proceeds from the sale of shares by the Selling
Shareholders.
SELLING STOCKHOLDERS
The following table sets forth certain information regarding the
beneficial ownership of our common stock as of April 25, 2000 and as
adjusted to reflect the sale of our common stock offered hereby, by each
of the Selling Stockholders.
Except as indicated below, none of the Selling Stockholders has had any
position, office or other material relationship within the past three years
with us or our affiliates. In addition, except as provided herein, we
believe, based on information provided to us by the Selling
Shareholders, that each Selling Stockholder has sole voting and
investment power with respect to the shares beneficially owned. For
more information regarding the shares offered, see "Plan of
Distribution" below.
<TABLE>
<CAPTION>
Shares Shares to be
Beneficially Beneficially
Owned Prior Shares Owned After
Name of Selling Stockholder to Offering Offered Offering
- --------------------------------- ----------- ------- ------------
<S> <C> <C> <C>
Gary & Barbara Allie 4,158 4,158 -
Alfred J. Anzalone Family Limited
Partnership 51,232 (1) 12,476 1,732 (2)
Alvin H. Einbender Revocable Trust 50,000 50,000 -
Amore Perpetuo, Trust 51,232 (1) 8,317 1,732 (2)
Anzalone 1995 Trust 51,232 (1) 20,794 1,732 (2)
Anzalone Family Limited
Partnership - dated 12/30/93 51,232 (1) 7,913 1,732 (2)
David P. & Meredith C. Ash 142,610 (1) 84,524 58,086 (2)
Benjamin J. Jesselson Trust 150,000 75,000 -
David Bartash 21,666 (1) 5,000 (2) 16,666 (1)
Ari Blech 13,500 13,500 -
Benjamin Blech 25,500 25,500 -
Harry Blumenthal 33,317 8,317 25,000
Douglas C. Carroll 1,039 1,039 -
James Carson 4,158 4,158 -
Central Yeshiva Beth Joseph 266,098 (1) 99,431 166,667 (1)
Chelsey Capital 1,039 1,039 -
Frank Chiarulli 1,039 1,039 -
Peter & Nancy Chidyllo 6,430 (1) 5,275 1,155 (2)
Judson Cooper 87,183 75,631 -
Charles J. Corbin (deceased)
Estate of Charles Corbin Sandy
Kay Yanes Administrator 1,039 1,039 -
Curran Partners LP 100,000 100,000 -
Dalton Kent Securities Group Inc. 4,000 (2) 4,000 (2) -
De Gucht Eduard 50,000 50,000 -
Richard H. Dolan & Marilyn D. Go 67,500 30,000 -
Dr. Daniel Fish 6,238 6,238 -
Howard E. Freidman 12,000 12,000 -
John Gallagher 10,491 (1) 10,491 (1) -
Genevieve Go 67,500 15,000 -
Kenneth D. Gold, MD 519 519 -
11
<PAGE>
Herbert L. & Marlene C. Goldblatt 519 519 -
Gross Foundation 215,392 (1) 127,725 87,667 (1)
William W. Hall 49,675 49,675 -
Gabriel B. & Ellen G. Herman 519 519 -
Jerry Heymann 28,664 8,664 20,000
Thomas Hudak 96,162 (1) 27,186 68,976 (1)
Marc Hurwitz 8,317 8,317 -
Eli Jacobson 42,545 25,545 17,000
Michael G. Jesselson 150,000 75,000 -
David Kaufman 11,552 11,552 -
Gary Kaufman 1,039 1,039 -
Eugene J. Keilen and Joanne Witty 50,000 50,000 -
Thomas Lanier 415 415 -
Lisa Low as Custodian for
Chantal Low 287,442 (1) 100,000 96,949 (1)
Nathan Low 287,442 (1) 36,823 96,949 (1)
Nathan A. Low Roth IRA 287,442 (1) 53,670 (2) 96,949 (1)
Donald J. McCarren 13,282 3,181 10,101
David J. McCooey 1,039 1,039 -
Jeffrey Markowitz 1,039 1,039 -
Gary Mendel 12,158 4,158 8,000
Maryann Michelizzi 3,465 3,465 -
Dwight Miller 5,000 (2) 5,000 (2) -
Larry Miller 125,000 125,000 -
Albert Milstein 1,039 1,039 -
Howard P. Milstein (3) 750,140 (1) 571,922 178,218 (1)
Denis J. Nayden 91,619 (1) 24,953 66,666 (1)
Steven Oliveira 90,974 90,974 -
Barton & Alice Peck 1,039 1,039 -
Robert R. Praschil, Jr. 1,039 1,039 -
Prism Ventures 262,814 11,552 -
Yaron Z. Reich 29,158 29,158 -
Robert Rickel 9,010 9,010 -
David Rozen 38,317 8,317 30,000
Joshua D. Schein 94,683 83,131 -
Schlam, Stone, Dolan, FBO
Richard Dolan 67,500 22,500 -
Lee Schlesinger 25,000 25,000 -
Marc Seelenfreund 6,250 (2) 6,250 (2) -
Jane Shoup 25,316 4,158 17,000
Stefan Shoup 25,316 4,158 17,000
Martin Sirotkin 8,317 8,317 -
Paul Sirotkin 8,317 8,317 -
Beverly Smith 3,465 3,465 -
Howard L. Spitz 623 623 -
Glen S. Stanley 1,039 1,039 -
Joseph L. Stanley 2,078 1,039 -
Rita M. Stanley 2,078 1,039 -
Stuart G. Stanley 1,039 1,039 -
David Stone 80,528 13,862 66,666
Richard B. Stone (3) 660,205 (1) 438,328 (1) 281,211 (1)
Hidshiro Takahashi 20,794 20,794 -
William Teate 7,079 2,079 5,000
12
<PAGE>
Preston Tsao (3) 26,325 (2) 15,310 (2) 11,015 (2)
Charles S. Whitman III 12,500 12,500 -
Winston IPO Investments 8,317 8,317 -
Wolfe Axelrod Associates 100,000 (2) 100,000 (2) -
Hersz Zukier 3,119 3,119 -
</TABLE>
(1) These share amounts include shares issuable upon exercise of
warrants.
(2) These share amounts represent shares issuable upon exercise of
warrants.
(3) Each of Messrs. Milstein, Stone and Tsao is one of our Directors.
Messrs. Stone and Tsao are also directors of Sunrise Securities
Corporation which acted as placement agent for our private placement
sales of our common stock in 2000, 1999 and 1998.
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 or otherwise, on, or settlement of short sales of, the
Shares.
Any of these transactions may be effected at market prices prevailing 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
prices in each case as determined by the Selling Stockholder or by
agreement between the Selling Stockholder and underwriters, brokers,
dealers or agents, or purchasers. If the Selling Stockholders effect such
transactions by selling Shares to or through underwriters, brokers,
dealers or agents, the Selling Stockholders may compensate these
underwriters, brokers, dealers or agents in the form of discounts,
concessions or commissions from the Selling Stockholders 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
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 $30,000, other
than commissions, fees and discounts of underwriters, brokers, dealers
and agents. Those commissions, fees and discounts, if any, will be borne
by the Selling Stockholder. We have agreed to indemnify 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.
13
<PAGE>
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 Dana LLP 150 Federal Street, Boston,
Massachusetts 02110. Justin P. Morreale, David L. Engel and John J.
Concannon III, partners of Bingham Dana LLP, beneficially own an
aggregate of 49,165 shares of our common stock and warrants to purchase
834 shares of our common stock. Mr. Concannon is the corporate Secretary.
EXPERTS
Our consolidated financial statements incorporated in this Prospectus by
reference to our Annual Report on Form 10-K for the two year period
ended December 31, 1999 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.
The consolidated statements of operations, stockholders' equity (deficit)
and cash flows of Access Pharmaceuticals, Inc. and subsidiary as
of and for the year ended December 31, 1997, have been incorporated by
reference herein and in the registration statement in reliance upon
the report of KPMG LLP, independent certified public accountants, incorporated
by reference herein, and upon the authority of said firm as experts in
accounting and auditing.
KPMG LLP's independent auditors' report on the consolidated statements of
operations, stockholders' equity (deficit) and cash flows of Access
Pharmaceuticals, Inc. and subsidiary for the year ended December 31, 1997,
contained a separate paragraph stating that "the Company has suffered
recurring losses from operations and has a net capital deficiency that raise
substantial doubt about its ability to continue as a going concern.
Management's plans in regard to these matters are also described in the notes
to the 1997 consolidated financial statements. The consolidated financial
statements do not include any adjustments that might result from the outcome
of this uncertainty."
The cumulative statements of operations, stockholders' equity (deficit)
and cash flows for the period February 24, 1988 (inception) to
December 31, 1994 incorporated in this prospectus by reference to our
Annual Report on Form 10-K have been so incorporated in reliance on the report
of Smith, Anglin & Co., independent certified public accountants, given on the
authority of said firm as experts in accounting and auditing.
14
<PAGE>
- ----------------------------------------------------------------------
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
<TABLE>
<CAPTION>
Page
------
<S> <C>
Where You Can Get More Information 2
Certain Information We Are Incorporating
By Reference 3
Forward Looking Statements 3
Risk Factors 4
Access Pharmaceuticals, Inc. 10
Recent Developments 10
Use of Proceeds 11
Selling Stockholders 11
Plan of Distribution 13
Legal Matters 14
Experts 14
</TABLE>
2,926,083 SHARES
[ LOGO ]
Access Pharmaceuticals, Inc.
COMMON STOCK
PROSPECTUS
________, 2000
<PAGE>
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:
<TABLE>
<S> <C>
SEC registration fee $ 3,042
Printing and engraving expenses 500
Legal fees and expenses 10,000
Accounting fees and expenses 5,000
Blue Sky fees and expenses (including legal fees) 1,000
Transfer agent and registrar fees and expenses 0
Miscellaneous 10,458
--------
Total $30,000
========
</TABLE>
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.
II-1
<PAGE>
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 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 of Merger and Plan of Reorganization, dated May 23,
1997 among us, Access Holdings, Inc and Tacora Corporation
(Incorporated by reference to Exhibit 10.11 of the Company's Form 10-
K for the year ended December 31, 1997)
2.3 Agreement of Merger and Plan of Reorganization, dated as of
February 23, 1999 among us, Access Holdings, Inc. and Virologix
Corporation (Incorporated by reference to Exhibit 2.2 of the Company's
Form 8-K filed on August 3, 1999)
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 Amended and Restated Bylaws (Incorporated by reference to
Exhibit 3.1 of our Form 10-Q for the quarter ended June 30, 1996)
3.6 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)
3.7 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)
5.1 Opinion of Bingham Dana, LLP, previously filed
23.0 Consent of Experts and Counsel
23(a) Consent of Bingham Dana LLP (included in Exhibit 5.1)
23(b) Consent of Grant Thornton LLP
23(c) Consent of KPMG LLP
23(d) Consent of Smith, Anglin & Co.
26 Power of Attorney (For information, see II-4)
II-2
<PAGE>
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.
II-3
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
Registrant has duly caused this Pre-Effective Amendment No. 1 of this
Registration Statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Dallas, Texas, on this 26th day
of April, 2000.
ACCESS PHARMACEUTICALS, INC.
By /s/ Kerry P. Gray
-------------------------
Kerry P. Gray
President and Chief Executive Officer, Director
POWER OF ATTORNEY AND SIGNATURES
Each person whose signature appears below hereby constitutes and
appoints Kerry P. Gray, as his attorney-in-fact and agent, with full
power of substitution and resubstitution, for him and in his name, place
and stead, in any and all capacities, (i) to sign any and all amendments
(including post-effective amendments) to this Registration Statement, (ii)
to sign any registration statement to be filed pursuant to Rule 462(b)
under the Securities Act of 1933 for the purpose of registering additional
shares of Common Stock for the same offering covered by this
Registration Statement, and (iii) to file any of the same, with all exhibits
thereto, and other documents in connection therewith, with the Securities
and Exchange Commission, granting unto said attorneys-in-fact and
agents, and each of them, full power and authority to do and perform
each and every act and thing requisite and necessary to be done in and
about the premises, as fully to all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents or any of them, or their or his substitute or
substitutes, may lawfully do or cause to be done by virtue thereof.
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.
<TABLE>
<CAPTION>
Signature Title Date
- ----------------------- -------------------------------- --------------
<S> <C> <C>
/s/ Kerry P. Gray
- ----------------------
Kerry P. Gray President and Chief Executive April 26, 2000
Officer, Director
*
- ----------------------
Herbert H. McDade, Jr. Director April 26, 2000
*
- ----------------------
J. Michael Flinn Director April 26, 2000
*
- ----------------------
Stephen B. Howell Director April 26, 2000
*
- ----------------------
Max Link Director April 26, 2000
*
- ----------------------
Howard P. Milstein Director April 26, 2000
*
- ----------------------
Richard Stone Director April 26, 2000
*
- ----------------------
Preston Tsao Director April 26, 2000
/s/ Stephen B. Thompson
- ------------------------
Stephen B. Thompson Vice President, April 26, 2000
Chief Financial Officer,
Treasurer
/s/ Kerry P. Gray
- ----------------------
* Attorney In Fact April 26, 2000
</TABLE>
II-4
EXHIBIT 23(b)
Consent of Independent Certified Public Accountants
The Board of Directors of
Access Pharmaceuticals, Inc.
We have issued our report dated March 3, 2000 accompanying the consolidated
financial statements of Access Pharmaceuticals, Inc. and subsidiaries
appearing in the 1999 Annual Report of the Company on Form 10-K
for the year ended December 31, 1999, which is incorporated by reference
in this Registration Statement. We consent to the incorporation by reference
in the Registration Statement of the aforementioned report and to the use
of our name as it appears under the caption "Experts".
/s/ Grant Thornton LLP
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GRANT THORNTON LLP
Dallas, Texas
April 26, 2000
EXHIBIT 23(c)
Independent Auditors' Consent
The Board of Directors of
Access Pharmaceuticals, Inc.
We consent to the use of our report incorporated herein by reference
and to the reference to our firm under the heading "Experts" in the prospectus.
Our report dated March 24, 1998 contains an explanatory paragraph that
states that the Company has suffered recurring losses from operations
and has a net capital deficiency, which raise substantial doubt about its
ability to continue as a going concern. The consolidated financial
statements do not include any adjustments that might result from the
outcome of that uncertainty.
/s/ KPMG LLP
- -------------
KPMG LLP
Dallas, Texas
April 26, 2000
EXHIBIT 23(d)
Consent of Independent Auditors
The Board of Directors
Access Pharmaceuticals, Inc.
We hereby consent to the incorporation by reference in this Pre-Effective
Amendment No. 1 To Form SB-2 of this Registration Statement on Form
S-3 to register 2,926,083 share of common stock of our report dated
September 21, 1995, relating to the consolidated financial statements,
which appear in the Access Pharmaceuticals, Inc. Annual Report on
Form 10-K for the year ended December 31, 1999. We also consent to
the reference to us under the heading "Experts" in the prospectus.
/s/ Smith Anglin & Co.
- ----------------------
Smith Anglin & Co.
Dallas, Texas
April 26, 2000
