Filed pursuant to Rule 424 (b) (1)
Registration No. 333-52030
934,605 SHARES
[ LOGO ]
Access Pharmaceuticlas, Inc.
COMMON STOCK
PROSPECTUS
January 26, 2001
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 solicitation of an offer to
buy these securities in any state in which an offer, solicitation or sale is
not permitted.
Subject to completion, January 16, 2001.
934,605 Shares of
Common Stock, $.01 par value
This prospectus relates to the sale of up to 934,605 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 January 25, 2001, the last sale price of our Common Stock was $6.25 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
factors you should consider, see "Risk Factors" beginning on Page 2.
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 January 26, 2001
Table of Contents
Page
------
Risk Factors 2
Forward Looking Statements 8
Access Pharmaceuticals, Inc. 8
Recent Developments 8
Use of Proceeds 8
Selling Stockholders 9
Plan of Distribution 9
Legal Matters 10
Experts 10
Where You Can Get More Information 11
Certain Information We Are Incorporating By Reference 12
1
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 $30.3 million through September 30,
2000. 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 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.
2
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 approximately
four 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.
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. 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.
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 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
3
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 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. 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 we obtain initial regulatory
approvals for our drug candidates, 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 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.
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. 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.
4
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.
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 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. 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.
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 upon reimbursement of the costs of the
resulting drugs and related treatments at acceptable
levels from government authorities, private health
5
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.
The market may not accept any pharmaceutical products
that we successfully develop.
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 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
6
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 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 individual investors.
Larry N. Feinberg (Oracle Partners LP, Oracle
Institutional Partners LP and Oracle Investment
Management Inc.), Richard Stone and Howard P.
Milstein currently beneficially own approximately
7.8%, 6.2% and 5.8% respectively, of our issued and
outstanding common stock.
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.
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 560,000 shares of our common stock
became eligible to sell such shares on January
11, 2001. Upon the effectiveness of this registration
statement an additional 324,761 shares of our common
stock will be eligible to be sold.
7
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
compatible terminology. These statements are only predictions
and involve known and unknown risks, uncertainties and other
factors, including 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 of 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 forward-looking statements
after the date of this prospectus to conform such statements
to actual results.
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, ResidermTM,
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 November 30, 2000, we announced the results of a
Phase IV European clinical study evaluating
amlexanox 5% paste for the prevention of aphthous
ulcers (canker sores). Amlexanox 5% paste was
effective in preventing the formation of an ulcer
when used at the first sign or symptom of the
disease.
USE OF PROCEEDS
We will not receive any proceeds from the sale of
shares by the Selling Stockholders.
8
SELLING STOCKHOLDERS
The following table sets forth certain information
regarding the beneficial ownership of our common
stock as of January 16, 2001 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 Stockholders, 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.
Shares Shares to be
Beneficially Beneficially
Owned Prior Shares Owned After
Name of Selling Stockholder to Offering Offered Offering
- ----------------------------- ------------ ------------ ------------
Christine Ferer (3) 750,140 (1) 83,333 666,807 (1)
Lloyd Constantine (3) 750,140 (1) 25,000 725,140 (1)
F. Joseph Daugherty 12,426 5,250 7,176
GHK Associates 250,000 21,000 229,000
Joseph M. Hiffa (4) 800 800 -
Philip D. Kaltenbacher 250,000 208,000 42,000
LDR Associates 250,000 21,000 229,000
David A. Loewenstein 20,000 20,000 -
Medical Innovation Fund II 37,607 37,607 -
Edward L. Milstein (3) 750,140 (1) 185,544 564,593 (1)
Daniel Myers 2,224 (2) 2,224 (2) - (2)
Panetta Partners, Ltd. 36,000 36,000 -
Marcia Riklis (3) 750,140 (1) 125,000 625,140 (1)
Linda Sincavage (3) 750,140 (1) 5,000 745,140 (1)
Eleanore Sniderman (3) 750,140 (1) 62,500 687,640 (1)
Marvin Sniderman (3) 750,140 (1) 66,667 683,473 (1)
Preston Tsao 93,552 (1) 29,680 (2) 63,872 (1)
(1) These share amounts include shares issuable
upon exercise of warrants.
(2) These share amounts represent shares issuable
upon exercise of warrants.
(3) These stockholders have entered into an
agreement with Howard P. Milstein and among
themselves that provides Mr. Milstein with sole
voting power and dispositive power with regard to
all of the shares of Common Stock.
(4) Mr. Hiffa is an attorney at Bingham Dana LLP. The
validity of our common stock to be sold in this
offering is being passed on for us by Bingham Dana LLP.
PLAN OF DISTRIBUTION
The Selling Stockholders may sell or distribute the
Shares directly to purchasers as principles 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;
9
* 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 the
Selling Stockholder or by agreement between the
Selling Stockholder and underwriters, brokers,
dealers or agents, or purchasers. If the Selling
Stockholder 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 $18,000, 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.
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, and Joseph M. Hiffa, an attorney
at Bingham Dana, LLP, beneficially own an aggregate of
182,299 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 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.
10
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.
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 supercede 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 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 therfore 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 special 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.
11
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;
* Quarterly Report on Form 10-Q for the quarter ended March 31, 2000;
* Quarterly Report on Form 10-Q for the quarter ended June 30, 2000;
* Quarterly Report on Form 10-Q for the quarter ended September 30, 2000;
and
* The description of the common stock contained in Access' 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) 904-5100
email: axcs@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.
12
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
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Risk Factors . . . . . . . . . . . . . . 2
Forward Looking Statements . . . . . . . . . . 8
Access Pharmaceuticals, Inc.. . . . . . . . . . 8
Recent Developments . . . . . . . . . . . . . . 8
Use of Proceeds . . . . . . . . . . . . . . . . 8
Selling Stockholders. . . . . . . . . . . . . . 9
Plan of Distribution. . . . . . . . . . . . . . 9
Legal Matters . . . . . . . . . . . . . . 10
Experts . . . . . . . . . . . . . . 10
Where You Can Get More Information . . . . . . 11
Certain Information We ARe Incorporating
By Reference . . . . . . . . . . . . . . . . 12