AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON DECEMBER 5, 2000
REGISTRATION NO. 333-
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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TITAN PHARMACEUTICALS, INC.
(Exact name of Issuer as specified in its charter)
DELAWARE 2836 94-3171940
(State or other jurisdiction (Primary standard (I.R.S. employer
of industrial identification number)
incorporation classification code number)
400 OYSTER POINT BLVD. SOUTH SAN FRANCISCO, CALIFORNIA 94080
(650) 244-4990
(Address and telephone number of principal executive offices and principal place
of business)
LOUIS R. BUCALO, M.D., CHAIRMAN,
PRESIDENT AND CHIEF EXECUTIVE OFFICER
TITAN PHARMACEUTICALS, INC.
400 OYSTER POINT BLVD.
SOUTH SAN FRANCISCO, CALIFORNIA 94080
(650) 244-4990
(Name, address and telephone number of agent for service)
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COPIES TO:
FRAN STOLLER, ESQ.
Loeb & Loeb LLP
345 Park Avenue
New York, New York 10154
(212) 407-4000
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APPROXIMATE DATE OF PROPOSED SALE TO THE PUBLIC:
AS SOON AS PRACTICABLE AFTER THIS REGISTRATION STATEMENT BECOMES EFFECTIVE.
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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, please check the following box. / /
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, check the following box and list the Securities Act
registration statement number of the earlier registration statement for the same
offering. / /
If the delivery of the prospectus is expected to be made pursuant to
Rule 434, please check the following box. / /
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CALCULATION OF REGISTRATION FEE UNDER THE SECURITIES ACT OF 1933
PROPOSED MAXIMUM PROPOSED MAXIMUM
TITLE OF EACH CLASS OF AMOUNT TO AGGREGATE PRICE PER AGGREGATE OFFERING AMOUNT OF
SECURITIES TO BE REGISTERED BE REGISTERED SECURITY(1) PRICE REGISTRATION FEE
Common Stock.................. 1,200,000 $34 $40,800,000 $10,771
(1) Estimated in accordance with Rule 457(c) solely for the purpose of
calculating the registration fee. The price shown is the average of the high
and low price of the Common Stock on November 30, 2000 as reported by the
American Stock Exchange.
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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 SAID SECTION 8(a),
MAY DETERMINE.
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SUBJECT TO COMPLETION DATED DECEMBER 5, 2000
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE MAY
NOT SELL THESE SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER
TO SELL THESE SECURITIES AND IT IS NOT SOLICITING AN OFFER TO BUY THESE
SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
PROSPECTUS
1,2000,000 SHARES
TITAN PHARMACEUTICALS, INC.
COMMON STOCK
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Selling stockholders named in this prospectus are offering all of the shares
to be sold in this offering. We will not receive any of the proceeds from the
sale of the shares.
Our common stock is traded on the American Stock Exchange under the symbol
TTP. On December , 2000, the closing price of the common stock was $ .
AN INVESTMENT IN OUR SECURITIES INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" BEGINNING ON PAGE 5.
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NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED 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
PROSPECTUS SUMMARY
THIS SUMMARY HIGHLIGHTS INFORMATION CONTAINED ELSEWHERE IN THIS PROSPECTUS
OR INCORPORATED BY REFERENCE HEREIN. IT IS NOT COMPLETE AND MAY NOT CONTAIN ALL
OF THE INFORMATION THAT YOU SHOULD CONSIDER BEFORE INVESTING IN OUR SECURITIES.
YOU SHOULD READ THE ENTIRE PROSPECTUS CAREFULLY, INCLUDING THE "RISK FACTORS"
SECTION, AND THE FINANCIAL STATEMENTS AND RELATED NOTES WHICH ARE INCORPORATED
BY REFERENCE HEREIN.
OUR COMPANY
We are a biopharmaceutical company developing proprietary therapeutics for
the treatment of central nervous system disorders and cancer. We currently have
nine products in development, with seven products in clinical development
including two products in expanded human trials for safety and efficacy, known
as Phase III clinical trials. We also have five products in trials for
preliminary efficacy and dosing and in trials for initial human safety and
evidence of efficacy, known as Phase II and Phase I/II clinical trials,
respectively. In addition to these programs, we have two products in preclinical
development. We are independently developing our product candidates as well as
utilizing strategic partnerships, including collaborations with Novartis Pharma
AG and Schering AG. These collaborations help fund product development and
enable us to retain significant economic interest in our products.
OUR CLINICAL DEVELOPMENT PROGRAMS
ZOMARIL--SCHIZOPHRENIA
Our lead product candidate, Zomaril, is being developed for the treatment of
schizophrenia, the most common form of psychosis. Approximately 2.5 million
people in the U.S. are afflicted with the disease, and in 1999, drug therapy for
schizophrenia totaled over $4.0 billion in sales worldwide. While efficacious in
reducing psychotic symptoms and allowing patients to function more normally,
currently marketed drugs are each marked by one or more side effects, including
weight gain and extrapyramidal symptoms such as involuntary muscle movements and
rigidity. Zomaril acts by selectively binding with serotonin and dopamine
receptors in the brain. This binding action helps to reverse the
neurotransmitter imbalance believed to be the cause of the symptoms of
schizophrenia. Novartis, our worlwide marketing partner in all countries except
Japan, is funding clinical trials and will pay us a royalty on net product
sales.
Zomaril is currently being evaluated in an extensive Phase III program
administered by Novartis comprising over 3,300 patients at 208 sites in 24
countries. Novartis has informed us that the first and second of three planned
efficacy studies have been completed, and enrollment in the third study has
passed the 50% level with completion expected around the end of the first
quarter of 2001. We have been advised by Novartis that in both completed
efficacy studies, Zomaril statistically significantly reduced the symptoms of
schizophrenia, and demonstrated an excellent tolerability profile with a lower
incidence of extrapyramidal symptoms and other significant side effects. Zomaril
is also being investigated in three 12 month safety studies as part of the Phase
III program.
SPHERAMINE--PARKINSON'S DISEASE
We are developing our Spheramine product for the treatment of Parkinson's
disease, a chronic and progressive neurological disease afflicting over one
million people in the U.S. that occurs when dopamine-producing neurons, or nerve
cells, die. Spheramine consists of cultured dopamine-producing human retinal
pigment epithelial, or RPE, cells. Using our patented cell-coated microcarrier
(CCM) technology, RPE cells are adhered to gelatin microcarriers, which enable
the long-term functioning of the cells in the brain. Blinded and controlled
preclinical studies have established the substantial and long-term effectiveness
of Spheramine in a primate model of Parkinson's disease. We have begun Phase
I/II clinical trials and initiated treatment in three patients. Schering, our
corporate partner in the
2
development of Spheramine, will fund clinical development, manufacturing and
commercialization and pay us a royalty on net product sales.
CANCER IMMUNOTHERAPEUTICS
We are developing three cancer immunotherapeutics which utilize monoclonal
antibodies to stimulate the immune system to treat cancer. We have established
several collaborations with government-sponsored clinical cooperative groups to
help fund our cancer immunotherapy products.
CEAVAC. Our CeaVac product has potential utility in the treatment of
cancers of the glands or glandular tissues. We are sponsoring a Phase III trial
of CeaVac in the treatment of Dukes D colorectal cancer, and a cooperative group
plans to initiate an additional Phase III trial this year in Dukes C colorectal
cancer. CeaVac will also be tested in two Phase II trials by cooperative groups.
TRIAB. Our TriAb product has potential utility in the treatment of breast,
ovarian and non-small cell lung cancers. We are evalutating TriAb in a Phase II
trial in advanced breast cancer.
TRIGEM. Our TriGem product has potential utility in the treatment of
melanoma, small cell lung cancer and sarcoma. TriGem has been studied in a Phase
II trial of malignant melanoma and a cooperative group plans to study a
combination of TriGem and TriAb in a Phase II trial in small cell lung cancer.
OTHER CANCER PRODUCTS
We are studying our Pivanex product in a Phase II trial in non-small cell
lung cancer patients and have planned a Phase II trial in liver cancer. We have
also planned studies of our gallium maltolate product in Phase II trials for
myeloma and prostate cancer.
OUR BUSINESS STRATEGY
Our objective is to become the leading biopharmaceuticals company focused on
central nervous system disorders and cancer. Key elements of our strategy
include the ability to:
ESTABLISH A LARGE AND DISVERSIFIED PRODUCT PORTFOLIO. We believe that by
building a large and diverse product line with product candidates at various
stages of clinical development, we can improve the probability of successful
product development.
COST-EFFECTIVELY ACQUIRE INNOVATIVE DRUG CANDIDATES. We have established
expertise in identifying, cost-effectively in-licensing and acquiring novel
product candidates, focusing on products and technologies with compelling
preclinical or early clinical data, or that offer promising therapeutic
approaches with demonstrated scientific proof of principle.
FOCUS ON LATER STAGE DEVELOPMENT. Our product acquisition strategy allows
us to focus on the clinical development stage of drug development by leveraging
the expertise and resources of third parties for clinical trial operations and
manufacturing.
ESTABLISH CORPORATE COLLABORATIONS WITH GLOBAL PHARMACEUTICAL COMPANIES. We
have established partnerships with global pharmaceutical companies to assist in
the development and commercialization of our products, helping to accelerate the
development time while allowing us to retain significant economic interest in
our products.
Our executive offices are located at 400 Oyster Point Blvd., Suite 505,
South San Francisco, California 94080, and our telephone number is
(650) 244-4990.
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RISK FACTORS
An investment in our shares involves various risks. You should carefully
consider the following risk factors and other information incorporated by
reference herein before deciding to purchase shares.
WE HAVE A HISTORY OF OPERATING LOSSES AND MAY NEVER BE PROFITABLE. From our
inception in 1992 through September 30, 2000, we had accumulated net losses of
approximately $80.2 million. We will continue to incur losses for the
foreseeable future as a result of the various costs associated with our
research, development, financial, administrative, regulatory and management
activities. We may never achieve or sustain profitability.
OUR PRODUCTS ARE AT VARIOUS STAGES OF DEVELOPMENT AND MAY NOT BE
SUCCESSFULLY DEVELOPED OR COMMERCIALIZED. We do not currently have any products
being sold on the commercial market. Our proposed products are at various stages
of development, but all will require significant further capital expenditures,
development, testing and regulatory clearances prior to commercialization. We
are subject to the risk that some or all of our proposed products:
- will be found to be ineffective or unsafe;
- will not receive necessary regulatory clearances;
- will be unable to get to market in a timely manner;
- will not be capable of being produced in commercial quantities at
reasonable costs;
- will not be successfully marketed; or
- will not be widely accepted by the physician community.
We may experience unanticipated problems relating to product development,
testing, regulatory compliance, manufacturing, marketing and competition, and
our costs and expenses could exceed current estimates. We cannot predict whether
we will successfully develop and commercialize any products. Of our product
candidates, Zomaril is furthest in development and any significant delays in its
development, regulatory approval or commercialization may seriously harm our
business.
Our Spheramine product is based upon new technology which may be risky and
fail to show efficacy. We are not aware of any other cell therapy products that
have been approved by the United States Food and Drug Administration (FDA) or
any similar foreign government entity and cannot assure you that we will be able
to obtain the required regulatory approvals for any products based upon such
technology.
WE MUST COMPLY WITH EXTENSIVE GOVERNMENT REGULATIONS. Our research,
development, preclinical and clinical trial activities and the manufacture and
marketing of any products that we may successfully develop are subject to an
extensive regulatory approval process by the FDA and other regulatory agencies
in the U.S. and other countries. The process of obtaining required regulatory
approvals for drugs, including conducting preclinical and clinical testing to
determine safety and efficacy, is lengthy, expensive and uncertain. Even after
such time and expenditures, we may not obtain necessary regulatory approvals for
clinical testing or for the manufacturing or marketing of any products. We have
limited experience in obtaining FDA approval. Regulatory approval may entail
limitations on the indicated usage of a drug, which may reduce the drug's market
potential. Even if regulatory clearance is obtained, post-market evaluation of
the products, if required, could result in restrictions on a product's marketing
or withdrawal of the product from the market as well as possible civil and
criminal sanctions. We depend on third-party laboratories and medical
institutions conducting preclinical studies and clinical trials for our products
to maintain both good laboratory and good clinical practices, which are outside
our direct control. We will also depend upon third party manufacturers for the
production
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of any products we may successfully develop to comply with current Good
Manufacturing Practices, which are similarly outside our direct control.
Our regulatory submissions may be delayed or we may cancel plans to make
submissions for proposed products for a number of reasons, including:
- unanticipated preclinical testing or clinical trial reports;
- changes in regulations or the adoption of new regulations;
- unanticipated enforcement of existing regulations;
- unexpected technological developments; and
- developments by our competitors.
Consequently, we cannot assure you that we will make our submissions
promptly, or at all, or that our submissions will meet the approval from the
FDA. If we and our corporate partners are unable to obtain regulatory approval
for our products, our business will be seriously harmed.
In addition, we and our collaborative partners may be subject to regulation
under state and federal laws, including requirements regarding occupational
safety, laboratory practices, environmental protection and hazardous substance
control, and may be subject to other local, state, federal and foreign
regulation. We cannot predict the impact of such regulation on us, although it
could seriously harm our business.
WE FACE MANY UNCERTAINTIES RELATING TO OUR HUMAN CLINICAL TRIAL STRATEGY AND
RESULTS. In order to obtain the regulatory approvals that we need to
commercialize any of our product candidates, we must demonstrate that each
product candidate is safe and effective for use in humans for each target
indication. Several of our product candidates, including Zomaril and CeaVac, are
currently in Phase II and Phase III human clinical trials. We may not be able to
demonstrate that any of our product candidates will be safe or effective in
these advanced trials that involve larger numbers of patients. Our product
development programs may be curtailed, redirected or eliminated at any time for
some or all of the following reasons:
- unanticipated, adverse or ambiguous results;
- undesirable side effects which delay or extend the trials;
- our inability to locate, recruit and qualify a sufficient number of
patients for our trials;
- regulatory delays or other regulatory actions;
- difficulties in manufacturing sufficient quantities of the particular
product candidate or any other components needed for our preclinical
testing or clinical trials;
- change in the focus of our development efforts; and
- reevaluation of our clinical development strategy.
Accordingly, our clinical trials may not proceed as anticipated or otherwise
adequately support our applications for regulatory approval.
We face an inherent risk of clinical trial liability claims in the event
that the use or misuse of our product candidates results in personal injury or
death. Our clinical liability insurance coverage may not be sufficient to cover
claims that may be made against us. Any claims against us, regardless of their
merit, could severely harm our financial condition, strain our management and
other resources or adversely impact or destroy the prospects for
commercialization of the product which is the subject of any such claim.
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WE MAY BE UNABLE TO PROTECT OUR PATENTS AND PROPRIETARY RIGHTS.
Our future success will depend to a significant extent on our ability to:
- obtain and keep patent protection for our products and technologies on an
international basis;
- enforce our patents to prevent others from using our inventions;
- maintain and prevent others from using our trade secrets; and
- operate and commercialize products without infringing on the patents or
proprietary rights of others.
We cannot assure you that our patent rights will afford any competitive
advantages and these rights may be challenged or circumvented by third parties.
Further, patents may not be issued on any of our pending patent applications in
the U.S. or abroad. Because of the extensive time required for development,
testing and regulatory review of a potential product, it is possible that before
a potential product can be commercialized, any related patent may expire, or
remain in existence for only a short period following commercialization,
reducing or eliminating any advantage of the patent.
If we sue others for infringing our patents, a court may determine that such
patents are invalid or unenforceable. Even if the validity of our patent rights
is upheld by a court, a court may not prevent the alleged infringement of our
patent rights on the grounds that such activity is not covered by our patent
claims.
In addition, third parties may sue us for infringing their patents. In the
event of a successful claim of infringement against us, we may be required to:
- pay substantial damages;
- stop using our technologies and methods;
- stop certain research and development efforts;
- develop non-infringing products or methods; and
- obtain one or more licenses from third parties.
If required, we cannot assure you that we will be able to obtain such
licenses on acceptable terms, or at all. If we are sued for infringement, we
could encounter substantial delays in development, manufacture and
commercialization of our product candidates. Any litigation, whether to enforce
our patent rights or to defend against allegations that we infringe third party
rights, will be costly, time consuming, and may distract management from other
important tasks.
We also rely in our business on trade secrets, know-how and other
proprietary information. We seek to protect this information, in part, through
the use of confidentiality agreements with employees, consultants, advisors and
others. Nonetheless, we cannot assure you that those agreements will provide
adequate protection for our trade secrets, know-how or other proprietary
information and prevent their unauthorized use or disclosure. To the extent that
consultants, key employees or other third parties apply technological
information independently developed by them or by others to our proposed
products, disputes may arise as to the proprietary rights to such information
which may not be resolved in our favor. Most of our consultants are employed by
or have consulting agreements with third parties and any inventions discovered
by such individuals generally will not become our property. There is a risk that
other parties may breach confidentiality agreements or that our trade secrets
become known or independently discovered by competitors, which could adversely
affect us.
WE FACE INTENSE COMPETITION. Competition in the pharmaceutical and
biotechnology industries is intense and is expected to increase. We face, and
will continue to face, competition from numerous companies that currently
market, or are developing, products for the treatment of the diseases and
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disorders we have targeted. Many of these entities have significantly greater
research and development capabilities, experience in obtaining regulatory
approvals and manufacturing, marketing, financial and managerial resources than
we have. We also compete with universities and other research institutions in
the development of products, technologies and processes, as well as the
recruitment of highly qualified personnel. Our competitors may succeed in
developing technologies or products that are more effective than the ones we
have under development or that render our proposed products or technologies
noncompetitive or obsolete. In addition, certain of such competitors may achieve
product commercialization or patent protection earlier than us. For example,
with respect to Zomaril, several competing products are already on the market
and Zomaril, expected to be the fifth or sixth such product, will face
significant competition.
WE ARE DEPENDENT UPON OUR KEY COLLABORATIVE RELATIONSHIPS AND LICENSE AND
SPONSORED RESEARCH AGREEMENTS. As a company with limited resources, we rely
significantly on the resources of third parties to conduct research and
development and complete the regulatory approval process on our behalf. For
example, our ability to ultimately derive revenues from Zomaril is almost
entirely dependent upon Novartis conducting the Phase III trials, completing the
regulatory approval process and implementing the marketing program necessary to
commercialize Zomaril if the product is approved by the FDA. Beyond our
contractual rights, we cannot control the amount or timing of resources that
Novartis devotes to these matters. In addition, we receive substantial
government funding for our Spheramine and cancer immunotherapeutic programs. We
cannot assure you that we will continue to receive such governmental funding. If
such funds are no longer available, some of our current and future development
efforts may be delayed or seriously harmed. We depend on our ability to maintain
existing collaborative relationships, to develop new collaborative relationships
with third parties and to acquire or in-license additional products and
technologies for the development of new product candidates. We cannot assure you
that any such third-party technology will be available on acceptable terms, if
at all.
Conflicts with our collaborators and strategic partners could have an
adverse impact on our relationships with them and impair our ability to enter
into future collaborations, either of which could seriously harm our business.
Our collaborators have, and may, to the extent permitted by our agreements,
develop competing products, preclude us from entering into collaborations with
their competitors or terminate their agreements with us prematurely. Moreover,
disagreements could arise with our collaborators or strategic partners over
rights to our intellectual property and our rights to share in any of the future
revenues from products or technologies resulting from use of our technologies,
or our activities in separate fields may conflict with other business plans of
our collaborators. Schering AG, our collaborator for the development and
commercialization of Spheramine, may terminate their sublicense agreement with
us for any reason by providing 90 days prior notice to us.
WE MUST MEET PAYMENT AND OTHER OBLIGATIONS UNDER OUR LICENSE AND SPONSORED
RESEARCH AGREEMENT. Our license agreements relating to the in-licensing of
technology generally require the payment of up-front license fees and royalties
based on sales with minimum annual royalties, the use of due diligence in
developing and bringing products to market, the achievement of funding
milestones and, in some cases, the grant of stock to the licensor. Our sponsored
research agreements generally require periodic payments on an annual or
quarterly basis. Our failure to meet financial or other obligations under
license or sponsored research agreements in a timely manner could result in the
loss of our rights to proprietary technology or our right to have the applicable
university or institution conduct research and development efforts.
WE MAY BE DEPENDENT UPON THIRD PARTIES TO MANUFACTURE AND MARKET ANY
PRODUCTS WE SUCCESSFULLY DEVELOP. We currently do not have the resources or
capacity to commercially manufacture or directly market any of our proposed
products. Collaborative arrangements may be pursued regarding the
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manufacture and marketing of any products that may be successfully developed. We
may be unable to enter into additional collaborative arrangements to manufacture
or market any proposed products or, in lieu thereof, establish our own
manufacturing operations or sales force.
WE MAY ENCOUNTER DIFFICULTIES MANAGING OUR GROWTH, WHICH COULD ADVERSELY
AFFECT OUR RESULTS OF OPERATIONS. Our success will depend on our ability to
expand and manage our growth. We may not be able to manage our growth, to meet
the staffing requirements of additional collaborative relationships or
successfully assimilate and train new employees. If we continue to grow, our
existing management skills and systems may not be adequate and we may not be
able to manage any additional growth effectively. If we fail to achieve any of
these goals, there could be a material adverse effect on our business, financial
condition or results of operations.
WE MAY NOT BE ABLE TO RETAIN OUR KEY MANAGEMENT AND SCIENTIFIC
PERSONNEL. As a small company with a limited number of personnel, we are highly
dependent on the services of Dr. Louis R. Bucalo, our Chairman, President and
Chief Executive Officer, as well as the other principal members of our
management and scientific staff. The loss of one or more of such individuals
could substantially impair ongoing research and development programs and could
hinder our ability to obtain corporate partners. Our success depends in large
part upon our ability to attract and retain highly qualified personnel. We
compete in our hiring efforts with other pharmaceutical and biotechnology
companies, as well as universities and nonprofit research organizations, and we
may have to pay higher salaries to attract and retain personnel.
WE MAY NEED ADDITIONAL FINANCING. At November 30, 2000, we had
approximately $116.5 million of cash and investments which we believe will
enable us to fund our operations at least through 2005. We may need to seek
additional financing after such time to continue our product development
activities, and will be required to obtain substantial funding to commercialize
any products that we may successfully develop. We do not have any funding
commitments or arrangements at this time. If we are unable to generate adequate
revenues, enter into a corporate collaboration, complete a debt or equity
offering, or otherwise obtain any needed financing, we will be required to
reduce, defer or discontinue our product development programs. We may be
required to obtain funds on terms that are not acceptable, if at all.
FUTURE SALES OF OUR COMMON STOCK IN THE PUBLIC MARKET COULD ADVERSELY IMPACT
OUR STOCK PRICE. Future sales of our common stock by existing stockholders
pursuant to Rule 144 under the Securities Act, pursuant to an effective
registration statement or otherwise, could have an adverse effect on the price
of our securities.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares by the selling
stockholders.
DIVIDEND POLICY
We have never paid cash dividends on our common stock and do not anticipate
paying cash dividends in the near future.
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FORWARD-LOOKING STATEMENTS
Statements in this prospectus or in the documents incorporated by reference
herein that are not descriptions of historical facts are forward-looking
statements within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. Reference is made in particular to the
description of our plans and objectives for future operations, assumptions
underlying such plans and objectives and other forward-looking terminology such
as "may," "expects," "believes," "anticipates," "intends," "expects,"
"projects," or similar terms, variations of such terms or the negative of such
terms. Forward-looking statements are based on management's current
expectations. Actual results could differ materially from those currently
anticipated due to a number of factors, including those set forth under "Risk
Factors" including, in particular, risks relating to:
- the results of ongoing research and development activities;
- uncertainties relating to pre-clinical and clinical testing, financing and
strategic agreements and relationships;
- the early stage of products under development;
- government regulation;
- patent matters; and
- competition.
We expressly disclaim any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained herein to
reflect any change in our expectations or any changes in events, conditions or
circumstances on which any such statement is based.
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SELLING STOCKHOLDERS
On November 21, 2000, we completed a private placement in which we sold an
aggregate of 1,200,000 shares to the selling stockholders listed in the table
below. We agreed to bear expenses, other than fees and expenses of counsel to
the selling stockholders, in connection with the registration and sale of the
shares. See "Plan of Distribution."
The following table sets forth information regarding the beneficial
ownership of our common stock by the selling stockholders and as adjusted to
give effect to the sale of the shares offered hereby. Other than as set forth
below, no selling stockholder has held any position nor had any material
relationship with Titan or its affiliates during the past three years.
NUMBER OF
NUMBER OF SHARES MAXIMUM SHARES
BENEFICIALLY NUMBER BENEFICIALLY PERCENTAGE
OWNED OF SHARES OWNED OWNERSHIP
NAME OF SELLING STOCKHOLDER PRIOR TO OFFERING TO BE SOLD AFTER OFFERING AFTER OFFERING
- --------------------------- ----------------- ---------- -------------- --------------
GFLK Partners L. P. (1)....................... 50,000 30,000 20,000 *
Janus Investment Fund (2)..................... 940,000 940,000 0 0
Pattern Recognition Fund L. P. (1)............ 18,560 16,670 1,890 *
Pattern Recognition Fund II L. P. (1)......... 30,660 25,280 5,080 *
Pattern Recognition Fund International Ltd.
(1)......................................... 8,430 8,050 380 *
Shaker Investments (3)........................ 89,200 80,000 9,200 *
The Galleon Group (4)......................... 100,000 100,000 0 0
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* Less than 1%
(1) GFLK Fund Management LLC ("GFLK LLC") is the general partner of GFLK
Partners L.P. Pattern Recognition Fund Management LLC ("Pattern LLC") is the
general partner of Pattern Recognition Fund L.P. ("Pattern") and Pattern
Recognition Fund II L.P. Gerard Klauer Mattison Inc., a registered
broker-dealer, is a member of Pattern LLC, GFLK LLC and a member of the
limited liability company which serves as manager/investment advisor to
Pattern Recognition Fund International Ltd.
(2) Represents shares held in accounts managed by Janus Capital Corporation for
which it has voting and dispositive power.
(3) Represents shares held in accounts managed by Shaker Investments for which
it has voting and dispositive power.
(4) Represents (i) 75,000 shares held by Galleon Healthcare Offshore, Ltd. and
(ii) 25,000 shares held by Galleon Healthcare Partners, L. P.
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PLAN OF DISTRIBUTION
The selling stockholders may sell shares from time to time:
- in transactions on the American Stock Exchange;
- in privately negotiated transactions;
- through the writing of options on the shares;
- or a combination of such methods of sale.
The may sell their shares:
- at fixed prices which may be changed;
- at market prices prevailing at the time of sale;
- at prices related to such prevailing market prices;
- or at negotiated prices.
The selling stockholders may sell shares to or through broker-dealers, and
such broker-dealers may receive compensation in the form of discounts,
concessions or commissions from either the selling stockholders, the purchasers
of the shares for whom such broker-dealers may act as agent or to whom they sell
as principal, or both. Compensation to a particular broker-dealer might be in
excess of customary commissions.
The selling stockholders and any broker-dealers who act in connection with
the sale of shares hereunder may be deemed to be "underwriters" as that term is
defined in the Securities Act of 1933, and any commissions received by them and
profit on any resale of the shares as principal might be deemed to be
underwriting discounts and commissions under the Securities Act.
We have agreed to indemnify the selling stockholders against certain
liabilities, including certain liabilities under the Securities Act.
LEGAL MATTERS
The validity of the securities offered hereby have been passed upon for
Titan by Loeb & Loeb LLP, New York, New York.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents which we have filed with the Commission (File
No. 0-27436) pursuant to the Exchange Act of 1934 are incorporated herein by
reference:
1. Our Annual Report on Form 10-K for the fiscal year ended December 31, 1999,
including any documents or portions thereof incorporated by reference
therein;
2. Our Quarterly Reports on Form 10-Q for the periods ended March 31, 2000,
June 30, 2000 and September 30, 2000;
3. Our Current Reports on Form 8-K dated February 28, 2000, July 20, 2000 and
November 16, 2000.
4. Our Registration Statement on Form 8-A registering the common stock under
the Exchange Act; and
5. All other documents filed by us pursuant to Sections 13(a), 13(c), 14 or
15(d) of the Exchange Act subsequent to the date of this prospectus and
prior to the termination of this offering.
11
Any statement contained in any document incorporated or deemed to be
incorporated by reference herein shall be deemed to be modified or superseded
for purposes of this prospectus to the extent that a statement contained herein
or in any subsequently filed document which also is or is deemed to be
incorporated by reference herein modifies or supersedes such statement. Any such
statement so modified or superseded shall not be deemed, except as modified or
superseded, to constitute a part of this prospectus.
We will provide without charge to each person to whom this prospectus is
delivered, upon written or oral request of any such person, a copy of any or all
of the documents incorporated herein by reference, other than exhibits to such
documents which are not specifically incorporated by reference into such
documents. Requests for documents should be directed to us at 400 Oyster Point
Boulevard, South San Francisco, California 94080, Attention: Chief Financial
Officer, telephone (650) 244-4990.
AVAILABLE INFORMATION
We have filed with the Commission a Registration Statement on Form S-3 under
the Securities Act of 1993 covering the shares offered by this prospectus. This
prospectus does not contain all of the information set forth in the Registration
Statement and the exhibits thereto. Statements contained in this prospectus as
to the contents of any contract or other document referred to are not
necessarily complete and in each instance such statement is qualified by
reference to each such contract or document. The Company is subject to the
informational requirements of the Exchange Act, and in accordance therewith
files reports and other information with the Commission. Copies of such material
can be obtained from the Public Reference Section of the Commission at 450 Fifth
Street, N.W., Washington, D.C. 20549 at prescribed rates. The Company is an
electronic filer, and the Commission maintains a web site that contains reports,
proxy and information statements and other information regarding the Company at
www.sec.gov./edgar.html.
12
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NO DEALER, SALESMAN OR OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY
INFORMATION OR TO MAKE ANY REPRESENTATIONS, OTHER THAN THOSE CONTAINED IN THIS
PROSPECTUS, AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATIONS MUST NOT
BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY. THIS PROSPECTUS DOES
NOT CONSTITUTE AN OFFER TO SELL, OR A SOLICITATION OF AN OFFER TO BUY, ANY
SECURITIES OFFERED HEREBY BY ANYONE IN ANY JURISDICTION IN WHICH SUCH OFFER OR
SOLICITATION IS NOT AUTHORIZED OR IN WHICH THE PERSON MAKING SUCH OFFER OR
SOLICITATION IS NOT QUALIFIED TO DO SO OR TO ANYONE TO WHOM IT IS UNLAWFUL TO
MAKE SUCH OFFER, OR SOLICITATION. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR
ANY SALE MADE HEREUNDER SHALL, UNDER ANY CIRCUMSTANCES, CREATE ANY IMPLICATION
THAT THE INFORMATION HEREIN CONTAINED IS CORRECT AS OF ANY TIME SUBSEQUENT TO
THE DATE OF THIS PROSPECTUS.
------------------------
TABLE OF CONTENTS
PAGE
--------
Prospectus Summary.................... 2
Risk Factors.......................... 4
Use Of Proceeds....................... 8
Dividend Policy....................... 8
Forward-Looking Statements............ 9
Selling Stockholders.................. 10
Plan Of Distribution.................. 11
Legal Matters......................... 11
Incorporation Of Certain Documents By
Reference........................... 11
Available Information................. 12
TITAN PHARMACEUTICALS, INC.
---------------------
PROSPECTUS
---------------------
, 2000
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The estimated expenses payable by the Registrant in connection with the
issuance and distribution of the securities being registered are as follows:
SEC Registration Fee........................................ $10,771.00
Printing and Engraving Expenses............................. 3,500.00
Legal Fees and Expenses..................................... 15,000.00
Blue Sky Fees and Expenses.................................. 1,000.00
Accounting Fees and Expenses................................ 4,500.00
----------
Total..................................................... $34,771.00
==========
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
The Amended and Restated Certificate of Incorporation and By-Laws of the
Registrant provide that the Registrant shall indemnify any person to the full
extent permitted by the Delaware General Corporation Law (the "GAL").
Section 145 of the GAL, relating to indemnification, is hereby incorporated
herein by reference.
In accordance with Section 102(a)(7) of the GAL, the Certificate of
Incorporation of the Registrant eliminates the personal liability of directors
to the Registrant or its stockholders for monetary damages for breach of
fiduciary duty as a director with certain limited exceptions set forth in
Section 102(a)(7).
The Registrant also enters into indemnification agreements with each of its
officers and directors, the form of which has been filed as Exhibit 10.6 and
reference is hereby made to such form.
In addition, the Registrant currently maintains an officers' and directors'
liability insurance policy which insures, subject to the exclusions and
limitations of the policy, officers and directors of the Company against certain
liabilities which might be incurred by them solely in such capacities.
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers or persons controlling the Registrant,
pursuant to the foregoing provisions, the Company has been informed that in the
opinion of the commission such indemnification is against public policy as
expressed in the Securities Act and is, therefore, unenforceable. See Item 17,
"Undertakings."
II-1
ITEM 16. EXHIBITS
3.1 Restated Certificate of Incorporation of the Registrant(1)
3.2 Form of Amendment to Restated Certificate of Incorporation
of the Registrant(1)
3.3 By-laws of the Registrant(1)
4.4 Form of Underwriter's Unit Purchase Option(1)
4.5 Form of Investor Rights Agreement between the Registrant and
the holders of Series A and Series B Preferred Stock(1)
4.6 Form of Placement Agent's Unit Purchase Option(4)
4.7 Certificate of Designation of Series C Preferred Stock(8)
5.1 Opinion of Loeb & Loeb re: Legality
10.1 1993 Stock Option Plan(1)
10.2 1995 Stock Option Plan(1)
10.3 Employment Agreement between the Registrant and Louis Bucalo
dated February 1, 1993, amended as of February 3, 1994(1)
10.4 Employment Agreement between Registrant and Richard Allen
dated July 28, 1995(1)
10.5 Employment Agreement between Registrant and Sunil Bhonsle,
dated August 6, 1995(1)
10.6 Form of Indemnification Agreement(1)
+10.9 MDR Exclusive License Agreement between Ingenex, Inc.
(formerly Pharm-Gen Systems Ltd.) and the Board of
Trustees of the University of Illinois dated May 6,
1992(1)
+10.11 License Agreement between Theracell, Inc. and New York
University dated November 20, 1992, as amended as of
February 23, 1993 and as of February 25, 1995(1)
+10.12 License Agreement between the Registrant and the
Massachusetts Institute of Technology dated September 28,
1995(1)
+10.14 Exclusive License Agreement between Ingenex, Inc. and the
Board of Trustees of the University of Illinois, dated
July 1, 1994(1)
+10.15 Exclusive License Agreement between Ingenex, Inc. and the
Board of Trustees of the University of Illinois, dated
July 1, 1994(1)
+10.16 License Agreement between Ingenex, Inc. and the
Massachusetts Institute of Technology, dated September
11,1 992(1)
+10.17 License Agreement between Ingenex, Inc. and Baylor College
of Medicine, dated October 21, 1992(1)
10.18 Lease for Registrant's facilities(2)
+10.19 License Agreement between Theracell, Inc. and the University
of South Florida dated March 15, 1996(3)
+10.20 License Agreement between Trilex Pharmaceuticals, Inc.
(formerly Ascalon Pharmaceuticals, Inc.) and the
University of Kentucky Research Foundation dated May 30,
1996(4)
+10.22 License Agreement between the Registrant and Hoechst Marion
Roussel, Inc. effective as of December 31, 1996(5)
10.23 Employment Agreement between Registrant and Robert E.
Farrell dated August 9, 1996(5)
10.24 Financing Agreement between the Registrant and Ansan
Pharmaceuticals, Inc. dated March 21, 1997(6)
II-2
10.25 Agreement for Purchase and Sale of Assets between the
Registrant and Pharmaceuticals Product Development, Inc.
dated June 4, 1997(6)
+10.27 License Agreement between the Registrant and Bar-Ilan
Research and Development Company Limited effective
November 25, 1997(7)
10.28 License Agreement between the Registrant and Ansan
Pharmaceuticals, Inc. dated November 24, 1997(7)
10.29 Stock Purchase Agreement between the Registrant and Ansan
Pharmaceuticals, Inc. effective November 25, 1997(7)
+10.30 Sublicense Agreement between the Registrant and Novartis
Pharma AG dated November 20, 1997(7)
10.31 1998 Stock Option Plan(9)
++10.32 License Agreement between the Registrant and Schering AG
dated January 25, 2000(10)
10.34 Agreement and Plan of Merger by and among the Registrant,
GeoMed Merger Sub Corp., and GeoMed, Inc. dated July 11,
2000(11)
23.1 Consent of Loeb & Loeb
23.2 Consent of Ernst & Young LLP, Independent Auditors
- ------------------------
+ Confidential treatment has been granted with respect to portions of this
exhibit.
++ Confidential treatment has been requested with respect to portions of this
exhibit.
(1) Incorporated by reference from the Registrant's Registration Statement on
Form SB-2 (File No. 33-99386).
(2) Incorporated by reference from the Registrant's Annual Report on
Form 10-KSB for the year ended December 31, 1995.
(3) Incorporated by reference from the Registrant's Quarterly Report on
Form 10-QSB for the period ended March 31, 1996.
(4) Incorporated by reference from the Registrant's Registration Statement on
Form SB-2 (File No. 333-13469).
(5) Incorporated by reference from the Registrant's Annual Report on
Form 10-KSB for the year ended December 31, 1996.
(6) Incorporated by reference from the Registrant's Quarterly Report on
Form 10-QSB for the period ended March 31, 1997.
(7) Incorporated by reference from the Registrant's Registration Statement on
Form S-3 (File No. 333-42367).
(8) Incorporated by reference from the Registrant's Annual Report on Form 10-K
for the year ended December 31, 1997.
(9) Incorporated by reference from the Registrant's Annual Report on Form 10-K
for the year ended December 31, 1998.
(10) Incorporated by reference from the Registrant's Annual Report on Form 10-K
for the year ended December 31, 1999.
(11) Incorporated by reference from the Registrant's Quarterly Report on
Form 10-Q for the period ended September 30, 2000.
II-3
ITEM 17. UNDERTAKINGS
Undertaking Required by Item 512 of Regulation S-K.
The undersigned registrant hereby undertakes that, for purpose 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 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.
II-4
SIGNATURES
In accordance with the requirements of the Securities Act of 1933, the
Registrant certifies that it has reasonable grounds to believe that it meets all
of the requirements for filing on Form S-3 and has authorized this Registration
Statement or Amendment thereto to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of South San Francisco, State of
California on the 30th day of November, 2000.
TITAN PHARMACEUTICALS, INC.
By: /s/ LOUIS R. BUCALO
-----------------------------------------
Louis R. Bucalo, M.D.,
CHAIRMAN, PRESIDENT AND CHIEF EXECUTIVE
OFFICER
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears
below under the heading "Signature" constitutes and appoints Louis R. Bucalo and
Robert Farrell, or either of them, his true and lawful 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 to sign any or all amendments
to this registration statement, and to file 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, each acting alone,
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 for all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, each acting alone, or his
substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
In accordance with the requirements of the Securities Act of 1933, this
Registration Statement or Amendment thereto has been signed by the following
persons in the capacities and on the dates stated.
SIGNATURE TITLE DATE
--------- ----- ----
Chairman of the Board,
/s/ LOUIS R. BUCALO President and Chief
------------------------------------------- Executive Officer November 30, 2000
Louis R. Bucalo, M.D. (principal executive
officer)
/s/ ERNST GUNTER-AFTING
------------------------------------------- Director November 30, 2000
Ernst-Gunter Afting, M.D., Ph.D.
/s/ VICTOR J. BAUER
------------------------------------------- Director November 30, 2000
Victor J. Bauer, Ph.D.
/s/ EURELIO CAVALIER
------------------------------------------- Director November 30, 2000
Eurelio Cavalier
II-5
SIGNATURE TITLE DATE
--------- ----- ----
/s/ MICHAEL K. HSU
------------------------------------------- Director November 30, 2000
Michael K. Hsu
/s/ HUBERT E. HUCKEL
------------------------------------------- Director November 30, 2000
Hubert E. Huckel, M.D.
/s/ LEY SMITH
------------------------------------------- Director November 30, 2000
Ley Smith, M.D.
/s/ KONRAD M. WEIS
------------------------------------------- Director November 30, 2000
Konrad M. Weis, Ph.D.
Executive Vice President
/s/ ROBERT E. FARRELL and Chief Financial
------------------------------------------- Officer (principal November 30, 2000
Robert E. Farrell financial and accounting
officer)
II-6