As filed with the Securities and Exchange Commission on April 7, 1999
Registration No. 333-
================================================================================
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
------------------------------
REGISTRATION STATEMENT ON FORM S-3 UNDER
THE SECURITIES ACT OF 1933
------------------------------
TITAN PHARMACEUTICALS, INC.
(Exact name of Small Business Issuer as specified in its charter)
Delaware 2836 94-3171940
- ------------------------- ---------------------------- ----------------------
State or other jurisdic- (Primary standard industrial (I.R.S. employer
tion of incorporation) classification code number) identification 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., 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)
------------------------------
Copies to:
Fran Stoller, Esq.
Bachner, Tally, Polevoy & Misher LLP
380 Madison Avenue
New York, New York 10017
(212) 687-7000
Approximate date of proposed sale to the public: As soon as practicable after
this Registration Statement becomes effective.
If the only securities being registered on this form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. |_|
If any of the securities being registered on this form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, please check the following box. |X|
If this form is filed to register additional securities for an offering pursuant
to Rule 462(b) under the Securities Act, please check the following box and list
the Securities Act registration statement number of the earlier effective
registration statement for the same |_|
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. |_|
CALCULATION OF REGISTRATION FEE UNDER THE SECURITIES ACT OF 1933
<TABLE>
<CAPTION>
===================================================================================================================
Proposed Proposed Maximum
Title of Each Class of Amount to Maximum Aggregate Aggregate Amount of
Securities to be Registered be Registered Price per Security(1) Offering Price Registration Fee
- -------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Common Stock, $.001 par value... 2,149,273 $3.50 $7,522,455.50 $2,091.24
===================================================================================================================
</TABLE>
(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 April 1, 1999 as reported by the American Stock
Exchange.
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.
<PAGE>
Subject to Completion - Dated April 7, 1999
Prospectus
---------------------------
2,149,273 Shares
TITAN PHARMACEUTICALS, INC.
Common Stock
---------------------------
Selling stockholders identified 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 and class A warrants are traded on the American Stock
Exchange under the symbols TTP and TTP:WS, respectively. On April __, 1999, the
closing prices of the common stock and warrants were $___ and $_____,
respectively.
------------------------
An investment in our securities involves a high degree
of risk. See "Risk Factors" beginning on page 3.
------------------------
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 , 1999
-----------
<PAGE>
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.
We are a biopharmaceutical company developing therapeutic products for the
treatment of cancer, disorders of the central nervous system and other serious
and life-threatening diseases.
Our lead product, Iloperidone, is currently in Phase III clinical testing
for schizophrenia through a strategic alliance with Novartis Pharma AG. Novartis
has tradenamed the product Zomaril(TM), and the Phase III program, which will
enroll 3,300 patients in 24 countries, has been named the ZEUS(TM) program, for
Zomaril Efficacy/Utility and Safety. Iloperidone is being developed for the
treatment of schizophrenia and related psychotic disorders - a market expected
to exceed $4 billion within two years. Also in the central nervous system arena,
we are developing a unique cell based therapeutic, Spheramine(TM), for the
treatment of Parkinson's disease. Our cancer therapeutics in clinical testing
include three immunotherapeutics --CeaVac(TM), TriAb(TM), and TriGem -- that are
designed to stimulate a patient's immune system against cancer cells. CeaVac(TM)
is currently in multicenter double-blind prospectively controlled Phase II
clinical testing for colorectal cancer. TriAb(TM) is currently in multicenter
double-blind prospectively controlled Phase II clinical testing for breast
cancer. TriGem(TM) has completed Phase I testing in melanoma and we are pursuing
later stage clinical trials through co-operative groups. Another product we have
in development, Pivanex(TM), is a small molecule drug that acts as a cell
differentiating agent. Pivanex is currently in Phase II clinical testing for
non-small cell lung cancer. Additionally, we are developing gene therapy
products for treating various cancers and, with the help of SBIR grants, an
implantable drug delivery system with applications in the treatment of central
nervous system disorders.
A portion of our operations are currently conducted through two
consolidated subsidiaries: Ingenex, Inc., engaged in the development of
proprietary gene-based therapies and ProNeura, Inc., engaged in research and
development activities relating to a polymeric implantable drug delivery
technology. Theracell, Inc., engaged in the development of cell-based
therapeutics intended for the restorative treatment of neurological diseases and
central nervous system disorders, was merged into Titan in March 1999.
References in this prospectus to our company and our products include the
operations and products of our operating subsidiaries.
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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<PAGE>
RISK FACTORS
An investment in our shares involves various risks. You should carefully
consider the following risks 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. Through
December 31, 1998, we had accumulated net losses since inception of
approximately $54.1 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.
We will need additional financing. At March 15, 1999, we had working capital of
approximately $13 million which we believe will enable us to fund our operations
for at least 18 months. We will be required to seek substantial additional
financing after such time to continue our product development activities and to
commercialize any products that we may successfully develop. We do not have any
funding commitments or arrangements other than our bank line. If we are unable
to 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 favorable to us and our stockholders.
Our products are at an early stage of development and may not be successfully
developed or commercialized. Our proposed products are at various stages of
development, but all will require significant further research, development,
testing and regulatory clearances prior to commercialization. We are subject to
the risk that some or all of our proposed products:
o will be found to be ineffective or unsafe;
o will not receive necessary regulatory clearances;
o will not be capable of being produced in commercial quantities at
reasonable costs; or
o will not be successfully marketed.
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.
We must comply with extensive government regulations. Our research,
development and pre-clinical and clinical trial activities and the manufacturing
and marketing of any products which 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, 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. 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
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<PAGE>
withdrawal of the product from the market as well as possible civil or criminal
sanctions. We depend on laboratories and medical institutions conducting
preclinical studies and clinical trials to maintain both good laboratory and
good clinical practices. We will also depend upon the manufacturers of any
products we may successfully develop to comply with cGMP.
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 be material and adverse.
We have limited patent protection and may be unable to obtain or retain
patents and proprietary rights.
Our future success will depend to a significant extent on our ability to:
o obtain and enforce patent protection on our products and technologies;
o maintain trade secrets; and
o operate and commercialize products without infringing on the patents or
proprietary rights of others.
Our patents may not afford any competitive advantages and may be challenged or
circumvented by third parties. Further, patents may not issue on pending patent
applications. 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 any advantage of the patent.
Our business may be materially adversely affected if we fail to obtain and
retain needed patents, licenses or proprietary information. Others may
independently develop similar technologies or duplicate any technology we
develop. Furthermore, costly and time consuming litigation may be necessary to:
o enforce any of our patents;
o determine the scope and validity of the patent rights of others; or
o respond to a legal action against us claiming damages for infringement of
patent rights or other proprietary rights or seeking to enjoin commercial
activities relating to the affected product or process.
The outcome of any such litigation is highly uncertain.
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
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<PAGE>
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 will face
competition from numerous companies that currently market, or are developing,
products for the treatment of the diseases and 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 us. 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.
We are dependent upon our key collaborative relationships and license and
sponsored research agreements. As a small company with limited resources, we
rely significantly on the resources of third parties to conduct research and
development on our behalf. For example, our ability to ultimately derive
revenues from Iloperidone is almost entirely dependent upon Novartis conducting
the Phase III trials and completing the regulatory approval process and
implementing the marketing program necessary to commercialize Iloperidone if the
trials are successful. Our success in the future will depend, in part, on our
ability to maintain existing collaborative relationships and to develop new
collaborative relationships with third parties. 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. Some agreements also require funding or production
facilities relating to clinical research. 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 will be dependent on third parties to manufacture and market any
products we may successfully develop. To date, we have not introduced any
products on the commercial market. We do not expect to have the resources in the
foreseeable future to allocate to the manufacture or direct marketing of any
proposed products and, therefore, it is intended that collaborative arrangements
be pursued regarding the 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,
estsablish our own manufacturing operations or sales force.
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, 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
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<PAGE>
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.
Futures 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 foreseeable future.
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:
o the results of ongoing research and development activities;
o uncertainties relating to pre-clinical and clinical testing, financing
and strategic agreements and relationships;
o the early stage of products under development;
o government regulation;
o patent matters; and
o 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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<PAGE>
SELLING STOCKHOLDERS
In January 1999, we completed a private placement in which we sold an
aggregate of 2,149,273 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. No selling stockholder has
held any position nor had any material relationship with Titan or its affiliates
during the past three years.
<TABLE>
<CAPTION>
Number of Number of Number Percentage
Shares Beneficially Shares of Shares Ownership
Name of Owned Prior Being Beneficially Owned After
Selling Stockholder To Offering Offered After Offering Offering
- ------------------- ----------- ------- -------------- --------
<S> <C> <C> <C> <C>
Biotechnology Value Fund, L.P. (1)(2) 703,648 316,273 387,375 2.5%
Biotechnology Value Fund, Ltd. (2) 354,000 354,000 0 *
Caduceus Capital II, L.P. (3) 80,000 80,000 0 *
Caduceus Capital Trust (3) 445,000 445,000 0 *
Clearwater Offshore Fund Ltd. (4) 254,000 185,000 69,000 *
Clearwater Fund I, L.P. (4) 200,000 200,000 0 *
Curran Partners L.P. (5) 100,000 100,000 0 *
Donald D. Graham 50,000 50,000 0 *
Investment 10 L.L.C.(2) 20,000 20,000 0 *
Michael T. Jackson Trust, 265,000 182,000 83,000 *
New Technologies Fund
James A. Ruffalo and Margaret 50,000 50,000 0 *
M. Ruffalo, JTROS
Ursus Capital, L.P.(6) 63,000 30,000 33,000 *
Worthington Growth L.P.(7) 100,000 100,000 0 *
ZPG Securities LLC (2) 37,000 37,000 0 *
</TABLE>
* Less than 1%
(1) Includes 112,375 shares underlying a warrant.
(2) The shares held by each of these selling stockholders are beneficially owned
by BVF Partners L.P. ("Partners"), the general partner of Biotechnology Value
Fund, L.P., and BVF Inc., the general partner of Partners. Biotechnology Value
Fund, Ltd., Investment 10 L.L.C and ZPG Securities LLC are investment accounts
managed by Partners.
(3) The shares held by these selling stockholders are beneficially owned by
OrbiMed Advisors LLC, the general partner of Caduceus Capital II, L.P. and the
investment advisor for Caduceus Capital Trust.
(4) These shares may be deemed to be beneficially owned by Hans F. Heye, the
trading manager of Clearwater Offshore Fund Ltd. and the president of the
corporate general partner of Clearwater Fund I, L.P.
(5) These shares may be deemed to be beneficially owned by John P. Curran, as
general partner.
(6) These shares may be deemed to be beneficially owned by Evan Sturza, as
manager and principal. Includes 14,400 shares underlying Class A Warrants owned
by Mr. Sturza.
(7) The shares may be deemed to be beneficially owned by Clifford W. Henry, as
general partner.
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<PAGE>
PLAN OF DISTRIBUTION
The selling stockholders may sell shares from time to time:
o in transactions on the American Stock Exchange or the Pacific Exchange;
o in privately negotiated transactions;
o through the writing of options on the shares;
o or a combination of such methods of sale.
The may sell their shares:
o at fixed prices which may be changed;
o at market prices prevailing at the time of sale;
o at prices related to such prevailing market prices;
o 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 Bachner, Tally, Polevoy & Misher 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 31,1998,
including any documents or portions thereof incorporated by reference therein;
2. Our definitive Proxy Statement dated June 29, 1998;
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<PAGE>
3. Our Registration Statement on Form 8-A registering the common stock and class
A warrants under the Exchange Act; and
4. 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.
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.
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================================================================================
[Back Cover]
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 or by the Underwriter.
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............................................................. 3
Use of Proceeds.......................................................... 6
Dividend Policy.......................................................... 6
Forward-Looking Statements .............................................. 6
Selling Stockholders..................................................... 7
Plan of Distribution..................................................... 8
Legal Matters............................................................ 8
Incorporation of Certain
Documents by Reference.............................................. 8
Available Information.................................................... 9
================================================================================
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TITAN PHARMACEUTICALS, INC.
PROSPECTUS
[date]
================================================================================
<PAGE>
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:
Amount
------
SEC Registration Fee............................... $ 2,091.24
Printing and Engraving Expenses.................... 3,500.00
Legal Fees and Expenses............................ 3,500.00
Blue Sky Fees and Expenses......................... 1,000.00
Accounting Fees and Expenses....................... 5,000.00
----------
Total........................................ $15,091.24
==========
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."
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)
4.3 - Form of Warrant Agreement(1)
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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)
4.8 - Certificate of Designation of Series D Preferred Stock(8)
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)
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)
II-2
<PAGE>
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)
23.1 - Consent of Ernst & Young LLP, Independent Auditors - Included on
Page II-6
+ Confidential treatment has been granted 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.
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-3
<PAGE>
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 5th day of April, 1999.
TITAN PHARMACEUTICALS, INC.
By: /s/ Louis R. Bucalo
----------------------------------
Louis R. Bucalo, M.D., President
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
- --------- ----- ----
/s/ Louis R. Bucalo
- -------------------------
Louis R. Bucalo, M.D. President, Chief Executive April 5, 1999
Officer and Director
(principal executive
officer)
/s/ Ernst Gunter-Afting
- -------------------------
Ernst Gunter-Afting Director April 5, 1999
/s/ Victor J. Bauer
- -------------------------
Victor J. Bauer Director April 5, 1999
/s/ Eurelio Cavalier
- -------------------------
Eurelio Cavalier Director April 5, 1999
- -------------------------
Michael K. Hsu Director April , 1999
/s/ Hubert E. Huckel
- -------------------------
Hubert E. Huckel, M.D. Director April 5, 1999
/s/ Marvin E. Jaffe
- -------------------------
Marvin E. Jaffe, M.D. Director April 5, 1999
/s/ Konrad M. Weis
- -------------------------
Konrad M. Weis, Ph.D. Director April 5, 1999
/s/ Kenneth J. Widder
- -------------------------
Kenneth J. Widder, M.D. Director April 5, 1999
/s/ Robert E. Farrell
- -------------------------
Robert E. Farrell Executive Vice President and April 5, 1999
Chief Financial Officer
(principal financial and
accounting officer)
II-4
<PAGE>
CONSENT OF COUNSEL
The consent of Bachner, Tally, Polevoy & Misher LLP is contained in its
opinion filed as Exhibit 5.1 to the Registration Statement.
II-5
April 6, 1999
Titan Pharmaceuticals, Inc.
400 Oyster Point Blvd., Suite 505
South San Francisco, California 94080
Re: Registration Statement on Form S-3
Gentlemen:
We have acted as counsel to Titan Pharmaceuticals, Inc., a Delaware
corporation (the "Company"), in connection with the preparation of a
registration statement on Form S-3 (the "Registration Statement") filed with the
Securities and Exchange Commission under the Securities Act of 1933, as amended
(the "Act"), relating to the registration of an aggregate of 2,149,273 shares
(the "Shares") of the common stock, par value $.001 per share, of the Company
(the "Common Stock") for resale by certain selling stockholders named in the
Registration Statement (the "Selling Stockholders").
In this connection, we have reviewed (a) the Registration Statement; (b)
the Company's Restated Certificate of Incorporation and Bylaws; (c) the form of
Subscription Agreement between the Company and each of the Selling Stockholders
dated January 27, 1999; and (d) certain records of the Company's corporate
proceedings as reflected in its minute books. In our examination, we have
assumed the genuineness of all signatures, the authenticity of all documents
submitted to us as originals and the conformity with the original of all
documents submitted to us as copies thereof. Where factual matters relevant to
such opinion were not independently established, we have relied upon
certificates of officers and responsible employees and agents of the Company.
Our opinion set forth below is limited to the General Corporation Law of the
State of Delaware.
Based upon the foregoing, it is our opinion that the Shares have been duly
and validly authorized and issued and are fully paid and nonassessable.
We hereby consent to the use of this opinion as Exhibit 5.1 to the
Registration Statement and to all references to our firm in the Registration
Statement. In giving this consent, we do not thereby concede that we come within
the categories of persons whose consent is required by the Act or the General
Rules and Regulations promulgated thereunder.
Very truly yours,
/s/ BACHNER, TALLY, POLEVOY & MISHER LLP
CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
We consent to the incorporation by reference in the Registration Statement (Form
S-3) and related Prospectus of Titan Pharmaceuticals, Inc. for the registration
of 2,149,273 shares of its common stock, of our report dated February 12, 1999
with respect to the consolidated financial statements of Titan Pharmaceuticals,
Inc. included in its Annual Report (Form 10-K) for the year ended December 31,
1998, filed with the Securities and Exchange Commission.
Palo Alto, California
April 5, 1999
II-6
