As filed with the Securities and Exchange Commission on October 8, 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 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 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 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. |_| CALCULATION OF REGISTRATION FEE UNDER THE SECURITIES ACT OF 1933 ================================================================================ Proposed Proposed Maximum Maximum Title of Each Class Amount to Aggregate Aggregate Amount of of Securities to be be Price per Offering Registration Registered Registered Security(1) Price Fee - -------------------------------------------------------------------------------- Common Stock, $.001 par value .................... 417,252 $10.125 $4,224,677 $1,174.46 - -------------------------------------------------------------------------------- Class A Warrants ......... 417,252 $ 4.219 $1,760,386 $ 489.39 - -------------------------------------------------------------------------------- Common Stock, $.001 par value(2) ................. 516,083 $10.125 $5,225,340 $1,452.64 - -------------------------------------------------------------------------------- Total .................... $3,116.49 ================================================================================ (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 and Warrants on October 6, 1999 as reported by the American Stock Exchange. (2) Issuable upon exercise of the Warrants being offered for resale hereby and certain additional Warrants issued by the Company upon exercise of Unit Purchase Options. Pursuant to Rule 416 under the Securities Act of 1933, as amended, there are also being registered such additional shares of Common Stock as may become issuable pursuant to anti-dilution provisions upon exercise of the Class A Warrants. ------------------------ 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. -ii- Subject to Completion - Dated October 8, 1999 Prospectus TITAN PHARMACEUTICALS, INC. Selling stockholders named in this prospectus are offering: o 206,251 shares of common stock and 206,251 class A warrants underlying unit purchase options we issued as underwriting compensation in connection with our initial public offering in January 1996; and o 211,001 shares of common stock and 211,001 class A warrants underlying unit purchase options we issued as placement agent compensation in connection with our private placement in August 1996. We are also offering 516,083 shares underlying class A warrants which have already been issued or may in the future be issued upon exercise of unit purchase options. Our common stock and class A warrants are traded on the American Stock Exchange under the symbols TTP and TTP:WS, respectively. On October 6, 1999, the closing prices of the common stock and warrants were $9.6875 and $3.75, 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 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 CNS therapeutic product, Iloperidone, is currently in Phase III clinical testing for schizophrenia through a corporate partnership with Novartis Pharma AG. Novartis has trade named the product ZomarilJ, and the Phase III program will enroll approximately 3,300 patients in 24 countries. Zomaril is being developed for the treatment of schizophrenia and related psychotic disorders - a market expected to reach $6 billion in 2002. Also in the central nervous system arena, we are developing a unique cell based therapeutic, SpheramineJ, for the treatment of Parkinson=s disease. Our cancer therapeutics in clinical testing include three monoclonal antibodies -- CeaVacJ, TriAbJ, and TriGem -- that are designed to stimulate a patient=s immune system against cancer cells. CeaVacJ is currently in multicenter, double-blind, prospectively controlled Phase II clinical testing for colorectal cancer. TriAbJ is currently in multicenter, double-blind, prospectively controlled Phase II clinical testing for breast cancer. TriGemJ has completed Phase I/II testing in melanoma and we are pursuing later stage clinical trials through co-operative groups. Another product we have in development, PivanexJ, 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. 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. -2- 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. Through June 30, 1999, we had accumulated net losses since inception of approximately $60 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 June 30, 1999, we had approximately $11.8 million of cash which we believe will enable us to fund our operations for at least 15 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 of credit. 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 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, 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 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. -3- 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 may be unable to protect our patents and proprietary rights. Our future success will depend to a significant extent on our ability to: o 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 others 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 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 -4- 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 Zomaril 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 Zomaril 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. 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 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 may not have the resources in the foreseeable future to allocate to the commercial manufacture or direct marketing of any proposed products. Collaborative arrangements may 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, establish 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 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. 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. We may redeem the class A warrants. We may redeem the warrants at a redemption price of $.05 per warrant if the closing bid price of our common stock averages in excess of $9.10 for 30 consecutive trading days ending within 15 days of the notice. If we redeem the warrants, you could be forced to: -5- o exercise the warrants and pay the exercise price therefor at a time when it may be disadvantageous for you to do so; o sell the warrants at the then current market price when you might otherwise wish to hold the warrants; or o accept the nominal redemption price. You may be unable to exercise your warrants if we do not have a current prospectus in effect. You may be unable to exercise your warrants if: o a current prospectus relating to the shares underlying the warrants is not in effect; and o the shares have not been qualified for sale under the applicable securities laws of the state where you reside or your exercise of warrants is exempt from qualification. Persons holding warrants who reside in jurisdictions in which the underlying shares are not qualified and in which there is no exemption will be unable to exercise their warrants and would either have to sell their warrants in the open market or allow them to expire unexercised. We may exercise our right to redeem the warrants even if we are unable to qualify the underlying shares for sale under all applicable state securities laws. USE OF PROCEEDS Holders of the unit purchase options are not obligated to exercise their unit purchase options or the underlying warrants and we cannot predict whether holders will choose to exercise all or any of their securities. Further, holders of the unit purchase options may exercise them on a cashless basis, and several holders have already done so. In the event that all of the remaining unit purchase options are exercised for cash, we will receive gross proceeds of approximately $3.47 million. See "Plan of Distribution." We will use any proceeds we receive from the exercise of unit purchase options for product development, product and technology acquisitions and general working capital purposes. DIVIDEND POLICY We have never paid cash dividends on our common stock and do not anticipate paying cash dividends in the near 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 -6- 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. SELLING STOCKHOLDERS In January 1996, in connection with the completion of our initial public offering, we issued to D. H. Blair Investment Banking Corp., as underwriter, and its designees, options to purchase an aggregate of 320,000 units, each unit consisting of one share and one warrant, for $6.50 per unit. The options became exercisable in January 1999. In August 1996, in connection with the completion of a private placement through Blair, we issued options to purchase an aggregate of 321,065 units for $9.97 per unit (after giving effect to anti-dilution adjustments subsequent to the date of issuance). 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 and warrants underlying the unit purchase options. See "Plan of Distribution." We may be required to pay a fee of 5% upon any exercise of warrants solicited by Blair or its agents if (i) the market price of our common stock on the date the warrant is exercised is greater than the then exercise price of the warrants; (ii) the exercise of the warrant was solicited by a member of the National Association of Securities Dealers, Inc. as designated in writing on the warrant certificate subscription form; (iii) the warrant is not held in a discretionary account; (iv) disclosure of compensation arrangements was made both at the time of the offering and at the time of exercise of the warrants, and (v) the solicitation of exercise of the warrant was not in violation of Regulation M promulgated under the Exchange Act. -7- 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 and warrants offered hereby. Other than as set forth above, no selling stockholder has held any position nor had any material relationship with Titan or its affiliates during the past three years.