Titan Reports Third Quarter 2003 Results

Titan Reports Third Quarter 2003 Results SOUTH SAN FRANCISCO, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Titan Pharmaceuticals, Inc. today reported financial results for the third quarter and first nine months of 2003. Operating expenses for the third quarter of 2003 decreased approximately 24% to $6.5 million compared with operating expenses of $8.5 million for the third quarter of 2002. For the first nine months of 2003, operating expenses were approximately $20.5 million, a reduction of $5.0 million compared with operating expenses of $25.5 million for the first nine months of 2002. Titan's net loss for the third quarter 2003 was $6.2 million, or $0.22 per share, compared to a net loss of $7.3 million, or $0.26 per share, for the same quarter in 2002. For the first nine months of 2003, net loss was $19.4 million, or $0.70 per share, compared to a net loss of $19.3 million, or $0.70 per share, for the same nine-month period in 2002. Revenues for the first nine months of 2003 were $28,000, compared to approximately $2.7 million for the same nine-month period in 2002. The difference in revenue is primarily due to a milestone payment Titan received from Schering AG for Spheramine(R) in the first quarter of 2002. Interest income, net of other expenses, for the third quarter 2003 was approximately $332,000 compared to $1.1 million for the same quarter in 2002. For the first nine months of 2003, interest income, net of other expenses, was $1.1 million compared to $3.6 million for the same nine-month period in 2002. At September 30, 2003, the Company had approximately $53.6 million in cash and marketable securities. "Our reduction in operating expenses on a quarter-over-quarter basis is in line with our strategic focus for the reporting period," stated Dr. Louis R. Bucalo, Chairman, President and CEO, "and has enabled the Company to maximize its cash position, while advancing progress in our core development programs." During the third quarter Titan announced additional positive results in several of its core development programs, and last month announced the acquisition of DITPA, a novel product in clinical testing for the treatment of congestive heart failure. Following is an update on the status and progress of Titan's five core development programs: Spheramine(R) Titan has completed enrollment of the first cohort of twelve patients in a randomized, controlled, blinded, multi-center Phase IIb clinical study of Spheramine in advanced Parkinson's disease, and enrollment of the second cohort of 24 patients is proceeding on schedule. Schering AG, Germany, Titan's corporate partner for the development of Spheramine, is funding and co-managing the study. Spheramine is Titan's novel cell therapy product in development for the treatment of late-stage Parkinson's disease. Pivanex(R) Positive results from a dose escalation study were presented at the 10th World Conference on Lung Cancer in August, demonstrating that Pivanex and the approved chemotherapeutic agent docetaxel can be administered safely in combination to non-small cell lung cancer (NSCLC) patients. In addition, Titan presented new data at the 94th annual meeting of the American Association for Cancer Research in July further demonstrating that Pivanex, administered in combination with docetaxel, significantly increased anti-tumor activity in NSCLC cells. Pivanex is a histone deacetylase inhibitor with potential activity in a wide range of cancers. A Phase IIb study of Pivanex in combination with docetaxel for the second-line treatment of NSCLC is currently in progress. Gallium Maltolate Favorable results from a 12-patient pilot clinical study evaluating the use of oral gallium maltolate in the treatment of advanced Paget's disease were presented at the 25th Annual Meeting of the American Society For Bone and Mineral Research in Minneapolis, Minnesota in September. The results of this study demonstrated that targeted, potentially therapeutic serum levels of gallium can be safely achieved with this oral formulation. Titan is currently completing the Phase I portion of a Phase I/II clinical study of gallium maltolate in cancer patients, and preclinical testing of gallium maltolate in other disease settings is also ongoing. Gallium maltolate is Titan's novel oral formulation of gallium, a semi-metallic element with potential utility in cancer, bone disease, and other diseases. Probuphine(TM) In September, at the International Society of Addiction Medicine in Amsterdam, Titan presented positive interim results for the first cohort of six patients enrolled in Titan's pilot clinical study evaluating the safety and efficacy of Probuphine, Titan's novel, proprietary product in development for the treatment of opiate addiction. These results demonstrated that all six patients treated with Probuphine at the first dose level were safely switched from daily sublingual buprenorphine therapy to Probuphine, with maintenance of therapeutic benefit and no significant adverse events during the first four months of this ongoing study. DITPA Titan recently announced the acquisition of DITPA, a novel product in clinical testing for the treatment of congestive heart failure (CHF). DITPA is an orally active analogue of thyroid hormone that has demonstrated in preclinical and clinical studies to date the ability to improve cardiac function, without significant adverse effects. Beneficial effects demonstrated in these studies include improved cardiac output, as well as potential improvement in measures of diastolic function. In addition, DITPA has also demonstrated significant cholesterol and triglyceride lowering capability in pilot clinical testing. A randomized, double blind Phase II clinical study in patients with CHF will be initiated in the next few months. This multicenter study is funded by a $3.8 million government grant from the federal Veterans Administration (VA) system. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. (ASE:TTP) is a biopharmaceutical company focused on the development and commercialization of novel treatments for central nervous system (CNS) disorders, cancer and cardiovascular disorders. Titan's numerous products in development utilize novel technologies that have the potential to significantly improve the treatment of these diseases. Titan also establishes partnerships with multinational pharmaceutical companies and government institutions for the development of its products. The press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company's development program and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product development or commercialization, the uncertainty of patent protection for the Company's intellectual property or trade secrets and the Company's ability to obtain additional financing if necessary. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. TITAN PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amount) Three Months Ended Nine Months Ended September 30, September 30, 2003 2002 2003 2002 (Unaudited) License and contract revenue $ -- $158 $28 $2,656 Total revenue -- 158 28 2,656 Operating expenses: Research and development 5,262 7,202 16,639 21,607 General and administrative 1,239 1,314 3,878 3,915 Total operating expenses 6,501 8,516 20,517 25,522 Loss from operations (6,501) (8,358) (20,489) (22,866) Interest income, net of other expense 332 1,062 1,109 3,588 Net loss $(6,169) $(7,296) $(19,380) $(19,278) Basic and diluted net loss per share $(0.22) $(0.26) $(0.70) $(0.70) Shares used in computing basic and diluted net loss per share 27,653 27,642 27,646 27,642 CONDENSED CONSOLIDATED BALANCE SHEETS September 30, December 31, 2003 2002 (unaudited) (Note A) Assets Cash, cash equivalents, and marketable securities $53,620 $73,450 Prepaid expenses, receivables, and other current assets 1,551 1,197 Total current assets 55,171 74,647 Furniture and equipment, net 850 979 Investment in other companies 300 300 $56,321 $75,926 Liabilities and Stockholders' Equity $3,785 $3,945 Current liabilities 1,241 1,241 Minority interest - Series B preferred stock of Ingenex, Inc. 51,295 70,740 Stockholders' Equity $56,321 $75,926 Note A: The balance sheet has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles in the United States for complete financial statement presentation. DATASOURCE: Titan Pharmaceuticals, Inc. CONTACT: Robert Farrell, Executive Vice President & CFO of Titan Pharmaceuticals, Inc., +1-650-244-4990; or Mark Padgett, Media, +1-212-537-8082, or Dawn Lauer, Investors, +1-212-537-8088, both of GCI Group, for Titan Pharmaceuticals, Inc.