SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Titan Pharmaceuticals, Inc. (AMEX:TTP) today reported financial results for the first quarter ended March 31, 2008. “We are continuing to make progress toward achieving several upcoming milestones in each of our key product development programs,” said Marc Rubin, M.D., President and CEO of Titan Pharmaceuticals. “In just a few months, during the third quarter, we expect to announce the first Phase III results for Probuphine(R) in opiate addiction, and Phase IIb results for Spheramine(R) in Parkinson’s disease. In addition, the FDA action date for approval of iloperidone is scheduled for the end of July 2008. We are encouraged with the progress that we are making in each of these key product development programs and believe we have strong opportunities to make tangible progress throughout 2008.”
Net loss for the first quarter of 2008 was $5.7 million or a loss of $0.10 per share, compared with a net loss of $3.6 million or a loss of $0.09 per share for the first quarter of 2007.
Research and development (R&D) expenses for the first quarter of 2008 were approximately $3.8 million, compared with approximately $2.0 million in the first quarter of 2007. The increase in R&D expenses during the first quarter of 2008 primarily reflects the costs associated with the continuation of planned Phase III clinical trials for the Company’s Probuphine product.
General and administrative expenses for the first quarter of 2008 were $2.2 million, compared with $1.5 million in the first quarter of 2007. The increase in general and administrative expenses is primarily related to the increased non-cash stock compensation costs, and market research costs associated with Probuphine for the treatment of opiate addiction and chronic pain.
At March 31, 2008, Titan had approximately $24.3 million in cash and marketable securities compared with $30.0 million at December 31, 2007. Approximately 58.3 million shares of common stock were outstanding at March 31, 2008.
The Company also announced today that the data from the Phase II study of DITPA for the treatment of congestive heart failure was inconclusive and that it has discontinued this development program. The Company’s resources remain focused on the development of Probuphine.
Recent Product Development Highlights & Upcoming Milestones
Iloperidone
Iloperidone is Titan’s novel agent for the treatment of schizophrenia and other psychiatric disorders being developed by Vanda Pharmaceuticals, Inc.
-- The FDA’s response to the iloperidone NDA for the treatment of schizophrenia is expected in the third quarter of 2008, with potential marketing approval shortly thereafter. The PDUFA date for iloperidone is July 27, 2008.
Probuphine
Probuphine is a novel formulation of buprenorphine designed to provide six months of continuous drug delivery. It is currently in Phase III development by Titan for the treatment of opioid addiction.
-- Results from the Phase III randomized, placebo-controlled, multi-center clinical study for the treatment of opioid addiction are expected to be available in the third quarter of 2008.
-- A Phase II clinical study of Probuphine in the treatment of chronic pain is expected to be initiated by Titan during the second half of 2008.
Spheramine
Spheramine is Titan’s novel cell therapy product in development for the treatment of moderate to advanced Parkinson’s disease by Titan’s partner Bayer Schering Pharma AG. The product has been granted Fast Track and Orphan Drug status by the FDA.
-- In April 2008, four-year follow-up data from an open label pilot study was presented at the 76th Annual Meeting of the American Association of Neurological Surgeons (AANS) in Chicago. Results included:
-- Long-term improvement of symptoms and significant improvements in mobility - patients experienced an average 44 percent improvement from baseline at 48 months in UPDRS motor scores.
-- Significant clinical improvement in patient-reported quality of life scores (a secondary efficacy variable) - 23 percent improvement from baseline at 48 months.
-- The clinical study activities are progressing on schedule, and the results of the 71-patient double blind Phase IIb trial are expected to be available in the third quarter of 2008.
Upcoming Investor Conference
Titan will be making a corporate presentation at the Rodman & Renshaw 5th Annual Global Healthcare Conference in Monte Carlo, Monaco, taking place May 19-20, 2008. Dr. Marc Rubin will present at 4:15 p.m. local time on May 19, 2008. This presentation will be webcast and can be accessed by visiting the investor relations section of the Company’s website at www.titanpharm.com.
Conference Call Today
Titan management will host a live call and webcast today, Monday, May 12, 2008 at 10:30 a.m. (EDT) to discuss the Company’s first quarter 2008 results and current corporate developments. The live webcast may be accessed by visiting the investor relations section of the Company’s website at www.titanpharm.com. The call can also be accessed by dialing 1-866-800-8651 (domestic) or 1-617-614-2704 (international) five minutes prior to the start time and providing the passcode 76814176. A replay of the call will be available on the Titan website approximately two hours after completion of the call and will be archived for two weeks.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (AMEX: TTP) is a biopharmaceutical company focused on the development and commercialization of novel and innovative treatments for central nervous system disorders. Titan has established partnerships with leading pharmaceutical companies and academic institutions to further advance these programs. For more information, please visit the Company’s website at www.titanpharm.com.
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, 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. 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.
