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TITAN PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2008 FINANCIAL RESULTS

Conference Call Tomorrow at 10:00 a.m. EST

SOUTH SAN FRANCISCO, CA November 10, 2008 – Titan Pharmaceuticals, Inc. (AMEX:TTP) today reported financial results for the third quarter ended September 30, 2008.

Total operating expenses for the third quarter of 2008 were $6.0 million, compared with $4.6 million for the third quarter of 2007.  Net loss for the third quarter of 2008 was $5.9 million or $0.10 per share, compared with a net loss of $4.3 million or $0.10 per share for the third quarter of 2007.  The year-over-year increase in expenses resulted primarily from the increased research and development (R&D) expense related to the completion of the first Phase 3 study and the continued late stage development of Probuphine®, and a slight increase in general and administrative (G&A) expense.

At September 30, 2008, the Company had cash and cash equivalents of $12.2 million, which it believes is sufficient to sustain its planned operations through January 2009. However, if the Company is unable in the immediate future to obtain a corporate partner or otherwise raise the funding necessary to continue development and commercialization of Probuphine it will be forced, in light of its known and contingent financial obligations, to consider various alternatives prior to year end, including the possible sale of assets, the discontinuance of product development programs and/or the winding up of the business.

“We have continued to streamline our expenses and focus our resources on the Phase 3 clinical development of Probuphine®,” said Marc Rubin, M.D., President and CEO of Titan Pharmaceuticals.  “During the third quarter, we have engaged in discussions with several potential partners both in the U.S. and Europe and we are continuing these efforts as we evaluate strategic alternatives for the Company.  We continue to receive strong support from key opinion leaders as well as the addiction community at large for Probuphine and its potential to provide a safe and effective treatment option for patients with opioid addiction.” 

Third Quarter 2008 Additional Financial Results
R&D expenses for the third quarter of 2008 were approximately $4.2 million, compared with approximately $3.1 million in the third quarter of 2007.  The increase in R&D expenses during the third quarter of 2008 primarily reflects the costs associated with the completion of the first Phase 3 study and the continuation of planned Phase 3 clinical trials for the Company’s Probuphine product.

G&A expenses for the third quarter of 2008 were $1.8 million, compared with $1.5 million in the third 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. 

Probuphine: Recent and Upcoming Events
Probuphine is a novel formulation of buprenorphine designed to provide six months of continuous drug delivery with a single administration.  It is in Phase 3 development by Titan for the treatment of opioid addiction and the Company is currently pursuing potential partnerships for the worldwide development and commercialization of Probuphine.   

  • In July 2008, Titan announced positive results from the first Phase 3 randomized, double-blind, placebo-controlled, multi-center clinical study (PRO-805) for the treatment of opioid addiction.  In the study, Probuphine reached both key primary and secondary endpoints as agreed to with the U.S. Food & Drug Administration (FDA).  Results of the study showed that Probuphine was an effective treatment for opioid addiction over a six-month period following a single administration.
  • Following the completion of the PRO-805 clinical study, 80% of eligible patients that completed the trial signed informed consent to enter the Company’s follow-on open-label retreatment study (PRO-807).  To date, the PRO-807 study has enrolled 62 patients.
  • On October 29, 2008, the Company received an Office Action from the U.S. Patent and Trademark Office (PTO) rejecting the claims in the Company’s method-of-use patent application for the use of Probuphine in the treatment of opioid addiction and chronic pain. Titan is preparing a response to be submitted to the PTO. 
  • The Company will report the detailed clinical results of the first Phase 3 Probuphine study at the Annual Meeting of the International Society of Addiction Medicine (ISAM) on November 19th.  The conference will take place November 16-20, 2008 in Cape Town, South Africa.

Conference Call Tomorrow
Titan management will host a live call and webcast tomorrow, Tuesday, November 11, 2008, at 10:00 a.m. EST to discuss the Company’s third 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 1-866-356-4281 (domestic) or 1-617-597-5395 (international) five minutes prior to the start time and providing the passcode 11261265.  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 focused primarily on the late-stage development and commercialization of innovative treatments for central nervous system disorders. Probuphine, which utilizes Titan's proprietary ProNeura long term drug delivery technology, has demonstrated positive results in Phase III testing for treatment of opiate addiction, and the Company is planning to develop this validated sustained drug delivery technology for other potential treatment applications in which conventional treatment is limited by variability in blood drug levels and poor patient compliance.  Products based on ProNeura technology can provide controlled drug release on an outpatient basis over extended periods of up to 6-12 months.  Titan also has two other products, gallium maltolate and DITPA, in earlier stages of development.  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.

 

Contact:

Company:
Robert Farrell
Executive Vice President & CFO

650-244-4990

Media/ Investors:

Jennifer Beugelmans
Pure Comminications
646-596-7473

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