Titan third quarter net loss decreases to $0.4 million

Nov 15 2010

Titan Pharmaceuticals, Inc. (OTC Bulletin Board: TTNP) today reported financial results for the third quarter ended September 30, 2010.

Total revenues for the third quarter of 2010 were approximately $3.6 million, consisting primarily of grant and royalty revenues. Grant revenue from the National Institutes of Health (NIH) in support of the Phase 3 clinical study of Probuphine® was approximately $3.2 million, while royalty revenue received from Novartis on net sales of Fanapt® was approximately $ 0.4 million.

Total operating expenses for the third quarter of 2010 were approximately $3.7 million, compared with $1.6 million for the third quarter of 2009.  The year-over-year increase in expenses resulted primarily from an increase of approximately $2.3 million in research and development (R&D) expense related to the Phase 3 clinical study of Probuphine currently in progress, which was offset in part by a decrease in general and administrative (G&A) expenses during the 2010 quarter of $0.2 million due primarily to lower non-cash stock compensation and facility related expenses.

Net loss for the third quarter of 2010 was approximately $0.4 million or $0.01 per share compared with a net loss of $1.6 million or $0.03 per share for the third quarter of 2009.  

At September 30, 2010, we had cash and cash equivalents of $6.4 million. We believe that our working capital at September 30, 2010, together with proceeds from the NIH grants and the royalty revenue expected from sales of Fanapt® will be sufficient to sustain our planned operations into the second quarter of 2011.  

"We have continued to make excellent progress with the confirmatory Phase 3 study of Probuphine with full enrollment completed in late September, and qualified patients completing this study will have the opportunity for an additional six months of treatment with Probuphine in an open label safety study" said Sunil Bhonsle, President of Titan Pharmaceuticals.  "We are also very pleased with the publication of the results from the first Phase 3 study in the Journal of the American Medical Association (JAMA) in October," he noted.  

"The board is very pleased by the continued progress in the development of Probuphine and fully supports the ongoing efforts," said Marc Rubin, M.D., Executive Chairman of Titan Pharmaceuticals. "The publication of the clinical results in JAMA recognize the innovative nature of Probuphine, and its potential to offer a meaningful therapeutic alternative to patients in the future," he added.

Third Quarter 2010 Additional Financial Results

R&D expenses for the third quarter of 2010 were approximately $3.0 million, compared with approximately $0.7 million in the third quarter of 2009.  The increase in R&D expense reflects the costs of conducting the Phase 3 clinical study of Probuphine and includes $2.5 million of external expenses such as clinical research organization charges, investigator and patient related clinical site expenses, and other associated costs. The remaining R&D expenses reflect internal operating costs such as personnel related expenses, meeting and travel expenses and allocation of facility and corporate costs.

G&A expenses for the third quarter of 2010 decreased to approximately $0.7 million from approximately $0.9 million in the comparable period of 2009 primarily due to decreases in non-cash stock compensation costs of approximately $0.1 million, and consulting fees and facility expenses of $0.1 million.

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 we are currently conducting a confirmatory Phase 3 clinical study in the U.S. which is partially funded through a two year $7.6 million National Institutes of Health (NIH) grant being administered by the National Institute on Drug Abuse (NIDA). Recent and upcoming events include the following:  

• Patient enrollment in the confirmatory Phase 3 study was completed in late September, with study results expected in mid second quarter 2011.
• A symposium on Probuphine was conducted at the International Society of Addiction Medicine annual meeting on October 6, 2010 in Milan, Italy. This symposium was co-sponsored by NIDA.
• Upcoming scientific presentations of Probuphine data:
  • Society for Neuroscience (SfN), November 2010, San Diego (Therapeutic area symposium)
  • American College of Neuropsychopharmacology (ACNP), December 2010, Miami (Poster presentation)

SOURCE Titan Pharmaceuticals, Inc.