Titan Pharmaceuticals second-quarter net loss increases to $1.84 million

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

Total revenues for the second quarter of 2010 were $1.34 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 $1.29 million, while royalty revenue received from Novartis on net sales of Fanapt® was approximately $ 55,000.

Total operating expenses for the second quarter of 2010 were approximately $3.07 million, compared with $1.77 million for the second quarter of 2009.  The year-over-year increase in expenses resulted primarily from an increase of approximately $1.68 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 $0.38 million due primarily to lower non-cash stock compensation expenses.

Net loss for the second quarter of 2010 was approximately $1.84 million or $0.03 per share compared with a net loss of $1.74 million or $0.03 per share for the second quarter of 2009.  

At June 30, 2010, we had cash and cash equivalents of $1.45 million. We believe that our working capital at June 30, 2010, together with proceeds from the NIH grants, in light of faster than expected patient enrollment in the Probuphine clinical study, will be sufficient to sustain our planned operations into November 2010.  

"During this quarter we made excellent progress with the confirmatory Phase 3 clinical study of Probuphine which continues to rapidly enroll patients, and we also received the U.S. patent covering Probuphine for the treatment of opioid addiction which provides protection until April 2024," said Sunil Bhonsle, President of Titan Pharmaceuticals.  "In addition to our ongoing royalty revenues, we will require additional capital to support the Probuphine development program, and we continue to explore a range of options to access additional funding," he noted.  

"The Probuphine clinical study is ahead of schedule and the board fully supports the plans to maintain this important progress," said Marc Rubin, MD, Executive Chairman of Titan Pharmaceuticals. "We are thankful for the support we have received from the NIH's National Institute on Drug Abuse and continue to be encouraged by the enthusiasm of the investigators and their staff in conducting this study," he added.

Second Quarter 2010 Additional Financial Results

R&D expenses for the second quarter of 2010 were approximately $2.06 million, compared with approximately $0.38 million in the second quarter of 2009.  The increase in R&D expense  primarily reflects the costs of conducting the Phase 3 clinical study of Probuphine and includes $1.6 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 second quarter of 2010 decreased to approximately $1.01 million from approximately $1.39 million in the comparable period of 2009 primarily due to decreases in non-cash stock compensation costs of approximately $0.8 million offset in part by increases in legal and consulting and professional fees of approximately $0.5 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 NIH grant being administered by the National Institute on Drug Abuse (NIDA). Recent and upcoming events include the following:  

• As recently announced, patient enrollment in the Phase 3 study is three months ahead of the original schedule and is expected to be completed in the next few weeks, with study completion expected in early second quarter 2011 with results available in late second quarter 2011.
• Upcoming scientific presentations of Probuphine data:
  • International Society of Addiction Medicine (ISAM), October 2010, Milan, Italy (Probuphine symposium co-sponsored with NIDA)
  • Society for Neuroscience (SfN), November 2010, San Diego, CA (Therapeutic area symposium)

SOURCE Titan Pharmaceuticals, Inc.