Pain Therapeutics reports net loss of $1.0 million for first-quarter 2010

Apr 29 2010

- $176 Million of Cash, No Debt -

- Cash Requirement in 2010 Under $10 Million -

- REMOXY^® NDA Resubmission Still Anticipated Q4 2010 -

Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported first quarter 2010 financial results. Net loss for Q1 2010 was $1.0 million, or $0.02 per share, compared to a net loss of $1.8 million, or $0.04 per share, for Q1 2009. 

At March 31, 2010 Pain Therapeutics had cash and cash equivalents of $175.5 million, or about $4.12 per share, no debt and approximately 42.6 million shares outstanding. We continue to expect our net cash requirement in 2010 will be under $10.0 million.

"Pain Therapeutics continues to make meaningful advancements across its business," said Remi Barbier, chairman, president and chief executive officer of Pain Therapeutics. "Importantly, our commercial partner for REMOXY, King Pharmaceuticals, Inc. continues to guide for a year-end resubmission of a New Drug Application for REMOXY."

"In melanoma, we recently released encouraging Phase I clinical data and we continue to engage in licensing discussions with potential collaborators around this program," said Remi Barbier. 

"In hemophilia, our exploratory preclinical studies are now largely completed. We continue to work with leading academic centers to optimize a delivery system for our potential treatment for hemophilia."

"Financially, we continue to run the business with tight fiscal discipline. We expect our net cash requirement in 2010 will be under $10.0 million."

"This is an exciting time for Pain Therapeutics. We are advancing late-stage and early-stage drug development programs in important disease areas as we continue to strengthen our business," Mr. Barbier concluded. 

REMOXY

Pain Therapeutics remains committed to the regulatory success of REMOXY, our lead drug candidate. REMOXY is a strong painkiller with a unique formulation designed to reduce potential risks of unintended use. REMOXY and other abuse-resistant painkillers are being developed pursuant to a strategic alliance we have with King Pharmaceuticals, Inc. We believe REMOXY represents the rare combination of a well-partnered, late-stage drug asset with a unique profile, and whose clinical efficacy has been substantially de-risked.

• Pursuant to the terms of a strategic alliance, King funds our development expenses incurred by us for REMOXY and three other abuse-resistant pain medications.
   
• From 2005 to 2008, we and King jointly managed a Phase III clinical program and New Drug Application (NDA) for REMOXY. In mid-2008, the U.S. Food and Drug Administration (FDA) accepted and NDA for REMOXY with Priority Review.
   
• In December 2008, we received from the FDA a Complete Response Letter which indicated additional non-clinical data is required to support the approval of REMOXY. The FDA has not requested or recommended additional clinical efficacy studies prior to approval.
   
• In March 2009, King assumed sole responsibility for the regulatory approval of REMOXY. This shift of responsibility does not change the economic terms of our strategic alliance with King.
   
• Upon FDA approval of REMOXY, we will receive a $15.0 million cash milestone payment and a running royalty equal to 20% of net sales of drugs developed under this strategic alliance, except as to the first $1.0 billion in cumulative net sales, which royalty is set at 15%.
   
• To date, King has made milestone payments to us of $25.0 million. We could receive from King up to $125.0 million in additional milestone payments in the course of the clinical and regulatory development of REMOXY and three other abuse-resistant pain medications.

Hematology/Oncology

Our corporate strategy is to spend carefully but to keep innovation at the top of our agenda. In Q1 2010, we continued to make disciplined investments in two important disease areas — hemophilia and melanoma.  We own commercial rights to all of our drug candidates in hematology/oncology.

• A radio-labeled monoclonal antibody program, developed at Albert Einstein College of Medicine, is aimed at treating patients with late-stage (metastatic) melanoma. This drug candidate is called PTI-188.
   
• On March, 2010, we announced encouraging clinical data with PTI-188 in metastatic melanoma. Although efficacy was not a primary endpoint, PTI and its clinical investigators were encouraged by the number of melanoma tumors that had either stabilized or decreased in size after a single dose of PTI-188. Preliminary analysis, combining two Phase I studies, indicated a median overall survival time of 13 months>  
• We have a gene transfer program, developed at Stanford University, aimed at correcting an underlying genetic defect in patients with hemophilia. Importantly, no viral vector is utilized. 

Q1 2010 Financial Results

• Collaboration revenue for Q1 2010 was $0.7 million, compared to $3.2 million for Q1 2009, and reflects reimbursement of our development expenses under our strategic alliance with King.
   
• Research and development expenses for Q1 2010 decreased to $3.1 million from $7.6 million for Q1 2009. This decrease was mostly due to decreased spending by us for REMOXY under our strategic alliance with King. Research and development expenses included non-cash stock-related compensation of $0.8 million for Q1 2010 and $1.1 million for Q1 2009.
   
• General and administrative expenses for Q1 2010 decreased to $1.5 million from $1.7 million for Q1 2009. This decrease was mostly due to lower operating costs. General and administrative expenses included non-cash stock-related compensation of $0.6 million for Q1 2010 and $0.5 million for Q1 2009.
   
• We received a $2.2 million federal tax refund in Q1 2010.
   
• Interest income for Q1 2010 decreased to $0.3 million from $0.4 million for Q1 2009. This decrease was primarily due to decreases in prevailing interest rates on investments.