SAN MATEO, Calif., April 30, 2009 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported financial results for the quarter ended March 31, 2009. Net loss for the quarter ended March 31, 2009 was $1.8 million, or $0.04 per diluted share, compared to net income of $2.6 million, or $0.06 per diluted share, for the first quarter of 2008.
"We recognize the importance of managing our balance sheet very carefully in this difficult macroeconomic environment," said Remi Barbier, president & chief executive officer of Pain Therapeutics. "Our strategy is to spend carefully but to keep innovation at the top of our agenda. Our immediate goals are to maintain regulatory momentum for Remoxy and to significantly advance our hematology/oncology programs."
At March 31, 2009, Pain Therapeutics had $185.6 million in cash, no debt and approximately 42.1 million shares outstanding, or $4.41 of cash per share. Net cash requirements in 2009 are still expected to be approximately $10 million, which includes a significant investment in the growth of its biotech pipeline.
Q1 2009 Financial and Operating Update
* We reiterate existing regulatory guidance for REMOXY. The U.S.
Food and Drug Administration (FDA) believes additional non-clinical
data will be required to support the approval of REMOXY. The FDA
has not requested or recommended additional clinical efficacy
studies prior to approval.
* As previously disclosed, regulatory responsibility for FDA approval
of REMOXY was recently shifted to King Pharmaceuticals, Inc. King
plans to meet with the FDA in mid-2009. This FDA meeting should
provide a more reliable context in which to make projections about
REMOXY.
* There are no changes to the economic terms of our strategic
alliance with King. Pursuant to the terms of a strategic alliance,
King will continue to fund development expenses incurred by us for
REMOXY and three other abuse-resistant pain medications. 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%.
* We retain all commercial rights to our biotech pipeline, which
includes a clinical-stage treatment for melanoma and a pre-clinical
program to cure hemophilia.
* In melanoma, we are developing a radio-labeled monoclonal antibody
program for patients with late-stage melanoma. We expect to
complete a second Phase I study with this technology in 2009. We
are also exploring the use of similar technology to treat other
important disease areas.
* In hemophilia, we are developing a biological agent aimed at
correcting an underlying genetic defect in patients with hemophilia.
We expect to complete a significant pre-clinical study with this
technology in 2009.
* In order to focus on the growth of our biotech pipeline, in Q1 2009
we discontinued the development of Oxytrex(tm) and reverted rights
to this drug to Albert Einstein College of Medicine.
* Collaboration revenue for Q1 2009 was $3.2 million, compared to
$11.1 million for Q1 2008 and reflects reimbursement of our
development expenses under our strategic alliance with King.
* Research and development expenses for Q1 2009 decreased to $7.6
million from $12.5 million for Q1 2008. This decrease was mostly
due to decreased spending for REMOXY and the other abuse-resistant
product candidates under our strategic alliance with King.
Research and development expenses included non-cash stock-related
compensation costs of $1.1 million for Q1 2009 and $1.0 million for
Q1 2008.
* General and administrative expenses for Q1 2009 decreased to $1.7
million from $1.8 million for Q1 2008. This decrease was mostly
due to lower operating costs.