Oct. 29, 2009 (GlobeNewswire) --
$177.5 Million of Cash and No Debt as of September 30, 2009
REMOXY(R) NDA Resubmission Still Anticipated for 2010
Hematology/Oncology Data Release Expected by Year End
SAN MATEO, Calif., Oct. 29, 2009 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported financial results for the quarter ended September 30, 2009.
Net loss for the quarter ended September 30, 2009 was $1.3 million, or $0.03 per share, compared to net income of $15.2 million, or $0.35 per share, for the third quarter of 2008. As of September 30, 2009, the Company had cash, cash equivalents and marketable securities of $177.5 million, or $4.21 per share, and no debt. Pain Therapeutics still believes its net cash requirement for the full year 2009 will be about $12.0 million.
"We remain excited about prospects for Remoxy in 2010," said Remi Barbier, Chairman, President and Chief Executive Officer of Pain Therapeutics. "Oxycodone abuse is not going away. More than ever, we believe Remoxy represents a potential first-in-class drug to deter common methods of formulation abuse. On the financial front, we continue to closely manage our use of cash. We think maintaining a strong balance sheet will enable us to continue to fund disciplined levels of drug development activities around our two novel therapies in hematology/oncology."
Remoxy Remains Top Priority
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. We are developing Remoxy, and other abuse-resistant painkillers, 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 all
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
an 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.
* In July 2009, King met with the FDA to discuss Remoxy. As a
result of this meeting, King anticipates a resubmission of the
Remoxy NDA in 2010.
* 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 & regulatory
development of Remoxy and three other abuse-resistant pain
medications.
Broad Commitment to Biotechnology
Our corporate strategy is to spend carefully but to keep innovation at the top of our agenda. We are making disciplined investments focused on advancing novel drugs in two important disease areas -- hemophilia and melanoma. We own all commercial rights to these novel drug candidates. We expect to announce new data in both disease areas by year end 2009.
* 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.
* In 2008, we completed a first-in-man clinical study with PTI-188.
In this study, researchers in Israel administered PTI-188 to 12
patients diagnosed with metastatic melanoma. Encouraging data
were observed, as published at the 2008 Meeting of the Society
for Nuclear Medicine.
* In May 2009, we announced the initiation of a new Phase I study
in Israel with PTI-188.