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Pain Therapeutics Reports Q2 2015 Financial Results

Company is Focused on REMOXY NDA Resubmission, Targeted for Q1 2016

AUSTIN, Texas, July 23, 2015 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the quarter ended June 30, 2015. Net loss in Q2 2015 was $3.4 million, or $0.07 per share, compared to a net loss in Q2 2014 of $3.2 million, or $0.07 per share. Cash and investments were $37.3 million at June 30, 2015. The Company continues to expect net cash usage in 2015 may be approximately $12 million.

"Results this quarter reflect our intense focus on REMOXY", said Remi Barbier, President & CEO. "We believe REMOXY and FENROCK, our abuse deterrent fentanyl pain patch, may well represent the most exciting pipeline of abuse-deterrent products in the industry. It is a rare opportunity these days to have an unencumbered, proprietary and differentiated portfolio of drugs, with a lengthy period of exclusivity, that fits precisely into a therapeutic focus on pain."

REMOXY Highlights for Q2 2015

Financial Highlights for Q2 2015

Other Highlights for Q2 2015

We are also developing FENROCK, a proprietary abuse deterrent transdermal pain patch (fentanyl).  We recently conducted proof-of-concept studies with FENROCK. Results from these studies may be announced in the second half of 2015, depending on the timing of certain intellectual property filings related to this drug candidate. We own all world-wide commercial rights to FENROCK. 

In the second half of 2015, we expect to announce a major new drug development initiative for CNS diseases. Our undisclosed new drug candidate was developed in-house in cooperation with academic researchers, and targets a large, non-pain, underserved chronic market.  We own all world-wide commercial rights to this drug candidate. In connection with this program, we also expect to also announce a new, non-dilutive source of funding that is intended to fund IND-enabling activities for our undisclosed new drug candidate.

About REMOXY®

We own world-wide commercial rights to our lead drug candidate, REMOXY Extended-Release Capsules CII, a unique, twice-a-day formulation of oral oxycodone. REMOXY's intended indication is for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time and for which alternative treatments are inadequate. REMOXY's high viscosity formulation is specifically intended to discourage certain common methods of drug tampering and misuse, such as injection and snorting. The REMOXY NDA is supported by multiple clinical trials, including a successful Phase III efficacy program that was conducted under a Special Protocol Assessment.

About Pain Therapeutics, Inc.

Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. The FDA has not approved our drug candidates for commercial sale. For more information, please visit www.paintrials.com.

Note Regarding Forward-Looking Statements:This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Pain Therapeutics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, our projected net cash usage in 2015; information and specific contents of an acceptable resubmission of the REMOXY New Drug Application, and the timing of such resubmission.  Such statements are based on management's current expectations, but actual results may differ materially due to various factors.  Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in the return of REMOXY to us in connection with the termination of the Collaboration Agreement with our former corporate partner; difficulties or delays in completion of non-clinical activities for REMOXY and development and testing of our other drug candidates; unexpected adverse side effects or inadequate therapeutic efficacy of our drug candidates; the uncertainty of patent protection for our intellectual property or trade secrets; unanticipated additional research and development, litigation and other costs; and the potential for abuse-deterrent pain medications or other competing products to be developed by competitors and potential competitors or others. For further information regarding these and other risks related to our business, investors should consult our filings with the U.S. Securities and Exchange Commission.

- Financial Tables Follow -

PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
       
  Three months ended June 30, Six months ended June 30,
  2015 2014 2015 2014
Operating expenses         
Research and development   $1,986  $1,935 $3,124  $4,081
General and administrative   1,401  1,322  2,858  2,639
Total operating expenses   3,387  3,257  5,982  6,720
Operating loss   (3,387)  (3,257)  (5,982)  (6,720)
Interest income   13  11  25  25
Net loss   $(3,374)  $(3,246)  $(5,957)  $(6,695)
         
Net loss per share, basic and diluted  $(0.07)  $(0.07)  $(0.13)  $(0.15)
         
Weighted-average shares used in computing net loss per share, basic and diluted  45,356  45,247  45,356  45,187
       
         
CONDENSED BALANCE SHEETS
(in thousands)  
      June 30,
2015
December 31,
2014(1)
      (Unaudited)  
 Assets         
Current assets         
Cash, cash equivalents and marketable securities       $37,302  $40,590
Other current assets       200  239
Total current assets       37,502  40,829
Other assets       254  77
Total assets       $37,756  $40,906
Liabilities and stockholders' equity         
Current liabilities         
Accounts payable and accrued development expenses       $913  $198
Other accrued liabilities       900  652
Total current liabilities       1,813  850
Non-current liabilities       —  —
Total liabilities       1,813  850
Stockholders' equity         
Common Stock and additional paid-in-capital       158,392  156,548
Accumulated other comprehensive income       1  1
Accumulated deficit       (122,450)  (116,493)
Total stockholders' equity       35,943  40,056
Total liabilities and stockholders' equity       $37,756  $40,906
     
(1)     Derived from the Company's annual financial statements as of December 31, 2014, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission.
CONTACT: Peter S. Roddy

         Vice President and Chief Financial Officer

         Pain Therapeutics, Inc.

         proddy@paintrials.com

         (512) 501-2450

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