- In September, the National Institutes of Health (NIH) awarded us a $1.8 million research grant to develop a blood-based diagnostic to detect Alzheimer's disease.
- In September, The National Institute on Drug Abuse (NIDA) awarded us a $2.2 million research grant to further develop FENROCK, an abuse-deterrent transdermal patch that contains the prescription drug fentanyl.
- In October, we announced a successful Phase I clinical study for PTI-125, our drug candidate for the treatment of Alzheimer's disease. As previously announced, our scientists plan to present full results of this study at the 10 th Annual International Conference on Clinical Trials on Alzheimer's Disease, in Boston, MA, on November 1-4 th.
- In October, we announced the FDA had agreed to a pre-NDA guidance meeting on November 14 th to discuss the upcoming resubmission of an NDA for REMOXY ER. We will provide details of this FDA meeting after receipt of final meeting minutes.
- Recently, we substantially completed a previously announced human nasal study with REMOXY ER. We plan to announce top-line results of this study by yearend 2017.
- At September 30, 2017, cash and investments were $11.9 million, compared to $14.1 million at June 30, 2017. The Company has no debt.
- Net cash used during the three months ended September 30, 2017 was $2.2 million.
- Research and development expenses for the three months ended September 30, 2017 decreased to $1.6 million, respectively, from $2.7 million for the same period in 2016, primarily due to decreases in REMOXY related expenses and the receipt of research grant funding from the National Institutes of Health for FENROCK and PTI-125, recorded as a reduction in research and development expenses activities. Research and development expenses included non-cash stock-related compensation of $0.3 million in both three months ended September 30, 2017 and 2016.
- General and administrative expenses increased slightly to $1.0 million in the three months ended September 30, 2017 from $0.9 million for the same period in 2016. General and administrative expenses included non-cash stock-related compensation of $0.4 million in the three months ended September 30, 2017 compared to $0.5 million for same period in 2016.
REMOXY ER - (extended-release oxycodone capsules) Proprietary abuse-deterrence, twice-daily oxycodone targeted at severe chronic pain. NDA resubmission planned for Q1 2018.PTI-125 Rx - Proprietary small molecule drug targeted at the treatment of Alzheimer's disease. Phase I clinical-stage program, substantially funded by a research grant award from the NIH. PTI-125 Dx - Blood-based diagnostic to detect Alzheimer's disease. Early-stage program, substantially funded by a research grant award from the NIH. FENROCK - (transdermal fentanyl patch system) Proprietary abuse-deterrent skin patch to treat severe pain. Early-stage program, substantially funded by a research grant award from National Institute on Drug Abuse. NOTE: REMOXY ™ ER and FENROCK ™ are trademarks of Pain Therapeutics, Inc. Important 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, statements regarding our projected cash usage in CY2017 and CY2018, statements regarding potential discussions with the FDA and the abuse-deterrent properties and potential benefits of REMOXY ER. Such statements are based on management's current expectations but actual results may vary materially due to various factors, many of which are beyond the control of management. Drug development involves substantial risks and uncertainties, including but not limited to those risks and uncertainties relating to successfully completing the activities required to address the issues raised by the FDA in the September 2016 Complete Response Letter for REMOXY ER and the time required to do so, including the time required to reach resolution with the FDA on the scope of the appropriate actions to be undertaken and the possibility that the FDA may raise additional issues in the future that were not raised in the past. In addition, the development of abuse-deterrent drug products is a young and still emerging area of drug development, with regulatory guidance that may be inconsistent, unclear or still in development. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. 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)|
|Three months ended September 30,||Nine months ended September 30,|
|Research and development||$||1,619||$||2,657||$||6,071||$||7,841|
|General and administrative||977||884||3,455||4,573|
|Total operating expenses||2,596||3,541||9,526||12,414|
|Net loss per share, basic and diluted||$||(0.40||)||$||(0.54||)||$||(1.45||)||$||(1.89||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||6,538||6,535||6,537||6,515|
|CONDENSED BALANCE SHEETS|
|September 30, 2017||December 31, 2016|
|Cash, cash equivalents and marketable securities||$||11,916||$||18,714|
|Other current assets||288||356|
|Total current assets||12,204||19,070|
|Liabilities and stockholders' equity|
|Accounts payable and accrued development expenses||$||712||$||330|
|Other accrued liabilities||298||335|
|Total current liabilities||1,010||665|
|Common Stock and additional paid-in-capital||166,349||164,125|
|Accumulated other comprehensive income||—||—|
|Total stockholders' equity||11,367||18,637|
|Total liabilities and stockholders' equity||$||12,377||$||19,302|