UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form 8-K
_____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): July 26, 2018
Pain Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 000-29959 | 91-1911336 |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) |
| 7801 N Capital of Texas Highway, Suite 260, Austin, TX 78731 |
| (Address of Principal Executive Offices) (Zip Code) |
512-501-2444
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
| Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | ||
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 2.02. Results of Operations and Financial Condition.
On July 26, 2018, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Pain Therapeutics, Inc. | ||
| Date: July 26, 2018 | By: | /s/ Remi Barbier |
| Remi Barbier | ||
| Chairman of the Board of Directors, President and Chief Executive Officer | ||
EXHIBIT 99.1
Pain Therapeutics Reports Second Quarter 2018 Financial Results
AUSTIN, Texas, July 26, 2018 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company, today reported financial results for the second quarter ended June 30, 2018. Net loss was $2.5 million, or $0.36 per share. This compared to a net loss of $4.2 million, or $0.64 per share, for the same period in the prior year. Cash and cash equivalents were $9.6 million as of June 30, 2018, with no debt.
The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target date of August 7, 2018 for the New Drug Application (NDA) for REMOXY ER, the Company’s lead product drug candidate, which is a unique, abuse-deterrent, twice-daily formulation of extended-release oxycodone.
On June 26, 2018, an FDA Advisory Committee voted 14-to-3 against REMOXY ER. The purpose of an Advisory Committee is to provide advice; however, FDA makes all final regulatory decisions.
Financial Highlights for Second Quarter 2018
- Net loss for the quarter was $2.5 million, or a net loss per share of $0.36. This compared to a net loss of $4.2 million, or $0.64 per share, for the same period in the prior year, representing a 41% decrease.
- Cash and cash equivalents were $9.6 million at June 30, 2018. This compared to $10.7 million in the prior quarter, representing a 10% decrease. We have no debt.
- We believe existing capital resources are sufficient to meet our projected operating requirements for at least the next 12 months.
- We received $0.4 million in research grant funding from the National Institutes of Health, recorded as a reduction in research and development expenses (R&D).
- R&D expenses were $1.5 million. This compared to $3.1 million for the same period in the prior year, representing a 52% decrease. R&D expenses included non-cash stock related compensation costs of $0.3 million for both current period and the prior year period.
- General and administrative (G&A) expenses were $1.0 million. This compared to $1.1 million for the same period in the prior year, representing a 10% decrease. G&A expenses included non-cash stock-related compensation costs of $0.4 million for both current period and the prior year period.
About REMOXY ER (extended-release oxycodone capsules CII)
REMOXY ER is in registration with the US Food and Drug Administration (FDA) as a new type of abuse-deterrent, twice-daily, capsule gel formulation of oral oxycodone, a strong opioid drug. REMOXY ER has physical/chemical properties intended to deter abuse and still provide 12 hours of steady pain relief when properly prescribed by physician and used appropriately by patients. REMOXY ER intends to address the public health epidemic related to prescription opioids by advancing the science of abuse deterrence, providing an additional treatment option for physicians and patients, and increasing the range of available abuse deterrent technologies.
About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remain serious, persistent problems. Opioid overdose deaths exceeded 64,000 in 2016, according to the Center for Disease Control (CDC). For over a decade, Pain Therapeutics has pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it more difficult, longer or aversive to abuse long-acting opioid formulations, recognizing that no drug can be made abuse-proof.
Our Pipeline of Drug Assets also Includes:
PTI-125 – This proprietary, small molecule drug candidate is aimed at the treatment of Alzheimer’s disease. In 2018, we completed a successful Phase I study with PTI-125. The study was substantially funded by a research grant award from the National Institutes of Health (NIH).
PTI-125DX – This is a proprietary blood-based test to detect Alzheimer’s disease. PTI-125DX is an early-stage program, substantially funded by a research grant award from the NIH.
FENROCK™ (transdermal fentanyl patch system) – This is a proprietary, abuse-deterrent skin patch for severe pain. FENROCK is an early-stage program, substantially funded by a research grant award from National Institute on Drug Abuse (NIDA).
About Pain Therapeutics, Inc.
We develop proprietary drugs that offer significant improvements to patients and physicians. Our expertise consists of developing new drugs and guiding these through various regulatory and development pathways in preparation for their eventual commercialization. We generally focus our drug development efforts around disorders of the nervous system. The FDA has not yet established the safety or efficacy of our drug candidates.
NOTE: REMOXY® ER and FENROCK™ are trademarks of Pain Therapeutics, Inc.
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 the Company’s financial future; the abuse deterrent properties of REMOXY ER; the PDUFA target action date for the FDA; the potential approval by the FDA of REMOXY ER; or the therapeutic and commercial value, if any, of our drug assets. The Company cautions that forward-looking statements are inherently uncertain. 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 development and testing of our 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; the need to raise additional funding from time-to-time, and the potential for abuse-deterrent pain medications or other competing products to be developed by competitors and potential competitors or others. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. 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 (SEC), which are available for free on the SEC's website at www.sec.gov.
– 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, | ||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||
| Operating expenses | |||||||||||||||
| Research and development | $ | 1,463 | $ | 3,063 | $ | 2,532 | $ | 4,452 | |||||||
| General and administrative | 998 | 1,103 | 2,097 | 2,478 | |||||||||||
| Total operating expenses | 2,461 | 4,166 | 4,629 | 6,930 | |||||||||||
| Operating loss | (2,461 | ) | (4,166 | ) | (4,629 | ) | (6,930 | ) | |||||||
| Interest income | 9 | 6 | 16 | 27 | |||||||||||
| Net loss | $ | (2,452 | ) | $ | (4,160 | ) | $ | (4,613 | ) | $ | (6,903 | ) | |||
| Net loss per share, basic and diluted | $ | (0.36 | ) | $ | (0.64 | ) | $ | (0.68 | ) | $ | (1.06 | ) | |||
| Weighted-average shares used in computing net loss per share, basic and diluted | 6,838 | 6,537 | 6,739 | 6,536 | |||||||||||
| CONDENSED BALANCE SHEETS | |||||||||||||||
| (in thousands) | |||||||||||||||
| (Unaudited) | |||||||||||||||
| June 30, 2018 | December 31, 2017 | ||||||||||||||
| Assets | |||||||||||||||
| Current assets | |||||||||||||||
| Cash, cash equivalents and marketable securities | $ | 9,608 | $ | 10,479 | |||||||||||
| Other current assets | 91 | 184 | |||||||||||||
| Total current assets | 9,699 | 10,663 | |||||||||||||
| Other assets | 134 | 168 | |||||||||||||
| Total assets | $ | 9,833 | $ | 10,831 | |||||||||||
| Liabilities and stockholders' equity | |||||||||||||||
| Current liabilities | |||||||||||||||
| Accounts payable and accrued development expenses | $ | 962 | $ | 823 | |||||||||||
| Other accrued liabilities | 325 | 309 | |||||||||||||
| Total current liabilities | 1,287 | 1,132 | |||||||||||||
| Non-current liabilities | — | — | |||||||||||||
| Total liabilities | 1,287 | 1,132 | |||||||||||||
| Stockholders' equity | |||||||||||||||
| Common Stock and additional paid-in-capital | 170,558 | 167,098 | |||||||||||||
| Accumulated other comprehensive income | — | — | |||||||||||||
| Accumulated deficit | (162,012 | ) | (157,399 | ) | |||||||||||
| Total stockholders' equity | 8,546 | 9,699 | |||||||||||||
| Total liabilities and stockholders' equity | $ | 9,833 | $ | 10,831 | |||||||||||
For More Information Contact:
Ruth Araya
Pain Therapeutics, Inc.
IR@paintrials.com
(512) 501-2485