On July 26, 2018 Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company, reported financial results for the second quarter ended June 30, 2018 (Press release, Pain Therapeutics, JUL 26, 2018, View Source [SID1234527905]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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).