On May 05, 2016 Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results for the first quarter of 2016 (Press release, Pain Therapeutics, MAY 5, 2016, View Source [SID:1234512056]). Net loss in Q1 2016 was $5.8 million, or $0.13 per share, compared to a net loss in Q1 2015 of $2.6 million, or $0.06 per share.
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Cash and investments were $28.1 million as of March 31, 2016, with no debt. We continue to expect net cash usage for the first half of 2016 will be approximately $8 million.
"Our focus continues to be on REMOXY and its potential to receive regulatory approval in 2016," said Remi Barbier, Chairman, President & CEO. "The REMOXY PDUFA target action date is September 25, 2016. Between now and then, we look forward to working closely with the FDA during the regulatory review process."
Financial Highlights for Q1 2016
At March 31, 2016, cash and investments were $28.1 million, compared to $31.3 million at December 31, 2015. The Company has no debt.
Net cash used in Q1 2016 was $3.2 million.
Research and development expenses increased to $3.6 million in Q1 2016 from $1.1 million in Q1 2015, primarily due to increased activities related to the REMOXY NDA resubmission. Research and development expenses included non-cash stock-related compensation costs of $0.8 million in Q1 2016 and $0.3 million in Q1 2015.
General and administrative expenses increased to $2.2 million in Q1 2016 from $1.5 million in Q1 2015 primarily due to increased non-cash stock-related compensation costs of $1.0 million in Q1 2016 compared to $0.6 million in Q1 2015.
About REMOXY (oxycodone capsules CII)
REMOXY is a proprietary, abuse-deterrent, oral, extended-release formulation of oxycodone (CII). The proposed indication for this drug candidate is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate." We developed REMOXY to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY’s thick, sticky, high-viscosity formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking. REMOXY targets the $2.5 billion marketplace for long-acting oxycodone. We own exclusive, worldwide rights to REMOXY. The FDA has not yet established the safety or efficacy of REMOXY.
About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, opioid abuse and misuse remains a serious, persistent problem. Nearly 19,000 people died from opioid overdose in 2014, according to the NIH’s National Institute on Drug Abuse. For over a decade, we have 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 tamper with a long-acting opioid formulation, recognizing that no drug or drug formulation can be made abuse-proof.