Pain Therapeutics Reports First Quarter 2018 Financial Results and Provides Corporate Update on REMOXY® ER
“FDA’s acceptance of the NDA filing for REMOXY ER in Q1 2018 is a milestone,” said
Financial Highlights for First Quarter 2018
- Net loss for the quarter was
$2.2 million, or a net loss per share of $0.33. This compared to a net loss of $2.7 million, or $0.42per share, for the same period in the prior year, representing a 19% decrease.
- Cash and cash equivalents were
$10.7 million. This compared to $10.5 millionin the prior quarter, representing a 2% increase. Cash and cash equivalents for the quarter includes $1.9 millionof net proceeds raised through issuance of shares of our common stock under a Capital on DemandTM program with JonesTrading Institutional Services LLC.
- 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 millionin research grant funding from the National Institutes of Health, recorded as a reduction in research and development expenses (R&D).
- R&D expenses were
$1.1 million. This compared to $1.4 millionfor the same period in the prior year, representing a 23% decrease. R&D expenses included non-cash stock related compensation costs of $0.4 million, versus $0.3 millionfor the same period in the prior year.
- General and administrative (G&A) expenses were
$1.1 million. This compared to $1.4 millionfor the same period in the prior year, representing a 20% decrease. G&A expenses included non-cash stock-related compensation costs of $0.5 million, versus $0.5 millionfor the same period in the prior year.
About REMOXYER (extended-release oxycodone capsules CII)
REMOXY ER is in registration with the
Studies were extensive. The clinical efficacy of REMOXY ER was established in a Phase III study conducted under a Special Protocol Assessment. In total, over 2,400 subjects were exposed to REMOXY ER in 30 clinical studies. 9,000 unique data points were generated from 11 lab studies. The assessment of REMOXY ER’s abuse deterrence is supported by data from FDA Category 1 (lab), Category 2 (pharmacokinetic) and Category 3 (human abuse potential) studies. In addition, in
REMOXY ER has a thick, sticky, high viscosity, hydrophobic, gel formulation that abusers cannot cut, grate or divide into smaller discrete particle sizes. The gel formulation resists syringe-ability, injection, and rapid extraction in ingestible solvents. REMOXY ER’s high viscosity and adhesive properties also cause it to stick to tools and equipment used for abuse. When exposed to heat, REMOXY ER releases an irritant to the eyes and lungs. REMOXY ER resists dose-dumping when challenged by alcohol and common physical and chemical manipulations.
We are requesting marketing approval of REMOXY ER as an analgesic drug with properties that can be expected to deter against injection, snorting and inhalation/smoking routes of abuse.
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
Our Pipeline of Drug Assets also Includes:
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
PTI-125 – This proprietary, small molecule drug candidate is aimed at the treatment of Alzheimer’s disease. PTI-125 is a Phase I clinical-stage program, substantially funded by a research grant award from the
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.
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
NOTE: REMOXY® ER and FENROCK™ are trademarks of
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").
– Financial Tables Follow –
|PAIN THERAPEUTICS, INC.|
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
|Three months ended March 31,|
|Research and development||$||1,068||$||1,388|
|General and administrative||1,099||1,376|
|Total operating expenses||2,167||2,764|
|Net loss per share, basic and diluted||$||(0.33||)||$||(0.42||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||6,638||6,535|
|CONDENSED BALANCE SHEETS|
|Cash, cash equivalents and marketable securities||$||10,734||$||10,479|
|Other current assets||155||184|
|Total current assets||10,889||10,663|
|Liabilities and stockholders' equity|
|Accounts payable and accrued development expenses||$||439||$||823|
|Other accrued liabilities||319||309|
|Total current liabilities||758||1,132|
|Common Stock and additional paid-in-capital||169,859||167,098|
|Accumulated other comprehensive income||—||—|
|Total stockholders' equity||10,300||9,699|
|Total liabilities and stockholders' equity||$||11,058||$||10,831|
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Source: Pain Therapeutics, Inc.