Pain Therapeutics Reports 2017 Financial Results and Corporate Update
– 2018 Focus will be on REMOXY, Fiscal Discipline and Advancing Pipeline –
Net cash used during the year ended
“In 2018, our focus will be on REMOXY and its potential to receive marketing clearance this year,” said
Financial Highlights for 2017
December 31, 2017, cash and investments were $10.5 million, compared to $18.7 millionfor the same period in 2016. We have no debt.
- Net cash used in the year ended
December 31, 2017was $8.2 million.
- We received
$1.4 millionin research grant funding in the year ended December 31, 2017from the National Institutes of Health(NIH) that we recorded as a reduction to our research and development expenses.
- Research and development expenses for the year ended
December 31, 2017decreased to $7.6 million, from $9.2 millionfor the same period in 2016, primarily due to decreases in REMOXY® ER (oxycodone CII) related expenses and non-cash stock related compensation costs as compared to the same period in 2016. Research and development expenses included non-cash stock related compensation costs of $1.2 millionfor the year ended December 31, 2017and $1.8 millionfor the same period in 2016.
- General and administrative expenses for the year ended
December 31, 2017decreased to $4.3 million, respectively, from $5.8 millionfor the same period in 2016, primarily due to a decrease in non-cash stock related compensation costs as compared to the same period in 2016. General and administrative expenses included non-cash stock-related compensation costs of $1.8 millionin the year ended December 31, 2017and $2.6 millionfor the same period in 2016.
Operating Highlights for 2017
- In Q4, we concluded a ‘pre-NDA’ meeting with the
U.S. Food and Drug Administration( FDA), which gives us regulatory clearance to resubmit the New Drug Application (NDA) for REMOXY in Q1 2018 with Priority (six-month) Review.
- In Q4, we concluded a successful nasal abuse potential study with REMOXY, whereby peak oxycodone concentrations (Cmax) were at least 4-fold lower for REMOXY compared to crushed OxyContin® ER (oxycodone HCl) or oxycodone immediate-release (p<0.01).
- In Q4, we concluded a series of successful in vitro studies comparing the abuse potential of REMOXY to OxyContin® ER and Xtampza® ER (oxycodone) in various household liquids.
- In Q2, we filed an Investigational New Drug (IND) application with the
FDAfor PTI-125, a small molecule drug to treat Alzheimer’s disease. In Q4, we announced successful results of a first-in-human, Phase I clinical study with PTI-125.
- In Q2 and in Q4, we announce new scientific publications in peer-reviewed journals regarding our program in Alzheimer’s disease.
- In Q1, we announced written agreement was reached with the
FDAon additional studies needed for REMOXY’s regulatory approval.
- Throughout 2017, we announced that the
National Institutes of Health(NIH) had awarded us research grants following a competitive, peer-reviewed evaluation of our technology for scientific and technical merit. Research awards included a grant to develop a simple blood-test to detect Alzheimer’s disease; a grant to study PTI-125, our clinical drug candidate to treat Alzheimer’s disease; and a grant to further develop FENROCK, an abuse-deterrent transdermal patch.
Our Pipeline of Drug Assets Includes:
REMOXY ER (extended-release oxycodone CII) – Proprietary abuse-deterrent, twice-daily, oral oxycodone capsules for severe chronic pain. NDA resubmission remains on-track for resubmission to the
FENROCK™ (transdermal fentanyl patch system) – Proprietary abuse-deterrent skin patch for severe pain. Early-stage program, substantially funded by a research grant award from
PTI-125 – Proprietary small molecule drug for the treatment of Alzheimer’s disease. Phase I clinical-stage program, substantially funded by a research grant award from the
PTI-125Dx – Blood-based diagnostic/biomarker to detect Alzheimer’s disease. Early-stage program, substantially funded by a research grant award from the NIH.
We own worldwide commercial rights to all of our drug assets.
About REMOXY ER (extended-release oxycodone capsules CII)
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. 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 gel-cap formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking.
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. Drug overdose deaths exceeded 64,000 in 2016, according to the
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|
|(unaudited, in thousands, except per share amounts)|
|Three Months Ended||Years Ended|
|December 31,||December 31,|
|Research and development||1,544||1,335||7,615||9,176|
|General and administrative||879||1,208||4,334||5,781|
|Total operating expenses||2,423||2,543||11,949||14,957|
|Net loss per share, basic and diluted||$||(0.37||)||$||(0.39||)||$||(1.82||)||$||(2.28||)|
|Weighted-average shares used in computing net loss per|
|share, basic and diluted||6,538||6,535||6,537||6,520|
|CONDENSED BALANCE SHEETS|
|Cash, cash equivalents||$||10,479||$||16,615|
|Other current assets||184||356|
|Total current assets||10,663||19,070|
|Other non-current assets||168||232|
|Liabilities and stockholders' equity|
|Accrued development expense||399||27|
|Other accrued liabilities||309||335|
|Total current liabilities||1,132||665|
|Accumulated other comprehensive income||—||—|
|Total stockholders' equity||9,699||18,637|
|Total liabilities and stockholders' equity||$||10,831||$||19,302|
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Source: Pain Therapeutics, Inc.