- At December 31, 2017, cash and investments were $10.5 million, compared to $18.7 million for the same period in 2016. We have no debt.
- Net cash used in the year ended December 31, 2017 was $8.2 million.
- We received $1.4 million in research grant funding in the year ended December 31, 2017 from 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, 2017 decreased to $7.6 million, from $9.2 million for 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 million for the year ended December 31, 2017 and $1.8 million for the same period in 2016.
- General and administrative expenses for the year ended December 31, 2017 decreased to $4.3 million, respectively, from $5.8 million for 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 million in the year ended December 31, 2017 and $2.6 million for the same period in 2016.
- 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 FDA for 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 FDA on 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.
|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|