Pain Therapeutics Reports 2018 Financial Results and Corporate Update
Historically, our focus was on analgesic drug development. In 2019, however, we will rebrand around neurodegenerative diseases, such as Alzheimer’s disease. Our rebranding plans include a new company name, logo, ticker symbol and website, as well as a comprehensive strategy to bolster media outreach and an active approach to engage with potential new shareholders.
“There’s never been a more exciting time to be in Alzheimer’s research,” said
Overview of Alzheimer’s Program
Over the past ten years, we have developed a new and highly promising scientific approach for the treatment and detection of Alzheimer’s disease. Importantly, our science does not seek to clear amyloid from the brain. Our approach is to stabilize a critical protein in the brain.
Starting with basic research, we have identified a structurally altered protein in the brain, also called a ‘proteopathy’. This proteopathy plays a critical role in the neurodegeneration observed in Alzheimer’s disease. Using scientific insight and advanced tools in biochemistry, bioinformatics and imaging, we have elucidated this protein dysfunction. We engineered a family of high-affinity small molecules to target the structurally altered protein and to restore this protein to its normal shape and function. Our drug candidate, PTI-125, is a small molecule that targets an altered form of a scaffolding protein called filamin A (FLNA). Study animals treated with PTI-125 showed significant improvements in neuronal function and decreases in neuroinflammation, resulting in cognitive improvement and slowing of disease progression.
In 2017, we successfully completed a Phase I clinical study with PTI-125. In 2018, we initiated a Phase IIa study with PTI-125 in patients with mild-to-moderate Alzheimer’s disease, with scientific and financial support from the
We are also developing an experimental biomarker/diagnostic, called PTI-125Dx, to detect Alzheimer’s disease with a simple blood test. This program has financial support from the NIH.
The underlying science for our programs in neurodegeneration is published in several prestigious, peer-reviewed technical journals, including
In addition, in 2018 the
Financial Highlights for 2018
December 31, 2018, cash and cash equivalents were $19.8 million, compared to $10.5 millionin 2017. We have no debt.
- Net cash used in operations during the year ended
December 31, 2018was $4.8 million.
- Research and development expenses for the year ended
December 31, 2018were $3.0 millioncompared to $7.6 millionfor the same period in 2017, or a 61% decrease. This was due primarily to decreases in analgesic drug development related expenses.
- We received reimbursements of
$3.0 million in 2018 from research grants from the NIH that we recorded as a reduction of research and development expense compared to $1.4 million in 2017.
- Research and development expenses included non-cash stock related compensation costs of
$1.0 millionfor the year ended December 31, 2018and $1.2 millionfor the same period in 2017.
- General and administrative expenses for the year ended
December 31, 2018were $3.7 millioncompared to $4.3 millionfor the same period in 2017, or a 15% decrease. This was due primarily to a decrease in non-cash stock-based compensation expenses as well as outside professional fees. General and administrative expenses included non-cash stock-based compensation costs of $1.4 millionin the year ended December 31, 2018and $1.8 millionfor the same period in 2017.
August 17, 2018, we announced the closing of a registered direct offering of 8,860,778 shares of our common stock and issuance of warrants. Total net proceeds from the offering were approximately $10.2 million. In addition, we raised approximately $3.9 millionof net proceeds through our At-The-Market common stock offerings during 2018.
- In August and in
October 2018, we announced that the NIH had awarded us research grants to support a Phase II program with PTI-125, our drug candidate to treat Alzheimer’s disease. Collectively, the NIH grants represent up to $6.7 millionof non-dilutive financing.
Operating Highlights for 2018 and Forecast for 2019
- Historically, our lead drug candidate had been REMOXY, which is the trade name for an abuse-deterrent, extended-release form of oxycodone to treat severe chronic pain.
The U.S. Food and Drug Administration( FDA) has previously found REMOXY to be an effective analgesic drug for the treatment of severe chronic pain. However, FDAhas not approved REMOXY on the basis that additional demonstrations of its abuse deterrent properties are needed, a matter of dispute between us and FDA.
March 20, 2019, we provided Durect Corporationwith written notice of termination of a Development and License Agreement (DLA). Termination of the DLA effectively ends our clinical development of REMOXY.
October 2018, we announced a strategic reorganization to align Company resources on advancing our programs in neurodegenerative diseases, such as Alzheimer’s disease.
December 2018, we announced the initiation of a Phase II study to evaluate PTI-125 in patients with Alzheimer’s disease. This clinical study is supported by a research grant award from the National Institute on Aging of the NIH, the primary Federal agency supporting innovative new research in Alzheimer’s disease.
- In 2019, we expect to rebrand the Company around neurodegeneration. Our rebranding plans include a new company name, logo, ticker symbol, website, as well as a comprehensive strategy to bolster media outreach and an active approach to engage with potential new shareholders.
About Alzheimer's Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Eventually, a person with Alzheimer’s disease may be unable to carry out even simple tasks. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. Alzheimer’s disease is likely to become one of the world’s most serious future health care crisis.
For More Information Contact:
Chief Financial Officer
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, net of grant reimbursement||2||1,544||2,969||7,615|
|General and administrative||748||879||3,693||4,334|
|Total operating expenses||750||2,423||6,662||11,949|
|Net loss per share, basic and diluted||$||(0.04||)||$||(0.37||)||$||(0.61||)||$||(1.82||)|
|Weighted-average shares used in computing net loss per|
|share, basic and diluted||17,162||6,538||10,682||6,537|
|CONDENSED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash, cash equivalents||$||19,807||$||10,479|
|Other current assets||233||184|
|Total current assets||20,040||10,663|
|Other non-current assets||99||168|
|Liabilities and stockholders' equity|
|Accrued development expense||156||399|
|Other accrued liabilities||61||309|
|Total current liabilities||511||1,132|
|Total stockholders' equity||19,628||9,699|
|Total liabilities and stockholders' equity||$||20,139||$||10,831|
Source: Pain Therapeutics, Inc.