Pain Therapeutics Reports Third Quarter 2018 Financial Results
- Phase IIa Study Initiation On-track for Q4 2018 -
“We are quite excited to advance our drug candidate for Alzheimer’s disease into a Phase IIa study,” said
Financial Highlights for Third Quarter 2018
- Net loss was
$1.3 millioncompared to $2.6 millionfor the same period in the prior year, representing a 51% decrease. Net loss per share was $0.11compared to $0.40for the same period in the prior year.
- Cash and cash equivalents were
$20.4 millionas of September 30, 2018, compared to $9.6 millionas of June 30, 2018. Cash and cash equivalents at September 30, 2018included $10.3 millionof net proceeds raised through a sale of common stock and issuance of warrants and $2.0 millionof net proceeds raised through our At-The-Market common stock offerings. We have no debt outstanding.
- We received research grant funding reimbursements of
$1.1 millionfrom the National Institutes of Health(“NIH”) and recorded this as a reduction in research and development expenses (“R&D”). This compared to $0.8 millionof NIH grant receipts received for the same period in the prior year.
- R&D expenses were
$0.4 million. This compared to $1.6 millionfor the same period in the prior year, representing a 73% decrease. R&D expenses included non-cash stock related compensation costs of $0.2 million, compared to $0.3 millionfor same period in the prior year.
- General and administrative (“G&A”) expenses were
$0.8 million. This compared to $1.0 millionfor the same period in the prior year, representing a 13% decrease. G&A expenses included non-cash stock-related compensation costs of $0.3 million, compared to $0.4 millionfor the same period in the prior year.
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 $10.3 million.
- 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, these two NIH grants represent up to $6.7 millionof non-dilutive financing.
Third Quarter Developments
- Our lead drug candidate has historically been REMOXY, a proprietary abuse-deterrent, extended-release form of oxycodone to treat severe chronic pain. On
August 3, 2018, we received a Complete Response Letter (“CRL”) from the Food and Drug Administration(“FDA”) for our New Drug Application (“NDA”) for REMOXY, stating that the data submitted in the NDA does not support the conclusion that the benefits of REMOXY outweigh the risks.
- Based on data, we disagree with the FDA’s actions around REMOXY. Consequently, a formal dispute may arise between ourselves and the FDA. The
FDAhas in-place an administrative process to resolve complex scientific/medical disputes, which is called a Formal Dispute Resolution (“FDR”). Pending further discussions with the FDA, we may or may not chose to appeal the REMOXY CRL through an FDR or take other measures. If we appeal there can be no assurance that such appeal will satisfactorily resolve any scientific/medical disputes between ourselves and the FDA.
- If we do not prevail in an FDR, or if we chose not to pursue an FDR, we may immediately cease development of REMOXY.
October 2, 2018, we announced a strategic reorganization to align Company resources on advancing our drug and diagnostic pipeline in Alzheimer’s disease. On October 4, 2018, we provided details of our neuroprotection program during a conference call and presentation.
October 11, 2018, we announced the appointment of Mr. Eric Schoenas Chief Financial Officer, effective on or before November 7, 2018.
About the Neuroprotection Program
Our lead drug candidate, PTI-125, is a small molecule with a unique mechanism of action for treating Alzheimer’s disease (“AD”). We expect to initiate a Phase IIa study with PTI-125 in AD in Q4 2018.
The underlying science for PTI-125 is published in prestigious peer-reviewed journals, including
We are also developing a blood-based test, called PTI-125Dx, to detect whether a person has Alzheimer’s disease, possibly years before any symptoms appear. An early diagnosis of AD could optimize treatment options and empower physicians and patients to slow or halt the disease.
About Alzheimer's Disease
Alzheimer’s Disease (AD) is a progressive brain disorder that destroys memory and thinking skills. Eventually, a person with AD may be unable to carry out even the simplest tasks. There is a profound and timely need to develop new drugs for Alzheimer’s. Currently, there are no drug therapies to halt Alzheimer’s, much less reverse its course.
We develop proprietary drugs and diagnostics that offer significant improvements to patients and physicians. Our expertise consists of developing new products and guiding these through various regulatory and development pathways in preparation for their eventual commercialization. The
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 September 30,||Nine months ended September 30,|
|Research and development||$||436||$||1,619||$||2,967||$||6,071|
|General and administrative||848||977||2,945||3,455|
|Total operating expenses||1,284||2,596||5,912||9,526|
|Net loss per share, basic and diluted||$||(0.11||)||$||(0.40||)||$||(0.69||)||$||(1.45||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||11,959||6,538||8,498||6,537|
|CONDENSED BALANCE SHEETS|
|Cash, cash equivalents and marketable securities||$||20,444||$||10,479|
|Other current assets||276||184|
|Total current assets||20,720||10,663|
|Liabilities and stockholders' equity|
|Accounts payable and accrued development expenses||$||549||$||823|
|Other accrued liabilities||313||309|
|Total current liabilities||862||1,132|
|Common Stock and additional paid-in-capital||183,253||167,098|
|Accumulated other comprehensive income||—||—|
|Total stockholders' equity||19,974||9,699|
|Total liabilities and stockholders' equity||$||20,836||$||10,831|
For More Information Contact:
Chief Financial Officer
Source: Pain Therapeutics, Inc.