Pain Therapeutics Reports Q2 2017 Financial Results And Mid-year Corporate Update
August 09 2017 - 08:00AM
Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial
results for the second quarter ended June 30, 2017 and provided an
update on mid-year progress and upcoming milestones.
“We made steady progress in the first half of
2017 toward building the business for the long-term,” said Remi
Barbier, President & CEO of Pain Therapeutics. “This
includes meeting with FDA to better understand the regulatory
requirements for approval of REMOXY ER; completing patient
enrollment for a clinical abuse potential study and initiating a
non-clinical abuse potential study, both with REMOXY; publishing
ground-breaking data for PTI-125 in a peer-reviewed scientific
journal; being awarded a $1.7 million grant from NIH following a
highly competitive, peer-reviewed evaluation of PTI-125;
receiving FDA clearance of an IND application for PTI-125; and
preparing for a Phase I ‘first-in-human’ study with PTI-125 in the
near future, with funding to be provided by NIH. We believe these
activities demonstrate our commitment to develop pioneering new
drug assets, while maintaining a careful watch on expenses and our
balance sheet.”
Net loss for the three months ended June 30,
2017 was $4.2 million, or $0.64 per share, compared to a net loss
of $3.0 million, or $0.46 per share, for the three months ended
June 30, 2016. Net cash used during the three months ended
June 30, 2017 was $3.2 million. Cash and investments were
$14.1 million as of June 30, 2017, with no debt. The Company
continues to expect net cash usage in 2017 may be approximately $10
million.
Update on REMOXY ER™
(extended-release oxycodone capsules CII)We are still
targeting resubmission of the New Drug Application (NDA) for REMOXY
ER for Q1 2018. In Q1 2017, we met with the U.S. Food and
Drug Administration (FDA) to better understand the requirements for
the regulatory approval of REMOXY ER. These discussions
confirmed two key requirements are needed for the resubmission and
potential approval of the REMOXY NDA:
- A clinical abuse potential study via the nasal route of abuse;
and
- A non-clinical (in vitro) abuse potential study using household
solvents.
In Q2 2017, we initiated an abuse potential
study via the nasal route of abuse with REMOXY ER. We
recently completed patient enrollment for this study. We
expect to announce top-line results by year-end 2017. In Q2
2017, we also finalized testing methodologies for a non-clinical
(in vitro) abuse potential study that evaluates the REMOXY
formulation in a variety of household solvents.
Update on PTI-125, a novel drug
candidate to treat Alzheimer’s DiseaseIn Q2 2017, we
announced a peer-reviewed publication in a scientific journal that
further details our novel therapeutic approach for Alzheimer's
Disease (AD). This ground-breaking publication showed that
PTI-125’s novel mechanism of action significantly improved working
memory and spatial ability in a transgenic mouse model of AD, and
reversed pathology in post-mortem brain tissue from patients.
Building on this science, we are also developing and evaluating a
blood-based diagnostic for AD.
In Q2 2017, we announced that the National
Institutes of Health (NIH) awarded us a $1.7 million research grant
to evaluate PTI-125 in Alzheimer's Disease. We also announced
that the FDA had cleared our investigational new drug application
(IND) for PTI-125. As a result, we plan to conduct a Phase I
‘first-in-human’ study with PTI-125 in the near future, with
funding provided by NIH. We expect to announce top-line
results of this Phase I study by year-end 2017.
Financial Highlights for Q2
2017
- At June 30, 2017, cash and investments were $14.1 million,
compared to $17.3 million at March 31, 2017. The Company has
no debt.
- Net cash used during the three months ended June 30, 2017 was
$3.2 million.
- Research and development expenses for the three months ended
June 30, 2017 were $3.1 million compared to $1.6 million in the
prior year period. The increase was primarily due to increased
activities related to REMOXY NDA resubmission. Research and
development expenses included non-cash stock-related compensation
of $0.3 million in the three months ended June 30, 2017 compared to
$0.4 million in the prior year period.
- General and administrative expenses for the three months ended
June 30, 2017 were $1.1 million compared to $1.5 million in the
prior year period. The decrease was primarily due to a decrease in
compensation expenses. General and administrative expenses included
non-cash stock-related compensation of $0.4 million in the three
months ended June 30, 2017 compared to $0.6 million in the prior
year period.
- During Q2 2017, we completed a 7-for-1 Reverse Split of our
outstanding shares of common stock. This reduced the number
of shares of common stock outstanding from about 46.1 million
shares pre-Reverse Split to about 6.6 million shares post-Reverse
Split. The Reverse Split did not affect any stockholder's
percentage equity ownership in Pain Therapeutics.
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 ER to make oxycodone difficult to abuse yet provide 12 hours
of steady pain relief when used appropriately by patients.
REMOXY's sticky, high-viscosity gel formulation may deter
unapproved routes of drug administration.
Pain Therapeutics owns exclusive, worldwide commercial rights to
REMOXY ER.
About Alzheimer's Disease and
PTI-125Alzheimer's Disease (AD) is a progressive brain
disorder that slowly destroys memory and thinking skills, and
eventually the ability to carry out the simplest tasks. There
is no approved drug therapy to reverse, or even halt, the course of
AD. PTI-125 is an oral, small molecule drug candidate that
was designed in-house and characterized by outside
collaborators. PTI-125 has been shown to significantly
improve AD neuropathologies in mouse models of the disease and in
post-mortem brain tissue from AD patients, including receptor
dysfunctions, neuroinflammation, tau hyperphosphorylation, insulin
resistance and plaques and tangles that are hallmarks of AD.
Building on this science, we also have under development a
blood-based diagnostic for AD.
Pain Therapeutics owns worldwide commercial
rights to PTI-125 and related technology.
About Pain
Therapeutics, Inc.Pain Therapeutics, Inc. is a
clinical-stage biopharmaceutical company that develops novel
drugs. The FDA has not yet established the safety or efficacy
of any of our drug candidates. For more information, please
visit www.paintrials.com.
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"). Pain Therapeutics disclaims any
intent or obligation to update these forward-looking statements,
and claims the protection of the Safe Harbor for forward-looking
statements contained in the Act. Examples of such statements
include, but are not limited to, statements regarding our projected
net cash usage in 2017; statements regarding regulatory plans and
strategies to resubmit the REMOXY NDA; statements regarding the
timing or estimated costs of studies and actions needed to resubmit
the REMOXY NDA to the FDA; and our plans to evaluate PTI-125 in a
first-in-human study. Such statements are based on management's
current expectations, but actual results may differ materially due
to various factors. Such statements involve risks and
uncertainties, including, but not limited to, those risks and
uncertainties relating to development and testing of our drug
candidates; unexpected adverse side effects or inadequate
therapeutic efficacy of our drug candidates; the uncertainty of
patent protection for our intellectual property or trade secrets;
unanticipated additional research and development, litigation and
other costs; and the potential for abuse-deterrent pain medications
or other competing products to be developed by competitors and
potential competitors or others. For further information
regarding these and other risks related to our business, investors
should consult our filings with the U.S. Securities and Exchange
Commission.
PAIN THERAPEUTICS, INC. |
CONDENSED STATEMENTS OF OPERATIONS |
(in thousands, except per share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
3,063 |
|
|
$ |
1,589 |
|
|
$ |
4,452 |
|
|
$ |
5,184 |
|
General
and administrative |
|
1,103 |
|
|
|
1,455 |
|
|
|
2,478 |
|
|
|
3,689 |
|
Total
operating expenses |
|
4,166 |
|
|
|
3,044 |
|
|
|
6,930 |
|
|
|
8,873 |
|
Operating
loss |
|
(4,166 |
) |
|
|
(3,044 |
) |
|
|
(6,930 |
) |
|
|
(8,873 |
) |
Interest
income |
|
6 |
|
|
|
29 |
|
|
|
27 |
|
|
|
63 |
|
Net
loss |
$ |
(4,160 |
) |
|
$ |
(3,015 |
) |
|
$ |
(6,903 |
) |
|
$ |
(8,810 |
) |
Net loss per share,
basic and diluted |
$ |
(0.64 |
) |
|
$ |
(0.46 |
) |
|
$ |
(1.06 |
) |
|
$ |
(1.35 |
) |
Weighted-average shares
used in computing net loss per share, basic and diluted |
|
6,537 |
|
|
|
6,530 |
|
|
|
6,536 |
|
|
|
6,505 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED BALANCE SHEETS |
(in thousands) |
(Unaudited) |
|
|
|
|
|
|
|
June 30, 2017 |
|
December 31,2016 |
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
|
|
|
Cash,
cash equivalents and marketable securities |
|
|
|
|
|
|
$ |
14,067 |
|
|
$ |
18,714 |
|
Other
current assets |
|
|
|
|
|
|
|
12 |
|
|
|
356 |
|
Total
current assets |
|
|
|
|
|
|
|
14,079 |
|
|
|
19,070 |
|
Other
assets |
|
|
|
|
|
|
|
190 |
|
|
|
232 |
|
Total
assets |
|
|
|
|
|
|
$ |
14,269 |
|
|
$ |
19,302 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued development expenses |
|
|
|
|
|
|
$ |
690 |
|
|
$ |
330 |
|
Other
accrued liabilities |
|
|
|
|
|
|
|
309 |
|
|
|
335 |
|
Total
current liabilities |
|
|
|
|
|
|
|
999 |
|
|
|
665 |
|
Non-current liabilities |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
Total
liabilities |
|
|
|
|
|
|
|
999 |
|
|
|
665 |
|
Stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
Common
Stock and additional paid-in-capital |
|
|
|
|
|
|
|
165,661 |
|
|
|
164,125 |
|
Accumulated other comprehensive income |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
Accumulated deficit |
|
|
|
|
|
|
|
(152,391 |
) |
|
|
(145,488 |
) |
Total
stockholders' equity |
|
|
|
|
|
|
|
13,270 |
|
|
|
18,637 |
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
14,269 |
|
|
$ |
19,302 |
|
For More Information Contact:
Ruth Araya
Pain Therapeutics, Inc.
IR@paintrials.com
(512) 501-2485
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