Pain Therapeutics Reports 2018 Financial Results and Corporate Update
March 25 2019 - 8:30AM
Pain Therapeutics, Inc. (Nasdaq: PTIE) today reported financial
results for the year ended December 31, 2018. Net loss in 2018 was
$6.6 million, or $0.61 per share, compared to a net loss in 2017 of
$11.9 million, or $1.82 per share. Cash used in operations during
the year ended December 31, 2018 was $4.8 million. Cash and cash
equivalents were $19.8 million as of December 31, 2018, with no
debt. We believe net cash utilization in 2019 will be in the range
of $5.0 - $6.0 million.
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 Remi Barbier, President & CEO.
“For many years, the prevailing scientific hypothesis said amyloid
must be cleared out of the brain. This hypothesis has been tested
in clinical studies using a variety of antibody backbones,
epitopes, target conformations, biomarkers and in various stages of
disease. These amyloid-clearing studies have one thing in common:
they’ve all failed. It’s now prudent to consider more recent
scientific breakthroughs in Alzheimer’s research. We think these
are the innovations that stand a chance of making a difference for
patients with Alzheimer’s disease.”
Overview of Alzheimer’s
ProgramOver 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 National
Institutes of Health (NIH). In 2019, we expect to conclude our
Phase IIa study and announce clinical results.
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 Journal of
Neuroscience, Neurobiology of Aging, and Journal of Biological
Chemistry.
In addition, in 2018 the National Institute on
Aging of the NIH awarded our scientific programs two research
grants. Collectively, these represent up to $6.7 million of
non-dilutive financing.
Financial Highlights for 2018
- At December 31, 2018, cash and cash equivalents were $19.8
million, compared to $10.5 million in 2017. We have no debt.
- Net cash used in operations during
the year ended December 31, 2018 was $4.8 million.
- Research and development expenses
for the year ended December 31, 2018 were $3.0 million compared to
$7.6 million for 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 million
for the year ended December 31, 2018 and $1.2 million for the same
period in 2017.
- General and administrative expenses
for the year ended December 31, 2018 were $3.7 million compared to
$4.3 million for 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 million in the year ended December 31,
2018 and $1.8 million for the same period in 2017.
- On 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 million of 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 million of 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,
FDA has not approved REMOXY on the basis that additional
demonstrations of its abuse deterrent properties are needed, a
matter of dispute between us and FDA.
- On March 20, 2019, we provided Durect Corporation with written
notice of termination of a Development and License Agreement
(DLA). Termination of the DLA effectively ends our clinical
development of REMOXY.
- In October 2018, we announced a strategic reorganization to
align Company resources on advancing our programs in
neurodegenerative diseases, such as Alzheimer’s disease.
- In 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.
About Pain
Therapeutics Pain Therapeutics is focused on the early
detection and treatment of Alzheimer’s disease. Since 2010, we have
combined state-of-the-art technology with new insights in
neurobiology to develop novel solutions for Alzheimer’s disease. We
own worldwide development and commercial rights to our research
programs in Alzheimer’s disease, and related technology, without
royalty obligations to any third-parties. For more information,
please visit www.paintrials.com.
For More Information Contact:Eric SchoenChief
Financial OfficerPain Therapeutics, Inc.(512) 501-2450
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 the timing of
clinical studies and the potential benefits of the Company’s
programs in Alzheimer’s disease including our ongoing Phase II
program, plans for rebranding the Company in 2019, and expected
cash use in future periods. The Company cautions that
forward-looking statements are inherently uncertain. 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; the need to raise additional funding
from time-to-time, and the potential for competing products to be
developed by competitors and potential competitors or
others. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Except as required by law, the
Company disclaims any intention or responsibility for updating or
revising any forward-looking statements contained in this press
release. 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 (SEC), which are
available for free on the SEC's website at www.sec.gov.
– 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, |
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
Operating loss |
|
(750 |
) |
|
|
(2,423 |
) |
|
|
(6,662 |
) |
|
|
(11,949 |
) |
Interest income |
|
73 |
|
|
|
5 |
|
|
|
105 |
|
|
|
38 |
|
Net loss |
$ |
(677 |
) |
|
$ |
(2,418 |
) |
|
$ |
(6,557 |
) |
|
$ |
(11,911 |
) |
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) |
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
Total
assets |
|
|
|
|
|
|
|
|
$ |
20,139 |
|
|
$ |
10,831 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable |
|
|
|
|
|
|
|
|
$ |
294 |
|
|
$ |
424 |
|
Accrued
development expense |
|
|
|
|
|
|
|
|
|
156 |
|
|
|
399 |
|
Other
accrued liabilities |
|
|
|
|
|
|
|
|
|
61 |
|
|
|
309 |
|
Total
current liabilities |
|
|
|
|
|
|
|
|
|
511 |
|
|
|
1,132 |
|
Total
liabilities |
|
|
|
|
|
|
|
|
|
511 |
|
|
|
1,132 |
|
Stockholders'
equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock |
|
|
|
|
|
|
|
|
|
17 |
|
|
|
7 |
|
Additional paid-in-capital |
|
|
|
|
|
|
|
|
|
183,567 |
|
|
|
167,091 |
|
Accumulated deficit |
|
|
|
|
|
|
|
|
|
(163,956 |
) |
|
|
(157,399 |
) |
Total
stockholders' equity |
|
|
|
|
|
|
|
|
|
19,628 |
|
|
|
9,699 |
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
$ |
20,139 |
|
|
$ |
10,831 |
|
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