Athersys, Inc. (Nasdaq:ATHX) today announced its financial results
for the fourth quarter and year ended December 31, 2013.
"We look forward to several important events this year, foremost
among these are reporting initial results from the Phase 2
ulcerative colitis study, and completing enrollment and reporting
results of our Phase 2 ischemic stroke trial," said Dr. Gil Van
Bokkelen, Ph.D. Chairman and Chief Executive Officer of Athersys.
"Our recent efforts, including the addition of capital to the
balance sheet, have put the Company in a solid position to achieve
some key milestones and continue building value for our
stockholders."
Highlights of the fourth quarter and 2013 and recent events
include:
- Announced completion of patient enrollment of Phase 2 clinical
study of MultiStem® cell therapy for ulcerative colitis being
conducted by our partner, Pfizer Inc. Initial results from this
double blind, placebo-controlled trial are expected by early May,
with additional results expected later in the second quarter;
- Accelerated enrollment in our Phase 2 clinical trial of
MultiStem cell therapy for the treatment of ischemic stroke
patients, initiating enrollment in the United Kingdom and expanding
United States activities. Enrollment completion is currently
anticipated to occur around the end of the summer, and initial
results are targeted for later in the year;
- Advanced planning and preparations for our Phase 2/3
graft-versus-host disease prophylaxis study, highlighted by our
receipt of orphan drug designation in Europe and recent request for
a FDA meeting to review the revised clinical trial design, and for
our Phase 2 acute myocardial infarction study;
- Completed financings in December 2013 and January 2014
generating over $40 million of gross proceeds;
- Entered into new $25 million equity facility with Aspire
Capital to replace the expiring agreement and provide the Company
with access to additional capital, as appropriate;
- Expanded intellectual property portfolio with approximately 60
patent issuances in 2013 covering key therapeutic areas and
geographies, such as the United States, Europe and Japan;
- Revenues of $0.9 million and net loss of $9.8 million, which
includes non-cash expense of $4.0 million related to the change in
fair value of our warrant liabilities, for quarter ended December
31, 2013; and revenues of $2.4 million and net loss of $30.7
million, which includes non-cash expense of $6.3 million related to
the change in fair value of our warrant liabilities, for year ended
December 31, 2013; and
- Ended year with $31.9 million in cash and cash equivalents,
with net proceeds of January 2014 financing adding another $18.7
million in cash to balance sheet.
"We continue to dedicate our resources to the development of
MultiStem cell therapy for the treatment and prevention of diseases
where there is a significant unmet medical need," continued Dr. Van
Bokkelen. "Our current programs are focused on evaluating the
potential benefit of MultiStem cell therapy administration to treat
neurological conditions, inflammatory and immune disorders, and
cardiovascular disease. Success in any of these areas could open up
a broader set of opportunities for Athersys and our partners, and
provide substantial value to our stockholders.
"In December, our partner, Pfizer, completed enrollment of the
ongoing Phase 2 clinical trial of MultiStem cell therapy as a
treatment for ulcerative colitis, which is a common form of
inflammatory bowel disease. The initial results from this study,
which we expect to be reported by early May, should provide initial
insight into the potential for MultiStem cell therapy for the
treatment of ulcerative colitis and Crohn's disease. Additional
data from the study that will be reported later in the second
quarter will also be important in our evaluation. We expect that
the study will provide further information about MultiStem cell
therapy administration, dosing and biological activity that could
be beneficial to development in other therapeutic areas.
"Enrollment has accelerated in the final cohort of our
Phase 2 clinical trial to evaluate MultiStem cell therapy
administered to patients who have suffered a moderate to
moderately-severe ischemic stroke, which is a program we are
currently developing on our own. In contrast to currently available
therapy, we are treating patients one to two days after the stroke
has occurred, which we believe is a clinically practical time frame
that would greatly expand the treatment window over the current
standard of care, enabling many more patients to receive
treatment," added Dr. Van Bokkelen.
"Since November, we have strengthened our balance sheet with two
successful financings, providing us with more than $50 million of
capital to start the year. Importantly, this infusion of cash
enables us to further progress our clinical development programs,
advance our process development activities and expand our late
stage development capabilities, while strengthening our position in
business development discussions. These ongoing partnering
activities relate to certain regenerative medicine programs, as
well as our novel 5HT2c receptor agonist program to treat obesity
and neurological conditions, such as schizophrenia.
"In sum, we believe we are on a path to delivering substantial
long-term value for our stockholders, through the execution of
well-designed, high-quality clinical programs and the advancement
of existing collaborations and new partnerships," concluded Dr. Van
Bokkelen.
Fourth Quarter Results
For the three months ended December 31, 2013, total revenues
were $0.9 million compared to $2.3 million in the same period in
2012, reflecting a decrease in contract revenues offset by a modest
increase in grant revenue. Contract revenues declined to $0.4
million from $2.0 million in the comparable 2012 period as a result
of timing of milestone and license payments from our collaborative
arrangements with RTI Surgical, Inc. (RTI) and Bristol-Myers
Squibb.
Research and development expenses were $5.1 million in the
fourth quarter of 2013 compared to $4.9 million in the 2012 fourth
quarter. Higher personnel costs, stock-based compensation and
patent legal fees were offset by lower clinical and preclinical
development costs. General and administrative expenses increased to
$1.6 million for the fourth quarter of 2013 from $1.3 million in
the comparable period in 2012 due primarily to an increase in
stock-based compensation.
Net loss for the three months ended December 31, 2013 was $9.8
million, compared to $3.2 million for the same period of
2012. The difference reflects the impact of the $5.0 million
negative variance in the fair value of our warrant liabilities, the
$1.4 million decrease in revenues and $0.5 million increase in
combined R&D and G&A expenses, and a $0.3 million reduction
in net other expenses related to the final cash and stock-based
milestone payment to our former lenders in the fourth quarter of
2012. At December 31, 2013, we had $31.9 million in cash and
cash equivalents.
2013 Annual Financial Results
For the year ended December 31, 2013, total revenues were $2.4
million compared to $8.7 million for 2012, reflecting a $6.6
million decrease in contract revenues offset by a $0.4 million
increase in grant revenues. Contract revenues were $0.8
million for the year ended December 31, 2013 compared to $7.4
million in 2012. Most of the decrease is related to the
completion in June 2012 of the R&D support and estimated
performance period of our Pfizer collaboration, over which the
upfront license fee and other revenues were being
amortized. Additionally, 2012 contract revenues included $2.2
million of license fees from our collaboration with RTI. Our
grant revenues increased to $1.7 million in 2013 from $1.3 million
in 2012, reflecting the impact of increased activity under
grant-funded programs.
Research and development expenses increased to $20.5 million in
2013 from $19.6 million in 2012 due to increased patent legal fees,
personnel costs, stock-based compensation and facility costs,
partially offset by decreased clinical and preclinical development
costs. General and administrative expenses increased to $6.1
million in 2013 from $4.8 million in 2012 due primarily to
increased stock-based compensation, outside services, legal and
professional fees and personnel costs.
Net loss for the year ended December 31, 2013 was $30.7 million,
compared to $14.7 million in 2012. The difference reflects an
$8.7 million increase in expense attributed to the change in the
fair value of our warrant liabilities, the $6.3 million decrease in
revenues, the $2.2 million increase in combined R&D and G&A
expenses, and the $1.1 million reduction in net other expense
primarily related to the final cash and stock-based milestone
payments to our former lenders in 2012. Cash used in
operating activities was $22.8 million and $17.7 million in 2013
and 2012, respectively. As of December 31, 2013, we had $31.9
million in cash and cash equivalents.
Conference Call
William (B.J.) Lehmann, President and Chief Operating Officer,
and Laura Campbell, Vice President of Finance, will host a
conference call today to review the results as follows:
Date |
Thursday, March 13, 2014 |
Time |
4:30 p.m. (Eastern Time) |
Telephone access: U.S. and
Canada |
800-273-1254 |
Telephone access: International |
973-638-3440 |
Access code |
96437720 |
Live webcast |
www.athersys.com, under the
Investors section |
A replay will be available for on-demand listening shortly after
the completion of the call until 11:59 PM (Eastern Time) on March
27, 2014, by dialing 800-585-8367 or 855-859-2056 (U.S. and
Canada), or 404-537-3406, and entering access code 96437720. The
archived webcast will be available for one year at the
aforementioned URL.
About Athersys
Athersys is a clinical stage biotechnology company engaged in
the discovery and development of therapeutic product candidates
designed to extend and enhance the quality of human life. The
Company is developing its MultiStem® cell therapy product, a
patented, adult-derived "off-the-shelf" stem cell product platform
for disease indications in the cardiovascular, neurological,
inflammatory and immune disease areas. The Company currently has
several clinical stage programs involving MultiStem, including for
treating inflammatory bowel disease, ischemic stroke, damage caused
by myocardial infarction, and for the prevention of
graft-versus-host disease. Athersys has also developed a diverse
portfolio that includes other technologies and product development
opportunities, and has forged strategic partnerships and
collaborations with leading pharmaceutical and biotechnology
companies, as well as world-renowned research institutions in the
United States and Europe to further develop its platform and
products. More information is available at www.athersys.com.
The Athersys, Inc. logo is available at:
http://www.globenewswire.com/newsroom/prs/?pkgid=4548
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. These forward-looking
statements relate to, among other things, the expected timetable
for development of our product candidates, our growth strategy, and
our future financial performance, including our operations,
economic performance, financial condition, prospects, and other
future events. We have attempted to identify forward-looking
statements by using such words as "anticipates," "believes," "can,"
"continue," "could," "estimates," "expects," "intends," "may,"
"plans," "potential," "should," "suggest," "will," or other similar
expressions. These forward-looking statements are only predictions
and are largely based on our current expectations. A number of
known and unknown risks, uncertainties, and other factors could
affect the accuracy of these statements. Some of the more
significant known risks that we face that could cause actual
results to differ materially from those implied by forward-looking
statements are the risks and uncertainties inherent in the process
of discovering, developing, and commercializing products that are
safe and effective for use as human therapeutics, such as the
uncertainty regarding market acceptance of our product candidates
and our ability to generate revenues, including MultiStem for the
treatment of inflammatory bowel disease, acute myocardial
infarction, stroke and other potential indications, including
lysosomal storage disorders and the prevention of graft-versus-host
disease. These risks and uncertainties may cause our actual
results, levels of activity, performance, or achievements to differ
materially from any future results, levels of activity,
performance, or achievements expressed or implied by these
forward-looking statements. Other important factors to consider in
evaluating our forward-looking statements include: our ability to
raise additional capital; final results from our MultiStem clinical
trials; the possibility of delays in, adverse results of, and
excessive costs of the development process; our ability to
successfully initiate and complete clinical trials and obtain all
necessary regulatory approvals; changes in external market factors;
changes in our industry's overall performance; changes in our
business strategy; our ability to protect our intellectual property
portfolio; our possible inability to realize commercially valuable
discoveries in our collaborations with pharmaceutical and other
biotechnology companies; our ability to meet milestones under our
collaboration agreements; our collaborators' ability to continue to
fulfill their obligations under the terms of our collaboration
agreements; the success of our efforts to enter into new strategic
partnerships and advance our programs; our possible inability to
execute our strategy due to changes in our industry or the economy
generally; changes in productivity and reliability of suppliers;
and the success of our competitors and the emergence of new
competitors. You should not place undue reliance on forward-looking
statements contained in this press release, and we undertake no
obligation to publicly update forward-looking statements, whether
as a result of new information, future events or otherwise.
(Tables Follow)
Athersys,
Inc. |
Condensed Consolidated
Balance Sheets |
(In thousands) |
|
|
|
|
December 31, |
December 31, |
|
2013 |
2012 |
|
(Unaudited) |
(Unaudited) |
Assets |
|
|
Cash and cash equivalents |
$31,948 |
$25,533 |
Other current assets |
907 |
776 |
Equipment, net |
1,333 |
1,294 |
Total assets |
$34,188 |
$27,603 |
|
|
|
Liabilities and stockholders'
equity |
|
|
Accounts payable and accrued expenses |
$4,282 |
$4,478 |
Deferred revenue |
86 |
-- |
Warrant liabilities and note payable |
9,999 |
2,878 |
Total stockholders' equity |
19,821 |
20,247 |
Total liabilities and stockholders'
equity |
$34,188 |
$27,603 |
|
|
|
|
|
|
Note: The
Condensed Consolidated Balance Sheet Data has been derived from the
audited financial statements as of that date. |
|
Athersys,
Inc. |
Condensed Consolidated
Statements of Operations and Comprehensive Loss |
(In thousands, except share and
per share data) |
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
Three months
ended |
Twelve months
ended |
|
December
31, |
December
31, |
|
2013 |
2012 |
2013 |
2012 |
Revenues |
|
|
|
|
Contract revenue |
$ 390 |
$ 2,024 |
$ 755 |
$ 7,380 |
Grant revenue |
530 |
265 |
1,683 |
1,328 |
Total revenues |
920 |
2,289 |
2,438 |
8,708 |
|
|
|
|
|
Costs and expenses |
|
|
|
|
Research and development |
5,112 |
4,935 |
20,484 |
19,636 |
General and administrative |
1,553 |
1,253 |
6,065 |
4,753 |
Depreciation |
89 |
84 |
346 |
320 |
Total costs and expenses |
6,754 |
6,272 |
26,895 |
24,709 |
Loss from operations |
(5,834) |
(3,983) |
(24,457) |
(16,001) |
Other income (expense), net |
9 |
(307) |
38 |
(1,138) |
(Expense) income from change in fair value of
warrants |
(3,970) |
1,053 |
(6,324) |
2,404 |
Net loss |
$ (9,795) |
$ (3,237) |
$ (30,743) |
$ (14,735) |
|
|
|
|
|
Basic and diluted net loss per
share |
$ (0.15) |
$ (0.07) |
$ (0.53) |
$ (0.45) |
|
|
|
|
|
Weighted average shares outstanding, basic
and diluted |
63,468,957 |
45,363,029 |
57,674,833 |
32,556,781 |
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
Other comprehensive loss items |
-- |
-- |
-- |
(28) |
Comprehensive loss |
$ (9,795) |
$ (3,237) |
$ (30,743) |
$ (14,763) |
CONTACT: William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
bjlehmann@athersys.com
Investor Relations:
Lisa M. Wilson
In-Site Communications
Tel: (917) 543-9932
lwilson@insitecony.com
Athersys (NASDAQ:ATHX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Athersys (NASDAQ:ATHX)
Historical Stock Chart
From Apr 2023 to Apr 2024