Athersys, Inc. (Nasdaq:ATHX) today announced its financial results
for the three months ended March 31, 2016.
Highlights of the first quarter of 2016 and
recent events include:
- Announced positive one-year follow-up results from the Phase 2
study of MultiStem® cell therapy to treat ischemic stroke –
demonstrating progressive improvements and significantly higher
rate of excellent outcomes at one year for MultiStem-treated
patients – with greater benefits for patients receiving MultiStem
treatment within 36 hours of the stroke;
- Established collaboration with HEALIOS K.K. (“Healios”) to
develop MultiStem cell therapy for stroke in Japan, which included
an upfront payment of $15 million, additional potential milestone
payments aggregating up to $225 million, double-digit royalties on
product sales and an option for Healios to expand the collaboration
to include acute respiratory distress syndrome (“ARDS”) and another
indication with a $10 million expansion payment and additional
associated milestone payments and royalties;
- Advanced preparations for next stroke trials, including working
with Healios to reach agreement with the Japanese Pharmaceuticals
and Medical Devices Agency (“PMDA”) on study design to potentially
clear the way for a Japanese investigational new drug (“J-IND”)
filing and subsequent trial launch, and engaging with other
regulators about requirements for the Company’s planned
international stroke study;
- Continued enrollment of Phase 2a study evaluating
administration of MultiStem therapy to ARDS patients, and Phase 2
acute myocardial infarction (“AMI”) study, evaluating and taking
measures to accelerate enrollment;
- Recorded revenues of $15.5 million for quarter ended March 31,
2016, reflecting the recognition of the $15.0 million license fee
payment from Healios, and net income of $4.8 million; and
- Ended the quarter with $30.4 million in cash and cash
equivalents.
“We remain very excited about our ischemic
stroke program,” stated Dr. Gil Van Bokkelen, Chairman & CEO at
Athersys. “As we have presented at several conferences, we
have seen that MultiStem® treatment has the potential to help
ischemic stroke victims, especially those who can be treated within
36 hours following the stroke. We were especially pleased
with the one-year follow-up results, which showed continued and
significant functional improvement with MultiStem treatment.
As a result, we are moving forward diligently with clinical
development in Japan with our partner Healios, and with planning
for a corresponding study in the United States and Europe, focused
on MultiStem treatment within 36 hours of the stroke.
“Our partnership with Healios is off to a strong
start,” continued Dr. Van Bokkelen. “Building from our
previous engagement with the PMDA and with our support, Healios has
reached general agreement with the PMDA about trial design and
requirements. Healios is preparing its J-IND filing and
planning for the subsequent launch of its planned study, and we are
engaged in manufacturing to support their clinical product
requirements. Based on discussions with the PMDA, we believe
that a successful trial in Japan could make contingent, or even
full, approval possible, utilizing Japan’s progressive regulations
for the development and approval of regenerative medicine
products.
“We are also fully engaged in planning and
preparing for an international ischemic stroke study focused in the
United States and several European countries. Upcoming
discussions with the U.S. Food and Drug Administration and other
regulators will help us refine and finalize the trial design and
complete trial preparations,” noted Dr. Van Bokkelen.
“We are also enrolling our two grant-supported
Phase 2 trials, in AMI and ARDS, although progress has been slower
than we have anticipated,” commented Dr. Van Bokkelen. “We
have undertaken a number of actions to accelerate enrollment,
including adding clinical sites. We believe that MultiStem
cell therapy is well-suited to treat these acute conditions based
on our preclinical and clinical experience to date, and we are
motivated to move these studies forward expeditiously.
“We continue to focus on other important areas,
including actively exploring partnering opportunities around
multiple programs. Finally, we have a substantial effort
underway in manufacturing and process development focused, first,
on supplying our planned clinical studies, and second, on advancing
our manufacturing platform and related capabilities to support
high-volume, low-cost production important to commercialization,”
concluded Dr. Van Bokkelen.
First Quarter
Results
For the three months ended March 31, 2016, total
revenues were $15.5 million compared to $0.7 million in the same
period in 2015, reflecting the recognition of $15.0 million in
contract revenue from our Healios collaboration in the first
quarter of 2016. Grant revenue was $0.3 million less in the
first quarter of 2016 compared to the same period in 2015, and
grant revenues may fluctuate from period to period based on the
timing of grant-related activities and the award and expiration of
new grants.
Research and development expenses increased to
$6.7 million in the 2016 first quarter from $5.7 million in the
2015 first quarter, primarily due to increased clinical and
preclinical development costs, including process development
activities to support manufacturing. General and administrative
expenses were relatively consistent at $2.0 million and $1.9
million for the three months ended March 31, 2016 and 2015,
respectively.
We recognized net income for the three months
ended March 31, 2016 of $4.8 million compared to net loss of $12.5
million for the same period in 2015. The $17.2 million net
variance includes the impact of the $15.0 million Healios license
revenue, the $0.3 million decrease in grant revenues, the $1.1
million increase in combined R&D and G&A expenses, a $3.4
million decrease in non-cash expense from the change in the fair
value of our warrant liabilities, and a $0.2 million increase in
net other income. Cash provided in operating activities was
$7.3 million during the 2016 first quarter (reflecting $14.8
million of cash received from Healios), compared to $1.1 million in
the 2015 first quarter (including $8.0 million of cash received
from our former collaborator, Chugai Pharmaceutical Co.,
Ltd). As of March 31, 2016, we had $30.4 million in cash and
cash equivalents, compared to $23.0 million at December 31,
2015.
Conference Call
Gil Van Bokkelen, Chairman and Chief Executive
Officer, and William (BJ) Lehmann, President and Chief Operating
Officer, will host a conference call today to review the results as
follows:
Date |
Thursday, May 5, 2016 |
Time |
4:30 p.m. (Eastern Time) |
Telephone access: U.S. and Canada |
800-273-1254 |
Telephone access: International |
973-638-3440 |
Access code |
22710393 |
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 May 19, 2016, by dialing 800-585-8367 or
855-859-2056 (U.S. and Canada), or 404-537-3406, and entering
access code 22710393. The archived webcast will be available for
one year at the aforementioned URL.
About Athersys
Athersys is an international 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, initially for disease indications in the cardiovascular,
neurological, inflammatory and immune disease areas, and has
several ongoing clinical trials evaluating this potential
regenerative medicine product. Athersys has forged strategic
partnerships and collaborations with leading pharmaceutical and
biotechnology companies, as well as world-renowned research
institutions to further develop its platform and products. More
information is available at www.athersys.com.
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 ischemic stroke,
acute myocardial infarction, spinal cord injury and acute
respiratory distress syndrome and other disease indications,
including graft-versus-host disease. These risks 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: the success of
our collaboration with Healios, our possible inability to realize
commercially valuable discoveries in our collaborations with
pharmaceutical and other biotechnology companies; the success of
our collaborations, including our ability to reach milestones and
receive milestone payments, including in connection with our
collaboration with Healios, and whether any products are
successfully developed and sold so that we earn royalty payments;
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 or collaborations
and advance our programs; our ability to raise additional capital;
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; 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 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) |
|
|
|
|
March
31, |
December
31, |
|
|
2016 |
|
|
2015 |
|
|
(Unaudited) |
(Note) |
Assets |
|
|
Cash and cash equivalents |
$ |
30,414 |
|
$ |
23,027 |
|
Other current assets |
|
1,132 |
|
|
790 |
|
Equipment, net |
|
1,253 |
|
|
1,135 |
|
Deferred tax assets |
|
184 |
|
|
177 |
|
Total assets |
$ |
32,983 |
|
$ |
25,129 |
|
|
|
|
Liabilities and stockholders’
equity |
|
|
Accounts payable and accrued expenses |
$ |
4,721 |
|
$ |
4,321 |
|
Deferred revenue |
|
0 |
|
|
245 |
|
Warrant liabilities and note payable |
|
2,830 |
|
|
839 |
|
Total stockholders’ equity |
|
25,432 |
|
|
19,724 |
|
Total liabilities and stockholders’
equity |
$ |
32,983 |
|
$ |
25,129 |
|
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 Income
(Loss) |
(In Thousands,
Except Per Share Amounts) |
|
|
|
|
|
Three months
endedMarch 31, |
|
|
|
2016 |
|
|
2015 |
|
|
Revenues |
|
|
|
Contract revenue |
$ |
15,124 |
|
$ |
106 |
|
|
Grant revenue |
|
334 |
|
|
625 |
|
|
Total revenues |
|
15,458 |
|
|
731 |
|
|
|
|
|
|
Costs and
expenses |
|
|
|
Research and development |
|
6,664 |
|
|
5,668 |
|
|
General and administrative |
|
2,014 |
|
|
1,886 |
|
|
Depreciation |
|
68 |
|
|
70 |
|
|
Total costs and
expenses |
|
8,746 |
|
|
7,624 |
|
|
Income (loss) from operations |
|
6,712 |
|
|
(6,893 |
) |
|
Expense from change in fair value of
warrants |
|
(2,181 |
) |
|
(5,604 |
) |
|
Other income, net |
|
210 |
|
|
15 |
|
|
Income
(loss) before income taxes |
|
4,741 |
|
|
(12,482 |
) |
|
Income tax
benefit |
|
9 |
|
|
-- |
|
|
|
|
|
|
|
|
|
|
Net income (loss)
and comprehensive income (loss) |
$ |
4,750 |
|
$ |
(12,482 |
) |
|
|
|
|
|
Net income
(loss) per share – Basic and Diluted |
$ |
0.06 |
|
$ |
(0.16 |
) |
|
Weighted average shares outstanding –
Basic |
|
83,781 |
|
|
79,181 |
|
|
Weighted average shares outstanding –
Diluted |
|
83,866 |
|
|
79,181 |
|
Contact:
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
bjlehmann@athersys.com
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