Athersys, Inc. (Nasdaq:ATHX) today announced its financial results
for the three months ended June 30, 2017.
Highlights of the second quarter of 2017 and
recent events include:
- Clinical program for stroke received Final Scientific Advice
positive opinion from the European Medicines Device Agency (“EMA”)
– establishing alignment between European and U.S. regulators about
the potential for approval based on the success of the planned
MASTERS-2 study;
- Stroke program awarded Fast Track Designation by U.S. Food
& Drug Administration (“FDA”) – meaning that the program is
eligible for accelerated approval, priority review and rolling
submission of the biologics license application, facilitating
timely regulatory review;
- Provided initial shipment of clinical product to HEALIOS K.K.
(“Healios”), our partner for stroke in Japan, for its TREASURE
study;
- Continued discussions, diligence activities and evaluation of
potential partnering opportunities for ischemic stroke and other
programs;
- Revenues of $0.7 million recognized for quarter ended June 30,
2017 and net loss of $6.3 million, or $0.06 net loss per share;
and
- Cash and cash equivalents balance of $28.6 million at the end
of the second quarter.
“We are pleased to have received the EMA
positive opinion for our pivotal MASTERS-2 stroke study and the
Fast Track Designation from the FDA earlier in the quarter,”
commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. “As
a result, we have now successfully established regulatory alignment
and clarity with respect to the development and approval path for
MultiStem® therapy for ischemic stroke for three major
pharmaceutical markets – the U.S., Europe and Japan.
“We have continued to advance our preparations
for the MASTERS-2 study and intend to be ready for launch later
this year, and in parallel, we are pursuing business development
and other initiatives to provide adequate funding for this pivotal
trial, as well as advancement of our other core programs. Our
partnering discussions continue to progress in stroke and other
areas and remain an important priority for the company, and the
regulatory clarity we have successfully established reinforces our
strong development position,” concluded Dr. Van Bokkelen.
Second Quarter Results
Revenues increased to $0.7 million for the three
months ended June 30, 2017 from $0.6 million in the comparable
period in 2016 due to an increase of $0.3 million in contract
revenue primarily from our collaboration with Healios, partially
offset by a $0.2 million decrease in grant revenue. Research and
development expenses decreased to $4.6 million for the three months
ended June 30, 2017 from $5.8 million for the comparable period in
2016. The $1.2 million decrease is primarily associated with
decreased clinical and preclinical development costs of $0.9
million, decreased sponsored research costs of $0.2 million and
decreased internal research supplies of $0.2 million, partially
offset by a $0.1 million increase in legal and professional
fees.
General and administrative expenses increased to
$2.2 million for the three months ended June 30, 2017 compared to
$2.0 million in 2016. The $0.2 million increase was primarily
due to increased legal and professional fees, salaries and
benefits, and other contracted services.
Net loss was $6.3 million in 2017, compared to
net loss of $7.0 million in 2016. The difference of $0.7
million reflects the above variances, as well as a $0.3 million
non-cash decrease in the gain related to the fair value of our
warrant liabilities. All outstanding warrants were either
exercised or expired as of March 31, 2017.
Cash used in operating activities was $5.7
million during the 2017 second quarter, compared to cash used of
$6.5 million in the 2016 second quarter. As of June 30, 2017, we
had $28.6 million in cash and cash equivalents, compared to $14.8
million at December 31, 2016, which includes, among other things,
the impact of the common stock offering in February 2017.
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 |
|
|
Wednesday, August 9, 2017 |
|
|
Time |
|
|
4:30 p.m. (Eastern Time) |
|
|
Telephone access: U.S. and Canada |
|
|
800-273-1254 |
|
|
Telephone access: International |
|
|
973-638-3440 |
|
|
Access code |
|
|
51542352 |
|
|
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 August 23, 2017 at the aforementioned URL, or by
dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or
from abroad (404) 537-3406, and entering access code 51542352.
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 neurological,
cardiovascular, and 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 regulatory
approval and 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 and others, including our
ability to reach milestones and receive milestone payments, and
whether any products are successfully developed and sold so that we
earn royalty payments; our possible inability to realize
commercially valuable discoveries in our collaborations with
pharmaceutical and other biotechnology companies; 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 ongoing and planned clinical trials,
including the MASTERS-2 Phase 3 clinical trial and the Healios
TREASURE clinical trial in Japan; the possibility of delays in,
adverse results of, and excessive costs of the development process;
our ability to successfully initiate and complete clinical trials
within the expected time frame or at all; 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.
ATHX-G
(Tables Follow)
|
Athersys, Inc. |
Condensed Consolidated Balance
Sheets |
(In thousands) |
|
|
|
|
June 30, |
December 31, |
|
2017 |
2016 |
|
(Unaudited) |
(Note) |
Assets |
|
|
Cash and cash
equivalents |
$ |
28,594 |
$ |
14,753 |
Other current
assets |
|
1,528 |
|
1,527 |
Equipment, net |
|
2,410 |
|
2,605 |
Deferred tax
assets |
|
191 |
|
175 |
Total
assets |
$ |
32,723 |
$ |
19,060 |
|
|
|
Liabilities and
stockholders’ equity |
|
|
Accounts payable and
accrued expenses |
$ |
6,205 |
$ |
6,875 |
Deferred revenue |
|
503 |
|
-- |
Warrant
liabilities |
|
-- |
|
1,004 |
Total stockholders’
equity |
|
26,015 |
|
11,181 |
Total
liabilities and stockholders’ equity |
$ |
32,723 |
$ |
19,060 |
|
|
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 Per Share Amounts) |
|
|
|
|
|
Three months
endedJune 30, |
|
|
2017 |
2016 |
|
Revenues |
|
|
|
Contract revenue |
$ |
449 |
|
$ |
136 |
|
|
Grant revenue |
|
220 |
|
|
459 |
|
|
Total revenues |
|
669 |
|
|
595 |
|
|
|
|
|
|
Costs and
expenses |
|
|
|
Research and
development |
|
4,633 |
|
|
5,824 |
|
|
General and
administrative |
|
2,207 |
|
|
1,985 |
|
|
Depreciation |
|
167 |
|
|
67 |
|
|
Total
costs and expenses |
|
7,007 |
|
|
7,876 |
|
|
Loss from
operations |
|
(6,338 |
) |
|
(7,281 |
) |
|
Income from change in
fair value of warrants |
|
-- |
|
|
301 |
|
|
Other income, net |
|
58 |
|
|
11 |
|
|
Loss before
income taxes |
|
(6,280 |
) |
|
(6,969 |
) |
|
Income tax benefit |
|
13 |
|
|
13 |
|
|
Net
loss and comprehensive loss |
$ |
(6,267 |
) |
$ |
(6,956 |
) |
|
Net loss per share –
Basic and Diluted |
$ |
(0.06 |
) |
$ |
(0.08 |
) |
|
Weighted average shares
outstanding – Basic |
|
111,819,655 |
|
|
84,341,401 |
|
|
Weighted average shares
outstanding – Diluted |
|
111,819,655 |
|
|
85,416,506 |
|
|
|
|
|
|
|
|
|
Contact:
William (B.J.) Lehmann
President and Chief Operating Officer
Tel: (216) 431-9900
bjlehmann@athersys.com
Karen Hunady
Corporate Communications
Tel: (216) 431-9900
khunady@athersys.com
David Schull
Russo Partners, LLC
Tel: (212) 845-4271 or (858) 717-2310
David.schull@russopartnersllc.com
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