Athersys, Inc. (NASDAQ:ATHX) today announced its financial results
for the three months ended September 30, 2016.
Highlights of the third quarter of 2016 and
recent events include:
- Announced agreement with U.S. Food and Drug Administration
(FDA) under Special Protocol Assessment (SPA) for design and
planned analysis of pivotal Phase 3 clinical trial of MultiStem®
cell therapy for treatment of ischemic stroke – “MultiStem
Administration for Stroke Treatment and Enhanced Recovery Study-2”
(MASTERS-2) – which would provide foundation for regulatory
submission for marketing approval, if successful;
- Announced successful completion of Japan’s Pharmaceutical and
Medical Devices Agency (PMDA) review of Clinical Trial Notification
(equivalent to Investigational New Drug application in U.S.),
allowing HEALIOS K.K. (Healios) to commence confirmatory trial of
MultiStem treatment of ischemic stroke, to be evaluated under new
Japan regenerative medicine regulatory framework;
- Initiated discussions with European regulators and advanced
preparations for planned stroke studies;
- Continued advancement of acute myocardial infarction study and
acute respiratory distress syndrome study – implementing protocol
amendments to improve enrollment;
- In fourth quarter 2016, received $0.6 million development
milestone from Bristol-Myers Squibb related to legacy drug target
program;
- Recorded revenues of $0.3 million and net loss of $6.0 million
for quarter ended September 30, 2016; and
- Ended quarter with $19.4 million in cash and cash equivalents
and available-for-sale securities.
“During the third quarter, we achieved two very
important regulatory milestones that support our progression into
late stage clinical development and towards commercialization. Most
notably, the agreement with the FDA on the conduct of a pivotal
study under a SPA is a significant achievement, since it defines a
clear and efficient path forward for the development of MultiStem
for the treatment of ischemic stroke patients. We remain actively
engaged with international regulators, as well as focused on other
important activities in anticipation of this important study,” said
Dr. Gil Van Bokkelen, Chairman & CEO of Athersys, Inc. “We
believe that success in this next development phase will put us in
a position to deliver a safe, effective and practical therapy for
stroke victims, with the potential to advance and redefine stroke
care as we know it.
“In addition, over the past few months, we have
worked closely with our partner in Japan to obtain acceptance from
the PMDA for the conduct in Japan of a confirmatory clinical trial
under the new accelerated regulatory framework for regenerative
medicine therapies, and we are pleased that Healios is now in a
position to move forward with that important study. Stroke is an
urgent and growing public health threat in Japan, which is
experiencing one of the most challenging demographic transitions of
any developed country due to the unprecedented expansion of the
elderly segment of the population,” he continued.
“In addition to the important progress on our
stroke program, we continue to focus on the achievement of our
other goals, including exploring additional partnering
opportunities, advancing our process development and manufacturing
related activities, and advancing our portfolio of other programs,”
concluded Dr. Van Bokkelen.
Our MASTERS-2 clinical trial will be a
randomized, double-blind, placebo-controlled clinical trial
designed to enroll 300 patients in North America and Europe who
have suffered moderate to moderate-severe ischemic stroke.
The enrolled subjects will receive either a single intravenous dose
of MultiStem cell therapy or placebo, administered within 18-36
hours of the occurrence of the stroke, in addition to the standard
of care. The primary endpoint will evaluate disability using
modified Rankin Scale (mRS) scores at three months, comparing the
distribution, or the “shift,” between the MultiStem treatment and
placebo groups. The mRS shift analysis evaluates patient
improvement across the full disability spectrum, enabling
recognition of improvements in disability and differences in
mortality and other serious outcomes, among strokes of different
severities. The study will also assess Excellent Outcome (the
achievement of mRS ≤1, NIHSS ≤1, and Barthel Index ≥95,
representing the three major indices of functional assessments for
stroke patients) at three months and one year as key secondary
endpoints. Additionally, the study will consider other
measures of functional recovery, biomarker data and clinical
outcomes, including hospitalization, mortality and life-threatening
adverse events, and post-stroke complications such as
infection.
Healios’ planned study in Japan will be a
randomized, double-blind, placebo-controlled clinical trial
designed to enroll 220 patients and conducted at hospitals in Japan
that have extensive experience at providing care for stroke
victims. Based on the experience from our B01-02 study,
subjects enrolled in the trial will receive either a single
intravenous dose of MultiStem or placebo, administered within 18–36
hours of the occurrence of the stroke, in addition to standard of
care. The primary endpoint will be the proportion of patients
with an Excellent Outcome functional assessment at 90
days.
Third Quarter Financial
Results
For the three months ended September 30, 2016,
total revenues were $0.3 million compared to $0.4 million in the
same period in 2015, reflecting a decrease in grant revenues
related to clinical and preclinical studies.
Research and development expenses increased to
$5.3 million in the 2016 third quarter from $5.1 million in the
2015 third quarter, with the variance primarily comprised of
increases in personnel costs, sponsored research, research supplies
and professional fees and a decrease in preclinical and clinical
development costs of $0.3 million, which fluctuate from
time-to-time. General and administrative expenses were $1.8 million
and $1.9 million in the third quarter of 2016 and 2015,
respectively. Non-cash expense from stock-based compensation was
$0.7 million in both of the 2016 and 2015 third quarters.
In the quarter ended September 30, 2016, our
operating loss included $0.7 million of a net gain from insurance
proceeds related to storm-related damage at our primary
facility. Non-cash income from the change in the fair value
of our warrant liabilities was $0.2 million and $0.3 million in the
third quarter of 2016 and 2015, respectively. Finally, net
loss for the three-month periods ended September 30, 2016 and 2015
was $6.0 and $6.5 million, respectively, with the net gain from
insurance proceeds being the primary variance between the
periods.
As of September 30, 2016, we had $19.4 million
in cash and cash equivalents and available-for-sale securities
compared to $23.0 million at December 31, 2015. Cash used in
operating activities during the third quarter of 2016 was $5.5
million compared to $3.7 million in the third quarter of 2015, with
the 2015 third quarter including a $2.0 million refund related to
Japan tax withholdings. Net loss per share was $(0.07) per
share for the current three-month period ended September 31, 2016
and was $(0.08) per share for the prior three-month period ended
September 31, 2015.
Conference Call
As previously announced, Gil Van Bokkelen,
Chairman and Chief Executive Officer, and William (B.J.) Lehmann,
President and Chief Operating Officer, will host a conference call
today to review the results as follows:
Date |
November 9, 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 |
97839505 |
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 November 23, 2016 by dialing 800-585-8367 or
855-859-2056 (U.S. and Canada), or 404-537-3406, and entering
access code 97839505. 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 cell therapy for the treatment of
ischemic stroke, acute myocardial infarction, 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 timing and
nature of results from our MultiStem cell therapy clinical trials,
including the MASTERS-2 Phase 3 clinical trial and the Healios
clinical trial in Japan; our ability to successfully initiate and
complete clinical trials of our product candidates within an
expected timeframe or at all; the possibility of delays in, adverse
results of, and excessive costs of the development process; the
productivity, reliability and availability of suppliers, including
contract research and contract manufacturing organizations; our
ability to raise capital to fund our operations; the success of our
efforts to enter into new strategic partnerships or collaborations
and advance our programs; 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; our
ability to protect and defend our intellectual property and related
business operations, including the successful prosecution of our
patent applications and enforcement of our patent rights, and
operate our business in an environment of rapid technology and
intellectual property development; changes in our business
strategy; changes in external economic and market factors; changes
in our industry's overall performance; 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) |
|
|
|
|
|
September
30, |
December
31, |
|
|
2016 |
|
|
2015 |
|
|
(Unaudited) |
(Note) |
Assets |
|
|
Cash and cash equivalents and available-for-sale
securities |
$ |
19,379 |
|
$ |
23,027 |
|
Receivables and other current assets |
|
1,153 |
|
|
790 |
|
Equipment, net |
|
2,597 |
|
|
1,135 |
|
Other noncurrent assets |
|
190 |
|
|
177 |
|
Total assets |
$ |
23,319 |
|
$ |
25,129 |
|
|
|
|
Liabilities and stockholders’
equity |
|
|
Accounts payable and accrued expenses |
$ |
5,161 |
|
$ |
4,321 |
|
Deferred revenue and note payable |
|
-- |
|
|
435 |
|
Warrant liabilities |
|
2,134 |
|
|
649 |
|
Total stockholders’ equity |
|
16,024 |
|
|
19,724 |
|
Total liabilities and stockholders’
equity |
$ |
23,319 |
|
$ |
25,129 |
|
|
Note: The
Condensed Consolidated Balance Sheet Data at December 31, 2015 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
ended September 30, |
|
|
2016 |
|
|
2015 |
|
|
(Unaudited) |
Revenues |
|
|
Contract revenue |
$ |
150 |
|
$ |
39 |
|
Grant revenue |
|
161 |
|
|
357 |
|
Total revenues |
|
311 |
|
|
396 |
|
|
|
|
Costs and Expenses |
|
|
Research and development |
|
5,263 |
|
|
5,089 |
|
General and administrative |
|
1,830 |
|
|
1,941 |
|
Depreciation |
|
114 |
|
|
66 |
|
Total costs and
expenses |
|
7,207 |
|
|
7,096 |
|
Gain from insurance proceeds, net |
|
682 |
|
|
-- |
|
Loss from operations |
|
(6,214 |
) |
|
(6,700 |
) |
Income from change in fair value of warrants,
net |
|
191 |
|
|
255 |
|
Other income (expense), net |
|
7 |
|
|
(79 |
) |
Loss before income taxes |
|
(6,016 |
) |
|
(6,524 |
) |
Tax benefit |
|
12 |
|
|
27 |
|
Net loss and comprehensive
loss |
$ |
(6,004 |
) |
$ |
(6,497 |
) |
|
|
|
|
|
|
|
Net loss per share - Basic |
$ |
(0.07 |
) |
$ |
(0.08 |
) |
Weighted average shares outstanding- Basic |
|
84,928 |
|
|
83,141 |
|
|
|
|
Net loss per share - Diluted |
$ |
(0.07 |
) |
$ |
(0.08 |
) |
Weighted average shares outstanding- Diluted |
|
85,897 |
|
|
83,426 |
|
|
|
|
Contact:
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
bjlehmann@athersys.com
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