Management to host conference call at 4:30
pm EDT today
Athersys, Inc. (NASDAQ: ATHX) announced today its financial
results for the three months ended March 31, 2020.
Highlights of the first quarter of 2020 and recent events
include:
- Received authorization from the U.S. Food and Drug
Administration (FDA) to initiate a Phase 2/3 COVID-19 induced acute
respiratory distress syndrome (ARDS) clinical trial; completed site
initiation and began enrolling patients in this trial referred to
as the MACOVIA study;
- Received FDA authorization to initiate a Phase 2 clinical trial
with The University of Texas Health Science Center at Houston
(UTHealth) titled MultiStem® Administration for Trauma Related
Inflammation and Complications (MATRICS-1); funded by a grant from
the Medical Technology Enterprise Consortium (MTEC) and the
Memorial Hermann Foundation;
- Announced positive one-year results from our exploratory
clinical study of MultiStem cell therapy for ARDS; MultiStem
treated patients reported consistent improvement in quality of life
over the one-year evaluation period and showed marked improvements
in key clinical metrics, including intensive care unit-free days,
ventilator-free days and mortality compared to placebo, especially
in patients with pneumonia-induced ARDS;
- Furthered discussions with the Biomedical Advanced Research and
Development Authority (BARDA) to establish a collaboration to
advance our MultiStem program;
- Appointed Mr. Ivor Macleod as our Chief Financial Officer and
Ms. Maia Hansen as Senior Vice President, Operations and Supply
Chain, adding their expertise to our leadership team to help plan
and execute our strategy as we approach potential product
commercialization;
- Initiated new sites for the MASTERS-2 ischemic stroke study
while continuing to enroll new patients into the trial;
- Advanced through our Japanese partner, HEALIOS K.K. (Healios),
its ARDS and ischemic stroke programs, with Healios disclosing its
intent to finish enrollment of both its ONE-BRIDGE ARDS study and
its TREASURE stroke study this year;
- Engaged in partnering discussions with companies interested in
MultiStem commercialization rights in Europe and other
regions;
- Received an additional $7.0 million investment from Healios
resulting from its exercise in full of a warrant to purchase
additional shares of Athersys common stock;
- Raised gross proceeds of approximately $57.6 million, before
deducting the underwriting discount and offering expenses, through
an underwritten public offering of 25,587,500 shares of common
stock, providing additional working capital for general corporate
purposes, including the initiation of the MACOVIA trial, further
advancement of process development and manufacturing projects, and
other key initiatives;
- Recognized net loss of $15.6 million, or $0.10 net loss per
share, for the quarter ended March 31, 2020; and
- Ended the first quarter with $32.7 million of cash and cash
equivalents, which excludes the impact of the Healios warrant
exercise and proceeds from the recent underwritten public
offering.
“We have achieved a number of important milestones recently,
including obtaining FDA authorization to move two important trials
forward. The first of these, the MACOVIA study for treating
patients suffering from COVID-19 induced ARDS and related
complications, represents our second pivotal trial, alongside our
ongoing MASTERS-2 trial evaluating the administration of MultiStem
for treating ischemic stroke. Working in collaboration with the FDA
and our clinical partners, we were able to get the MACOVIA trial
designed, authorized and up and running very quickly, and we thank
everyone for their tremendous commitment and effort over the past
several months,” commented Dr. Gil Van Bokkelen, Chairman and CEO
of Athersys. “In addition, we recently announced authorization to
initiate the MATRICS-1 trial for evaluating administration of
MultiStem to patients suffering from serious traumatic injury,
which is being supported by MTEC, the funding arm of the Department
of Defense, and UTHealth. We thank the FDA, MTEC and our clinical
collaborators for their support in these advancements.
“Following the successful completion of the recent fundraising
and the full exercise of the outstanding warrant by our partner,
Healios, we have strengthened our financial position, and are
focused on making further progress in our important programs and
core capabilities. Despite the challenging and chaotic environment
created by the COVID-19 pandemic, we have maintained our commitment
to the advancement of our portfolio of critical care programs and
to helping patients in areas of significant unmet clinical need.
I’d like to thank each of our employees for their dedication,
determination and extraordinary effort,” concluded Dr. Van
Bokkelen.
First Quarter Results
There were no revenues for the three months ended March 31, 2020
compared to $1.4 million for the three months ended March 31, 2019.
The revenues in the prior period were generated from our
collaboration with Healios related to manufacturing services
performed. We expect our collaboration revenues to vary over time
as we contract with Healios to perform manufacturing services and
as we potentially enter into new collaborations.
Research and development expenses increased to $12.1 million for
the three months ended March 31, 2020 from $11.4 million for the
comparable period in 2019. The $0.7 million net increase is
associated with increases in research supplies of $0.7 million,
personnel costs of $0.3 million, outside services of $0.2 million,
consulting costs of $0.1 million, stock compensation costs of $0.1
million and other research and development costs of $0.2 million
with such increases partially offset by decreases in clinical trial
and manufacturing process development costs of $0.9 million. Our
clinical development, clinical manufacturing and manufacturing
process development expenses vary over time based on the timing and
stage of clinical trials underway, manufacturing campaigns for
clinical trials and manufacturing process development projects.
General and administrative expenses increased to $3.5 million
for the three months ended March 31, 2020 compared to $3.1 million
in the comparable period in 2019. The $0.4 million increase was
primarily due to increased personnel costs, outside services and
stock compensation costs.
Net loss for the first quarter of 2020 was $15.6 million
compared to a net loss of $13.0 million in the first quarter of
2019. The difference primarily results from the above
variances.
During the three months ended March 31, 2020, net cash used in
operating activities was $12.1 million compared to $5.5 million in
the three months ended March 31, 2019. At March 31, 2020, we had
$32.7 million in cash and cash equivalents, compared to $35.0
million at December 31, 2019.
Conference Call
Gil Van Bokkelen, Chairman and Chief Executive Officer, Ivor
Macleod, Chief Financial Officer, and Karen Hunady, Director of
Corporate Communications and Investor Relations will host a
conference call today to review the results as follows:
Date
May 7, 2020
Time
4:30 p.m. (Eastern Time)
Telephone access: U.S. and
Canada
(877) 396-3286
Telephone access:
International
(647) 689-5528
Access code
6575418
Live webcast
webcast
link
We encourage shareholders to listen using the webcast link and
to use the phone line if you intend to ask a question. A replay
will be available on the webcast at www.athersys.com under the Investors section
approximately two hours after the call has ended. Shareholders may
also call in for on-demand listening shortly after the completion
of the call until 11:59 PM Eastern Time on May 14, 2020 by dialing
(800) 585-8367 or (416) 621-4642 and entering Encore passcode
6575418.
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, inflammatory
and immune, cardiovascular, and other critical care indications and
has several ongoing clinical trials evaluating this potential
regenerative medicine product. Athersys has forged strategic
partnerships and a broad network of collaborations to further
advance the MultiStem cell therapy toward commercialization. More
information is available at www.athersys.com. Follow Athersys on
Twitter at www.twitter.com/athersys.
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 are the risks and
uncertainties inherent in the process of discovering, developing,
and commercializing products that are safe and effective for use as
therapeutics, including the uncertainty regarding market acceptance
of our product candidates and our ability to generate revenues. The
following 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: our ability to raise capital to fund
our operations; our ability to successfully finalize and implement
an alliance with BARDA, and the terms of any such alliance,
including the amount, if any, of funding that we might receive; the
success of our MACOVIA study and MATRICS-1 clinical trial; the
timing and nature of results from MultiStem clinical trials,
including the MASTERS-2 Phase 3 clinical trial, the Phase 2
clinical trial conducted by The University of Texas Health Science
Center at Houston at the Memorial Hermann-Texas Medical Center
evaluating MultiStem cell therapy for the early treatment of
traumatic injuries, and the HEALIOS K.K. (Healios) TREASURE and
ONE-BRIDGE clinical trials in Japan; the impact on our business,
results of operations and financial condition from the ongoing and
global COVID-19 pandemic, or any other pandemic, epidemic or
outbreak of infectious disease in the United States; the
possibility of delays in, adverse results of, and excessive costs
of the development process; our ability to successfully initiate
and complete clinical trials of our product candidates; the
possibility of delays, work stoppages or interruptions in
manufacturing by third parties or us, such as due to material
supply constraints, contaminations, or regulatory issues, which
could negatively impact our trials and the trials of our
collaborators; uncertainty regarding market acceptance of our
product candidates and our ability to generate revenues, including
MultiStem cell therapy for the treatment of ischemic stroke, ARDS,
acute myocardial infarction and trauma, and the prevention of
graft-versus-host disease and other disease indications; changes in
external market factors; changes in our industry’s overall
performance; changes in our business strategy; 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; our possible inability to realize
commercially valuable discoveries in our collaborations with
pharmaceutical and other biotechnology companies; our ability to
meet milestones and earn royalties under our collaboration
agreements, including the success of our collaboration with
Healios; our collaborators’ ability to continue to fulfill their
obligations under the terms of our collaboration agreements and
generate sales related to our technologies; the success of our
efforts to enter into new strategic partnerships and advance our
programs, including, without limitation, in North America, Europe
and Japan; our possible inability to execute our strategy due to
changes in our industry or the economy generally; changes in
productivity and reliability of suppliers; the success of our
competitors and the emergence of new competitors; and the risks
mentioned elsewhere in our Annual Report on Form 10-K for the year
ended December 31, 2019 under Item 1A, “Risk Factors” and our other
filings with the Securities and Exchange Commission. 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, 2020
December 31, 2019
(Unaudited)
(Note)
Assets
Cash and cash equivalents
$
32,692
$
35,041
Accounts receivable
17
17
Accounts receivable from Healios
259
945
Prepaid expenses, deposits and other
3,061
2,781
Equipment, net
3,039
2,882
Total assets
$
39,068
$
41,666
Liabilities and stockholders’
equity
Accounts payable, accrued expenses and
other
$
13,589
$
11,924
Accounts payable to Healios
1,068
1,068
Deferred revenue - Healios
65
65
Advance from Healios
5,338
5,338
Total stockholders' equity
19,008
23,271
Total liabilities and stockholders'
equity
$
39,068
$
41,666
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
(Unaudited)
(In Thousands, Except Per Share
Amounts)
Three months ended March
31,
2020
2019
Revenues
Contract revenue from Healios
$
—
$
1,441
Grant revenue
—
4
Total revenues
—
1,445
Costs and expenses
Research and development
12,095
11,415
General and administrative
3,474
3,106
Depreciation
190
184
Total costs and expenses
15,759
14,705
Loss from operations
(15,759
)
(13,260
)
Other income, net
115
304
Net loss and comprehensive loss
$
(15,644
)
$
(12,956
)
Net loss per share, basic and diluted
$
(0.10
)
$
(0.09
)
Weighted average shares outstanding, basic
and diluted
162,715
145,964
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200507006013/en/
Ivor Macleod Chief Financial Officer Tel: (216) 431-9900
ir@athersys.com Karen Hunady Director of Corporate Communications
& Investor Relations 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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