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, 2021 and provided a
corporate update.
“Since our recent call, we remain on track with respect to our
operating plans,” stated Mr. William (B.J.) Lehmann, Jr., Interim
Chief Executive Officer of Athersys. “We look forward to important
progress during the remaining course of the year, including
expected top-line results from the TREASURE and ONE-BRIDGE studies
in Japan.”
“Additionally, we remain focused on important priorities for the
year, which include advancing our MASTERS-2 study and other
clinical programs, supporting our partner, Healios, as it prepares
for important regulatory applications, and in further developing
our commercial manufacturing processes and planning,” added Mr.
Lehmann.
Highlights of the first quarter of 2021 and recent events
include:
- Announcement by our Japanese partner, HEALIOS K.K. (Healios),
of the completion of patient enrollment in the ONE-BRIDGE study
evaluating the safety and efficacy of MultiStem® (invimestrocel)
cell therapy for the treatment of pneumonia-induced acute
respiratory distress syndrome (ARDS) and COVID-induced ARDS;
- Reached a cooperation agreement with Healios to resolve the
legal matter between its CEO and Athersys Board member, Dr.
Kagimoto, and the Company, and initiated negotiations to address
open matters important to continued development, regulatory
progress and successful commercialization in Japan following
approval;
- Recognized net loss of $26.5 million, or $0.13 net loss per
share, for the quarter ended March 31, 2021; and
- Ended the first quarter with $64.2 million of cash and cash
equivalents.
“We believe that we are well positioned to advance our MultiStem
programs over this year and further develop the capabilities
important to longer term commercial success,” concluded Mr.
Lehmann.
First Quarter Results
There were no revenues for the three months ended March 31, 2021
and March 31, 2020, respectively. Our collaboration revenues
currently fluctuate from period to period based on the delivery of
goods and services under our arrangement with Healios.
Research and development expenses increased to $17.5 million for
the three months ended March 31, 2021 from $12.1 million for the
comparable period in 2020. The $5.4 million net increase is
primarily associated with increases in clinical trial and
manufacturing process development costs of $4.3 million, personnel
costs of $0.7 million and stock compensation costs of $0.4 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 $8.8 million
for the three months ended March 31, 2021 compared to $3.5 million
in the comparable period in 2020. The $5.3 million increase was
primarily related to legal expenses incurred in connection with the
complaint filed by Dr. Kagimoto against the Company, its
settlement, and the expenses associated with Dr. Van Bokkelen’s
resignation and his separation letter agreement, including $2.3
million of non-cash stock compensation expense.
Net loss for the first quarter of 2021 was $26.5 million
compared to a net loss of $15.6 million in the first quarter of
2020. The difference primarily results from the above
variances.
During the three months ended March 31, 2021, net cash used in
operating activities was $17.1 million compared to $12.1 million in
the three months ended March 31, 2020. At March 31, 2021, we had
$64.2 million in cash and cash equivalents, compared to $51.5
million at December 31, 2020.
Conference Call
William (B.J.) Lehmann, Jr., Interim Chief Executive Officer,
Ivor Macleod, Chief Financial Officer, John Harrington, Executive
Vice President and Chief Scientific 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 6, 2021
Time
4:30 p.m. (Eastern Time)
Live webcast registration
Webcast Link
Phone registration
http://www.directeventreg.com/registration/event/4548767
We encourage shareholders to listen using the webcast link
above. If you would like to dial in using the phone to ask a
question, please register for the conference call ahead of time
using the call registration link above. Once registered, you will
receive the toll-free number, a direct entry passcode and a
registrant ID.
On May 7th at 12:00 PM EDT, a replay of the event will be
available on the webcast link at www.athersys.com under the
investors' section. Shareholders may also call in for on-demand
listening on May 7th at 12:00 PM EDT until 11:59 PM Eastern Time on
May 12, 2021, by dialing (800) 585-8367 or (416) 621-4642 and
entering the conference code 4548767.
About Athersys
Athersys is a 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, including but not limited to, our ability to access
our traditional financing sources on the same or reasonably similar
terms as were available to us before the COVID-19 pandemic; the
timing and nature of results from MultiStem clinical trials,
including the MASTERS-2 Phase 3 clinical trial evaluating the
administration of MultiStem for the treatment of ischemic stroke,
and the Healios TREASURE and ONE-BRIDGE clinical trials in Japan
evaluating the treatment in stroke and ARDS patients, respectively;
the success of our MACOVIA clinical trial evaluating the
administration of MultiStem for the treatment of COVID-19 induced
ARDS, and the MATRICS-1 clinical trial being conducted with The
University of Texas Health Science Center at Houston evaluating the
treatment of patients with serious traumatic injuries; the impact
of the COVID-19 pandemic on our ability to complete planned or
ongoing clinical trials; the possibility that the COVID-19 pandemic
could delay clinical site initiation, clinical trial enrollment,
regulatory review and potential receipt of regulatory approvals,
payments of milestones under our license agreements and
commercialization of one or more of our product candidates, if
approved; the availability of product sufficient to meet commercial
demand shortly following any approval, such as in the case of
accelerated approval for the treatment of COVID-19 induced ARDS;
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 impact of the COVID-19 pandemic on the production
capabilities of our contract manufacturing partners and our
MultiStem trial supply chain; the possibility of delays, work
stoppages or interruptions in manufacturing by third parties or us,
such as due to material supply constraints, contamination,
operational restrictions due to COVID-19 or other public health
emergencies, labor constraints, regulatory issues or other factors
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 neurological, inflammatory and immune,
cardiovascular and other critical care 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, 2020 under Item 1A, “Risk Factors” and our other
filings with the SEC. 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,
2021
December 31,
2020
(Unaudited)
(Note)
Assets
Cash and cash equivalents
$
64,223
$
51,546
Accounts receivable from Healios
89
89
Prepaid expenses, deposits and other
4,969
4,924
Property and equipment, net
3,025
3,155
Total assets
$
72,306
$
59,714
Liabilities and stockholders’
equity
Accounts payable, accrued expenses and
other
$
26,654
$
21,381
Accounts payable to Healios
1,705
1,705
Deferred revenue - Healios
65
65
Advance from Healios
5,201
5,201
Total stockholders' equity
38,681
31,362
Total liabilities and stockholders'
equity
$
72,306
$
59,714
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,
2021
2020
Revenues
Total revenues
—
—
Costs and expenses
Research and development
17,508
12,095
General and administrative
8,837
3,474
Depreciation
244
190
Total costs and expenses
26,589
15,759
Loss from operations
(26,589)
(15,759)
Other income, net
121
115
Net loss and comprehensive loss
$
(26,468)
$
(15,644)
Net loss per share, basic and diluted
$
(0.13)
$
(0.10)
Weighted average shares outstanding, basic
and diluted
208,192
162,715
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version on businesswire.com: https://www.businesswire.com/news/home/20210506005876/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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