Management to host conference call following
announcement of Phase 2/3 TREASURE data in May
Athersys, Inc. (NASDAQ: ATHX) announced today its financial
results for the three months ended March 31, 2022. In anticipation
of the announcement in May of topline data from Athersys’ partner,
HEALIOS K.K. (Healios), for its Phase 2/3 TREASURE study evaluating
MultiStem® (invimestrocel, HLCM051) for the treatment of ischemic
stroke, Athersys will host its next investor conference call after
the data are released. Athersys will share the conference call
details in its news release reporting the data.
“Since joining the Company in February, I’ve immersed myself in
all aspects of the business to gain a better understanding of
MultiStem, our clinical trial progress and our performance to
date,” commented Dan Camardo, Chief Executive Officer of Athersys.
“I have had numerous introductory calls and discussions with
stockholders who have been very supportive and patient of the work
we’re doing to advance MultiStem and bring this unique cell therapy
to market. I’ve also had discussions with the Board and I’m
confident that we have the right strategy in place. With thoughtful
and timely execution, we will be well-positioned to meet our
long-term goals.”
First quarter 2022 highlights and recent events:
- Received approval from the U.S. Food and Drug Administration
(FDA) to use bioreactor manufactured MultiStem product in our
MACOVIA and MATRICS studies, enabling the generation of critical
clinical data with this next-generation bioreactor-based product
and laying the groundwork for subsequent clinical work with the
larger-scale bioreactor format. The approval of the bioreactor
process represents a significant milestone in transitioning from
small scale 2-dimensional manufacturing to large scale
3-dimensional manufacturing, thereby allowing significantly more
product to be produced at lower cost of goods. The ability to
produce product at these large scales represents a significant
competitive advantage in the cell therapy field;
- Appointed Daniel A. Camardo as Chief Executive Officer,
effective February 14, 2022. Mr. Camardo is a senior pharmaceutical
and biotech executive with more than 25 years of commercial
leadership experience. He joins Athersys to lead the Company
forward to complete the development, approval, launch and
commercialization of the Company’s MultiStem cell therapy;
- Noted completion by the last patient in the Healios TREASURE
study of the 365-day visit, fulfilling the required secondary
endpoint measures and completing the data set for the study.
Topline data are expected in May;
- Continued enrollment in the Athersys Phase 3 MASTERS-2 study
evaluating MultiStem cell therapy to treat ischemic stroke in the
United States, Europe and other regions. Initiated new clinical
sites in Europe and Asia;
- Reached agreements with both the FDA and the European Medicinal
Agency (EMA) on the pediatric development plan with MultiStem for
the stroke program;
- Filed for a new patent application that covers multiple aspects
of the large scale bioreactor process for MultiStem production,
building on our extensive intellectual property portfolio; and
- Held a virtual investor event titled “MultiStem Clinical
Programs: An In-Depth Look”. The program provided an understanding
of the anticipated program milestones and why the Company is
well-positioned to deliver on its mission to change the future of
regenerative medicine.
“Receiving FDA approval to use the bioreactor manufactured
product gives us confidence as we further scale our
third-generation bioreactor manufacturing process to be able to
produce product to meet potential commercial demand. I’m very proud
of everyone involved in helping make this achievement a reality,”
commented Dr. John Harrington, Executive Vice President and Chief
Scientific Officer.
“An important priority for us is to continue strengthening the
partnership we have with Healios. We are working closely together
to advance the clinical programs in stroke and acute respiratory
distress syndrome and establish appropriate manufacturing supply
for potential commercialization in Japan,” added Mr. Camardo. “With
the last TREASURE trial patient completing their 365-day visit, we
are now actively planning with Healios for the release of topline
data in May. This is an important milestone for both companies and
we plan to host a conference call soon after the data are released
to discuss the details.”
First Quarter Results
Revenues increased to $2.9 million for the three months ended
March 31, 2022 compared to no revenues for the three months ended
March 31, 2021. Our collaboration revenues currently fluctuate from
period to period based on the delivery of services under our
arrangement with Healios.
Research and development expenses increased to $20.9 million for
the three months ended March 31, 2022 from $17.5 million for the
comparable period in 2021. The $3.4 million increase is associated
with increases in clinical trial and manufacturing process
development costs of $1.8 million, personnel costs of $0.8 million,
outside service costs of $0.7 million and internal research
supplies of $0.4 million. These increases were partially offset by
decreases in other research and development costs of $0.3 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 decreased to $4.1 million
for the three months ended March 31, 2022 from $8.8 million for the
comparable period in 2021. The decrease is primarily related to
legal expenses incurred in connection with the complaint filed by
Dr. Hardy Kagimoto against the Company, its settlement, and the
expenses associated with Dr. Gil Van Bokkelen’s separation letter
agreement, including $2.3 million of one-time non-cash stock
compensation expense in the first quarter of 2021.
Net loss for the first quarter of 2022 was $22.2 million
compared to a net loss of $26.5 million in the first quarter of
2021. The difference primarily results from the above
variances.
During the three months ended March 31, 2022, net cash used in
operating activities was $20.2 million compared to $17.1 million in
the three months ended March 31, 2021. At March 31, 2022, we had
$21.8 million in cash and cash equivalents, compared to $37.4
million at December 31, 2021.
Conference Call
Members of the management team will host a conference call soon
after the TREASURE data are released. The details for the
conference call will be included in the data release.
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 MultiStem cell
therapy toward commercialization. Investors and others should note
that we may post information about the Company on our website at
www.athersys.com and/or on our accounts on Twitter, Facebook,
LinkedIn or other social media platforms. It is possible that the
postings could include information deemed to be material
information. Therefore, we encourage investors, the media and
others interested in the Company to review the information we post
on our website at www.athersys.com and on our social media
accounts. 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: the possibility of unfavorable results
from ongoing and additional clinical trials involving MultiStem;
the risk that positive results in a clinical trial may not be
replicated in subsequent or confirmatory trials or success in an
early stage clinical trial may not be predictive of results in
later stage or large scale clinical trials; our ability to raise
capital to fund our operations, including but not limited to, our
ability to access our traditional financing sources and to continue
as a going concern; our ability to regain compliance with the
requirement to maintain a minimum closing bid price of $1.00 per
share as set forth in Nasdaq Listing Rule 5550(a)(2); 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 clinical trial in Japan, including the timing of the
release of data by Healios from its clinical trial; 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 possibility that the
COVID-19 pandemic could continue to 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; 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, 2021 under Item 1A, “Risk Factors” and our other
filings with the SEC. You should not place undue reliance on
forward-looking statements contained on our website and/or on our
accounts on Twitter, Facebook, LinkedIn or other social media
platforms, and we undertake no obligation to publicly update
forward-looking statements, whether as a result of new information,
future events or otherwise.
Athersys, Inc.
Condensed Consolidated Balance
Sheets
(In thousands)
March 31,
2022
December 31,
2021
(Unaudited)
(Note)
Assets
Cash and cash equivalents
$
21,797
$
37,407
Accounts receivable from Healios, billed
and unbilled
4,643
4,414
Prepaid expenses, deposits and other
6,181
5,711
Operating right-of-use assets, net
8,707
8,960
Property and equipment, net
3,631
3,692
Total assets
$
44,959
$
60,184
Liabilities and stockholders’
equity
Accounts payable, accrued expenses and
other current liabilities
$
26,613
$
24,391
Deferred revenue - Healios
2,202
3,340
Operating lease liabilities
9,519
9,766
Accounts payable to Healios
1,119
1,119
Advance from Healios
5,199
5,199
Total stockholders' equity
307
16,369
Total liabilities and stockholders'
equity
$
44,959
$
60,184
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,
2022
2021
Revenues
Contract revenue from Healios
$
2,912
$
—
Total revenues
2,912
—
Costs and expenses
Research and development
20,944
17,508
General and administrative
4,099
8,837
Depreciation
247
244
Total costs and expenses
25,290
26,589
Loss from operations
(22,378
)
(26,589
)
Other income, net
162
121
Net loss and comprehensive loss
$
(22,216
)
$
(26,468
)
Net loss per share, basic and diluted
$
(0.09
)
$
(0.13
)
Weighted average shares outstanding, basic
and diluted
244,197
208,192
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version on businesswire.com: https://www.businesswire.com/news/home/20220506005073/en/
Ivor Macleod Chief Financial Officer Tel: (216) 431-9900
ir@athersys.com Karen Hunady Director of Corporate Communications
and 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 Peter Vozzo ICR
Westwicke Tel: (443) 213-0505 peter.vozzo@westwicke.com
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