Athersys Reports Interim Analysis Results of MASTERS-2 Clinical Study with MultiStem in Ischemic Stroke, Signs Memorandum of Understanding (MOU) for Global ARDS License with Healios
October 10 2023 - 8:30AM
Business Wire
The MOU includes $1.5M to $4.5M near term
payments plus up to $150M in milestones
Athersys, Inc. (Nasdaq: ATHX), a cell therapy and
regenerative medicine company developing MultiStem® (invimestrocel)
for critical care indications, announces that the independent data
safety monitoring board (DSMB) has completed a pre-planned interim
analysis of the Company’s ongoing Phase 3 MASTERS-2 pivotal
clinical trial evaluating MultiStem® for the treatment of acute
moderate-to-severe ischemic stroke, and concluded that the current
sample size of 300 patients is insufficiently powered to achieve
the primary endpoint of mRS Shift analysis at Day 365. There were
no safety issues identified. Because the sample size required to
achieve statistical significance is considerably larger, Athersys
intends to conduct additional data analysis with independent
statisticians. The Company plans to pause enrollment of new
patients while this analysis is being conducted.
Separately, Athersys announces that it has entered into a
Memorandum of Understanding (MOU) granting HEALIOS K.K. (Healios)
global rights to develop and commercialize MultiStem for the
treatment of acute respiratory distress syndrome (ARDS). Under the
terms of the MOU, Athersys will receive between $1.5M and $4.5M in
near term payments with up to $150 million in potential development
and sales milestones and additional royalties. Athersys also
expects to receive revenue from the sale of existing clinical doses
of MultiStem-- which were manufactured in accordance with its 3D
bioreactor process that earlier this year received approval from
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)--for
Healios to use in its Phase 3 clinical trial in ARDS.
Athersys intends to continue exploring available strategic
options. However, in the event Athersys is unable in the near-term
to enter into a strategic transaction or obtain adequate financing,
it expects to have to file for protection under the bankruptcy laws
to allow the Company to conduct an orderly wind down of operations.
In the interim, the Company is streamlining its operations to
preserve its capital and cash resources.
“I’d like to thank the many patients, clinicians and vendors
that have supported this pivotal phase 3 trial since its start in
2018. We’re disappointed with the results of the unblinded interim
analysis indicating a large sample size adjustment would be
required to achieve our primary endpoint. We intend to conduct
further analysis to better understand these results. The new MOU
we’ve signed with Healios for ARDS provides the company near-term
capital and the potential for meaningful milestone payments as we
continue to pursue various strategic solutions,” said Dan Camardo,
Chief Executive Officer of Athersys.
About MultiStem®
MultiStem® (invimestrocel) cell therapy is a patented
regenerative medicine product in clinical development that has
shown the ability to promote tissue repair and healing in a variety
of ways, such as through the production of therapeutic factors in
response to signals of inflammation and tissue damage. MultiStem
therapy’s potential for multidimensional therapeutic impact
distinguishes it from traditional biopharmaceutical therapies
focused on a single mechanism of benefit. The therapy represents a
unique "off-the-shelf" stem cell product that can be manufactured
in a scalable manner, may be stored for years in frozen form, and
is administered without tissue matching or the need for immune
suppression. Based upon its efficacy profile, its novel mechanisms
of action, and a favorable and consistent tolerability demonstrated
in clinical studies, we believe that MultiStem therapy could
provide a meaningful benefit to patients, including those suffering
from serious diseases and conditions with unmet medical need.
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. Athersys 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, 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 Athersys 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 Athersys
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. Information that we may
post about Athersys on our website and/or on our accounts on
Twitter, Facebook, LinkedIn or other social media platforms may
contain forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that involve risks
and uncertainties. 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.
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 anticipated use of
grant funding, the anticipated completion of any study or studies
funded using grant funding, the anticipated outcome of any study or
studies funded using grant funding, 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. In addition, 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 risk that we will be
unable to raise capital to fund our operations in the near term and
long term, including our ability to obtain funding through public
or private equity offerings, debt financings, collaborations and
licensing arrangements or other sources, on terms acceptable to us
or at all, and to continue as a going concern. 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 in the near term and long
term, including our ability to obtain funding through public or
private equity offerings, debt financings, collaborations and
licensing arrangements or other sources, on terms acceptable to us
or at all, and to continue as a going concern; whether we receive a
grant from BARDA; our collaborators’ ability and willingness to
continue to fulfill their obligations under the terms of our
collaboration agreements and generate sales related to our
technologies; 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 successfully license
our SIFU technology; our ability to regain and maintain compliance
with the Nasdaq continued listing requirements; 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; our ability to meet
milestones and earn royalties under our collaboration agreements,
including the success of our collaboration with Healios; 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 availability of
product sufficient to meet our clinical needs and potential
commercial demand following any approval; 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, contamination,
operational restrictions due to COVID-19 or other public health
emergencies, labor constraints, regulatory issues or other factors
that 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; 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 ability to execute
our strategic review process; 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,
2022 under Item 1A, “Risk Factors” and our other filings with the
U.S. Securities and Exchange Commission. You should not place undue
reliance on forward-looking statements, and we undertake no
obligation to publicly update forward-looking statements, whether
as a result of new information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20231010500674/en/
Athersys Ellen Gurley Manager of Corporate Communications
and Investor Relations ir@athersys.com
LHA Investor Relations Tirth T. Patel 212-201-6614
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