Athersys, Inc. (NASDAQ: ATHX), a regenerative medicine
company developing MultiStem® (invimestrocel) cell therapy for
critical care indications announced it has restructured its
outstanding debt with a supplier (“the supplier”). The Company
previously entered into agreements with the supplier to assist in
the scale-up and manufacturing of clinical and commercial grade
MultiStem® using Athersys’ bioreactor production processes.
Under the new agreement, Athersys will pay the supplier $11.8
million in monthly cash payments of $250,000 each, beginning
October 2023. In addition, Athersys has issued a $15 million
convertible note. The three-year note carries interest of 10.0% and
is convertible after 18 months into Athersys common stock at $1.30
per share, at the supplier’s sole discretion.
The restructured agreement provides the supplier with the right
of first refusal to supply 50% of all material required to
manufacture MultiStem until five years after MultiStem receives
regulatory approval for commercial sale.
“I’m delighted to announce the successful restructuring of our
agreement with our supplier. This liability represented more than
80% of our accounts payable balance and was largely driven by
commitments made prior to the release of the TREASURE trial
results,” said Dan Camardo, Chief Executive Officer of Athersys.
“This new agreement reflects Athersys’ post-restructuring
development and manufacturing needs, which prioritize MultiStem for
the treatment of ischemic stroke. Following our successful Type B
Meeting with the FDA, we gained a clear understanding of our
timeline to complete the MASTERS-2 trial which was an important
step in negotiating this agreement.”
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. 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, 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.Information that we may post about the
Company 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 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. 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 and our ability to
successfully resolve the payment issues with our primary contract
manufacturer and gain access to our clinical product. 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; our ability to successfully license our SIFU
technology; 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 regain 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
success of our MACOVIA clinical trial evaluating the administration
of MultiStem for the treatment of ARDS induced by COVID-19 and
other pathogens, 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 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 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 lings with the SEC. 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/20230517005778/en/
Athersys Ellen Gurley Manager of Corporate Communications
and Investor Relations ir@athersys.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
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