Athersys, Inc. (Nasdaq: ATHX), a cell therapy and
regenerative medicine company developing MultiStem® (invimestrocel)
for critical care indications, and Multipotent Adult Progenitor
Cell (MAPC®) technology for equine, canine, and feline health
applications, announces the signing of a licensing agreement with
Ardent Animal Health (Ardent). Ardent is a privately held
veterinary biotechnology company developing regenerative medicine
and cancer therapies for animals.
Under the terms of the agreement, Athersys will receive an
initial fee from Ardent in exchange for an exclusive license to
Athersys’ Multipotent Adult Progenitor Cell (MAPC®) technology for
non-human mammal applications in the United States. The agreement
includes pre- and post-regulatory approval milestone payments to
Athersys, including payments on conditional and full product
approval for each species/indication combination. Athersys will
also receive tiered, double-digit royalties on commercial
sales.
Athersys has also granted Ardent rights of first refusal to be
the exclusive distributor for Athersys’ novel cryogenic storage
system, the Secure Integrated Freezer Unit (SIFU) in the United
States animal health space.
“We’re excited to announce this agreement with Ardent based on
their proven capabilities in developing stem cell-based treatment
options for animals. This agreement recognizes the progress we’ve
made in preclinical research and manufacturing of MAPC for animal
health and provides Ardent a solid foundation to build on,” stated
Dan Camardo, Chief Executive Officer of Athersys.
“We look forward to this partnership with Athersys as we develop
innovative and life-changing treatments for animals. Through
partnerships like this and with the strong results generated to
date with MAPC, we’re better able to advance stem cell therapy for
joint disease and other areas of unmet need in animal health,”
added Thomas Masterson, President of Ardent.
About Ardent Animal Health
Ardent Animal Health is a veterinary biotechnology company based
in Lexington, Kentucky. Founded in 2016, its mission is to improve
the lives of pets and people. Ardent’s pipeline includes novel
cancer and regenerative medicine treatments for veterinary patients
suffering from cancer and other inflammatory diseases. Ardent is a
synonym for passionate, fiery and committed, which manifests
through Ardent’s worldwide referral network providing advanced care
for complicated diseases. Ardent is a Breakthru Portfolio company
(see www.realbreakthru.com). For more information, please visit
https://ardentanimalhealth.com/.
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. While development of our clinical programs for
human health indications remains our priority, our wholly owned
subsidiary, ReGenesys developed a cell therapy based on Athersys’
Multipotent Adult Progenitor Cell (MAPC®) technology for use in
treating diseases and conditions in the animal health area. We have
conducted research in preclinical canine, equine and feline models
to establish safety and explore the potential for MAPC cells to
reduce inflammation and promote healing which could provide
meaningful benefits to animals. Investors and others should note
that we may post information about Athersys on its website at
www.athersys.com and/or on its 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, Athersys encourages investors, the media
and others interested in Athersys to review the information it
posts on its website at www.athersys.com and on its social media
accounts. Follow Athersys on Twitter at www.twitter.com/athersys.
Information that Athersys may post about itself on its website
and/or on its 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 Athersys’
website and/or on its accounts on Twitter, Facebook, LinkedIn or
other social media platforms, and Athersys undertakes 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 product candidates, Athersys’ growth strategy,
and its future financial performance, including its operations,
economic performance, financial condition, prospects, and other
future events, and any results from the license to Ardent and any
revenues to Athersys as a result of such license. Athersys has
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 Athersys’ 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 Athersys faces are the risk that it
will be unable to raise capital to fund its operations in the near
term and long term, including its ability to obtain funding through
public or private equity offerings, debt financings, collaborations
and licensing arrangements or other sources, on terms acceptable to
it or at all, and to continue as a going concern. The following
risks and uncertainties may cause Athersys’ 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: its ability to raise capital to fund its operations in
the near term and long term, including its ability to obtain
funding through public or private equity offerings, debt
financings, collaborations and licensing arrangements or other
sources, on terms acceptable to it or at all, and to continue as a
going concern; whether Athersys receives a grant from BARDA;
Athersys’ collaborators’ ability and willingness to continue to
fulfill their obligations under the terms of Athersys’
collaboration agreements and generate sales related to its
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; Athersys’ ability to successfully
license its SIFU technology; Athersys 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;
Athersys’ ability to meet milestones and earn royalties under its
collaboration agreements, including the success of its
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 Athersys’
clinical needs and potential commercial demand following any
approval; the possibility of delays in, adverse results of, and
excessive costs of the development process; Athersys’ ability to
successfully initiate and complete clinical trials of its product
candidates; the possibility of delays, work stoppages or
interruptions in manufacturing by third parties or Athersys, 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 Athersys’ trials and the trials of its
collaborators; uncertainty regarding market acceptance of Athersys’
product candidates and Athersys’ 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 Athersys’ industry’s overall
performance; changes in Athersys’ business strategy; Athersys’
ability to protect and defend its intellectual property and related
business operations, including the successful prosecution of its
patent applications and enforcement of its patent rights, and
operate its business in an environment of rapid technology and
intellectual property development; Athersys’ possible inability to
realize commercially valuable discoveries in its collaborations
with pharmaceutical and other biotechnology companies; the success
of our efforts to enter into new strategic partnerships and advance
Athersys’ programs; Athersys’ possible inability to execute its
strategy due to changes in its industry or the economy generally;
changes in productivity and reliability of suppliers; the success
of Athersys’ competitors and the emergence of new competitors; and
the risks mentioned elsewhere in Athersys’ Annual Report on Form
10-K for the year ended December 31, 2022 under Item 1A, “Risk
Factors” and its other lings with the SEC. You should not place
undue reliance on forward-looking statements, and Athersys
undertakes no obligation to publicly update forward-looking
statements, whether as a result of new information, future events
or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231003236554/en/
Athersys Ellen Gurley Manager of Corporate Communications
and Investor Relations ir@athersys.com LHA Investor
Relations Tirth T. Patel 212-201-6614
Ardent Animal Health Matt Yeich Marketing Manager
matt@ardentanimalhealth.com
Athersys (NASDAQ:ATHX)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Athersys (NASDAQ:ATHX)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024