Athersys, Inc. (NASDAQ: ATHX) announced today the extension of
HEALIOS K.K.’s (Healios) exclusive period to negotiate an option
that would allow Healios to obtain a license for the development
and commercialization of MultiStem therapy for certain indications
in China. Healios has agreed to make a one-time $2.0 million
payment in December 2018 for an extension through June 30, 2019.
Furthermore, Healios may make an additional payment of $3.0 million
to extend the negotiation period for another six months through
December 31, 2019. All such payments would be creditable against
the $15 million option fee that would be payable by Healios upon
execution of the China option agreement, and milestones for any
licensed program, if applicable.
“China now represents the second largest
healthcare market in the world, surpassing Japan, and we and
Healios both view it as being strategically important to our
long-term goals and objectives,” commented Dr. Gil Van Bokkelen,
Chairman & CEO at Athersys. “An executive advisor with
extensive experience in China has been engaged by Healios to advise
on multiple aspects of the opportunity, and we agreed with Healios
that it was appropriate to implement this extension to allow us
sufficient time to work together to more precisely define
regulatory, manufacturing and potential commercialization
activities in China.
“We maintain a strong and close relationship
with Healios, as evidenced by their good faith payment related to
the China negotiation period, as well as our ongoing collaborative
activities focused on treating stroke patients and those afflicted
with acute respiratory distress syndrome (“ARDS”) and other areas
of unmet medical need where we are working together. We share a
global vision of the potential for regenerative medicine technology
and how it might be used to benefit patients in multiple
therapeutic areas and create substantial value for our
shareholders,” concluded Dr. Van Bokkelen.
Athersys’ collaboration with Healios was
established in 2016 for the development of MultiStem cell therapy
in Japan for the treatment of ischemic stroke, and Healios is
conducting an ongoing registrational clinical trial referred to as
TREASURE. In March 2018, Healios made a $21.1 million equity
investment in Athersys, and in June 2018, the partnership was
further expanded to include a license to additional therapeutic
areas in exchange for a $20 million license fee, additional
milestones and royalties. As part of the collaboration
expansion, Healios obtained exclusive licenses for the development
and commercialization in Japan of MultiStem therapy for the
treatment of ARDS and for MultiStem cells used in combination with
iPSC-derived cells for the treatment of certain organ dysfunction
indications. Healios also received an exclusive global license to
develop and commercialize MultiStem cells, either as a standalone
therapy or in combination with retinal pigmented epithelial (“RPE”)
cells for certain ophthalmological indications, and an expansion of
its license to use Athersys technology to support its organ bud
programs to include certain other transplantation areas. As Healios
announced in November 2018, it is planning to conduct an open-label
clinical trial of MultiStem therapy to treat patients with
pneumonia-induced ARDS.
About MultiStem
MultiStem 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
produced 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 safety
profile demonstrated in clinical studies, 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 an international biotechnology
company engaged in the development of therapeutic products 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, cardiovascular, and
inflammatory and immune disease areas, 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. 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
that could cause actual results to differ materially from those
implied by forward-looking statements 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.
These risks 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. Other important
factors to consider in evaluating our forward-looking statements
include: our ability to raise capital to fund our operations; the
timing and nature of results from our MultiStem clinical trials,
including the MASTERS-2 Phase 3 clinical trial and the Healios’
TREASURE clinical trial in Japan; 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 to us,
such as due to material supply constraints, contaminations, or
regulatory issues, 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 the treatment of
stroke, acute respiratory distress syndrome, acute myocardial
infarction and trauma, and the prevention of graft-versus-host
disease and other disease 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 work with Healios to
reach an agreement for an option in China; 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; and the success of our competitors and
the emergence of new competitors. 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.
Contacts:
William (B.J.) LehmannPresident and Chief
Operating OfficerTel: (216) 431-9900bjlehmann@athersys.com
Karen Hunady Corporate Communications &
Investor RelationsTel: (216) 431-9900khunady@athersys.com
David Schull Russo Partners,
LLCTel: (212) 845-4271 or (858)
717-2310David.schull@russopartnersllc.com
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