Athersys, Inc. (NASDAQ: ATHX) announced today the addition of Mr.
Ivor Macleod, CPA, MBA, a highly experienced pharmaceutical
executive, to the Athersys leadership team. Mr. Macleod has been
appointed Chief Financial Officer, effective as of January 31,
2020, to help plan and execute the financial strategy through
potential product commercialization. Ms. Laura Campbell, the
Company’s Senior Vice President of Finance, will continue to serve
as the principal accounting officer. As the Company prepares for
the potential approval of MultiStem cell therapy and
commercialization, Mr. Macleod will play an integral role that
includes financial planning related to commercial manufacturing,
marketing, distribution and reimbursement of MultiStem cell therapy
to drive substantial value creation.
Mr. Macleod has over three decades of global
experience across all aspects of the life sciences value chain,
from basic research to commercialization, serving in various
executive finance and leadership roles within the life sciences
industry. Prior to joining Athersys, Mr. Macleod served as Chief
Financial Officer and Chief Compliance Officer of Eisai Inc., the
U.S. subsidiary of the Japanese company, Eisai Ltd, where he led
the overall financial strategy and performance of the company,
including several strategic projects to both commercialize and
optimize performance of portfolio products. He has held key
leadership positions at Merck & Co., F. Hoffmann-La Roche, and
Boehringer Mannheim Therapeutics, among others. Mr. Macleod has a
proven record of helping lead global marketing strategy and
initiatives, formulating long-term strategic plans, managing costs
and annual operating budgets, and leading investor relations. Mr.
Macleod also has extensive experience of bringing therapeutics to
market. While at Merck, he provided financial support and
collaborated on the successful development and competitive launch
of Pembrolizumab (Keytruda®), the first FDA approved PD-1
inhibitor.
“We are truly excited to have Ivor Macleod join
the Athersys team. He has a long and distinguished career in key
roles at leading biopharmaceutical organizations, and we expect him
to be an important addition to our executive leadership team as we
continue our plans and preparations for commercial readiness and
the envisioned transition into commercialization,” said Dr. Gil Van
Bokkelen, Chairman and Chief Executive Officer at Athersys. “He
brings a wealth of experience and a proven track record when it
comes to financial and strategic leadership and commercialization,
and we look forward to working alongside him as we advance toward
achieving our goals,” concluded Dr. Gil Van Bokkelen.
“It is a thrill to be joining Athersys at such
an exciting time. The opportunity to work alongside such a talented
team focused on addressing critical areas of unmet medical need was
too good to pass up,” commented Mr. Macleod.
“I look forward to being a significant
contributor to the Athersys leadership team and more importantly to
their mission of developing best in class regenerative medicine
therapies to significantly improve quality of human life,”
concluded Mr. Macleod.
Athersys is committed to developing therapies
that address key areas of unmet medical need in order to extend and
enhance the quality of human life. The Company has a clinical
pipeline focused on critical care indications using its proprietary
therapeutic platform, MultiStem cell therapy. Current clinical
programs include the MASTERS-2 trial, a pivotal Phase 3 study of
MultiStem cell therapy for the treatment of ischemic stroke, which
has received Fast Track and Regenerative Medicine Advanced Therapy
designation from the U.S. Food and Drug Administration and positive
scientific advice from the European Medicines Agency, and is being
conducted under a Special Protocol Assessment. The Company’s
partner, HEALIOS K.K. (“Healios”), currently has two clinical
programs using MultiStem cell therapy, including the TREASURE study
for the treatment of ischemic stroke and the ONE-BRIDGE study for
the treatment of ARDS. With its progressing clinical programs, the
Company is pleased to welcome Mr. Macleod to the executive team as
an experienced leader to help plan and prepare for potential
commercialization.
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 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 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 the 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 Healios’
TREASURE and ONE-BRIDGE clinical trials 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
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.
Contact:
William (B.J.)
Lehmann
President and Chief Operating
Officer
Tel: (216) 431-9900bjlehmann@athersys.com
Karen Hunady Director of 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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