Athersys and Nikon CeLL Innovation to Collaborate on MultiStem® Commercial Manufacturing in Japan

Technology transfer of stem cell production methods in preparation for potential commercialization in Japan following TREASURE clinical study

CLEVELAND, Oct. 11, 2017 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced that it has entered into a manufacturing services agreement with Nikon CeLL innovation Co., Ltd. (NCLi) for commercial production of its stem cell therapy, MultiStem^®, in Japan for ischemic stroke.  NCLi is a wholly-owned subsidiary of Nikon Corporation and provides a wide range of process development and manufacturing services, from pre-clinical to commercial manufacturing of cell and gene therapies.

Based on the agreement, Athersys and NCLi will engage in technology transfer activities at NCLi's facility in Japan, and NCLi will begin contract manufacturing support for commercial development of the product in Japan.  Athersys' collaborator, HEALIOS K.K. (Healios), has an exclusive license to develop and market MultiStem in Japan for ischemic stroke, and is currently conducting its registrational clinical study, TREASURE, in Japan.  

Therapeutic treatment with MultiStem may extend the stroke treatment window to 36 hours from the current three to four and a half hours with existing standard of care, which would enable many more stroke patients to receive treatment than under the current standard of care and may also meaningfully enhance patient recovery. 

"We are excited about our new alliance with Nikon CeLL innovation, focused on establishing the manufacturing infrastructure that will enable us and Healios to achieve our goals in Japan.  Nikon brings important capabilities to the partnership, including an extensive investment in facilities and technology.  We and Healios agree that this puts us both in a strong position to achieve our goals," commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys.  "With a successful study outcome and subsequent product registration, Athersys' MultiStem cell therapy would represent the first major advancement in more than twenty years for the treatment of acute stroke.  We intend to be ready for success, and this alliance represents an important step toward establishing the capabilities that will enable us to take full advantage of this significant opportunity."

About Ischemic Stroke

Stroke represents an area where the clinical need is particularly significant, since it is a leading cause of death and serious disability worldwide, with a substantially impaired quality of life for many stroke victims. Currently, there are nearly 17 million people that suffer a stroke globally and, on average, someone in the United States has a stroke every 40 seconds.  Ischemic strokes, which represent the most common form of stroke, are caused by a blockage of blood flow in the brain that cuts off the supply of oxygen and nutrients and can result in long-term or permanent disability due to neurological damage. Unfortunately, current therapeutic options for ischemic stroke victims are limited, since the only available therapies, administration of the clot dissolving agent tPA, or "thrombolytic," or surgical intervention using mechanical reperfusion to remove the clot, must be conducted within several hours of the occurrence of the stroke. As a consequence of this limited time window, only a small percentage of stroke victims are treated with the currently available therapy—most simply receive supportive or "palliative" care. The long-term costs of stroke are substantial, with many patients requiring extended hospitalization, extended physical therapy or rehabilitation (for those patients that are capable of entering such programs), and many require long-term institutional or family care.

About MultiStem

MultiStem cell therapy is a patented regenerative medicine product 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 product 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 both preclinical and clinical settings, MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need. Athersys has forged strategic partnerships and a broad network of collaborations to develop MultiStem cell therapy for a variety of indications, with an initial focus in the neurological, cardiovascular and inflammatory and immune disorder areas.

About Athersys

Athersys is an international 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, 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 the MultiStem cell therapy toward commercialization.  More information is available at www.athersys.com.

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 human therapeutics, such as the uncertainty regarding regulatory approvals and market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of ischemic stroke, acute myocardial infarction, spinal cord injury and acute respiratory distress syndrome and other disease indications, including graft-versus-host disease. 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: the success of our collaboration with Healios and others, including our ability to reach milestones and receive milestone payments, and whether any products are successfully developed and sold so that we earn royalty payments; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements; the success of our efforts to enter into new strategic partnerships or collaborations and advance our programs; our ability to raise additional capital; results from our MultiStem ongoing and planned 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 within the expected time frame or at all; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; 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.

ATHX-STR

Contact:                                                                     
William (B.J.) Lehmann                                  
President and Chief Operating Officer                                    
Tel: (216) 431-9900
bjlehmann@athersys.com

Karen Hunady
Corporate Communications
Tel: (216) 431-9900
khunady@athersys.com 

David Schull   
Russo Partners, LLC
Tel: (212) 845-4271 or (858) 717-2310
David.schull@russopartnersllc.com 

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