May 1, 2018

Athersys and Healios Extend by One Month the Period to Complete Collaboration Expansion Agreements

CLEVELAND and TOKYO, May 01, 2018 (GLOBE NEWSWIRE) -- Athersys, Inc. (NASDAQ:ATHX) and HEALIOS K.K. ("Healios") (TSE Mothers Code:4593) have agreed to extend the period from April 30, 2018 to May 31, 2018 to complete their planned collaboration expansion agreements, as defined in the March 13, 2018 Binding Letter of Intent. In March 2018, Healios invested $21.1 million in Athersys common stock and deposited an initial license fee payment of $10 million related to the planned expansion into an escrow account. The parties agreed to this one-month extension to allow for additional time to complete all of the agreements needed to define the expansion terms. 

"With the Golden Week national holiday in Japan now upon us and some remaining work to be completed, rather than trying to rush to finish things, we mutually agreed that we should extend the window until the end of the month," commented Gil Van Bokkelen, Chairman & CEO of Athersys. "As we have discussed previously, both companies remain firmly committed to expanding their partnership into several additional areas, and to completing this process as efficiently as possible."

"I sincerely appreciate the efforts undertaken by both teams thus far, as we work towards finalizing the expansion of our collaboration with Athersys. We look forward to completing this process in the near future," commented Dr. Hardy Kagimoto, Chairman & CEO of Healios.

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.

About Healios

Healios is a biotechnology venture leading the field of developing iPS cell-based products for regenerative medicine. It was founded in 2011 and listed on the stock exchange (Tokyo Security Exchange Mothers:4593) in 2015. In Japan, the company is developing a product for treatment of age-related macular degeneration (an intractable ocular disease) jointly with Suimitomo Dainippon Pharma Co., Ltd., under the plan of obtaining approval of its manufacture/distribution in 2020. In fields other than ophthalmology, the company has started R&D of products for regenerative medicine capable of creating functional human organs (three-dimensional organs) jointly with Yokohama City University. The company may be viewed as an enterprise providing products for regenerative medicine as a solution to the significant global issue "aging of the society." See the website(https://www.healios.co.jp/)for details.

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 approval 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: our ability to work with Healios under the terms of the letter of intent described elsewhere in the press release to successfully negotiate the terms of and execute, the agreements necessary to expand the existing collaboration; 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 clinical trials, including the MASTERS-2 Phase 3 clinical trial and the TREASURE 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-G

Contact:
 
Athersys, Inc.
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
Fax: (216) 432-2461
bjlehmann@athersys.com
HEALIOS K.K.
Department of Public Relations
Tel: 81-(0) 3-5777-8308
Fax: 81-(0) 3-3434-7231
pr@healios.jp 
   
Karen Hunady - Athersys
Corporate Communications & Investor Relations
Tel: (216) 431-9900
khunady@athersys.com
 
   
David Schull - Athersys
Russo Partners, LLC
Tel: (212) 845-4271 or (858) 717-2310
David.schull@russopartnersllc.com
 

 

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Source: Athersys, Inc.; Healios

 

 

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