Athersys to Present at 2017 Cell & Gene Meeting on the Mesa and Announces Regenerative Medicine Advanced Therapy (RMAT) Designation From FDA

CLEVELAND, Oct. 05, 2017 -- Athersys, Inc. (NASDAQ:ATHX) announced today that Robert W. Mays, Ph.D., Vice President, Regenerative Medicine and Head of Neuroscience Programs, will present at the annual Partnering Forum as part of the Cell & Gene Meeting on the Mesa to be held October 4-6 in La Jolla, California.

Dr. Mays will provide a brief overview of the Company’s neuroscience programs, focusing on the Phase 3 clinical program for ischemic stroke, which previously received special Protocol Assessment (SPA) and Fast Track designations from the U.S. Food and Drug Administration (FDA), and recently obtained a Final Scientific Advice positive opinion from the European Medicines Agency.

The Company is also pleased to announce that it has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, recently established under the 21^st Century Cures Legislation.  The RMAT designation may be obtained for eligible cell therapy and other regenerative medicine and advanced therapies when the FDA agrees that preliminary clinical evidence indicates that the therapy has demonstrated the potential to address unmet medical needs for a serious or life threatening disease or condition. The designation enables sponsors to discuss with the FDA multidisciplinary strategic development plans, including expediting manufacturing development plans for commercialization to support priority review and accelerated approval.

The following are specific details regarding Athersys’ presentation at the conference:

This conference is the largest partnering meeting organized specifically for the cell and gene therapy sector, providing the opportunity for participants to establish key relationships and accelerate business development.  Organized by ARM and the Sanford Stem Cell Clinical Center at UC San Diego, the Cell & Gene Meeting on the Mesa is a three-day conference featuring three distinct parts, the program’s two-day Partnering Forum, a Public Forum lecture and a full-day Scientific Symposium. The event’s Partnering Forum on October 4-5, features more than 70 dedicated company presentations in addition to 90 panelists and featured speakers.

A live video webcast of all company presentations will be available at: http://www.meetingonthemesa.com/webcast/ and will also be published on ARM’s website shortly after the event. Please visit www.meetingonthemesa.com for full information including registration. Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Laura Parsons at [email protected] and interested media should contact Lyndsey Scull at [email protected].

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.

ATHX-G

Contact:
William (B.J.) Lehmann
President and Chief Operating Officer
Tel: (216) 431-9900
[email protected]

Karen Hunady
Corporate Communications
Tel: (216) 431-9900
[email protected]

David Schull
Russo Partners, LLC
Tel: (212) 845-4271 or (858) 717-2310
[email protected]