Athersys Announces Financial Results for Fourth Quarter and Full Year 2020

Athersys, Inc. (NASDAQ: ATHX) announced today its fourth quarter 2020 and annual 2020 financial results and recent highlights.

"Despite a difficult operating environment, Athersys has made meaningful progress over the past year,” commented Mr. William (B.J.) Lehmann, Interim Chief Executive Officer of Athersys. “We made considerable progress in developing our large-scale manufacturing processes. On the clinical front, we took advantage of the opportunity, with the onset of the COVID-19 pandemic, to accelerate the development of our MultiStem^® therapy for ARDS with the launch of the MACOVIA study. The MASTERS-2 study moved forward but at a slower pace than expected. Importantly, we entered into a cooperation agreement with our partner, Healios, to put us on a better path to jointly prepare for potential commercialization of the MultiStem therapy in Japan.

“In 2021, we expect to see the top-line results from both the TREASURE and ONE-BRIDGE studies, the TREASURE study giving us the first look at late-stage clinical trial data for MultiStem treatment of ischemic stroke. We are also working to achieve proof-of-principle for our large-scale manufacturing processes, an important milestone on the way to establishing the capability to serve large potential markets such as ischemic stroke,” added Mr. Lehmann.

Fourth Quarter, 2020 and Recent Highlights:

• Assisted HEALIOS K.K. (Healios), our partner in Japan, in its regulatory preparations as it advanced enrollment to near completion in its TREASURE ischemic stroke and ONE-BRIDGE acute respiratory distress syndrome (ARDS) studies;
• Reached a cooperation agreement with Healios to resolve the legal matter between its CEO and Athersys Board member, Dr. Kagimoto, and the Company, and to set the stage for addressing open matters important to continued development, regulatory progress and successful commercialization in Japan following approval;
• Received INN designation for “invimestrocel” as the non-proprietary name for the MultiStem cell therapy and made progress in registering our proprietary brand name for the product candidate;
• Received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for MultiStem therapy for the treatment of ARDS;
• Initiated and conducting the MACOVIA study for the treatment of ARDS in COVID-19 patients, and amended the protocol with the FDA to include other pathogen-induced ARDS patients;
• Launched the MATRICS-1 study evaluating MultiStem treatment in severe trauma patients, with the first patient enrolled in the fourth quarter;
• Made important leadership hires in key areas, including Mr. Ivor Macleod as Chief Financial Officer and Ms. Maia Hansen as Senior Vice President, Operations and Supply Chain;
• Appointed four new directors to our board, adding