Company announces Fast Track Designation by FDA for Stroke Program and other progress
Management to host conference call at 4:30pm EDT today
CLEVELAND, May 09, 2017 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced its financial results for the three months ended March 31, 2017.
Highlights of the first quarter of 2017 and recent events include:
- Clinical program for stroke awarded Fast Track Designation by U.S. Food & Drug Administration (“FDA”) – designation means that the program becomes eligible for Rolling Submission, Accelerated Approval and Priority Review of the biologics license application, facilitating timely regulatory review;
- Clinical investigators published two articles in March 2017 in peer-reviewed journals, Stem Cells and Lancet Neurology, respectively, with the first article describing preclinical results showing how MultiStem® cell therapy could provide benefit to patients following ischemic stroke and the second article describing results from Phase 2 trial of MultiStem cell therapy for treating ischemic stroke patients (the “MASTERS” trial);
- Following completion of an assessment of operational issues related to a recent FDA inspection at our contract manufacturer, Lonza, investigational product is now being released, and our partner, HEALIOS K.K., is preparing for patient enrollment of the TREASURE study in Japan;
- Commercial milestone payment of $1.0 million received from collaboration with RTI Surgical, Inc. (“RTI”);
- Net proceeds of $20.9 million received in February 2017 from common stock offering in support of ongoing and planned clinical and process development activities;
- Proceeds from warrant exercises of $1.9 million received in first quarter of 2017, resulting in the issuance of approximately 1.8 million shares of common stock, and no warrants remain outstanding;
- Revenues of $1.5 million recognized for quarter ended March 31, 2017 and net loss of $5.6 million, or $0.06 loss per share; and
- Cash and cash equivalents balance of $31.9 million at first quarter-end.
“We are excited about receiving Fast Track designation for our clinical stroke program, and we thank the FDA for its continued support of our efforts to develop and provide an important new treatment option for patients in this area of unmet medical need,” commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. “Recent publications and presentations continue to illustrate how we might be able to extend the treatment window for stroke patients out to 36 hours with MultiStem, beyond the narrow window for treatment that exists today, and also the important biological mechanisms that our cell therapy may provide to help patients recover from a debilitating stroke event. Stroke remains the leading cause of serious disability, yet many people are still unaware of the signs and symptoms of stroke, or the need to take action right away, and we are committed to building public awareness in this area.
“We are pleased that the Healios TREASURE trial in Japan is now getting underway,” added Dr. Van Bokkelen. “Additionally, we are actively engaged with the FDA, European Medicines Agency and other regulators to obtain regulatory alignment for our planned Phase 3 clinical trial for stroke, MASTERS-2, and we anticipate completing the key regulatory activities for our study sometime this summer. In parallel, we are advancing our partnering discussions in stroke and other areas, which represent an important priority for the company,” concluded Dr. Van Bokkelen.
