Athersys, Inc. - ATHX STOCK NEWS

Athersys, Inc. has appointed Daniel A. Camardo as CEO, effective February 14, 2022. With over 25 years of experience in the pharmaceutical and biotech industry, Camardo will guide the company in the commercialization of its MultiStem cell therapy, aimed at treating serious medical conditions like ischemic stroke. Previously at Horizon Therapeutics, he has a history of transforming startups into successful organizations. Interim CEO William (B.J.) Lehmann will remain as President and COO, ensuring continuity during this transition.

Athersys announced the publication of data from the MUST-ARDS clinical trial in the journal Intensive Care Medicine, which evaluated MultiStem cell therapy for acute respiratory distress syndrome (ARDS). The Phase 1/2 trial found the treatment well-tolerated, with no serious adverse reactions and significant benefits including lower mortality and increased ICU-free and ventilator-free days. Furthermore, pooled data from this and another study indicated potential additional clinical benefits. The FDA granted Regenerative Medicine Advanced Therapy and Fast Track designations for the ARDS program.

Athersys, Inc. (NASDAQ: ATHX) reported positive advancements in its MultiStem® cell therapy program during Q3 2021. Key highlights include positive topline results from Healios' ONE-BRIDGE study on ARDS, completion of enrollment in the TREASURE study for ischemic stroke, and improved collaboration with Healios for commercialization in Japan. Financially, Athersys recorded revenues of $4.8 million, significantly up from $0.1 million year-over-year, and a reduced net loss of $16.2 million. The company ended the quarter with $49.7 million in cash.

Athersys has announced an update from its partner Healios regarding clinical programs for acute respiratory distress syndrome (ARDS) and ischemic stroke involving MultiStem therapy. Healios plans to file for regulatory approval for MultiStem in ARDS by Q4 2021/Q1 2022. Additionally, topline data from the TREASURE study on ischemic stroke will be disclosed after the last patient's one-year follow-up visit in March 2022, with results expected in Q2 2022. Athersys will discuss these updates in its Q3 financial results call on November 15, 2021.

Athersys, Inc. (NASDAQ: ATHX) is set to release its third quarter 2021 financial results on November 15, 2021, at 4:00 PM ET. A conference call will follow at 4:30 PM ET to discuss the results. Shareholders can register for the call via the provided links to participate and can access a replay post-event through the company's website, available until November 22, 2021. Athersys focuses on developing its MultiStem® cell therapy for various critical care indications, as it continues to advance its clinical trials and strategic partnerships.

Athersys, Inc. (NASDAQ: ATHX) announced that Dr. Robert W. Mays and Mr. B.J. Lehmann will attend the Cell & Gene Meeting on the Mesa in Carlsbad, California from October 12-14, 2021. Dr. Mays will present on the company’s MultiStem cell therapy, focusing on its clinical trials for ischemic stroke and acute respiratory distress syndrome. Positive topline data from a recent ONE-BRIDGE study in Japan will be highlighted. Mr. Lehmann will speak at a panel on personalized cardiovascular therapies on October 13. The conference will host over 1,200 attendees.

Athersys, Inc. (NASDAQ: ATHX) announced that its partner, Healios, completed enrollment in the TREASURE study in Japan, testing MultiStem (invimestrocel) cell therapy for ischemic stroke patients. This phase 2/3 placebo-controlled trial aims to confirm the therapy's efficacy and safety. Athersys is also conducting the MASTERS-2 study, a phase 3 trial in various regions, which has received FDA Fast Track and RMAT designations. Mr. Lehmann, Athersys President, expressed optimism about MultiStem's potential to improve stroke treatments and looks forward to topline results later this year.

Athersys, Inc. (NASDAQ: ATHX) announced its Q2 2021 financial results, reporting a net loss of $22.6 million, or $0.10 per share. The company had no revenues, a decrease from $0.1 million in Q2 2020. R&D expenses rose to $17.7 million due to increased clinical trial and manufacturing costs. Athersys highlighted positive topline results from the ONE-BRIDGE ARDS study in Japan, reinforcing the potential of its MultiStem cell therapy. Collaborations with Healios are expanding, focusing on commercialization in Japan, while the company maintains $56.7 million in cash as of June 30, 2021.

Athersys, Inc. (NASDAQ: ATHX) reported that its partner, HEALIOS K.K., has achieved positive topline results from the ONE-BRIDGE clinical trial for MultiStem^® cell therapy in patients with acute respiratory distress syndrome (ARDS). The trial included two cohorts: pneumonia-induced ARDS and COVID-induced ARDS. Key outcomes showed favorable data regarding ventilator-free days and 90-day mortality, aligning with Athersys's previous MUST-ARDS study results. MultiStem has orphan regenerative medicine designation in Japan, highlighting its therapeutic potential for ARDS.