Athersys Inc., the Cleveland regenerative medicine startup, is "a very different company" from the one CEO Daniel Camardo joined more than a year ago.
"I'm very proud of the progress we've made in a relatively short period of time under some challenging circumstances," Camardo told equity analysts during a business update on Tuesday.
"Every aspect of our business has been re-evaluated, and thoughtful and decisive actions have been taken to create a more disciplined, focused, transparent and accountable organization," Camardo said. "But make no mistake: I recognize we still have a lot more work to do."
In June 2022, Athersys embarked on a financial and operational restructuring — what Camardo calls a "transformation" — to lower its cost and conserve cash while completing the testing and commercialization of its adult stem-cell therapy, MultiStem, to treat certain stroke patients.
On Tuesday, Athersys said the U.S. Food & Drug Administration has agreed to meet with the company in March to discuss proposed modifications to its pivotal ischemic stroke study to better reflect the potential long-term benefit of MultiStem treatment.
The company's clinical trial progress was interrupted in May 2022 after MultiStem failed to meet the primary research outcome in a stroke study done by Athersys partner Healios KK in Japan.
The Japanese study included many older patients who had pre-existing conditions, such as mobility issues, prior to having strokes for which they were treated with MultiStem. These patients were tracked for only 90 days after receiving treatment.
"We have confidence in the ability of MultiStem cells to provide continual recovery benefit in stroke patients and eventually other injuries, as well," Robert "Willie" Mays, head of regenerative medicine and neuroscience programs at Athersys said on Tuesday.
"However, when limited to a 90-day evaluation window, the full potential of the MultiStem cell treatment is likely not fully realized," Mays said.
Athersys also has been looking for partners to license or co-commercialize the company's technology as a step toward solving its serious cash shortage.
More recently, Athersys executives have been talking with companies that might want to buy or license technologies that are not core to its stroke clinical trials, Camardo said on Tuesday.
Shares of Athersys (Nasdaq: ATHX), which had risen as high as $1.90 on Feb. 10, were down nearly 15% to about $1.51 in late-afternoon trading on Tuesday.
