Athersys Inc., which has "overcome many difficult challenges" on the road to taking its stem cell therapy and other technologies to market, is seeing some near-term catalysts that could ease its journey, CEO Dan Camardo told investors late Wednesday afternoon.
The Cleveland regenerative medicine company has been working since 1994 to develop MultiStem, an off-the-shelf therapy derived from adult stem cells, to treat some stroke, acute respiratory distress syndrome (ARDS) and traumatic injury patients.
Several challenges, including dwindling cash, loss of a $100 million equity purchase agreement, struggles with meeting Nasdaq listing requirements for its stock and some disappointing clinical study results from Japanese development partner Healios K.K. have threatened the company's existence over the last 18 months.
Athersys recently restructured more than $30 million in current and future debt with its primary contract manufacturer to buy time to raise more money from investors and wring cost from its operations, an effort the company began in June 2022 by cutting 70% of its workforce.
"We've made substantial progress in our clinical trials and in streamlining our business operations, and we now have several meaningful catalysts in front of us," Camardo, the company's CEO since February 2022, told investors on Wednesday's call. "We've overcome many difficult challenges to get to this point, and we're excited to be approaching several key, near-term milestones."
The milestones include:
- Potential milestone and royalty payments from partner Healios, should the Tokyo-based therapeutics company elect to join Athersys clinical trials for treating stroke and ARDS patients.
- Winning the Biomedical Advanced Research and Development Authority's Just Breathe pitch event for therapies that can treat ARDS. The authority, which is part of the U.S. Department of Health and Human Services, plans to support a Phase 2 platform clinical trial in hospitalized adult patients who have acute respiratory distress syndrome.
- On July 6, Healios announced a letter of intent to establish a subsidiary to support ARDS treatment development in Japan. Athersys stands to receive both development and sales milestone payments, along with tiered, double-digit royalties on net sales from Healios, if it decides to go forward with its development plans.
Meanwhile, Athersys continues to talk with companies about licensing its MultiStem and animal health technologies, Camardo said.
"We also have [had] a number of conversations with venture capital firms and other potential investors in potentially spinning out our SIFU technology so that it can be developed more broadly as a standard infrastructure for the industry," he said.
Atherysys' Secure Integrated Freezer Unit (SIFU) is a cryogenic storage device designed for hospital settings that requires no liquid nitrogen to do its job.
"Our team's dedication and engagement over the past several months with regulatory and government agencies has renewed our confidence in the potential of MultiStem and reminded us of the important work we're doing and the immense responsibility we have to offer hope to patients that suffer from these debilitating diseases," Camardo said.
Shares of Athersys (Nasdaq: ATHX) rose 3.3% to 44 cents on Wednesday and is up again in Thursday trading.
