Athersys, Inc. (Nasdaq: ATHX), a regenerative medicine company developing MultiStem (invimestrocel) cell therapy for critical care indications, announced financial results for the three and six months ended June 30, 2023 and provided a business update.
Second Quarter 2023 and Recent Corporate and Operational Highlights:
Nominated healthcare executive and strategy consultant Neema Mayhugh, Ph.D. to the Companys Board of Directors
Surpassed two-thirds patient enrollment in the MASTERS-2 clinical trial with MultiStem for ischemic stroke
Completed Memorandum of Understanding with Healios to provide consulting support with PMDA to explore the feasibility of adding Japanese patients to MASTERS-2 trial
Presented as a finalist for the Biomedical Advanced Research and Development Authoritys (BARDA) Just Breathe program for a proposed clinical trial with MultiStem for acute respiratory distress syndrome (ARDS) and other COVID-19 co-morbidities
Initiated enrollment of cohort 3 in the MATRICS-1 clinical trial with MultiStem for trauma using 3-D bioreactor manufactured clinical product
Raised $3.7 million through a registered direct offering with institutional investors
Continued reducing expenses to conserve cash and heightened focus on execution of MASTERS-2 trial
Maintained operating expenses below $2.5 million per month
Participated in several industry conferences to build awareness of Athersys and share MultiStem clinical and manufacturing progress, including:
The American Society for Neural Therapy and Repair Annual Conference
Cellular Therapies and Transfusion Medicine in Trauma and Critical Care Conference
Pharma Manufacturing World Summit
Allogeneic Cell Therapies Summit
American Thoracic Societys Respiratory Innovation Summit
The second quarter of 2023 was marked by improved execution on all fronts, from continuing to maintain low operating expenses to improved enrollment in our ongoing clinical trials, including the start of cohort 3 enrollment in our MATRICS-1 trauma trial following a positive DSMB review. We also implemented the MASTERS-2 protocol changes agreed upon with the U.S. FDA in more than 60% of our trial sites with the remainder expected to be completed by the end of August. These protocol modifications now reflect the full potential benefit of MultiStem for patients with acute, moderate-to-severe ischemic stroke as well as the evolving standard of care. In addition, the FDA approved our request to conduct an unblinded interim analysis to evaluate whether the study size is sufficiently powered to achieve statistical significance. We look forward to sharing these results in early October, said Daniel Camardo, Chief Executive Officer of Athersys.
Second Quarter Results
There was $48.8 thousand of revenue for the second quarter of 2023 compared with $2.3 million for the second quarter of 2022, which included the delivery of services under the arrangement with Healios. As of September 30, 2022, services under this arrangement were largely complete and were limited to close-out activities.
Research and development expenses were $10.6 million for the second quarter of 2023 compared with $20.8 million for the comparable period in 2022. The decrease reflects our restructuring plan which resulted in reduced clinical trial expenses which includes personnel, manufacturing, and other costs.
General and administrative expenses were $2.3 million for the second quarter of 2023 compared with $5.2 million for the comparable period in 2022, with the decrease primarily due to the restructuring.
Net loss for the second quarter of 2023 was $(12.9) million, or $(0.62) per share, compared with a net loss of $(23.6) million, or $(2.28) per share, for the comparable period in 2022.
Cash and cash equivalents were $1.8 million as of June 30, 2023, compared with $9.0 million as of December 31, 2022.