Athersys, Inc. (NASDAQ: ATHX), a regenerative medicine company developing MultiStem (invimestrocel) cell therapy for critical care indications, announced on Monday, May 15th financial results for the three months ended March 31, 2023 and provided a business update.
First Quarter 2023 and Recent Corporate and Operational Highlights
Continued reducing expenses to conserve cash and heightened focus on MASTERS-2 trial, thereby making Athersys more attractive to potential financial and strategic partners
Maintained operating expenses below $2.5 million per month
Raised $3.7 million through a registered direct offering with institutional investors
Appointed biotechnology and pharmaceutical executive Joseph Nolan to the Board of Directors
Participated in Request for Proposal (RFP) process with the Biomedical Advanced Research and Development Authority (BARDA) for a proposed clinical trial with MultiStem for acute respiratory distress syndrome (ARDS) and other COVID-19 co-morbidities
Completed DSMB review of cohort 1 & 2 of MATRICS trauma trial using both cell factory and bioreactor manufactured clinical product
Awarded a U.S. patent for the novel SIFU cryogenic storage system, the Companys user-friendly system to improve storage and handling of cryogenic products in hospital settings
Amended the clinical trial protocol reflecting modifications proposed during a Type B meeting with the U.S. FDA that best reflect the potential benefits of MultiStem in treating acute, moderate-to-severe, ischemic stroke; protocol modifications include:
Primary endpoint assessed by shift analysis in modified Rankin Scale (mRS) score was changed to Day 365, from Day 90 previously
Shift analysis in mRS score at Day 90 is retained as a key secondary endpoint
Eligibility caps on concomitant reperfusion therapy (e.g., tPA, MR or tPA+MR) were removed to ensure the study population appropriately reflects the evolving standard of care in ischemic stroke treatment
Added the option to conduct an interim analysis for powering to confirm 300 patient sample size is adequate to achieve statistical significance with new primary endpoint
Athersys executives participated in several industry conferences to build awareness of Athersys and share clinical and manufacturing progress achieved with MultiStem, including:
Advanced Therapies Week presented by Phacilitate
2nd Allogeneic Cell Therapies Summit Europe
International Stroke Conference 2023
BioProcess International US West
The American Society for Neural Therapy and Repair Annual Conference
Cellular Therapies and Transfusion Medicine in Trauma and Critical Care Conference
We entered 2023 with greater clarity and confidence on our path forward with MultiStem, having largely completed a significant restructuring in the second half of last year that reduced our operating expenses below $2.5 million per month. In addition, achieving a successful Type B meeting with the FDA on proposed MASTERS-2 trial modifications will now more appropriately represent the regenerative benefits of MultiStem over a longer period and reflect changes weve observed in ischemic stroke standard of care. Weve also made meaningful progress with trial enrollment and advanced conversations with multiple parties exploring business development opportunities with MultiStem as well as our animal health franchise and SIFU, said Dan Camardo, Chief Executive Officer of Athersys. We have more work to do, but Im encouraged by the progress weve made and the catalysts we are working toward in the coming year.
First Quarter Results
There was no revenue for the first quarter of 2023 compared with $2.9 million for the first 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 $4.5 million for the first quarter of 2023 compared with $20.9 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 $2.8 million for the first quarter of 2023 compared with $4.1 million for the comparable period in 2022, with the decrease primarily due to the restructuring. The Company expects further decreases in general and administrative expenses.
Net loss for the first quarter of 2023 was $7.8 million, or $0.43 per share, compared with a net loss of $22.2 million, or $2.27 per share, for the comparable period in 2022.
Cash and cash equivalents were $3.1 million as of March 31, 2023 compared with $9.0 million as of December 31, 2022.