Athersys, Inc. (OTC: ATHX), a regenerative medicine company developing MultiStem (invimestrocel) cell therapy for critical care indications, announced financial results for the three and nine months ended September 30, 2023 and provided a business update.
Third Quarter 2023 and Recent Corporate and Operational Highlights:
Announced results of a blinded interim analysis of Phase 3 MASTERS-2 clinical trial studying MultiStem for treatment of ischemic stroke indicating additional patients would need to be added to the trial to achieve statistical significance with a primary endpoint of mRS Shift Analysis at Day 365.
Completed warrant exercise inducement generating gross proceeds of $3.9M, extending near term liquidity.
Executed a Memorandum of Understanding (MOU) with Healios for global rights to develop and commercialize MultiStem for the treatment of Acute Respiratory Distress Syndrome (ARDS) and received a $1.5M upfront payment along with potential future development milestones and royalties.
Received a second $1.5M payment from Healios under the terms of the MOU associated with purchasing MultiStem bioreactor manufactured clinical doses to support Healios Phase 3 ARDS trial.
Engaged Outcome Capital to assist Athersys in evaluating strategic alternatives, which could include exploring potential for a merger, business combination, investment into the company, or a purchase, license or other acquisition of assets.
Completed a $3.5M public offering with institutional investors to fund ongoing operations.
Completed license of animal health assets to Ardent Health for future development milestones and royalties.
Appointed Ms. Jane Wasman as Chair of the Board of Directors.
Since announcing the results of the blinded interim analysis of MASTERS-2 indicating additional patients would be needed to achieve statistical significance on the primary endpoint, weve been actively engaged in exploring strategic options with interested parties to determine the best path forward for MultiStem and Athersys. Capital raised from the recent warrant inducement transaction and MOU with Healios provides us additional funding to support business operations while we explore strategic options, said Daniel Camardo, Chief Executive Officer of Athersys.
Third Quarter Results
There was no revenue for the third quarter of 2023 compared with $0.1 million for the third 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 $4.0 million for the third quarter of 2023 compared with $12.4 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 third quarter of 2023 compared with $3.7 million for the comparable period in 2022, with the decrease primarily due to the restructuring.
Net loss for the third quarter of 2023 was $(3.8) million, or $0.15 per share, compared with a net loss of $(13.7) million, or $1.15 per share, for the comparable period in 2022.
Cash and cash equivalents were $1.0 million as of September 30, 2023, compared with $9.0 million as of December 31, 2022.