Athersys, Inc. (NASDAQ: ATHX) announced today its financial results for the three and nine months ended September 30, 2022 and provided a business update.
Third quarter 2022 Corporate and Operational Highlights:
Raised gross proceeds of $12.0 million in a registered direct offering with a U.S. healthcare-focused institutional investor and, following the close of the quarter, raised an additional $5.5 million in gross proceeds in a best efforts public offering
Executed a 1-for-25 reverse stock split to bring Athersys into compliance with Nasdaqs minimum bid price continued-listing requirement
Largely completed restructuring initiative with the goal of significantly reducing expenses, conserving cash, improving focus and increasing attractiveness to financial and strategic partners
Suspended certain high-cost manufacturing and process-development initiatives
Initiated efforts to sublet the Stow, Ohio facility
Paused work at the ReGenesys animal health-focused division in Belgium, leased half the facility and identified potential opportunities to license related patents
Reduced and streamlined internal research function to focus resources on MASTERS-2
Business Development Strategy
Participated in several industry conferences to build awareness of Athersys and MultiStem, including:
4th World Stroke Congress
2022 Cell & Gene Meeting on the Mesa
Pursuing a business development strategy focused on securing regional and/or global MultiStem partners, non-dilutive funding and complementary capabilities across clinical, regulatory, commercial and manufacturing functions
Held a webinar to review preclinical research across multiple indications with MultiStem hosted by Dr. Willie Mays, Executive Vice President and Head of Regenerative Medicine & Neuroscience Programs, and Dr. Sarah Busch, Vice President, Regenerative Medicine & Head of Nonclinical Development
Announced preclinical research by the Armed Forces Radiobiology Research Institute showing the benefit of MultiStem in an animal model of acute radiation syndrome
Transferred MultiStem manufacturing rights to Healios to support their clinical work in acute respiratory distress syndrome (ARDS) and stroke
Third Quarter MultiStem Clinical Trial Updates
MASTERS-2 (Phase 3 global study in ischemic stroke)
Doubled the average number of patients enrolled per month in 2022 from prior years
Expanded the network of active trial sites by adding new locations including key stroke centers in Germany, the UK, Taiwan and Australia
Analyzed TREASURE clinical trial results for potential read through to MASTERS-2 trial design
MATRICS-1 (Phase 2 study in trauma)
Collaborating with The University of Texas Health Science Center at Houston, one of the busiest Level 1 trauma centers in the U.S.
Initiated dosing with product derived from Athersys large-scale bioreactors, providing greater scalability and efficiency
Working to facilitate subject enrollment in the trial without the need to secure prior patient consent
Our restructuring initiative is now largely complete and has yielded significant expense savings and a streamlined organization, said Dan Camardo, Chief Executive Officer of Athersys, Enrollment in our MASTERS-2 clinical trial has stepped up considerably and we continue to seek strategic partnership opportunities to advance our MultiStem platform and provide non-dilutive funding.
Third Quarter Results
Revenues for the third quarter of 2022 were $0.1 million compared to $4.8 million for the he third quarter of 2021. Collaboration revenues fluctuate from period to period based on the delivery of services under the arrangement with Healios. As of September 30, 2022 and during the third quarter of 2022, the services under the Healios arrangement are largely complete and are limited to close-out activities.
Research and development expenses were $12.4 million for the third quarter of 2022 compared with $17.2 million for the comparable period in 2021. The decrease is due to reduced salaries and benefits of $2.0 million, internal research supplies of $1.6 million, manufacturing costs of $0.2 million, outside services of $0.6 million and decreases in other research and development costs of $0.4 million. The Company expects research and development expenses to decrease in connection with its restructuring plan.
General and administrative expenses were $3.7 million for the third quarter of 2022, compared with $3.6 million for the comparable period in 2021. The increase is primarily related to restructuring costs. We expect our general and administrative expenses to decrease in connection with our restructuring plan.
Net loss for the third quarter of 2022 was $13.7 million, or $1.15 per share, compared to a net loss of $16.2 million, or $1.76 per share, for the third quarter of 2021.
During the nine months ended September 30, 2022, net cash used in operating activities was $47.0 million compared to $56.9 million in the nine months ended months September 30, 2021. At September 30, 2022, we had $13.8 million in cash and cash equivalents, compared to $37.4 million at December 31, 2021.