On May 6, 2022 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended March 31, 2022 (Press release, Athersys, MAY 6, 2022, View Source [SID1234613779]). In anticipation of the announcement in May of topline data from Athersys’ partner, HEALIOS K.K. (Healios), for its Phase 2/3 TREASURE study evaluating MultiStem (invimestrocel, HLCM051) for the treatment of ischemic stroke, Athersys will host its next investor conference call after the data are released. Athersys will share the conference call details in its news release reporting the data.
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"Since joining the Company in February, I’ve immersed myself in all aspects of the business to gain a better understanding of MultiStem, our clinical trial progress and our performance to date," commented Dan Camardo, Chief Executive Officer of Athersys. "I have had numerous introductory calls and discussions with stockholders who have been very supportive and patient of the work we’re doing to advance MultiStem and bring this unique cell therapy to market. I’ve also had discussions with the Board and I’m confident that we have the right strategy in place. With thoughtful and timely execution, we will be well-positioned to meet our long-term goals."
First quarter 2022 highlights and recent events:
Received approval from the U.S. Food and Drug Administration (FDA) to use bioreactor manufactured MultiStem product in our MACOVIA and MATRICS studies, enabling the generation of critical clinical data with this next-generation bioreactor-based product and laying the groundwork for subsequent clinical work with the larger-scale bioreactor format. The approval of the bioreactor process represents a significant milestone in transitioning from small scale 2-dimensional manufacturing to large scale 3-dimensional manufacturing, thereby allowing significantly more product to be produced at lower cost of goods. The ability to produce product at these large scales represents a significant competitive advantage in the cell therapy field;
Appointed Daniel A. Camardo as Chief Executive Officer, effective February 14, 2022. Mr. Camardo is a senior pharmaceutical and biotech executive with more than 25 years of commercial leadership experience. He joins Athersys to lead the Company forward to complete the development, approval, launch and commercialization of the Company’s MultiStem cell therapy;
Noted completion by the last patient in the Healios TREASURE study of the 365-day visit, fulfilling the required secondary endpoint measures and completing the data set for the study. Topline data are expected in May;
Continued enrollment in the Athersys Phase 3 MASTERS-2 study evaluating MultiStem cell therapy to treat ischemic stroke in the United States, Europe and other regions. Initiated new clinical sites in Europe and Asia;
Reached agreements with both the FDA and the European Medicinal Agency (EMA) on the pediatric development plan with MultiStem for the stroke program;
Filed for a new patent application that covers multiple aspects of the large scale bioreactor process for MultiStem production, building on our extensive intellectual property portfolio; and
Held a virtual investor event titled "MultiStem Clinical Programs: An In-Depth Look". The program provided an understanding of the anticipated program milestones and why the Company is well-positioned to deliver on its mission to change the future of regenerative medicine.
"Receiving FDA approval to use the bioreactor manufactured product gives us confidence as we further scale our third-generation bioreactor manufacturing process to be able to produce product to meet potential commercial demand. I’m very proud of everyone involved in helping make this achievement a reality," commented Dr. John Harrington, Executive Vice President and Chief Scientific Officer.
"An important priority for us is to continue strengthening the partnership we have with Healios. We are working closely together to advance the clinical programs in stroke and acute respiratory distress syndrome and establish appropriate manufacturing supply for potential commercialization in Japan," added Mr. Camardo. "With the last TREASURE trial patient completing their 365-day visit, we are now actively planning with Healios for the release of topline data in May. This is an important milestone for both companies and we plan to host a conference call soon after the data are released to discuss the details."
First Quarter Results
Revenues increased to $2.9 million for the three months ended March 31, 2022 compared to no revenues for the three months ended March 31, 2021. Our collaboration revenues currently fluctuate from period to period based on the delivery of services under our arrangement with Healios.
Research and development expenses increased to $20.9 million for the three months ended March 31, 2022 from $17.5 million for the comparable period in 2021. The $3.4 million increase is associated with increases in clinical trial and manufacturing process development costs of $1.8 million, personnel costs of $0.8 million, outside service costs of $0.7 million and internal research supplies of $0.4 million. These increases were partially offset by decreases in other research and development costs of $0.3 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.
General and administrative expenses decreased to $4.1 million for the three months ended March 31, 2022 from $8.8 million for the comparable period in 2021. The decrease is primarily related to legal expenses incurred in connection with the complaint filed by Dr. Hardy Kagimoto against the Company, its settlement, and the expenses associated with Dr. Gil Van Bokkelen’s separation letter agreement, including $2.3 million of one-time non-cash stock compensation expense in the first quarter of 2021.
Net loss for the first quarter of 2022 was $22.2 million compared to a net loss of $26.5 million in the first quarter of 2021. The difference primarily results from the above variances.
During the three months ended March 31, 2022, net cash used in operating activities was $20.2 million compared to $17.1 million in the three months ended March 31, 2021. At March 31, 2022, we had $21.8 million in cash and cash equivalents, compared to $37.4 million at December 31, 2021.
Conference Call
Members of the management team will host a conference call soon after the TREASURE data are released. The details for the conference call will be included in the data release.