On March 15, 2022 Athersys, Inc. (Nasdaq: ATHX) reported its financial results for the three months and full year ended December 31, 2021, along with a corporate update (Press release, Athersys, MAR 15, 2022, View Source [SID1234610094]).
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Daniel A. Camardo, Athersys’ new Chief Executive Officer as of February 14, 2022, commented, "I’m excited to be leading Athersys at such a pivotal time as I believe we have the potential to be a global leader in cell therapy and regenerative medicine and effectively treat various diseases with significant unmet medical need. I am also well aware of the challenges the company has faced over the years and I am prepared and eager to meet those challenges while capitalizing on the opportunities ahead.
"I came to Athersys with over 25 years’ experience in the pharmaceutical and biotech industry, most recently as Executive Vice President of Horizon Therapeutics and I’ve had the privilege of delivering numerous successful therapies to market which brings the great dual satisfaction of helping patients and creating shareholder value. I enthusiastically accepted the CEO role at Athersys after an extensive due diligence process and came away believing that with the right leadership in place, the Company has a unique opportunity with MultiStem (invimestrocel) as a product platform in cell therapy. Since joining the Company on February 14th and learning more about MultiStem’s unique properties, meeting the internal team, assessing the recent positive developments with Healios and better understanding the business opportunity, my conviction has become even stronger. 2022 will be a transformational year for the Company and I look forward to leading the team to achieve our corporate goals and further establish Athersys as a leader in cell therapy and regenerative medicine," concluded Mr. Camardo.
"I’m very proud of what we achieved in 2021. Despite a challenging start to the year, we were able to persevere and accomplish many important things," stated Mr. William (B.J.) Lehmann, President and Chief Operating Officer of Athersys. "Most notably, we announced positive data for the Phase 2 ONE-BRIDGE clinical trial evaluating MultiStem cell therapy for the treatment of acute respiratory distress syndrome (ARDS), completed by our partner, HEALIOS K.K. (Healios). This data set, combined with our own MUST-ARDS data results, suggests a meaningful treatment effect and gives us confidence that MultiStem can help ARDS patients. We look forward to Healios’ potential regulatory submission of the ARDS data with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. We also look forward to the data read-out for the Healios Phase 2/3 TREASURE study, evaluating MultiStem cell therapy for the treatment of ischemic stroke, expected in the second quarter of 2022.
"Additionally, we re-established and strengthened our collaboration and relationship with our partner, Healios, important to the success of both companies. We also published several scientific publications during the past year, adding to our understanding of MultiStem’s mechanism of action and how these dynamic cells react to the body’s response to an injury," concluded Mr. Lehmann.
2021 Highlights and Recent Highlights
Development Programs
Commenced the technology transfer for the second-generation large-scale bioreactor manufacturing platform to a contract manufacturing organization (CMO) to establish processes and capacity to support commercialization of invimestrocel in the Company’s targeted segments, building on the first-generation bioreactor manufacturing campaign generating product approved by the FDA for use in the Company’s ARDS and trauma clinical studies;
Positive topline results from the ONE-BRIDGE study announced by the Company’s partner, Healios. The Phase 2 ONE-BRIDGE study evaluated the Company’s proprietary cell therapy, MultiStem (HLCM051), to treat pneumonia-induced and COVID-induced ARDS in Japan. Analyses of the data pooled from the Company’s MUST-ARDS study and the ONE-BRIDGE study further support potential clinically meaningful benefit of MultiStem as a treatment for ARDS patients;
Continued to support Healios with their potential regulatory filings in Japan;
Announced completion of Phase 2/3 TREASURE study enrollment by Healios. The 90-day and one-year results are expected to be unblinded and released in the second quarter of 2022 following the last patient’s one year follow-up visit in March 2022. The TREASURE study is a Phase 2/3 double-blind, randomized, placebo-controlled clinical trial evaluating MultiStem for the treatment of ischemic stroke in over 200 patients in Japan;
Progressed enrollment in Athersys’ MASTERS-2 study, evaluating MultiStem cell therapy to treat ischemic stroke. We have undertaken initiatives intended to accelerate new site openings in the U.S. and abroad, and increase patient enrollment at sites that are currently open, including addressing site operations issues and local product supply constraints. These actions are intended to enable the Company to finish enrollment of the MASTERS-2 study by the end of 2022 or as soon as possible thereafter;
Published positive data from the Company’s MUST-ARDS clinical trial in the peer-reviewed journal Intensive Care Medicine. MUST-ARDS was a randomized, double-blind placebo-controlled Phase 1/2 trial evaluating the safety and efficacy of MultiStem in patients with ARDS;
Published multiple peer-reviewed articles describing the use of MultiStem cells in prestigious medical journals, including Frontiers in Immunology, Stem Cells Translational Medicine, Scientific Reports, Stem Cells, and Wound Repair and Regeneration; and
Reached agreements with both the FDA and the European Medicinal Agency (EMA) on the deferral of the pediatric development plan with MultiStem for the stroke program.
Corporate Developments
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;
Added James Glover as Senior Vice President of Commercial Manufacturing; and
Consummated new agreements with Healios including a Cooperation Agreement and a Comprehensive Framework Agreement for Commercial Manufacturing and Ongoing Support. The agreements facilitate the regulatory approval process for MultiStem in Japan, prepare the companies for commercial manufacturing and supply and expand the overall scope of collaboration between the companies.
Fourth Quarter 2021 Financial Results
Revenues were $0.7 million for the three months ended December 31, 2021 compared to $1.3 million for the three months ended December 31, 2020. Our quarterly revenues were derived from our collaboration with our partner, Healios.
Research and development expenses were $18.7 million for the three months ended December 31, 2021, consistent with the comparable period in 2020.
General and administrative expenses decreased to $3.4 million for the three months ended December 31, 2021 from $4.3 million in the comparable period in 2020. The $0.9 million decrease in the fourth quarter of 2021 over the same period of 2020 was due primarily to decreased stock compensation costs, as well as reduced legal and professional services.
Net loss for the fourth quarter was $21.7 million in 2021 compared to a net loss of $22.2 million in the fourth quarter of 2020. The difference of $0.5 million reflects the above variances, as well as a decrease of $0.2 million in other expense items.
Full Year 2021 Financial Results
Revenues increased to $5.5 million for the year ended December 31, 2021 from $1.4 million in 2020. Our revenues from our collaboration with Healios increased $4.1 million year over year. Our collaboration revenues fluctuate from period-to-period based on the delivery of goods and services under our arrangement with Healios.
Research and development expenses increased to $71.1 million for the year ended December 31, 2021 from $63.0 million for the year ended December 31, 2020. The $8.1 million increase in research and development expenses year-over-year was due primarily to increased clinical trial and manufacturing process development costs of $5.3 million, and personnel costs of $3.2 million, including stock-based compensation, offset by decreased sponsored research of $0.2 million, and other costs of $0.2 million.
General and administrative expenses increased to $20.1 million in 2021 from $15.9 million in 2020. The $4.2 million increase was due primarily to increases in personnel costs including stock-based compensation, legal and professional services, and other outside services.
Net loss was $87.0 million in 2021 compared to a net loss of $78.8 million in 2020. The difference of $8.2 million reflects the above variances.
In the twelve months ended December 31, 2021, net cash used in operating activities was $76.2 million compared to $61.8 million in the twelve months ended December 31, 2020. The difference is primarily associated with overall increases in cash usage to fund our clinical development activity in 2021.
At December 31, 2021, we had $37.4 million in cash and cash equivalents, compared to $51.5 million at December 31, 2020.
Conference Call
Management will host a conference call today to review Athersys’ fourth quarter and full year 2021 financial results and provide a general business update:
We encourage listeners to access the call using the webcast link. If you would like to dial in using the phone, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive an email containing the toll-free number, a direct entry passcode and a registrant ID.
A replay of the event will be available at www.athersys.com under the investors’ section approximately two hours after the call has ended. Shareholders may also call in for on-demand listening approximately three hours after the completion of the call until 11:59 p.m. Eastern Time on March 22, 2022, by dialing (866) 813-9403 or (929) 458-6194 and entering the access code 084558.