On November 15, 2021 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended September 30, 2021 and provided a corporate update (Press release, Athersys, NOV 15, 2021, View Source [SID1234595602]).

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"The third quarter brought several important milestones in the development and potential commercialization of MultiStem cell therapy," stated Mr. William (B.J.) Lehmann, Jr., Interim Chief Executive Officer of Athersys. "First, our partner Healios announced positive topline data from its ONE-BRIDGE acute respiratory distress syndrome (ARDS) study, giving us further confidence in the potential of our cell therapy for the treatment of ARDS and critical care more generally. Second, enrollment has been completed for the Japan TREASURE study of MultiStem treatment for ischemic stroke patients, starting the countdown to the release of pivotal study data in this area. And third, we realigned our collaboration with Healios to put us in the best position to prepare together for commercialization in Japan.

"Additionally, we demonstrated steady progress in our MASTERS-2 study as well as in the steps necessary to establish commercial manufacturing capability," added Mr. Lehmann. "We look forward to important data readouts ahead of us, our partner’s progress in Japan in the application process for marketing approval, and further development of our commercial capabilities."

Highlights of the third quarter of 2021 and recent events include:

Positive topline results from the ONE-BRIDGE study announced by HEALIOS K.K. (Healios). The ONE-BRIDGE study evaluated the Company’s proprietary cell therapy, MultiStem (HLCM051; invimestrocel), for the treatment of pneumonia-induced and COVID-induced acute respiratory distress syndrome (ARDS) in Japan. Data from the study are consistent with the Company’s MUST-ARDS study results, and analyses of the pooled data of both studies reflect positive benefit trends;
Completion of TREASURE study enrollment announced by Healios. The TREASURE study is evaluating MultiStem for the treatment of ischemic stroke patients in Japan. Based on the advice from the Pharmaceuticals and Medical Devices Agency (PMDA), in order to avoid any potential bias to the 365-day data (and related secondary endpoints) that could result from unblinding and disclosure of 90-day data (primary endpoint) the decision was made that the 90-day unblinding, data analysis and release would take place after the 365-day data is locked. This will follow the last patient’s one-year follow up visit which Healios expects to occur in March of 2022;
Improved our collaboration with Healios and optimized the structure of the relationship to help drive commercial success for MultiStem therapy in Japan;
Steadily progressed our MASTERS-2 study, including the initiation of new sites, including our first sites outside of the U.S.;
Published additional important research findings covering Multipotent Adult Progenitor Cells (MAPC) and Treg biology and MAPC mechanisms of action, with references available on the Company’s website;
Achieved a "Prime" corporate rating from Institutional Shareholder Services Environmental, Social and Governance (ISS ESG) for fulfilling the requirements regarding sustainability performance in the Pharmaceuticals & Biotechnology sector;
Recognized net loss of $16.2 million, or $0.07 net loss per share, for the quarter ended September 30, 2021; and
Ended the third quarter with $49.7 million of cash and cash equivalents.
Third Quarter Results

Revenues increased to $4.8 million for the three months ended September 30, 2021 compared to $0.1 million for the three months ended September 30, 2020. Our collaboration revenues currently fluctuate from period to period based on the delivery of goods and services under our arrangement with Healios.

Research and development expenses decreased to $17.2 million for the three months ended September 30, 2021 from $18.5 million for the comparable period in 2020. The $1.3 million decrease is associated with decreases in clinical trial and manufacturing process development costs of $2.0 million and internal research supplies of $0.6 million. These decreases were partially offset by increases in personnel costs of $0.5 million, facilities costs of $0.4 million and outside service costs of $0.4 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 $3.6 million for the three months ended September 30, 2021 from $3.7 million for the comparable period in 2020.

Net loss for the third quarter of 2021 was $16.2 million compared to a net loss of $22.5 million in the third quarter of 2020. The difference primarily results from the above variances.

During the nine months ended September 30, 2021, net cash used in operating activities was $56.9 million compared to $44.5 million in the nine months ended September 30, 2020. At September 30, 2021, we had $49.7 million in cash and cash equivalents, compared to $51.5 million at December 31, 2020.

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A replay of the event will be available on the webcast link 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 PM EST on November 22, 2021, by dialing (800) 585-8367 or (416) 621-4642 and entering the conference code 6652068.