On May 6, 2021 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended March 31, 2021 and provided a corporate update (Press release, Athersys, MAY 6, 2021, View Source [SID1234579359]).
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"Since our recent call, we remain on track with respect to our operating plans," stated Mr. William (B.J.) Lehmann, Jr., Interim Chief Executive Officer of Athersys. "We look forward to important progress during the remaining course of the year, including expected top-line results from the TREASURE and ONE-BRIDGE studies in Japan."
"Additionally, we remain focused on important priorities for the year, which include advancing our MASTERS-2 study and other clinical programs, supporting our partner, Healios, as it prepares for important regulatory applications, and in further developing our commercial manufacturing processes and planning," added Mr. Lehmann.
Highlights of the first quarter of 2021 and recent events include:
Announcement by our Japanese partner, HEALIOS K.K. (Healios), of the completion of patient enrollment in the ONE-BRIDGE study evaluating the safety and efficacy of MultiStem (invimestrocel) cell therapy for the treatment of pneumonia-induced acute respiratory distress syndrome (ARDS) and COVID-induced ARDS;
Reached a cooperation agreement with Healios to resolve the legal matter between its CEO and Athersys Board member, Dr. Kagimoto, and the Company, and initiated negotiations to address open matters important to continued development, regulatory progress and successful commercialization in Japan following approval;
Recognized net loss of $26.5 million, or $0.13 net loss per share, for the quarter ended March 31, 2021; and
Ended the first quarter with $64.2 million of cash and cash equivalents.
"We believe that we are well positioned to advance our MultiStem programs over this year and further develop the capabilities important to longer term commercial success," concluded Mr. Lehmann.
First Quarter Results
There were no revenues for the three months ended March 31, 2021 and March 31, 2020, respectively. 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 increased to $17.5 million for the three months ended March 31, 2021 from $12.1 million for the comparable period in 2020. The $5.4 million net increase is primarily associated with increases in clinical trial and manufacturing process development costs of $4.3 million, personnel costs of $0.7 million and stock compensation 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 increased to $8.8 million for the three months ended March 31, 2021 compared to $3.5 million in the comparable period in 2020. The $5.3 million increase was primarily related to legal expenses incurred in connection with the complaint filed by Dr. Kagimoto against the Company, its settlement, and the expenses associated with Dr. Van Bokkelen’s resignation and his separation letter agreement, including $2.3 million of non-cash stock compensation expense.
Net loss for the first quarter of 2021 was $26.5 million compared to a net loss of $15.6 million in the first quarter of 2020. The difference primarily results from the above variances.
During the three months ended March 31, 2021, net cash used in operating activities was $17.1 million compared to $12.1 million in the three months ended March 31, 2020. At March 31, 2021, we had $64.2 million in cash and cash equivalents, compared to $51.5 million at December 31, 2020.
Conference Call
William (B.J.) Lehmann, Jr., Interim Chief Executive Officer, Ivor Macleod, Chief Financial Officer, John Harrington, Executive Vice President and Chief Scientific Officer and Karen Hunady, Director of Corporate Communications and Investor Relations will host a conference call today to review the results as follows:
We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive the toll-free number, a direct entry passcode and a registrant ID.
On May 7th at 12:00 PM EDT, a replay of the event will be available on the webcast link at www.athersys.com under the investors’ section. Shareholders may also call in for on-demand listening on May 7th at 12:00 PM EDT until 11:59 PM Eastern Time on May 12, 2021, by dialing (800) 585-8367 or (416) 621-4642 and entering the conference code 4548767.