On November 6, 2018 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the period ended September 30, 2018 (Press release, Athersys, NOV 6, 2018, View Source [SID1234530876]).

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Highlights of the third quarter of 2018 and recent events include:

Completed enrollment of our Phase 1/2 study evaluating MultiStem therapy in acute respiratory distress syndrome (ARDS) patients;

Commenced enrollment of patients in the MASTERS-2 Phase 3 registration study for ischemic stroke;

Continued to support Healios’ ongoing TREASURE study for ischemic stroke in Japan by providing clinical product;

Extended to December 6, 2018, Healios’ option and negotiation period for further expansion of the collaboration, including an exclusive option for a license to develop and commercialize MultiStem therapy in China for certain indications;

Recognized revenues of $2.3 million for the quarter ended September 30, 2018 and net loss of $9.7 million, or $0.07 net loss per share, for the quarter ended September 30, 2018; and

Cash and cash equivalents were $48.0 million at the end of the third quarter.

"We had another solid quarter in the third quarter of 2018 as we advanced key initiatives, reflected by the completion of enrollment in our exploratory clinical trial evaluating administration of MultiStem to patients suffering from ARDS and the initiation of enrollment in the Phase 3 MASTERS-2 study for treating ischemic stroke," commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. "We are working collaboratively with Healios in multiple areas, and we further strengthened our core capabilities.

"In addition, we have maintained a solid balance sheet as we continue to implement our strategic plan, working toward the achievement of our key goals on behalf of our shareholders and the patients we are committed to help," concluded Dr. Van Bokkelen.

Third Quarter Results

Revenues increased to $2.3 million for the three months ended September 30, 2018 compared to $0.4 million for the three months ended September 30, 2017. Our revenues are generally derived from license fees, manufacturing-related activities for Healios, royalty and related contract revenue from our collaborations, and grant revenue.

Research and development expenses increased to $9.5 million for the three months ended September 30, 2018 from $5.4 million for the comparable period in 2017. The $4.1 million increase is primarily associated with increased clinical development costs of $3.0 million, increased personnel costs of $0.6 million, increased license fees of $0.2 million and increased internal research supplies and other of $0.3 million. The $3.0 million increase in our clinical costs during the period is primarily a result of increased clinical product manufacturing costs, covered in part by Healios, technology transfer services associated with planned Japan manufacturing for Healios, process development activities to support large-scale manufacturing, and costs related to our MASTERS-2 clinical trial that began enrolling patients in the third quarter of 2018.

General and administrative expenses increased to $2.6 million for the three months ended September 30, 2018 from $2.1 million in the comparable period in 2017. The $0.5 million increase was due primarily to increases in professional fees, consulting services, personnel costs and other administrative costs compared to the same period last year.

Net loss for the third quarter was $9.7 million in 2018 compared to a net loss of $7.2 million in 2017. The difference of $2.5 million reflects the above variances, as well as an increase of $0.2 million in other income.

In the nine months ended September 30, 2018, net cash used in operating activities was $8.8 million compared to $17.9 million in the nine months ended September 30, 2017. The difference reflects in part $15.0 million in license fees paid by Healios in connection with the collaboration expansion and an increase in clinical development activity in 2018. Healios is obligated to make two more license fee payments of $2.5 million each in December 2018 and March 2019. At September 30, 2018, we had $48.0 million in cash and cash equivalents, compared to $29.3 million at December 31, 2017.

Conference Call

William (B.J.) Lehmann, President and Chief Operating Officer, and Laura Campbell, Senior Vice President of Finance, will host a conference call today to review the results as follows:

Date Tuesday, November 6th, 2018
Time 4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada 800-273-1254
Telephone access: International 973-638-3440
Access code 7396506
Live webcast

www.athersys.com, under the Investors section
A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on November 20, 2018 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 7396506.