2Q 2019 Financial Results | ATHX Message Board Posts

Athersys, Inc.

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Msg  1559 of 1564  at  8/7/2019 4:11:29 PM  by

CHM_760


2Q 2019 Financial Results

CLEVELAND, Aug. 07, 2019 (GLOBE NEWSWIRE) -- Athersys, Inc. (NASDAQ: ATHX) announced today its financial results for the three months ended June 30, 2019.

Highlights of the second quarter of 2019 and recent events include:

    Received Fast Track designation from the FDA for our clinical development program involving administration of MultiStem® cell therapy for treatment of acute respiratory distress syndrome (“ARDS”);
    Presented positive results from the MUST-ARDS study at the American Thoracic Society International Conference in May 2019;
    Announced first patient enrolled in the ONE-BRIDGE study in Japan being conducted by our partner in Japan, HEALIOS K.K. (“Healios”), evaluating MultiStem cell therapy treatment of patients suffering from pneumonia-induced ARDS;
    Advanced our ischemic stroke program, both through support of Healios' TREASURE study in Japan and increased enrollment in our MASTERS-2 Phase 3 registrational study;
    Entered into an open market sales agreement with Jefferies LLC, i.e., an 'at-the-market' equity program, providing additional flexibility and capital markets access as we progress to important milestones;
    Hosted a successful investor day in New York City in May 2019 highlighting our capabilities and technologies, as well as progress made developing the MultiStem product platform;
    Increased our media exposure as we were featured in video, podcasts and articles in the major publications Fortune and Forbes;
    Participated in several events at the International Society of Cell and Gene Therapy Conference in June 2019, including podium presentations, a panel participation and chairing a session, further establishing the Company as a leader and significant contributor in the field of cell therapy;
    Recognized revenues of $4.3 million and net loss of $9.7 million, or $0.06 net loss per share, for the quarter ended June 30, 2019; and
    Ended the 2019 second quarter with $44.2 million of cash and cash equivalents.

“We continue to make steady progress in key areas, including advancing our Phase 3 clinical program for treating ischemic stroke, while supporting Healios in the advancement of its TREASURE study for stroke patients and ONE-BRIDGE study for ARDS patients in Japan,” commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. “Given our progress in multiple areas, including the recently announced Fast Track designation and promising results from our ARDS clinical program, we are exploring partnering opportunities in several important geographic areas, while we continue to advance our key initiatives and expand core capabilities. This includes continuing to advance our manufacturing activities and initiatives, that we believe will represent a significant competitive advantage as we move into commercialization.

“While we advance our programs through clinical development and toward commercialization, we have also taken prudent and appropriate steps to maintain a solid balance sheet, ensuring we have access to additional capital while we continue to maintain a long-term focus on creating value for our shareholders,” concluded Dr. Van Bokkelen.

Second Quarter Results

Revenues were $4.3 million for the three months ended June 30, 2019 compared to $19.4 million for the three months ended June 30, 2018. Revenues from our collaboration with Healios were $4.2 million in the second quarter of 2019 compared to $18.8 million for the same period last year, which included the impact of the June 2018 collaboration expansion. Royalty revenue from RTI Surgical, Inc. ceased late in 2018 upon its decision to discontinue distribution of the licensed product. Our revenues are generally derived from license fees, manufacturing-related activities for Healios, other contract revenue from our collaborations and grant revenue.

Research and development expenses increased to $11.1 million for the three months ended June 30, 2019 from $10.1 million for the comparable period in 2018. The $1.0 million net increase is associated with increases in clinical trial and manufacturing process development costs of $0.7 million, personnel costs of $0.4 million, internal research supplies of $0.3 million and stock compensation costs of $0.2 million, with such increases partially offset by a decrease in license fees of $0.6 million. Included in our clinical expenses are costs associated with providing manufacturing services to Healios, which are invoiced to Healios in accordance with our collaboration agreements.

General and administrative expenses increased to $2.9 million for the three months ended June 30, 2019 from $2.4 million in the comparable period in 2018. The $0.5 million increase was due primarily to increased personnel costs, legal and professional fees, travel costs and stock compensation costs compared to the same period last year.

Net loss for the second quarter of 2019 was $9.7 million compared to net income of $6.9 million in the second quarter of 2018. The variance of $16.6 million is primarily attributable to the June 2018 expansion of the Healios collaboration.

In the six months ended June 30, 2019, net cash used in operating activities was $17.0 million compared to $1.3 million in the six months ended June 30, 2018, with 2018 being impacted by proceeds from the Healios collaboration expansion. At June 30, 2019, we had $44.2 million in cash and cash equivalents, compared to $51.1 million at December 31, 2018.

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         August 7, 2019
Time         4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada         (877) 396-3286
Telephone access: International         (647) 689-5528
Access code         5087881
Live webcast         www.athersys.com, under the Investors section

We encourage shareholders to listen using the webcast link and to use the phone line if you intend to ask a question. A replay 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 shortly after the completion of the call until 11:59 PM Eastern Time on August 14, 2019 by dialing (800) 585-8367 or (416) 621-4642 and entering Encore passcode 5087881.
 


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