Athersys, Inc. (“we,” “our,” “us,” “Athersys” or the “Company”) is filing this Current Report on Form8-K to (1) provide certain updates regarding its operations and financial condition and (2) update Item 1. “Business” in its Annual Report on Form10-K for the year ended December 31, 2019, filed on March 16, 2020 (the “2019Form 10-K”), to correct a statement regarding the duration of coverage for its stem cell product candidates that could be provided by its current intellectual property estate made.
Phase 2/3COVID-19 ARDS Study
On April 9, 2020, the U.S. Food and Drug Administration (the “FDA”) authorized us to initiate a Phase 2/3 study, which will assess the safety and efficacy of MultiStem® therapy in subjects with moderate to severe acute respiratory distress syndrome (“ARDS”) due to the novel strain of the coronavirus disease(“COVID-19”), which we refer to as our MACOVIA study. We plan to open the first clinical sites for recruitment of the MACOVIA study in the second quarter of 2020.
The trial will be a multicenter study featuring an open-labellead-in followed by a double-blind, randomized, placebo-controlled Phase 2/3 portion. The primary objectives of this study are to evaluate the safety and efficacy of MultiStem as a treatment for subjects with moderate to severe ARDS induced byCOVID-19. The primary efficacy endpoint will be an analysis of ventilator-free days through day 28 as compared to placebo, a well-established endpoint for ARDS trials that evaluates an intervention’s combined impact on survival and liberation from invasive mechanical ventilation. The secondary objectives of this study are to evaluate pulmonary function,all-cause mortality, tolerability and quality of life among survivors associated with MultiStem as a treatment for subjects with moderate to severe ARDS due toCOVID-19. The study is designed to enroll up to 400 subjects and will be conducted at leading pulmonary critical care centers throughout the United States.
The first cohort of the study will be open-label, with a single active treatment arm to evaluate the safety of the MultiStem product candidate. The second cohort will be a double-blind, randomized, placebo-controlledrun-in phase to evaluate the efficacy of MultiStem. The design of the third planned cohort will be based on analysis of the results of the second cohort. Theintent-to-treat population will include all randomized subjects (i.e., subjects from the second and third cohorts).
Phase 2 Trauma Study
On April 15, 2020, the FDA authorized an Investigational New Drug (“IND”) application to initiate a Phase 2 clinical trial evaluating MultiStem cell therapy for early treatment of traumatic injuries and the subsequent complications that result following severe trauma. The trial will be conducted by The University of Texas Health Science Center at Houston (“UTHealth”) at Memorial Hermann-Texas Medical Center in Houston, Texas.
The objective of the clinical study is to evaluate the safety and effectiveness of MultiStem for the treatment of severely injured patients for the prevention and mitigation of complications that can result following severe traumatic injury. The proposed study will be a randomized, double-blind, placebo-controlled Phase 2 clinical trial estimated to enroll approximately 150 severely injured trauma patients following hospitalization, initial treatment and admission to the intensive care unit. These patients will be randomly assigned to receive MultiStem or placebo and both groups will receive the standard of care for their injuries.
As previously disclosed, this study is being supported under a grant awarded to McGovern Medical School at UTHealth from the Medical Technology Enterprise Consortium. Also, Memorial Hermann Foundation will provide additional funding. The study will be conducted under an Athersys IND, and Athersys will provide the investigational clinical product for the conduct of the trial, as well as regulatory and operational support. The trial protocol authorized by the FDA will be reviewed by the UTHealth Institutional Review Board to provide approval before trial initiation.
BARDA
As part of the U.S. Government’s response to the outbreak ofCOVID-19 we have held discussions with and made presentations under the Medical Countermeasures TechWatch program to the Biomedical Advanced Research and Development Authority (“BARDA”) and to the U.S. Government interagencyCOVID-19 Medical Countermeasures task force led by BARDA that also included other relevant governmental agencies and public health institutions (also referred to as the CoronaWatch task force). As a result of this review, our program involving administration of MultiStem for the treatment of ARDS was designated as highly relevant by the Medical Countermeasures TechWatch program. Following infection withCOVID-19, or other viruses or pathogens that trigger severe pulmonary inflammation, ARDS can occur, resulting in significant morbidity or death.
Discussions between Athersys and BARDA are continuing regarding a potential collaboration for which Athersys has submitted its formal proposal. However, there can be no assurance that BARDA will elect to pursue such collaboration with us, or as to the amount of funding, if any, that we might receive in connection with any such collaboration.
Financial Position
As of April 9, 2020, we had approximately $37.5 million of cash and cash equivalents, which gives effect to the receipt of approximately $7.0 million of proceeds from the issuance of 4,000,000 shares of common stock to HEALIOS K.K. upon its exercise in full of a warrant in March 2020 and the receipt of approximately $10.3 million of proceeds from the issuance of a total of 6,825,000 shares of common stock to Aspire Capital Fund, LLC (“Aspire Capital”), since December 31, 2019 pursuant to common stock purchase agreements that we previously entered into with Aspire Capital.
COVID-19
In December 2019,COVID-19 was identified in Wuhan, China, and has since spread to other countries, including the United States. In March 2020, the World Health Organization characterizedCOVID-19 as a pandemic. Several countries, including the United States, have taken steps to restrict travel, temporarily close businesses and issue quarantine orders, and it remains unclear how long such measures will remain in place.
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