ATHERSYS, INC. Fourth Quarter 2022 and Recent Corporate and Operational Highlights
Largely completed the company's restructuring initiative with the goal of significantly reducing expenses, conserving cash, improving focus and making
Reduced operating expenses below
Reduced headcount by 70% to 20 FTEs currently
Closed ReGenesys,
Initiated efforts to sublet the
Reduced and streamlined internal research functions to focus on the pivotal Phase 3 MASTERS-2 clinical trial in ischemic stroke
Appointed experienced biotechnology and pharmaceutical executive
Raised gross proceeds of
Completed enrollment in cohorts 1 and 2 of MATRICS-1, the investigator-initiated Phase 2 trial evaluating MultiStem in patients following resuscitation from hemorrhagic trauma
Announced participation in a Request for Proposal process with the
Healios announced regulatory agreement on the outline for a clinical trial in
Granted first
MASTERS-2
Announced planned amendments to MASTERS-2 clinical trial protocol following a successful Type B meeting with the
Proposed modifications establish primary and secondary endpoints that best reflect the full potential benefit of MultiStem treatment for patients with acute, moderate-to-severe ischemic stroke as well as the evolving standard of care
Primary endpoint will become mRS shift analysis at Day 365
Convened a meeting of stroke Key Opinion Leaders (KOLs) to discuss potential changes to the MASTERS-2 trial design, given clinical findings from Healios' TREASURE trial in
Exceeded 50% enrollment in MASTERS-2 and significantly increased the rate of patient enrollment due in part to increased trial site engagement and opening new sites across more geographies, with more sites expected to be activated throughout 2023
Three sites in the
Management Commentary
'Last year was a transformative year for
'We remain focused on advancing MASTERS-2 in ischemic stroke and look forward to meeting with FDA and EMA regulators later this month to discuss insights gained from the TREASURE trial conducted in
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as 'anticipates,' 'believes,' 'can,' 'continue,' 'could,' 'estimates,' 'expects,' 'intends,' 'may,' 'plans,' 'potential,' 'should,' 'suggest,' 'will,' or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. In addition, a number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face are the risk that we will be unable to raise capital to fund our operations in the near term and long term, including our ability to obtain funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, on terms acceptable to us or at all, and to continue as a going concern and our ability to successfully resolve the payment issues with our primary contract manufacturer and gain access to our clinical product. The following risks and uncertainties may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements: our ability to raise capital to fund our operations in the near term and long term, including our ability to obtain funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, on terms acceptable to us or at all, and to continue as a going concern; our ability to successfully license our SIFU technology; our ability to successfully resolve the payment issues with our primary contract manufacturer and gain access to our clinical product our collaborators' ability and willingness to continue to fulfill their obligations under the terms of our collaboration agreements and generate sales related to our technologies; the possibility of unfavorable results from ongoing and additional clinical trials involving MultiStem; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in an early stage clinical trial may not be predictive of results in later stage or large scale clinical trials; our ability to regain compliance with the Nasdaq continued listing requirements; the timing and nature of results from MultiStem clinical trials, including the MASTERS-2 Phase 3 clinical trial evaluating the administration of MultiStem for the treatment of ischemic stroke and the effect of amendments to its clinical trial protocol; our ability to meet milestones and earn royalties under our collaboration agreements, including the success of our collaboration with Healios; the success of our MACOVIA clinical trial evaluating the administration of MultiStem for the treatment of ARDS induced by COVID-19 and other pathogens, and the MATRICS-1 clinical trial being conducted with
Contact:
Tel: 212-201-6614
Email: tpatel@lhai.com
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