Third Quarter 2023 and Recent Corporate and Operational Highlights
Announced results of a blinded interim analysis of Phase 3 MASTERS-2 clinical trial studying MultiStem for treatment of ischemic stroke indicating additional patients would need to be added to the trial to achieve statistical significance with a primary endpoint of mRS Shift Analysis at Day 365.
Completed warrant exercise inducement generating gross proceeds of
Executed a Memorandum of Understanding (MOU) with Healios for global rights to develop and commercialize MultiStem for the treatment of Acute Respiratory Distress Syndrome (ARDS) and received a
Received a second
Completed a
Completed license of animal health assets to
Appointed Ms.
Management Commentary
'Since announcing the results of the blinded interim analysis of MASTERS-2 indicating additional patients would be needed to achieve statistical significance on the primary endpoint, we've been actively engaged in exploring strategic options with interested parties to determine the best path forward for MultiStem and
Third Quarter Results
There was no revenue for the third quarter of 2023 compared with
Research and development expenses were
General and administrative expenses were
Net loss for the third quarter of 2023 was
Cash and cash equivalents were
About MultiStem
MultiStem (invimestrocel) cell therapy is a patented regenerative medicine product in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapy's potential for multidimensional therapeutic impact distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. The therapy represents a unique 'off-the-shelf' stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon its efficacy profile, its novel mechanisms of action, and a favorable and consistent tolerability demonstrated in clinical studies, we believe that MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.
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, expected timetable for any results of our trials or analyses, the consummation or timing of any strategic transaction, 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. 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; whether we receive a grant from BARDA; 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 successfully license our SIFU technology; our ability to regain and maintain 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; 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:
Email: ir@athersys.com
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