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The MOU includes $1.5M to $4.5M near term payments plus up to $150M in milestones
Athersys, Inc. (NASDAQ:ATHX), a cell therapy and regenerative medicine company developing MultiStem® (invimestrocel) for critical care indications, announces that the independent data safety monitoring board (DSMB) has completed a pre-planned interim analysis of the Company's ongoing Phase 3 MASTERS-2 pivotal clinical trial evaluating MultiStem® for the treatment of acute moderate-to-severe ischemic stroke, and concluded that the current sample size of 300 patients is insufficiently powered to achieve the primary endpoint of mRS Shift analysis at Day 365. There were no safety issues identified. Because the sample size required to achieve statistical significance is considerably larger, Athersys intends to conduct additional data analysis with independent statisticians. The Company plans to pause enrollment of new patients while this analysis is being conducted.
Separately, Athersys announces that it has entered into a Memorandum of Understanding (MOU) granting HEALIOS K.K. (Healios) global rights to develop and commercialize MultiStem for the treatment of acute respiratory distress syndrome (ARDS). Under the terms of the MOU, Athersys will receive between $1.5M and $4.5M in near term payments with up to $150 million in potential development and sales milestones and additional royalties. Athersys also expects to receive revenue from the sale of existing clinical doses of MultiStem-- which were manufactured in accordance with its 3D bioreactor process that earlier this year received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA)--for Healios to use in its Phase 3 clinical trial in ARDS.
Athersys intends to continue exploring available strategic options. However, in the event Athersys is unable in the near-term to enter into a strategic transaction or obtain adequate financing, it expects to have to file for protection under the bankruptcy laws to allow the Company to conduct an orderly wind down of operations. In the interim, the Company is streamlining its operations to preserve its capital and cash resources.
"I'd like to thank the many patients, clinicians and vendors that have supported this pivotal phase 3 trial since its start in 2018. We're disappointed with the results of the unblinded interim analysis indicating a large sample size adjustment would be required to achieve our primary endpoint. We intend to conduct further analysis to better understand these results. The new MOU we've signed with Healios for ARDS provides the company near-term capital and the potential for meaningful milestone payments as we continue to pursue various strategic solutions," said Dan Camardo, Chief Executive Officer of Athersys.
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.
Posted In: ATHX
