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Athersys, Inc.
5/6/2022
Good morning. My name is Chris, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the AtherSys Investor Conference. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star, then 1 on your telephone keypad. To withdraw your question, please press star 1 again. Thank you. Karen Honody, you may begin.
Thank you, Chris, and good morning, everyone. I'm Karen Honody, Director of Corporate Communications and Investor Relations for Athersys. Thank you for joining today's call. Earlier this morning, we distributed a press release announcing the treasure data from our partner Helios in Japan. If you do not have a copy of the press release, it is available on the Athersys website at athersys.com. We also have slides for today's presentation for those attending on the webcast. A webcast of the audio and the slides presented today will be available within two hours after the call's conclusion on our website under the Events section. The access information for the replay is also in today's press release. Today I'm joined by several members of our Adversities Management team, and we look forward to walking you through this important data. I'm here with Dan Camardo, our Chief Executive Officer, BJ Lehman, our President and Chief Operating Officer, John Harrington, our Chief Scientific Officer, Ivor McLeod, our Chief Financial Officer, Robert Willie Mays, our Vice President of Regenerative Medicine and Head of Neuroscience Programs, and Eric Jenkins, our Senior Medical Director and Head of Clinical Operations. Any remarks that we may make about future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by the forward-looking statements as a result of various important factors, including those discussed in our Forms 10-Q, 10-K, and other public SEC filings. We anticipate that subsequent events and developments may cause our outlook to change While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. For the benefit of those who may be listening to the replay, this call was held and recorded on May 20th of 2022. Since then, we may have made announcements related to the topics discussed, so please reference our most recent press releases and SEC filings. At this time, I would like to turn the call over to Dan Combardo, our Chief Executive Officer. Dan?
Thank you, Karen. First, I'd like to start by congratulating our partner, Helios, on the completion of their multi-stem ischemic stroke study called TREASURE. This is the largest randomized double-blind placebo-controlled trial with a cell therapy in ischemic stroke conducted in Japan. And as we reported earlier this morning, we are excited about the top-line results that show evidence of therapeutic impact, although the primary endpoint of excellent outcome at 90 days did not reach statistical significance. Preliminary data analysis suggests a path forward for Helios to meet with PMDA under the Sagagaki designation for innovative pharmaceutical products and regenerative medicines. Furthermore, the treasure data suggests a high potential for success on our own Masters II ischemic stroke trial, which has a primary outcome measure of MRS shifts. So in addition this morning to John Harrington, B.J. Lehman, and Ivor McLeod, we also have in the room with us today Dr. Willie Mays and Dr. Eric Jenkins, who are also available to answer questions at the end of our call. So I'd now like to turn the call over to John Harrington, our Chief Scientific Officer, who will provide more details on the trial data. Thanks, Dan.
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