Athersys, Inc.

to the Athers' first quarter 2021 results conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised today's conference is being recorded. If you require any further assistance, please press star 0. I would now hand the conference over to Ms. Karen Honaday. Thank you. Please go ahead.

Thank you, and good afternoon, everyone. I'm Karen Hannity, Director of Corporate Communications and Investor Relations for Athersys. Thank you for joining today's call. If you do not have a copy of the press release issued at the close of market, it is available on the Athersys website at athersys.com. I'm here with BJ Lehman, our President, Chief Operating Officer, and Interim CEO, John Harrington, Executive Vice President and our Chief Scientific Officer, and Ivor McLeod, our Chief Financial Officer. A webcast of the audio will be available starting tomorrow, Friday, May 7th, at 12 p.m. Eastern Time on our website under the Events section. The access information for the replay is also in today's press release. 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 IPC 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 6th of 2021. Since then, we may have made announcements related to the topics discussed, so please reference our most recent press releases and SEC filings. With that, I'd like to turn the call over to B.J. Lehman. B.J.?

Thanks, Karen. I am B.J. Lehman, President, COO, and Interim CEO of Atrisys. It's been just six weeks since we had our 2020 year-end earnings call. We remain on track with our priorities and look forward to important progress during the remaining course of the year. In our call today, I will provide a short update on our business operations. I will then hand it off to John Harrington, our Chief Scientific Officer, who will share some highlights of our activities associated with developing and preparing for commercial scale manufacturing. And finally, Ivor McLeod, our Chief Financial Officer, will share information about the company's financial position. This will be followed by a brief question and answer period. To get started, I would like to provide a short reminder of our priorities this year. First, we are focused on advancing our clinical programs with particular attention to our Master's II study and in supporting Helios, our partner in Japan, as it prepares for applications to the PMDA for potential approval of multi-stem therapy for ARDS and stroke, assuming successful trial readouts. Second, we are preparing for commercial product manufacturing by further developing our bioreactor-based process for commercial scale production, planning for manufacturing capacity for this purpose, and taking the first steps on the path to put this capacity in place. Third, we have underway important activities intended to prepare us for commercialization, assuming successful trial results and marketing approval applications. In a prudent and staged way, we will continue to develop and invest in commercialization-enabling capabilities. As for important 2021 milestones of particular notes, we expect to see top-line results from our Japanese partners' ischemic stroke study treasure, providing us our first look at late-stage clinical trial data for the treatment of stroke with multi-stem cell therapy, or MV-MestroCell, We are also working to refine our large-scale manufacturing process, establishing technology transfer readiness to enable us to transfer efficiently the process into the GMP manufacturing environment. In Japan, Helios recently announced the completion of enrollment of its OneBridge clinical trial, which is evaluating multi-stem treatment of pneumonia-induced and COVID-induced acute respiratory distress syndrome, or ARDS. This study, including 35 subjects, was designed as an open-label study. Though the size and design of the study may affect the weight of the findings, we hope to see results that are in line with our previous Mustard study and that could provide the foundation for conditional or full approval for this orphaned indication in Japan. Overall, in the short period from our last call, we are operating on plan and in line with expectations shared on that call. We look forward to updating you on progress in subsequent calls over the course of the year. On another note, I would like to remind you that our annual meeting of stockholders is approaching. You should be receiving our annual report and proxy statement by regular mail or email very soon. We encourage you to vote on the proposals included in the proxy statement, and our Board of Directors recommends unanimously that you vote in favor of the four proposals. I would like to bring to your attention one of the proposals in particular, the proposal to increase the number of shares of authorized common stock, which requires the approval of at least 50% of the total outstanding shares and makes your voting participation especially important. With respect to the path of our development into a commercial-stage biopharmaceutical company, 2021 is an important transition year. As we await completion and results of our own pivotal studies, such as MASTERS II, favorable results from the Japanese clinical trials and successful establishment of a large-scale manufacturing process would be expected to provide the foundation for putting in place over the next several years the capabilities and assets to enable long-term success, including commercial operations, commercial manufacturing capacity, and distribution, among other things. Ultimately, we may put these capabilities in place through partnerships, hiring, or investment. By approving the proposal and increasing the authorized number of common shares, you would be providing the company with the ability and flexibility to consider business or financial transactions involving stock, which are intended to support, when needed, the development of these important capabilities and assets essential to commercial success. It is important to keep in mind that for the company to issue shares in the context of a business or financial transaction, the approval of our board of directors is required. This authorization would enable the board to make financing decisions in the best interest of the company and our shareholders. Without approval of this proposal by our stockholders, the company may be hamstrung in its ability to invest in commercial preparations, in conjunction with favorable results, potentially delaying our impact with patients and adversely affecting our commercial opportunities. We ask you to vote and vote in favor of the four proposals recommended by the Board of Directors. Thank you. I would now like to turn it over to John Harrington to highlight our recent process development and large-scale manufacturing preparation activities and accomplishments. John?