Everyone, welcome to the Athersys August Business Update. Today's call is being recorded. I would now like to turn the conference over to Ellen Gurley, Corporate Communications and Investor Relations Manager. Please go ahead. Good afternoon, welcome to the Athersys August 2023 Business Update conference call. Please note that any remarks by management 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 factors, including those contained in our Forms 10-Q, 10-K, and other SEC filings. Also, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 9, 2023. Athersys undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law. I would like to now turn the call over to Dan Camardo, Chief Executive Officer. Dan, please go ahead. Thank you, Ellen. Good afternoon, everyone, and thank you for joining us today. Over the past few months, we've made several meaningful advancements with our clinical programs and related opportunities. This includes positive engagement with regulators in the United States and Japan, continued momentum with trial execution, and advanced conversations with potential partners and federal programs. We've made significant progress by being focused on specific priorities, being more disciplined in our approach, and managing our operating costs thoughtfully. We still have more work to do, but I'm proud of the new company we've become and the meaningful catalysts we now see in front of us. On today's call, I would like to cover the progress we've made on our three lead indications for MultiStem, namely ischemic stroke, acute respiratory distress syndrome or ARDS, and trauma. I'll start with our most advanced program. MASTERS-2 is our ongoing pivotal phase III clinical trial, evaluating MultiStem for the treatment of adults who have suffered an acute ischemic stroke. As a reminder, in March, we held a highly constructive Type B meeting with the FDA to discuss modifications we proposed to the study design that established primary and secondary endpoints that best reflect the full potential benefit of MultiStem for patients with acute, moderate to severe ischemic stroke, as well as taking into account the evolving standard of care. As we've discussed, the most impactful result of that meeting was agreement with the FDA to extend the timing of the primary endpoint, assessed by shift analysis in modified Rankin Scale score to day 365 from day 90, the previous primary endpoint. The MRS shift analysis score at day 90 is now a secondary endpoint. This change was made to reflect our understanding of the mechanism of action of MultiStem from preclinical studies and more recent clinical trials, including the phase II/III TREASURE trial completed in Japan last year by our partner, Healios. Based on this data, we believe MultiStem continues to improve patient outcomes over time, unlike current available treatments, and the MASTERS-2 trial is now designed to capture this extended benefit. Also, a key factor to accelerating our pace of enrollment in the study was the FDA's agreement to remove eligibility caps on non-commitment reperfusion therapy. This change is vitally important because it will ensure the final study population is representative of the current standard of care in patients that we expect to be eligible for treatment with MultiStem. For context, reperfusion refers to the restoration of blood flow to an area of the brain that has been deprived of oxygen and nutrients due to an ischemic stroke. Ischemic strokes occur when a vessel supplying blood to the brain is obstructed, often by a blood clot. Reperfusion strategies, such as thrombolytic therapy like tPA or mechanical thrombectomy, aim to dissolve or remove the clot, thereby reestablishing blood flow and minimizing damage to the brain tissue. The MASTERS-2 current trial design allows for patients to be randomized for treatment of MultiStem or placebo at 18 to 36 hours after stroke onset if a patient demonstrates stable deficits. In the context of ischemic stroke clinical trials, reperfusion caps have traditionally been used to set predefined limits on the number of patients who can achieve successful reperfusion. There are several benefits to removing these caps in our trial. First, without reperfusion caps, MASTERS-2 offers a more accurate representation of the real-world applicability of trial findings. Second, removing caps allows for a more thorough evaluation of MultiStem's efficacy, as the results won't be restricted or prematurely halted by reaching a set cap. The trial is now appropriately designed to demonstrate clinical efficacy of MultiStem as either adjunct therapy to reperfusion or as a standalone therapy when reperfusion is not appropriate. We have now implemented this update protocol in more than 60% of active MASTERS-2 clinical trial sites, We expect the remaining sites to be completed by the end of this month. The removal of eligibility caps, along with improved execution, has. We have now surpassed the two-thirds enrollment mark for MASTERS-2 and expect to complete enrollment of 300 subjects by the second quarter of 2024. In addition to changing the primary endpoint and removal of eligibility caps, the FDA also accepted our recommendation to conduct an unblinded interim analysis for the purpose of evaluating whether the study size is sufficiently powered to achieve statistical significance. I'm happy to report that we expect to begin conducting this unblinded interim analysis in the next few weeks and anticipate the results will be available to share in early October. As part of this interim analysis, the FDA also offered us an opportunity to conduct a subset analysis to identify the proper patient population that may benefit from MultiStem the most. This subset analysis will allow us a chance to assess potential differential subgroup effects and ensure sample sizes of the subgroups are adequate to detect a clinically meaningful treatment effect. As a result of these trial modifications, we are in active discussion with our Japanese partner, Healios, and the PMDA, to determine the feasibility of adding Japanese patients to the MASTERS-2 trial to support an application for approval in Japan. This will enable our partner, Healios, to join MASTERS-2 and potentially pursue approval for ischemic stroke under their Sakigake designation. We have available clinical product to support the addition of sites and continue to work closely with Healios as they develop their strategy for approval in Japan. As communicated in earlier updates, Athersys would receive both development and sales milestone payments, along with tiered double digit royalties on net sales based on our 2018 license agreement with Healios. On the topic of industry partnerships, we continue to make meaningful progress with potential partners, and we are pursuing both the option of global licensing as well as regional agreements. On today's call, I won't speak of any particular opportunities, but we remain in active conversations and under confidentiality agreements with several organizations. This includes conversations we're having with interested parties to license MultiStem to develop differentiated products, as well as for use in animal health and our SIFU device. We remain committed to finding a partner that aligns with our mission of bringing MultiStem to market and pursuing a deal or multiple deals that are in the best economic and strategic interest of our shareholders. Turning now to our progress in acute respiratory distress syndrome, or ARDS, which represents a significant unmet medical need and currently has no FDA-approved treatment. With approximately 200,000 ARDS cases annually in the United States and over two million cases globally, along with a mortality rate of 30%-50%, we feel our work in ARDS is critical. In addition, ARDS has been a leading cause of death from severe COVID-19, and this has increased awareness of the need for an effective FDA-approved treatment. Our work in ARDS is built upon prior favorable results from our Phase I/II MUST-ARDS study and the unblinded Phase II bridge study conducted by our partner, Healios, in Japan. MultiStem was recently selected to present as a finalist in the Just Breathe program, sponsored by the Biomedical Advanced Research and Development Authority, also called BARDA, which is part of the U.S. Department of Health and Human Services. Under this agreement, BARDA reviewed submissions from various U.S. drug sponsors and called finalists to present to its Influenza and Emerging Infectious Diseases Division in late July. BARDA will select three therapies to be included in a Phase II platform clinical trial in hospitalized adults with ARDS. This study will evaluate the safety and efficacy of novel, threat-agnostic, and host-directed therapeutics that could address ARDS caused by known or unknown health security threats, such as pandemic influenza, COVID-19, and other emerging infectious diseases, as well as chemical, biological, radiological, and nuclear incidents. We believe MultiStem is well aligned with the criteria for this program, while we do not currently have a final announcement from BARDA, we expect to hear their decision within the next two weeks. Lastly, on ARDS, we are happy to announce that in March, earlier this year, Healios, with support from Athersys, received approval from Japan's PMDA to conduct a Phase III trial with MultiStem in approximately 80 ARDS patients. Healios also received PMDA approval to utilize our 3D manufactured 4x40 liter clinical doses of MultiStem in that trial, which we are currently using in our MATRICS-1 Phase II trial for trauma. On July 6th, Healios announced a letter of intent to establish a subsidiary with Saisei Ventures to support ARDS treatment development in Japan. If Healios is successful with this Phase III trial, Athersys stands to receive both development and sales milestone payments, along with tiered double-digit royalties on net sales. We will continue to work with Healios to pursue MultiStem approval for ARDS in Japan. We look forward to providing you further updates in the future. This brings us to our third topic. Patient enrollment began in the 3rd and final cohort of MATRICS-1, evaluating MultiStem in patients following resuscitation from hemorrhagic trauma. This study is being conducted at The University of Texas Health Science Center at Houston and Memorial Hermann-Texas Medical Center, a leading certified Level I trauma center. They'll be enrolling a total of 140 patients in the third cohort using our 3D bioreactor manufactured product. The initiation of enrollment in cohort one follows a successful DSMB review of cohort one, using our 2D cell factory manufactured product, and cohort two, using our 3D bioreactor manufactured product. We expect enrollment in cohort three to be completed sometime in 2025, and we will communicate progress made in this trial in future business updates. I'd like to make a few comments regarding our finances with the understanding that we have not filed our second quarter earnings statement yet. Back in May, we met with an independent Nasdaq panel to appeal the delisting notice we received regarding non-compliance with maintaining a $35 million market value of listed securities requirement. We presented a comprehensive plan detailing specific actions and milestones that we believe, if achieved, would allow us to regain compliance with this Nasdaq requirement. On June 26, we were granted an extension from Nasdaq, allowing us until September 15, 2023, to regain compliance with the market value of listed securities requirement. In addition, on July 28, we received a non-compliance notice from Nasdaq related to our share price trading below $1 for 30 consecutive days. We have 180 days or until January 24, 2024, to regain compliance with this requirement. Additional details regarding our financial status will be provided in our 2Q 10-Q once it's filed. Finally, I would like to share how we are raising accountability across the organization and evolving our approach to corporate goals and compensation. In many discussions with shareholders over nearly a year and a half as CEO of Athersys, I've heard frustration with early practices around this topic. I take this feedback very seriously. We have made progress in this area of our business by revamping our approach to individual performance reviews. As an example, after discussing our performance in 2022 with the board, we made the decision not to award cash bonuses. This applied to all active employees, including our executive team. While some of the circumstances for last year's performance were out of our control, we share the accountability for the results. When our goals are achieved, we'll share in the rewards. This is just one example of how we've changed our company culture to be more transparent and more accountable in achieving our goals and listening to shareholders. In conclusion, we've made substantial progress in our clinical trials and in streamlining our business operations, and we now have several meaningful catalysts in front of us. Our team's dedication and engagement over the past several months with regulatory and government agencies has renewed our confidence in the potential of MultiStem and reminded us of the important work we're doing and the immense responsibility we have to offer hope to patients that suffer from these debilitating diseases. We've overcome many difficult challenges to get to this point, and we're excited to be approaching several key near-term milestones. I look forward to updating you again following our MASTERS-2 interim analysis results. On behalf of the entire Athersys leadership team, I want to thank you for your continued support. With that, I'll conclude today's prepared remarks and turn the Q&A portion of the call over to Ellen. Thanks, Dan. For this portion of the call, I'm going to summarize several questions and common themes that we've received via email. Then I'll allow Dan and other leaders the opportunity to answer each. Starting with question number one: What is the status of BARDA, and when do you expect to hear a decision? Willie, you want to handle that one? Sure. Thanks, Dan. Thanks, Ellen. Yeah, just by way of a quick background, we've been talking with BARDA now for almost a year. We knew that they were going to be coming out with some form of a ARDS-related request for proposals. We've been involved in writing and talking and dialogue. The most recent initiative, this Just Breathe platform trial. They reached out to us, we supplied them with all the information they asked for in June. They notified us that we'd made it to sort of the final cut, where there was going to be presentations. I presented to them over a Zoom meeting in the week of July 24th, on Monday, July 31st, they reached back out to me and said, "Hey, thanks for the presentation. You've answered all of our questions. We're going to spend the next two weeks determining who the, the winners are." We're in that window right now. Based on what I know and what they've provided to me, I would expect the end of this week or sometime next week to find out. Thank you, Willie. Thank you. Question number two: Can you provide more details on the interim analysis and progress on patient enrollment in MASTERS-2? You want to take that one, too? Sure. Yeah, no problem. As Dan said, we've passed the two-thirds mark of the 300-patient trial, that's pretty basic math for those of you that are out there. We've enrolled more than 200 patients in the trial to date. The interim analysis was sort of proposed by us to the FDA in our Type B meeting, because as we moved the primary endpoint from MRS shift analysis at day 90 to MRS shift at day 365, we wanted to make sure that the data would be mapping or providing us with support for a trial that was powered to 90%, as was the original trial based off of the MASTERS-1 data. It gives us a chance to, at the midway point of the trial, evaluate the power of the patient population through through the midpoint, and then, see if we need to potentially add more patients or are we on track to reach 90% power for the day 365 endpoint. They also provided us the opportunity, as you mentioned, to look at subgroup analysis to see if the cells were working, and enhance... showing an enhanced benefit in certain potential subgroups. I'll give you one quick example. We learned in MASTERS-1 that time was critical. The earlier patients received the cells, the better the, the outcomes were. We can do that same sort of analysis in the subgroup analysis here and see if the cells given at the early window of 18 to 36 hours are superior compared to later time points. That's the sort of thing we're finalizing right now and hope to be done doing the interim analysis in the next month. Great. Thank you very much. Question number three: What is the status with Healios? Sure. Maybe I'll make a comment and then hand it over to Maia Hansen. We've obviously been working very closely with Healios. They're our only partner, and, and an important partner to us in Japan, and have been, in some cases, out in front of us, particularly with their TREASURE trial and for ischemic stroke. We've learned a lot through that trial as well as their ONE-BRIDGE trial for ARDS. You know, the partnership is really important to us, and Maia has been working very closely with Healios on our plans going forward. Maia, maybe I'll invite you to maybe make a comment. Yeah. Thank you, Dan. As Dan indicated, we have a very productive working relationship with Healios, right now, and we're working with them across three broad areas. We've talked about those already a little bit in Dan's remarks, but just to add a couple additional details. The first area is around stroke. We have been working closely with Healios, as they have been talking to the PMDA, with our support as a global sponsor, about the potential to add Healios to the MASTERS-2 trial. We're currently ramping up our collaboration with them in terms of that support so that we can ultimately have a final consultation meeting with the PMDA and clarify any expectations that they have, relative to things like inclusion of Japanese patients. Once that is done, Healios will then decide whether they will elect to join the trial. If they do, we already have agreements in our current contracts on the support that we would provide them and the payment that they would make to us, both for trial management as well as for doses. We look forward to keeping all of you updated as that progresses. Secondly, related to ARDS, for those of you who follow Healios, you may have already seen their press releases, but they've made quite a bit of progress with our help, working with the PMDA to define a Phase III trial for ARDS. They've already defined the trial size for that. They've also made progress in getting PMDA support to use our bioreactor 4x40 liter product. Again, we've been working with them behind the scenes on pulling all of the right documentation for that. If they decide to go forward, in conjunction with the subsidiary that they have just developed, we would be providing clinical doses to them, also at, with some compensation. We will continue to work with them in other ways to support that trial. As Dan noted, both for ARDS and MASTERS-2, we, and over time, would benefit from royalties and other milestone payments. In a third area, we have over time been working with them on manufacturing. We haven't talked about that much in the last business update, we are working jointly on the next generation of 3D bioreactor processes, and also on some of our CMC-related topics around, for example, potency testing, where we are currently getting ready to do joint testing on some samples to evaluate our new potency test that would complement our existing potency test. Just summarizing all of that, we have a lot going on, it's very productive, and as Healios reaches certain decisions, we will continue to ramp up our support. Thank you. Thanks, Maia. Thank you. Question number four is: Can you update us on business development discussions? Sure. I'll make another comment and then hand it back to Maya again, because she has been leading this effort as well. We have had, and I know that, this has been said previously on business update calls, but we've had many conversations, and have discussed not only opportunity for licensing with ischemic stroke, but also other indications, that we've been in discussion with, with different companies. We're currently under, as I mentioned, confidentiality agreements in progressing those conversations. We have not yet gotten to a point where we feel comfortable that it represents the value that we believe MultiStem represents. So, we have nothing to report yet, but we are actively in conversations. Maya, maybe I'll turn it over to you to speak to some of the other areas we're building. Yeah, sure. In addition to global partner discussions, we've had a number of discussions around regional licenses, and then we are continuing to progress our discussions on animal health, and have been in some significant discussions with a potential partner there. We also have a number of conversations with venture capital firms and other potential investors in potentially spinning out our SIFU technology, so that it can be developed more broadly as a standard infrastructure for the industry. Okay, thank you. Our last question is: what is your financial status, and how do you intend to fund the company going forward? Obviously, we're limited in terms of what we can say, because we have not filed our second quarter earnings statement yet. Let me turn that over to Kasey Rosado, who's been our Interim CFO and has been doing a tremendous job of helping us navigate obligations that we've had in place for the last year, working with all of our vendors, as well as just understanding how to appropriately finance operations going forward. We've made some significant gains in terms of reducing our overall burn rate and operating expenses. We are down to… I think we've spent in the last year, probably what was being spent on a quarterly basis, more than a year ago, we've really taken some strong steps to put ourselves in a much better position, under her leadership. Let me, with that, kind of introduction, let me turn it over to Kasey Rosado. Thank you, Dan. Yeah, so you know, out of the gate, let me start by, you know, kind of again, echoing what Dan mentioned. I'm very limited as to what I can say at this time, since our second quarter 10-Q has not been filed yet. With that said, I do want to highlight that the restructuring efforts that we've put in place have been essential. The ones that, you know, both at the operational and the clinical level, streamlining our cost structure and, and maintaining and reducing our cash burn, is a critical path to stabilizing and managing our business. As part of those efforts, we continue to work with our suppliers and our service providers to align, align both our short-term and our long-term needs. A good example, of that is the restructuring efforts, of these efforts that we've been underway, is back in May of 2023, we announced the successful restructuring of our agreement with a key supplier. This is an essential step, because as we continue to focus and prioritize bringing MultiStem to market, this new agreement is reflective of our post-restructuring development and manufacturing needs. We recognize that bringing MultiStem to market requires capital. Therefore, we remain optimistic about securing funding for our immediate cash needs and eventually start to build for the future. In anticipation of our capital needs, we are positioned to complete a financing in line with our recent public filing. As I've stated in the past, we will remain resolute and disciplined in how we allocate capital and operate judiciously in support of our top priority, which is MASTERS-2. You can expect more details, you know, along our financials, once we file our second quarter 10-Q. Thank you, Kasey. All right, thank you. That was our final question for today. If you have additional questions following this call, please send an email to ir@athersys.com. We do appreciate all the questions. We, we do get quite a few, and, and, some, some we are able to answer, some we will be able to answer in time, particularly around our financings. Thank you for those that took the time to send in questions. Ellen, thank you, for kind of organizing this call. I'd like to thank all shareholders, that are on the call today for your continued support. We look forward to keeping you updated on our progress with some exciting milestones that are in front of us that we'll be working to accomplish over the next couple of weeks, and into, early October. Thank you very much for joining us today, and we will keep you posted, as we make progress and hopefully, provide another update with the results of our MASTERS-2 interim analysis. Thank you very much. That concludes today's presentation. Thank you for your participation, and you may now disconnect.