This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk06: 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.
spk01: 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?
spk09: 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.
spk02: Good morning. My name's John Harrington. I'm the Chief Scientific Officer at Athercys. I will begin this presentation on slide four. This morning, our Japanese partner, Helios, announced top-line data from TREASURE, their clinical study evaluating multi-stem and ischemic stroke. Before I go into the data in more detail, I'd like to begin by providing a few high-level take-home messages. First, multi-SIM treatment was numerically better than placebo in essentially all functional endpoint measures, and this benefit continued to increase over time. Improvement in pre-specified measures of functional independence by multiple clinical scales was also demonstrated, confirming key hypotheses and the design of our Master's II study. The primary endpoint in TREASURE, which is different than the primary endpoint in MASTERS II, however, was not statistically significant. Importantly, based upon further analysis of the TREASURE data in patients most representative of MASTERS II patients, we believe that we have a high potential for success against our primary endpoint MRS shift, and I will walk you through some of that analysis today. Finally, based upon The evidence of good clinical outcomes, including global recovery and their Sakagaki designation in stroke, Helios has a potential regulatory path for approval in Japan and plans to meet with PMDA to discuss their path forward. Today I'll be discussing several different clinical scales used in the stroke field to measure recovery and functional outcomes. These are shown in the appendix for your reference. Briefly, the scales that I'll discuss today are the NIH Stroke Scale, which measures neurological deficits, the Modified Rankin Scale, or MRS, which measures global disability, and the Barthel Index, which measures one's ability to carry out activities of daily living. I'm moving on to slide five. So with that, I'd like to turn our attention to the treasure results, beginning with some background information on the study. First, let me remind you that the TREASURE study was conducted under Sakagaki designation from PMDA. This is important because it allows a product to potentially receive conditional approval based upon demonstration of safety and evidence of efficacy. This lower bar for efficacy in turn allowed Helios to run a smaller study than MASTERS II. And this has important implications when we discuss the potential read-through of the TREASURE data to MASTERS II. In total, TREASURE enrolled 206 patients, 104 of which were treated with multi-stem, and 102 were placebo treated. And the study was carried out at 48 clinical sites in Japan. The patients had a moderate to moderate severe stroke as defined by an NIH stroke score of 8 to 20 at baseline. Patients received multi-stem or placebo on top of standard of care. and randomized patients went on to receive either a single dose of 1.2 billion multi-stem cells or placebo by IV infusion between 18 and 36 hours of stroke onset or last known normal. And the primary endpoint was excellent outcome, which again is different than the primary endpoint in MASTERS II. I also want to point out that the patients in TREASURE were substantially older than the patients in MASTERS I. and in the patients expected in and observed thus far in Masters II. In general, we would expect a slower and less robust recovery in this older population. So the TREASURE study has a different primary endpoint. It's significantly smaller and has a substantially older population than Masters II. But sit. So here are the key baseline factors. Overall, there was good balance across all groups, including across the stratification factors of age, stroke severity, and reperfusion status. Again, I note the age of patients with approximately 78 in TREASURE compared to approximately 63 in MASTERS I. Slide 7. The key TREASURE results that Helios announced today are shown here. As I indicated, while there was a numerical benefit in favor of multi-STEM for excellent outcome, the result was not statistically significant at day 90 or day 365. However, Sakagaki designation may allow other evidence of efficacy to be considered for initial approval in Japan. In this respect, Helios also analyzed a number of additional pre-specified measures and found that several endpoints did show a statistically significant benefit of multi-STEM in their patient population. For example, for global recovery, which is a measure of good clinical outcome and functional independence, 27.9% of multi-stem patients compared with only 15.7% of placebo patients achieved this outcome, and this was statistically significant at one year. Helios also noted that significance was observed by the Barthel Index, which measures the ability to carry out activities of daily living, again, consistent with a good outcome in this older population. Slide eight. Helios also found that multi-stem patients continued to improve over time by essentially all measures, two of which are shown here. And the degree of benefit in multi-stem versus placebo patients grew larger with time. In the first example on the left, you can see a higher proportion of multi-STEM patients achieved an MRS of less than or equal to two, indicating that multi-STEM patients were more likely to be capable of living independently, and this benefit increased with time. Consistent with this, the proportion of patients that achieved a Barthel index of greater than or equal to 95, which indicates they can carry out essentially all activities of daily living, continued to improve over time, whereas the placebo group plateaued at day 90. And again, this was statistically significant out here. Slide 9, to summarize the analysis of the full treasure data set, less impact was seen with measures of X1 outcome, or so-called return to normal, in this more elderly population. And the primary endpoint was not reached at day 90 or day 365. However, evidence of good outcomes, including functional independence, is measured by an MRS less than or equal to 2, a Barthel index greater than or equal to 95, and global recovery at one year was observed. In addition, for essentially all efficacy measures, Multisim was numerically better than placebo and showed improvement relative to placebo over time. Multisim appeared to show benefit in patients of all ages, However, the relative benefit was more substantial in younger patients. Importantly, multi-stim was found to be safe and no significant differences in safety outcomes were observed. Slide 10. So now I'd like to turn our attention to evaluating the TREASURE results in the context of Masters 2 and discuss how these results affect the read-through to our study. As I mentioned earlier, the demographics in TREASURE differ substantially from Masters 1. and also from our experience to date with MASTERS II. Specifically, the patients in TREASURE are meaningfully older, with a median age of 78, and many patients were in their mid-80s to mid-90s. Shown on the left of this slide is the age distribution in MASTERS I and TREASURE. It's worth noting that in Masters I, we had only one patient over the age of 80 who received multi-STEM in the current 36-hour infusion window. So we really had no experience with patients older than about 83 years of age. Based on our enrollment data in Masters II today, we are seeing that the vast majority of patients are younger than 80 years of age, consistent with Masters I. To allow us to predict how the TREASURE results will likely read through to Master's II, we identified the TREASURE patient population who are most representative of our Master's II patient population. And these patients are labeled as TREASURE representative. Ultimately, we expect that the Master's II results will reflect the weighted average of the TREASURE representative and Master's I population. Slide 11. Using the data from the treasure representative patients, we carried out a statistical analysis of our primary and key secondary endpoints. The results of that analysis are shown here. First, looking at our primary endpoint, we see a very encouraging odds ratio at both day 90 and day 365, approaching statistical significance at day 365. And this is with a sample size of only 117 patients. Consistent with this finding at our primary endpoint, we also see an impact of multi-STEM on one of our key secondary endpoints. That is the proportion of patients who achieve an MRS of less than or equal to two, which indicates the ability to live independently. In the treasure representative population, a higher proportion of patients achieved an MRS less than or equal to two at both day 90 and day 365. and this was significant or near significant at both time points. The fact that our primary endpoint and a key secondary endpoint are approaching significance with only 117 patients in the treasure representative population suggests that Masters II, which has 300 patients, has a high potential for success. Slide 12, to conclude, While the TREASURE study did not achieve its primary endpoint, the data from the study looks very promising for success in Master's II, where we had a younger population, a larger study, and a different primary endpoint. Slide 13. As we look forward, we will continue to evaluate the data from TREASURE as more data becomes available. In particular, we will be evaluating biomarker data such as inflammatory cytokines in various T-cell populations. We will evaluate more thoroughly the patient characteristics, including covariates with linkages to outcomes. And we will further evaluate the MASTERS I data in the context of the TREASURE data. We also will proceed in earnest to improve enrollment rates in our MASTERS II study by further expanding the number of sites and increasing site engagement. And finally, we will support regulatory engagement with Helios in Japan to advance the stroke program towards commercialization in Japan. We will be happy to take questions in a few moments, but first, I'd like to turn it over to Ivor McLeod to provide a brief business update. Ivor.
spk08: Thank you, Dan, and thank you, John. I'm Ivor McLeod, Chief Financial Officer of Asasys, and thank you once again, everybody, for joining the call. I do want to highlight that for a detailed review of our 2022 first quarter financial results, I refer you to our press release of May the 6th of this year, as well as our 10 key quarterly report, which we released on the same day. Our cash balance at the end of the first quarter was $21.8 million. As we look forward to future financing, our preference continues to be the sourcing of non-dilutive capital. Late-stage clinical data does open up potential additional business development opportunities for us, and we intend to move very aggressively on that front, as well as continuing our discussions with companies that we are already in touch with. We also continue to have access to both our existing and new equity lines should we decide to utilize them. Our cash burn for the most recent quarter was approximately $19 million. and we are currently taking steps to reduce our burn, continuing to fund our priorities while de-emphasizing investments in other areas. With that, I will pass the call back to Dan for Q&A. Dan?
spk09: Thank you, Ivor, and thank you, John, for reviewing the results of the treasure data. I just want to remind everyone that we do have several folks in the room here that can provide more context for any questions that we receive. So at this time, I'd like to open up the lines to answer questions.
spk06: As a reminder, if you'd like to ask a question, please press star then 1 on your telephone keypad. Our first question is from Greg Harrison with Bank of America. Your line is open.
spk14: Good morning. Thanks for taking the questions. I guess the first one is, what in your mind does this update mean for your efforts to secure a partner in Europe?
spk13: Yeah, Greg, that's a great question. I think one of the key messages that Dr. Harrington covered here today is critically important to answer that question. And that is, if you look at the implications for the data from Treasure, for our study, Masters II, we feel very confident about the design of that study and the potential for success. And we believe when we sit down with the potential partners that we've had discussions with up until this point and we talk to additional folks and we work through the data set with them, they will see clearly what this data translates into for Masters II. So I think our view is this enhances strongly at the potential to get a partnership done. It's a question of timing, a question of the right partnership, right structure, et cetera. But what this means is higher success potential for the Master's II study, and that means higher potential for better business partnership for multi-stem and ischemic stroke.
spk00: The other thing I'd add to that, too,
spk09: The other thing I'd add to what Vijay is saying, too, is I think this gives us even more robust data on multistem and how it's working. And in addition to moving forward, as we have been with Masters II and enrolling patients, and we'll continue to do that with a lot of enthusiasm, I think it also does open up the conversation to some of the other indications that we've kind of put on hold. until we could see the outcome of a trial like a treasure trial. So I think that also opens up the conversation a little bit more broadly with prospective partners for co-development and for licensing. So we're optimistic based upon some of the work that's already been ongoing that we'll be able to, you know, find the right partner that will fit our future plans.
spk14: Got it. And then with respect to the data, has any subgroup analysis been done to determine whether patients treated earlier had better outcomes? And is this a pre-specified analysis in Master's II?
spk13: That's also a good question. We talked about this historically. What we learned from the Master's I study, the kind of principle takeaway from that study was earlier treatment mattered. And if we got inside 36 hours for administration, of multi-stem, you know, from the stroke event, we had a much greater potential for success. I think we saw an analysis of that data that if you look at the window 24 to 36 hours, you know, it appeared that patients treated earlier did benefit. We have not completed analysis. What we've seen at the high level on the preliminary, you know, top line data set is that there is effect through that range. So that's good news, right? 18 to 36 hours, we're seeing effect through the range. We're seeing that differential effect through the range. We will definitely take a look more closely at breaking down that timing to understand if we're getting better affected with treatment at 18 hours versus 36 hours. There's still work to be done. And Greg, as you know, there are a lot of, you know, confounding factors we have to tease out when we do that analysis, age being one, severity being another. Um, but, uh, yeah, we're going to do it. It's an important question, you know, and as we, as we develop a perspective on that, we can certainly communicate about that.
spk14: Great. Thanks. And is, is that pre-specified for your, your trial here in the US?
spk13: No, infusion timing is not a pre-specified, uh, element, uh, with respect to the masters too.
spk02: Nor do we stratify for it. So we take all patients. We're not trying to achieve balance, for example. within that, you know, within that 18-hour window.
spk13: Right. And our view is that, just to be clear, our view is treatment inside 36 hours is the more definitive point. Right. Right. There might be some, you know, slight benefit with earlier treatment. But, you know, we've got work to do on treasure, and it's not a stratification factor as a result for masters, too.
spk02: Yeah. You know, as we think about, you know, the infusion window, What is particularly important for our study is that we confirm that the patients have a stable deficit. So this is on top of standard of care. Patients are reperfused if they're eligible for that, including mechanical reperfusion, which can happen at later time points. And for mechanical reperfusion, there's anesthesia involved, and so too, have the patient come out of anesthesia and recover to a point where they can be accurately assessed to determine their neurological deficit takes a few hours. So it's important that we confirm that the patient has a stable deficit and is eligible to be enrolled in the study.
spk10: Understood. That's helpful. Thanks for taking the question. Thank you, Greg. Thank you.
spk06: The next question is from David Huang with SMBC NICO Securities. Your line is open.
spk11: Hey, thanks for taking my questions. So first, I wanted just to ask on this analysis, I guess this post hoc analysis that was conducted for a younger population in Treasure. So I understand that looking at the younger population yields better results, especially on MRS, which is your primary endpoint in Masters 2. But if I look at these p-values, they do still appear relatively borderline, so I'm just wondering what gives you confidence that you'll be able to solidly be within the realm of StatSig in Masters 2?
spk02: Yeah, so that's a good question. First, in terms of the p-values for MRS-SHIFT, we're actually approaching statistical significance, strong trend, and really close to hitting significance with only 117 patients. And it's the 117 patients that are most representative of Master's II patients. And so, you know, with a larger study and that same effect size, so we're not asking for there to be a different effect size, for example, you know, we would expect to have significance at both time points in our population.
spk13: Yeah, and I think it's worth adding to, David, that the population we expect to have in Masters 2 is going to be younger, right? And we see from the earlier Masters 1 data that that population that's not represented in the sample that we did the analysis on that you're referring to is likely to have even more differential benefit between multistem and placebo. So that gives us even more confidence and more cushion when we think about the larger sample size and the design of the MASTERS II study.
spk02: Yeah, so put differently, on the lower end of the age range, you know, in MASTERS I, for example, we saw patients who were in their 40s and 50s. There were very few patients in TREASURE that were at that younger end of the spectrum. And the younger end of the spectrum clearly have much better chance of achieving an excellent outcome. It's very difficult for, you know, someone who's 91 years old and has a traumatic injury such as stroke, you know, to recover, you know, given their conditions prior to the event.
spk10: So to get back to essentially normal, what would be considered normal, it's just a very high hurdle. Got it. That's helpful. I have a follow-up there.
spk11: And that's in terms of the data at 90 days versus one year. So one year clearly looks better. Would you consider approaching FDA for a protocol amendment so that you can use one year as the primary endpoint? Because as far as I recall, 90 days is still the primary for Masters 2. Sure.
spk13: David, I'll turn it over to the team here in a second. I think that's a good question. I think, as you know, and we've talked about before, we designed MASTERS II for a 90-day efficacy endpoint. Our primary is built around 90 days. Speaking very simply, based on the results from TREASURE, we have confidence that we will hit significance based on these results at 90 days, given the larger sample sizes. That said, your point is correct. There is some improvement over the one-year period, and if we had a later date for that primary endpoint, we would have even more confidence. But let me turn it over to Dr. Jenkins. He might be able to add some color to this.
spk04: Yeah, sure. It's Eric Jenkins. Certainly, we do see that you're spreading gaps between the placebo and multistem patients between day 90 and all the way up to one year, which, you know, was seen consistently across some of the preclinical animal data, then in Masters I, and now recapitulated again in Treasure. So I think we have increasing confidence that this is a real effect, and it ties back to the mechanism of action of multistem. But we have pre-specified the 90-day time point as the primary outcome analysis in MASTERS II. And we have agreements with the regulators for the design of that study, specifically a special protocol assessment with the FDA in the US, and scientific advice positive opinion with the European Medicines Agency in the EU. And so any potential or change to the protocol would have to be done in careful consultation with both of those regulatory agencies in parallel. So it's not a trivial process to make such an amendment, obviously, in a late-phase pivotal trial. And I think with the confidence that we have with this data suggesting that the 90-day data is very likely to result in a statistically significant outcome. While we wouldn't rule that out in our discussions with the regulators, it's not a reflective plan at this point in time.
spk10: Okay, great. Thanks for that.
spk11: And then one last one, if I may, just more on housekeeping and probably for Ivor. In terms of You know, cash, I know you said, I think, $1.8 million at the end of Q1, and certainly you have Aspire, and certainly you're looking at non-dilutive funding options. Do you have any, are you providing, I guess, any guidance on where cash runway, current cash runway takes you or, you know, how far out that goes?
spk08: We've not given guidance on that, David. Suffice to say that our cash burn will be reduced. So one can't look at the previous courses and predict the future. But we are looking at reducing our cash burn, continuing to fund our priorities, but also de-emphasizing other areas.
spk11: Okay, great. Thanks for taking the question. Thank you, David.
spk06: The next question is from Chang Lu with Needham and Company. Your line is open.
spk05: This is Chang for Bill. Thank you for taking our questions. I just want to make sure we're understanding it correctly. So Helios is still planning to file in Japan. And the second question is, could you remind us the powering of the studies in Treasure and Master 2?
spk10: Mm-hmm, sure.
spk05: You want to talk about the PMDA?
spk02: Yeah, I'll speak to the, you know, the, you know, Helios' plans on next steps. And, you know, they continue to look at the data. They are gearing up to meet with the PMDA. We will support those interactions. And, again, with their Sakagaki designation, they believe that they have a good case for moving forward towards commercialization and conditional approval. Clearly, the data is supporting good safety. And as I mentioned, there's multiple efficacy signals that could support that approval. So it's premature to understand exactly the likelihood a strong case, then we'll be meeting with TMDA to discuss that step.
spk13: And with respect to your second question on the power, I think it's safe to say that the Treasure Study had high power for detecting efficacy for the primary endpoint, excellent outcome. And I think as Dr. Harrington said in his remarks, one of the key observations here relates to the elderly nature of the population here. And, you know, what that essentially translates into, as John said, is slower and less robust recovery. And in retrospect, had we had a perspective on what this population would look like, as we talked to our KOLs, in fact, they would have suggested a measure of independence, like MRS less than equal to two, is a much more appropriate endpoint for this population. So it was well powered for excellent outcome, but it looks like retrospectively excellent outcome wasn't the best choice for the population we ended up with.
spk10: This question is from Jason Colbert with Dawson James.
spk06: Your line is open.
spk12: Yeah, I'd like to follow up on the question, which is, what was the assumed effect size for the Japan study? And what's the assumed effect size in a master study that led to the powering calculations?
spk13: Yeah, that's a good question. It's a detailed question. Not sure we'll be able to answer that on the phone right here in great detail. But I can say with respect to the treasure design, We took the learnings from the masters one study as the basis for designing the treasure study. And again, with excellent outcome in mind that what that means is we looked at some of the results and as it relates to excellent outcome from the masters one study for the patients that were treated early. So that was kind of the underlying assumption. In general, with respect to masters two, remember our primary endpoint there is MRS shift. And by the way, It's worth noting that the MRS shift is a really good choice for us because we're going to be able to see the benefit across the spectrum, and it allows us to see the benefit for patients that are younger, less severe at the one end of the spectrum, and for patients who are perhaps a little bit older and more severe at the other end of the spectrum. It's a really good choice, and I think TREASURE validates that choice for us in Masters II. The assumptions for sample size empowering where that study, again, reflects our experience with the Master's I study. And we think that experience is still relevant. And as John said earlier, given the results we see in Treasure, in the population that's most represented for Master's II, It gives us much more comfort about those assumptions. We feel good about that design right now. Of course, we're going to think about this more thoroughly as we analyze the data a little bit more deeply. But we feel pretty good about those assumptions in MASTERS II right now based on the results here.
spk12: And regarding the Sakagake designation, My understanding is that's a relatively new designation that exists in Japan. Are you aware of any other that have gotten approved when you had a miss on a primary endpoint, but the totality of the data and the risk profile combined led to an approval? I don't know. Maybe there is an example. Maybe there isn't. That's why I'm asking.
spk13: That's a good question. I don't know if we know the answer to that. We do know that some of the earlier approvals utilizing Sakagaki designation were actually very small studies. Not all of them were actually controlled. They had some positive signals. I think there was one in cardiovascular as an example. Spinal cord. Spinal cord was another one. which would suggest to us that, you know, the PMDA is going to take a look at the totality of the data, balancing that against the potential need and unmet needs in the treatment population and make a decision on that. But we can't say anything definitively here at the moment, Jason.
spk12: Okay. And my last question, again, has to, you know, deals with finance because clearly the cash balance is getting tight and I expect the stock may face pressure today. So I understand BD is active, but I'm also trying to understand kind of how you're thinking in terms of getting through the balance of the year.
spk09: Yeah. That's a good question. Ivor, you want to start and then we can add to it?
spk08: Yeah, by all means. So Jason, yes. I mean, as I said, our preference is non-dilutive. And of course, it's difficult to predict how quickly our business development discussions will progress. But now that we have Late stage clinical data in hand, we expect it to go quicker than leading up to that. With regard to our equity line, we can actually access that. We have a new one in place. So that certainly takes care of the short and the medium term. We also have milestones coming up, which we haven't disclosed the specific details, but there is one coming up in the short term. But there's no doubt that as we look forward to, say, a year from now, we are hoping for non-dilutive financing by virtue of a partner. But we do have access to capital to continue in the meantime. And as I said earlier, we will be reducing our burn fairly significantly.
spk07: Okay. Thank you. Thank you very much.
spk06: Our next question is from Steve Brozak with WBB Securities. Your line is open.
spk07: Hey, good morning, and thank you for taking all these questions. Most of the questions that I had were asked and answered, but there is another one, and obviously the N is small, but what we've learned with COVID is that not all patients are created equal, and not all 79-year-olds are created equal. And I know it's very early, and it's top-line data, given how some of these patients presented prior to stroke, could you differentiate any better outcomes? So the point is specifically this, that some higher performing 79-year-olds may have had a much, much better outcome and because of different comorbidities, which are obviously going to be aggravated here in the United States, you may see different outcomes and different outcome potentials. So Anything you can give us on that, I'd very much appreciate. And I have a follow-up on that, please.
spk13: Yeah. That's a great question again. I would say this. Our analysis is preliminary. Of course, there's data on the comorbidities, and something we'll take a look at. I think at the high level, first review, there wasn't anything that jumped out. But it certainly requires kind of deeper analysis and understanding. you know, across the age spectrum, severity spectrum, et cetera, to see if there's any kind of differential impact for certain patient populations. Certainly, we're going to take a look at that over time.
spk02: I would just add that, you know, a criteria for being included in a study is that the patient either themselves or through family members confirm that they were a zero or one and that they had, you know, no or minimal disability prior to the stroke. So we know they come in and they, you know, from a disability standpoint, you know, they're normal. You know, what we don't know, for example, you know, are some of the other functional, you know, measures, like in-eye stroke scale, which is not given, you know, it's acute. It's given in an acute setting. So we don't know what their so-called neurological function is. Were they a zero or one, for example? If they're a 90-year-old, they might not have been a one or a zero. So their prospect of getting back to a one or zero is nil, right? Same thing with Barthel. Some of them could have been below a 95 before the study. They're not going to, after the stroke, all of a sudden become 100. when they weren't that prior to the injury. So your point's a good one. Again, we had minimal experience with this more elderly population, and these types of issues are more significant in an elderly population than they would be in a younger population.
spk07: Okay, and the last one is a different question or pointing to the same areas, though. Did you see any... any kind of uh drug drug uh and in terms of uh areas where there was anything you were looking at because obviously when you start to hit the 79 year old you're talking about uh other things between blood thinners or any other medications and i know you were probably scrupulous in terms of making sure that these people were not you know that didn't have devastating issues but Were there any other items that were teased out that you were looking at or that you found anything, even on an anecdotal basis? And I'll hop back in the queue. Thank you.
spk04: Yeah, this is Eric Jenkins, medical director at AtherCis. And I think, again, with the caveat that this data analysis is preliminary and we do intend to dive more deeply into looking at some of these compromised illnesses and medication regimens and whether there's any effect at all on treatment. You're right, in an older population, they tend to have more concomitant medications coming into the study. There are some differences in the medications that are used in the hyperacute treatment of stroke in Japan than in the U.S. and EU population. So that is something else we will be looking at as well. We do test mechanism of action of multistem with a wide array of drugs that are known to be used in the complement treatment of acute ischemic stroke just to ensure that there's no effect on the biological activity or viability of the cells. And we've identified no common complement medication that would interfere with the mechanism of action of the cells on that basis. But absolutely, we'll be looking at that data in much more detail over the coming weeks.
spk03: And just as an add-on, we did test the three drugs that are approved in Japan for stroke patients that aren't approved here in the United States in co-culture with our cells and saw no effect on our cells with those drugs at all either. So we've done all the batteries that you can do to ensure that multi-stem stays as multi-stem.
spk07: Great. Again, thanks very much for taking the questions.
spk06: Thanks, Steve. We have no further questions at this time. I'll turn it over to Dan Camardo for any closing remarks. Okay, great. Thank you.
spk09: Thank you for the questions because we're digging into the data and trying to share our insights as quickly as we can. We're going to be receiving more data, as we mentioned, including biomarker impact, things like that. So as we receive that data and have a chance to analyze it, we'll be sharing it with everybody. If you do have other questions that we're not answering, answered on this call and come up in the future, please contact our investor relations team through our website. We'll be sure to make time to answer those questions. We thank everyone for your support. We will continue to work with Helios on the path forward for working with PMDA, and we will continue to press forward on our trial with Masters, too, with some enthusiasm. So thank you very much, and I hope everyone has a good afternoon.
spk06: Ladies and gentlemen, this concludes today's conference call and webcast. Thank you for participating. You may now disconnect.
Disclaimer