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spk01: Good day and thank you for standing by. Welcome to the AuthorFace 3rd Quarter 2021 Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Karen Honody, Director of Corporate Communications and Investor Relations. Thank you. Please go ahead.
spk02: Thank you, Abigail, and good afternoon, everyone. As Abigail mentioned, I'm Karen Honody. I'm the Director of Corporate Communications and Investor Relations for Adversis. 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, and Ivor MacLeod, our Chief Financial Officer. A webcast of the audio will be available three 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. 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 Form 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 November 15th 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 BJ Lehman. BJ?
spk05: Thanks, Karen. On behalf of the ATHERSIS team, in our call today, I will provide an overview and summarize recent corporate operations and business activities and developments. In addition, I will reflect on our 2021 performance and the emerging focus for 2022. Ivor will then provide an update on our company's financial position. We will then address several questions submitted by our shareholders and open it up to general Q&A. For a more comprehensive overview of our company and platform, I would like to refer you to our website and our updated corporate presentation. First, we provide an update on our ARDS program. As for the program, we provided a thorough update in our last quarterly call, which followed shortly after the release of data from Helios' OneBridge study. To summarize, the results from the OneBridge study appear to be consistent with results from our MustArt study, with Helios reporting higher ventilator-free days, or VFD, over a 28-day period and lower mortality in the multi-stem treated group compared to standard therapy. Last week, Helios reported in its third quarter financial results update presentation that that it plans to file in either Q4 of 2021 or Q1 of 2022 a JNDA for the ARDS program, which is designated as an orphan regenerative medicine product. Further, preliminary analysis of the data pooled from both the Mustards and OneBridge studies suggests a strong signal of potential impact. This pool data set includes 40 non-COVID ARDS patients treated with multi-stem cell therapy and 20 ARDS patients treated with placebo or receiving standard of care. According to this analysis, average VFD was higher in the multi-stem treated group compared to non-treatment group, 13.9 days compared to 10.1 days, with a p-value of 0.07 when adjusting for baseline differences in condition severity and age, and using a two-tailed statistical test. Median VFD was also substantially higher. Based on this data, there was also a trend to lower mortality in the multi-stem treatment group. These data are provided in our updated corporate presentation deck, which is available on our website. We are also pleased to announce that the manuscript describing the must ARDS study results has been accepted for publication shortly. Further details will be forthcoming. We look forward to continued progress in our Mecovia study, treating patients with ARDS induced by COVID and other pathogens. Our intention is to continue and complete enrollment of the studies cohort two and reflect on the evolving standard of care as a result of the COVID pandemic before proceeding with cohort three, the phase three efficacy cohort. It is possible that we would make changes to the design of the phase three efficacy cohort to improve our chances to help patients and have a successful clinical trial. Separately, in our Q&A section, I will address some recent questions about BARDA and the recent amendment to the broad agency announcement reinstating a revised version of Area of Interest 9.3. To conclude, we remain very enthusiastic about the potential for our multi-STEM or, indeed, MRS cell therapy to help these ARDS patients. and we will continue to actively support efforts in Japan to advance the program to JNDA submission and, if approved, into commercialization. Next, we turn to our stroke program. As we noted in a press release on Friday, Helios has provided further clarity about the timing of disclosure of top-line data from its treasure study, evaluating multi-stem administration to Japanese stroke patients. Simply put, the treasure study has not been delayed. Enrollment completion was announced several months ago. However, based on advice received from the PMDA in conjunction with recent regulatory interactions, Helios now plans to disclose top-line results from the Japanese study after data from the one-year follow-up visit of the last patient has been collected. Helios expects this last follow-up visit late in March 2022 and top-line data disclosure to be made as soon as possible thereafter. To be clear, the available data set has not been unblinded and would not be unblinded for analysis until after the last patient last visit. We would expect the pre-specified analyses to be completed expeditiously once the dataset is unblinded. This approach, advised by the PMDA, is intended to preserve the integrity of the data collected from the last patients in the study during the one-year follow-up visit. A conservative approach, given the number of subjects whose one-year data could be affected by disclosure is very small, and other less restrictive measures to protect and study data integrity are available. as we used in our own Master's I study, for example. This outcome is additionally frustrating given that the analysis and disclosure of 90-day data was included in the submitted TREASURE study protocol approved for the study. We are optimistic that the TREASURE study will show therapeutic impact from administration to patients shortly following an ischemic stroke. Our conviction is founded on a number of important factors, including A, the study design, including the targeted subjects, screening guidelines, and evaluation metrics that replicates the core design elements of our Master's I study. B, early administration of multistem therapy during 18 to 36 hours post-stroke. And within this window, an expected shift to earlier administration compared to Master's I, which appears to be associated with better outcomes based on statistical analyses. And C, evidence from the Master's I study that multistem is greater relative benefit in older patients. That said, there are some risks, such as limited prior data from Japanese or Asian ischemic stroke patients and very old patients. and some differences in the standard of care compared to our Master's I study. Additionally, this approach would make available 90-day and one-year results, likely both during the second quarter of 2022. Note that in the Master's I study, patients who received multi-stem treatment within 36 hours of stroke continued to improve after 90 days, as shown in several outcome measures, including excellent outcome in the MRS shift analysis, the primary outcome measures for the TREASURE and MASTERS II studies respectively. For example, the proportion of multi-stem treated patients achieving excellent outcome increased from 16% at three months to 29% at one year. 16 out of 100 serious stroke patients were essentially back to normal by 90 days. and another 13 were back to normal by one year, compared to non-treatment, where just seven of 100 patients were back to normal at 90 days, and only one more had achieved this degree of improvement by one year. We also observed continuing improvement for multi-stem treatment across the severity spectrum, as is evident in improvements in MRS distribution through one year, which is shown in our corporate presentation. We eagerly await the treasure data, and we are planning for a positive outcome that would enable Helios to move forward with the JNDA by making preparations in the regulatory and manufacturing areas in particular. We are making progress in our Master's II study. As we have noted in previous communications and calls, we have had challenges over the past 18 months tied to COVID-19 and supply constraints. However, over the past quarters, we have focused heavily on site-level operations to enable us to meet our development objectives. We have recently initiated sites outside of the United States as we continue to add more sites to the study. Increasing the number of sites, including outside of the U.S., will be an important element to accelerating our monthly enrollment figures. We have also been investing meaningfully in site-level support to supplement local clinical research operations and increase the pool of patients eligible for the study. This includes increased clinical research personnel deployment and site investigator and personnel engagement and problem solving through meetings and other communications. Based on our current plans and assumptions regarding the site network and site level activity, we hope to complete planned enrollment before the end of 2022. However, regional COVID surges or other unanticipated factors may impact site initiation, operations, and enrollment activity, or even the product supply chain, with impact on enrollment timelines. To summarize, we believe that both the TREASURE and MASTERS II studies are well-designed and well-powered to show positive impact for multi-stem treatment of moderate to moderate severe stroke patients. We remain confident in our cell therapy's potential to change treatment and outcomes for a significant proportion of ischemic stroke patients. A major area of focus for the company, as we have discussed in the past, is planning and preparing for manufacturing and supply of product for commercialization if the product is approved for marketing. This is a multi-year effort with emphasis on making product at scale and reasonable cost, supply chain security and redundancy, and distribution of the product into hospitals. We continue to make progress with establishing our larger-scale bioreactor-based production process, working internally with outside experts and commercial manufacturers to build capacity in a stepwise fashion to align with our regulatory and commercial needs. We have made substantial progress in solidifying our supply relationships with long-term continuity and redundancy in mind. and we continue to advance our thinking and technologies for localized product distribution. Indeed, recently we have completed our alpha prototype for the Secured Integrated Freezer Unit, or SIFU, demonstrating how the SIFU would work in practice. As we have discussed previously, generally speaking, 2021 has been focused on advancing the development of our platform and programs with a focus on manufacturing supply chain, clinical development, and initial planning and preparations for commercialization. We resolved open issues with our Japan partner, Helios, to set the stage for the completion of development and commercialization in Japan, and we have made substantial progress in the area of manufacturing supply chain and distribution, as noted above. We have fallen short of our clinical development objectives, in particular our progress in our Master's II study. However, as discussed above, we have taken several actions to execute a strategy that will improve our trajectory and progress. As we look forward to 2022, several important themes will be reflected in our objectives and actions. As we await data from the Important Treasures Study, We will be devoting our attention and substantial efforts to enabling and supporting our clinical development, particularly the completion of enrollment of our Master's II study as soon as possible. We plan to continue preparing for manufacturing and supply of product in a commercial setting, which is noted as a multi-year effort. Also, we plan to further ramp up our other efforts to support commercialization, providing support to our partner in Japan, further developing internal commercial capability and personnel, and building out our market access and reimbursement strategy. In addition, we will continue efforts focused on securing the best possible partner to develop and commercialize the European markets with us for one or more of the multi-STEM critical care indications. Though we believe our platform has broad applicability and potential beyond our current activities, we plan to remain focused on the critical value drivers in the near term. With that, I will turn it over to Ivor for an update on the financial results.
spk03: Thank you, Vijay. Good afternoon, everybody, and once again, thank you for joining today's call. I am Ivor McLeod, Chief Financial Officer of ATHASIS, and it's my pleasure to give you an overview of the financial results for the third quarter of 2021. For the three months ended September 30th, 2021, we recognized $4.8 million in revenues, compared to $86,000 for the three months ended September 30th, 2020, related to our collaboration with Helios. Our collaboration revenues currently fluctuate from period to period based on the delivery of goods and services under our arrangement with Helios. Research and development expenses decreased by $1.3 million to $17.2 million for the third quarter of 2021, compared to $18.5 million for the comparable period in 2020. The $1.3 million decrease is primarily associated with decreases in clinical trial and manufacturing process development costs of $2 million and internal research supplies of 600,000. These decreases were partially offset by increases in personnel costs of 500,000, facilities costs of 400,000, and outside service costs of 400,000. Our clinical development, clinical manufacturing, and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials, and manufacturing process development projects. Our general and administrative expenses remained consistent at $3.6 million for the three months ended September 30th, 2021. and a comparable period in 2020. The net loss for the third quarter of 2021 was $16.2 million, a decrease of $6.3 million compared to the net loss of $22.5 million in the third quarter of 2020. The difference is primarily a consequence of the previously mentioned variances. During the nine months ended September 30, 2021, net cash used in operating activities was $56.9 million compared to $44.5 million in the nine months ended September 30, 2020. At September 30, 2021, we had $49.7 million in cash and cash equivalents. compared to $51.5 million at December 31st, 2020. During the third quarter of 2021, we raised $13.2 million through our equity purchase agreement with Aspire. We have not utilized the Aspire equity purchase agreement in the fourth quarter of 2021. Our burn rate this year has averaged between $17 and $20 million per quarter, which includes some significant one-time expenses. These one-time expenses were related to executive severance as well as professional fees associated with the past litigation with Helios and the subsequent consummation of our comprehensive framework agreement. In aggregate, these one-time expenses are in the $3.5 to $4 million range. Moving forward, we continue to have the ability to dial up or dial down our burn rate based on our priorities and capital availability. With a cash balance of $50 million and access to our equity line of up to $100 million, we feel we have adequate cash to fund our near-term priorities through and beyond the publication of Helios' top-line stroke data. On a non-financial note, and front of mind with both current and prospective investors, we recently received our ESG corporate rating from ISS, the proxy advisory firm. ESG stands for Environmental, Social, and Governance, and the score is a measure of the company's collective consciousness for social and environmental factors. It is an important benchmark for ATHASIS. We received a grade in the top 20% of our peer group of companies, and consequentially were awarded prime status. This will resonate well with all investors, particularly institutional, with whom we will be engaging in the coming months. With that, I will turn the call back over to BJ for Q&A. BJ?
spk05: Thanks, Ivor. As we have done in the past, we'd like to start by addressing some questions submitted by our shareholders over the past days and weeks. Before I begin, I want to thank all of you for these questions and your input over this period. We recently received many questions about BARDA and our ARDS program, so we wanted to address that here. As some of you know, BARDA has recently upgraded its guidance with respect to programs eligible for funding. Specifically, as it relates to activities in our area, BARDA has amended its broad agency announcement reinstating an updated Area of Interest 9.3 directed to immunomodulators or therapeutics targeting lung repair. Given our past interactions with BARDA, it is useful to provide some context regarding Section 9.3 in our past proposals. In early 2020, at the request of BARDA, we submitted our first proposal under broad agency announcement Amendment 15, Area of Interest 9.3, which called for the development of therapies targeting lung injury caused by COVID. BARDA noted that it would prioritize candidates against COVID. Our Macovia study was designed originally with this in mind. In response to questions and to the request of BARDA, we submitted an updated proposal in May of last year. In the meantime, however, BARDA amended the BAA, modifying 9.3 to prioritize submissions demonstrating the availability of 10,000 treatment courses, or doses in our case, within six months. And about six weeks later, BARDA suspended area of interest 9.3 altogether. Given that we applied under Amendment 15 with the advice of counsel and other outside experts, We continue to pursue possible BARDA funding to support our Macobia study and manufacturing preparations, ultimately to no avail. BAA Amendment 29, issued on October 26, 2021, reinstates and revises Area of Interest 9.3. Importantly, the revised 9.3 specifically mentions ARDS for the first time. It no longer prioritizes candidates for COVID, and the requirement for 10,000 treatment doses in six months has been dropped. It is possible that a revised MacCobia program and arts development strategy, together with our planned strategic build-out of manufacturing, may be consistent with the revised agency call. However, it is too early to determine if there would be a fit. Naturally, we will take a close look at the opportunity, evaluate our eligibility, and the potential for funding to support our arts program, which would likely be based on a cost-sharing mechanism. And if it makes sense, proceed with preliminary inquiries and submissions as appropriate. To the extent we proceed, we would expect the application process to take at least four to six months to play out, given guidance in the new issuance. Furthermore, given the recent R&D focus in the arts area, given COVID, we would expect a competitive application process. Several of you have asked about the status of our CEO search. As we have said from the beginning, our focus is on recruiting the best leader for addresses in a very competitive biotech hiring environment. And the board continues to seek out candidates whose skills, knowledge, and career experiences would add substantial value to AtherSys at this stage in the company's evolution. We will provide additional information and updates as things further progress and develop in the CEO search, and with other hires important to our preparations for commercialization. Some of our investors have asked about how we are raising awareness or planning to raise awareness in the medical community and in the investment community. First, let me say we are constantly working to raise awareness in the medical investment communities. On the investment side, for example, we continue to present at high-profile healthcare conferences, most recently the 2021 Cell and Gene Therapy Meeting on the MESA. and we plan to attend the J.P. Morgan Conference this coming January. We keep our analysts and bankers updated with regard to our progress to proactively reach out to both existing and potential new investors to update them on or introduce them to our story. We remain active on social media, and with the help of our outside advisors, we are always looking for opportunities for media coverage for the company, for technologies, and other topics as well. Specifically on the medical side, in addition to the activities already mentioned and continuing with scientific and medical publications, we have recently focused on increasing awareness of our ongoing Master's II study, pursuing media opportunities in the geographic areas of some of our clinical sites. Recently, this included television slots in Chicago and Miami, as well as an article and the Augusta Chronicle. All of these pieces are available for viewing on our website in addition to our updated corporate presentation. Looking forward, this will be an increasing area of emphasis as we approach commercialization and will include efforts specific to ultimately building interest in the treatment and influencing uptake of the therapy and supporting reimbursement coverage and pricing. So with that, we will now take some additional questions from today's participants.
spk01: And as a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash key. Please stand by while we compile the Q&A roster. Again, to ask a question, you will need to press star 1 on your telephone. Our first question comes from the line of Greg Harrison with Bank of America. Your line is now open.
spk04: Good afternoon. Thanks for taking our questions. First one is just on the status of the McCovey trial. You know, can you give us an update on maybe where enrollment stands You know, I know it's a little bit of a fluid situation, you know, the focus between COVID-based ARDS and ARDS from other pathogens, but maybe you could give an update there on enrollment, and then would there be an interim look at any point to give investors a sense of how the data is looking without having to wait for the entire trial to finish?
spk05: Thanks, Greg. Those are good questions. So update enrollment and then the potential for an interim look. So I addressed this briefly in the discussion, but I think the current plan is to work to wrap up our quote-unquote cohort two sometime as early as possible next year. I don't want to give any more specific guidance than that. As you remember, There are three cohorts to the study, cohort one, cohort two, and cohort three. Cohort one is really focused to introducing these patients to the product to ensure safety. Cohort two is to develop some perspectives on feasibility and potential for the therapy. And cohort three is really the larger efficacy cohort. That was originally targeted for COVID-induced ARDS patients. As you know, we've expanded that to include other non-COVID pathogens, which is consistent with our long-term strategy. At the end of the day, we want to treat ARDS irrespective of the underlying cause. So again, our enrollment objectives are to move through and complete enrollment of cohort two as soon as possible in 2022. At this point, our expectation is we would take an opportunity to take a look at the results through Cohort 2. We haven't made a final decision on that. It's not driven to give information to investors per se. It's really more focused on allowing us to confirm that the design for Cohort 3 is appropriate given what has happened with respect to standard care for treating these patients. I think as we've talked about in the past, and as you know, there has been, you know, a fair degree of movement, I'd say, in the standard of care, you know, introduction of new therapies, you know, some different approaches for treatment or pre-treatment of ARDS patients, so non-invasive methods of treatment, et cetera, some of which have had some success and we expect will impact treatment of ARDS patients more generally over time. So I expect at this point, we would take a look at the experiences we've had in cohort two and reflect on that to be sure that we're set up for a successful efficacy part of the study. And maybe we create a true phase three study, or it is we make amendments to this current study with cohort three. So we haven't made that determination yet. That's the current plan. We remain excited about the area. I mean, the data from Helios is very, very encouraging. We believe that the upcoming opportunity for them to apply, make an application to the PMBA would be a very important milestone, you know, demonstrating that the platform in this particular application, you know, has got real potential for approval and commercialization. So we're very encouraged about, you know, the potential for the area, but we want to make sure that when we go into the larger efficacy cohort, you know, we're set up for success.
spk04: Okay, that's helpful. One more, if I could, real quick. Sure. You mentioned cash burn earlier in the call. get a sense of what is the urgency right now to maybe enter a partnership to secure some non-dilutive capital? And how does Helios' decision to push back the stroke readout affect that? I think previously that may have been considered a catalyst that you would want to have kind of under your belt before you entered a partnership.
spk05: Yeah, another good question. I think you're quite right. We've talked about this in the context of partnership in the past, and I think it's been our view for some time that our ability to get a very high-value deal done would be greatly facilitated by positive results from the Treasurer's study and ultimately from the Master's II study if we wanted to wait that long. So, you know, in a sense, it's disappointing the way that this has been pushed off because it's pushed off our efforts to really drive for the highest value potential partnership we could in the critical care area around stroke, I guess, more specifically. That said, your question about urgency and the need to drive faster, I guess, to address a perceived need for cash in there. I think we believe, as Ivor said, that, you know, from a cash position perspective, now that we have fairly specific clarity around the timing for the Helios disclosures, we feel very comfortable about where we're positioned from a cash perspective, what we have in the bank, our access to capital, et cetera. You know, that said, we're going to continue our discussions on the business development side. And if there is an opportunity for us to do something earlier We're going to take a look at it. And, of course, we'll be balancing a whole set of things. As we said in the past, the key priority in finding a partner for Europe is to find a partner who is going to create the best chances for commercial success. And that's driven by commitment. It's driven by capabilities. It's driven by plan. And we're going to be looking at that. Obviously, we want to get fair value. But if we can find such a partner in the near term, you know, we're going to explore opportunities to get something done earlier than we had originally planned. But I still remain of the opinion that we would get the best possible kind of financial terms with positive data in hand. So we're going to keep all of our options open. We're going to continue to press ahead and continue with our discussions. And if there's an opportunity before the data, we're going to consider it. But I wouldn't say there is urgency or a critical need to get something done before that data to answer your question.
spk04: Got it. Thanks again for taking the question. No problem. Thank you.
spk01: Our next question comes from the line of David Wang with SMBC NICO Securities. Your line is now open.
spk06: Hi. Thanks for taking the question. So I just had a few questions. Maybe the first one, continuing on the line of questioning around, you know, your efforts at a partnership. You talked a lot previously, I think, about, you know, Europe really being the focus for any future partnerships. And so I'm just curious as to, you know, why has the focus been on Europe as a geography? Have you considered, you know, maybe worldwide-type partnership where you would also be, you know... giving up essentially rights in the U.S. for, you know, for development and commercialization, but maybe that could, you know, that could help drive a partnership forward. Yeah.
spk05: Yeah, that's a good question as well. I think, you know, our strategy has been clear for some time, and that is to prepare for commercialization of our critical care portfolio in the United States. and to partner with strong partners ex-US with a focus on Japan and a focus on Europe as the leading geographies. Certainly there are opportunities beyond that. We've talked with folks about potential opportunities well beyond those, you know, kind of those limited geographic contexts. You know, quite clearly many of the companies we've talked to and continue to talk to have global aspirations. And the discussion around the potential for them to be involved in a broader partnership with a broader global dimension is part of these dialogues, for sure. But we would like to preserve the U.S. markets. We think we can be effective there with the right capabilities added to the company over the next couple of years. And we think that preserves and allows us to build the greatest value for our shareholders. If there is an opportunity that comes along, perhaps as part of the discussions around Europe, that would include the U.S., we will hear that out. And, of course, if it makes sense, we'll consider it seriously.
spk06: Okay. Thanks for the perspective there. I had just another question on, you know, in terms of the feedback that Elios received from the Japan regulator asking for a look at the 365-day data, keeping 90-day blinded until that was the case. Does that influence your thinking at all in terms of interactions with FDA? You know, would it make sense to have a conversation with FDA as to whether they may enter a similar course of action in reviewing Masters II read out down the line?
spk05: You know, we have a strategy there. We do believe that we'll be able to announce or disclose our 90-day interim data. We do have to have a discussion with the FDA about that over time. You know, I would say that the ultimate outcome in Japan was not expected for Helios. It wasn't expected for us. I think, as I noted, the approach that was taken is very reasonable. The plan approach was very reasonable. It was laid out in the original protocol, submitted with the PMDA, and it's defensible in terms of protecting the integrity of data. We think the same arguments apply in the United States. I think the PMDA is in my view, is being conservative here. And in the end, I don't think it's a bad idea for them to be conservative. I don't think what we're doing here is going to have a profound impact on the outcome of the data. But I look forward to the data. The fact that it's delayed a quarter disappoints us in the sense that we'd like to get that positive data out and move forward with a lot of the things we have ahead of us. It's also going to give us the opportunity to look at the 90-day top-line data and simultaneously or very shortly thereafter look at the 365-day data. And, you know, as I pointed out, that data in our MASTERS I study was even more compelling than the 90-day data we saw improvement over that period of time. So it does create the opportunity for that short timeframe between those two data points. So I think that's a positive opportunity here. But yes, our strategy with the FDA is not to wait to the collection of the last data from the 365th day or one-year follow-up visit before we announce data. We are right now planning for collection and disclosure of 90-day data. That's also part of our protocol but is subject to confirmation discussions with the fda as we move forward okay thanks so much for taking the question yep sure our next question is from missions gandhi with needleman company your line is now open
spk07: Hi, good afternoon. Thank you for taking my questions. My question is regarding metric study. I just wanted to ask, do you have any further updates on the metric space to clinical study enrollment? Or is the trial enrollment being affected by COVID as well, or any of which will be? Thank you.
spk05: Yeah, thanks for asking. We didn't cover it here, but trauma is also an area of real interest for the company. We've been working very closely with the chief clinical site in Texas. We've made good progress early in that study. I think our expectation is to make good progress into 2022 with that study. We are negotiating some things with the FDA about the basic approach for enrollment, which is fairly typical in trauma studies. One of the challenges in enrolling these patients is they're typically unconscious. And so if you want to treat early, you have to figure out ways to get them into the study as quickly as possible. And typically, that would involve consent from a legal representative of some sort. But we're working as well with the FDA to figure out ways to make the season more streamlined as we move forward. That would be pretty important, I think, to very accelerated enrollment. There's still opportunity to get this done in a reasonable timeframe, even if we can't, you know, reach an accommodation with the FDA on that. But, you know, that is something that is part of the ongoing dialogue or interaction we have with the FDA. positive in terms of enrollment. There's nothing untoward to report, which is what you want to hear in the earlier stages of the study. And we're very encouraged and optimistic about that study and its progress in 2022. Great. Thank you.
spk06: Okay. Thank you.
spk01: And there are no further questions, so I'll now turn the call back over to BJ Lehman for closing comments.
spk05: Well, thank you for your participation today. We remain focused on the task ahead of us here, but we will continue to cultivate broader opportunities that create value over the longer term. And, again, I want to thank all of you for your participation today and your interest in the weeks and the past months. on the questions and the input. Though we don't answer all your questions, we try to respond to the input and interactions. And even where we don't, we do value the input you provide to us, and we try to build that in to our thinking and incorporate it into our plans in business as we move forward. So thanks again, and have a good night.
spk01: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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