Athersys, Inc.
Q3 2021 Earnings Call Transcript

Published: 15 Nov 2021

[Operator:]

Good day and thank you for standing by. Welcome to the Athersys Third 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. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today. Karen Hunady, Director of Corporate Communications and Investor Relations. Thank you. Please go ahead.

[Karen Hunady:]

Thank you, Abigail, and good afternoon, everyone. As Abigail mentioned I'm Karen Hunady. I'm Director of Corporate Communications and Investor Relations for Athersys. Thank you for joining today's call. If you do not have a copy of the press release issued at the close-up market, it is available on the Athersys website at athersys.com. I'm here with B.J. Lehmann, our President, Chief Operating Officer, and Interim CEO, and Ivor Macleod, our Chief Financial Officer. A webcast of the audio will be available 3 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 B.J. Lehmann. B.J.

[B.J. Lehmann:]

Thanks, Karen. On behalf of the Athersys 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. I will then provide an update on our Company's financial positions. 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 Healios is ONE-BRIDGE Study. To summarize, the results from the ONE-BRIDGE Study appear to be consistent with results from our MUST-ARDS Study. With Healios reporting higher ventilator-free days or VFD over a 28-day period, and lower mortality in the MultiStem treated group compared with standard therapy. Lastly, Healios reported in its third quarter financial results update presentation that it plans to file an either Q&A of 2021 or Q1 of 2022 a JNDA for the ARDS programs, which is designated as an orphan regenerative medicine product. Further, preliminary analysis of the data pool from both the MUST-ARDS, and ONE-BRIDGE studies suggest a strong signal of potential impact. This pool data set includes 49 COVID ARDS patients treated with MultiStem cell therapy in 20 ARDS patients treated with placebo are receiving standard of care. According to this analysis, average VFD was higher in the MultiStem 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 and conditions, severity, and age, and using a two-tail statistical test. Medium VFD was also substantially higher. Based on those data, there was also a trend to lower mortality in the MultiStem treatment group. These data are provided in our corporate -- 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 on our MACOVIA Study, treating patients with ARDS induced by COVID and other pathogens. Our intention is to continue and complete enrollment of the studies cohort 2 and reflect on the evolving standard of care, as result of the COVID pandemic before proceeding with cohort 3, the Phase 3 efficacy cohort. It is possible that we would make changes to the design of the Phase 3 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 a MultiStem or in the master (ph) cell therapy to help these ARDS patients. And we will continue to actively support efforts in Japanese to advance the program to JNDA submission, and if approved in to commercialization. Next, we turn to our stroke program. As we noted in our press release on Friday, Healios has provided further clarity about the timing of disclosure of top-line data from its TREASURE study, evaluating MultiStem 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, Healios now plans to disclose top line results from the Japanese study after data from the 1-year follow-up visit that the last patient has been collected. Healios inspects 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, 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 analysis to be completed expeditiously once the data set is unblinded. This is 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 protecting study data integrity are available. as we used in our own MASTERS-1 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 MASTERS-1 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 MASTERS-1 which appears to be associated with better outcomes based on statistical analysis. And C, evidence from the MASTERS-1 study get MultiStem 's 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 MASTERS-1 study. Additionally, this approach would make available 90-day and 1-year results, likely both during the second quarter of 2022. Note that in the MASTERS-1 study, patients who received MultiStem treatment within 36 hours of stroke continue to improve after 90 days, as shown in several outcome measures, including excellent outcome in the MRI shift analysis, the primary outcome measures for the TREASURE and MASTERS-2 studies respectively. For example, the proportion of MultiStem treated patients achieving excellent outcome increased from 16% at 3 months, 29% at 1 year. Translation, 16 out of a 100 serious stroke patients were essentially back-to-normal by 90 days. And another 13 were back to normal by 1 year, compared to non-treatment where just 7 of 100 patients were back to normal at 90 days and only 1 more had achieved this degree of improvement by 1 year. We also observed continuing improvement for MultiStem treatment across the severity spectrum, as is evidenced, improvements in mRS Distribution for 1 year, which is shown in our corporate presentation. We eagerly await the TREASURE data and we're planning for positive outcome that would enable Healios to move forward with the JNDA by making preparations in the regulatory and manufacturing areas in particular. We're making progress on MASTERS-2 study. As we have noted in previous communications and calls, we've had challenges over the past 18 months, by the 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 have 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've also been investing meaningfully in site level support and supplement local clinical research operations, 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-2 studies are well-designed and well-powered to show positive impact from MultiStem 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've discussed in the past, is planning and preparing for manufacturing and supply product for commercialization if the products improved marking. This is a multi-year effort with emphasis on making products at scale and reasonable costs, supply chain security and redundancy, and distribution of the product in the hospitals. We continue to make progress with establishing our larger scale bioreactor base production process, working internally and with outside experts in 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 Secure 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 Healios 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 MASTERS-2 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 in 2022, several important themes would be reflected in our objectives and actions. As we await data from the important treasurer study, we will be devoting our intention and substantial efforts to enabling and supporting our clinical development, particularly the completion of enrollment of our MASTERS-2 studies as soon as possible. We plan to continue preparing for manufacturing and supply products in a commercial setting, which is noted is a multiyear 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 1 or more of the MultiStem 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.

[Ivor Macleod:]

Thank you, B.J. Good afternoon, everybody. And once again, thank you for joining today's call. I'm Ivor Macleod, Chief Financial Officer of Athersys. And it's my pleasure to give you an overview of the financial results for the third quarter of 2021. For the 3 months ended September 30 2021, we recognized $4.8 million in revenues compared to $86,000 for the 3 months ended September 30th, 2020, related to our collaboration with Healios. Our collaboration revenues currently fluctuate from period-to-period based on the delivery of goods and services under our arrangement with Healios. Research and development expenses 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. These decreases were partially offset by increased -- personnel costs of -- an outside service costs of $400,000. Our clinical development clinical manufacturing, and manufacturing campaigns for clinical trials, and manufacturing process development projects. Our general and administrative expenses remained consistent at $3.6 million for the 3 months ended September 30, 2021, and the 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 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 9 months ended September 30th, 2021, net cash used in operating activities was $56.9 million compared to $44.5 million in the 9 months ended September 30, 2020. As 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 million and $20 million per quarter, which includes some significant 1-time expenses. These 1-time expenses were related to executive severance, as well as professional fees associated with the past litigation with Healios and the subsequent consummation of our comprehensive framework agreement. In aggregate, these 1-time expenses are in the $3.5 million 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 the 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 Healios ' top-line stroke data. On a non-financial note, and front of mind with both current and perspective 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 if the Company's collective consciousness for social and environmental factors. It is an important benchmark for Athersys. We received a grade in the top 20% of our peer group of companies. Consequentially, we were awarded prime stasis. 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 B.J. for Q&A, B.J.

[B.J. Lehmann:]

Thanks, Ivor. As we've done in the past, we'd like to start by addressing some questions submitted by our shareholders over the past days and weeks. And 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. in some of email 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, Amendments 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 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 and treatment courses or doses, on our case within six months. In about six weeks later, BARDA suspended area of interest 9.3 altogether, given that we had applied under Amendment 15 with the advice of counsel, other outside experts we continue to pursue possible BARDA funding to support on MACOVIA Study and in 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 mentioned ARDS for the first time, it no longer prioritizes candidates for COVID and the requirements for 10,000 treatment doses in 6 months has been dropped. It is possible that our revised MACOVIA program in ARDS 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 in the potential for funding to support our ARDS program, which would likely be based on a cost sharing mechanism. And if it makes sense, proceed with preliminary increase in submissions as appropriate. To the extent we proceed, we would expect the application process to take at least 4 to 6 months to play out, given guidance in the new issuance. Furthermore, given the recent R&D focus in the ARDS 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 Athersys. 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 developed in the CEO search and with other tires 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 a high-profile healthcare conferences, most recently the 2021 Cell & Gene Therapy meeting on the Mesa. And we plan to attend the JP Morgan Conference this coming January. We keep our analysts and bankers updated with regards to our progress to proactively reach out both existing and potential new investors to update them on or introduce them to our story. We remain active on social media with the help of our outside advisors, we are always looking for opportunities for media coverage for the Company or 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've recently focused on increasing awareness of our ongoing MASTERS-2 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 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 the supporting reimbursement coverage and pricing. So with that, we will now take some additional questions from today's participants.

[Operator:]

Please stand by while they compile the Q&A roster. Our first question comes from the line of Greg Harrison with Bank of America. Your line is now open.

[Greg Harrison:]

Good afternoon and thanks for taking our questions. First one is just on the status of the MACOVIA trial. Can you give us an update on maybe where enrollment stands and I know that's a little bit of a fluid situation, 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 trials to finish?

[B.J. Lehmann:]

Thanks, Greg. Those are good questions. So update enrollment and then the potential for the interim look. I address this briefly in the discussion, but I think the current plan is to work to wrap up our " Cohort 2 " some time as early as possible next year. I don't want to give any more specific guidance than that. As you remember, there are 3 cohorts to this study, Cohort 1, Cohort 2 and Cohort 3. Cohort 1 is really focused to introducing these patients through the product insured safety. Cohort 2 is to develop some perspectives on feasibility and potential for the therapy and Cohort 3 is really the larger efficacy cohort that was originally targeted for COVID and so that you know we've expanded that 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 more irrespective of the underlying costs. So again, our enrollment objectives are to move through and complete enrollment of Cohort 2 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 Give you information, investments, investors per stage, 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 talked about in the past that you know, there has been a fair degree of movement I'd say in the standard of care introduction to new therapies. It is a different approaches for treatment or pre -treatment of ARDS stations to a non-invasive methods of treatment, etc.. Some of which have had some success 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 2 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 III study, or it is we make amendments to this current study with Cohort 3. We haven't made that determination yet. That's the current plan. We remain excited about the area. I mean, the data from Healios is very, very encouraging. We believe that the upcoming opportunities for them to apply, make an application to the PMDA would be a very important milestone, demonstrating that the platform in this particular application has got real potential for approval and commercialization. So we're very encouraged about the potential for the area, but we want to make sure that when we go into the larger efficacy cohort, we're set up for success.

[Greg Harrison:]

Okay, that's helpful. One more if I could real quick?,

[B.J. Lehmann:]

Sure.

[Greg Harrison:]

You mentioned cash burn earlier in the call. Just wanted to get a sense of what is the urgency right now to maybe enter a partnership to secure some non - dilutive capital? And how does Healios ' decision to push back the stroke readout effect that previously that may have been considered a catalyst that you would want to have under your belt before you entered a partnership?

[B.J. Lehmann:]

Yes, another good question. I think the -- you're quite right. We've talked about this in the context of partnerships 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 TREASURE study and, ultimately, from the MASTERS-2 study, if we wanted to wait that long. So it's disappointing 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. The need to drive faster, I guess, to address a perceived need for cash in their first, let me say. I think we believe is Ivor said that from a cash position perspective. Now that we have fairly specific clarity around the timing for the Healios disclosures. We feel very comfortable about where we're positioned from a cash perspective. What we have in the bank, our access to capital, etc. 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. Of course, we will 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, 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 financial terms, with positive data in the end. 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 is an opportunity to forward the data, we're going to consider it. But there is -- I wouldn't say there is urgency where a critical need to get something done before that data, to answer your question.

[Greg Harrison:]

Got it. Thanks again for taking the question.

[B.J. Lehmann:]

No problem, thank you.

[Operator:]

Our next question comes from the line of David Wang with SMBC Nikko Securities. Your line is now open.

[David Wang:]

Hi, thanks for taking the questions. So I had a few. Maybe the first 1 continuing on the line of questioning around your efforts of the partnerships. You talked a lot previous; I think about Europe really being the focus for any future partnerships. And so I'm just curious as to why has the focus has been on Europe as a geography? Have you considered maybe worldwide partnership where you would also be giving up essentially wise in the U.S. or for development and commercialization, but maybe that could help drive the partnership.

[B.J. Lehmann:]

Yes, that's a good question. Well, I think 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-U.S. With a focus on Japan and a focus on Europe, is the leading geographies. Certainly, there are opportunities beyond that. We've talked with folks about the potential opportunities well beyond those limited geographic context. Quite clearly, many of the companies we 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, it's part of these dialogues, for sure. But we would like to preserve the U.S. markets, we think we can be a sector 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.

[David Wang:]

Okay. Thanks for the perspective there. I had another question in terms of the feedback that Healios received from the Japan regulator asking for a look at the 365-day data being 90-day blinded until that was the case. Does that influence our thinking at all in terms of interactions with FDA? And would it make sense to have a conversation with FDA as to whether the FDA answers a similar course of action in their reviewing MASTERS-2 readout down the line?

[B.J. Lehmann:]

We have the strategy there. We do believe that we'll be able to announce or disclose the 90-day interim(ph) data. We do have to have discussion with the FDA about that over time. I would say that the ultimate outcome in Japan was not expected for Healios. It wasn't expected for us. I think as I noted, the approach that mistaken is very reasonable in the plant approach. It was very reasonable. It was laid out the original protocol submitted with PMDA.

[Ivor Macleod:]

And is successful in terms of protecting the integrity via data. We think there's the same margin supply 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 data. The fact that it's delayed a quarter, disappoints us in the sense that we'd like to get advice to get data out, and move forward with a lot of things we have ahead of us. But it's also going to give us the opportunity to look at the 90-day topline data and simultaneously very shortly thereafter, look at the 365-day data and the pointed out that data. MASTERS-1 studies 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-time time-frame between those 2 data points. I think that's the positive opportunity here. But yes, our strategy with the FDA is not weight to the question. The last data from the 365 days or 1 year follow-up business before we announced data, we are right now planning

[B.J. Lehmann:]

for collection and disclosure of 90-day data, that's also part of our protocol, but is subject to confirmation and discussions with the FDA as we move forward.

[David Wang:]

Okay. Thanks so much for taking the question.

[B.J. Lehmann:]

Yes, sure.

[Operator:]

Our next question is from Nishant Gandhi with Needham & Company, your line is now open.

[Nishant Gandhi:]

Hi. Good afternoon. Thank you for getting a lot of questions. My question is regarding metrics study. I wanted to ask, do you have any further updates on the metrics Phase II, study enrollment or is the trial environment being affected by COVID as well or any updates on them. Thank you.

[B.J. Lehmann:]

Yes. Thanks for asking. We didn't cover 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 had -- we've made good progress early in that study. I think our expectation is to make good progress into 2022 with that study. We're negotiating some things with the FDA about the basic approach for enrollment, which is fairly typical on trauma studies. One of the challenges in enrolling these stations is they're typically on 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 representatives and some sort of where we're working as well with the FDA to figure out ways to make the season more streamlined since going forward. That would be 3 important thing to you very accelerated enrollment. There's still opportunity to get this done in a reasonable timeframe. Even if we can't reach an accommodation with the FDA on an asset that is something that is part of an ongoing dialogue or even actually, we have with the FDA, but things so far been 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.

[David Wang:]

Great. Thank you.

[B.J. Lehmann:]

Okay, thank you.

[Operator:]

As there are no further questions. I'll now turn the call back over to B.J. Lehmann for closing comments.

[B.J. Lehmann:]

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, want to thank all of you for your participation today and your interest in the weeks, in the past month’s 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 tried 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.

[Operator:]

Ladies and gentlemen. This concludes today's conference call. Thank you for participating. You may now disconnect.