Athersys (ATHX) Q3 2021 Earnings Call Transcript

Athersys (ATHX 36.36%)
Q3 2021 Earnings Call
Nov 15, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, and thank you for standing by. Welcome to the Athersys third quarter 2021 results conference call. [Operator instructions] Please be advised that today's conference is being recorded. [Operator instructions] 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 -- Director of Corporate Communications and Investor Relations

Thank you, Abigail, and good afternoon, everyone. As Abigail mentioned, I'm Karen Hunady, I'm the director of corporate communications and investor relations for Athersys. Thank you for joining today's call. If you do not have a copy of the press release issued at the close of market, it is available on the Athersys website at athersys.com.

I'm here with 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 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 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 November 15, 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 -- President, Chief Operating Officer, and Interim Chief Executive Officer

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. 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 Healios's 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 to standard therapy. Last week, Healios reported in its third quarter financial results update presentation that it plans to file in either Q4 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 MUST-ARDS and ONE-BRIDGE studies suggest a strong signal of potential impact. This pool data set includes 40 non-COVID ARDS patients treated with MultiStem cell therapy and 20 ARDS patients treated with placebo or receiving standard of care.

According to this analysis, average VFD was higher in the MultiStem treated group compared to nontreatment group, 13.9 days, compared to 10.1 days with a p-value of 0.07 when adjusting for baseline differences and condition severity and age and using a two-tail statistical test. Median VFD was also substantially higher. Based on this 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 in our MACOVIA study treating patients with ARDS induced by COVID and other pathogens. Our intention is to continue and complete enrollment of the study's cohort 2 and reflect on the evolving standard of care as a 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 our MultiStem or indeed MASTERS 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, 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 one-year follow-up is that the last patient has been collected.

Healios 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 prespecified analyses to be completed expeditiously once the data set is unblinded. This approach advised by the PMDA is intended to preserve the integrity of the data collected from the last patient 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 analyses; and c, evidence from the MASTERS-1 study, get 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 in 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 one-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 and the MRS 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% in three months to 29% at one year. Translation, 16 out of 100 serious stroke patients were essentially back to normal by 90 days and another 13 back to normal by one year, compared to nontreatment, were 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 MultiStem treatment across the severity spectrum as is evident improvements in MRS distribution for 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 Healios to move forward with the JNDA by making preparations in the regulatory and manufacturing areas in particular. We are making progress on our MASTERS-2 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-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 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 multiyear 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 seafood, demonstrating how the seafood would work in practice.

As we have discussed previously, generally speaking, 2021 and 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 to 2022, several important themes would be reflected in our objectives and actions. As we await data from the important TREASURE 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 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 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 in 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 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 -- Chief Financial Officer

Thank you, B.J. Good afternoon, everybody, and once again, thank you for joining today's call. I am 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 three months ended September 30, 2021, we recognized $4.8 million in revenues, compared to $86,000 for the three months ended September 30, 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 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 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 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 31, 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 one-time expenses. These one-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 one-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 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 Healios's top line stroke data. On a nonfinancial note, at 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 Athersys. 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 B.J.

for Q&A. B.J.?

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

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. 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 in 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, amendments 15 area of interest 9.3, which calls 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've 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. 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 and other outside experts, we continue to pursue possible BARDA funding to support our MACOVIA 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 prioritize candidates for COVID and the requirement for 10,000 treatment doses in six months has been dropped. It is possible that a 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 and 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 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, giving 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 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, 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, 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 our 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 MASTERS-2 study, pursuing immediate 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 in 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.

Questions & Answers:

Operator

[Operator instructions] Our first question comes from the line of Greg Harrison with Bank of America. Your line is now open. 

Greg Harrison -- Bank of America Merrill Lynch -- Analyst

Good afternoon. 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 it'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 trial to finish.

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

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 cohort 2 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 1, cohort 2 and cohort 3. Cohort 1 is really focused on introducing these patients to the product and ensure safety.

Cohort 2 is to develop some perspectives and feasibility and potential for the therapy in cohort 3 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 cost. So again, our enrollment objectives are to move through a complete enrollment of cohort 2 as soon as possible in 2022.

At this point, our expectations, we would take an opportunity to take a look at the results of cohort 2. We haven't made a final decision on that. It's not driven to give information, the 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 of care for treating these patients.

I think as we've talked about in the past and as you know, there has been a fair degree of movement, I'd say, the standard of care introduction of new therapies, some different approaches for treatment or pretreatment of ARDS patients to noninvasive methods of treatment, etc., 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 2 and reflect on that to be sure that we're set up for a successful efficacy part of the study. Maybe we create a true Phase 3 study, or it is we make amendments to this current study with cohort 3. So we haven't made that determination.

That's the current plan. And we remain excited about the area. I mean the data from Healios is very, very encouraging. We believe that the upcoming opportunity 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 for success.

Greg Harrison -- Bank of America Merrill Lynch -- Analyst

OK. That's helpful. One more, if I could, real quick. How -- 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 nondilutive capital. And how does Healios' decision to push back the stroke readout effect 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?

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

Yeah, 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 in a sense, it's disappointing a 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 there. First, let me say I think we believe as 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, but we have the bank or 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. 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, 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 there's -- I wouldn't say there is urgency or a critical need to get something done before that data to answer your question.

Greg Harrison -- Bank of America Merrill Lynch -- Analyst

Got it. Thanks again for taking my questions.

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

No problem. Thank you.

Operator

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

David Hoang -- SMBC Nikko. Securities -- Analyst

Hi. Thanks for taking the question. So I just had a few. Maybe the first one, continuing on the line of questioning around your efforts at a partnership.

You talked a lot previously, I think about Europe really being the focus for future partnerships. And so I'm just curious as to why has the focus been on Europe as a geography. Have you considered maybe worldwide type partnership where you would also be giving up essentially right in the U.S. for development and commercialization, but maybe that could help drive the partnership forward?

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

Yeah. Yeah, that's a good question as 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 to folks about potential opportunities well beyond those kind of limited geographic context. 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.

David Hoang -- SMBC Nikko. Securities -- Analyst

OK. Thanks for the perspective there. I had just another question on -- in terms of the feedback that Healios 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? Would it make sense to have a conversation with FDA as to whether they may enter a similar course of action in reviewing MASTERS-2 readout down the line?

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

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. 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 was taken is very reasonable -- the planned approach, it was very reasonable. It was laid out the original protocol submitted with the PMDA, and it's defensible in terms of protecting the integrity data. We think the same are supply in the United States.

I think the PMDA is -- in my view, it's been 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 the 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. But 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 as I pointed out, that data, our MASTERS-1 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 time frame 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 360-foot 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 and discussions with the FDA as we move forward.

David Hoang -- SMBC Nikko. Securities -- Analyst

OK. Thanks so much for taking the question.

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

Sure.

Operator

Our next question is from Nishant Gandhi with Needham and Company. Your line is now open.

Nishant Gandhi -- Needham and Company -- Analyst

Hi. Good afternoon. Thank you for taking my questions. My question is regarding MATRICS study.

just wanted to ask, like, do you have any further updates on the MATRICS Phase 2 clinical enrollment? Or is the trial environments being affected by COVID as well or any update would be helpful. Thank you.

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

Yeah, thanks for asking. We didn't cover it here, but trial 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 are 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 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 this even 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 time frame, even if we can't reach an accommodation with the FDA on that, but that is something that is part of an ongoing dialogue or interaction we have with the FDA. But things so far have 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.

Nishant Gandhi -- Needham and Company -- Analyst

Great. Thank you.

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

OK. Thank you.

Operator

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

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

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 in the past months, the questions and the input, though we don't answer all your questions. We tried 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 into our thinking and incorporate it into our plans and business as we move forward. So thanks again, and have a good night.

Operator

[Operator signoff]

Duration: 45 minutes

Call participants:

Karen Hunady -- Director of Corporate Communications and Investor Relations

B.J. Lehmann -- President, Chief Operating Officer, and Interim Chief Executive Officer

Ivor Macleod -- Chief Financial Officer

Greg Harrison -- Bank of America Merrill Lynch -- Analyst

David Hoang -- SMBC Nikko. Securities -- Analyst

Nishant Gandhi -- Needham and Company -- Analyst

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