Seres Therapeutics, Inc. (MCRB) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the SER-109 ECOSPOR IV Study Results Conference Call. [Operator Instructions] Please be advised today's conference may be recorded. [Operator Instructions]. I'd now like to hand the conference over to Dr. Carlo Tanzi of Investor Relations. Please go ahead.

Thank you, and good morning. A press release and accompanying slide presentation highlighting the positive SER-109 and ECOSPOR IV study results became available earlier this morning and can be found on the Investors & Media section of the company's website. I'd like to remind you that we'll be making forward-looking statements relating to the timing of completion of the BLA filing, potential approval and commercial launch of SER-109, the marketing commercial opportunity for SER-109 and the potential for SER-109 to transform the treatment of CDI. Actual results may differ materially. Additionally, these statements are subject to certain risks and uncertainties, which are discussed under the Risk Factors section and elsewhere in our recent SEC filings. Any forward-looking statements made on today's call represent our views as of today only. We may update these statements in the future, but we disclaim any obligation to do so. On today's call, with prepared remarks, I'm joined by Eric Shaff, Seres' President and CEO; and Dr. Lisa von Moltke, Chief Medical Officer. Additional members of our management team will also be available during the Q&A. With that, I'll pass the call to Eric.

Thank you, Carlo, and good morning, everyone. We are very happy to share with you today our positive topline results from our ECOSPOR IV study of SER-109 in patients with recurrent C. diff infection. These results complete our Phase III program for SER-109 and along with the previously announced ECOSPOR III results, will serve as the basis for our BLA filing. I'd like to begin with some brief context for the study and what these data mean for recurrent CDI patients and for Seres. I'll begin on Slide 3. Seres has been pioneering the development of Microbiome Therapeutics, an entirely new field of medicine since the company's inception over 10 years ago. Along this path, as is often the case with new treatment modalities, we have gained critical scientific knowledge that has been essential in bringing us to where we are today, approaching anticipated BLA filing completion and FDA approval for a potentially first-in-class medicine. On Slide 4, you can see that Seres microbiome therapeutics' pipeline, which includes a number of highly promising opportunities, targeting infection protection and immune modulation. In addition to SER-109, we are also advancing SER-155 in an ongoing Phase Ib study for individuals who are undergoing a stem cell transplant and are therefore at high risk of infections engraft versus host disease. Our clear top priority across this portfolio is the advancement of SER-109 to FDA approval and working to position SER-109 for a successful product launch. Moving to Slide 5. C. difficile infection, or CDI, is debilitating and too often a deadly disease. CDI has been designated by public health agencies as one of the most urgent bacterial infectious diseases in both the United States and globally. CDI is the leading cause of hospital-acquired infection in the U.S. and is responsible for the deaths of more than 20,000 Americans each year. Furthermore, the direct and indirect costs of CDI are significant, and we believe that substantial value would be created for the health care system with an effective and safe new treatment option. Moving to Slide 6. To remind you briefly of our prior ECOSPOR III results, the remarkable SER-109 pivotal study data with an 80% sustained clinical response rate represented a best case scenario and landmark events for the field. These data were published earlier this year in the New England Journal of Medicine. Not only did the data demonstrated a highly statistically significant and clinically meaningful treatment benefit, they also exceeded the statistical thresholds for efficacy previously discussed with the FDA, allowing us to support the basis of efficacy for SER-109 with this single study in our BLA filing. Moving to Slide 7. We also observed a highly favorable safety profile in ECOSPOR III comparable to placebo. This combination of efficacy and safety results we obtained are rarely seen in late-stage clinical studies. Following the ECOSPOR III data, we have further discussions with the FDA regarding the requirements for a BLA filing. At the time, the FDA informed us that they would require a safety database to support a BLA filing that would include at least 300 total patients followed for 6 months. To obtain these data, we initiated the ECOSPOR IV open-label study, and this study reached target enrollment last fall. As Lisa will discuss in more detail, today's ECOSPOR IV study results were consistent with the favorable safety profile observed in the ECOSPOR III study and marked completion of the safety database previously requested by the FDA. Furthermore, these study data also provides strong additional evidence, confirming the excellent efficacy profile observed in ECOSPOR III. These data also build upon the ECOSPOR III results by evaluating the benefit of SER-109 in a broad patient population, including patients with a first recurrence of CDI. Together, these data deepen our conviction and the potential to transform how recurrent C. diff is managed as well as the substantial commercial opportunity that we see in SER-109. I will now pass the call to Lisa to review the study and the results in more detail.

Thanks, Eric. I'll begin on Slide 9 with an overview of the ECOSPOR IV open-label study. ECOSPOR IV was designed to provide additional safety information in adults with recurrent CDI, following administration of SER-109. This is a 24-week study that included 263 enrolled subjects. Along with the SER-109 dosed patients in the ECOSPOR III study, we expect that this study completes the safety database exceeding the 300 patients requested by the FDA with a total of 326 subjects who received SER-109 completing 24 weeks of follow-up. In addition to safety information, we also collected additional valuable sustained clinical response data, which I will also review. With prior agreement from the FDA, the study also included 77 patients or 29% that had only 1 recurrence of CDI. This is a population that was not included in our prior ECOSPOR III study. In addition, we allowed patients entering the study to be diagnosed with either PCR or toxin testing, reflecting local diagnostic approaches and preferences. The ECOSPOR IV study included 2 patient cohorts. Cohort 1 included 29 patients from ECOSPOR III, who experienced a CDI recurrence after enrollment. These cohort 1 patients could have been on either SER-109 or placebo. In Cohort 2, we enrolled eligible adult subjects who had at least 1 CDI recurrence and responded to standard CDI antibiotic therapy. On Slide 10, we provide a summary comparison of ECOSPOR III and ECOSPOR IV. As I noted, with these 2 studies, we have exceeded the requested patient number communicated by FDA to fulfill the required safety database for the SER-109 BLA filing. Also, as I previously mentioned, 2 differences in these studies are that ECOSPOR IV allowed enrollment of patients with a first recurrence and also allowed a CDI diagnosis at study entry to be performed with either PCR or toxin testing. Moving to Slide 11. This table summarizes the baseline demographics from ECOSPOR IV. The median age was 65, and the study population was approximately 68% female, reflecting the higher proportion of women impacted by CDI. Overall, we believe that the demographics included in this study are representative of the overall rCDI population in the United States. On Slide 12, we highlight the baseline characteristics with regard to number of prior CDI episodes. The study included 77 individuals or 29% with a first recurrence of disease. These first recurrence patients reflect a group that was not included in our prior ECOSPOR III study and are significant interest as it is a large patient group with the prevalence estimated at approximately 100,000 in the U.S. alone. We expected to observe consistent results in this first recurrence group because the underlying pathology of the disease is believed to be the same across recurrent population. In all recurrent patients, microbiome disruption is a key root cause of disease. Microbiome disruption is believed to occur in all recurrent CDI patients, and SER-109 is designed to directly address this underlying issue. The very favorable sustained clinical response data we observed in first recurrence patients provides additional evidence supporting the benefits that SER-109 may provide to this patient group. Across ECOSPOR IV, approximately 73% of patients had been treated for their most recent CDI episode with vancomycin with the remainder receiving fidaxomicin. We believe this split between treatment with vancomycin versus fidaxomicin is reflective of the overall standard of care in the U.S. In ECOSPOR IV, we also wanted to include patients diagnosed with either PCR or toxin assays. This variation in diagnostic method reflects current medical practice across the U.S. Approximately 26% of study subjects were diagnosed with PCR and the remainder with toxin. As a reminder, in the ECOSPOR III study, only diagnosis with toxin was allowed. While both PCR and toxin were permitted as a diagnostic for entry in the open-label study, we confirmed any in-study suspected recurrence with toxin testing for data integrity. Now moving to Slide 13. Let's review the results of ECOSPOR IV beginning with safety. Overall, the safety profile through 24 weeks of follow-up indicated that SER-109 was well tolerated. This was consistent with the safety profile observed in the placebo-controlled ECOSPOR III study where we observed a highly favorable safety profile for SER-109 that was consistent with placebo. In ECOSPOR IV, the most common treatment-emergent adverse events were diarrhea, flatulence, nausea, abdominal pain, abdominal distension, urinary tract infections and fatigue, all issues common to the CDI population. Approximately 12.5% of patients in ECOSPOR IV experienced a severe adverse event. However, none of these were deemed related or possibly related to the study drug by study investigators. As would be expected in this population, we did observe 8 deaths in the study. None of these were deemed by investigators to be related or possibly related to SER-109. Moving to Slide 14. We also evaluated the CDI recurrence rates in this study. Overall, we observed a sustained clinical response up to week 8 in approximately 91% of subjects, which was remarkably similar to the 88% rate observed in ECOSPOR III. Response rates did not differ between those treated with vancomycin or fidaxomicin. We were very pleased to see this level of apparent clinical activity in this study, which is substantially different from the 60% sustained clinical response rate in the placebo arm of ECOSPOR III. Turning to Slide 15. We also evaluated sustained clinical response rates based on the number of prior CDI episodes. As expected, we were very pleased to see a similar recurrence rate across the study population, regardless of the number of prior episodes. This includes first recurrence patients where we observed that only 6.5% of patients experienced a recurrence, which is a sustained clinical response in 93.5%. Our clinical results in this first recurrence population are consistent with our understanding of the underlying pathophysiology of the disease, which is believed to be similar across rCDI patients regardless of the number of prior episodes. In addition, for those enrolled using PCR, 95.7% had a sustained clinical response. Also of note on Slide 16, we evaluated sustained clinical response rates out to week 24, and our data suggests these rates are durable over time. Moving to Slide 17. I would like to summarize our conclusions from this important study. First, the results of ECOSPOR IV provide additional support from over 260 individuals with a highly favorable SER-109 safety profile that we observed in our prior placebo-controlled ECOSPOR III study; second, the results reaffirm and extend the SER-109 ECOSPOR III efficacy results. The results provide compelling additional evidence of efficacy suggesting a marked benefit in sustained clinical response rates. Moreover, our data suggests similar activity in patients with a first recurrence of CDI. Overall, we are thrilled with the data from this study, and it confirms the remarkable results previously obtained in ECOSPOR III. Based on the clinical profile we have observed to date, we believe that SER-109 could benefit patients across the entire recurrent CDI population, which is estimated at approximately 170,000 annual cases in the U.S. alone. However, the utilization of SER-109 would, of course, be based on the product label pending FDA approval. Now turning to Slide 18. The completion of the ECOSPOR IV study marks the critical final component required to submit the SER-109 BLA. We are very happy to announce today that the SER-109 BLA filing is now underway and that we have already submitted the first modules to the FDA. We expect to complete the BLA mid-year. And based on SER-109's breakthrough therapy designation, we expect to obtain an expedited review timeline. As a result, we anticipate a potential product launch in the first half of 2023. With that, I'll now pass the call back to Eric.

Thanks, Lisa. Supported by the exceptional clinical profile we have observed with SER-109, let me update you on our preparations for product launch. Highlighted on Slide 19. From a CMC perspective, we have allocated substantial effort to ensure a high-quality BLA filing. In addition, pending product approval, we have taken meaningful steps to be well positioned to meet commercial demand in all launch scenarios. This includes both Seres' in-house manufacturing and quality control capabilities that are supported by external contract manufacturing organizations. Furthermore, last year, we entered into a collaboration with Bacthera that provides redundancy and expands upon existing commercial supply capabilities and capacity. Moving to Slide 20. We also continue to prepare, alongside our Nestle Indian collaborators for a successful product launch. We plan to continue to engage with physicians through our medical affairs group. The ECOSPOR IV results provide a rich data set, and we look forward to presenting these data at upcoming medical meetings. Terri is available during the Q&A session to further discuss our progress preparing for a product launch. As I conclude, I briefly want to also mention our development efforts more broadly. Our SER-109 clinical data provides very clear evidence of the power of Microbiome Therapeutics in infection protection. We believe that our data in CDI may be extrapolated to many other areas of medicine. Supported by our data and as depicted on Slide 21, we have clinical and pre-clinical programs underway, targeting multiple additional patient populations and disease states where we believe that our microbiome therapeutic approach could provide transformational clinical benefit. We look forward to keeping you informed of our progress and our work to advance SER-109 to FDA approval and also moving our other promising microbiome therapeutics forward. With that, operator, let's open the call for questions.

[Operator Instructions] Our first question comes from Joseph Thome with Cowen.

Congratulations on the great update here. Maybe just a first one, great to see that the BLA process has started. Maybe what are the remaining steps to kind of finalize the BLA submission? That's my first question. And then second, just in terms of labeling, will the label actually indicate -- or I guess is this important for reimbursement decision if a patient is diagnosed via PCR or toxin? And maybe you can just give us a little bit of information on kind of what's the standard of care? And if you'll need to do anything to educate physicians on that?

Joe, thanks for the question. Maybe I can take the first, and I'll ask Lisa to comment on the second. But in terms of the BLA process, we haven't provided the kind of blow-by-blow interactions with the agency. But what I can tell you is we feel that we are on track and on time. And our engagement with the agency and a time in which -- perhaps it's been difficult for the field has been very constructive, whether it's our pre-BLA meeting or our proposal for rolling submission, they've gotten back to us in a timely manner, and we feel that our interactions with them have been very constructive. So the team is active in working to finalize the BLA, and we are, as we said beforehand, on track for mid-2022. And we're looking, of course, with urgency to try to get this drug to them as quickly as possible. In terms of label and PCR and toxin, maybe I can ask Lisa to comment on label, and maybe Terri can comment on the reimbursement side of things.

Sure. We would not anticipate that the specifics of diagnosis -- diagnostic testing would be in the label. I mean recurrent CDI is above all, it's a clinical diagnosis. And diagnostic testing is part of that. What kind of testing a particular location uses depends a lot on other factors that they may have in place to increase the specificity of whatever testing they decide to use, and many places actually use an algorithm, a series of tests. So we would not expect those specifics around the practice of medicine to be in the label. And I think it's reassuring as we looked at our study that the -- regardless of how patients came in, whether it was toxin or PCR, they did equally well with regard to sustained clinical response.

Terri, any comment on the reimbursement side of things?

Sure. So just to build on that, we've recently deployed the immune payer field team to educate payers about the role of the microbiome in this disease as well as the profile of SER-109. And they're very interested in the patient journey and the diagnostic algorithms who treats the disease as well as all the data around the rich data sets that we have around SER-109. And I think Lisa really answered the question well, this is a diagnostic algorithm. And once payers understand that this is not some sort of predictive biomarker-driven disease like oncology, they're very willing to let physicians take hold of that. And that's not something that they plan to widely use to manage the disease or utilization.

Our next question comes from Mark Breidenbach with Oppenheimer.

And let me add my congrats, very nice data. A couple of questions from me, probably both directed towards Lisa. First of all, I was curious if you saw any difference in the recurrence rates depending on whether the CDI diagnosis was made via toxin assay or via PCR? And the second question, is really, I was hoping you could just remind us what we should be expecting in terms of recurrence rates for -- in a first-time recurrent setting for retreatment with fidaxomicin or vancomycin. How do these antibiotics do 8 week and 24 weeks relative to something like SER-109?

Sure. So I'll answer the last question, first. And there are data that -- I have not seen 24-week data. And in fact, we're one of the few CDI programs that's ever produced data out to 24 weeks. But on 8 weeks, the published literature is in first recurrence is 30% to 35%, can be expected to recur. With regard to your other question, we have looked at the recurrence rate according to entry diagnostic testing. And there really isn't any difference. The PCR is a bit lower, but both were lower than we had seen in ECOSPOR III. The toxin testing was under 10%. The PCR testing was closer to 5%.

Our next question comes from Ted Tenthoff with Piper Sandler.

My sincere congratulations too. I know it's been a long path to get here, but I really appreciate the methodical approach and the data, I think, speak for themselves. A question with regard to sort of FDA. And I know this may be a little bit unfair, but we've really seen the FDA, for a variety of reasons, a lot of different PDUFA dates get pushed back. One of the main reasons I've been witnessing is manufacturing reviews. So I wanted to get a sense for sort of the complexity of the CMC module and what goes into that? And just to be a little bit more specific. Obviously, I think Nestle is involved in that process and really get a sense for how you plan to schedule site visits and anything along those lines?

Ted, thanks for the question. Maybe I'll start and we've got Dave here who can help and of course, Lisa can comment on the regulatory side, too. But I think I would say we certainly are aware of the environment and perhaps some of the other data points in the field. All we can tell you is that our interactions continue to be very positive. We have never, will never speak for the FDA, but we think that they recognize that there is a need for a drug in this space, right? You know the history, Ted, the meeting that the FDA convened following the deaths of -- with the transmission of the pathogen through FMT and the warning that the FDA put out around the potential transmission of COVID-19 through fecal matter. What does this field need something that's efficacious, that's oral, that's rigorously tested, that's GMP manufactured, and that's what we think -- that's -- we're hoping to provide the patients with SER-109, and we're working with urgency to do that. So we don't speak to the FDA, but all we can tell you is that our interactions have been very constructive and continue to be. Maybe I can ask Dave to comment a little further on -- I think Ted appropriately highlights the fact that CMC is important, and we take it obviously very seriously and if Dave can comment on that.

Yes. Absolutely, Ted. So I think the first thing to emphasize is you asked about complexity, right? I think something that's really elegant about the Seres manufacturing process is, it doesn't use any novel unit operations. We're using standard production techniques for purification, et cetera. So I think what they're going to find when they come in to inspect our process is processing approaches, et cetera, that they're familiar with, right, but applied to a new modality. So that's sort of point number one. And that was very deliberate on our part over many years. The second, you asked about Nestle being involved, that's actually incorrect. Nestle is not involved in the manufacturing aspects of this. So that's another thing that stands out per Seres, as Seres is invested since the very beginning in CMC, both internal capabilities. And another thing worth reminding is that our manufacturing supply chain for launch is the same manufacturing supply chain that we utilized for Phase III, our external partners or for -- fewer number and worked with them for 8 or more years in manufacturing this product. So we have a lot of knowledge and a lot of relationships. And so we feel good about that. And the last thing you asked about is spot on about site visits and whatnot. The way we're approaching this is exactly as I was accustomed to doing it at Merck, nearly 20 years in vaccines there. We've been having mock inspections. We've brought in former FDA inspectors to simulate a real inspection and observe things that they would encourage us to tighten up and be more prepared for with FDA, and we feel really good where we are with that. So we're on track and, of course, looking forward to those conversations with the agency.

Excellent. That's really helpful and very thorough. The Nestle involvement, and it's great to have Bacthera involved, would their sites need to be visited as well?

Yes. Certainly, yes. So a clarification here. So our partner historically has been Genentech in Portugal and they're a unit of Recipharm, which is a large multinational CDMO. And indeed, the Recipharm sites will be inspected and those were the ones I was referring to when I was talking about that 8-year collaboration together with them. So I've been there many times, and we'll be here many times again between now and the inspection. They've been a great partner. Bacthera, that facility is more in preparation for later years of U.S. supply and what we hope to be future filings outside of the U.S. So Bacthera is not in scope for this particular first approval.

Our next question comes from Chris Howerton with Jefferies.

I guess for me, it's really around how should the FDA think about the diagnostic criteria, I think point taken with respect to the results that we've observed. But I think it's fair to say that it had a material impact on ECOSPOR II and III in terms of the design and observing the effect size. So I guess, the specific question is, how are you going to position that to the FDA? And how would you expect them to kind of think about the diagnostic criteria in light of the fact that it was so important to obtaining positive results?

Yes, Chris, maybe I can -- I'll start, and I'll ask Lisa to comment. I think we answered a kind of similar question beforehand, and we can hit that again. We certainly saw this part of ECOSPOR III that the toxin upon entry and exit of the study provided the clearest data set. But as Lisa mentioned, in the ECOSPOR IV study, there really was not a meaningful difference between the inclusion diagnostic choice, but maybe Lisa you can comment further as well as maybe our thoughts on the FDA and how they might adjudicate the assay?

Yes. No, I think, again, I don't think that the FDA gets into the specifics of clinical practice. And I just want to clarify with regard to the positioning in the clinical trial. The critical piece was toxin testing for suspected recurrence. And there's nothing in a clinical practice situation that suggests that PCR is actually helpful in that kind of setting, just because we know what somebody's had, C. diff, they're very likely to just continue to turn up positive. And that's why you don't test to see if somebody has cleared. So it really was the toxin testing for suspected recurrence was really the critical piece there. And again, I think that trial guidelines with regard to how you assess whether a patient has recurred really are going to trump.

Our next question comes from Chris Shibutani with Goldman Sachs.

This is Stephen on for Chris. Congratulations on the data. So we noted that about 3% of patients or 29% in the open-label extension had a first recurrence. We're just wondering how confident are you based on prior dialogue with the FDA that this study population is sufficient for inclusion of language on the potential label with regards to less recurrent or patients with first recurrent disease?

Yes, Stephen, thanks for the question. Let me start, and I'll take it to Lisa. But we have always said that label will be part of a negotiation with the FDA as part of the -- and really, at the end of the BLA process, right? So again, we don't speak for the FDA. What I will also say is that we weren't counting on this ECOSPOR IV data to support the idea of a broad label or a first recurrence label, which is what we certainly intend to put forward for the FDA, and we think it's absolutely appropriate. And maybe I can ask Lisa to comment further on that.

Yes. It's the generalizability of the ECOSPOR III population that is really the key here. And that is based on the known pathophysiology of recurrent CDI. As soon as you're a recurrent patient, there's an indicator that you basically have microbiome disruption, and you can't -- you're not resilient enough with regard to microbiome to do the healing on your own. So in SER-109 is obviously specifically designed to fix that. So it's -- as Eric said, it wasn't the data from ECOSPOR IV that we were counting on, we're making the argument based on the understanding of the disease.

And they will look at all the data, right, as they would do?

Yes.

Our next question comes from Vernon Bernardino with H.C. Wainwright.

Congratulations on the results, been the long journey. And it's good to see this coming out to -- near the end. Just had 2 questions. In your stated timeline for, I guess, expected approval, is part of that an expectation? I just wanted to confirm. And you have said this in the past that whether or not there'll be an advisory committee meeting to review the data.

Yes. Vernon, I'm going to continue the theme of saying we don't speak for the FDA, but I will say that our expectation is that there would be if they come.

Okay. And so your timeline does include that?

It does, yes.

Okay. Second question. So at ECOSPOR IV, the -- in Slide 10, antibiotic treatment of infection episode, it's a little different as far as ECOSPOR IV as far as the days of vancomycin or fidaxomicin in total duration of maximum treatment. Do you anticipate any differences? I saw that the sustained responses were very close. But do you anticipate any differences as far as the species of bacteria that you might see that may have led to a little bit of a difference as far as the sustained response?

I don't. I think the numbers were pretty close. Maybe I'll invite Matt or Lisa to comment on that. But -- yes, Matt, do you want to take that one? I think we lost Matt. Lisa, do you want to comment on -- the numbers were very similar.

Yes. So I mean, in terms of just the response rates, they were almost identical in terms of the recurrence rates in fidaxo and vanco. And with regard to species, I don't -- I would turn it to Matt, but apparently, he's not able to connect right now.

Yes. It's hard to comment on that, Vernon. I think that the numbers were so close that we wouldn't expect a difference.

But you'll have that data and possibly published in the future?

Well, I think it's a good question. We -- all of our studies are -- tend to be very rich in terms of data. And we've -- this is the topline safety and efficacy results. But of course, we'll do our typical microbiome analysis, and we will continue to learn from that analysis. And I think you've seen, over the years, each opportunity to have human data sets in the microbiome field where there aren't a lot of human data sets is somewhat of a unique opportunity for us to learn and accrue value to the overall pipeline that we apply for, not just in C. diff, but really in adjacencies to C. diff, including other areas of infection protection, which is where we're pointing the early stage research right now.

Right. That's exactly what I was thinking because it would be further confirmation of your rational approach as far as the species and kind of repopulation and restoration of this function that you see. Looking forward to that data and congratulations again.

Thanks, Vernon.

[Operator Instructions] Our next question comes from Keay Nakae with Chardan.

A question about site visit by the FDA in terms of manufacturing. Do you foresee any issues scheduling that -- given that it's outside the U.S.?

Yes. Good question. And I think Dave commented on that before, and maybe I can ask him just to reiterate the comments.

Yes, of course, I mean, it will depend on the FDA's availability, right? In their timing for scheduling. We are certainly prepared to host them as quickly as they're willing to come, right? Well, I think I would just emphasize what Eric said earlier. The obvious question out there is, this is governed by the office of vaccines and [ CBR ] and obviously, with the pandemic, there's a lot of on their plate and whatnot. However, throughout the pandemic, we've had really strong engagement. There appears to be a lot of interest within the agency to have a drug in this space, as Eric talked about. And I, for one, have been really pleased by the timeliness of their communication back and forth. It was highlighted earlier in this call that when we requested permission for a rolling BLA, they responded back to us in a timely manner, and we were really pleased to hear that back. And even technical requests back and forth are handled in a timely manner. So they're definitely engaged with us. We've had an ongoing dialogue for some time given the breakthrough designation, and we're hopeful that they're going to continue that timely interaction with us, including those site inspections and we'll be ready.

Do you have any kind of read on whether the backlog that was created by the pandemic for OUS site visits has been cleared up at all?

We don't. I mean it really -- the first step is getting our BLA in and then the interactions will be specific. We haven't talked to them about that because it's just not appropriate as yet.

Every indication that we have is that we continue to be on track and on time. And in an environment where -- that -- we've seen a lot of setbacks. I think we're really thrilled. And I think it was mentioned earlier, this has been a long journey where this is an idea on a whiteboard a number of years ago. And to be able to serve patients and have potentially the first microbiome therapeutic. The team is really energetic, galvanized, enthused. There's a sense of urgency we know that patients are waiting for us, and we will do everything in our power to get to them as quickly as possible.

That concludes today's question-and-answer session. I'd like to turn the call back to management for closing remarks.

Thank you, operator, and thank you all for joining us this morning during this exciting time. We look forward to keeping you updated on our progress. Have a great day, and we will connect soon. Thanks.

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