Protara Therapeutics, Inc. (TARA) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by, and welcome to Protara Therapeutics call. [Operator Instructions] Please be advised that today's conference is being recorded. I would like now to turn the conference over to Justine O'Malley, Senior Vice President of Investor Relations. Please go ahead.

Thank you, Michelle. Good morning. Thank you all for joining us today to review updated results from our ongoing open-label Phase II ADVANCED-2 clinical trial of TARA-002 in patients with non-muscle invasive bladder cancer. The press release and scientific poster outlining the updated data can be found on the Investors section of the Protara Therapeutics website. Before we begin, I would like to remind you that during today's call, we will be making certain forward-looking statements. These statements represent our views as of today only and should not be relied upon as representing our views as of any subsequent date. Actual results may differ from our forward-looking statements due to various factors, including those described in the Risk Factors section of our most recent annual report and subsequent quarterly reports that are on file with the SEC. Except as required by law, we disclaim any obligation to update these statements even if our views change. Joining me on today's call are Jesse Shefferman, Co-Founder, Director and Chief Executive Officer; Dr. Jackie Zummo, Co-Founder and Chief Scientific Operations Officer; Pat Fabbio, Chief Financial Officer; and Dr. Leo Nicacio, our new Chief Medical Officer. With that, I will now turn the call over to Jesse.

Thank you, Justine, and thank you all for joining us this morning. We are excited to share with you positive interim results from our ongoing Phase II ADVANCED-2 clinical trial of TARA-002 in non-muscle invasive bladder cancer or NMIBC. 002 is an investigational genetically distinct strain of Strep pyogenes that is fully inactivated while retaining its immunopotentiating properties. We are very encouraged by this positive interim update, which builds on the strong data that we presented at the SUO conference at the end of last year. 002 continues to demonstrate favorable safety and encouraging efficacy with clearly competitive response rates and now is driving durable responses at 12 months in both the registrational BCG unresponsive patient cohort as well as the proof-of-concept BCG-naive cohort. These durable responses, along with 002's simple 15-minute administration via catheter with no special handling requirements represent key competitive advantages within the evolving NMIBC treatment landscape. With these data now in hand and additional potential value-creating milestones anticipated throughout the year ahead, we believe we are well positioned to continue success and represent a compelling opportunity for the investment community. Before I turn the call over to Jackie to discuss 002 in greater detail and the updated interim results from the ADVANCED-2 trial, I would like to remind everyone that beyond NMIBC, we have 2 mid- to late-stage rare disease programs that have the potential to contribute meaningful additional value. Both programs address significant unmet needs, and we look forward to discussing them in greater detail throughout the remainder of the year. With that, I will now turn the call over to Jackie.

Thank you, Jesse. TARA-002 is unique among investigational or recently approved NMIBC therapies. Our investigational treatments for NMIBC are either enhanced chemotherapeutics or targeted immunotherapies. TARA-002 activates not only the specific cytokines that other approved or experimental immune therapies do, but TARA-002 also activates a much broader immunologic profile. We believe this profile provides a biologic underpinning for the durable antitumor responses we are beginning to see in ADVANCED-2. TARA-002's related history in Japan also gives us insight into potential continued durable response. 002 is manufactured from the same master cell bank as the originator therapy, OK-432, which was developed by Chugai Pharmaceuticals and is approved for a number of oncology indications in Japan with over a 65,000 patient safety database. Now I will walk you through the interim results that were presented Saturday in a poster at the American Urological Association Annual Meeting. We are presenting interim data from our ongoing Phase II open-label ADVANCED-2 clinical trial, assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ with or without papillary disease, who are either BCG unresponsive or BCG naive. The BCG unresponsive cohort has been designed to be registrational in alignment with the FDA's updated 2024 BCG unresponsive NMIBC guidance. Patients in the trial receive an induction course with or without a reinduction course of 6 weekly intravesical installations of TARA-002, followed by a maintenance course of 3 weekly installations every 3 months. Patients are eligible for reinduction if they have residual CIS and/or a recurrence of high-grade Ta at 12 weeks. They are not eligible for reinduction if they experience disease progression or treatment failure. Complete responses are confirmed by negative cystoscopy and negative urine cytology. Additionally, based on feedback from the FDA, in our registrational BCG unresponsive cohort, there is a mandatory biopsy at month 3. Our landmark CR rates include all patients evaluated at the time point, including those who discontinued treatment due to disease progression or treatment failure. As of the data cutoff of April 16, 2025, in the pivotal BCG unresponsive cohort of 5 patients, TARA-002 demonstrated a CR rate of 100% at any time and a CR rate of 100% at 6 months, a CR rate of 80% at 9 months and a CR rate of 67% at 12 months. Overall, we are very pleased with these encouraging results. As you can see, our site expansion efforts have led to an increase in trial enrollment. Currently, we have 17 patients enrolled, including 12 who have not yet reached the first efficacy assessment at month 3 as well as several additional patients in screening. We look forward to our next data update in the BCG unresponsive cohort toward the end of this year. I'd like to take a moment to talk about TARA-002's mechanism of action. As many of you are aware, across the various mechanisms and modalities employed to treat NMIBC, TARA-002 is most similar to BCG, which is the standard of care for NMIBC. Both are bacterial immune potentiators that drive a Th1 pro-inflammatory response. Both have a preference to M1 polarization. While there are similarities, there are also important differences that make us believe that 002 has the potential to be an important treatment for BCG unresponsive NMIBC. Where we know the 2 therapies differ is that TARA-002 is a NOD2/TLR2 agonist, and BCG is a TLR4 agonist. In preclinical studies, 002 demonstrates significantly stronger tumor cell killing properties compared to BCG with higher upregulation of key pro-inflammatory cytokines and chemokines, including TNF alpha and interferon gamma. TARA-002 also downregulates IL-8, which is known to be associated with tumor recurrence in NMIBC. Overall, we are encouraged by the strong results demonstrated by TARA-002 in BCG unresponsive patients. Moving on to the proof-of-concept BCG-naive cohort of 21 evaluable patients. TARA-002 demonstrated a CR rate of 76% at any time and a CR rate of 63% at both month 6 and month 9 with a CR rate of 43% at month 12. What we find encouraging in this data set is that over 80% of patients maintain a complete response from 6 to 9 months and 100% of patients maintained a CR from 9 to 12 months. These results make us optimistic that as the data from this cohort matures, an increase in the 12-month CR rate is possible. Based on the positive responses demonstrated by 002 in this patient population, we intend to engage with the FDA on the design of a registrational study in BCG-naive patients as a potential follow-on indication for TARA-002. Overall, we believe these data are compelling and position 002 as an important potential therapy in the NMIBC treatment landscape in both the BCG unresponsive and the BCG-naive settings. Moving on to the safety results. You will see that 002 demonstrated a favorable safety and tolerability profile with the majority of adverse events being grade 1 and transient. There were no grade 3 or greater treatment-related adverse events and no patients have discontinued due to adverse events. The most common AEs were in line with typical responses to bacterial immune potentiation such as flu-like symptoms and those associated with urinary tract instrumentation effects. To summarize, we find these interim results compelling and believe that 002 has the potential to be a meaningful treatment option for patients with NMIBC. I'll now pass it back over to Jesse to close.

Thanks, Jackie. Again, we are very excited by these data. They further build upon the positive results we shared at SUO this past December. And with an increased number of patients in the data set, we are encouraged by the consistent and durable CR rates demonstrated by TARA-002. After TARA, we are truly focused on the patients we hope to serve. So while today's update represents an exciting development for our company, more importantly, it's an exciting day for patients with NMIBC in need of new and effective treatment options. With our recent financing in December, we have cash runway into 2027 and the ability to reach several exciting milestones. We look forward to continued acceleration in patient enrollment in the registrational BCG unresponsive cohort and remain on track to have 6-month results in 25 BCG unresponsive patients towards the end of 2025. Additionally, we expect to be able to share feedback on a registrational path for 002 in the BCG-naive patient population later this year. Before we open up the call to questions, I would like to introduce our new Chief Medical Officer, Leo Nicacio. We are excited to have him on board. I will now turn the call over to Leo to say a few words.

Thank you, Jesse. It's a pleasure to be on the team. After more than 2 decades in oncology drug development and experience in bladder cancer, I joined Protara because I believe TARA-002 has the potential to be best-in-class in this difficult-to-treat population. I'm thrilled to be here, and I look forward to continuing to advance TARA-002 program across NMIBC landscape. With that, I will turn the call back over to Jesse.

Thanks very much, Leo. And now I would like to open the call up for Q&A.

[Operator Instructions] And our first question will come from Stacy Ku with TD Cowen.

Congratulations on the efficacy update and a quick welcome to Leo. So our first question -- nice to see the number of BCG unresponsive patients added to the study. As we think about the interim update for year-end, maybe discuss your progress with adding sites, especially as KOLs are seeing the competitive efficacy and early signs of durability. Also, can you provide your updated views on the split of CIS and papillary patients? So maybe talk about your level of confidence that you can maintain that sweet spot of 70% CIS, 25% concomitant split for BCG unresponsive patients. So that's the first question. And then second question is, do you think you could get an update ahead of the year-end interim either in these new BCG unresponsive patients or any kind of longer follow-up? That's the second question. And I have a follow-up on first one.

Okay. So thanks, Stacy. I'm going to ask Jackie to handle the first question, which is about enrollment and the percentage of patients in the unresponsive that we anticipate will be concomitant papillary. And then I'll take the second question about any interim updates.

So as far as expansion efforts, we had mentioned on our call when we -- back in December that we had undertaken global expansion back in early 2024 and that we were going to start to see that pay off towards this time period. What we're seeing is that our U.S. sites from an academic perspective, where we have long IRB and cancer committee time lines have now started to open up. So that's driving enrollment. As we had mentioned, unresponsive patients are concentrated in some instances at these larger academic centers. And now with those open, we are seeing an uptick in recruitment in the unresponsive setting. That's coupled with, again, our global expansion into the countries that we had mentioned in Latin America and also expansion into the Asian countries that we had targeted as having reasonable numbers of patients that were BCG unresponsive. As far as what we believe will be the split between papillary -- concomitant papillary and CIS only, I think that we will continue to enroll concomitant papillary patients into our trial. We are not excluding them. And what we are doing is making sure that the right patients are coming into this trial, and those are those patients that can actually benefit from a drug like 002. I do think that as you look at all of these studies in the NMIBC BCG unresponsive space, we do see a larger number of CIS-only patients. And I think that, that is just the way that this is in terms of the epidemiology of who actually qualifies for these studies. So I think our split will likely be consistent with what other investigational programs that are more advanced than us have, which is somewhere around the 25% mark.

And then to take on your second question, while this is an open-label study, we still have obligations related to data integrity. We are very focused on being as transparent as we can with our shareholder base and are committed to certainly the 25-patient preplanned analysis in December. And what I can say is that, that will be as robust a data set as we can possibly deliver at that time. So it will definitely include these patients, which will be further along in their treatment profile as well as patients that we have been enrolling throughout the first quarter of the year, those will be evaluable at a longer time point than 6 months. We got to be careful that we don't take a look too often because this is a registrational study.

Okay. That makes a lot of sense. And then our last question is on kind of your first-line approach. In our past discussions, docs have always been really excited for additional first-line agents versus BCG and maybe chemotherapy. So can you talk about that BCG patient population approach? What have been KOL views on the data feedback you've been hearing at AUA?

Sure. So I think evidence of answer to your question is in the poster itself. You can see that we enrolled a lot of naive in the same time frame that we were enrolling in responses. In fact, our naive proof-of-concept cohort is fully enrolled and in fact, over-enrolled. We originally were going to enroll 27, and we got 31 into that cohort. The reality is that this is a product that has all of the characteristics that drive adoption of BCG. It's easy to use. There are no special handling requirements, Nurses and those who administer the product in the practice do not have to change behavior, and that is driving a lot of enthusiasm in the KOL community. I think the fact that also this is a slightly better tolerated bacterial immunopotentiator, there's a lot that you have to do with BCG that you don't have to do with 002, and that, too, drives a lot of enthusiasm. So it's not only that we're hearing enthusiasm for 002 and its unique characteristics, but we're actually seeing evidence of that enthusiasm through the rapid enrollment that we experienced in the Cohort A of the study.

And our next question will come from Leland Gershell with Oppenheimer.

Great to see the continued positive data for 002. A few questions from us. With respect to the baseline characteristics, I know it's just a handful of patients in the BCG unresponsive who you had reported on. But could you share maybe some more with respect to the amount of prior BCG exposure or other therapies those patients had before coming into the trial? And maybe sort of in correlation with that, Jesse, is there a concern that as time goes on and the amount of development work in the space continues to ramp up that the patients coming into trials may be more challenging, again, because of patients that have already been through perhaps other studies or fewer patients available because of the demand for clinical development? And then I have a follow-up.

Yes. Leland, that's a really good question. And it's something that we have begun to sort of see across the -- both the unresponsive, of course, but even the naive landscape of patients that we've treated. Yes, there are a number of patients, some who are in long-term durable response in the unresponsive cohort, who were very heavily pretreated. We have patients that have obviously failed BCG, but have also been failed by Gem/Doce, by pembrolizumab. We have patients that have failed recently approved NMIBC monotherapies. And look, as more products are approved, which we anticipate will be the case, we anticipate that we'll be seeing a lot of patients that are fourth and fifth line. I think that supports 2 things. First is there is no ultimate or final number of treatments that patients will go through or that will be offered to patients. If somebody wants to save their bladder, they're going to save their bladder and they're going to try whatever they can. We're seeing that in these patients. As we move out into more formal data releases that are tied to the protocol, most notably the preplanned efficacy analysis for December, we'll spend a lot of time delivering granular details on some of the baseline characteristics of patients because the reality is this, is you've had a number of BCG unresponsive patients treated in the last 4 or 5 years in registrational studies. Now you have commercial products. It just stands to reason that as we enroll the tail end of the study, we're probably going to see patients that have more and more experience with treatment before they get to 002. And based on what we're seeing so far, that doesn't scare us off, but I think we have to be sanguine about what exactly we're getting. And then a final note, in our naive cohort, while those patients have not been treated by BCG in the last 2 years, remember that the inclusion criteria for a naive patient in that cohort is -- has not had BCG for the past 2 years. So we do have patients in that cohort that have experience with BCG. But also in the naive cohort, we have a majority of patients that have undergone previous rounds of chemotherapeutic treatment. So in the study, there are very, very few sort of first-time diagnosed BCG naive patients. And again, we're seeing what we believe are very competitive and compelling response rates in the naive patients despite the fact that, again, almost all of our patients have undergone prior treatment.

That's very helpful. And then I just wanted to check in on upcoming plans broadening development of 002 in terms of the systemic priming and perhaps combination. I think you had mentioned moving those forward into starting trials later this year. Just wondering if you could share any further dates for us there.

Yes. Thanks for bringing that up. We're obviously very excited about the potential to kind of change the paradigm of drug delivery for patients with NMIBC through systemic administration. There is a lot of literature out there and studies out there that utilize a priming dose to sort of kickstart the adaptive immune system. I'm thinking about the SWOG S1602 study. So we're not necessarily with priming doing anything that is particularly super novel. But what I can say is that we've completed the nonclinical work necessary to understand both what that priming dose would be as well as the priming regimen. And we'll be able to talk more about that as we get closer to launching the 2 additional cohorts that we're discussing, Cohort C and Cohort D, Cohort C being a priming dose followed by intravesical installation and intravesical maintenance as well as Cohort D, which would be a priming regimen followed by intravesical administration and then subcutaneous administration for a 2-year maintenance schedule. So more to come on that, but that obviously would, in our view, as we think about what really impacts these patients' lives, once you're sparing cystectomy or once you're sparing the bladder because you've got all these really strong agents in the unresponsive setting, how else might you improve the quality of life of patients. We know that most oncology settings as they mature, move to combo therapy, and we're ready to participate in that. We'll be announcing some combo work kind of later in the year. But I want to point out that we have no overlapping toxicities with any of the agents that are either approved or that are in clinical studies and just thinking that this will probably become a combo market to drive towards higher and higher response rates, we're very well positioned there. And again, can lean into that systemic possibility as a way to really synergize in a combo setting. So more to come on that, but that really is animating the team right now.

And our next question will come from Li Watsek with Cantor Fitzgerald.

I wanted to add our congrats as well. I guess 2 from us. I'm wondering if you can just comment on the reduction rate and the salvage rate that you've seen with 002 relative to the competitors. It does seem to us that both rates are high. And then anything you can comment on your interactions with the agency on the trial design in the naive patients? Any disruptions or changes that you've seen so far?

Jackie, why don't you take the first one, just characterizing what we're seeing with reinduction, and I'll comment on the FDA.

Sure. So our rates of reinduction are extremely encouraging. As you mentioned, we do have high rates of patients who are able to enter into response or complete response at the 6-month mark. And then what we're seeing is that once reinduction is done and they are responders at 6 months that they go on to be durable responses at 9 and 12, which I think is really important. I think that with a drug like this and what we know from nonclinical work and just really, again, relying on what we know in terms of similarities to BCG, I don't think we're surprised by seeing that a reinduction course allows for patients that are in need of that additional treatment to get to a response. I think that we would like to be able to say that reinduction is not necessary for everyone, but there's something about these patients' biology that requires them to have that extra dosing. And for us, the fact that we are able to actually put them into a response state and then keep them in a response state is really encouraging to us. And what we're seeing is residual CIS. And I think if you look at the rechallenge of BCG and what's in the guidelines and why it's there to say rechallenge with BCG, you're seeing the same thing with 002, and I think that's mechanistically driven.

And as it relates to your question on FDA, just to sort of take a step back, we are in mid- to late-stage development in all 3 of our programs in 3 different divisions of the FDA. In NMIBC, we're in OTP. In the choline program, we're in hepatology and metabolic. And in the lymphatic malformations program, we're actually in the vaccines division. And what I can tell you is that we have not seen any disruption across any of our programs because of what's going on at FDA. I mean, hats off to the folks that are doing their jobs, keeping their heads down over there. It's got to be a tough environment, and we're just incredibly impressed with the professionalism and the willingness to engage with sponsors despite all the noise that's going on sort of at the macro level. So a big shout out to our friends and colleagues at the FDA. They are doing their work and engaging with us as if nothing has changed. So that's about all I have on that.

Our next question will come from Charles Zhu with LifeSci Capital.

Congratulations on this update. Maybe one that hasn't quite yet been asked yet. Can you also talk about just given your high reinduction into CR rate, maybe some color around like what proportion of patients at 3 months that were perhaps nonresponders you would expect to be eligible versus ineligible for reinduction and some color on what kinds of patients get these versus those that do not?

Yes. I'll comment quickly and then ask Jackie to kind of round out my views. I think it's important to take a step back and remember that we are subject to mandatory biopsy at the 3-month time point, and we're the only sponsor currently in development or sponsors that have already had their drugs developed or approved that have a mandatory biopsy at 3 months. We know that biopsy versus visual inspection followed by cytology is going to capture more cancer. We've had cases where a physician has called a CR at 3 months based on visual inspection and was contradicted by biopsy. So our sense is that at the 3-month time point, we're just seeing more patients that have that last little bit of residual CIS. We aren't seeing papillary recurrence or high-grade recurrence. What we're seeing is patients that started off with baseline CIS or CIS with papillary. And at the 3-month time point, there is after significant tumor regression, a smaller lesion that is requiring biopsy either because it was noted by the physician -- I'm sorry, that requires reinduction, either because it was noted by the physician or because it's picked up by biopsy. So I think reinduction -- remember that it's 3 additional doses on top of what is already a 3-dose maintenance regimen at that 6-month time point -- rather at that 3-month time point. So it sort of is just an extra little boost. It's not really like you're starting over again as it were. And again, I want to reiterate, we have not seen any null responders. Everyone that has undergone reinduction has, at a minimum, visual tumor regression. Did I get -- did I answer your question, Charles?

Yes.

And our next question will come from Andres Maldonado with H.C. Wainwright.

Congrats on the data again. So first question, given a lot of noise here at AUA comparing 12-month CR rates towards competitors, curious on what -- how should we be thinking about the magnitude of how those rates come down in the real world and what that means for 002? And then a follow-up question would be, given the significant genetic heterogeneity and high-risk features seen between cyst versus papillary patients, where should be our expectations on how 002's profile may diverge in these 2 patient subsets going into the future?

Yes. Thanks, Andres. That's a great question. So your first question in terms of cross comparisons of 12-month CR rates, the reality is that all of these programs, these registrational programs in BCG unresponsive differ pretty significantly, whether it's time points for mandatory biopsy or sort of visual or baseline characteristics, what constitutes the BCG unresponsive patient, et cetera, et cetera. So it starts to get a little dangerous to compare across and within all these studies. But of course, people want to understand what sequencing looks like. So what I would say is we have pretty good information from BCG in terms of long-term utilization that at 12 months, if you're at sort of a 50 or 40-ish percent response rate, that's a pretty significant improvement in durability versus what was previously available before new drugs were coming into this NMIBC setting. And when you're talking in the 40s and 50s, you got to remember, it was only a year ago that the best anyone saw at 12 months was in the 20s, right? So this industry is doing a lot of work on behalf of these NMIBC patients to drive towards great response rates. I think at the end of the day, every single oncology study sees some degradation of the published CR rates in the real world. And also, there are patients that do better in the real world than those that were in the study. So I think right now, you've got 2 major folks out there that are solidly in the 40% range. We're at 67%, but we know that, that will probably come down as the -- as we include more concomitant papillary patients. We know that those patients drive lower overall response rates. You can look across the swimmers plot of our naive to sort of get a sense of what that looks like. We know that cross comparisons between naive and unresponses, it's the best we have in order -- in terms of what we can utilize to predict where our unresponsive numbers wind up as the end goes up. And look, in the naive population, we're at 90% CR rate in CIS only, and we're at 60% in the concomitant papillary. 60% at 6 months is a medically meaningful number and competitive there. If those were the numbers that we were demonstrating in the BCG unresponsive setting, that to me represents sort of a floor of where we would expect to see the unresponsive numbers come in. And so if we continue to be in the 80s or around there at any time, and we're 30 percentage points below that in the concomitant papillary, that would be able to give you a sense if we enroll 25% concomitant papillary, there's an algorithm you can run that would be sort of allowing you -- that would allow you to kind of land at a final number there. And that number -- things have to go pretty badly for us to get to a level where our response rates are functionally irrelevant.

And our next question comes from George Farmer with Scotiabank.

I was wondering if perhaps you could comment on the 2 patients at the 9-month mark that have yet to reach the 12-month mark that are still in CR. Just -- I know we're talking about small patient numbers, but just thinking about what maybe that -- the 12-month CR rate in these first 5 patients may look like? And also, could you comment a little bit on any potential impact of Pfizer's data that we saw at AUA combining their PD-1 inhibitor BCG in high-risk naive patients?

Yes. Jackie, why don't you talk about just sort of what we describe as response dynamics, right? It's less a canonical number and more just sort of an observational number in terms of when a patient is in response and what that has demonstrated.

Sure. So I think if you look at the swimmer plot, you can see that we really do have good durability from 9 to 12 months. There's nothing about these patients that give me pause to think that they could not continue to be durable at 12 months. In terms of baseline characteristics, in terms of prior BCG exposure, they're very consistent with the 2 patients that have gone on to be durable at 12 months. So I think that there's nothing about these patients that make me think that they couldn't be responders at 12 months. I think this is not a cure, right? So we're going to have patients that are in response and then at 12 months are no longer responders. And that's true of all of these drugs, whether they are the investigational drugs or the approved drugs. So we're optimistic and encouraged by what we've seen so far, and we think that, that will continue.

And I'd layer on top of that, this is purely observational and is perhaps not even hypothesis generating. But George, as you look at the sort of the top 4 patients on the swimmer plot that are either 9 or 12-month evaluable, you'll see that of the 4 that were still in response at 9 months, 3 were reinduced. And so our -- we look at that and ask ourselves, does that high reinduction rate correlate with some type of enhanced durability. That will be -- we're not -- again, we're not positing it as a hypothesis, but it is an observation. And so as that expands, we'll want to try and understand if reinduction not only contributes to what we'll call salvage of a 6-month CR rate, but potentially, is there something associated with durability from that reinduction.

Okay. Great. That's helpful. And yes, maybe just some comments on what we saw with Pfizer study at the 3-year mark in naive. Is that -- do you think that could have any broader impact on what the true patient size for the unresponsive segment might be?

Yes. I'm going to be honest and say that we are still kind of absorbing the CREST study data that Pfizer put out yesterday. Obviously, we're still here in Las Vegas and have a poster and a panel still today. So we're still here to do the work that we set out to do, which is to engage any KOL that will talk to us, and we're very lucky that our schedules are quite busy. Look, I think at the end of the day, what we're seeing are contemporary data sets that include BCG monotherapy. And some of the studies that are out there that use BCG as a comparator have interesting response rates and some have different response rates. And so we look at that more as a, again, I won't comment on sort of where an ICI plus BCG regimen sort of fits from a practice perspective or an adoption perspective. But when you get a product approved in a patient population, that does raise the question of will that be a part of FDA's consideration as we think about addressing the naive population. If one of these ICIs plus BCG get approved in the naive setting, then you've got potentially a therapeutic that all adoption questions aside might in the eyes of the agency be a reasonable comparator in a naive study. Too soon to tell, and our engagement with FDA is already far enough along. But we've always said that our future strategy in naive is dependent on FDA allowing us to design a study that is practicable and sort of easy to implement and sort of replicate real-world experience for the naive patients.

I show no further questions at this time. This will conclude today's conference call, and we thank you for participating. You may now disconnect.

Thank you.