UroGen Pharma Ltd. (URGN) Earnings Call Transcript & Summary

Okay. Thank you. We'll continue with the next session. I'm Paul Choi, and I cover SMID Cap Biotechnology here at the firm. It's my pleasure to welcome UroGen to this session. To my immediate left is Liz, CEO; and at the far end is Mark, CMO. What I'll do is maybe give Liz a minute or two to maybe do some introductory remarks, and then we'll get into Q&A. We'll do that.

Sure. Yes, that would be great. First of all, I just want to say thank you for having us here. Always a pleasure to be here. Very excited about UroGen and the place that we are in our company's history. It's a real pivotal year for us. I think a lot of people know that we're awaiting some data later this week, so it's a big week for us. And our company was really founded on the idea that patients with urothelial cancers deserve better. And we developed a technology called RTGel technology, which allows for medicines to dwell longer in the cavity. And so we're really happy that we have one medicine on the market today called JELMYTO, and anxiously awaiting our second medicine, UGN-102 for a low-grade intermediate risk non-muscle invasive bladder cancer. And I'm happy to be here. And again, thank you for having us. Thrilled to have Mark with us. I always blame him for the reason that I joined the company because when he talked about the high unmet need in this space. But Mark, maybe just introduce yourself, it would be great.

Thank you, and thanks again for the invitation. Hello. Great to be here. Mark Schoenberg, Chief Medical Officer of UroGen. I've been with the company for 10 years, since even before our first drug was approved. I specialize in taking care of patients in my other job, patients who have urothelial carcinoma. So the mission of UroGen and the drugs we're bringing to help patients are very dear to my heart. So very nice to be here and looking forward to the conversation.

Okay. Great. Liz, you actually sort of touched on my first question here, which is people are focused on bladder cancer and urothelial cancer. But really, I think at your core, UroGen is sort of a platform company. You have this central technology, which you could theoretically leverage into multiple areas beyond oncology. But just maybe, if you could maybe just explain sort of the origins of UroGen and just how the RTGel technology was developed and just how you initially developed it in JELMYTO?

Yes, sure. And it's really important to understand how urologists treat urothelial cancers, right? And they treat them locally. So very different than oncologists and other cancer settings. Urothelial cancers really get treated locally with local medicines. The problem is because of the urinary canal just gets voided out very quickly. And so these urologists, then in Israel, and our company was founded in Israel said, wouldn't it be great if we could figure out a way for medicines to stay longer. And that is basically what happened, right? And these chemists went about developing the RTGel, reverse thermal gel, because it's actually liquid when it's cold. It gets mixed with an active. And we've actually demonstrated with our technology that there's pretty much not -- we've been able to mix pretty much all types of different therapies with it. So we can do small molecules. We can do large molecules. We believe we can put a vaccine. We believe IO agents in our CTLA-4. So we have a lot of opportunity to really advance the way that these cancers are treated. And to your point, not just for urothelial cancers, but other diseases in urology, but then also other adjacent cancers like rectal cancer as an example. So we believe that the technology has a lot of broad utility. We've been focused on urothelial cancers, but when we think about our company and building a long-term growth company, we absolutely want to look at more products in connection with our technology as well as moving it into other areas.

Okay. Great. And for people who are new to the story, people forgot your chair, or if they don't know, your chairs are [indiscernible], a legend in the biotech community here. But your first application of RTGel has been obviously for your approved commercial stage product, JELMYTO, which is approved for upper tract. And can you maybe talk a little bit about how the launch experience has been? You've launched a few years ago. It's a small opportunity versus some of the things that are ahead of you. But can you maybe describe the commercial progress to date and just sort of the trends you're seeing in terms of recent JELMYTO commercial performance.

Yes, absolutely. And JELMYTO is for upper tract urothelial carcinoma. And again, low-grade upper tract urothelial carcinoma. And the reason I sort of put an emphasis on the low-grade is these patients, first of all, the median age is 74, and because either you can't reach the tumor or you're not able to ablate it or it comes back, these patients were losing their kidney. And when you think about kidney function, we know that age is a driver of reduced kidney function. So even though you can live with one kidney, you don't really want to if you don't have to. So the idea of being able to actually treat these medicines and be able to maintain the kidney was a big driver in the success of JELMYTO. So we launched JELMYTO actually in 2020, right into the head of the pandemic. So we weren't able to actually have an in-person launch. We did everything virtually. It has continued to grow. We have about a 12% penetration today. It was not as fast as we expected. Part of that was driven by the pandemic, but also part of it is driven by the fact that there's only 6,000 patients who have this every year, and you've got 6,000 neurologists, right? So it's on a situation where in a rare disease, you can go to the top 20 institutions and they treat all the patients, right?

It's not a concentrated market.

It's not. It's a mile-wide and inch-deep. And really finding these patients has probably been one of the biggest challenges. But the good news is, we have what we call patient enrollment forms. So for every patient we've had, we've hit records on our patient enrollment forms in Q1 of this year. We've continued to see double-digit growth year-over-year and we expect to continue that. We've sort of guided to $200 million to $300 million peak revenue, but it's a slow, steady growth, and that's what we've seen, introducing new sites of care so that we -- wherever the patient goes that we're there is really important to our continued success.

Could you maybe elaborate a little bit on the tweaks you've done since the launch to further implement penetration? You talked about relatively low market penetration relative to the opportunities which your commercial is annualizing at, roughly half of your peak sales potential, roughly, give or take here. So just kind of what you've done and what you think you might need to do to further drive adoption here and awareness?

Yes. I think the #1 thing is around generation of data. When we launched, we launched on one single-arm study, 70 patients. But since then and actually recently at the AUA, and I'll ask Mark to talk about the data that was presented, we've gotten a lot more data. And actually, the experience that physicians and patients are having post the clinical study is actually even better than what we've seen in the clinical study. But Mark, maybe just talk about the increasing data that we have with JELMYTO.

Yes, one of the really nice developments in the world of JELMYTO has been the generation of real-world data as more and more practitioners have become familiar with the asset. And what we've learned, and some of this was actually presented at the May Annual Urological Association Meeting, was that maintenance therapy appears to be beneficial. So we now have very concrete evidence, although it's a small group of patients, that maintenance therapy, which was available in the original clinical trial but not used by investigators, is a real benefit to patients. Also the durability of response turns out to be exceedingly long. Patients who achieved a complete response after surgery typically relapse within about 6 to 12 months. In the JELMYTO population, if you get a complete response, you can be disease-free for more than 4 years. So these are really sort of incredible data in the context of the contemporary treatment of this population. And then finally, it's becoming clear that since JELMYTO can be delivered as it was in the clinical trial in a retrograde fashion with a catheter passed through the bladder up into the kidney or through a tube passed directly through the back by a radiologist into the kidney, just called a nephrostomy tube. The adoption of both method seems to be getting traction in the community and there was a very nice video by investigators at University of Michigan, detailing the exact steps involved. So people are becoming more and more comfortable with the variety of ways you can deliver this medication in practice.

Okay. Great. I don't want to steal your thunder because you obviously have a new event coming up later this week, but I think the regular pattern we've seen among biotech investors is when there's a catalyst or a data set coming up, the interest in the stock and the company, obviously, it goes up exponentially versus companies that don't have updates or catalysts coming up. And in your case, it's the 12-month durability data from the ENVISION study. Can you maybe just, first, remind us sort of how to think of -- what is this data set? How much of data will you disclose? And sort of what do data mechanics look like? And maybe we'll start there just in terms of the process and mechanics and then just sort of understanding the sort of clinical expectations.

Sure.

So I guess I can't say, no comment. So thanks for the question. So this is very exciting for us. The ENVISION trial is the pivotal trial that will complete our clinical data package for submission of our NDA for UGN-102, which we expect to submit in September of this year. And we're very excited because as we announced last year, in a very large study, 240 patients who received UGN-102 for the treatment of recurrent low-grade intermediate risk disease, the complete response rate was essentially 80%. It's a very high clinical response rate for this group of patients. And so now we have the privilege because we've really committed to the FDA to do this to present data on durability response with a minimum of 12 months follow-up from that initial evaluation time point, which as you will remember now, is 15 months into this trial. So a very robust durability data set. So we're excited to offer those data on Thursday. I hope everyone will turn into the webcast. We'll have safety data as well. And just to remind everybody, this is the culmination of a long clinical development program that included a Phase II program called OPTIMA II and then ATLAS, which is a randomized trial against the standard of care, which is transurethral resection of the bladder tumor. In those 2 predicate trials, new and recurrent patients were treated. So we have a robust data set that includes patients with de novo disease, recurrent disease, but remember that the ENVISION trial is focused on recurrent disease.

Okay. So it is, again, a treatment experience population. And again, maybe just in terms of minimum follow-up for this population, correct?

The time that patients were evaluated 15 months.

Only in recurrent population?

Yes. ENVISION is a recurrent population. Yes.

Right. So maybe before we get into sort of data and thinking about durability response here, can you maybe remind us just in terms of the patient population and the demographics and how does this patient population compare relative to the one that you're currently tackling or addressing with JELMYTO?

Right. So with JELMYTO, it's the upper tract urothelial carcinoma. In here, it's actually bladder cancer. And what's interesting about is when we talk about the complexities associated with delivering JELMYTO, which has been one of the challenges, it's actually much easier with bladder. And it's mainly geography or anatomy, right? So you don't have to manipulate the upper tract. It's very simple to access the bladder. But they're very similar in the sense that they use our RTGel and they use mitomycin, but it's a different issue and a different volume because the bladder is much bigger. So we, even though the disease is very similar from a genetic and molecular makeup, so we expected to see very similar results. And I think one of the things that I can say about our clinical experience, it's been very consistent. We've seen very consistent data, both in our clinical studies in real-world use in JELMYTO, with JELMYTO on the upper tract and with the UGN-102 in the bladder. And so that gives us a lot of confidence about what we'll see going forward and how these medicines will impact patients in the real world. So we're excited to bring a very similar but yet different product. And the main big -- other big difference is you've got 6,000 patients in upper tract, you've got 82,000 patients in bladder. And why that makes such a difference from a commercial standpoint is finding these patients is so much easier. Every urologist sees bladder cancer patient. Every urologist sees these low-grade bladder cancer patients. And every urologist know that they have these patients that they consider to be frequent flyers, those that typically recur and those that are intermediate risk. And so physicians have experience with those patients and are interested in seeing UGN-102 to provide a new therapy option for these patients who are going through these repetitive surgeries right now.

Okay. And just to remind us, Liz, that 82,000 is inclusive of all grades and various treatment paradigms, whether it's post-BCG or intermediate or higher risk? Or is that just the lower?

Actually, no. It is both de novo, so newly diagnosed as well as [indiscernible] of the 80,000 is the newly diagnosed. So every year, about 20,000 are diagnosed, and about 60,000 recur every year. So they come from the recurrent pool. Mark talked earlier about the fact that ENVISION is just the recurrent patient population. We believe that the bigger majority of the opportunity for UGN-102 is in the recurrent patient population because these patients have gone through a TURBT and then they come back at the point they recur and they'll see UGN-102. But no, that is just our targeted. You're actually looking with bladder cancer in the United States alone.

Great. Mark, maybe coming back to you. You, on your most recent earnings call, recently talked a little bit about the ATLAS data and just reference that as a potential proxy for ENVISION. Remind us that there are obviously some major differences in terms of both the population and studies in ATLAS versus ENVISION. But just how should we think about ATLAS as potentially being representative for the outcome here with regard to durability in terms of the like-for-like population?

Sure. So ATLAS, there is a subpopulation in ATLAS of patients who had recurrent disease when they entered the trial. And in a manner that is completely analogous to the ENVISION population, these patients had on average about 2 prior surgical procedures. That's also consistent with our experience in the ENVISION population. So they looked at the get-go, like the ENVISION patients we've enrolled and their experience we think is reflective of what to expect of the durability from the ENVISION population. In that recurrent subset in ATLAS, the durability of response at 12 months was 66%. And so we are expecting that the durability in ENVISION for the entire population, because it's entirely recurred, would somewhat mirror the ATLAS experience as well.

Okay. Great. One of the things I think that investors also are diligent seeing at the moment is just, what does it mean for your typical -- to the degree there is a typical practice in urologists in this field, what does something like that, a data in the mid-60s percent type range mean? What is the clinical meaningfulness of that? And just how does -- I guess, as you speak to KOLs and physician practitioners, how does that sort of number resonate versus some of the benchmarks that are out there for TURBT?

Go ahead, Dr. Schoenberg.

I think what we've learned from talking to KOLs, and I'll speak also from my personal experience, this is an older population of patients, whom we are all, as physicians, well aware are ill-served by repetitive surgical intervention. There's a variety of morbidities associated with TURBT that's very familiar to urologists in addition to an emerging set of information about the morbidity of repetitive anesthesia in this population, which actually can contribute to cognitive decline over time. So we know about the morbidity of the standard of care. Here, we are offering both physicians and patients the opportunity for an in-office nonoperative alternative to repetitive surgery for a group of patients who have a very minor risk of disease worsening over their lifetime. So here, because the goal is to both treat the disease and then for stall recurrence, we have what we think is a very cogent alternative to the standard of care, which we think will be appealing, not only to physicians who are familiar with the procedure and its downsides, but also the patients who, as we talk to more patients and we are doing that, inform us that while surgeons think this is a relatively minor procedure, patients don't. And Liz, you might want to actually...

A couple of comments. One, we actually did a questionnaire in the ENVISION study specifically because we wanted to get feedback from patients, and over 90% of patients preferred. These are patients that had already had a prior TURBT at one point and they overwhelmingly preferred UGN-102. And a lot of it was driven by exactly what Mark said, that they could go on about their daily lives. And so they didn't have the type of bleeding and they could leave their appointment and stop at the grocery store on their way home versus if they had a TURBT, they were home, they were in bed, there was weeks of time. And we'll see some of that at our event on Thursday. We actually have a patient who was in our study, he's going to be there and I'll get to talk to him. But we also have a physician from UNC, who will talk about the data from patients. So we're excited about that. And I think physicians want this as an alternative. And Mark, correct me if you disagree, but the data that they've seen so far is actually much better than they expected. I think it's better than we expected. It's better than the physicians expected. And so they actually -- their bar was even lower than ours. We've always said for years, as we've been talking, 50% and 50% of them are still in response to 12 months. That's meaningful. Physicians have said even lower than that, but then our data has shown that it's actually more, it's better than that. So with that robustness of all of the data that we have in connection with that. And physicians have said, look, in the beginning, I'm going to use it in 3 -- they have low-hanging fruit. I'm going to use it in 3 patient populations. We know it from pure data, 23% of patients have 5 or more recurrences. They have what they call early recurs and they are estimating about 25% of their patients early recurs. So they come back to their 3 months, 6 months, 9-month visit and they've already recurred. And there's a group of patients, as Mark talked about earlier, that really should not be going through surgery. And for those patients, when you put those 3 buckets together, physicians have told us that's who I'll try UGN-102 on first. And then I think from there, they'll expand it, assuming they get a positive experience. And we also believe that engaging the patient, especially after the feedback we got from the study, that we would want to do that and the patient will have a voice in that decision as well.

Okay. And again, maybe just to remind the audience, this is 12-month data in a responder population, not the entire ICT population. Okay, very good. So knock on wood, the data holds up here. And you can advance to the regulatory stage. You talked about filing basically by the end of next quarter, completing your filing here. And so maybe sort of if the data is consistent with ATLAS, how do you think about what the timeline post-acceptance of filing might look like? You had a priority review for JELMYTO, just something like this I guess in your mind, potentially support a similar priority review here. Or should we think about more of a regular review cycle?

Mark, do you want to talk about the timing?

Sure. So we'll submit, as I said, in September. And we will submit for -- we will apply rather for priority review, and we're hopeful that we'll get it based on the strength of our data. And assuming that, and we've actually been told that we will be taken to an ODAC because this is paradigm-changing therapy. And it's not, I think, a criticism of what we're doing, but simply a way of having the FDA get some comfort from the community that this is both an acceptable and actually a desirable alternative to the standard of care. So we look forward to that ODAC actually, talking about our therapy. And then I think, if granted priority review and a successful application and approval by the FDA, then we would launch at the end of Q1.

Okay. Great. I guess another question is, since you brought up the ODAC and just thinking about changing hearts and minds of a community that's been used to TURBT for a couple of generations now, I guess, in terms of training of urologists. I guess what data, as you think, that might come up in an ODAC versus historical are sort of key in your mind?

Yes. I mean I think the safety profile will obviously be key to that conversation. And when I say safety, I'm not simply talking about local symptoms or the things that bother patients, but also things that concern physicians and particularly oncologists. Mainly concerns about the forward progression of disease, what percent of the people who had UGN-102 got into trouble. And then we know, thankfully, that particularly because of the population we're working on, the likelihood of developing worsening disease is low and the likelihood of developing stage migration to actually invasive cancer is incredibly low. So we're not expecting to see those type of safety signals. But we will certainly be asked about that. And based on what we know from our predicate experience, we're pretty confident that we'll be able to answer that in a very affirmative and reassuring way, both to the FDA and the ODAC.

Okay. Great. I'm sure you guys will do lots of practice or mock with that over fourth quarter and first quarter.

[indiscernible] has already started.

Great. Okay. Maybe question looking forward, hoping for approval next year and launch, how you think about where your commercial footprint is in terms of your sales force and marketing spend potentially for UGN-102 launch? And how can you leverage the existing infrastructure in terms of existing sales call points versus what you may need to do in terms of additive increases to the sales force?

Yes. The great news is that it has about a 95% overlap. So those physicians, as I mentioned before, all of these patients really treat the UTUC patient and they treat the bladder cancer patient. Having said that, we have about 42 reps today, and we're going to go to 60. A lot of that driven frankly, by geography. You need the reach and frequency, you need to reach these patients, the physicians on an ongoing basis. So we'll move. We'll add a region to our current organization. And we'll have like 1 to 2 of field reimbursement manager, a clinical nurse educator, and so the support staff to go along with those. So again, we expect to have about 60 reps, about 8 regions across the country, and we believe that we will be able to capture 80% to 90% of the patient population.

Okay. Great. Maybe also looking a little further ahead in terms of the -- on the commercial side, talking a little bit about coverage and J-codes as needed and so forth like that. You obviously have some experience with that with JELMYTO. Maybe just in broad strokes, how do you think about the cadence of that sort of developing over time post an approval and just sort of what sort of major landmarks would be in terms of getting payer coverage in what is largely a Medicare age population?

Yes. No, look, great question. The good news is, is that when you get an approval, Medicare does cover medicines, they get FDA approval. But you are right, in the beginning, for the first 6 months, we'll have a miscellaneous code. And that does call some pause for physicians, particularly in the community practice. So much like we saw in JELMYTO, we expected in the beginning, more institutions would use it because they don't worry about reimbursement as much. In the institution, they actually can get reimbursement sooner, they'll get a C-code versus the J-code. But it takes, again, about 6 months. We're actually very fortunate now because they used to -- they only looked at J-codes once a year, now they actually do them every quarter. So we should, for the first 6 months. So you're right, in the beginning, we expect, until we get that J-code, it to be a little bit slower, be more toward the institutions. But then we really expect that this is a community-driven medicine, right? Because as Mark said before, it can be done in the doctor's office. It doesn't even need to be done by a physician. It can be done by an extender. So one of the first things we'll do as soon as we get EOBs or explanation of benefits, we take out the patient identification information and really show the practices that they can get reimbursed. We also have other programs in place. We have [ dating ] that we provide. We actually have a very generous return policy. So if the drug gets delivered and, for some reason, the patient can't show up, they're not out that amount of money because obviously, that's very concerning. Having said that, the practice economics for the practice is actually very positive. So if you think about it from a perspective of being able to, again, see these patients in the office, they'll get reimbursed for their CPT Code, for the installation, for the visits and for the drug, right? So it's a buy-and-bill drug. They just have to get over that initial hump and get to the point where we have a permanent J-code.

Okay. Great. I want to talk maybe just briefly, and you and I have had conversations on this before. It's just where your current thoughts are in terms of product profile relative to JELMYTO. For those of you who are unfamiliar with JELMYTO, there is some mixing involved, at least with the initial product profile and just what you can do in terms of make the physician and office experience the easiest -- as easy as possible. And just how you think about the product profile. Do you want a premix drug, the whole setup is ready to go and you just unwrap it and deliver the therapy? Just kind of where is the current product profile and shelf life and things like that?

Sure. No, great. As you know, when we launched JELMYTO, that was other challenge. You actually only had 8 hours from the time the drug was mixed to the time it needed to be instilled into the patient. And then we were able to get it up to 96 hours for JELMYTO after a couple of years on the market. Actually, we will be launching UGN-102 with 7 days. So there won't be any need to rush. We will have it mixed or you can mix it yourselves. And really, we were initially going to have an all mix. But the hospitals prefer to mix it themselves. They don't want someone else to mix it, they want to mix it themselves. So we will have both, so you'll be able to order it. And as I said, it's simple as to deliver JELMYTO because you need a fluoroscopy. You need to have certain equipment. You're manipulating the upper tract. It's just not like that for UGN-102. So this is something that Mark can expand on this, but 95% of what gets done, they do it on an ongoing basis. So they're used to giving these intravascular therapies in their office. So being able to do it -- and actually, we did a small home study. I don't know if you remember that. A small home study, really just to demonstrate that you can give it at home. Now we don't expect much uptake at home, but it's available. So hopefully, if a patient can't -- is in a situation where they can't come to the doctor's office, that they would be able to use it through a home health nurse. And we were able to demonstrate the ease of use, and that was actually the purpose of the study, it was to demonstrate how easy it is to use. And so we are definitely doing everything we can to make the ease of use as seamless as possible for the physician office because that's very important.

Great. We still haven't seen the longer-term ENVISION data yet, but I do want to actually talk a little bit about life cycle management as you think about 102. And just how do you think about advancing it into other populations, whether it's high risk, post-BCG, whatever you think is relevant here? And just sort of what are sort of clinical development plans as you're thinking about life cycle management?

It's a great question and something we spend a lot of time talking about. There's actually a lot of different populations where you can move UGN-102 and into the high-grade space. You can do it in combination with our CTLA-4 that we've talked about. One of the areas that I'm interested in is even actually the larger low-grade patient population for those unwilling or unable to go through surgery, right? We talked about the fact that the intermediate risk is only about 20% of the patient population, but you have patients in the broader patient population that shouldn't be going through. There's a lot of opportunity for UGN-102. We also have our next-generation formulation that we'll be launching. And so there's a lot of interest by physicians and by us internally to do more with UGN-102. Mark, I don't know if I missed something there?

No, that was great. I think Liz's remarks really demonstrate or really showcased the fact that we think there's a lot of potential for other underserved populations of patients. And we'd love to work on those and we intend to do that as we move forward.

Okay. I want to touch a little bit, Liz, on something we were talking about before the session, which is just sort of investor interest in the space has picked up just because there are some novel companies or established companies that are working in different areas of bladder cancer that I think have sparked greater investor interest in the category versus in recent years. And so as you look at the competitive landscape, Liz, whether it's a CG or a J&J, tell us advice, maybe. How do you think about the competitive landscape versus advancing life cycle management for your existing programs and maybe cutting off potential competition at the past?

Yes. I think, look, it's a great question, and you're right. I was actually -- I know people think it's sort of weird, but I always say, the more the merrier, because it does bring more attention to the space. And actually not only that, but these patients, these are not cures. Patients need more treatments. So in bladder cancer, it had really been pretty much ignored by most companies up until now. If you think about other tumors, there's multiple lines of therapy. We need multiple lines of therapy for these patients because again, they need to have more treatments, particularly in high-grade disease. Now as we think about competition from the low-grade space. First of all, we'll be the first, assuming we get approval, we'll be the first in this space and no one will be there for a few years after us. I think you have to look at it from the data. Let's see what happens on Thursday. So I think we will be the bar in the low-grade intermediate risk. I think it remains to be seen what the real bar is for some of the medicines coming out today. If you look at the ones that are there, ADSTILADRIN, KEYTRUDA, look at those 12-month CR rates, they're not similar to where -- to what we have. J&J's has been better, CG's has been better, but there's still limited data out there. So on one hand, I'm very excited about the fact that there's more energy around bladder cancer. I think it's great for patients. I think it will -- more companies talking about it will expand the category, will help physicians make the transition from doing surgery on everyone to using these medicines. So I'm happy to have more coming. I think what you'll see is, I think, will be the bar. And I think we have a lot of positives in our company, and we're excited about our ability to be the first medicine approved in this patient population. And as we move into other patient populations, obviously, the bars will be different, and we'll have to only bring products to market that we believe have been meaningful advance with patients. But I think that's great. Let's continue to raise the bar.

Okay. Great. Maybe one conceptual question is as you think about competition down the road, let's say, in the low-grade space, you envision competitors requiring head-to-head studies, whether it's a full approval down the road in terms of your label, just head-to-head studies? Or just do you think people, just for the time being, will benchmark against your pending data here?

Yes. I think right now, like if you start a study today, obviously, nothing else is approved. So I think you don't -- you probably won't have to do a head-to-head study. I think a couple of years from now, if you start studies, then you'll have to -- when medicines are available, you'll have to have a head-to-head. I think you're starting to see that in high-grade disease, right? Most of you go after post BCG or BCG failures, and now you're going to get to the point where it's like after you failed 2 therapies, which is pretty typical in oncology, right? You start late. You come up earlier. But I do think it will change. I mean, right now, the FDA, before because there was nothing there, but if you're going to go into front line and high grade, you have to compare against BCG, right? You can't go in without comparing against BCG. But I think you'll start to see that more and more in the future.

Okay. Very good. we're almost up on time here. So I think we'll end it on that note. My thanks to Liz and Mark from UroGen for joining us. Thank you very much.

Thank you. Thanks, Paul. Really appreciate it.

Thank you.