UroGen Pharma Ltd. ($URGN)

Good morning, everyone. Hi. I'm Liz Barrett, and I'm the CEO of UroGen Pharma. Thank you for joining us today. We're here in Washington, D.C. at the AUA. Very excited to be here, a very exciting time for our company. I'm going to talk to you a little bit through the agenda today, and then we have an exciting agenda for you, and then there'll be an opportunity for Q&A at the end. So of course, our normal disclaimers here. I won't read them. Thank goodness. We won't have time for that. We wouldn't have time for anything else. The agenda, I'm exciting after I'm going to make a few opening remarks, show you a few slides. I'm going to turn it over to Dr. Schoenberg and he's going to moderate a panel discussion with our esteemed urologists. You'll be excited to hear from them. All of them have had experience with ZUSDURI, and we're very excited about that. But more importantly, actually, I have the opportunity to interview and share with you a story of a patient who has received ZUSDURI and recently received a complete response. So I'm very excited about that, and I think you'll enjoy it. And then again, as I said, we'll have an opportunity for Q&A. So of course, I'd be remiss if I didn't take an opportunity to brag a little bit about the ZUSDURI. We're very excited, as everyone knows, we had approval of ZUSDURI about almost a year ago. I think we could all -- would love to forget about how that happened, but happy that we're here today. But it is a very differentiated, scalable therapy. And it's important because we've been talking this morning a lot about the large, underserved, highly recurrent disease. And it brought me back to actually when I started with UroGen. And one of the things that I remember most is talking to Mark, Dr. Schoenberg, and talking about the fact that there hadn't been anything in this disease since everyone started using TURBT. And so the fact that we get to pioneer and bring the first therapy to this market is a very exciting time for us. And as I mentioned and as I think a lot of you know, patients unfortunately have recurrence. It's a history of recurrence. They'll continue to have recurrence throughout their lifetime. And before ZUSDURI, the only thing available to them was surgery, a transurethral resection of the bladder tumor. We're going to talk a little bit about the TURBT today, some of the limitations of a TURBT. And I think most importantly, and I was also talking to Cynthia this morning, our patient, about when I first heard the efficacy and the data and when Mark called, I think the first thing he said is, are you sitting down? Because when we heard about the durability, the efficacy, the complete response rate and durability of, at that time, UGN-102 was a very exciting time for us. We had spent years, as everyone knows, getting to this point. So we are able and we're very excited about the potential for patients to have durable, recurrence-free and treatment-free living. But that's what patients are looking for. And the other thing, lastly, I'll just say, it fits nicely into how urologists practice. Our Chairman loves to say it's urologists who designed it for urology. And hopefully, it fits very nicely again in the way they treat. So as I just mentioned, first and only FDA-approved medicine for the adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer in our innovative reverse thermal gel. And I think most of you know, our company was founded on the reverse thermal gel being designed because urologists actually identified this unmet need. And what's nice about it, it's called reverse thermal because it's actually liquid when it's cold, so it hits the warm temperature of the body, turns to a gel and sustain releases medicine over a several hour time period. In ZUSDURI, at about an 80% complete response rate and 80% durability of response. But really most importantly, and hopefully, you heard last week in our press release around our 36-month data. What's most exciting about this is we still have not reached the median. And that means the median duration of response for patients is going to be greater than 36 months. So we're very excited about that, 82% at 12 months, 72% and almost 65% at 36 months. As everyone also knows, we're advancing our next-generation mitomycin formulation called UGN-103. And the great news on Friday, we also announced our 6-month durability, and you can see very consistent data. And we have communicated that we'll be filing our FDA approval for -- during Q3 and expect approval in 2027. But ZUSDURI is just beginning. We're excited about our company and where we're going from here. So after ZUSDURI, we have a strong portfolio with the potential to deliver long-term sustainable growth for patients and for our shareholders and our company. So we have our UGN-103 and 104 and then an exciting UGN-501, which is our oncolytic virus, next-generation oncolytic virus that we plan to go into man this year. So a very exciting time for our company. And with that, I'm going to turn it over to Mark Schoenberg to moderate our panel. So Mark?

Liz, thank you very much, and good morning, everybody. It's a pleasure to be here. And as Liz said, at a busy meeting like the AUA this year, it's really nice that we were able to get the attention of 2 -- rather 3 distinguished leaders in urology who have experience with ZUSDURI. I'm joined this morning by Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Urology Alliance in Chicago; Dr. Karim Chamie, Professor of Urology and Director of Bladder Cancer Program at UCLA; and Jennifer Linehan, who is Chair of Urology at Saint John's Cancer Center in Santa Monica. So thank you all very much for coming this morning. I think probably the way to start this out is since you have experience with this drug, maybe to ask you, how did you decide to use it? And who did you decide to use it in? Aaron, can I start with you?

Sure. Yes. Thanks for having us here to discuss this morning. I think most of us had experience with UroGen for upper tract disease and believed in the power of the reverse thermal gel for ablating tumors. And we've all seen these patients who just come back and it's tumor after tumor after tumor and it's like, okay, now you need another surgery. So I think we've been hearing about this for a while in development phase and trial phase. So it's certainly exciting when they got their approval. So pretty much as soon as we had the opportunity on a commercial side and independent practitioner, we're making sure we're getting reimbursed for the product. We've been offering it to pretty much everyone who qualifies with low-grade intermediate risk disease. I think it's certainly worth a discussion for all those patients. I think many of them would certainly prefer to have an alternative to surgery. So, so far, patients have done great and excited to be able to use it more moving forward.

Let me follow up on that. Karim, maybe you could comment on this. So specifically, how do you -- when you look at patients whom you think might be appropriate, what are the criteria you use? How do you decide who to offer this?

Yes. I mean I think to a large extent, people who looked at this drug and who it's potentially being marketed for. I mean we all thought, well, TURBT is the most definitive way to treat bladder cancer, and this should really be used for patients who may not be good operative candidates. And I think what we're really seeing is that this drug actually works better than TURBT alone. And there's no reason to limit it to patients who may be still operative candidates. And so to be able to allow the drug to be given to patients who are young and healthy who have no comorbid conditions, but just don't want to go through the trauma of a repeated TURBT every 6 months or 9 months. I think that's what's changed as I've gone through and seen patients with recurrent bladder cancer.

Interesting. So Jen, maybe you can comment on this. I think when this drug first came out, people felt it would be appropriate for a relatively small segment of the bladder cancer population. Based on what Karim said, are you thinking maybe it's appropriate for a larger group of people than we originally appreciated based on the demography of -- that was available?

Yes, definitely. I think it's -- for a lot of patients that have this low-grade intermediate risk, either they're older, right, and they don't want to have a surgery, they'd rather have a chemoablative therapy. If you look at urologists across the country, like a lot of us, if you call any of our offices, you're not getting in for TURBT for at least 6 weeks. Patients want therapy that they can start now in the office. So that was another thing that was a game changer for a lot of my patients. And they would rather do the therapy, see if it worked and then follow up with the TURBT. And if you look -- when I talk to them about the data, they're like, wait, why would I do the TURBT? So...

Interesting. So maybe talk a little bit about how you actually talk to the patients and how do you present this? Because, of course, we've been doing TURBT for a long time, and everybody said, sort of, oh, that's the standard of care. Now there's an alternative. Now there's something that's nonsurgical. So how do you explain that to patients?

So when I talk to the patients, I'm like, listen, you've had this low-risk disease before. This is now the third time you've come back. We're doing a cysto. I'm seeing the carpeting, we get the biopsy. I think it would be a great idea if we just did the ZUSDURI this time and see what we got out of this instead of going back with TURBT because when we do TURBT, you know your recurrence rate is still high. With ZUSDURI, the recurrence rate is going to be much, much lower, and you may never have to have another TURBT. So I think that's what I'm talking to the patients.

Are people coming in asking for this drug already? I mean it hasn't been out for that long. But of course, what is long for doctors and long for companies is a little bit different. The company has had the drug approved for a year almost. But it takes a while for these kinds of ideas to penetrate medical practice. What's your experience been with respect to talking to colleagues and also hearing from patients?

Yes. I think it's -- we're still in the early phase. I think I was talking with someone earlier today, and I said, we would see a sharp rise once all of a sudden, these AI platforms will start counseling patients because patients will go to ChatGPT. They'll go to Gemini and they'll start asking the chatbots, I've got low-grade intermediate risk bladder cancer. What should I do? I keep having recurrences. And I think patients are going to be doing their independent research, and they're going to be coming out to us and probably requesting this. And I think the whole idea of commercials and marketing to patients, I think, is going to change as patients talk to their chatbots more often. I haven't seen patients come to me requesting this, but I do bring it up to all my patients who have recurrent low-grade intermediate risk non-muscle invasive bladder cancer. And I talked to all of them because I know how -- I used to think that a TURBT for low-grade bladder cancer was not a big deal until I talk to patients and some have been devastated by it. And it's very traumatic. And I think offering them an alternative that avoids that trauma, I think, is meaningful. And I think the demographics is changing. You're asking the demographics. Our patient populations are changing. I mean, we used to think that bladder cancer is a smoking-related cancer. And what we're seeing is that fine, we're -- our patients are smoking less, but the incidence of bladder cancer continues to go up. And so -- and the type of cancers that we're seeing as the incident goes up is these low-grade recurrent non-muscle invasive bladder cancer. So I think the market share is going to grow for UroGen, but I think we, as a urologic community need to come up with these alternatives to treat patients other than just TURBT alone. So...

So there's perception, I don't know if it's a reality, that a modern private practice is very different than academic practice. And Karim's practicing in a big university. Jen's practicing in an academic community setting. How about in a true community-based practice? Do you find this is true as well? How do you -- how are patients responding to this? And how are you talking to them about this?

Yes. I think it's -- certainly, the community practices have also gotten very more sophisticated over the years and a lot of integrations and shared practices and all those kind of things. But I have not had either any patients coming in and asking for ZUSDURI yet by name, but I think you're 100% right, like people will find this and ask their AI helpers or once this gets out more and they'll be interested in this. And I think the biggest thing that we are dealing with now is really education of colleagues because not everyone comes to these types of meetings in the community setting or is staying up on education. So we -- the main difference is when you look and see a bladder tumor that's recurrent, the reflex for everyone is, okay, let me get my surgery schedule or let's get you set up for your surgery. But -- so changing that mindset that, hey, there's different option, not only for the patients that -- I mean, because a lot of these patients have had this 5, 6, 7 times, at least sometimes. And to say, hey, we're not going to do your surgery. There's this new option that you can avoid surgery will work probably as well or better perhaps. It's a total paradigm shift and not only what the patients are taking in on this front, but also for all my colleagues because we've had several patients, several -- because I get all the approvals for these new bladder drugs and have to review and make sure they're good candidates. So we've had a few where it's -- they've requested it in the post-TURBT setting. So I said, no, this is instead of like you asked me too late, like next time they have a recurrence, that's the time to bring this up. But at this point, you did your surgery, it's too late for ZUSDURI now. But in the future, like if this happens again for this patient, like you have this great option to move forward.

So it's interesting that you bring this up, and I'm glad you did. How we talk to patients and how we talk to colleagues is obviously a little bit different. When you meet a colleague who is resistant to the idea of using this, of embracing this paradigm change, what arguments do you offer to that doctor?

Well, I think the -- I mean, you brought up the point of the morbidity of TURBT. And I think people don't appreciate that. And for us, it's a pretty easy surgery. A lot of these low-grade tumors, especially recurrent ones. It's a pretty quick procedure for us, but patients still have side effects. They have catheters potentially. They may need medical clearance. They're getting anesthesia. All the stuff that goes along with a quick TURBT for us is a lot for patients. And all those repeated resections, I think, as we all know, is compromising their bladder health and may be getting more irritative symptoms and frequency and urgency and all the things that go along with it. So I think really explaining that to our colleagues and also showing them data and the effectiveness. And many have had experience with upper tract disease with this product with JELMYTO, and they've seen results. So say, hey, this is -- you had that patient a couple of years ago that got JELMYTO. This is very similar now for bladder. It gets rid of the tumor. So I think that sometimes turns the light bulb on, like this is the same kind of thing.

Yes. Great point. When you think about this drug, obviously, there's no such thing as a drug for everybody. We've talked a little bit about who you think it's for. Who's it not for?

I mean if I have patients that have high-grade disease, if I have patients have very large tumors, those are the patients that I might be thinking more about resection and seeing what's there. But I do have this population of patients that this is not recurrent disease. This is something that I'm finding in their bladder for the first time for cysto, small tiny papillary lesions. I biopsy them in the office. And we actually have a conversation about ZUSDURI. I mean they could be 90 years old and not trying to avoid TURBT. And obviously, I was on a webinar and one of the other urologists was like, well, how do you know it's not high-grade disease? And I was like, well, we get cytologies, I take several biopsies. And they're 90, like they don't want to have a TURBT. This is a better direction for them if things come back low grade.

Yes. Interesting. I mean, I think it is important to remember that the approval is for recurrent disease, and you're describing a situation that is new disease. So that would be obviously a decision you make at the discretion as a physician with your patient, but it's for recurrent disease currently in its labeling. Would you agree with all this?

I do think that it is available for patients with recurrent disease. And I think some people may use it as an adjuvant and some people may use it as a high-grade TA, I mean small volume. I think we're going to be using it for a number of different reasons. And they have their own reasons why they want to use it. But I think, obviously, you got to stick to the label, at least for now until more data comes out. I do think that there is -- I do think that there's a mechanism by which this would be effective even for high-grade TA probably in the future.

Yes. Interesting. Well, there are obviously a lot of opportunities for future research for this type of medication, and the company is very interested in pursuing that. With respect to bringing this drug into your practice, I mean, one of the -- obviously, this fits into a general intravesical therapy paradigm that we're all familiar with. But what's been your experience about bringing this into your practice? And Aaron, maybe I'll start with you thinking not only about bringing it in mechanically into the practice, but financially. What's been the experience there?

I think from the operations standpoint, it's -- I mean, this is not challenging to deliver. I mean I think the UroGen team is for all our first patients going through this. I mean they're helping our staff, making sure the process of the instillation is done properly, but this is not challenging from a operational standpoint. It doesn't take a real long time. Patients can get in and out of the office pretty quickly, which is always a concern for independent practices when our my parking lot is full and patients come and saying, there's no parking spaces. I had to wait. So I think that's always a concern with any treatment. Like are they going to be there for an extended period of time. So I think that part of it is easy. The installation is pretty easy. I think it's well tolerated. And on the financial piece, we did need to wait -- I mean, this has been approved for, what, 8, 9 months, I think, FDA-wise, but we did need to wait to have the permanent J-code from a billing aspect because certainly, we're paying the full price in the independent practice for this. We don't get special rates as some academic centers may. So it is very important. All these -- there's a lot of new drugs in the bladder cancer world. This is -- certainly, this has with the low-grade intermediate ablative space. This is really it right now, and it's very exciting, but we do need to be conscious of cost. And if you start doing this and you tell your partners, hey, this is a great product, let's do this and not do surgery and then for whatever reason, like the billing side doesn't match up and we're underwater with even one patient have a lot of partners who are very reactionary and I'll say we're done. We're not doing this. And that would be certainly unfortunate. So we did want to take our time. And I think that the UroGen team was patient and understands that this is how it needs to be for certain practice settings. But now that we have the J-code, we've so far had really no issues. I think the important piece for the independent practice folks that may listen to us who are doing this. Is this not a matter of just learning how to do the authorization process and making sure the documentation is correct that they meet the FDA indication, but you also have your contracting correct. I think we've all seen explosion in Medicare Advantage plans. And I think that's the part a lot of people missed because your Medicare Advantage contract in your individual practice, may not actually reimburse the cost of the drug. So it's covered, but you may actually not get your cost back, which is obviously problematic. So that's the part that really needs to be addressed and remind people of that. But from an operational standpoint, I don't think this is challenging to bring into any independent practice.

I won't ask you to comment on the finances of the University of California, which sounds a little bit daunting. But I was curious to know, at your institution, how has it gone?

Yes. So we have this pseudo academic practice, and my practice is still inside the hospital. But it's gone very well and Neurogen has worked incredibly hard to work us through getting the drug covered working with patients, working with our billing team. And so we've not had any issues. I mean, that started with the JELMYTO as well and now with ZUSDURI. So it's been a good experience, and we haven't had any trouble getting it covered, and we can -- I mean, the patients can start on the drug within a week.

So good experiences, it sounds like, and not a lot of friction. Just a sort of a hypothetical question because you're just beginning to treat patients with this drug now. But you saw Liz's comments about the data for the follow-up of this drug, and it's durability of effect. So it will be a while probably until patients start to recur. But if you have a patient with a good response to this drug, could you envision retreating with this drug? Karim, do you want to take that one starting out?

Well, I mean, you guys are, what, 3 years out. And I mean, that means essentially half the patients that ever got onto this trial have had a recurrence, right? I mean so you got about 80% or so who had a complete response and 3 years later, 65%, 64.5% of those 80% are still cancer free. So you put -- you do the math back of the envelope math. So you've got a path of patients who had a recurrence either initially or subsequently later, 3 years out, which is pretty impressive, right? I mean, for this disease space. I don't know. I mean, I don't -- I think now that you've hit the 2-year or 3-year time point, I don't know if there's going to be that many more recurrences. I think you've kind of hit a point where it's -- you're not going to have -- that number is not going to be decreasing by much any longer. And I think your median time to recurrence may take 7, 8-plus years to happen. But amongst those that I've seen every single patient that I've assessed with -- that has had cystos had a complete response. If I were given a situation where a patient has a complete response and they go a year, 2 years, 3 years and then they have a recurrence, absolutely, I would reinduce them.

But I think you're making an interesting point. I'm curious to know what Aaron and Jen think of this. It may be changing the biology, the clinical biology of what we're seeing for this disease because we're so accustomed after a surgery to seeing relatively rapid recurrence that may now be changing with this type of intervention. But would you consider retreating if you had a good response?

I think if patients get -- I mean we've had a couple of patients for upper tract disease, like there's not great surgical candidates, they had substantial tumor shrinkage. So I think in a setting like this, I mean, I just had a patient recently who went through their treatments, probably 95% of the tumor was gone. There was like one tiny, like one millimeter little thing that we just are going to zap in the office. We talked about renal reinducing and are trying again. But for that, it's -- that will take me all of 5 seconds to do that. It doesn't require TURBT. So-- but I think if you do have, especially if they had a great response and you're out 2, 3, 4 years later and they have some recurrent tumors again, I think it certainly would make sense that they had a good response initially to give it another try. I don't see why not.

Yes. Jen, any additional comments?

Yes. I mean that's what we would do, I think, with the patients that if it was a PC, if you were giving BCG, even though I'm talking about high-grade disease, I mean, I don't think it's an uncommon oncology protocol that if they responded in a 2 or 3 years out to give them another induction course. I also wanted to say, when you were talking about the feasibility of instilling the drug, the patients actually in my practice like it more because a lot of them have a hard time holding liquid, right? They don't have to worry about that anymore. They get the installation, it turns into the gel and then they can walk out of the office and don't have to sit there and be worried that they're not going to make their 90-minute time limit.

Yes. Yes, it's a nice feature of this, and it does take some of the burden off the patient in contrast to our aqueous approaches historically with chemotherapy. Aaron, I think you brought up the burgeoning field of urologic therapeutics for bladder cancer. It's a brand-new universe with all these new drugs that are coming in admittedly in the high-grade space. But there is some migration into -- or some interest in entering the intermediate risk space. Karim, do you want to start a conversation about how you view those drugs? And how do you think about them compared to ZUSDURI? If some of them enter the intermediate risk space, how would they compare in terms of how they might be used and how you might think about using them now that ZUSDURI is available as well?

Well, I think first and foremost, I think you want to talk about what UroGen's leadership in this field. I mean, first, they're the first to actually think about sustained release for the treatment of urothelial cancers, right? I mean we had the first sustained release for the treatment of protractothuo carcinoma. You've got a drug that had a 59% complete response rate for the upper tract tumor. It was great. It was up there for a few hours. We've seen the data, the preclinical data, the clinical data. And that was really exciting. And then UroGen is kind of the first one to go down the road of chemoablative. And they've kind of set the benchmark and the 59% complete response for the upper tract increased to 78% for the bladder. So that's kind of exciting. So the complete response rates have gotten better. And I think UroGen is the only game in town with regards to the chemoablative treatment of patients with low-grade intermediate risk disease. That said, I do think that there's others that are coming in. You got CG Oncology that has their adenoviral technology for the treatment of patients with broad intermediate risk disease. So that includes patients with high-grade TA and recurrent low grade. We don't know what the data looks like. They're waiting for enough events in order to get a data readout. You've got TAR-210, which is the pretzel technology with erdafitinib or an FGFR inhibitor. That's only marketed for patients who have FGFR alteration, which probably 20%, 30%, 40% of non-muscle invasive bladder cancers may harbor. And so we don't -- early data shows that, that may be -- that may have some cumulative properties. So that's kind of exciting. But we don't know yet. But for the time being, I think UroGen's first to market, and I think they've got significant head start compared to their peers. But I think it's exciting because for a long time, urothelial carcinoma was the red-headed stepchild of all the urologic malignancies and now it's the darling of the room, and everyone is in the field and everyone's developing drugs for it. And it's really exciting us, as scientists and doctors but also for our patients.

For the most part, these therapies that you alluded to are being developed as adjuvants following surgery, which obviously is a big distinguishing characteristic when you compare it to zoster, which is a primary therapy. Jen, when you think about those adjuvant therapies, many of them are given not only as an induction course but also there's a degree of maintenance, they have some of them permit reinduction. That's for the high-grade space. But presumably, it will, in some way, mirror what happens in the intermediate risk space if they migrate into that. How does that burden of treatment figure into your thinking about offering these therapies if they become available to patients, particularly compared to ZUSDURI, which is, of course, 6 doses, and then you're done?

I think any patient would tell you that if they could just do 6 doses and not have to do maintenance therapy every month or every 3 months, they're going to prefer that. So I think for patient feasibility and for patient comfort, that's going to be a much better option. But because it has the chemoablative properties, which a lot of those other drugs don't have or at least we don't know that yet. I think that's the real benefit that they're going to be able to get the drug not only is it going to help prevent the cancer from coming back, but it's going to take care of any cancer that's already in there. And I don't think there's anyone else in the space that can say that.

Yes. Interesting. I know, Aaron, that you've thought about and I think you're participating in trials related to the oral FGFR3 inhibitor that's available. I think it's manufactured by TYRA. Could you comment a little bit on your thoughts about how a pill might compare to ZUSDURI if it enters the intermediate risk base? I mean a pill sounds like a great thing initially, but I don't know, you've obviously thought about this.

Yes. I think -- I mean, just to echo what was said. I mean, it's really exciting to have all these options available the TYRA product, I think, is -- will be a similar indication down the road, assuming the data is positive, but it is for FGFR mutations only, which as you mentioned, is not everybody. And then it really comes down to having that discussion with patients. Pill may sound great. But I think until we get more information on tolerability and safety data. It's really hard to make that determination currently. Certainly, like oral erdafitinib has lots of systemic side effects, which is why it's interesting on the TAR device that it may be a much better option there. But the TYRA, it's a different drug, much better tolerated at least in the early phase data. So we'll see. I mean, I think as you mentioned, it's another -- it's nice to have options and potentially for patients in the future, like if they go through ZUSDURI and they are not in the fortunate -- the low percentage that unfortunately didn't respond, and maybe that's another alternative. The whole concept of sequencing these drugs, it's getting a little crazy in the high-grade space. We have more treatments than patients at this point. But in low-grade intermediate, maybe that's what's going to happen. Maybe there's some sequencing that eventually happens. And again, I think if we can avoid more surgery for patients and you see some of these new options, I think that's great. But I think patients are having a quick installation in the bladder in the office that they don't have to worry about holding in and don't have a lot of toxicity from, I think, it's still a very appealing option as opposed to potentially some skin issues or nail issues or diarrhea issues or things that can happen with oral immunotherapies.

Thank you for bringing that up because I was sort of where I was going to close out, which is sort of the whole concept of sequencing, which is very hot in our field right now. And it sounds like, correct me if I'm wrong, you're suggesting that ZUSDURI might, in fact, particularly for the recurrent patient considering the label might be the first thing to go to with these other therapies that are being developed as things to follow on with in that small population of patients that don't get an appropriate result with history. Would the 3 of you agree with that? I mean, does that sort of feel correct?

Yes. I mean I'm a little bit more hesitant about a systemic therapy like a pill. I mean I feel like bladder cancer, especially low-grade bladder cancer should be treated locally if you can. But I think for patients, if they did fail, that's definitely options that they want to look into because, again, the recurrence rates are going to be challenging for them.

Yes. Karim?

Yes, I agree with Jen. I think the intensity and the adverse events profile should kind of be commensurate with the lethality of the disease. So I think for cancers that are low-grade, recurrent, I mean I don't think many urologists are interested in giving systemic therapies. Unless, of course, you've got patients who have significant lower urinary tract symptoms and are truly unable to hold it, and they've got pretty bad lower urine tract symptoms that maybe precludes them from getting it. I haven't seen it amongst the patients we've treated. I mean sometimes we skip a dose here or there, but to a large extent, it's not something that I've seen as being very problematic. So I think most of the patients are going to be able to tolerate it. I think if a patient goes a year or 2 years without a recurrence, I think providers are going to probably retreat with ZUSDURI again. I do think that amongst the patients, amongst the 22% of patients who don't complete response, I think they are going to probably go to something else. I think amongst those patients, they're going to get cycled to a second-line agent, whether it's CG or whether it's TAR-210 or something, I think there is an opportunity for cycling. And I think we, as a field, are becoming more comfortable with it. If we're comfortable doing cycling patients through BCG unresponsive, we're definitely going to be comfortable cycling patients through recurrent low-grade intermediate risk disease.

Well, thank all of you for this wonderful session and for your insight is really valuable. We are now going to be able to move to Liz and her patient interview with Cynthia. And again, thanks for your time and taking time out from the meeting to join us. Thank you.

Thank you.

Hello. Liz again. Nice to be here. I want to introduce [ Cynthia Phelps ] to you. And the first thing I want to do is thank her for traveling all the way from California. Her and her husband got here last evening. And so first of all, thank you for coming.

Well, thank you for having this wonderful drug.

Well, we're thrilled to -- for you to share your story. It's a very compelling story for so many reasons. But before we get into the story around ZUSDURI, tell us a little bit about your family. And then when we spoke before, you actually unfortunately have a history of cancer in your family. But fortunately, everyone's doing well. So please, if you could just share a little bit about your background and your family, that would be great.

I'm a mom and a grandma, 4 grandchildren, and 2 of my children have had cancer. My 36-year-old son was diagnosed with testicular cancer when he was 19 and was treated at UCLA, had surgery, chemo. And then about 2 years ago, it incurred, which is a very low chance of it's happening. But he's all good now. He has a beautiful baby girl through IVF. And this year, my 40-year-old daughter went for her first mammogram, and they discovered cancer. So she had a double mastectomy but no chemo radiation and she's going to have reconstruction. So we've all come through it.

Yes. So tell us a little bit about your cancer. And when you were first diagnosed with cancer, and obviously, you saw Dr. Chamie, so we're happy for him to be here. And I think we were all on pins and needles as we were waiting to see if your ZUSDURI is a complete response and I'm sure you were to. But take us back to when you were first diagnosed.

I was first diagnosed in 2023, and there was just 1 tumor and I had a TURBT and went home, thought, "Oh, it's all done". I went in from my 3-month check and there was more cancer. So another TURBT was scheduled and that one, there was over 60 tumors. And Dr. Chamie removed them all and then decided that I needed to do chemo. So I had many courses of gemcitabine than in August of that same year, another cysto, and there was more tumors. So you get to the point we're just like, more? And Dr. Chamie always kept telling me, it's okay. It's okay. This is not life-threatening. I said -- he said, it's annoying. And I was like, It's super annoying. So I had another TURBT, more gemcitabine. This time I was like laying on my stomach. I did the trick where you land your stomach for the first 30 minutes and then flip over. And I was like, I'll do whatever I need to do. This is what you do. And then when I had another cysto this past August, and there were tumors. I was like, okay, [ Andy ] said there's something -- we're going to switch -- there's something new, and I was like, there is? And he's like, yes, we might have to wait for it. And we did. That was August and I started in February, and it was so easy I had some side effects with the gem. And there were no side effects. I was like I used to -- being a former kindergarten teacher, I can recognize when children have to go to the bathroom. When I was with the gem, I was like, I'm like a kindergartener wiggling around here, it was hard for me. I counted it down to the last second, so I could run to the bathroom at the office. And there was none of that with the ZUSDURI, it was just so easy. I have about a 2-hour commute back home, able to go all the way home. I think the first treatment, I was like, I got home and I was like, I still don't need to go to the bathroom. And it was like 4 hours. And then just looking myself at what the drug is, and it just totally made sense to me that, yes, we're quoting work. And it's just -- it was an easy experience for me. Everyone was so nice from the company, and they were always there. And I was -- I still -- I just a week off of my cystoscopy, and I still don't quite completely believe it. It's like no, I can say there's no cancer. I can say there's no cancer.

That must be a great feeling.

It is. It really is.

Talk just a little bit about -- you shared with me some of the side effects of gemcitabine. Obviously, when you're getting in an acreage solution, you have to sit there, the amount of time. But also some the things -- the side effects that you experienced.

I had like some -- well, I just didn't feel -- I explained to -- I felt like kind of a little bit like morning sickness.

Unfortunately, I remember that.

Yes, yes. I just -- it got to the point where I was throwing up and I also had like bladder spasms on my drive home a one time. It was like, okay, I'm stopping. I'm stopping again. I'm stopping again. And at one point, I e-mail Dr. Chamie and said something is wrong here. I can't stop going to the bathroom. So yes, that was not...

Not exciting to have to do that again, right?

No, no. My husband always make fun of me. I traveled -- after that incident, I always traveled with a beach towel, an extra set of clothes. And it was like you don't -- I was taking it back by that experience.

Well, look, we're so thrilled that you were able to get ZUSDURI. Dr. Chamie were talking to him, and he said when he looked in and saw 66 tumors, he's thinking, "Oh, my goodness". And it's just -- we hear different stories about different patients, but it is really, really thrilled that you were able to. And like I said, we were all on pins and needles because to see whether you would and given your situation having after so many TURBTs. Tell us a little bit about a TURBT and how that -- just the procedure is for you or was for you?

Well, it's surgery. You've got to get your clearance from your primary you got to then get clearance from -- there was another doctor and it's surgery, right? You go home, you've been under anesthetic, you're out for a couple of days. I think the biggest thing for me was after the surgery, not lifting anything, I think they told me heavier than a gallon of milk and I'm a very active grandma with my grandkids, and they had to be told no. I can't pick you up.

Yes, I have my first grandmother, actually. Very exciting time. She's 1, but not being able to pick them up, I can't even imagine, right, thinking about that, right?

Yes, it's really hard. And because I felt okay for 4 weeks because you had to do it for 4 weeks, but it was like to not be able to do that right now.

It does impact your life. And it's actually one of the greatest benefits, as you know, we've talked about with ZUSDURI, you don't have to do surgery. So we're really happy about that. And hope that you get the same result that we've seen so far. So you had the 6 doses of ZUSDURI and now it's pretty easy for you. Any side effects?

May be like towards the end of the cycle of treatment, a little bit of pain like but not nothing is bad is like a bladder infection, just still a little bit...

Yes, I thought it was important to share. We had talked about that, look it's great. I'm glad that you didn't, that was very minor, but just in the sense of for people to understand what they might expect and expect to see. So where do you go from here? So you're down in D.C. Your husband is going to spend a couple of days here. And so where do you go from here?

You mean in terms of my treatment?

Yes.

I'm on the 3-month schedule for, I think, a year at least, and then we'll go to 6 months. And I'm just so happy I'm part of that 80% initial and I'm going to be part of that 64.5%, keep going. Absolutely.

That's fantastic. Last -- we just almost out of time, but you talked about there was another person that was having treatment at the same time as you. And that was such a great story. Can you just share that with everyone?

He was patient 1 and I was patient 2. He got it a half hour before me. And when he -- after he had his -- we became friends. I mean, we talked about our kids and where did you go for your second, all the things, and I felt very comforted by him. He was -- he's such a nice man. Just very comforted talking to somebody else about the same situation. And he had his cysto after me, and he sent me a text. And I was at my phone, I said, he must have just walked out of the like, oh, Cynthia, I'm so excited. I just had mine and there's no cancer. I was glad to be able to share that experience with him that we both...

You get to share it together, and that's fantastic. Well, I just want to take an opportunity to say thank you, one, for traveling so far to be with us today. But importantly, for taking the chance on our medicine. We are so thrilled that it worked for you.

I thank everyone at your UroGen for -- this is just life-changing and amazing. And thank you for emphasizing this kind of cancer recurs. It's not life threatening, but it's cancer.

It's life altering, right? Well, thank you. Thank you very much. Thank you for being here. And I think now we're going to go to Q&A. Thank you.

And it's great to be able to hear the patient voice. We spend a lot of time talking about the doctor's voice, but it's wonderful to hear about a patient experience and Liz's interview brought that out. So now we're lucky Liz's joining us for the Q&A, and we'll be able to start that now. So I'll turn it over to Liz.

Yes. So hello, everyone. Before I ask any questions, just wondering, Vincent, do we have some questions from the audience?

Yes. We'll take our first question from Nick Lorusso with TD Cowen.

Question for the position since we have you guys. But now that you've had experience with ZUSDURI, what percentage of patients do you believe would be ideal for this treatment over TURBT? And what are the defining characteristics of these patients?

I mean it's -- I think there's really not, as I think we talked about before. I don't think there's a person that is not a candidate. I mean if they meet the definition of low-grade intermediate risk and have recurrent disease, I mean, I don't see a reason why we wouldn't have that discussion with all those patients. I mean even if they're young and healthy and can get anesthesia and get surgery, like why would you want more surgery? I mean, so I think that the numbers, we've gone through our database of patients in our group of 17, in our kind of pod, we've got pretty long list of low-grade intermediate patients that we're now tracking and finding when they're coming in and making sure all our providers are updated like, hey, this is an option. And it just takes -- with any new product, it takes reminders for -- since I'm not the one doing all the surveillance cystoscopies like maybe in an academic center. So it's just a reminder, but I don't really see a reason why this can be discussed with all patients. I mean who meet the criteria. I mean, I think as we just heard, it works great for patients who've had multiple surgeries like I think this is -- even if they've only had 1 surgery. Like I'm sure the first TURBT was not a cakewalk. So like say, hey, you don't even need more surgery, let's do this instead. I think that's -- it's certainly something that will be discussed with all patients that meet the criteria.

Nick, I don't know whether Nick is trying to get at the demographics. But if we actually look at the number of patients that have -- that are diagnosed new incident cases of bladder cancer. So you've got 80,000 patients, of which probably about 30,000, 40,000 or probably low grade. And then you've got a cohort of patients that are walking around with bladder cancer are probably like 600,000, 700,000 in America. I think this is probably going to be marketable to maybe tens of thousands of patients with bladder cancer. What that number is, maybe 30,000, 40,000, I don't know. But I think it's in that ballpark because I think this is a highly recurrent disease. And as the population gets healthier as we age, these patients are living longer. So the competing risk of developing -- the competing risk goes down, meaning they're less likely to die of heart disease because we've got cardiologists and primary care physicians who are taking better care of our patients. So the overall risk of getting bladder cancer recurrence continues to go up. So I think this has a pretty sizable addressable market as we continue to see that you don't necessarily need a TURBT and you're seeing probably better efficacy with regards to recurrence-free survival.

Great. Dr. Linehan?

So I would say 100% of my patients would be candidates for this. If they had low-grade disease with recurrence. I mean, unless there was some kind of allergy or something like that, I would talk to all my patients in that space. And like Aaron said, even if there was one recurrence, I think I would already be bringing it up because it's going to prevent them from having more surgeries, more cystoscopes and more worry, like their overall worry and concern that this is coming back. It's growing inside me and I'm sitting here with this like what else can we do.

Our next question will come from Ram Selvaraju with H.C. Wainwright.

Firstly, I was wondering if I could ask the doctors on the panel, if they could comment on, firstly, how important TURBT is as a determinant of whether or not a patient would be eligible for ZUSDURI or if it is really a situation where TURBT may have been done at least once in the past, a significant amount of information was already obtained from that procedure. And therefore, TURBT does not necessarily need to be done in order to determine whether or not a patient would be a candidate for ZUSDURI. Secondly, I was wondering if it would be possible to opine on the decision tree that could take place theoretically, within the intermediate risk population that would determine whether or not a patient would get the story versus other therapies that I think as Dr. Chamie alluded to, are coming down the pike specifically aimed at the intermediate risk population and perhaps how BCG responsive or unresponsive status fits into all of this. And then lastly, perhaps a question for Liz and Mark. How are you thinking not just about the future of UroGen's participation in the urothelial carcinoma in the bladder cancer space with respect to ZUSDURI and UGN-103, but also more broadly across the treatment continuum given not only a drug like 501, but also other elements of your pipeline? And do you ultimately see UroGen as a company, given your existing status as a pioneer in this space, as potentially ultimately evolving into a one-stop shop for all forms of bladder cancer?

A lot of questions there, Ram. Thank you. Thank you very much. I'll ask Dr. Linehan maybe to take to take the first question, and then we could go from there.

Can you repeat the first question? The TUR. No. So you do not need to do the TUR. I mean if this is a patient that has had a consistent history of low-grade disease, you know that you've done the TURBT before. They come back in the clinic, the tumors are smaller. You can also biopsy the tumor in the clinic, which a lot of us do. And so you would have a confirmatory biopsy. So the TURBT is definitely not necessary, and that's the point that we're trying to avoid.

Yes. I mean I think, obviously, the more TURBTs you do and the more you can document that they're low grade, the greater you're comfortable in your own skin that the patient has low-grade disease. But for me, that number is maybe 1 or 2 prior TURBTs that have documented low grade. I don't need 7 prior TURBT to say, "Oh, okay, now we're going to do ZUSDURI". I think probably 1 or 2 is probably the minimum number, I think.

That's great. So maybe the second question, Dr. Berger, if you -- do you want us to remind what the second...

Yes, I think decision tree, I think it will become more complicated, certainly, I mean, assuming these other trials have positive results at some point. But I think this is nice as you don't need to do any additional testing. Like you look in, you see a tumor like, okay, you're a ZUSDURI candidate versus potentially TAR-210 or TYRA, you may need the FGFR testing, which in low-grade disease is pretty high percentage, but it's definitely not all. We've had some screen fails on trials that they're FGFR negative, and they're not candidates. So I think as we talked about before, it may be where there is some sequencing. I mean no one's figured out sequencing in prostate cancer after 15 years. So I mean, I don't think anyone's going to have a definitive answer on sequencing. No one's going to do a trial to say, okay, the ZUSDURI first and then this, then this. It's just never going to happen. But I think you do what's easy and well tolerated first. And I think that certainly being first to market in this space, certainly is a great benefit. And I think as a lot of people get familiar with this, when new products come out, that's going to kind of take -- unless the data is overwhelmingly better than this, which I find hard to believe. It's going to be hard to kind of leapfrog over ZUSDURI and say, let's do this first, especially when you need additional testing with the mutations for FGFR and potentially more toxicities. And I think like TAR-210, I think I do a lot of TAR-200s currently. I think it's a great product. But the device is in there for 3 months. Toxicity-wise, how is that going to be versus having ZUSDURI gel there for a few hours. So we'll see. I want to see what the date is, but I think it is it's great to have all these options, as you just mentioned, like it was a dark age for a while. It was not an offer, and now we have lots of options.

Yes. I think in many ways, it's actually a blessing, right? I mean I think getting ZUSDURI approved as the only chemoablative agent, and the next one in line, it's going to be a while before you get a competitor in this disease space. May actually be good for the urologic community, right? I mean you want to get urologists used to consider the idea of chemoablative, right? I mean -- and I think once we get used to it and once we get comfortable, I think you're going to see the market shift a little bit where I think some of these pharmaceutical companies may say like, look, urologists are actually now becoming comfortable giving these drugs in lieu of TURBT. And that may change their research portfolios and where they go. So I mean, I think it's dynamic, it's fluid and it's moving and the fact that you've got your first to market, and it's going to be years before somebody comes in and competes in this disease space is probably going to be good for the urologic community.

Yes, I'd like to -- I always say that we get asked a lot about it, but I think it's great for patients. I've been in oncology for 30 years. Was in oncology back when 5-year survival of cancer was very low. So I think it's great. Like you said, I think it's great to have multiple therapies. I do think that we have a benefit we've talked a lot about today and most patient-friendly, and we'll see what the data looks like, but I also find it hard to believe anybody is going to be better than we are. And to your point, Dr. Chamie, we've got a 2-year, 3-year head start. So I think we're very excited about that, which kind of shifts to your third question, Ram, and I'm going to ask Mark to comment on sort of our pipeline, what we sort of see ourselves in urothelial cancers and that could add anything.

Yes. Thanks, Liz. So Ram, thanks for the question. I think the audience may know that we are currently finalizing a trial that will bring 103, which is the successor molecule to ZUSDURI into the high-grade space. So that trial will start this year. And we're very excited about bringing this in as an adjuvant therapy for high-grade disease. We see that as a real unmet medical need. And then, of course, we have our oncolytic virus that is in the final stages of IND-enabling studies. And we are planning on starting a Phase I dose escalation for that, and we think that is going to be yet another opportunity to show not only that we have a pipeline of very impressive drugs to bring to the high-grade space. But we are exploring bringing that to the market in our gel as well, making -- taking advantage of that platform because there may be some additional significant advantages to patients delivering the oncolytic virus in the RTGel. So in the very short term, we are going to make some big steps forward in bringing our high-grade program forward and then I would defer to Liz, actually, with regard to where she sees UroGen going as a one-stop shop.

Well, no, I think, Ram, we do have aspirations to see whether our medicines can work across the continuum of urothelial cancers. And to Dr. Linehan's point earlier about even newly diagnosed IR patients there as well. And we have some data from our ATLAS study in that space. We believe that it would work in that space. And so we will, as Mark said, not only move forward in the high-grade space, but try to see all of the different patient populations, it's a highly segmented disease. So where do we fit in and where might we fit in. So we're here to stay in urothelial cancers. We want to be a leader in this space and expect to see more coming in the future. So thank you for the question. So next question?

Our next question is from Amin Makarem with Jefferies.

Very informative session. I have a couple of questions. One, first, I have a question on potential UGN-103 use in adjuvant setting that you just mentioned. My question is, are there any potential benefits of using ZUSDURI in adjuvant setting versus chemoablative, meaning which patients are most likely to benefit using ZUSDURI in the adjuvant setting versus using it as chemoablative? And my second question is with few more drugs are being developed in the intermediate risk NMIBC, especially in the adjuvant, I think, how should we benchmark them versus ZUSDURI? If we think about the efficacy parameters, when we see their data that is like simply better or worse ZUSDURI or just because it's an adjuvant setting, it's different game basically?

Yes. Dr. Linehan, I don't know if you want to comment first on ZUSDURI in adjuvant setting. Would that be something that's that you think might benefit and then any other comments?

I mean I do have a subset of patients that can be symptomatic from the tumors that they have in their bladder that sometimes could be bleeding, that's one to be stone, sometimes infections. And so we have to treat those first and then you can give it adjuvant. But I think the adjuvant portion of that is that the durability is so good that that's what you're offering them that just the TURBT cannot. So you may not have a recurrence in 3 years. It's a 65% chance of that, that's TURBT is not going to give you that. And so that's where it plays the role in the adjuvant space.

Okay. Great. And any thoughts on -- as others pan out. I know we've talked a little bit about it, but as other adjuvants get enter into the market, any comments on...

I think for me, that's going to be very patient dependent like the benefit of the history is that they don't have to stay in the office. You don't have to hold it for 90 minutes. It goes in, they actually empty the bladder. They pee out the medication in 4 to 6 hours, and that convenience of it play to probably the biggest role in helping me decide which agent is next.

Okay. Great. Thank you Other comments about the -- we talked a little bit about it already, but...

Yes. I think it's going to be complex because I think with ZUSDURI, you know what it is, right? It's a chemoablative agent. It gives you 78% complete response, and you got a durability of 65% of those patients are still disease-free at 3 years. Becomes a little complicated when you're talking about adjuvant therapies, right? If you're talking about these other therapies, what's doing the work? Is it the surgery that did the work? Is it the adjuvant agent that you put in the bladder? And how do you compare this apple to this orange. And I think comparisons going to be a little bit complex as far as seeing which drugs may be more efficacious because the comparisons aren't similar. And so I think I mean that's probably maybe worthy of a future study, but I think, obviously, for UroGen, I mean the data is kind of clean. You know what you got as far as complete response, you know what the durability is. There's no surgical component to it, right? Nobody had a TURBT amongst the patients that had a complete response, and you know what it's like. So it's going to be tough comparing them to patients who are getting in an adjuvant setting.

I mean, I don't have a whole lot of else to add up, but then in the high-grade data, we're always looking at cystectomy-free rates this is like where we should be talking about, TURBT free rates or something similar as a caveat. So I think having the option of ablative. I mean, certainly adjuvant is important. But I think the benefit here is to be able to do chemoablative. And I think that's something that we need to kind of get used to doing, as you mentioned earlier, like it's not -- normally, you see tumor resect tumor kind of reflex. So as people get more comfortable with that and they see these impressive results, I think the need for that adjuvant therapy may decrease because there's -- we're not going to have as many recurrences in as many surgeries, hopefully.

Our next question will come from Kelsey Goodwin with Piper Sandler.

Thanks for hosting this. Super helpful. I really appreciated the patient story as well. Maybe building on her journey, I guess, given ZUSDURI approved in the recurrent setting for the KOLs. You should have kind of firsthand experience within each individual patient, how they're responding to TURBT and for how long, and then same how they respond to ZUSDURI for how long. I guess -- maybe could you comment on that and what you're seeing, how it differs within any given patient?

Great. Thank you, Kelsey. And good to see you yesterday here at the AUA. I don't know if anyone want to comment?

I mean, I think we've a couple of our patients that we've gotten started. I mean, we're probably on their fifth or sixth -- 5 or 6 previous TURBT. So I think that as far as -- the one patient had that tiny little thing we zapped, but that's -- I'd say that's still a big win, not to have to go back to the OR and general anesthesia and catheters and all that stuff. So I think as we move forward, and I'll get more experienced, hopefully, we don't have to put patients through 5 or 6 surgeries. I mean we're just doing that now just from the time frame we're in, in patients I've already -- like our patient here has already had multiple surgeries. But hopefully, moving forward, you have surgery once, you have your pathology, first recurrence, like this -- I think this is where we should be headed.

I think Mark and I have talked about this before that maybe the worst thing you can do to a tumor is resected, right? I mean you're chopping it up and then you're resecting the base of it where you leave this nice fertile layer for a tumor to reimplant. And so in many ways, maybe the TURBT is the most -- the worst thing we can do to a tumor as far as recurrence. I mean, obviously, you give chemotherapy at the time of the TURBT, but we know the uptake of doing perioperative chemotherapy at the time the TURBT is low. But still, I mean, maybe this is going to fix that issue of maybe minimizing recurrences because we're not resecting tumors and leaving a fertile ground for this tumor to regrow and reimplant.

Dr. Linehan, anything to add?

Yes. I mean, I think this product will also -- you were saying before, Karim, is teach us about this space because we actually don't know a lot about this space. We know that they recur, we know they're low grade, and we know we do TURBTs. And that's it. Now that the ZUSDURI is here, we're going to learn a lot more about, I think, the natural physiology of it.

Our next question will come from Paul Choi with Goldman Sachs.

Liz. Good morning, everyone, and thank you for sharing that patient experience. It's nice to see the journey result in a good outcome. And thanks to the doctors for joining us. My question is on use of gel-based mitomycin in high-grade disease. I know there's development plans for 103 potentially in this population. But I'm just curious from the doctor's perspective, thoughts on using a gel-based mitomycin for this high-grade population? Would you go ahead, potentially use it here now with JELMYTO available here? And just -- sorry, ZUSDURI available here and just sort of what you think about as criteria for use of the ZUSDURI here in this population?

Yes, great question. Anybody want to start there around high grade, your thoughts about ZUSDURI and high grade.

I'm very excited about ZUSDURI and high-grade patients. And I keep going back to this, but one of the reasons is a lot of my patients cannot hold the BCG. They can't hold the gem side, I mean they can't hold all the other drugs, and that's one option. And if you actually looked at the NCCN guidelines, mitomycin was one of the original drugs that we use to treat high-grade bladder cancer. And it worked very well. It didn't have the durability that the BCG did, but I think if you already have patients that have failed BCG or they can't even hold the BCG. This is where I think ZUSDURI is going to play a big role.

I mean I've had to use it off-label for patients with upper tract urothelial carcinoma. So I've had patients who've had a solitary kidney, and they've got high-grade upper tract disease, and I've had to use it. And I've got a few patients where you give them a little bit of systemic therapy. And then I put JELMYTO. And I've got, I think, 5 patients with solitary kidneys that will be facing dialysis, if I did, I took it out. And fortunately, every single one has had a complete response. So I do think that there is activity there. And I think, obviously, for the upper tract, the complete response rate is like 59%. I think for the bladder is 78%. So I expect that the bladder would work similarly well for high-grade disease, just like I've seen it in the upper tract. But more -- we can't wait to see what the clinical trial looks like and happy to participate.

Yes. I would just echo what you were saying earlier, I think, I mean, all the new options we have, which have very strong data, but patients have to be able to hold them in there. So whether it's a children [indiscernible] imaging at some point, like you have to keep that dwell time there. And a lot of these patients, their bladders are so beat up after BCG. They just can't do it. So I think this is a great option to keep the drug where it needs to be for a prolonged time, and I'm excited to see where it goes.

We'll take our last question from Kevin DeGeeter with Ladenburg Thalmann.

Great. I want to just thank everyone for this discussion. It's incredibly helpful for me. I particularly appreciate the conversation with regard to how to think about reexposing patients after recurrence and really clear commentary for the patient that has the great durable response out 3 years or more to recurrence. But how do you talk to your patient who has a good response, maybe 15 months, maybe closer to 12 months and has recurrence and -- after being treated on ZUSDURI? I mean, just how do you think about the patients who have done well, but not as well as we might hope. Is that sort of the same discussion at recurrence? Or help me walk through some of the nuance you might bring to that discussion.

I think that's a great question. I guess the short answer is it remains to be seen. I mean I don't think -- I certainly don't have enough experience yet with this to see those patients that are 12 months, 18 months and now have more tumor and we haven't had those conversations yet about should we try this again. I mean I think if they tolerated it well, and they had a pretty good response upfront. I don't see why there would be a reason to shift gears completely and say, let's just go back to surgery. Like, I mean that's -- it's like, okay, here's a great new option. Let's go back to the old option, which didn't work in the first place. So I think those are conversations that I will definitely be having. I just haven't had them yet, but I'm sure it'll...

We're looking forward to gathering some data around that in the -- good news is it won't be for a while, hopefully.

I mean a lot of the other new products out there that didn't have reinduction in their trials. Now there's real-world evidence coming out kind of showing improved results in the real world with reinduction. So doing repeat again another 6 courses down the road. If it's 1 year, 1.5 years, whatever, I think we'll probably see that in real-world data down the line.

Absolutely. Dr. Linehan, Dr. Chamie, any other comments?

I agree with all, everything that you said. I would do another induction of course, if they came back in 1.5 years and had more cancer.

Yes, I agree. I think the difference is, is that I wouldn't call that a recurring tumor, I'd probably call that a new tumor, right? Because I think once you go 1 year, 1.5 years out, and they've been disease-free for that period of time, that tells you that that's probably a new tumor that developed there. And so I absolutely would retreat them with.

It's good to know. Like Dr. Linehan said, we still have a lot to learn in this disease, in this space, but hopefully, we'll be learning that as we go forward. Well, thank you, everybody. Thanks for participating today. I want to thank our panel and importantly, our patient, Cynthia, for being here, and we appreciate your time and support. So have a great day, everybody.