UroGen Pharma Ltd. ($URGN)

Earnings Call Transcript · June 10, 2026

NasdaqGM US Health Care Biotechnology Company Conference Presentations 36 min

Earnings Call Speaker Segments

Kyuwon Choi

Analysts
#1

Okay. We'll continue with the next session. I'm Paul Choi, and I cover the mid-cap biotech sector here at the firm. And it's our pleasure to have UroGen here for this session. Joining me is Liz Barrett. .

Kyuwon Choi

Analysts
#2

Maybe what we'll do, Liz is let you kick it off with maybe some high-level comments on what are your strategic priorities for the remainder of 2026 and going into 2027? And what are you seeking to accomplish with UroGen here over the near term?

Elizabeth Barrett

Executives
#3

No, great question. And we -- I'm glad you started it with what's your sort of strategy and focus, right? Because I think one of the things we're starting to do shift actually from the very, very near term to more of a longer-term look at the company and where we're going as a company. As you know and most people know, we wanted ZUSDURI, which was our second medicine which has been in the works for longer than I've been with the company, and that's been over 7 years now. And that finally launched last summer, but more importantly, we got J-code in January. So while we have been laser-focused on ensuring the commercial success of ZUSDURI and obviously JELMYTO as well, and that's a key driver for us. We're very confident in our success. And so what that success will allow us to do is actually invest in the company to build a long-term sustainable growth company, which is really what we want to do. And we're squarely in the uro-oncology space right now. Arie likes to say, we're urologists who developed a company for urologists, right? So -- and we are. But at the same time, we do also have our eye on expanding and diverse [indiscernible]. Our near-term 2026 [indiscernible] ZUSDURI adoption ZUSDURI because at that point, that allows us as a company to be able to turn around and invest in longer-term growth.

Kyuwon Choi

Analysts
#4

Great. and for those listening in by Arie, I think Liz means Arie Belldegrun, the Chairman of the company just for anyone listening in. Let's start with ZUSDURI here. You had an excellent first quarter with the launch. And maybe you can just sort of remind us how ZUSDURI did. I think it's already sort of performing better than JELMYTO is a couple of years into that launch. And so the trajectories of the 2 products are very different. What do you think is maybe in your view, driving the early adoption here?

Elizabeth Barrett

Executives
#5

There's a few things. And I think it's important to take a step back and think about JELMYTO in the context of it's a rare disease. But it's a rare disease that dispersed among all urologists. So unlike other rare diseases, where you have about 6,000 patients in the U.S., a typically rare disease gets treated by a handful of physicians. Here and with JELMYTO, you have a disease that gets treated by every urologist. And so they may only see 1 or 2 patients a year. To your point, what's really different with ZUSDURI are 2 things. One, there's 60,000 patients. And now we're talking about 10x the number of patients. So any 1 doctor sees several of these. And we've been talking recently, we actually have 1 doctor in New York City, who's already treated 20 patients. So you have doctors who see a lot of these patients in any given year. And so there's a lot more patients. But also the medicine is easier to give. So it's a very simple procedure. So unlike JELMYTO, which has to -- you have to have a fluoroscopy or you have to have a nephrostomy tube, this is a simple installation into the ladder. So the patient comes in, it's an outpatient. They don't need to have any general anesthesia or anything like that. It can be given by a nurse. They don't have to sit there and most intravascular therapies, they have to sort of say how long can I hold my urine. They don't have that because the gel solidifies and they're able to deliver the medicine over several hours. So it's much easier to give. So between the fact that the data, we believe, is unprecedented when you look at it from an 80% complete response rate, 80% of those patients still in response at 12 months, and we just recently shared our 36-month data with 65% of those patients still in response at 3 years. I think you have the compelling data, you have the ease of use and you actually have a lot of patients out there.

Kyuwon Choi

Analysts
#6

Can you maybe provide some color on what your sales force is hearing, I guess, a few quarters into the launch here. Just first on how it's being utilized. What sort of ablative or adjuvant use are you seeing versus 1 versus the other? I'm just sort of curious how doctors are using it versus what's on label?

Elizabeth Barrett

Executives
#7

Right. Well, actually, I would say, on label, our label, the indication is for low-grade intermediate risk non muscle-based bladder cancer, right? It doesn't specify anything more than that from a label perspective. We do know and this is all anecdotal that some physicians do use it after they've done surgery. But mostly, we're shifting towards the primary use, and that is using it without surgery. Because one of the great benefits is you don't have to have surgery. And those are patients unfortunately who have had multiple surgeries that clearly hasn't worked for them because they continue to recur. . So even though physicians may use it in an adjuvant setting, again, we see this shift. Sometimes they want to do that first because maybe they get well nervous well, I better go in, make sure it's low grade. As they're getting experience with it, they become more comfortable in not doing surgery and using it as a primary. So we believe that 1 -- again, one of the benefit is not having to do surgery. So if you can be in a situation where you can get the type of response and the type of durability that you're assuming with ZUSDURI without doing surgery. That's a big benefit for patients. And so look, in the beginning, it's typically what you would expect in any oncology drug. They start with your hard-to-treat patients. They start with those patients that have had multiple TURBTs. They start with a patient that they don't want to take to the operating room. And the -- what they're seeing so far are good results. So that then -- so let me see how it works, and we're hearing really great experience. And we actually had a patient at AUA. We did an event. As you know, you participate, we appreciated your participation there. And the patient had been through 3 TURBTs, 25 doses of intravascular gemcitabine and still was recurring. And so she got a complete response after only 6 doses of ZUSDURI. So those are the type of patients that we're hearing about. And it's just great to see that even in these harder-to-treat patients, the story is working.

Kyuwon Choi

Analysts
#8

I am sort of also curious relative to the clinical trial population. Are you seeing -- in terms of the patient types you're seeing, are you seeing any first recurrent use? That would be super interesting and that would be a great leading indicator, obviously, products. So I was just curious in terms of the target patient population, what you're seeing?

Elizabeth Barrett

Executives
#9

I think you're right in the sense of in our clinical trial, most of those patients had only 1 or 2 recurrences. But like I said, it typically in an oncology drug, you start later. But yes, we already know that we have some doctors that are real adopters, and they're real champions because they have bought into this approach is a better approach for their patient. So they actually have put into place in their practices that any patient who is a recurrent low-grade intermediate risk patient should get ZUSDURI or should at least have the option to give ZUSDURI because what you want to do is you want to have a shared decision-making with the patient. So they want to share. So yes, a lot of physicians were starting to see shift to, let me fly it on 1 or 2 patients. they see good results, then they're going to open it up to their entire patient population. And to your point, we want to make sure that everybody can benefit has the ability to benefit from our medicine.

Kyuwon Choi

Analysts
#10

Great. Can you maybe comment on the types of practices or centers where you're seeing initial use of ZUSDURI compared to JELMYTO? How much of the utilization is sort of academic or large hospital driven versus sort of large group practices or community practices? Just -- so where is the strongest adoption in the early part of the launch?

Elizabeth Barrett

Executives
#11

In the beginning, before there was a J code, it was mostly institutions, and that makes sense. -- because they don't worry as much about reimbursement, the pharmacy worries about that. The doctor doesn't worry about that so much. But now we've seen it shift. It's already at 50-50, and we're seeing it even more than 50% of it is in the community practices. That's where most of the patients are, again, low-grade intermediate risk. These patients are treated in the community setting. Particularly to your point in the large group practices because you still have some reimbursement concerns in your [indiscernible] doctors and say, "Oh, I don't know if I want to put -- just in case something happens. . So we actually are working to ensure reimbursement confidence. But as we do that, the large group practices are the ones who are adopting more than you see the smaller groups. And that's what we need. That's where the patients are being seen. So you are seeing it kind of across the board, but definitely our biggest opportunity is in these large group community practices, and we're seeing this shift go there.

Kyuwon Choi

Analysts
#12

Great. Can you maybe speak to how you took your learnings from the JELMYTO launch and adapted it or evolve your commercial strategy to sort of hopefully ensure success for ZUSDURI this year and in the coming years. And just sort of what your bigger learnings were from your first efforts at commercialization?

Elizabeth Barrett

Executives
#13

Yes. I think our -- the biggest, I would say, miss for us with JELMYTO was really understanding the rare disease nature. So unfortunately or fortunately, we don't deal with that with ZUSDURI. And that was the hardest learning that these patients and practices don't want to change the way that they practice for 1 or 2 patients a year. And that was a learning that we got out of JELMYTO, plus the second piece is you have to make it easy on the doctor's office. You have to integrate it. So what we do, we have regional operations managers now. So they try they work very closely with the office to ensure that seamless integration into doctor's office. And so we -- even though we had that -- we didn't have that role, but we knew that there was a logistical challenges with JELMYTO. There's not as many logistical challenges with ZUSDURI, but -- we are doing everything. The second thing we're doing is going to patients. I think it's really -- we really do believe that this is the most patient-friendly therapy for patients with this disease. And so we want to make sure that we educate patients. You can do that when you have a little bit of a larger group. Again, the rare disease nature of JELMYTO doesn't allow you to really find those patients very difficult. So we definitely learned quite a bit during JELMYTO and ensuring that we are covering our logistical and reimbursement challenges. We have field reimbursement managers. We have, again, ROMs, what we call regional operations. We also have clinical nurse educators. So we actually -- think about the reps we hear often about how many reps you have? What's important is we probably almost double the number of customer-facing roles when you add all of these others into it.

Kyuwon Choi

Analysts
#14

Great. When I look at your reimbursement literature for ZUSDURI that's out there and how to sort of code it in terms of FX codes, ICD codes -- ICD-10 codes, excuse me, and so forth. Can you maybe talk about anything else that you're going to make the experience and sort of drug access frictionless for the providers? How much time is your team spending in doctors' offices versus sort of virtual training and just to help them figure out how to do the paperwork correct and get it approved on the first try there?

Elizabeth Barrett

Executives
#15

That's -- look, I think you can only do so much when it comes to that because you are right in the sense of you're really depending on the office to ensure that the patient enrollment form is complete and all of these things we talked earlier about compressing the amount of time between a patient enrollment form and the patient actually getting the medicine. One of the biggest challenges to your point, is actually filling up the form. So we -- our team, again, very hands on, very much a white glove service. making sure that doctors understand and if there is missing information, we get flagged so that you can go right back to the doctor's office ensure that you have. . So there's a lot that goes behind the scenes that we typically don't -- that most people don't know about or hear about, but there's a lot that goes on the scenes. And that -- there was no -- we weren't worried to invest to ensure that reimbursement confidence and even we even had a challenge with one of the Medicare payers that has taken a really long time. So when we hear about that, we're proactive. They are down there, not only talk working with the office, but working with the payer to say, "Hey, look, they're holding up patients because of reimbursement and just ensuring that we're educating the payers as much as we're educating the office staff, to your point. So we really do have kind of what I call surround sound when it comes to supporting doctors' offices. We have specialty distributors. We have a mixing pharmacy. We're bringing a specialty pharmacy on. It's not a big portion of our business, but some of your one Zs, 2 Zs, just prefer to use a specialty pharmacy. So that's coming on board. So everything we can do again to make it easy for the doctor to adopt.

Kyuwon Choi

Analysts
#16

Great. I want to talk a little bit about the patient experience and the patient journey. And in a scenario, let's say, if a patient has some sort of medical event that disrupts their treatment installation schedule or goes off on vacation or something like that. How does it work? Can they still be continuing their treatment under the initial authorization. Does the doctor have to go through it again? Or is it sort of covered under that first [indiscernible]?

Elizabeth Barrett

Executives
#17

It actually depends on the payer and it depends on the time, to your point. If it wasn't feeling well. I missed a week, no big deal. But most payers will give a certain time frame. So even though it supposed to be 6 weekly doses, maybe they'll say, well, it has to be done within 10 weeks. So if it's outside of the 10 weeks, then yes, they have to get reauthorized. And so what's really important in what we do because we -- most -- almost all of your community practices, they want the drug already mixed, and we provide that service for them free, right? So it's built into our own gross to net. So our own cost of goods. So we bring to the mix. If something happens and they get it mix, they have 7 days from the time it's mixed and still into the patient. We have a returns policy if the patient doesn't show up and they can't use it within that 7 days if they are not. We haven't had to use that very often, which is good, but it's there and it gives them the confidence. But absolutely, the devil is in the details when it comes, unfortunately, to reimbursement. And that's, I think, the difference -- the other thing we've learned to your point, urologists are not oncologists right? Oncologists, they have this down to a science because they've got the infrastructure in place, they have the staff because they've been doing buy and bill drugs forever. That was always a 70% of profit comes from buy and build drugs. That's not the case with urologists. And so this is fairly new to urologists. They need some handholding. So they don't necessarily have all the staff in place. So you really have to ensure that they're educated on the reimbursement process that they understand their own personal contract with the payers because against different. I mean, you think about it from our own health care my health care plan is different than your health care plan, even though we could have the same carrier, but every plan is different. So when it comes to those types of things, and that's why, again, we make sure that we have not only our sales rep who responsible for ensuring the accelerated adoption, but we have other services available.

Kyuwon Choi

Analysts
#18

Enough time may not have quite passed for this to happen, but I'm just sort of curious how you and physicians in the field are thinking about retreatment with ZUSDURI for someone who may have a recurrence down the road. It's only been a few quarters, so there may not be many instances of this. But I'm just sort of curious what you're hearing from your sales force or in the field about how docs are thinking about repeat use in a patient who may have a recurrence?

Elizabeth Barrett

Executives
#19

Yes. I think right now, what we're hearing from doctors is that they are very comfortable retreating. It's within our label, right? There's nothing that in our labels that you can't retreat. We don't have data around retreatment. So from our perspective as a company, one of the things we want to do is generate that data. But you're right, that takes time. You have to have patients who start to recur. The good news is they have a very long durability. So as they start to recur, we will either through our own Phase IV study through a registry. We have a registry for JELMYTO. We're more likely than not to have a registry for ZUSDURI in UGN-103 as well. the nice thing about a registries, you can really capture data. So we -- but we are hearing from doctors as long as they've had a good experience when they recur, then they're likely to retreat.

Kyuwon Choi

Analysts
#20

Great. I want to talk a little bit about the AUA meeting, which just recurred -- just occurred, excuse me. And I guess from your perspective, what was sort of the level of awareness of ZUSDURI there? How many sort of docs, I guess? Or what was your sense of human docs are like, "Oh, now it's available. And something else start to use maybe starting there.

Elizabeth Barrett

Executives
#21

Absolutely. Not only at AUA, we had a great AUA meeting there. It was our real first AUA meeting since the approval of ZUSDURI because that was last summer. And so even though it wasn't new, it was new in a lot of ways. And so physicians' feedback has been very positive. We've done our own ATUs in addition to the anecdotal information from there that 92% of docs say that they will use the ZUSDURI. So at one point in time. 100% of doctors that -- and this is newly off the press, 100% of doctors that have used it have said that they'll use it again. And so that's just in our recent survey. It wasn't at AUA, but it's our recent on information that we have. And so we're seeing, which tells us, okay, they're happy with the experience. They're happy with what they're seeing. And so we're getting very, very positive responses. We seldom ever talk to a doctor who says, I'm not going to use this, right? You have your -- you do have your continuum of adoption that I always talk about, those that I mentioned the doctor in New York that has seen 20 patients. He made the decision that every recurrent patient is going to get ZUSDURI. Then you have the other end of the spectrum, which says, I'm only going to use it in those limited patients that I just can't take to the operating room. And then you have everybody in between. And our job, as you know, is to move all of those that are on the left over to the right. So they're comfortable, and that's what we're hearing so far out in the marketplace. We don't hear a lot of -- I don't know anything about it. Maybe they don't know the data exactly. And I think it's important Unfortunately, we rarely have to talk about the clinical data, but you want to make sure you talk about the clinical data because it really is very compelling. And so we have to remind them, oh, 80% because yes, they may know about ZUSDURI, but do they really know the data, the clinical data. So ensuring clinical conviction and then it's around the logistics. -- it really ends up being around that. .

Kyuwon Choi

Analysts
#22

Great. You mentioned earlier, you presented a patient story at AOA of a woman who had multiple recurrences went through multiple surgeries, multiple treatments before as a start, but now has a complete response. You also noted that this is an interesting case because she had a multifocal disease as well. And so I'm just sort of curious, this wasn't something to my recollection to specifically in your clinical study. But as you think about this, does this make maybe -- start making most sense for these kinds of multifocal cases where just given the sheer number of lesions, something like surgery or laser ablation may be potentially clinically challenging here.

Elizabeth Barrett

Executives
#23

You're absolutely right. I'll say 2 things about that. One, if you do look at our clinical data, you'll see that ZUSDURI worked across all patient types. But you will also see that the majority of patients and not just in our clinical study, but overall, the majority of patients that recur do recur with multi vocal disease, right? And so that makes it very difficult to ablate the tumor. So the chemoablation makes sense, right? It makes sense because it's seeing the entire bladder. So you're able not only to get to all of the multiple tumors, but you're also able to get tumors you can't see. Because from a physician standpoint, a surgeon, you can only cut out what you can see. So you're right in the sense of it makes a lot of sense but that doesn't mean it doesn't work for other types of tumors. And I think that's interesting, we have to make sure that we don't get niched even though it's the majority of the patient population, you don't want physicians or patients to believe, well, just because they have this type of tumor the story probably won't work because so far, we haven't seen that in our clinical data, and we haven't seen it in real practice. Although it's good to note that most patients that do recur, recur with these multi-local, smaller tumors, which are harder to treat via surgeon.

Kyuwon Choi

Analysts
#24

Great. As we look ahead, can you maybe tell us how you're thinking about penetration, both in terms of breadth and depth of your target prescriber population. Where are you now in sort of that hierarchy or carrying of prescriber base and just sort of maybe update us on where you are in terms of depth and breadth versus how much -- how you're targeting that over time?

Elizabeth Barrett

Executives
#25

Yes, absolutely. I mean the interesting thing for us is there's urologists that we call on that captures about 90% of the patient population. But as you know, they're not all created equal. And you're absolutely right. You have your higher decile doctors. So what we are doing is we are definitely focused on those higher decile doctors, and we do need both breadth and depth. But we have identified sort of our top 250. And if you take those top 250 accounts and ensure that not only do they have the trial, but that they're really treating multiple patients. So how do you get multiple patients out of these high-prescribing doctors? Absolutely one of our core strategies. And that's the sort of short-term focus. But we also cannot forget that we'll never get there if you don't have the breadth, right? When we talk about ZUSDURI being a $1 billion-plus revenue medicine, you're looking at less than a 20% penetration to get there. That's why we always have the plus on the end. So we believe that we're fairly conservative to get to that number. And we -- so far, what we're seeing is we're really giving us confidence that we will get there. And to your question, Q1, we more than doubled the number of doctors. We're continuing to see more doctors coming on board. We've talked about into Q2. We saw Q1 a lot more not only physicians trying but physicians are using it more than once, but we see our patient enrollment forms. We see our new patient starts in our doses, which had already eclipsed to your point earlier, JELMYTO. We're continuing to see that growth in Q2. And so we believe that we're right on track with where we expect it to be. Right now, we're comfortable with kind of where the market is looking and seeing where we will be. And we think that we'll see by the end of the year that we're really on our way to hitting that adoption.

Kyuwon Choi

Analysts
#26

Great. Let's turn to the pipeline and maybe talk about UGN-103. Can you provide an update on sort of what the filing status and plans are and just sort of how you're currently thinking about time lines for 103?

Elizabeth Barrett

Executives
#27

Sure. So UGN-103, as you know, is the next generation for ZUSDURI. And we also shared not only the 36-month data as far as a story, but the 6-month data that we got in. And the great news is it's very consistent. And so we expect to file within Q3. So by the end of Q3 of this year, we will file with the -- we've got an approval from the FDA in agreement with the FDA that we can update the 12-month data during the filing. So during the review. So it won't hold up the filing at all. So our date starts, the 10-month review will start when we file. -- even though we'll have an update during that time period. So assuming that it remains in system, which we have no reason to believe that it won't, you're looking at an approval time in 2027. And then what we will do is to ensure reimbursement is we will have both products on the market until we get our for UGN-103. And then at some point, we will do a swap, and we'll do the switch. And when we do that, we'll pull the story off of the market. So we expect, again, there not to be a lot of clinical differences, but there are some meaningful preparation differences. There's the life of the drug once it's mixed, will be longer. And with UGN-103. So there's definitely some practice benefits to it in some -- so we expect the clinical data to be very similar, but UGN-103 to have other benefits along with that and ensuring supply, which is a big deal these days. because we know that the maker of the new mitomycin is well known. It's been around for a long time, has the capacity that we need to ensure that we have supply for the long term. So that's the plan right now. we don't have an exact date on when we will do the switch because we will, again, make sure that we have our J code in place before we do anything. The worthy that could happen is the patient doesn't have access to 1 of our medicines. -- but at the appropriate time, and my expectation that will be in 2028.

Kyuwon Choi

Analysts
#28

Just on the J-code mechanics. You talked about for the filing slide, filing in the third quarter, which I think investors agree with support and approval in the later part of 2027 under normal review. And then just on the J-code mechanics, is that something you can potentially have in place for the start of calendar 2028?

Elizabeth Barrett

Executives
#29

Yes. That's it.

Kyuwon Choi

Analysts
#30

Okay. That's expectation. Okay. And then I guess with that code being available just in terms of supply that you mentioned earlier, how do you think about building up supply for that at that point because presumably, the prescriber base for the start will be meaningfully larger than where it is right now 1.5 years time. And so -- just how do you think about launch supply, I guess, and just having enough supply on hand for that switch. For both, yes.

Elizabeth Barrett

Executives
#31

Yes, that will definitely be an art and a science as we start to look at ensuring ZUSDURI supply that we don't run out of ZUSDURI at the same time, we don't. So we will ensure that both of our manufacturers, the manufacturers for ZUSDURI and for UGN-103 that we have enough supply. I mean the good news is both we have very, very great partners in manufacturing. And so we will, to your point, build up supply. But at some point, we will need to make the switch, right? So we will have to ensure to -- you've said it by that time, we expect ZUSDURI adoption to be much greater. So we will not make that switch, we'll not take the ZUSDURI off of the market until we ensure that everybody can be supplied with our products.

Kyuwon Choi

Analysts
#32

You talked about some features, including longer shelf life for 103, which should be helpful for practitioners. Any other things that you would highlight for us as you think about brand and creating brand awareness for 103 down the road that you think would drive sort of natural preference share for 103 versus ZUSDURI?

Elizabeth Barrett

Executives
#33

I think definitely in the institutions because it is easier to mix. So there is a, again, an art and a science to mixing the gel with the mitomycin today. it takes longer. You have to -- it actually is pretty intense from a patient -- from a personnel perspective. that UGN went through much easier. So it's much faster to reconstitute and you don't have -- because it's more soluble. So one of the biggest issue is particles. So you have to make sure that it gets mixed a certain way. So that will be particularly in the hospital pharmacy because most of, I mentioned before, the community tries they want it premix. So for them, the longer shelf life will be very key. So that will be very important because they'll be able to keep it if a patient doesn't show up, they'll -- so they'll be able to keep it mixed for longer. And so -- but absolutely for the personnel and the amount of time they take that into consideration when they think about cost. -- the cost of reconstituting the cost that their staff has to spend -- that's the cost to them and they add that cost when they're thinking it out using any therapy. It's like, okay, that comes into their cost of goods. And so they'll save time from there as well. So those types of benefits are important while they may not hit the clinical piece of it, absolutely matters from a practice perspective.

Kyuwon Choi

Analysts
#34

I want to look down the road a little bit and think about your development plans for UGN-103. Specifically, how are you thinking about a potential trial in the adjuvant setting. I'm also curious how you're thinking about designing and sort of what's required to move it down the risk curve into sort of a higher risk population, maybe a muscle-invasive population where some other companies are studying developmental candidates there. .

Elizabeth Barrett

Executives
#35

Yes. We really believe that UGN-103 will be able to provide benefits for patients with high-grade disease to your point. that market is getting more crowded, the clinical we actually have already interacted with the FDA. So we know what we have to do. And it will be an adjuvant in high grade, and it will be against the control arm. And right now, we're just finalizing the details as well as the patient population because the interesting thing about high grade is that talking about high-grade [indiscernible] base in bladder cancer, there are so many different types of patients within there. There's the BCG responsive. There's a BCG unresponsive, there's the BCG exposed. So which patient population do you go into. And so that's what we're finalizing those details, but we expect to start that study this year. So that high-grade we're really thinking about papillary-only disease because everyone else, if you think about where they've been with CIS with or without Papalari. So we -- and it makes sense that our approach works in that patient population. So that's what we'll be kicking that off. And again, it will be a controlled study against not only TURBT but TURBT plus, and the question right now is what's the plus. So working with the FDA, and I don't know if you've heard it, but there was a 5-hour meeting right after AUA with the people from the FDA getting input. And I think what came out of that is that there's actually no real standard of care right now. So there's not one way of looking at it. And so there's -- there really -- so there's options available. So we'll move into that space. We also think about muscle invasive disease in combination, what are the best combinations and so we think about that. And so we're working on that. And then lastly, what we've talked about is I want to be very careful in the IR space with adjuvant because of course, believe the drug will work in adjuvant. But we also believe that one of the greatest benefits of our drug is you don't have to do a surgery. But I do think that some physicians, there's going to be a group of physicians that want to use it earlier in the disease. And so we want to generate data in the low-grade IR and then make decision do we want to have a pivotal study in that space. We want to generate data, ensure that it's positive, which we believe it will be, and then make a decision as whether we want to go forward with a pivotal study. So we're working those final details out. But a lot of room for UGN-103 across the continuum of patients, mostly nonbase of bladder cancer, but there's a real story to be had to your point for even going into muscle invasive bladder cancer.

Kyuwon Choi

Analysts
#36

We have 1 minute left. So I just want to touch briefly on your 501 oncolytic virus program and just maybe remind us sort of what are the milestones over the near term for that program? And just how you're thinking about the sort of cadence of updates to -- the Street for 501 .

Elizabeth Barrett

Executives
#37

Yes, absolutely very excited about 501. We get more -- the more data we generate, even though it's preclinical day, then we're excited we get. We believe it's very differentiated. -- from a perspective that it not only is an immune response, but it also has direct cancer south kill. So the ability for that drug to be very meaningful in the high good space. So we are going into Phase I this year. So we will be in patients this year. We'll have a broad patient population for our Phase I. We do our dose finding, I'm setting mostly safety, but we expect that we'll see a signal. So I don't -- there won't be any updates, obviously, in 2026, but there should be updates in 2027 as we move that forward. The other good thing about UGN-501, when we talked earlier about our long-term strategy for the company is we believe it will work in other tumors as well. We know from the work that was done at a Conigan when they don't -- they had this product. that it will work across other tumors. And so right now, we're looking at what is the best next tumor to look out outside of urothelial cancer. So again, stay tuned on 501, but I would -- suffice it to say, we're very excited about what's happened in that space.

Kyuwon Choi

Analysts
#38

Great. I think we're out of time, so we'll have to stop on that note. My thanks to Liz and UroGen Pharma for joining us. Thanks.

Elizabeth Barrett

Executives
#39

Thank you, Paul. Good to see you as always.

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