Prepared remarks
Good day, and thank you for standing by. Welcome to the UroGen Pharma's Q2 2026 Earnings Conference Call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Vincent Perrone, Senior Director of Investor Relations. Please go ahead.
Thank you, and good morning, everyone. Welcome to UroGen Pharma's Second Quarter 2026 Financial Results and Business Update Conference Call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended June 30, 2026. The release can be accessed on the Investors portion of our website at investors.urogen.com. Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; and Chris Degnan, Chief Financial Officer. On today's call, we will be making certain forward-looking statements. These may include, among other things, statements regarding our ongoing commercialization activities related to ZUSDURI and JELMYTO, ongoing and planned clinical and nonclinical trials, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations as well as anticipated data, regulatory filings and decisions, the importance of ZUSDURI's growth for UroGen's long-term strategy, the potential benefits of our products and product candidates and all future R&D efforts and milestones, our corporate goals and 2026 financial guidance. These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. I'll now turn the call over to Liz Barrett, Chief Executive Officer.
Good morning, and thank you all for joining us today. I'm so pleased to share the results for another strong quarter, driven by continued momentum across the ZUSDURI launch and meaningful progress advancing our long-term growth strategy. ZUSDURI generated $50.4 million in net product revenue during the second quarter, representing a 73% growth over the first quarter. More importantly, the commercial trends underlying that growth continue to strengthen. We are seeing expanding adoption across both hospital and community practices, increasing repeat utilization and growing physician confidence, all of which reinforces our confidence that we are building a meaningful commercial franchise. That progress reflects the compelling value proposition of ZUSDURI. As the first and only FDA-approved medicine for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer, ZUSDURI offers patients a treatment that provides unprecedented recurrence and treatment-free intervals. ZUSDURI is a primary nonsurgical option for a disease that historically has been managed through repeated surgical intervention under general anesthesia. We believe its unique clinical profile is changing how physicians think about treating these patients and increasingly establishing ZUSDURI as a foundational treatment in this setting. As with prior quarters, I'd like to provide an update on the operating metrics that we track most closely, as they continue to provide valuable insight into the trajectory of the launch. As of June 30, 2026, we had 1,444 activated accounts, up from 972 at the end of the first quarter. Unique prescribers increased to 452 compared to 256 in Q1, while repeat prescribers nearly doubled to 204. Importantly, repeat prescribers now represent approximately 45% of writers compared with around 40% in the first quarter. We continue to view repeat utilization as one of the strongest indicators of potential long-term success. It demonstrates that physicians are gaining confidence through real-world experience and increasingly incorporating ZUSDURI into routine clinical practice. Equally encouraging, these trends remain consistent throughout the quarter, giving us confidence the launch is advancing and increasingly sustainable. We continue to see increased utilization within existing accounts, demonstrating that adoption is expanding across practices and within them. Patient enrollment forms are increasing and new patient starts are tracking in line with that growth. Operationally, we continue to improve the time from patient enrollment to treatment initiation. As practices gain familiarity with ordering, reimbursement and administration, workflows continue to become more efficient. Our goal is to achieve the 2- to 3-week enrollment to treatment conversion cycle we see today with JELMYTO, and we expect continued progress toward that goal over the balance of the year. Another encouraging trend is expansion into community urology practices. By the end of the quarter, approximately 55% of utilization was in community practices compared to 45% from hospitals. This is important because we estimate approximately 70% of the addressable market resides in the community practices. As adoption continues to broaden, we believe the community setting will become an increasingly important driver of long-term growth, and we still see significant runway ahead. From an access perspective, we have open access across more than 95% of covered lives, and we see no material reimbursement barriers. The permanent J-code has performed exactly as anticipated by improving reimbursement confidence and enabling broader utilization. At this stage, reimbursement uncertainty is no longer a meaningful constraint to adoption. Looking ahead, we believe there remains a significant opportunity to build on this momentum through the remainder of 2026 and beyond. Our priorities remain clear: expanding community adoption, increasing repeat utilization, continued improvement of patient conversion and increasing awareness among both physicians and patients. We are beginning to invest more directly in patient awareness. Many patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer are not aware that a nonsurgical treatment option exists, and we believe increasing that awareness represents an important opportunity to expand utilization in the mid- to long term. Turning to JELMYTO. Revenue was $22 million in the second quarter compared to $21.7 million in the first quarter. JELMYTO continues to demonstrate a stable and predictable demand profile while also continuing to add new users. We believe we're on track to deliver within our full year revenue guidance of $97 million to $101 million. During the quarter, we continued to strengthen the long-term foundation of our uro-oncology portfolio. We reached a settlement and license agreement with Teva that resolved the JELMYTO patent litigation, providing greater visibility into the product's long-term commercial runway while reinforcing the strength of our RTGel intellectual property portfolio. In addition, we received a notice of allowance from the U.S. Patent and Trademark Office for a new method of treatment patent covering both ZUSDURI and UGN-103. This patent, once issued, is expected to provide protection into July of 2044, strengthening the intellectual property supporting the franchise and reinforcing the long-term commercial opportunity for both products. We continue to make meaningful progress across our pipeline. UGN-103 remains on track for NDA submission in the next few weeks. UGN-104 continues progress through Phase III and following FDA acceptance of our IND, we're excited to begin Phase I development of UGN-501 this year. Overall, the first half of 2026 has significantly strengthened our conviction in the long-term opportunity ahead. We are successfully scaling the ZUSDURI launch, advancing multiple pipeline programs and building a company positioned for sustained growth. We believe this positions UroGen to deliver meaningful outcomes for patients while creating significant long-term value for shareholders. With that, I'll turn the call over to Mark for a clinical update.
Thank you, Vincent, and good morning, everyone. Let me begin with the most recent update from the Phase III ENVISION trial. In May, we announced updated durability data from ENVISION with nearly 3 years of follow-up. Among patients who achieved a complete response at 3 months, the probability of remaining disease-free at 36 months was 64.5% by Kaplan-Meier estimate. Importantly, at a median follow-up of 35.5 months, the median duration of response has still not been reached. The most important takeaway is that the complete response obtained with ZUSDURI is highly durable through 3 years and was achieved without any maintenance therapy. In practical terms, by Kaplan-Meier estimate, most complete responders remain disease-free nearly 3 years after achieving a complete response. For a disease characterized by repeated recurrences and repeated surgeries, these data highlight ZUSDURI's potential to interrupt that cycle. The clinical data are important, but equally important is that we are now seeing similar results in routine clinical practice. At the American Urologic Association Annual Meeting in May, we hosted a panel of leading academic and community urologists to discuss their real-world experience with ZUSDURI. The discussion provided strong corroboration of both the clinical profile and commercial adoption we are seeing today. Several consistent themes emerged. First, the panelists described ZUSDURI administration as easy to integrate into routine urology practice without meaningful disruption to existing workflows. Second, as physicians gain experience, they are becoming increasingly confident in expanding use beyond their initial patients. Rather than reserving ZUSDURI for patients who may not be ideal surgical candidates, many are now considering it earlier for a broader range of patients with recurrent low-grade intermediate risk disease, including younger and otherwise healthy patients who simply wish to avoid repeated TURBT procedures. And finally, the panel also discussed how they expect ZUSDURI to fit within the evolving treatment landscape. Their view is that physicians will continue to prioritize therapies that combine durable efficacy with ease of administration, minimal disruption to practice workflow and a finite treatment course. We believe these characteristics position ZUSDURI favorably as the treatment landscape continues to evolve. The event also included a patient perspective, one that reinforced what we heard from physicians. She described the burden of repeated recurrences in multiple TURBT procedures before she received ZUSDURI, as well as the impact that achieving a durable complete response had on allowing her to return to her normal life. We believe it reflects the experiences of many patients now being treated with ZUSDURI, and it's a reminder of why we think the opportunity here is so meaningful. For those of you who are unable to join the live event, a replay is available on our website. While the commercial launch continues to validate ZUSDURI in clinical practice today, we remain equally focused on extending the leadership through our next-generation pipeline. UGN-103 represents our next-generation investigational medicine for recurrent low-grade intermediate risk NMIBC, and we remain on track to submit our NDA in the third quarter of 2026. As we announced previously, the Phase III UTOPIA trial demonstrated a 6-month duration of response of 94.5% by Kaplan-Meier estimate, which is generally consistent with the 91.9% 6-month durability observed with ZUSDURI in the pivotal ENVISION trial. We continue to believe these data support the regulatory pathway for UGN-103, and we remain aligned with the FDA on our planned NDA submission. Looking beyond the initial indication, we continue to expand the long-term opportunity for UGN-103. Following a productive Type C meeting with the FDA, we plan to initiate a Phase III trial later this year to evaluate UGN-103 in high-grade NMIBC and in the adjuvant setting for newly diagnosed patients with low-grade intermediate risk disease, which remains on track for 2027. Our Phase III program for UGN-104 in low-grade upper tract urothelial cancer continues to progress well, and we expect to complete enrollment by the end of 2026. UGN-501 is our investigational next-generation oncolytic virus being developed for high-grade NMIBC. In July, the FDA cleared our IND, and we expect to initiate a Phase I trial later this year. What continues to excite us about this program is its differentiated biology. UGN-501 is engineered to combine direct tumor cell destruction with a subsequent immunomodulatory effect, providing what we believe is a unique mechanism among oncolytic viruses currently in development. Our nonclinical studies demonstrated broad cytotoxic activity across multiple bladder cancer cell lines, reinforcing our belief that UGN-501 has the potential to become a differentiated therapy in this space. The Phase I trial will initially evaluate intravesical administration, while future development will explore delivery using our RTGel technology to potentially extend dwell time and enhance local activity. With that, I'll turn the call over to Chris to review our financial results.
Thank you, Mark, and good morning, everyone. Total revenue was $72.5 million in the second quarter of 2026 compared with $24.2 million in the second quarter of 2025. This increase was driven by the continued commercial launch of ZUSDURI. Research and development expenses were $17.3 million in the second quarter of 2026 compared with $18.9 million in the same period last year. The decrease in R&D expenses was primarily attributable to ZUSDURI manufacturing costs, which were recognized as an R&D expense in the second quarter of 2025 prior to receiving FDA approval. Selling, general and administrative expenses were $48.4 million in the second quarter of 2026 compared with $43.2 million in the same period last year. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities, including sales force expansion following ZUSDURI approval and higher brand marketing expenses and an increase in overall commercial operation costs. We recorded noncash financing expense related to our prepaid forward obligation to RTW investments of $4.5 million in the quarter compared with $4.6 million in the second quarter of 2025. Interest expense on our long-term debt was $4.9 million compared with $4.1 million in the same period last year. We reported a net loss of $14.4 million or $0.28 per basic and diluted share in the second quarter of 2026 compared with a net loss of $49.9 million or $1.05 per basic and diluted share in the second quarter of 2025. As of June 30, 2026, we had $108 million in cash, cash equivalents and marketable securities. Turning to guidance. We continue to expect JELMYTO net product revenue of $97 million to $101 million for 2026, which represents growth of roughly 3% to 7% over 2025. As we have noted prior, we are not issuing full year ZUSDURI guidance while the launch is still in its early stages. We are increasing our full year operating expense guidance to $260 million to $270 million, including approximately $20 million to $24 million of noncash share-based compensation expense. This increase reflects our decision to accelerate investment behind the business in response to the continued strength of the ZUSDURI launch. Specifically, we plan to increase investment in ZUSDURI, health care professional promotional education and patient awareness initiatives to support long-term commercial adoption and also accelerate start-up activities for the UGN-103 high-grade trial and development activities to explore UGN-501 with our RTGel technology. We view these as disciplined high-return investments that have the potential to strengthen the long-term profile of the business. Importantly, this increased investment does not change our confidence to reach profitability with our existing capital resources. That concludes our remarks. We will now open the call to questions.
Questions and answers
Our first question comes from the line of Raghuram Selvaraju of H.C. Wainwright & Company.
Congratulations on a highly impressive quarter. I was wondering if you could provide us with some additional color regarding the demand level that exists for ZUSDURI at the community practice setting, how ZUSDURI might potentially be viewed as a privileged product, an attractively priced and highly impactful product at the community practice level, and how the community practice setting compares in terms of overall market size opportunity to the opportunity that exists for ZUSDURI at the academic center level?
Ram, it's Liz. Thanks, and thank you for your comments. I want to just make sure when you're saying community practice, you're really talking about community practices, right, not necessarily community hospitals? Okay, yes. So look, at the end of the day, what we've said in the remarks is that about — we know that most patients, roughly around 70% of patients are actually seen in the community setting. So getting to the community setting is obviously very key for us. You have your LUGPAs, your large group practices. We also have a lot of practices that have now been consolidated under some of the private equity groups. But for the most part, they all work independently. They operate really independently. So while there's a huge opportunity there, there's also a lot of work that has to get done to operationalize that, particularly with a therapy such as ours. So we're just really scratching the surface of the opportunity in community practices. They get it, the financial piece of it. They understand that adding this 'service line' is great for them to attract patients. So there's a lot of reason to do it. But again, the adoption is still really, really early. Academic centers, I think, for the most part, you see a faster uptake in those areas, but they don't see the majority of the patients. They want to be at the forefront of medicine. It's much easier for them to operationalize because they're not having to deal with the pharmacy deals with most of it. So I think what I'll say is that we see uptake across the board in all types. We see the biggest opportunity for accelerating growth to bring on some of these large group practices. Once you really get it integrated into their practice where they're using it all the time, that's going to be the biggest driver of any inflection. I mean, we hear a lot about inflection. But the reality of it is we've talked about this before, urology is a little slow. They're slower compared to oncologists. So even though we had a great quarter, we're really thrilled with where we are, there's still so much opportunity out there for us to accelerate growth. So I hope that helps to understand kind of the way that they're looking at it, we're looking at it, but also the way community practices look at it versus academic centers.
No, that's very helpful. And then just very quickly, I was wondering when you believe you might be in a position to provide ZUSDURI revenue guidance, if you're thinking about doing that before the year closes, or failing that possibly to start off 2027? Also, I wanted to see if you felt you had a handle at this point on the timing of completion of the Phase III trial of UGN-104. And this is something that I've asked before, with the added momentum behind ZUSDURI, any meaningful sort of spillover positive impact on JELMYTO uptake at this time?
Just on the guidance front, Ram, thanks for the question. We're pleased with the progress. It still remains in the early stages. So we think it's prudent to allow the demand trends to play out through the rest of this year before we consider introducing formal guidance for ZUSDURI. So I would think more for next year in terms of ZUSDURI guidance.
UGN-104 is on track to complete enrollment this year. And regarding JELMYTO, no, we have not seen a clear halo effect on JELMYTO from the ZUSDURI launch. You can look at it both ways. On one side, the priority for the sales team is ZUSDURI, and we made that intentional decision because we believe it's the right decision. Having said that, we want to continue to drive JELMYTO revenue and give patients access. We are seeing some new doctors use JELMYTO who had not used it when we first talked to them about ZUSDURI. But overall, we have not seen a pronounced positive spillover. We do hope to see it over time as we continue to go to more doctors. I should also note that there are a number of clinical trials enrolling this year, both our own UGN-104 study as well as competitor studies, which are taking patients that might otherwise have been JELMYTO patients. So it's a bit hard to disentangle the effects at this point.
Our next question comes from the line of Tara Bancroft of TD Cowen.
I also want to offer my congratulations on the very strong quarter. It obviously far outperformed linear growth metrics that we were all thinking of. So I'm curious to hear which metric or factor particularly drove that acceleration in growth that you're seeing the most, especially compared to last quarter? And then based on that, how should we think about growth throughout the rest of the year — continued acceleration, linear or something else?
Thanks, Tara. As Liz mentioned in the prior question, urologists tend to be slower to adopt and they will try it on one or two patients and then expand to other patients. That was the reason for our linear growth expectation. We did outpace that a bit in Q2. We do expect some quarter-to-quarter variability. One thing we're watching is potential summer seasonality as an example. Nothing specific in terms of what's driving the slightly faster than linear growth within Q2; we've just seen consistent growth across all the commercial metrics, which gives us confidence in the sustainability of the growth trajectory. But I would expect some quarter-to-quarter variability and still think a linear growth profile is a reasonable way to think about it from now until peak.
Great question. We want to be cautious on Q3. We do expect growth and quarter-over-quarter increases, but we do not expect to see a pronounced acceleration in Q3. We're hopeful that as we continue to grow throughout the year we'll see continued acceleration longer term, but given what we've seen so far we're comfortable characterizing the near-term trajectory as linear growth with some variability.
Our next question comes from the line of Kelsey Goodwin of Piper Sandler.
Congrats on a really great quarter. Two quick questions. First, based on your channel checks, after how many TURBTs are patients getting ZUSDURI now? And do you have a sense for what the split is among ZUSDURI users that are eligible versus ineligible for surgery? Second, you mentioned some physicians being hesitant to try new things and using ZUSDURI in the adjuvant setting initially — are you still seeing that, are physicians moving away from that, and how do you see that trend evolving over time?
Great question. We're still in the relatively early stages of the launch. Anecdotally, usage is occurring after a wide range of TURBTs: after 1, after 2, after 3, after 5, and even after many more. So we're seeing it across the board. We're not seeing physicians only treat patients who are strictly ineligible for surgery. While a very small portion are truly ineligible, a larger portion prefer not to put patients through repeated general anesthesia or multiple TURBTs. Regarding adjuvant versus primary use, as physicians gain experience they're increasingly comfortable using ZUSDURI without prior surgery. Some physicians still perform TURBT first and then use ZUSDURI afterward, but we're seeing more and more physicians use it as a primary nonsurgical option. We are investing more in patient-facing programs because many patients prefer to avoid surgery, and increased patient awareness should help continue to drive adoption. We do not promote adjuvant over primary; physicians can use it per their clinical judgment as long as reimbursement allows.
Almost nobody is truly ineligible for surgery. The majority of decisions are driven by patient preference or comorbidities that make repeated surgery less desirable. That's what we're seeing in practice.
One quick follow-up: what are your updated thoughts on profitability? Are you still comfortable with cash getting you to and through profitability?
Good question, Kelsey. Yes, we are still confident that our capital resources will get us to and through profitability.
Yes. We've been disciplined with our spending and have not under-resourced the launch. We see a number of opportunities we'd like to invest in, but the increased investment we've announced does not change our path to profitability.
Our next question comes from the line of Leland Gershell of Oppenheimer.
Let me also add my congratulations on the ZUSDURI number. It certainly makes sense to be further in support for this key growth driver. A couple of questions. Liz, in the past you've said you see $1 billion or maybe over $1 billion in total revenue for UroGen by the end of the decade. I'm wondering if there's any contemplation of potentially revising that number upward given the strong sales trajectory? Also, when you make the transition in the marketplace from ZUSDURI to UGN-103, and similarly for JELMYTO to UGN-104, could you walk us through what that will mechanically look like? Presumably you'll wait for not just the approval, but the J-code, and then you will introduce one product and then withdraw the prior one. How do you plan to manage that?
Thanks, Leland. I've always said $1 billion-plus, and that comment has been focused on ZUSDURI alone. When you think about the total company opportunity across products and pipeline, there's potential to exceed that substantially. We have said that 20% market share for ZUSDURI corresponds to approximately a $1.2 billion market. Is there upside beyond that? Absolutely. Timing and physician adoption will determine how quickly we reach that level, but we do believe the opportunity is very large. Regarding the transition from ZUSDURI to UGN-103, the patent developments have given us flexibility. We would plan to wait for appropriate coding (e.g., a J-code) and ensure a seamless transition so as not to disrupt physician adoption or patient access. There will be a period when both products may be on the market. UGN-103 offers manufacturing and supply advantages, extended dating, and other benefits, so we would want to switch as quickly as practicable while ensuring continuity. The transition from JELMYTO to UGN-104 is similar but may be easier given smaller patient and physician populations. The key is to manage the transition without jeopardizing adoption or availability for patients. The additional patent protection into 2044 is an important development for our long-term strategy.
Our next question comes from the line of Amin Makarem of Jefferies.
Congrats on the quarter. With the number of sites activated so far, which is around 1,400, and around 450 prescribers, how quickly can you close the gap between prescribers and activated sites? And how many eligible patients do you expect to have within these 1,400 activated sites?
From the site activation perspective, those are sites operationally ready to administer ZUSDURI — they're through credit checks, on-boarded with our specialty distributor, and ready to go. We spent a lot of time last year building the foundation to get sites activated and ready. We'll continue to add new sites between quarters. In terms of conversion from activated sites to physician utilization, focus more on physician adoption metrics and the adoption curve rather than a simple sites-to-prescribers ratio. We feel good about the number of sites ready, and physician adoption will drive conversions.
Our next question comes from the line of Michael Schmidt of Guggenheim.
A pipeline question on UGN-103. With the planned Phase III study in high-risk NMIBC starting later this year, could you comment on how you think about the competitive landscape there, which differs from the low-grade space? How is UGN-103 positioned in the high-risk category relative to other available and emerging therapies?
The study we're beginning in high-grade disease will focus particularly on papillary disease where we see opportunity. It will be an adjuvant study compared to an active control of TURBT plus intravesical chemotherapy. The value proposition is familiar: the advantage of delivering an active agent in an RTGel formulation is extended dwell time compared to aqueous chemotherapy, which should convey a therapeutic benefit. That study will include both induction and maintenance therapy. It remains incumbent upon us to prove benefit in the study, but we're optimistic that UGN-103 in this context will provide an advantage compared to conventional therapy. Regarding the size of the opportunity, high-grade NMIBC is a substantial market and a meaningful portion of urothelial cancer patients fall into this papillary category. While the space is competitive, bladder cancer has comparatively fewer players than many oncology spaces, and we believe 103 can be at least as good as, if not better than, competing approaches in efficacy, safety profile and ease of use. These patients often need multiple options over time, and pricing that reflects maintenance therapy can make the opportunity significant.
To add, the market opportunity is considerable for both low-grade and high-grade indications. UGN-103 has manufacturing and supply advantages and clinical profile advantages that position it well, and we're excited about the potential to deliver meaningful options for patients across these settings.
Our next question comes from the line of Paul Choi of Goldman Sachs.
This is Eric on for Paul Choi. Regarding sequencing of adjuvant therapies: as competitive oncolytic immunotherapies begin establishing adjuvant treatment roles in the intermediate risk segment, how do you expect urologists to sequence ZUSDURI upon recurrence? Do you think they will bypass adjuvant treatments entirely in favor of ZUSDURI? How do you perceive the treatment algorithm evolving?
This topic came up during our AUA panel. Panelists believe the likely sequence will be: patients undergo TURBT for diagnosis and staging. If a patient has low-grade intermediate risk disease upon recurrence, literature shows these patients have a low likelihood of progression and a high likelihood of further recurrence after TURBT. The panelists expect that, as physicians become more familiar with ZUSDURI, ZUSDURI will increasingly become the default next therapy when a patient fails or recurs following TURBT. If a patient achieves a long-term disease-free interval following ZUSDURI, there's no reason to believe the patient couldn't be retreated with ZUSDURI upon future recurrence, although data on retreatment are still emerging. If a patient is refractory to ZUSDURI, physicians will consider other therapies, typically another TURBT followed by some other intravesical agent. So ZUSDURI looks like it will emerge as the next step after recurrence post-TURBT.
We feel very confident in that sequencing given the recurrence-free and treatment-free interval data. Six weeks and you're done for many patients — no surgery if it's not needed — and we are already past 36 months median follow-up without having reached median duration of response in many responders.
Our next question comes from the line of Kevin DeGeeter of Ladenburg Thalmann.
A question on UGN-501. Can you walk through the thinking on what will characterize a go/no-go from Phase I beyond safety? Should I think about replication within cells, indications of oncolytic activity, or other efficacy parameters? And is there an opportunity for a meaningful update in 2027?
We're excited about UGN-501 because of its differentiated biology. It's engineered to act initially with high cytolytic activity — effectively tumor cell destruction — and then elicit a secondary immune response. Our preclinical and additional clinical data suggest strong activity; preclinical data in bladder cancer cell lines show broad cytotoxic activity across various urothelial cancer models. Phase I will be focused primarily on safety and tolerability, but we will be actively searching for efficacy signals in the patient population we study, namely those with high-grade noninvasive disease. Those efficacy signals will help inform the design of Phase II. We have high expectations and do expect to gather meaningful data in 2027 that will inform next steps.
I'm now showing no further questions at this time. I would now like to turn it back to Liz for closing remarks.
All right. I just want to say thank you, everybody. For those of you who have supported us for several years, it's nice to be in the place that we're in right now. As I mentioned earlier, we're just scratching the surface. The opportunity for ZUSDURI and JELMYTO to continue to grow and then for our company in the long term, given our pipeline and where we're headed, our long-term strategic outlook is very positive, and we're very excited about it and appreciate all the support. We'll continue to provide updates as we go along. So thanks, everybody, for joining this morning. Take care.
Okay. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.