Conference Operator: Good morning, and thank you for standing by. Welcome to the EuroGen Pharma third quarter 2025 earnings call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised, today's conference is being recorded. I'd now like to go ahead and hand the conference over to your first speaker today, Vincent Perron, Investor Relations. Vincent, you have the floor.
Vincent Perron: Thank you. Good morning, everyone, and welcome to Eurogen Pharma's third quarter 2025 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 September 30th, 2025. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Joining me today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, David Lin, Chief Commercial Officer, and Chris Degnan, Chief Financial Officer. On today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to Gelmito and Zesturi, our ongoing and planned clinical trials and non-clinical trials, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data, regulatory filings, and decisions. So, story being the primary growth driver for Eurogen, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals, and 2025 financial guidance, among other things. 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 your agent disclaims any obligation to update these statements. I'll now turn the call over to Liz Barrett, Chief Executive Officer.
Liz Barrett: Thank you, Vincent. I'd like to address what I know is on everyone's mind, and that is the progress of the Sisturi launch. While we had expected a faster uptake, there are many factors that support our belief that the near and long-term opportunity for Zysteri is on track. The preliminary demand revenue for October is more than double the previous three months, demonstrating increased usage and adoption. Importantly, our patient enrollment forms, or PESTS, in Q3 were actually on track with our initial expectation, But as we've communicated, it is taking longer to convert a PEP to an actual patient being dosed. We believe the delay is driven solely by logistical and operational challenges, including reimbursement concerns with a miscellaneous J-code. PEPs continue to grow and are currently on pace with Jelmido after only four months on the market. Since launch, physician enthusiasm has been encouraging. There's clear recognition of the need for new therapeutic options for these patients. And our market access team has executed well to secure broad coverage across major payers. I am pleased to say that we do have paid claims. Feedback on the clinical profile of this jury continues to be very positive with high intent to prescribe by physicians. As we anticipated, usage has been greater in the hospitals than in community practices. but in both settings often requires formal approval before physician ability to use. Remember, we are changing the way physicians practice, and Zosturi is the first and only FDA-approved treatment for patients with low-grade intermediate-risk non-muscle-invasive bladder cancer. Zosturi addresses an estimated $5 billion annual market, and we are well-positioned to take advantage of this significant opportunity. We remain confident in the long-term potential versus jury to deliver an important advance for patients, becoming standard of care and delivering over $1 billion in peak revenue. We expect to see an acceleration in adoption once the permanent product-specific J-code goes into effect on January 1, 2026. David will provide more details on the launch in a few minutes. Turning to Gemido, we delivered another solid quarter with net product revenue of $25.7 million, representing a 13% increase in underlying demand revenue over the same period in 2024. Now, five years post-launch, Gemido continues to demonstrate its clinical value and prescriber confidence remains strong. With our expanded field team, we see additional opportunities to drive further growth. On the clinical front, we continue to advance our next-generation mitomycin programs. We are pleased to see the three-month complete response rate from Utopia is consistent with what was observed in the Envision trial, and our plan for a new drug application or NDA submission and approval is on track. We plan to submit an NDA for UGM-103 in the second half of 2026, with potential approval anticipated in 2027. This is a very exciting time for URGEN. We've entered a new phase of growth from a position of strength with a solid balance sheet, a capable and focused team, and a portfolio that positions us for durable long-term success. We remain guided by our mission to bring meaningful new treatments to patients and deliver sustained value for our shareholders. I will now turn the call over to Dr. Mark Schomburg. Mark?
Dr. Mark Schoenberg: Thank you, Liz. In the Envision study, Zesturi demonstrated a compelling and clinically meaningful profile with 80% of patients achieving a complete response at three months and 80% of those patients remaining disease-free at 12 months and remarkably 72% at 24 months. It's important to note that Zesturi median duration of response has not been reached. This level of sustained response is unprecedented and highly meaningful for a population that has historically faced repeated surgeries and the burden of chronic disease management. The growing body of evidence supporting Zesturi was recently highlighted in a comprehensive review published in Reviews in Urology this October by Dr. Sandeep Prasad, one of our leading clinical investigators. This article reviewed results from our three late phase clinical trials, Optima 2, Atlas, and Envision, and underscored the consistency and robustness of Zesturi's clinical performance. Importantly, the review also explored the patient perspective on Zysduri. Across multiple studies, including the phase 3b home installation study and sub-analyses of Optima 2 and Envision, patients consistently reported that Zysduri was a less invasive, less painful, and less time-consuming alternative to repeated TRBT surgeries. Turning to UGN103, our next generation formulation for low-grade intermediate risk non-muscle invasive bladder cancer. UGN 103 is designed to offer practical advantages over Zesturi, including a shorter manufacturing process and simplified reconstitution. We've completed enrollment in the phase three utopia study and are very pleased to report that the three-month complete response rate was 77.8%. This is consistent with results from the Envision Clinical Trial. reinforcing the strength and productivity of our RT-GL platform. In October, the FDA agreed that our pivotal study, Utopia, can serve as the basis for a new drug application. We plan to submit the NDA in the second half of 2026, with approval anticipated in 2027. In June this year, we initiated a phase three trial of UGN-104, our next generation mitomycin-based formulation for low-grade UTUC. We expect UGN104 will follow a similar regulatory pathway to UGN103. Turning to UGN301, our anti-CTLA-4 monoclonal antibody being evaluated for high-grade disease. We have completed a phase one dose escalation study assessing UGN301 both as monotherapy and in combination with UGN-201 or gemcitabine. The study confirmed proof of concept for our RT-gel as a viable platform for local delivery of complex immunotherapies. UGN-301 achieved sustained bladder exposure of Xalafrilumab with minimal systemic absorption, demonstrating our ability to mitigate anti-CTLA-4 related toxicities. The treatment was well tolerated with a favorable safety profile and efficacy signals were observed across cohorts. However, the overall clinical profile did not warrant advancement to a Phase II study. As such, we have made the strategic decision to discontinue the UGN 301 program and focus our resources on UGN 103 and UGN 501 in high-grade non-muscle invasive bladder cancer. We plan to share safety and efficacy data in a future publication. The important takeaway from this program is that it successfully validates our ability to locally deliver complex immunotherapies using our RTGL technology, a capability we believe will be foundational as we advance future oncology programs. One such program is UGN501, our next generation oncolytic virus acquired earlier this year. UGN501 is designed to selectively destroy cancer cells while retaining potency and triggering a robust immune response. We are pleased with the results we are seeing in our early work with IND enabling studies ongoing and planned initiation of a phase one trial in recurrent non-muscle invasive bladder cancer in 2026 with additional potential applications beyond the urinary tract. I'll now turn it over the call to David Lin for a commercial update.
David Lin: Thank you, Mark. I will spend most of my time today discussing the ongoing launch of Zesturi. Overall, we remain encouraged by the strong engagement we're seeing across the urology community and the early commercial traction we've achieved, while also recognizing the headwinds that accompany the introduction of a new therapy. Our commercial infrastructure is now fully operational. By early August, we onboarded, trained, and deployed 30 new sales representatives, bringing our total to 82 in the field. Along with our regional operations managers, field reimbursement managers, and nurse educators, we now have approximately 130 customer-facing professionals supporting Zesturi as well as Jelmido. As Liz mentioned, Zesturi generated sales of $1.8 million during the third quarter, and we're pleased to report a preliminary demand revenue estimate of $4.5 million for October, reflecting encouraging early momentum in Q4. From launch on July 1st, 2025, through the end of October, there were 54 unique Zesturi prescribers and 16 repeat Zesturi prescribers. I'd like to spend a few minutes highlighting what's driving these numbers, as well as some of the challenges we're addressing. First, we're very encouraged by the level of interest we're seeing in the urology community. Awareness among urologists is strong, and we're seeing consistent engagement with our team to better understand Zesturi's clinical profile and appropriate use in the eligible patients. Second, market access progress has been excellent. Zesturi is now broadly accessible to patients through commercial, Medicare, and Medicaid insurance programs with open access to more than 95% of covered lives and approximately 296 million eligible patients. Third, operational execution remains a major focus as it is a complex network and what we believe is the biggest driver of delayed treatment. We are partnering closely with practices and hospitals to ensure sites are prepared for ordering and administration, including distributor onboarding, pharmacy workflows, and clinical training. We now have nearly 600 sites activated and are ready to order and administer Zesturi. It's important to note that activation reflects site readiness, not necessarily that a patient has been treated. so it remains an early indicator rather than a measure of utilization. Still, it is a positive sign that the infrastructure and operational readiness for adoption continue to expand. We closely monitor patient enrollment as a leading indicator of demand. When a physician identifies an eligible patient, they submit a patient enrollment form, or PEF, to our hub, a clear intent to treat with Zesturi. Weekly PEF volumes are showing strong growth and are now equal to, or in some weeks, greater than gel mito PEFs, reflecting increasing demand and intent to treat. We are, however, seeing an average of 45 to 60 day lag between PEF submission and patient dosing. We believe this is largely because many initial cases are occurring in hospital settings where formulary and P&T approvals can extend timelines. Our field team is actively working to shorten that conversion window by providing education on streamlining reimbursement workflows, accelerating patient benefit verification, and ensuring sites are fully ready to administer treatment. Over time, we expect conversions to narrow to two to three weeks, similar to gel mito. As these processes improve and clinical teams gain experience, we expect conversion rates to increase meaningfully in the months ahead. As you are aware, we are also navigating the temporary use of the miscellaneous J-code, which adds administrative complexity for practices given that Zesturi is a buy and build drug. Many large community practices have indicated strong interest in treating with Zesturi once a permanent J-code is available. We were pleased to announce last week that we have been assigned the permanent J-code by CMS that will go into effect on January 1st, 2026. In the interim, We've prioritized around 2,000 early adopter physicians who have shown a willingness to prescribe under a miscellaneous J-code. Once the permanent J-code becomes effective, we expect to see acceleration in adoption, primarily in the community setting, where physicians tend to be more cautious with new buy and build therapies during miscellaneous J-code periods. This change will simplify reimbursement and significantly reduce several of the barriers we are currently seeing. Taken together, While the temporary J-code has presented near-term headwinds, we continue to see strong interest, expanding the site readiness, and a clear path to broader adoption as we move into the first half of 2026. Turning to Gelmito, we're seeing continued demand growth and steady utilization among high-performing accounts. Our expanded sales force, which now also promotes Gelmito alongside Zesturi, is helping us reach more urology practices with greater frequency and depth. In addition, gross-to-net adjustments have normalized further, providing a clearer view of consistent underlying revenue growth. Taken together, these trends reflect durable demand and strong commercial execution that continue to position Gelmito as a standard of care for patients with low-grade upper-track urothelial cancer. I will now turn the call over to Chris to review our financial results.
Chris Degnan: Thank you, David. Total revenues in the third quarter were $27.5 million, and this consisted of $25.7 million in Jolmito sales and $1.8 million in Zestori sales. Jolmito sales in the same period of 2024 were $25.2 million. However, this included $2.6 million in Creates Act sales. On an underlying basis, excluding Creates Act sales, this represents 13% year-over-year revenue growth for Gelmito, driven by both price favorability and volume growth. R&D expenses for the third quarter of 2025 were $14 million, including non-cash share-based compensation expense of $0.7 million. This compares to $11.4 million, including non-cash share-based compensation expense of $0.6 million for the same period in 2024. The increase in R&D expenses of $2.6 million was primarily driven by costs associated with the Phase III utopia trial for UGN-103, partially offset by lower clinical trial costs, manufacturing costs, and regulatory expenses in connection with SESTORI. Selling, general, and administrative expenses for the third quarter of 2025 were $37.6 million, including non-cash, share-based compensation expense of $2.3 million. This compares to $28.9 million, including non-cash share-based compensation expense of $2.9 million for the same period in 2024. The year-over-year increase of $8.7 million was primarily driven by the storied commercial preparation activities, as well as an increase in overall commercial operation costs, including the expansion of the sales force. We reported non-cash financing expense related to the prepaid forward obligation of RTW investments of $4.6 million in the third quarter of 2025 compared to $5.9 million in the same period in 2024. Interest expense related to the term loan facility with funds managed by Pharmacon Advisors was $3.4 million in the third quarter of 2025 compared to $2.7 million in the same period in 2024. The increase was primarily driven by interest expense related to the third tranche of the loan that was funded in September 2024. Net loss was $33.3 million, or 69 cents, per basic and diluted share in the third quarter of 2025 compared to a net loss of $23.7 million, or 51 cents, per basic and diluted share in the same period in 2024. As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $127.4 million. Turning now to guidance. We are providing revenue guidance for Gelmito only at this point. We continue to expect 2025 Gelmito net product revenues to be in the range of $94 to $98 million. This implies year-over-year growth of approximately 8 to 12 percent over the $87.4 million in demand-driven Gelmito sales in 2024. This excludes the $3 million in CREATES Act sales reported in 2024. Guidance on full-year 2025 operating expenses is also unchanged and is expected to be in the range of $215 to $225 million, including non-cash share-based compensation expense of $11 to $14 million. I'll now turn it back to Liz for summary remarks.
Liz Barrett: I want to take a moment to acknowledge that this era for Urogen is the result of many years of hard work in a challenging environment. The company was founded for this exact moment, to deliver a better option for patients with bladder cancer, and we believe we can deliver that promise. The journey has not been easy, but we have demonstrated unprecedented clinical results where no other FDA-approved treatments exist. We are creating a new path and opportunity for patients, and it would not be possible without the URGEN team, and for them, I am grateful. We believe we will deliver on our commitment for sustainable and meaningful growth and the creation of shareholder value. With that, we can open the call to Q&A.
Conference Operator: Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star 11 again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Tara Bancroft with TD Cal, and your line is open.
Tara Bancroft: Hi. Good morning, everyone. So, my question is, I'm hoping you can maybe explain for us a little more specifics on the timing that you mentioned to revenue recording. I know you stated previously that 45 to 60-day time to treatment. And then a similar time to remittance, but I'd really love to hear more on, you know, the actual timing that you observed in real time, like did it end up on the longer end of those ranges or even longer, and especially for the remittance time, you know, where that ended up. And then any outlook on how you think that timing in Q4 could play out, if that should stay consistent until the permanent J code or not. Thank you so much.
Liz Barrett: Yeah, great, Tara. Hi. Thanks for the question. And I'll ask David to sort of, you know, give you more information about, you know, why the 45 to 60, what we're actually seeing, and then, you know, how we expect that to evolve over time. So, David.
David Lin: Yeah, hi, Tara. This is David. In terms of the time to treat patients, really the main components are we have to do a benefit investigation. And because this is a new therapy, we are seeing a lot of prior authorizations. But the good news, as you know, is that we have very broad coverage across Medicaid, I'm sorry, Medicare, Medicaid, and commercial lives. But anytime you have a new therapy, we anticipate some extra time with the prior authorization. The other main element that we commented on is that we have to get sites to make sure they're set up. And as Liz commented, there's also, because it's a new therapy, approvals needed to use the drug. So while physician interest is strong, There are a number of administrative things that we need to work through. We do expect that as practices get more experience, and particularly as we turn the corner into 2026, we will see those times improve, and we will obviously head toward a much smoother path in terms of time to first dose. And then I think on your second question on remittance, we have paid claims now. And on average, I think what we have experienced in terms of what our practices or customers have told us is that it does take a little longer during the miscellaneous J-code. And so that's playing out as we anticipated. Thanks for the question.
Liz Barrett: Yeah, I guess so. Only other thing, David, was how do we expect it to be in Q4 and then going into Q1?
David Lin: Yeah. Thank you, Liz. We expect the same dynamic to play out through Q4, Tara, and as we turn the corner into to the first half of 2026. Much of that dynamic will start to wane, but it'll take some time. But we do see gradual improvement across all those measures during the first half of 2026.
Tara Bancroft: Okay, very helpful. Thank you so much.
Conference Operator: One moment for our next question. Our next question comes from Michael Schmidt with Guggenheim. Your line is open.
Paul Osborne-Michael: Paul Osborne- Hey, good morning. It's Paul Osborne-Michael. Thanks for taking our question. For this jury, just wondering how much visibility you have into physicians who are waiting for the permanent J-code to kick in on January 1st to begin submitting those patient enrollment forms. Are there any qualitative metrics you could share on feedback from those docs, or is there a way to quantify the sort of kind of demand that's maybe being held up until the J-code is effective?
Liz Barrett: Yeah, great question, Paul. So I'll ask David to comment and may add some commentary myself at the end, but David.
David Lin: Yeah, thanks for the question. We do hear from quite a few physicians, particularly in a community setting, that they are interested in prescribing Zesturi, have identified patients, but really want to wait until January until the permanent J-code is in effect. So that's been encouraging in terms of understanding the demand and also having the transparency from the customers as to when they anticipate starting. So we're going to do everything we can during the fourth quarter to make sure that they are set up so that all they need to do is really activate the patient enrollment form come January 1st. But it is really encouraging what we're seeing so far.
Liz Barrett: Yeah, and I'll just make a couple of comments just on my personal experience going out to the field and talking to doctors, to practice managers. And, you know, one of the things that David mentioned around administrative approvals, I think we're seeing more of that now that you've seen the consolidation in private equity, you've seen the buyout of, you know, from Cardinals. So we are seeing more sort of top-down where the practice is saying, no, you can't prescribe it prior to getting a J-code. So I think my experience anecdotally is that more physicians than not and more practices than not are waiting, which is why we have a good outlook for what we expect to see going into 2026 because They have all identified patients, but have just made it very clear for several reasons that they will not prescribe until they see a J-code. To your point about quantifying that, what I can say is that the team has a list. We haven't quantified that, but we have a list. And to David's point, our top priority is pulling through our patient enrollment forms and getting P&T committees That's our number one objective. But the second objective is ensuring that all of those patients and physicians who have said to us, I have patients identified, and then once we get into the new year, I will prescribe with a permanent J code. To David's point, we're making sure that they're ready to go as quickly as they can be when we do get to the new year. So that's our second priority. But priority number one is, is, you know, we have a lot of pests, as we've said many times. The top of the funnel is actually very strong, and it's just our ability to pull it through. And so that's got to be our number one objective. And so hopefully that helps, Paul, you know, to provide some extra color.
Conference Operator: Great. Thank you very much. One moment for our next question. Our next question comes from Kelsey Goodwin with Piper Stanley. Your line is open.
Kelsey Goodwin: Hey, thanks for taking our questions. Congrats on the quarter. Two quick ones from us. In terms of the patient enrollment forms, I know you've mentioned you won't quantify those, but I guess could you maybe provide some color in how those are tracking kind of month over month from a growth perspective? And then secondly, we've gotten a couple questions specifically on the wording of demand revenue estimate. I guess that 4.5 million figure, is that the actual sales estimate for October or the implied demand, you know, 45 to 60 days later? Thank you.
Liz Barrett: Oh, no, that would be closer to actual. It's not implied demand, but of the demand revenue, that would actually, it's not implied. It's not like 45 to 60 days later, but a great question. So I'll ask David to sort of answer your first question.
David Lin: Yeah, on your question around the trend of enrollments, we are seeing very steady demand or steady growth in enrollment forms month over month, and we're while we're really in the second full quarter of the launch, early signs are that we are seeing that average per week continue to go up. So we're very encouraged by that demand. And as we mentioned, you know, we're at that point where on some weeks we're actually equal to or greater than, you know, my dose. So it gives you a sense that we're crossing an inflection barrier there.
Liz Barrett: Yeah, and the only other thing I'll say about the pass from, you know, without giving the actual number is it's very strong, right? And if our 60 days was, you know, 30 days or was three weeks, then, you know, you would obviously see a very different, you know, different revenue number. So, you know, suffice it to say that October revenue that you see in versus Q3 is we're seeing the same trend, you know, in patient enrollment forms. And, you know, if we don't give the number because it's a very clunky number and, you know, some fall out and then, you know, it's just too much. But the number of a patient enrollment form, a patient has been identified. And the other good news is that we don't get PEPs for everybody. So on top of the PEPs, there's revenue that comes in through hospitals. So, you know, we have to take that PEP number and, you know, add something to it and then subtract, you know, from it for those, you know, there's always a conversion rate. And we see that on still gel mito today. You're never going to get 100% of those. But Kelsey to say it's healthy is, you know, I think it's very healthy. And so I feel really good, which is why we feel very good about the outlook. If the patient enrollment forms weren't there, that's showing clear demand because a patient has been identified.
Kelsey Goodwin: Perfect. Thanks so much, and congrats again.
Aidan Husinov: Thank you.
Conference Operator: One moment for our next question. Our next question comes from Raghuram Selvaraju with AC Rainwright. Your line is open.
Raghuram Selvaraju: Thanks very much for taking my questions. Firstly, I just wanted to drill down a little bit further on what you expect the granular quantitative impact of the J-code to be, you know, as soon as it comes online. And in particular, if you could comment on what you anticipate the reduction in lag time between the receipt of the patient enrollment form relative to actual patient dosing could be once the J-code takes effect? In other words, you know, with the active J-code, you know, will the lag time be reduced from 45 to 60 days to under 30 days? Or, you know, do you have a more granular sense of what the impact of the J-code is going to have on that timeframe? And then my second question is related to UGN 103. I was just wondering if you could give us some additional granularity on what the FDA is likely to consider sufficient longitudinal clinical data, including but not limited to the sustained complete response rate achieved in the utopia trial for you to be able to file for approval of the product. So obviously, you've announced the three-month data. We just want to know how much additional long-term sustained complete response data and any other efficacy parameters you will need to furnish in order to be in position to file the UGN 103 NDA. Thank you.
Liz Barrett: Yeah, thanks, Ram. I'll ask David to answer the first question, then Mark will comment on the FDA.
David Lin: Ram, in terms of your question around the impact of having a permanent J-code, I can say to you this. When you break down the overall components of having a enrollment form to getting a new patient treated, Think about it as – I think about it in three parts, right? There's the benefit investigation, which often entails a prior authorization. There's the initial site setup. It's to make sure that the actual site can order the product and that they're trained. And then, of course, as Liz mentioned earlier on, we want to make sure that they have permission. So while physicians are interested in using it, they have to make sure that they have permission, whether it's in the hospital setting or in their practice. All of those things will improve over time, particularly as a practice treats a patient and they're on to the second patient. So you can imagine a lot of that starts to ease. So we do anticipate steady improvement in terms of the time to new patients start. It will be gradual. It will not be an overnight sensation. It'll just be something that we continue to work through. But the key to that is going, as you go to a practice and you get deeper into into the practice where they're treating more than one patient, a lot of that becomes much more standardized and they're not doing it for the first time. The other question you had was around just the other component around J-code. It makes it a lot simpler for the office. Remember that during the miscellaneous J-code period, the primary thing that practices have to deal with is that they're doing a manual claim submission and it takes on average about 2X the time to remittance as it would be when they have a permanent j code so once we have turned the corner into 2026 the claim submissions are going to be electronic and then the remittance will be considerably faster that should increase their confidence in terms of reimbursement and then when you add that to the overall operational readiness that we'll have we do anticipate that overall adoption can accelerate then the final point i'll make is to our comments We have been actively setting up the sites of care, and that just means while they may not have treated a patient, they are operationally ready to order Zesturi. And so because we got out ahead of that, we realized that's going to be important for the first half of 2026. We do feel good that we're laying a good foundation in terms of supporting broader adoption.
Liz Barrett: Yeah, and the only thing that I'll add to that, Ron, is right now with Jomito, it takes us, you know, it's about two to three weeks. right, from, you know, depending on the patient. So we expect to get similarly there, but I do agree with David that it's not going to happen January 1st, right? It's not a flip of a switch because the J code is just one component of why it takes the 45 to 60 days. So you'll see that improve over time, but it will take some time to get there, and we will eventually get below 30 days. So, Mark, maybe comment on the 103.
Dr. Mark Schoenberg: Yeah, Ron, thanks for the question. So, our expectation is, as we've previously announced publicly, that we'd submit in 26 with expectation of approval in 27. And our experience with the FDA and the Envision trial suggests that ultimately they're going to want a preponderance of follow-up data around 12 months. So we would submit, and then as we have done previously in the number of applications update during the submission process. So that's probably what we'd be looking at with 103 as well.
Conference Operator: Thank you. One moment for our next question. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.
Paul Choi: Hi. Good morning, everyone. Thanks for taking our questions. Along a similar line, I want to ask, do you think you can get the time between the enrollment form to revenue recognition down to where Jill Meidel currently is in the timeframe of 2026, or will that be something that'll take a little longer? Any color on that would be helpful. And my second question is, as we look at your cash position and your net loss for the quarter, Can you comment on whether you feel like you'll need additional capital in 26 just at the current run rate, or are you assuming either the revenue side or the cost-saving sides will be sufficient to transition you to profitability relative to your current cash position? Thank you very much.
Liz Barrett: Yeah, thanks, Paul. David can answer the first question and turn it over to Chris to talk about the cash position. So, David.
David Lin: Hi, Paul. In terms of your question around getting the time to new patients start equal to that of gel mito, one of the things we'll be tracking very closely, and we're putting in a lot of extra effort, obviously, to accelerate, but we do anticipate that over the course of 2026, those times to new patient starts will converge. It's hard to say exactly when that will be, but the key is we understand the components of that, and so we have very deliberate plans and actions to actually do everything we can to shorten each component of that time from PEF to new patient start.
Liz Barrett: So the short answer is yes. It will get there in 2026.
Chris Degnan: Okay, great. Thanks, Liz. And then Paul on cash. So as you saw, you know, we have a little over $127 million in cash. So, you know, we're well positioned to be able to, you know, deliver on our core priorities. There's a story launch. And with the expectations around revenue growth, you know, and based off our current operational plan, You know, we continue to believe that we do have cash to profitability, but, you know, we will continue and remain disciplined in terms of how we think about and be opportunistic, you know, future capital needs.
Conference Operator: Okay. Thank you. One moment for our next question. Our next question comes from Leland Gershaw with Oppenheimer. Your line is open.
Leland Gershaw: Thank you for this update and for taking our question. You know, for David, wondering if you could share with us, I know it's early days and, you know, the JCO dynamic, but as you've progressed in this very early launch, could you comment on kind of the ratio of, you know, community uptake versus institution? You know, is it fair to say that community practitioners are really still waiting for the J-code and minimal contribution to demand from community? Or has there been sort of a somewhat of a rise in community demand as you progressed in the first couple quarters? Thank you.
David Lin: Hey, Leland. Thanks for the question. You know, launch to date, we're seeing approximately 35 to 40% of our patients treated in the community in roughly 60, 65 in the hospital setting. As we have outlined even prior to launch, a lot of the HCPs are going to find it advantageous to treat in a hospital outpatient setting just because of the economics. But we're very encouraged that the interest level in the community practice among those who are willing to treat right now and also with those who have indicated a sincere desire to treat come January 1st. So hopefully that gives you a little bit of color. But one of the things I'll say is as we turn the corner into 2026, As the permanent J code is in effect, we do anticipate the proportion of community physicians to steadily increase over the course of the year into the out years.
Leland Gershaw: Thanks. And again, early days, but I'm not sure if you, I don't think you commented on this in the prepared remarks, but can you just give us some color on what the overlap is in historical Gelmito users? and their interest in zysteri versus what would be, you know, untapped, previously untapped urologists and their interest in zysteri. Thank you.
David Lin: Yeah, I think with gel mito, it was a little bit heavier in the institution. And today with gel mito, it's probably half-half, 50-50. And so that gives you a sense. We do expect, though, because the patient population for LGIR and MIBC patients is largely seen in the community practices. We do expect, like I said, to continue to see more uptake in that community setting.
Liz Barrett: No, but I think what he's asking is of the Zosturi, people are using Zosturi, how many of those are Jomito users? And a lot of them are, Leland. So a lot of our initial usage of Zosturi has been with Jomito users. The good news is that we also are seeing some new physicians using Jomito because we're going in to talk about Zesturi. So as we've talked about before, with the expansion of the sales organization, we're seeing more doctors, and we have seen this reverse halo start to generate some demand for gelmito in physicians that hadn't seen it before. So to your point, absolutely, some of our first prescribers have been gelmito users, but not all of them, but definitely those familiar with gelmito And we expect, you know, that to continue and the halo to continue into 2026. Great.
Conference Operator: Thank you both. One moment from our next question. Our next question comes from Aidan Husinov with Leidenberg. Your line is open.
Aidan Husinov: Hi. Thanks so much for taking our questions. I've got a couple. So could you remind us how long it usually takes for a patient to schedule a repetitive TURP surgery? And if those are the same urologists, do you think they have more financial incentives to run another TURP surgery or administer the story?
Liz Barrett: Yeah, great question, Aiden. David, you want to?
David Lin: Yeah, thanks for the question. In terms of scheduling a TURPT, what we generally hear from our customers is it takes them four to six weeks to actually schedule one. With respect to the alternative of using Zesturi, if they choose to administer Zesturi, it can be roughly right now. They've got to schedule the patient in, but again, it's based on the patient's desire and their schedules. From a financial perspective, one of the things that we'll think about is a physician's fee for doing a TURBT is going to be in a couple hundred dollar range. And that is excluding any sort of fee for the actual hospital. And one of the things that we have been asked a lot in terms of the financial economics of Zesturi that our market access team can speak to is that there is ability to be positive from administering Zesturi. And then importantly, because it can be done by a nurse, it does allow the urologist to actually attend to other matters. So hopefully that gives you a little color in terms of the time to schedule and also the economics.
Aidan Husinov: Thank you, very helpful. And another question I have on UGN501, next-generation oncolytic virus. So can you help us understand the competitive landscape for UGN501, and what are the possible parallels with the CG oncologist story?
Dr. Mark Schoenberg: So thank you. It is analogous, at least in terms of the type of asset and the purported mechanism of action that the CG asset utilizes in its effect on BCG refractory carcinoma in situ and associated papillary disease. So this falls into the asset class of developed for high-grade disease, high-grade non-muscle invasive cancer. The thing about the 501 asset to keep in mind, although obviously we are in IND enabling stage and anticipate phase one in 26, is that Based on what we know about this highly, very specifically engineered virus, it has very specific replication advantages in terms of its potency, its replication speed, and also its ability to affect both primary tumor cell lysis and an adjunctive anti-tumor immune response. So, it would be unfair at this stage to directly compare this asset to the CG asset. It's a similar class. We think it is a very, very potent and very promising molecule. And just to close, remember, this is an asset that we are going to be primarily developing in the context of treating patients with non-muscle invasive bladder cancer, starting with high-grade disease, but we also believe that it will have application beyond urologic oncology, and we are having internal conversations about the development of that plan as well. So something for the future to think about.
Aidan Husinov: Thank you. Very helpful.
Conference Operator: And I'm not showing any further questions at this time. I'll turn the call back over to Liz for any further remarks.
Liz Barrett: Great. Thank you. I just want to take the opportunity to say thank you to everybody on the call for joining. Hopefully, we've got a lot of things to look forward to over the next few months as we continue to accelerate adoption with this jury, deliver on your MITO revenue, and importantly, advance our pipeline. So again, thanks, everybody, for joining. And we look forward to keeping you guys abreast. Thanks.
Conference Operator: Ladies and gentlemen, this concludes today's presentation. We thank you for your participation. You may now disconnect and have a wonderful day.
