UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by and welcome to the Eurogen Pharma third quarter 2024 earnings call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vincent Perrone, head of investor relations. You may now begin.

Thank you, operator. Good morning, everyone, and welcome to Eurogen Pharma's third quarter 2024 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 30, 2024. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Joining me on the call 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. During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to Gelmido, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as future commercialization activities for UGN 102 if approved, anticipated data, regulatory filings and decisions, UGN 102 being the growth driver for Eurogen if approved, future R&D efforts, our corporate goals, and 2024 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. Your caution not to place undue reliance on these forward-looking statements, and Eurogen disclaims any obligation to update these statements. I'll now turn the call over to Liz Barron.

Thank you, Vincent, and thank you for joining us this morning. As we continue to innovate and pioneer new treatment paradigms in urothelial cancers, I'm excited to highlight the progress we've made with UGN-102, our groundbreaking therapy for low-grade intermediate-risk non-muscle-invasive bladder cancer. Ahead of schedule, we successfully submitted the new drug application for UGN-102 in August, And in October, we were pleased to announce the FDA's acceptance of the NDA with a PDUFA target date of June 13th, 2025. This milestone represents more than a regulatory achievement. It is a testament to the dedication of our team and a pivotal step toward our goal of changing how low-grade intermediate-risk non-Muslim-based bladder cancer is treated. Our regulatory and clinical teams are committed to working closely with the FDA during the review process as we move toward a potential approval. Meanwhile, we are initiating our pre-commercial activities to position ourselves for a robust launch with the ability to deliver UGN 102 to patients at the earliest opportunity. David will provide more details on this shortly. If approved, UGN 102 will become the first FDA-approved medicine for this patient population. introducing a novel solution that can significantly reduce recurrent rates while extending the time between treatments. UGM-102 aligns with our commitment to enhancing patient outcomes and reshaping treatment paradigms in urologic oncology. The market opportunity for UGM-102 has the potential to be transformative for our company. With more than 80,000 addressable patients annually in the U.S., This market is approximately 10 times larger than the market gel mito currently serves and represents an estimated total addressable market of over $5 billion. In contrast to the gel mito market opportunity in low-grade upper tracheothelial carcinoma, which is a rare disease, which is dispersed and episodic, low-grade intermediate risk non-loss invasive bladder cancer is widespread and regularly managed by nearly all urologists. UGN 102 is straightforward to administer and integrates seamlessly into existing outpatient practice workflows without the need for special equipment. Delmido delivered $25.2 million in net product revenue for the third quarter, representing a 21% year-over-year increase. The revenue reflected strong underlying patient demand, but also included $2.6 million from CREATE-ACT cells, in Q3 of 2024 compared to 1.1 million in the same period in 2023. Recognizing the high-touch nature of this product, we strategically focused on increasing our reach and frequency with key accounts in the quarter, which we believe is contributing to improved demand growth in the third quarter compared to the first half of this year. In fact, new patient enrollments in Q3 increased over 30% versus prior year, representing an all-time high since launch. Similarly, we continue to drive a healthy increase in new prescribers, up over 30% versus a year ago. We are seeing signs of continued momentum in early Q4 and expect to be able to deliver low double-digit revenue growth for Gemido for the full year 2024. despite the gross-to-net headwinds that we've experienced in recent quarters. Looking ahead at the core of URGEN's lifecycle management strategy is ensuring the long-term success and growth of our uro-oncology franchise. In September, we announced receipt of a notice of allowance from the U.S. Patent and Trademark Office for a patent covering key technology used in the development of UGN-103 and UGN-104. our next-generation therapies for UGM-102 and gel mito, respectively. Upon issuance, the patent will extend through December of 2041 and cover the innovative combination of our proprietary RT gel technology with a unique mitomycin formulation licensed from Med-Act. This is a critical step in strengthening our intellectual property portfolio and providing lifecycle management that extends our franchise for the long term. Dosing in the phase three utopia trial for UGM-103 commenced in early October, demonstrated continued momentum in our clinical development. Mark will provide further details on this exciting progress. In October, we appointed Chris Degnan as chief financial officer. Chris has extensive CFO experience with publicly traded biotech companies. most recently at Galera Therapeutics and Verica Pharmaceuticals. He has also held senior positions at Endo International and worked at AstraZeneca for more than 10 years. He has broad expertise in financial strategy, investor relations, SEC reporting, accounting, and compliance. I want to take this opportunity to formally welcome Craig Urgen. He is joining us on the call today and will provide financial results for the quarter shortly. Chris's appointment is part of the broader initiative to enhance our leadership team as we prepare to commercialize UGN 102 and take Urogen to the next stage of growth. We also welcome David Lin as our new chief commercial officer in June. I will now turn the call over to Mark Schomburg, our chief medical officer, for a clinical update.

Mark? Thank you, Liz. I want to begin by echoing Liz's sentiments regarding the FDA's acceptance of our NDA for UGN 102. This is a significant milestone for our company. Our regulatory and clinical teams look forward to collaborating closely with the agency throughout the review process. The UGN 102 NDA is supported by a robust and comprehensive development program that demonstrated a clinically meaningful complete response rate and a strong duration of response across three late phase clinical trials, along with an acceptable safety profile. The Phase III Envision trial, which serves as the pivotal trial for the NDA, successfully met its primary endpoint, demonstrating a 79.6% complete response rate at three months after the first installation of UGN-102. More recently, durability data from Envision revealed an impressive 82.3% 12-month duration of response by Kaplan-Meier analysis in patients who had achieved a complete response at three months. Notably, this represents the highest duration of response ever reported in this patient population. I am also pleased to report that the long-term durability data from the ENVISION trial were recently published online in the Journal of Urology. The article will appear in print early next year. As we have communicated, we are anticipating an advisory committee and are proactively preparing for this meeting. The FDA has not notified us of the timing, but we expect to receive notification early in 2025. If approved, we believe UGN-102 will represent a significant advancement in the treatment of low-grade intermediate-risk non-muscle-invasive bladder cancer. Turning now to the pipeline, as Liz mentioned, we have a comprehensive lifecycle management plan for gel mito and UGN-102. In October, we announced the dosing of the first patient in the Phase III clinical trial evaluating UGN-103 for the treatment of low-grade intermediate-risk non-muscle-invasive bladder cancer. The UTOPIA trial is a single-arm phase 3 multicenter study designed to evaluate the efficacy and safety of UGN-103. Our goal is to enroll 87 patients. The study protocol mirrors that of the Envision trial with low-grade intermediate-risk NMIBC patients with recurrent disease receiving UGN-103 via intravesical installation once a week for six weeks. Efficacy will be assessed based on the complete response rate at the three-month mark. Patients achieving a complete response, defined as having no detectable disease in the bladder at this visit, will enter a follow-up period during which they will return to the clinic every three months for ongoing evaluation of duration of response. We anticipate filing the new drug application with the FDA in 2026, and if approved, the commercial launch in 2027. We foresee a similar development plan for UGN-104, our next generation formulation of gel mito, and expect to commence a single-arm Phase III study early next year. Turning to our high-grade bladder cancer pipeline, we continue to develop our immuno-oncology candidate, UGN301. UGN301 is an anti-CTLA-4 antibody delivered using our proprietary RT-gel technology. We are conducting a Phase I clinical study to evaluate safety, tolerability, and to establish a recommended Phase II dose for UGN301. We will present an update of our UGN 301 program at the upcoming Society of Urologic Oncology meeting scheduled for December 4 through 6 in Dallas. Additional abstracts were accepted for poster presentation, including the envisioned duration of response data and long-term follow-up results from the Gelmito Olympus trial. This year's meeting promises to be particularly productive for our team. And now over to David Lin for a commercial update. David?

Thank you, Mark. Good morning, everyone. As we focus on the journey ahead with UGN 102, my top priority continues to be preparing URGEN for an anticipated commercial launch in 2025. With the target PDUFA date of June 13th, 2025 now established, we have a clear timeline for potential approval and launch. Our immediate priority is executing a robust pre-commercial strategy that will establish a solid foundation for making UGN 102 accessible to the medical community, and driving widespread adoption. We are confident in the strength of our clinical data and the transformative opportunity it presents to enhance outcomes for patients with low-grade, intermediate-risk, non-muscle-invasive bladder cancer. The launch of UGN-102 would mark Urigin's evolution from a rare disease-focused organization to a specialty-focused, multi-product team. We are scaling our commercial capabilities including patient support and distribution infrastructure. Importantly, we plan to expand our sales force from approximately 42 reps to over 80 at launch. A significant factor in our decision to expand our sales force stems from our learnings and experiences with gel mito. We have learned that more engagement from our sales and support teams leads to more effective responses from clinical practices. To that end, we are committed to having an appropriately sized field force in place by the launch of UGN 102. Our updated launch plan is designed to significantly increase the frequency of interactions with targeted physicians, ensuring we maximize our impact in the market. At the same time, we are actively advancing our pre-launch activities for UGN 102. Our focus includes education through various programs aimed at raising awareness of the unmet need in low-grade intermediate risk non-muscle invasive bladder cancer, while our medical affairs team is also sharing our clinical data to appropriately communicate the value proposition ahead of approval. To facilitate the integration of UGN-102 into treatment protocols, we will provide comprehensive support, including training for healthcare professionals and their office staff. Additionally, we are implementing engagement initiatives to inform both clinical practices and patients about UGN-102's coverage options and reimbursement. It's important to note that upon approval, UGN-102 will initially be assigned a miscellaneous J code for billing, which is standard for new drugs. Based on the June 2025 PDUFA date, we would expect to secure a unique permanent J code for UGN-102 by January 2026. While a miscellaneous J-code may pose fewer challenges for hospitals and oncology centers, the permanent J-code is particularly important in the community setting. Throughout this period, we are fully committed to offering robust reimbursement support to help providers navigate the interim coding process smoothly, ensuring integration of UGN-102 is seamless. I will now turn the call over to Chris Degnan to discuss our financials.

Thank you, David, and good morning, everyone. Before I get into the financials, I would first like to take a moment to say that I'm thrilled to join Urgent at such a pivotal time for the company. The strength of our pipeline and the significant market opportunities ahead present a unique moment for growth and innovation. I'm excited to work with the talented team that we have here to help bring our transformative therapies to patients and drive long-term value for our shareholders. Turning now to the quarter, as Liz mentioned, Gilmito net product revenues reached $25.2 million in the third quarter of 2024, compared to $20.9 million for the same period in 2023, primarily driven by strong underlying demand growth. Our focus efforts to increase our reach and frequency with key accounts generated solid momentum, which positively impacted Q3 results. Volume growth was partially offset by continued year-over-year gross to net erosion due in part to the Medicare wastage provision and growing 340B utilization. The overall gross to net rate for Gelmito was relatively consistent quarter over quarter. Cost of revenue in the third quarter was $2.5 million compared with $2.4 million for the comparable period in 2023. The slight increase was primarily attributable to the increased volume of sales of Gelmito partially offset by certain non-recurring payments made in connection with our supply arrangement in the prior year. Research and development expenses in the third quarter were $11.4 million compared with $10.2 million for the comparable quarter in 2023. The increase year-over-year was primarily attributable to higher costs related to the initiation of the Phase III utopia trial for UGN-103 partially offset by lower UGN 102 clinical trial costs and costs related to the research into ingredient scale-up and production efficiency for Joe Mito. Selling, general, and administrative expenses for the third quarter of 2024 were $28.9 million, including non-cash share-based compensation expense of $2.9 million. This compares to $21.8 million, including non-cash share-based compensation expense of $1.8 million for the same period in 2023. The year-over-year increase was primarily driven by UGN 102 pre-commercialization activities. We reported non-cash financing expense of $5.9 million in the third quarter, relating to the prepaid forward obligation to RTW Investments. This compares with $5.5 million in the comparable period in 2023. The increase of $0.4 million was driven primarily by changes in underlying assumptions for re-measuring the effective rate. Interest expense related to the $125 million term loan facility with Pharmacon Advisors was $2.7 million in the third quarter, compared with $3.8 million for the comparable period in 2023. The decrease was primarily attributable to the decrease in the margin interest rate and the related impact to amortization of the discount on the Pharmacon loan as a result of the amended and restated loan agreement in March 2024. The third tranche of $25 million under the amended and restated loan agreement was funded in late September 2024. Net loss for the third quarter was $23.7 million or 55 cents per basic and diluted ordinary share as compared to a net loss of $21.9 million or 68 cents per basic and diluted share in the same period in 2023. As of September 30, 2024, we had $254.2 million in cash and cash equivalents and marketable securities. With our fortified balance sheet, we believe we have the requisite cash and capital to execute our business objectives. Turning to forward guidance. Although we saw strong underlying demand in the quarter, we expect full-year Gelmito revenues to fall below the low end of our previous guidance. However, we do believe that Gelmito will deliver low double-digit revenue growth for the full year, despite the higher-than-expected gross-to-net headwinds in recent quarters. Regarding 2024 full-year operating expense guidance, we now expect operating expenses to be near the midpoint of our previously guided range of $175 to $185 million, including non-cash share-based compensation expense of $9 to $13 million. This outlook reflects the shift in timing of expenditures tied to the PDUFA target date and preparations for the potential commercial launch of UGN-102. The anticipated full-year 2024 non-cash financing expense related to the prepaid obligation to RTW Investments is unchanged and expected to be in the range of $21 to $26 million. The rate for the cash component of the RTW obligation will be 13% of global net product sales of Gelmito in 2024. We're now ready to open the call for questions. Operator?

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw a question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Tara Bancroft with TD Cohen. Your line is now open. Hi, and good morning.

First of all, congrats on the NDA acceptance. It's really great to see. And I was wondering if you received and got any more clarity from the 72-day letter in writing, perhaps on why the decision was made for standard review or, you know, aside from the letter, do you have any other insight into that based on your interactions? Thanks.

Yeah, thanks, Terrence, Liz. They didn't say anything about priority review in the letter. They just talked about, obviously, the review questions, you know, which are, does Envision, you know, provide enough data for, you know, to demonstrate efficacy? You know, what's the role of ATLAS? And, you know, overall, you know, is the AE profile, you know, acceptable? So kind of the typical what you expect the FDA to say at this point in time. We do know just from correspondence with them and in our initial meeting where we did the application review that they had not at that point in time actually reviewed our data. We know they reviewed the portions that we sent in back in January, the non-clinical, but they had not yet reviewed the clinical portion. Look, we can sit here and guess as to why my view on it is obviously priority review would have put them against the wall from a timing standpoint. And the argument has always been, well, they can go back to surgery. And we don't think that's a great argument. We actually very much believed that we qualified for priority review, but obviously they saw it differently. And I think the other thing is we've consistently said that we expect an ODAC And so I think, again, from a timing perspective, had we gotten priority review, it would have been, I think, a very short period of time for them to prepare. So that's the only sort of guess we have, but nothing, they didn't even acknowledge one way or the other, the priority versus standard review, just gave us our timing and then gave us the, here are your potential review issues, the three that I mentioned.

Okay, great. Yeah, that makes a lot of sense. Thanks so much. Thanks, Tara.

Thank you. Our next question comes from the line of Ram Selvaraju with HC Wainwright & Co. Your line is now open.

Thanks very much for taking my questions. Firstly, I was wondering if you could elaborate on a couple of commercial points, particularly the gross-to-net discounting with respect to Jomido and why you expect that not to be a factor for UGM-102.

Sure. Chris, do you want to take that?

Sure, Ram. So the two big headwinds we've been seeing on gross-to-net, one is 340B, and the second is the Medicare wastes provision. With respect to 102, we don't expect the wastes provision to apply just given the you know, the yield loss that we see with the mixing of gel mito and the size of the kidney relative to be able to use the full dose within the bladder. And then from a 340B pricing perspective, we do expect more utilization over time in the community setting, which should mitigate some of the 340B exposure that we're seeing with gel mito.

And then with respect to the commercial preparations for UGN-102, Can you maybe give us a sense of how the timeline might have shifted with respect to the receipt of standard review for the 102 NDA application and when you expect to incept specific prelaunch activities as you approach the PDUFA date?

David? Yeah, hi, this is David. The standard review doesn't change consequentially any of the major things we're doing in terms of prelaunch education. As we mentioned, our top priority right now is, from an organization standpoint, is to educate on the unmet need in non-muscle invasive low-grade intermediate bladder cancer. And our medical teams continue to share the clinical data with providers in the field of uro-oncology. So otherwise, the preparations remain largely intact, which is preparing our infrastructure and our distribution networks to take on a new product that is considerably larger. And as we mentioned, we will be increasing the size of our field team by about 2x by the time we launch UGN 102.

Okay, and then just two very quick additional questions. Firstly, I was wondering if you could comment on the timing with which you expect office action on the patent covering, the patent application covering the MED-AC formulation of mitomycin that, Liz, you mentioned in your prepared remarks. And also, maybe, Mark, I don't know if you want to comment at this time on what you anticipate the composition of the future ADCOM panel to be, just on a qualitative basis, but if you had any insights there, that would be much appreciated. Thank you.

Yeah, why don't you go ahead, Mark, and then... Yeah, thanks, Ron.

So, I think the short answer is, while I don't know the composition, my suspicion would be that it would be reflective of other ADCOMs, particularly reflected by, you know, the evaluation of other drugs in this space. So, we'd expect some urologists, particularly urologic oncologists, would expect with experience in treating this disease surgically. But I imagine there will also be medical oncologists as well, and then specialists in biostatistics. So, probably a fairly typical and expected composition of the group, but certainly some urologic oncologists who have familiarity with non-muscle invasive bladder cancer.

Yeah, unfortunately, Ram, I don't have an answer to your question around the IP, but I'll find out from the GC and let you know.

Thank you very much, and congrats on all the progress, particularly the NDA acceptance. Very important for the company.

Great. Thank you, Ram. Appreciate it.

Thank you. One moment for our next question. Our next question comes from the line of Leland Gershell with Oppenheimer. Your line is now open.

Thanks for the commentary and taking my questions. So I just wanted to go in further on the IP with respect to the technical litigation. I'm wondering if you can give us any timelines with respect to next steps. Is a Markman hearing being scheduled or hasn't been scheduled? Do you have any visibility on when that may occur?

Yeah, Leland. we don't have any additional updates at this point. We're obviously waiting to get our trial date. But typically what happens is you see that closer to the 30-month mark. So we expect that likely to happen in 2026. But, you know, we don't have that information yet. So, you know, to be honest with you, we're sort of just moving forward with all of the you know, typical, you know, things that we have to do at this point in relation to that. We feel very strongly, feel very good about our position and where we are, and nothing has changed around that. So, you know, again, we're just going forward and waiting, you know, waiting for the date, but, you know, preparing and making sure that we're fully prepared for that outcome.

Okay. And with the Would the implications be, you know, for whatever the outcome is with the Jalmaito litigation, you know, would those carry over to presumably UGN 102 given overlapping IP? In other words, if he were to prevail, then presumably that would injure the ability for generic to 102. Is that a fair conclusion?

Yes, that's a fair conclusion on that. And, you know, reality of it is, is that until we get an approval, they can't do anything. But yes, we, we fully expect that to happen. In addition, a little difference with 102, we do have some other pending patents for UGN 102 that we think will even make that stronger than where we are to just put other things around it. Just keep in mind and remember that for both of them, the next generation formulation for UGN 102, which is UGN 103, will actually expect approval in 27. So that would actually be on the market before you ever even got regulatory exclusivity was up for, you know, for UDM 102. So we feel really good about kind of where we are with our patents, feel very strongly about them, but also feel good around the strategy that we've built around it.

Okay. Thanks for taking the questions.

Yep. Thanks, Leland.

Thank you. Our next question comes from the line of Kelsey Goodwin with Guggenheim. Your line is now open.

Oh, hey, everyone. Thanks for taking our questions and congrats on all the progress the last few months. I guess first from us, when would you expect to hear from the FDA around an ODAC timing or scheduling? Is there a time after which it could be ruled out? And then second, to what extent do you expect impact to the UGN 102 uptake in the initial quarters with the miscellaneous J-code versus the permanent J-code likely in 2026? Thank you.

Yeah, great, and nice to talk to you, Kelsey. We, you know, from the standpoint of your last question on UGN, you know, on the miscellaneous code, I'll ask David to sort of comment on that. But so, David, you want to take that first?

Yeah. Hi, Kelsey. Our expectation in terms of that initial period is not unlike a lot of the other drugs that are launched that have that same billing phenomenon. So we expect that some customers may have a little bit more reservation around adopting, but we fully intend to be promoting the be educating and showing them with our reassurance in terms of training and operations of how to manage the billing during that cycle and there's plenty of examples that we can draw on from not only gel mitre but also other products that have launched in the space yeah and I think you know in addition to that you I think what you would expect is in the beginning the sites of care and

very much like John Mito as well, were more in the hospital than they were in the community setting for that exact reason. To the question around the timing around ODAC, look, I think we've been very clear. We expect an ODAC. We are in full preparation for an ODAC. We expect an ODAC. The agency has been very clear on that from the beginning, really driven by the fact that this is a completely new way of treating these patients, and they want to hear from key stakeholders. So we expect that to happen. The timing on it, usually you see the ODAC two to three months prior to the PDUFA. We would expect the ODAC in the April timeframe. It could go as late as May. We expect a two to three month notice. If it's May, then we expect to find out by the beginning of March. If it's April, maybe the February, beginning of March, depending on when in April. April-May timing for the actual ODAC. There is the other sort of the next step is our mid-cycle review meeting. We actually do have a meeting with them, and that would be in kind of the January-February timeframe. And we will ask at that meeting for an update on the ODAC and expect that we at least will get some acknowledgement and idea of timing, but just to know we're in full ODAC preparation. We've actually always been welcomed in ODAC. I know that that sounds odd, but given what we know about users and physicians and practitioners and the way that they think about this, we believe that that would actually be helpful for us. And so, you know, we're very much, like I said, in planning mode and excited about the team that we have around us and including the external experts that will be talking at the ODAC on our behalf, the patients that will be talking at ODAC on our behalf and believe that physicians and clinicians will actually welcome the opportunity to have a medicine like UGM-102.

Great. Thank you so much.

Thanks. Thank you. Our next question comes from the line of Matt Kaplan with Leidenberg-Solomon. Your line is now open.

Hey, guys. Thanks for taking the question. And just wanted to follow up on the ODAC. I guess, you know, frequently ODACs are called if there's some controversy. Can you talk a little bit about the buy-in that you have from the FDA the envisioned trial design as a single harm study and how it could suffice for the approval of 102. And does that also, is there any controversy there with respect to also, I guess, utopia's phase three design as very similar design to the envisioned study as well?

Hey, Matt, it's Mark. Thanks for the question. So, I'm going to try to compress a long story into a short answer, but the answer is we had a meeting with the FDA during which they agreed in writing that Envision could potentially support approval of EGN-102, which was, in fact, the gating conversation to the transition from the ATLAS randomized trial to the Envision single-arm trial. So, we feel quite comfortable that there was a meeting of the minds on that question. With respect to your sort of larger question about what are the controversies or what might be underlying the need for an ODAC, I think we've also been great about the idea that UGN-102 presents urologists and patients with a potentially paradigm-changing approach to non-muscle-based bladder cancer. So we believe, and I think with good reason, that the FDA would like to hold a public vetting with experts in the room to talk about what that would mean in terms of a practical application of UGM-102 and its inclusion in the armamentarium currently available to urologists for the treatment of this population of patients.

Okay.

Thanks, Mark.

That's very helpful. And then just a question for Chris. With respect to your cash runway, how should we think about that? You finished the quarter in a strong cash position, but I guess with the pending launch, coming up second half of next year for 102.

Yeah, Matt, thanks for the question. So, you know, we exited with a four to five balance sheet, you know, $254 million in cash, and we believe that we have the requisite cash to get the business, you know, to profitability based off of our current business objectives based off of the June PDUFA date.

Great. Thanks for taking the question, guys.

Thanks, Matt. Thanks, Matt. Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.

Hi, everyone. This is Khalil calling in for Paul. Thank you so much for taking our questions, and congratulations on the NDA acceptance. I guess with regard to the updated commercial plan for UGN 102, could you perhaps provide an overview of how the whole process works? could be improved incrementally perhaps. Just in the context of the challenges some of the urologists face with gel mito, whether that's access, reimbursement, the process of actually administering the drug itself, et cetera, that'd be really helpful if you get like a 30,000-foot view. Thank you so much.

Absolutely. David?

Yeah, thanks for the question. So I think a couple of things. When we draw on, we take what we've learned from gel mito, and we also think about the unique nature of treating patients with low-grade intermediate risk non-muscle invasive bladder cancer. So a couple of things. What we learned about gel mito is that the operational financial support has to immediately follow the clinical discussion. So once we've identified that there's clinical conviction around identifying patients and treating with gel mito, we immediately follow up with helping them to operationalize the actual six doses and then make sure that they have the education and support from a reimbursement perspective. All of that will still hold true with a potential UGN 102 approval. What's important also is what's different with UGN 102, I'll say, is that because it is a process that is much more familiar to the physician offices, we will still do the requisite training from a clinical perspective, but one of the things we will also do is right up front help them understand how this fits into their workflow and how they identify the low-grade intermediate risk non-muscle invasive bladder cancer patient. So all of that together is we will leverage everything we learned with gel mito. We'll pivot accordingly to the new patient population. But all of that just means that we will continue to drive clinical conviction upon approval and also support them operationally and financially. And it is worth reminding that ahead of PDUFA, our medical affairs team continues to educate the urology community on the Envision data and an unmet need in low-grade intermediate-risk non-muscle invasive bladder cancer.

And just to add a couple of things to that, one, remember the rare disease nature of gel mito versus the not-so-rare disease nature versus of Eugene-102. So all physicians I mentioned earlier see these patients. And you don't need special equipment. It's done by a nurse in the office, to your point about the ease of use And we have learned that, you know, gel mito is hard. You know, the physicians will say it's a heavy lift for the practice and a heavy lift. And so the bar was definitely very different. And even though we've done, I think, a really good job of supporting as best we can, at the end of the day, it is what it is, right? You either have to have a fluoroscopy, you know, manipulate the upper tract, or you've got to have a nephrostomy tube. And so I think when you look at UGM-102 and the ease of use around that, and we've heard that from, got the feedback from all the physicians we've spoken to, and the practices that we've spoken to, it's going to be a very, very different situation. But thanks for the question.

Thank you.

Thank you. I am showing no further questions at this time. I would now like to turn it back to Liz Barrett for closing remarks.

Okay, thank you. You know, we continue to make progress across the company with our priorities and, you know, really do believe that we're a uniquely positioned company to change the practice for bladder cancer in these patients and also to bring significant value to our shareholders. So, as always, we appreciate your support and we'll keep you posted on things as they arise. So, appreciate it. Thank you.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.