Unfortunately, we only have 30 minutes to get through a lot of topics, so let's just get started. Sure. For those newer to the UroGen story, perhaps you could give a quick snapshot of the company, where you are today, and what's changed over the last year to get you here. Do you want to start a little bit with the history of the company? Sure. Nice to be here, and thanks for having us. UroGen comes from an apocryphal conversation 20 years ago between a urologist and a chemist. As the story is told, the urologist says to the chemist, "We put a lot of aqueous drugs in the bladder to treat cancer, and patients just urinate them out very quickly. Is there something you've got in your armamentarium that would help us keep drugs in the bladder longer to treat cancer more effectively?" The result of that conversation was a very elegant material science solution that is our technology platform that has made it possible for us to make the progress we've made to date. It's called RTGel. It is a reverse thermal gel that is very accommodating of molecules of vastly different sizes. I am sure we will have an opportunity to talk about the success of using that platform and the drugs we have deployed to date to treat cancer. In the past 12 months, as you asked, the big progress we have made is our first product was approved back in 2020 in the Upper Tract Urothelial Cancer. That is where our focus is in UC. In 2025, we got approved for Zusduri, which is the first and only FDA-approved product in low-grade intermediate-risk non-muscle invasive bladder cancer, so an area of high unmet need. We started with the commercial launch of that product in the second half of last year. We got the permanent J-code at the start of this year, and we are in the early stages of a very promising commercial launch, so a very exciting time for the company. Okay, great, and maybe you can help frame the two markets that you are playing in, low-grade Upper Tract Urothelial Carcinoma and low-grade intermediate-risk NMIBC. How large are these populations, and why do you think they have gone so long without a good non-surgical option? Yeah. Just the size of the markets, the low-grade UTUC, which is where Jelmyto was indicated, it is a smaller rare disease market. It is about 6,000-7,000 patients in the U.S. With that market, the other part is it is a dispersed rare disease, so these 6,000-7,000 patients present across roughly 10,000 urologists. It is a bit of a different rare disease market opportunity. On the other side is the low-grade intermediate-risk non-muscle invasive bladder cancer market, which is much larger. It is about 10 times the size. Zusduri is indicated in the recurrent low-grade population, which means patients that have previously had a TURBT, generally, or have recurred with their disease, so it is a much larger opportunity. In terms of why there haven't been good therapeutic approaches in these marketplaces, Mark mentioned, when you try and put aqueous solutions in the urinary tract, obviously the anatomy, it naturally tries to avoid that. Trying to find an option where the medication can dwell in the cavity long enough to provide the therapeutic benefit has been a challenge, and that's where RTGel fits in nicely. Okay, great, before we get into the details of your commercial products and what else you have in the pipeline, maybe you can just answer what you think investors are still underappreciating about the UroGen story right now. Yeah, I think coming into this year and with the approval of Zusduri, again, there haven't been therapies in this space, so people trying to understand how big truly is this NMIBC market. We've thought coming in that we believe Zusduri has the potential to be over a $1 billion peak sales opportunity. I think coming into the year was a bit of a show-me story. I think people wanted to see the traction and the trajectory towards that opportunity. So I think that was one piece. I think the other piece is just better understanding the durability of revenue. We've done some good things to solidify our intellectual property. We'll talk about it. We have some next-gen formulations that we're developing, with additional intellectual property for both Jelmyto and Zusduri. I think the other piece, too, is the competitive landscape in this space is really evolving at a fairly rapid pace. So I think people are trying to understand where these competitive data sets are going to land and where we're positioned, and we'll talk about it, but we think we have a very unique value proposition with Zusduri. We'll definitely get into that, but I guess what do you think are the most important milestones or execution priorities that you believe can drive shareholder value over the next 12 months? Yeah. Well, obviously, just continued strong progress with Zusduri. We're off to a really strong start this year and feel like, again, we're just in the early stages of that launch, so continuing to execute and demonstrate that good launch trajectory are going to be important. The progress that we're making on our next-gen formulations, specifically UGN-103 is our next-gen formulation for Zusduri. We've shown good data, 3-month complete response and 6-month durability of response data that are very similar to Zusduri, which is what our expectations were, and we just submitted the NDA for that drug back in the middle of August. So that's on track for potential approval in the mid part of next year, June of next year. We'll also have some durability of response data, and that continued to mature, so we'll have 12-month DOR data for UGN-103 likely by the end of the year, potentially early next year. So I think that's another piece to monitor. We're making good progress in our pipeline. We acquired an oncolytic virus last year. We moved that through IND-enabling studies. That's UGN-501, we think is a chance to be a best-in-class oncolytic virus. We're excited to get that drug into phase I later this year. Chris, just on the Zusduri opportunity, a billion dollars plus, if I do the math on your net price and your patient population here, that kind of implies still a pretty low penetration into the low-grade intermediate-risk NMIBC market. Why not a bigger drug? Yeah. We think it possibly can be, Eric. That's a good question. I think conservatively to your point, if you do the math, we say 60,000 patients a year, a 20% market share, call it $100,000 net price, you're looking at a $1.2 billion product opportunity. We do think there's an opportunity to exceed that. That's just in the low-grade intermediate-risk population alone. We do think there's opportunity for higher peak potential for Zusduri. On top of that, we're also looking at some potential life cycle expansion opportunities, getting into high-grade, for example, whether UGN-103, which would be even incremental to that. What do you think is going to be most, I don't know, rate limiting or capping of your opportunity in that 60,000 patient population? I think the biggest thing is we're changing the treatment paradigm. We go back to the fact that there hasn't been an approved therapeutic in the space. The only method of treatment has been TURBT. These uro-oncologists are surgeons. It's changing their mindset from, "I'm going to do a surgical approach and remove the tumor," versus taking this ablative approach, which we believe is a very patient-friendly approach with Zusduri. I think that's part of it. The other piece of it is just changing the dynamics associated with it. It's making sure they understand the clinical data, understand the operational aspects of this, how do they incorporate it into their workflow, and also just making sure they have reimbursement confidence. The good news is we have really good reimbursement. We have strong coverage. We have over 95% of cover lives have access to Zusduri, but it's just demonstrating that and making sure they're comfortable there. All right. Zusduri has had several strong quarters since launch. Maybe walking through that trajectory, what do you think have been the biggest drivers? What marketing strategies have been the most effective? Maybe you can also chat about adoption in both the community and academic urology practices. Sure. Happy to. Just to ground folks on the trajectory, we did just under $30 million in revenue in Q1 for Zusduri. We did $50 million in revenue in Q2. We are seeing a nice trajectory. Coming into the year, a big piece, in terms of an inflection, was getting the permanent J-code. Going back to talking about reimbursement confidence, having that permanent J-code in place has certainly given some reimbursement confidence. Coming into this, talking about some of the dynamics, changing the treatment paradigm, urologists aren't as familiar with buy and bill drugs, so they are a little bit slower to adopt. We said, "Look, we don't expect necessarily an accelerating growth curve." It's going to be more of a steady linear growth curve as we continue to expand both the breadth and depth of utilization. We expect more of that linear trajectory going across the year and into the future. We're just still in the early stages of this launch. In terms of what's working, we find that peer-to-peer interactions, speaker programs where they're hearing from other physicians with experience with the drug, has really been helpful. We've actually said we're going to increase some of our operating expenses and invest in the back part of this year to lean into that a little bit further. Then, just from a sales force perspective, we're well-positioned. We have about 450 physicians who have used Zusduri through the first half of the year. Our call point, our core targets are about 6,500 physicians. We still have a long way to go in terms of breadth of utilization. Just continuing to make sure we're out there talking to the physicians. What sort of feedback have you been hearing from physicians since the launch of Zusduri? It's been very positive. I think one of the things that's been remarkable to us, and Chris mentioned this is a paradigm-changing therapy. I think a real concern initially was that surgeons, as Eric was pointing out, are going to want to do surgery, and they'll resist the opportunity to not do surgery. That actually seems not to be as big a problem as we or anybody else maybe anticipated. Embracing the clinical data and the unmet medical need and the value to patients has been a pleasant surprise. I think the other thing we're beginning to see anecdotally is patients are now hearing about this therapy and coming in and asking for it. So an opportunity for us not only to work to educate physicians about the value of this therapy, but also to make that information available to patients who can benefit from it. Can you give us a little bit more first-hand view of the patient journey on TURBT versus Zusduri? Sure. The historic therapy for this disease was a surgical procedure called transurethral resection of a bladder tumor. It goes by the acronym TURBT or TURBT, depending on who you're talking to. This is an operation that's done under anesthesia. It used to be done in hospitals. It's increasingly done in ambulatory surgical centers. But it encumbers the patient and the patient's family with all of the rigorous pre- and postoperative concerns associated with a real operation. There is the preparation for the operation, the fasting before coming to the operating room the night before surgery. There's the operation itself. These typically take about an hour or so under anesthesia, but can take longer. Then there's the postoperative recovery in the recovery room, which may or may not require a catheter, and patients may need to go home with a urinary catheter for some number of days after surgery. That was the standard of care. I will tell you, unprompted, patients will come into the office four weeks after having had one of these operations, and the first thing they'll tell you is, "It wasn't so bad, but I feel like I'm urinating razor blades." Let me just let that sit for a second and think about what it's like to urinate razor blades. That was the standard of care. Now what instead we offer patients is the and I just actually had an opportunity to see one of our patients get this medication, is an opportunity to come to the office by yourself. You can drive yourself if you're a driver. Come to the office, have a nurse put a catheter in your bladder, instill the medication in your bladder, and within an hour, you're on your way back to your house, to the grocery store, to work unencumbered by any of the things I described associated with surgery. It is a much gentler approach to treating the patient than our historic standard of care. I think patients appreciate that, and I can tell you from personal experience in my practice, they certainly voice it when you give them the opportunity to take advantage of this therapy. Then I guess as you look at other therapies in clinical development for intermediate-risk NMIBC, what do you see as the key points of differentiation for Zusduri? I think one of the things that's important to remember about the entire exciting field of non-invasive bladder cancer therapy, because there's a lot going on, most of it initially focused on high-grade disease, but now migrating into the space that Zusduri occupies in intermediate-risk disease, is that all of the other therapies follow a surgical procedure. Zusduri is the only therapy currently available, or actually even in the pipeline, that represents a primary non-surgical approach to this disease. So that, for me as a clinician, is the key differentiator, and Chris may want to comment on this as well. But the other thing to think about is all of the other drugs in development that you'll hear about not only follow an operation, but require that patients be exposed to the medication however it's delivered, whether it's oral or a device placed in the bladder or instillation for many months after the operation. Liz Barrett, our CEO, has said this on many occasions publicly. There's not only the time on treatment, but the treatment-free interval that patients enjoy when you compare Zusduri to the other drugs in development. Those drugs have a long time on therapy, on treatment, and Zusduri is a very brief six-week interval period of treatment. No maintenance, and you're done with really outstanding complete response and durability of response data. Oh. I guess just quickly on Jelmyto. It grew 7% in 2025, and it's been down a bit from prior years. I guess how should we think about the growth trajectory from here? Yeah, Jelmyto is at this point five, six years into its launch, so it's more mature. We do still think there's opportunity for some modest growth with Jelmyto. Obviously, we expanded our sales force when we launched Zusduri last year. We went from 50 reps to 80, so we have more folks out there talking to physicians about both of our products. There's a lot of overlap in terms of the call point between Jelmyto and Zusduri. So we think there's still opportunity for growth. Some of the things we're watching, obviously, been very focused on the Zusduri launch at the start of the year. The other, we talked about the size of the UTUC market being only about 6,000 or 7,000 patients, and so it's a rare disease market. There has been quite a bit of increased activity in terms of potential competition in that space and a lot of clinical trial activity, not only with our UGN-104 follow-on product, as well as some other assets in development in this space. So watching the dynamics of how clinical trial enrollment might be a little bit of a headwind on Jelmyto is also something we're looking at. All right. I have one last question before we get into the next-generation compounds. For Zusduri, you've now activated over 1,400 sites, but you have around 500 unique prescribers. Just how are you thinking about closing that gap, and what must happen for greater adoption? Yeah. When we talk about activated sites, this was a big focus for us last year, establishing a good foundation. What we mean by an activated site is a site that has gone through the process of getting onboarded with one or multiple of our specialty distributors or our specialty pharmacies so they can acquire the product, get their staff trained so they understand how to incorporate it and acquire it from an operational workflow. There is some indication of interest from those sites, obviously, to go through that process. The big focus now, especially with the Zusduri in place, has been now just expanding the prescriber universe. We've been really focused on one breadth of utilization. As I mentioned before, broad HCP target universe, about 8,000 physicians. Our core target's about 6,500. The 450 you mentioned, there's a lot of room for us to continue to really grow in terms of breadth of prescribers. We've been focused on that. Also depth of utilization. So getting physicians not only to use it on one, but on use it on multiple patients. Really pleased to see when we looked at repeat writers in the first quarter of the year, they're about 40% of our prescriber base. That increased to 45%. We want to continue to see that percentage grow as well as the number of prescribers grow. All right. Now let's shift to the next-generation compound, UGN-103 and UGN-104. I guess beyond the manufacturing and supply advantages, how does this next generation of formulations change the IP picture for the franchise? Yeah. If we just start with UGN-103 and Zusduri, just to ground you. Zusduri, the core patents around the RTGel go until January 2031. We're also really pleased to have just gotten a notice of allowance for an additional method of use patent in the low-grade IR space for both Zusduri and UGN-103 that takes IP protection out to July of 2044. If we look then at the UGN-103 product, you mentioned when we started looking for additional supply for Zusduri, we found a company called medac GmbH who has a proprietary mitomycin formulation. With their mitomycin, we have exclusive license for that. They have a composition of matter patent that goes to mid-2035. The parameters for the gel are different with that mitomycin formulation, so we have additional IP with the gel and 103 that goes all the way through 2041, to December of 2041. Again, we also have that July 2044 patent there for 103. So 103 has got a strong patent estate with IP well into the 2040s. But outside of the IP, are there business reasons to go with either Zusduri or 103? Yeah. Good question, Eric. Alexa alluded to it. One, there is supply and production efficiencies that come along with the new product. Our current formulation takes about three weeks to lyophilize. The 103 mitomycin can be lyophilized in three days. So, from a supply flexibility as well as some cost benefit in terms of being able to be manufactured more quickly is part of it. The other is 103 is more soluble, and so when we think about our drugs, the mitomycin has to be mixed with the RTGel. Right now, that mixing process takes about 45 minutes. In the hospitals, they often mix it themselves. For community practices, we offer the mixing services for them. But once we move to 103, that mixing time comes down from 45 to about 15 minutes. So there is efficiency from an operational workflow in the pharmacy. The last piece is once mixed, right now with Zusduri, it has to be instilled in the patient in seven days, so there is a certain shelf life once reconstituted. With 103, we haven't finished all the stability data, but we expect it to be multiple weeks, so it will also give us some additional flexibility in the community practices. So there are some supply and operational enhancements. I think you're guiding towards a potential approval next year for UGN-103. I guess what's the potential transition plan from Zusduri to UGN-103? Is this a pretty much straightforward switch, and are you expecting Zusduri and I guess Jelmyto for UGN-104? Will these remain on the market after these next-gen products are approved? We'll ultimately remove them from the market, but for a period of time, both will be on. Just from a timeline for UGN-103, we submitted the NDA in mid-August. We expect the PDUFA to be mid-June. That sets us up well to be able to apply for the J-code by the July 1 quarterly deadline. That would then allow us to have a J-code in place for UGN-103 by January 1, 2028, if everything goes to plan. We just talked about the importance of the J-code for Zusduri. We'll wait for the J-code for UGN-103 before we fully commercialize and introduce UGN-103 into the market, and then we'll work through the transition, where both products will be available on the market for a period of time, and then ultimately, we'll pull Zusduri from the market once that transition's occurred. We'll follow a similar timeline for UGN-104. UGN-104 is just further behind in development. We prioritized UGN-103 just given the size of the market. We expect to complete the UGN-104 phase III trial enrollment by the end of this year, and then we'll wait for six-month durability response data and submit the NDA, and we'll go from there. Maybe you can just quickly outline what a potential switch could look like for patients. Yeah. The one thing, too, is from a clinical profile, expect very similar clinical results. We talked about the operational efficiencies that come along with it. Part of it's going to be just educating the market, educating physicians as we go through that process. There are some benefits of being a buy-and-bill drug, where we can leverage our specialty distributors or specialty pharmacies to help as physicians go to acquire the product in terms of making them aware of the next-gen formulation and help work through that transition. The one thing is just given the IP for both drugs, we have the benefit of time. We'll be thoughtful, but at some point, we'll have to make the move and pull the other product from the market. I believe you're also planning to study UGN-103 in the adjuvant setting in newly diagnosed intermediate-risk patients. I guess this is a different point in the disease course than where Zusduri plays today. What was the strategic thinking behind moving upstream? We know anecdotally that some physicians are using Zusduri in an adjuvant setting now. This was obviously not our label, not our indication. We wanted to be able to provide some safety information about the adjuvant use. We thought this was an opportunity to do that in a phase II design. We will execute that trial probably starting next year. The purpose, of course, is to provide additional information, not for the purposes of changing the label, but for reassuring physicians that, in fact, should they choose to use it in adjuvant, which is, of course, an individual decision off-label, that there are some safety data to support that. Mark, what patients are more suitable for surgery and adjuvant use relative to use in the recurrent setting? One of the dilemmas when you meet a patient for the first time with a tumor is determining what the nature of that tumor is. Newly diagnosed patients are required effectively to undergo a transurethral resection for the purposes of not only removing the visible tumor but also for staging and pathologic analysis of the tumor to verify its nature, whether it is high or low grade. Newly diagnosed de novo disease is axiomatically treated with surgery first. However, some physicians are going to be interested in using Zusduri or 103 in that context, and this would provide some additional information to inform that decision. I also believe there is a planned study for 103 in high-risk disease. I guess there is a ton of activity in that space already. How are you thinking about potential differentiation and what the commercial opportunity is there? High-grade disease obviously is a hotly contested area within the context of non-muscle invasive bladder cancer therapy. However, as you have heard from us before, there is a lot of opportunity because there are a lot of patients who are failing various therapies that have already been approved. We think because UGN-103 is really effectively optimized mitomycin, and we know that aqueous mitomycin is active in high-grade disease, we believe there is an opportunity to add to the armamentarium treating patients with high-grade disease, and that is the purpose of the randomized trial, which will start this year and will compare TURBT followed by UGN-103 to TURBT followed by induction and maintenance gemcitabine. I should point out that in the experimental arm, the 103 arm, we will not only do induction but also maintenance because patients with high-grade disease have a higher likelihood of relapse. We will give them maximum therapy. In terms of the commercial potential, the patient population is smaller in high-grade, so it is roughly 20,000 patients versus the 60,000 we talked about. But the TAM is relatively similar mainly because of the price. The price point in the high-grade setting, just given the nature of more progressive opportunity for higher price points. Also with that, in the low-grade IR, one of our benefits is six weeks of therapy, no maintenance, and you are done. In the high-grade setting, we will do maintenance therapy. You are not only going to have the six-week induction course, you will also have monthly maintenance on the back end. From a number of doses, you are going to then garner a larger or higher aggregate price per patient. I see. On the topic of high-grade disease, let's talk about UGN-501. Maybe you can share some insights on this program, where things stand today, how you're thinking about the development pathway, and when can we expect to see clinical data? Sure. UGN-501 is an oncolytic virus that we brought into our portfolio recently and which we are taking into phase I dose escalation this year. The rationale here is that oncolytic viruses have been shown to show great promise, particularly recently because of CG Oncology's experience in high-grade disease using their oncolytic virus. The 501 asset is a highly engineered, very intelligently thought out, and highly active and potent version of an oncolytic virus. We think it's best in class based on some of the preliminary work we've done non-clinically. As I said, we will take this into phase I this year, data next year. We'll dose our first patient this year. On the basis of the phase I, we'll obviously be able to provide safety and tolerability information as well as a recommended phase II dose. If we get an efficacy signal, we'd obviously share that as well. The interesting thing about 501 is that it gives us an opportunity to think beyond the urinary tract. Oncolytic viruses have been used to treat, both systemically and intratumorally, a variety of other solid tumors. We are now in the process of looking at the opportunities to take 501 outside of urologic applications to other promising targets in solid tumor oncology. More details on that as we hone in on the targets for the company. Does this use the RTGel technology as well? Thanks for asking that. Initially, we're going to develop this in an aqueous solution, but we are in parallel working on formulation of the virus asset in our RTGel. This may provide a couple of benefits within the context of the intravesical application, specifically maybe obviating the need for a detergent wash for intravesical instillation. It may also impact interval of dosing and the amount of virus necessary for treating patients. But it also may provide us with opportunities beyond the urinary tract in the intratumoral setting, and more details on that as we do more research. All right. And I know we only have a few more minutes left, but maybe in the remainder of time, you can give us some more details on the recent strategic collaboration with IntraGel. Maybe where do you plan to take this program, and what indications are you looking at? IntraGel is a very interesting collaboration for us because our RTGel platform is biocompatible but not biodegradable. So it must be placed in a part of the body that it can exit naturally. We were in search of, and have found in the IntraGel collaboration, an opportunity to use a biodegradable gel to deliver drugs in a sustained manner into closed spaces. We are still in internal conversations about where the targets for the IntraGel program will focus, but I don't know if you want to comment further. We're very excited about the collaboration. Yeah, the one other specific area we were able to negotiate as part of this deal is they do have a asset that they're developing in advanced head and neck cancer with their sustained release gel. And they have some early data, clinical data, that they presented at ASCO, which shows some efficacy in terms of tumor reduction as well as good safety profile, and they're planning to move that into a phase II study. As part of this deal, we'll have first rights once that phase II data card is turned over to potentially license it in for head and neck cancer. Okay, great. Maybe you can quickly remind us of your cash and runway. Sure. Yep. We had $180 million of cash as of the end of June. That cash is sufficient to get us to and through profitability, so we're sitting in a good place there. Okay. When is profitability? Good question, Eric. We haven't guided to Zusduri revenues, and that obviously is going to be the big driver to our path to profitability. We haven't guided to when, but we are getting closer. Thank you, guys. Thank you. Thank you very much. All right. Chris, Mark, thank you so much. Thank you everybody for tuning in today. Thanks.