Hello, everyone. My name is Mitchell Kapoor. I'm a Senior Biotech Analyst at H.C. Wainwright. Thank you for joining our conference this morning. Today, it's my pleasure to welcome the UroGen team. Today with us, we have Mark Schoenberg, the CMO. Thank you for joining us, Dr. Schoenberg. Oh, well, it's a pleasure to be here. Thank you for having us. Great. So we'll jump right into it. This is a fireside chat, and so I'll just start off with the overview of the company. If you could provide a brief overview of UroGen, where you stand today, and what, the core technology RTGel is saying. Thanks for the question. For those who are not familiar, and since I'm a urologist, I have to start with a joke. A urologist walks into a bar. This is the history of the company, supposedly, that a conversation between a urologist and a chemist at a cocktail party in Israel, where the company was founded, led to a discussion of how to deliver medicines most effectively to the inside of the urinary tract. The end result of that was the evaluation of what now is called our platform technology, a reverse thermal gel, which is a mixture of safe polymers, which, when cooled, is a liquid, and when warmed to body temperature, forms a soft gel that can deliver medicines to the inside of the urinary tract and other body cavities for extended periods of time. The core technology is a reverse thermal gel, and it can be mixed with all kinds of drugs of all kinds of sizes, and that is what we use to treat urothelial cancer, which is our focus right now clinically. Great. That's awesome. Could you just step back and talk about UGN-102? So, I know we're jumping right into it. So UGN-102, you had unprecedented data with the ENVISION and ATLAS studies. Could you just summarize that? And you know, what non-muscle invasive bladder cancer populations are you targeting versus others? Sure. So the clinical problem we're dealing with is called non-muscle invasive bladder cancer, which is a big swath of disease that urologists care for routinely all over the world. Urothelial cancer is the most common malignancy of the urinary tract, and the most common form is what's called low-grade disease. This is a chronically relapsing form of cancer that occurs in the bladder, inside the ureter, and also inside the kidney. And although we initially focused on the inside of the kidney for our first product that's approved and on the market, our focus now is on UGN-102, which is our reverse thermal gel mixed with a drug called mitomycin, and it is used to primarily treat urothelial cancer, and the type we're treating is intermediate risk. There are a variety of types of bladder cancer. Intermediate risk is one characterized by larger, low-grade tumors, multifocal tumors, chronically relapsing tumors, and these tumors have historically been treated by surgical intervention. The surgery is done under anesthesia with a scope. There are specific morbidities, and even a potential mortality risk associated with the use of surgery in this population, which is an elderly population of patients. The average age of diagnosis is seventy-four. So what we are doing with UGN-102 is moving the therapy of this population of patients from the operating room to the office setting, where UGN-102 can be given just by simply placing a catheter in the bladder. In fact, a nurse can do this. It doesn't require a doctor. Treating the bladder cancer with UGN-102 once a week for six weeks, and then evaluating the patient about six weeks after the last dose. Our studies to date show, and this is probably, the take-home baby number to remember, that the complete response rate in our pivotal trial, which is called ENVISION, using this format for treating bladder cancer, is 80%. So patients receiving six doses of this drug in an office setting rather than surgery for primary therapy had an 80% likelihood of being disease-free three months after starting therapy. And of those complete responders, by Kaplan-Meier analysis, 80% of those people were free of disease a year later. Probably the most important thing to remember about those statistics is how they compare to the standard of care. We know that in this population, if you treat them primarily with surgery, 50% of these individuals would have relapsed by a year. So not only are the complete response rates very promising, both in recurrent, which is the focus of the ENVISION trial, patients with chronically recurrent disease, but even in patients with new disease, which were studied in another trial called ATLAS, we know the complete response rates were very good, easily comparable to surgery, but the durability of that complete response was better than expected and probably better than achievable by surgery. So very useful clinically, a non-surgical therapy for the treatment of a population of patients typically treated by surgical means. Great. Yeah, that's a great overview, and we certainly think that this could be a potential game changer in this space. Related to that program, you recently filed an NDA for U.S. approval. I'm wondering, you know, could you just talk a little bit about if priority review is a possibility? When would you expect the FDA might assign a PDUFA date, and, when could we ultimately see a launch for UGN-102? Thanks. So yes, we have filed the NDA, and we in fact have an application orientation meeting coming up, and we certainly will apply for priority review. Obviously, we don't know when that would be granted, but assuming it is granted, and we think we have a pretty good case for the bestowal of priority review on this program, then assuming approval, we would launch at the end of Q1. If that is not given, if we don't get priority review, it would put us off by about a quarter, but nonetheless, certainly early spring, late spring, you'll see UGN-102 on the market, if approved. Okay. We haven't, I don't think, publicly disclosed the PDUFA date. I mean, we don't know that yet. Okay, great. And then how soon after approval might you potentially receive a J-code? And could you just talk about how that could facilitate market uptake of one or two? Sure, there are practitioners who are sensitive to J-codes, and J-codes take about six months of following approval to be obtained. So there would be a miscellaneous code available to practitioners until it is granted. That said, there are plenty of practitioners who are comfortable with the miscellaneous code. We would target those practices initially and then focus on those more sensitive to J-code later in the launch. But we will have a robust sales force available to tackle this at the time of launch. Okay, great. And on the sales force, could you just talk about the expectations for launch? What's the game plan, and what kind of sales and marketing infrastructure remains to be built out at this juncture? So as you probably know, because we have a marketed product now, we have a sales force existing, and there is significant overlap in the target population of physicians we'll be talking to for the launch of UGN-102 with our Jelmyto product for upper tract urothelial cancer. We know that we will have to expand the sales force. We are actually finalizing our calculations regarding what that expansion would look like, but we are fully engaged in planning for the launch already and making great headway in getting everybody ready for what we hope will be an early launch. Great. Yeah, it sounds like there's a lot of synergies between the programs and the sales force. On the Jelmyto note, could you just talk about kind of the commercial receptivity to Jelmyto to date, and what kind of learnings can you take away from that program? Let me remind everyone, Jelmyto is a product that is analogous to UGN-102, in the sense that it is a reverse thermal gel containing mitomycin that is used to treat the interior of the kidney when a cancer called upper tract urothelial cancer is diagnosed. Again, this is for low-grade disease, not high-grade disease. This is an orphan indication. It's a very small number of patients by comparison, one-tenth, we think, the size of the UGN-102 market. That is the intermediate-risk non-muscle invasive bladder cancer market. Six to seven thousand patients, newly diagnosed each year. We think the total number of patients available in the United States on an annual basis is somewhere between twelve and fifteen thousand. A smaller group of patients spread out all over the country, so a harder population of patients to access. So this requires a lot of work on the part of the sales force. Nonetheless, we've made progress in accessing these patients and engaging physicians. Uptake has been slow and steady. We expect that to continue. And a couple of technical things have helped, including the adoption of what's called nephrostomy tube administration. This is a tube directly into the kidney through the back, sort of functioning like a chemotherapy port that has made it easier for practices to use UGN-102, excuse me, for Jelmyto, and that has, I think, facilitated uptake as well. So we continue to see growth and expect that to continue. Okay, great. And so for the potential outlook for this program, Jelmyto, could you just talk about what you're doing to most effectively capture those 6,000-7,000 patients? What is really UroGen focused on at this juncture with that program? So, you know, I think, it's fair to say that we have, really engaged, the urologic community in every conceivable way through peer-reviewed publications, presence at lots and lots of, professional meetings, engagement with large group practices, the LUGPA organizations, that, really are very dominant in the private practice space right now. So in every way possible, we are engaging physicians in the conversation. But it is important to remember that on an annual basis, a given urologist may only see one or two of these patients a year. So it is a slog, and it, you know, it requires a lot of face time with, our sales force, and they're making the effort. Again, the upper tract administration technique of antegrade administration, I think, has facilitated improved uptake of this drug, and we continue to see the efforts translate into more adoption. Okay, great. And so now that we have an overview of one oh two, Jelmyto, could you just talk about the markets for both in an IBC as well as UTUC? Just kind of compare, you know, what the potential is for one oh two versus Jelmyto. Sure. So we think, and this is based upon SEER data, so we, you know, we're using independent peer-reviewed sources for estimating populations, that the market for UGN-102, the bladder cancer product, is about 80,000 people in the United States on an annual basis. So these are people with new and recurrent intermediate-risk non-muscle invasive bladder cancer. That is about 10 times as much as you would see for the UTUC market. So, you know, given what, and, you know, our CEO, Liz Barrett, has said on numerous occasions, that, you know, the pricing for this drug would suggest that it's absolutely got billion-dollar potential on market opportunity, even if you consider a relatively modest market share of 20%-30% of that population. So it's a very big market. It's an underappreciated market. It's underappreciated, I think, as a clinical problem. This is the lion's share of bladder cancer that doctors deal with on a regular basis, and for years, there has been no alternative, apart from repetitive surgical intervention, for this population, and I think what we're seeing, both in conversation with physicians and also with patients, is that there is going to be tremendous receptivity to an alternative to the standard of care, which, frankly, is very burdensome for patients, uncomfortable, and for which there hasn't been a contemporary alternative. Great. Just jumping a little bit into the pipeline beyond these two, could you just talk about what you're thinking about—how you're thinking about the rest of the UroGen pipeline? And, just thinking about if you're contemplating in-licensing or out-licensing BD activities, what does that side of the business look like for UroGen? Sure. So we have focused our attention on low-grade disease to date, and we've done that for a variety of reasons having to do with what we know about the activity of mitomycin, which is the active in our drugs. It is true that there is also a smaller segment of the population of bladder cancer patients who have a potentially life-threatening disease called high-grade disease. And as anybody who's been following this space knows, there's a lot of activity in the high-grade space, although almost all of that activity is exclusively in the adjuvant setting, which is to say, following surgery. We have a high-grade program as well that focuses on using multiple drugs as immunomodulators to treat high-grade urothelial cancer, and we're currently advancing a phase I program using a checkpoint inhibitor delivered in our platform directly to the bladder in conjunction with other drugs, such as a TLR7 agonist in our portfolio called UGN-201, as well as gemcitabine. That program is in progress. We're gonna announce data regarding our phase I program at the SUO later this year, and the combination data will probably be available in 2025. As for in-licensing, we are actively engaged in looking at other assets. We've been approached by a number of companies interested in using our platform or partnering with us to use our platform to deliver their assets, so we are actively engaged in evaluating multiple opportunities at this time, and we'll announce them when they're more mature. Yep, great. We'll be waiting on it. Okay, and then thinking about, you know, a little bit more of the financial arrangements and partnerships you have there, could you talk about your relationship with RTW Investments and the royalty obligations, as well as the relationship with Pharmakon? I will do my best. Maybe I should ask others. RTW is a prepaid forward obligation. The rate is 13%. We've taken $75 million. We have, I think, up to $300 million available to us in that, and it functions effectively as a royalty. With respect to Pharmakon, that is a debt facility. We've taken $100 million. We will actually take another $25 million this year, and after approval of one oh two, we would have the opportunity to take yet another $75 million. So between money we've raised and money we have available to us, we feel very well-financed, not only for some of our BD opportunities, but more importantly, for our complete launch of one oh two, which we anticipate again in 2025. Okay, great. And, as we're kind of winding the conversation down, wanted to talk about the next twelve months for UroGen. What, what's the outlook for the company and, the road ahead? This is a very exciting year for us. We have a drug in the market, and it continues to grow and be adopted, and we have another drug going to the agency that we think will have a tremendous impact on urologic care. We are busily preparing and actually submitting and corresponding with journals about manuscripts related to our experience at our clinical trials. The Journal of Urology is evaluating three different manuscripts right now for us regarding our clinical trials experience. We'll be very busy at conferences, updating folks on our data through the rest of the year, and then going into next year with the you know anticipated launch and the AUA. We have a lot to do, but again, a very exciting time for us and a very positive outlook, and we're well-positioned, we think, to bring yet another transformative therapy to urology and to our patients. Great. Mark, thank you. Dr. Schoenberg, thank you so much. Mark's okay. My patients call me Mark. Really appreciate the time. Thanks very much. And, uh- A pleasure. It's always a pleasure. Thanks again. Thanks a lot. Take care.