Good morning, ladies and gentlemen. Thank you for standing by and welcome to the UroGen Pharma Q1 2023 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 begin. Thank you, operator. Good morning, everyone. Welcome to UroGen Pharma's first quarter 2023 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 March 31, 2023. The press release can be accessed on the investors portion of our website at investors.urogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, Jeff Bova, Chief Commercial Officer, and Don Kim, 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 Jelmyto, anticipated seasonality for Jelmyto in 2023, our ongoing and planned clinical trials, commercial and clinical milestones in the year ahead, the potential of UroGen's product and product candidates to transform the treatment paradigm of urothelial and specialty cancers, market opportunities, potential future commercialization activities for UGN-102 if approved, data presentations, regulatory filings, future R&D development efforts, our corporate goals, our optimism regarding multiple avenues available to us to further strengthen our balance sheet and 2023 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 UroGen disclaims any obligation to update these statements. I will now turn the call over to Liz. Liz? Thank you, Vincent, and thank you to everyone joining us today. UroGen remains focused on developing novel therapies for urothelial and specialty cancers with the goal of fundamentally transforming the treatment paradigm for what we believe is a largely underserved patient population. With the launch of Jelmyto, we took an important first step in bringing to market an innovative non-surgical therapy designed to improve the standard of care for treating low-grade upper tract urothelial cancer. In achieving this goal, we have demonstrated the viability of intravesical delivery of chemotherapy and our proprietary RTGel to treat urinary cancer, setting the stage for our lead development program, UGN-102, which aims to address a major unmet need in low-grade, intermediate-risk non-muscle invasive bladder cancer, an indication impacting approximately 80,000 patients in the United States each year. Turning to the quarter, I'm pleased to announce that first quarter Jelmyto net revenues were $17.2 million, our second-best quarter ever since launch and a 27% increase from the same quarter one year prior. While continued growth in Jelmyto adoption is encouraging, we are further assured to see our guidance model consistent with actual results, indicating that the seasonality we've previously observed may be reliably predictable. As the utility and benefits of Jelmyto are increasingly recognized in the real world, it has also come to be acknowledged by the urology community, as we recently saw at the 2023 American Urological Association meeting in April. Mark and Jack will provide highlights from the conference. At a high level, two additional studies reinforcing the utility and efficacy of Jelmyto were presented, further strengthening the growing body of real-world outcomes data supporting its broad use. As we look ahead, the focus of our development strategy is very much on UGN-102 and its several near-term catalysts. Specifically, we remain on track to provide top-line data from our phase III studies of UGN-102 this summer. For ENVISION, we anticipate providing the primary endpoint of complete response rate from approximately 240 patients who completed this study. For ATLAS, the predecessor to ENVISION, we will provide complete response, durability and safety data from approximately 280 patients that completed the study. Assuming positive results, the ENVISION trial will form the basis of our FDA submission once durability can be appropriately measured. In anticipation of prospective favorable results, we expect to submit an NDA with the FDA in 2024. The goal would be to target priority review, which if granted, may potentially result in approval at the end of 2024 or early 2025. Our optimism in the potential outcome of ENVISION stems from its similarity to the phase II OPTIMA II trial of UGN-102, which demonstrated a 65% complete response rate and duration of response at 12 months of 72.5% using Kaplan-Meier analysis. We believe UGN-102 can be a transformational product and represent a significant opportunity to address a much larger patient population. Unlike Jelmyto, administration is much simpler without the need for oscopy. If approved, we anticipate UGN-102 will be a significant driver of future growth as it will be the only primary non-surgical therapy addressing the nearly 80,000 new patients in the U.S. alone, who will undergo repetitive endoscopic resection and are burdened with the risk of surgery and anesthesia as the only recourse for disease control. Before turning the call over to my colleagues, I would like to quickly address our balance sheet. We continue to emphasize rigorous fiscal prudence and prioritize our cash spend on advancing our core value drivers, Jelmyto sales and UGN-102 development. Given what we believe is a significant market potential for UGN-102, we are optimistic that we can take advantage of a number of potential viable opportunities to further strengthen our balance sheet when appropriate. I'll pass the call over to Mark. Mark? Thank you, Liz, and hello, everyone. I'd like to begin by commenting on 2 recent Jelmyto real-world outcomes studies, which were accepted for podium presentations at the 2023 AUA meeting held in Chicago at the end of April. The first of these studies was conducted by Dr. Joseph Jacob and colleagues and highlighted results from a subanalysis of the first and largest post-commercial utilization review of Jelmyto in treating ureteral tumors. In this analysis, 47 patients had UTUC tumors involving the ureter, with 12 cases of ureteral tumor only and 35 cases of ureteral plus renal pelvic tumors. Data from this study demonstrated no difference in Jelmyto outcomes at first endoscopic evaluation based on tumor location, adding to the growing body of real-world evidence supporting broad use of Jelmyto in treating low-grade UTUC patients with multifocal disease. In addition to similar efficacy and safety results at first endoscopic evaluation, there was also no difference in recurrence rate or progression based on tumor location. 14 patients with ureteral tumor had significant ureteral stenosis at first post-treatment evaluation. However, only 5.4% of patients developed new clinically significant stenosis when excluding patients with pre-existing hydronephrosis, which is the buildup of excess fluid in the kidney due to a backup of urine. The second study was conducted by Dr. Craig Labbate and colleagues and highlighted results of a subanalysis from the same post-commercialization review of Jelmyto. The study aimed to evaluate efficacy and safety of Jelmyto when administered following complete endoscopic resection. Results from this study were also published in the May issue of The Journal of Urology. In the publication, the authors noted that UTUC patients in this retrospective study who received Jelmyto following complete endoscopic ablation achieved a 69% complete response rate at first endoscopic evaluation. Whereas in the OLYMPUS study, patients achieved a 58% complete response rate at first endoscopic evaluation. The rate of ureteral stenosis for those in this study who underwent complete endoscopic ablation followed by Jelmyto treatment was 23% compared to 44% observed in the OLYMPUS study. The authors also note that UTUC disease recurrence is often detected at the first ureteroscopic evaluation after endoscopic ablation only. Early failure is a drawback for endoscopic ablation, which occurs in 40%-50% of UTUC patients by six months. It's noted in the study that this may be due to incomplete resection or ablation of the primary tumor for which post-ablation therapy is intended to treat. We are pleased to see the growing body of real-world outcome data providing compelling evidence supporting the use of Jelmyto in a diverse low-grade UTUC population. The acceptance for presentation of these studies at the AUA underscores the attention and recognition that these important data warrant. To further explore the full potential of Jelmyto for the treatment of patients with UTUC, investigators are in the process of enrolling the prospective and retrospective uTRACT Registry to capture data in a large-scale standardized manner to report further on patient outcomes following Jelmyto treatment, including longitudinal follow-up. I'd like to turn now to UGN-102, which we view as a potentially transformative therapeutic advance that I believe will be welcomed by my colleagues and patients alike. As Liz noted, we're excited to report data from the ENVISION and ATLAS clinical trials by the end of this summer. Our optimism about potential outcomes from both trials stems from their similarity to the phase II OPTIMA II trial of UGN-102, which demonstrated a 65% complete response rate and duration of response at 12 months to 72.5% using a Kaplan-Meier analysis. UGN-102 also has key similarities with Jelmyto. Both products utilize mitomycin, allow for local delivery, and sustained exposure to mitomycin for up to six hours. Importantly, both low-grade NMIBC and low-grade UTUC share many biological and clinical similarities, which leads to common clinical features, including the responsiveness to chemotherapy. UGN-102, however, has several unique advantages over Jelmyto, which we believe will have a direct impact on its use. It does not require special equipment for procedures and is designed to be instilled into the bladder via urethral catheter in an outpatient setting, a common and routine procedure in most urology practices. This advantage will be critical as low-grade intermediate-risk NMIBC is eight to 10 times more common, and a condition that is routinely managed by 80%-90% of urologists, inferring a significantly larger addressable patient population. Meanwhile, our phase I trial with UGN-301, our in-licensed anti-CTLA-4 antibody for intravesical administration using RTGel technology, continues to enroll. UGN-301 is in development for use in combination with other immunomodulators, including UGN-201, our proprietary TLR7 agonist, and other potential chemotherapy and immunotherapies to treat high-grade MIBC. This study is aimed at identifying the suitable dose for a subsequent phase II trial. The first arm of this study, evaluating dose ranges of UGN-301 as monotherapy, is expected to be completed later this year. Results from this arm will inform the appropriate dose of UGN-301 for our first combination arm, which could potentially begin before the end of the year. We view UGN-301 as a cornerstone checkpoint inhibitor for a variety of potential combination therapies targeting high-grade MIBC. With that, I'll turn the call over to Jeff for a commercial update. Jeff? Thanks, Mark. I'm pleased to see momentum in patient uptake, activated sites, and repeat prescribers from the end of last year carry into 2023, as Q1 represented our second strongest quarter for Jelmyto since launch. Adoption metrics in the first quarter continued to demonstrate encouraging trends in the new and repeat accounts. Activated sites on May 1, 2023 were 1,009, compared to 983 on March 1, 2023, and repeat accounts were 235 compared to 214 for the same period. Reimbursement remains at approximately 99% across all coverage types. During the first quarter, we held our national sales meeting in San Diego. I'd like to take a moment to share several key takeaways. First, we recognize our top territory performers who have demonstrated sustainable growth in their accounts. They have shown that the opportunity for meaningful adoption in low-grade UTUC exists once physicians embrace Jelmyto. We've previously discussed our revised sales strategy designed to emulate the success observed in over-performing territories, which I'm pleased to say is improving penetration in developing territories. At the meeting, we also rolled out enhanced messaging and sales resources from the growing body of real-world evidence data that has demonstrated the viability of Jelmyto across various practice patterns. We expect these new resources to improve our team's ability to effectively engage with new and existing accounts in the field to further drive appropriate adoption and patient penetration. UroGen again had a major presence at this year's AUA meeting. Building on Mark and Liz's comment, we are very pleased to see specific mention of Jelmyto in the AUA and SUO first-ever low-grade UTUC treatment guideline. The guideline states clearly that tumor ablation should be the initial management option for patients with low risk UTUC, for which Jelmyto can be a treatment option as a part of a kidney-sparing approach to disease management. With the use of Jelmyto in a multimodal regimen, patients with UTUC can achieve a durable, complete response. This is an important advancement in the treatment of UTUC, and we are proud to offer a treatment that is backed up by the latest AUA guidelines. We view the guideline as an important milestone for low-grade UTUC patients and broad recognition by AUA and SUO of the positive impact new and innovative therapies such as Jelmyto can have in treating low-grade tumors. Our booth featured demonstrations on how our innovative RTGel technology is advancing care in uro-oncology and allowed the team to meet with physicians. It also included a product theater featuring KOLs Jennifer Linehan and Sandip Prasad, which focused on the Jelmyto data, including recently published real-world outcomes data and actual patient case studies. Overall, we are very pleased to see acknowledgment of our clinical progress and real-world impact filtering through to clinician communities and societies. We look forward to continuing to work with the AUA and SUO as we further develop and expand Jelmyto and prospectively introduce UGN-102. With that, I'll turn the call over to Don to discuss our financials. Don? Thank you, Jeff, thank you to everyone for joining today's call. I'm pleased to be with you today to review our financial results for the first quarter ended March 31st, 2023. For the first quarter of 2023, we reported Jelmyto net product revenues of $17.2 million, in line with consensus estimates and an increase of 27% compared to $13.6 million in the same period last year. For the first quarter of 2023, R&D expenses were $12.5 million as compared to $12.7 million for the same period in 2022. The decrease is primarily due to lower expenses related to the ENVISION trial, manufacturing, and clinical compensation, offset by higher R&D expense related to the phase I study for UGN-301. Selling, general, and administrative expenses for the first quarter 2023 were $24.5 million. This compares to $21.3 million for the same period in 2022. The increase to SG&A is primarily due to higher marketing, commercial, information technology, and advisory expenses, offset by lower market access, medical affairs, and stock-based compensation expenses. UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $5.2 million for the first quarter 2023. UroGen reported a net loss of $30.2 million, or a basic and diluted net loss per ordinary share of $1.30 for the first quarter 2023, as compared to $28.4 million or basic and diluted net loss per ordinary share of $1.25 for the same period in 2022. Turning to forward guidance, we reiterate anticipated full year 2023 net product revenues from Jelmyto to be in the range of $76 million-$86 million. We reiterate full year 2023 operating expenses to be in the range of $135 million-$145 million, including non-cash share-based compensation expense of $6 million-$11 million, subject to market conditions. The company reiterates anticipated full year 2023 non-cash financing expense related to the prepaid forward obligation to RTW Investments in the range of $21 million-$26 million. Of this amount, approximately $9.9 million-$11.2 million is expected to be in cash. We ended the first quarter with $75.2 million in cash and cash equivalents and marketable securities, which is expected to finance its operations into 2024. To echo Liz, we are committed to diligently and proactively managing our balance sheet in support of our commercial and clinical development activities. With that, I would like to turn the call over to operator for questions. Operator? Thank you. At this time, we will be conducting the question and answer session. If you would like to ask a question, you will need to press star one one on your telephone. Once again, that's star one one on your telephone and wait for your name to be announced. To withdraw your 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 Ram Selvaraju of H.C. Wainwright & Co. Your line is now open. Hi, thanks very much for taking my questions. Firstly, I wanted to see if you could give us a sense of how long you expect it to take for the findings from the real-world retrospective analyses on Jelmyto to effectively begin to inform clinical practice, and to what extent you're seeing changes in clinical practice now, particularly with regard to the use of anterograde installation. Yeah. Thanks, Ram. Jeff, do you wanna, take a stab at it? Mark, you know, you may want to add to that as well. Jeff? Sure. Thanks. Hi, Ram. The answer to the question is immediately. The reps are out there right now with new data. Physicians, urologists wanna hear about the new study, particularly because it's how they practice. Typically, what they've been doing is endoscopically resecting and bringing in Jelmyto. They're able to see a better CR rate. Yeah, I expect that to continue. I expect it to reinforce how physicians are using it for those that are using it. We're already seeing some big accounts come on board after there's been, as you know, this significant buzz with the AUA, and all of this data that's come out that is really opening doors to the territory business managers to talk about this new data. Regarding antegrade, your question, it continues to go up. The Dr. Rose data will certainly help justify the data that we see in and around the lower stenosis rate. It continues to go up, and accounts continue to talk about getting it out of the hospital outpatient and bringing it into their clinic. It provides that flexibility to the physician with their patients as to whether or not they wanna do it retrograde or antegrade. Yeah. Ram, the only thing I would add to that is that in a sort of strange way, I think the publication is actually evidence that doctors are already using this in creative ways that were not originally explored in the OLYMPUS trial. I think it's very validating, and I support what Jeff said, we expect to see more and more of this, and I think the publication simply gives you an indication of what doctors will do with this new medication. Okay, great. Can you just remind us what timeline you expect the uTRACT registry study to be on, and when you anticipate the potential publication of data from that study? I can comment to the timeline. We continue to recruit the investigators and get everything taken care of from an IRB standpoint. That's gonna continue through the remainder of the year. The data point, I'll let Liz comment, but it's really sort of once you hit a number that is meaningful from a number of patients, whether that's retreatment data, maintenance, urethral only, a lot of things are being looked at and studied in the registry. For my standpoint, it's really sort of when you get to that meaningful number of patients. Yeah, I mean, nothing really to add here. I think, you know, it's an ongoing registry, so to Jeff's point, we'll continue to mine the data. You know, we have certain queries and as, you know, as we feel like there's enough, you know, enough of a mass to be able to publish, we'll have an ongoing publication plan around the registry. It's not unreasonable to assume that in 2024 and possibly 2025, there would be useful information from the registry that could inform Jelmyto uptake, right? Oh, yeah, absolutely. Yeah, I mean, definitely by 2024. Yeah, sure. If not earlier, sure. No, absolutely. We'll continue, you know, like I said, I mean, Jeff commented, look, we wanna understand more about maintenance. We wanna understand more about retreatment. We wanna understand, you know, continue to understand how physicians are using it, to Mark's point. We will, as I said, have an ongoing stream of data coming out, and to your point, will inform, you know, the optimal way to use it in real world. Okay. Last quick question from me is with respect to UGN-102, can you just give us a sense of how much larger the target market size is for UGN-102 versus Jelmyto, and the extent to which you would be able to use physician awareness of Jelmyto to effectively give UGN-102 a running start, assuming that the ENVISION study data is positive and you receive timely regulatory approval? No, great question. You know, as we mentioned earlier, there's about 80,000 patients who have what we consider to be intermediate risk non-muscle invasive bladder cancer as compared to the 6,000-7,000 patients with low-grade UTUC, which is a challenge, right? We've always said all along that one of our key critical success factors for Jelmyto was patient identification. You don't have that issue, you know, or that challenge with UGN-102. Every doctor, as Mark commented about earlier in his prepared remarks, you know, see these patients. It's not a situation where you're only gonna see one or two of these patients a year. You know, they see them on an ongoing basis and very familiar. I do absolutely think what you said is that, you know, the usage of Jelmyto and, you know, for even between now and then, the continued uptake, the continued adoption by new doctors will absolutely give us a, a head start with UGN-102, plus taking into consideration that the big difference here is the ease of use of UGN-102. Most patients are really seen initially at the community level, and UGN-102 will be much easier, right, to be done in the clinic versus needing to go to a surgery center or a hospital where there is, you know, where you have the appropriate equipment. You know, we know there's a lot of anticipation for UGN-102, and absolutely what we've said all along is that Jelmyto, you know, is proof of concept around our RTGel. The biggest opportunity for us is obviously as we get into the larger patient population around bladder. Thank you. Thanks. Appreciate it. Thank you for your questions. Please stand by while we compile the Q&A roster. Our next question comes from the line of Paul Choi of Goldman Sachs. Your line is now open. Hi. Thanks for taking our questions. This is Roderick Kang for Paul. We have a couple of questions. The first one is what kind of factors in ENVISION study do you think that it could help the UGN-102 to incrementally improve upon the 65% CR rate in the phase II-B? I'm not sure I really understand your question, but we don't expect, frankly, that there's anything different, in, you know, in the expectation around those studies. I think the important thing to note is, you know, typically when you move to a larger phase III study, you actually, you know, lose a little bit in the efficacy. You know, our expectation is that, you know, the data will be meaningful. We feel like, you know, there's a lot of similarities between the two. From that standpoint, you know, we're excited to see the data. I don't, Mark, do you have anything to add, or I'm not sure if I misunderstood the question, Roderick? You understood it the way I did, and I think that it's important to remember that we're studying the same people that we studied in the phase II. As Liz pointed out, we expect, you know, within reason for the results to be directionally similar. Got it. Thanks for that. Just a follow-up question on that. Since the AUA presentations, has your sales force seen any change in the physician interest in Jelmyto? What would probably increase the uptake on the forward based on the feedback from your sales force? Yeah. Jeff? Yes, a short answer. It was hard to ignore all of the what we had going at AUA between the two presentations, the AUA guidelines coming out, the product theater. The AUA really reinforcing what we have been saying for four years in and around preserving kidney function and not removing the kidney in this low-grade space. Obviously to hear it from us is one thing, but to hear it from their colleagues, from urologists that, you know, basically says, you know, we should be doing everything to preserve the kidney, and obviously, Jelmyto is part, we're part of those guidelines. Super excited and, you know, obviously it'll be in waves. Some physicians that were there got it firsthand. Others that weren't able to attend will continue to hear the guideline updates from their local representatives. Got it. Just to confirm, your current cash runway is guided into 2024, right? That's correct. Okay. Got it. Thank you. Thanks, Roderick. Appreciate it. Thank you. Please stand by for our next question. Our next question comes from the line of Matthew Kaplan of Ladenburg Thalmann. Your line is now open. Thank you. Good morning. Congrats on the first quarter results. Liz, could you talk a little bit more about the seasonality that you're seeing for Jelmyto and what that means for the product? Yeah, absolutely. I'll actually ask Jeff to comment about that and happy to add any commentary at the end. Jeff? Sure. Hi, Matt. We see early on the beginning of the year, your typical patient co-pay resets. January is a PEP buildup, so we're building up patient enrollment forms. Then they have to get through the donut hole, and then we're seeing a strong start to Q2 as a result from the reset. Your Q3, there is some seasonality with regards to, you know, folks taking vacation, not wanting to go to the OR six times or the clinic six times. You see, again, sort of this PEP buildup in Q3 and hopeful continued strong Q4. you know, it's important for us to have that quarter, you know, Q3 quarter this year over Q3 quarter last year and continue to have that trend. We do think that the seasonality is as common with Part B drugs, with procedures in general. We do believe we'll continue to see that, particularly in the third quarter. All right. The only comment I'll make additionally, Matthew Kaplan, is, I think it's important to look at the difference between Q4 of 2022 and Q1 of 2023 versus last year. Point being the Q1 of 2022 was about a $3 million drop from Q4 of 2021, whereas this year was, you know, it was about a $1.5 million. We are seeing that gap close a little bit, and the same thing sort of happened if you remember last year. You know, basically Q3 was, you know, almost flat with Q2. While you didn't see the, you know, uptake quarter over quarter, you kind of saw, you know, a, you know, sort of a flatness. We expect that the difference in the quarter and seasonality will be, you know, muted to compare to where it had been in the past. While we do expect to continue to see that, we don't think it will be at the same level. Okay. That's really helpful. Thank you. As we're thinking about the summer, and the ENVISION and ATLAS readouts, can you give us a sense in terms of are you going to announce them at the same time or does one come before the other? Can you narrow the summer timing for us a little bit more as well? Yeah. I wish I could. You know, it's like I'm always saying, you know, like I wish the 12 months of follow-up from ENVISION that I can make those days go away. You know, that, you know, we're really sort of held by the time that it takes, you know, for the database lock, and it's really around durability. What I will tell you is that we're going to wait and do it all together, and the plan right now is to, you know, have, you know, have sort of a virtual event where we share the data. We will be limited to the amount of data we can share because we do wanna get it published, both in a publication as well as presented at a medical meeting. We will have both of those. You know, I would say, you know, it won't be July 1st, maybe toward the end of July or the 1st half of August. As soon as we have both sets of data, you know, we will wanna share that. The intention is to do it together, yeah, at this point. Okay. That's helpful. What type of read-through do you think the ATLAS duration of response will provide for what to expect for ENVISION? Yeah, I mean, you know, and Mark, you may wanna comment as well on this. You know, we expect it to be similar, right? The only difference. You know, Mark, why don't you just talk about maybe the differences between ENVISION and ATLAS and why we think that they'll be fairly similar. Sure. Thanks, Matt. As you I'm sure remember, the ATLAS trial includes patients that have both new and recurrent intermediate risk disease, which is similar to what we saw or what we studied in the phase II trial. ENVISION is limited to patients who have recurrent disease only. We don't think that from a biological or clinical perspective that actually matters. In our hands so far, patients with new and recurrent disease respond similarly to UGN-102. Our expectation is that ENVISION and ATLAS should look similar and that the ATLAS data should give us some indication as to what to expect from the ENVISION trial. All right. Thanks, Mark. Last question. As you complete the dose ranging monotherapy for UGN-301, what combinations with UGN-301 are you contemplating to initiate later this year? Mark, you wanna comment? Yeah, sure. As you know, we've studied in our preclinical models, the combination of the anti-CTLA-4 antibody with the UGN-201, which is our TLR7 agonist. That is certainly a potential candidate. We've obviously also thought long and hard about other potential, both immunomodulators and chemotherapeutics. Those are not off the table either, but a certainly plausible candidate would be UGN-201. Liz may wanna elaborate further on that. Yeah, I agree. I think we haven't at all decided, you know, exactly which one will be first, but, you know, we could do multiple ones. You know, we're sort of evaluating what we think is the best one. The TLR7 UGN-102, you know, potentially partnering with others that we know are interested in doing combinations as well. I think it all depends on how those conversations go and what, you know, what we sort of see as the one that makes sense and, you know, would wanna quickly do that, you know, hopefully again in partnership with others. Great. Thanks, guys. Thank you. Thanks, Matt. Thank you. Please stand by for our next question. Our next question comes from the line of Rohan Mathur from Oppenheimer. Your line is now open. Hey, guys. Rohan here, speaking on behalf of Leland Gershell. Just one question from me. For UGN-102, what do you think regulatory authorities are looking for when it comes to efficacy and durability in low-grade MIBC compared to high-grade? Where do you see 102 fitting in the current low-grade MIBC paradigm alongside surgical intervention and current disease management? Thank you. Yeah. Mark, why don't you start? Sure. In terms of what we think the regulators are looking for with respect to our phase III program for UGN-102, it's the totality of the clinical data and clinical meaningfulness of the outcome. That'll be a combination, obviously, of both the complete response rate and the durability of that response in complete responders. There's no number attached to that. Liz and I have previously said on multiple occasions that, you know, in line with what we observed in our phase II program, if, you know, about half of the patients achieve a complete response and half of those patients continue to maintain that response at 12 months follow-up, that would be clinically meaningful. That, you know, we need to see what the results are, obviously. Hopefully that gives you a sense of what we're at least thinking, but it will be the totality of the data. In terms of where this will fit into clinical practice, there's already a discussion going on in our peer review literature about chemoablation as a primary approach to patients with recurrent non-muscle invasive disease, which is a big population of patients who represent a real clinical opportunity, because these patients are, as Liz has already alluded to, treated by chronic surgical intervention, which in elderly populations is a disadvantageous approach, many think, including those who urologic. We think that there is a real opportunity for primary therapy to replace transurethral resection in some patients with recurrent disease. That's the group we're studying in the ENVISION trial. Then in terms of how this compares with high-grade disease, you know, high-grade disease is a totally different animal. The benchmarks and hurdles for approval are substantially different because of the nature of the disease. I'm not really sure, and Liz may wanna comment on this, that it's a fair comparison to make with the approach and the population we're studying. Yeah, I agree. It's probably not a fair comparison. The thing I will say is that when you hear and what do you see when you're looking at the competitive landscape, all of those drugs are being studied in high-grade disease. You know, as you're hearing more and more from the FDA about wanting more comparative studies or wanting longer studies, that's because there's now multiple products being studied and approved in the high-grade space. That's actually not the case in the low-grade space. We will be the only ones, and we're the only ones that are anywhere near, you know, being in a phase III. There's, you know, a couple of other, you know, that we hear about, but they're very early. You know, I think we're in a very different situation, and a, and position because we'll be the only alternative, you know, for these patients. I do think, you know, what we're seeing with Jelmyto, the whole idea, and we believe the biggest benefit for these patients, you know, is to, you know, have UGN-102 instead of having a TURBT. Just as we're seeing with Jelmyto, the use in addition to, you also may see that in real practice. These patients, you know, 75% of the patient population, when we talk about 80,000, 75% of those are the recurrent pool, so they're the prevalent pool, and they're, those patients are recurring. We really see that, you know, about 68% have two or more recurrences, and 25%, you know, a quarter of them have five or more recurrences. I think it's fair to say that, you know, the low-hanging fruit are these patients who are already going through these multiple recurrences and, you know, we expect to be able to, you know, access that entire population. Thank you. Thank you. Appreciate it. Thank you. Please stand by for our next question. Our next question comes from the line of Boris Peaker from TD Cowen. Your line is now open. Great. thanks for squeezing me in. first on the ENVISION data, can you comment if the FDA said specifically you could file on three months data or if they'd like to see longer term follow-up? What exactly is the hurdle for durability and follow-up from the regulatory perspectives? Yeah. Mark, you wanna comment? Yeah. We're not filing exclusively on the primary endpoint, which is the complete response rate at three months. The durability of that response, and we've targeted 12 months following the assessment of complete response as the durability window for our assessment, is key to the approval we think, and to demonstrate the value of the therapy compared to surgery. It's a combination both of the complete response rate and that durability of response. Liz may wanna elaborate also. Yeah, just gonna comment that the FDA made it very clear that durability is important. We agree. While it is a secondary endpoint, it's an important secondary endpoint. What we've talked about in the past is we'll file once we have 12 months of data on all patients in ENVISION. That will allow us to go to the FDA with all patients at 12 months, some patients obviously beyond that. That we did something similar to that with Jelmyto. We actually did a little bit earlier here. Again, we wanna make sure we have all patients at 12 months. Look, at the end of the day, I'll be honest with you, we're gonna see how the data plays out that we see this summer. You know, we'll start having conversations with the FDA as soon as possible. Depending on the level of data that that is, we'll talk about them, you know, how quickly can we get patients to have access to this medicine. Got it. Then maybe on ATLAS. Do you think the FDA will wanna review the ATLAS study as well as part of the approval process and considering the fact that- Ab-absolutely ... more patients in ATLAS than in ENVISION. If that's the case, what do you think you need to show in ATLAS in parallel for the filing? Yeah. I think ATLAS, and Mark may wanna comment as well, is mostly gonna be around safety. Because the data, as you know, we stopped the study, there, you know, the 280 patients, remember, you know, about half of those will be UGN-102, but about half of those will be TURBT. You know, there'll be data, particularly around the safety of it. You won't be able to make comparisons. The FDA won't be able to make comparisons because it wasn't powered to do so. We expect that the FDA is gonna be mostly interested in the safety from that study. Great. Thank you very much for taking my questions. Thanks, Boris. Thank you. At this time, I see no more questions in the queue. I would like to now turn it back to Liz Barrett for closing remarks. Thanks, thanks everybody. I mean, as you can see, it's an exciting time for us in 2023. I think I say every year it's a pivotal year for us. We've got a lot of catalysts this year. We need to continue, we will continue to execute on Jelmyto. We feel like we have a lot of, you know, incremental data associated with Jelmyto and really showing how it's used. We expect to continue to see adoption. I will comment that so far in Q2, I know, you know, we talked about Q1. We feel good about Q2 as well. You know, things are, you know, continue to advance for Jelmyto. In addition to that, I think everybody's excited, and we hear a lot about UGN-102 and excited to see the data, you know, catalyst as coming up. You know, we look forward to staying in touch and, you know, please let us know if you have any additional questions. As always, thanks for your support and interest in our company. You can disconnect now, Operator. Thank you for participation in today's conference. This concludes the program. You may disconnect.