Welcome to day two of the 2026 Bank of America Healthcare Conference. My name is Alec Stranahan. I cover biotech at Bank of America, and welcome to this session with Nuvation Bio. Very pleased to introduce to my left, David Hung, Chief Executive Officer, and Philippe Sauvage, the Chief Financial Officer of Nuvation. Thanks for being here, guys. Thanks for having us. Yeah. Looking forward to our conversation here. I guess maybe just jumping right in, you've reported three consecutive quarters of accelerating and growing new patient starts. You know, net product revenue is beginning to catch up with that. I guess, how has the launch been tracking with sort of your expectations, and what are sort of the near-term catalysts to look out for, for continuing the growth? I think the launch has gone, you know, very well. We've said that if you look at our new patient starts, so far in our launch we've had more new patient starts than both previous TKIs combined. We're pretty excited about that. The real name of the game is to move to the first line setting, and I think this is something that's maybe an unusual concept in oncology, 'cause very few oncology drugs have durations of response in the range of what we've seen with IBTROZI. We mentioned previously having a DOR of over four years is highly unusual, in fact, in all of oncology. If you look at any drug in the history of oncology in any indication, there's actually only one drug that actually has a response rate even approaching ours with a PFS that's longer than ours. That's lorlatinib. We think that having a 90% response rate in the first line setting and over four-year duration of response sets up a very interesting dynamic for this drug commercially. As you start to get first line patients and you expect them to stay on therapy for years, you start to see revenue stacking, which is not very commonly seen with most oncology drugs because their durations of response are so short. We're just starting to see that now. We've gone from about 30% first line patients in our first quarter of launch to over 40% in our second quarter, and now over 50% in our third quarter. As we start to see that dynamic increase, we think that the durations of response should be significantly longer with additional follow-up, and we're really looking forward to seeing how that grows our revenue, and we're pretty excited about that. Great. Well, maybe on that point, I think for the first time this quarter, like you said, more than half of new starts for TKI and naive. I guess, what's sort of driving the acceleration? Is it physician confidence with the clinical data? Is it, maybe, increased testing in the community setting? What are sort of the tailwinds for that? I think if there was a shortcoming of AnHeart when we, you know, before we acquired the company, it was that they had a relatively limited U.S. presence. They did two pivotal studies. TRUST-I was an all-Chinese study. TRUST-II was a global study, but that included U.S., Europe, Canada, other Western sites. If you look at the actual U.S. experience, it was relatively limited. Most physicians, when they're unfamiliar with the drug, will start off in late line settings where there are really no alternatives to get familiar with the drug, and that's what we saw. If you look at our first quarter, we had primarily third line or later patients. When you see very late patients, they stay on drug for a very short period. Some of these third, fourth line patients will last, you know, a month or two. They drop off very quickly, which is why you don't really see revenue stacking for late line patients. As you move from now from late line patients to early line patients, not only do you not get the same level of dropouts that you see in late line patients, but you now start to see very durable treatment durations, and that starts to really change your revenue. I think what's happened in this launch is, as expected, we were primarily used in the very late line setting, third, fourth line plus. When we started in the first quarter, that already came down the second quarter. In the third quarter, we're now seeing now more than half of our starts in the first line setting. Correspondingly, that late line use has dropped considerably, and we expect that to continue. I also think that there is just more familiarity with ROS1. I think that, you know, there were three previous TKIs in the ROS1 space. Durability and response rates like IBTROZI's have not previously been seen. When physicians see that profile, I think it's impressive, and I think that for those who are not as familiar with ROS1, it's hard to ignore any new product with a profile like that. You know, when you have a profile of a drug, even though the first gens might have a duration of response of a year and a half, it's not four-plus years. I think that seeing a new drug that has a 90% response rate and a four-plus year duration of response is hard to ignore. I think what's happening in the market is that physicians are getting comfortable with the drug, having started in the later line patients, even seeing it work there, but now are moving it to the first line. Secondly, I think just the appreciation that this efficacy profile is pretty unique. I think is causing physicians to adopt it more rapidly than we might have thought. Okay. It's kind of a build it and they will come. I think so. Yeah. I guess there was some foundation laid by the prior ROS1s. Is that, what have been the benefits of that? Is it, you know, adoption of ROS1 testing at academic centers? How have you been. I think that the whole lung cancer space has shown the utility of finding precision oncology mutations because lung cancer in 20 years has moved from one of the worst, most untreatable cancers to now maybe the most treatable cancer on the planet. If you look at EGFR, ALK, ROS, RET, these are mutations where the survival with precision oncology drugs is dramatically different from what used to be standard of care IO chemo. I think that that's a rising tide that's floating all boats. I think the stage has been well set for IBTROZI because if you look at our the predecessor to IBTROZI, repotrectinib, even though the ORR and the DOR of repotrectinib was significantly better than first generation agents like crizotinib or entrectinib, the tolerability profile left much to be desired. If you look at the discontinuation rate of repotrectinib, it was pretty high due to CNS toxicity. I think that set a stage for what to look for for physicians and seeing now an efficacy profile that now shows a 90% response rate and more than four-year PFS, but coupled with really, really tolerable profile, I think has led to the adoption of IBTROZI the way it has been adopted in the last three quarters. Yeah. Yeah. Especially I imagine on the durability piece for like an extra year on the PFS is very meaningful. Yeah. If you look at all marketing studies, the single most important attribute for a drug in terms of what physicians and patients look for when they select a drug is actually durability of response. 'Cause once you fail a drug, you're not going to do nearly as well. You're gonna have a lot of other issues. Having a drug that works a long time is the single most important thing that patients and doctors look for when they pick a drug, and we think it's appropriate that they're picking IBTROZI, and that's what we're seeing. Okay. Maybe you can just speak to the intracranial response rate. I think it was 66% versus 45% for competitors. I guess, how does this sort of feed into the CNS NCCN guideline addition you mentioned? Yes, that's a great point. We just got listed on NCCN guidelines for CNS control. I think that's because the response rate of IBTROZI in the brain is outstanding. It's, you know, as you mentioned, 66% intracranial response rate in the second-line setting. ROS1 lung cancer is a particularly aggressive disease because, number one, it starts in the brain 36% of the time. In another 50%, if patients progress in the brain as the first site of disease progression. Once you have CNS disease, you don't do nearly as well, as brain tumors are just really, really hard to treat. The fact that we have such a durability in the first line setting suggests that we protect the brain for a really, really long time. That DOR of over four years suggests that we control CNS development of metastases, which we think is a really, really important attribute. Even when they do get it in the second line setting, 2/3 of the time, they still have responses to IBTROZI, which is really heartening. There isn't any other ROS1 TKI that has a published CNS response rate close to our response rate, as you mentioned. We think that it's appropriate that NCCN lists us as an agent for CNS control because, you know, because no one has been able to match our CNS response rates. We think that our durability in both the first and second line setting speaks to that. Does that allow for any unique aspects in terms of reimbursement being on the guidelines? Yeah, we do. We've had really good experience with reimbursement with IBTROZI so far. You know, Philippe can talk a little bit more about how we decide to price it and all that. I think that, you know, overall, I would say that the data are so compelling, it's really hard to stop it, this drug, because there is no other agent that has shown a response rate or durability anywhere near the ballpark of IBTROZI. Maybe Philippe, if you wanna talk about gross to net. Yeah, I mean, to David's point, it was really important for us to make sure that patients could access IBTROZI in the first line because there is no comparison between the experience of a patient that goes on our drug and then on IBTROZI or goes straight on IBTROZI, you know, exactly the point that David was making. In terms of discussion with payers and that was really something important to us to make sure that there was access. Our gross to net is pretty has been increasing a little bit in the first quarter, that's mostly driven by phenomena that have nothing to do with general reimbursement debate. It's driven by 340B use, which is typically something that goes up when a drug is launched. It basically takes some time from hospital to get the drug on their 340B listing, and so your 340B use just drops at the beginning, and then it will stabilize. That's what we think we're gonna see. The other thing is that we did a price increase like many company does. When you do that in a period that until the end of last year was low inflation, you get some additional rebates in 340B and Medicaid. Again, drives your gross to net up. Nothing there which is really different from what we were expecting at launch. The success, to David's point, was really to get this broad access to patients because that's what we wanted in a market that was very dormant, we felt, before us. Really being there, being accessible, giving to doctors and patients the possibility to use IBTROZI in first line where it is the most impactful was what we wanted to achieve. It does sound like that pricing dynamic that you observed in 1Q should stabilize. Yes. Sort of on the course of the year. Yeah. Yeah. Okay. I wanna ask on safusidenib. You recently regained, or you gained the rights from Daiichi Sankyo. Maybe just talk about what gets you excited about this asset. I think it's first stop is IDH1-mutant glioma. What's sort of the unmet need here, and, you know, how do you plan to push this forward? We are really excited about this program because we think our data are unprecedented. If you look at the only drug approved in glioma, and I divide glioma into a four-piece pie. The only drug on the market for glioma, vorasidenib, is approved in one of the four pieces of that pie. It's only in low risk, low-grade glioma. If you In spite of their response rate of only 11% in that population and a progression rate of 41% at two years in low risk, low-grade glioma, in their first year of sales, they have generated almost $1 billion of revenue. Their revenue for the last quarter was $312 million, which is just incredible for a first-year launch. That just speaks to how large the opportunity is. If you look at safusidenib's data in the same population as vorasidenib's low risk, low grade, our response rate was 44%. Four times higher than that. At two years, instead of a 41% progression rate, our progression rate was 12%. Even beyond that, if you look at the high-risk population, which is half of glioma patients, the high grade, high-grade patients, and that's divided to high risk and low risk. Vorasidenib's response rate there is 0%. Ours is still 17%, but a third of those response were complete responses, including a GBM that's been gone for three and a half years and another high-grade glioma that's been gone for about two years. We're seeing significant responses in the high-grade population, which vorasidenib doesn't have, as well as responses in the low-grade population that we think are superior to voro. We think that safusidenib's is good for the entire pie, all four pieces of that pie. We're doing now a number of pivotal studies to address that. We think this is an extremely large unmet need. As good as vorasidenib's data are compared to what was previously available, we think that there's still a lot of room for improvement and are really excited about this asset. We acquired worldwide rights in the last rights from Japan because we just think this is such an incredible opportunity, and we want to, you know, maximize the potential of that. Okay. Just in terms of upcoming data timing and, you know, path to approval, is it accelerated approval in some of these? So. Types on the data? We're doing a number of studies. We have a pivotal study called SIGMA. It's a progression-free survival study. As a result, it doesn't read out till 2029. We are also starting pivotal studies that are hopefully gonna be much shorter than that. We're starting a grade three oligodendroglioma study, which is a response rate study. We're gonna have a significant number of patients enrolled this year, and we're gonna complete it by next year. If we see a significant response rate there, anything north of 20%, we think that warrants a discussion with FDA on potential accelerator approval. We're also looking at other ways to get safusidenib developed in the vorasidenib space, the low-risk, low-grade glioma space. We're gonna be announcing plans on that later this year. We think that, you know, those are much shorter term opportunities to create value with safusidenib. Great. Maybe just last question on the cash runway. I think you ended 1Q with just over $500 million in cash. How does this help you support the SIGMA study and also leave room for, you know, sort of development out of the pipeline? Well, from our perspective, it really helps us to support everything. Like we've said multiple times that we have enough cash to get us to profitability, to cash flow positivity with the launch of IBTROZI. We're very confident about that and very confident about the future and our ability to invest behind all great assets, being SAFU or antibody-drug conjugate program. Okay. Very good. Well, with that, I think we're out of time. David, Philippe, thank you so much for the conversation. Thanks for being with us. Thank you for having us. Thank you. Going. Thanks for joining the session with UroGen Pharma. My name is Alec Stranahan. I cover SMid-Cap Biotech here at Bank of America, and I have the pleasure of introducing Liz Barrett, the President and CEO of UroGen. Thanks for being here, Liz. Oh, thanks for having us. Yeah, looking forward to the discussion. Maybe since it's a 15-minute one, we can just jump right in. Please. You reported, 1Q ZUSDURI revenue of about $30 million. That's more than 100% quarter-over-quarter growth. Obviously, still early days in. Yeah. in the launch, you know, maybe you can just walk us through how that launch has been tracking versus your internal metrics. Look, we're very excited about the results from Q1, more excited about even more patients having access to the drug going forward. You know, we talked often about the J-code, and I think some of us, including myself, it wasn't expecting it to be as hard as it was prior to getting the permanent J-code. You know, practices are really concerned about reimbursement. We absolutely saw the inflection as soon as we got that J-code. We started seeing it in January. By February, we had already surpassed JELMYTO in doses, we just continued to go from there. Really pleased with where we are, you know, looking at sort of our top 250 accounts, looking at penetration where we are. Importantly, what we're really seeing is some doctors who adopt this for most of their patients, and that's, I think, something that we will look forward to. They really buy into the new approach of treating these patients differently, and we're seeing them, you know, treat patients across the continuum of care. So it's a very exciting time for us, as you can imagine. We expect to continue to see linear growth, you know, quarter over quarter for the rest of 2026 and into 2027. Again, very exciting time. Great. I imagine that the early repeat adoption is only a positive speaking to the profile for ZUSDURI. Yes, absolutely. You know, a lot of physicians will say, "I'm gonna try it on one patient, gonna see how it goes, make sure I get reimbursed." When you see the repeat prescriber, you know that not only did they have a good experience, but the patient had a positive experience as well. We're hearing, of course, a lot of it anecdotal, you know, feedback, but hearing a lot of physicians even surprised sometimes at getting a CR in some very, very difficult to treat patients. Okay. You mentioned the J-code as being kind of maybe watershed's not the right term, but it's definitely it unlocks a door for the rollout. Do you see this as benefiting, you know, the academic setting or the community setting? I think you've said that you're approaching maybe a 50/50 hospital to community mix now, which is up from 60/40, I think, in 4Q. How does the community adoption ramp? I know that this is maybe, you know, 70% or so of the. Right. Total market. Yeah, absolutely. I mean, most patients, it's particularly with the low grade, non-muscle invasive bladder cancer seen in the community. Getting to the community practice, getting the community practice to adopt is very important. Those were the physicians that were very gun shy with the J-code. You know, the academic centers, you have the P&T committee you have to go through, so there, you know, there are some barriers there. They don't look at it from a financial standpoint as much as, you know, community practices do because if they just don't get reimbursed for one patient, it's a big deal. Now that we have reimbursement, but more importantly, that it fits into the way that they practice. Having intravesical therapy, they're used to intravesical therapy. They do it in other ways. It really fits into their practice. It fits into the way that they treat patients, and it's economically beneficial for them. Once they get, again, over that hump, you'll start to see more and more communities. I don't think even though 70% of patients are seen there, I expect that they ultimately 65% of their revenue will come from the community practices. Right. From a patient convenience perspective, you wanna treat them where they are. Sure. Right. Absolutely. Yeah. The doctor also doesn't wanna lose the patient, so they don't wanna send them to the hospital. They wanna keep that patient. The way they do that is by treating them in their office. That makes sense. I guess when you think about the total addressable market, I think there's some publications out there that estimate maybe, you know, 85,000 annual patients roughly, in this setting. You mentioned, you know, the physician feedback and getting CRs in patients that, you know, even the treating physician didn't think that, you know, they'd be able to get to that point. Do you sort of see this addressable market expanding, or is that more of like a percentage applicable within that? I think it's more of a percentage applicable. Because again, like what typically happens in oncology drugs, you always use the new drug in your hardest patient first. Because they, unfortunately, have gone through a lot of other treatments and haven't had much success. That's, I think, why we're seeing some of these. It's very, it's very, for me, heartwarming to hear about these patients, again, that have had such a difficult time for many, many years, then they come, they do six weekly doses. They can get up and go home after. There's no you know, real barrier to them going about their daily life, then they come back, they've gotten a complete response. Both from a patient perspective and a physician perspective, that's what has to happen for a doctor to further adopt it, they'll move it up in the continuum. In our study, most of the patients had only had one or two recurrences. We expect that as the, you know, as the drug gets adopted more broadly, you'll move up in the continuum of care. Okay. We've talked about kind of the demand components from the patient and then the prescriber. How is payer access and reimbursements trended? The good news is we have 95% open access for reimbursement. Knock on wood, we haven't had any denials yet. We're really, really pleased that everyone has been able to get reimbursed. You know, some payers take longer than others, sometimes the paperwork's. Once you get through all of that, we've had very positive reimbursement. As again, as physicians start to see that, the practices start to see that, we have a team that works with practices if there are issues to ensure. We have field reimbursement managers, we have a hub to ensure that they get all of the service that they need to help them, you know, again, remove any barrier that they might have for, you know, to be able to use this in patients. We are starting to also hear about patients walking in and asking the doctor for the drug, and we've just started to do more engagement with patients. Believing that will be a big driver for us going forward. Okay, that's great. I imagine when you set the price, you had already, you know, approached in terms of cost benefit with all these. Oh, absolutely. Yeah. No, absolutely. With our price, you know, it was particularly when you compare it to the high-grade, you know, we are, you know, our drug is for the low-grade patients, so we priced appropriately for that market as we have the, you know, the low-grade IR. We feel really good about our pricing, feel really good about reimbursement, and really it's just a matter of physicians trying it and getting a positive experience. Okay. Whenever we think about new oncology launches, we think about the on rate, but also the duration on therapy. This morning I think you had a press release talking about 36 month follow-up. Yes. VISION trial. I think it was 64.5% of patients had a 36 month duration of response. Maybe you can just speak to, you know, how this evolving data set is, you know, favorable or in your view, and how this kind of feeds into your communication with prescribers. Well, we were thrilled to be able to share that data. What it says, and we have to keep in mind that the low grade intermediate risk patient is all about recurrence. These patients recur. In our own ATLAS study, the median time to recurrence in the TURBT alone arm was nine months. We now are at past 36 months, and we still haven't reached the median. With six weekly doses of ZUSDURI, you know, we believe that the median will be close to where we are with JELMYTO, which is about four years. Wow. If you think about it again from a patient perspective, that's why we often talk about not only recurrence free, but treatment free living because they can do the six doses. Again, the median hasn't been reached and it's been over 36 months. We just recently got that data. I'm very thrilled to see the durability of response because that's really important, you know, for patients and patient care. Yeah. Yeah, I imagine so. This weekend is AUA. Yes. I imagine you guys are gonna fly out to D.C. right after this. We are. Are you planning to host, you know, any panels? I guess, how are you know, trying to use the conference to increase awareness? Obviously there's already great awareness of ZUSDURI, but anything that we should expect coming up at AUA? It's a great opportunity to have a lot of key stakeholders in one place at one time. It's a busy time. We have not only We're doing ad boards across our portfolio, but we are hosting an event on Sunday morning, specifically around ZUSDURI. Dr. Schoenberg, our Chief Medical Officer, will interview physicians who have used it. We also were really thrilled that we're also going to have a patient who's flying out from California, and we'll be able to talk to her as well, and that will be webcast. We're excited about that. Dr. Schoenberg will also present on Monday morning our 24-month data, which is kind of interesting 'cause now we have 36 months, so he'll be able to put a plug in for our 36-month data. You know, we importantly wanna spend the time making sure that any physician who has questions or those that are thinking about ZUSDURI or JELMYTO but maybe aren't quite over the hump, it's a good opportunity for people like myself and Mark and Mike, our chief development officer, to be able to engage one-on-one with these doctors. I myself have, you know, a lot of meetings over the next, over the three days, but we're really trying to get to ensuring that we understand if there are any barriers to using our medicines, what are they, and what can we do to overcome them. We wanna make sure that every patient that can benefit from our medicines has the opportunity to benefit. Great. Yeah, we'll definitely be tuning in to the webcast. That's great. Thank you. Looking forward to that. I do want to ask about your pipeline. Yes. I'm sure you get a lot of focus on ZUSDURI, but I think we should shine a light on, you know, you've got NUV-1511, which is your next generation mitomycin formulation, streamlined reconstitution process patents out into the 2040s. Yes. Maybe you can just speak at a high level to what you're seeing in the phase III UTOPIA trial as well. Yeah. What we're seeing in the UTOPIA trial is very consistent data to what we see in ZUSDURI, and that's what's most important, right? When we worked with the FDA initially, they said we couldn't do a bridging study. You actually have to do a patient study because the drug is a different drug. Luckily, what we've seen so far has been very consistent, and that's what we wanna see. The other good news about having the patent extended is we have a lot of aspirations for moving UGN-103 into other patient populations with bladder cancer. We're moving very quickly into high grade. We're also going to do an adjuvant study, we're looking at being able to cover patients, again, not just in the IR space that we have today, but also in other spaces as well. UGN-104 for UTUC, upper tract, same thing. You know, we expect a full finish enrollment this year. The thing I think what we're most excited about is our oncolytic virus. It's early, and we actually are going in first in human this year, but we really believe based on the preclinical data and the experiments that we've been doing, that we have a truly differentiated and potentially best-in-class molecule. That's exciting for us because not just will it be best in class in bladder cancer, but it gives our company the opportunity to actually move outside of bladder cancer and outside of urothelial cancers, because that oncolytic virus can work across many cancers. Okay. Very good. Maybe talking about the expansion opportunity beyond low-grade for 103. Yes. I guess, how are you thinking about moving up the spectrum and, you know, adding different sleeves of patients within NMIBC? Yeah, I think, you know, obviously there's a lot. It's a fairly crowded market, but unfortunately these patients aren't cured. There's no drug that's perfect, right? We actually believe that given the results that we've seen in the low-grade intermediate-risk patient, that we believe it will also work very well in the high-grade patient. Now the difference is it will be an adjuvant. The difference, it will be maintenance therapy because these patients are at a higher risk for mortality. They're at a higher risk for moving to metastatic disease. We would treat those patients longer. We definitely believe, and we have seen so far that the, you know, that it works with bladder cancer, and we expect it to work across the spectrum. We're finalizing right now exactly what the patient population will look like and what our control will look like, because it will be a comparative study. We could go into BCG naive and a BCG unresponsive, you know, those, you know. A lot of different spaces to go into there, and still a very high unmet need despite the fact that others are in that space. Okay. I guess you have some experience from the ATLAS study, is that right? The ATLAS study was also in low-grade IR, you know, as well. It was in that study as well. Okay. So, At least comparing against. Exactly. The TURBT. The TURBT. Yes, absolutely. Okay. Absolutely. Maybe we can talk about 501 too. Sure. How is this maybe symbolic of how you imagine the company growing, you know, beyond sort of your current? Well, you know, I think that everyone, you know, UroGen has been around, and we've had JELMYTO and we've had ZUSDURI, right? That's been kind of the focus externally, but, and internally for a long time. We have aspirations to be, you know, a leader in urothelial and specialty cancers, and we believe 501 gives us that opportunity. Again, it's a oncolytic virus that's differentiated. It not only works with immune system, but it has direct cancer kill. We believe we actually can put in our gel and maybe even see better efficacy. That we know based off of the work that IconOvir did before we acquired it, that it works in other cancers as well. That's why we believe that 501 is the catalyst that will bring our company from just being a leader in urothelial cancers to expanding beyond and diversifying outside of urothelial cancers. Okay. Very good. Lots of exciting things going on. Yes. At UroGen. Unfortunately we'll have to leave it there, so please join me in thanking Liz for the great conversation. Thank you, Alec. I appreciate it.