My name is Cory Kasimov, one of the senior biotech analysts here at Evercore ISI, and it's my pleasure to host our next discussion with Nuvation Bio and the company's CEO, David Hung, and CFO, Philippe Sauvage. Thank you both for being here today. Really appreciate it. You know, to begin, it's really hard to believe we're already in December, but given the timing, I'd love to start the discussion by asking you to sort of reflect back on 2025 and what's been clearly a very big year for you. Talk about some of the company's accomplishments, both the obvious ones and maybe some of the more nuanced ones as well. I think the most, probably the most transformative event of 2025 was our acquisition of AnHeart and getting the FDA approval and launching Ibtrozi. I think those have really changed, you know, the company's profile. We're now a commercial stage company. Our first full quarter of sales was very robust. The recent data we just presented recently at Jefferies on the Safusidenib low-grade data, I think, was also a big accomplishment, showing the PFS that we demonstrated and the response rate, I think, makes that a really exciting program. Great. Let's not surprisingly start with Ibtrozi, the recently approved ROS1 inhibitor in lung cancer. Maybe quickly elaborate or just elaborate to the extent you think is necessary on the data observed from the Truist I and II trials and how it differentiates the product within the landscape. I think, you know, a couple of things are notable about this disease. First of all, ROS1 is a very aggressive form of lung cancer, so patients tend to present with brain metastases more than a third of the time and progress in the brain more than 50% of the time. You need to intervene as early as possible, and intracranial response rate is really important. If you look at our data compared to, you know, other earlier generation TKIs, crizotinib and entretinib response rates are about 70%, PFS about a year and a half. Repotretinib response rate is about almost 80%, and PFS is double to 36 months in the first line setting. What we just announced relatively recently is that our latest data show now our response rate around 90% and a PFS now at 40 months, our duration of response and PFS at 50 months, sorry, at 50 months, so more than four years. That is really not been seen very often in all of oncology. The only drug that we are aware of with a PFS longer than that is lorlatinib in the ALK space, but their response rate is lower, 76%. If you look at our combination of response rate and duration of response, it is really one of the highest ever seen with any drug in any cancer. We think that makes it a really, really exciting drug for patients and for physicians. If you look at even the second line response rates at 56% systemic response rate and an intracranial response rate of 66%, that again is at the top of the heap. We think that from an efficacy standpoint, that drug has not been matched by any other agents in the space. If you look at tolerability, we think the profile is also very compelling. If you look at our top six adverse events, LFT elevations, nausea, vomiting, diarrhea, dizziness, even if you add up all those six and look at the number of patients who discontinued drug for any of those top six adverse events, out of 337 patients, it was one patient. Discontinuation rate of 0.3% for the top six adverse events. That is important because the less discontinuations and the longer that patients are on drug, you really start to be able to invoke this revenue stacking that we expect to see with this drug. With a 50-month duration of response and a low dropout rate, you can expect those revenues to stack to an excess of $4 billion a year just by DNA testing, and we think over $5 billion a year with RNA testing. We think that makes it a very exciting opportunity. Yeah, absolutely. We're going to get into a bunch of the things you just mentioned. Maybe just kind of the initial start this product is off to. You recently posted very strong numbers for Q3, I believe it was 204 patient starts. Can you kind of talk about the evolution of demand as you kind of get into year-end and going into next year and, you know, how much of a patient bolus was involved in this encouraging start? First of all, just to put this in context, if you look at repotretinib's first full quarter of sales, they had 34 patient starts. We had 204, so six times the repo start number. What was striking about that 204 starts is that we had no patients from the clinical trial. In the first few weeks, we had, I think, six patients from the EAP. Really virtually no bolus of patients at all. These are just completely new patients. I think that speaks to the fact that the market really is there and there are a lot of patients that need a drug like this. We're excited about that. I think that, you know, we anticipate growth going forward. Most of our patient starts were in the academic centers. Community centers tend to be a little slower to adopt, but we do expect most of the growth going forward to be from the community centers because the academic centers are all very aware of ROS1, and I think that's where most of our starts have been. We think community will come online in the next few quarters, and we think that will be a significant growth area. Okay. I want to ask about the NCCN guidelines. Can obviously have a pretty impactful element adds to a product launch. Ibtrozi recently added, like, how do you, how are you anticipating this impacts the market? I think, you know, that was a very fortuitous event. We certainly did not anticipate that. On January seven of this year, the NCCN changed their guidelines, where previously the 2024 guidelines said you had two choices for ROS1. You could either finish your IO chemo or give a ROS1 agent. On January seven, they changed that. Now the first option is eliminated. Not only can you not give IO chemo, it is actually contraindicated. You have to give a ROS1 agent. In fact, if you are on an IO chemo regimen, you need to stop that and start a ROS1 regimen. That is a great development for us. I think another tailwind. We do think that there has been a lot of IO chemo use in the community. If you look at the progression-free survival of IO chemo at six to 12 months, you know, as I said, our DOR is 50 months. So it's really, really hard to justify giving anything other than a ROS1 agent. What goes just even before we were on the market, the guidelines already started to change behaviors. Like we saw an uptake of TKI in ROS1 by about 20% even before we launched. We think this tailwind has already proven it's going to happen, right? It's going to transform behavior in the right way for patients. What drove it from a first-line recommendation to a contraindication? I think that if you look at the first generation TKIs, as I mentioned, if you look at entretinib's PFS, it was 16 months. IO chemo is 6-12 months. One could argue that if you're at the upper limit of IO chemo, 12 months, 12 months and 16 months isn't that different. One could argue that perhaps that's still okay. Now with 50 months and repotretinib's 36 months, 36 months is 20 months longer than entretinib's PFS. It's very hard to now justify that. I think that the NCCN guidelines were really changed because of repotretinib's PFS. We hadn't even gotten approval at that time. I think because repotretinib showed 20 months more PFS than entretinib, it was hard to justify anything other than a ROS1 agent for a ROS1 disease. Right. Okay. All right. Obviously you have very, very strong data. You've put up a good start from a numbers point of view. The guidelines are helping you out. The answer to this question is kind of obvious, but I'm curious about the evolution of physician feedback. Now that docs, like they can, I'm sure, appreciate everything you mentioned, but now that they have hands-on experience, how are you seeing the feedback from the field evolve? The feedback's been really great. There was a great article by Jeff Liu, one of our top prescribers, and he talks about how he believes Ibtrozi is now the standard of care. I believe his feelings are echoed by quite a few KOLs we've spoken to, and it's reflected in the 204 scripts we got in the first quarter. The feedback we're getting is really, really positive. It's hard to argue with a 50-month DOR and a 90% response rate. I think that's clear. I think what's been surprising to a lot of KOLs is the tolerability. I think that just having not as much experience because our first trial was done in China and the second trial was done in the United States, there were still a lot of academic KOLs who didn't have hands-on experience with taletrectinib. Now that they have, as I mentioned, the discontinuation rates for this drug are so low that I do not think people expected that level of tolerability with the kind of efficacy we are seeing. I think overall people have been very pleasantly surprised by the profile of the drug. Right. Okay. You talked about sort of the DNA to RNA shift and how that will impact stacking over time. Can you maybe speak a little bit more on, you know, DNA-based testing to RNA-based testing, that expansion of the opportunity? Yeah. Because ROS1 is a fusion, RNA is more effective at finding that fusion than DNA, about 30% more sensitive. Right now there are about 3,000 patients a year in the U.S. alone by DNA testing. That should increase to about 4,000 patients a year by RNA testing. If you multiply 4,000 times the current price of Ibtrozi, $350,000 a year, you know, that's well over a billion dollars a year. Now stack that for more than four years, you can see that by the fifth year you're getting above $5 billion a year in sales. Okay. That makes sense. How commonplace is the RNA testing today? It was approved about a year ago, a little over a year ago, but it takes a while to get anything adopted into standard of care. I think that it's going to probably become standard of care over the next, my guess is one to two years. Okay. Is that something your field force speaks to as well when they're talking? We do. We've already, so we're already seeing it in academic centers. Of course, academic centers are the first to adopt. We're already seeing that in academic centers. Again, in the community where the most patients are, still they'll take some education. Okay. All right. Have to move on to IDH1. I guess, you know, with your pivotal trial now underway for Safusidenib for high-grade glioma, can you talk about the anticipated differentiation here as you see it and then the potential of this opportunity as well? The only other drug approved in the treatment of glioma today is vorasidenib, and that's only in low-grade glioma. Vorasidenib was approved based on an 11% response rate. At two years, you know, 58% of patients had not progressed. They had about a 41-42% progression rate at two years. The data that we just presented at Jefferies showed that instead of an 11% response rate in low-grade glioma, our response rate is 44%. Four times the vorasidenib response rate. At two years, instead of 42% of patients progressing, we had 12. Twelve percent progression at two years just starts to show you how long that might go out. We believe that those data are hands down the best data ever generated in low-grade glioma. On top of that, we've also shown high-grade data that's pretty differentiated. Vorasidenib's high-grade response rate is zero. That is why they are not approved in high-grade and they are not moving that forward. Our high-grade response rate was 17%, but interestingly, a third of those responses were complete responses, which means that tumor is gone and very durable complete responses. One of our GBMs has been gone for three and a half years. Oligodendroglioma gone for about two years. These are things that you just do not see in high-grade glioma. We are also very excited about our adverse event profile, not only because it is well tolerated, almost all our AEs are grade one and two, but because the AEs that we are seeing are very immune-like in nature, unlike vorasidenib. If you look at our top eight AEs, five of them are immune-related, like vitiligo-like skin changes or arthralgia-like rheumatoid arthritis. That suggests to us that our drug has an immune mechanism of action, which is different from vorasidenib. We think that if you look at all our responses, which take about 6 to 12 months to kick in, and when they do kick in, last for years, I think that's suggestive of an IO-type profile. We think that that makes us potentially a really exciting drug. In fact, we're even exploring right now whether or not this is a drug that could work in non-IDH1 mutated tumors. To begin with, we are in IDH1, so we've now kicked off a pivotal study that includes both high-grade patients as well as low-grade patients. You know, our high-grade patients will certainly give us a high-grade label, but our low-grade patients that we've enrolled will include high-risk features. We believe that that will make an argument as to what, and these are patients that are not covered in the vorasidenib label, and we think will give us access to both low-grade patients in addition to high-grade. Is the trial stratified wherein you could get approval for one or the other, or is it the entire thing? We haven't really talked about our statistical analysis plan, but the whole idea is to generate data in both high-grade and low-grade glioma. Okay. Data from that trial, my understanding is for by 2029. You know, it's hard to know exactly how long it'll take. It depends on really how, you know, how the placebo arm progresses and how fast we enroll the study. We've guided that the latest it'll read out is 2029. You know, could it be earlier? Possibly. The other thing is that, you know, the FDA is changing, and a lot of things in this space are changing, especially imaging. The image criteria for neurooncology has shifted from RANO criteria to RANO 2.0 recently. There's also been a shift from 2D imaging to 3D imaging. Part of the FDA's reluctance to give us response rate as a primary endpoint is because based on old imaging, there was variable enough that the FDA was more comfortable with PFS as a primary endpoint. That's why this study start is a primary endpoint of PFS. It doesn't mean that that's the way it's going to stay. This field is evolving. If over the next year or two or three, the FDA decides that the imaging techniques now are robust enough that OR could be a primary endpoint, that would shorten the trial dramatically. You know, we're just kind of following and keeping our discussions with the FDA and seeing. We do have imaging for this study as an endpoint. Whether or not it can be a primary endpoint, we'll have to see with further discussions. Okay. Makes sense. One quick one on your DDC, your drug-drug candidate platform. I understand that NUV1511 was discontinued. Can you speak to what you saw there in that phase one study and what's the plan for this platform going forward? Yeah. We took this first DDC into five different tumor types, which were, you know, untreatable tumor types. Post-Trodelvy or post-HER2 breast cancer, which nothing works, and platinum failures in ovarian cancer, which nothing works, and Xtandi failures in prostate, pancreatic cancer. We did see some very significant responses. You know, we've had some patients, you know, a year or longer out on therapy, but the responses weren't consistent enough for us to make a $100 million-plus investment in a pivotal study. We learned a lot of things in this trial, and we think that there are some things about a DDC molecule that we can change to improve its profile and make it a molecule that we could potentially invest, you know, $100 million-plus in a pivotal study. It just wasn't this one. We are still very excited about the DDC platform. This is a first in human-ever concept. As much as you learn in animals, you do not see it all until you get to humans. We learned about things in humans that we now know we need to change and can change. We are continuing with DDCs, but down a new pathway based on what we learned from the phase one study. Okay. As we wrap up, final question here, just a sneak peek into 2026, kind of set the stage for Nuvation next year and how you're thinking about key catalysts and key objectives. Ibtrozi sales are certainly front of mind for investors. You know, we expect to continue to post strong sales for Ibtrozi. We think that we are the best-in-class agent in the ROS1 space. Safusidenib will be enrolling. It's a pivotal study. Hopefully, that enrollment rate will be robust and allow us to get to trial completion earlier than we said. We have a ton of cash, $550 million as of our last quarter. We anticipate, you know, we've always said BD is an important part of our strategy. We are looking at lots of different things. On top of that, we are still working on DDCs, and we have other internal programs that we think are exciting. We think we're really well positioned in terms of what programs we already have and programs we are developing to give us a lot of legs to this company. Terrific. Maybe you can strike gold again in BD like you did already. Thank you guys very much for all your time. Appreciate it.