Nuvation Bio Inc. ($NUVB)

Welcome to day 2 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.

Yes. Looking forward to our conversation here.

I guess maybe just jumping right in. You've reported 3 consecutive quarters of accelerating and growing new patient starts. Net product revenues 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 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. So 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 because very few oncology drugs have durations of response in the range of what we've seen with IBTROZI. So we mentioned previously, having a DOR of over 4 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. So we think that having a 90% response rate in the first-line setting and over 4-year duration of response sets up a very interesting dynamic for this drug commercially because 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. So 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. And as we start to see that dynamic increase, we think that the duration 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 were TKI 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?

So I think if there was a shortcoming of AnHeart when we -- before we acquired the company, it was that they had a relatively limited U.S. So they did two pivotal studies. TRUST-I was an all-Chinese study. TRUST-II was a global study, but that included the U.S., Europe, Canada and other western sites. And so 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. So if you look at our first quarter, we had primarily third-line or later patients. And when you see very late patients, they stay on drug very short -- for a very short period. So some of these third-, fourth-line patients will last a month or 2, and they drop off very quickly, which is why you don't really see revenue stacking for late-line patients. As you move 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. So 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 in the second quarter and the third quarter, we're now seeing now more than half of our starts in the first-line setting and 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 although there were three previous TKIs in the ROS1 space, durability and response rates like IBTROZI have not previously been seen. And 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. When you have a profile and you're -- of a drug, even though the first-gens might have a duration of response of 1.5 years, it's not 4-plus years. And I think that seeing a new drug that has a 90% response rate and a 4-plus year duration of response is hard to ignore. So 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. And 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. So it's kind of a build it and they will come.

I think so.

Yes. And I guess there was some foundation laid by the prior ROS1s. Is that -- what have been the benefits of that? Is it adoption of ROS1 testing at academic centers...

So 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. So I think that that's a rising tide that's floating all boats. But I think the stage has been well set for IBTROZI because if you look at 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. And if you look at the discontinuation rate of repotrectinib, it was pretty high due to CNS toxicity. So 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 4-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 3 quarters.

Yes. Yes. Especially, I imagine on the durability piece, like an extra year on the PFS is very meaningful...

Yes. 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 because no -- because once you fail a drug, you're not going to do nearly as well. You're going to have a lot of other issues. So 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?

So yes, that's a great point. So we just got listed on NCCN guidelines for CNS control. And I think that's because the response rate of IBTROZI in the brain is outstanding. It's -- as you mentioned, 66% intracranial response rate in the second-line setting. So ROS1 lung cancer is a particularly aggressive disease because, number one, it starts in the brain 36% of the time. But in another 50%, patients progress in the brain as the first sign 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. So 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 4 years suggests that we control CNS development of metastases, which we think is a really, really important attribute. But 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. So we think that it's appropriate that NCCN lists us as an agent for CNS control because no one has been able to match our CNS response rates. And 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 on the guidelines?

Yes. So we do -- so we've had really good experience with reimbursement with IBTROZI so far. And Philippe can talk a little bit more about how we decide to price it and all that. But I think that overall, I would say that the data are so compelling, it's really hard to [indiscernible] this drug because there is no other agent that has shown a response rate or durability anywhere near the ballpark of IBTROZI.

And maybe, Philippe, if you want to talk about gross to net and...

Yes. 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 [ other ] drug and then on IBTROZI or goes straight on IBTROZI, exactly the point that David was making. And so in terms of discussion with payers, 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, and that's mostly driven by phenomenon 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 drives at the beginning. And then it will stabilize. That's what we think we're going to see. And the other thing is that we did a price increase like many company does. And when you do that in a period that until the end of last year with low inflation, you get some additional rebates in 340B and Medicaid that again drives your gross to net up. But nothing there, which is really different from what we were expecting at launch. And 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. And 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 sort of on the course of the year.

Yes.

Yes. Okay. I want to ask on safusidenib. You recently regained -- you gained the rights from Daiichi Sankyo. Maybe just talk about what gets you excited about this asset? I think its -- first stop is IDH1-mutant glioma. What's sort of the unmet need here? And how do you plan to push this forward?

So we are really excited about this program because we think our data are unprecedented. And if you look at the only drug approved in glioma, and I divide glioma to a 4-piece pie, the only drug on the market for glioma, vorasidenib, is approved in 1 of the 4 pieces of that pie. It's only low-risk, low-grade glioma. And in spite of the response rate of only 11% in that population, and a progression rate of 41% at 2 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. So 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%. So 4x higher than that. At 2 years instead of a 41% progression rate, our progression rate was 12%. But even beyond that, if you look at the high-risk population, which is half of glioma patients, the high-grade patients, and that's divided into high-risk and low-risk, vorasidenib's response rate there is 0%. Ours is still 17%, but 1/3 of those responses were complete responses, including a GBM that's been gone for 3.5 years and another high-grade glioma that's been gone for about 2 years. So 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 vora. So we think that safusidenib is good for the entire pie, all 4 pieces of that pie, and we're doing now a number of pivotal studies to address that. But we think this is an extremely large unmet need. As good as vorasidenib data are compared to what was prior -- previously available, we think that there's still a lot of room for improvement and are really excited about this asset. So we acquired worldwide rights -- the last rights from Japan because we just think this is such an incredible opportunity, and we want to maximize the potential of that.

Okay. And just in terms of upcoming data timing and path to approval, is it accelerated approval in some of these...

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 until 2029. But we are also starting pivotal studies that are hopefully going to be much shorter than that. We're starting a Grade 3 oligodendroglioma study, which is a response rate study. We're going to have a significant number of patients enrolled this year, and we're going to complete it by next year. If we see a significant response rate there, anything north of 20%, we think that's that warrants a discussion with FDA on potential accelerated approval. We're also looking at other ways to get safusidenib developed in the vora space, the low-risk, low-grade glioma space. And so we're going to be announcing plans on that later this year. And we think that those are much shorter-term opportunities to create value with safusidenib.

Great. And 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 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. So we're very confident about that and very confident about the future and our ability to invest behind our great assets being safu or drug-drug conjugate program.

Okay. Very good. Well, with that, I think we're out of time. So David, Philippe, thank you so much for the conversation. Thanks for...

Thank you.