Nuvation Bio Inc. Citigroup’s Biopharma Back to School Summit 2026

Thanks for having us. Yeah.

Yeah, I think it has been a really great year for us. As you know, IBTROZI got FDA approval a little over a year ago. We have had a little over a year of launch, and IBTROZI has been a very strong launch. We are already the number one ROS1 TKI today on the market. I think that the uptick of IBTROZI is consistent with what we believe is a best-in-class profile, an unmatched duration and response of over 4 years, a very tolerable safety profile with an extremely low discontinuation rate. I think that a very strong CNS control for a disease that gets to the brain a lot.

I think that the launch of Eptrizo has gone really well, and I think that it will continue to go well, considering the fact that now we don't see any real competitors on our horizon, given the most recent label for lurasidentinib, which I think is challenging. Again, with CNS warnings and precautions, which we don't have, adverse events that, again, we don't have, and frankly, efficacy that doesn't match our metrics. I think that we are in a good position there. safusidenib, you saw the 3-year data. I would say that data's pretty unprecedented. 52% response rate at 3 years, 79% non-progression at 3 years. That's just not been seen in glioma, high or low-grade glioma, by the way. We feel very comfortable there.

We're in a number of pivotal studies for safusidenib and are just in the process of getting those trials enrolled and hopefully completed soon. I think we're in a comfortable position there. Our cash with the shoe now is about $700 million, so we're comfortable on cash. We have plenty to get us through to profitability, as we've said. We have internal programs with our DDC platform that we're going to be updating the street on later this year. But I would say all in all, it's been a pretty strong year for us, and we're in a pretty comfortable position.

Yeah. About 85% of our patients right now are first-line patients, which is pretty good. As I said, we are the leading ROS1 TKI among our competitors. But our biggest challenge isn't really so much our competitors as just the practice, especially in the community. Right now, even with ROS1 disease, there's still a lot of IO chemo being given, more than it should be. There's a huge difference in outcome with IO chemo versus a precision oncology agent like a ROS1 TKI. And there are multiple publications showing that even if you were to switch patients to a ROS1 agent after just 35 days on IO chemo, your survival never catches up. In spite of that, we still see significant amount of IO chemo use. So that we're trying to change, and we're all over NCCN trying to make sure that those guidelines are really adopted.

The NCCN actually contraindicates IO for a ROS1 disease, yet it is still done. We are trying to really make sure we educate physicians on that point.

Yeah. The NCCN guidelines changed about a year and a half ago. Nothing happens quickly in clinical practice, but I think that we are at that point where I do think that ROS1 TKIs are being appreciated more on IO chemo, at least. We have had a very concerted effort at multiple community centers, some of the larger aggregators to review their IO chemo use compared to their ROS1 use. When we educated them, we were actually able, in one center, to double their ROS1 TKI use, and another center, to triple their use. Education does work, but it is a little bit of a center-by-center education program. Some of these centers are very large, so that if you hit one center, you can capture many patients in many states. It is worth doing, and we are doing that.

One big competitor for us is IO chemo. I think that is where we have a lot of improvement to have. The second thing that we need to improve is just testing in general. Even if you look at other precision oncology cancers like ALK or EGFR, even 10 years out, even those cancers are not being tested for 100%. We have seen that in academic centers, ROS1 testing is close to 100%, but in community centers, some of the lower centers can have testing rates as low as 30% or 40%. That is another major educational effort. I think that now there are so many precision oncology agents that gradually will increase. That is a rising tide that should float all boats.

I think that the recent selpercatinib data in REPO, showing the incredibly robust hazard ratio, 0.17 in the adjuvant setting compels even earlier testing for RET, and as a result, it should compel testing for all lung cancer mutations. You can't just look for one mutation. You're going to look for all of them. I think there are a number of tailwinds that should help us, but right now, I would say those are our biggest challenges.