Arcus Biosciences, Inc. Morgan Stanley 24th Annual Global Healthcare Conference

First of all, thank you, Terence, for doing this, and thank you for all of those of you who are joining us. I think very clearly casdatifan obviously is a center of focus, for us, for the world. We believe very strongly it's going to be a $5 billion-$10 billion drug. Not surprisingly, that question will come up. But I think Arcus continues to be as we planned since its inception to be a company that's focused on with a long-term vision. We have a very sustainable pipeline. We have a program, quemliclustat, in frontline pancreatic cancer, its interim analysis happening this quarter. We feel that casdatifan's going to lead the way, but that we can build a great long-term and highly valuable company. If you put in economics, we can become the $10 billion, $20 billion, $50 billion plus company.

That continues to be our approach.

Yeah. Interestingly enough, that question, you know, you get asked that, and I'll share what an investor recently told me what he thought investors were missing. I think he hit it spot on. When you think about casdatifan and that opportunity, if you go back to the earliest data we generated, the PK/PD profile, which is dramatically different from belzutifan. Then you think about the data that we generated subsequent to that. A lot of the questions about the ultimate commercial opportunity with casdatifan as we think about frontline, second line, third line, should really just come from that simple observation.

Because at the outset, we just had those data, but now we've done three medical conference presentations, we've had an investor event, we had a Nature publication, we've published all the details, and it's very clear that those data drive all this efficacy that reads through to all lines. In the front line, we don't even have a competitor. I think the thing that's missing is those data tell you that casdatifan is going to win in the front line, it's going to win in the second line, it's going to win in the late line, no caveats. We have an event coming up in October, and I think the data are going to demonstrate that.

Perfect. The reason we are doing this, there is a convergence of datasets that read on all of the lines of therapy, frontline, second line, and late line. We felt like the best venue and best way to communicate all of that was in a single form, and it is over 200 patients worth of data. Since we will talk about metrics for each of these and what we need to be successful, let me just describe what those various studies will be. This is all of the data that we will be presenting come under the umbrella of a platform study called ARC-20. Within that study, since we are talking about frontline, second line, and late line, you can basically think about those three buckets of being the primary data that we are going to speak to. On the frontline, the standard of care that we are going against is ipi/nivo.

It is clear cell renal cell carcinoma, and we are talking about a standard care in the frontline, ipi/nivo. What we are going to have for that is a dataset where we are looking at anti-PD-1 plus casdatifan without the ipi, and we are going to have about 11 plus months of data to compare to, and we will talk about how that fits into the metrics. That will give you a good feel for the efficacy, even without the ipi. The second component there is in that triplet, we will have anti-PD-1, ipi, and Cas. What we are running right now is what will generate the safety dataset that both the FDA and the EMA have told us we need to start the registrational study at the end of this year. That cohort is fully enrolled. It is 30 patients, and what they want to see is 12 weeks of safety data.

Why 12 weeks? When you think about what is ipi/nivo, ipi/nivo is four cycles of ipi/nivo, which is 12 weeks, and then you get nivo for the rest of the therapy. They want to see that 25 patients with that sort of follow-up, and by the data update, we will have roughly 20 patients that have had that 12 weeks. A very good read on the safety. That brings me to the second line. Again, if you think about what we are doing, we believe that we are going to transform the paradigm in this field. But we are doing it in a way where we are providing a HIF-2 inhibitor on top of standards of care that physicians like. We have taken a lot of feedback from physicians in so far as what they want to see, and that reflects our strategy.

In the second line, the standard of care, 40% of that second-line therapy is monotherapy cabo. What we will have is a data set combining cabo plus casdatifan with roughly 20 months of follow-up, and that is a 40-plus patient data set. Finally, in the late line, we have used 120 patients' data set to really dramatically show the differentiation between casdatifan and belzutifan. I think that is what really established a major inflection in our program. What we will have for those 120 patients will now have almost 30 months of median follow-up. That is going to lead us to not only show how that data set continues to evolve and how it continues to differentiate itself, but for the first time, we will have an endpoint where we can look at overall survival.

Given that Merck with belzutifan has run three registrational trials, it hasn't hit statistical significance on OS yet, we think that could be very meaningful.