IDEAYA Biosciences, Inc. Common Stock Wells Fargo 21st Annual Healthcare Conference

Great. Thank you for having us.

Yeah. Darovasertib, for those maybe less familiar with the company, has been in a frontline registrational study in metastatic uveal melanoma. We did receive RTOR, so we've been through the NDA pre-submission module process. The first three modules have been submitted. Our final module is about to be submitted. Everything is on track. All of our commercial preparations continue to be on track. I think we're in very good shape from that perspective.

Yeah. We haven't given more specificity on that exact timing, Eva. As you're aware, most of our analysts are projecting a first half of next year launch.

Because we get expedited review through Fast Track designation, and because we've been going through this rolling process with the NDA under RTOR, we are also prepared for a potential earlier date for a potential launch date. But I think until we submit the final portion of the NDA, the NDA is accepted, we probably won't be giving more visibility at this time.

Yeah. I would say they are your classic steps within the final submission module process. I am not sure we will go into too many more details beyond that, but I would say everything is very much well under control, and we do feel very confident in our ability to hit our timeline goal, which, as I noted, the first three modules are in. The final module will get submitted here very shortly.

Sure. Stu, do you want to take that?

Well, I will say a couple of different things. First, from a regulatory perspective, we have had very positive engagement and collaboration with FDA so far. While we certainly cannot guarantee whether an indication statement would be across all MUM, we remain very hopeful about that. What I would say from a commercial opportunity perspective is that almost regardless of what that label looks like, we have got significant feedback from market research, KOL engagements, that there is a very high degree of expectation of use across both HLA positive as well as HLA-A2 negative. We believe that we have meaningful differentiation in the space, both in the negative setting where nothing is approved, but even in the HLA-A2 positive setting where there is an approved agent.

Stu, go ahead. Yeah. Well, I think from a HLA-A2 positive perspective, if you look at our data, we have meaningful response rate, meaningful PFS, and albeit from a phase II study, we already have overall survival data that is very comparable to the existing therapy in that space.