IDEAYA Biosciences, Inc. Common Stock 12th Annual Cantor Fitzgerald Global Healthcare Conference

Great. Lee, thank you so much, and thank you to Cantor for the kind invitation this year. IDEAYA Biosciences, we're a leading precision medicine oncology company. We have a deep, diversified pipeline. Our most advanced program is darovasertib. As Lee, as you're aware, we're going through the final NDA submission process under RTOR. The first three modules have been submitted. The final will get submitted here very shortly, and that's for our attempt to get approval in the first-line metastatic uveal melanoma setting. Beyond that, we have several additional studies ongoing in the pre-metastatic setting, including a phase III adjuvant study, which we announced first patient was dosed this morning. Beyond that, I would focus in on two additional programs. First is IDE849. This is our DLL3 topo ADC. Here, we have a significant focus in small cell lung cancer and neuroendocrine carcinoma.

We did recently announce successful Type C meeting with the FDA to finalize a phase III study design in later line small cell lung cancer. Beyond that, we have a significant focus in MTAP deletion. We have two clinical programs here. We've also announced two recent collaborations with Roche, with both our pan-RAS inhibitor, KRAS G12D, with a primary focus on pancreatic cancer. We have much more in the pipeline, Lee, as you know, but I think if we cover that, we'll cover a lot of the company.

Okay, great. That was a very good high-level overview. I wanted to start with darovasertib submission. Yujiro, you mentioned you're going to submit the second module very soon. What are the gating steps here? I also know you guys have a pre-NDA meeting scheduled. What will be on the agenda for that meeting?

Yeah. In terms of gating items for the final NDA submission, there's nothing specific that's gating now. It's essentially QC that's ongoing for both the overview of clinical efficacy, overview of clinical safety, and the overall clinical overview for the program.

That is really all that is remaining. That process is going well. We very much remain on track, so we feel very good about what that is. In terms of the pre-NDA meeting, that action meeting has now occurred.

The primary discussion that was had as part of that pre-NDA discussion has been around the label and should we be pursuing an all-comers versus an HLA-A2 negative?

I would say here, we have been pleasantly just hearing the enthusiasm around at least a potential opportunity for an all-comers approach. We will have to make that final decision when that final portion of the NDA is submitted, and we will likely provide a public disclosure on what we decided to move forward with. But at least at this time, it is at least good to hear the receptivity from the FDA.

Okay. Yujiro, you mentioned, in terms of the label, the base case scenario for you guys is that you are going to have HLA-A2 negative patients. But it sounds like your dialogue with FDA has been pretty positive in terms of HLA agnostic patient population. Do you feel better about you may be able to get an all-comer label at this point?

Yeah, I would say from when we started the process with RTOR.

Which was largely from when the top-line results happened, which as you know was in that April timeframe. We started that RTOR process within weeks of those top-line results to today. Yes, we do feel more encouraged based on the discussions we've had through RTOR with FDA.

Okay. In terms of thinking about this HLA positive patient population, you guys also mentioned you might be able to pursue compendium listing as an alternative. Maybe talk to us about what the next steps are if you're going to go that route.

Yeah. So here, this would be largely based on the published data.

So, as you know here, Lee, we're going to be publishing data in HLA-A2 positive at ESMO here shortly. I think, as well, we would hope to be able to put that in manuscript form as well as in the future. Then assuming we do get approval and launch, we would then pursue that NCCN guideline process. Typically, they meet once a year, but based on the high unmet need, we think there is an opportunity to hopefully have an ad hoc discussion on that.

Mm-hmm. So it sounds like in terms of the sequence of events, is that you guys are going to be publishing all the data first, get approval, and then pursue a compendium listing. Is that reasonable? That's correct.