IDEAYA Biosciences Inc at RBC Capital Markets Ophthalmology Conference (Virtual) Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : Yes, that's great. And maybe before we dig into the melanoma and darovasertib, maybe Yujiro, just a comment on what has enabled all of these development programs as you think about IDEAYA's precision medicine platform, the drug discovery capabilities, integrated nature, that focus on tumor heterogeneity, which is obviously complex, rational combinations. Maybe just comment a bit about what kind of ties that together, what underlies the development of all these assets.

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : That's great. Thank you for that. Let's talk uveal melanoma and daro and the program. Maybe just walk us through how daro fits into the current treatment paradigm. And maybe talk a bit about some of those assumptions when we think about a high opportunity but small market but certainly very opportunistic here.

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : That's really helpful. And I like, Darrin, how you reflect on that patient journey to just put, I think, a real-world nature in the context of daro. And maybe just keeping with the metastatic and that first-line setting, you alluded to the standards of care and also your Phase 1/2 data that you have. And we're going to see some more data later this year. I want to get to that. But as we put the study and what you've shown already into context and first line with daro and crizo, just talk about how you look at that with respect to the standard of care with the available agents that are used today.

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : And you're certainly alluding to the end of the year with the data for the registrational trial. But before that, it looks like there's a plan to show the OS data for the Phase 1/2 coming this year. Maybe talk a little bit about that. What should investors look at as that clinically meaningful benchmark on the OS that, frankly, would give you and us greater confidence in the trial that's underway now?

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : Great, great, and that update will give way to the year-end PFS update for the registrational enabling Phase 3. Maybe just talk about how that's enrolling, how that's progressing, and just how that you're tracking to that year-end update.

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : And what would be the current assumption on approvability based on PFS?

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : Fantastic. And just remind us, Darrin, just investigator choice in terms of the control, maybe what are the assumptions there on performance?

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : Excellent. And you discussed earlier just the SKU on the HLA negative versus HLA positive. This study is designed to support approval in the negative. Just remind us of that strategy of opening up to positive, how you think about either potential listings, how daro-crizo can be used in the broader population.

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : Yes, that's helpful. And also reminding, we tend to overlook that daro is an oral option versus some of the others. And I want to take the conversation earlier in that patient journey to the neoadjuvant setting; and certainly, some meaningful updates this week, Yujiro, just on your FDA engagement. Just walk us through -- and Darrin, you spoke about the rationale, which is super helpful. But just walk us through some of those updates that you received this week, the breakthrough, and just how that's fitting into the updates that are coming this year.

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : That's great, Darrin. Thank you for that overview. And maybe, Yujiro, just to close, and you touched on this a bit at the top, but beyond the ocular malignancies, there's so much more for IDEAYA and even what we discussed today. You mentioned ACR and Werner's. Maybe just close with some of the other programs that you think could drive that increased and continued interest in the pipeline, starting with ACR and Werner's and maybe some of the other programs.

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : That's great. Yujiro, Darrin, thank you so much. It's a great place to leave it. A lot going on, as always, with you and IDEAYA, even after 10 years of being a company. Congratulations, and we look forward to all the updates. Thanks for joining us.