IDEAYA Biosciences Inc Interim Phase 2 Data for Darovasertib and Regulatory Update from FDA Type C Meeting in Neoadjuvant Uveal Melanoma Transcript

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

Question: Anupam Rama - JPMorgan Chase & Co - Analyst : Hey, guys, thanks so much for taking the question and congrats on the update. Just two quick ones for me. The first one, in your discussions with the FDA, what remains the kind of push-pull levers to consider here with diameter ORR as a basis for early accelerated approval in the neoadjuvant setting? And then second question, and sorry if I missed this, can you give a little bit more color on what the Grade 3 AEs were and if they resolved or how they were addressed? Thanks so much.

Question: Anupam Rama - JPMorgan Chase & Co - Analyst : Thanks so much for taking our questions.

Question: Maury Raycroft - Jefferies Group LLC - Analyst : Hi, good morning. Congrats on the update and thank you for taking my questions. For the registrational study, what are the landmark times for measuring eye preservation and vision loss, respectively? Or is this something that is still being determined with FDA and we'll learn more about this later this year? I guess how could that be operationalized in the study?

Question: Maury Raycroft - Jefferies Group LLC - Analyst : Got it. Yeah, that makes sense. And then for measuring and controlling radiation reduction in the registrational study, can you talk about what worked and what didn't work in the Phase 2? And what is the most likely scenario for how you'll operationalize that in the Phase 3?

Question: Maury Raycroft - Jefferies Group LLC - Analyst : For measuring radiation reduction and controlling radiation reduction in the registrational study.

Question: Maury Raycroft - Jefferies Group LLC - Analyst : Got it. Understood. Thanks for taking my questions.

Question: Andy Berens - Leerink Partners LLC - Analyst : Hi. Thanks, and congrats on the data and the progress. Just a couple for me. If you guys can do an interim look using ORR, would you also have to show a trend in Event-Free-Survival? Could that trend be non-inferior? And if so, how long do you think the agency would want to see this trend maintained to have convection in the interim results? And then you also mentioned in the press release, earlier stage uveal melanoma. Are you referring to patients that have very early disease like indeterminate lesions? Will they actually be enrolled in the trial? And if not, how much does that impact the addressable market? And then I have two for Dr. Shields, too, if that's okay. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 23, 2024 / 12:00PM, IDYA.OQ - IDEAYA Biosciences Inc Interim Phase 2 Data for Darovasertib and Regulatory Update from FDA Type C Meeting in Neoadjuvant Uveal Melanoma

Question: Andy Berens - Leerink Partners LLC - Analyst : Yeah. Just on -- and in the definition of it of that, would enucleation count as an event? Or will that be excluded?

Question: Andy Berens - Leerink Partners LLC - Analyst : Okay. Got it. Thank you.

Question: Andy Berens - Leerink Partners LLC - Analyst : Yeah. I was just wondering, in the patients that had enucleation converted to brachy and the eye was preserved, wondering what you would expect the longer outcome to be in these patients? Would they likely avoid it in the future? Or would most of them eventually have their eye removed? And then just in the context of other options that could be available in the future like Aura Biosciences' bel-sar. I was just wondering how she sees this intervention could fit into the treatment paradigm versus what they're targeting.

Question: Andy Berens - Leerink Partners LLC - Analyst : Okay. That's very helpful. Thanks. And congrats again. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 23, 2024 / 12:00PM, IDYA.OQ - IDEAYA Biosciences Inc Interim Phase 2 Data for Darovasertib and Regulatory Update from FDA Type C Meeting in Neoadjuvant Uveal Melanoma

Question: Yigal Nochomovitz - Citigroup Inc - Analyst : Yeah. Hi, thank you. Could you just clarify, Dr. Shields, if you wouldn't mind, you mentioned the simulation of the radiation dose before daro and then after daro, I'm just curious, why wasn't it compared to the actual dose delivered post-daro versus the simulated dose?

Question: Yigal Nochomovitz - Citigroup Inc - Analyst : Okay. Thank you. And then can you just confirm that in the patients that were spared enucleation, that all of them achieved at least the 20% or greater tumor shrinkage that was considered clinically meaningful by your advisory board?

Question: Yigal Nochomovitz - Citigroup Inc - Analyst : Okay. And then with the discussion with the FDA on EFS, did you come to an agreement on the number of events that would require to trigger the interim analysis? Because I recall for Kimmtrak, that took much, much, much longer. I think it was over five years before they got to an answer.

Question: Yigal Nochomovitz - Citigroup Inc - Analyst : Great. Thank you very much.

Question: Matt Biegler - Oppenheimer & Co Inc - Analyst : Hey. Good morning, guys. I also had a question on timelines and kind of tagging on to Yigal's here, because Kimmtrak's adjuvant trial, I think, is estimated on ClinicalTrials.gov at around eight years. So it sounds like from the previous question that you think that you can do it faster based on a degree of benefit that you're seeing here. And obviously, we're going to get that interim look at two years. And then I also had a question --

Question: Matt Biegler - Oppenheimer & Co Inc - Analyst : Got it. I think you actually just answered my second question for Dr. Shields, so I'll jump back in the queue. Thanks, guys.

Question: Charles Zhu - LifeSci Capital LLC - Analyst : Hey. Good morning, everyone and thanks for providing the update and congrats on all the progress. One clarifying question here. Is vision loss, as it pertains as a regulatory endpoint, a binary outcome based on whether or not the patient is legally bind? Or is there a spectrum to consider based on visual acuity measures like letters or remaining letters the patient is able to visualize. And how do things like peripheral vision factor into this, if at all? Thank you.

Question: Charles Zhu - LifeSci Capital LLC - Analyst : Got it. Great. And perhaps for my next question, I think a prior analyst asked this as well. Maybe I'll ask in a slightly different way, but it feels like your intended registrational trial could have perhaps a bit of a more focused patient enrollment baseline criteria relative to how broad of a label you could potentially obtain. So maybe a question for not only the company but also for Dr. Shields, how would you think about the data from the registrational trial being applied in potentially treating patients as part of the broader label, but maybe may not have fallen into the baseline characteristics of the registrational trial? Thank you.

Question: Charles Zhu - LifeSci Capital LLC - Analyst : Got it. Great. Thank you. One last quick clarifying check the box from me. I may have missed this, but have you provided the split amongst these 400 patients between Cohort 1 and Cohort 2? And I'd assume there's an opportunity for separate filings for each of these discrete patient populations, but I wanted to clarify that.

Question: Charles Zhu - LifeSci Capital LLC - Analyst : Whether or not there would be an opportunity for separate filings? One, specifically to enucleation, the other specifically for brachytherapy cohort.

Question: Charles Zhu - LifeSci Capital LLC - Analyst : Great. Thank you for taking all my questions and congrats again.

Question: Justin Zelin - BTIG LLC - Analyst : Thanks for taking my questions and congrats on the progress here. Can you hear me okay?

Question: Justin Zelin - BTIG LLC - Analyst : Great. Just a few questions. Dr. Shields mentioned the importance of reducing progression metastasis in this population. Just a few questions surrounding that. Would you have any data thus far to suggest that daro is reducing metastasis or is it too immature yet to present data like that? Second, just clarifying, would metastasis or progression be considered to be an event? And maybe if Dr. Shields has any data on when typically, uveal melanoma high-risk patients do metastasize, just the timeline of that, that would be helpful. Thank you.

Question: Justin Zelin - BTIG LLC - Analyst : Yeah. The first question was just if you had any data to support daro reducing metastasis or is it maybe too immature?

Question: Justin Zelin - BTIG LLC - Analyst : Yeah. That makes sense. And I don't know if Dr. Shields is able to comment on typically how quickly a high-risk uveal melanoma patients typically metastasize?

Question: Justin Zelin - BTIG LLC - Analyst : Perfect.

Question: Timothy Chiang - Capital One Financial Corporation - Analyst : Thanks. Yujiro, I wanted to ask you just about the timing for the start of the pivotal study. When do you think that the study could possibly be initiated? I know it seems like your discussions with the FDA are still ongoing. But one, what do you still need to sort of lock down with the FDA before you can initiate this study? And two, how long would it take to actually enroll the 400 patients that you're targeting?

Question: Timothy Chiang - Capital One Financial Corporation - Analyst : Okay, great. Thank you very much.

Question: Ben Burnett - Stifel Financial Corp - Analyst : Hey, guys. Thank you. I was wondering if you could maybe talk about the duration of treatment you're seeing in the neoadjuvant setting. And I guess what will be specified in the Phase 3 protocol, just in terms of dosing daro in that setting? And also, curious if there's opportunities for the patient to continue therapy thereafter in the adjuvant setting.

Question: Ben Burnett - Stifel Financial Corp - Analyst : Okay. Thank you. And if I could just ask maybe kind of another timing question. How long does it take for vision preservation to sort of be clear? I guess, focusing on the sort of brachytherapy cohort, it's my understanding that radiation effects on vision can take kind of time to materialize. So just trying to get a sense for how much follow-up time you would need to sort of assess vision preservation?

Question: Ben Burnett - Stifel Financial Corp - Analyst : Okay. Thanks very much. Appreciate it.

Question: Corinne Johnson - The Goldman Sachs Group Inc - Analyst : Good morning. I think you mentioned that you would anticipate timely enrollment in the Phase 3 study or in the registrational trial. But would you anticipate any difference between the pace of enrollment in the enucleation patients versus the plaque brachytherapy patients? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 23, 2024 / 12:00PM, IDYA.OQ - IDEAYA Biosciences Inc Interim Phase 2 Data for Darovasertib and Regulatory Update from FDA Type C Meeting in Neoadjuvant Uveal Melanoma And then one for the doctor. I guess, how are you thinking about kind of like stopping thresholds for therapy in these patients? For example, how long would you wait to see tumor shrinkage before you move on? And how long would you look to see stabilization before kind of deciding to go forward with a plaque brachytherapy? Thanks.

Question: Corinne Johnson - The Goldman Sachs Group Inc - Analyst : Thank you.