IDEAYA Biosciences, Inc. Common Stock Morgan Stanley 24th Annual Global Healthcare Conference

Good morning. Thank you for coming this morning to the Morgan Stanley Healthcare Conference. My name is Ruk Byun, I am head of West Coast Healthcare Investment Banking at Morgan Stanley. I have the pleasure of hosting management team from IDEAYA Biosciences, Yujiro Hata and Josh Bleharski. Just ask a couple questions to get the conversation started. Yujiro and Josh, for somebody that is encountering IDEAYA for the first time, what is maybe the simplest way to understand where the company is today?

Yeah. Ruk, thank you for the introduction, and thank you to Morgan Stanley for the invitation at this year's conference. IDEAYA Biosciences, I think maybe the best way to summarize it, we are a leading precision medicine oncology company. We have very deep and diversified pipeline in the area of precision medicine oncology in particular. Our lead program is an agent called darovasertib. We are in the process of submitting the final NDA submission under RTOR. Most of our analysts are projecting a launch timeframe in the first half of next year. In addition to frontline metastatic uveal melanoma, we have several additional phase III studies ongoing, including in the new adjuvant and adjuvant setting. Here, our view is this molecule has the opportunity be hopefully standard of care across uveal melanoma patient journey.

Beyond that, Ruk, as you know, we believe we have one of the deepest clinical pipelines in precision medicine oncology today. I would say next program to focus is on DLL3. This is a Topo ADC. We recently announced a successful Type C meeting with the FDA, with our intent to start a randomized phase III study in later stage small cell lung cancer. We do also believe there is an opportunity in neuroendocrine carcinoma. Beyond that, we have an exciting set of assets in MTAP deletion. This is a key tumor suppressor loss gene. It represents about 15% of all solid tumors, including about 40% of pancreatic cancer. Ruk, as you know, we announced two collaborations with Roche in the last several months, both with our pan-RAS inhibitor, second with our KRAS G12D inhibitor, all in pancreatic cancer.

We have multiple assets beyond that, but I think that is a good high level summary.

Great. Maybe talking a little bit about darovasertib and the regulatory path forward. Obviously showed a clear PFS and response rate benefit, and OS is still maturing. Between now and potential approval, what is the most important remaining question for regulators or physicians or investors?

Yeah, there is not much remaining as part of the NDA submission under RTOR. It has primarily been QC related to clinical summaries of both safety, efficacy, and the broader clinical overview for the program, so there is nothing specific gating. I would probably say the primary question that is open is what will be our label strategy. Ruk, as you are aware, the randomized phase III study was done in HLA-A2 negative, so KIMMTRAK was approved in positive. We believe the negative population is the majority, approximately in that 60/40 to two-thirds/one-third split. Based on additional discussions with the FDA under RTOR, we do believe there is receptivity to an all-comers approach. So we are still communicating base case as A2 negative with NCCN guidelines as base case, but I would say we are feeling more confident, at least around that FDA receptivity piece.

Got it. So in terms of how investors should be thinking about the A2 positive population, where could you fit in in terms of sequencing or even patient selection?

Yeah, look, we think that darovasertib has several components that are quite attractive relative to the peer agent that you mentioned. So first, we have a confirmed response rate that is approaching 40%. We have a progression-free survival that is approximately 7 months. On both of those measures, we believe we are significantly above what is available, including KIMMTRAK or epacadostat. In addition, Ruk, as you are aware, we have presented single-arm OS data, and we have reported just over 21 months at the Society for Melanoma Research last fall. We believe the control arm will come in 12 to 13 months. In addition, it is an oral available therapy versus a weekly IV infusion. So I do think we are going to have a lot of benefit, and at least our perspective is we should get robust uptake both in the front line as well as pretreated setting of HLA-A2 positive.

Got it. Thank you. How are you thinking about gearing up for your commercialization efforts in terms of physician education, patient identification, so on and so forth?

Yeah, that's a big emphasis for us right now, Ruk. Our senior leadership has been hired and is in place for the commercial launch. We're in the process of doing a lot of that market research, meeting with KOLs, talking to payers, really to the point you made, trying to raise awareness for the daro-kras combo, educating people about the data set, the value proposition. That's work that's been ongoing for many quarters, and will continue. I think The other piece of this is really trying to understand how patients are seen and where they are.

That's going to be a combination of some of the KOL networks that we've built and established over the years, as well as some technological tools that we're using to help identify patients, understand treatment paradigms, and make sure that if we're approved, we can get to those patients as efficiently as possible.

Great. Now, maybe think about darovasertib beyond metastatic disease. What gives you confidence that the activity in the metastatic disease will translate into preventing or delaying recurrence in the adjuvant setting?

Yeah. I think the good news here, Ruk, is we have a lot of confidence in the activity we're seeing in the metastatic setting. I think that hopefully bodes well in the pre-metastatic setting, as you mentioned, specifically as it relates to relapse or recurrence. In addition, I would just highlight, we just launched our phase III randomized adjuvant study that is randomized against observation, right? We're essentially randomizing against nothing there. We think that's a very low benchmark. In addition, we've well-powered this study. It's about 450 patients, so we feel good about the target hazard ratio and what that benchmark looks like.

Got it. Now, could successful use in earlier stage disease reduce future metastatic population? How do you balance that possibility against the much larger opportunity to treat patients across the disease continuum?