IDEAYA Biosciences, Inc. Common Stock Citigroup’s Biopharma Back to School Summit 2026

Yeah. First, thank you, Yigal, for the introduction, and thank you to Citi for the invitation to participate again this year. So IDEAYA Biosciences, we're a leading precision medicine oncology company. I think where we're unique is that we have a very late-stage asset in darovasertib. The lead indication there is metastatic uveal melanoma. We are in the process of submitting the NDA under RTOR. The first 3 modules have been submitted, and we have the final module to submit here very soon. Most of our analysts are projecting a first half of next year commercial launch. So again, a very late-stage asset. In addition to that, we have 2 additional indications we're pursuing, phase III studies, both in the neoadjuvant setting, as well as in the adjuvant setting. So a very broad set of clinical activities to also expand the opportunity into the earlier line settings.

In addition, we have IDE849, a DLL3 Topo ADC. We announced recently that we had a successful Type C meeting with the FDA to advance into a phase III registrational study for monotherapy approval in extensive stage small cell lung cancer. Here, the primary endpoint for accelerated approval will be overall response rate. For full approval, median overall survival. Beyond that, Yigal, as you know, we have a very broad set of assets in the area of MTAP deletion and CDKN2A. We've announced 2 recent collaborations with Roche, with their both our pan-RAS inhibitor and their KRAS G12D inhibitor. And that will be exclusively focused on the area of pancreatic cancer. So for those that may or may not be familiar, the overlap between all of the KRAS mutations with MTAP deletion, we believe is about 40% of that population. So a very significant population.

We announced those relationships in the last few months. We have more in the pipeline, but I think if we covered that, we would have done very well.

Yeah, that is correct. We have fast track designation, so we will have expedited review through that, and as you noted, RTOR in terms of the rolling review. There is no specific gating item at this point. It is largely QC that has been ongoing, related to summaries of both clinical safety and clinical efficacy, as well as the clinical overview section. So that is the good news. We are getting very close. There is no specific gating item that is right now in front of us. It is mainly a QC process that is ongoing.

Yeah. We have two fairly sizable updates that is going to be upcoming at ESMO. First, Yigal, as you noted, we have about 100 patients worth of data in metastatic uveal melanoma in HLA A2 positive, so this is where KIMMTRAK is approved. We will share response rate PFS and median overall survival data. We will break that out into first line, and then all patients, which is consistent with how we have presented in the past. Our sense is that the biggest investor focus is, even though it is going to be in the subset of patients, which is what does the frontline OS data look like? As you can appreciate, that will be the second time we will share OS data in the first-line setting. Just as a reminder, at ESMO last fall, we did share OS, which was just over 21 months.

Here, we think the control arm will likely be in that 12 to 13-month range. For neoadjuvant, we will also have about 100 patient data set that is presented at ESMO. This will include both the iodine plaque therapy patients, consistent with prior disclosures related to eye preservation rate, predicted visual acuity. The actual visual acuity will be still too early. My understanding is we will have some commentary related to relapse. I think that should be helpful as well. We will utilize this data with a strategy towards a NCCN guideline usage in the neoadjuvant setting with the anticipation of commercial launch in the metastatic setting.

Sure. Josh? Okay. Yeah. We've had a lot of good dialogue with the FDA and, through the RTOR designation, have had the chance to share some of the data that we'll be having at ESMO, and they've seen that data now.