IDEAYA Biosciences, Inc. (IDYA) September 10, 2026 Conference Transcript

Everyone, we're on day two in the afternoon session of Citi's Biofarmer Back to School Summit here in New York City. I'm Miguel Nachamovitz, Senior Biotech Analyst at Citi. We have our next company, which is IDEA. Great platform, great pipeline, and we've been covering them for a number of years. And it's really been a great journey and a lot more to come. So I'm pleased to introduce Yajiro Hata, who's the CEO, founder of the company. And then also we have Josh Blaharsky, who's the CFO, and Daniel Simon, the chief business officer. So welcome, all of you. So Yajiro, a lot's going to happen in the next several months with regard to readouts. But before we get to all that, you know, for those a little bit less familiar, just kind of identify the, you know, the key programs that you're focused on and, you know, the key opportunities in the different market segments that you guys are pursuing.

First, thank you, Yagol, for the introduction, and thank you to Citi for the invitation to participate against this year. So, I did Biosciences. We're a leading precision medicine oncology company. I think where we're unique is that we have a very late-stage asset, Endurovisertib. The lead indication there is metastatic eweb melanoma. We are in the process of submitting the NDA under RTOR. The first three modules have been submitted, and we have the final module to submit here very soon. Most of our analysts are projecting our first half of next year commercial launch. So again, a very late-stage asset. In addition to that, we have two additional indications we're pursuing phase three 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 a ID 849, a DLL-3 topo ADC. We announced recently that we had a successful type C meeting with the FDA to advance into a phase three registrational study for monotherapy approval and extensive stage small cell lung cancer. Here, the primary endpoint for accelerated approval will be overall response rate for full approval of median overall survival. Beyond that, Yagal, as you know, we have a very broad set of assets in the area of MTAP deletion and CDK2A. We've announced two recent collaborations with Roche with both their PANRAS inhibitor and their KRAS-G12D inhibitor, and that will be exclusively focused in the area of pancreatic 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. And we have 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.

Okay. All right. All right. So let's go to the first thing. So you said you did three out of the four modules and potential launch in the first half of next year. So what's left to do with this? What is the last module? What's left to do. And it seems like you would need a Purdue for data sign, you know, pretty soon in order to make, to do the one half 27 launch. So, but you have the RTOR and you have the rolling submission. So you have some leverage there.

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

Okay. But the stated guidance submission is this year?

Correct. Okay.

All right. Right. Now, related to that, obviously, there's an important data set in the HLA to positive group. So, you know, can you speak to that? I believe you're going to be showing some of that data relatively soon. And there's a potential for, you know, getting that sort of into the marketplace through the compendia, potentially, as a strategy. So just can you kind of elaborate on that?

Yeah, so we have two fairly sizable updates that's going to be upcoming at ESMO. So first, Yagala, as you noted, we have about 100 patients with the data in metastatic uvomelanoma and HLA-A2 positive. So this is where ChemTrek is approved. We will share responsory PFS and median overall survival data. We will break that out into first line and then all patients, which is consistent with how we've presented it in the past. Our sense is that the biggest investor focus is even though it's going to be in the subset of patients, which is what is the frontline OS data look like, as you can appreciate. That will be the second time we'll share OS data in the first line setting. And just as a reminder, at SMR 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'll also have about 100-patient data set that's presented at ESMO. This will include both the enucleation plaque therapy patients, consistent with prior disclosures related to eye preservation rate, predicted visual acuity. The actual visual acuity will be still too early. And my understanding is we'll have some commentary related to relapse. So I think that should be helpful as well.

And we will utilize this data with a strategy towards a NCN guideline usage in the neoadjuvant setting with the anticipation of commercial launch in the metastatic setting. okay um and then as far as the um so for the hla positives that would be uh also with this compendia strategy or that could potentially work its way into the into the label uh if you fold that into the rolling submission is that a is that a plan of action or you may not necessarily need to do that sure okay yeah so um we've had a lot of good dialogue with the fda and uh you

know, through the RTOR designation have had the chance to share some of the data that we be having at ESMO. And they've seen that data now. And I think our sense from the interaction is that they're actually, they're encouraging us to try and seek a broader label. I think they understand the unmet need there. I think the data sets are remarkably consistent. And I think, you know, our intention is to have that dialogue with them and see if we can get an HLA agnostic label at approval. So that's a little bit of an evolution from where we started, but I think it's really, you know, a testament to the drug's benefit and the unmet need. And I think the FDA has been very aligned with us in trying to move this forward as quickly as possible so we could get it.

So that sounds like a relatively new development. Yeah. Yeah. I mean, it is. I hadn't heard it quite like that before. So that sounds good. Yeah.

Yeah.

Okay.

Yeah. And maybe part of that, Yagala, is we did have their pre-NDA meeting, and that was largely the focus of the pre-NDA meeting topics, and that's why now we had that meeting, we got that feedback, and so you're seeing our communication evolve from that feedback.

Which is recent, I gather.

Correct, yeah, it was recent.

Okay, and then for, so then for NeoEdge, as you pointed out, compendial listing, but does this mean you may take another think as far as what to do with optum 10 yeah i i think in any scenario we'll we'll submit for for compendia for guideline inclusion based on the data we've generated already um you know what we're thinking about now is just you know whether that's enough um and whether in light of some of the enrollment delays we've had it with the 10 study that we've talked about, you know, would it be better for us to sort of pivot, rely exclusively on the compendia strategy for the neoadjuvant subset and reallocate some of the funds we'd set aside to run that registrational study towards other high priority programs in the pipeline. And so we have not yet made a determination there, but we are actively kind of thinking through the options and trying to do the analysis to support the decision, which we'd expect would be before the end of the year okay um and what so the gating factors there are just showing the data as mo getting more kol buy-in on that data i gather or yeah i mean so we've had i mean the combination of our own market research and some of the work we've done with kols and people who have sat on the the nccn panel you know our take of that is that uh there's a reasonable likelihood that we would get included in the compendia so if that were the case it's a question of you know

what would that mean commercially so we're doing some of those you know some of that work to try and understand that a little bit better but you know suffice to say we think um that may be a viable route in light of some of the other uh challenges i highlighted and and could allow us you know to to invest in other things in the pipeline that we'll get to all right um so related to all that can we talk a bit about just the commercial uh setup the build i mean you're getting very very close obviously to a to a launch uh which would be great uh the first uh launch so um you know where are you with the commercial build who have you hired um you know all the all the market intelligence um work to to set yourself up to uh you know to launch yeah so i

Josh and I could tag team on this. I mean, I think it's a fairly straightforward build out. You know, we're just focused on the U.S. launch. As you know, Serbia is handling XUS for us. The Salesforce side is, we believe, approximately 25 individuals, very similar to what Immunicore has done with ChemTrack. The base commercial leadership team has been hired. So that's all set. Everything on the supply chain side is also very much on track.

So we do have a early scenario commercial readiness and preparation uh that we'll be prepared for uh but everything uh is all systems go right now um and and anything early that you can you know communicate in terms of how you see the early launch progressing you know relative to relative to the the obvious uh competitor kim track do you mean specifically in the a2 population or sorry the positives yeah yeah yeah yeah so um look we we have seen and heard a lot of enthusiasm from the people that we've talked to about the profile of the drug obviously when we we were at asmo presenting this you know the discussion after our presentation you know noted that this is a big and you know a big advance for the field where there's a lot of unmet needs still so you know we feel pretty good about the uptake particularly in the a2 negatives where there are no approved therapies, but certainly in A2 positives, where there still remains a lot of unmet needs. So, you know, time will tell, but we continue to believe that the drug delivers a lot of benefit.

And, you know, for patients where there's quick progression, or even in the in the in the post chemtrax setting, you know, we think that this is a nice viable alternative should be approved for those patients and we we'd expect to see reasonably quick uptake okay so that sounds that sounds good well let's move over to talking about DLL3 and the so first of all in terms of the the type c meeting and the the alignment on the phase three design is that did that sort of square with your goals for what you wanted to to get agreement on there in terms of the endpoints you mentioned Obviously, ORR and OS.

Yeah, it was, Yagal. I think the biggest question for us when we had the type C meeting was around, you know, how do we think about pre-indulter versus post-indulter patients? And that was really the key question for us. And the feedback was very clear that if we did do a pre- and post-indulter study, that it would be viewed as more of a heterogeneous population. and so at least for the U.S. approval portion. So we just felt it was a cleaner study to do it as a purely a post-Indultra study population. In addition, we also did it this way with the mindset that you always want to do a study that's going to be somewhat relevant at the time of hopefully potential approval. And we did anticipate that Indultra would hit their endpoint for frontline approval. And as you probably know, earlier this week, they announced that they did hit their OSN point for frontline maintenance. So that exactly, I think, further just reinforces the trial design that we're pursuing. I think the main questions we've been getting is, you know, are we seeing responses post-indulter? You know, is there any concern that you might have DLL3 down regulation post-indulter? And I think there we can, you know, that that's not a concern. And then second, we are, you know, clearly seeing responses in the post-indulterous setting, which gives us confidence in the study design. The last two parts I'll mention is we are interested in neuroendocrine carcinoma. So we are, we believe we're clearly seeing monotherapy activity there. So we do have another meeting with the FDA set up in the fall to get more clarity on what a registrational path could look like there for monotherapy, both accelerated and full approval. Here, it's a lot less crowded of an area, a lot less activity with antibody drug conjugates. We don't have really in Delta here as well. So there's a lot more white space. And then lastly, it's around frontline small cell lung cancer. And there, I think we can maybe talk about it more, but we think we have more work to do and thinking through what the right strategy is for frontline.

What are the factors that need to be weighed on the frontline that you're weighing?

Yeah, so first is the landscape is evolving rapidly, right? So as we just saw, Indeltra hit their endpoint of frontline maintenance. They have another randomized V3 study that has not read out yet in frontline induction. So those type of things, it'd be nice to get some sense of where that's all coming out, just so we know we have the right things in the compared arm. So that's one. I think second, when you think about what you combine it with. At least our view is PD-L1 is fairly table stakes. I think there has been some questions around plus or minus chemo, obviously our antibody drug conjugate. And then, of course, as you know, you all were quite interested in the PAR combination that we're doing, which is a novel combination. And if that does enhance durability, that would clearly provide us a differentiated path forward than others. So if we did do a PD-L1 plus ADC versus PA1 plus chemo, and now with possibly Indeltra in the control arm, you know, that may be a high bar study, right? So I think that's what we want to think through before we just sort of launch into the trial, that we have just a better sense of all these various parameters.

Have the KOL suggested, like, even combining 849 with Indeltra? Or has that come up or not really?

Yes, it has. Yeah. And that would be another piece of the story, right? But once you do that, But you have to think about a lot of other considerations from cost, logistics. I think there's a lot of things that you would have to think through there. So that's why, you know, I think, as we mentioned, versus sort of rushing into a frontline study, just making sure we have clarity on what is the highest POS study. And then in the interim, making sure that we get these monotherapy later line accelerated approval studies off the ground, first in small cell, and then next we'll evaluate if there's a viable path forward for neuroendocrine carcinoma as we collect more information on this question of the front line. Because, yes, you could consider it.

Yeah, well, because some other companies are combining, as you know, right?

That work has just begun. So it doesn't look like it's going to be in the first wave of those front lines, just because that dosing just began. But yeah, those are the questions. But we know in the past, right, Amgen had done B7H3, ADC combinations. Those were halted, right? So why were they halted? So I think those are the type of questions I think are going to be important to have answers to.

But for neuroendocrine, it's more white space, right? So, like, there you could do frontline more easily or not necessarily?

There's not a real, depending on which subtype of neuroendocrine carcinomas, but some of the subtypes we're considering, there's not really a clear standard of care. So, yes, absolutely. There's more white space. You see less activity from Amgen there as well within Deltra and the NEC space. And as you know, there's not as much activity ongoing with other ADCs. So there could be a unique opportunity for a DLL-3 topo UDC in the NSE area. And as I mentioned, we are clearly seeing activity there as a single agent.

And then the question of the dose. So 2.4, 3.5 are the finalists, I guess. So what's left to determine there? I mean, 2.4 looked pretty good. What else do you want to know about 3.5?

Yeah, we know that our closest peer company has picked an expansion dose of 1.6 mix per keg. At 2.4, we're already 50% higher. At 3.5, we would be over 100% more, which means it appears that we could deliver more payload. then now the question will be how will that translate into a response rate PFS and ultimately OS. But I think the good news is we did share all of the data we had with the FDA as part of the type C meeting. They were in agreement to us that those should be the two doses we should pick from. And it appears that we can go higher than where Hungary decided to expand at 2.4. So if we can deliver that payload and we could do it safely, then I think 3.5 would be a great dose, but 2.4, as you noted, Yagal, is also a very viable dose.

Is this sort of under the Project Optimus umbrella, or is it just a little bit separate? And actually, you know, because sometimes the FDA just asks for this, because you check boxes, but you kind of, you guys already know what you're going to do for phase three. In this case, it sounds like there is real, there is more of an actual debate as to which one to take forward, or?

I mean, I would say the majority or the vast majority of interactions we've had on dose optimization with the FDA as you enter into a registrational study, this is a regular topic now at this point. So there was discussion around not a blinded, but a randomized dose optimization that we do in this process as we initiate the phase three. So we're going through that right now. So taking the existing data we have, but also doing these two cohorts.

And are you going to tell the markets the answer by the end of the year, or are you just going to announce the design and say that's the dose? Are we going to see the comparative data or not really?

Yeah, we haven't said exactly when that would be, but we're defining that right now with the data we're developing.

But yes, we anticipate we will disclose ultimately what that dose is. okay um and then uh another important question um you know just as you pointed out they're competitors so just it would be helpful if you could sort of delineate you know what what you view is differentiated from your and your drug both on the efficacy and uh you know safety side both you know in terms of response rates um cns activity um a profile etc you know what how do you how do you see it as a unique asset?

In terms of within the DL-3 area? Yes, yes, yes.

No, within the DL-3. Yeah, yeah, yeah.

Look, I think at the end, our view is directionally. Obviously, we need to prove that with more data. That's one that's going to get presented. So I should have mentioned we'll have about 100 patients with the data presented at ESMO. About two-thirds of that will be in small cell. The remainder are neuroendocrinoma. There will be a robust data set from response rate, PFS, and survival data. We'll also share full AE information. We'll also provide an update by the end of the year in the U.S.-Europe population as well. And big picture, our view is that we believe directionally we are seeing higher response rate. As you may know, in the World Cancer Lung Conference, we also reported roughly a six-and-a-half-month PFS, So Indeltra was, you know, roughly four and a half months or so in their approval readout. And we will share, for the first time, 12-month landmark OS data. You may know that Indeltra's OS in that leader line setting was 12 and a half months. So we think anything above 50% in terms of that landmark OS would, you know, would be a win there.

So, and then I think from a safety perspective, we will share more information here. but i think big picture we we feel very good about what we're seeing okay um that sounds uh good um all right let's talk a little bit about some of the other assets then because you have a lot in the uh the mtep pathway um so tell us a little bit more about the scientific rationale for the for the combo work with uh you know both the the the roast drugs the the pan the pan k-ras and their KRAS, or two, the PAN KRAS and the G12D.

I'll let Daniel on.

Great. Thanks, Udre. Great, great question. So we've got these two collaborations with Roche that we executed early this year. In the first, they are providing their PAN RAS inhibitor, which is a molecular glue, to us to combine with our PRMT5 inhibitor. And in the second, we had additional conversations. We're providing our PRMT5 to Genentech to combine with their G12D. Now, as everyone's probably well aware, I think 92% of pancreatic of PDAC patients have got KRAS mutations, co-occurring in roughly 40% of those patients are MTAP deletions. And so, you know, there's strong scientific rationale to hit both of those drivers simultaneously and clearly the data that's already been put out there from the combination of Diraxol, RASIB, and Tango's PMT5 is hugely compelling. These were a 94% response rate with Diraxon-Rasib. And then in the G12D population with Zoldon-Rasib, I think it was a 62% response rate. So we're excited to have those two combinations going. Within the RAS mutant population within PDAC, G12D mutations are roughly 40% of those patients. So, you know, 40% times by 40% is roughly 50% and 16%, and so that's still a significantly sizable population within PDAC. Okay.

And then there's some other combinations, too, beyond that, though, right? I mean, there's potential for even, if I'm not mistaken, a triple combination with the CDKN2A asset. Is that right?

Yeah, so there are several other combinations. So one is in the PANRAS agreement with Roche, it is contemplated that we also have the ability to enable MAT2A, PRM25, and PANRAS. That's one. Your goal, as you mentioned, which will be part of the R&D Day in London that we'll showcase in the fall, which is CDK2A deficiency, which we know is prevalent in roughly 70% of all pancreatic cancer. There, you could enable a doublet with PANRAS. You could also do a doublet between PANRAS and PRMT5, and then you could also consider a triplet with all of those straight for pancreatic cancer. Right now, we're probably most excited about the CD-Cancery PANRAS combination, and some of that data that we'll have, we'll plan to share that at that R&D day. And perhaps there, you may not even need to do patient selection.

Because as you point out, there's a lot of combinatorics here as to how you could do So maybe just to reiterate for everyone, the one that you sort of see, is there one, the one you just mentioned, you see as the front runner? Or how do you sort of prioritize or what's the hierarchy in terms of, you know, your views on putting all these different assets together?

Yes, with PRMT5 and CDK-N2A, because they're both on the 9P21 chromosome and they're about 2,000 base pairs apart, when MTAP is deleted, CDK-N2A is almost always co-deleted. So because of that, PRMT5 and the CDK-N2A asset, we can pursue as a combo in any MTAP solid tumor indication. So that will be a plug and play all across all of those indications. We obviously wholly own that, right? So in pancreatic cancer, because the CDK and SUA deficiency is even higher now than MTAP, and we don't believe others have this molecule of this type, except for us, if we get this into the clinic, that uniquely positions us to do a doublet with pan-ras in pancreatic cancer to capture even larger population. And yes, based on our preclinical data, we do believe that data actually looks the most exciting. And we're building a larger and larger data set, and hopefully by now until when we hope this molecule will be in the clinic, which is first half of next year. But we're already getting interest to do this doublet with RAS, so in pancreatic cancer.

Now, maybe you have time to go into some of the other assets, like the CAT6 program. Can we talk about that one briefly?

Yeah, so CAT6-7 and the lysine acetyltransferase area were also relevant to the biology of chromatin remodeling. Yagal, as you know, there's been a lot of activity with CAT6 and breast cancer, in particular in combination with filvestrin, in the ESR1 mutant setting. Pfizer has presented multiple times and has now initiated a phase three study. so clearly in our eyes a validated target. Where we think this could hopefully be brought to a step change advancement in this area is by hitting what we'll describe for now as a paralog with CAT6 and 7. As you know, we presented that data in peer-reviewed settings like AACR multiple times where we clearly see more activity preclinically with a 6-7 dual inhibitor versus 6, both in breast, CRC models, and lung models. And so that's the plan. We're in dose escalation now. The priorities are breast, CRC, and lung cancer. Pfizer also has a 6-7. They're side-by-side with us. They're also evaluating CRC. It looks like they also have an arm of just monotherapy in CRC, which is exciting. So we have cleared multiple dose cohorts. We believe we're now entering into the clinical efficacious range. So hopefully by the end of the year, we'll have a lot more information. And the last part I will mention, two combinations we're focused on. One is with CERD and breast cancer. And then the second is with PANRAS and KRAS-CRC. And we did publish that data as well at this last AACR.

Okay. And the significance, because that's an important point that you hit the 7-isoform 2, which gives you what exactly? What's the difference between that and ones that are just hitting the CAT6?

Yeah, so we have preclinical data, which we've published on publicly, both in vitro data as well as in vivo data. We believe there are specific bypass-type mechanisms with just CAT6 alone that you cannot fully suppress that pathway. and by doing that our hope is you know can we then deliver monotherapy activity because as you may know with cat six it's largely been dependent on this fulvestrin combination right so if you show real monotherapy activity you know right out of the gates it's clearly delineated we also know with cat six alone there has never been a pursuit of crc but now that's being pursued by fives over the six seven so again i think clearly shows there's fundamentally important biology by hitting both six and seven. So this is similar to how you think about, you know, CDK2 and four or MEK1 and two. So no different.

Okay. And versus Pfizer, I mean, you're basically doing something relatively similar in terms of the molecule. Have you done the comping? Has yours got more potency on one or both of the isoforms? Or is it more going to differentiate on, you know, the clinical development strategy?

Because you pointed out that, you know, they're already in late stage trial yeah we haven't seen much information published from them so you know it's hard for us to say at this point uh all we know is that they started dosing the clinic this year and as did we so you know i think we're basically side by side right now and you know hopefully there will be more information and data uh that's that's presented out there but clearly an exciting area uh an area that there's a lot less competition right now there's only two companies with a six, seven inhibitor in the clinic.

Right. Okay. And then briefly on, we want to ask all the companies about AI really fast. So if you could, anyone want to comment on how you're using AI tools, either with your rolling submission, with clinical work, with data analysis, with internal efficiencies, you know, other specific modules or platforms you're using more than the others, like, you know, Gemini versus cloud versus Copilot?

Yeah, I think I could contact him on this one. But yeah, so you got the the answer is it is a priority for us. We're integrating across drug discovery, clinical site, clinical site selection from a regulatory perspective. I know we're even having discussions around further downstream, such as, you know, reimbursement processes as well. I don't know, Daniel, do you want to?

Sure. I think in answer to your question, I could just say yes and put the mic down. You know, we're looking at this across the entire pipeline. We've been most public historically about the work that we're doing within Discovery using AI. So, for example, if you know the protein structure and you've got a specific binding pocket you're trying to generate a hit for based on the distribution of large and small amino acid side chains, positive and negative, hydrophobic, hydrophilic, there is a series of physical constraints within that pocket that we use AI to then try and generate a series of hits that may optimally fit within that space. We use additional software to then pass those molecules and say actually you know of these 100 possible hits focus on making these 20. Clearly that saves huge amounts of time and cost and we also analyze molecules from both sides and yes the ones that the software recommends to actually make do seem to generally do better although there's still some less good fits within those um there have been a number of discussions this year about using ai to improve the process around the incredibly heavy left uh to get all these documents together generate all the summaries within the regular documents that's that is ongoing work and i hope there'll be many more filings and regulatory documents to come um using ai to help identify where we'll find patients when it comes to commercialization to say nothing of all of the process efficiencies in gathering competitive intelligence running analyses helping with finance um it's been a big strategic priority this year and there remains a lot to do to your other question we use chat gpt some folks use clawed we've just started rolling out co-pilot so we're exploring multiple platforms to support the company um and uh any closing closing remarks or just maybe recap the key catalysts for the next, you know, through the Vermitt balance of the year?

Yeah, sure.

Lots coming. Exciting 12 months ahead. I think to recap, ESMO updates on the DLL3 asset, the neoadjuvant study, NDA submission on track for the second half into next year, preparing for commercial launch, hopefully in the first half. and additional progress that you should see throughout 2027 with regards to the mtap portfolio both the roche collaborations um the 892 program um hopefully getting additional registrational study studies started there um so lots more to look forward to when is the london day you mentioned oh yeah it's enough yeah yeah no it's it's uh november it's during the the

jeffreys conference in london okay so maybe i need to get a plane ticket all right all right thank you very much a great great discussion thank you great thanks