Hey, everyone. Thanks for joining the Oppenheimer Conference. Pleased to be with our next presenting company. We're gonna do a fireside with them, IDEAYA. Pleased to be joined by CEO Yujiro Hata. Yujiro, thanks for joining us.
Thanks so much, Matt, for the introduction, and thank you to Oppenheimer for the opportunity to participate this year. We look forward to the discussion today.
Totally. It's been a really good two years for you guys, and it seems like the story is really captivating people finally. I know it's been a long slog, but what's kind of happened over the last year, two years, that you think is really generating the momentum that we're seeing now?
Yeah, look, you know, I think it's several pieces here, Matt. So first, as you know, you know, darovasertib, I think we had a lot of key inflection points for that program in the last year and a half, including, you know, a lot of key phase II data, an oral presentation at ESMO, getting, you know, alignment with the FDA on what a potential registrational path can be. And here, you know, we're targeting a very high unmet need. We believe, clearly, this is gonna be a blockbuster opportunity, and, you know, we're trying to pursue first-line opportunities, which is, as you know, quite rare-
Mm-hmm.
... in the solid tumor space. So I think that's, you know, I would start with that. The second is our broader portfolio is maturing. So next, in the MTAP deletion space, as you know, you know, it's an area of high interest. Obviously, large patient population has been reported as high as 15% of all solid tumors. And Matt, as you're aware, you know, our thesis going into this pathway has been, for many years, the way we're gonna deliver the greatest patient benefit is through rational combinations.
Yeah.
And we believe when you look at it at that lens, I think it's clear, at least from our perspective, that we believe we're one of the leaders here. You know, we're most advanced with Amgen on the PRMT5 combination. You know, we dosed that first patient in August. We recently announced a second collaboration with Gilead and with Trodelvy and MTAP bladder. And both of those are big opportunities, but most importantly, areas where we have high scientific conviction, and clearly combinations that we believe are first in class.
Mm-hmm.
And then if you go beyond that, the last, you know, 18-24 months has been a period of high productivity in terms of continued advance for portfolio. As you know, PARG inhibitor 161 now is in phase I. We're seeing early efficacy there. Pol Theta is now in phase I. You know, we're targeting to get, hopefully, our fifth program in the clinic here shortly with Werner. So I think that is unique, you know, having five first-in-class programs, you know, all opportunities that we believe we have the opportunity to be first in class, and that we think are, you know, bona fide blockbuster opportunities, each. And then beyond that, you know, just kind of going back to our platform and our productivity there, you know, we're guiding for multiple candidates this year, right?
And so, you know, within a few quarters, I mean, you know, we, you know, we're at least targeting to have 7 or more first-in-class-
Mm.
... programs in the clinic. And then on top of that, you know, as you know, we have about $1 billion in cash. You know, prior to the financing we did recently, we had a runway already into 2028. So I think from that aspect as well, you know, it's been a lot of different pieces, I would say.
Yeah, the research engine is definitely humming right along. Let's start with darovasertib. That's, I guess you could say, the lead program here. You mentioned front-line opportunity in uveal melanoma. You're even going ahead of front line. You're, you're looking at neoadjuvant, and I think probably, correct me if I'm wrong, it seems like a lot of the interest in the story in, in the next few months is gonna be on that opportunity. Could you just talk about kind of what we're expected in terms of data flow? And I think you also mentioned maybe some comments on regulatory guidance.
Sure, yeah. I mean, maybe, maybe kind of take a step back here, Matt. Obviously, we're extraordinarily excited about the progress we're making on our first line potential registrational trial in metastatic uveal melanoma. But with that said, you know, I think when you think about oncology more broadly, and we brought this up in our R&D day in December, you know, I think where you can really make significant patient impact is in the pre-metastatic disease setting. And so for us, you know, what's unique here is that there's nothing approved, you know, from a systemic therapy perspective in either the neoadjuvant or adjuvant setting. And so it's, you know, it's, it's really unbelievable. I mean, this, you know, this whole space is completely wide open, and, and we believe based on the specific properties of this molecule, and we...
What we've seen clinically, that, you know, we have a real opportunity here to really make a difference for these patients. And, you know, perhaps even, you know, in many ways, I'm an optimist here, but to really, hopefully, alter the patient journey for these patients, which, you know, frankly, once you're at the point of metastatic disease, it's a really tough situation.
Mm.
So I think here, you know, maybe for the viewers and listeners that may have less knowledge, but, you know, we've already shared early clinical efficacy data in the neoadjuvant setting. You know, I think really the key takeaways here is the drug appears to be working as a monotherapy. The drug appears to be generally well-tolerated from what we've observed already and already shared publicly, and we're seeing a clear signal. We're shrinking tumors consistently, and in many cases, you know, very robust tumor shrinkage. And for patients where we've treated that are enucleation candidates, we're preserving a lot of these patients' eyes.
So, you know, so the alternative here are these patients start getting either their eye surgically removed, or they're getting plaque therapy, which, you know, frankly, is not a great procedure either. So on adjuvant, we view that as a separate opportunity. You know, we'll likely be splitting up those two opportunities, and, you know, I, I think we'll be talking more about adjuvant here, through this fireside.
Interesting. So but in the neoadjuvant, you are also kind of splitting it up into two groups. One, right, I mean, you mentioned one is those patients whose tumors are so large that they are enucleation candidates. They are candidates to get their eye removed, basically what it means. And then for the smaller ones, they can be treated, perhaps with brachytherapy. So you're segregating the trial into two different buckets, right?
That's correct. Yeah, so there's really two patient populations within the subgroup of neoadjuvant to think about. The first are patients that are scheduled to get enucleated, and, you know, we hope there, the endpoint's pretty clear, right? It could be, you know, can we get endorsement from the FDA that it's around eye preservation? You know, what % of those eyes can we get them off of the enucleation track? So I think there, the great part about that kind of endpoint would be, one, it's very clear. You hit your result or you haven't. Second is we think that endpoint could get read out quite early, and depending on what threshold would be deemed as acceptable by the FDA, the benchmark might be quite low relative to what were already shared publicly.
And that's really gonna be the focus of the conversation with the FDA, that we've already guided, that we'd like to have that discussion this year. But, you know, I think from our perspective, it's gonna just be about what effect size we see, the risk-benefit, and, you know, we do think this is just an extremely important area for these patients. On the plaque therapy side, that's the second group. You know, here, what we would likely do ultimately is do darovasertib, followed by plaque versus plaque alone in a randomized fashion. You know, here, you could potentially look at endpoints like, for example, response rate, radiation reduction, and vision preservation. There is precedence for several of those endpoints with the FDA, so we're not completely paving new ground.
Just so it's clear, our effort here is not to just address the large ocular tumors in the primary setting-
Right.
... but to treat all of these tumors, all of these patients in the primary uveal melanoma setting, and we want to be very clear about that. You know, we think ultimately, this therapy should, should, you know, all of those patients should get access to it. Just the last piece, Matt, I, I probably should have mentioned, you know, as you know, we've guided towards a mid-year clinical efficacy update. You know, to date, we've shared, patients that are gonna get enucleated. We already have data also on patients that were gonna get plaque therapy, and those are smaller tumors, right? And so now the question is, what kind of effect are we having on those? Because the enucleation, from our perspective, is sort of worst-case scenario, right?
Mm-hmm.
'Cause those are patients where these tumors have already grown to, in some cases, you know, just massive sizes. So, so I think that'll be also very informative as, as part of this update 'cause it won't just be enucleation, but, you know, we will also anticipate to have a decent amount of, you know, those small to medium-sized tumors as well.
Yeah, I see. 'Cause initially, this was driven by an investigator-sponsored study that you did out in Australia, I believe, and some of the data looked compelling there. You decided to kind of bring it in-house, but at the IST was all based on kind of the larger tumors. Now, adding the smaller ones was something that you've done in-house, right?
Correct. Yeah, and then, and then the question there is, what do you see in those small to medium-sized tumors, right? Is the, is the data worse, is it similar, or is it better, right? So, 'cause again, you know, those are the predominance of patients, and, you know, from our perspective, at least going into this, our view was enucleation from a prognosis perspective were probably the toughest patients to treat, right? 'Cause they were the latest-stage patients. And already there, you know, we've seen, you know, exciting data based on what's already been publicly shared.
Are the goal—like, the goalposts pretty well established in terms of the size of the lesions, where you say, "Okay, if you're above this size, you're enucleation. If you're above this size, you do brachy"?" So this is... You're not gonna be arguing with the FDA on kind of treatment protocols themselves versus just endpoints.
Yeah, so I would say they're standardized within regions. So in the U.S. and certain parts of Europe, they're fairly standardized. So I think that's gonna be fairly straightforward. You know, one of the concepts that we're thinking about internally, as opposed to kind of describing it as enucleation, which I think is probably more very specific, you know, could we sort of do the trial and just describe them as large tumors? So we just create some threshold to size and say, "You know, we're gonna treat those patients," 'cause ultimately, those ones that are getting to the larger size, right, they may eventually also get enucleated as well. So I think that's kind of our current thinking, but, you know, we're still finalizing the plans.
I know the team has been very active at work, meeting with leading KOLs here to just refine our thinking on some of the questions you're bringing up-
Mm-hmm.
... just in preparation for this potential discussion with the FDA that we've guided for this year. So the team has been doing a lot of great legwork there. And, you know, I think we should be in, I would say, good shape here, fairly shortly.
Good to hear. I think you brought it up earlier, but the adjuvant setting is, is one that you mentioned, and I think that that might have been the first time I've heard you mention that. So can you just talk about the differences between neoadjuvant and adjuvant? Obviously, everyone knows, like, neoadjuvant is before surgery, but how does this manifest in uveal melanoma? Effectively, patients get their eye removed, and then they would have treatment on top of that?
Correct, yeah. So the way I would think about it is, you know, the neoadjuvant, our, you know, patients who are getting initially diagnosed with a tumor in their eye, right? And then they have several treatment options. "Okay, we'll remove your eye, we'll give you plaque therapy," or a large subset of patients are actually just a wait and see. And-
Yeah.
... you know, I think later we may talk about the market size, but that pool of patients that are wait and see, you know, our, our patients, we think we can capture. So that's why we think this could be much larger than just annual incidents 'cause there is that total prevalence piece as well.
Mm.
But to be more direct to your question, then they'll get that, as you said, the primary procedure, enucleation, plaque therapy, and then they would continue on into the adjuvant phase. So and then there, you would wanna measure endpoints, specifically relapse-free survival. You know, typically, you'd wanna monitor 1 year, 2 year, 3 year. In this situation, 'cause there's nothing approved, I mean, what we would target is to try to get front line approval in the adjuvant setting. This would be, what we anticipate would be randomized against placebo. So obviously, you know, quite a low bar. And, you know, we would have, you know, personally, I think, quite a bit of confidence going into that study as well, because we're seeing activity in the metastatic setting, we're seeing activity in the neoadjuvant setting.
I just don't see why we're not gonna see activity in the adjuvant setting. We are thinking about, you know, the dosing schema, which, if that's helpful, I could go into more detail. I think we've been refining our thinking on this, but, you know, as part of one of the reasons why, you know, the recent financing is that, you know, should we go ahead and launch, an adjuvant trial, you know, potentially even a registration-enabling trial? So we're, you know, having that discussion internally. But as you know, you know, if you can really deliver on adjuvant, I mean, it's a game changer, right? I mean, that's really where you're gonna drive the greatest patient benefit.
If you could really impact relapse, then, you know, you've got a chance to change the course of this disease, which is, you know, I think ultimately, as an organization, what we're about. But it's a longer trial, right?
Sure.
I think that from that aspect, the sooner we get it going, the better, frankly.
What is your ideas on dosing? Would you dose down in an adjuvant, considering it'd probably be used much longer than just the six months that the neoadjuvant is being tested in?
Yeah, so I think, Matt, we're not too worried about that because we know that daro at, you know, at the dose we've tested in the metastatic setting, as a monotherapy, has been well-tolerated for years, right? We've had patients that were confirmed PRs, that were on treatment, you know, 2.5, 3 years. We even had a complete CR that was on treatment going out to 5 years. So we know patients could tolerate quite long. I think here, what we're thinking about is, you know, should we consider, let's say, starting as a combo first for a few months, and then transitioning to mono and, you know, maybe try to have a longer duration of treatment in the adjuvant setting. You know, let's just say, for example, 1 year, versus 6 months.
So that would have two benefits. You know, one is, could it drive greater activity in the adjuvant setting? And as you know, duration directly impacts market size, right? And so we can extend market size further even by about, you know, having a longer duration. And we're thinking the same with neoadjuvant. Our, you know, our existing protocol, we're treating up to six months, but we ultimately, frankly, we think it could be a lot longer than that.
Okay.
You know, maybe it's a year, and maybe in a subset of patients, might even be actually longer than that as well.
Gotcha. So kind of maybe just touching on the metastatic setting now. We've talked about neoadjuvant, we've talked about adjuvant, now we have to talk about metastatic. Metastatic obviously was the first one.
Yeah.
We had really nice data last year. Phase III is up and running. It kind of seems like that program's now maybe on the back burner for investors, given that it's, it's gonna take some time to accrue. Have you updated at all kind of guidance on when you think top line from that trial will be and when you could file?
Yeah, we haven't, Matt. I think what I can say though, however, high level, is you know, a lot of our analysts are projecting sort of a late 2026 launch, and so we have pegged our enrollment targets based on that. You know, I think as you said, ultimately, you know, right now it's just about execution. You know, for accelerated approval, the primary endpoint would be median progression-free survival. You know, all the data that we've seen so far gives us confidence around that in terms of at least our, you know, our prior phase II study. And so now we just have to execute and enroll it as fast as we can.
You know, at the end of the day, as you know, all that matters now is the hazard ratio and what that readout is in this randomized fashion. So I think here, the primary update investors should, you know, be watching is just what is our cadence of enrollment, right? And we've already given some update on that during early January at JP Morgan week, where we noted double-digit enrollment had already been achieved. So this is just, you know, pure execution. We're trying to get our international sites activated as fast as we can and just ensure that we're remaining at enrollment clip that we feel good about to hit our, at least some of the guidance from our analysts.
No, that makes sense. And I mean, there are precedents, too. I mean, you just had Immunocore get approved, albeit in a different HLA segment. But, you know, there are precedents for kind of what enrollment should be, and we know-
Mm.
... kind of how big this market is. I think the size of the market may have caught a lot of people off guard, that it's a lot bigger than many had thought.
Yeah, and I, and I would hope in some ways, you know, our, our enrollment, you know, hopefully could go faster, right? I mean, it's an oral agent. We think the HLA-A2 negative is the majority of the population. So you know, like, and so I, you know, so I think that that would be the case, but, you know, we just have to continue to see how it goes. But thus far, everything's on, on track as we had hoped.
Good to hear. Let's switch to IDE397, MAT2A inhibitor program that I think you guys may have even started out with before darovasertib kind of took over in the limelight. And, you know, so oncology drug development's never a straight line, right? But it does seem like now, MTAP deletion is getting a lot more excitement, a lot more buzz, than it has in the past. For good reason, it's 15% of all tumors, so it, it's a potentially a goldmine of an indication. But your thoughts have always been on combinations here, and very early on, you, you identified PRMT5 as a potential partner. Amgen has a PRMT5 that they're developing. You have a partnership with them. You're studying it in combination.
What did you think of the Amgen monotherapy PRMT5 data that they presented at Triple Meeting, you know, back in October, September?
Yeah, look, you know, you know, obviously it's, it's Amgen's data, so, you know, I just wanna be thoughtful about that. But, you know, look, I, I thought the data was exactly as we had expected. You know, I know there's been different data reported here publicly in terms of clinical data. I, I think Amgen's right in there. You know, I think they've got a really good opportunity to be both first and best-in-class. And as you know, you know, Matt, especially in oncology, first mover, especially first mover to market, has a huge advantage, right? And so, you know, and I, and I think Amgen's as well-positioned as anybody.
You know, I think ultimately at the end, as you know, Matt, our, our perspective has been for a very long time that, you know, we, we wanna see more efficacy, including from what's been publicly disclosed. We wanna, you know, drive greater durability. And, you know, especially if you wanna go after difficult indications like lung cancer, or you wanna get into the earlier line setting lung cancer, you know, there's just a lot of therapies there, and that's agnostic of specific biomarkers, right? And so we know, you know, and as you're well aware, you know, therapies such as, you know, PD-1 and, and chemo are, are high bars. So, you know, you're gonna have to come in and deliver a pretty dramatic result if, if you really wanna gain market share there.
Ultimately at the end, you know, based on all the basic science we've done, we're just... You know, that's our view. We just believe that's gonna be delivered through combination. And, you know, again, we're not just trying to enhance response rate. Ultimately, we wanna ensure we can drive durability. So, 'cause at the end, as you know, you know, the importance here is gonna be, you know, a lot of this is gonna be about the time to event endpoints, including PFS and OS, at the end.
How would you characterize your relationship with Amgen right now on running this combination trials? Is it collaborative, or are they kind of working behind a dark room?
No, look, Amgen's been great. I mean, we... You know, look, I, we give them a lot of credit. You know, they, not a lot of companies kinda came in. They jumped right into a novel combination. You know, I think we're very strategically aligned on the importance of this combination and the importance of the mechanistic rationale. They've got a really good molecule there, and we're ahead, right? So we dosed our first patient in August, and, you know, we've also generated a lot of preclinical data that I would, you know, at least from our perspective, you know, just gives us further confidence of the importance of this combination from a pure mechanistic perspective. So and, you know, and I think at the end now, we're generating clinical data, right?
Which is, which is really what's gonna matter. So, but no, overall, we would say, they've been a terrific partner, very collaborative. I, I know the research teams are in, are in dialogue regularly. I know we're actually doing more and more work with them on that front, even in the last couple of weeks. I think we expanded, what we're doing there. So, and as you know, you know, we have already jointly published together in a peer-reviewed setting last year at AACR, and, you know, you probably saw the guidance for 2024, where we've now noted, you know, development of a joint publication strategy with Amgen, this year as well. So I, I think it'll be exciting.
I think if anything, you know, what we could say is, you know, I think IDEAYA and Amgen, you know, hopefully will be trailblazing this area and, and really helping the public understand why, you know, this is exciting from, from a pure, you know, scientific perspective as well.
I think a lot of people lose sight of the fact that GSK that you originally had partnered out this program to GSK, and they gave you the rights back. So how, how funny would it be, and how... We never see it when something like, when you get, when a company gets the rights back to a drug, it actually works out the best in the end, 'cause it allowed you to partner with Amgen then. Would that be it?
Yeah, look, you know, I think there's always complicated calculus at the end, Matt. But, you know, I think from our perspective, it's all about the data we're generating now.
Mm-hmm.
You know, obviously a lot of this data is new, you know, was not there at the time of the decision from GSK. But, you know, I think right now we're feeling really good about where we are. We continue to feel very confident about the mechanistic rationale, preclinically. And, you know, ultimately, our view is to really drive that durability, particularly in tumor types like lung cancer. You know, this combination, you know, we think is really one of the most important potentially, and, you know, 2024, without a doubt, we know we will have a lot of data-
Yeah.
... on this combination this year.
Well, based on that, I mean, the strength of the preclinical data, I think speaks for itself on the efficacy side. But the concern from the investor side, as and maybe investigators as well, has always been on safety. You're kind of taking an interesting approach here, where you're starting at very low doses. Do you think that they could be efficacious in combination?
I mean, the preclinical data would support that comment, Matt. I mean, the preclinical data, you know, right now says that the... Again, that's been published in a peer-reviewed setting, is that, you know, we are seeing, you know, dramatic efficacy, much-reduced doses versus, you know, each monotherapy dose, individually, right? And so obviously now the question will be, in the clinically, what, you know, what are we seeing? You know, look, I, I think at the end of the day, you know, Matt, here, I think just this is really important for us and our, our communication on this. You know, preclinically, you know, we, we didn't see anything specifically of concern, right? We've, we've published data around body weight changes, et cetera.
You know, we've already noted publicly that there's nothing specific we're concerned about in terms of the AE profile observed clinically on each agent. Obviously, Amgen, of course, looked at this, as did we. But ultimately at the end, you know, we just have to, we have to go in there, which we are, in the clinic, treat patients, and see what we see. But I think the good news is, you know, thus far, we, you know, we, as you know, we dosed our first patient in August, and we're, we're pushing forward. And so, but, you know, I think as this year continues and, you know, there, there will be different milestones, you know, we have the opportunity ahead, including, you know, picking an expansion dose, et cetera.
You know, hopefully defining what our publication strategy with Amgen is. And, you know, with time, more of that data will get generated. But, you know, thus far, you know, going into this, there wasn't a specific, you know, item that we were, you know, focused on from an AE perspective.
Do you think all MTAP deletions are created equal, or are there going to be some tumors that respond better than others? You mentioned lung. Do you think that's really the best, best location for this?
So I can answer that question pre-clinically, and I think pre-clinically, the answer to that is definitely yes. MTAP tumors are different. And, you know, some of that is based on the level of MT elevation, different sensitivity we see, as it relates to that. And, you know, that's not specific to a target of PRMT5 or MAT2A. You know, we see differences across these tumor types. So, you know, I think clinically, you know, we're still interrogating that. But, you know, all I can say is that, you know, we do see translation and consistency from pre-clinical to clinical.
I see.
You know, as you know, Matt, I think the comment I made about they are different across tumor types, you know, we would basically fall in pretty much what's been almost always the case or, you know, usually the case, across precision oncology with a biomarker, right? I mean, it's been rare. We haven't really seen situations where it's been just consistently across the board.
Mm.
So, I think we're just falling in the bucket of what's typically been seen in precision oncology in general.
Do you want to talk a little bit about your recent collaboration with Gilead? You're not married to Amgen on this particular asset. The Trodelvy combo has kind of a different biological rationale, but I'm kind of wondering, given some of Gilead's struggles with Trodelvy of late, if maybe lung cancer might be another possible opportunity for you.
Yeah. So, so maybe for the listeners here, yeah, we're very excited about the new relationship with Gilead. You know, it leverages a distinct MOA than what we're doing with Amgen. I think there's a lot of positives here with Gilead. You know, one is Trodelvy is approved, right, in bladder cancer, which is our focus right now, for the combination study. And just, you know, maybe just high level here, you know, what we're really leveraging is around this biology, around the purine and pyrimidine pathway. And, you know, as you probably know, there's been data that's already been published, around sensitivity of chemos, like pemetrexed in the MTAP setting. There's been retrospective analysis of Trodelvy as well in bladder, which has demonstrated a higher response rate in MTAP.
And we think this is all connected around this purine, pyrimidine, folate pathway. And so, you know, we think there's already clinical data out there that supports this hypothesis. We know our drug is also active at MTAP bladder, that that's been publicly shared. And I think we have an opportunity... Well, you know, we think we can create a perfect storm here because, you know, one of the key aspects of MAT2A and an impact on purine and pyrimidine is, is around impact to what's called nucleotide pools. And, you know, without getting into too much details, when you have DNA damage that occurs, you know, through these topo payloads, nucleotide pools actually play a critical role, as it relates to that repair. And so, you know, we're basically gonna try to leverage that, that aspect of this.
So I think, you know, similar to what we're doing with Amgen, A, we think the mechanistic rationale is very clear, B, you know, we have preclinical data that supports it. Now, in terms of other tumor types, yeah, I mean, I think probably the next most obvious one to think about would be lung cancer. So, you know, I think here, let's, you know, kind of go in there, generate some of the data we see in bladder. But, you know, similar to what we're doing in Amgen, where that focus is lung cancer, our focus with Gilead is in bladder cancer. Our expectations are high here. You know, the first is, as you know, we're gonna have to again establish safety, hopefully find a well-tolerated combination dose.
But, MTAP bladder is a big opportunity because the prevalence is almost 30% of bladder cancer.
Yeah.
Sorry, I should have mentioned, you know, EV and pembro, you know, which is now becoming kind of the frontline care in bladder. There's also again been done studies both with checkpoint and EV, where they show a worse prognosis, both PFS and OS, in the MTAP setting. So it's kind of a very unique situation because what's frontline is not doing as well, it appears, in MTAP. And then in the flip, you know, we're seeing, we think, enrichment with Trodelvy. Our drug is also working in that setting, and so we hope in combination. You know, if it's successful, I think really the opportunity is that we could try to get this combination in MTAP bladder into the earlier line setting, and even potentially in the frontline setting.
Yeah, I was gonna comment. It almost seems kind of like from a higher level, the strategy behind your different pairings for the MAT2A, it almost seems like you're setting yourself up for a bidding war, but you don't have to answer that question.
Well, I think what we're setting ourselves up for is, you know, two shots on goal that we have high conviction on in terms of the combination, you know, two shots on goal that right now are first in class. And they, you know, address, you know, big patient populations where there, where there's a high unmet need, right? There's nothing approved in MTAP lung, and there's nothing approved in MTAP bladder.
Yeah. We're basically out of time, but maybe just quickly, if you want to talk about milestones that we haven't talked about yet. Again, I mean, the darovasertib, neoadjuvant data, regulatory strategy this year, probably, a MAT2A combo with PRMT5 this year, and also maybe some PARP data. Is that right?
Yeah. So the guidance we've given on PARP is that we'll be giving program updates this year. We were not specific to data updates, but here, you know, I think we want to, you know, still pick an expansion dose for phase II. Hopefully, we can continue to prioritize the tumor types. You know, we have publicly disclosed that we're gonna enable combinations this year. Those discussions are going very well, so, you know, we feel good about that guidance. Werner, as you know, we're planning to deliver an IND, and, you know, hopefully, that'll be in the clinic this year as well. So I think we'll be, as you said, you know, across the portfolio, hopefully driving value, for our shareholders and, you know, opportunities that we have, you know, very high conviction on.
And then on top of that, you know, hopefully, we'll be able to pick multiple candidates this year. You know, we will likely, you know, disclose putting out releases when we achieve those, which, you know, then puts us in a really unique opportunity, as we said in the very beginning, you know, seven or more potential first-in-class opportunities, hopefully by the time we close out this year. So there's a lot of catalysts, and, you know, across the portfolio, you know, basically from our most advanced to our earliest. So it's, you know, at least from our perspective, it's, you know. You know, there's obviously a lot of execution this year, but, you know, we're very excited about what's to come.
Lots going on. It's tough for your analysts to stay on top of the story with so many different moving pieces. Congrats on all the progress. Thanks for coming to the conference this year, Yujiro. It's good to have you.
Yeah. No, definitely. Thank you, Matt, and again, thank you to Oppenheimer for the opportunity today.
Talk soon. Okay, bye.
Bye for now.