Kura Oncology, Inc.

Good day, everyone. My name is Abigail, and I will be your conference operator today. At this time, I would like to welcome you to the Cura Oncology's Q4 and FY 2025 financial results earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, and if you have joined via the webinar, please use the raise hand icon, which can be found at the bottom of your webinar application. To allow everybody the opportunity to participate, we ask that you please limit yourself to one question and then re-enter the queue for any follow-ups. At this time, I would like to turn the call over to Greg Mann, SVP of Investor Relations and Corporate Affairs of Cura Oncology. Please go ahead.

Thank you, Abigail. Good morning and welcome to Cura Oncology's fourth quarter 2025 conference call. Joining the call today are Dr. Troy Wilson, President and Chief Executive Officer, Brian Powell, Chief Commercial Officer, Dr. Molly Leone, Chief Medical Officer, and Tom Doyle, Senior Vice President, Finance and Accounting. We remind you that today's call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that cause actual results to differ materially from expected results. Please refer to Cura's filings with the SEC, which are available from the SEC or on the Cura Oncology website, for information concerning risk factors that could affect the company. With that, I'll turn the call over to Troy.

Thank you, Greg, and good morning, everyone. 2025 was a defining year for Cura, marked by FDA approval of ComSifty and initiation of a successful commercial launch. As we enter 2026, our priorities are clear. Execute commercially, move aggressively into frontline AML and combinations, and build long-term leadership in men and innovation while advancing a data-rich pipeline. ComSifty generated $2.1 million in net product revenue in the final weeks of 2025. Although it's early, the launch is off to a strong start. Feedback from physicians, pharmacists, and payers has been consistent. Comsifty delivers meaningful efficacy with differentiated safety, simplicity, and combinability with concomitant medications. In medically complex AML patients, that matters. We believe leadership in relapsed and refractory NPM1 mutant AML will be determined by preference, not by who enters the market first. Importantly, Comsifty is now listed in the FDA's Orange Book with patent protection through July 2044. That runway strengthens the long-term value of the franchise, particularly as we expand into frontline AML and combination settings. Our strategy extends well beyond the initial approval. Enrollment is underway in our Pivotal Comet 017 frontline trials, and 2026 will bring important data in both the frontline and relapse refractory settings. We're positioning Zip2Mentib as a foundational combination partner in AML, including with FLT3 inhibitors and standard backbone regimens. Across relapsed refractory and frontline AML, we estimate the total U.S. opportunity at approximately $7 billion. Beyond AML, we're advancing a focused solid tumor strategy. Our ziftamidib combination with imatinib in gastrointestinal stromal tumors, or GIST, is progressing in dose escalation, and our next-generation MENIN programs are advancing. Darlifarnib, our farnesyl transferase inhibitor, is designed to address resistance mechanisms across multiple oncogenic pathways. Its combination flexibility, including with cabozantinib, KRAS inhibitors, and PI3 kinase inhibitors, gives it potential to impact more than 200,000 patients annually in the U.S. We expect multiple clinical updates this year. In short, we're executing commercially, expanding development of Zip2Mentib across the AML treatment continuum, and advancing a pipeline with meaningful catalysts in 2026. With that, I'll turn it over to Brian.

Thank you, Troy. Good morning. Our commercial objectives for ComZip2 are straightforward. Establish clear differentiation in the menin inhibitor class, deliver strong quarter-over-quarter growth, and achieve leading class share in relapse refractory MPM1 mutant AML. The early launch is exceeding expectations. I could not be happier with the execution of a world-class team who have been laser-focused on delivering a strong launch. Prescription trends are strong, and the qualitative feedback has been consistent and encouraging. Physicians, both academic and community-based, consistently cite ComZifty's clinical activity and ease of use. Once daily dosing and lack of required azole dose adjustments are meaningful advantages in real-world AML practice. Institutional pharmacists firmly echo this. In complex patients on multiple medications, safety and predictability drive confidence. We also hear clearly that the safety profile matters. ComSifty carries a single box warning for differentiation syndrome compared to multiple box warnings for a competitor. That difference is resonating. Importantly, ComSifty was added to the NCCN guidelines as a Category 2A recommendation within a week of Cura's submission. That rapid decision reflects enthusiasm and strong alignment among clinical thought leaders. Operational execution has been strong. ComSifty was shipped within days of approval, and our experienced sales force brings an average of more than 20 years of industry experience and deep hematology expertise. The team was trained and fully deployed, and in partnership with Kiwakirin is targeting more than 4,000 hematology professionals. Our message is simple. NPM1 mutations are now actionable, and ComSifty offers a differentiated profile. Access has been a major strength and highlights a powerful leading indicator early in the launch. We engage payers covering approximately 90% of insured lives prior to approval. Within 90 days, approximately 84% of private payers had established coverage aligned with the label and without additional restrictions. That speed of coverage surpasses both industry benchmarks and our internal expectations. We're also thrilled to report that certain blue plans are now requiring patients to go on ComZifty before allowing coverage for the other approved med and inhibitor. It's our understanding that their decision to implement this step edit was based on the efficacy, safety, and predictable price per patient. Step editing is uncommon in oncology. We view this as a meaningful, independent validation of ComZifty's profile and competitive advantage as the class evolves. ComSifty is distributed through a focused network of specialty distributors and pharmacies. Through CuraRx Connect, the average time for prescription to payer decision is two days. Patients are getting rapid access. We estimate the initial U.S. market for NPM1 mutated relapse refractory AML at approximately $350 to $400 million annually. This is our starting point. On top of our enthusiasm about our early launch, we strongly believe that long-term leadership across the AML continuum will be determined by breadth, by who can combine effectively with Veneza, 7 Plus 3, and FLT3 inhibitors and take the lead in frontline disease. ComSifty's profile, particularly its safety, combinability, and simplicity, position us to maximize the efficacy benefit across settings and drive class leadership. In the near term, we'll remain focused on quarter-over-quarter growth, net revenue, and new patient starts. Over time, we anticipate providing additional metrics to track progress. I'll now turn it over to Molly to discuss our pipeline.

Thank you, Brian. FDA approval in relapsed refractory NPM1 mutant AML was a major milestone, and it's just the beginning. We are building a durable, expanding franchise backed by the most comprehensive development strategy. Our goal is clear. Make ZIFTA men of a foundational therapy across AML. We are executing the most comprehensive development strategy in the category. We expect to deliver multiple updates this year across key programs at major medical meetings supported by an expanding publication plan. Relapse rates in AML remain high, up to 70% within three years. We believe deeper and more durable outcomes require moving effective therapies earlier in treatment. This drives our first-to-frontline strategy. We are rapidly advancing our registrational COMET-017 program in newly diagnosed AML, which will recruit patients at approximately 200 global sites. The program includes two independently-powered trials, intensive and non-intensive chemotherapies, each designed to support potential U.S. accelerated approval and full approval. Data from the Phase I COMET-007 trial support this strategy. In newly diagnosed patients treated with 7 plus 3 or Veneza plus F-Dumeneb, We observed high CR rates and deep MRD negativity. Importantly, the addition of ziptomenib did not meaningfully delay platelet or neutrophil count recovery in either combination. We expect to present updated intensive chemotherapy data from COMET-007 in the first half of 2026. In parallel, we are preparing a manuscript detailing ziptomenib in combination with veneza in the relapse refractory MPM1 mutant AML setting. Data presented last December showed encouraging safety, tolerability, and clinical activity in this population. The combination was generally well-tolerated without additive toxicity and meaningfully improved overall response rate, composite CR rate, and overall survival relative to ziptomenib alone. We view this as an important component of our strategy, and we believe it has the potential to significantly improve outcomes in patients with relapsed refractory MPM1 mutant AML. FLT3 commutations present another significant opportunity, and one we are well ahead of competitors. We are evaluating zyptometab in combination with giltaritinib in the relapse refractory setting and with quisartinib in the frontline setting. If we can demonstrate the ability to combine zyptometab safely with FLT3 inhibitors, we believe that will be a key differentiator. Outside AML, Comido 15 is evaluating ciptometabatinib in patients with advanced GIST. Dose escalation continues without dose-limiting toxicities in a broad range of doses. We remain very encouraged and plan to provide an update when appropriate. Turning to Darlafarnib, we are advancing this FTI in combinations to address resistance biology across solid tumors. We announced today the initiation of the Phase 1B dose expansion of FIT001 with cabozantinib in advanced renal cell carcinoma. The Phase 1B portion comprises a randomization into three arms in line with Project Optimus, including one cabozantinib monotherapy arm. This third arm provides a control benchmark and enables us to evaluate the combination in patients who are not responding to or just beginning to fail cabozantinib therapy. Phase 1a dose escalation data from FIT001 showed encouraging safety and tolerability as well as antitumor activity, including in patients previously treated with cabozanib. Updated data will be presented in the second half of this year. We also plan to present preliminary data from our Phase Ia study evaluating darlofarnib with adagracib in patients with KRAS G12C-butated lung, colorectal, and pancreatic cancers in the first half of 2026. Finally, our menin inhibitor programs continue to advance, including preclinical work in solid tumors, as well as diabetes and cardiometabolic indications. In summary, we are working to move ZIFTA men up earlier in the AML treatment paradigm, expanding our combination strategies and advancing a second growth pillar with the FTI platform with multiple catalysts this year. And with that, I'll turn it over to Tom for a financial update.

Thank you, Molly. I'm happy to provide a brief overview of our financial results for the fourth quarter of 2025. As we pre-announced in January, our net product revenue from COMS 50 sales was $2.1 million compared to none for the fourth quarter of 2024. The first commercial sale triggered a $135 million milestone payment under our collaboration agreement with Kiowa Karen. Collaboration revenue from our Kiowa Karen partnership was $15.2 million compared to $53.9 million for the same period in 2024. Research and development expenses were $64.4 million compared to $52.3 million for the fourth quarter of 2024. The increase was driven by ZeptoMedib combination trials, including the start of enrollment in our Comet 017 trial in 2025. Sales, general, and administrative expenses were $39.1 million compared to $24.1 million for the fourth quarter of 2024. The increase was driven by the commercial launch of ComSifty. Net loss for the fourth quarter of 2025 was $81 million compared to a net loss of $19.2 million for the fourth quarter of 2024. This includes non-cash share-based compensation expense of $11.3 million compared to $8.6 million for the same period in 2024. As of December 31st, 2025, car ad cash, cash equivalents, and short-term investments of $667.2 million compared to $727.4 million as of December 31st, 2024. Our $667.2 million balance at the end of 2025 reflects fourth quarter 2025 receipts of $195 million for the first commercial sale of ComSifty and Comet 017 enrollment milestone payments. CUR is providing guidance for collaboration revenue, which reflects non-cash-based accounting recognition of performance obligations under our collaboration agreement with Keogh Cairn. We expect this to be $45 to $55 million in 2026, $90 to $110 million in 2027, and $90 to $110 million in 2028. Current cash, cash equivalents, and short-term investments as of December 31st, 2025, together with anticipated milestones of $180 million under our collaboration agreement with Kiowa Current, are expected to fund our Zepto-Managed AML Program through the first top-line Phase III results from Comet 017 anticipated in 2028. With that, I turn the call back over to Troy.

Thank you, Tom. Cura enters 2026 with strong momentum. We have a launched product, which is performing well. We have the broadest frontline AML development strategy underway. We have multiple data readouts ahead, and we have a second platform advancing in solid tumors. Our priorities are clear. Accelerate uptake of COM50 and relapsed refractory NPM1 mutant AML. Deliver strong quarter-over-quarter product revenue growth. Advance and execute on our first-to-frontline strategy. generate and publish combination data which guides treatment decisions and deliver clinical updates across our FDI platform. 2026 will be a year of execution, expansion, and data. We're building a durable franchise in AML and a broader oncology pipeline with both breadth and depth. Everything is moving forward commercially, clinically, and operationally, and we're focused on converting that momentum into long-term value for patients and shareholders. With that, Abigail will conclude and open the call for questions.

We will now move to our question and answer session. If you have joined via the webinar, please use the raise hand icon, which can be found at the bottom of your webinar application. When you are called on, please unmute your line and ask your question. Our first question comes from Lee Watzek with Cantor Fitzgerald. Lee, please unmute your line and ask your question.

Hey, good morning. Congrats on the progress. Maybe a commercial question for Brian. You made a very interesting comment about step editing that some peers may require to use CompZipT before the competitor product. I just wonder if you can, you know, give us a little bit more information about that. What percentage of peers have implemented this step through policy? and any specific feedback you can share from peers regarding this data.

Yeah, thanks, Lee, for the question. I'm going to just to remind everyone, we're going to try to limit one question per analyst so that we can get through everyone. But, Brian, I'll let you, you know, there's two or three questions tucked in there. I'll let you, you know, speak to them.

All right, thanks. And thanks, Lee, for the question. Yeah, yeah, as was shared in the remarks, I think We think that this news of a step added and required from some payers that's just come forward is a powerful leading indicator that supports kind of our overall assertion about CompZifty being differentiated. You know, I will say that our team, the market access team, has done a phenomenal job securing access and working with payers so broadly to get this access so early. What I can kind of share around the step-edit, and as you know, the recommendation from some of these payers is that a patient would be recommended to receive ComZipty before receiving any other med and inhibitor. Our understanding is the basis of that is built on a patient's And a report from a group called IPD Analytics, it's an independent consulting firm who is influential to many payers. And their recent reports of the relapse refractory market and evaluating COM-50 recommended this step edit for adult patients with relapse refractory and PIM1 mutant AML. We know that there are some payers that have started to implement that, as I shared. The biggest driver from what we can understand from the from the consulting summary from IPD is that Really, you know, the four pillars we talked about around the differentiation of ComXifty stood out, particularly because of the predictability of the cost. If you look at the – based on their assessment, the annual WAC for ComXifty in this setting is about just under $600,000 a year. But with our competitor, MedInhibitor, because of the different dosing schemas and SKUs that come forward, it comes out to almost a million dollars a year. And I think that's where we see they're driving the difference when you also add in the safety profile, the combinability and the predictability of that. So I can't really give you, you know, an overview of how many plans. There are a handful. And we can't predict how many other plans may do this in the future. But it's encouraging for us as we look to become the class leader here in the NPM1 space.

Thank you.

Your next question comes from Roger. Your next question comes with Roger Song from Jefferies. Please unmute your line and ask your question.

Excellent. Congrats for the update and then the very encouraging early launch signal. So the step-by-step is certainly very interesting. Maybe just given the access is very rapid and broad, Can you comment on the patient demand side versus the revenue generation? If anything, you can comment on the trend for the rest of the year. That would be helpful. Thank you.

Yeah, thanks, Roger. I'm happy to do that. So, you know, we haven't – We're not going to be giving you guidance specifically on the trend. What we can tell you is that the launch has, as I said, has been off to a very strong start. We are seeing patient demand. You know, the feedback we've heard from physicians has echoed back the differentiation pillars that we've talked about. Payers, physicians, and pharmacists have all kind of given us similar feedback. So what we anticipate and anticipate you know, as we get into our next quarters, we'll start to see a little bit more data we'll be able to share around, you know, new patient starts and things. I can tell you that the demand has been strong and that we've been pleased with the direction that the launch has gone so far.

Action. Thank you.

Our next question comes from Jonathan Chang with Lee Rink Partners. Jonathan, you may now unmute and ask your question.

Good morning. This is Albert Augustinez for Jonathan Chang. Thanks for taking my questions, and congratulations on all your progress. So my question is, what do you see as the biggest hurdle now for CompZifty to gain market share in 2026? Now, is it just prescribers inertia or something else? Thanks.

Yeah, sure. Sure. Thanks, Albert, for that. Yeah, I mean, I think that what we anticipate with the NPM-1 market, this is a market that is really going to be driven on new patients coming forward and kind of incident patients as they're diagnosed or progress into the second, third, fourth line setting. So it really will come down for us as to getting those patients into our queue. One of the parts, I think one element of this market that's a bit unpredictable for us, as you well know, is that, you know, we're approved in a monotherapy setting, and that's where our teams are going to be promoting. But we've heard a lot from physicians that they're looking to use MEN and inhibitors and COMS-FD in combination. That will be one of the questions for us to understand is how that uptake comes up in the combination setting. It That will be something we'll be able to see coming forward in the future. But, you know, we don't see, you know, the payer hurdles have been, you know, really nonexistent. We're really pleased with how quickly our uptake has been getting on policies. So we don't really see any major hurdles other than just getting those incident patients on to therapy.

Yeah, Albert, this is Troy. I might just add a comment or two to Brian's response. This is why we've laid out, you know, in our milestones for 2026, the significance of the publication in relapsed refractory imaging. NPM1 mutant AML with venaza that Molly mentioned, as well as the combination with giltaritinib. You know, as Brian mentioned, this is a very different market than KMT2A. We're obviously going to have a sales team promoting on-label with monotherapy, but what's clear, and I will continue to be clear, is the ability to combine, the ability to drive better outcomes for patients is ultimately going to, you know, be of great value. And what we see, it's why we feel confident that, you know, we're going to take leadership not only of the NPM-1 mutant class, but ultimately, you know, of the much larger opportunity because it's going to be about combinations. And those attributes that Brian mentioned that were highlighted in the IPD analytics report, those become ever more important as you move into combinations. Just to make an example, we're well ahead of the competition in terms of combining with FLT3 inhibitors. As you know, that's half of the NPM1 population. So it's an important part of our leadership strategy.

Thank you.

Your next question comes from Celine Syed with Mizuho Securities. Please unmute and ask your question.

Great. Thanks so much, guys. Congrats on the progress. Just one from us on the 50% that you noted here, Troy, you know, the market feedback suggests you feed up to 50% of AML patients here. Just what is the assumptions that you put in front of these doctors when you're kind of doing your market feedback work? And is it just based on the existing data, or is there something that you're still planning to get to sort of get to that, you know, leading point? you know, the leading share, I think, as you put it.

Yeah. And, Salim, I take from your question, you're referring to the relapsed refractory segment. Is that where your question was pointed? Yeah. Yeah. Yeah. I'll ask Brian to speak to that. Thanks for the clarification, Brian.

Yeah. No, absolutely. And And, you know, we've gotten feedback as we, you know, both from physicians, but we do physician market research as well. And it's interesting. We've had, you know, we basically provide the profiles of the products. It's blinded. We don't ask them which company. They don't know who's asking the questions. And of those we found that have familiarity with the men in class, the profile that we've outlined has come back to be the preferred profile. both across efficacy, safety, the simplicity, combinability, compatibility of working with other agents. So that's the feedback we've heard is that it gives us the confidence that as we build into this market, we'll have an opportunity to become that market leader and take the lead share in the men in class.

Yeah, and I'll just add to that, Salim. I'll just add to that. I mean, at this point, we're not really talking about FLT3 in terms of doing the market research. This is really focused on the monotherapy. But one of the differences between this market and the KMT2A market is, obviously, if you have a FLT3 mutation, giltaritinib has a survival advantage. And so it's reasonable to assume a menin inhibitor is going to be sequenced after gilt. If you can demonstrate, as Molly indicated, that you can safely combine and that that's beneficial to the patient, that's going to ultimately drive kind of a next leg within that relapsed refractory segment. We're not really yet there with the physicians because we obviously have to do that with data. But that's what gives us the encouragement. Today it's monotherapy. Tomorrow it's the combination with Veneza. You know, the day or two after tomorrow it's the flip three combination. And it just builds, you know, one after the other.

Got it. Super helpful. Thanks so much, guys. Sure.

Your next question comes from Rennie Benjamin with JMP Securities. Please unmute and ask your question.

Hey, good morning, guys. Thanks for taking the questions, and congratulations on the early launch, and hopefully it's going well for 2026. You know, you talked a little bit, Molly talked a little bit about the combination of cruzartinib and giltaritinib and the FLT3 opportunity. Can you talk a little bit about what you're hoping to see? is kind of maximizing the flip three opportunity when we're thinking about, you know, the potential seven billion TAM for ZIFTA. Thanks.

Yes, thanks for that question. So The most important thing you can see when you look at our combination data is going to be safety, safety indicating that you actually can combine. And obviously, after that, looking to improve upon the agents in isolation. So, as I said, we'll be presenting our relapse refractory gilt-to-rent div data towards the end of the year. We will be presenting both the dose escalation and the expansion, which should tell you that we were able to combine the drugs successfully and safely for these patients. With the frontline, we are in the process of dose escalation with quizartanib, a combination with zifdomenib plus 7 plus 3. And again, that continues to advance. So overall, we expect to be able to show you not just the fact that we can combine, but that we can improve upon the outcomes of these drugs in isolation.

Yeah. And, Ren, just to build on Molly's comments, you know, we've seen commentary recently from Astellas that have identified giltaritinib as one of their blockbusters, one of the five sort of emerging blockbusters. They have a frontline trial that was conducted with Hovon that is expected to read out any day now. As we said, FLT3 is a third of all of AML patients. It's hard to imagine you can have a market leadership strategy without including FLT3. That's why we're combining with both Quisartinib and Giltoritinib. you will see us over the next quarter or two move more aggressively into the FLT3 frontline setting because we haven't really yet broken it out. But that will be, you know, it's a major driver in that $7 billion TAM, ultimately, as you look across all lines of therapy.

Perfect. Thanks very much, Chris.

Your next question comes from Charles Yu with LifeSci Capital. Please unmute and ask your question.

Hey, good morning, everyone. Thanks for taking our questions and congrats on all the progress. I'll ask one on a slightly different topic regarding FTIs. We had a lot of updates from the recent ASCO GU conference, particularly in renal cell carcinoma and some of the emerging HIF-2-alpha or emerging and approved HIF-2-alpha inhibitors in that space. Maybe could you help contextualize your upcoming second half data for DALI plus CAVO, not only within the current standard of care, but also amongst the potential emerging standard of care as well? Thank you.

Sure. Yeah, we're following that data very closely as well, and it's looking very good for patients. In fact, I think as you're referring to, it's looking so good that it probably will end up moving up in line, in line of therapy for these patients. We, as we announced, have just started our Phase 1B, which is a randomized Phase 1B so that we can both contend with Project Optimist, but also set some baseline data for ourselves with Cabozantinib in this particular line of therapy. And we will be able to also see if patients that are randomized to the Cabo monotherapy can cross over and successfully either gain or regain responses when you combine it with Darlafarnib, which I think is an important demonstration of our mechanism of action. We do think that our data, as progressed as they are, and we have limited follow-up time compared to some of these other studies, are still competitive with a lot of these data that are being presented. And we look forward to sharing that updated information with you. But what we do think is, again, that these – These good outcomes for patients with HIF-2 alphas, we'll move them earlier in lines of therapy, so you'll see them in the front line, and ultimately it can open a rather big vacuous space in the second line that we could then jump right into with this CAVO-Dylofarnib combination.

Got it. Thanks.

Your next question comes from Jason Zemanski with Free of A. Please unmute and ask your question.

Good morning. Thanks so much for taking our question and congrats on the progress. Brian, I was hoping you could share some of the early feedback from your prescribers that are new to Come50, maybe that haven't been associated with any of your clinical programs or at least minimally associated. We recognize this is a small community in its early days, but maybe for those especially who have participated in a trial associated with your rival or don't have a large AML population, how has the product profile resonated? Thanks.

Yeah, thanks for that question, Jason. And I'd speak to it, you know, both from physicians we've heard from, but I'd also point to pharmacists, like the pharmacists that are, you know, have maybe not been involved so much with treating the patients outside of the trials. The feedback that we've heard has really, you know, they recognize that there are, you know, there's multiple meta-inhibitors available. The efficacy that we've heard seems to be, you know, table stakes essentially. I think both products have similar efficacy there. What really does outline is, you know, the questions around how to manage QT, understanding what monitoring for QT prolongation means versus, and it's not just having to monitor, but to understand the potential implication of a higher risk of cardiac issues has come back from us, as well as, I mean, even the simplicity of treating patients once a day without having to do a lot of you know, dose modifications based on the complexity of other therapies they have. So, we've heard that. I mean, I think what we know is that, of course, a lot of probably early scripts are going to be those for people who've had a lot of experience with us, but we have received, you know, feedback from physicians who are new to the men in class, and we've been spending our time educating them around Comsifty. So, we're As we said, it's early days, but we're pleased with what we're hearing so far, and it seems to be consistent from what we've heard from those who do have experience.

As a reminder, if you wish to ask a question, please use the raise hand button, which can be found at the bottom of your Zoom screen. Our next question comes from Etta DeRout with Barclays. Please unmute and ask your question.

Hi, good morning. This is Gustav on for XR. Thank you for taking our question. I'd like to ask about Comet 008, guided to showing data in combination with Geltoritinib in the second half of this year. Could you remind us where you stand with regards to the combination of Zipto with Flag IDA and with the load of Cetarabin? Thank you.

Sure. No, as you said, we've been guiding to release the giltaritinib data because, in large part, we think that is very informative to physicians in how to treat the relapse refractory MPM1 mutants co-mutated with FLT3 as well. But also within that study are our flag-ida combination, which sees mostly second-line patients. and our LDAC combination, which allows for an easy combination with Zipdomenid that gives time for this differentiating agent to really take effect while keeping disease control simultaneously. So we haven't guided to when we'll be releasing that data, but I do think that it'll be – We'll do it pieces at a time to keep the information coming and also be writing a publication. But again, we haven't guided as to when those additional cohorts will be shared.

Your next question comes from Phil Meadow with TD Cowan. Please unmute your line and ask your question.

Good morning. Thanks for taking our question, and it was great to see the team this week in Boston. We have one commercial question. I think you suggested that the relapse directory NPM1 market is about $300 million to $400 million in revenue. We're curious to hear how quickly you think the MNN class can penetrate the market. It seems like the value proposition is pretty clear today, but we're wondering if there's any gating, like combo therapy data in particular, that could be necessary to fully penetrate the opportunity. Thank you.

Great. Thanks, Phil, and thanks again for seeing me. Good to see you yesterday. Yeah, as we've said, you know, this TAM of 350 to 400 million is kind of representing that relapse refractory space. We think because of the dynamics of the NPM1 population where physicians have previously had choices for their patients to either get Veneza or a FLT3 inhibitor for those who are commutated. We anticipate early on there'll probably be more of the relapse, you know, kind of the relapse refractory in the third or fourth line setting. Combinations will help to drive that into the second line where you'd be able to see, you know, more patients get therapy and benefit earlier. Our expectation is that there'll be a lot of, you know, as you said, there's a lot of use likely as a monotherapy, but the physicians are very excited about using in combination. It's not something we can promote on actively, but we will educate based on publications around the, like the Veneza publication that we plan to publish based on COMET-007. So we're What we anticipate is that there will be, you know, a ramp-up based on incident patients coming forward, probably starting more in the third, fourth line. But we will see and we are starting to see that, you know, those second-line patients as well. We'll need a little bit of time to really get an understanding as to how comes if he's being used in combination relative to monotherapy. Okay.

Your next question comes from David Dye with UBS. Please unmute and ask your question.

Great. Thanks for taking my questions. And welcome to the quarter. Just, you know, one question on the duration of therapy. So I understand it's just the early innings, but any thoughts on duration of therapy for comsifide so far? And as you are thinking about combination with vanesa or good retinib, how do you think the duration of therapy could evolve over time?

Great. Thanks, David, for that question. Obviously, we're sharing five weeks of data. We can't really give you a lot of detail around duration of therapy at this point. Our expectation is that patients will be able to get therapy for up to, you know, we think an average of six months. Our label suggests that patients are treated for up to six months to maximize the depth of their response. And for those patients who do get a response, we've seen duration of therapy of five months, duration of response of five months, and oftentimes it takes three months or so for them to get that response, to achieve the deep response. So we think that we'll get to, we're not seeing any signs yet because it's too early to see. We are seeing repeat prescriptions, but it's too early to talk through any duration right now. To your question around FLT3 inhibitors, I think that Any combination is expected to give a longer duration of treatment than you would expect as a monotherapy.

There are no more questions at this time. I'd now like to turn the call over to Troy Wilson for closing remarks.

Thank you, Abigail. Thanks, everyone, for joining the call today, and thanks for all the questions. We will see many of you next week in Miami at the various events and conferences. If you have any additional questions, please reach out to Greg or me, and we wish all of you a good morning and a good rest of the day. Thanks again.