Kura Oncology, Inc.

Good day, everyone. My name is Layla, and I will be your conference operator today. At this time, I would like to welcome you to the Cura Oncology first quarter 2026 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 everyone 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, Leila. Good afternoon and welcome to Cura Oncology's first quarter 2026 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 discussion will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today, and they involve risks and uncertainties that cause actual results to differ materially from expected results. Please refer to Kerr's filings with the SEC, which are available from the SEC or on the Kerr Oncology website for information concerning risk factors that could affect the company. With that, I'll call the call over to Troy.

Thank you, Greg. Good afternoon, everyone. CUR is at an inflection point. What we've been building over the last several years is now showing up clearly in the clinic, in the market, and in the way physicians are making treatment decisions. Our first commercial launch is off to a strong start. Our phase three programs are ahead of plan, and over the next 12 to 24 months, we expect a steady flow of data that we believe will define leadership in the menin inhibitor class. Most importantly, we're executing with focus, discipline, and a very clear strategy. Let me start with ComSifty. In our first full quarter of launch, we generated $5.8 million in net product revenue ahead of expectations. But what matters more to us is what's underneath those numbers. We're seeing repeat prescriptions. We're seeing broad uptake. and use expand across treatment centers. We're seeing increasing payer preference, and we're seeing early instances of physicians switching patients from other men and inhibitors to Comsifty. That tells us something important. This is not just a class story anymore. Physicians are starting to differentiate based on product profile, and we believe Comsifty is standing out. We see that differentiation coming from a combination of compelling efficacy, a predictable safety profile, simple and convenient dosing, and potential for broad combinability. In real-world practice, these things matter, and they're driving how physicians choose therapy. It's early, but based on what we're seeing, we believe ComSifty is well-positioned to emerge as a leader in the treatment of adult patients with relapsed refractory NPM1 mutant AML. At the same time, we're not building this as a single indication product. Our focus is to expand Zip2Mentive across the AML treatment continuum and establish it as a backbone therapy in combination. This year, we expect to generate multiple data readouts to support that strategy, including updated data from our 7 plus 3 combination in newly diagnosed AML at EHA, publication of our venetoclax azacitidine combination, and initial data from our giltarithinib combination in relapsed and refractory AML patients with NPM1 and FLT3 commutations. Taken together, these data sets are designed to answer a simple question. Can comZifty be used broadly, safely, and effectively in combination across AML? Based on what we've seen so far, we believe the answer will be yes. In parallel, our frontline phase three program, Comet 017, is progressing ahead of plan with strong enrollment for both studies across leading global sites. Our one-stop shop design is doing exactly what we intended, accelerating execution without compromising rigor. Beyond AML, we continue to build a broader pipeline with meaningful upside. Darlifarnib is a good example. The data we've generated reinforce its mechanism and potential to overcome resistance to targeted therapies. We'll have additional combination data this year, including in KRAS G12C mutated cancers, where we think there's an opportunity to open up new treatment approaches across large solid tumor indications. So when we step back, we think Kerr is in a very strong position. We have a commercial product that is gaining traction and beginning to differentiate in the real world. We have a pipeline with multiple anticipated near-term clinical catalysts that can expand that opportunity significantly. And we have the balance sheet to execute our strategy and reach key value-creating milestones. The menin inhibitor class in AML is still early. The next year or two will determine how it evolves and who leads. Based on what we're seeing today in the clinic and in the market, we're confident in our ability to play a leading role in shaping that future. With that, I'll turn it over to Brian.

Thanks, Troy. We're very encouraged by ComSifty's performance in the first full quarter of launch. And although we're pleased by the first quarter results, we're even more encouraged by the underlying trends driving that revenue. Our early momentum reflects three core strengths, strong preparation, an experienced commercial team, and most importantly, a clearly differentiated product profile defined by efficacy, safety, combinability, and convenient dosing. Our commercial strategy is focused on three priorities. Drive broad awareness of ComSifty's differentiated profile, deliver strong and consistent quarter-over-quarter growth, and established leadership in relapse refractory MPM1 mutant AML, a $350 to $400 million market opportunity. In the first quarter, we generated $5.8 million in net product revenue, with 85 new patient starts and nearly 160 total prescriptions. Patients were treated across approximately 60 activated accounts, including ZIFTA-Mentive trial sites, other Menin Experience Centers, and accounts new to Menin Inhibitors. More importantly, we are seeing clear signs of growing physician adoption. First, repeat prescriptions and expanding use across treatment settings indicate growing physician confidence with ComSifty in real-world practice. Second, following our approval, we have observed physicians switching patients from other menin inhibitors to ComSifty. Although still early, this is a meaningful signal that physicians are making active treatment decisions based on the product profile. Third, we are aware of early physician-initiated use of COM-ZIFTI in combination with commonly used agents, including venetoclaxazacitidine and with giltaritinib in FLT3 commutated patients. This physician-initiated use reinforces our belief that ZIFTI-MENIV has potential to be a highly combinable backbone for use across AML patient populations. Feedback from physicians, pharmacists, and nurses consistently highlights the practical advantages of ComZifty, particularly its dosing simplicity and convenience for patients, which we believe are important factors in real-world treatment decisions when monotherapy efficacy is viewed as similar. Collectively, these dynamics point to a clear conclusion. Increasingly, physicians, pharmacists, and nurses are selecting ComZifty, which offers strong efficacy with a well-characterized and manageable safety profile and convenient once-daily dosing compatible with concomitant therapies, what we describe as efficacy without compromise. Turning to access. We've secured coverage at parity or better for more than 93% of covered lives with no label restrictions. Achieving this level of access this early in launch, particularly as a second to market therapy, reflects the strong payer recognition of ComSifty's value. We're also seeing favorable formulary positioning and step edit dynamics. I'm thrilled to report more than 10 plans covering more than 12 million lives have placed ComSifty in a favorable policy position. These decisions reflect payer recognition of ComSifty's differentiated profile and the predictability of its cost in managing patients in this setting. Operationally, execution remains strong. Time from prescription to patient receipt is approximately three days, ensuring rapid access to therapy. And our field teams, in collaboration with Kiowa Kirin, are driving strong engagement across both academic and community settings. Looking at the bigger picture, the combination of repeat prescriptions, broad access, payer preferences, expanding real-world use, and early instances of switching gives us confidence that ComZifty is not just participating in the medicine inhibitor class, but is increasingly defining its leadership position in the NPM1 market. The success we are seeing in this initial monotherapy setting is an important first step and reflects our foundational advantage of delivering strong efficacy with a predictable safety profile and convenient dosing that, in our view, represents efficacy without compromise. Importantly, this early momentum lays the foundation for our next phase of growth as we expand into combination and frontline settings. I'll now turn it over to Molly.

Thank you, Brian. In 2026, we expect a continued steady cadence of clinically meaningful data for Zifto-Meneb and Darla Farno. Our strategy for Zifto-Meneb is focused on one clear objective, establishing it as a highly active and broadly combinable backbone therapy across the AML treatment landscape. supported by our registrational clinical programs spanning multiple lines of therapy and patient populations. As treatment paradigms evolve, physicians are increasingly looking for therapies that can be safely and effectively combined with existing standards of care, and ZIFTA-Meneb is specifically designed to address that need. At the upcoming EHA meeting in June, We plan to present updated data from ZIFTA-MENIB in combination with 7 plus 3, newly diagnosed NPM1 mutant, and KMT2A rearranged AML. This updated data set will include extended follow-up with a median of approximately 16 months, including treatment course and response durability. We also expect to publish data showcasing venetoclax and azacitabine in combination with zivdomenib in relapsory refractory MPM1 mutant AML. These data expand upon our presentation at ASH 2025, where we reported a striking 70% composite CR rate in patients without prior venetoclax exposure. This is an important regimen as venazer remains a widely used standard of care. In parallel, we are advancing combinations with FLT3 inhibitors. As a reminder, FLT3 mutations occur in approximately one-third of AML patients, and notably half of NPM1 mutant patients have FLT3 commutations. We anticipate preliminary data in the second half of the year from Zipdomenib in combination with Giltoritinib in relapsed or refractory NPM1 mutant FLT3 mutated AML. We are also evaluating zift amenib in combination with quizartinib in the newly diagnosed setting. As a whole, these data are building a consistent picture. Zift amenib can be integrated across multiple treatment approaches without compromising safety or activity in clinical studies, an attribute we believe will be essential for long-term use in both relapsed and frontline settings. Turning to our frontline development program, our COMET-017 trial is an innovative one-stop shop design, which enables simultaneous enrollment into two independent phase three trials at each activated site. This streamlined approach is a meaningful differentiator, an operational advantage, allowing us to accelerate enrollment while maintaining vigorous study, design, and execution. We are very pleased with the progress to date. Site activation and enrollment are ahead of projections, with strong participation from leading academic centers across the U.S., Europe, and Asia. This level of engagement reflects both the clinical interest in Mennon inhibition and the confidence investigators have in Zipfda Mennon's profile, particularly its potential to be combined with standard frontline regimens. Beyond AML, we continue to explore the broader opportunity of menin inhibition. Our study evaluating zyptomenib plus imatinib in GIST is progressing well, and we hope to provide updates when appropriate. In addition, we are evaluating the role of menin inhibition in other solid tumors. and turning to darlafarnib, which also continues to make important progress. Recent data presented at the International Kidney Cancer Symposium provided clear proof of mechanism, demonstrating activity in cabozantinib pretreated clear cell renal cell carcinoma, a setting where clinicians would not typically expect to reinduce responses. with the same TKI after progression. These findings support the role of the REV-MTORC1 resistance pathway and reinforce potential for darlofarnib to restore sensitivity to targeted therapies. Enrollment in the Phase 1b portion of the darlofarnib plus cabozantinib trial is now underway. In addition, we intend to present an update on the full Phase 1a data set later this year. We see combinations of FTIs and KRAS inhibitors as a potential next advance for patients. At ASCO, we will present preliminary data evaluating Darlafardib plus Adagrasib and KRAS G12C mutated solid tumors. And we look forward to discussing that data at a virtual event on June 3rd. I'm incredibly proud of our teams at Cura for the disciplined, focused execution behind these programs. Their cross-functional commitment and operational excellence are helping translate our strategy into meaningful clinical progress for patients. And with that, I'll turn the call over to Tom for financial updates.

Thank you, Molly. I'm happy to provide a brief overview of our financial results for the first quarter of 2026. Our net product revenue from comms empty sales was $5.8 million compared to none for the first quarter of 2025. Collaboration revenue from our Keogh-Carran partnership was $12.5 million compared to 14.1 million for the same period in 2025. Research and development expenses were $65.3 million compared to 56 million for the first quarter of 2025. The increase was driven by ZIPDOM and accommodation trials, including the start of enrollment in our COMET 017 trials in the second half of 2025. Selling, general, and administrative expenses were $31.6 million compared to $22.8 million for the first quarter of 2025. This increase was driven by Net loss for the first quarter of 2026 was $73.3 million compared to a net loss of $57.4 million for the first quarter of 2025. This includes non-cash share-based compensation expense of $8.4 million compared to $7.8 million for the same period in 2025. As of March 31st, 2026, Cura had cash, cash equivalents, and short-term compared to $667.2 million as of December 31, 2025. We are maintaining our previously communicated guidance for collaboration revenue. We expect this to be $45 to $55 million in 2026, $90 to $110 million in 2027, and $90 to $110 million in 2028. This revenue reflects non-cash based accounting recognition of performance obligations under our collaboration agreement with Keohokalani. Current cash, cash equivalents, and short-term investments as of March 31st, 2026, together with anticipated payments of 180 million under our collaboration agreement with Keohokalani, are expected to fund our ZipDominated AML program through the first top-line phase three results from Commodore 17 anticipated in 2028. With that, I'll turn the call back over to Sean.

Thank you, Tom. As I said at the outset, companies firing on all cylinders. Our first commercial launch is off to a strong start. Our phase three programs are ahead of plan, and we expect a strong cadence of data over the next 12 to 24 months that will further define leadership for Zip2Med and the Medin inhibitor class. With that, we'll conclude our prepared comments, and we're happy to, Leila, to open the call up for questions.

We will now move to our question and answer session. If you've 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. We will now pause a moment to assemble the queue. And again, we ask that you please limit yourself to one question. You're welcome to then re-enter the queue for any follow-up questions. Our first question will come from Lee Watzek with Kantor. You may now unmute and ask your question.

Hey team, this is Dan Bronner on for Lee. What's that? Thanks so much for taking our question and congrats on the update and the commercial launch. Can you give us some color on how we should think about the duration of treatment with comes 50 early on, given that it sounds like you have patients on one of therapy as well as some that might be receiving combination with greatly appreciate it. Thank you.

Sure, Dan. Thanks for the question. Let me ask Brian if he can speak to them.

Sure. Thanks, Dan, for the question. I think it is difficult at this point to really give too much detail on duration of treatment because, you know, we have one full quarter. We've reiterated before that our expectation is to get around six months of treatment. What I can say is that we're very pleased, of course, with the number of new patient starts. We think that's really the measurement at this early in the launch to measure how well we're doing. And I think the 85 new patients starts us up well. What we need to do is really track for several quarters to get a better sense of that.

Your next question will come from Peter Green with LifeSci Capital.

Hi, this is Peter on for Charles. Congrats on the results team. You mentioned a few times that the frontline opportunity and also strong enrollment in Comet 017 and in light of, sorry, EHA abstracts today, I have a question there. You know, I'm noticing from last year that complete response rates across both MPM1 mutant and CanT2A rearrange AML, and that's in the front line for Zifto in combination with 7 plus 3. I'm noticing those CR rates are increasing. I'm also noticing that CR MRD negativity is, you know, in MPM1 occurring potentially out to 43 weeks in some patients. So I guess with all of that said, What have you learned from Comet 007 about Zifto's profile in the frontline, especially over longer-term use? Is there some response deepening happening, or is this just kind of an artifact of increasing or of including kind of less adverse risk patients? Thanks.

So I think we've learned foremost that we're using it correctly and that doing it with this staggered start and a start that enables patients to continue to remain on without having to interrupt or lower dose or discontinue for adverse events is a really powerful way to keep these patients both in a response, have that response deepen over time, and have these patients be able to continue on into some form of continuation treatment, whether that be post-transplant or post-consolidation. We continue to gather more data, and we continue to be extremely encouraged that the way we've designed 007, the data we continue to gather from 007, helps us to really reinforce that we've correctly designed 007, 017 data. so that we can expect great outcomes for these patients in the frontline as well.

Yeah, Peter, this is Troy. Just to add to Molly's comments, I agree with everything she said. One of the things you'll see at EHA is really this is probably the most mature set of data in the frontline, and it's really a story of durability and clinical benefit for patients. The data will be updated at the presentation, but response rate, MRD negativity are important. We'll really draw people's attention as well, as Molly said, to the durability. We're really, you know, this data is pretty unprecedented, and I think very encouraging for the promise of menin inhibitors and the O17 study, as she said.

Thank you.

Your next question will come from Jonathan Chang with Lyric Partners.

Hi, guys. Thanks for taking my question. On the ComZifty launch, can you provide more color in what you're seeing in terms of initial combination use and instances of switching from other meta-inhibitors? How common is combination use and switching? Thank you.

Yes, thanks for that question, Jonathan. Yeah, so what I can share about the combination use for this, of course, as you know, our promotional teams, our commercial teams are focusing on promoting on label as a monotherapy, but physicians are choosing to use in combination. The data we're seeing so far is that it's about, probably about 40% of patients are getting used, using CumZifty in combination, either with or in those FLT3 commutated also with Giltaritinib. So that's what we're seeing early on. I think that getting to the expectation of how those patients will do is something we'll follow. And regarding your question around switching, that is something that we, as I said, we observed, especially as two products then became available. It just kind of drove where physicians are choosing to use ComSifty based on the profile. I think that's going to be probably less of a trend than the combination use that we expect to go forward. But nevertheless, it does demonstrate the strength of the ComSifty profile and really, I think, supports the strong initial early momentum we've had in this first quarter of launch.

Thanks for taking my question.

Your next question will come from Etzer Darut with Barclays. Etzer, feel free to unmute and ask your question.

Great. Thanks for taking the question. Congrats on the quarter. Just to follow up on the question, if maybe you could comment on the primary reason patients have been switching from other menin inhibitors. Not sure how much data point you've gotten at this point, but just wondered if something you could comment on. Thank you.

Yeah, I don't think I can. Thanks for the question. I don't think I can go into the detail of each patient that switched really. It's probably more at a high level. We're seeing that physicians now they have a choice between multiple menin inhibitors. And there have been physicians who've chosen to switch those patients from another menin inhibitor to give them the opportunity to benefit from COMS-50. So it could be based on the profile, based on whatever the decision the physician feels, based on if it's efficacy, the safety profile, the simplicity of use. All of those things are what we've heard has resonated from a number of physicians.

Yeah, Ed, sir, just to jump in for a second and build on that. I mean, the switching is, to some extent, what we expected. You know, I agree with Brian. I don't think it's probably the most significant aspect. What we draw your attention to is, as Brian said in his prepared remarks, the new patient starts. You know, the other Menon inhibitor had approximately 130 new patient starts. We've had 85 in our first full quarter. That's about 40%. Given that the story prior to this was kind of a winner take all, we think we've got, you know, really strong momentum to be able to take, you know, leading market share in NPM1. You are going to see some switching. I mean, as we've said, we think we have the superior overall profile. But where we really think you're going to see it is in the new patient, you know, Again, use in combination, although that's not our labeled indication, you know, that's physician discretion. Those are some of the elements we draw folks' attention to.

Great. Thanks for the color.

Your next question will come from Rennie Benjamin with Citizens.

Hey, good afternoon, guys. Thanks for taking the questions, and congrats on the progress. Maybe just sticking with the new patient starts, you know, I guess any other – or additional color you can provide, anything regarding growth to net dynamics. And when you talk about the 157 total prescriptions, are these, you know, are the scripts typically like one month in average, are they three months in average? Can you give us some sort of details there? And just, you know, if I can throw one more in regarding the commercialization, you said 60 activated accounts. Brian, what's kind of the total number of accounts that you're that you're targeting? You know, just to give us a sense as to where we are in the cycle. Thanks.

Yeah, sure. So thanks for the question, Ren. So. You know, with regards to these new patient starts, the color we're seeing, and I shared a little bit, these are, you know, the relapse refractory patients that kind of fit across, that we're seeing it across accounts that are either, you know, comsifty patients, trial sites. We're seeing it from those who have experience with other meta-inhibitors, as well as those who haven't had any experience. What we're seeing is a very strong start this early on that we're able to get, as Troy mentioned, 40% of the kind of new patient starts in this first quarter alone, gives us a lot of confidence that there are patients out there who may benefit from ComSifty, and we're very pleased with the opportunity we have to move forward with that at this point in time. We do said, and as I mentioned in the remarks, we're going to continue to see quarter-on-quarter growth. We'll continue to go deeper into other accounts and ultimately become the market leader in this space, you know, based on that MedinClass share. So we're very encouraged by the start right now. We look forward to that in the future. And, Ren, the scripts are one month, right?

Oh, yeah. These are one-month scripts.

Got it. And the growth to net dynamics?

Thanks, Ren, for that question. Those are within normal ranges, so in that 20% to 30% range.

Excellent. Thanks very much, guys. Thanks, Ren.

Your next question will come from Roger Song with Jefferies.

Hey team, thanks for taking our question. This is Nabil on for Roger. Encouraged to hear on the open label, the combo use at 40% in combination. So I'm just kind of curious if you'd give us color on how this looks in academic and community settings. And then as we get more data, the Vanessa publication, and then the second half data with the flip three combo, how do we expect this to sort of evolve? And, and does the comes if you have any advantage here? Yeah.

Yeah. So, I mean, I think that as we said, you know, this is the combination use is not what we're promoting actively, but it's based on a lot of the data. I think that in the remarks that as we've shared here, Molly's Molly's remarks around the combination use. This really shows that we have a potential to become that strong leader, both in the relapse factory, but in the frontline setting. The data that we'll be presenting in the publication with Vanessa will be coming, as we said, you know, in the first half of the year. We think that will help to draw momentum. Of course, our objective is to submit that to NCCN guidelines, but we can't determine whether or not that will be incorporated. But we have heard feedback from physicians that the publication of the data are very important for them. So we'll see that plus the potential unique combination to be able to combine with the FLT3 inhibitor, I think also gives us a strong avenue to build strength in a market where there's 50% of the MPM1 patients who have a FLT3 commutation, which may be unique to ComZipty's profile to be able to do.

Your next question will come from Phil Nadeau with TD Cowan.

Good afternoon. Thanks for taking our question and congrats on the progress. In regards to the frontline data that's going to be at eHow, we're curious to get your most recent thoughts as to what measures you think investigators and physicians are going to look to when thinking of adopting the maintenance in the front line? Do you think ultimately the most powerful data will be the durability of the response? Could it be progression and transplant, ultimately overall survival? I guess in your conversations, what are physicians evaluating most prominently as they think about moving the maintenance forward? Thanks.

Sure. I actually think it's a combination of all of those things you said. Ultimately, survival is the primary endpoint. You want these patients to live. There's some ability to get to curative intent with transplant, and we want to be able to expand patients' ability to get to curative intent. So the durability I think is going to be your best prognostic indicator for our ability to increase the survival and I think the MRD negativity is going to be what actually predicts the durability as well so all of them are extremely important. We're seeing extremely high response rates. You'd expect to see maybe 70 to 80 percent of patients having a complete response with seven plus three. And we're seeing things in the high 90s. You'd expect to see about 45 percent of patients have MRD negativity in the bone marrow. And we're seeing that in the 80s. So, again, I think that all signs are pointing to these patients increasing. having really strong, really deep responses and a great chance of having an effect on survival overall. That's very helpful. Thank you.

Thanks.

Your next question will come from Salim Syed with Mizuho.

Great. Congrats on the quarter, guys, and thanks for the question. There's one for us on that 40% number, Troy. Could you maybe comment on the cadence through the quarter? Is that something that is also representative of your exit NBRX share for NPM1, or was it higher kind of coming out of the quarter? And similarly, I guess, is that similar to the dynamics you're seeing for this current quarter? Thank you.

Yeah, Salim, I mean, we're talking about small numbers. Our goal here is to be the market leader in relapsed refractory NPM1. You know, that's 51% or more. I think you're going to see us push that as high as we can. As you know, I mean, you've been doing this a long time. There's a lot of variability week to week, month to month. What I think we're really encouraged by is we're second to market behind another product that's been on the market now for 15 months, and we've taken 40% of new patient starts in the first full quarter. That's what we set out to do. That's... you know, that's just the beginning. I think we're very optimistic. You're hearing it, whether it's in the performance of the field force and the commercial team, whether it's the EHA abstract, this, this, this, you know, ZIFTA or COMZIFTA in the commercial setting has a real opportunity. So, you know, look for us to build on that. As Brian said, I think we're just getting started. We're still learning. We're still educating. This is the first step, but I think a very, very encouraging first step.

Okay. Sounds good. Thanks so much.

Sure. Thanks for the question.

As a reminder, if you'd like to ask the question, please use the raise hand icon, which can be found at the bottom of your webinar application. Our next question will come from David Dye with UBS.

X.Y. Great thanks for seeing my questions and class on the quarter, so a few questions for me one is on that 5.8 million revenue, how much of that is inventory stocking. X.Y. And then, how should we think about the you the combo used to could extend the duration of therapy beyond the six months on our therapy and then, lastly, do you think the patients will actually continue to use many inhibitors beyond progression.

So just a reminder to everybody, David, I don't mean to single you out, but we're trying to limit people to one question. So there isn't any meaningful stocking. I mean, you can see this in the numbers. But, Brian, maybe you can speak to durability, the question on durability and combo.

Yeah. I mean, I think that, as I said earlier, David, I think the – Duration of treatment is something we'll be seeing over time. It's difficult to say within a first full quarter of how much that duration is used. Our expectation is that patients who are on therapy in combination will likely have a longer duration. But we need a little more time to play that out because you need to understand what type of patients are getting on therapy. Is it more the second line versus third or fourth line or something? Those are the things that we're tracking. We're pleased with where we're heading now. But I could ask if we could get a couple more quarters under our belt to get a better sense on what that durability could be. But we would reiterate that we believe that this overall market opportunity in the relapse refractory setting still remains around that $350 to $400 million.

Yeah, David, what I might add to that is we were not surprised to see some spontaneous combination usage. I think we were pleasantly surprised to see physicians choosing to combine with giltaritinib, given that we're not even planning to present that data until sort of toward the end of the year. But given the overall profile, the combinability of ZIFTO, It's nice that physicians have that option for their patients, and we're starting to see that kind of work its way into the commercial setting. That's very gratifying. It's not anything we're promoting, but it is nice to see.

Thank you so much for taking the time to ask my questions. Sure.

Your next question will come from Daniel Brims with Lake Street.

Thanks for taking my questions. Congratulations on the strong launch. For ASCO, I was just curious, will we be seeing any monotherapy data there or just combination data for darlifarnib with adagrassib?

Yeah, so we've actually previously presented the monotherapy data last year. And to give you an idea of the really wide therapeutic window that we have with the monotherapy, balancing both efficacy and safety so that we'll be able to do an extensive amount of combinations over time. At the ASCA presentation, you're going to see it in combination with the KRAS inhibitor adagracib. You will see dose escalation data, and you will see it across multiple tumor types, including non-small cell lung, PDAC, and colorectal cancer. And we're very excited to be able to share this with you, kind of our third installment of the REB mTORC inhibition pathway that is helping to overcome adaptive and innate resistance for these patients with suffering from cancer.

Thanks.

Your next question will come from Peter Green with LifeSci Capital.

Hi, this is Peter again for Charles. Just wondering, you mentioned that the Comet 017 trial is enrolling ahead of schedule. Just wondering if there's any more details on that, what you're hearing from investigators. And then remind me, does that change any guidance for potential future readouts? Thanks.

Yeah, maybe Molly can speak to anything we're hearing, Peter, and then I can address your question about guidance. Molly?

All we hear is excitement, excitement for new sites to get up and running, new regions to get up and running. I can tell you that participation both in the U.S., Europe, and Asia is extremely strong and has come to that level of strength very, very quickly. I would say 007 was a great indicator of how quickly we could enroll, you know, 200 patients into a phase one trial. The phase three is going incredibly well and it's really well predicted by that enrollment rate we saw in 007.

And on the guidance question, Peter, we haven't changed anything at this point. We've guided to the initial top line results from the first, from the intensive chemotherapy combo in 2028. We haven't been more specific. You know, we might tighten that up as we get closer. I will highlight we're significantly ahead as far as we can tell the competition in that setting. But even in the Veneza setting, which is the other side of 017, you know, we're making the team is making just incredible progress. Really credit to Molly for combining these two phase threes into a single protocol such that every time we activate a clinical site, we're getting two phase three starts for the price of one. And so I think you're going to see that continue to get pulled through. The excitement has just been palpable. We did an investigator meeting recently, and it was incredibly well attended and well received. So onward we go.

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, Leila. Thank you all for joining us today. We're encouraged by the early performance of the ComSifty launch, the momentum we're seeing across our clinical programs, the clarity of our strategy moving forward. With continued commercial execution, multiple clinical catalysts ahead, including EHA and ASCO, and a strong financial position, we believe Cura is well-positioned. to drive meaningful impact for patients, and to create long-term value. We look forward to updating you again soon and to engaging with many of you at our upcoming investor event later this month. Thank you all once again, and we'll adjourn.