Earnings Call Transcripts
Operator: Good day, everyone. My name is Leila, and I will be your conference operator today. At this time, I would like to welcome you to the Kura Oncology First Quarter 2026 Financial Results Earnings Call. [Operator Instructions] At this time, I would like to turn the call over to Greg Mann, SVP of Investor Relations and Corporate Affairs of Kura Oncology. Please go ahead.
Greg Mann: Thank you, Leila. Good afternoon, and welcome to Kura Oncology's First Quarter 2026 Conference Call. Joining the call today are Dr. Troy Wilson, President and Chief Executive Officer; Brian Powl, Chief Commercial Officer; Dr. Mollie Leoni, 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 may involve risks and uncertainties that cause actual results to differ materially from expected results. Please refer to Kura's filings with the SEC, which are available from the SEC or on the Kura Oncology website for information concerning risk factors that could affect the company. With that, I'll call the call over to Troy.
Troy Wilson: Thank you, Greg. Good afternoon, everyone. Kura's 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 III 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 KOMZIFTI. 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 menin inhibitors to KOMZIFTI. 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 KOMZIFTI 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 KOMZIFTI is well positioned to emerge as a leader in the treatment of adult patients with relapsed or refractory NPM1 mutant in AML. At the same time, we're not building this as a single indication product. Our focus is to expand ziftomenib 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+3 combination in newly diagnosed AML at EHA, publication of our venetoclax/azacitidine combination and initial data from our gilteritinib combination in relapsed and refractory AML patients with NPM1 and FLT3 co-mutations. Taken together, these data sets are designed to answer a simple question. Can KOMZIFTI 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 III program, KOMET-017, is progressing ahead of plan with strong enrollment for both studies across leading global science. 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, reinforced 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 Kura is in a very strong position. We have a commercial product beginning to gain -- 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 2 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.
Brian Powl: Thanks, Troy. We're very encouraged by KOMZIFTI'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 3 core strengths: strong preparation and 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 3 priorities: drive broad awareness of KOMZIFTI's differentiated profile, deliver strong and consistent quarter-over-quarter growth and established leadership in relapsed or refractory NPM1 mutant AML, a $350 million 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 ziftomenib 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 KOMZIFTI in real-world practice. Second, following our approval, we have observed physicians switching patients from other menin inhibitors to KOMZIFTI. 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 KOMZIFTI in combination with commonly used agents, including venetoclax azacitidine and with gilteritinib and FLT3 co-mutated patients. This physician-initiated use reinforces our belief that ziftomenib 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 KOMZIFTI, particularly as 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 KOMZIFTI, 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 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 KOMZIFTI'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 has placed KOMZIFTI in a favorable policy position. These decisions reflect payer recognition of KOMZIFTI'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 3 days, ensuring rapid access to therapy. And our field teams in collaboration with Kyowa 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 KOMZIFTI is not just participating in the mein 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 expanded the combination in frontline settings. I'll now turn it over to Mollie.
Mollie Leoni: Thank you, Brian. In 2026, we expect a continued steady cadence of clinically meaningful data for ziftomenib and darlifarnib. Our strategy for ziftomenib is focused on 1 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 ziftomenib is specifically designed to address that need. At the upcoming EHA meeting in June, we plan to present updated data from ziftomenib in combination with 7+3 in 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 azacitidine in combination with ziftomenib in relapsed or refractory NPM1 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 ven/aza remains a widely used standard of care. In parallel, we are advancing combinations with FLT3 inhibitors. As a reminder, FLT3 mutations occur in approximately 1/3 of AML patients and notably half of NPM1 mutant patients have FLT3 co-mutations. We anticipate preliminary data in the second half of the year from ziftomenib in combination with gilteritinib and relapsed or refractory NPM1 mutant FLT3-mutated AML. We are also evaluating ziftomenib in combination with quizartinib in the newly diagnosed setting. As a whole, these data are building a consistent picture. Ziftomenib 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 KOMET-017 trial is an innovative one-stop shop design, which enables simultaneous enrollment into 2 independent Phase III trials at each activated site. This streamlined approach is a meaningful differentiator and operational advantage, allowing us to accelerate enrollment while maintaining rigorous 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 menin inhibition and the confidence investigators have in ziftomenib'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 ziftomenib 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 darlifarnib, 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 darlifarnib to restore sensitivity to targeted therapies. Enrollment in the Phase Ib portion of the darlifarnib plus cabozantinib trial is now underway. In addition, we intend to present an update on the full Phase Ia data set later this year. We see combinations of FTIs and KRAS inhibitors with a potential next advance for patients. At ASCO, we will present preliminary data evaluating darlifarnib plus adagrasib and KRAS G12C mutated solid tumors, and we look forward to discussing that data at a virtual event on June 3. I'm incredibly proud of our teams at Kura 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.
Thomas Doyle: Thank you, Mollie. I'm happy to provide a brief overview of our financial results for the first quarter of 2026. Our net product revenue from KOMZIFTI sales was $5.8 million compared to none in the first quarter of 2025. Collaboration revenue from our Kyowa Kirin 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 ziftomenib combination trials, including the start of enrollment in our KOMET-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 the commercial launch of KOMZIFTI. 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 noncash share-based compensation expense of $8.4 million compared to $7.8 million for the same period in 2025. As of March 31, 2026, Kura had cash, cash equivalents and short-term investments of $580.8 million compared to $667.2 million as of December 31, 2025. We are maintaining our previously communicated guidance for collaboration. We expect this to be $45 million to $55 million in 2026, $90 million to $110 million in 2027 and $90 million to $110 million in 2028. This revenue reflects noncash based accounting recognition of performance obligations under our collaboration agreement with Kyowa Kirin. Current cash, cash equivalents and short-term investments as of March 31, 2026, together with anticipated payments of $180 million under our collaboration agreement with Kyowa Kirin are expected to fund our ziftomenib AML program through the first top line Phase III results from KOMET-017 anticipated in 2028. With that, I'll turn the call back over to Troy.
Troy Wilson: Thank you, Tom. As I said at the outset, the company is firing on all cylinders. Our first commercial launch is off to a strong start. Our Phase III 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 ziftomenib and the menin inhibitor class. With that, we'll conclude our prepared comments and we're happy to Leila to open the call up for questions.
Operator: [Operator Instructions] Our first question will come from Li Watsek with Cantor.
Daniel Bronder: This is Dan Bronder on for Li Watsek. 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 KOMZIFTI early on, given that it sounds like you have patients on monotherapy as well as some that might be receiving combination? Greatly appreciated.
Troy Wilson: Sure, Dan. Thanks for the question. Let me ask Brian if he can speak to them.
Brian Powl: 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 we have 1 full quarter. We've reiterated before that our expectation is to get around 6 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 patient starts us up well. What we need to do is really track for several quarters to get a better sense of that.
Operator: Your next question will come from Peter Green with LifeSci Capital.
Peter Green: This is Peter on for Charles. Congrats on the results team. You mentioned a few times the frontline opportunity and also strong enrollment in KOMET-017. And in light of -- sorry, EHA abstracts today. I have a question there. I'm noticing from last year that complete response rates across both NPM1 mutant and KMT to rearrange AML, that's in the front line for zifto in combination with 7+3. I'm Noticing those CR rates are increasing. I'm also noticing that CR MRD negativity is an NPM1 occurring potentially out to 43 weeks in some patients. So I guess with all of that said, what have you learned from KOMET-007 about the dose profile in the front line, especially over longer-term use? Is there some response deepening? Happening? Or is this just kind of an artifact of increasing -- of including kind of less adverse risk patients?
Mollie Leoni: So I think we've learned foremost that we're using it correctly. And that doing it with a 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 into some sort 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 017, so that we can expect great outcomes for these patients in the front line as well.
Troy Wilson: Yes. Peter, this is Troy. Just to add to Mollie'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 front line 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 Mollie said, to the durability. We're really -- this is -- this data is pretty unprecedented and I think very encouraging from the promise of menin inhibitors and the 017 study, as she said.
Operator: Your next question will come from Jonathan Chang with Leerink Partners.
Jonathan Chang: On the KOMZIFTI launch, can you provide more color on what you're seeing in terms of initial combination use and instances of switching from other menin inhibitors? How common is combination use in switching?
Brian Powl: Yes. Thanks for that question, Jonathan. Yes. 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 -- using KOMZIFTI combination, either with ven/aza or in those FLT3 co-mutated also with gilteritinib. So that's what we're seeing early on. I think that getting to the expectation of how those patients will do is something will follow. And regarding your question around switching, that is something that we -- as I said, we observed, especially as 2 products that became available. It just kind of drove where physicians are choosing to use KOMZIFTI 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 KOMZIFTI profile and really, I think, supports the strong initial early momentum we've had in this first quarter of launch.
Operator: Your next question will come from Etzer Darout with Barclays.
Etzer Darout: Just a follow-up on a question. Maybe you could comment on the primary reason patients have been switching from other menin inhibitors. I'm not sure how much data point you've gotten at this point, but just wondered if it's something you could comment on?
Brian Powl: Yes. I don't think I can -- thanks for the question, Etzer. 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 chose to switch those patients from another menin inhibitor to give them the opportunity to benefit from KOMZIFTI. So it could be based on the profile. Based on whatever the decision the physician feels. Based on if its efficacy, the safety profile, the simplicity of use, all of those things are what we've heard has resonated from a number of physicians.
Troy Wilson: Yes, Etzer, just to jump in for a second and build on that. I mean the switching is, to some extent, what we expected. I don't -- 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. The other menin 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 really strong momentum to be able to take leading market share in NPM1. You are going to see some switching. I mean, as we've said, we think we have a superior overall profile, but where we really think you're going to see it is in the new patient -- increased new patient starts again, use in combination, although that's not our labeled indication, that's physician discretion. Those are some of the elements we draw folks' attention to.
Operator: Your next question will come from Reni Benjamin with Citizens.
Reni Benjamin: Congrats on the progress. Maybe just sticking with the new patient starts. I guess, any other or additional color you can provide, anything regarding gross to net dynamics? And when you talk about the 157 total prescriptions, are these -- are the scripts typically like 1 month on average, are they 3 months on average? Can you give us some sort of details there. And just if I can throw 1 more in regarding the commercialization, you said 60 activated accounts. Brian, what's kind of the total number of accounts that you're targeting? Just to give us a sense as to where we are in the cycle.
Brian Powl: Yes, sure. So thanks for the question, Reni. So with regards to these new patient starts, the color we're seeing, and I shared a little bit, these are the relapsed/refractory patients to kind of fit across -- we're seeing it across accounts that are either KOMZIFTI trial sites. We're seeing it from those who have experience with other menin 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 KOMZIFTI, and we're very pleased with the opportunity we have to move forward with that at this point in time. We do say, 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 based on that menin class share. So we're very encouraged by the start right now. We look forward to that in the future.
Troy Wilson: And Reni, the scripts are 1 month, right? These are 1 month scripts.
Reni Benjamin: Got it. And the gross to net dynamics?
Thomas Doyle: Thanks, Reni, for that question. Those are within normal ranges, so in that 20% to 30% range.
Operator: Your next question will come from Roger Song with Jefferies.
Nabeel Nissar: This is Nabeel on for Roger. I'm encouraged to hear on the open label, the combo use at 40% in combination. So I'm just kind of curious if you could give us color on how this looks in academic and community settings? And then as we get more data, the ven/aza publication and then the second half data with the FLT3 combo, how do we expect this to sort of evolve? And does the KOMZIFTI have any advantage here?
Brian Powl: Yes. So I mean, I think that as we said, 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, Mollie's remarks around the combination use. This really shows that we have a potential to become that strong leader, both in the relapse/refractory, but in the front line setting. The data that we'll be presenting in the publication with ven/aza, will be coming, as we said, 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 NPM1 patients who have a FLT3 co-mutation, which may be unique to KOMZIFTI's profile to be able to do.
Operator: Your next question will come from Phil Nadeau with TD Cowen.
Philip Nadeau: Congrats on the progress. In regards to the frontline data that's going to be at EHA, we're curious to get your most recent thoughts as to what measures you think investigators and physicians are going to look to you when thinking of adopting the menin ins in the front line. Do you think ultimately the most powerful data will be the durability of the response? Could it be progressing to transplant, ultimately, overall survival? I guess in your conversations what are physicians evaluating most prominently as they think about moving the menin ins forward?
Mollie Leoni: 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% of patients having a complete response to 7+3, and we're seeing things in the high 90s. You'd expect to see about 45% 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 having really strong, really deep responses and a great chance of having an effect on survival overall.
Operator: Your next question will come from Salim Syed with Mizuho.
Salim Syed: Great. Congrats on the quarter, guys. Just 1 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?
Troy Wilson: Yes. Salim, I mean we're talking about small numbers. Our goal here is to be the market leader in relapsed/refractory NPM1, that's 51% or more. I think you're going to see us push that as high as we can. There's -- as you 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 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 -- ziftomenib or KOMZIFTI in the commercial setting has a real opportunity. So 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.
Operator: [Operator Instructions] Our next question will come from David Dai with UBS.
Xiaochuan Dai: Congrats on the quarter. So a few questions from me. One is on the $5.8 million revenue. How much of that is inventory stocking? And then how should we think about the combo use could extend the duration of therapy beyond the 6 months on monotherapy? And then lastly, do you think the patients will actually continue to use menin inhibitors beyond progression?
Troy Wilson: So just a reminder to everybody. David, I'm going to -- I don't mean to single you out, but we're trying to limit people to 1 question. So there isn't any meaningful stock in. I mean this is -- you can see this in the numbers. But Brian, maybe you can speak to durably -- the question on durability of combo?
Brian Powl: Yes. I mean I think that, as I said earlier, David, I think 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 which type of patients are getting on therapy. Is it more 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 our -- we believe that this overall market opportunity in the relapsed/refractory setting still remains around that $350 million to $400 million.
Troy Wilson: Yes, 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 gilteritinib, given that we're not even planning to present that data until sort of towards 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.
Operator: Your next question will come from Daniel Brims with Lake Street.
Daniel Brims: 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 adagrasib?
Mollie Leoni: Yes. 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 ASCO presentation, you're going to see it in combination with the KRAS inhibitor adagrasib. You will see dose escalation data, and you will see it across multiple time 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 REV mTORC inhibition pathway that is helping to overcome adaptive and innate resistance for these patients with suffering from cancer.
Operator: Your next question will come from Peter Green with LifeSci Capital.
Peter Green: This is Peter again on for Charles. Just wondering, you mentioned that the KOMET-017 trials is going -- 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?
Troy Wilson: Yes. Maybe Mollie can speak to anything we're hearing, Peter, and then I can address your question about guidance. Mollie?
Mollie Leoni: All we hear is excitement. Excitement for new sites to get up and running, the 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. So I would say 007 was a great indicator of how quickly we could enroll 200 patients into a Phase I trial. The Phase III is going incredibly well, and it's really well predicted by that enrollment rate we saw in 007.
Troy Wilson: 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. 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 ven/aza setting, which is the other side of 017, we're -- the team is making just incredible progress. And really credit to Mollie for combining these 2 Phase IIIs into a single protocol, since that every time we activate a clinical site, we're getting 2 Phase III starts for the price of one. And so you're going to -- I think you're going to see that continue to get pulled through. The excitement has just been helpful. We did an investigator meeting recently, and it was incredibly well attended and well received. So onward we go.
Operator: There are no more questions at this time. I'd now like to turn the call over to Troy Wilson for closing remarks.
Troy Wilson: Thank you, Leila, and thank you all for joining us today. We're encouraged by the early performance of the KOMZIFTI launch, the momentum we're seeing across our clinical programs, the clarity of our strategy moving forward. With continued commercial execution, multiple clinical catalysts and including EHA and ASCO and a strong financial position, we believe, Kura's 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.