Operator
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 Kura Oncology's Q4 and FY 2025 Financial Results Earnings Call. All lines have been placed on mute to prevent any background noise.
After the speakers' 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 Kura Oncology.
Please go ahead.
Pete De Spain
Thank you, Abigail. Good morning and welcome to Kura Oncology's fourth quarter 2025 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 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 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 turn the call over to Troy.
Troy Wilson
Thank you, Greg, and good morning, everyone. 2025 was a defining year for Kura, marked by FDA approval of KRAZATI and initiation of a successful commercial launch.
As we enter 2026, our priorities are clear: execute commercially, move aggressively into front-line AML and combinations, and build long-term leadership in menin inhibition while advancing a data-rich pipeline. KRAZATI 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.
KRAZATI 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, KRAZATI 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 front-line AML and combination settings. Our strategy extends well beyond the initial approval.
Enrollment is underway in our pivotal KOMET-017 front-line trials, and 2026 will bring important data in both the front-line and relapsed/refractory settings. We're positioning ziftomenib as a foundational combination partner in AML, including with FLT3 inhibitors and standard backbone regimens.
Across relapsed/refractory and front-line AML, we estimate the total U.S. opportunity at approximately $7 billion.
Beyond AML, we're advancing a focused solid tumor strategy. Our ziftomenib combination with imatinib in gastrointestinal stromal tumors, or GIST, is progressing in dose escalation, and our next-generation menin programs are advancing.
Tipifarnib, our farnesyltransferase 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 ziftomenib across the AML treatment continuum, and advancing a pipeline with meaningful catalysts in 2026.
With that, I'll turn it over to Brian.
Brian Powl
Thank you, Troy. Good morning.
Our commercial objectives for KRAZATI are straightforward: establish clear differentiation in the menin inhibitor class, deliver strong quarter-over-quarter growth, and achieve leading class share in relapsed/refractory NPM1-mutant AML. The early launch is exceeding expectations.
I could not be happier with the execution of our 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 KRAZATI'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. KRAZATI carries a single boxed warning for differentiation syndrome compared to multiple boxed warnings for a competitor.
That difference is resonating. Importantly, KRAZATI was added to the NCCN guidelines as a Category 2A recommendation within a week of Kura's submission.
That rapid decision reflects enthusiasm and strong alignment among clinical thought leaders. Operational execution has been strong.
KRAZATI was shipped within days of approval, and our experienced sales force brings an average more than 20 years of industry experience and deep hematology expertise. The team is trained and fully deployed, and in partnership with Kyowa Kirin, is targeting more than 4,000 hematology professionals.
Our message is simple: NPM1 mutations are now actionable, and KRAZATI offers a differentiated profile. Access has been a major strength and highlights a powerful leading indicator early in the launch.
We engaged 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 KRAZATI before allowing coverage for the other approved menin 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 KRAZATI's profile and competitive advantage as the class evolves. KRAZATI is distributed through a focused network of specialty distributors and pharmacies.
Through Kura Rx Connect, the average time for prescription to payer decision is 2 days. Patients are getting rapid access.
We estimate the initial U.S. market for NPM1-mutated relapsed/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 Ven/Aza, 7+3, and FLT3 inhibitors, and take the lead in front-line disease.
KRAZATI'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.
Mollie Leoni
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 ziftomenib the 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 3 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 KOMET-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 1 KOMET-007 trial support this strategy. In newly diagnosed patients treated with 7+3 or Ven/Aza plus ziftomenib, we observed high CR rates and deep MRD negativity.
Importantly, the addition of ziftomenib did not meaningfully delay platelet or neutrophil count recovery in either combination. We expect to present updated intensive chemotherapy data from KOMET-007 in the first half of 2026.
In parallel, we are preparing a manuscript detailing ziftomenib in combination with Ven/Aza in the relapsed/refractory NPM1-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 ziftomenib 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 NPM1-mutant AML.
FLT3 co-mutations present another significant opportunity, and one we are well ahead of competitors. We are evaluating ziftomenib in combination with gilteritinib in the relapsed/refractory setting, and with quizartinib in the front-line setting.
If we can demonstrate the ability to combine ziftomenib safely with FLT3 inhibitors, we believe that will be a key differentiator. Outside AML, KOMET-015 is evaluating ziftomenib and imatinib 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 tipifarnib, 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 FIT-001 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 FIT-001 showed encouraging safety and tolerability, as well as antitumor activity, including in patients previously treated with cabozantinib. Updated data will be presented in the second half of this year.
We also plan to present preliminary data from our Phase 1a study evaluating tipifarnib with adagrasib in patients with KRAS G12C-mutated 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 ziftomenib 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. With that, I'll turn it over to Tom for a financial update.
Tom Doyle
Thank you, Mollie. I'm happy to provide a brief overview of our financial results for the fourth quarter of 2025.
As we preannounced in January, our net product revenue from KRAZATI 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 Kyowa Kirin.
Collaboration revenue from our Kyowa Kirin 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 ziftomenib combination trials, including the start of enrollment in our KOMET-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 KRAZATI. 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, Kura had 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 KRAZATI and KOMET-017 enrollment milestone payments. Kura is providing guidance for collaboration revenue, which reflects non-cash-based accounting recognition of performance obligations under our collaboration agreement with Kyowa Kirin.
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 Kyowa Kirin, are expected to fund our ziftomenib AML program through the first topline Phase 3 results from KOMET-017 anticipated in 2028.
With that, I turn the call back over to Troy.
Troy Wilson
Thank you, Tom. Kura enters 2026 with strong momentum.
We have a launched product, which is performing well. We have the broadest front-line 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 KRAZATI in relapsed and 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 FTI 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.
Operator
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 Li Watsek with Cantor Fitzgerald.
Li, please unmute your line and ask your question.
Li Watsek
Hey, good morning. Congrats on the progress.
Maybe a commercial question for Brian. You made a very interesting comment about step editing that some payers may require to use KRAZATI before the competitor product.
I just wonder if you can give us a little bit more information about that, what percentage of payers have implemented this step-through policy, and any specific sort of feedback you can share from payers regarding the step
Troy Wilson
edit. Thanks, Li, for the question.
Just to remind everyone, we're going to try to limit one question per analyst so that we can get through everyone. Brian, I'll let you, there's two or three questions tucked in there, also let you speak to them.
Brian Powl
Right, thanks. Thanks, Li, for the question.
As we shared in the remarks, I think we we think that this this news of a of a step edit required from some payers that's just come forward is a powerful leading indicator that supports kind of our overall assertion about KRAZATI being differentiated. I will say that our team, the the market access team has done a phenomenal job securing access and working with the with payers so broadly to get this access so early.
What I can kind of share around the step edit, and as you know what that recommend the recommendation from some of these payers is that a patient should would be recommended to receive KRAZATI before receiving any other menin inhibitor. Our understanding is the base the basis of that is is built on a on a an a report from a group called IPD Analytics.
It's a independent consulting firm who is influential to many payers. Their their recent reports of of the relapsed/refractory market and evaluating KRAZATI recommended this step edit for adult patients with relapsed/refractory NPM1-mutant AML.
We know that there are some payers that have started to implement that as as I shared. The biggest driver, from what we can understand, from the the this from from the consulting summary from IPD, is that really, the the four pillars we talked about around the differentiation of of KRAZATI stood stood out, particularly because of the predictability of the cost.
If you look at the the based on their assessment, the annual WAC for KRAZATI in the setting is about just under $600,000 a year, but with their competitor menin inhibitor, because of the different dosing schemas and and SKUs that come forward, it comes out to almost $1 million a year. I think that's where we see their driving the difference when you also add in the the safety profile, the combinability, and the predictability of that.
I I can't really give you, 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 to become the class leader here in in the NPM1 space.
Li Watsek
Thank you.
Operator
Your next question comes with Roger Song from Jefferies. Please unmute your line and ask your question.
Roger Song
Hi, team. Congrats for the update, and then the very encouraging early launch signal.
The step edits 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 any thing you can comment on the trend for the rest of the year?
That will be helpful. Thank you.
Brian Powl
Thanks, Roger. Happy to do that.
We're not going to be giving you guidance specifically on the trend. What we can tell you is that the launch, as I said, has been off to a very strong start.
We are seeing patient demand. 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. As we get into our next quarters, we'll start to see a little bit more data we'll be able to share around 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.
Roger Song
Excellent. Thank you.
Operator
Our next question comes from Jonathan Chang with Leerink Partners. Jonathan, you may now unmute and ask your question.
Albert Agustinus
Good morning. This is Albert Agustinus on for Jonathan Chang.
Thanks for taking my questions, and congratulations on all your progress. My question is, what do you see as the biggest hurdle now for KRAZATI to gain market share in 2026 now?
Is it just prescribers' inertia or something else? Thanks.
Brian Powl
Sure. Thanks, Albert, for that.
What we anticipate with the NPM1 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. It really will come down for us is to getting those patients into our queue.
I think one element of this market that's a bit unpredictable for us, as you well know, is that we're approved in a monotherapy setting, and that's where our team's going to be promoting. We've heard a lot from physicians that they're looking to use menin inhibitors and KRAZATI in combination.
That will be one of the questions for us to understand is how that uptake comes out in the combination setting. That will be something we'll be able to see coming forward in the future.
The payer hurdles have been really non-existent. We're really pleased with how quickly our uptake has been on getting on policies.
We don't really see any major hurdles other than just getting those incident patients onto therapy.
Troy Wilson
Albert, this is Troy. I might just add a comment or two to Brian's response.
This is why we've laid out in our milestones for 2026, the significance of the publication in relapsed/refractory NPM1-mutant AML with Ven/Aza that Molly mentioned, as well as the combination with gilteritinib. 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 think will continue to be clear is the ability to combine, the ability to drive better outcomes for patients is ultimately going to be of great value. It's why we feel confident that we're going to take leadership not only of the NPM1-mutant class, but ultimately of the much larger opportunity, because it's going to be about combinations.
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 that's half of the NPM1 population. It's an important part of our leadership strategy.
Albert Agustinus
Thank you.
Operator
Your next question comes from Salim Syed with Mizuho Securities. Please unmute and ask your question.
Salim Syed
Great. Thanks so much, guys.
Congrats on the progress. Just one from us on the 50% that you noted here, Troy, the market feedback suggests you get 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? Is it just based on the existing data, or is there something that you're still planning to get to the leading share, I think, as you put it?
Troy Wilson
Yeah. Salim, I take from your question, you're referring to the relapsed/refractory segment.
Is that where your question is pointed? Yeah.
Correct,
Salim Syed
yes. The market feedback.
Troy Wilson
I'll ask Brian to speak to that. Thanks for the clarification.
Brian?
Brian Powl
No, absolutely. We've gotten feedback both from physicians, but we do physician market research as well.
It's interesting, 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.
Of those, we've found that have familiarity with the menin 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. 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 menin class.
Troy Wilson
I'll just add to that, Salim. At this point, we're not really talking about FLT3 in terms of doing the market research.
This is really focused on the monotherapy. One of the differences between this market and the KMT2A market is, obviously, if you have a FLT3 mutation, gilteritinib has a survival advantage.
It's reasonable to assume a menin inhibitor is going to be sequenced after gilt. If you can demonstrate, as Mollie 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. That's what gives us the encouragement.
Today it's monotherapy, tomorrow it's the combination with Ven/Aza, the day or two after tomorrow, it's the FLT3 combination, and it just builds one after the other.
Salim Syed
Got it. Super helpful.
Thanks so much, guys.
Troy Wilson
Sure.
Operator
Your next question comes from Reni Benjamin with JMP Securities. Please unmute and ask your question.
Reni Benjamin
Hey, good morning, guys. Thanks for taking the questions, and congratulations on the early launch, and hopefully it's gone well for 2026.
Mollie talked a little bit about the combination of quizartinib and gilteritinib and the FLT3 opportunity. Can you talk a little bit about what you're hoping to see in your FLT3 data and how important is kind of maximizing the FLT3 opportunity when we're thinking about the potential $7 billion TAM for zifto?
Thanks.
Mollie Leoni
Thanks for that question. The most important thing you can see when you look at our combination data is going to be safety, indicating that you actually can combine.
Obviously, after that, looking to improve upon the agents in isolation. As I said, we'll be presenting our relapsed/refractory gilteritinib 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 drug successfully and safely for these patients. With the front-line, we are in the process of dose escalation with quizartinib in combination with ziftomenib plus 7+3.
Again, that continues to advance. 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.
Troy Wilson
Ren, just to build on Molly's comments, we've seen commentary recently from Astellas that have identified gilteritinib as one of their blockbusters, one of the five sort of emerging blockbusters. They have a front-line 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 quizartinib and gilteritinib. You will see us over the next quarter or two move more aggressively into the FLT3 front-line setting, because we haven't really yet broken it out, but it's a major driver in that $7 billion TAM, ultimately, as you look across all lines of therapy.
Reni Benjamin
Perfect. Thanks very much, guys.
Operator
Your next question comes from Charles Zhu with LifeSci Capital. Please unmute and ask your question.
Charles Zhu
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 these some of the emerging HIF-2alpha or emerging and approved HIF-2alpha inhibitors in that space.
Maybe could you help contextualize your upcoming second-half data for darli plus cabo, not only within the current standard of care, but also amongst the potential emerging standard of care as well? Thank you.
Mollie Leoni
Sure. 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 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 Optimus, but also set some baseline data for ourselves with cabozantinib in this particular line of therapy.
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 tipifarnib, which I think is an important demonstration of our mechanism of action. We do think that our data, as progress 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.
What we do think is again that these good outcomes for patients with HIF-2alphas will move them earlier in lines of therapy, 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 cabo-tipifarnib combination.
Charles Zhu
Got it. Thanks.
Operator
Your next question comes from Jason Zemansky with BofA. Please unmute and ask your question.
Jason Zemansky
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 KRAZATI, maybe that haven't been associated with any of your clinical programs, or at least minimally associated. We recognize this is a small community and it's 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 is the product profile resonated?
Thanks.
Brian Powl
Thanks for that question, Jason. I'd speak to it both from physicians we've heard from, but I'd also point to pharmacists.
The pharmacists that have maybe not been involved so much with treating the patients outside of the trials. The feedback that we've heard, that they recognize that there's multiple menin inhibitors available.
The efficacy we've heard seems to be table stakes essentially. I think both products have similar efficacy.
What really does outline is the questions around how to manage QT, understanding what monitoring for QT prolongation means versus 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 even the simplicity of treating patients once a day without having to do a lot of dose modifications based on the complexity of other therapies they have. We've heard that.
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 feedback from physicians who are new to the menin class, and we've been spending our time educating them around KRAZATI. 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.
Operator
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 Etzer Darout with Barclays.
Please unmute and ask your question.
Hi, good morning. This is Gustav on for Etzer.
Thank you for taking our question. I'd like to ask about KOMET-008, guided to showing data in combination with gilteritinib in the second half of this year.
Can you remind us where you stand with regards to the combination of zifto with FLAG-IDA and with the low-dose cytarabine? Thank you.
Mollie Leoni
Sure. Now, as you said, we've been guiding to release the gilteritinib data because, in large part, we think that is very informative to physicians in how to treat the relapsed/refractory NPM1 mutants co-mutated with FLT3 as well.
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 ziftomenib that gives time for this differentiating agent to really take effect while keeping disease control simultaneously. We haven't guided to when we'll be releasing that data, but I do think that we'll do it pieces at a time to keep the information coming, and also be writing a publication.
Again, we haven't guided as to when those additional cohorts will be shared.
Operator
Your next question comes from Phil Nadeau with TD Cowen. Please unmute your line and ask your question.
Phil Nadeau
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 relapsed/refractory NPM1 market is about $3 to $400 million in revenue.
We're curious to hear how quickly you think the menin class can penetrate the market. 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.
Brian Powl
Oh, great. Thanks, Phil, and good to see you yesterday.
As we've said, this TAM of $350 to $400 million is kind of representing that relapsed/refractory space. We think because of the dynamics of the NPM1 population, where physicians have previously had choices for their patients to either get Ven/Aza or a FLT3 inhibitor for those who are co-mutated, we anticipate early on there'll probably be more of the relapse or kind of the relapsed/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 more patients get therapy and benefit earlier. Our expectation is that, as we've 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 Ven/Aza publication that we plan to publish based on KOMET-007. What we anticipate is that there will be 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 the second-line patients as well.
We'll need a little bit of time to really get an understanding as to how KRAZATI is being used in combination relative to monotherapy.
Operator
Your next question comes from David Dai with UBS. Please unmute and ask your question.
David Dai
Great. Thanks for taking my questions, and congrats on the quarter.
Just one question on the duration of therapy. Understand it's the early innings, but any thoughts on duration of therapy for KRAZATI so far?
As you are thinking about combination with Ven/Aza or gilteritinib, how do you think the duration of therapy could evolve over time?
Brian Powl
Great. Thanks, David, for that question.
Obviously, with sharing 5 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 we think an average of 6 months.
Our label suggests that patients are treated for up to 6 months to maximize the depth of their response. For those patients who do get a response, we've seen duration of therapy of 5 months, duration of response of 5 months, and oftentimes it takes 3 months or so for them to get that response, to achieve that deep response.
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.
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, 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.
We wish all of you a good morning and a good rest of the day. Thanks again.