Kura Oncology, Inc. (KURA) 2025 Q4 法說會逐字稿

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. (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.

Thank you, Abigail. Good morning, and welcome to Kura Oncology's fourth quarter 2020 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.

Thank you, Greg, and good morning, everyone. 2025 was a defining year for Kura, marked by FDA approval of KOMZIFTI and initiation of a successful commercial launch. As we enter 2026, our priorities are clear: execute commercially, move aggressively into frontline AML and combinations and build long-term leadership in menin inhibition while advancing a data-rich pipeline. KOMZIFTI 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. KOMZIFTI 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, KOMZIFTI is now listed in the FDA's Orange Book with patent protection through July 2044. That runway strengthens the long-term value of the franchise, particularly as we expand into frontline AML and combination settings.

Our strategy extends well beyond the initial approval. Enrollment is underway in our pivotal KOMET-017 frontline trials and 2026 will bring important data in both the frontline and relapsed/refractory settings. We're positioned Ziptomenib as a foundational combination partner in AML, including with FLT3 inhibitors and standard backbone regimens.

Across relapsed/refractory and frontline AML, we estimate the total US 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.

Darlifarnib, our farnesyl transferase inhibitor is designed to address resistance mechanisms across multiple oncogenic pathways. It's combination flexibility, including with cabozantinib, KRAS inhibitors and PI3 kinase inhibitors gives it potential to impact more than 200,000 patients annually in the US.

We expect multiple clinical updates this year. In short, we're executing commercially, expanding development of ziftimenib across the AML treatment continuum and advancing a pipeline with meaningful catalysts in 2026.

With that, I'll turn it over to Brian.

Thank you, Troy. Good morning. Our commercial objectives for KOMZIFTI 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 quality of the feedback has been consistent and encouraging. Positions, both academic and community-based, consistently site KOMZIFTI'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 echoed this in complex patients on multiple medications, safety and predictability drive confidence. We also hear clearly that the safety profile matters. KOMZIFTI carries a single boxed warning for differentiation syndrome compared to multiple box warnings for a competitor. That difference is resonating.

Importantly, KOMZIFTI 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. KOMZIFTI was shipped within days of approval, and our experienced sales force brings an average of more than 20 years of industry experience and deep hematology expertise. The team was trained and fully deployed and in partnership with Kyowa Kirin is targeting more than 4,000 hematology professionals. Our message is simple. NPM1 mutations are now actionable and KOMZIFTI offers a differentiated profile.

Access has been a major strength and highlights a powerful leading indicator early in the launch. We engage payers covering approximately 90% of insured lives prior to approval. Within 90 days, approximately 84% of private payers had established coverage aligned with the label and without additional restrictions.

That speed of coverage surpasses both industry benchmarks and our internal expectations. We're also thrilled to report that certain blue plans are now requiring patients to go on KOMZIFTI before allowing coverage for the [other] approvement in inhibitor.

It's our understanding that their decision to implement this stat 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 KOMZIFTI's profile and competitive advantage as the class evolves.

KOMZIFTI is distributed through a focused network of specialty distributors and pharmacies through Kura RxKonnect the average time for prescription to payer decision is two days. Patients are getting rapid access.

We estimate the initial US market for NPM1 mutated relapsed/refractory AML at approximately $350 million 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 frontline disease.

KOMZIFTI's profile, particularly at 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 Mollie to discuss our pipeline.

Thank you, Brian. FDA approval in relapsed refractory NPM1 mutant AML was a major milestone, and it's just the beginning. We are building a durable expanding franchise backed by the most comprehensive development strategy. Our goal is clear, makes ziftomenib a foundational therapy across AML. We are executing the most comprehensive development strategy in the category.

We expect to deliver multiple updates this year across key programs at major medical meetings supported by an expanding publication plan. Relapse rates in AML remain high, up to 70% within three years. We believe deeper and more durable outcomes require moving effective therapies earlier in treatment. This drives our first to frontline strategy.

We are rapidly advancing our registrational COVID-17 program in newly diagnosed AML, which will recruit patients at approximately 200 global sites. The program includes two independently powered trials, intensive and nonintensive chemotherapies, each designed to support potential US 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 neutral account 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 is implemented 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 CRE 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 frontline setting. If we can demonstrate the ability to combine ziftomenib C with FLT3 inhibitors, we believe that will be a key differentiator.

Outside AML, KOMET-015 is evaluating ziftomenib with 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 darlafarnib. We are advancing this FTI in combinations to address resistance biology across solid tumors. We announced today the initiation of the Phase 1b dose expansion of FIT-001 with cabozantinib in advanced renal cell carcinoma.

The Phase 1b portion comprises of randomization into three arms in line with project Optimus, including on cabozantinib monotherapy arm. This third arm provides a controlled benchmark and enables us to evaluate the combination in patients who are not responding to or just beginning to fail cabozatinib 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 darlifarnib 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 cardio metabolic indications. In summary, we are working to move zitiminib earlier in the AML treatment paradigm, expanding our combination strategies and advancing a second growth pillar with the FTI platform with multiple catalysts this year.

And with that, I'll turn it over to Tom for a financial update.

Thank you, 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 KOMZIFTI 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 zitomentid 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 KOMZIFTI. Net loss for the fourth quarter of 2025 was $8 million compared to a net loss of $19.2 million for the fourth quarter of 2024. This includes noncash share-based compensation expense of $11.3 million compared to $8.6 million for the same period in 2024.

As of December 31, 2025, Kura had cash, cash equivalents and short-term investments of $667.2 million compared to $727.4 million as of December 31, 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 KOMZIFTI and KOMET-017 enrollment milestone payments.

Kura is providing guidance for collaboration revenue, which reflects noncash-based accounting recognition of performance obligations under our collaboration agreement with Kyowa Kirin. 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.

Current cash, cash equivalents and short-term investments as of December 31, 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 top line Phase 3 results from KOMET-017 anticipated in 2028.

With that, I turn the call back over to Troy.

Thank you, Tom. Kura enters 2026 with strong momentum. We have a launched product, which is performing well. We have the broadest frontline AML development strategy underway. We have multiple data readouts ahead and we have a second platform advancing in solid tumors.

Our priorities are clear: accelerate uptake of KOMZIFTI in relapsed refractory NPM1 mutant AML and delivered 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, we'll conclude and open the call for questions.

(Operator Instructions) Li Watsek, Cantor Fitzgerald.

Congrats on the progress. Maybe a commercial question for Brian. You made a very interesting comment about step editing that some peers may require to use KOMZIFTI 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 the stop through policy and any specific feedback you can share from peers regarding KOMZIFTI?

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

Right. Thanks. And thanks, Li, for the question. Yeah. Yeah, as we shared in the remarks, I think -- we think that this news of a step edting required from some payers that's just come forward is a powerful leading indicator that supports kind of our overall assertion about KOMZIFTI being differentiated. I will say that our team -- the market access team has done a phenomenal job securing access and working with payers so broadly to get this access so early.

What I can kind of share around the step edit and as you know what that recommend -- the recommendation from some of these payers is that a patient should -- would be recommended to receive KOMZIFTI before receiving any other menin inhibitor.

Our understanding is the basis of that is built on a report from a group called IPD Analytics. It's an independent consulting firm who is influential to many payers. And their recent reports of the relapsed refractory market in evaluating KOMZIFTI, recommended the step that for adult patients with relapsed/refractory and PM1-mutant AML. We know that there are some payers that have started to implement that, as I shared.

The biggest driver from what we can understand from this -- from the consulting summary from IPD, is that really, the four pillars we talked about around the differentiation of KOMZIFTI stood out, particularly because of the predictability of the cost.

If you look at the -- based on their assessment, the annual WACC for KOMZIFTI in this setting is about just under $600,000 a year. But with our competitor menin inhibitor because of the different dosing schemes and SKUs that come forward, it comes up to almost $1 million a year.

And I think that's where we see they're driving the difference when you also add in the safety profile, the combinability and the predictability of that. So I can't really give you an overview of how many plans, there are a handful, and we can't predict how many other plans may do this in the future, but it's encouraging for us as we look to become the class leader here in the NPM1 space.

Roger Song, Jefferies.

Congrats for the update. And then the very encouraging early launch. So the stablity certainly very interesting, maybe just given the excess 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 would be helpful.

Yeah. Thanks, Roger. I'm happy to do that. So we haven't -- we're not going to be giving you guidance specifically on the trend. What we can tell you is that the launches, 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.

So what we anticipate and as we get into our next quarter, we'll start to see a little bit more data, we'll be able to share around new patient starts of 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.

Jonathan Chang, Leerink Partners.

This is Albert Augustinus on for Jonathan Chen. Congratulations on all your progress. So my question is what do you see as the biggest hurdle now for KOMZIFTI to gain market share in 2026. Now is it just prescribers' inertia or something else?

Yeah, sure. Sure. Thanks, Albert, for that. Yeah, I mean, I think that we're -- 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 into -- or progress into the second, third, fourth-line setting. So it really will come down for us as to getting those patients into our queue.

One of the part -- I think one element of this market that's a bit unpredictable for us as you as you well know, is that we're approved in a monotherapy setting, and that's where our teams are going to be promoting. But we do -- we've heard a lot from physicians that they're looking to use menin inhibitors and KOMZIFTI 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.

But we don't see -- the payer hurdles have been really non-existent. We're really pleased with how quickly our uptake has been getting on policies. So we don't really see any major hurdles other than just getting those incident patients onto therapy.

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 Mollie 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 the sales team promoting on label with monotherapy. But what's clear, and I think we'll 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.

And what we see, it's why we feel confident that we're going to take leadership not only of the NPM mutant class, but ultimately, of the much larger opportunity because it's going to be about combinations and the 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 FLT inhibitors. As you know, that's half of the NPM1 population. So it's an important part of our leadership strategy.

Salim Syed, Mizuho Securities.

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

Yeah. And Salim, I take from your question, you're referring to the relapsed refractories segment. Is that your question point (multiple speakers) the market feedback Yes, I'll ask Brian to speak to that. Thanks for the clarification, Brian?

Yeah. No, absolutely. And. And we've gotten feedback as we -- both from physicians, but we do physician market research as well. And it's interesting, we've had -- we basically provide the profiles of the products. It's blinded. We don't ask them which company, they don't know who's asking the questions. And of those, we found that have had 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.

So those are -- the feedback we've heard is that 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.

Yeah. And I'll just add to that. Salim, I'd just add to that. I mean at this point, we're not really talking about FLT3 in terms of doing the market research. This is really focused on the monotherapy. But one of the differences between this market and the KMT2A market is, obviously, if you have a FLT3 mutation, gilteritinib has a survival advantage. And so it's reasonable to assume a menin inhibitor is going to be sequenced after GILT.

If you can demonstrate as 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 relaxed refractory segment. We're not really yet there with the physicians because we obviously have to do that with data. But that's what gives us the encouragement.

Today, it's monotherapy tomorrow, it's the combination with ven/aza, the day or two after tomorrow, it's the FLT3 combination and it just builds one after the other.

Reni Benjamin, JMP Securities.

Congratulations on the early launch and hopefully, it's going well for 2026. You talked a little bit -- Mollie talked a little bit about the combination of bazartinib 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?

Yeah. Thanks for that question. So the most important thing you can see when you look at our combination data is going to be safety. Safety indicating that you actually can combine. And obviously, after that, to improve upon the agents in isolation. So 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, a combination with ziftomenib plus 7+3. And again, that continues to advance. So overall, we expect to be able to show you not just the fact that we can combine, but that we can improve upon the outcomes of these drugs in isolation.

Yeah. And Ren, just to build on Mollie'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 frontline trial that's -- 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 three frontline setting because that -- we haven't really yet broken it out, but that will be -- it's a major driver in that $7 billion TAM ultimately as you look across all lines of therapy.

Charles Zhu, LifeSci Capital.

Congrats on all the progress. I'll ask one on a slightly different topic regarding FTIs. We had a lot of updates from the recent ASCO GU conference, particularly in renal cell carcinoma and some of the emerging HIF2 alpha or emerging an approved HIF2 alpha 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?

Sure. Yeah. We're following that data very closely as well, and it's looking very good for patients. In fact, I think as you're referring to, it's looking so good that it probably will end up moving up in line in line of therapy for these patients. We, as we announced, have just started our Phase 1b which is a randomized Phase 1b so that we can both contend with project Optimus, but also set some baseline data for ourselves with cabozantinib in this particular line of therapy.

And we will be able to also see if patients that are randomized to the cabo monotherapy can cross over and successfully either gain or regain responses when you combine it with darlifarnib, 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.

But what we do think is again, that these good outcomes for patients, [pif-2] alphas, we'll move them earlier in lines of therapy. So you'll see them in the front line. And ultimately, it can open a rather big vacuous space in the second line. that we could then jump right into with this cabo-dalafarnib combination.

Jason Zemansky, BofA.

Congrats on the progress. Brian, I was hoping you could share some of the early feedback from your prescribers that are new to come if 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 I participated in a trial associated with your rival or don't have a large AML population, how has the product profile resonated?

Yeah. Thanks for that question, Jason. And I'd speak to it both from physicians we've heard from, but I'd also point to pharmacists like the pharmacists that are -- have maybe not been involved so much with treating the patients outside of the trials. The feedback that we've heard has really -- they recognize that there are -- 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 edits the not just having to monitor, but to understand the potential implication of a higher risk of cardiac issues has come back from us as well as -- I mean, even the simplicity of treating patients once a day without having to do a lot of dose modifications based on the complexity of other therapies they have. So we've heard that.

I mean I think what we know is that, of course, a lot of probably early scripts are going to be those for people who've had a lot of experience with us. But we have received feedback from physicians who are new to the men in class, and we've been spending our time educating them around comp. So we're as we said, it's early days, but we're pleased with what we're hearing so far and it seems to be consistent from what we've heard from those who do have experience.

(Operator Instructions) Etzer Darout, Barclays.

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 Zip to with flag IDA and with the low-dose cytarabine?

Sure. No. As you said, we have been guiding to release the gilteritinib data because -- in large part, we think that is very informative to physicians and how to treat DeBlase refractory NPM1 mutant co-mutated with FLT3 as well. but also within that study are our flag IDA combination, which sees mostly second-line patients and our LDAC combination, which allows for an easy combination with ziftomenib that gives time for this differentiating agent to really take effect while keeping disease control simultaneously.

So we haven't guided to when we'll be releasing that data. But I do think that it will be -- we'll do it pieces at a time to keep the information coming and also be writing a publication. But again, we haven't guided as to when those additional cohorts will be shared.

Phil Nadeau, TD Cowen.

It was great to see the team this week in Boston. We have 1 commercial question. I think you suggested that the relapsed refractory NPM1 market is about $300 million to $400 million. in revenue. We're curious to hear how quickly you think the menin class can penetrate the market. It seems like the value proposition is pretty clear today. But we're wondering if there's any gating like combo therapy data, in particular, that could be necessary to fully penetrate the opportunity?

Great. Thanks, Phil, and thanks again for seeing you. Good to see you yesterday. Yeah. The -- as we've said, this TAM of $350 million 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 will probably be more of the -- 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 there'll be a lot of -- as we said, there's a lot of use likely in the -- 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 like the ven/aza publication that we plan to publish in the -- with -- based on KOMET-007.

So what we anticipate is that there will be a ramp-up based on incident patients coming forward, probably starting more in the in the third, fourth line, but we will see and we are starting to see those second line patients as well. We'll need a little bit of time to really get an understanding as to how the how KOMZIFTI is being used in combination relative to monotherapy.

David Dai, UBS.

Congrats on the quarter. Just one question on the duration of therapy. So I understand it's early innings, but any thoughts on duration of therapy for KOMZIFTI so far. And as you are thinking about combination with ven/aza or gueritinib, how do you think the duration of therapy call evolve over time?

Great. Thanks, David, for that question. Obviously, we're sharing five weeks of data. We can't really give you a lot of detail around duration of therapy at this point. Our expectation is that patients will be able to get therapy for up to -- we think an average of six months, our label suggests that patients are treated for up to six months to maximize the depth of their response.

And for those patients who do get a response, we've seen duration of therapy of five months duration of response of five months and oftentimes it takes three months or so then to get that response to achieve the response. So we think that we'll get to -- we're not seeing any signs yet because it's too early to see -- we are seeing repeat prescriptions but it's too early to talk through any duration right now.

To your question around FLT3 inhibitors, I think that any combination is expected to give a longer duration of treatment than you would expect as a monotherapy.

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

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

Thanks, again.