Prepared remarks
My name is Lenias, and I will be your conference operator today. At this time, I would like to welcome you to the Kura Oncology Second Quarter 2026 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 everyone the opportunity to participate, we ask that you please limit yourself to one question and one follow-up question. If time permits, at the end of the Q&A session, we invite you to rejoin the queue for additional questions. At this time, I would like to turn the call over to Greg Mann, Senior Vice President of Investor Relations and Corporate Affairs of Kura Oncology. Please go ahead.
Thank you, Lenias. Good afternoon, and welcome to Kura Oncology's second quarter 2026 conference call. Joining the call today are Dr. Troy Edward Wilson, President and Chief Executive Officer; Brian T. Powl, Chief Commercial Officer; Dr. Mollie Leoni, Chief Medical Officer; and Thomas 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 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 will turn the call over to Troy.
Thank you, Greg, and good afternoon, everyone. The second quarter marked another step forward in Kura's evolution as a commercial-stage oncology company. COMZIFTI moved into a leadership position in relapsed/refractory NPM1-mutant AML in the menin inhibitor market, and new clinical data further strengthened our confidence in our strategy of building two differentiated growth franchises. I will start with COMZIFTI. In only our second full quarter on the market, COMZIFTI generated $9.1 million in net product revenue, exceeding our expectations, and captured a majority of new patient starts in the relapsed/refractory NPM1-mutant AML menin inhibitor market. At this stage of the launch, new patient starts are the clearest leading indicator of commercial performance. They measure which therapy physicians are choosing today, and they establish the base for future prescriptions and revenue. Achieving majority share of new patient starts in only our second full commercial quarter, despite entering the market second, is clear evidence physicians are differentiating within the menin inhibitor class. In real-world AML practice, physicians choose therapies based on the total treatment profile: efficacy, predictable and manageable safety, dosing convenience, drug interactions, and increasingly potential to combine with existing treatment approaches. We believe COMZIFTI's rapid adoption reflects the strength of that differentiated profile in the largest currently FDA-approved menin inhibitor opportunity. But the monotherapy launch is only the beginning. Our objective is to establish Ziftomenib as a foundational therapy across AML by combining it with multiple standards of care. The long-term frontline data we reported at EHA demonstrated that Ziftomenib combines cleanly with standard therapy, deepens responses, and supports more durable outcomes. With nearly 100 patients and extended follow-up, KOMET-007 meaningfully increases our confidence in our frontline strategy. Mollie will discuss those data in more detail. Looking ahead, we expect multiple clinical updates in the second half of the year across monotherapy, combination therapy, and multiple treatment settings. Turning to darlifarnib, we now believe we have a second wholly owned strategic asset capable of creating significant value independent of our menin inhibitor franchise. Across cabozantinib-exposed and cabozantinib-naive renal cell carcinoma as well as in KRAS G12C-mutated solid tumors, we have generated clinical evidence that darlifarnib has the potential to enhance the activity of targeted therapy backbones through a common biological mechanism while maintaining a manageable safety profile. Our strategy is straightforward: pair darlifarnib with established and emerging targeted therapies, allowing us to advance the program efficiently while preserving opportunities for future strategic collaboration. Stepping back, Kura is substantially stronger than it was even just one quarter ago. We have established commercial leadership in new patient starts in relapsed/refractory NPM1-mutant AML. We have built one of the most mature and robust frontline menin inhibitor data sets in AML. We have advanced a wholly owned precision oncology platform beyond menin inhibition, and we have maintained the financial strength to execute through multiple value-creating milestones. Together, these assets position us to create value through commercial execution, pipeline expansion, and disciplined capital deployment. With that, I will turn it over to Brian.
Thanks, Troy. In the second quarter, COMZIFTI generated $9.1 million in net product revenue, approximately 115 new patient starts and more than 250 total prescriptions. Based on current prescription data, COMZIFTI captured a majority share of new patient starts in the relapsed/refractory NPM1-mutant AML menin inhibitor market in only its second full quarter of launch. That is the headline for the quarter. New patient starts are the clearest indicator of physician choice today and one of the strongest predictors of future commercial performance. The quality of the launch is evidenced across multiple metrics. Repeat prescribing continued to increase, adoption expanded across both academic and community treatment centers, and new accounts continued to initiate menin inhibitor therapy with COMZIFTI. Physician-initiated combination use with venetoclax and azacitidine and with FLT3 inhibitors in co-mutated patients represented approximately 40% of new patient starts. And with more than 95% of covered lives and no label restrictions, physicians are confident to prescribe the therapy they believe is best for their patients. Physicians are increasingly choosing COMZIFTI because of its differentiated profile; we believe that profile is driving adoption. Our focus is simple: win every eligible patient. Every new patient creates the opportunity for repeat prescriptions and revenue. Our field force continues to execute at a high level, delivering consistent engagement with primary AML prescribers nationwide. We maintained engagement with more than 90% of our top priority AML accounts during the quarter, while increasing the frequency of interactions with high-value treatment centers. Despite being second to market, COMZIFTI achieved majority share of new patients in only its second full commercial quarter. This is uncommon in oncology. We believe it reflects meaningful product differentiation, growing physician adoption of COMZIFTI, and exceptional commercial execution. Although we promote COMZIFTI only for its approved monotherapy indication, physician-initiated combination use provides an early signal that clinicians see the product fitting naturally in future treatment paradigms. We view the prescribing behavior as evidence of practical fit, which is strategically important as Ziftomenib advances into FLT3-mutated disease and newly diagnosed AML where combination therapies will define the largest opportunities. We believe the confidence physicians are showing today can extend COMZIFTI's leadership into earlier lines and additional patient populations, ultimately positioning Ziftomenib as a foundational therapy across AML. For the balance of the year our priorities are clear: maintain leadership within the relapsed/refractory NPM1-mutant AML menin inhibitor market; continue to expand physician adoption by reinforcing the product attributes that physicians value most; and deliver consistent quarter-over-quarter growth in new patient starts, total prescriptions, and revenue. Our objective is straightforward: establish COMZIFTI as the leading menin inhibitor today while building physician, payer, and patient confidence to become a cornerstone therapy across AML tomorrow. With that, I will turn the call over to Mollie.
Thank you, Brian. The second quarter strengthened both of our precision oncology franchises. For Ziftomenib, new clinical data increased our confidence in its potential to become a foundational therapy across AML. For darlifarnib, the data continued to support its potential as a broad and differentiated combination platform in solid tumors. I will begin with Ziftomenib. Just before EHA, peer-reviewed results from the KOMET-007 relapsed/refractory Ziftomenib plus venetoclax and azacitidine study were published in Blood. The regimen demonstrated meaningful activity in a heavily pretreated population, including patients previously treated with venetoclax. Impressively, among venetoclax-naive patients, the overall response rate was 87%, the CRc rate was 70%, and median overall survival was not reached as of almost 11 months' follow-up. Turning to EHA, we presented long-term results from KOMET-007 evaluating Ziftomenib plus 7+3 in 99 patients with newly diagnosed NPM1-mutant and/or KMT2A-rearranged AML. Remission rates were high. Responses were deep. With a 96% ORR in relapsed/refractory NPM1-mutant AML, at 12 months overall survival was 94%, and median overall survival had not been reached after a median follow-up of 17.6 months. These results compare favorably with historical 12-month overall survival of 70% to 80% in younger, fit patients and 45% to 55% in older adults who receive intensive chemotherapy alone. Importantly, Ziftomenib did not appear to add any meaningful myelosuppression to intensive chemotherapy. To our knowledge, this remains the largest frontline intensive chemotherapy dataset reported for any menin inhibitor, making it a key indicator of the potential for the Phase 3 KOMET-017 program. Continuing to enhance that data pool, the pivotal trial KOMET-017, our one-stop-shop design, continues to accrue across the U.S., Europe, and Asia. We continue to expect to report top-line results from our intensive chemo–Ziftomenib trial in 2028, and our clinical data and operational execution gives us the confidence that we are well positioned to lead in frontline AML. Our FLT3 combination program is also advancing. We expect preliminary clinical data later this year from Ziftomenib plus gilteritinib in relapsed/refractory NPM1 and FLT3-mutated patients. In the second half of 2026, we also expect to provide combination data with 7+3 plus quizartinib. Additionally, there will be other updates, including long-term KOMET-001 data and an exploratory analysis evaluating Ziftomenib activity in additional non-NPM1, non-KMT2A-rearranged, menin-dependent AML subtypes. Taken together, these studies aim to demonstrate Ziftomenib's potential to combine effectively across multiple treatment approaches while maintaining the safety profile needed for long-term use in both relapsed and frontline AML. Turning to darlifarnib, our second major strategic asset. Starting with renal cell carcinoma, we have reported powerful data in both cabozantinib-exposed and cabozantinib-naive patients. In the cabozantinib-exposed setting, darlifarnib plus cabozantinib demonstrated a 44% objective response rate and a 94% disease control rate. Expected response rates in this patient population would be approximately 17% to 22%. The ability to generate responses when cabozantinib had previously failed provides compelling clinical proof of mechanism. The data in cabozantinib-naive patients was even more encouraging. In 34 patients with advanced clear-cell renal cell carcinoma, objective response rates ranged from 33% to 50% across dose levels with a median progression-free survival of 13 months. For context, historical response rates in this setting range from 18% to 40% with median progression-free survival of approximately 6 to 11 months. The safety profile of the combination was manageable across doses tested. These data informed the dose combinations being evaluated in the randomized Phase 1b portion of FIT001, which is comparing darlifarnib plus cabozantinib with cabozantinib alone in cabozantinib-naive clear-cell renal cell carcinoma. The study is designed to select a recommended dose and inform a potential registrational strategy. We expect enrollment to complete in the first half of 2027 with initial data in the second half of the year. In addition, at ASCO, first-in-human data with darlifarnib plus adagrasib demonstrated tumor shrinkage in 77% of response-evaluable patients with KRAS G12C-mutated cancers. Activity was observed across tumor types and dose levels, resulting in an approximate doubling of the response rate expected with monotherapy adagrasib. This combination was also well tolerated. These results in both cabozantinib and adagrasib combinations consistently and independently tell the story of darlifarnib's proposed mechanism of enhancing a targeted therapy backbone via a tolerable method of MAP kinase pathway inhibition. We plan to initiate our darlifarnib platform study evaluating darlifarnib plus daraxonrasib in second-line or later KRAS-mutant pancreatic cancer in the first half of 2027. Our priorities remain clear: execute our registrational studies, generate high-quality, practice-informing clinical data, and continue building two differentiated precision oncology franchises. I will now turn the call over to Tom to discuss our second quarter financial results.
Thank you, Mollie. I am happy to provide a brief overview of our financial results for the second quarter of 2026. Our net product revenue from COMZIFTI sales was $9.1 million compared to none for the second quarter of 2025. Collaboration revenue from our Kyowa Kirin partnership was $11.8 million compared to $15.3 million for the same period in 2025. Research and development expenses were $61.9 million compared to $62.8 million for the second quarter of 2025. Selling, general and administrative expenses were $31.8 million compared to $25.2 million for the second quarter of 2025. Net loss for the second quarter of 2026 was $68.3 million compared to a net loss of $66.1 million for the second quarter of 2025. This includes non-cash share-based compensation expense of $8.2 million compared to $6.9 million for the same period in 2025. As of June 30, 2026, Kura had cash, cash equivalents, and short-term investments of $519 million compared to $667.2 million as of December 31, 2025. We are maintaining our previously communicated guidance for collaboration revenue. 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 non-cash-based accounting recognition of performance obligations under our collaboration agreement with Kyowa Kirin. Our current cash, cash equivalents, and short-term investments as of June 30 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 topline Phase 3 results from KOMET-017 anticipated in 2028. With that, I will turn the call back over to Troy.
Thank you, Tom. The second quarter demonstrates Kura is converting product differentiation into commercial leadership. COMZIFTI is winning new patient starts in adult relapsed and refractory NPM1-mutant AML, while our clinical programs continue to expand Ziftomenib toward the much larger frontline opportunity. At the same time, darlifarnib is emerging as a potentially differentiated precision combination platform with broad applicability across solid tumors. Together, these programs give us multiple independent drivers of long-term value creation backed by the capital and execution to realize those opportunities. With that, Lenias, we are ready to take questions.
Questions and answers
Thank you. 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. We will now pause a moment to assemble the queue. Again, we ask that you please limit yourself to one question and one follow-up question. You are welcome to reenter the queue for any additional follow-up questions. Your first question comes from the line of Jason Eron Zemansky with BofA Securities. Please unmute and ask your question.
Good afternoon. Congratulations on the great quarter, and thanks so much for taking our question. Two quick ones for me. Regarding the 115 new-patient starts, can you help us separate how much of the sequential increase reflected growth in overall menin-class penetration versus share gains from your competitor? And then secondarily, can you help us understand the emerging relationship among starts, refills, and recognized revenue, including any inventory or gross-to-net effects in the quarter? Thanks so much.
Thanks, Jason. I will ask Brian to take each of those questions in turn.
Sure. Thanks, Jason, for the questions. We are very pleased with that sequential growth over quarter-to-quarter. I think what that represents, as we said, is continued execution on the team to penetrate new accounts and extend to new patients. Our goal is to become the majority market leader in this space and this indication, and leading in only the second quarter summarizes that. I think what that shows is we are both taking share from competitors and also growing the overall market. To your second question around refills and the dynamics of growth, you can see in the results that we shared, going from our first full quarter of launch into the second quarter we demonstrated quarter-over-quarter growth of new patient starts of about 35%, and TRx growth was about 60% quarter-over-quarter. So we are seeing repeat prescriptions and new prescriptions, and we are able to see continued good growth. There has not really been any inventory or stocking one-time events that contributed to that. The story is really growth here.
Great. Thanks for the color.
Thanks, Jason.
Thank you. Your next question comes from the line of Li Wang Watsek with Cantor Fitzgerald. Please unmute your line and ask your question.
Hey, guys. Thanks for taking my questions. Just curious, how do you expect COMZIFTI's market leadership to evolve over time? And how much of that do you think is driven by combination use?
Okay. I am going to take this. Sure.
Thanks for that, Li. When we first launched, we said we have a differentiated product profile that we think will be preferential for physicians, and we expected quarter-over-quarter growth throughout the year as well as becoming the market leader in the menin space for the NPM1-mutant population. We have achieved that market leadership based on new patient starts already in the second quarter. With growth in TRx and revenue, the indicators are positive and momentum is on our side to continue to evolve that. Duration is something that will come over time, and that is something we will monitor as we continue to grow. But our focus is getting every new patient the opportunity to be on COMZIFTI, and that is what we have achieved so far. Regarding combination use, approximately 40% of new patient starts are in combination, and that is consistent with where we were last quarter. We are seeing that usage in combination growing. The team is focused on promoting on-label, but physicians see the choice and are looking to combine. We believe that is a real growth opportunity for COMZIFTI in the relapsed/refractory space because of the data Mollie mentioned, including the publication in Blood. We will present new data in combination with FLT3 inhibitors, which, as you know, is relevant because a substantial portion of the NPM1-mutated market is co-mutated with FLT3. We are well positioned to continue the data generation that will support physicians' choices to use COMZIFTI.
Thank you. Your next question comes from the line of Asthika Goonewardene with Leerink Partners. Please unmute your line and ask your question.
Hey, guys. Thanks for taking my question, and congrats on the growth this quarter. A couple quick hits on the inter-quarter dynamics. Could you tell us about your preferred coverage status for COMZIFTI? And for patients requiring a prior authorization, what proportion of those authorizations were converted? I have a quick follow-up as well.
Yes. Go ahead, Asthika.
Thanks, Asthika, for the questions. I didn't go into too much detail about market access coverage earlier, but it represents continued success. We have over 95% of lives covered and approximately 16 million lives covered with a preferred status where they have to step through COMZIFTI before receiving other menin inhibitors. That translates into the growth we are seeing. Prior authorizations are a standard mechanism in oncology, and we have not seen any challenges for physicians to access COMZIFTI for their patients. I think that is reflected in our quarter-over-quarter growth.
That is good to hear. Just a quick follow-up on KOMET-017: it looks like on ClinicalTrials.gov that you have all the sites active. Can you tell us when you expect to complete enrollment in the intensive chemo arm?
Mollie, would you like to take Asthika's question about KOMET-017?
Sure. To be clear, we will have over 200 sites when all sites are active, so we are still in the process of activating them. Things have been going extremely well. Our guidance toward first data update and readout in 2028 remains fully on track.
Got it. Thank you.
Thank you.
Thank you. Your next question comes from the line of Roger Song with Jefferies. Please unmute your line and ask your question.
Hey, team. Thanks for the updates and congrats on the launch progress so far. This is Nabeel on for Roger Song. On KOMET-017, you mentioned enrollment is running ahead of plan. What is driving that, and how are you thinking about the value of being first to build that frontline dataset in this class? Thank you.
Mollie?
There are a few factors. KOMET-017's design is convenient for sites and prescribers: having both intensive and non-intensive chemotherapy within the same trial reduces start-up activities and makes it easier to enroll patients with a menin-dependent disease. The phase 1 data we've presented has bolstered excitement. Patients are doing very well, the addition of a menin inhibitor does not seem to add toxicity and appears to add benefit. So it's a mix of trial design convenience and strong underlying data that is driving faster enrollment.
Thanks, Troy.
Thank you. Your next question comes from the line of Charles Zhu with LifeSci Capital. Please unmute and ask your question.
Hi. This is Peter Green on for Charles. Quick question on the darlifarnib platform. It sounds like first half of 2027 you're launching a platform trial combining darlifarnib with daraxonrasib in PDAC. Wondering if your thinking has changed on potential other combinations — for example, colorectal cancer with EGFR, G12D, or combinations with RAS-targeted agents such as RMC-6236 gaining in the competitive landscape. Curious on your thoughts there. Thanks.
Thanks, Peter. Mollie, do you want to comment?
That's a very good question. Daraxonrasib will be our first agent in the platform design, but the reason we designed a platform is to explore other combinations that make scientific and clinical sense in parallel. Daraxonrasib will be first, but we are absolutely looking for additional combinations in other indications and with other drugs.
To add to Mollie's comment, we see an opportunity to combine with daraxonrasib in second-line PDAC. Many companies are steering toward frontline, but if we can replicate with daraxonrasib what we saw with adagrasib, we can add clinical value for second-line-plus patients. Revolution Medicines has advanced the field, and this gives us a platform to build through combinations. We are being selective — we cannot do everything — but we have a number of combinations under consideration, some of which may require collaborations, and we'll provide more detail as appropriate.
Thanks. Quick follow-up: are funds currently earmarked for this trial and what are the expected costs?
There are funds. We have not broken out specific expense details. At this point, we would plan for the Phase 1a to confirm safety and tolerability; if that looks good, we will reassess. We're at a point where we have a wealth of opportunities to invest in and will continue to be focused in our capital allocation. We are fortunate that darlifarnib is still in early development, so the dollars are not on the same scale as registration-enabling studies. We will be disciplined and deliberate in how we invest.
Your next question will come from the line of Salim Syed with Mizuho. Please unmute your line and ask your question.
Great. Congrats on the quarter. Quick question: you stated majority share of new patient starts in relapsed/refractory NPM1. Another company has also stated they're seeing a majority share. Both cannot be true. Where is the confusion coming from in the data that both parties can claim majority share of new patient starts?
Thanks, Salim. Let me be clear. We have 115 new patient starts. We and the competitor are both reading claims data. They reported 250 new patient starts for the quarter and said approximately 40% were NPM1, which by my math is 100 NPM1 starts. That would represent a decline in their new patient starts quarter-over-quarter while we grew 35% quarter-over-quarter. They have the KMT2A business as well. We are only speaking to NPM1. NPM1 is the much larger opportunity, including potentially FLT3 and the frontline. KMT2A is a smaller segment. When comparing claims numbers, you need to be clear on which population is being referenced. As Brian said, whether it's NPS, TRx, or net revenue, the indicators are all growing and trending positively for COMZIFTI.
Okay. Thanks so much, Troy. Appreciate it.
Your next question will come from the line of Philip Nadeau with TD Cowen. Please unmute your line and ask your question.
Good afternoon. Thanks for taking our question. Now that you have several quarters of commercial experience, have you seen any differences in commercial experience with COMZIFTI versus what we see in clinical trials? Anything notable that physicians are pointing to? As a follow-up, on the FLT3 combo data expected later this year, can you give a sense of what you'd like to see from that data and what next steps could be?
Sure. Brian, do you want to take the question on commercial experience versus clinical trials, and Mollie can speak to the FLT3 combination expectations?
Thanks, Philip. It's a bit early to measure long-term outcomes, but uptake has been supportive of COMZIFTI's differentiation. Physicians value the efficacy, safety, compatibility with other agents, and the simplicity of dosing. That has driven prescription increases and physician choice. We continue to track duration and outcomes over time, but early indicators, including physician-initiated combination use, show strong interest in using these therapies in combination. We made the Blood publication available quickly because physicians wanted the data to support decisions. We'll continue to follow and present more data over time.
Regarding the FLT3 data, both the relapsed/refractory combination with gilteritinib and the frontline quadruplet with quizartinib: the first thing to look for is safety and the ability to combine. Demonstrating safe combinations and dose escalation is crucial because AML is a combination game. You should also look at the associated efficacy data. The quizartinib trial is newer and still enrolling quickly, but we'll share data as it becomes available and discuss next steps when we present the results.
That is very helpful. Thank you.
Thank you. Your next question comes from the line of Etzer Darout with Barclays. Please unmute and ask your question.
Great. Thanks for taking the question. Can you hear me okay?
Yes, we can hear you. Thanks.
Thank you. A follow-up related to the earlier questions around real-world versus clinical use: the combination use you noted at 40% — how much of that is in the relapsed/refractory NPM1 population and potentially an off-label use, versus earlier line use or patients beyond the current label? Any color would be helpful. Thank you.
Thanks, Etzer. The data we reported is primarily in the relapsed/refractory population. Our goal is to enroll newly diagnosed patients into KOMET-017, but much of the combination use we're seeing is in patients who are immediately refractory to frontline therapy and may be preferentially treated in combination. So there's not a large dynamic outside the population that we're treating today.
Thank you.
Thanks, Etzer.
Your next question comes from the line of Reni Benjamin with Citizens JMP Securities. Please unmute and ask your question.
Great. Thanks for taking the questions, and congrats on the quarter. I would love to understand more about the rationale behind evaluating Ziftomenib in MEIS1-addicted AML patients who are not NPM1 or KMT2A. How important is this to market potential versus a 'nice to have'? And as a follow-up, given the KRAS data at ASCO and Tom's comments about cash to fund Ziftomenib readouts, what is the best strategy to fund the darlifarnib franchise? What collaboration structures would you look for? Thanks.
Two very different questions. Mollie, could you speak to the MEIS1-addicted population? I'll take the funding question after Mollie.
When we did Phase 1 dose escalation, we saw activity outside of the expected populations, including a CR in a CEBPA/RUNX1 patient. Data from prior work suggests up to 50% of AML may have MEIS1-high expression, indicating potential responsiveness to menin inhibition. If we can show activity beyond NPM1 and KMT2A, we could potentially help up to 50% of AML patients. We'll present data that supports why we believe that.
On the funding and strategy for darlifarnib: our goal is to establish a registrational path in solid tumors that provides meaningful clinical value and is differentiated. We see an opportunity in advanced renal cell carcinoma and in combinations with agents like daraxonrasib. We could partner or make darlifarnib available to others to expand the program, but it's a strategic decision. Importantly, these two programs — Ziftomenib and darlifarnib — work together in timing: initial topline Ziftomenib frontline results in 2028 align with when investment decisions for darlifarnib registrational studies would be made. We're being disciplined with spend; our R&D expense ticked down slightly year-over-year. We will continue to be responsible stewards of capital while creating value.
Got it. So the funds on hand can get you to those registrational studies, and the timing works with the Ziftomenib readout and moving darlifarnib into registrational studies.
That is the way we think about it. We are in a good position with two programs and we will continue to be disciplined in allocation.
Your next question comes from the line of David Dai with UBS. Please unmute and ask your question.
Great. Thanks for taking my question and congratulations on the quarter. On the Ziftomenib and FLT3 combo, how large do you believe the FLT3 and NPM1 co-mutated population could ultimately become within the broader Ziftomenib franchise? You mentioned roughly half of NPM1 patients have FLT3 co-mutation. Could you help us understand the potential market size in dollar amount?
David, to clarify: about half of NPM1 patients have a FLT3 co-mutation. If you want to maximize clinical benefit, combinations will be important. FLT3 comprises about 30% of AML and roughly half overlaps with NPM1. The other half are NPM1 wild type or have other mutations. We have consistently said a menin inhibitor could be active in the co-mutated population and possibly beyond. We believe there is potential to treat roughly 50% or more of AML patients across the treatment continuum. When we look at the frontline opportunity, we have discussed a multi-billion-dollar TAM — previously we cited roughly $7 billion as a TAM and projected peak sales of $3 billion under certain assumptions and broad approval scenarios. FLT3 is a portion of that overall opportunity. The FLT3 data later this year will help refine these estimates.
Great. Thank you so much.
Our next question comes from the line of Daniel Brims with Lake Street. Please unmute your line and ask your question.
Thanks. Great quarter. Quick question about switching dynamics between menin inhibitors. Are you seeing patients start on competitors and then switch to Ziftomenib as doctors seek a better safety profile or ability to combine? Any color would be helpful.
Thanks, Daniel. Brian, do you want to take that?
Sure. There is a dynamic of switching; some physicians are shifting patients to COMZIFTI. Our goal is to optimize benefit for every patient and to grow the market while taking share. Achieving majority share of new patient starts in the second full quarter shows we're attracting both patients who might have been on other therapies and new patients. Physicians are choosing COMZIFTI based on its profile and opportunities for combinations. We expect this dynamic to continue to evolve.
Thanks, guys. Great work.
Thanks, Daniel.
Your final question of today comes from the line of Peter Green with LifeSci Capital. Please unmute your line and ask your question.
Yes, hello again. Thanks for taking the additional question. Could you contrast the field team experience at sites familiar with Ziftomenib, perhaps investigators on trials, versus sites unfamiliar with Ziftomenib? Also, what proportion of prescriptions are coming from trial investigators?
Peter, thanks for re-entering the queue and asking an additional question. Brian, please comment on field experience and site differences.
Thanks, Peter. The team has been executing well and is experienced in hematology, so we are able to engage effectively across account types. Some sites are early adopters and have trial experience with menin inhibitors; others are transitioning from other menin inhibitors or are newer to the class. The messaging and engagement are slightly different by account type, but we are seeing growth across all segments. There is opportunity for further penetration, and the team is focused on continuing to expand adoption.
Thank you.
There are no more questions at this time. I would now like to turn the call over to Troy Edward Wilson for closing remarks.
Thank you, Lenias. I want to thank you all once again, and in particular to call out Brian's team at Kura and the physicians and care teams. At the end of the day, what we are trying to do is help patients, and I could not be more proud of the team's progress. The team's making tremendous progress from commercial execution in relapsed/refractory to frontline execution and the data you will see later this year. It's everybody working together on behalf of patients. We appreciate your interest and your questions. We will be attending multiple conferences in September and look forward to seeing many of you there. In the meantime, if you have questions, please reach out to Greg or me. Thank you all, and have a good evening.