KURA Kura Oncology, Inc.
$10.86
Kura Oncology, Inc. Q2 F2026 Earnings Call Transcript
Wednesday, August 12, 2026
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Conference Operator
Good day, everyone. My name is Lenius, and I will be your conference operator today. At this time, I would like to welcome you to the Cura Oncology second quarter 2026 financial results earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, and if you've 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 Cura Oncology. Please go ahead.
Greg Mann
Senior Vice President, Investor Relations and Corporate Affairs
Thank you, Linnaeus. Good afternoon and welcome to Cura Oncology's second quarter 2026 conference call. Joining the call today are Dr. Troy Wilson, President and Chief Executive Officer, Brian Powl, Chief Commercial Officer, Dr. Mollie Leoni, Chief Medical Officer, and Tom Doyle, Senior Vice President, Finance and Accounting. We remind you that today's discussion will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that cause actual results to differ materially from expected results. Please refer to Cura's filings with the SEC, which are available from the SEC or on the Cura Oncology website for information concerning risk factors that could affect the company. With that, I'll turn the call over to Troy.
Dr. Troy Wilson
President and Chief Executive Officer
Thank you, Greg, and good afternoon, everyone. The second quarter marked another step forward in Cura's evolution as a commercial-stage oncology company. ComSifty moved into a leadership position in relapsed refractory and PM1 mutant AML, menin inhibitor market, and new clinical data further strengthened our confidence in our strategy of building two differentiated growth franchises. I'll start with Comsifty. In only our second full quarter on the market, Comsifty 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 med and 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-drug interactions, and increasingly, the potential to combine with existing treatment approaches. We believe ComSifty's rapid adoption reflects the strength of that differentiated profile in the largest currently FDA-approved MedIn inhibitor opportunity. Thank you for joining us. Thank you for joining us. Turning to Darla Farnham, 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've generated clinical evidence that Darla Farnham has the potential to to enhance the activity of targeted therapy backbones through a common biological mechanism while maintaining a manageable safety profile. Our strategy is straightforward. Pair duralafarnib with established and emerging targeted therapies, allowing us to advance the program efficiently while preserving opportunities for future strategic collaboration. Stepping back, Cura 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've advanced a wholly owned precision oncology platform beyond menin inhibition, and we've 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'll turn it over to Brian.
Brian Powl
Chief Commercial Officer
Thanks, Troy. In the second quarter, CommZifty generated $9.1 million in net product revenue, with approximately 115 new patient starts and more than 250 total prescriptions. Based on current prescription data, CommZifty captured a majority share of new patient starts in the relapse refractory, MPM1 mutant, AML minute inhibitor market in only its second full quarter of launch. That's 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 ComSifty. Physician-initiated combination use with venetoclax and azacitidine and with FLT3 inhibitors in commutated 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. Positions are increasingly choosing CompZifty because of its differentiated profile, and 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 priority AML prescribers nationwide. We maintain 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, ComSifty 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 ComSifty, and exceptional commercial execution. Although we promote COM-ZIFTI only for its approved monotherapy indication, physician-initiated combination use provides an early signal that clinicians see the product fitting naturally in the future treatment paradigms. We view the prescribing behavior as evidence of practical fit, which is strategically important as ZIFTA-magnitive advances into FLT3-mutated disease and newly diagnosed AML or combination therapies will define the largest opportunities. We believe the confidence physicians are showing today can extend ComXifty's leadership into earlier lines and additional patient populations, ultimately positioning Xifta-Menev as a foundational therapy across AML. For the balance of the year, our priorities are clear. Maintain leadership within the relapsed refractory MPM1 mutant AML minute 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 ConZifty as the leading menin inhibitor today while building physician, payer, and patient confidence to become a cornerstone therapy across AML tomorrow. With that, I'll turn the call over to Molly.
Dr. Mollie Leoni
Chief Medical Officer
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'll begin with Ziftomenib. Just before EHA, peer-reviewed results from the Kama 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 Comet 007, evaluating ZiptoMetab plus 7 plus 3, in 99 patients with newly diagnosed MPM1 mutant and or KMT2A rearranged AML. Remission rates were high, responses were deep, with a 96% ORR in relapsed refractory MPM1 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 70-80% in younger FIT patients and 45-55% in older adults who receive intensive chemotherapy alone. Importantly, Zyptomenib 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 MEN inhibitor, making it a key indicator of the potential for the Phase 3 Commodose 17 program. Continuing to enhance that data pool, the pivotal trial, Commodose 17, our one-stop shop design, continues to accrue across the U.S., Europe, and Asia. We continue to expect to report top-line results for our intensive chemo zyptomenib 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 ZIFT-amended plus giltaritinib in relapsed or refractory MPM1 and FLT3 mutated patients. In the second half of 2026, we also expect to provide combination data with 7 plus 3 plus quisartinib. Additionally, there will be other updates, including long-term Veneza data and an exploratory analysis evaluating ZIFT-amended activity in additional Non-MPM1, Non-KMT2A Rearranged Mennon-Dependent AML Subtypes. Taken together, these studies aim to demonstrate ZIFTA-Mena'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 Cabo 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 CABO had previously failed provides compelling clinical proof of mechanism. The data in CABO's 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 ranged from 18% to 40%, with medium 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. 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 Darlifardib 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-polarated. These results in both CABO and adagrassib combinations consistently and independently tell the story of darlafarnib's proposed mechanism of enhancing a targeted therapy backbone via a tolerable method of MAP kinase pathway inhibition. We plan to initiate our darlafarnib platform study evaluating darlafarnib plus daroxanracib 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'll now turn the call over to Tom to discuss our second quarter financial results.
Tom Doyle
Senior Vice President, Finance and Accounting
Thank you, Mollie. I'm happy to provide a brief overview of our financial results for the second quarter of 2026. Our net product revenue from comms empty sales was $9.1 million compared to none for the second quarter of 2025. Collaboration revenue from our Kiowa Care and 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 Thank you for joining us. We are maintaining our previously communicated guidance for collaboration revenue. We expect this to be $45 to $55 million in 2026, $90 to $110 million in 2027, and $90 to $110 million in 2028. This revenue reflects non-cash-based accounting recognition of performance obligations under our collaboration agreement with Keogh & Karen. Our current cash, cash equivalents, and short-term investments as of June 30th, together with anticipated payments of $180 million under our collaboration agreement with Cable Karen, are expected to fund our ZipDominated AML program through the first top-line Phase 3 results from Comet 017 anticipated in 2028. With that, I'll turn the call back over to Troy. Thank you, Tom.
Dr. Troy Wilson
President and Chief Executive Officer
The second quarter demonstrates Cura is converting product differentiation into commercial leadership. ComSifty is winning new patient starts in adult relapsed and refractory NPM1 mutant AML, while our clinical programs continue to expand Ziv Demetov toward the much larger frontline opportunity. At the same time, Darla Farniv 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, Lennius, we're ready to take questions.
Linnaeus
Conference Operator
Thank you. We will now move to our question and answer session. If you've joined via the webinar, please use the raise hand icon which can be found at the bottom of your webinar application. When you're 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're welcome to re-enter the queue for any additional follow-up questions. Your first question comes from the line of Jason Zemanski with Bank of America. Please unmute and ask your question.
Jason Zemanski
Analyst, Bank of America
Good afternoon. Congratulations on the great quarter and thanks so much for taking our question. Too quick for me. Regarding the 115 new patient starts, can you help us separate how much of the sequential increase reflected growth in overall men in 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 growth to net effects in the quarter? Thanks so much.
Dr. Troy Wilson
President and Chief Executive Officer
Thanks, Jason. Yeah, I'll ask Brian to take each of those questions in turn.
Brian Powl
Chief Commercial Officer
Sure. Thanks, Jason, for the questions. So, yeah, so as we've said, we're very pleased with that sequential growth over quarter over quarter. And I think what that represents, as we said, is, you know, continued execution on the team to penetrate into new accounts and extend for new patients. Our goal is to become the majority share, the majority market leader in this space. And this indication of new patients starts leading in only the second quarter, summarizes that. I think what that shows is we're both taking share from competitors, but also having the opportunity to grow the market. To your second question around kind of refills and dynamic kind of growing that forward, I mean, I think what you can see is in the results that we've shared, we've got a, you know, going from first quarter, our first full quarter of launch into the second quarter, we demonstrated quarter-on-quarter growth of the new patient starts about 35%, and the TRX growth is actually about 60% growth quarter-over-quarter growth. So we're seeing repeat prescriptions. We're seeing new prescriptions. And I think we're able to see continued good growth. And there hasn't really been any inventory or stocking one-time events that really contributed to that. But the story is really growth here.
Jason Zemanski
Analyst, Bank of America
Great. Thanks for the color. Thanks, Jason.
Linnaeus
Conference Operator
Thank you. Your next question comes from the line of Lee Wozzeck with Cantor Fitzgerald. Please unmute your line and ask your question.
Lee Wozzeck
Analyst, Cantor Fitzgerald
Hey, guys. Thanks for taking my questions. Just curious, how do you expect Conv50's market leadership to evolve over time? And how much of that do you think is driven by Convo use?
Brian Powl
Chief Commercial Officer
Sure. Sure. Thanks for that, Lee. I think that we, as we've said, when we first launched, we said that we have a differentiated product profile that we think will be preferential for physicians. And we expected that we would deliver quarter on quarter growth throughout the year, as well as becoming the market leader in the men in space in the NPM1 population. We've achieved that market leadership, as we've shared here, based on new patient starts already in the second quarter. With the growth in TRX, the growth in revenue, what we think is all kind of signs are kind of, you know, arrows are green. They're turning in the direction of growth here. And we think momentum is on our side to continue to evolve that. I know we've been asked questions around duration. Duration is something that will come over time, and that's something we'll be seeing as we continue to grow. But the focus is getting every new patient have the opportunity to get them on ComZifty, and that's what we've achieved so far. And we continue to execute on that will enable us to get to that overall market leadership. For combination use, yes, your question there. As we shared in the remarks, we have approximately 40% use in combination. That's consistent with where we were last quarter, where we had obviously lower volumes. So we're seeing that usage in combination growing. Obviously, the team is focused on promoting on-label products. But physicians see the choice and are looking to find ways to combine. We think that's a real growth opportunity for comSifty in the relapse refractory space because of the data recently that Mollie mentioned about the publication in blood. We'll be presenting new data in combination with FLT3 inhibitors, which, as you know, is approximately half of the NPM1 mutated market is co-mutated. So we'll be able to continue to develop that. We are seeing, as we said, kind of a split of both veneza combinations as well as flip-free currently, but we think we're well positioned to continue the data generation that will support physicians' choices to use CompZipT.
Linnaeus
Conference Operator
Thank you. Your next question comes from the line of Astika Gunwardena with Learing Partners. Please unmute your line and ask your question.
Astika Gunwardena
Analyst, Learing Partners
Hey, guys. Thanks for taking my question and also my congrats for the growth this quarter. Just got a couple of quick hits on the inter-quarter dynamics here. Could you tell us a little bit about what your tier two or preferred coverage was for CumSifty? I'm sorry, can you hear me okay? Yes.
Dr. Troy Wilson
President and Chief Executive Officer
Go ahead, Astaka.
Astika Gunwardena
Analyst, Learing Partners
Yeah, sorry. So the question was, can you tell us about your Tier 2 or your preferred coverage of COM-ZFT? And for patients requiring a prior authorization, what proportion of those prior authorizations were converted? And then I have a quick follow-up.
Brian Powl
Chief Commercial Officer
Thank you for the questions. I didn't go into too much detail about our market access coverage, but I think it represents the continued success of the story. We have over 95% of lives now covered And we have approximately 16 million lives are actually covered with a preferred status where patients have to step through comsifty before receiving other menin inhibitors. And I think what that translates into is the growth that we're seeing. Prior authorizations have been, it's a standard, I think, mechanism in oncology. And I think what's been very important for us is we have not seen any challenges for physicians to be able to access to CompZifty for their patients. And I think that's reflected in the growth we've seen quarter over quarter.
Astika Gunwardena
Analyst, Learing Partners
Yeah, go ahead.
Dr. Troy Wilson
President and Chief Executive Officer
You said you had a quick follow-up.
Astika Gunwardena
Analyst, Learing Partners
Yeah, it's just on Comet 017. So it looks like on clintrials.gov that you have all the sites active. So can you tell us when you expect to complete enrollment in the intensive Kiva arm? Thanks, guys.
Dr. Troy Wilson
President and Chief Executive Officer
Molly, would you like to take Astika's question about 017?
Dr. Mollie Leoni
Chief Medical Officer
Sure. Just to be clear, we'll have over 200 sites when all sites are active, so we're still in the process of activating them. But really, things have been going extremely well. So our guidance towards first data update and readout in 2028 remains fully on track.
Astika Gunwardena
Analyst, Learing Partners
Thank you.
Linnaeus
Conference Operator
Thank you. Your next question comes from the line of Roger Song with Jefferies. Please unmute your line and ask your question.
Nabil (for Roger Song)
Analyst, Jefferies
18, thanks for the updates. Congrats on the launch progress so far. This is Nabil on for Roger. One from us. So on COMET 017, you've mentioned the enrollment is running ahead of plan. Curious what's driving that and how are you thinking about the value of being first to build that frontline data set in this class? Thank you.
Dr. Mollie Leoni
Chief Medical Officer
Mollie? Well, you know, ultimately there's a few different factors, but O17 is successful because the design is actually so incredibly convenient for sites to use and for prescribers to put their patients on. Having both studies for intensive and non-intensive chemotherapy within the same trial so that you do one round of bureaucratic Thank you for joining us. Thanks, Nabil. Thank you.
Linnaeus
Conference Operator
Your next question comes from the line of Charles Hsu with LifeSci Capital. Please unmute and ask your question.
Peter Green
Analyst, LifeSci Capital
Hi, this is Peter Green. I'm for Charles. Just actually a quick question on FTIs. It sounds like early or first half of 2027, launching a platform trial combining Darla Farnham with Drax on RACID you've committed to and PDAC. I'm wondering if your thinking has changed on potential other combinations. For example, we had talked about colorectal cancer with EGFR and G12D, and we're also seeing other combinations with RAS such as PRMT5 gaining in the competitive landscape. So I'm just curious what your thoughts are there. Thanks.
Dr. Troy Wilson
President and Chief Executive Officer
Yeah, thanks, Peter. Molly, do you want to you want to comment?
Dr. Mollie Leoni
Chief Medical Officer
Sure. That's a very, very good question. So obviously, Derek's honors will be our first in the platform design. But the reason we did the platform design is so that we can explore all of these other combinations that make a lot of sense for patients and scientifically in parallel. So the Deroxonracib will be the first, but absolutely be looking for additional combinations in other indications and with other drugs.
Dr. Troy Wilson
President and Chief Executive Officer
Yeah, and Peter, just to add to Mollie's comment, we see an opportunity to combine with deroxonracib in second-line PDAC. A lot of companies look to be steering into the front line, perhaps trying to get there before a potential approval or maybe not to have to go head-to-head to be able to go against chemo. In our view, if we can replicate with deroxonracib what we've seen with adagracib, Thank you for joining us. We have a number of combinations under consideration, some of which require cooperative groups with other parties. And we'll provide more detail as it's appropriate.
Peter Green
Analyst, LifeSci Capital
Thanks. And just a quick follow-up. Are there funds currently earmarked for this trial, and what are the expected costs?
Dr. Troy Wilson
President and Chief Executive Officer
Yeah, there are funds. Peter, we haven't broken out the specific expense. I mean, at this point, we would plan for the Phase 1A. You want to confirm that you have adequate safety and tolerability. If that looks good, then we'll reassess. We are at a point, you can probably hear it in the call, where, you know, we have a wealth of opportunities that we could invest in. We're going to be, we're going to continue to be very focused in our capital allocation. We think, you know, we now have leadership, at least in new patient starts. We think soon in the other metrics with Zipto, we want to put Darlie, you know, Darlie similarly. So, you know, all good things in time. We're fortunate with Darley that this is still early development. So, you know, we're not talking about huge dollars relative to, for example, registration enabling studies.
Linnaeus
Conference Operator
Thank you. Your next question will come from the line of Salim Syed with Mizuho. Please unmute your line and ask your question.
Salim Syed
Analyst, Mizuho
Great. Congrats on the quarter, guys. Thanks for the question. I'll try to try to keep you back and get you back on track with a single question rule here. Appreciate it. So, Troy, you guys are saying in the press release here, majority share of new patients starts, you know, for relapse refractory NPM1. Syndex is also saying, you know, 60% or two-thirds of the business, two-thirds of the NPM1 business is what they're seeing on their side. Obviously, both of these can't be true. So, I'm just wondering, Troy, Where is it in the data that there's this confusion that both parties can claim majority share of new patient starts here?
Dr. Troy Wilson
President and Chief Executive Officer
Yeah, Salim, so thanks for the question. And actually, as the operator indicated, you know, we are allowing people to ask one follow-up, so feel free to ask a follow-up. But let me dispel the confusion. We've said, you know, we have 115 new patient starts. We're reading the competitor, both us and the competitor off of claims data. They had 250 new patient starts for the quarter. and said approximately 40% of them were NPM1. So by my math, that's 100. And, you know, a 25% decline in new patients starts quarter over quarter, whereas we're growing 35% quarter over quarter. They do have the KMT2A business. And I think when they're talking about, you know, we want to be very clear. We're talking only about NPM1. We're only speaking to NPM1. NPM1, ultimately, as you well know, is the much larger opportunity that includes potentially FLT3 and as we go out to the front line. Okay, all right. Thanks so much, Troy. Appreciate it. Yeah, happy to.
Linnaeus
Conference Operator
Your next question will come from the line of Phil Nader with TD Cohen. Please unmute your line and ask your question.
Phil Nader
Analyst, TD Cowen
Good afternoon. Thanks for taking our question as well. Now that you've had several quarters of commercial experience, I'm curious whether there's been any differences in the commercial experience with ComZifty versus what we're seeing in the clinical trials. Anything notable that physicians are pointing to? That's the first question. Then just to follow up on the FLT3 combo data that we're going to see later this year, can you give us some sense of what you're hoping to see from that data and what next steps could be? Thank you.
Dr. Troy Wilson
President and Chief Executive Officer
Sure. Thanks, Phil, for the two questions. Brian, do you want to take the question on are we seeing things differently in the market versus maybe what we'd say? Yeah, versus the clinical experience.
Brian Powl
Chief Commercial Officer
Absolutely. Yeah, thanks for that question, Phil. And I'm happy to just kind of give a little bit of color there, but... With the patients that have been, you know, kind of coming on to our studies, it's still a little bit early to see, to kind of measure outcomes, as you know, but we've seen, you know, the uptake has been really supportive of the differentiation of COM-ZIFTI as a new minute inhibitor in the market. The physician, the profile of, you know, kind of the efficacy, safety, compatibility with other agents and the simplicity is, are what's leading to the increase in prescriptions, leading to the physician choice, and our team is executing clearly in order to get that. I think as we continue to follow, we'll be tracking the duration story over time and getting an understanding of outcomes, but I think one indicator is that the combination use that we outlined shows you that physicians are very interested in using these therapies in combination. We were able to get the publication of the blood propagation out And speaking of combinations, Molly, do you want to speak to the sort of what to expect from FLT3 and maybe thoughts around potential next steps?
Dr. Mollie Leoni
Chief Medical Officer
Absolutely. So with regards to the FLT3 data that we're going to show you, both the combination, the relapse refractory setting with giltaritinib, as well as in the frontline setting, the quadruplet with quisartinib, the first, second, and third things you should be looking for is safety and the ability to combine. So the fact that we're actually able to show you these data, show you safe combinations, show you safe dose escalation should be really important. Because as we've always said, AML is a combination of Thank you. Thank you. Thank you. I think that that will be a topic that will be covered actually when we present the data.
Phil Nader
Analyst, TD Cowen
That's very helpful. Thank you.
Linnaeus
Conference Operator
Thanks, Phil, for the question. Thank you. As a reminder, if you would like to ask a question, please use the raise hand icon, which can be found at the bottom of your webinar application. We ask that you please limit yourself to one question and one follow-up question. Your next question comes from the line of Etzer Darut with Barclays. Please unmute and ask your question.
Etzer Darut
Analyst, Barclays
Great. Thanks for taking a question. Can you guys hear me okay?
Dr. Troy Wilson
President and Chief Executive Officer
Yes, Etzer, we can hear you.
Etzer Darut
Analyst, Barclays
Great.
Phil Nader
Analyst, TD Cowen
Thank you.
Etzer Darut
Analyst, Barclays
Just a question, I guess, a little bit of a follow-up related question to the earlier questions around real world versus... Thank you.
Brian Powl
Chief Commercial Officer
Thanks, Ed, sir, for that. The data that we reported is primarily in this relapse refractory population. It's not our indication, but in that population. Our goal is, because we have COMET-017 enrolling, I think we want to get any of those newly diagnosed patients to be put on those trials. But a lot of the dynamic... Thank you. Thanks, Spencer.
Linnaeus
Conference Operator
Your next question comes from the line of Branny Benjamin with Citizens. Please unmute and ask your question.
Branny Benjamin
Analyst, Citizens
Great. Thanks for taking the questions and congrats on the quarter. I guess, Troy, I'd love to understand a little bit more about the rationale behind the evaluation of ZIFTO in these MIS-1 AML patients that are not NPM-1 or KMT-2A. How important is this in terms of market potential or is this just a nice-to-have situation? And as a follow up, you know, kind of on the heels of the KCRS and ASCO data and Tom's comments about the cash on the hand to fund the ZIFTA readouts. Can you talk about what might be the best strategy to fund the Darla Farnham franchise and what might be the best sort of collaboration structures that you'd be looking at?
Dr. Troy Wilson
President and Chief Executive Officer
Yeah, thanks, Ren. Two very different questions. Let me ask Mollie, just a reminder for everyone, back when we were doing dose escalation, we did see activity, including a CR, in a SETD2 RUNX1 patient. And that was kind of an important marker. But Mollie, maybe you can speak a little bit to the rationale for that study. Obviously, we can't go under the abstract. But Mollie, maybe you can speak to Ren's first question. I'll take the second.
Dr. Mollie Leoni
Chief Medical Officer
Yeah, what you said is extraordinarily important. When we did the phase 1A dose escalation, we saw activity outside of the places where you'd expect, quote unquote, to see it. And then from what we know from data that has been generated previously, up to 50% of AML probably has at least some form of MIS-1 activity. And we'll show you the data as to why we believe that. Yep.
Dr. Troy Wilson
President and Chief Executive Officer
And, Ren, to your second question, just very quickly. At this point, you know, our goal is to establish a registrational path in solid tumors for Darla Farniv that provides meaningful clinical value and is differentiated from the competition. We think there's an opportunity in advanced renal cell carcinoma. Mollie spoke to that with her prepared comments. We think there's an opportunity on top of Darla Farniv. Anything else, I think we have to be very thoughtful. We could make Darla Farnham available to others. That would be an easy way to sort of expand the playing field. Importantly, as we think about this, what you're picking up on now strategically is these two programs work together. So as we're moving toward initial top-line results for Zift Amenib in front-line AML in 28. That jives very nicely with the timing when you'd be making investment decisions for Darla Farnib to be able to move it into a registrational setting. That's important in terms of building value for patients and shareholders. It's also interesting from a strategic perspective because now you have two potential blockbusters, one of which has hopefully a positive front-line data set Thank you for joining us. And you see we're being very, very disciplined with our spend. Our R&D expense actually ticked down just slightly from last year. So we're going to continue to be very responsible stewards of capital and look to create value for shareholders.
Branny Benjamin
Analyst, Citizens
Got it. So the funds on hand can get you to those registrational studies and then the timing will work out right with the ZIFTO readout and moving this on to registrational studies.
Dr. Troy Wilson
President and Chief Executive Officer
I think, you know... Let me put it this way. Let me say it slightly differently. We look at all the options all the time. Personally, I don't know that doing a strategic collaboration on Darlie would necessarily be the right thing to do at this stage. There's a lot of value there, particularly if folks remember, we have what we believe will be the market-leading menin inhibitor throughout the AML treatment continuum. And we've cited a $7 billion TAMP. Look at our frontline data. That's a very reasonable town. We are the senior party in that collaboration. We book all U.S. sales. We control global development. We control U.S. commercial. Now, Ren, you have a second asset sort of sliding in behind it. That's a pretty nice setup in terms of building value. So that's the way we think about it.
Branny Benjamin
Analyst, Citizens
Excellent. Thanks for taking the questions.
Linnaeus
Conference Operator
Your next question comes from the line of David Dye with UBS. Please unmute and ask your question.
David Dye
Analyst, UBS
Great. Thanks for taking my questions. I also want to congrats on this great quarter. Just a quick question from me on the Zipto and Flif3 combo. I'm just wondering how large do you believe this Flif3 and MPM1 commutated population could ultimately become within the broader Zipto franchise? So I think you mentioned that there's 50% of the AML patients have the Flif3 and MPM1 commutation. Could you help us understand how big the market is in dollar amount?
Dr. Troy Wilson
President and Chief Executive Officer
Yeah, maybe I can take that, David. So just maybe take half a step back. Just so everybody's clear, half of your NPM1 incident population has a co-mutation in FLT3. So if you really want to drive the greatest clinical benefit for patients, just as Mollie said, you're going to want to go to combinations. We know that's the future. Then there's another equally sized population. So You know, FLT3 is 30% of AML. Half of that, or 15%, is overlapping with NPM1. The other half, David, are either with NPM1 wild type or have other mutations. To Molly's point, I think it's reasonable to believe that a metanin inhibitor certainly would be active in the commutated population. It may even be active in the wild type, the NPM1 wild type. So let's stay tuned. We have said consistently we see an opportunity to treat 50%, maybe more, of AML patients throughout the treatment continuum. So when we go to that frontline setting, David, of right now we've put a $7 billion TAM on it, $3 billion projected peak sales for us, you know, all approvals, FLT3 is a portion of that. The big ones right now are KMT2A, NPM1. and let's see the FLT3 data, as Mollie said, a little later this year. Hopefully that clarifies, is the answer you're looking for.
David Dye
Analyst, UBS
Thank you so much. Sure.
Linnaeus
Conference Operator
Thank you. As another reminder, if you would like to ask a question, please use the raise hand feature at the bottom of your webinar application. Our next question comes from the line of Daniel Brims at Lake Street. Please unmute your line and ask your question.
Daniel Brims
Analyst, Lake Street
Thanks. Great quarter, guys. Just a quick question about what you're seeing as far as some kind of switching dynamic. between the menin inhibitors. You know, obviously it sounds like you guys can combine much more easily than your competitor. So just wondering if you're seeing patients, you know, starting there and then switching over to Zipto as docs want to, you know, have better safety profile or, you know, be able to combine it with other things.
Dr. Troy Wilson
President and Chief Executive Officer
Thanks, Daniel. Brian, do you want to take Daniel's question?
Brian Powl
Chief Commercial Officer
Sure. Thanks, Daniel, for that. There is certainly a dynamic of switching. I think there are some physicians who see an opportunity to shift to ComZifty. Our goal is to obviously optimize the benefit for every patient. We're looking to both grow the market and and Tape Share from other products in the space. And I think what we're showing you is that we're doing both. By getting to this majority share of the new patient starts within our second full quarter shows that we're able to get patients not just who may have been on other therapy, but we're bringing in new patients. And as the new patient flow comes forward, Thank you for that question. Thanks, guys. Great work. Thanks. Thanks, Daniel. Thank you.
Linnaeus
Conference Operator
Your final question of today comes from the line of Peter Green at LifeSci Capital. Please unmute your line and ask your question.
Peter Green
Analyst, LifeSci Capital
Hello again, thanks for taking the additional question. I'm just wondering if you could contrast the Salesforce experience at sites Thank you.
Dr. Troy Wilson
President and Chief Executive Officer
Peter, thanks for getting back in the queue and asking an additional question. I'm going to turn it over to Brian for just a second, but let me just comment. There isn't any one thing, right? The good news is the team is executing. Everything is going in the right direction. We were hopeful this was what we would see. I have to give great credit to Brian and his team. The team, as you said, has been executing, you know,
Brian Powl
Chief Commercial Officer
Thank you for joining us. As I've said, coming from experience with other menin inhibitors on other clinical trials, but then also those who haven't really had experience with menin inhibitors. And I think that the discussion with each of those groups may be slightly different than each other. So we have a great team that's able to engage and experience that. We're seeing growth everywhere. And I think that's what's been encouraging for us. And we're encouraged to see that momentum continue.
Linnaeus
Conference Operator
Thank you. There are no more questions at this time. I'd now like to turn the call over to Troy Wilson for closing remarks.
Dr. Troy Wilson
President and Chief Executive Officer
Thank you, Linnaeus. I want to thank you all once again, and in particular, I want to call out Not only my team, everybody at Cura, but also the physicians and the care teams. At the end of the day, what we're trying to do is help patients. I couldn't be more proud. The team's making just tremendous progress. You hear it from the commercial setting, relapsed refractory, to the frontline execution, to to the data that you'll see later this year. It's really just everybody working together on behalf of patients. We appreciate your interest. We appreciate your questions. We're going to be attending multiple conferences in September and we look forward to seeing many of you there. In the meantime, if you have questions, you know how to find us, please reach out to Greg or me. Thank you all and have a good evening.