On Wednesday, Kura Oncology (NASDAQ:KURA) discussed second-quarter financial results during its earnings call. The full transcript is provided below.
Benzinga APIs provide real-time access to earnings call transcripts and financial data. Visit https://www.benzinga.com/apis/ to learn more.
View the webcast at https://kura-oncology-q2-2026-financial-results.open-exchange.net/registration
Summary
Kura Oncology reported $9.1 million in net product revenue for Comzifti in its second full quarter, capturing a majority of new patient starts in the relapsed refractory NPM1 mutant AML menin inhibitor market.
The company aims to establish xifdomnib as a foundational therapy across AML by combining it with multiple standards of care, supported by new clinical data showing promising long-term outcomes.
Darla Farnab is positioned as a second strategic asset, with clinical evidence supporting its potential to enhance targeted therapies in renal cell carcinoma and KRAS G12C mutated solid tumors.
Financially, Kura reported a net loss of $68.3 million, with cash, cash equivalents, and short-term investments totaling $519 million, expected to fund the ziftomenib AML program through 2028.
Future outlook includes multiple clinical updates in the second half of 2026, focusing on monotherapy, combination therapy, and treatment settings, with ongoing strategic collaborations and disciplined capital deployment.
Full Transcript
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 Kura 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 and 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.
Greg Mann, Senior Vice President, Investor Relations & Corporate Affairs
Thank you, Lenius. Good afternoon and welcome to Kura 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 Kura's filings with the SEC, which are available from the SEC or on the Kura Oncology website, for information concerning risk factors that could affect the company. With that, I'll turn the call over to Troy.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
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 menin inhibitor market and new clinical data further strengthened our confidence in our strategy of building two differentiated growth franchises. I'll start with Comzifti. In only our second full quarter on the market, Comzifty 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–drug interactions, and increasingly, the 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 xifdomnib 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 xiftamentib combines cleanly with standard therapy, deepens responses and supports more durable outcomes.
With nearly 100 patients and extended follow up, comment 007 meaningfully increases our confidence in our frontline strategy. Molly 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 Darla Farnab, 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 KRASG12C mutated solid tumors, we've generated clinical evidence that Darle Farnab 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 Darla Farnab 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'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, Comziffy 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, Comzifte 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'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 continue to initiate menin inhibitor therapy with Comzifti. Physician-initiated combination use with venetoclax and nasalcitidine 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.
Physicians are increasingly choosing Comzifti 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 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, 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 Comzifti, and exceptional commercial execution. Although we promote Comzifty only for its approved monotherapy indication, physician-initiated combination use provides an early signal that clinicians see the product fitting naturally into future treatment paradigms.
We view the prescribing behavior as evidence of practical fit, which is strategically important as if diminutive 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 ziftimentiv is 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 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.
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 darlafarnib, 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 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 + 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 data set 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 give 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 or refractory NPM1- and FLT3-mutated patients. In the second half of 2026, we also expect to provide combination data with 7+3/quizartinib. Additionally, there will be other updates, including long-term ven-aza 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 darlafarnib, 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, darlafarnib plus cabo demonstrated a 44% objective response rate and 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 cabozantinib-naive patients were 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 FIT-001, which is comparing darlafarnib plus cabo with cabo alone in cabo-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 darlafarnib 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 cabo and adagrasib 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 daraxanrecib 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.
Thomas Doyle, Senior Vice President, Finance and Accounting & Principal Accounting Officer
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 Comzyfti 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. 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 Kyowa Kirin. 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 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'll turn the call back over to Troy.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Thank you, Tom. The second quarter demonstrates Kura Oncology is converting product differentiation into commercial leadership. Comzyfti 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, darlafarnib 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, Linneus, we're ready to take questions.
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 Zymanski with Bank of America. Please unmute and ask your question.
Jason Zymanski, Analyst at Bank of America
Good afternoon. Congratulations on the great quarter and thanks so much for taking our question. Two quick from 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.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
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, as we've said, we're very pleased with that sequential growth quarter over quarter, and I think what that represents, as we said, is 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 patient 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, going from first quarter, our first full quarter of launch, into this second quarter we demonstrated quarter-over-quarter growth of the new patient starts of about 35%, and then the TRx growth is actually about 60% growth quarter over quarter.
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 contribute to that. But the story is really growth here.
Jason Zymanski, Analyst at Bank of America
Great, thanks for the color.
Brian Powl, Chief Commercial Officer
Thanks, Jason.
OPERATOR
Thank you. Your next question comes from the line of Lee Watseg with Cantor Fitzgerald. Please unmute your line and ask your question.
Lee Watseg, Analyst at Cantor Fitzgerald
Hey guys, thanks for taking my questions. Just curious, how do you expect Comzyfti’s market leadership to evolve over time and how much of that do you think is driven by combo 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 menin space in the NPM1-mutant 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. We, 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 over as we continue to grow. But the focus is getting all the new, you know, every new patient, have the opportunity to get them on Comzyfti, 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.
Lee Watseg, Analyst at Cantor Fitzgerald
Combination use.
Brian Powl, Chief Commercial Officer
And 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 volume. So we're seeing that usage in combination growing. Obviously, the team is focused on promoting on-label, but physicians see the choice and are looking to find ways to combine. We think that's a real growth opportunity for ziftomenib in the relapsed/refractory space because of the data that Molly mentioned.
With 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 that's co-mutated, so we'll be able to continue to develop that. We are seeing, as we said, kind of a split of both ven accommodations as well as FLT3 currently. But we think we're well positioned to continue the data generation that will support physicians' choices to use ziftomenib.
OPERATOR
Thank you. Your next question comes from the line of Astika Gunwardine with Lyring Partners. Please unmute your line and ask your question.
Astika Gunwardine, Analyst at Lyring 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 maybe tell us a little bit about what your Tier 2 or preferred coverage was for ziftomenib? I'm sorry, can you hear me okay? Yeah, sorry. So the question was, can you tell us about your Tier 2 or your preferred coverage of ziftomenib and, for patients requiring a prior authorization, what proportion of those prior authorizations were converted?
And then I have a quick follow-up.
OPERATOR
Yes, yes, go ahead. Astika.
Brian Powl, Chief Commercial Officer
Take that. Sure. Thanks, Astika, for the questions. So, yeah, we didn't go into too much detail about our market access coverage, but I think it represents the continued success in the story. We have over 95% of lives now covered, and we have approximately 16 million lives actually covered with a preferred status where patients have to step through ziftomenib 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 ziftomenib for their patients. And I think that's reflected in the growth we've seen quarter over quarter. That's good. Go ahead. You said you had a quick follow-up.
Astika Gunwardine, Analyst at Lyring Partners
Yeah, it's just on COMET-017. So it looks like on ClinicalTrials.gov that you have all the sites active. So can you tell us when you expect to complete enrollment in the intensive chemotherapy arm? Thanks, guys.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Molly, would you like to take Astika's question about 017?
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.
Astika Gunwardine, Analyst at Lyring Partners
Got it. Thank you.
OPERATOR
Thank you. Thank you. Your next question comes from the line of Roger Song with Jefferies. Please unmute your line and ask your question.
Nabil, Analyst at Jefferies
Hey team, 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 dataset in this class? Thank you, Molly.
Mollie Leoni, Chief Medical Officer
Well, you know, ultimately there's a few different factors, but 017 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 startup activities and operational activities really does make a difference. And it makes it easy for any patient with a menin inhibitor–dependent disease to have a place to go as soon as they walk into their physician's office.
And beyond that, the 007 data, the phase 1 data that we continue to present at various conferences, really just bolsters everyone's excitement. These patients are doing very well. The addition of a menin inhibitor seems to not add any toxicity and probably is adding a good deal of benefit. So I think it's all around excitement over the data we're showing and the structure of the trial that these patients are able to enroll in.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Thanks, Nabil.
OPERATOR
Thank you. Your next question comes from the line of Charles Shue with Lifestyle Capital. Please unmute and ask your question.
Peter Green, Analyst at Lifestyle Capital
Hi, this is Peter Green on for Charles. Just actually a quick question on FTIs. It sounds like early or first half of 2027, launching a platform trial combining darolfenib with diroxanrasib you've committed to in PDAC. 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 pure MTA5, gaining in the competitive landscape.
So I'm just curious what your thoughts are there. Thanks.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Yeah, thanks, Peter. Molly, do you want to comment?
Mollie Leoni, Chief Medical Officer
Sure. That's a very, very good question. So obviously diroxanrasib 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 diroxanrasib will be the first, but absolutely be looking for additional combinations in other indications and with other drugs.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Yeah. And Peter, just to add to Molly's comment, we see an opportunity to combine with diroxanrasib in second-line PDAC. A lot of companies look to be steering into the frontline, 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 diroxanrasib what we've seen with adagrasib, we think we can add clinical value to those second-line-plus patients.
And hats off to the Revolution Medicines team for what they've brought to patients. But I think it now gives us a platform on which to build through combinations. And you've mentioned some of them. We're really looking, as Molly said, to be selective. We can't do everything, right. But 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 at Lifestyle Capital
Thanks. And just a quick follow-up. Are there funds currently earmarked for this trial and what are the expected costs?
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
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 we have a wealth of opportunities that we could invest in. We're going to continue to be very focused in our capital allocation. We think we now have leadership at least in new patient starts, we think soon in the other metrics with ziftomenib.
We want to position Darli, you know, Darli similarly. So, you know, all good things in time. We're fortunate with Darli that this is still early development. So we're not talking about huge dollars relative to, for example, registration-enabling studies.
Peter Green, Analyst at Lifestyle Capital
Thank you.
OPERATOR
Your next question will come from the line of Salim Syed with Mizuho. Please unmute your line and ask your question.
Salim Syed, Analyst at Mizuho
Great. Congrats on the quarter, guys. Thanks for the question. I'll 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 patient starts for relapsed/refractory NPM1. Syndax 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, where is it in the data that there's this confusion that both parties can claim majority share of new patient starts here?
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Yeah, Salim, so thanks for the question. And actually, as the operator indicated, 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 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 patient 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 frontline—not to take anything away from the KMT2A market, but that's 5% of AML—so I think you have to be clear about what question are we asking exactly. And back to something Brian said, Salim: whether it's NPS, whether it's TRx, whether it's net revenue, they're all growing. They're all strongly growing. I think that's a good sign.
Salim Syed, Analyst at Mizuho
Okay. All right, thanks so much, Troy. Appreciate it.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Yeah, happy to.
OPERATOR
Your next question will come from the line of Phil Nader with TD Cowen. Please unmute your line and ask a question.
Phil Nader, Analyst at TD Cowen
Good afternoon. Thanks for taking our question as well. Now that you've had several quarters of commercial experience, we're curious whether there's been any differences in the commercial experience with ziftomenib versus what was seen 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 what you're hoping to see from that data and what next steps could be?
Thank you.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
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—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 onto our studies, it's still a little bit early to kind of measure outcomes, as you know. But we've seen the uptake has been really supportive of the differentiation of ziftomenib as a new menin inhibitor in the market. The profile of the efficacy, safety, compatibility with other agents, and the simplicity 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 Blood publication out quickly based on the feedback from physicians who really wanted to ensure they had the data available for them to make those decisions.
We'll continue to follow and we'll, over time, be able to present that. But we're seeing consistency, I think, in the responses and the outline that we've gotten from the clinical data.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
And speaking of combinations, Pauline, do you want to speak to what to expect from FLT3 and maybe thoughts around potential next steps?
Mollie Leoni, Chief Medical Officer
Absolutely. So with regards to the FLT3 data that we're going to show you, both the combination in the relapsed/refractory setting with gilteritinib as well as in the frontline setting, the quadruplet with quizartinib. 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 game.
It requires these combinations in order to successfully treat patients. So really you should be looking to see the safety and tolerability. But obviously we'll also be showing you the associated efficacy. Some is evolving at this time. The quizartinib trial is still rather new, but it's enrolling so quickly. We wanted to share data with you as soon as we could, and we'll continue to update as everything evolves. For next steps, I think that that will be a topic that will be covered actually when we present the.
Phil Nader, Analyst at TD Cowen
That's very helpful. Thank you.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Thanks, Phil, for the question.
OPERATOR
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 de Route with Barclays. Please unmute and ask your question.
Etzer de Route, Analyst at Barclays
Great. Thanks for taking a question. Can you guys hear me okay?
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Yes, Etzer, we can hear you.
Etzer de Route, Analyst at Barclays
Great. Thank you. Just a question, I guess a little bit of a follow up related question to the earlier questions around real world versus clinical use. Wondering more around the combination use that you've noted, the 40%. How much of that is in that relapsed/refractory NPM1 patient, basically the unlabeled indication, versus maybe even earlier line use or uses just in patient populations beyond what's currently on the label? Anything there would be helpful.
Thank you.
Brian Powl, Chief Commercial Officer
Yes, thanks, Etzer, for that. The data that we reported is primarily in this relapsed/refractory population—it's not our indication—but in that population, you know, 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, you know, the dynamic that we've seen is that patients who are immediately refractory to frontline therapy may be preferentially treated in combination.
And that's what I think physicians are using. So there's not really a big story in terms of dynamic outside of the population that we're treating.
Etzer de Route, Analyst at Barclays
Thank you.
Brian Powl, Chief Commercial Officer
Thanks, Etzer.
OPERATOR
Your next question comes from the line of Brannie Benjamin with Citizens. Please unmute and ask your question.
Brannie Benjamin, Analyst at 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 ziftomenib in these MEIS1 AML patients that are not NPM1 or KMT2A. You know, how important is this in terms of market potential, or is this just a nice to have? And as a follow up, you know, kind of on the heels of the QCRs and ASCO data and Tom's comments about the cash on hand to fund the ziftomenib readouts, can you talk about what might be the best strategy to fund the Darla Farnab franchise and what might be the best sort of collaboration structures that you'd be looking at?
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
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 SETBP1/ 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 could speak to Ren's first question. I'll take the second.
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 MEIS1 expression high, meaning that it would probably be responsive to menin inhibition. So this is huge. If we can show you additional patient populations besides the NPM1, the KMT2A, we really do think that we would be able to help up to 50% of AML patients.
And we'll show you the data as to why we—why we believe that.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
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 Farnab 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 deroxanracib. Anything else, I think we, you know, we have to be very thoughtful.
We could make Darla Farnab available to others. That would be an easy way to sort of expand the playing field. Importantly, as we think about this, you know, 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 ziftomenib in frontline AML in '28, that jives very nicely with the timing when you'd be making investment decisions for Darla Farnab to be able to move it into a registrational setting.
That's important in terms of building, you know, 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 frontline data set—one or more—and then a second one that's coming up behind it. And as we indicated, the opportunity in renal cell and PDAC—either of those is on the same order as all of AML. Right. So I think we're really in a good position to have now two programs that are relatively close in time.
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.
Ren, Analyst at Citizens
Got it. So the funds on hand can get you to those registrational studies and then the timing, you know, will work out, right, with the ziftomenib readout and moving this on to registrational studies.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Yeah, I think, you know, we—wait, let me put it this way, let me say it slightly differently. We look at all the options all the time. I, personally, I don't know that doing a strategic collaboration on Darla Farnab would necessarily be the right thing to do at this stage. There's a lot of value there, particularly if folks remember, you know, we have what we believe will be the market-leading menin inhibitor throughout the AML treatment continuum.
And we've cited a $7 billion TAM. Look at our frontline data—like that's a very reasonable TAM. 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.
Ren, Analyst at Citizens
Excellent. Thanks for taking the questions.
OPERATOR
Your next question comes from the line of David Dye with UBS. Please unmute and ask your question.
David Dye, Analyst at UBS
Great. Thanks for taking my questions. I also want to congrats on this great quarter. Just a quick question from me on the ziftomenib and FLT3 combo. I'm just wondering how large do you believe this FLT3 and NPM1 co-mutated population could ultimately become within the broader ziftomenib franchise? So I think you mentioned that there's 50% of the AML patients have the FLT3/NPM1 mutation. But could you help us understand how big the market is in dollar amount?
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
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 NPM1 wild type or have other mutations. To Mollie's point, I think it's reasonable to believe that a menin inhibitor certainly would be active in the co-mutated population. It may even be active in the NPM1 wild type. 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, 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 the answer you're looking for.
David Dye, Analyst at UBS
Yeah. Troy, thank you so much.
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 at 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 starting there and then switching over to ziftomenib as docs want to have better safety profile or be able to combine it with other things.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Yeah. Thanks, Daniel. Brian, 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 ziftomenib. Our goal is to obviously optimize benefit for every patient. We're looking to both grow the market and take 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, we're very happy to see the physicians are choosing ziftomenib based on, you know, all the things that I've outlined—our profile, their choice and the opportunity for things like combinations as well. So I think it's going to be a dynamic that will continue to evolve in this space. Thank you for that question.
Daniel Brims, Analyst at Lake Street
Thanks, guys. Great work.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Thanks, Daniel.
OPERATOR
Thank you. Your final question of today comes from the line of Peter Green at Lifestyle Capital. Please unmute your line and ask your question.
Peter Green, Analyst at Lifestyle Capital
Yeah. Hello again. Thanks for taking the additional question. Just wondering if you could contrast the salesforce experience at sites familiar with ziftomenib—perhaps they have had trials or investigators there—versus sites that are unfamiliar with ziftomenib, and if there's what proportion of prescriptions are coming from trial investigators. Thanks.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Yeah, Peter, thanks actually 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 physician engagement, the preferences we're seeing. The commercial execution is really top notch.
But, Brian, do you want to speak to any differences between people who haven't worked with it and those who have?
Brian Powl, Chief Commercial Officer
Of course. Thanks, Peter. And thanks, Troy, for the accolades to a great team. The team, as you said, has been executing even better than we could have expected. They're very experienced. They know a lot of these accounts because of their experience in hematology. And I would say that we're, you know, we're very pleased with where we're going, but we also haven't said that we penetrated every account. There's opportunity for growth and we'll continue to see that opportunity.
There are, of course, some. Some sites that are more early adopters, those who've had experience. Others are, as I've said, you know, coming from, you know, 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.
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.
Troy Wilson, President, Chief Executive Officer and Chairman of the Board
Thank you, Linnus. I want to thank you all once again. And in particular, I want to call out not only my team, you know, everybody at Kura Oncology, but also the physicians and their, you know, the care teams. At the end of the day, what we're trying to do is help patients. And I think, you know, the team is I couldn't be more proud. The team's making just tremendous progress. You hear it from, you know, the commercial setting, relapsed refractory to the frontline execution 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.
Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.
Login to comment