Image source: The Motley Fool.

DATE

Wednesday, Aug. 12, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Senior Vice President of Investor Relations and Corporate Affairs - Greg Mann
• President and Chief Executive Officer - Troy Edward Wilson
• Chief Commercial Officer - Brian T. Powl
• Chief Medical Officer - Mollie Leoni
• Senior Vice President, Finance and Accounting - Thomas Doyle

Need a quote from a Motley Fool analyst? Email [email protected]

TAKEAWAYS

• KOMZIFTI Net Product Revenue -- $9.1 million, representing a 57% increase from the first quarter of 2026.
• New Patient Starts -- 115, a 35% increase quarter over quarter, allowing the company to capture a majority market share in the relapsed or refractory NPM1-mutant acute myeloid leukemia segment.
• Total Prescriptions -- 250, representing a 59% increase from the first quarter of 2026.
• Cash and Short-Term Investments -- $519 million as of June 30, 2026, compared to $667.2 million as of Dec. 31, 2025.
• Collaboration Revenue Guidance -- $45 million to $55 million for 2026, with 2027 and 2028 guidance maintained at $90 million to $110 million annually.
• Anticipated Collaboration Payments -- $180 million expected from Kyowa Kirin to fund the ziftomenib program through its first pivotal results.
• Research and Development Expenses -- $61.9 million, compared to $62.8 million in the second quarter of 2025.
• Selling, General and Administrative Expenses -- $31.8 million, up from $25.2 million in the prior year period due to commercial launch activities.
• Net Loss -- $68.3 million, compared to $66.1 million in the second quarter of 2025.
• Frontline AML Response Rate -- 96% overall response rate in newly diagnosed patients treated with ziftomenib and intensive chemotherapy in the KOMET-007 study.
• 12-Month Overall Survival -- 94% for newly diagnosed NPM1-mutant acute myeloid leukemia patients in the frontline intensive chemotherapy cohort.
• Composite Complete Remission Rate -- 70% in venetoclax-naive relapsed or refractory patients, with a median duration of remission of 9.2 months.
• Physician Combination Use -- 40% of new patient starts were physician-initiated combinations with venetoclax, azacitidine, or FLT3 inhibitors.
• Darlifarnib Objective Response Rate -- 44% in patients with cabozantinib-exposed renal cell carcinoma, with a 94% disease control rate.
• Renal Cell Carcinoma Median PFS -- 13 months for cabozantinib-naive patients treated with the darlifarnib and cabozantinib combination.
• KRAS G12C Tumor Shrinkage -- 77% in response-evaluable patients treated with the darlifarnib and adagrasib combination.
• Preferred Payer Coverage -- 16 million lives covered under preferred status where patients must use KOMZIFTI before other menin inhibitors.
• Market Access -- 95% of covered lives currently have access to the therapy with no label restrictions.
• Account Engagement -- 90% of top-priority acute myeloid leukemia accounts maintained engagement with the field force during the quarter.
• KOMET-017 Site Scale -- 200 sites expected to be active globally for the registrational Phase 3 trial.
• Total Addressable Market -- $7 billion identified by management for ziftomenib across the acute myeloid leukemia treatment continuum.
• Pivotal Data Projection -- Top-line results from the KOMET-017 frontline intensive chemotherapy trial are anticipated in 2028.
• Share-Based Compensation -- $8.2 million in non-cash expense, compared to $6.9 million in the second quarter of 2025.

SUMMARY

Kura Oncology, Inc. (KURA +1.62%) reported achieving majority market share in new patient starts for its lead therapy within the relapsed or refractory NPM1-mutant acute myeloid leukemia segment during its second full quarter on the market. Management identified new patient starts as the primary leading indicator for future commercial performance and prescription volume. The company stated that it is advancing darlifarnib as a second independent precision oncology platform, citing clinical data that suggests the asset can enhance targeted therapy backbones in solid tumors such as renal cell carcinoma and KRAS-mutated cancers. Financial strategy remains focused on maintaining a cash runway through the primary pivotal trial results anticipated in 2028, supported by anticipated milestone payments from its collaboration with Kyowa Kirin.

• CEO Wilson attributed the adoption of KOMZIFTI to physicians selecting therapies based on "the total treatment profile," which includes efficacy, safety, and dosing convenience.
• CCO Powl indicated that the 40% combination use rate provides an early signal that clinicians see the product fitting "naturally in the future treatment paradigms."
• The KOMET-017 trial design, which management described as a "1-stop-shop," integrates intensive and non-intensive chemotherapy cohorts to streamline operational activities and site activation.
• Management expects preliminary clinical data from the ziftomenib and gilteritinib combination in NPM1 and FLT3 mutated patients in the second half of 2026.
• CEO Wilson noted the company is "being very, very disciplined with our spend," as research and development expenses decreased slightly year over year.
• The company plans to initiate a platform study of darlifarnib plus daraxonrasib in patients with KRAS-mutant second-line pancreatic cancer in the first half of 2027.
• CMO Leoni reported that the company will conduct an exploratory analysis to evaluate ziftomenib activity in MEIS1-associated acute myeloid leukemia subtypes beyond current genetic targets.

INDUSTRY GLOSSARY

• NPM1: Nucleophosmin 1, a gene that is frequently mutated in acute myeloid leukemia and serves as a target for menin inhibition.
• AML: Acute Myeloid Leukemia, a type of cancer that starts in the blood-forming cells of the bone marrow and progresses rapidly.
• KMT2A: A gene that, when rearranged, is associated with specific aggressive subtypes of leukemia.
• Menin Inhibitor: A class of drugs that blocks the interaction between the menin protein and KMT2A, which is critical for the survival of certain leukemia cells.
• ccRCC: Clear cell renal cell carcinoma, the most common histological form of kidney cancer.
• PDAC: Pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer.
• ORR: Objective Response Rate, the percentage of patients whose cancer shrinks or disappears after a specific treatment.
• OS: Overall Survival, the length of time from the start of treatment that patients remain alive.
• CRc: Composite Complete Remission, a clinical endpoint measuring the disappearance of all signs of cancer in the blood and bone marrow.
• MRD: Minimal Residual Disease, the small number of cancer cells that remain in the body after treatment, often used to predict relapse.
• FLT3: Fms-like tyrosine kinase 3, a gene that when mutated can lead to the rapid growth of leukemia cells.
• FTI: Farnesyltransferase Inhibitor, a drug class that blocks the activity of proteins that require farnesylation for their cellular function.

Full Conference Call Transcript

Operator: My name is Lenias, and I will be your conference operator today. At this time, I would like to welcome you to the Kura Oncology Second Quarter 26 Financial Results Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. If you would like to ask a question during this time and if you have joined via the webinar, please use the raise hand icon, which can be found at the bottom of your webinar application to allow everyone the opportunity to participate, we ask that you please limit yourself to 1 question. And 1 follow-up question.

If time permits, at the end of the Q&A session, we invite you to rejoin the queue for additional questions. At this time, I would like to turn the call over to Greg Mann. Senior vice president of investor relations and corporate affairs of Kura Oncology. Please go ahead.

Greg Mann: Thank you, Lenias. Good afternoon, and welcome to Kura Oncology's quarter 26 conference call. Joining the call today are Dr. Troy Edward Wilson, President and Chief Executive Officer; Brian T. Powl, Chief Commercial Officer; Dr. Mollie Leoni, Chief Medical Officer and Thomas Doyle, Senior Vice President, Finance and Accounting. We remind you, that today's discussion will include forward looking statements based on current expectations. Such statements represent judgment as of today and may involve risks and uncertainties that cause actual results to differ materially from expected results. Please refer to Kura's filings with the SEC, which are available from the SEC or on the Kura Oncology website for information concerning risk factors that could affect the company.

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

Troy Edward Wilson: Thank you, Greg, and good afternoon, everyone. Second quarter marked another step forward in Kura's evolution as a commercial stage oncology company. KOMZIFTI 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 2 differentiated growth franchises. I will start with COMZIFTI. In only our second full quarter on the market COMZIFTI generated $9.1 million in net product revenue, exceeding our expectations, and captured a majority of new patient starts in the relapsed refractory NPM1 mutant AML menin inhibitor market. At this stage of the launch, new patient starts are the clearest leading indicator of commercial performance.

They measure which therapy physicians are choosing today, and they establish the base for future prescriptions and revenue. Achieving majority share of new patient starts in only our second full commercial quarter. Despite entering the market second, it is clear evidence physicians are differentiating within the menin inhibitor class. In real world AML practice, physicians choose therapies based on the total treatment profile, efficacy, predictable and manageable safety, dosing convenience, drug interactions, and increasingly potential to combine with existing treatment approaches. We believe KOMZIFTI's rapid adoption reflects the strength of that differentiated profile in the largest currently FDA approved menin inhibitor opportunity. But the monotherapy launch is only the beginning.

Our objective is to establish Ziftomenib as a foundational therapy across AML by combining it with multiple standards of care. The long term frontline data we reported at EHA demonstrated that Ziftomenib combines cleanly with standard therapy deepens responses, and supports more durable outcomes. Nearly 100 patients and extended follow-up, KOMET-007 meaningfully increases our confidence in our frontline strategy. Mollie will discuss those data in more detail. Looking ahead, we expect multiple clinical updates in the second half of the year across monotherapy, combination therapy, and multiple treatment settings. Turning to darlifarnib, we now believe we have a second wholly owned strategic asset capable of creating significant value in independent of our menin inhibitor franchise.

Across cabozantinib exposed, and cabozantinib naive renal cell carcinoma as well as in KRAS G12C mutated solid tumors, we have generated clinical evidence that darlifarnib has the potential to enhance the activity of targeted therapy backbones through a common biological mechanism while maintaining a manageable safety profile. Our strategy is straightforward. Pair darlifarnib with established and emerging targeted therapies allowing us to advance the program efficiently while preserving opportunities for future strategic collaboration. Stepping back, Kura is substantially stronger than it was even just 1 quarter ago. We have established commercial leadership in new patient starts in relapsed/refractory NPM1 mutant AML.

We have built 1 of the most mature and robust frontline menin inhibitor data sets in AML We have advanced a wholly owned precision oncology platform beyond menin inhibition and we have maintained the financial strength to execute through multiple value creating milestones. Together, these assets position us to create value through commercial execution, pipeline expansion, and disciplined capital deployment. With that, I will turn it over to Brian.

Brian T. Powl: Thanks Troy. In the second quarter, COMZIFTI generated $9.1 million in net product revenue, approximately 115 new patient starts more than 250 total prescriptions. Based on current prescription data COMZIFTI captured a majority share of new patient starts in the relapsed/refractory NPM1-mutant AML menin inhibitor market in only its second full quarter of launch. that is the headline for the quarter. New patient starts are the clearest indicator of physician choice today and 1 of the strongest predictors of future commercial performance. The quality of the launch is evidenced across multiple metrics. Repeat prescribing continued to increase adoption expanded across both academic and community treatment centers, and new accounts continued to initiate menin inhibitor therapy with COMZIFTI.

Physician initiated combination use with venetoclax and azacitidine and with FLT3 inhibitors in co mutated patients represented approximately 40% of new patient starts. And with more than 95% of covered lives and no label restrictions, physicians are confident to prescribe the therapy they believe is best for their patients. Physicians are increasingly choosing KOMZIFTI because of its differentiated profile we believe that profile is driving adoption. Our focus is simple, win every eligible patient Every new patient creates the opportunity for repeat prescriptions and revenue. Our field force continues to execute at a high level delivering consistent engagement with primary AML prescribers nationwide.

We maintained engagement with more than 90% of our top priority AML accounts during the quarter, while increasing the frequency of interactions with high value treatment centers. Despite being second to market, COMZIFTI achieved majority share of new patients in only its second full commercial quarter. This is uncommon in oncology. We believe it reflects meaningful product differentiation growing physician adoption of COMZIFTI and exceptional commercial execution. Although we promote COMZIFTI only for its approved monotherapy indication, physician initiated combination use provides an early signal that clinicians see the product fitting naturally in the future treatment paradigms.

We view the prescribing behavior as evidence of practical fit, which is strategically important as Ziftomenib advances into FLT3 mutated disease and newly diagnosed AML where combination therapies will define the largest opportunities. We believe the confidence physicians are showing today can extend COMZIFTI's leadership into earlier lines and additional patient populations ultimately positioning Ziftomenib as a foundational therapy across AML. For the balance of the year our priorities are clear. Maintain leadership within the relapsed refractory MPM1 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 KOMZIFTI as the leading menin inhibitor today while building physician payer, and patient confidence to become a cornerstone therapy across AML tomorrow. With that, I will turn the call over to Mollie.

Mollie Leoni: Thank you, Brian. Second quarter strengthened both of our precision oncology franchises. For Ziftomenib, new clinical data increased our confidence in its potential to become a foundational therapy across AML. For darlifarnib, the data continued to support its potential as a broad and differentiated combination platform in solid tumors. I will begin with Ziftomenib. Just before EHA, peer reviewed results from the KOMET-007 relapsed/refractory Ziftomenib plus venetoclax and azacitidine study were published in blood. The regimen demonstrated meaningful activity in a heavily pretreated population, including patients previously treated with venetoclax.

Impressively, among venetoclax naive patients, the overall response rate was 87 percent, The CRC rate was 70 percent, and median overall survival was not reached as of almost 11 months follow-up. Turning to EHA, we presented long term results from KOMET-007 evaluating Ziftomenib plus 7 plus 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, ziptomenib did not appear to add any meaningful myelosuppression to intensive chemotherapy. To our knowledge, this remains the largest frontline intensive chemotherapy dataset reported for any menin inhibitor. Making it a key indicator of the potential for the phase 3 KOMET-017 program. Continuing to enhance that data pool, the pivotal trial KOMET-017 our 1-stop-shop design continues to accrue across The US, Europe, and Asia.

We continue to expect to report top line results from our intensive chemo-Ziftomenib trial in 2028, and our clinical data and operational execution gives us the confidence that we are well positioned to lead in frontline AML. Our FLT3 combination program is also advancing. We expect preliminary clinical data later this year from Ziftomenib plus gilteritinib in relapsed/refractory NPM1 and FLT3 mutated patients. In the second half of 26, we also expect to provide combination data with 7 plus 3 plus quasartanib. Additionally, there will be other updates, including long term KOMET-001 data and an exploratory analysis evaluating Ziftomenib activity in additional non-NPM1, non-KMT2A rearranged menin dependent AML subtypes.

Taken together, these studies aim to demonstrate Ziftomenib's potential to combine effectively across multiple treatment approaches while maintaining the safety profile needed for long term use in both relapsed and frontline AML. Turning to darlifarnib, our second major strategic asset. Starting with renal cell carcinoma, we have reported powerful data in both cabozantinib exposed and cabozantinib naive patients. In the cabozantinib exposed setting, darlifarnib plus 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 percent. Ability to generate responses when cabo had previously failed provides compelling clinical proof of mechanism. The data in cabozantinib naive patients was even more encouraging.

In 34 patients with advanced clear cell renal cell carcinoma, objective response rates ranged from 33 to 50 percent across dose levels with a median progression free survival of 13 months. For context, historical response rates in this setting range from 18% to 40% with median progression free survival of approximately 6 to 11 months. The safety profile of the combination was manageable across doses tested. These data informed the dose combinations being evaluated in the randomized phase 1b portion of FIT001, which is comparing darlifarnib plus cabo with cabo alone and 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 27 with initial data in the second half of the year. In addition, at ASCO, first in human data with darlifarnib plus adagrasib demonstrated tumor shrinkage in 77% of response evaluable patients with KRAS g 12 c 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 darlifarnib's proposed mechanism of enhancing a targeted therapy backbone via a tolerable method of MAP kinase pathway inhibition.

We plan to initiate our darlifarnib platform study evaluating darlifarnib plus daraxonrasib in second line or later KRAS mutant pancreatic cancer in the first half of 27. Our priorities remain clear. Execute our registrational studies, generate high quality practice informing clinical data and continue building 2 differentiated precision oncology franchises. I will now turn the call over to Tom to discuss our second quarter financial results.

Thomas Doyle: Thank you, Mollie. I am happy to provide a brief overview of our financial results for the second quarter of 26. Our net product revenue from COMZIFTI sales was $9.1 million compared to none for the second quarter of 25. 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 25. Selling, general and administrative expenses were $31.8 million compared to $25.2 million for the second quarter of 25. Net loss for the second quarter of 26 was $68.3 million compared to a net loss of $66.1 million for the second quarter of 25.

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 equivalents and short term investments of $519 million compared to $667.2 million as of December 31, 2025. We are maintaining our previously communicated guidance for collaboration revenue. Expect this to be $45 million to $55 million in 2026. $ 90 million to $110 million in 2027, and $90 million to $110 million in 2028. This revenue reflects non-cash-based accounting recognition of performance obligations under our collaboration agreement with Kyowa Kirin.

Our current cash, cash equivalents and short term investments as of June 30 together with anticipated payments of $180 million under our collaboration agreement with Kyowa Kirin are expected to fund our Ziftomenib AML program through the first topline Phase 3 results from KOMET-017 anticipated in 2028. With that, I will turn the call back over to Troy.

Troy Edward Wilson: Thank you, Tom. The second quarter demonstrates Kura is converting product differentiation into commercial leadership. COMZIFTI is winning new patient starts in adult relapsed and refractory NPM1-mutant AML, while our clinical programs continue to expand Ziftomenib toward the much larger frontline opportunity. At the same time, darlifarnib is emerging as a potentially differentiated precision combination platform with broad applicability across solid tumors. Together, these programs give us multiple independent drivers of long term value creation backed by the capital and execution to realize those opportunities. With that, Lenias, we are ready to take questions.

Operator: Thank you. We will now move to our question-and-answer session. If you have joined via the webinar, please use the raise hand icon which can be found at the bottom of your webinar application. When you are called on, please unmute your line and ask your question. Will now pause a moment to assemble the queue. Again, we ask that you please limit yourself to 1 and 1 follow-up question. You are welcome to reenter the queue for any additional follow-up questions. Your first question comes from the line of Jason Eron Zemansky with BofA Securities. Please unmute and ask your question.

Jason Eron Zemansky: Good afternoon. Congratulations on the great quarter, and thanks so much for taking our question. 2 quick ones for me. Regarding the 115 new-patient starts, can you help us separate how much of the sequential increase reflected growth in overall menin-class penetration versus share gains from your competitor? And then secondarily, can you help us understand the emerging relationship among starts, refills, and recognize revenue, including any inventory or gross to net effects in the quarter? Thanks so much.

Troy Edward Wilson: Thanks, Jason. Yeah. I will ask Brian to take each of those questions in turn.

Brian T. Powl: Sure. Thanks, Jason, for the questions. So, yeah, so, we have said, we are very pleased with that sequential growth over 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 are both taking share from competitors, but also having the opportunity to grow the market.

To your second question around refills and dynamic of growing, growing that forward, I mean, I think what you can see is in the results that we have shared, we have got a 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 then the TRx growth is actually about 60% growth quarter over quarter. So we are seeing repeat prescriptions. We are seeing new prescriptions. And I think, you know, we are able to see continued good growth. And there has not really been any inventory or stocking onetime events that really have contributed to that.

But the story is really growth here.

Jason Eron Zemansky: Great. Thanks for the color.

Troy Edward Wilson: Thanks, Jason.

Operator: Thank you. Your next question comes from the line of Li Wang Watsek with Cantor Fitzgerald. Please unmute your line and ask your question.

Li Wang Watsek: Hey, guys. Thanks for taking my questions. Just curious, how do you expect COMZIFTI's market leadership to evolve over time? And how much of that do you think is driven by combo use?

Troy Edward Wilson: Okay. I am going to take this. Sure.

Brian T. Powl: Thanks for that, Li. I think that we as we have said, when we first launched, we said that we have a differentiated product profile that we think will be preferential for physicians, and we expect 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 have achieved that market leadership as we have 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 signs are--you know, arrows are green. They are turning in the direction of growth here.

And we think momentum is on our side to continue to evolve that. We I know you we have asked been asked questions around, duration. Duration is something that will come over time, and that is something we will be seeing as we continue to grow. But the focus is getting all the new-- every new patient to have the opportunity to get them on COMZIFTI, and that is what we have achieved so far. And we continue to execute on that. that will enable us to get to that overall market leadership. Combination use. Yeah. And for combination use, yes, your question there.

As we shared in the remarks, we have approximately 40% use in combination. that is consistent with where we were last quarter where we had a, obviously, lower volume. So we are 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. Think that is a real growth opportunity for COMZIFTI in the relapsed/refractory space because of the data that Mollie mentioned. About the publication in blood. We will 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 will be able to continue to develop that.

We are seeing, as we said, kind of a split of both venetoclax combinations as well as FLT3 currently. We think we are well positioned to continue the data generation that will support physicians' choices to use COMZIFTI.

Operator: Thank you. Your next question comes from the line of Asthika Goonewardene with Leerink Partners. Please unmute your line and ask your question.

Asthika Goonewardene: Hey, guys. Thanks for taking my question, and I will also add 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 was COMZIFTI? I am sorry. Can you hear me okay?

Operator: Yes. Go ahead, Asthika.

Asthika Goonewardene: Oh, yeah. Sorry. So the question was, can you tell us about your tier 2 or your preferred coverage for COMZIFTI? And for patients requiring a prior authorization, what proportion of those authorizations were converted? And then I have a quick follow-up.

Brian T. Powl: Sure. Thanks, Asthika, for the questions. So yeah, so did not 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 or actually covered with a preferred, status where they were have to step through COMZIFTI before receiving other menin inhibitors. And I think what that translates into is the growth that we are seeing.

Prior authorizations have been it is a standard, I think, mechanism in oncology, and I think what is been very important for us is we have not seen any challenges for physicians to be able to access to COMZIFTI for their patients, and I think that is reflected in the growth we have seen quarter over quarter.

Asthika Goonewardene: that is good to hear, and then

Troy Edward Wilson: Yeah. Go ahead. You said you had a quick follow-up.

Asthika Goonewardene: Yeah. On it is just on KOMET-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 chemo arm? Thanks, guys.

Troy Edward Wilson: Mollie, would you like to take Asthika's question about KOMET-017?

Mollie Leoni: Sure. Just to be clear, we will have over 200 sites when all sites are active, so we are 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.

Asthika Goonewardene: Got it. Thank you.

Troy Edward Wilson: Thank you.

Operator: Thank you. Your next question comes from the line of Roger Song with Jefferies. Please unmute your line and ask your question.

Nabeel Nissar: Hey, team. Thanks for the updates. Congrats on the launch progress so far. This is Nabeel on for Roger Song. 1 from us. So on KOMET-017, you have mentioned the enrollment is running ahead of plan. Curious what is driving that, and how are you thinking about the value of being first to build that frontline dataset in this class? Thank you.

Troy Edward Wilson: Mollie?

Mollie Leoni: Well, you know, ultimately, there are a few different factors, but KOMET-017 is successful because the design is actually so incredibly convenient for our 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 1 round of bureaucratic start up activities and operational activities really does make a difference, and it makes it easy for any patient with a menin inhibit inhibitor dependent disease to have a place to go as soon as they walk into their physician's office.

And beyond that, the double o 7 data, the phase 1 data that we continue to present at various conferences, really just bolsters everyone's excitement. 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 is all around excitement over the data we are showing and the structure of the trial that these patients are able to enroll in.

Nabeel Nissar: Thanks, Troy.

Operator: Thank you. Your next question comes from the line of Charles Zhu with LifeSci Capital. Please unmute and ask your question.

Peter Green: Hi. This is, Peter Green on for Charles. Just actually a quick question on FTIs. It sounds like early or first half of 27, launching a platform trial combining darlifarnib with daraxonrasib, you have committed to and PDAC. Wondering if your thinking has changed on potential other combinations For example, we had talked about colorectal cancer with EGFR, G12D. And we are also seeing other combinations with RAS such as RMC-6236 gaining in the competitive landscape. So I am just curious what your thoughts are there. Thanks.

Troy Edward Wilson: Yeah. Thanks, Peter. Mollie, do you want to wanna comment and

Mollie Leoni: Sure. that is a very, very good question. So obviously, daraxonrasib 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 daraxonrasib will be the first, but absolutely be looking for additional combinations in other indications and with other drugs.

Troy Edward Wilson: Yeah. And, Peter, just to add to Mollie's comment, we see an opportunity to combine with daraxonrasib in second line PDAC. A lot of companies look to be steering into the frontline. Perhaps, you know, trying to get there before a potential approval or maybe, you know, not to have to go head to head to be able to go against chemo In our view, if we can replicate with daraxonrasib what we have 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 have brought to patients.

But I think it now gives us, you know, a platform on which to build through combinations, and you have mentioned some of them. We are really looking, as Mollie said, to be selective We are not we cannot do everything. Right? But, we have number of combinations under consideration. that is with, you know, some of which require cooperative groups with other parties, and we will provide more detail as it is appropriate.

Peter Green: Thanks. And, and just a quick follow-up. Are there, funds currently earmarked for this trial? And what are the expected costs?

Troy Edward Wilson: There are yeah. There are funds, Peter. We have not broken out the specific expense. I mean, at this point, we would plan for the phase 1 a. You wanna you wanna confirm that you can that you have adequate safety and tolerability. If that, you know, that looks good, then we will reassess. We are at a point, you can probably hear it in the call, where we have wealth of opportunities that we could invest in. We are going to continue to be very focused in our capital allocation.

We think we now have leadership in at least in new patient starts, and I think soon in the other metrics with ZIFTO, we want to darlifarnib, you know, with darlifarnib similarly. So, you know, all good things in time. We are fortunate with darlifarnib that this is still, early development. So, you know, we are not talking about huge dollars relative to for example, registration enabling studies. 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: Great. Congrats on the quarter, guys. Thanks for question. I will try to keep you back and get you back on track with the single question rule here. Yeah. Appreciate it. The so, Troy, the you guys are saying in the press release here, majority share of new patient starts you know, for relapsed/refractory NPM1. Syndax is also saying you know, 60 percent or 2 thirds of the business, 2-thirds of the NPM1 1 business is what they are seeing on their side. I see both of these cannot be true. So I am just wondering where is it in the data that there is this confusion that both parties can claim majority share of new patient starts here?

Troy Edward Wilson: Yeah. Salim. So thanks for the question. And actually, as the operator indicated, we are allowing people to ask 1 follow-up. So feel free to ask a follow-up. But let me dispel the confusion. We have said, we have 115 new patient starts. We are reading the competitor--both us and the competitor off of claims data. They had 250 new patient starts for the quarter and set approximately 40% of them were NPM1. So by my math, that is 100. And a 25% decline in new patient starts quarter-over-quarter. quarter. Whereas we are growing 35% quarter-over-quarter. quarter. They do have the KMT2A business. And I think when they are talking about there is a we wanna be very clear.

We are talking only about NPM1. We are 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 is 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 is NPS, whether it is TRX, whether it is net revenue, they are all growing. They are all strongly growing. I think that is a good sign.

Salim Syed: Okay. Alright. Thanks so much, Troy. Appreciate it.

Troy Edward Wilson: Yeah. Thank you, too.

Operator: Your next question will come from the line of Philip Nadeau with TD Cowen. Please unmute your line and ask your question.

Philip Nadeau: Good afternoon. Thanks for taking our question as well. Now that you have had several quarters of commercial experience curious whether there is been any differences in the commercial experience with COMZIFTI versus what we are seeing in clinical trials. Anything notable that physicians are pointing to first question. Then just to follow-up on the on the FLT3 combo data that we are gonna see later this year. Can you give us some sense you are hoping to see from that data and what next steps could be? Thank you.

Troy Edward Wilson: Sure. Thanks, Philip, for the for the 2 questions. Do you wanna take the question on are we seeing things differently in the market versus maybe is what we would see. Yeah, the clinical experience.

Brian T. Powl: Absolutely. Yeah, thanks for that question, Philip, and I am 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 is still a little bit early to see, to kind of measure out outcomes, as you know, but we have seen, you know, the uptake has been really supportive of the differentiation of COMZIFTI as a new menin inhibitor in the market.

The physician the profile of, you know, kind of the efficacy, safety, compatibility with other agents, and the simplicity, are what is 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 will be tracking the duration story over time and getting an understanding of outcomes.

But I think 1 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 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. So we will continue to follow, and we will be, you know, over time, able to present that. But we are seeing consistency, I think, in the responses and the outline that we have gotten from the clinical data.

Troy Edward Wilson: And speaking of combinations, Mollie, you want to speak to the sort of what to expect from FLT3 and maybe thoughts around potential next steps?

Mollie Leoni: Absolutely. So with regards to the FLT3 data that we are gonna show you, both the combination, the relapsedrefractory 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 are actually able to show you these data, show you safe combinations, show you safe dose escalation should be really important. Because as we have 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 will also be showing you the associated efficacy Some of this is evolving at this time. The quizartinib trial is still rather new, but it is enrolling so quickly. We wanted to share data with you, know, as soon as we could. And, you know, continue to update as everything evolves for next steps. I think that will be a topic that will be covered actually when we present the data.

Philip Nadeau: that is very helpful. Thank you.

Troy Edward Wilson: Thanks, Philip.

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 1 question and 1 follow-up question. Your next question comes from the line of Etzer Darout with Barclays. Please unmute and ask your question.

Etzer Darout: Great. Thanks for taking the question. Can you guys hear me okay?

Troy Edward Wilson: Yes, we can hear you. Thanks.

Etzer Darout: 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 have 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 is currently on the label. Anything there would be would be helpful. Thank you.

Brian T. Powl: Yes. Thanks, Etzer, for that. The data that we reported is primarily in this relapsed refractory, you know, in the population. it is not our indication, but in that population. You know, our goal is because we have KOMET-017, enrolling, I think we wanna get any of those newly diagnosed patients to be put on those trials. But a lot of the, you know, the dynamic that we have seen is that patients who are immediately refractory to frontline therapy, may be preferentially treated in combination, and that is what I think physicians are using. So there is not really a big story in terms of dynamic outside of the population that we are treating.

Etzer Darout: Thank you.

Troy Edward Wilson: Thanks, Etzer.

Operator: Your next question comes from the line of Reni Benjamin with Citizens JMP Securities. Please unmute and ask your question.

Reni Benjamin: Great. Thanks for taking the questions, and congrats on the quarter. I guess, Troy, I would love to understand a little bit more about the rationale behind the evaluation of ZIFTO in these MEIS1-addicted AML patients that, you know, 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, kind of on the heels of the KRAS 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 darlifarnib franchise what might be the best sort of collaboration structures that you would be looking at? Thanks.

Troy Edward Wilson: Yeah. Thanks, Reni. 2 very different questions. Let me ask Mollie just a reminder for everyone, back when we were doing dose escalation, we did see activity, the CR in a CEBPA/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 cannot--we, you know, we cannot go under the abstract, but Mollie, maybe you could speak to Reni's first question. I will take the second.

Mollie Leoni: Yeah. What you said is extraordinarily important. When we did the phase 1 a dose escalation, we saw activity outside of the places where you would 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 a MEIS1 expression high, meaning that it would probably be a responsive to MEN inhibition. So this is huge. If we can show you additional patient populations, besides the NPM1 and the KMT2A, we really do think that we would be able to help up to 50% of AML patients. And we will show you the data as to why we believe that.

Troy Edward Wilson: Yep. And, Reni, to your second question, just very quickly. At this point, you know, our goal is to establish a registrational path, in solid tumors for darlifarnib that provides meaningful clinical value and is differentiated from the competition. We think there is an opportunity in advanced renal cell carcinoma, Mollie spoke to that with her prepared comments. We think there is an opportunity on top of daraxonrasib. Anything else, I think we, you know, we have to be very thoughtful. We could make darlifarnib 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 are picking up on now strategically is these 2 programs work together. So as we are moving toward initial top line results for ziftomenib in frontline AML in 2028, that drives very nicely with the timing of when you would be making investment decisions for darlifarnib to be able to move it into a registrational setting. that is important in terms of building, you know, value for patients and shareholders. it is also interesting from a strategic perspective.

Because now you have 2 potential blockbusters, 1 of which you know, has hopefully a front a positive frontline dataset, 1 or more, and then a second 1 that is coming up behind you, 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 we really are--I think we are really in a good position to have now 2 programs that are relatively close in time And you see we are being very, very disciplined with our spend. Our R&D expense actually ticked down just slightly from last year.

So we are gonna continue to be very responsible stewards of capital and look to create value for shareholders.

Reni Benjamin: 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 Edward Wilson: You know, I think, you know, we wait. Let me put it this way. Let me say it slightly differently. We look at all the time. time. I personally I do not know that doing a strategic collaboration on darlifarnib would necessarily be the right thing to do at this stage. there is 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 have cited a $7 billion TAM. Look at our frontline data. Li, that is not that is a very reasonable TAM. We have you know, we are the senior party in that collaboration.

We book all US sales. We control global development. We control US commercial. Now Reni, you have a second asset sort of sliding in behind it. that is a pretty nice setup in terms of building value. So that is the way we think about it.

Reni Benjamin: Excellent. Thanks for taking the questions.

Troy Edward Wilson: Sure.

Operator: Your next question comes from the line of David Dai with UBS. Please unmute and ask your question.

David Dai: Great. Thanks for taking my questions. I also want to congratulate you on this great quarter. Just a quick question from me. On the Ziftomenib and FLT3 combo. I am 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 is 50% of the AML patients have the FLT3 NPM1 mutation. Could you help us understand how big the market is in dollar amount?

Troy Edward Wilson: Yeah. Maybe I can take that David. So just be able to 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 are gonna wanna go to combinations. We know that is the future. Then there is another equally sized population. So you know, FLT3 has 30 percent 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 Mollie's point, I think it is reasonable to believe that a menin inhibitor certainly would be active in the co mutated 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 have 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 are looking for.

David Dai: Great. Thank you so much.

Troy Edward Wilson: Sure.

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 with Lake Street. Please unmute your line and ask your question.

Daniel Brims: Thanks. Great quarter, guys. Just a quick question about what you are 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 are seeing patients starting there and then switching over to Ziftomenib as docs want to, you know, have better safety profile or you know, be able to combine it with other things. Yeah.

Troy Edward Wilson: Thanks, Daniel. Brian, you wanna take Daniel's question?

Brian T. Powl: Sure. Thanks, Daniel, for that. Yeah. There is certainly a dynamic of switching. I think there are some physicians who see an opportunity to shift to KOMZIFTI. Our goal is to obviously optimize benefit for every patient. We are looking to both grow the market and take share from other products in the space. And I think what we are showing you is that we are doing both. By getting to, you know, this majority share of the new patient starts within our second full quarter, shows that we are able to get patients not just who may have been on other therapy, but we are bringing in new patients.

And as the new patient flow comes forward, we are very, you know, happy to see the physicians are choosing KOMZIFTI based on, you know, all the things that I have outlined, our profile, their choice, and the opportunity for things like combinations as well. So I think it is going to be a dynamic that will continue to evolve in this space. Thank you for that question.

Daniel Brims: Thanks, guys. Great work.

Troy Edward Wilson: Thanks. Thanks, Daniel.

Operator: Thank you. Your final question of today comes from the line of Peter Green with LifeSci Capital. Please unmute your line and ask your question.

Peter Green: Yes, hello again. Thanks for taking the additional question. I am just wondering if you could contrast the Salesforce experience at sites familiar with Ziftomenib. Perhaps they, you know, have had trials or investigators there, versus sites that are, you know, unfamiliar with Ziftomenib. And if there is know, what proportion of, of prescriptions are coming from trial investigators? Thanks.

Troy Edward Wilson: Yeah. Peter, thanks for the thanks, actually, for getting back in the queue and asking an additional question. I am going to turn it over to Brian for just a second, but let me just comment There is not any 1 thing, right? The good news is like every the team is executing. Everything is going in the right direction. And we are you know, we were hopeful this was what we would see. I have to give great credit to Brian and team, the physician engagement, the preferences we are seeing, the commercial execution is really top notch.

But, Brian, you wanna speak to, you know, any differences between people who have not worked with it and those who have.

Brian T. Powl: Of course and thanks, Peter. 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 are very experienced. They know this market; they know a lot of these high accounts because of their experience in hematology. And I would say that we are, you know, we are very pleased with where we are going, but we also have not said that we penetrated every account. there is opportunity for growth, and we will continue to see that opportunity. There are, of course, some sites that are more early adopters, those who have had experience.

Others, are as I have said, you know, coming from, you know, experience with other menin inhibitors, on other clinical trials, but then also those who have not really had experience with MEN 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 is able to engage and experience that. We are seeing growth everywhere, and I think that is what is been encouraging us. And we are encouraged to see that momentum continue.

Peter Green: Thank you.

Operator: There are no more questions at this time. I would now like to turn the call over to Troy Edward Wilson for closing remarks.

Troy Edward Wilson: Thank you, Lenias. Wanna thank you all once again. And in particular, I wanna call out not only Brian's team, you know, at Kura, but also the physicians and their, you know, the care teams At the end of the day, what we are trying to do is help patients and I think, you know, the team is I could not 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 will see later this year. it is really just everybody working together on behalf of patients. We appreciate your interest. We appreciate your questions.

We are gonna 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.