KURA

Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 4:30 p.m. ET 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] 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. Before you buy stock in Kura Oncology, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Kura Oncology wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $419,408!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,348,694!* Now, it’s worth noting Stock Advisor’s total average return is 966% — a market-crushing outperformance compared to 213% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 19, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Kura Oncology (KURA) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Kura Oncology recently reported past second-quarter 2026 results, with revenue rising to US$20.87 million while net loss widened to US$68.33 million, alongside the publication in Blood of extensive preclinical data on its FDA-approved menin inhibitor ziftomenib (KOMZIFTI) for relapsed or refractory NPM1-mutated AML. The Blood manuscript highlights ziftomenib’s differentiated binding profile, activity across genetically defined leukemia models, and retained activity against certain resistance-linked MEN1 mutations, deepening scientific confidence in a therapy already on the market and under investigation for broader oncology uses. Next, we’ll examine how the new Blood data on ziftomenib’s differentiated resistance profile could influence Kura Oncology’s investment narrative. Invest in the nuclear renaissance through our list of 92 elite nuclear energy infrastructure plays powering the global AI revolution. To own Kura Oncology today, you need to believe that KOMZIFTI can grow into a meaningful commercial menin franchise while the broader pipeline justifies continued R&D losses. The latest quarter reinforces that tension: revenue is rising but net loss remains large, so near term the key catalyst is still ziftomenib’s clinical and commercial traction, while persistent cash burn and ongoing losses are the central risk. The new Blood data supports the science but does not fundamentally change that equation. Among recent announcements, the Blood publication on ziftomenib’s activity against certain MEN1 resistance mutations feels most relevant. It adds weight to the idea that KOMZIFTI may have a differentiated durability profile, which matters for the longer term AML story and potential label expansions. However, with Q2 2026 net loss at US$68.33 million and Kura still unprofitable, investors will likely focus just as much on how quickly this scientific edge can translate into sustainable, growing revenue. Yet behind KOMZIFTI’s promise, investors should still pay close attention to the growing net losses and the possibility of future dilution... Read the full narrative on Kura Oncology (it's free!) Kura Oncology's narrative projects $353.2 million revenue and $67.2 million earnings by 2029. Uncover how Kura Oncology's forecasts yield a $31.17 fair value, a 176% upside to its current price. Some of the most optimistic analysts were previously modeling revenue to reach about US$861.5 million by 2029, which is far more bullish than consensus and assumes ziftomenib overcomes the very real risk that Kura’s narrow pipeline and rising losses could bite harder than expected, so this new data may ultimately push you to rethink which side of that wide opinion range you are more comfortable with. Explore 4 other fair value estimates on Kura Oncology - why the stock might be worth 40% less than the current price! Don't just follow the ticker - dig into the data and build a conviction that's truly your own. A great starting point for your Kura Oncology research is our analysis highlighting 1 key reward and 1 important warning sign that could impact your investment decision. Our free Kura Oncology research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Kura Oncology's overall financial health at a glance. Opportunities like this don't last. These are today's most promising picks. Check them out now: This technology could replace computers: discover 24 stocks that are working to make quantum computing a reality. The latest GPUs need a type of rare earth metal called Neodymium and there are only 28 companies in the world exploring or producing it. Find the list for free. We've uncovered the 10 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include KURA. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved majority share of new patient starts in the relapsed/refractory NPM1-mutant AML menin inhibitor market within the second full commercial quarter, despite being second to market. Management attributes rapid adoption to a differentiated product profile characterized by predictable safety, dosing convenience, and lack of meaningful myelosuppression when combined with intensive chemotherapy. Strategic focus is shifting toward establishing Ziftomenib as a foundational therapy through combinations with standards of care, supported by frontline data showing a 96% ORR in certain populations. Darlifarnib is emerging as a second wholly owned strategic pillar, demonstrating the ability to enhance targeted therapy backbones in renal cell carcinoma and KRAS-mutated solid tumors. Commercial execution is driven by high engagement with over 90% of top-priority AML accounts and successful navigation of market access, covering over 95% of lives. Performance in the quarter was bolstered by physician-initiated combination use, which accounted for approximately 40% of new patient starts, signaling future treatment paradigm shifts. Anticipate multiple clinical updates in the second half of 2026, including preliminary data for Ziftomenib combinations with gilteritinib and quizartinib. The pivotal KOMET-017 Phase 3 trial remains on track for top-line results in 2028, utilizing a 'one-stop-shop' design to accrue both intensive and non-intensive chemotherapy patients. Plan to initiate a darlifarnib platform study in second-line or later KRAS-mutant pancreatic cancer in the first half of 2027. Current cash reserves and anticipated collaboration payments are expected to fund the Ziftomenib AML program through its first Phase 3 readout in 2028. Management intends to maintain disciplined capital allocation, prioritizing registrational paths for both franchises while remaining open to selective strategic collaborations. Reported $9.1 million in net product revenue for COMZIFTI, exceeding internal expectations for the second full quarter of launch. Maintained collaboration revenue guidance of $45 million to $55 million for 2026, reflecting non-cash accounting for the Kyowa Kirin partnership. R&D expenses slightly decreased year-over-year, reflecting a disciplined approach to pipeline expansion despite increased clinical activity. Identified a potential total addressable market of $7 billion for Ziftomenib across the AML treatment continuum, assuming successful frontline expansion. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that while competitors may claim high overall starts, Kura holds the majority in the specific NPM1-mutant segment, which is the larger commercial opportunity. Noted a 35% quarter-over-quarter growth in new patient starts and a 60% growth in total prescriptions, contrasting with a perceived decline in competitor starts. Management believes up to 50% of AML cases may be menin-dependent due to high MEIS1 expression, expanding the potential patient population beyond current genetic markers. Early clinical signals, including a complete response in a CEBPA/RUNX1 patient, support the exploratory analysis of broader menin-dependent AML subtypes. Management prefers to retain full ownership of darlifarnib at this stage to maximize value, noting its potential as a 'blockbuster' asset alongside Ziftomenib. The timing of investment decisions for darlifarnib registrational studies is designed to align with the 2028 Ziftomenib Phase 3 data readouts. Approximately 40% of new starts are in combination with venetoclax, azacitidine, or FLT3 inhibitors, which management views as a validation of the drug's 'practical fit'. While promoting only the monotherapy label, Kura is accelerating data generation for these combinations to support physician choice and future label expansions.

Interested in Kura Oncology, Inc.? Here are five stocks we like better. KOMZIFTI generated $9.1 million in Q2 revenue, with about 115 new patient starts and more than 250 prescriptions. Kura said the drug captured a majority of new starts in the NPM1-mutated AML menin inhibitor market, supported by broad market access and growing repeat prescribing. Kura reported encouraging clinical data for ziftomenib combinations, including high response rates in relapsed and frontline AML. The pivotal KOMET-017 trial is enrolling globally, with top-line results still expected in 2028. The company ended June with $519 million in cash and short-term investments and expects collaboration payments from Kyowa Kirin to help fund the AML program through the anticipated 2028 phase 3 readout. Kura also advanced darlifarnib combinations in renal cell carcinoma and KRAS-mutated cancers. Is Kintara Therapeutics A Hidden Gem? Kura Oncology (NASDAQ:KURA) reported second-quarter net product revenue of $9.1 million from KOMZIFTI, its treatment for relapsed or refractory NPM1-mutated acute myeloid leukemia, as the company said the drug captured a majority share of new patient starts in the menin inhibitor market for that indication. The company recorded approximately 115 new patient starts and more than 250 total prescriptions during the quarter. Chief Commercial Officer Brian Powl said new patient starts increased about 35% sequentially, while total prescriptions rose about 60% from the prior quarter. He said the prescription growth reflected both repeat prescribing and new prescriptions, without meaningful contributions from inventory stocking or other one-time events. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat “KOMZIFTI moved into a leadership position in relapsed refractory NPM1-mutated AML menin inhibitor market,” President and Chief Executive Officer Troy Wilson said during the earnings call. Kura entered the market after a competitor but said its early share performance indicated that physicians are differentiating among therapies in the class. Kura said KOMZIFTI adoption expanded across academic and community treatment centers, while repeat prescribing increased and additional accounts began using menin inhibitor therapy. Powl said the company engaged with more than 90% of its top-priority AML accounts during the quarter. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Physician-initiated combination use of KOMZIFTI with venetoclax and azacitidine, as well as with FLT3 inhibitors in patients with co-mutations, represented about 40% of new patient starts. The company promotes the product for its approved monotherapy indication, but management said the combination prescribing activity suggests clinicians see potential for the drug alongside other AML treatments. Kura said more than 95% of covered lives have access to KOMZIFTI, with no label restrictions. Powl added that approximately 16 million covered lives have preferred status that requires patients to step through KOMZIFTI before receiving other menin inhibitors. He said prior authorization requirements have not created material access challenges for prescribers. → First Solar’s Profit Engine Faces a New Policy Test in Washington During the question-and-answer session, Wilson said Kura’s claim of majority share applies specifically to new patient starts in NPM1-mutated AML. He said the company’s 115 new patient starts compared with an estimated 100 NPM1-related starts for its competitor, based on that company’s reported total patient starts and stated mix of NPM1 patients. Kura is pursuing a broader development strategy for ziftomenib, the active ingredient in KOMZIFTI, in AML combination regimens and earlier treatment settings. Chief Medical Officer Mollie Leoni highlighted results from the KOMET-007 study of ziftomenib plus venetoclax and azacitidine in relapsed or refractory disease, which were published in Blood before the European Hematology Association meeting. Among venetoclax-naive patients in that study, Kura reported an 87% overall response rate, a 70% complete remission or complete remission with incomplete hematologic recovery rate, and median overall survival not reached at nearly 11 months of follow-up. At EHA, the company presented long-term data from KOMET-007 evaluating ziftomenib plus 7+3 chemotherapy in 99 patients with newly diagnosed NPM1-mutated and/or KMT2A-rearranged AML. Leoni said the data showed high remission rates and deep responses. The company reported a 96% overall response rate in relapsed or refractory NPM1-mutated AML, 94% overall survival at 12 months, and median overall survival not reached after a median follow-up of 17.6 months. Leoni said ziftomenib did not appear to add meaningful myelosuppression to intensive chemotherapy. Kura believes the dataset is the largest frontline intensive-chemotherapy dataset reported for a menin inhibitor. The pivotal KOMET-017 trial, which includes intensive and non-intensive chemotherapy settings, is enrolling across the U.S., Europe and Asia. Kura said it expects more than 200 sites to be active as enrollment progresses and continues to anticipate top-line results in 2028. The company also expects preliminary data later this year for ziftomenib plus gilteritinib in relapsed or refractory NPM1- and FLT3-mutated AML. It also plans to provide data in the second half of 2026 from a regimen combining ziftomenib, 7+3 chemotherapy and quizartinib, along with updated venetoclax/azacitidine data and an exploratory analysis in other menin-dependent AML subtypes. Kura also discussed darlifarnib, a wholly owned precision-oncology asset being developed in combination with targeted therapies. In patients with renal cell carcinoma previously exposed to cabozantinib, darlifarnib plus cabozantinib produced a 44% objective response rate and 94% disease control rate, according to the company. In 34 cabozantinib-naive patients with advanced clear-cell renal cell carcinoma, objective response rates ranged from 33% to 50% across dose levels, and median progression-free survival was 13 months. Kura said the combination’s safety profile was manageable. The randomized phase 1b portion of the FIT-001 study is comparing darlifarnib plus cabozantinib with cabozantinib alone in cabozantinib-naive clear-cell renal cell carcinoma. Kura expects enrollment to finish in the first half of 2027 and initial data in the second half of that year. Separately, first-in-human data presented at ASCO for darlifarnib plus adagrasib showed tumor shrinkage in 77% of response-evaluable patients with KRAS G12C-mutated cancers. Kura plans to begin a platform study of darlifarnib plus daraxonrasib in second-line or later KRAS-mutant pancreatic cancer in the first half of 2027. Collaboration revenue from Kyowa Kirin was $11.8 million, down from $15.3 million a year earlier. Research and development expense was $61.9 million, compared with $62.8 million in the prior-year quarter. Selling, general and administrative expense rose to $31.8 million from $25.2 million. Net loss was $68.3 million, compared with a $66.1 million loss in the second quarter of 2025. Cash equivalents and short-term investments totaled $519 million as of June 30, down from $667.2 million at year-end 2025. Kura maintained its guidance for collaboration revenue of $45 million to $55 million in 2026, $90 million to $110 million in 2027, and $90 million to $110 million in 2028. The company said its cash balance, together with anticipated $180 million in payments under its Kyowa Kirin collaboration, is expected to fund the ziftomenib AML program through the first anticipated phase 3 KOMET-017 top-line results in 2028. Kura Oncology, Inc (NASDAQ: KURA) is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted oncology therapies. Headquartered in La Jolla, California, the company leverages expertise in molecular biology and precision medicine to identify key drivers of cancer growth and design small-molecule inhibitors that block those pathways. Kura's research platform integrates genomic insights with medicinal chemistry to advance candidates against well-validated targets in solid tumors and hematologic malignancies. The company's lead clinical candidate, tipifarnib, is a farnesyltransferase inhibitor being evaluated for the treatment of HRAS-mutant head and neck squamous cell carcinoma and various non-small cell lung cancers. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Kura Oncology Q2 Earnings Call Highlights" was originally published by MarketBeat. 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– KOMZIFTI® (ziftomenib) generated $9.1 million in net product revenue, up 57% over 1Q, and approximately 115 new patient starts, up 35% over 1Q – – KOMZIFTI® achieved majority share of new patient starts in R/R NPM1-m AML menin inhibitor class, establishing leadership after just two full quarters of launch – – Long-term, frontline AML data presented at EHA 2026 support potential for ziftomenib to transform standard of care and a $7 billion TAM – – Clinical updates support darlifarnib’s potential to enhance targeted therapies in RCC and KRAS-mutated tumors – – $519.0 million in cash, cash equivalents and short-term investments, plus $180 million in anticipated collaboration payments – – Management to host webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT – SAN DIEGO, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, today reported second quarter 2026 financial results and provided a corporate update. “In only its second full quarter of launch, KOMZIFTI established early leadership in relapsed or refractory NPM1-mutant AML, achieving a majority share of new patient starts in the menin inhibitor class,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Increasing physician preference for KOMZIFTI, combined with outstanding commercial execution and encouraging frontline data, establish a strong foundation for ziftomenib as a potential market leader throughout the AML treatment continuum. In parallel, darlifarnib is emerging as a differentiated precision combination platform across multiple targeted therapies in major solid tumor indications. Together, these programs position Kura to build long-term value while advancing innovative therapies for patients with significant unmet need.” Recent Developments KOMZIFTI Commercial Launch Commercial highlights for the quarter included: $9.1 million in net product revenue, a 57% increase from 1Q 2026 Approximately 115 new patient starts (NPS), a 35% increase from 1Q 2026 More than 250 total prescriptions (TRx) in 2Q 2026, including repeat prescriptions, a 59% increase from 1Q 2026 In its second full quarter on the market, KOMZIFTI achieved a majority share of new patient starts in the R/R NPM1-m AML menin inhibitor class New patient starts are a key indicator of physician preference, future prescription growth, and overall market leadership. Additional indicators of KOMZIFTI’s commercial momentum included broader adoption across academic and community treatment centers, increasing repeat prescribing, and physician-directed use of KOMZIFTI in combination with established standards of care. Advancing Ziftomenib Across the Broader AML Treatment Landscape EHA 2026 Long-term KOMET-007 data demonstrated high and durable clinical activity with 600 mg ziftomenib plus intensive chemotherapy (7+3) in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML, including: Blood Publication (June 2026) Updated KOMET-007 results demonstrated deep and durable responses with 600 mg ziftomenib plus venetoclax and azacitidine in R/R NPM1-m AML. Venetoclax-naïve patients achieved an 87% ORR and 70% CRc rate, with 75% of composite complete responders achieving central MRD negativity. Median duration of CRc was 9.2 months. Median OS in these patients was not reached after 10.7 months of follow-up. The regimen was generally well tolerated, with low rates of differentiation syndrome and QTc prolongation. Together, these results support the potential of ziftomenib in combination with standard-of-care regimens, increasing confidence in the ongoing KOMET-017 frontline program. Registrational and Combination Programs Advancing Darlifarnib as a Precision Combination Platform Across Solid Tumors KRAS G12C-mutated Solid Tumors (ASCO 2026) First-in-human Phase 1 FIT-001 data evaluating darlifarnib plus adagrasib provided clinical proof of mechanism, including tumor shrinkage in 77% of response-evaluable patients and confirmed ORRs of: Cabozantinib-naïve Clear Cell Renal Cell Carcinoma (KCRS 2026) Updated Phase 1 FIT-001 results demonstrated encouraging and durable clinical activity with darlifarnib plus cabozantinib, with ORRs of up to 50% across dose levels and an mPFS of 13 months. Cabozantinib-exposed Clear Cell Renal Cell Carcinoma (IKCS 2026) Phase 1 FIT-001 data demonstrated darlifarnib’s potential to overcome resistance to VEGFR-targeted therapy. Despite prior cabozantinib exposure, patients on the combination of darlifarnib plus cabozantinib, across multiple dose levels of each, achieved a: Collectively, these data continue to support darlifarnib’s potential as a precision combination platform capable of enhancing multiple targeted therapy classes while creating opportunities for future development opportunities, potential strategic collaborations, and multiple registrational paths. FIT-001 Phase 1b Dose Expansion Enrollment continues in the global, randomized FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib versus cabozantinib alone to establish the recommended Phase 3 dose in patients with cabozantinib-naïve ccRCC. Anticipated Milestones: Commercial and Development Priorities Kura expects multiple commercial and clinical catalysts over the next 12 to 18 months. KOMZIFTI 2026 Commercial Execution Expand physician adoption across academic and community treatment centers Increase repeat prescribing and broaden physician adoption Deliver sustained quarter-over-quarter growth Strengthen leadership within R/R NPM1-m AML menin inhibitor market Building on Emerging Leadership Across the AML Treatment Continuum Kura’s strategy is to build on KOMZIFTI’s early commercial success by moving ziftomenib into earlier lines of therapy, combining it with multiple standards of care and expanding its use across genetically defined AML populations. Key near-term milestones include anticipated presentation of: Updated long-term KOMET-007 Phase 1b data evaluating ziftomenib with venetoclax and azacitidine in newly diagnosed, intensive chemotherapy-ineligible NPM1-m AML patients, including durability, survival, and MRD outcomes – 2H 2026 Initial data from the KOMET-007 Phase 1b study evaluating ziftomenib with 7+3 intensive chemotherapy and quizartinib in patients with newly diagnosed NPM1-m/FLT3-ITD AML – 2H 2026 Initial KOMET-008 data evaluating ziftomenib with gilteritinib in patients with R/R NPM1-m/FLT3-m AML, including activity in patients previously treated with FLT3 inhibitors – 2H 2026 An exploratory analysis from the KOMET-001 study evaluating ziftomenib monotherapy activity in molecularly defined, MEIS1-associated AML subtypes beyond NPM1-m and KMT2A-r disease – 2H 2026 Ziftomenib and Menin Inhibition – Expansion Beyond AML Continue enrollment of KOMET-015 study evaluating ziftomenib plus imatinib in patients with gastrointestinal stromal tumors Progress preclinical development of next-generation menin inhibitor for use in other solid tumors KO-7246 (Next-Generation Menin Inhibitor) Advance KO-7246, a next-generation menin inhibitor specifically designed for use in diabetes and cardiometabolic disease, into IND-enabling studies Present additional scientific data characterizing menin inhibitors in preclinical models of diabetes Darlifarnib – Precision Combination Platform in Solid Tumors Complete enrollment in the randomized FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib in cabozantinib-naïve ccRCC in 1H 2027 and report initial clinical data in 2H 2027 Initiate a platform study of darlifarnib plus daraxonrasib in patients with KRAS-mutant 2L+ PDAC in 1H 2027 Advance darlifarnib as a precision combination platform across additional targeted therapy classes Second Quarter 2026 Financial Results Net product revenue: $9.1 million, compared to none for 2Q 2025 Collaboration revenue: $11.8 million, compared to $15.3 million for 2Q 2025 R&D expenses: $61.9 million, compared to $62.8 million for 2Q 2025 SG&A expenses: $31.8 million, compared to $25.2 million for 2Q 2025 Net loss: $68.3 million, compared to $66.1 million for 2Q 2025. Net loss includes $8.2 million in non-cash, share-based compensation expense compared to $6.9 million for the same period in 2025. As of June 30, 2026, Kura had $519.0 million in cash, cash equivalents and short-term investments, compared to $667.2 million as of December 31, 2025.   Combined with $180 million in anticipated collaboration payments from Kyowa Kirin, the Company believes its current cash resources will be sufficient to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 trial, anticipated in 2028. Conference Call and Webcast Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, August 12, 2026, to discuss financial results and to provide a corporate update. A live webcast and archived replay of the event will be available on the Investors section of the Company’s website at www.kuraoncology.com. About Kura Oncology Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website and follow us on X and LinkedIn. Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the commercial potential of KOMZIFTI; physician preference for KOMZIFTI; Kura’s research, preclinical and clinical development activities; plans and projected timelines for ziftomenib, darlifarnib, KO-7246, and other preclinical assets; ziftomenib’s potential to transform the standard of care for AML and to serve as a foundational therapy and market leader across the AML treatment continuum; the market opportunity for ziftomenib; darlifarnib’s potential to serve as a precision combination platform and enhance clinical activity in multiple targeted therapy classes, while creating opportunities for future development, potential strategic collaborations, and multiple registrational paths; the expected timing and presentation of results and data from clinical trials; Kura’s ability to generate long-term value; and Kura’s anticipated cash runway. Factors that may cause actual results to differ materially include risks associated with market competition, market acceptance and commercialization of KOMZIFTI and Kura’s product candidates; risks associated with the conduct of preclinical studies and clinical trials; the risk that Kura may not obtain access to third-party compounds Kura seeks to evaluate in combination with its product candidates; the risk of the FDA not permitting Kura’s planned trials to proceed; the risk that Kura’s product candidates may not receive regulatory approval; the potential for KOMZIFTI or Kura’s product candidates to have unexpected adverse side effects; risks that Kura’s actual future financial and operating results may differ from its expectations or goals; the risk that Kura may not be able to obtain additional financing; the risk that the collaboration with Kyowa Kirin is unsuccessful; and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Abbreviations 7+3, cytarabine plus daunorubicin; AML, acute myeloid leukemia; ccRCC, clear cell renal cell carcinoma; CRc, composite complete remission; DCR, disease control rate; FLT3, Fms-like tyrosine kinase 3 gene; FLT3-ITD, FMS-like tyrosine kinase 3 internal tandem duplication; G12C, a specific amino-acid substitution; IND, Investigational New Drug application; KMT2A, lysine methyltransferase 2A gene; -m, mutant; MEIS1, Myeloid Ecotropic Viral Integration Site 1; NPM1, nucleophosmin 1 gene; ITD, Internal Random Duplication; ORR, overall response rate; OS, overall survival; PDAC, pancreatic ductal adenocarcinoma; -r, rearranged; KRAS, Kirsten Rat Sarcoma Virus oncogene homolog; mPFS, median progression free survival, MRD, minimal residual disease; QTc, corrected QT interval; R/R, relapsed/refractory; VEGFR, vascular endothelial growth factor receptor About KOMZIFTI® (ziftomenib)KOMZIFTI (ziftomenib) is an oral menin inhibitor approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Ziftomenib is in development for the treatment of frontline and R/R AML harboring NPM1 mutations, KMT2A translocations and FLT3 mutations, with the potential to be combined with approved therapies and benefit a broad spectrum of patients. IMPORTANT SAFETY INFORMATION FOR KOMZIFTI FROM THE U.S. PRESCRIBING INFORMATION Boxed WARNING: DIFFERENTIATION SYNDROME Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If differentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement. WARNINGS AND PRECAUTIONS Differentiation Syndrome KOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). DS is associated with rapid proliferation and differentiation of myeloid cells. Symptoms of DS, including those seen in patients treated with KOMZIFTI, may include fever, hypoxia, joint pain, hypotension, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, acute kidney injury, and rashes. In the clinical trial, DS occurred in 29 (26%) of 112 patients with R/R AML with an NPM1 mutation who were treated with KOMZIFTI at the recommended dosage. DS was Grade 3 in 13% and fatal in two patients. In broader evaluation of all patients with any genetic form of AML treated with KOMZIFTI monotherapy in clinical trials, DS occurred in 25% of patients. Four fatal cases of DS occurred out of 39 patients with KMT2A-rearranged AML treated with KOMZIFTI. KOMZIFTI is not approved for use in patients with KMT2A-rearranged AML. In the 112 patients with an NPM1 mutation, DS was observed with and without concomitant hyperleukocytosis, in as early as 3 days and up to 46 days after KOMZIFTI initiation. The median time to onset was 15 days. Two patients experienced more than one DS event. Treatment was interrupted and resumed in 15 (13%) patients, while it was permanently discontinued in 2 (2%) patients. Prior to starting treatment with KOMZIFTI, reduce the WBC counts to less than 25 x 10⁹/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a minimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment with KOMZIFTI at the same dose level when signs and symptoms improve and are Grade 2 or lower. Taper corticosteroids over a minimum of 3 days after adequate control or resolution of symptoms. Symptoms of DS may recur with premature discontinuation of corticosteroid treatment. QTc Interval Prolongation KOMZIFTI can cause QTc interval prolongation. In the clinical trial, QTc interval prolongation was reported as an adverse reaction in 12% of 112 patients treated with KOMZIFTI at the recommended dosage for R/R AML with an NPM1 mutation. QTc interval prolongation was Grade 3 in 8% of patients. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 9% of patients, and the increase from baseline QTcF was greater than 60 msec in 12% of patients. KOMZIFTI dose reduction was required for 1% of patients due to QTc interval prolongation. QTc prolongation occurred in 14% of the 42 patients less than 65 years of age and in 10% of the 70 patients 65 years of age or older. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to treatment with KOMZIFTI. Perform an ECG prior to initiation of treatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF > 480 msec. Perform an ECG at least once weekly for the first four weeks on treatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use of KOMZIFTI with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation, result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsades de Pointes, other serious arrhythmias, and sudden death. Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 3 months after the last dose. ADVERSE REACTIONS Fatal adverse reactions occurred in 4 (4%) patients who received KOMZIFTI, including 2 with differentiation syndrome, 1 with infection, and 1 with sudden death. Serious adverse reactions were reported in 79% of patients who received KOMZIFTI. Serious adverse reactions occurring in ≥ 5% of patients included infection without an identified pathogen (29%), febrile neutropenia (18%), bacterial infection (16%), differentiation syndrome (16%), and dyspnea (6%). Dosage interruption of KOMZIFTI due to an adverse reaction occurred in 54% of patients. Adverse reactions that required dose interruption in ≥ 2% of patients included infection without an identified pathogen (15%), differentiation syndrome (13%), febrile neutropenia (5%), pyrexia (4%), electrocardiogram QT prolonged (4%), leukocytosis (4%), bacterial infection (3%), cardiac failure (2%), cholecystitis (2%), diarrhea (2%), pruritus (2%), and thrombosis (2%). Dose reduction of KOMZIFTI due to an adverse reaction occurred in 4% of patients. Permanent discontinuation of KOMZIFTI due to an adverse reaction occurred in 21% of patients. Adverse reactions that required permanent discontinuation of KOMZIFTI in ≥ 2% of patients were infection without an identified pathogen (8%), bacterial infection (4%), cardiac arrest (2%), and differentiation syndrome (2%). Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased (53%), infection without an identified pathogen (52%), potassium decreased (52%), albumin decreased (51%), alanine aminotransferase increased (50%), sodium decreased (49%), creatinine increased (45%), alkaline phosphatase increased (41%), hemorrhage (38%), diarrhea (36%), nausea (35%), fatigue (34%), edema (30%), bacterial infection (28%), musculoskeletal pain (28%), bilirubin increased (27%), potassium increased (26%), differentiation syndrome (26%), pruritus (23%), febrile neutropenia (22%), and transaminases increased (21%). DRUG INTERACTIONS Drug interactions may occur when KOMZIFTI is concomitantly used with: Strong or Moderate CYP3A4 Inhibitors: Monitor patients more frequently for KOMZIFTI-associated adverse reactions. Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of KOMZIFTI. Gastric Acid Reducing Agents: Avoid concomitant use of KOMZIFTI with proton pump inhibitors (PPIs), H2 receptor antagonists (H2RAs), or locally acting antacids. If concomitant use with H2RAs or locally acting antacids cannot be avoided, modify KOMZIFTI administration time. Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms. USE IN SPECIFIC POPULATIONS Pregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to starting KOMZIFTI. Lactation: Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with KOMZIFTI and for 2 weeks after the last dose. Infertility: Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential. Please see full Prescribing Information, including Boxed WARNING. Contacts Investors and media: Greg [email protected]

– 12-month OS rate 94% among NPM1-m AML patients and 71% among KMT2A-r AML patients in single-arm KOMET-007 trial – – 96% CRc in newly diagnosed NPM1-m AML; 90% CRc in newly diagnosed KMT2A-r AML – – High rates of MRD negativity among NPM1-m AML responders assessed by both local assays and central testing – – Median OS not reached in either NPM1-m or KMT2A-r population with median follow-up of 17.6 months and 11.0 months, respectively – – 12-month survival rate, remission rates, MRD negativity, durability of CR and tolerability compare favorably to 7+3 precedents and strengthen confidence in ongoing KOMET-017 Phase 3 registrational study – – Kura to host a virtual investor event tomorrow, June 12, 2026, at 8:00 a.m. ET / 5:00 a.m. PT – SAN DIEGO and TOKYO, June 11, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced encouraging long-term results from the Phase 1/2 KOMET-007 single-arm trial (NCT05735184) evaluating ziftomenib in combination with intensive chemotherapy, 7+3, in newly diagnosed NPM1-m or KMT2A-r AML. These results will be presented at the European Hematology Association 2026 Congress. These data compare favorably to historical standard-of-care data with 7+3 alone: 1KOMET-007 (N=49) at 600 mg ziftomenib; MRD neg -4; 2Lachowiez et al., Blood Adv. 2020; 4(7): 1311–1320; 3Hernández-Sánchez et al., Leukemia. 2026; 40(2): 418-428; 4Othus et al. Leukemia. 2019; 33(2):371-378; 5Othman et al., Blood. 2024; 144(7):714-728, including Supplemental Material; 6Recher et al., Leukemia. 2022; 36(4): 913-922. Overall Survival (OS) for NPM1-m Patient Subset in Single-Arm KOMET-007 Trial: Median OS Not Reached KOMZIFTI™ (ziftomenib) is approved by the U.S. Food and Drug Administration (FDA) as monotherapy for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. The use of ziftomenib in combination with 7+3 is investigational and has not been approved by any health authority. “The updated results from the KOMET-007 trial provide important evidence supporting the safety and clinical activity of adding ziftomenib to intensive chemotherapy for patients with newly diagnosed NPM1-m and KMT2A-r AML,” said Amer Zeidan, M.B.B.S., M.H.S., Chief, Division of Hematologic Malignancies at Yale Cancer Center and Professor of Medicine at Yale School of Medicine, and the lead investigator for the registrational KOMET-017 program. “Across nearly 100 patients treated to date, composite remission rates reaching 90-96%, high rates of MRD negativity and encouraging durability are especially meaningful in a disease where depth of response can inform long-term treatment decisions. The 12-month survival estimate of 94% for the NPM1-m patient cohort is particularly impressive. Based on the results observed to date, this regimen could represent a transformative therapeutic approach and may allow some patients to avoid allogeneic hematopoietic cell transplantation, a procedure that carries a significant risk of mortality and morbidity. We will continue to follow patients to assess long-term safety and clinical activity, including outcomes for those who do not undergo transplantation, and these results continue to strongly support the registrational Phase 3 KOMET-017 trials.” As of the data cut-off on April 10, 2026: High remission rates across both molecular subtypes 96% CRc and 98% ORR in NPM1-m AML, 90% CRc and 92% ORR in KMT2A-r AML Deep molecular responses, including marrow central MRD assessment Local CRc MRD-negativity rates were 85% in NPM1-m AML and 82% in KMT2A-r AML In NPM1-m AML, marrow central MRD negativity (10-4, NGS) among CRc responders was 79% (31/39) at the <0.1% threshold and 56% (22/39) at the <0.01% threshold, with all CRc responders who achieved central MRD negativity doing so by Cycle 2 Durable responses and encouraging durability with extended follow-up After median follow-up of nearly 18 months (range 1.0-23.5) in NPM1-m AML and 11.0 months (range 0.9-21.9) in KMT2A-r AML, median duration of complete response was not reached for the NPM1-m AML cohort and was 12 months for the KMT2A-r AML cohort Median OS was not reached, with median follow-up of 17.6 months in NPM1-m and 11.0 in KMT2A-r, respectively The majority of patients remained alive and continued on study at time of data cut-off: Consistent and manageable safety profile Ziftomenib 600 mg once-daily plus 7+3 was generally well tolerated, with no new or unexpected safety signals observed with longer follow-up Low rates of ziftomenib-related cytopenias and minimal additive myelosuppression were observed with this combination Ziftomenib 600 mg once-daily did not delay neutrophil or platelet count recovery No Grade 4 differentiation syndrome or QTc prolongation events were reported Four patients (4%) experienced Grade 3 differentiation syndrome; all cases successfully resolved with protocol-specified mitigation and three continued on ziftomenib treatment Three patients (3%) experienced Grade 3 investigator-assessed QTc prolongation (all three on azole antifungals, fluoroquinolones, or other medications at time of assessment; one with ongoing hypokalemia and hypomagnesemia); none were assessed as ziftomenib-related and all QTc events successfully resolved with all patients continuing on ziftomenib treatment 60-day mortality rate of 2% (1/49) in NPM1-m patients “KOMET-007 has meaningfully strengthened the scientific and clinical foundation for KOMET-017 after ziftomenib was successfully integrated into intensive frontline therapy resulting in high remission rates, deep molecular clearance, encouraging durability and a favorable tolerability profile,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “These data increase our confidence in the ongoing registrational program and support the potential for ziftomenib to serve as a foundational menin inhibitor backbone in frontline AML. Importantly, as more patients in clinical trials receive ziftomenib earlier in the treatment course and remain on therapy for longer periods, we believe there may be an opportunity to extend the benefit of menin inhibition beyond induction and deepen its impact across the AML treatment continuum.” “These data strongly support the continued study of ziftomenib as part of a frontline regime in newly diagnosed AML,” said Yoshifumi Torii, Ph.D., Chief Medical Officer of Kyowa Kirin. “We view the high remission rates, along with deep MRD negativity and encouraging durability, as particularly meaningful. Despite advances in treatment, AML remains associated with a high risk of relapse, underscoring the continued need for improved long-term treatment strategies. These results suggest that ziftomenib, when combined with standard therapy, has the potential to advance the current treatment paradigm. We look forward to further evaluating its clinical value through the ongoing Phase 3 KOMET-017 trial.” The companies plan to publish these data in a peer-reviewed publication in the second half of 2026. Copies of the presentation will be available on Kura’s website at www.kuraoncology.com/pipeline/publications following presentation at the meeting. Virtual Investor EventKura will host a webcast and conference call on June 12, 2026, at 8:00 am ET / 5:00 am PT, featuring management and Amer Zeidan, M.B.B.S., M.H.S., Chief, Division of Hematologic Malignancies and Professor of Medicine at Yale School of Medicine, and the lead investigator for the registrational KOMET-017 study. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section. Abbreviations7+3 (cytarabine plus daunorubicin), AML (acute myeloid leukemia), CR (complete response), CRc (composite complete remission), KMT2A-r (KMT2A-rearranged), MRD (measurable residual disease), NGS (next-generation sequencing), NPM1-m (NPM1-mutant), ORR (objective response rate), OS (overall survival), QTc (corrected QT interval) About Kura Oncology Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI™ (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn. About Kyowa KirinKyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato-oncology and rare diseases. A shared commitment to Kyowa Kirin’s values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com. About Ziftomenib Ziftomenib (marketed as KOMZIFTI™ in the U.S.) is a once-daily, oral menin inhibitor approved by the U.S. Food and Drug Administration for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Ziftomenib is being studied across the AML treatment continuum, including in combination studies in newly diagnosed and relapsed/refractory NPM1-mutated AML, KMT2A-rearranged AML, and FLT3-mutated AML. Ziftomenib is also being explored in additional oncology indications, including advanced gastrointestinal stromal tumors. IMPORTANT SAFETY INFORMATION FOR KOMZIFTI FROM THE U.S. PRESCRIBING INFORMATION Boxed WARNING: DIFFERENTIATION SYNDROME Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If differentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement. WARNINGS AND PRECAUTIONS Differentiation SyndromeKOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). DS is associated with rapid proliferation and differentiation of myeloid cells. Symptoms of DS, including those seen in patients treated with KOMZIFTI, may include fever, hypoxia, joint pain, hypotension, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, acute kidney injury, and rashes. In the clinical trial, DS occurred in 29 (26%) of 112 patients with R/R AML with an NPM1 mutation who were treated with KOMZIFTI at the recommended dosage. DS was Grade 3 in 13% and fatal in two patients. In broader evaluation of all patients with any genetic form of AML treated with KOMZIFTI monotherapy in clinical trials, DS occurred in 25% of patients. Four fatal cases of DS occurred out of 39 patients with KMT2A-rearranged AML treated with KOMZIFTI. KOMZIFTI is not approved for use in patients with KMT2A-rearranged AML. In the 112 patients with an NPM1 mutation, DS was observed with and without concomitant hyperleukocytosis, in as early as 3 days and up to 46 days after KOMZIFTI initiation. The median time to onset was 15 days. Two patients experienced more than one DS event. Treatment was interrupted and resumed in 15 (13%) patients, while it was permanently discontinued in 2 (2%) patients. Prior to starting treatment with KOMZIFTI, reduce the WBC counts to less than 25 x 10⁹/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a minimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment with KOMZIFTI at the same dose level when signs and symptoms improve and are Grade 2 or lower. Taper corticosteroids over a minimum of 3 days after adequate control or resolution of symptoms. Symptoms of DS may recur with premature discontinuation of corticosteroid treatment. QTc Interval Prolongation KOMZIFTI can cause QTc interval prolongation. In the clinical trial, QTc interval prolongation was reported as an adverse reaction in 12% of 112 patients treated with KOMZIFTI at the recommended dosage for R/R AML with an NPM1 mutation. QTc interval prolongation was Grade 3 in 8% of patients. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 9% of patients, and the increase from baseline QTcF was greater than 60 msec in 12% of patients. KOMZIFTI dose reduction was required for 1% of patients due to QTc interval prolongation. QTc prolongation occurred in 14% of the 42 patients less than 65 years of age and in 10% of the 70 patients 65 years of age or older. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to treatment with KOMZIFTI. Perform an ECG prior to initiation of treatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF > 480 msec. Perform an ECG at least once weekly for the first four weeks on treatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use of KOMZIFTI with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation, result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsades de Pointes, other serious arrhythmias, and sudden death. Embryo-Fetal ToxicityBased on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 3 months after the last dose. ADVERSE REACTIONS Fatal adverse reactions occurred in 4 (4%) patients who received KOMZIFTI, including 2 with differentiation syndrome, 1 with infection, and 1 with sudden death. Serious adverse reactions were reported in 79% of patients who received KOMZIFTI. Serious adverse reactions occurring in ≥ 5% of patients included infection without an identified pathogen (29%), febrile neutropenia (18%), bacterial infection (16%), differentiation syndrome (16%), and dyspnea (6%). Dosage interruption of KOMZIFTI due to an adverse reaction occurred in 54% of patients. Adverse reactions that required dose interruption in ≥ 2% of patients included infection without an identified pathogen (15%), differentiation syndrome (13%), febrile neutropenia (5%), pyrexia (4%), electrocardiogram QT prolonged (4%), leukocytosis (4%), bacterial infection (3%), cardiac failure (2%), cholecystitis (2%), diarrhea (2%), pruritus (2%), and thrombosis (2%). Dose reduction of KOMZIFTI due to an adverse reaction occurred in 4% of patients. Permanent discontinuation of KOMZIFTI due to an adverse reaction occurred in 21% of patients. Adverse reactions that required permanent discontinuation of KOMZIFTI in ≥ 2% of patients were infection without an identified pathogen (8%), bacterial infection (4%), cardiac arrest (2%), and differentiation syndrome (2%). Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased (53%), infection without an identified pathogen (52%), potassium decreased (52%), albumin decreased (51%), alanine aminotransferase increased (50%), sodium decreased (49%), creatinine increased (45%), alkaline phosphatase increased (41%), hemorrhage (38%), diarrhea (36%), nausea (35%), fatigue (34%), edema (30%), bacterial infection (28%), musculoskeletal pain (28%), bilirubin increased (27%), potassium increased (26%), differentiation syndrome (26%), pruritus (23%), febrile neutropenia (22%), and transaminases increased (21%). DRUG INTERACTIONS Drug interactions may occur when KOMZIFTI is concomitantly used with: Strong or Moderate CYP3A4 Inhibitors: Monitor patients more frequently for KOMZIFTI-associated adverse reactions. Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of KOMZIFTI. Gastric Acid Reducing Agents: Avoid concomitant use of KOMZIFTI with proton pump inhibitors (PPIs), H2 receptor antagonists (H2RAs), or locally acting antacids. If concomitant use with H2RAs or locally acting antacids cannot be avoided, modify KOMZIFTI administration time. Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms. USE IN SPECIFIC POPULATIONS Pregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to starting KOMZIFTI. Lactation: Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with KOMZIFTI and for 2 weeks after the last dose. Infertility: Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential. Please see full Prescribing Information, including Boxed WARNING. Kura Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, ziftomenib’s therapeutic potential, including as a foundational backbone in frontline AML; the safety and clinical activity of adding ziftomenib to intensive chemotherapy for patients with newly diagnosed NPM1-m or KMT2A-r AML; the potential of ziftomenib plus intensive chemotherapy to extend the benefit of menin inhibition beyond induction, reduce reliance on transplant, and deepen ziftomenib’s impact across the AML treatment continuum; and Kura’s confidence in the Phase 3 KOMET-017 trials. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risk that the collaboration with Kyowa Kirin is unsuccessful, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Kura ContactGreg Mann (Investors and Media)[email protected] Kyowa Kirin ContactsRyohei Kawai (Investors)Kyowa [email protected] Sachiko Kido (Media, Global)Kyowa [email protected] A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/330268d8-ff56-433d-a2f5-39bbbc75cff0

It's been a good week for Kura Oncology, Inc. (NASDAQ:KURA) shareholders, because the company has just released its latest first-quarter results, and the shares gained 4.5% to US$9.74. Statutory results overall were mixed, with revenues coming in 30% lower than the analysts predicted. What's really surprising is that losses of US$0.83 per share were pretty much in line with forecasts, despite the revenue miss. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. So we collected the latest post-earnings statutory consensus estimates to see what could be in store for next year. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. Following the latest results, Kura Oncology's 13 analysts are now forecasting revenues of US$97.6m in 2026. This would be a substantial 36% improvement in revenue compared to the last 12 months. Losses are expected to increase slightly, to US$3.51 per share. Before this latest report, the consensus had been expecting revenues of US$111.4m and US$3.55 per share in losses. So there's definitely been a change in sentiment in this update, with the analysts administering a substantial haircut to next year's revenue estimates, while at the same time holding losses per share steady. View our latest analysis for Kura Oncology The consensus price target was broadly unchanged at US$31.17, implying that the business is performing roughly in line with expectations, despite a downwards adjustment to forecast revenue next year. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. There are some variant perceptions on Kura Oncology, with the most bullish analyst valuing it at US$76.00 and the most bearish at US$15.00 per share. We would probably assign less value to the analyst forecasts in this situation, because such a wide range of estimates could imply that the future of this business is difficult to value accurately. As a result it might not be a great idea to make decisions based on the consensus price target, which is after all just an average of this wide range of estimates. One way to get more context on these forecasts is to look at how they compare to both past performance, and how other companies in the same industry are performing. It's pretty clear that there is an expectation that Kura Oncology's revenue growth will slow down substantially, with revenues to the end of 2026 expected to display 51% growth on an annualised basis. This is compared to a historical growth rate of 83% over the past five years. Juxtapose this against the other companies in the industry with analyst coverage, which are forecast to grow their revenues (in aggregate) 22% per year. Even after the forecast slowdown in growth, it seems obvious that Kura Oncology is also expected to grow faster than the wider industry. The most important thing to take away is that the analysts reconfirmed their loss per share estimates for next year. They also downgraded Kura Oncology's revenue estimates, but industry data suggests that it is expected to grow faster than the wider industry. The consensus price target held steady at US$31.17, with the latest estimates not enough to have an impact on their price targets. Keeping that in mind, we still think that the longer term trajectory of the business is much more important for investors to consider. We have estimates - from multiple Kura Oncology analysts - going out to 2028, and you can see them free on our platform here. And what about risks? Every company has them, and we've spotted 1 warning sign for Kura Oncology you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Interested in Kura Oncology, Inc.? Here are five stocks we like better. Kura Oncology reported its first full quarter of KOMZIFTI sales at $5.8 million, with management saying the launch is off to a strong start thanks to physician uptake, broad payer coverage and early use in combination regimens. The company said its AML pipeline remains on track, with KOMET-017 ahead of plan and multiple ziftomenib data readouts expected in 2026, including updates at EHA and preliminary gilteritinib-combination data in the second half of the year. Quarterly losses widened as launch and trial spending increased, but Kura ended March with $580.8 million in cash and investments and said existing resources plus Kyowa Kirin payments should fund the AML program through first top-line phase III results in 2028. Is Kintara Therapeutics A Hidden Gem? Kura Oncology (NASDAQ:KURA) reported $5.8 million in first-quarter net product revenue from KOMZIFTI, its first commercial product, and said the launch is showing early signs of physician uptake, broad payer coverage and use in combination regimens, according to management’s earnings call for the first quarter of 2026. President and Chief Executive Officer Dr. Troy Wilson described the company as being “at an inflection point,” citing the commercial launch, phase III programs that he said are ahead of plan and an expected flow of clinical data over the next 12 to 24 months. Wilson said KOMZIFTI’s first full quarter of launch came in ahead of company expectations, with revenue supported by repeat prescriptions, use across treatment centers and what the company described as early instances of physicians switching patients from other menin inhibitors. → MercadoLibre Boldly Invests in Growth: Discount Deepens “This is not just a class story anymore,” Wilson said. “Physicians are starting to differentiate based on product profile, and we believe KOMZIFTI is standing out.” Chief Commercial Officer Brian Powl said Kura recorded 85 new patient starts and nearly 160 total prescriptions during the quarter. Patients were treated across approximately 60 activated accounts, including ziftomenib trial sites, centers with prior menin inhibitor experience and accounts new to the class. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Powl said the company is focused on establishing relapsed or refractory NPM1-mutant acute myeloid leukemia as a $350 million to $400 million market opportunity. He said Kura’s early launch strategy is centered on broad awareness of KOMZIFTI’s profile, consistent quarter-over-quarter growth and expansion within the approved setting. Management said approximately 40% of patients were receiving KOMZIFTI in combination, based on early data, including with venetoclax and azacitidine or, in FLT3 co-mutated patients, with gilteritinib. Powl emphasized that the company’s commercial teams promote KOMZIFTI only as an approved monotherapy, and that the combination use reflects physician discretion. → MP Materials Is Quietly Building a Rare Earth Powerhouse On the question of treatment duration, Powl said it is too early to draw conclusions after one full quarter, but reiterated Kura’s expectation of approximately six months of treatment. He said the company will need additional quarters to better understand duration, particularly among patients receiving combination therapy. Wilson said there was no meaningful inventory stocking reflected in first-quarter revenue. Powl said Kura has secured coverage at parity or better for more than 93% of covered lives, with no label restrictions. He also said more than 10 plans representing more than 12 million lives have placed KOMZIFTI in a favorable policy position. Time from prescription to patient receipt is approximately three days, Powl said. He added that feedback from physicians, pharmacists and nurses has highlighted KOMZIFTI’s once-daily dosing and convenience, which management said may be important in real-world treatment decisions when monotherapy efficacy is viewed as similar. During the question-and-answer portion of the call, Tom Doyle, senior vice president of finance and accounting, said gross-to-net dynamics were within normal ranges, in the 20% to 30% range. Wilson said prescriptions referenced on the call were one-month scripts. Chief Medical Officer Dr. Mollie Leoni said Kura expects a continued cadence of data in 2026 for ziftomenib and darlifarnib. The company’s ziftomenib strategy is to establish the drug as a broadly combinable backbone therapy across the AML treatment landscape. At the European Hematology Association meeting in June, Kura plans to present updated data from ziftomenib in combination with 7+3 chemotherapy in newly diagnosed NPM1-mutant and KMT2A-rearranged AML. Leoni said the update will include extended follow-up with a median of approximately 16 months, including treatment course and response durability. Kura also expects to publish data on ziftomenib with venetoclax and azacitidine in relapsed or refractory NPM1-mutant AML. Leoni referenced prior ASH 2025 data showing a 70% composite complete remission rate in patients without prior venetoclax exposure. The company also expects preliminary data in the second half of the year from ziftomenib with gilteritinib in relapsed or refractory NPM1-mutant, FLT3-mutated AML. Leoni said the company’s KOMET-017 frontline program, which uses a “one-stop-shop” design to enroll patients into two independent phase III trials at each activated site, is ahead of projections. She cited strong participation from leading academic centers in the U.S., Europe and Asia. Wilson said Kura continues to guide to initial top-line results from the intensive chemotherapy combination portion of KOMET-017 in 2028. Beyond AML, Leoni said Kura continues to evaluate ziftomenib plus imatinib in gastrointestinal stromal tumors and is exploring menin inhibition in other solid tumors. For darlifarnib, Leoni said recent data in cabozantinib-pretreated clear cell renal cell carcinoma supported the drug’s mechanism and its potential to restore sensitivity to targeted therapies through the RAS/mTORC1 resistance pathway. Enrollment is underway in the phase Ib portion of a darlifarnib plus cabozantinib trial, and Kura plans to provide an update on the full phase Ia data set later this year. At ASCO, the company plans to present preliminary data evaluating darlifarnib with adagrasib in KRAS G12C-mutated solid tumors. Leoni said the data will include dose escalation results across multiple tumor types, including non-small cell lung cancer, pancreatic ductal adenocarcinoma and colorectal cancer. Kura reported collaboration revenue of $12.5 million from its Kyowa Kirin partnership, compared with $14.1 million in the prior-year quarter. Research and development expenses rose to $65.3 million from $56 million, which Doyle attributed to ziftomenib combination trials and enrollment in KOMET-017. Selling, general and administrative expenses increased to $31.6 million from $22.8 million, driven by the KOMZIFTI launch. The company posted a first-quarter net loss of $73.3 million, compared with a net loss of $57.4 million a year earlier. The latest quarter included $8.4 million of non-cash share-based compensation expense. As of March 31, 2026, Kura had $580.8 million in cash, cash equivalents and short-term investments, down from $667.2 million at the end of 2025. Doyle said Kura is maintaining its collaboration revenue guidance of $45 million to $55 million for 2026, $90 million to $110 million for 2027 and $90 million to $110 million for 2028. He said current cash and investments, together with anticipated $180 million in payments under the Kyowa Kirin collaboration, are expected to fund the ziftomenib AML program through the first top-line phase III results from KOMET-017, anticipated in 2028. Kura Oncology, Inc (NASDAQ: KURA) is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted oncology therapies. Headquartered in La Jolla, California, the company leverages expertise in molecular biology and precision medicine to identify key drivers of cancer growth and design small-molecule inhibitors that block those pathways. Kura's research platform integrates genomic insights with medicinal chemistry to advance candidates against well-validated targets in solid tumors and hematologic malignancies. The company's lead clinical candidate, tipifarnib, is a farnesyltransferase inhibitor being evaluated for the treatment of HRAS-mutant head and neck squamous cell carcinoma and various non-small cell lung cancers. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Kura Oncology Q1 Earnings Call Highlights" was originally published by MarketBeat. 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