Good day, everyone. My name is Abigail, and I will be your conference operator today. At this time, I would like to welcome you to the Kura Oncology, Inc. fourth-quarter 2025 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 everybody the opportunity to participate, we ask that you please limit yourself to one question and then reenter the queue for any follow-ups. At this time, I would like to turn the call over to Greg Mann, SVP of Investor Relations and Corporate Affairs of Kura Oncology, Inc. Please go ahead.

Thank you, Abigail. Good morning, and welcome to Kura Oncology, Inc.'s fourth-quarter 2025 conference call. Joining the call today are Dr. Troy Wilson, President and Chief Executive Officer; Brian T. Powl, Chief Commercial Officer; Dr. Mollie Leoni, Chief Medical Officer; and Tom Doyle, Senior Vice President, Finance and Accounting. We remind you that today's call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today, and may involve risks and uncertainties that cause actual results to differ materially from expected results. Please refer to Kura Oncology, Inc.'s filings with the SEC, which are available from the SEC or on the Kura Oncology, Inc. website for information concerning risk factors that could affect the company. With that, I will turn the call over to Troy.

Thank you, Greg, and good morning, everyone. 2025 was a defining year for Kura Oncology, Inc. Marked by FDA approval of Comzifty and initiation of a successful commercial launch. As we enter 2026, our priorities are clear. Execute commercially, move aggressively into frontline AML and combinations, and build long-term leadership in menin inhibition while advancing a data-rich pipeline. Comzifty generated $2.1 million in net product revenue in the final weeks of 2025. Although it is early, the launch is off to a strong start. Feedback from physicians, pharmacists, and payers has been consistent. Comzifty delivers meaningful efficacy with differentiated safety, simplicity, and combinability with concomitant medications. In medically complex AML patients, that matters. We believe leadership in relapsed and refractory NPM1-mutant AML will be determined by preference, not by who enters the market first. Importantly, Comzifty is now listed in the FDA's Orange Book with patent protection through July 2044. That runway strengthens the long-term value of the franchise, particularly as we expand into frontline AML and combination settings. Our strategy extends well beyond the initial approval. Enrollment is underway in our pivotal COMET-017 frontline trials, and 2026 will bring important data in both the frontline and relapsed/refractory settings. We are positioning ziftomenib as a foundational combination partner in AML, including with FLT3 inhibitors and standard backbone regimens. Across relapsed/refractory and frontline AML, we estimate the total U.S. opportunity at approximately $7 billion. Beyond AML, we are advancing a focused solid tumor strategy. Our ziftomenib combination with imatinib in gastrointestinal stromal tumors, or GIST, is progressing in dose escalation, and our next-generation menin programs are advancing. Darlafarnib, our farnesyl transferase inhibitor, is designed to address resistance mechanisms across multiple oncogenic pathways. Its combination flexibility, including with cabozantinib, KRAS inhibitors, and PI3K inhibitors, gives it potential to impact more than 200,000 patients annually in the U.S. We expect multiple clinical updates this year. In short, we are executing commercially, expanding development of ziftomenib across the AML treatment continuum, and advancing a pipeline with meaningful catalysts in 2026. With that, I will turn it over to Brian.

Thank you, Troy. Good morning. Our commercial objectives for Comzifty are straightforward. Establish clear differentiation in the menin inhibitor class, deliver strong quarter-over-quarter growth, and achieve leading class share in relapsed/refractory NPM1-mutant AML. The early launch is exceeding expectations. I could not be happier with the execution of our world-class team, which has been laser-focused on delivering a strong launch. Prescription trends are strong, and the qualitative feedback has been consistent and encouraging. Physicians, both academic and community-based, consistently cite Comzifty's clinical activity and ease of use. Once-daily dosing and lack of required azole dose adjustments are meaningful advantages in real-world AML practice. Institutional pharmacists firmly echo this. In complex patients on multiple medications, safety and predictability drive confidence. We also hear clearly that the safety profile matters. Comzifty carries a single boxed warning for differentiation syndrome compared to multiple boxed warnings for a competitor. That difference is resonating. Importantly, Comzifty was added to the NCCN Guidelines as a Category 2A recommendation within a week of Kura Oncology, Inc.'s submission. That rapid decision reflects enthusiasm and strong alignment among clinical thought leaders. Operational execution has been strong. Comzifty was shipped within days of approval, and our experienced sales force, which brings an average of more than 20 years of industry experience and deep hematology expertise, was trained and fully deployed in partnership with Kyowa Kirin, targeting more than 4,000 hematology professionals. Our message is simple. NPM1 mutations are now actionable, and Comzifty offers a differentiated profile. Access has been a major strength and highlights a powerful leading indicator early in the launch. We engaged payers covering approximately 90% of insured lives prior to approval. Within 90 days, approximately 84% of private payers had established coverage aligned with the label and without additional restrictions. That speed of coverage surpasses both industry…

Thank you, Brian. FDA approval in relapsed/refractory NPM1-mutant AML was a major milestone, and it is just the beginning. We are building a durable, expanding franchise backed by the most comprehensive development strategy. Our goal is clear: make ziftomenib the foundational therapy across AML. We are executing the most comprehensive development strategy in the category. We expect to deliver multiple updates this year across key programs at major medical meetings, supported by an expanding publication plan. Relapse rates in AML remain high, up to 70% within three years. We believe deeper and more durable outcomes require moving therapies earlier in treatment. This drives our first-to-frontline strategy. We are rapidly advancing our registrational COMET-017 program in newly diagnosed AML, which will recruit patients at approximately 200 global sites. The program includes two independently powered trials, intensive and non-intensive chemotherapies, each designed to support potential U.S. accelerated approval and full approval. Data from the Phase 1 COMET-007 trial support this strategy. In newly diagnosed patients treated with 7+3 or venetoclax plus ziftomenib, we observed high CR rates and deep MRD negativity. Importantly, the addition of ziftomenib did not meaningfully delay platelet or neutrophil count recovery in either combination. We expect to present updated intensive chemotherapy data from COMET-007 in 2026. In parallel, we are preparing a manuscript detailing ziftomenib in combination with venetoclax in the relapsed/refractory NPM1-mutant AML setting. Data presented last December showed encouraging safety, tolerability, and clinical activity in this population. The combination was generally well tolerated without additive toxicity and meaningfully improved overall response rate, composite CR rate, and overall survival relative to ziftomenib alone. We view this as an important component of our strategy. We believe it has the potential to significantly improve outcomes in patients with relapsed/refractory NPM1-mutant AML. FLT3 co-mutations present another significant opportunity and one…

Thank you, Mollie. I am happy to provide a brief overview of our financial results for 2025. As we preannounced in January, our net product revenue from Comzifty sales was $2.1 million compared to none for 2024. The first commercial sale triggered a $135 million milestone payment under our collaboration agreement with Kyowa Kirin. Collaboration revenue from our Kyowa Kirin partnership was $15.2 million compared to $53.9 million for the same period in 2024. Research and development expenses were $64.4 million compared to $52.3 million for 2024. The increase was driven by ziftomenib combination trials, including the start of enrollment in our COMET-017 trial in 2025. Sales, general and administrative expenses were $39.1 million compared to $24.1 million for 2024. The increase was driven by the commercial launch of Comzifty. Net loss for 2025 was $81 million compared to a net loss of $19.2 million for 2024. This includes non-cash share-based compensation expense of $11.3 million compared to $8.6 million for the same period in 2024. As of 12/31/2025, Kura Oncology, Inc. had cash, cash equivalents, and short-term investments of $667.2 million compared to $727.4 million as of 12/31/2024. Our $667.2 million balance at year-end 2025 reflects fourth-quarter 2025 receipts of $195 million for the first commercial sale of Comzifty and COMET-017 enrollment milestone payments. Kura Oncology, Inc. is providing guidance for collaboration revenue, which reflects non-cash-based accounting recognition of performance obligations under our collaboration agreement with Kyowa Kirin. We 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. Current cash, cash equivalents, and short-term investments as of 12/31/2025, together with anticipated milestones of $180 million under our collaboration agreement with Kyowa Kirin, are expected to fund our ziftomenib AML program through the first top-line Phase 3 results from COMET-017, anticipated in 2028. With that, I turn the call back over to Troy.

Kura Oncology, Inc. enters 2026 with strong momentum. We have a launched product which is performing well. We have the broadest frontline AML development strategy underway. We have multiple data readouts ahead, and we have a second platform advancing in solid tumors. Our priorities are clear. Accelerate uptake of Comzifty in relapsed and refractory NPM1-mutant AML, deliver strong quarter-over-quarter product revenue growth, advance and execute on our first-to-frontline strategy, generate and publish combination data which guides treatment decisions, and deliver clinical updates across our FTI platform. 2026 will be a year of execution, expansion, and data. We are building a durable franchise in AML and a broader oncology pipeline with both breadth and depth. Everything is moving forward commercially, clinically, and operationally, and we are focused on converting that momentum into long-term value for patients and shareholders. With that, Abigail, we will conclude and open the call for questions.

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. Our first question comes from Li Watsek with Cantor Fitzgerald. Li, please unmute your line and ask your question.

Hey. Good morning. Congrats on the progress. Maybe a commercial question for Brian. You made a very interesting comment about step editing, that some payers may require use of Comzifty before the competitor product. I just wonder if you can give us a little bit more information about that. What percentage of payers have implemented this step-through policy? And any specific feedback you can share from payers regarding the status?

Yeah. Thanks, Li, for the question. I am going to, just to remind everyone, we are going to try to limit to one question per analyst so that we can get through everyone. But, Brian, I will let you—you know, there are two or three questions tucked in there. I will sort of let you speak to them.

Alright. Thanks, and thanks, Li, for the question. As we shared in the remarks, we think that this news of a step edit required from some payers that has just come forward is a powerful leading indicator that supports our overall assertion about Comzifty being differentiated. I will say that our market access team has done a phenomenal job securing access and working with payers so broadly to get this access so early. What I can share around the step edit, and as you know what that recommendation from some of these payers is, is that a patient would be recommended to receive Comzifty before receiving any other menin inhibitor. Our understanding is the basis of that is built on a report from a group called IPD Analytics. It is an independent consulting firm that is influential to many payers. And their recent reports evaluating Comzifty in relapsed/refractory recommended this step edit for adult patients with relapsed/refractory NPM1-mutant AML. We know that there are some payers that have started to implement that, as I shared. The biggest driver, from what we can understand from the consulting summary from IPD, is that the four pillars we talked about around the differentiation of Comzifty stood out, particularly because of the predictability of the cost. If you look at, based on their assessment, the annual WAC for Comzifty in this setting is just under $600,000 a year, but with our competitor menin inhibitor, because of the different dosing schemas and SKUs that come forward, it comes up to almost $1 million a year. And I think that is where we see they are driving the difference when you also add in the safety profile, the combinability, and the predictability of that. So I cannot really give you an overview of how many plans—there are a handful—and we cannot predict how many other plans may do this in the future, but it is encouraging for us as we look to become the class leader here in the NPM1 space. Thank you.

Next question comes from Roger Song from Jefferies. Please unmute your line and ask your question.

Congrats for the update and the very encouraging early launch signal. So the step edit is certainly very interesting. Maybe just given the access is very rapid and broad, can you comment on the patient demand side versus the revenue generation? If anything you can comment on the trend for the rest of the year, that would be helpful. Thank you.

Thanks, Roger. I am happy to do that. We are not going to be giving guidance specifically on the trend. What we can tell you is that the launch has been off to a very strong start. We are seeing patient demand. The feedback we have heard from physicians has echoed back the differentiation pillars that we have talked about. Payers, physicians, and pharmacists have all given us similar feedback. So what we anticipate, as we get into our next quarters, we will start to see a little bit more data we will be able to share around new patient starts and other things. I can tell you that the demand has been strong and that we have been pleased with the direction that the launch has gone so far. Action. Thank you.

Our next question comes from Jonathan Chang with Leerink Partners. Jonathan, you may now unmute and ask your question.

Good morning. This is Albert Augustines on for Jonathan Chang. Thank you for taking my question, and congratulations on all your progress. So my question is, what do you see as the biggest hurdle now for Comzifty to gain market share in 2026? Is it just prescriber inertia or something else? Thanks.

Thanks, Albert, for that. We anticipate that the NPM1 market is a market that is really going to be driven on new patients coming forward and incident patients, as they are diagnosed into or progress into second-, third-, and fourth-line settings. So it really will come down for us to getting those patients into our queue. One element of this market that is a bit unpredictable for us, as you well know, is that we are approved in a monotherapy setting. That is where our teams are going to be promoting. But we have heard a lot from physicians that they are looking to use menin inhibitors and Comzifty in combination. That will be one of the questions for us to understand—how that uptake comes up in the combination setting. That will be something we will be able to see coming forward in the future. We do not see payer hurdles; the payer hurdles have been really nonexistent. We are very pleased with how quickly our uptake has been getting on policies. So we do not really see any major hurdles other than just getting those incident patients onto therapy.

Yeah. Albert, this is Troy. I might just add a comment or two to Brian’s response. This is why we have laid out, in our milestones for 2026, the significance of the publication in relapsed/refractory NPM1-mutant AML with venetoclax that Mollie mentioned, as well as the combination with gilteritinib. As Brian mentioned, this is a very different market than KMT2A. We are obviously going to have the sales team promoting on-label with monotherapy. But what is clear, and I think will continue to be clear, is the ability to combine—the ability to drive better outcomes for patients—is ultimately going to be of great value. And it is what we see. It is why we feel confident that we are going to take leadership not only of the NPM1-mutant class, but ultimately of the much larger opportunity. Because it is going to be about combinations. Those attributes that Brian mentioned that were highlighted in the IPD Analytics report become ever more important as you move into combinations. Just to make an example, we are well ahead of the competition in terms of combining with FLT3 inhibitors. As you know, that is half of the NPM1 population. So it is an important part of our leadership strategy. Thank you.

Your next question comes from Salim Syed with Mizuho Securities. Please unmute and ask your question.

Great. Thanks so much, guys. Congrats on the progress. Just one from us on the 50% that you noted here, Troy. Market feedback suggests you get up to 50% of AML patients here. We are targeting just—what are the assumptions that you put in front of these doctors when you are doing your market feedback work? Is it just based on the existing data, or is there something that you are still planning to get to that leads you to that leading share, as you put it?

And, Salim, I take from your question you are referring to the relapsed/refractory segment—is that where your question is?

Correct, correct.

Yeah. I will ask Brian to speak to that. Thanks for the clarification. Brian?

Absolutely. We have gotten feedback both from physicians and from physician market research as well. We basically provide the profiles of the products. It is blinded. We do not ask them which company; they do not know who is asking the questions. Of those who have had familiarity with the menin class, the profile that we have outlined has come back as the preferred profile, across efficacy, safety, simplicity, combinability, and compatibility of working with other agents. That is the feedback we have heard that gives us confidence that as we build into this market, we will have an opportunity to become the market leader and take the lead share in the menin class.

And I will just add to that, Salim. At this point, we are not really talking about FLT3 in terms of doing the market research. This is really focused on the monotherapy. But one of the differences between this market and the KMT2A market is, obviously, if you have an FLT3 mutation, gilteritinib has a survival advantage. And so it is reasonable to assume a menin inhibitor is going to be sequenced after gilt. If you can demonstrate, as Mollie indicated, that you can safely combine and that that is beneficial to the patient, that is going to ultimately drive a next leg within that relapsed/refractory segment. We are not really yet there with the physicians because we obviously have to do that with data. But that is what gives us the encouragement. Today, it is monotherapy. Tomorrow, it is the combination with venetoclax. The day or two after tomorrow, it is the FLT3 combination. And it just builds one after the other.

Got it. Super helpful. Thanks so much, guys. Sure.

Your next question comes from Reni Benjamin with JMP Securities. Please unmute and ask your question.

Hey, good morning, guys. Thanks for taking the question, and congratulations on the early launch. Hopefully, it is going well for 2026. You talked a little bit—Mollie talked a little bit—about the combination of quizartinib and gilteritinib and the FLT3 opportunity. Can you talk a little bit about what you are hoping to see in your FLT3 data and how important is maximizing the FLT3 opportunity when we are thinking about the potential $7 billion TAM for ziftomenib? Thanks.

Yes. Thanks for that question. The most important thing you can see when you look at our combination data is going to be safety—safety indicating that you actually can combine. And obviously after that, looking to improve upon the agents in isolation. As I said, we will be presenting our relapsed data towards the end of the year. We will be presenting both the dose escalation and the expansion, which should tell you that we were able to combine the drugs successfully and safely for these patients. With the frontline, we are in the process of dose escalation with quizartinib in combination with ziftomenib plus 7+3. And again, that continues to advance. Overall, we expect to be able to show you not just the fact that we can combine, but that we can improve upon the outcomes of these drugs in isolation.

And, Ren, just to build on Mollie’s comments, we have seen commentary recently from Astellas that has identified gilteritinib as one of their blockbusters, one of the five sort of emerging blockbusters. They have a frontline trial that was conducted with HOVON that is expected to read out any day now. As we said, FLT3 is a third of all AML patients. It is hard to imagine you can have a market leadership strategy without including FLT3. That is why we are combining with both quizartinib and gilteritinib. You will see us over the next quarter or two move more aggressively into the FLT3 frontline setting, because we have not really yet broken it out, but that will be a major driver in that $7 billion TAM as you look across all lines of therapy.

Perfect. Thanks very much, guys.

Your next question comes from Charles Yu with LifeSci Capital. Please unmute and ask your question.

Hey. Good morning, everyone. Thanks for taking our questions, and congrats on all the progress. I will ask one on a slightly different topic, regarding RCC. We had a lot of updates from the recent ASCO GU conference, particularly in renal cell carcinoma, and some of the emerging HIF-2α—or emerging and approved HIF-2α—inhibitors in that space. Maybe could you help contextualize your upcoming second-half data for darla plus cabo, not only within the current standard of care, but also amongst the potential emerging standard of care as well? Thank you.

Sure. We are following that data very closely as well, and it is looking very good for patients. In fact, I think, as you are referring to, it is looking so good that it probably will end up moving up in line of therapy for these patients. We, as we announced, have just started our Phase 1b, which is a randomized Phase 1b, so that we can both contend with Project Optimus but also set some baseline data for ourselves with cabozantinib in this particular line of therapy. And we will be able to also see if patients that are randomized to the cabo monotherapy can cross over and successfully either gain or regain responses when you combine it with darlafarnib, which I think is an important demonstration of our mechanism of action. We do think that our data, as they are progressing—and we have limited follow-up time compared to some of these other studies—are still competitive with a lot of these data that are being presented, and we look forward to sharing that updated information with you. What we do think is, again, that these good outcomes for patients with HIF-2α inhibitors will move them earlier in lines of therapy, so you will see them in the frontline, and ultimately it can open a rather big vacuous space in the second line that we could then jump right into with this cabo–darlafarnib combination.

Got it. Thanks.

Your next question comes from Jason Zemansky with BofA. Please unmute and ask your question.

Good morning. Thanks so much for taking our question, and congrats on the progress. Brian, I was hoping you could share some of the early feedback from your prescribers that are new to Comzifty, maybe that have not been associated with any of your clinical programs or at least minimally associated. Recognize this is a small community and it is early days, but for those especially who have not participated in a trial associated with your rival or who do not have a large AML population, how has the product profile resonated? Thanks.

Thanks for that question, Jason. I would speak to it both from physicians we have heard from, but I would also point to pharmacists—the pharmacists that have maybe not been involved so much with treating the patients in the trials. The feedback that we have heard is that they recognize there are multiple menin inhibitors available. The efficacy, we have heard, seems to be table stakes, essentially. I think both products have similar efficacy. What really does stand out are the questions around how to manage QT, understanding what monitoring for QT prolongation means, and the potential implication of higher risk of cardiac issues, as well as the simplicity of treating patients once a day without having to do a lot of dose modifications based on the complexity of other therapies they have. So we have heard that. Of course, a lot of early scripts are probably going to be those for people who have had a lot of experience with us. But we have received feedback from physicians who are new to the menin class, and we have been spending our time educating them around Comzifty. As we said, it is early days, but we are pleased with what we are hearing so far, and it seems to be consistent with what we have heard from those who do have experience.

As a reminder, if you wish to ask a question, please use the raise hand button which can be found at the bottom of your Zoom screen. Our next question comes from Gustav on for Etzer DeRoute with Barclays. Please unmute and ask your question.

Hi. Good morning. This is Gustav on for Etzer. Thank you for taking our question. I would like to ask about COMET-008, guided to showing data in combination with gilteritinib in the back half of this year. Could you remind us where you stand with regards to combination of ziftomenib with FLAG-IDA and with low-dose cytarabine? Thank you.

Sure. As you said, we have been guiding to release the gilteritinib data because, in large part, we think that is very informative to physicians on how to treat the relapsed/refractory NPM1 mutants co-mutated with FLT3 as well. But also within that study are our FLAG-IDA combination, which sees mostly second-line patients, and our LDAC combination, which allows for an easy combination with ziftomenib that gives time for this differentiating agent to really take effect while keeping disease control simultaneously. We have not guided to when we will be releasing that data. But I do think that we will do it in pieces at a time to keep the information coming, and also be writing a publication. But again, we have not guided as to when those additional cohorts will be shared.

Your next question comes from Philip Nadeau with TD Cowen. Please unmute your line and ask your question.

Morning. Thanks for taking our question, and it was great to see the team this week in Boston. We have one commercial question. I think you suggested that the relapsed/refractory NPM1 market is about $300 million to $400 million in revenue. We are curious to hear how quickly you think the menin class can penetrate the market. Seems like the value proposition is pretty clear today, but we are wondering if there is any gating, like combo therapy data in particular, that could be necessary to fully penetrate the opportunity. Thank you.

Thanks, Phil, and thanks again—good to see you yesterday. As we have said, this TAM of $350 million to $400 million represents that relapsed/refractory space. We think, because of the dynamics of the NPM1 population, where physicians have previously had choices for their patients to either get venetoclax or an FLT3 inhibitor for those who are co-mutated, we anticipate that early on there will probably be more in the relapsed/refractory third- or fourth-line setting. Combinations will help to drive that into the second line, where you would be able to see more patients get therapy and benefit earlier. Our expectation is that there will be a lot of use as a monotherapy, but physicians are very excited about using in combination. It is not something we can promote on actively, but we will educate based on publications, like the venetoclax publication we plan to publish based on COMET-007. We anticipate there will be a ramp based on incident patients coming forward, probably starting more in the third/fourth line, but we will see, and we are starting to see, those second-line patients as well. We will need a little bit of time to get an understanding as to how Comzifty is being used in combination relative to monotherapy.

Your next question comes from David Dai with UBS. Please unmute and ask your question.

Great. Thanks for taking my question, and congrats on the quarter. Just one question on the duration of therapy. I understand early innings, but any thoughts on duration of therapy for Comzifty so far? And as you are thinking about combination with venetoclax or gilteritinib, how do you think the duration of therapy could evolve over time?

Great. Thanks, David, for that question. Obviously, we are sharing five weeks of data. We cannot really give you a lot of detail around duration of therapy at this point. Our expectation is that patients will be able to get therapy for, on average, six months. Our label suggests that patients are treated for up to six months to maximize the depth of their response. And for those patients who do get a response, we have seen duration of response of five months, and oftentimes it takes three months or so for them to achieve that deep response. We are not seeing any signs yet because it is too early. We are seeing repeat prescriptions, but it is too early to talk through any duration right now. To your question around FLT3 inhibitors, I think that any combination is expected to give a longer duration of treatment than you would expect as a monotherapy.

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

Thank you, Abigail. Thanks, everyone, for joining the call today, and thanks for all the questions. We will see many of you next week in Miami at the various events and conferences. If you have any additional questions, please reach out to Greg or me. We wish all of you a good morning and a good rest of the day. Thanks again.