Hello, and welcome, everyone, joining today's Second Quarter 2025 Kura Oncology, Inc. Financial Results Conference Call. Please note this call is being recorded. It is now my pleasure to turn the meeting over to Greg Mann, SVP of Investor Relations and Corporate Affairs. Please go ahead.

Thank you, Brittany. Good afternoon, and welcome to Kura Oncology's Second Quarter 2025 Conference Call. Joining the call today are Dr. Troy Wilson, President and Chief Executive Officer; Dr. Mollie Leoni, Chief Medical Officer; Brian Powl, Chief Commercial Officer; and Tom Doyle, Senior Vice President of Finance and Accounting. Before I turn the call over to Dr. Wilson, 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's filings with the SEC for information concerning risk factors that could affect the company. With that, I'll turn the call over to Troy.

Thank you, Greg. Good afternoon, and thank you all for joining us. At Kura, we're committed to transforming outcomes for patients with AML. Today, we'll provide updates on our global development progress for our lead program, ziftomenib, the regulatory status of our new drug application, preparations for commercialization with our partners at Kyowa Kirin, and advances in our pipeline, including menin inhibitors for treatment of GIST and diabetes, as well as farnesyl transferase inhibitors or FTIs for solid tumors. Starting with development, we were thrilled to present positive monotherapy data from the KOMET-001 trial at ASCO. Ziftomenib showed promising results in relapsed or refractory NPM1-mutated AML, offering hope for this heavily pretreated population. We're also encouraged by ziftomenib's consistent safety and tolerability profile in this setting. We were pleased to announce the FDA accepted our NDA for ziftomenib in adults with relapsed or refractory NPM1-mutant AML, granting priority review with a PDUFA target action date of November 30, 2025. We're encouraged by the FDA's engagement and are focused on achieving a successful review outcome by our PDUFA date. In the frontline setting, we reported updated combination data for ziftomenib with intensive chemotherapy in newly diagnosed AML at EHA. These results highlight ziftomenib's potential as an early intervention, offering a meaningful opportunity to improve patient outcomes. Building upon the EHA data, as well as emerging data for ziftomenib combined with venetoclax and azacitidine, which we plan to share later this year, we're accelerating development of ziftomenib in frontline AML. Toward this end, we are in study start-up for the two Phase III frontline trials under the KOMET-017 protocol. Along with the opportunity to treat FLT3 mutant AML patients, these two Phase III trials could open up the opportunity to impact up to 50% of patients with AML. Mollie will expand on our development activities for ziftomenib later in this call. On pre-commercial activities, we're actively preparing for potential approval by building commercial supply and quality systems, advancing pre-approval inspection readiness for CM&C and manufacturing, and recruiting and training our sales force, as well as collaborating with our partner, Kyowa Kirin, on launch planning. Our partnership with Kyowa Kirin continues to bolster the global development and commercialization of ziftomenib. We're aligned on advancing both relapsed/refractory and frontline programs, and we value our shared commitment to bringing ziftomenib to patients. Beyond menin inhibitors, we're making strong progress with our fully owned next-generation farnesyl transferase inhibitor, KO-2806. We're excited to announce three clinical abstracts from our FTI program have been accepted for presentation at the 2025 ESMO Congress. Mollie will share more details on the upcoming presentations a bit later. We're also thrilled to welcome Greg Mann to our leadership team as our Senior Vice President, Investor Relations and Corporate Affairs. Greg brings extensive biotechnology and pharmaceutical experience with a proven track record of strategic communications and investor engagement, fostering strong relationships with analysts, investors, and key stakeholders. As of June 30, 2025, Kura had $630.7 million in cash, cash equivalents, and short-term investments. Under our Kyowa Kirin collaboration, we stand to receive up to $375 million in additional near-term milestones, including significant milestones tied to the initiation of our Phase III frontline trials and the first commercial sale of ziftomenib in the relapsed/refractory setting. As our data continues to demonstrate, we believe ziftomenib represents a potential best-in-class menin inhibitor for AML and GIST. And with our current cash reserves and anticipated milestones, we're well funded to become the market leader, continue to advance our ziftomenib AML program through to commercialization in the frontline setting, and drive our pipeline to multiple value inflection points. With that overview, let's dive in, starting with ziftomenib. I'll turn it over to Mollie to highlight our development activities.

Thank you, Troy. Let's begin with highlights from our ziftomenib development program. At ASCO 2025, Dr. Eunice Wang of Roswell Park presented data from the KOMET-001 trial evaluating ziftomenib monotherapy in 92 heavily pretreated relapsed/refractory patients with NPM1-mutant AML. The trial achieved a CR/CRh rate of 23%, surpassing historical controls, with consistent activity across prespecified subgroups, including those with prior transplant, prior venetoclax, those with numerous prior therapies, and those with FLT3 or IDH co-mutations. At the time of the data cut, 63% of responders were MRD negative. Ziftomenib's consistent safety and tolerability profile, including effective management of differentiation syndrome, low rate of myelosuppression, lack of clinically significant QTc prolongation, and absence of drug-drug interactions underscores its favorable benefit-risk profile for patients with relapsed/refractory NPM1-mutated AML. We're progressing through regulatory milestones for our NDA submission, including information requests and pre-approval inspections, in line with timelines for priority review. As Troy noted, our interactions with the FDA remain collaborative and constructive. Ziftomenib's favorable safety profile supports its broad use in combinations in both the relapsed/refractory and frontline settings. KOMET-007 and KOMET-008 are evaluating ziftomenib in combination with various standards of care in patients with both newly diagnosed and heavily pretreated disease. At the 2025 EHA Congress, Dr. Harry Erba of Duke University presented Phase Ia/Ib data from the KOMET-007 trial testing ziftomenib at a 600-milligram once-daily dose plus intensive chemotherapy in newly diagnosed NPM1-mutant and KMT2A rearranged AML. Despite available therapies, it's important to remember that up to 70% of AML patients relapse within three years, highlighting a substantial unmet need, and only one-third are alive at the five-year mark. KOMET-007 data were highly encouraging, with rates of complete remission and MRD negativity across the 7+3 cohorts and a safety profile consistent with previous reports. The safety profile observed with ziftomenib in combination with intensive chemotherapy was similar to what is expected in patients treated with 7+3 alone. Ziftomenib's continuous daily dosing was maintained through count recovery and consolidation therapy, as well as maintenance without delaying neutrophil or platelet recovery or causing any additional myelosuppression. A single case of Grade 3 differentiation syndrome in a patient with KMT2A rearranged AML was successfully managed. Composite complete remission rates were 93% for patients with NPM1-mutant and 89% for KMT2A rearranged AML. Complete remission rates were 84% and 74%, respectively, at the time of this data cut. 96% of NPM1-mutated and 88% of KMT2A rearranged patients remained alive and on study with a median follow-up of 25 and 16 weeks, respectively. MRD negativity was achieved in 68% of NPM1-mutant and 83% of KMT2A rearranged patients with a composite CR at medians of 4.7 and 4.1 weeks, respectively. We anticipate presenting preliminary clinical data from the KOMET-007 trial evaluating ziftomenib at a 600-milligram dose with venetoclax and azacitidine in both newly diagnosed and relapsed/refractory AML patients in the second half of this year, potentially at ASH. Last quarter, we broke new ground, aligning with the FDA and EMA on the KOMET-017 protocol, which comprises two independent, randomized, double-blind, placebo-controlled Phase III trials. The first is KOMET-017-IC, which is ziftomenib with 7+3 intensive chemotherapy, and the second is KOMET-017-NIC, ziftomenib with venetoclax and azacitidine or non-intensive chemotherapy. FDA alignment on the use of MRD-negative CR and CR as dual primary endpoints for accelerated approval in both trials could substantially shorten development timelines. The single protocol design streamlines trial startup and is attractive to clinical sites because it accommodates nearly all eligible frontline patients. KOMET-017 is now in study startup and on track for initiation in the second half of this year. Turning our attention to ziftomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors or GIST. Approximately 4,000 to 6,000 new cases of GIST are diagnosed each year in the United States, and advanced GIST patients have limited treatment options. Imatinib, the current frontline standard of care for advanced GIST, targets KIT via tyrosine kinase inhibition, but resistance often develops due to secondary KIT mutations. The KOMET-015 trial will be combining a dose escalation to evaluate the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib in adults with GIST who are currently on or have previously been treated with imatinib. We're advancing in dose escalation, and we will share clinical data updates as it becomes appropriate. Progress also continues in our next-generation menin inhibitor program for diabetes. We see strategic potential to expand menin inhibition to diabetes and cardiometabolic disease. We've nominated a next-generation development candidate for diabetes, and we'll share development plans and timelines in a future update. Moving now from menin to our FTI development programs. Our FIT-001 trial evaluating our next-generation farnesyl transferase inhibitor, KO-2806, is progressing significantly. Our innovative approach combines FTIs with targeted therapies to overcome resistance and enhance response durability, reshaping the FTI story and expanding the use of these combinations. As Troy mentioned, three clinical abstracts from our FTI program were accepted for presentation at the 2025 ESMO Congress, covering KO-2806 with cabozantinib in renal cell carcinomas, KO-2806 monotherapy in advanced RAS-mutant solid tumors, and tipifarnib and alpelisib in patients with PIK3CA mutant head and neck squamous cell carcinoma. We plan to host a virtual event in concordance with the ESMO Congress in October to discuss the emerging clinical data, and we'll share more details ahead of that conference. We're also evaluating KO-2806 and adagrasib in patients with KRAS-G12C mutant solid tumors and are already encouraged by the data being generated in dose escalation. We will look to share data from this combination likely next year. And with that, I'll turn it over to Brian to discuss our commercial readiness activities.

Thank you, Mollie. With the ziftomenib PDUFA date of November 30 well in sight, our pre-commercial activities continue at a brisk pace. We're confident Kura's commercial organization will be fully prepared for launch ahead of potential approval. As Mollie noted, the KOMET-001 and KOMET-007 clinical data were well received by the clinical community. We're encouraged by positive feedback from the KOLs highlighting four key aspects of ziftomenib in the relapsed/refractory setting. First is efficacy: strong CR, CRh rates, and durable responses in heavily pretreated patients with overall survival among responders exceeding the KOLs' expectations. Second, simplicity: the once-daily dosing facilitates adoption and integrates seamlessly into patient care, benefiting both providers and patients. Third, compatibility: no clinically meaningful drug-drug interactions with CYP3A4 inhibitors enable combination with antifungals or other concomitant medications. And fourth, safety: the low rates of QTc prolongation eliminate the need for burdensome weekly cardiac monitoring and alleviate concerns about combining with other agents known to prolong QT. This KOL feedback reinforces ziftomenib's potentially best-in-class profile in the relapsed/refractory space and their enthusiasm for its use in combination with frontline standard of care therapy in patients with newly diagnosed AML. On commercial readiness, our team is focused on raising awareness about menin inhibition in NPM1-mutated AML, ensuring access, and upon approval, communicating ziftomenib's best-in-class potential to accelerate adoption and build trust with patients and providers. Our medical affairs and market access teams are fully staffed to engage thought leaders, payers, and group purchasing organizations or GPOs. We're executing educational initiatives on disease awareness and menin inhibition in NPM1-mutant AML alongside ongoing pre-approval information exchanges with key stakeholders, including payers, GPOs, and other market decision-makers. We've recently onboarded our sales team, selected through a rigorous nationwide screening process. The group has deep experience in hematology/oncology, with an average of 21 years of experience in sales and over 7 years of average experience in hematology. As they deploy, they will work alongside the experienced Kyowa Kirin U.S.-based field team. As the lead party in the U.S., we are building capabilities across commercial functions while working collaboratively with Kyowa Kirin on field operations, account planning, training materials, and team building. Our market access, trade, and distribution team has identified patient support needs and is designing programs to help eligible patients navigate their treatment journey. Finally, we are implementing a focused distribution network to maximize ziftomenib access at oncology centers, enhance provider satisfaction, and drive early uptake to ensure a rapid launch of ziftomenib upon FDA approval. Together with Kyowa Kirin, we are confident in our commercial readiness and ability to deliver ziftomenib to eligible patients at launch. The relapsed/refractory AML population is our initial market entry and a critical step toward building a successful commercial product. Ziftomenib's potential best-in-class profile in NPM1-mutant AML gives us confidence in capturing robust market share in this high unmet need population. We estimate the total addressable market for NPM1-mutated relapsed/refractory AML is between $350 million to $400 million annually, driven by a patient population that can reach up to 30% of relapsed/refractory AML patients who could benefit from an average of 6 months of treatment. Ziftomenib's efficacy, safety, tolerability, and convenience position it for market leadership share in this setting. Our launch planning for the NPM1-mutated relapsed/refractory AML market lays the groundwork for the substantial opportunity we see in the frontline AML space. For transformative impact, a therapy must deliver deep durable responses to the maximum number of patients with a tolerable profile for extended use. Ziftomenib's data, unhindered by complex dosing, excessive myelosuppression, or burdensome monitoring, supports its potential best-in-class profile. Of the 22,000 newly diagnosed AML cases in the U.S., we believe menin inhibitors can reach 50% of patients where the KMT2A pathway is a driver of their disease. This includes both NPM1-mutated and KMT2A rearranged patients. Our comprehensive development plan is designed to address multiple populations where patients may benefit from ziftomenib for 12 to 24 months or more, leading to a total addressable U.S. market potential of over $7 billion per year. I will now turn it over to Tom to provide the second quarter financial highlights.

Thank you, Brian, and good afternoon, everyone. Collaboration revenue from our Kyowa Kirin partnership for the second quarter of 2025 was $15.3 million compared to no revenue for the second quarter of 2024. Research and development expenses for the second quarter of 2025 were $62.8 million compared to $39.7 million for the second quarter of 2024, driven by spending on our ziftomenib combination clinical trials. General and administrative expenses for the second quarter of 2025 were $25.2 million compared to $16.7 million for the second quarter of 2024. This increase was predominantly due to pre-commercial activities. Net loss for the second quarter of 2025 was $66.1 million compared to a net loss of $50.8 million for the second quarter of 2024. This included non-cash share-based compensation expense of $6.9 million compared to $8.4 million for the same period in 2024. As of June 30, 2025, Kura had cash, cash equivalents, and short-term investments of $630.7 million compared to $727.4 million as of December 31, 2024. Based on our current plans, we believe that our cash, cash equivalents, and short-term investments as of June 30 will be sufficient to fund our current operating expenses into 2027. If we include anticipated collaboration funding and milestones under our Kyowa Kirin agreement, Kura's financial resources should support advancement of our ziftomenib AML program and commercialization in the frontline combination setting. I'll now turn the call back over to Troy for final comments.

Thank you, Tom. Before we jump into the question-and-answer session, let me just lay out our anticipated upcoming milestones. For ziftomenib and our menin inhibitor programs, we look forward to continued engagement with FDA reviewers as we approach our PDUFA target action date of November 30 for ziftomenib as monotherapy for patients with relapsed/refractory NPM1-mutant AML, initiating KOMET-017, our two independent Phase III registration-enabling trials in frontline intensive and non-intensive AML in the second half of 2025, and presenting preliminary clinical data from the KOMET-007 Phase Ib expansion cohort evaluating ziftomenib with venetoclax and azacitidine at a medical meeting in the second half of 2025. For our farnesyl transferase inhibitor programs, we expect the following milestones: to initiate one or more expansion cohorts of KO-2806 in cabozantinib in patients with advanced renal cell carcinoma in the second half of 2025. We also plan to have a strong presence at the 2025 ESMO Congress this October with three presentations: data from the FIT-001 Phase I monotherapy dose escalation of KO-2806 in patients with RAS mutations; data from the FIT-001 Phase I trial evaluating KO-2806 and cabozantinib in patients with renal cell carcinoma; and finally, data from the KURRENT-HN trial evaluating tipifarnib and alpelisib in PIK3CA-mutant head and neck squamous cell carcinoma. As Mollie mentioned, we expect to host a virtual event around the time of the ESMO Congress in October to discuss the clinical data for our FTI programs; more details and a safety date to come. With that, Brittany, we're now ready for questions.

Our first question comes from Jonathan Chang with Leerink Partners.

A couple. First, can you give us some color on how the regulatory interactions on ziftomenib have progressed as we look towards the PDUFA date later this year? And then second question, how are you thinking about the scope of the farnesyl transferase inhibitor opportunity? Between the possible combinations and tumor types, what do you see as an area or areas that Kura can move forward with alone? And which do you see as areas better suited for a potential partner?

Jonathan, thanks for the questions. Let's take them in turn. With respect to any additional color on the regulatory interactions, Mollie, would you like to comment to the extent that we can?

Yes, sure. And as Troy is alluding to, we're currently within our active NDA review. And so we can't really provide details about every evolving interaction with the FDA, but the interactions have all been collaborative. They've been very constructive, a lot of back and forth. And everything we've seen to date is in alignment with the timeline for a priority review with an approval of November 30. So again, we're very encouraged by the way things have progressed thus far.

Yes. Thanks, Mollie. And Jonathan, on your second question, maybe I'll take a crack at it. And then again, I'll ask Mollie to add her comments. As she said in her prepared remarks, what I think you're going to see is really a reshaping of the FTI story. So we're showing you data not only with 2806 as a monotherapy, but in two of the three possible opportunities. So renal cell carcinoma, where there's obviously been a lot of activity with HIF-2 alpha and TKIs, as well as PI3-kinase alpha, where again, we've seen work from Scorpion, from Relay, and really a lot of interesting opportunity. The third one where hopefully, we'll have something to share next year is, of course, in the KRAS space. And we've put out a lot of preclinical data that's available on our website. You'll see us set the context and I think help analysts and investors set expectations as we get closer to ESMO. But suffice it to say, with each of these areas, RCC, PI3 kinase, and KRAS, they all have the common problem of innate and adaptive resistance. That's what we're looking to address, and we're looking to share further data with you. Mollie, anything you'd add to that?

No, that was a good segue. I was actually going to comment that not only does this reshape the FTI field, it also reshapes these other targeted agents, as we look to prevent or prolong these patients' ability to respond to these drugs. There's no reason to think that the results from one particular combination wouldn't be generalizable to similar drugs in the same class. So we're very excited to see where this leads.

Congrats on the progress. Maybe a little curious about your thoughts on the menin class launch so far. It looks like even in KMT2A patients, the market opportunity could be quite sizable. Any read-through to your own launch of ziftomenib? And then in terms of Phase III trial starts in the second half this year, wondering if you can elaborate a little bit more in terms of the progress that you made since last quarter and your confidence that you could still potentially be first-in-class in the frontline?

Yes. Lee, thanks for the questions. Again, let's take them in turn. So Brian, could you address Lee's first couple of questions, which is our impression of the KMT2A relapsed/refractory market opportunity and some of the results we've seen from some of our competitors, and perhaps any read-through to our own thinking or our own program?

Thanks, Troy, and thanks, Li, for the question. Yes, I think we've obviously been watching closely, as you have, on understanding the launch, first launch in the KMT2A space of the menin class. I mean I think our first impression is that it's great news for patients that there is a new class of therapies available that could help to target a broader range of patients with a high unmet need. The KMT2A population has, as we know, is a smaller population in incidence relative to the NPM1-mutated population. I think we're encouraged to see the preliminary uptake and activity of our competitor. When we think about what that means as we read it through into ziftomenib, first, we understand that this will be a competitive space. We feel pretty confident, as we mentioned in our prepared remarks, that ziftomenib has the properties that we believe have the potential of being best-in-class as their profile across both efficacy, safety, combinability of the drug, and also convenience. We think that as we bring or hopefully get to our FDA approval, our commercial, medical, and market access teams will be able to quickly begin communicating and be competitive in this space, where we see a very high unmet need for this population who are in need of new therapies.

Thanks, Brian. And Mollie, for you on the second question, I'm just going to restate it. Looking at the Phase III starts here in the second half of the year for KOMET-017, can we elaborate on the progress since the last quarter? And what gives us confidence we'll be potentially first and best-in-class in those combinations?

I would like to highlight what the 007 data has revealed. It has shown the significant need for this patient population, the speed at which these patients enroll, and the eagerness of these sites to have dedicated trials for these types of AML. With 017, we have combined both trials under a single protocol. This simplifies the process for every site and every IRB by allowing them to go through one contracting process instead of multiple negotiations, eliminating the need to choose between trials. Opting for our 017 trial provides access to two trials simultaneously. We are receiving a lot of enthusiasm from our sites that want to participate. We're making substantial progress, although starting a study takes time as we need to finalize all contracts. However, progress is being made quickly, and I am confident that we will initiate the trial in the second half of this year. I am also confident that the enrollment numbers will be impressive and will help us achieve the additional high-level data we have discussed for 2028. Importantly, this will provide almost any patient with a KMT2A or NPM1 mutation a pathway for their frontline treatment. I believe the potential patient population we can address will be vast, and I am looking forward to strong enrollment and a wide patient base for the 017 trial.

Great, congrats for the progress. So seeing your upcoming milestone, you talked about the RCC expansion cohort since you already made the decision. If that's the case, what's the criteria for the expansion cohort? And then what will be the next step in timing for JAK2 and then KRAS and the program? And then second question relates to regulatory interaction. Given all the changes within the FDA, have you had any recent interaction with the FDA regarding your Phase III pivotal design? And I understand you're about to start, but any last minutes kind of feedback you're getting from the FDA?

Yes. Roger, if we may, Mollie is going to answer both of those questions. Mollie, maybe we can take them in reverse order. Let's start with the first one, which is any recent interactions with the agency on the Phase III designs for KOMET-017.

No, and thank you for that. No, it's the usual interactions, just making sure we're all in agreement on even the nitty-gritty. But overall, it was agreed to back months ago what the design would be, and now it's really just operationalizing. There hasn't been any additional concern or additives by people coming or going from the FDA. So all is holding pretty steady for us.

Yes. To expand on Mollie's comment, this isn't a new concept in oncology. When the agency provides a pathway for accelerated approval, whether it’s for monotherapy or combination therapy, the expectation is that you'll follow up with data. What may be different in this case is the acknowledgment in AML that it is not always in the best interest of patients to wait for survival endpoints. Therefore, the FDA is open to considering accelerated approval pathways. Mollie and her team have been very effective in coordinating with the FDA on this. From our perspective, everything is on track. Mollie, regarding the first question, it's probably a bit premature, but Roger asked about our decision-making process for RCC for KRAS. Can you share some insights on that? I recognize it's still early in the process.

Yes, it's early. I'll focus on RCC because that's probably the easier story to explain at this point. So we're going through our dose escalation, of course, and we had our go/no-go criteria that we established prior to starting the study. I will say that we've not really shared publicly our go/no-go criteria, but we had no problems in meeting that. Currently, when we talk about our expansion cohort, it's really with the thought of correctly fulfilling Project Optimus and giving them the data that they want. So we will expand out to at least two doses and look to see which dose is best tolerated and most efficacious at the same time. At that time, obviously, we will look for convincing data that you're seeing more than just cabo monotherapy activity, which these patients that have already failed cabo shouldn't be too hard to demonstrate. Similarly, with adagrasib, as we keep on with the dose escalation, we'll probably proceed in a very similar fashion.

Congrats on the progress. Maybe a high-level question for you, Troy. Now that the die has been cast regarding timelines, so to speak, can you speak to some of the puts and takes regarding the commercial dynamics in the relapsed/refractory NPM1 setting? How much is your competitors' first-to-market advantage and current inroads as a hurdle? I mean, ultimately, how quickly do you think you can overcome any residual or at least initial physician inertia here? And then maybe secondarily, what are your expectations regarding the evolution of NCCN guidelines for the class, whether they include zifto specifically or sort of just reference the larger menin inhibitor class?

Yes, Jason, thank you for your questions. I will start with a few general comments and then ask Brian to address your inquiry. To summarize your question, it seems to focus on the significance of having a first-mover advantage. From what we are observing, the situation appears favorable for patients. There has been considerable interest and uptake in menin inhibitors. As we have mentioned, ziftomenib is poised to be a leading option, particularly for NPM1-mutated AML, and we believe it will also be competitive in the KMT2A rearranged subset when used in combination therapies. Patients in these categories are in urgent need of treatment options, and we are excited to provide those opportunities. Brian will now discuss the feedback we have received from key opinion leaders and the positioning, after which we will return to your question about the NCCN guidelines. Brian, could you expand on my remarks?

Sure. Thanks, Troy, and thanks, Jason, for the great question. Yes, as Troy mentioned, we've been focused on establishing our presence and securing our first approval in this market. We're pleased that patients will have multiple options available to them. Our team has been preparing for the last two years, engaging with key opinion leaders through our medical science liaison team. Over the past year, our market access team has been actively interacting with payers via pre-approval information exchanges, and we are building a solid reputation among these groups. This foundation has largely been built on the strong reputation that Mollie and her team have developed through their efficient execution of clinical trials and their successful partnerships with U.S. physicians. We acknowledge that there may be competition with potentially two approved agents in this space, but we are confident in ziftomenib's profile and believe we will quickly connect with physicians upon its approval. Our sales teams will begin profiling once they complete their training in the lead-up to approval, allowing them to engage on Kura's behalf. We believe we are taking all the necessary steps for success, and while there may be initial awareness from competitors, the high demand and enthusiasm for ziftomenib suggest that we will be well-positioned once we receive approval.

Thanks, Brian. Brian, do you want to just add to that and address Jason's second question, which is around how do we think about the evolution of the NCCN guidelines? Is it menin as a class? Is it ziftomenib-specific? Any color you want to give?

Yes, absolutely. I mean I would say at the highest level, Jason, since we only have external visibility to what the NCCN AML committee does, we can't really comment as to when they will be addressing the NPM1-mutated population. Our intent within our team is as soon as our data are published and we have our approval, we'll be submitting the application to NCCN for consideration on the guidelines as soon as possible. It's one of those key early launch metrics that we'll be putting towards to get ziftomenib on those guidelines. Mollie, would you want to add anything else to that?

Yes. I thought the question about whether they would list out individual drugs or menin as a class is an interesting one. I mean, obviously, we don't know, but as we are the only two companies that will really have strong data packages already produced, I would think, at least for the foreseeable future, it would be named menin inhibitors in the guidelines rather than just a class.

Congrats on such an exciting quarter. I'm just wondering what you think are the biggest potential risks to the pivotal program timelines, if there's anything that could potentially push initial data out past 2028. And then is there any risk to running combined studies with both the KMT2A population and the NPM1 population?

Yes. Thanks, Ellen, for the questions. Mollie, do you want to speak to that risks to timelines sort of getting extended or risks to running the blended populations?

Yes. I mean, obviously, we can't predict the future. And if something really unexpected happens, obviously, it could push out the readout dates. But we're very, very conservative. So we only released that 2028 date when we felt very confident in our ability to be able to meet it. With regards to the mixing of the populations, again, I will go back to our 007 trial. It has taught us so much. We understand what these patients now look like in these settings to a great extent with very robust data sets. So the mixing of the populations doesn't frighten us. And we've obviously approached it from many different scenarios to make sure that this was the appropriate way for us to proceed as a company. So 007 really was the best building block for this big trial.

I joined late, so I apologize if the question has already been asked just around about your FDA dialogue, how that's proceeding, if it's changed in frequency or any emphasis that's changed around that? And the second question would be around importance of the AML maintenance setting. And do you think you have the ability to kind of capture that market as well?

Yes, Peter. Mollie, can you just maybe summarize the FDA dialogue for Peter?

Sure, sure. We're under active review. We are regularly interacting, as you would expect, being on a priority review timeline. We really haven't seen any change in the quality, the quantity, or the frequency of interactions with the agency. So things have been progressing as expected.

And then, Mollie, maybe you can take the second question around how one thinks about maintenance, and then Brian, I'll probably ask you to build on that from a commercial perspective. But Mollie, do you want to start?

In our 001 trial, we're not aiming for a maintenance indication, but there are expectations for its use in that context. Our 007 trial has provided significant insights. While most NPM1 patients in the frontline setting typically do not require a transplant, those who do often return to a maintenance protocol, and KMT2A patients are particularly likely to re-enter trials. Therefore, the maintenance indication included in the 017 design will be very beneficial for properly addressing that patient population.

Thank you, Troy. To expand on that, we believe that from a commercial perspective, a significant portion of post-transplant maintenance or extended non-post-transplant care will likely be seen in the newly diagnosed group. As KOMET-017 progresses, we see potential for extended treatment durations in both the IC and non-IC settings, which could result in 12 to 24 months of continuous therapy for patients. In the relapsed/refractory area, based on market observations so far, KMT2A may have more patients opting for transplant compared to the older group of NPM1-mutated patients in the relapsed/refractory setting. We're monitoring this closely as we anticipate a lower transplant rate among those relapsed/refractory NPM1-mutated patients. Our objective remains clear: to initiate therapy for patients and ensure they remain on it for an extended period.

This is Peter on for Charles. A couple of questions from my end. First of all, for the 2806 data in RCC at ESMO this fall, just wondering if you could provide some color on patient baselines, how heavily pretreated rates of prior cabozantinib exposure? And then second question, as you're looking down the nose of approval in relapsed/refractory NPM1 for ziftomenib, just wondering what your plans are, if any, for additional data disclosures in that setting, for example, at ASH or in a journal release? Congrats on all the progress.

Thanks, Peter. Mollie, do you want to take those questions? I mean we don't want to go into too much detail, but any additional color we can give on RCC?

That's exactly what I would say is I don't want to preempt the abstracts, but they will be sharing all of that data with you. But you can expect a typical Phase I patient population where initially it could be you are most heavily pretreated and then as investigators feel more comfortable, you come further and further in line. So you'll see a variety of patients at baseline.

Great. And Mollie, what about Peter's second question about any additional disclosures on the monotherapy, it could be the KOMET-001 study for people to look forward to?

You should expect a publication within the coming months.

This is Eric on for Salim. I just wanted to get your thoughts on potential launch ramp as you get into relapsed/refractory NPM1-m given what we've seen with the KMT2A launch here recently. And given that there was no really good reason to expect any warehousing of patients with KMT2Ar in relapsed/refractory, but might there be a bit with the NPM1-m population?

Yes. Thanks, Eric. Brian, do you want to address Eric's question about any launch dynamics?

Sure, Eric. Thanks for your question. I don’t think we’re ready to disclose what our expected launch ramp-up will be. However, our immediate focus is to make the product available for patients, secure access with our payers, and build on the work our team has done so far. We aim to highlight the ways in which ziftomenib stands out, particularly regarding its robust efficacy, safety and tolerability, convenience, and the simplicity of dosing without the significant additional monitoring challenges that some competitors might have. Regarding your second question about whether we expect to see a large influx of patients, we don’t anticipate that. This patient population isn’t one where patients are waiting for a new therapy due to the high unmet need. These are typically elderly relapsed/refractory patients who have been significantly treated before and may have a relatively short life expectancy. Consequently, we think the pool of patients by the time we get approval may have already been addressed by other therapies. I hope this provides some clarity.

Yes, very helpful. Building on Brian's comments, another thing to look forward to is that we will provide an update on the combinations of ziftomenib with venetoclax. We are also exploring combinations with other standards of care, including gilteritinib. All of that data is forthcoming. While we will be promoting on-label, we are committed to publishing as much data as possible to assist physicians and patients. The four pillars Brian mentioned will ultimately position ziftomenib to potentially become the market leader: efficacy, safety, compatibility, and convenience. We are excited to expand our offerings for patients and expect an exciting next few quarters.

We'll take our next question from Jeet Mukherjee with BTIG.

Just to follow up on maybe your comments previously. Just any sense from your investigators about their willingness to use zifto off-label frontline or perhaps in the relapsed/refractory setting in combination pending a potential approval? And my second question was, can you provide any commentary on the percent site overlap you have with your approved competitor, at least among your current clinical trials?

Yes, Jeet, let's address those two questions separately. Mollie, can you share the feedback we've received from key opinion leaders regarding the willingness to combine ziftomenib with other standard treatments?

Yes. I mean what we hear is ultimately, they're going to do what's best for the patient. If they have a safe way to administer our drug in combination that they feel would be more beneficial to the patient, then they would. With regards to in the front line, they have the option of putting them on our trial. So I'm hoping that they will do that so that we can fill up just as quickly as we plan to. But yes, we do hear, not just our investigators, but other KOLs discussing their liking to have the information available to be able to safely use drugs in combination. Yes. That's all right. So for 001, the monotherapy study, it was very few, a handful, probably mostly in the United States. With 017, you can expect that number to drop precipitously because sites don't have the capability of conducting multiple Phase III studies in the same or similar indication.

Yes, Jeet, I want to emphasize that we've designed 017 to serve as a comprehensive solution for these clinical sites. Our aim is to establish strong partnerships with many leading centers globally. If they can treat nearly all eligible patients in the front line with a single trial, they will choose to do so. Therefore, in response to Li’s earlier question, we're not overly worried about the timing of the first patient; it’s more about who is the last patient in and who secures the data. I believe we are very well positioned to compete effectively in that regard. Thank you for your questions.

We'll take our next question from David Dai with UBS.

This is Eric Musonza asking for David Dai. About the commercial readiness, could you share some more details about how Kyowa Kirin's existing commercial sales force could help expedite the commercial execution? How many salespeople do you think will be needed for a successful launch? And then just a quick follow-up on that. J&J just initiated their Phase III trials for bleximenib in frontline AML. How are you planning to catch up or potentially leapfrog?

Yes. Thanks, Eric, for the two questions. Let's start with the commercial readiness question and the relationship with Kyowa Kirin. Brian, do you want to address Eric's question?

Thank you, Eric, for that question. Our commercial team is now fully established, and we will share more details about our sales organization and field force as we approach the launch. Our team is building out according to the target physicians we've identified in the AML space, and we will have national coverage with Kura representatives who will work closely with the existing national team at KK. KK currently promotes a product in the lymphoma space, which has significant overlap with the AML population at the account level. Their team will allocate some effort towards ziftomenib while the remainder focuses on their other product. By partnering with our team for ziftomenib, we will enhance our capacity to reach physicians more effectively than we could independently. This is expected to provide a significant advantage for ziftomenib at launch, as we will have a broader and more dedicated field force that can engage with more physicians and facilitate frequent interactions. This will help us communicate effectively and support patients in the community who may need or are potential candidates for ziftomenib. As we finalize our preparations for the launch, we will provide further details, but I can assure you that the teams are collaborating effectively, undergoing training, and will be ready to communicate from both Kura and our partners at KK.

Thanks, Brian. And Eric, I'll take your second question around the timelines for Janssen. I mean, everyone knows Janssen is a formidable development organization. I think though, the answer is kind of in your question, right? You mentioned the two Phase III trials. To our knowledge, they've only initiated the one CAMELOT study in the frontline ven/aza, and as Mollie indicated, I mean we've just seen overwhelming enthusiasm and enrollment in both 007 and enthusiasm for 017. So I think we'll be very well positioned to compete with them in terms of enrollment globally, and you'll see us initiate those trials here shortly in the second half, and we're looking forward to it. So thanks for the questions.

At this time, this concludes our question-and-answer session. I will now turn the meeting back over to Troy Wilson.

Thank you, Brittany, and thank you all once again for joining the call today. We'll be participating in several investor conferences over the next couple of months as well as the ESMO Congress in Berlin, where, as Mollie mentioned, we're planning to hold a virtual investor event to discuss our presentations of clinical data from our FTI program. In the meantime, if you have any additional questions, please feel free to reach out. So thank you all again, and have a good evening, everyone.

This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect. Thank you.