Q2 2025 Kura Oncology Inc Earnings Call

Please stand by. Your program is about to begin.

The question and answer session, you may register to ask a question at any time by pressing star and 1 on your telephone keypad. Please note this call is being recorded. I am standing by. Should you need any assistance? 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 second quarter 2025 conference call.

Joining the call today are Dr. Troy Wilson, president and chief executive officer, Dr. Molly Leoni. Chief medical officer. Brian Powell 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 koors filings with the SEC, which are available from the SEC, or on the Kuro oncology website, 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 programs. If a minute regulatory status of our new drug application,

Preparations for commercialization with our partners at Kiron and advances in our pipeline including men and inhibitors for treatment of gist and diabetes as well as Barnacle transferase Inhibitors or FTI for solid tumors.

Starting with development, we were thrilled to present positive monotherapy data from the Comet 00001 trial at ASCO. The data showed promising results in relapsed or refractory NPM1-mutated AML, offering hope for this heavily pretreated population. We're also encouraged by Zip's consistent safety and tolerability profile in this setting.

We were pleased to announce FDA accepted our NDA for Zeb and adults with relapsed or refractory npm1 mutant AML granting priority review with a Padua Target action date of November 30th 2025.

We're encouraged by the fda's engagement and our focused on achieving a successful review outcome by our Paducah date. In the front line setting, we reported updated combination data for zift amended with intensive chemotherapy in newly diagnosed AML and eha these results, highlight zip them in its potential as an early intervention offering a meaningful opportunity to improve patient outcomes.

Building upon the eha data as well as emerging data for zyto combined, with phonetic lacks and is a Saito or vinasa, which we plan to share later. This year, we're accelerating development as if to men have been Frontline AML. For this end, we are in study startup for the 2. Phase 3 Frontline trials under the comet 017 protocol. Along with the opportunity to treat. Flip 3 mutant AML patients, these 2 phase 3 trials could open up the opportunity to impact up to 50% of patients with AML

Molly will expand on our development activities, for zift a minute 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 cmnc and Manufacturing and recruiting and training our sales force as well as collaborating with our partner. Kia Kieran on launch planning. Brian, will elaborate on our commercial Readiness later in the call.

Our partnership with Kia Kirin to bolster the global development. And commercialization of zift amended, we're aligned on advancing both relapsed refractory and Frontline programs. And we value our shared commitment to Bringing zift amended to patients.

Beyond men and Inhibitors were making strong progress with our fully owned Next Generation, Farnell transfers inhibitor KO 2806, we're excited to announce 3 clinical abstracts from our FTI program have been accepted for presentation at the 2025. Esmo Congress Molly will share more of the 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 an 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.

Of our Phase 3 frontline trials, as well as first commercial sales of demented in the relapse refractory setting.

As our data continues to demonstrate, We Believe Z to many represents a potential best-in-class men in inhibitor for AML and Geist. And with our cash cash Reserve, our current cash reserves and anticipated. Milestones were well, funded to become the market leader continue to advance. Our if demand of 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 zip dometa. I'll turn it over to Molly to highlight our development activities. Molly,

Thank you, Troy. Let's begin with highlights from our ZIP and then of development program.

At ASCO 2025, Dr. Eunice, Wong of Roswell Park presented data from the comet 00001 trial, evaluating zip code and a monotherapy in 92 heavily. Pre-treated relapse refractory patients with npm1 mutant AML

The trial achieved. The CRC rate of 23% through passing historical controls with consistent activity, across pre-specified subgroups, including those with prior transplant. Prior genetic lacks those with numerous prior therapies and those with Flip 3 or idh commutations.

At the time of the data, cut 63% of responders were mrd negative, Zippo menb, consistent safety and tolerability profile, including effective management of differentiation syndrome low rate of Milo suppression, lack of clinically significant QTC prolongation and absence of drug drug interactions underscores. 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 FDA remain collaborative and constructive.

Zitios favorable safety profile supports its broad use and combinations in both the relapse refractory and Frontline settings.

Kombat 007 and Comet 008 are evaluating Ziptomab in combination with various standards of care for patients with both newly diagnosed and heavily pre-treated disease at the 2025 EHA Congress. Dr. Harry BBA of Duke University presented Phase 1/1B data from the Comet 007 trial, testing Ziptomab at a 600 mg once daily dose plus intensive keto therapy 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 3 years. Highlighting a substantial unmet need and only a third or Alive at the 5-year, mark.

Comet 007 data were highly encouraging with rates of complete remission and mrd negativity across the 7, plus 3, cohorts, and a safety profile. Consistent with previous reports, the safety profile observed was 50 in combination with intensive chemotherapy with actually similar to what is expected in patients treated with 7 plus 3 alone,

Zips continuous, daily dosing was maintained through count, recovery and consolidation therapy, as well as maintenance without delaying neutral or platelet recovery or causing any additional mile of suppression.

A single case of grade 3, differentiation syndrome and 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, for 84% and 74% respectively. At the time of this data, cut 96% of npm1 mutated in 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 Crescent at medians of 4.7 and 4.1 weeks respectively.

We anticipate presenting preliminary clinical data from the common 007 trial evaluating Stomatab at a 600 mg dose with the Netacademy diagnosed and relapsed refractory AML patients in the second half of this year, potentially at ASH.

Phase 3 trials.

The first is Comet 017, I see, which is Zippo Mena. But with 7 plus 3, intensive chemotherapy, and the second is keto 17 Nic zyto with venetoclax and a society or non-intensive chemotherapy.

Negative Crescent and CR is dual primary endpoints for Accelerated approval and both trials. Could substantially shorten development timelines.

The single protocol designed streamlined trial startup and is attractive to clinical sites because of the accommodates nearly all eligible Frontline patients.

Commodo 17 is now in study startup and on track for initiation in the second half of this year.

Turning our attention to zip de in combination with a matte nib for patients with Advanced gastrointestinal, stimulus or gist.

Approximately 4,000 to 6,000, new cases of gist are diagnosed each year in the United States and advanced just patients have limited treatment options.

And mathibe, the current Frontline standard of care for advanced Geist targets kit via tyrosine kinase inhibition, but resistance often develops due to secondary kit mutations.

The commodo 15 trials.

15 trial will be combining a dose escalation to evaluate the safety, tolerability, and preliminary anti-tumor activity of zipamen and combination with a matnib in adults with GISTs, who are currently on, or have previously been treated with a matnib. We are advancing in dose escalation, and we will share clinical data updates as it becomes appropriate.

Progress. Also continues in our next Generation men, and inhibitor program for diabetes. We see strategic potential to expand men and inhibition to diabetes and cardio metabolic disease. We've nominated the Next Generation development candidate for diabetes and will share development plans and timelines in a future update.

Moving now from men and to our FTI. Development programs, our fit, 00001 trial, evaluating our next generation for Nestle transferase inhibitor KO, 20806 is progressing significantly, our Innovative approach combines fti's with targeted therapies to overcome resistance and enhance response durability, reshaping the FTI story and expanding the use of these combinations. As Troy mentioned, 3 clinical, abstracts from our FTI program work accepted for presentation at the 2025. Esmo Congress covering KO 20806 with Cabos at nib and renal cell carcinomas.

KO 2806 monotherapy, in advanced Ras mutant solid, tumors. And tippy farab and alpelisib in patients with P3 CA mutant, head and neck, squamous cell carcinoma, we plan to host a virtual event in concordance with the asthma Congress in October to discuss the emerging clinical data and we'll share more details ahead of that conference

We're also about.

Evaluating KO 20806 and add a graphic in patients with K. Russ, g12c, mutant solid, tumors and our 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, Molly with the zip to Paducah date of November 30th. Well, on site, our pre-commercial activities continue at a Brisk Pace. We're confident careers. Commercial organization will be fully prepared for launch ahead of potential approval.

As Molly, noted, the commodo, 01, and commodo 07. Clinical data were well-received by the clinical Community. We're encouraged by positive feedback from the KO Wells highlighting, 4, key aspects of zip demented in the relapse of pory setting.

First is efficacy. Strong crcr rates, crh rates and durable responses and heavily pretreated patients with overall survival among responders exceeding. The kol's expectations

Second Simplicity, the once daily dosing facilitates adoption and integrate seamlessly into patient care benefiting benefiting both providers and patients.

Third compatibility. No, clinically. Meaningful drug drug interactions with CIP, 34 Inhibitors, and enable combination with antifungals or other Conant medications and forth. Safety, a low rates of QTC prolongation eliminate the need for burdensome weekly. Cardiac monitoring and alleviate concerns of combining with other agents, known to prolong QT.

On Commercial Readiness, our team is focused on raising awareness about men and inhibition in npm1 mutated AML ensuring access and upon approval communicating systematic 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 men and 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 on boarded our sales, team selected through a rigorous Nationwide, screening process, the group has deep experience in Hematology Oncology with over 21 years average, experience in sales and over 7 years, average experience in hematology. As they deploy, they will work alongside the experienced QA here in us-based field team.

As the lead party in the US. We are building capabilities across commercial functions while working collaboratively with kiwak 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 if demand of access at oncology centers, and enhance provider satisfaction and drive early uptake, to ensure a rapid launch of zip de upon FDA approval,

Together with Kia Kieran, we're confident in our commercial readiness and ability to deliver if demanded to eligible patients at launch.

The relapse refractory AML population is our initial Market entry, and a critical step toward building a successful commercial commercial product zip the menus 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 relapse, refractory AML is between 350 to 400 million dollars, annually driven by a patient population that can reach up to 30% of relapse, ofra AML patients, who could benefit from an average of 6 months of treatment is efficacy, safety, tolerability and convenience positioned for Market leadership, share in this setting.

Our launch planning for the npm1 mutated relapse. 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, just a minute's data, unhindered by complex, dosing excessive Milo suppression or burdensome monitoring support, its potential best-in-class profile.

Of the 22,000 newly diagnosed AML cases in the US. We Believe men and Inhibitors can reach 50% of patients, where the km2a kmt2a pathway is a driver of their disease. This includes both npm1 mutated and kmt2a rearranged

Our comprehensive development plan is designed to address multiple populations or patients May benefit from zip demented, for 12 to 24 months or more of zift.

I will now turn it over to Tom to provide the second quarter financial highlights. Tom, thank you, Brian and good afternoon. Everyone collaboration revenue for our from our Superior, current 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 was 62.8 Million.

Compared to 3 9. 7.

General and administrative expenses for the second quarter of 2025 for 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.

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 30th, will be sufficient to fund our current operating expenses into 2027.

If we include anticipated collaboration funding and Milestones under our kilo care and agreement karaz, Financial Resources should support advancements of our zepto and ml program. And to commercialization in the Frontline combination set,

I'll now turn the call back over to Troy for final comments. Troy.

Thank you, Tom, before we jump into the question and answer session, let me just lay out our anticipated upcoming milestones.

For zip and our men and inhibitor programs. We look forward to continued engagement with FDA, reviewers, as we approach our Padua Target action, day of November 30th, or as if to many of his monotherapy, for patients with relapsed refractory npm1 mutant AML

Initiating Commodore 17 are 2 independent phase 3 registration enabling trials in Frontline, intensive and non-intensive AML in the second half of 2025 and presenting preliminary clinical data from the comet 007 Phase 1 B expansion cohorts evaluating zift amended with phonetic Clacks in Asia citadine at a medical meeting in the second half of 2025.

For our financial transparency inhibitor programs. We expect the following Milestones to initiate 1 or more expansion. Cohorts of Cayo, 2806 and Cabo antonym 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 3 presentations.

Data from the fit 0001 Phase 1 monotherapy dose escalation if KO 286 in patients with Ras mutations.

data from the fit 00001 Phase 1 trial, evaluating KO 20806 and khabaz antib in patients with renal cell carcinoma

And finally data from the current hn trial, evaluating tippy farno and alpelisib in. Pick 3, cm mutant head and neck squamous cell carcinoma, as Molly 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 safe to date to come.

With that. Britney, we're now ready for questions?

Thank you.

if you like to ask a question,

star 1 on your key.

And 1 to ask a question. Our first question comes from Jonathan Cheng with ler Nick Partners. Please go ahead. Your line is now open,

Hi guys, thanks for taking the questions. Uh, a couple first. Can you give us, uh, some color on how the regulatory interactions on zyto manip. Have progressed as, as we look towards the pufa date, uh, later this year.

Um, and then second question, uh, how are you thinking about the scope of the Ferno transferase inhibitor opportunity, uh, between the possible combinations and tumor types. What do you see as an area or areas that cure can move forward uh with a loan and which do you see as areas better suited for potential partner? Thank you.

Jonathan thanks for the questions. Um let's take them in turn with respect to um any additional color on the regulatory interactions. Molly, would you like to would you like to comment to the extent that we can?

Yeah, sure. And and as Troy is alluding to, you know, we're currently, um, within our under our active under, uh, our active, NDA review. And so we can't really provide details about every involving interaction with the FDA. But the, the interactions have all been collaborative. Um, they've been very constructive, a lot of back and forth and everything we've seen to date, um, is in alignment that with the timeline for a priority review with a an approval of November 30th. So, again, we're we're very encouraged by the way. Things have progressed thus far.

Relay and really a lot of a lot of interesting opportunity. Uh, the third 1 where, hopefully, we'll have we'll have something to share next year is, of course in the kras space. Um, and we've put out a lot of, um, preclinical data that's available on our website. You'll see us, uh, set the context and I think helped, uh, analysts and investors, uh, set expectations as we, um, as we get closer to esmo, but suffice it to say, you know, with each of these areas, RCC, pi3 kinase and cos they all have the common problem of of resist innate and adaptive resistance. That's what we're looking to address. And we're looking to to um, to share further data with you, Molly anything. You

no, no, no.

Field. It also reshapes these other targeted agencies um because a target targeted agents, excuse me. As we you know, look to prevent or prolong these patients ability to respond to these drugs and there's no reason to think that the results, um, from 1 particular combination, it wouldn't be generalizable to similar drugs in the same class. So we're very excited to see where this leads.

Understood. Thanks for attending questions.

Thank you, Jonathan.

Thank you. We'll move on to the next item.

Your line is now open.

Uh, hey guys, congrats on the progress. Um, maybe I'm a little, you know, curious about your thoughts on the men and class launched so far. Looks like in, um, even in K2A patients, the market opportunity could be quite sizable. Um, you know, any rate through to your online, um, of the to manip. Um, and then in terms of, um, phase 3 trial starts in the second half of this year, I'm wondering if you can elaborate a little bit more in terms of the progress that you made since last quarter, um, and then your confidence that you could still, um, potentially be first in class in the front line.

Sure. Yeah, Lee, thanks, thanks for the questions again. Um, let's take them in turn. So, uh, Brian, could you address um Lee's first couple of questions, which is our impression of the kmt2a, uh, relapse refractory Market opportunity and some of the results we've seen from our, some of our competitors and perhaps any read through to our own, you know, our own thinking or our own program

Thanks Troy and, and and thanks Lee for the question. Um, yeah, I think we've obviously been watching closely as you have on, on understanding, kind of the launch. Um uh, first launched in the kmt2a space of the men in class. Um, I I mean, I think our first impression is that it it's, uh, great news for patients that there is a new class of therapies available, um, uh, that could help to Target, you know, a broader range of patients with a high-end met need. Um, the the kmt2a population has uh um, as we know as a, as a smaller population, um, in incidents, relative to the mpm, 1 mutated population, um, and I think we're encouraged to see the the preliminary, um, um, uptake and activity, um, of our competitor. Um, when we think about what that means, as we read it through into the menu. Um, we we first we understand that this will be a competitive space. Um, we feel pretty confident, um, as as we mentioned in our prepared remarks that uh, zipped a mehtab, has the properties that

We Believe of the potential of being a best-in-class, um, um, as their profile, um, across both the efficacy, the safety, uh, the combin of the drug, it also, the convenience. Um, we think that, uh, uh, as we, uh, bring our, our, our hopefully get to our FTA approval, um, our commercial, our medical and Market access teams will be able to quickly, um, begin communicating and and, uh, and be able to be competitive in this space, where we see, um, a very high-end need

For for this population who are in need of new Therapies.

Thanks Brian and and Molly for you on the maybe on the second question. Um, I'm just going to restate it. You know, looking at the phase 3 starts here in the second half of the year for commodo 17. Can we elaborate on the progress since the last quarter? And what gives us confidence will be potentially first and and best-in-class in those combinations? Yeah.

I mean, I think I'd

We have put both trials under a single protocol. So what does that do? That makes it easier for every single site every IRB um, all of your Contracting resource resources to go through, 1 contract and not laboriously. Go through multiple stages or multiple negotiations, and not have to choose 1 trial over. Another choosing 1 trial, gives choosing our 07 trial gives you access to 2 trials in 1. We hear enormous amounts of excitement coming from all of our sites that have kind of put their hands up to participate. Um, we continue to make a lot of progress, it does take time to get a study started. Uh, we have to work out all of the, the, the contracts and, and everything else as, you know. Um, but it's, it's going quickly and I have no doubt that we will start that trial, um, the second half of this year and I have no doubt that the enrollment will be really impressive, um, and we'll get us to that.

202028 additional high-level data that we've. We've been talking about all along and keep in mind, this really does allow any patient with a kmt2a or npm1 mutation will almost any patient with those mutations to have a place to go in their front line treatment setting. So I I think that the the potential patient population that we will be able to address is is going to be enormous. So I look forward to um, very robust enrollment,

And a a broad patient base to be able to treat in this particular 07 trial.

Thank you, Molly.

Thanks Lee for the questions.

Thanks. Thanks for taking questions. So, um, seeing your, um, the upcoming Milestone. Um, you talked about the RCC expansion cohort since you already made the decision. Uh, if that's the case, you know, what's the criteria for the um, the expansion cohorts? Uh, and then what will be the next step in timing for checking to see and then cos, uh, and the the program and then second question is related to the regulatory interaction, uh, given the all the changes uh within uh FDA uh, have you have any recent interaction with the FDA regarding your phase 3 pivotal uh design and understanding your uh about your start? But any last minute uh kind of for uh feedback you're getting from the FDA. Thank you.

Yeah, um Roger if we met Molly is going to answer both of those questions? Molly, maybe we can take them in reverse order. Let's start with the first 1, which is, you know, any recent interactions with the agency on the phase 3 uh designs for commodo 17.

No and and thank you for that. No, it's 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 um additional concern or or additives by people coming or going from the FDA so all is holding pretty steady for us.

Yeah and and maybe just to build on that. Roger on Molly's comment. I mean this is nothing new in oncology, right? When the agency gives you the pathway to accelerated approval, whether that's monotherapy or in combo that the condition is always that you come back with the data. I think maybe what's different here is, there's a recognition in AML uh, that, you know, it, it, it may not be or it isn't in the best interest of patients, to wait around for survival end points in some cases. And so, there's a real willingness on the part of the FDA to consider accelerated approvals, uh, or some Pathways to accelerate approval. And that's what Molly her team were so, so skilled in in coordinating with the FDA. Um, so everything is on track from our perspective. Uh, Molly on the first question. Um, it's probably a little early.

But Roger asked, you know, what's our decision making process for RCC for kras, you want to speak a little bit to that. I know it's early in in Where We Are.

Yeah, it's early. I I'll focus in on RCC because that's probably the easiest story to explain at this point. Um, so we um, 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. Um, I will say that we've not really shared publicly are going to go criteria, but we, we had no problems in meeting that. And currently when we talk about our expansion cohort, it's really, with the thought of, um,

And giving them the data that they want. So we will expand out to, at least 2 Doses and, uh, look to see, um, which dose is best tolerated and most efficacious at the same time. Um, and at that time, obviously we will be, um, you know, we will look for convincing data that you're seeing more than just a Cabo, uh, monotherapy activity um which these patients that have already failed, Cabo shouldn't be that hard to to demonstrate.

Similarly, without a grasset as we keep on with the does escalation will probably proceed in a very similar fashion.

Thank you. Molly. Thanks. Roger for the questions.

Thank you, thank you. We'll take.

We'll take our next question. From Jason zamansky with Bank of America. Your line is now open.

Great, good afternoon. Thanks for taking our questions and congrats on the progress. Um, maybe a high level question for you Troy. Um, now that the dye 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? Um, you know, how much is your, your competitor's first to Market advantage and, and current inroads, um, as uh, as a hurdle. I mean, ultimately, how quickly do you think you can overcome any residual or at least initial uh, Fick physician inertia here and they may be secondarily. What are your expectations regarding the evolution of nccn?

And guidelines for for the class. Um, whether they include xephos specifically or or sort of just reference the larger men in, uh, inhibitor class. Thanks.

Yeah, Jason um, thanks for the, thanks for the questions. Let Let Me, Maybe I'll just make a couple of of overarching comments and then I'm going to ask Brian to speak to your question. I think, if I were to distill your question down, it's really like, what's the what's the meaning of a first mover Advantage? Right, what what does that mean here what I'd say is

Uh, everything we're seeing I think is good for patients. Um, we've seen you know, strong interest and strong uptake in men and Inhibitors. As you've heard us say zifty Best in Class. I think not only in npm1 mutated AML, but increasingly as you'll see in combination, you know, we think it's going to be very competitive in the kmt2a rearrange subset. Um, and we're looking forward to giving Physicians and patients options for therapy. Um, these patients are in desperate need and, um, I'll let Brian speak, uh, really to the feedback that we've heard from Ko's and, and sort of the positioning and then we'll come back to your question on nccn. And, um, when he's done with that Brian, could could you maybe build on my comments?

Sure. Thanks Troy and thanks Jason for the, for the great question. Um, yeah, I think, as Troy said, uh, we're we've been working towards, uh, I think, you know, building that that first, you know, our our presence and, and first approval in this market, um, as, as you said, we're we're we're happy that patients may have a number of options available for them. Um, our our team has been working for, you know, really the last 2 years to start to begin this preparation. We've actually from a medical perspective have been engaging with Ko's um um you know, from with our MSL team over the last, you know, 2 years or more our Market access team has actually been, um, out in the field and engaging with payers, um, through pre-approval information exchanges, um, over the last year and we're really building a, uh, a, a, a strong reputation among those teams. A lot of that's actually built. I would say as as Kuro oncology based on the strong. Um, uh, uh,

Reputation that Molly and her team have really built and executing on these clinical trials and how quickly they've been able to enroll patients and and really partner strongly with the um a number of the US positions. So I think that, you know, there will be, of course, we recognize there'll be some uh you know competition coming forward between potentially 2 approved agents in the space. Um, we're confident in the profile that zipto menopause that we'd be able to, um, you know, rapidly, um, engage with Physicians upon approval.

Um, our sales teams will actually begin some uh, uh profiling once they finish their training and the and the short time frame between now and as they get closer to the approval, so they could start to engage in, get to introduce and engage on on koors behalf as we get closer to our approvals. So we think that we're going to, we're doing all the right things that that, um, a company like her needs to do and, uh, while there may be some initial awareness from some of the competitors, um, we think that the need is substantially High and the enthusiasm we've heard around zip the minute, um, continues to be high. That we'll, we'll be in a good position once we get that approval,

You want to just add to that and and address Jason's second question, which is around. How do we think about the evolution of the nccn guidelines, is it? You know, men, and as a class is it, is it a specific any, any, any color you want to? Yeah, absolutely. I mean, I I would say at at the highest level Jason, since we, we, we only have, uh, you know, uh, external visibility to what the the NCC and AML committee does. We can't really comment as to when they will be um addressing the npm1 mutated population. Um, our intent within our team is as soon as our data are published and we have our approval, we'll be submitting, um the the application to nccn for consideration on the guidelines as soon as as possible. It's 1 of those key early launch metrics that we'll be putting towards uh to to get uh um um zip the men up on on those guidelines.

Molly, would you want to add anything else to that?

Yeah, I thought the the question about whether they would list out individual drugs or uh, men. And as a class as an interesting 1, I mean obviously we don't know. Um, but as we are the only 2 companies that will really have uh strong data packages already produced. I would think at least for the foreseeable future. It would be named men the Inhibitors um the the in the guidelines rather than just a class

Yeah, got it. Thanks so much for the um good color. Appreciate it.

Thanks Jason.

Thank you, we'll take our next question. From Ellen horse with TD Cowen. Please go ahead. Your line is open.

Hi, guys. Um, congrats on patreon, exciting quarter um and thanks for taking the question. I'm just wondering, um, 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 kmt 2A population, and the npm1 population. Thanks.

Yeah, thanks Ellen for the questions. Molly, you want to speak to that risks to timelines sort of getting extended or risks to running the the Blended populations?

Yeah. I mean, obviously.

Future and and if something really unexpected happens, obviously, I could push out the the readout dates, but we're very, very conservative. Um, and so we only released that 2028 date when we felt very confident in our ability to be able to meet it, um, with regards to the mixing of the populations again, I will go back to our 07 trial. It has taught us so much. We understand what these patients now. Look like in these settings to a great extent, that's very robust data sets. Um, so the mixing of the population

Um, does it frighten us? And, you know, we've we've obviously approached it from many different scenarios to make sure that that this was the appropriate way for us to proceed as a company. So, 007 really was, um, the best building block for this big trial.

Thanks.

Thank you, Ellen, for the questions.

Thank you, we'll take our next.

Peter Lawson with Barclays, please go ahead. Your line is open.

Thank you so much. Um, I joined later, I apologize. If, um, the questions already been asked just around.

Dialogue how that's proceeding if it's changed in frequency or any emphasis has changed around that and then 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.

Yeah. Peter um, Molly. Can you just maybe summarize uh, the the FDA dialogue? Yeah, for Peter, sure.

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

Expected.

10 p.m. 1 patients, don't need to go to transplant in that Frontline setting. Um, the ones that do have in general, come back onto a maintenance, uh, protocol and the kmt2a is especially um are are very um apt to come back uh to trial. So I think the maintenance indication that has been built in to the 07 design is going to be extremely valuable and appropriately. Capturing that patient population.

Right. Is there anything you'd like to add on on Peter's question around maintenance?

Thanks Troy, maybe just to, to add on that. I think that, um, the way we view it from a commercial perspective, um, a lot of the post-transplant maintenance or extended non post-transplant, that that would likely be, um, something we would observe or expect to see in that, uh, in the newly diagnosed settings. So, um, as as Commodore 117, um, builds out, we think that gives us an opportunity for significant um uh durations of treatment in both of the uh IC and the nanak setting. Um,

That could lead to anywhere from you know, 12 to 24 months of uh continuous therapy for patients in the relapse or factory space you know the based on what we've seen in the market so far. Um you know kmt2a there may be more patients who would go to transplant relative to the older population um of npm1 mutated patients.

In the relapse of directory setting so we're observing and we'll be following to see but that we expect that to be a lower rate of uh of transplant. Um for those uh relapse refractory mpm, 1 mutations but we'll be tracking that and try to understand and our goal of course will be to get patients on therapy and to stay on therapy um for a longer period of time.

Thanks Brian.

Thanks Peter for the questions.

Thank you. We'll take our next question from Charles Zoo with Life-Size Capital. Please go ahead, your line is open.

Hi. This is Peter on for Charles a couple of questions from my end. Um first of all for the 2806 data in RCC at esmo, this fall, just wondering, if you could provide some color on patient baselines, um, how heavily pretreated uh, rates of Prior khabaz exposure.

Um, and then second question, as you're looking down the nose of approval, um, in relapse refractory npm1 for zyto manob, just wondering what your plans are, if any, for additional data disclosures in that setting, uh, for example, at at Ash or, uh, you know, a journal release. Um, thanks and, uh,

Congrats on all the progress.

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

That's exactly what I would say is. I don't want to preempt the the abstracts, um, but they will be sharing all of that data with you but you can expect um you know a typical Phase 1 patient population where initially it could be your your most heavily pretreated and then as investigators feel more comfortable, you come further and further in line. So you'll see a variety of about of of patients at Baseline.

Great. And, and Molly, what about Peter's second question about it. You know, any additional disclosures on the monotherapy? The the Commodore 01 study for people to, uh, to look forward to

Additional data disclosures. Um, well we should be expecting obviously.

Yeah, that's that was what I was getting at. Uh, yeah. So you should expect a publication, um, within the coming months.

Thanks Peter. Thanks so much.

Thanks. Yeah. Our pleasure.

Thank you, we'll take our next question. From salaam sing with

Mizo. Please go ahead. Your line is now open.

Hi. Thanks for taking our question. This is Eric on for sale. Um, I just wanted to um, get your thoughts and uh, on

Potential, uh, launch ramp. As you get into relapse, refractory npm 1M given what, uh, you know, we've seen with the kmt2a,

Launch your recently and um, you know, given that there was no really good reason to expect anywhere warehouses of warehousing of patients with kmt2a are, uh, in the relapse refractory. But might there be a bit, uh, with the npm 1M.

The population. Thanks.

Yeah, thanks Eric. Um, Brian you want to?

Eric's question about about any launch Dynamics.

Eric, thanks. Thanks for that question. Um, I mean, I think that, you know, we're...

I don't think we're ready to disclose what our expected launch ramp up will be what I can tell. You is the focus that we've been working towards right now is to immediately, get the product available for, uh, for patients, um, get access from with our, uh, um, payers and and build on the, the work. The team is, um, working on so far and and really communicating around, uh, the areas where we see if the men of is differentiated, as I've said before around our, uh, you know, robust efficacy, the the, the safety, and tolerability that convenience, and the ability to, to, um, have a kind of Simplicity of dosing without, um, some significant additional monitoring challenges, uh, um, as, as some of the competition may have. So, um, our

Our expectation, your second question around whether or not you would expect to see a bolus. We haven't actually, um, we don't expect to see a large bolus. This is not a patient population where patients are um are are waiting for a new therapy to come forward unfortunately because of this very high-end met need. These are going to be elderly relapse refractory patients that have probably been significantly uh pre-treated and um may not have the expected uh you know the expected life expectancy in this space is pretty short unfortunately. So I think the there there's less of a dynamic of a of a pool of pain.

We think that have already been kind of taken up by other therapies. By the time we get to approval, I hope that helps with some clarity.

Yeah. And and very helpful to build on just to build on Brian's comments. Um, and another thing you'll look forward to is, you know, as Molly indicated, we're going to give an update on on the combinations of Zippo with phonetic lacks. We're also looking at combinations with other standards of care including guilt written nib. All of that data is coming while we'll be promoting on label. Um, you know, we're looking really to publish as much data as possible to help, inform, Physicians and patients and those those 4 pillars that Brian hit on. I think that's really ultimately going to go into allows, if to potentially become the market leader, um, uh, the efficacy to safety, to compatibility, and the convenience. Um, so, you know, we're excited to get out there and, and, and, uh, offer more options to patients. Um, it's going to be an exciting, you know. Next few quarters,

All right. Uh, thank you. Okay.

Yes, thank you.

Thank you. We'll take our next question from Jeet. Mari. Margie with btig. Please go ahead. Your line is now open.

Great. Thank you for taking my question. Um, just to follow up on, maybe your comments, um, previously, just, um, any sense from your investigators about their willingness to use zipto, um, off label Frontline, or perhaps in the, uh, relapse refractory setting in combination pending, uh, potential approval. Uh, and my second question was, can you provide any commentary on the percent site overlap? Uh, you have with your approved competitor? At least among your current, uh, clinical trials. Thank you.

Yeah, gee so. So let's let's tease. Those 2 questions apart. Um, Molly do you do you want to speak to the the feedback from we've heard from Ko's on a on a jade, I think your question was sort of a willingness to combine a willingness to yeah to um, to to combine zip demented with other standards of care.

Yeah, I I mean what we hear is ultimately they're going to do what's best for the patient.

Best way to administer our drug in combination.

Um, that would they feel would be more beneficial to the patient, uh, then they would, um, with regards to in the front line, they have the option of putting them on our trial. So I'm hoping that they will, they will do that, so that we can fill up just, as quickly as we plan to. Um, but yes, we do hear, not just our investigators, but but other um, Kos, discuss, uh, liking to have the information available to be able to safely use drugs and comp

Yeah. Yeah. The site overlap. Yep.

That's all right. Um, so, for 001 the monotherapy study, it was very few, um, you know, a handful probably mostly in the United States with 07. You can expect that number to drop. Um, precipitously because sites don't have the capability of conducting multiple phase 3 studies in a, the same or similar indication.

The way that we did because it's really a 1 for these clinical sites. And, you know, we we um, we're really looking to build relationships with, um, many of the leading centers all over the world. And if, if they can treat nearly all eligible patients in the front line with 1 trial, they've they've they've they've shown us that that's what they're going to do. So we're not to to lease earlier question, we're not overly concerned, it's not really first patient in. It's going to be last patient in and who gets the data. Um and I think we're very well positioned to compete on that. So appreciate your questions.

Thank you. We'll take our next question from.

vid day.

Please go ahead. Your line is now open.

Hi, this is Eric sza asking for a David Die. Thanks for asking taking our questions. Um, about the commercial Readiness, could you share some more details about how cure cures, existing commercial sales force, could help expedite the commercial execution? Um, how many sales people do you think will be needed for a successful launch?

And then just a quick follow-up on that. Um, J&J just initiated their phase 3 trials for black women and Frontline. AML how are you planning to catch up with potentially reproduce?

Yeah, um uh thanks Eric for the 2. Let's start with the commercial Readiness question and, and the relationship with Kia and Brian. Do you want to, you want to address Eric's question?

Sure, sure. Thank you, Eric for that question. Um, yeah. So the, um, our team, our commercial, uh, team has been, as I mentioned, has been fully built out our sales organization. Um, we'll share, um, probably as we get up to launch a bit more details of the size of that field Force, um, and uh, um, and how they'll be working with, uh, with KK. What I can say, is that our team is building out based on the target, um, the target Physicians that we've outlined for, um, the the AML space we'll have a national coverage of, uh, of with Kura, um, uh, field representatives. And they'll partner, very closely with the national, uh, team that that, uh, um, KK already has in the field. You may know that they have a, a product that they currently are promoting in the, uh, um, lymphoma space, which has a a pretty, uh, significant overlap at an account level, um, with the AML population. So what what we're working on is have um, their team

I have a portion of their effort focused on, uh, on zipto, the other rest of their effort will be focused on their other product. And uh, for zip de Mana, they will be partnering very closely with our team to essentially give a broader depth and breadth of our ability to reach Physicians. Um, then we would, if we were to be alone. So we think this is going to be a significant Advantage for uh, zipto manip as we launched because we'll have uh, a field force that is um, maybe maybe broader more dedicated to, to extend to more Physicians, um, to have more frequent interactions and contacts so that we'll be able to communicate our messages and support patients, who are in the community, who could who may need to, uh, or have the potential to get zipped demented. So, as we're working towards that launched, we'll be able to provide a little bit more detail. But I could tell you that the teams have been working very well together. Um, they're going through their training to be ensured that as we get to our launch. They'll be uh, uh, ready to go and start to communicate both.

From the the kouros side as well as our partners at KK.

Thanks, Brian, and Eric, I'll I'll take your second question. Um, around. You know, the the timelines for Jansen. I mean, everyone knows the answer is a formidable development organization, uh, I think though the answer is kind of in your question, right? Um, you mentioned the 2, phase 3 trials to our knowledge. They've only initiated uh, the 1 Camelot study, in the Frontline vinasa. Um, and as Molly indicated, I mean, we've just seen

Overwhelming enthusiasm and, and enrollment in, in both 007 and enthusiasm for 07. So, um, I think we'll be very well positioned to compete with them, um, in terms of enrollment uh, globally and, um, you'll see us initiate those trials here, um, shortly in the second half and we're looking forward to it. So,

Thanks for the questions.

Thank you at this time. This concludes our question and answer session, I will now turn the meeting back over to Troy Wilson.

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.