Kura Oncology, Inc.

Good day, everybody. My name is Dani, and I will be your conference operator today. At this time, I would like to welcome you to the Cura Oncology Third Quarter 2025 conference call. All lines have been placed on mute to prevent any background noises. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time and have joined via the webinar, please use the raised hand icon, which can be found at the bottom of your webinar application. To allow everybody the opportunity to participate, we ask that you please limit yourself to one question and then re-enter the queue for any follow-ups. At this time, I would like to turn the call over to Greg Mann from Cura Oncology. Thank you.

Thank you, Danny. Good morning and welcome to Cura Oncology's third quarter 2025 conference call. Joining the call today are Dr. Troy Wilson, President and Chief Executive Officer, Tom Doyle, Senior Vice President, Finance and Accounting. Dr. Molly Leone, Chief Medical Officer, and Brian Powell, Chief Commercial Officer, are also on the call and available to answer questions. 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 Cura's filings with the SEC, which are available from the SEC or on the Cura 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 morning, and thank you all for joining our third quarter financial results conference call. Over the past quarter, we've continued to significantly advance both our clinical pipeline as well as preparations for the anticipated commercial launch of Zifto-Menib, our once-daily investigational menin inhibitor for acute myeloid leukemia. I'll begin with an update on Zifto, followed by brief remarks on our commercial readiness and our farnesyl transferase inhibitor program. The FDA review of Ziftimenib for treatment of patients with relapsed and refractory NPM1 mutated AML remains on track, with a PDUFA target action date of November 30, 2025. Communication with FDA continues to be open and constructive, and we remain focused on achieving a successful review outcome. Based on clinical data from the COMET-001 study, which has been presented at major medical meetings and published in the Journal of Clinical Oncology in September, we're confident Ziftamidib has a differentiated and favorable benefit-risk profile, and if approved, Ziftamidib could potentially reset the commercial landscape and become the menin inhibitor of choice for eligible patients. Although while the regulatory review process for Zifdomenib progresses, our clinical team continues to execute on a strategic development plan targeted at addressing the large unmet need beyond the relapsed refractory setting, where we believe Zifdomenib's benefit-risk profile will be even more competitive and more impactful for patients. At EHA earlier this year, we reported updated combination data for ziftamenib with 7 plus 3 intensive chemotherapy in newly diagnosed NPM1 mutant and KMT2A rearranged AML. These data were very encouraging, showing high rates of complete remission and MRD negativity. in over 70 patients across the combination cohorts, with a safety profile consistent with what is expected in patients treated with 7 plus 3 alone. These results highlight ziftaminib's potential as an early intervention, offering a meaningful opportunity to improve patient outcomes. Yesterday, we announced acceptance of two oral presentations at ASH, which will feature data on ziftaminib in combination with venetoclax and azacitidine chemotherapy. Both abstracts, one in the newly diagnosed setting and the second in the relapsed refractory setting, reported high response rates and MRD negativity with a safety profile consistent with previous reports. The abstracts used data cutoff of June 25, 2025, and updated results reflecting additional follow-up will be reported in the oral presentations next month. We plan to host a virtual investor and analyst event to discuss these ASH presentations on Monday, December 8th at 12.30 p.m. Eastern Time. Details will be available on our website. Encouraged by these positive results, we've advanced rapidly into our Comet 017 Frontline Phase 3 trials. COMET017 comprises two randomized, double-blind, placebo-controlled trials to evaluate ziptomenib in combination with both intensive 7 plus 3 and non-intensive Veneza chemotherapy regimens in patients with newly diagnosed NPM1 mutant or KMT2A rearranged AML. The program aims to advance sift amenib to the frontline setting with potential to treat patients earlier in their disease course when the opportunity to alter its trajectory is greatest. We're targeting enrollment at over 150 global sites with a large proportion in the U.S. Each COMET-017 trial includes dual primary endpoints to support potential U.S. accelerated and full approvals. The intensive chemotherapy combination study evaluates MRD negative complete response, or CR, and event-free survival. The non-intensive chemotherapy combination study assesses CR and overall survival. Site activation is accelerating. In each of these companies sponsored registrational trials and patient enrollment is progressing well. Continuing this momentum, last month we opened a trial cohort to assess Ziftimidib combined with 7 plus 3 induction chemotherapy and Quisartinib, an approved FLT3 inhibitor in patients with newly diagnosed AML harboring FLT3 ITD and PM1 mutant co-mutations. FLT3 mutations represent one of the most common and challenging genetic mutations in AML with limited durable treatment options. Our preclinical studies suggest Ziftimenib and Quisartinib synergize to enhance activity without undue toxicity. Note, this effort also builds on our clinical experience with the combination of ziftamenib and giltaritinib in the relapsed refractory NPM1 mutant setting. Enrollment in that trial has been robust, and we intend to present preliminary Phase I data at a major medical meeting next year. With these studies now underway, ziftamenib development is active in all three major frontline settings, collectively representing up to 50% of incident AML cases in the U.S., Turning now to commercial preparations, our teams are launch ready and confident in our execution plan. Across the commercial organization from marketing, market access, as well as patient support and sales analytics, field operations and sales, our teams are fully mobilized and prepared to execute as soon as Zip2Mentive is approved. Our disease awareness campaigns have exceeded their targets. Our pre-approval information exchanges with key payers and other market decision makers are complete, offering us confidence that we will facilitate rapid access and uptake. Our limited distribution network is fully aligned and ready to support product upon approval. And our team of experienced oncology account managers is already engaged in profiling target accounts. In early October, we and our partner, Kyokuren, held a joint launch readiness meeting where our two field teams of Kura and Kyokuren, what we fondly call 1K, completed their training and pre-certification. The excitement and alignment across both organizations is palpable, and the 1K team stands ready to deliver upon approval. Turning now to our farnesyl transferase inhibitor portfolio, last month we presented new clinical data highlighting the potential of FTIs to safely combine with major classes of targeted therapies, including PI3 kinase alpha inhibitors, KRAS inhibitors, and anti-angiogenic tyrosine kinase inhibitors, to overcome resistance pathways and enhance antitumor activity. In our FIT-001 Phase I trial evaluating darlafarnib, our next-generation FTI, in combination with cabozantinib in patients with renal cell carcinoma, we observed a manageable safety profile across multiple dose levels of each agent, including at the full labeled dose of cabozantinib. Antitumor activity was seen across all dose combinations, including in patients with prior exposure to cabozantinib. The objective response rate, or ORR, was 33% to 50% in clear cell renal cell carcinoma and 17% to 50% in patients with prior cabozantinib exposure. The current HN trial evaluates tipifarnib, our first-generation FTI, with alpelicib in patients with PIK3CA-dependent head and neck squamous cell carcinoma. This combination also demonstrated a manageable safety profile and robust antitumor activity in a heavily pretreated patient population where meaningful benefit would not be expected from either agent alone. An ORR of 47% was observed at a dose of tipifarnib of 1,200 milligrams per day and dalpelicib at 250 milligrams per day. We see tremendous promise in darlafarnib and the broader potential of farnesyl transferase inhibition as a differentiated mechanism to extend the reach of precision oncology. With the potential to enhance activity of PI3 kinase alpha inhibitors, KRAS inhibitors, and TKIs, darlafarnib represents a very substantial commercial opportunity with the potential to address more than 200,000 incident patients annually in the US alone. We view our FTI platform as a strategically important pillar of growth that complements our leadership in menin inhibition. Our dual pipeline strategy positions Cura with two clinically validated mechanisms that address some of the most pressing needs in precision oncology. We expect to have more to share regarding our FDI clinical development plans and business development strategy in 2026, supported by a steady cadence of data presentations at medical meetings throughout the year. Kuro remains in a strong financial position to execute across our pipeline, advance the development of Zip2Mentib, and support our commercialization activities. Our partnership with Kyowa Kirin has enabled us to invest in a robust, expansive, and accelerated development plan for Zip2Mentib. We recently received two $30 million milestone payments. payable for the first patients dosed in the two Comet 017 Phase 3 trials, which brings the total milestones received this year to $105 million. We expect approximately $315 million more in near-term milestone payments, including a substantial milestone payment associated with commercial launch of Ziftamenib. This is consistent with the $420 million in near-term milestones we announced at the inception of the partnership with Kyokuren last November. We reported pro forma cash of $609.7 million for the period. This figure includes milestone payments received in October and November 2025 and reflects a strong capital position to advance our pipeline through key clinical and regulatory milestones. I'll now turn it over to Tom, who will review the third quarter financial results.

Thank you, Troy. Collaboration revenue from our Keogh Care and Partnership for the third quarter of 2025 was $20.8 million compared to no revenue for the third quarter of 2024. Research and development expenses for the third quarter of 2025 were $67.9 million compared to $41.7 million for the third quarter of 2024. General and administrative expenses for the third quarter compared to $18.2 million for the same period of 2024. Net loss for the third quarter of 2025 quarter of 2024. This included non-cash, share-based compensation expense of $11 million compared to $8.3 million for the same period in 2024. As of September 30, 2025, Cura had cash, cash equivalents, and short-term investments of $549.7 million compared to $727.4 million as of December 31, 2024. has adjusted for the $60 million in Comet 017 milestone payments under our collaboration agreement with Keohokalani on a pro forma basis $609.7 million in cash, cash equivalents, and short-term investments as of September 30th, 2025. Based on our current operating plans, we believe that our cash, cash equivalents, and short-term investments as of the end of the 30th operating expenses into 2027. And if we include anticipated collaboration funding under the Keogh-Keran Agreement, CURIS financial resources should support advancement of our ZIPPT amended AML program through top-line results in our Frontline Combination Program. With that, I'll turn the call back over to Troy.

Thank you, Tom. Before we open the call for questions, let me just briefly highlight the key milestones we expect over the coming months and into next year. For Ziftimenib and our menin inhibitor programs, we look forward to continued engagement with FDA reviewers as we approach our PDUFA target action date of November 30th for Ziftimenib as a monotherapy for patients with relapsed refractory NPM1 mutant AML. Present preliminary clinical data in newly diagnosed NPM1 mutant AML and updated clinical data in relapsed refractory NPM1 mutant and KMT2A rearranged AML from our COMET007 cohorts, evaluating ziftaminib in combination with veneza at the ASH annual meeting to be held next month in Orlando. And finally, presenting preliminary clinical data from the COMET-008 cohort, evaluating ziftamenib in combination with the FLT3 inhibitor giltaritinib in patients with relapsed refractory NPM1 mutant AML in 2026. For our farnesyl transferase inhibitor programs, we expect to initiate one or more expansion cohorts of darlafarnib and cabozantinib in patients with advanced renal cell carcinoma in the first half of 2026. To present updated dose escalation data from the combination of darlafarnib and cabozantinib in advanced renal cell carcinoma in 2026. to present clinical data from the combination of Darlafarnib and Adagrasib in patients with KRAS G12C mutated solid tumor indications in 2026. With that, Dani, we're ready to begin the question and answer session.

Thank you. We will now move to our question and answer session. If you have joined by the webinar, please use the raised hand icon, which can be found at the bottom of your webinar application. When you are called upon, please unmute your line and ask your question. We will now pause for a moment to assemble the queue. Once again, we ask that you please limit yourself to one question and then re-enter the queue for any follow-ups. Thank you. Our first question today comes from Jonathan Chang at Lyric Partners. Jonathan, please unmute your line and ask your question. Thank you.

Good morning. This is Albert Augustinus on for Jonathan Chang. Thank you for taking my questions. What do you foresee will be the makeup of account types that you are trying to penetrate for Zipto launch? Are there any particular account types that you are focusing on? And also, are there any plans to include Zipto in the NCCN guideline? Thank you.

Sure. Thanks, Albert. In general, we're going to try to limit it to one question. The second one is easy, but please, if folks can limit it to one question so we can get everybody. Brian, let me ask you if you can take Albert's two questions in turn.

Absolutely. Thanks, Albert, for the questions. So our expected account types here are typically going to be the specialty hematologists. We anticipate a mix of large academic institutions as well as in some of the larger community oncology practices. It's going to be similar. I think we get into our overall targeting strategy, but probably about 4,000 HCPs that we're Within that range, I'd say probably 78% of that is going to be the academic setting, and then the rest of the focus will be on the community oncology practices that are treating those AML patients and particularly the relapsed refractory patients. To your second question, just quickly to answer, yeah. data on the basis of our approval soon after approval, you can't submit to the NCCN for a listing until you have FDA approval. So our plans are to submit that within days of approval.

Thank you. Our next question comes from Lee Watsett at Kantar Fitzgerald. Please unmute your line and ask your question, Lee.

Hey, guys. Congrats on the progress. Maybe just one on the ASH update. Can you just talk about what we should expect for the actual oral presentations versus what's in the abstract release yesterday?

Yeah. Thanks, Lee, for the question. Molly, do you want to take that one?

Sure. As Troy pointed out, the The data cut was back in June for what was submitted to ASH. So obviously we've got many months more worth of data. So you'll see not only more evaluable patients being able to be reported and the evolution of responses across the whole patient population, you'll also see new information about MRD negativity, as well as just longer follow-up and safety information in general.

Our next question comes from Saleem Syed at Mizuho Securities. Saleem, please unmute your line and ask your question. Thank you.

Great. Thanks for the question, guys, and love the revised format of the call. Appreciate it. I got one for us, Troy, maybe just on the new label that we got from Syndex, which includes TorSats now in the black box. Just curious, you know, there seems to be varying views on if this actually matters or not. Um, what does it mean for you? What does it mean for the space as you think about your own NPM one launch? And also as you progress here towards first line in particular, which I guess there's a view out there that it doesn't matter. Cause first line maybe is, you know, you wouldn't see the tour size as much, but curious to just get your view is, is the space of all here. Thank you.

Yes. Thanks for the question. I'm glad you're glad you're appreciating the new format. Um, This is, you know, there's a lot that I think we can talk about here. We'll have more to say if and when we get approval of Ziftimenib here coming up, you know, very quickly on our PDUFA action date. A few thoughts, and I'm going to give my comments and then I'm going to ask Molly, you know, for hers because she really needs to speak to this from a clinical perspective. But first of all, Salim, maybe the magnitude of the risk. You know, this is a box warning. So a box warning is as serious as one can have as far as warnings and precautions. It isn't so much the frequency, it is the severity, particularly torsades, right? Torsades for everyone on the call. I mean, we're talking about a risk of sudden cardiac death. There are numbers that are getting bantied around that it's one in a thousand. It's not. You don't typically see this as much in younger patients. So you really need to focus on the NPM1 population. And we're looking at maybe somewhere between one in a hundred or perhaps even more frequent than that. And I guess I would just put it to anyone, right? If you have two agents, both of which are efficacious, but one of which has a, you know, a one in a hundred or more chance of sudden cardiac death, what are you going to choose? I think that's where we feel increasingly confident based on the clinical data that's been presented at major medical meetings, it's published in JCO, you know, we're going to have a differentiated and favorable benefit-risk profile. And I think that'll start in the relapsed refractory setting. But to the comment about it's less relevant in the front line, the risk doesn't go away. In fact, you know, what you're dealing with is those patients are healthier, and they're presumably going to stay on therapy for much longer. So if anything, you want a more favorable benefit risk profile in that population, which means I think the ability to differentiate on a favorable safety profile that doesn't have a box warning for QTC prolongation and torsades becomes even more significant. Let's see. The last thing I'll say before I turn it over to Molly is the ASH abstract, there was a giant data dump. Despite comments from some others that there's really no room for another menin inhibitor, there's a lot of activity in the menin space from us and from other competitors. You can parse through the abstracts. What I think you'll see is that the benefit-risk profiles of the different agents are continuing to be defined as we go. draw your attention not only to the activity, and all of these agents are very active and that's good for patients, but the safety and tolerability is also coming much more into focus. And I would invite you to look at the various combinations. But Molly, let me invite you to add any thoughts or comments maybe to build on mine.

Absolutely. As Troy said, it's not the black box warning that in and of itself is something that to focus on, it's what it means the data has shown. And one of the best ways of understanding that is to look at the FDA's actual guidance document on the topic. It is very clear that once a drug causes at least a 20 millisecond change in the QTC prolongation, it is now considered to be significantly more likely to cause sudden cardiac death. It's not just torsades we're looking at, it's any ventricular arrhythmia. And so the risk just becomes so much more increased that that is why they put the black box. So it's understanding what data requires a black box warning that becomes really important in this situation and to patients who are trying to decide between options of what risks they are willing to take on and what risks they would rather avoid if they have the option to do so. And as Troy pointed out, while something like differentiation syndrome is very well mitigated in earlier lines with combination therapy, you would actually potentially expect more issues with the ability to handle, or at least equal issues with the ability to handle QTC prolongation just because of the various medications that are going to be given as concurrent therapies and as additional oncology therapies for these patients' treatments. And it becomes more complex when deciding how to administer a drug with QTC black box warning with other drugs that have QTC prolongation. And so dosing and monitoring become extraordinarily important versus if you're going to administer it as a monotherapy in the relapse refractory setting. And again, as Troy said, the right denominator for looking at this is really your elderly patients. Where in some of our competitors, we see you know, almost a 50% rate of QTC prolongation, that is going to be your NPM1 mutant patient population. So your NPM1 mutant patient population becomes a denominator that really is more appropriate for looking at these more severe QTC prolongations and episodes of torsades and sudden cardiac death.

Thank you. Our next question comes from Charles Yu at LifeSize Capital. Charles, unmute your line, please, and ask your question. Thank you.

Great. Hello, can you hear me? We can.

Hi, Charles.

Oh, perfect. Okay, great. Good morning, everyone. Thanks for the call and for taking the questions. So I guess with all of that in mind, for one, What kind of level of penetration or market share would you either expect or hope to achieve relative to your first mover competitor in the space, at least in the near term, the relapse refractory setting? And can you also perhaps give a little bit more color around the ongoing points of FDA regulatory engagement that seem to be continuing on as you head close to your PDUFA date? Thank you.

So, Charles, I don't want to scold you. You asked two questions. And so we'll answer the first one. And then if there's time after others, we'll come back and get the second one. So, Brian, could you please speak to Charles's first question relating to penetration and sort of how we're going to compete with our competitor who is out there with a first mover advantage?

Yeah, thanks Charles for that question. So we haven't guided on our market share penetration expectations quite yet, but what I can do is kind of just share some of the feedback and expectations we have. So we've conducted extensive engagements with treating physicians, KOLs, community practitioners, academics, and tested our profile and between a strong efficacy profile with good safety and tolerability that allows patients with the combinability and even the convenience of a once daily oral medication, all come out to factors that suggest that Zipdomenib has a best-in-class profile and that we'll be confident we'll be able to communicate on that best-in-class profile coming into the market. So without really guiding on any share calls quite yet, we anticipate Well, we give credit that we have a competitor who's already in the market, but we recognize that we anticipate both the skill of our team that we've hired that are ready to go and are ready to launch this product and the profile of the product are really going to help us to capture a majority share in this space.

Thanks, Brian. Danny, can we go on to the next question? Yeah.

Yes, as a gentle reminder, we please ask that you limit yourself to one question and then re-enter the queue for any follow-ups. Thank you. Our next question comes from Roger Song at Jefferies. Roger, please unmute your line and ask your question. Thank you.

Hey team, this is Nabil on for Roger. Thanks for taking my question. As we, just a quick one on the ASH data, so The early data looked pretty encouraging with the CR rates and MRD negativity. As we head into the meeting, what other analyses or long-term outcomes are we expecting to see, like durability? Will we have also subgroup insights? Thank you.

Yeah, thanks, Nabil, for the question. Molly, do you want to take Nabil's question?

Sure. As I said, you know, the biggest thing you'll see is much longer follow-up. You'll see more granularity around the MRD negativity, breaking it down so that you have maybe some, some comparisons that you can make to previous Venice data to understand if there is additional impact with a targeted agent added on and you'll see more durability, et cetera. And yes, we can, we will be breaking it down by subgroups. You'll understand what our flip three patients look like that were in the trial, what our, you know, IDH patients look like they were in the trial. So it should just be a much more even comprehensive view of the data that we have seen thus far in our rather large patient pool that we're being able to present in both the relapse refractory and the frontline setting where you're going to see, you know, 30 to 70 patients, which is extremely robust and able to to really show you more, maybe the truth of what these patient populations look like. So we're excited to share it with you.

Thank you. Our next question comes from Jason Zemanski at Bank of America. Jason, please unmute your line and ask your question. Thank you.

Good morning. Congrats on the great progress and thank you for taking our question. Troy, I wanted to ask a follow-up regarding the commercial launch and NPM one, but is having a differentiated label enough to overcome the second mover advantage? Um, you know, when you think about sort of prescriber inertia, um, is, is it more so that, that, you know, a, just, I guess, getting drug to patients. I mean, how do you, how do you overcome, uh, some of the hurdles here just given kind of the timelines? Thanks.

Sure. Maybe I'll just make a quick comment and then I'll let Brian take it because he's really the one who should speak to this. These physicians, I mean, you all talk to them, right? They are very sophisticated, constantly taking in new data and looking for options that offer the best benefit risk for their patients. The patients are also extremely sophisticated. They have, you know, all sorts of access to information. And they are, you know, again, others might say it's efficacy, efficacy, efficacy. Yeah, that's important. All of these agents are efficacious, right? That's the great thing for patients. And we should all celebrate the fact that patients have multiple options. But these docs are now having conversations with their patients about the risk benefit. And there's a striking difference between the relapsed refractory setting where a you know, a number of these patients are inpatient versus the frontline setting where our hope is that we send them home and they're able to stay on continuation therapy for months or even years. So Jason, I don't, I mean, I'm not going to deny there is an advantage to an incumbent, but I think when you're coming forward as we believe we are with a superior benefit-risk profile in a very competitive space, I think we will see the market reach its equilibrium. Brian, what thoughts would you like to add to my comments? Thanks, Troy.

I think, I mean, you captured it well, I think, but maybe just add just a couple of points that, you know, the advantage I think right now that you're seeing, there's a one-year advantage in the market potentially, but it's a few weeks, five weeks at most advantage in the MPM1 space. Our teams are out there, as I mentioned, we've been engaging, we've been spending the last year working with payers to ensure that they're going to be any kind of blocking available. And the profile of Zip2Metab, I think, really has resonated where payers wouldn't see a need to do something like that. So from an access perspective, we think that we'll have a very powerful, strong position in that space. You know, our goal is to build a distribution model that is seamless and easy for physicians and their practices to prescribe Zifto-Medib. One of the things that might be even more simplistic, as we talked about the simplicity, is that worry about inventory and dosing challenges things like that so there may be some advantages we think that we'll be able to capitalize on in the near term but i just go back finally to say that the the the field team that we've hired has extensive experience with these uh um these um practices they are itching to be out there to speak about uh are ready to go. And I feel like that, you know, if you give us the time for launch, I think you'll see that the profile that Troy outlined and our ability to execute is going to be on par better than anyone in the industry. So I'm very confident we'll have an opportunity to really, you know, overcome any second move or disadvantage that may be perceived.

And let me Thank you, Brian. That was great. Let me just add just a couple more thoughts, Jason, to your question. we're going to be promoting on labels. The label is going to be relapsed refractory NPM1 mutant AML, clearly the adult population. But as we indicated in the prepared remarks, and as you've seen, I think we have now the most comprehensive, and I would argue the most aggressive overall development program. We have two phase threes underway in intensive and non-intensive. We're combining with both FLT3 inhibitors. We have combinations with LDAC, with flagidae, And as Molly said, we're coming forward not with a handful of patients. We're coming forward with 20, 30, 40, 70, 100 patients at a time. So we're really giving, which is why... I think our two presentations at ASH are both orals. We have a massive development and medical affairs effort supporting our commercial launch. We won't be able to promote in those. We'll be publishing, we'll be educating, we'll be collaborating, but everyone is looking forward to combinations. Everyone's looking forward to earlier lines of therapy. Um, this is not, uh, this, you know, we're not looking at one quarter or even two quarters. Our goal is how do we make Ziftamentib, you know, the cornerstone therapy, uh, throughout the treatment continuum. And I think we have the right strategy to do that. As Brian said, you know, a few weeks, uh, coming behind isn't really going to make much of a difference at all. So appreciate the question.

Thank you. As a reminder, if you would like to ask a question during this session, please use the raised hand icon, which can be found at the bottom of your application window. Our next question comes from Rennie Benjamin at JMP Securities. Rennie, please unmute your line and ask your question. Thank you.

Great. Thank you. And congrats on all the progress. Thanks for taking the questions. I guess, Troy, you had mentioned in your prepared remarks regarding the joint launch meetings. I'd love to know, can you provide any sort of color in kind of what goes on in these meetings? How many people kind of what's the split between you and K.K.? ? Do you hit the ground running as soon as you get approval? Do you wait until next year? Just any sort of color as to how this will move forward. Thanks.

Yeah. Yeah, Ren, thanks for the question. This was the best launch meeting I've ever attended. It was electrifying. It really was. I mean, people are so excited to bring this therapy forward. But let me turn it over to Brian, who can maybe give you a bit more specificity about what the goals of the launch meeting were. and how the two teams came together as 1K to really move this forward. Brian? Sure. Thanks, Troy.

Yeah, Randy, so this launch meeting and typically what you'll do as you prepare is to bring the field teams together so that they're well-trained and ensure that they're ready to go in case we have an approval. You know, timing of a launch meeting, you can do them after you get approval. You can do them before. We tried to build a bit of a buffer. gives us an opportunity for the teams to be ready as close as possible to a potential approval. And essentially, this is a team where we had all of the field members that are both from Kio Akira and from Kura, that not just for our sales organizations that are going to be working together, we'll have the two field forces are going to be putting their efforts towards raising awareness and selling Zip2Med to the to the target physicians, but they're basically, we put that group together as well as our field market access teams, our field medical teams. And we spent several days just working through men in AML, the challenges for patients with relapsed refractory AML, did some certifications, pre-certifications for the team so they're ready to go and are prepared. As soon as we get to an anticipated FDA approval, the teams will then recertify on that final prescribing information and we'll be able to get out in the field immediately. We've We've been planning our our organizational readiness in case of an early approval. So the teams that I can say have been ready to go for at least since that meeting in October and probably even before that, we had all the rest of our organizational readiness put together. So so we've been trying to pull together that full team. And as Troy said, it was a really well executed meeting between both companies. And there's a tremendous amount of energy and readiness for that anticipated approval as soon as, you know, by end of November is our target to do for the day. We'll be ready to go.

Thank you. Our next question comes from Peter Lawson at Barclays. Peter, you may unmute your line and ask your question. Thank you.

Hey guys, it's Alex on for Peter. Thanks for taking our question. Just a quick one for me on what the label could look like. I guess, is there any potential for the monitoring requirements for differentiation syndrome to be different from other AML drugs?

Alex, you're asking, let me make sure I'm reading your question back. Are you asking, is there going to be potentially a difference in the monitoring requirements for DS in the label? Is that your question? Yeah, absolutely.

Yeah. Molly, do you want to? Yeah. Or how to address it just versus prior drugs. Yep. Thank you.

Yeah. Yeah, absolutely. So I, you know, obviously I don't want to comment on ongoing discussions. We're still nearing our PDUFA date. And so obviously things are still evolving. However, our differentiation syndrome guidance has been laid out in our protocols and in our IB for for years now and it is unchanged. I don't think that it is any additional monitoring that would be unexpected for this patient population in general who is regularly getting labs tested, et cetera. So, but let's wait and see and have a more fulsome discussion once we actually have hopefully the approval in hand.

Thank you. Thanks, Alex.

Thank you. Our next question comes from David Dye at UBS. David, unmute your line, please, and ask your question.

Great. Thanks for taking my questions. And I just want to come back to that, sort of the market dynamics between you and the competitors. So, Troy, I'm wondering, this is basically your pre-launch work you and Kira Kieran have been doing. Could you maybe share some initial feedback from physicians on how they're viewing the phytocephalus inhalability versus the competitor inhibitors in the space, the IPM1 space.

Yeah, David. I'm going to ask Brian to speak to that. As you can imagine, we've done a lot of market research and sought the opinions of KOLs and practicing physicians. But Brian, maybe you can speak to the lessons learned thus far about our Zip2Minutes profile relative to our competitors. Sure.

Thank you, David, for that question. So I'll speak to the feedback we received and really kind of aligning around four key parameters or pillars, you could call them. First is the efficacy. You know, we've tested the profiles of Zip2Meta relative to other potential meta inhibitor competition. And it seems that the view is that the efficacy is kind of a table stakes to get in. and then you'll see that the CRCRH duration response things like that are seem to be relatively similar. Safety and tolerability is something that did stand out as a differentiator between Zipdomenib and other products, which that alone, as Troy said, is not, you know, safety is not something that wins on a product, but it's that balance of benefit and risk and the tolerability of that really things can tip the scales. The other two pillars around that we found really helped to differentiate Zipdomenib Zipdomenib is one around the combinability with current concomitant medications. As Troy mentioned, we're going to be focusing on our on-label use emotionally, which is going to be in that relapse refractory monotherapy space. But those patients typically get concomitant meds like Azols and others to manage the challenges of being a relapse refractory ML patient. And the combinability, the simplicity of a dose where you don't have to do a lot of modifications seems to be meaningful for physicians as well and for patients because it's more straightforward. And then finally, the third was around simplicity. Once a day, daily dosing, there's one dose that most patients or all patients really need is at that 600 milligram dose is very straightforward. And imagine for an NPM1 relapse refractory patient who is typically in the elderly population, the simplicity of having that once daily dose is also meaningful. So that's really kind of what we've heard is that there are, of course, we've also heard, as Troy said, anything, any therapies for these patients are really going to be important that can deliver some efficacy. But when you have choices, that's when you start to parse out what those differences may be. And that's where we feel pretty confident in the profile of Zyftamidib as a differentiated agent coming into the market.

Thank you. We will now allow follow-up questions. Our first follow-up question is from Lee. Lee, what's that at Cantor Fitzgerald? Please unmute your line and ask your follow-up. Thank you.

Hey, guys, thanks for taking my second question. And I guess just given the recent disruptions at FDA, including within CDER, I'm just curious, have you noticed or anticipate any changes in terms of, you know, cadence and discussions with agencies?

Short-answerly, we haven't noticed any difference. We don't anticipate any difference. You know, we're on track for our November 30th PDUFA date. I think we characterized the interactions with the agency as open and constructive. You know, we don't know what we don't know, but I think at this point, we feel like we're in good shape and we're tracking toward, you know, a positive review outcome. The path to approval in AML is much better precedented than some of these other instances. The fact that we have a competitor who was just approved in the same indication just a few weeks before, I think, gives us good confidence that we're on track. But obviously, we'll continue to stay vigilant. And Molly and her regulatory team are doing a terrific job. But so far, it's all systems are go.

There are no further questions at this time. So I would now like to turn the call back over to Troy Wilson for our closing remarks. Thank you.

Thank you, Dani. Thank you all once again for joining the call today and for your questions and the discussion. We'll be participating in the Jefferies Investor Conference in London later this month. And just as a reminder, we'll also be hosting a virtual analyst and investor event next on December 8th at the ASH annual meeting in Orlando. So we'll look forward to speaking with many of you at these events. As we move forward, our focus remains on executing with discipline, investing wisely, and advancing a pipeline designed to make a real difference for patients. With our pipeline, our experienced, passionate team, and a strong balance sheet, we think we're well positioned to deliver long-term value for both our patients and our shareholders. Until our next update, if you have any additional questions, you know how to find us. Please reach out. Thank you all once again, and we hope you all have an enjoyable Tuesday morning and a productive day. With that, we'll adjourn the call. Thanks, everyone.