KURA - NASDAQ

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" Cantor Fitzgerald & Co., Research Division

" BofA Securities, Research Division

" LifeSci Capital, LLC, Research Division

Good day, everybody. My name is Danny, and I will be your conference operator today. At this time, I would like to welcome you to the Kura Oncology Third Quarter 2025 Conference Call. [Operator Instructions]. At this time, I would like to turn the call over to Greg Mann from Kura Oncology.

Thank you. Thank you, Danny. Good morning, and welcome to Kura 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. Mollie Leone, Chief Medical Officer; and Brian Powl, 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 Kura's filings with the SEC, which are available from the SEC or on the Kura Oncology website for information concerning risk factors that could affect the company. With that, I'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 ziftomenib, 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 ziftomenib 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 KOMET-001 study, which has been presented at a major medical meetings and published in the Journal of Clinical Oncology in September, we're confident ziftomenib has a differentiated and favorable benefit risk profile. And if approved, ziftomenib could potentially reset the commercial landscape and become the menin inhibitor of choice for eligible patients. Although while the regulatory review process for ziftomenib 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 ziftomenib'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 ziftomenib with 7+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+3 alone. These results highlight ziftomenib's potential as an early intervention, offering a meaningful opportunity to improve patient outcomes. Yesterday, we announced acceptance of 2 oral presentations at ASH, which will feature data on ziftomenib 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 20, 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 8, 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 KOMET-017 frontline Phase III trials. KOMET-017 comprises 2 randomized, double-blind, placebo-controlled trials to evaluate ziftomenib in combination with both intensive 7+3 and non-intensive ven/aza chemotherapy regimens in patients with newly diagnosed NPM1 mutant or KMT2A rearranged AML. The program aims to advance ziftomenib 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 KOMET-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 nonintensive chemotherapy combination study assesses CR and overall survival. Site activation is accelerating in each of these company-sponsored registrational trials and patient enrollment is progressing well. Continuing this momentum, last month, we opened a trial cohort to assess ziftomenib combined with 7+3 induction chemotherapy and quizartinib, an approved FLT3 inhibitor in patients with newly diagnosed AML harboring FLT3-ITD NPM1 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 ziftomenib and quizartinib synergize to enhance activity without undue toxicity. Note, this effort also builds on our clinical experience with the combination of ziftomenib and gilteritinib 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, ziftomenib development is active in all 3 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 ziftomenib is approved. Our disease awareness campaigns have exceeded their targets. Our preapproval 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, Kyowa Kirin, held a joint launch readiness meeting where our 2 field teams of Kura and Kyowa Kirin what we finally call 1K completed their training and precertification. 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 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 label 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 KURRENT-HN trial evaluates tipifarnib, our first-generation FTI with alpelisib 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 alpelisib 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, darlaifarnib represents a very substantial commercial opportunity with the potential to address more than 200,000 incident patients annually in the U.S. 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 Kura with 2 clinically validated mechanisms that address some of the most pressing needs in precision oncology. We expect to have more to share regarding our FTI clinical development plans and business development strategy in 2026, supported by a steady cadence of data presentations at medical meetings throughout the year. Kura remains in a strong financial position to execute across our pipeline, advance the development of ziftomenib and support our commercialization activities. Our partnership with Kyowa Kirin has enabled us to invest in a robust, expansive and accelerated development plan for ziftomenib. We recently received 2 $30 million milestone payments payable for the first patients dosed in the 2 KOMET-017 Phase III 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 ziftomenib. This is consistent with the $420 million in near-term milestones we announced at the inception of the partnership with Kyowa Kirin 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 Kyowa Kirin 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 of 2025 were $32.8 million compared to $18.2 million for the same period of 2024. Net loss for the third quarter of 2025 was $74.1 million compared to a net loss of $54.4 million for the third quarter of 2024. This included noncash 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. As adjusted for the $60 million in KOMET-017 milestone payments under our collaboration agreement with Kyowa Kirin, Kura had on a pro forma basis, $609.7 million in cash, cash equivalents and short-term investments as of September 30, 2025. Based on our current operating plans, we believe that our cash, cash equivalents and short-term investments as of the end of the third quarter will be sufficient to fund our current operating expenses in 2027. And if we include anticipated collaboration funding under the Kyowa Kirin agreement, Kura's financial resources should support advancement of our ziftomenib 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 ziftomenib and our menin inhibitor programs, we look forward to continued engagement with FDA reviewers as we approach our PDUFA target action date of November 30 for ziftomenib as 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 KOMET-007 cohorts evaluating ziftomenib in combination with ven/aza at the ASH Annual Meeting to be held next month in Orlando. And finally, presenting preliminary clinical data from the KOMET-008 cohort evaluating ziftomenib in combination with the FLT3 inhibitor gilteritinib 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, Danny, we're ready to begin the question-and-answer session.

[Operator Instructions] Our first question today comes from [ Jonathan Chang ] at Leerink Partners.

This is [ Albert Agustin ] on for [ Jonathan Chang ]. What do you foresee will be the makeup of account types that you are trying to penetrate for zifto launch? Are there any particular account types that you are focusing on? And also, are there any plans to include zifto in the NCCN guideline?

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 2 questions in turn.

Sure, 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 academic -- large academic institutions as well as in some of the larger community oncology practices. It's going to be similar. Well, I think we get into our overall targeting strategy. We have probably about 4,000 HCPs that we're targeting. Within that range, I'd say, probably 78% of that is going to be in the academic setting, and then we'll have -- 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, yes, our plans are to submit the KOMET-01 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.

Our next question comes from Li Watsek at Cantor Fitzgerald.

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? Yes.

Thanks, Li, for the question. Mollie, do you want to take that one?

Sure. As Troy pointed out, 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 Salim Syed of Mizuho Securities.

I love the revised format of the call. I appreciate it. I guess one for us, Troy, maybe just on the new label that we got from Syndax, which includes Tsad now and the black box. Just curious, there seems to be varying views on if this actually matters or not. Just what does it mean for you? What does it mean for the space as you think about your own NPM1 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 because first line maybe is -- you wouldn't see Tad as much. But curious to just get your view as the space evolves here.

Yes. Salim, thanks for the question, and glad you're appreciating the new format. This is -- 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 ziftomenib here coming up very quickly on our PDUFA action date. A few thoughts. And I'm going to give my comments, and I'm going to ask Mollie for her because she really needs to speak to this from a clinical perspective. But first of all, Salim, maybe the magnitude of the risk. 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 tors, right? Tors 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 1 in 1,000, 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 1 in 100 or perhaps even more frequent than that. And I guess I would just put it to anyone, right? If you have 2 agents, both of which are efficacious, but one of which has a 1 in 100 or more chance of sudden cardiac death, what are you going to I think that's where we feel increasingly confident based on the clinical data that's been presented at major medical meetings that's published in JCO, we're going to have a differentiated and favorable benefit risk profile. And I think that will 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, what you're dealing with is those patients are healthier, therefore -- 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 you -- your -- the ability to differentiate on a favo. Let's see. I would -- the last thing I'll say before I turn it over to Mollie 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 go -- you can parse through the abstracts. What I think you'll see is that the benefit risk profiles of the difUFnt agents are continuing to be defined as we go. And I would 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 Mollie, 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 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 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' treatment. 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 relapsed/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 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 tors and sudden cardiac death.

Our next question comes from Charles

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 in the relapsed/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?

So Charles, I don't want scold you. You asked 2 questions. And so we're going to -- 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' 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?

Yes. 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 relative to others. And I think that the benefit risk balance and between a strong efficacy, safety -- efficacy profile with good safety and tolerability that allows patients to be able to be well managed, along with the combinability and even the convenience of a once-daily oral medication, all come out to factors that suggest that ziftomenib 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 our competitor is 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.

[Operator Instructions] Our next question comes from Roger Song at Jefferies.

This is Na Phil on for Roger. As we -- just a quick one on the ASH data. So the early data look 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?

Yes. Thanks, Na Phil, for the question. Mollie, do you want to... Take Na Phil's question?

Sure. As I said, 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 comparisons that you can make to previous ven/aza 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 FLT3 patients look like that were in the trial, what our IDH patients look like that 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'll be able to present in both the relapsed/refractory and the frontline setting where you're going to see 30 to 70 patients, which is extremely robust and able to really show you more maybe the truth of what these patient populations look like. So we're excited to share it with you.

Our next question comes from Jason

Congrats on the great progress. Troy, I wanted to ask a follow-up regarding the commercial launch in NPM1. But is having a differentiated label enough to overcome the second mover advantage when you think about sort of prescriber inertia? Is it more so that just, I guess, getting drug to patients? I mean, how do you overcome some of the hurdles here just given kind of the time lines?

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 all sorts of access to information. And they are -- again, others might say it's efficacy, efficacy, efficacy. Yes, that's important. All of these agents are 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 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, any -- what thoughts would you like to add to my comments?

Thanks, Troy. I think -- I mean, you captured it well, I think, but what I'd maybe just add just a couple of points that -- the advantage, I think, right now that you're seeing -- there's a 1-year advantage in the market potentially, but it's a few weeks, 5 weeks at most advantage in the NPM1 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 there is not going to be any kind of blocking available. And the profile of ziftomenib, 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 kind of a very powerful strong position in that space. Our goal is to build a distribution model that is seamless and easy for physicians and their practices to prescribe ziftomenib. One of the things that might be even more simplistic as we talked about the simplicity is that we'll have one SKU. We're not going to have multiple SKUs of different products that they have to 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 would just go back finally to say that the field team that we've hired has extensive experience with these practices. They are itching to be out there speak about ziftomenib and they're ready to go. And I feel like that 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 or better than anyone in the industry. So I'm very confident we'll have an opportunity to really 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 are going to be promoting on label. 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 2 Phase IIIs underway in intensive and nonintensive. We're combining with both FLT3 inhibitors. We have combinations with LDAC, with FLAGIDA. 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 -- and which is why I think we have -- our 2 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 is looking forward to earlier lines of therapy. This is not -- we're not looking at 1 quarter or even 2 quarters. Our goal is how do we make ziftomenib the cornerstone therapy throughout the treatment continuum. And I think we have the right strategy to do that. As Brian said, a few weeks coming behind isn't really going to make much of a difference at all. So I appreciate the question.

[Operator Instructions] Our next question comes from Reni Benjamin at JMP Securities.

Congrats on all the progress. I guess, Troy, you had mentioned in your prepared remarks regarding the joint launch meetings. I'd love to -- 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 KK? Do you wait for the -- 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.

Yes, 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 2 teams came together as 1K to really move this forward. Brian?

Yes, sure. Thanks, Ty. Yes, Reni so this launch meeting and typically what you will do as you prepare is to bring the field teams together so that they're well trained and ensured that they're ready to go in case we have an approval. 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 where we thought October 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 Kyowa Kirin and from Kura that not just for our sales organizations that are going to be working together. We'll have the 2 field forces are going to be putting their efforts towards raising awareness and selling ziftomenib 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 understanding the role of menin in AML, the challenges for patients with relapsed/refractory AML, did some certifications, precertifications 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 been planning our organizational readiness in case of an early approval. So the teams have -- 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 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 by end of November is our target PDUFA date, we'll be ready to go.

Our next question comes from Peter Lawson at Barclays.

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

Alex, you're asking is -- 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?

Yes.

Mollie, do you want to...

Yes, for how to address it just versus prior drugs. Yes. No, absolutely. So I -- 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 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.

Our next question comes from David Ruch at UBS.

And I just want to kind of come back to that sort of the market dynamics between you and your competitors. So I'm wondering based on your prelaunch work you and have been doing, could you maybe share some initial feedback from physicians on how they're efficacy and tolerability versus competitor inhibitors in the space, the IPM1 space?

Yes, David. I'm going to ask Brian to speak to that. As you can imagine, we've done kind of 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 ziftomenib's profile relative to our competitors.

Sure. Thank you, David, for that question. So the -- I'll speak to the feedback we've received and really kind of align it around 4 key parameters or pillars, you could call them. First is the efficacy. We've tested the profiles of ziftomenib relative to other potential menin inhibitor competition. And it seems that the view is that the efficacy is kind of the table stakes to get in. You'll see that the CR/CRh, duration of response, things like that are seem to be relatively similar. Safety and tolerability is something that did stand out as a differentiator between ziftomenib and other products, which that alone, as Troy said, is not -- 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 hit the scales. The other 2 pillars around -- that we found really help to differentiate ziftomenib is one around the combinability with current -- with current concomitant medications. As Troy mentioned, we're going to be focusing on our on-label use promotionally, which is going to be in that relapsed/refractory monotherapy space. But those patients typically get concomitant meds like azoles and others to manage the challenges of being a relapsed/refractory AML patient. And the combinability and the simplicity of a dose where you don't have to do a lot of modifications seems to be meaningful for physicians as well because -- 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 each -- most patients or all patients really need at that 600-milligram dose is very straightforward. And imagine for an NPM1 relapsed/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 ziftomenib as a differentiated agent coming into the market.

Our first follow-up question is from Li Watsek at Cantor Fitzgerald.

And I guess just given the recent disruptions at FDA, including within CEDAR, just curious, have you noticed or anticipate any changes in terms of cadence and discussions with the agency?

Short answer, Lee, we haven't noticed any difference. We don't anticipate any difference. We're on track for our November 30 PDUFA date. I think we characterize the interactions with the agency as open and constructive. We don't know what we don't know. But I think at this point, we're -- we feel like we're in good shape, and we're tracking toward a positive review outcome. The path to approval in AML is much more -- 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 Mollie 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.