Earnings Call Transcript - KURA Q3 2025

Operator, Operator

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.

Troy Wilson, CEO

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 ziftomenib, 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 the 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 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 a 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 the 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 non-intensive 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 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, Kyowa Kirin, held a joint launch readiness meeting where our 2 field teams of Kura and Kyowa Kirin, whom 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. Darlafarnib 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 the 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.

Thomas Doyle, CFO

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 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, Kura 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.

Troy Wilson, CEO

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.

Unknown Analyst, Analyst

This is Albert Agustin on for Jonathan Chang. What do you anticipate will be the types of accounts you are targeting for the zifto launch? Are there specific account types you are concentrating on? Additionally, are there plans to include zifto in the NCCN guideline?

Troy Wilson, CEO

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.

Brian Powl, Chief Commercial Officer

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 large academic institutions as well as 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.

Li Wang Watsek, Analyst

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.

Troy Wilson, CEO

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

Mollie Leoni, Chief Medical Officer

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.

Salim Syed, Analyst

I really like the new format of the call and appreciate it. Troy, I have a question regarding the new label we received from Syndax, which now includes Tsad and the black box. There seems to be differing opinions on whether this is significant or not. What does it mean for you and for the industry as you plan for the NPM1 launch and progress towards the first line, particularly given that some believe it may not matter since Tsad might not be as visible in that setting? I'm interested in your perspective as the industry continues to evolve.

Troy Wilson, CEO

Yes, thank you for the question, and I'm glad you like the new format. There’s a lot we can discuss regarding this topic. We'll have more information to share soon if we receive approval for ziftomenib on our upcoming action date. First, I want to address the potential risk involved, especially since it carries a boxed warning, which indicates a serious level of caution. It’s more about the severity than the frequency, particularly concerning torsades. For context, torsades can lead to sudden cardiac death. While there are various estimates suggesting a risk of 1 in 1,000, that’s misleading. This isn't as commonly seen in younger patients, so it's essential to focus on the NPM1 population, where the risk could be closer to 1 in 100 or potentially more frequent. If presented with two effective agents, one of which carries a 1 in 100 or higher risk of sudden cardiac death, how would you proceed? Our confidence is growing based on the clinical data we've presented at major medical meetings and published in JCO, indicating that we expect a distinct and favorable benefit-risk profile, starting with those who have relapsed or refractory conditions. However, regarding its relevance in the frontline setting, the risk doesn't diminish. In fact, healthier patients will likely remain on therapy longer, emphasizing the need for a more favorable benefit-risk profile in that group. Lastly, I want to mention the recent ASH abstracts, which presented significant new data. Despite some opinions suggesting there’s no need for another menin inhibitor, activity in this space is substantial from us and other competitors. As you review the abstracts, you'll find that the benefit-risk profiles of these agents are still being established. It’s important to not only note the effectiveness of these agents, which is promising for patients, but also to consider their safety and tolerability as they become clearer. Now, I would like to invite Mollie to share her insights or add to my comments.

Mollie Leoni, Chief Medical Officer

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 a 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 torsade and sudden cardiac death.

Yue-Wen Zhu, Analyst

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?

Troy Wilson, CEO

So Charles, I don't want to scold you. You asked two questions. We will answer the first one, and then if there's time after others, we will come back to the second one. Brian, could you please address Charles' first question about penetration and how we will compete with our competitor who has a first-mover advantage?

Brian Powl, Chief Commercial Officer

Thank you for the question, Charles. We haven’t provided specific guidance on our market share expectations yet. However, I can share some insights from our feedback and expectations. We’ve engaged extensively with treating physicians, key opinion leaders, community practitioners, and academics, and have tested our product’s profile against others. The benefit-risk balance, characterized by a strong efficacy and safety profile, allows for effective patient management. Additionally, the convenience of a once-daily oral medication contributes to a profile that suggests ziftomenib has the potential to be best-in-class. While we are not providing specific market share guidance at this point, we acknowledge that our competitor is already established in the market. However, we are confident that the skills of our newly hired team and the product's profile will help us capture a significant share in this space.

Unknown Analyst, Analyst

This is Na Phil on for Roger. The early data from ASH looks quite encouraging with the CR rates and MRD negativity. As we approach the meeting, what other analyses or long-term outcomes, such as durability, are we expecting to see? Will there also be insights into subgroups?

Troy Wilson, CEO

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

Mollie Leoni, Chief Medical Officer

Sure. The main point you'll notice is a significantly longer follow-up period. We'll provide more detailed information regarding MRD negativity, allowing for comparisons to earlier ven/aza data to assess any additional effects from the targeted agent. You can also expect to see greater durability in the results. We will be breaking down data by subgroups, giving a clearer picture of our FLT3 and IDH patients who participated in the trial. This will offer a much more comprehensive view of the data we've gathered from our extensive patient pool, which will be presented in both the relapsed/refractory and frontline settings, showcasing 30 to 70 patients. This should provide a robust insight into these patient populations, and we are eager to share this with you.

Jason Zemansky, Analyst

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 timelines?

Troy Wilson, CEO

Sure. I'll make a brief comment and then hand it over to Brian, as he should address this better. The physicians you speak with are quite sophisticated; they constantly review new data and seek options that provide the best benefit-risk for their patients. Patients, too, are very informed and have access to various information. While efficacy is essential, these doctors are increasingly discussing risk and benefit with their patients. There is a notable contrast between the relapsed/refractory setting, where many patients are hospitalized, and the frontline setting, where we hope to send patients home to continue therapy for months or even years. So, Jason, while I acknowledge there is an advantage to established players, I believe that as we introduce a product with a superior benefit-risk profile in a competitive landscape, the market will find its balance. Brian, do you have any additional thoughts on my comments?

Brian Powl, Chief Commercial Officer

Thanks, Troy. You captured it well, but I'd like to add a couple of points. Right now, there's a one-year advantage in the market potentially, but we're looking at a few weeks, at most five weeks, of advantage in the NPM1 space. Our teams have been actively engaging and working with payers over the past year to ensure there won't be any obstacles. The profile of ziftomenib has resonated well, leading payers to see no need for blocking access. We believe we will have a strong position in that area. Our goal is to develop a distribution model that is seamless and easy for physicians to prescribe ziftomenib. One simplification is that we will have a single SKU, eliminating concerns over multiple SKUs and related inventory and dosing challenges. We see potential advantages to capitalize on in the near term. Finally, our field team, which has extensive experience, is eager to discuss ziftomenib and is ready for launch. If given the time, I believe our abilities to execute will be on par or better than anyone in the industry, allowing us to overcome any perceived second mover disadvantages.

Troy Wilson, CEO

Thank you, Brian. That was great. I just want to add a few more thoughts, Jason, regarding your question. We will be promoting on label for relapsed/refractory NPM1 mutant AML, primarily targeting the adult population. As we mentioned earlier, I believe we now have the most comprehensive and aggressive overall development program. We have two Phase IIIs in progress, both intensive and non-intensive, and we are combining therapies with both FLT3 inhibitors and LDAC, as well as FLAG-IDA. As Mollie mentioned, we are not approaching this with a small number of patients, but rather with groups of 20, 30, 40, 70, or even 100 at a time. This is why our two presentations at ASH will be oral. We have a substantial development and medical affairs effort to support our commercial launch. While we cannot promote in certain areas, we will focus on publishing, educating, and collaborating. There is a high interest in combinations and earlier lines of therapy. We are not looking at just one or two quarters; our objective is to establish ziftomenib as the cornerstone therapy throughout the treatment continuum, and I believe we have the right strategy for that. As Brian stated, a few weeks behind will not significantly impact us, and I appreciate the question.

Reni Benjamin, Analyst

Congratulations on all the progress. Troy, you mentioned in your prepared remarks about the joint launch meetings. Can you provide some details about what happens in these meetings? How many participants are typically involved, and what is the division of responsibilities between you and KK? Do you start working right after you get approval, or do you hold off until next year? Any insights on how this will move forward would be appreciated.

Troy Wilson, CEO

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 Powl, Chief Commercial Officer

Yes, definitely. Thank you, Ty. Reni, in preparation for the launch meeting, we bring our field teams together to ensure they are well trained and ready in the event we receive approval. The timing for this meeting can happen either before or after we obtain approval. We aimed to create a buffer, with October being the target to have our teams prepared as closely as possible to a potential approval. This gathering included field members from both Kyowa Kirin and Kura, spanning all sales organizations that will collaborate. Both field forces will focus on raising awareness and promoting ziftomenib to targeted physicians. We also integrated our field market access and field medical teams. We spent several days discussing the role of menin in AML, the challenges faced by patients with relapsed/refractory AML, and conducting some preliminary certifications to ensure our team is prepared. As soon as we receive the anticipated FDA approval, our teams will re-certify on the final prescribing information, allowing us to deploy into the field immediately. We have been preparing for our organizational readiness in anticipation of an early approval. The teams have been on standby since our October meeting and likely even before, as we completed all our organizational preparations. We have been working hard to assemble the entire team. As Troy mentioned, the meeting was executed very well by both companies, generating significant energy and enthusiasm for the anticipated approval, which we are targeting to occur by the end of November, aligning with our PDUFA date. We're ready to go.

Alexandre Bouilloux, Analyst

It's Alex standing in for Peter. I have a quick question regarding what the label might look like. Is there a possibility that the monitoring requirements for the differentiation syndrome could differ from those of other AML drugs?

Troy Wilson, CEO

Alex, let me confirm that I'm understanding your question correctly. Are you asking if there will be a difference in the monitoring requirements for DS in the label?

Mollie Leoni, Chief Medical Officer

Yes, regarding how to address it compared to previous drugs, I don't want to discuss ongoing conversations as we approach our PDUFA date. Things are still evolving. However, our guidance on differentiation syndrome has been established in our protocols and investigator brochures for years and remains unchanged. I don't believe there will be any unexpected additional monitoring for this patient population, who are typically undergoing regular lab testing. Let's wait for the approval before having a more comprehensive discussion.

David Ruch, Analyst

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 NPM1 space?

Troy Wilson, CEO

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.

Brian Powl, Chief Commercial Officer

Thank you, David, for your question. I would like to share the feedback we've received and highlight four key aspects. The first is efficacy. We've compared ziftomenib's profiles to other potential menin inhibitors, and it's clear that efficacy is essential to enter the market. The CR/CRh, duration of response, and similar metrics appear to be fairly comparable. Safety and tolerability emerged as a distinguishing factor between ziftomenib and other products. While safety alone does not guarantee a product's success, the balance of benefit and risk along with tolerability makes a significant impact. The second aspect that helps differentiate ziftomenib is its combinability with current medications. As Troy mentioned, our promotional focus will be on on-label usage, primarily in the relapsed/refractory monotherapy space. Patients in this category often require concomitant medications like azoles to manage the challenges associated with relapsed/refractory AML. The easy combinability and straightforward dosing, which require minimal adjustments, are important for physicians and beneficial for patients. Lastly, the simplicity of dosing is another critical factor. Once-daily dosing at a 600-milligram dose is very straightforward, especially for elderly patients with NPM1 relapsed/refractory conditions. The ease of a once-daily dose is significant. Overall, we've learned that while any therapies for these patients are valuable and focus on efficacy, having options allows us to highlight the differences. We feel confident about the profile of ziftomenib as a differentiated product entering the market.

Li Wang Watsek, Analyst

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?

Troy Wilson, CEO

Short answer, Li, we haven't noticed any difference and don't expect any. We're on track for our November 30 PDUFA date. We view our interactions with the agency as open and constructive. While there are uncertainties, we feel confident about our position and are aiming for a positive review outcome. The approval path in AML is more established compared to other cases. The recent approval of a competitor in the same indication boosts our confidence that we're on the right track. We'll remain vigilant, and Mollie and her regulatory team are doing an excellent job. For now, everything is proceeding as planned.

Operator, Operator

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.

Troy Wilson, CEO

Thank you, Danny. Thank you all once again for joining the call today and for your questions and the discussion. We'll be participating at 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 on December 8 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 experience, 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.