Q3 2025 Kura Oncology Inc Earnings Call

Speaker #1: At this time, I would like to welcome you to the Kura Oncology third quarter 2025 conference call. To all lines have been placed on mute to prevent any background noises.

Speaker #1: After the speakers' 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.

Speaker #1: 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.

Speaker #1: At this time, I would like to turn the call over to Greg Mann from Kura Oncology. Thank you.

Speaker #2: 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 Leoni, Chief Medical Officer, and Brian Powl, Chief Commercial Officer, are also on the call and available to answer questions.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: With that, I'll turn the call over to Troy.

Speaker #3: 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 Zipto-Menip, our once-daily investigational menin inhibitor for acute myeloid leukemia.

Speaker #3: I'll begin with an update on Zipto followed by a brief remarks on our commercial readiness and our pharmaceutical transfer inhibitor program. The FDA review of Zipto-Menip for treatment of patients with relapsed and refractory NPM1 mutated AML remains on track, with a PDUFA target action date of November 30th, 2025.

Speaker #3: 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 a major medical meeting and published in the Journal of Clinical Oncology in September, we're confident Zipto-Menip has a differentiated and favorable benefit-risk profile and, if approved, Zipto-Menip could potentially reset the commercial landscape and become the menin inhibitor of choice for eligible patients.

Speaker #3: Although while the regulatory review process for Zipto-Menip 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 Zipto-Menip's benefit-risk profile will be even more competitive and more impactful for patients.

Speaker #3: At EHA earlier this year, we reported updated combination data for Zipto-Menip with seven plus three intensive chemotherapy in newly diagnosed NPM1 mutant and KMT2A rearranged AML.

Speaker #3: 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 seven plus three alone.

Speaker #3: These results highlight Zipto-Menip'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 Zipto-Menip in combination with venetoclax and azacitidine chemotherapy.

Speaker #3: 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.

Speaker #3: The abstracts used data cutoff of June 25th, 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 PM Eastern Time.

Speaker #3: Details will be available on our website. Encouraged by these positive results, we've advanced rapidly into our COMET-017 frontline phase three trials. COMET-017 comprises two randomized double-blind placebo-controlled trials to evaluate Zipto-Menip in combination with both intensive seven plus three and non-intensive Veneza chemotherapy regimens in patients with newly diagnosed NPM1 mutant or KMT2A rearranged AML.

Speaker #3: The program aims to advance Zipto-Menip to the frontline setting with potential to treat patients earlier in their disease course when the opportunity to alter its trajectory is greatest.

Speaker #3: We're targeting enrollment at over 150 global sites, with a large proportion in the US. Each COMET-017 trial includes dual primary endpoints to support potential US accelerated and full approvals.

Speaker #3: 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.

Speaker #3: Site activation is accelerating in each of these companies' sponsored registrational trials, and patient enrollment is progressing well. Continuing this momentum last month, assess Zipto-Menip combined with seven plus three induction chemotherapy and Quizartinib, and 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.

Speaker #3: Our preclinical studies suggest Zipto-Menip and Quizartinib synergize to enhance activity without undue toxicity. Note this effort also builds on our clinical experience with the combination of Zipto-Menip and Gilteritinib in the relapsed refractory NPM1 mutant setting.

Speaker #3: Enrollment in that trial has been robust, and we intend to present preliminary phase one data at a major medical meeting next year. With these studies now underway, Zipto-Menip development is active in all three major frontline settings, collectively representing up to 50% of incident AML cases in the US.

Speaker #3: 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 Zipto-Menip is approved.

Speaker #3: 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.

Kuro remains in a strong financial position to execute across our pipeline Advance, the development of zip, tamev and support our commercialization activities, our partnership with Kyo, Kirin has enabled us to invest in a robust, expansive and accelerated development plan for zip to many. We recently received 2 30 million Milestone payments

Uh payable for the first patients, dosed in the 2 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 zip domenic. This is consistent with the 420 million in near-term. Milestones we announced at the Inception of the partnership with Kieran last November.

We reported pro forma, cash at 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 for our qo care and Partnerships. 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 at 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 $72.4 million.

As adjusted for the 60 million in Comet, 017 Milestone payments. Under our collaboration agreement, with keto caring for a hat, on a pro form of basis 609.79 in cash, cash equivalents and short-term Investments as 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 third quarter will be sufficient to fund our current operating expenses and in 2027, and if we include anticipated collaboration, funding under tequila, caring agreement, kuris Financial Resources should support advancement of our ZIP code and ml program through Topline results and our Frontline combination program.

With that. I'll try to 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.

Inhibitor programs. We look forward to continued engagement with FDA reviewers, as we approach our Padua Target action date of November 30th for zip de as a monotherapy for patients with relaxed refractory npm1 beaten ml.

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 COMET 00007 cohorts, evaluating Zipmen in combination with Vasa at the ASH annual meeting to be held next month in Orlando.

And finally presenting preliminary clinical data from the comment 008 cohort, evaluating zip to Manu in combination with the 3 in or guilt written nib in patients with relapsed refractory npm1 mutant AML and 2026.

For our Forrestal transfer its inhibitor programs. We expect to initiate 1 or more expansion cohorts of Darla fahrney in Capo. Antip, in patients with Advanced renal cell carcinoma in the first half of 2026,

% updated dose escalation data from the combination of Darla Farab and Khabaz Antibody in advanced renal cell carcinoma in 2026.

To present clinical data from the combination of Darla Farah banana. Grasset in patients with cos g12c. Mutated solid tumor indications in 20206

With that Danny, we're ready to begin the question and answer session.

Thank you. We will now move to our question and answer session.

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Once again, we ask that you please limit yourself to 1 question and then re-enter the queue 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. Um this is Albert. Augustine's on for Jonathan Chang. Thank you for taking my questions.

Um, what do you foresee will be the makeup of account types that you are trying to penetrate for a zip to? Launch are there any particular account types that you are focusing on and also, are there any plans to enforce include zip code in the nccn guideline? Thank you.

Sure. Uh thanks Albert for uh uh in general, we're going to try to limit it to 1 question. Um, the the second 1 is easy uh but but please, if folks can limit it to 1 question so we can get everybody. Uh, Brian. Let me ask you, if you, if you can take Albert's 2 questions in turn

Sure, absolutely. Thanks Albert for the questions. Um, so our, uh, our expected account types here, um, are typically going to be the specialty, uh, hematologists. Um, we we anticipate a mix of academic large academic institutions as well as in some of the larger, uh, Community oncology practices. Um, it's going to be similar. We we'll, I think we get into our overall targeting strategy, but probably about 4,000, hcps that we're targeting, um, within that um, range of let's say, probably 78% of that is going to be the academic setting. And then we'll have the rest of the focus will be on the community oncology practices, that that are treating those AML patients and and particularly the relapse of trafficking patients. Um, to your second question just to quickly to answer. Yeah, we our plans are to submit uh um the common 01 uh data on the basis of of our approval. Um, soon after approval, you can't submit to the nccn for a listing until you have FDA approval. So our plans are to submit

Submit that within days of approval.

Thank you. Our next question comes from Lee WhatsApp at Cantor. Fitzgerald, please unmute your line, and ask your question, Lee.

Uh, Hey guys, congrats on the progress. Um, maybe just 1 on the ash update. Um, can you just talk about what we should expect poorly? Um, actual oral presentations versus what seeing the abstract release yesterday?

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

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

our next question comes from. Saleem sad at mizuho securities.

Seline, please unmute your line and ask your question. Thank you.

Great. Uh thanks for the question guys. And uh love the revised format of the call um appreciate it. Um I guess 1 for us uh Troy maybe just on the the new label that we got from syndex which includes torsades now in the Black Box, just curious, you know there's it seems to be very in view some if this actually matters or not.

Um 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 through the view out there that it doesn't matter. Because first line maybe is, you know,

You wouldn't see the tour size as much, but it's curious to get your view is, is the space of all here. Thank you.

To say, um, if and when we get approval of of zift, Amen. Um, here coming up, you know, very quickly on our PDF action date, um, a few thoughts. And, and I'm going to give my comments and I'm going to ask Molly, you know, for hers because she really needs to speak to this, from a clinical perspective. But, um, first of all, Seline, maybe the magnitude of the risk. Um, you know, this is a box warning. So, a box warning is, is, is a serious as 1 can have. Um, as far as as warnings and precautions, it, it isn't so much the, the frequency. Uh, um, it is the severity, um, particularly towards odds. Right. Torsades

For for, for, for, for everyone, on the call. I mean, we're talking about a, you know, a risk of sudden cardiac death. Um, there are numbers that are getting banty around that, it's 1 in a thousand, you know. 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 and 100 or perhaps, you know, even, even more frequent than that. Um, and I guess I would just put it to to anyone, right? If you have 2 agents, uh, both of which are efficacious, but 1 of which has a, you know, a 1 in a 100th, what are you going to choose? Um, I think 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

Have a differentiated and favorable benefit risk profile. And I think that'll start in the in the relapse refractory setting. Um, but to the comments about it's it's less relevant in the front line, the risk doesn't go away. Um, in fact it, you know, what you're dealing with is those patients are healthier therefore and, and they're presumably going to stay on therapy for much longer. So, if anything you want, a more favorable benefit risk, uh, profile in that population, um, which means I think you you know, the the your the ability to differentiate on on a favorable safety profile that doesn't have a, you know, a box warning for QTC prolongation and torsades becomes even more significant. Let's see. You know, I would the last thing I'll say before I turn it over to Molly is, you know, the ash abstracts, there was a giant data dump, um, you know, despite comments from some others, uh, that there's really no room for another men. Inhibitor, you know, there's a lot of activity in the men in space.

As from us and from other competitors. Um, you can go, you can parse through the abstracts, um, what I think you'll see is that the benefit risk profiles of the different agents are continuing to be defined as we go, and I would draw your attention, not only to the activity and, and all of these, you know, all of these agents are very active and that's good for patients. But the safety and tolerability is, is also, uh, coming much more into focus and and I would invite you to look at the various combinations. But Molly, let me invite you to add any any

Any thoughts or comments maybe to to build on online? Absolutely. Um, as Troy said, it's not the black box morning that in and of itself is something um to focus on its what it means. The data has shown and 1 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, um, 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 its any ventricular arrhythmia. And so the risk just becomes so much more increased. If 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, um, decide, you know, between options of of what risks they are willing to take on and what risk

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, um, more issues with with the ability to handle, um, or at least equal issues with the ability to handle QTC prolongation just because of the, the various medications that are going to be given as concurrent therapy,

At. This is really your elderly patients. We're in in some of our competitors. We see um, you know, almost a 50% rate of QTC prolongation. Um, 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 um more severe uh QTC prolongations and episodes of torsades and sudden cardiac death.

Thank you. Our next question comes from, Charles you at life-size capital.

Tell the meat your line please. And ask your question. Thank you.

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. Um, so I guess with all of that in mind, uh, for 1, what kind of level of penetration or market share, would you either expect or hope to achieve relative to your first, Uber competitor? But in the space at least in the near term, the real love for factory is setting in. Can you also perhaps give a little bit more color around the um ongoing points of FDA regulatory engagement? Um that seem to be continuing on as you head. Um, close to your Pua date. Thank you.

So so Charles I don't want to scold you. You asked 2 questions.

And and it. And so we're gonna we'll uh we'll um we'll answer the first 1 and then if there's time we'll, you know, uh, after others we'll come back and get the second 1. Um, uh, so Brian, could you please speak to Charles's? First question, uh relating to penetration and sort of uh how we're going to compete with our competitor with who, who, who is out there with the first mover advantage.

Yeah, thanks Charles for that question. Um, so so we haven't guided on our market share penetration, expectations quite yet. But what I can do is kind of just share, um, some of the feedback and, and expectations we have. So, um, we we've conducted, uh, you know, extensive engagements with uh, um, with treating Physicians. Uh, KO Wells, uh, Community practitioners academics. Um, and and tested, our profiles relative to others and I think that the benefit risk, um, balance and and, um, between a strong efficacy, safety efficacy profile with, um, with good safety and tolerability, that allows patients to be able to to be well, managed, um, um, along with the combined ability and the uh, um, and the uh, even the convenience of a 1, daily oral medication. Um, I'll come out to factors that. That suggests that uh, uh,

That zipto map has a, has a best-in-class profile, and that will be confident, we'll be able to, to communicate on that best-in-class profile, um, coming into the market. So, um, Without Really guiding on any share calls. Quite yet. We anticipate, well, we give credit that. Our we have a competitor who's already in the market, but we recognize that we, we anticipate both the, the, the, uh, scale of our team. Um, that we've hired that are ready to go and are ready to to launch this product. Um and the profile. The products are really going to help us to uh capture a majority share in this space.

Thanks Brian.

Danny. Can the next question? Yeah, yes. As a dental reminder, we please ask that. You limit yourself to 1 question and then re-enter the key for any follow-ups. Thank you.

Our next question comes from, Roger song at Jefferies.

Roger, please unmute your line and ask your questions. Thank you.

Hey team. This is Nabil on for Roger, thanks for taking my question. Um as we uh just a quick 1 on the ash um data show the early data, look pretty encouraging with the CRA rates and mrd negativity. Um, as we head into the meeting, what other um analyses or long-term outcomes? Are we expecting to see like durability? Will we have also subgroup insights, thank you.

Yeah, thanks nil for the question. Molly, do you want to

That we have seen thus far in our rather large patient pool, that we'll be able able to present in both the relapse refractory and the Frontline setting where you're going to see you know, 30 to 70 patients um which is extremely robust and 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 zamansky 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 questions. Troy, I wanted to ask a follow-up regarding the, um, commercial launch in npm1, but is having a differentiated label enough to overcome the, the second Uber Advantage. Um, you know, when you think about sort of prescriber, inertia, um, is is it?

More. So that, that, you know, a you 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, the timelines. Thanks.

Sure. Um, maybe I'll just make a quick comment and then I'll, I'll, I'll let Brian take it because he's really the 1 who should speak to this, um, the 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 patience. Um the patients are also extremely sophisticated. They have you know all sorts of access to information and um and they are you know, again others might say its 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 have multiple options. But these docs are now having conversations with their patients about the, the the risk benefit. And uh, there's a there's a striking difference between the relapse refractory setting where 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 for months or even years. So Jason I I I don't, I mean I'm not going to deny there is an advantage uh, to an to an incumbent. But I think when you're coming forward, as we believe, we are with a superior benefit risk profile than a very competitive space. Um, you know, I think we'll, uh, we will see, uh, the market reach, its equilibrium, uh, Brian any any, what thoughts, would you like to add to my cam?

Thanks Troy. I think you. I mean, you captured it. Well, I think but what I maybe just added just a couple points that you know 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. Um, um, in the mpm 1 space, um, our teams are out there. As I mentioned, we've been engaging, we've been spending the last year, um, working with payers to ensure that there is uh, um, not going to be any kind of blocking, uh, available. And the profile is just a mehtab. I think really, um, 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 a a very powerful strong position in that space. Um, you know, with our our goal is to build a, a distribution of model, that is seamless and and easy for Physicians and their and and their practices to to prescribe the just a minute. Um, you know, 1 of the things that might be even, you know, more simplistic. As we talked about the Simplicity is that we'll have 1 ski.

You. Um, we're not going to have multiple skus of different, uh, um, 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, um, in the near term. Um, 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, uh, practices. They are itching to be out there to speak about the systemic and they're ready to go. And I feel like that, you know, it if you give us the time for launch, um, I I think you'll see that the profile of the Troy outlined and our um 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 to um, really you know, overcome any any second move or disadvantage that, that may be perceived.

The label's going to be relapsed refractory npm1 mutant AML clearly the adult population. But um, 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. You know, we're the we have 2 phase 3s underway, um, in intensive and non-intensive. We're combining with both Flip 3 Inhibitors. We have combinations with ldac with flag Ida. Um, and as Molly said, we're coming forward knot with you know, a handful of patients, we're coming forward with, you know, 20, 30, 40, 70, 70, 100% at a time. Um, so we're really giving uh and which is why I think we have 2, you know, our our 2 presentations at Ash are both orals. Um we have we have a massive uh development in medical Affairs effort supporting our 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 uh, everyone is looking forward to combinations. Everyone's looking forward to earlier lines of therapy. Um, this is not, uh, this we know we're not looking at 1 quarter or even 2 quarters. Our goal is how do we make zippy men of the? 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 is, 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 Reni. Benjamin at JMP. Securities, Renee, please unmute your line and ask your question. Thank you.

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

Caller as to how this will move forward. Thanks. Yeah. Yeah. Ren, I'm thanks for the question. This was, uh, you know, this this was the best launch meeting I've ever attended. It was, uh, it was electrifying, it really was. I mean, people are so excited to bring this therapy forward, but, but let me, let me turn it over to Brian. Who can maybe give you a bit more specificity about, you know, what, the goals of the launch meeting were and and and how the 2 teams came together as 1K to to really move this forward, right?

Yeah sure thanks for it. Uh yeah Randy. So the this launch meeting and and as typically what we'll you'll do is you prepare is to bring the field teams together so that they're um, well trained and ensured that that they're um 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, you know, buffer where we thought October gives us an opportunity for the teams to be ready as close as possible to a potential approval. Um, and essentially, this is a team where we had all of the fields, uh, uh, uh, uh, members that are both from Kiawah Kieran. And from Kura that not just for our sales organizations, um, that are going to be working together. Uh, we'll have the 2 field forces that are going to be putting their efforts towards uh, um, raising awareness and, and selling, uh, uh, ZIP them in, uh, to the um, to the, to, the Target positions. But they're, they're basically we we put that group together as well, as our field Market action.

Access teams, our field Medical Teams. Um, and we spent, you know, several days just working through, um, understanding the, the, the role of, uh, um, men in in, uh, in AML the, the challenges for patients, with relapse or factory, um, AML, um, did some certifications pre-certification for the team? So they're ready to go. And, and and are um, are prepared as soon as we get to um, an anticipated FDA approval. The teams will then um resert on that final. Um procedure

Approval. As soon as, um, you know, that by end of November is our Target to do for today, 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 uh, Alex. I'm from Peter. Thanks for taking our question. Um, just a quick 1 for me on the, the, the label could look like, um, I guess is there any, um, is there any potential for the monitoring requirements? The differentiation syndrome, um, to be different from other, um, AML drugs.

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

In the, in the label. Is that your question? Yeah, yeah, yeah. Molly. Do you want? Yeah, or how to address it? Just prior drugs. Yep, thank you. Yeah, yeah, absolutely. Um, so I, uh, you know, obviously, I don't want to comment on ongoing discussions. We're still nearing our Paducah date. And so obviously um things are still evolving. However our our differentiation syndrome guidance has been laid out in our protocols uh and and and in our IB for for years now and it is unchanged. Um, I I don't think that it is any additional. Um,

Monitoring. That would be unexpected for this patient population in general who is regularly getting Labs tested Etc. Um, so but let's wait. Let's wait and see. And have a more false discussion once we actually have. Um, 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 question as I and I just want to kind of come back to that.

Answer em with the market dynamics between you and the competitors. So, shortly, I'm wondering is basically your pre-launch work with you and has been doing. Could you give me a share some initial feedback from positions on how they're viewing, how abilities versus competitive Inhibitors? Uh, you know, in the space C1 space,

Yeah, David. Um,

I'm gonna ask Brian to speak to that as you can imagine. You know we've done a kind of a lot of uh um a lot of market research and and sought the opinions of of kol's and and practicing Physicians but Brian. Maybe you can speak to the Lessons Learned thus far about our OIP demands profile relative to to our competitors.

Thank you, David for that question. So so the um I I'll speak to the the feedback we received um and really kind of aligning around for key parameters or pillars, you could call them um,

First is the efficacy, you know, we we've uh tested the the profiles of uh system and a relative to other potential um men inhibited competition. Um, and it seems that the the view is that the efficacy is kind of a table Stakes uh, to get in. You'll see the uh it the CRC duration response, things like that are seen to be relatively, um, similar, um, safety and tolerability is something that did steep step. Stand out as a differentiator, um, between zip the menu and other products, um, which that alone is Troy said is not, um, you know, safety is not something that wins on a, on a product, but it's that balance of benefit and risk. And the, and the tolerability of that, um, really, um, kind of things. Consider the scales. Um, the the other 2 pillars around that, that we found really helped to differentiate. Uh, uh, just a minute is, uh, 1 around the combined ability with currently uh, with current Conant medications, um, is is

In the, the, um, elderly population. You know, the Simplicity of having that 1 Staley dose, um, is, is also meaningful. So, that's really kind of what we've heard is that, that, you know, there are. Of course, we've also heard as Troy said, um, you know anything, any therapies for these patients are really going to be important. That can deliver some efficacy. Um, 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 just a minute. Um, as a differentiated agent coming into the market,

thank you. Uh, we will now allow follow-up questions. Our first follow-up question is from Lee. Lee Lee, what stack at Cantor Fitzgerald, please unmute your line and ask your follow-up. Thank you.

Uh hey guys, thanks for taking um my second question. Um and I guess just gave them the reason disruptions at FDA including within Cedar.

um, just curious have you noticed or anticipate any changes in terms of, you know, Cadence and discussions uh, with agency

Um, short answer lie, we haven't noticed any difference. We don't anticipate any difference. Um, you know, we we're on track for our November 30th Padua date. Uh, if we, we characterize the interactions with the agency as open and constructive. Um, you know, we don't know what we don't know. But I think at this point we are, we're in, we feel like we're in good shape and we're tracking toward, you know, a positive review outcome, um, the, the path to approval in AML is much more much better precedented than some of these other instances. Um, the fact that we have a, you know, 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. Uh, but obviously we'll we'll continue to, you know, to to stay vigilant and the team Molly, and and her regulatory team are doing a terrific job. But, but so far, it's it's all systems are go.

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

Thank you, Danny. Uh, thank you all once again, for joining the call today and, and for your questions, and the discussion, uh, we'll be participating in the Jeffrey's investor conference in London later this month. And, uh, just as a reminder, we'll also be hosting a virtual analyst and investor event, on December 8th, uh, from at the ash annual meeting in Orlando. Um, so we'll look forward to speaking with many of you, um, 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, uh, with our pipeline. Our, 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. Um, please reach out, thank you all. Once again, and we hope you all have an enjoyable Tuesday, uh, morning and our productive day. Uh, with that. We'll adjourn the call. Thanks everyone.