Kura Oncology Inc Q4 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Li Watsek - Cantor Fitzgerald - Analyst : Troy, you guided to the Phase 3 top line in frontline intensive AML setting in 2028. Just curious what assumptions went into that guidance? And anything you can share on the trial size, that plan or enrollment timeline?

Question: Li Watsek - Cantor Fitzgerald - Analyst : Yes, understood. And then just wondering what the remaining items that you may need to work through before the NDA submission. Any notable feedback from the pre-NDA meeting?

Question: Yen-Der Li - Leerink Partners - Analyst : This is Yen-Der Li on for Jonathan Chang. So the first question I have is that when we look at the commercial opportunities for ziftomenib, I guess, the most important variable is the treatment duration. Could you share the reason behind your confidence that frontline AML patients will be able to stay on the treatment for more than a year?

Question: Yen-Der Li - Leerink Partners - Analyst : Got it. And I have also a follow-up question related to that. So for the KOMET-017 intensive combination study, if I recall correctly, the patient will include both transplant and non-transplant chemo as consolidation options. And is there a concern about the imbalance of consolidation treatment received in each arm? And do you have any like protocol to mitigate such concern?

Question: Jason Zemansky - BofA Global Research - Analyst : Congrats on the progress. I was curious, as you look to the additional dose expansion data from the 007 study, what in your view would be encouraging from the 7+3 combo as you start to expand into the non-adverse risk group? Specifically in terms of MRD negativity, what gives you -- what would give you confidence that addition of zifto would ultimately give you a survival benefit?

Question: Jason Zemansky - BofA Global Research - Analyst : Got it. Makes sense. And maybe just a quick follow-up here. I noticed the other mutations bucket, about 10% to 15% of the population. Curious, what does it take to get there to that group of individuals? And what gives you confidence, I guess, that a menin will be active in these subtypes?

Question: Peter Lawson - Barclays - Analyst : I wonder if you could just kind of talk a few minutes just around where you stand for diabetes and the nomination of the candidate and kind of where that fits in your priorities and how you're thinking whether it's type 1, type 2 or particular stage of the disease?

Question: Peter Lawson - Barclays - Analyst : Yes, that's great. I guess there was a breadcrumb in there for me, just kind of what's the right route forward so you kind of capture the potential upside of something like diabetes yet not dilute yourself?

Question: Peter Lawson - Barclays - Analyst : What's the right strategy there? Is it like a JV partnership? How should we think about so you kind of capture upside yet you don't lose your focus around oncology? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 26, 2025 / 9:30PM, KURA.OQ - Q4 2024 Kura Oncology Inc Earnings Call

Question: Ernesto Rodriguez - TD Cowen - Analyst : This is Ernie Rodriguez for Phil. I will start with -- I have two questions. First one is on the competitive landscape. Now that you have at hand the results from KOMET-001 and we had updated data from several other menin inhibitors that were presented at ASH, how do you think or expect zifto to be differentiated from the others or how do you see the competitive landscape ultimately playing out?

Question: Ernesto Rodriguez - TD Cowen - Analyst : Got it. That's very helpful. And on the earlier pipeline, 015 on GIST, you have mentioned the potential to delay the onset of resistance in that population. So as we look forward to the clinical data in the future, is it more relevant for us to be looking at the duration of the response aside from ORR or how should we be looking at the data once it's ready to come out?

Question: Dara Azar - Stifel - Analyst : This is Dara Azar on for Brad. First, on the frontline development, do you expect EMA to have an entirely different opinion than the FDA on MRD negativity as a regulatory endpoint? And maybe tell us more on how you expect to conduct 017 trial to support a global approval? And I do have a different question after this.

Question: Dara Azar - Stifel - Analyst : Yes. Helpful commentary. Now switching over to relapsed and refractory, will the data cut and patient denominators match between your upcoming medical meeting presentation, I suppose, first would be ASCO abstract and the NDA submission?

Question: Charles Zhu - LifeSci Capital - Analyst : Maybe one outside of AML. So maybe one program where, frankly, lots of folks have been paying very little attention to, farnesyl transferase's KO-2806. I mean, like what would you say you need to deliver here in the second half of 2025 in order to gain more conviction on this asset and also to gain more conviction from the investment community on these, especially not only in context with the assets themselves, but also in context of some of the emerging competitive landscapes in areas like RAS or renal cell carcinoma?

Question: David Dai - UBS - Analyst : Two from me actually. One is just on the relapsed/refractory pivotal data read-out at ASCO. You mentioned that it will be a later data cut. So could you maybe just help us understand how do you think the later data cut could change the CR/CRh rate? And then on that, can you just talk a little more about the baseline characteristics of the patients that we'll potentially see? Would you expect the patients to have similar prior venetoclax treatment?

Question: David Dai - UBS - Analyst : That's really helpful. And then just on the frontline KOMET-017 trial, how should we think about the contribution of Kyowa Kirin on the clinical trial? And do you think they could potentially have them help out with some of the clinical trial development to expedite the clinical trial development?

Question: Justin Zelin - BTIG - Analyst : Maybe just a follow-up on Charles' earlier question. I also find the FTIs quite interesting and also important given that you have wholly owned economics on the programs and are the only companies developing the programs. Troy, you mentioned the combination approach with KRAS, which I find quite compelling. Can you talk to whether you have preclinical data with a pan-KRAS inhibitor? And just how you kind of view that landscape on the combination potential with the pan-KRAS inhibitors or the KRAS variants?

Question: Justin Zelin - BTIG - Analyst : And maybe just quickly, how should we think about business development activities from Kura, either in-licensing or out-licensing throughout the rest of the remainder of this year and into next?

Question: George Farmer - Scotiabank GBM - Analyst : A couple from me. Troy, you and Mollie indicated on your last call that we would be seeing a slightly later data cut at the medical meeting versus what you would be submitting to the agency. And now you're saying it's going to be the same cut. I was -- perhaps you could elaborate on why that shift. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 26, 2025 / 9:30PM, KURA.OQ - Q4 2024 Kura Oncology Inc Earnings Call And then also in your conversations with the agency agreeing to this MRD endpoint, that seems to be very different than how the agency has approached other hematologic indications like multiple myeloma, where they called a committee to talk about this. Can you talk about your interactions with the agency? And do you think this is something that we could see with other programs beyond Kura's?

Question: George Farmer - Scotiabank GBM - Analyst : Yes. That's very helpful. And when do you think you would capture the EFS endpoint from the study? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 26, 2025 / 9:30PM, KURA.OQ - Q4 2024 Kura Oncology Inc Earnings Call