Kura Oncology Inc Q1 2025 Earnings Call Transcript

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

Question: Jonathan Chang - Leerink Partners - Analyst : Hi, guys. Thanks for taking my questions. First question, can you discuss how the changes at the regulatory agency have impacted or not the potential approval process and timelines for ziftomenib? The second question, Troy, go ahead.

Question: Jonathan Chang - Leerink Partners - Analyst : The second question, can you help set expectations for the upcoming ASCO presentation of the KOMET-001 results? And how should we be thinking about what will be in the abstract versus the full presentation? Thank you.

Question: Jonathan Chang - Leerink Partners - Analyst : Got it. Thanks for taking my questions.

Question: Salim Syed - Mizuho Securities - Analyst : Great. Thanks for the question and the commentary today, Troy and team. I guess, one just for your upcoming expected launch in the NPM1 setting. A lot of people I think are thinking here that at least in terms of CRh rates here, that these two menin inhibitor molecules seem more or less the same. Just curious what your updated market share work is sort of telling you, Troy, how these are going to get used once if and when they're both on the mark in the relapsed/refractory setting.

Question: Salim Syed - Mizuho Securities - Analyst : Okay, perfect. Thanks so much.

Question: Cameron Bozdog - BofA Global Research - Analyst : Hey, team, this is Cameron on for Jason. Congrats on the updates and thanks so much for taking our question. So connecting the dots from some of your earlier comments as you look to additional combination data from KOMET-007 at EHA, starting with the fit population, what in your view would constitute a win from the 7+3 combo, specifically on response rates in KMT2A and NPM1? How does that change now that we should see data in non-adverse risk patients? And then as we start to get additional insights into MRD negativity what would drive confidence here and a potential pathway to accelerate approval for zifto ultimately.

Question: Cameron Bozdog - BofA Global Research - Analyst : Great. Thank you.

Question: Charles Zhu - LifeSci Capital LLC - Analyst : Hey, everyone, thanks for taking the question. I'll start off by saying congratulations on submitting your NDA in NPM1 AML. Interesting timeline relative to your competitors sNDA even though they hit top line months before you did. But anyways onto the question I'll ask one actually on farnesyl transferase inhibitors regarding KO-2806. How do you envision the longer-term in combination development with VEGF TKIs in RCC? Just given the movement in that space with next-gen VEGF TKIs, HIF2 as well as checkpoint inhibitors. And how do you see KO-2806 fitting into that as it shapes out longer-term? Thank you.

Question: Charles Zhu - LifeSci Capital LLC - Analyst : Got it. Great. Thank you.

Question: Ellen Horste - TD Cowen - Analyst : Great. Thank you for taking the question and congrats on the NDA, super exciting. Couple questions. What is Kyowa Kirin strategy to capture the share of the NPM1 market and overcome zifto second to market position? And what points of differentiation do you think will resonate most with investors?

Question: Ellen Horste - TD Cowen - Analyst : Thank you, Troy. That's helpful.

Question: Peter Lawson - Barclays - Analyst : Thanks for taking my questions. Troy, just on the GIST side of things, what patient segments do you think are going to be more responsive to the combination and the particular subgroups you are going to be focused on, whether it's the imatinib refractory or nanve.

Question: Peter Lawson - Barclays - Analyst : How do you think that kind of plays out? Does that play out in ORR or PFS and kind of what are the goals, I think or the go forward decisions around those? I know it's early, but around ORR or PFS.

Question: Peter Lawson - Barclays - Analyst : Got you. Thank you so much.

Question: Peter Lawson - Barclays - Analyst : Perfect. Thank you so much.

Question: David Dai - UBS Equities - Analyst : Great, thanks for taking my questions. And I also want to add my congratulations to a great quarter. So just focusing on Phase 3 KOMET-017 trial, what are some of the gating steps before you're able to initiate the trial in second half? And then just more specifically around that. So how are the site activations going and what are some earliest reception from trial investigators on the ziftomenib's profile that could really accelerate your initiation in that trial? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 8:30PM, KURA.OQ - Q1 2025 Kura Oncology Inc Earnings Call

Question: David Dai - UBS Equities - Analyst : Thank you so much.

Question: Jeet Mukherjee - BTIG - Analyst : Great, thank you for taking the question and congrats again on the NDA submission. So my first question was we do hear anecdotal off label use of other currently approved menin inhibitors in relapsed/refractory NPM1 patients. So my question was what do you think is perhaps needed to pull clinicians who are perhaps familiar and comfortable with one agent over to zifto following a potential approval? Thanks.

Question: Jeet Mukherjee - BTIG - Analyst : Great, thanks. Maybe just a quick follow-up with all that's going on in the FTI franchise between RCC, RAS mutations, and head and neck as well. Just are you looking to advance all these indications in parallel? Or what will it take to make you have a go/no-go decision with all these indications? Thanks.

Question: George Farmer - Scotiabank - Analyst : Hi, thanks for taking my questions. So, Troy, given that you do have BTD with zifto and NPM1 disease, shouldn't you have a good feel about whether you can get priority review by now? Also, do you think you'll need that FDA will want to convene an ODAC meeting. And also regarding the co-primary endpoint in your Phase 3's MRD negativity and CR/CH. Do you need to hit both of those in order for a win or can you just hit one or the other? Thanks.

Question: George Farmer - Scotiabank - Analyst : ODAC question.

Question: George Farmer - Scotiabank - Analyst : Okay, thank you.

Question: Roger Song - Jefferies - Analyst : Great, thanks for the update and then taking our questions. So, the first is a clarification. Maybe, Troy, I'm not sure I misheard that. You say the ASCO abstract and the presentation will be the same data cut. So, just can you just confirm that? And then also, you're ready to your 017, the first line combination pivotal. How should we think about enrollment given you will soon have approved the drug and you already have approved the drug and then soon, as ziftomenib will be approved in the RNR setting, how should we think about the pivotal first line enrollment timeline?

Question: Roger Song - Jefferies - Analyst : Yes, that's fair. Thank you.