Kura Oncology Inc Q3 2024 Earnings Call Transcript

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

Question: Li Watsek - Cantor Fitzgerald - Analyst : On the progress. Troy, I guess, how are you thinking about the potential of using MRD negativity as part of the frontline endpoints? And then for the MRD data, negativity data that was just presented in your ASH abstract, is there any difference in the methodology used by you versus your peers?

Question: Li Watsek - Cantor Fitzgerald - Analyst : Okay. And then for the 6 mg data that you'll present at ASH, I just wonder if you can give us a sense of number of patients, follow-up and what types of data that we might see?

Question: Jonathan Chang - Leerink Partners - Analyst : As we're starting to see longer-term data for zifto and other menin inhibitors in the space, how has that impacted your thinking on what the opportunity could be for the class? And what do you see as the key factors determining how long patients can stay on treatment and benefit?

Question: Jason Zemansky - BofA Global Research - Analyst : Congratulations on the progress. Regarding the combination updates at ASH, what should we be thinking in terms of benchmarking a win here? Is safety still the focus? Or do you expect the data at that point to be mature enough to gain key insights into efficacy? And then a follow-up.

Question: Jason Zemansky - BofA Global Research - Analyst : Got it. That's helpful. And maybe to circle back on your comments on tolerability and safety. The team has been guiding away from a 0% DS rate, which makes sense. But I'm curious, is there a level that you think would be especially encouraging in both the 7+3 and ven/aza settings? And is there a ceiling here as well?

Question: Roger Song - Jefferies - Analyst : Congrats for all the progress. Maybe one question related to the -- again, back to the potential pivotal plan, understanding you're discussing with the FDA right now. Just curious about the timing for the pivotal study initiation versus your expansion data release. Do you need to see more dose-dependent efficacy at the higher dose or RP2D dose, 600 milligram versus the others? Or the current dose exposure or the total package sufficient for you to move into the pivotal once you finalize the design?

Question: Roger Song - Jefferies - Analyst : Excellent. That's very helpful. And similar in terms of the time line regarding your -- the monotherapy NPM1, the data continue to be early 2025. And how should we think about the NDA filing for that monotherapy?

Question: Charles Zhu - LifeSci Capital LLC - Analyst : Congrats on the progress. A couple from us. First, could you remind us what proportion of patients are adverse risk? And if you're including this a broader population beyond adverse risk in your Phase Ib expansion cohorts, how should we be thinking about enrollment speed there?

Question: Charles Zhu - LifeSci Capital LLC - Analyst : Got it. Great. And regarding your ASH abstract, one clarifying question here. Is there a response deepening effect that we could be seeing at the lower 200-milligram dose given that it has longer follow-up versus the 400? And granted, these are very small end, but how should we be thinking about what appears to be a numerically inverse dose response between 200 and 400 milligrams in combination?

Question: Charles Zhu - LifeSci Capital LLC - Analyst : Perfect. Great. Makes sense. If you could humor maybe just one last one from me. Regarding the on-target menin resistance mutations, we've heard a few things from some third parties out there, but could you clarify the assay that you used relative to one of your peers/competitor's assays when they reported their 38.7% rate of mutations and how similar or different are the sensitivities of those assays? And what does that mean with the rate of emergent menin resistance on zifto?

Question: Philip Nadeau - TD Cowen - Analyst : We were intrigued by your comments about safety improving for zifto as the doses increase. Is there a mechanistic rationale as to why safety should improve with increased exposure?

Question: Philip Nadeau - TD Cowen - Analyst : That is very helpful. And then second question on the next-generation menin inhibitors. I think you mentioned specifically that you will nominate a candidate for diabetes in the first half of 2025. Are there efforts underway to identify next-generation menin inhibitors to advance in heme malignancies as well?

Question: Peter Lawson - Barclays - Analyst : Just as we think about expectations for kind of prior then treated patients in the pivotal study, how should we think about that versus what we saw in the Phase I data that was published?

Question: Peter Lawson - Barclays - Analyst : Perfect. Really interesting. On the 7+3 adverse risk patients, what would the duration of response? How could that differ between do you think the NPM1 versus the KMT2A patients?

Question: Peter Lawson - Barclays - Analyst : There's no kind of fundamental difference do you think between the NPM1 and KMT2A patients?

Question: Justin Zelin - BTIG - Analyst : Congrats on the progress. Maybe following up on an earlier question about resistance mutations. Would you look to do that analysis in your combination and earlier line studies? And just expectations there if you think that it might differ in those settings?

Question: Brad Canino - Stifel Nicolaus and Company, Incorporated - Analyst : Just one for me. Wondering, given we've seen one of the peer med companies initiate a frontline trial in collaboration with one of the European cooperative groups. Just what's your current thinking about employing a similar strategy? How do you think about the pros and cons of using such a collaboration versus, say, doing a full company-sponsored one?

Question: Xiaochuan Dai - UBS Equities - Analyst : This is Xiaochuan on for David. Congrats on the quarter. So I guess our first question is kind of like for the pin data, ziftomenib pivotal data in relapsed or refractory NPM1 mutated AML in early 2025. So just curious if you could set some expectations on the clinical meaningful efficacy as well as duration bar. And the second one, I think for your ASH abstract for the ziftomenib plus aza cohort, so we saw there were around like 25% patients who actually have prior Menin inhibitor. So just curious if we are going to see the efficacy profile from the set of patients at the presentation? Yes, I think it's just like related to potentially like higher activity against some mutation resistance to the patient..