The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Jason Zemansky - BofA Global Research - Analyst
: Absolutely. Well, maybe just to start broadly for those less familiar with the story, can you provide a brief overview of your two clinical programs
just at a high level? I mean, what is a menin inhibitor and how does it work?
Question: Jason Zemansky - BofA Global Research - Analyst
: Yeah, absolutely. Well, maybe just to dive right in, the upcoming ASCO meeting is shaping up to be critical for Kura with the presentation of the
highly anticipated ziftomenib (inaudible) data in NPM1 relapsed/refractory AML. So beyond the CR/CRh rates, what else do you plan to reveal and
what do you think investors should be focused on?
Question: Jason Zemansky - BofA Global Research - Analyst
: Interesting. So you mentioned safety tolerability as a key potential differentiator. Let's dive a little bit deeper on this. I mean, beyond kind of the
CR/CRh rates, what would be encouraging here?
Question: Jason Zemansky - BofA Global Research - Analyst
: Safety and tolerability.
Question: Jason Zemansky - BofA Global Research - Analyst
: Makes sense. So Kura submitted its NDA March 31 where it had breakthrough designation. I guess the two-level question here is, how is your
interactions with the agency been granted? It is still somewhat earlier. And then if you could speculate on timelines here, when do we get updates
and what is the pathway look for look for throughout the rest of the year?
Question: Jason Zemansky - BofA Global Research - Analyst
: Got it. You've been doing this for a while. What do you think really factors into the decision for, yes or no via priority review? And I guess, specifically
with another menin inhibitor that's already been approved, does that changed the agency's calculus?
Question: Jason Zemansky - BofA Global Research - Analyst
: For your chemo combination, you're pursuing a trial design that would leverage MRD negativity for accelerated approval first for AML. What did
you have to demonstrate to FDA to make them comfortable, to allow that surrogate endpoint?
Question: Jason Zemansky - BofA Global Research - Analyst
: It is a good segue for the next question. But turning to the second half of this year, you have guided to presenting data from KOMET-007 frontline
non-intensive AML. This would be a zifto plus ven/aza combo. Ideally, what do you think a menin inhibitor can provide on top of ven/aza? Is the
former just eliminating an escape mechanism, or is there potential for kind of a synergistic improved CR?
Question: Jason Zemansky - BofA Global Research - Analyst
: Got it. Looking at KOMET-008, this is the Phase 1 evaluating zifto plus FLAG-IDA or LDAC, and more importantly, I think gilteritinib. Any updates
you can provide there?
Question: Jason Zemansky - BofA Global Research - Analyst
: Sure. You bring up sort of an interesting point. I think if you talk to most docs, ven/aza seems to be the combo partner that they point to in terms
of opening up, use in the frontline setting. Do you think that's still the case?
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MAY 13, 2025 / 10:00PM, KURA.OQ - Kura Oncology Inc at Bank of America Global Healthcare Conference
Question: Jason Zemansky - BofA Global Research - Analyst
: Got it. Well, the brief time that we have left, I did want to give an opportunity to discuss the partnership that you mentioned earlier with Kirin.
Especially in light of everything that's what's happened, what made this partnership make sense to you strategically and financially?
Question: Jason Zemansky - BofA Global Research - Analyst
: Sounds good. Troy, it's been a privilege and a pleasure. Thank you so much for joining us.
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