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: Peter Lawson - Barclays - Analyst
: Questions we have been asking today have just been kind of some macro questions around whether you think there's any impact on the supply
chain with tariffs and any worries or learnings from COVID as we think about the new environment that we're in.
Question: Peter Lawson - Barclays - Analyst
: Has there been any changes in the rate of communication and any levels of confusion there?
Question: Peter Lawson - Barclays - Analyst
: And I know you're funding your own trials, but are there any kind of knock-on effects that we should be thinking around for NIH budgetary, funding,
and if that trickles through to clinical trial sites?
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MARCH 11, 2025 / 1:30PM, KURA.OQ - Kura Oncology Inc at Barclays Global Healthcare Conference
Question: Peter Lawson - Barclays - Analyst
: Maybe before we dive into the Q&A around the various aspects, but if there's any kind of state of the union or any kind of initial lead-ins you want
to prepare or talk through around the catalyst that we should be thinking through over the next 6 to 12 months.
Question: Peter Lawson - Barclays - Analyst
: Thank you. And just specifically around [KOMET-001] and you've got the 2Q top line data kind of -- where do we see that data? Is that kind of an
ASCO thing, abstract? How do we -- how much do we see?
Question: Peter Lawson - Barclays - Analyst
: What should we expect to be seen in terms of CR, CRh rates and response rates in that data set?
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MARCH 11, 2025 / 1:30PM, KURA.OQ - Kura Oncology Inc at Barclays Global Healthcare Conference
Question: Peter Lawson - Barclays - Analyst
: How should we think about patients that are pre-treated with venetoclax, does that have any impact on the results and does that matter?
Question: Peter Lawson - Barclays - Analyst
: And remind us the number of patients you expect to see and then also I guess on the side effect profile, is it differentiation syndrome that kind of
we hone in on, or are there other components that we should be thinking about?
Question: Peter Lawson - Barclays - Analyst
: Okay, perfect. And then are you on track for the BLA submission?
Question: Peter Lawson - Barclays - Analyst
: NDA. And what are the gating factors that we should be thinking about?
Question: Peter Lawson - Barclays - Analyst
: But it's not kind of last minute 2Q you're thinking.
Question: Peter Lawson - Barclays - Analyst
: And then [KOMET-007], so the fit population 7+3 and for that data when should we expect that 2Q and kind of what do you want us to hone in on
that data set?
Question: Peter Lawson - Barclays - Analyst
: Got you. And for that combinability and what we should hone in on the particular segments of that safety profile that we should be focused on
round?
Question: Peter Lawson - Barclays - Analyst
: Good. Okay. Well, for the 7+3 alone, what's the best bar that we should be thinking about?
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MARCH 11, 2025 / 1:30PM, KURA.OQ - Kura Oncology Inc at Barclays Global Healthcare Conference
Question: Peter Lawson - Barclays - Analyst
: And what's a good bar for success when you add on top of something that's already getting kind of 80%, or do we think about it in terms of
durability, et cetera?
Question: Peter Lawson - Barclays - Analyst
: Thank you. And then I was moving on to the unfit populations of the ven/aza arm, kind of what should we be thinking about for the ven/aza arm
and what's the appropriate for ven/aza and where do you want that to go and again around durability, how should we be thinking about that?
Question: Peter Lawson - Barclays - Analyst
: Got you. Did we get any other doses with the updates? Like, do we get higher dose levels?
Question: Peter Lawson - Barclays - Analyst
: So there's no worry that physicians in the real world setting will end up dose reducing one of these components.
Question: Peter Lawson - Barclays - Analyst
: How's enrollment proceeding as you kind of think about the ven/aza versus the 7+3 combination? Is there any kind of delta between the two? Is
there anything to read between the lines?
Question: Peter Lawson - Barclays - Analyst
: Is there any reason to believe menin is going to combine better or generate better results with 7+3 versus ven/aza.
Question: Peter Lawson - Barclays - Analyst
: What's the read through from these studies to the frontline study and you mentioned that the frontline data with ven/aza and 600 milligrams, but
there are other read throughs we should be thinking about triangulating between this data set and future data sets.
Question: Peter Lawson - Barclays - Analyst
: And then thinking about 017, what are the timelines for initiation for that pivotal study?
Question: Peter Lawson - Barclays - Analyst
: Okay, what are the gating factors there?
Question: Peter Lawson - Barclays - Analyst
: Clever design. And just the rationale for [Kyowa Kirin], what do they add to that process? Do they slow it down? Do they speed it up?
Question: Peter Lawson - Barclays - Analyst
: And the MRD negative CR, that's changed the field and kind of I guess what drove that all the new trials in frontline do you think are going to be
MRD negative CRs?
Question: Peter Lawson - Barclays - Analyst
: And how should we think about interim analysis when would you want -- if there is that built-in?
Question: Peter Lawson - Barclays - Analyst
: Okay, perfect. And the expectations of the control arms whether it's for the MRD negative CR rates or event free survivals?
Question: Peter Lawson - Barclays - Analyst
: Got you. Just left three minutes or so on the clock. I'd love to kind of pivot a bit to the diabetes program and kind of what we should expect to see
over the next 6 to 12 months?
Question: Peter Lawson - Barclays - Analyst
: The assumption would be it's probably not just your own spend as you go into something like that.
Question: Peter Lawson - Barclays - Analyst
: And the competitive menin drug, does that kind of help inform that process or are you looking more broadly?
Question: Peter Lawson - Barclays - Analyst
: And so degrader versus inhibitor, is that -- where are you in?
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MARCH 11, 2025 / 1:30PM, KURA.OQ - Kura Oncology Inc at Barclays Global Healthcare Conference
Question: Peter Lawson - Barclays - Analyst
: Okay. It's perfect. Thank you so much.
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