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: Phil Nadeau - TD Cowen - Analyst
: So let's start with ASCO and the pivotal data from ziftomenib in NPM1 acute leukemia. Can you summarize what you have disclosed about the data
so far?
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MARCH 04, 2025 / 7:30PM, KURA.OQ - Kura Oncology Inc at TD Cowen Healthcare Conference
Question: Phil Nadeau - TD Cowen - Analyst
: We will dive into the frontline market in a lot of detail, given your novel trial designs. But before we get there, just to knock off a few more questions,
relapsed/refractory.
Question: Phil Nadeau - TD Cowen - Analyst
: So you've disclosed that the results have been submitted to ASCO and will be disclosed in the abstract. So can you give us some sense of what
measures will be in the abstract versus the presentation? Will the presentation be the same data cut as the abstract? Will there be a new one?
Question: Phil Nadeau - TD Cowen - Analyst
: Got it. And what has to be completed before the NDA can be submitted? Any key rate-limiting factors? No?
Question: Phil Nadeau - TD Cowen - Analyst
: And what are you doing today to prepare for the launch?
Question: Phil Nadeau - TD Cowen - Analyst
: And can you remind us, under the collaborative agreement, who is in charge of the sales force? Is it a joint steering committee? Is it Kura? Is it Kura
--?
Question: Phil Nadeau - TD Cowen - Analyst
: Perfect.
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MARCH 04, 2025 / 7:30PM, KURA.OQ - Kura Oncology Inc at TD Cowen Healthcare Conference
Question: Phil Nadeau - TD Cowen - Analyst
: With that, we'll transition to the first line. The KOMET-017 design was recently disclosed, has some novel elements in it. Can you outline the design
of the KOMET-017 trial?
Question: Phil Nadeau - TD Cowen - Analyst
: To drill down on a few more of the novel aspects of the trial, you mentioned CR, MRD negative CR as the endpoints for accelerated approval. Many
companies have hoped to use those endpoints in the past, but you're the first one to successfully secure them. Can you talk about the regulatory
discussions that enabled you to get those into the trial design?
Question: Phil Nadeau - TD Cowen - Analyst
: And what's the significance of using the bone marrow to assess CR versus plasma markers?
Question: Phil Nadeau - TD Cowen - Analyst
: Can you discuss the powering of the 017 trial?
Question: Phil Nadeau - TD Cowen - Analyst
: When do you think you will be in a position?
Question: Phil Nadeau - TD Cowen - Analyst
: 2028 does seem like an aggressive timeline. How confident are you, you can hit that?
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MARCH 04, 2025 / 7:30PM, KURA.OQ - Kura Oncology Inc at TD Cowen Healthcare Conference
Question: Phil Nadeau - TD Cowen - Analyst
: What other registrational trials are you considering?
Question: Phil Nadeau - TD Cowen - Analyst
: Another piece of your guidance for this year is that we'll get updated data from zifto 600 milligrams plus ven/aza during the second half of the
year.
Question: Phil Nadeau - TD Cowen - Analyst
: Sorry, 7 + 3.
Question: Phil Nadeau - TD Cowen - Analyst
: We'll maybe set the table for that by outlining what was presented at ASH and what will be incremental in these new updates.
Question: Phil Nadeau - TD Cowen - Analyst
: Perfect. Actually, speaking of Kyowa Kirin, you recently signed that global strategic collaboration. Can you talk about the rationale for the collaboration
and maybe a bit more about the structure?
Question: Phil Nadeau - TD Cowen - Analyst
: It does seem like Kura is getting more and more enthusiastic about zifto in GIST. Can you talk about the scientific rationale for that combination?
Question: Phil Nadeau - TD Cowen - Analyst
: Great. Maybe the last question is on the FTI program, a brief update on the status.
Question: Phil Nadeau - TD Cowen - Analyst
: Perfect. Well, thank you for making the trip to Cowen's 45th Annual Healthcare Conference.
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