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: Alethia Young - Cantor Fitzgerald - Analyst
: Awesome. So I wanted to start with the menin program since that gets a lot of attention. I guess what led you to focus on making a small molecule
to inhibit MLL1, KMT2A? Is it a relatively new concept based on emerging biology or is it something where you can build a better mousetrap?
Question: Alethia Young - Cantor Fitzgerald - Analyst
: Awesome. So maybe first, talk about KOMET-001. There was some data at ASH. I think you had like eight patients evaluable for efficacy. Just talk a
little bit about the findings from that study both on the efficacy and on the safety basis.
Question: Alethia Young - Cantor Fitzgerald - Analyst
: Well, maybe we just move to that and talk a little bit about the Phase 1b study, talk a little bit about the dosing and how many patients you're
trying to enroll and when you will get to full enrollment, and hopefully have data. Just give us timelines.
Question: Alethia Young - Cantor Fitzgerald - Analyst
: Great. So I guess just to make sure we all heard it properly. You will have the enrollment done by the first quarter of 2022, but then you will -- you
could be peppering out updates qualitatively throughout the year. And then you would ultimately decide to put the data out at a medical meeting
probably versus like a press release somewhere later, but you probably would just --?
Question: Alethia Young - Cantor Fitzgerald - Analyst
: That makes sense. That's helpful. I guess, but looking at what happened in KOMET-001, do you have a good amount of confidence heading into
this 1b (inaudible)? I've seen some efficacy albeit low doses. So do you have a lot -- does that really give you confidence in this 1b that you believe
the drug is highly active and --?
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SEPTEMBER 27, 2021 / 7:20PM, KURA.OQ - Kura Oncology Inc at Cantor Fitzgerald Global Healthcare
Conference (Virtual)
Question: Alethia Young - Cantor Fitzgerald - Analyst
: And maybe just a follow-up on that. Do you think those need to be big studies or relatively small studies?
Question: Alethia Young - Cantor Fitzgerald - Analyst
: That makes sense. So another thing that gets a lot of attention is that one of your competitors showed like QTc prolongation, and we haven't seen
that with 539. So I just want to get your perspective on why you think differentiated -- the molecules are different.
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SEPTEMBER 27, 2021 / 7:20PM, KURA.OQ - Kura Oncology Inc at Cantor Fitzgerald Global Healthcare
Conference (Virtual)
Question: Alethia Young - Cantor Fitzgerald - Analyst
: Okay. And then maybe just also talk a little bit about does your drug interact with the CYP3A pathway or does it not?
Question: Alethia Young - Cantor Fitzgerald - Analyst
: Okay, that's helpful. Can you talk a little bit about the profile -- the safety profile may be differentiated if this kind of holds up? Just talk strategically
about what that means in earlier lines of therapy or in combinations?
Question: Alethia Young - Cantor Fitzgerald - Analyst
: And you touched on it, but just are there any timelines on when you're thinking about starting potential combination work, or is this something
you would do after you get 539 to the finish line as a monotherapy?
Question: Alethia Young - Cantor Fitzgerald - Analyst
: Well, in the last 10 minutes, let's talk a little about tipifarnib and obviously 2806. So just walk us through the initial data that led to the breakthrough
designation and moving into your current pivotal study in head and neck.
Question: Alethia Young - Cantor Fitzgerald - Analyst
: Okay. So that should be an interesting study, it seems like, to kind of help provide the market opportunity.
Question: Alethia Young - Cantor Fitzgerald - Analyst
: Do you think this trial would be a little bit easier to enroll or --?
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SEPTEMBER 27, 2021 / 7:20PM, KURA.OQ - Kura Oncology Inc at Cantor Fitzgerald Global Healthcare
Conference (Virtual)
Question: Alethia Young - Cantor Fitzgerald - Analyst
: And maybe just one last one to round it out. Let's talk a little bit about the next generation FDI. You nominated 2806. And just maybe talk about
the goals of the molecule versus tipi and maybe what other indications you might think about taking it in beyond head and neck.
Question: Alethia Young - Cantor Fitzgerald - Analyst
: Awesome. Well, I think we are at time, Troy. So thank you very much, and I'm looking forward to all the updates over 2022.
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