Kura Oncology Inc Q2 2024 Earnings Call Transcript

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

Question: Li Watsek - Cantor Fitzgerald - Analyst : Greta, congrats on the progress. Maybe just first on the update in Q4 and Troy, can you tell us a little bit about, in terms of patient distribution being the expansion cohort and I believe there are 100 patients. And so we're looking at multiple cohorts at different doses. So maybe a little bit of information there will be helpful. And then the second question is on GIST, and I thought I was very interesting biology. So just wondering what are the gating that's our before you move into proof of concept study in first half of next year and what would be the bar for success? Thank you.

Question: Jonathan Chang - Leerink Partners LLC - Analyst : Hi, guys. Thanks for taking my questions. First question with the Phase 2 registration directed KOMET-001 study fully enrolled as you look ahead to interactions with regulators? How are you thinking about what you can do to minimize any potential hiccups along the regulatory process? And second question on KOMET-007, can you provide any color around your experience with the different ziftomenib dose levels and going with the 600 mic dose in the expansion combination cohorts? Thank you.

Question: Jonathan Chang - Leerink Partners LLC - Analyst : Understood. Thanks for taking the questions.

Question: Roger Song - Jefferies - Analyst : Great. Congrats for the progress and thank you for taking our question. So maybe we looking ahead for your expansion cohort four 007. How should we think about that data release versus the potential pivotal for those standard of care combination? Given you will potentially have the label for monotherapy soon? And how should we think about a combo into the label? Thank you.

Question: Roger Song - Jefferies - Analyst : Yeah, sure. So the expansion cohort, just curious about the data timing versus the potential pivotal plans for the combination and then the monotherapy, you're going to have the data next year, but how we should think about the combination pivotal plan? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 08, 2024 / 8:30PM, KURA.OQ - Q2 2024 Kura Oncology Inc Earnings Call

Question: Roger Song - Jefferies - Analyst : Excellent. Thank you. Thank you for the guidance regarding the combo pivotal next year -- early next year. Okay. Maybe just a follow-up question related to the next-gen Menin inhibitor. And I think you mentioned mostly focused on the diabetes type I type II. Just curious, would you be also considering next gen Menin inhibitor in other therapeutic areas, including the oncology, solid tumor, et cetera? Thank you.

Question: Roger Song - Jefferies - Analyst : Thanks so much, Troy.

Question: Brad Camino - Stifel - Analyst : Hi, thank you and impressive enrollment here. I wanted to ask about what we saw from J&J's Menin combos at EHA is last year in '23, they reported the monotherapy DS rates around 12%. They had one grade five events and then recently at EHA '24, they showed the combo work where they did the schema where they pre-dose with Ven to reduce blast burden, which is very similar. What you're doing and the combo did cut rates down to about 3% in 60 patients, which I think is very validating for your approach. But when they had DS, it was again a grade five. So first, I want to know, do you think it's unfair to draw parallels here at zifto, but under that assumption, I'm wondering how you think about the level of assurance that you can have for a Menin inhibitor with the high end monotherapy DS signal when it comes to the ability to completely avoid grade five even in combos. Thank you.

Question: Brad Camino - Stifel - Analyst : I don't believe it's disclosed in the deck.

Question: Brad Camino - Stifel - Analyst : Thanks Troy.

Question: Phil Nadeau - TD Cowen - Analyst : Thanks for taking my questions. A couple on the combo data and then one on just in terms of the combo data for zifto, you're not calling the 600 milligram dose at the recommended Phase 2 dose. So it's it doesn't sound like it is, I was curious why that is it just a question of semantics or is there another step that's necessary before 600 milligrams? The formal Phase 2 dose for combo therapies? And second, on the combos, do you anticipate providing overall survival data from the combos when you reported at presumably at ASH? And is there an overall survival profile you need to see before moving into pivotal studies. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 08, 2024 / 8:30PM, KURA.OQ - Q2 2024 Kura Oncology Inc Earnings Call And then I just our understanding is that the vast majority of patients who are resistant to imatinib have secondary mutations. So we're kind of curious as to the mechanism by which zifto can resensitize, we don't want to steal the thunder of the upcoming medical presentation, but we're curious, if you give any details?

Question: Phil Nadeau - TD Cowen - Analyst : That makes a lot of sense. Thanks for taking our questions.

Question: Justin Zelin - BTIG - Analyst : Thanks for taking my question and congrats on the progress. So Troy, you made a comment earlier about patients on zifto may not have to go on to transplant. They might be able to stay on drug here, but just wanted to hear your latest thoughts about use in the maintenance setting. And do you expect the usage of zifto in the maintenance setting after you get your first approval here? Thanks.

Question: Justin Zelin - BTIG - Analyst : Great. That's helpful. Thanks for taking the questions.

Question: George Farmer - Scotiabank - Analyst : Hi, good afternoon and thanks for taking my question. Troy, I was wondering if you could elaborate a little bit more on your diabetes data. Other than safety, how do you think zifto compares? And maybe one of your follow-on compounds compares to existing Menin inhibitor data that's out there in the clinic? And how does this program differentiate itself from others?

Question: George Farmer - Scotiabank - Analyst : Okay, great. That's very helpful Troy. Thanks.