Kura Oncology Inc Q1 2024 Earnings Call Transcript

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

Question: Jonathan Chang - Leerink Partners LLC - Analyst : Hi, guys. Congrats on the progress, and thanks for taking my question. First question, how should we be thinking about the implications of ziftomenib getting Breakthrough Therapy Designation on the likelihood of success of KOMET-001 and the time line for potential approval?

Question: Jonathan Chang - Leerink Partners LLC - Analyst : Great. Thank you. And just one more question for me. Can you provide any color on when we might see more this domain of clinical data over the course of the year?

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

Question: Jason Zemansky - BofA Securities - Analyst : Good afternoon. Thank you so much for taking our questions and congratulations on the progress thus far. I was hoping maybe you could shed some light into of the patients who have remained on the trial. I mentioned 16 of 20 patients, including all 11 NPM1 patients are still in the study. What happened with the four? Was it disease progression or something else? What dose were they being treated with?

Question: Jason Zemansky - BofA Securities - Analyst : Got it. Perfect. Thanks for the color.

Question: Roger Song - Jefferies - Analyst : Great. Congrats for the progress and thank you for taking the question, Troy. Maybe start with the one clarification question and one follow-up question. For clarification, just to confirm, for the RP2D you're about to declare that is in all of those four cohorts first-line and relapsed/refractory in both ven/aza and the 7+3, but your Phase Ib trial or the Phase Ib expansion trial, you plan to do only in first-line ven/aza, is that correct? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 02, 2024 / 8:30PM, KURA.OQ - Q1 2024 Kura Oncology Inc Earnings Call

Question: Roger Song - Jefferies - Analyst : Yeah. I think you answered the first part. The second part really is just to clarify what is the Phase Ib expansion cohort because you mentioned the first line ven/aza combo, but how about the relapsed/refractory and the 7+3? Thank you.

Question: Roger Song - Jefferies - Analyst : Excellent. Okay. So that's clear now. Actually, you already partially answered my last question, follow-up question is the registration path. Maybe can you give us a little bit in terms of time line guidance when you will start to think about the registration for either of those cohorts? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 02, 2024 / 8:30PM, KURA.OQ - Q1 2024 Kura Oncology Inc Earnings Call

Question: Roger Song - Jefferies - Analyst : Excellent. Thank you, Troy for all the comments. That's it from us.

Question: Li Watsek - Cantor Fitzgerald - Analyst : Hey, good afternoon. Congrats on the progress. Just a couple of questions from me. Troy, I wonder if you can provide any color on whether the FDA has seen additional data for the breakthrough definition potentially from the ongoing pivotal study as well?

Question: Li Watsek - Cantor Fitzgerald - Analyst : Okay. Thanks. And then for the 400 meg dose, it sounds like it's being cleared. So I wonder if you can share any maybe early indication whether you're seeing a dose response here relative to the 200 mg. I understand the patient population is slightly different, but any color there would be helpful.

Question: Li Watsek - Cantor Fitzgerald - Analyst : Okay. Thank you.

Question: Brad Camino - Stifel - Analyst : Great. Thank you, and it's nice to be able to focus on just your call this evening. I just wanted to check in on the BTD. Can you help me understand when you submitted for that designation? And why it ended up at that submission date?

Question: Brad Camino - Stifel - Analyst : Okay. And maybe if I can ask one more. As you're progressing through the combo dose escalation, have the enrollment rate across the different cohort mutations come in line with your expectations headed into the trial? Thank you.

Question: Brad Camino - Stifel - Analyst : Thank you.

Question: Peter Lawson - Barclays - Analyst : Hey. Thanks for the taking the questions. Just around the 200 milligram dose in combination, are there any trends emerging from the duration on therapy between the KMT2A versus the NPM1 patients, Troy?

Question: Peter Lawson - Barclays - Analyst : Got you. And then are you seeing anything in the side effect profile when you combine, is there anything that would be impacting duration of therapy or any quirks from particular regimens?

Question: Peter Lawson - Barclays - Analyst : Great. Thank you so much. Thanks for taking the question.

Question: Ernie Rodriguez - TD Cowen - Analyst : Thank you. This is Ernie Rodriguez for Phil. Thanks for taking our questions. We have one. With the competitors many inhibitors launching, even though it's in another indication, the KMT2A, is there anything -- they're likely launching soon in this year -- later this year, is there anything on that launch that you would be looking to or any metrics or any other aspects that you would expect will be useful or informative to your strategy?

Question: Ernie Rodriguez - TD Cowen - Analyst : It does. And another quick one on the preclinical data in solid tumors that you expect to disclose in H2. What should we expect on that -- are we going to be able to determine like what -- which kind of solid tumors would be most amenable -- or you will be pursuing on the clinical side or is it more like a broad proof of concept in a broader range of solid tumors.

Question: Ernie Rodriguez - TD Cowen - Analyst : Got it. Thank you. That's helpful. Thanks for taking our questions.

Question: Ren Benjamin - JMP Securities LLC - Analyst : Hey, good afternoon, guys. Thanks for taking the questions. Maybe I missed it, Troy, in your prepared remarks, but what's happening with the post-transplant program? Has that been initiated, maybe I missed it, is one of the upcoming milestones. Just wanted to know how you're thinking about that.

Question: Ren Benjamin - JMP Securities LLC - Analyst : Got it. Thank you for that added clarity. Just switching gears a little quick to 2806. When I look at KURRENT-HN and the potential to complete enrollment in the two expansion cohorts, and still identify the optimal biologically active dose in -- by the end of 2024. Is -- can I take that kind of REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 02, 2024 / 8:30PM, KURA.OQ - Q1 2024 Kura Oncology Inc Earnings Call a time line and apply it to 2806 or is 2806 such a unique molecule and very different from tipi that maybe that entire enrollment of the combination studies is going to be a lot quicker, we might see data a lot faster than we're seeing in KURRENT-HN.

Question: Ren Benjamin - JMP Securities LLC - Analyst : Excellent. Thanks for taking the questions.

Question: Justin Zelin - BTIG - Analyst : Thanks for taking the questions. Troy, just with the KOMET-001 enrollment completion coming up here. Any thoughts on when we could see data from that study? Could that be a 2024 event or in 2025?

Question: Justin Zelin - BTIG - Analyst : Great. That makes sense to me just on 2806, could we expect some additional studies with other combination agents in the future? Or are you pretty comfortable with what you have right now? Thanks.

Question: Justin Zelin - BTIG - Analyst : Great. Thanks for taking my questions.

Question: George Farmer - Scotiabank - Analyst : Hi. Thanks for taking my question. I have two. Troy, could you address what you think the hurdles are for zifto approval in NPM1 in relapsed/refractory setting. It's the first question. The second question is, on how you think about resource allocation when developing zifto in earlier lines of therapy combining with 7+3 or ven/aza?

Question: George Farmer - Scotiabank - Analyst : Yeah. What do you think the hurdles are for FDA approval of zifto, refractory?

Question: George Farmer - Scotiabank - Analyst : Okay. 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. MAY 02, 2024 / 8:30PM, KURA.OQ - Q1 2024 Kura Oncology Inc Earnings Call