Kura Oncology Inc To Host Investor Event Transcript

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

Question: Li Watsek - Cantor Fitzgerald & Co - Analyst : Hey. Thanks and congrats on the top-line data and the regulatory update. I guess just at the top-line level, wondering if you can just comment on what you've seen from your pivotal study relative to the data from the Phase 1b trial. And then just give them the profile you've seen, can you talk

Question: Li Watsek - Cantor Fitzgerald & Co - Analyst : Okay. I wonder if you can also provide more color on the frontline trial size and powering assumptions and what the timeline will look like for AA and full approval.

Question: Li Watsek - Cantor Fitzgerald & Co - Analyst : Okay, thank you.

Question: Yen-Der Li - Leerink Partners - Analyst : Hi, so this is Yen-Der here on for Jonathan Chang. So congratulations on the positive result and also on the positive FDA feedback. So we have one question about the upcoming 007 data that is going to be presented in QQ. Could you help us set some expectation on what we're going to see? For example, are we going to know about durability or other profiles? And also there is another like non intensive chemotherapy combination. Will we also get update on that this year? Thank you.

Question: Yen-Der Li - Leerink Partners - Analyst : Understood. Thank you and congratulations, again.

Question: Jason Zemansky - BofA Global Research - Analyst : Good afternoon. Thank you so much for taking our questions. Appreciate the regulatory and developmental updates. We were hoping you might be able to provide some color about what a positive result for 001 means in terms of capturing that $350 million to $400 million market opportunity, again, recognizing that you may not be able to disclose the number itself.

Question: Jason Zemansky - BofA Global Research - Analyst : Got it. Thanks for the color. And then maybe Mollie, regarding the MRD-negative CR endpoint for 017-IC, what do you think the community, be it prescribers or regulators, need to see here to be encouraged?

Question: Jason Zemansky - BofA Global Research - Analyst : Got it. Thanks for the update.

Question: Roger Song - Jefferies - Analyst : Great. Congrats on both monotherapy pivotal data and then the combo pivotal plan. So a couple questions from us. The first one is related to the pivotal monotherapy data. So it seems you are hitting the statistical hurdle. I know you may not be ready to share with us the hurdle, but just curious that the data you will present at the medical meeting, it will be the data cut when you hit a stat critical hurdle, or you will keep following them to the time you will submit the data with the later data cut.

Question: Roger Song - Jefferies - Analyst : Great. Thanks. Maybe just a quick follow-up. In terms of the regulatory submission, it will be which data card will be used or reviewed by the FDA. Thank you.

Question: Roger Song - Jefferies - Analyst : Got it, yeah, really helpful. Maybe on the combination, seems you're trying to design a study to skip the transplant. So how should we think about those patients if a physician or patient decided to go to the transplant will be censored or how we account for those potential transplant in the trial? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 05, 2025 / 9:30PM, KURA.OQ - Kura Oncology Inc To Host Investor Event

Question: Roger Song - Jefferies - Analyst : Got it. Yeah. Thanks for the clarification. Congrats, again.

Question: Phil Nadeau - TD Cowen - Analyst : Good afternoon. Thanks for taking our questions. Just a few from us. So first, in terms of the top-line data from 01, can you talk about your rationale a bit more about why you're not disclosing numbers this morning? Is that simply the embargo policy at the medical meetings or just key or Karen typically not disclose data outside of the context of a medical meeting?

Question: Phil Nadeau - TD Cowen - Analyst : Got it. That makes sense. Then a clarifying question on the design of the intensive chemotherapy trial. Given that there's two zifto arms versus one placebo arm, how are the primary endpoints going to be calculated? So for CRD, MRD, negativity, will both zifto arms be combined and compared to placebo? And then similarly for EFS, how will the maintenance versus non-maintenance be contemplated in calculating that endpoint?

Question: Phil Nadeau - TD Cowen - Analyst : Got it. Okay. That is helpful. Thanks for taking our questions.

Question: Charles Zhu - LifeSci Capital - Analyst : Hey guys, good afternoon. Thanks for taking the questions and for hosting this event. I guess we'll just wait till second quarter for those top-line figures. But in the meantime, I was wondering, it sounded like you wanted to stress the importance and correct me if I'm wrong on this, the FDA agreement to allow modified dosing of the venetoclax. Could you expand on that a little bit? How might these modifications, for example, impact control on or experimental on performance relative to what we saw in the VIALE-A trial? Thank you.

Question: Charles Zhu - LifeSci Capital - Analyst : Great. Thank you.

Question: Brad Canino - Stifel Nicolaus & Co - Analyst : Thank you. The potential to use MRD negativity in AML is really encouraging, but I guess everything the FDA has written the past five years for AML has expressed a lot of concern, the lack of assay and quantification, level standardization, false negatives due to disease clonality. And I think they've talked about the absence of convincing meta-analysis data to validate it as a surrogate. So how did you address these elements? And do you expect an ODAC meeting to talk about this for AML like we saw for multiple myeloma last year? Thank you.

Question: Peter Lawson - Barclays Capital - Analyst : Hey, Troy. Thanks for taking the questions. Just going back to the data that we're going to see in two weeks, were there any new side effects that emerged from the dataset or as we think about efficacy, did it fall within the normal bounds that we've seen in the past or has anything emerge from in that data set. Anything you can say would be great.

Question: Peter Lawson - Barclays Capital - Analyst : Okay. Thank you so much. And then just on the venetoclax down dosing, is there anything we should read into that or the negatives, any worries that we should be thinking about for drug-drug interactions?

Question: Peter Lawson - Barclays Capital - Analyst : Okay, perfect. Thank you so much. Thanks for addressing my question.

Question: Reni Benjamin - JMP Securities - Analyst : Hey. Thanks for taking the questions and congratulations on the data. I guess our question is primarily around the use of MRD negativity for the intensive combo and then just using CR for non-intensive combo. Can you talk a little bit about why MRD negativity wasn't used for both? trial sets. And then also, I guess, related to that, I think it was mentioned on the call that you'll be using bone marrow. Can you remind us of the CR MRD negativity rate from 07 and was that bone marrow or peripheral blood?

Question: Reni Benjamin - JMP Securities - Analyst : Got it. Okay. Thanks for the clarification. And then maybe just as a quick follow up. Should we expect like maybe some diminution of activity when we -- as we go from this is what we got using peripheral blood and this is the kind of MRD negativity we're seeing from bone marrow, would you expect to see some sort of a decrease or will it be pretty much in line?

Question: Reni Benjamin - JMP Securities - Analyst : Got it. Thanks for taking the follow up and congrats.

Question: Erik Lavington - Mizuho Securities - Analyst : Hi. Congratulations again and thanks for taking our questions. I'm on for Salim here. So, just wondering if we could, if you could share anything else, share anything about the secondary endpoints. And as I'm looking at the data readout timelines, it looks like KURRENT-HN got pushed out a little bit. I'm just wondering what the puts and takes on that are. Thank you.

Question: Erik Lavington - Mizuho Securities - Analyst : All right. Thanks. And can you comment on any of the secondary endpoints on the 001?

Question: Erik Lavington - Mizuho Securities - Analyst : All right. Thank you.

Question: Chitavi Maulloo - Scotiabank - Analyst : Hi, good evening. This is Chloe on for George. Thank you for taking our questions. Two from us. First, related to MRD negativity. So I know you can't share too much here, but on timing and timelines, to what extent do you think having MRD is the accelerated approval endpoints will be able to shave off time as opposed to if you had the more traditional yes or no. Or as time point, did you get a sense of whether it would be shaving off a couple of months or maybe a year or two? Would be great to get your impressions on this. And then on diabetes, we were wondering for your plans to nominate a candidate in, I guess, later this year, would you be doing that at a company event or a medical meeting and if at a medical meeting could be expect more pre-clinical data as well?

Question: Chitavi Maulloo - Scotiabank - Analyst : All right. Thank you very much.

Question: Jeet Mukherjee - BTIG - Analyst : Hey, this is Jeet on for Justin. Congrats on the data and the progress. Just two questions from us. To get a bit more granular on the mode of disclosure for the 001 update on a medical conference, will everything be fully presented as part of a conference abstract or will perhaps more be saved for the conference itself? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 05, 2025 / 9:30PM, KURA.OQ - Kura Oncology Inc To Host Investor Event

Question: Jeet Mukherjee - BTIG - Analyst : Understood. And just as a follow up, can you speak to the process that led to the alignment for settling on CR and overall survival as a dual primary endpoints for the ven/aza study, whereas others in the space appear to be using overall survival alone?

Question: Jeet Mukherjee - BTIG - Analyst : Great. Thank you for taking our questions.

Question: Joseph Pantginis - H.C. Wainwright & Co. - Analyst : Everybody, thank you. First, just a quick thank you for taking the most canonical path forward to reporting data and medically sound approach. So two questions, please. First, on 001, I know you might not be able to answer this, but directionally speaking, did you hit? targets for both CR and CRh, number one. And then for 017, regarding the SAP, can you talk about or anything about the alpha spend for the first look for CRs? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 05, 2025 / 9:30PM, KURA.OQ - Kura Oncology Inc To Host Investor Event

Question: Joseph Pantginis - H.C. Wainwright & Co. - Analyst : Understood. Thank you very much.