Kura Oncology, Inc. (NASDAQ:KURA) Q3 2023 Earnings Call Transcript

Troy Wilson: Sure, Roger. So there’s again a few questions in there. So this is the first time we’ve really put it on our milestone slide drawing a line as far as completion of enrollment of an 85 patient study no later than the middle of next year. I’ll note that one of our principal competitors is expecting to enroll its NPM1 cohort now sometime between Q1 and Q2 of next year a 64-patient study. So we’re clearly I think neck and neck and closing ground. The reason we picked 85 patients was driven by safety and tolerability. That always has to be paramount. That’s why we are doing 007 the way we’re doing it. That’s really what the FDA wants to see even in these devastating diseases. So 85 patients plus the experience we have in NPM1 from the Phase 1 study we think gives us approximately 100 patients.

That should meet the agency’s expectation as far as safety and tolerability. We have not disclosed a statistical plan or the no-hypothesis. I can tell you we are being very conservative. We are, I think quite encouraged by the 35% CR rate with full count recovery in the Phase 1b that we saw. But we’re giving the trial every opportunity to be successful and we’re taking advantage of every opportunity we can to pull the time lines forward. So I think it’s important to put that out there. As far as disclosure of data that was the last of your questions, let’s get to that maybe a little further along. We want to make sure we’ve got really clear visibility into the end of enrollment. And as you know, you need enrollment, you need follow-up, you need data cleaning.

And ideally your data release coincides with the scientific or medical meeting. We want all those stars to align. We’re working on it. We’ll give you an update when it’s appropriate. I think I’ve answered all your questions Roger, but tell me if I missed anything.

Roger Song: No that’s great. Thanks. Enjoyed as always, and congrats again. That’s all from us.

Troy Wilson: I appreciate the question.

Operator: Your next question comes from Li Watsek from Cantor Fitzgerald. Your line is now open.

Li Watsek: Hey, great. Thanks for taking my questions. Just wondering, Troy, if you can just comment on the combo data from your competitor released from [Indiscernible] this morning. And then since you had some initial experience with your own combo, I understand it’s not really apples-to-apples. But just from the safety perspective, how do you see a trend relative to your competition?

Troy Wilson: Yeah. Li, really good question, two good questions. I think — let’s just — a lot of drug development is pattern recognition and learning from the past. And if we go to other areas where people are developing targeted therapies, safety, tolerability, drug-drug interactions ability to combine or what’s sine everybody right? We’ve seen this in the KRAS field ability or not to combine with checkpoint inhibitors. We’ve seen it in combining with inhibitors of the RAS pathway in the PI3 kinase pathway. That’s why we’re so excited about 2806 and adagrasib. Here is no different. I think Li some of the critical questions are going to be what are the drug-related AEs that you see both as a monotherapy and in combination.

Are you seeing high rates of neutropenia, thrombocytopenia, febrile neutropenia that’s what we’re seeing. You would of course expect activity the standard of care gives you activity. But what you’re really looking for is are there going to be challenges that are going to be posed in being able to either administer the standard of care or really optimize it. I’ll just go back to what do you already know about zifto. We’ve given you a very robust data set at the 600-milligram dose that I believe despite the data from the handful of competitors here at ASH really shows that we have a best-in-class menin inhibitor from the perspective of safety and tolerability. That’s going to have two important considerations lead. One is the challenges that limit the duration of exposure in combo is one of the things you want to focus on.