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

Cabozantinib is well understood. And if you again look at the preclinical data that was published at the Triple Meeting, very, very impressive activity in a second-line setting and in particular even after patients have progressed on one TKI the combination of a second TKI plus 2806 really drives meaningful benefit. And that’s again a lot of the things that we’ve learned about FTIs over the years they have anti-angiogenic properties. They have other reasons that make that combination really pretty slick. And so we’ll look forward to getting into that combination again approximately middle of next year.

Peter Lawson: Perfect. Thanks so much.

Troy Wilson: My pleasure. Thank you, Peter.

Operator: Your next question comes from Roger Song from Jefferies. Your line is now open.

Roger Song: Great. Congrats for the progress. Thanks for taking the question. A couple from us. Maybe still focusing on the combo given that will be the most upcoming data readouts you will have. Maybe just to drill down some of the details Troy if you can for those 20 patients how balanced we should see for the first time versus the relapsed/refractory and NPM1 versus KMT2A understanding you have two cohorts by the dosing but how balanced within the dose we will be able to look at it. And then also just confirm that 20-patient or will be from the 200-milligram, but not a 600-milligram. That’s my first question.

Troy Wilson: Sure. Yes, Roger. So let me take your second question first. So we’re starting the dosing at 200 milligrams. Obviously, I don’t want to there is an intention to escalate all four cohorts. I don’t want to speak to exactly sort of what you’ll see yet. But what I can tell you with respect to your first question is we have KMT2A and NPM1 as six patient each separate cohorts for each of the two regimens. I can tell you this. They’re all enrolling well. There’s strong activity for each of the four of those cohorts. We anticipate that the data set when you see it in early Q1 next year will be well-balanced in terms of NPM1 and KMT2A both frontline and relapsed. So again an early data set but we think an important data set in terms of addressing this question of can we mitigate differentiation syndrome.

And it’s just a credit to our team and we talk a lot about being highly encouraged. We started dosing this study in July. We’re already at a point where if we can guide to giving you data in early Q1 2024 our team is just crushing it on the operational execution. And we’ll of course continue to dose escalate as appropriate. That’s why I want to be careful how we answer the question on exactly what dose level. Let just — when we share the data we think it will address these questions around safety, tolerability, combinability, ability to mitigate DS et cetera. We’ll of course look then to providing a subsequent update that will continue to flush-out that picture.

Roger Song: Sure. Yeah I agree. It’s pretty rapid enrollment. And then so I don’t want to lose sight of your pivotal monotherapy data the study for NPM1. So I think that’s the first time you guide you will close the enrollment by midyear. Just curious any statistical plan you have disclosed to us in terms of maybe any interim analysis or the non-hypothesis? What is the minimum follow-up to have the final readout? And since you are guiding the enrollment completion any guidance around the timing of the readout? Thank you.