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

We dosed them for seven days and then we start zifto on day eight. There’s really three reasons for doing that. Number one, you get a safety baseline on the standard of care. So that helps you deconvolute any talks that you see in the combination. Secondly, of course, it allows you time to genotype. And then third, it helps to debulk the patient further mitigating the risk of differentiation syndrome. I don’t want to speak to what others are doing but we found that approach to be very successful and it’s something that we’re implementing kind of across the board. Starting with these two combinations and as you hear in 008, we’re going to roll out to some additional combinations most notably gilteritinib.

Q – Jeet Mukherjee: Got it. That makes perfect sense. And just a second question I had. Turning to the FTI program. Could you just share your thinking and strategy a bit more broadly around this program? What would you be looking for from a safety and efficacy perspective to justify moving tipi forward as a monotherapy or the alpelisib combo? Thanks.

Troy Wilson: Yes. So – sorry, you’re asking specifically about tipi or about 2806. I just want to make sure I answer the question. You asked tipi and head and neck.

Q – Jeet Mukherjee: Yeah. Perspective on both programs would be helpful.

Troy Wilson: Okay. So with head and neck, I mean — and this was one of the takeaways from the AMJ data that was presented by Dr. Ho in the Mini Oral session at ESMO. You have at best in the second line with standard of care and 20% response rate. The third line is 5%. Tipi as a monotherapy is driving sort of meaningful activity with very — and it has a favorable safety and tolerability profile. What we know is tipi is not active as a monotherapy in the PIK3CA setting. Alpelisib is reported to drive only stable disease. Clearly, if you can drive responses with reasonable durability and you have an acceptable safety and tolerability profile then you start to look at it. The bigger question and let me come to 2806, is as you’re hearing this is a busy quarter.

I think subsequent quarters may be equally busy. We have a number of investments in zifto. You’ve heard relapsed setting, frontline settings, we’re going to start into maintenance. You’re hearing us now push forward with 2806 in both non-small cell lung and renal cell carcinoma. I’m interested if there’s an opportunity with 2806 in pancreatic cancer, RAS-driven pancreatic. I think that’s a huge unmet need and a huge opportunity in a rapidly evolving space. The other thing we’ve got to do is be good fiduciaries and say, how can we be as disciplined on the investment side as we are on the scientific and clinical side and that’s the calculus we go through on a pretty regular basis. So we’re going to get everything we can out of head and neck and then we’re going to fold that into where do we make these investments, where are we going to drive the greatest amount of value for patients for employees and for our shareholders.

And that’s how we’ll do it.

Q – Jeet Mukherjee: Thank you.

Troy Wilson: You’re welcome.

Operator: Your next question comes from Phil Nadeau from TD Cowen. Your line is now open.

Troy Wilson: Hello? Hey Phil.

Phil Nadeau: Hey, guys. Sorry about that.

Troy Wilson: Of course.

Phil Nadeau: Thanks for taking our questions. A quick question from us on the updated enrollment time lines. When do you think you have clarity to really say when the moment in the pivotal trial is going to complete? Do you think that’s likely early next year or will we know it is complete once it’s completed?