Kura Oncology, Inc. (NASDAQ:KURA) Q4 2022 Earnings Call Transcript

Reni Benjamin: Hey, thanks for taking the questions and squeezing me in. Just, I guess, starting off, Troy, can you talk a little bit about a clinically meaningful median duration of response? I think in the Phase 1, we had seen somewhere around 4 to 5 months or so. And €“ but we’re looking at different doses, we have different genetic types. I guess, within the NPM1 population, what do you feel really drive kind of uptake? And we’ll give you kind of the go ahead that you want? And then also, I guess, it’s my second question, as you know just building on Brad’s kind of benchmarking of efficacy and the combination studies, as you think about prioritizing these studies, just within 007 is like echo or it’s right. How do you go about doing that, if the efficacy is meeting your benchmarks?

Do you focus on frontline? Do you just spend everything you can on both frontline and relapsed/refractory? Any sort of thoughts as to how you start to funnel these studies into registrational combination study?

Troy Wilson: Yeah. So 2 good questions, Reni, and let’s take them in turn. So as far as we know and the kind of the guidance that we’re using 4 to 6 months duration of response in the relapsed/refractory population is approvable. Now, you’d like to do, obviously, you want to do as good as you can, you want to give these patients the longest duration possible, but the bar to approval is probably 4 to 6 months. And you were right, kind of in the €“ we were €“ the data was immature. But we were getting into the right zip code at the time of the ASH presentation. Look forward to providing an update sort of mid-year here this year. Consider that the NPM1 overall survival is a median of about 6 months without menin inhibitors.

So if you’re talking about four 4 to 6 months duration of response, that’s a good improvement that’s where that number comes from. The second piece of your question is kind of how do €“ a prioritization. And I would say the following, in your scenario, where multiple regimens look good. This is €“ I’d like to say several of you’ve heard me, say, let’s put that in our bucket of extremely high class problems, right? If we’ve got multiple regimens that look good, you don’t have to register all of them. We will continue to be good fiduciaries, and prioritize those combinations that we believe are going to drive the greatest commercial value. And you already know what they are, it’s clear. Venetoclax containing regimen with or without azacitidine, let’s see, how that plays out, would you need the triplet or the doublet.

And then, of course, the FLT3 containing regimens, because at least in the relapsed population, a significant number of the NPM1-mutants are also FLT3 new mutant, co-mutant those are probably ran the 2 greatest populations. But if we got a handful of 10 to 20 patients worth of safety and activity data to support other regimens that just helps broaden the utility, broaden the knowledge base and the comfort among the hematologist, oncologist, who ultimately are out in the community using ziftomenib. So we’re going to do just enough that we give everybody comfort that that zifto is almost €“ it’s an amazing drug, right? It’s highly mutant selective, extremely efficacious, and yet it’s also extremely tolerable. The patients say to us, the only reason I know on the drug is I take a pill once a day in the morning.

If we can couple that up with the commonly used regimens, we think we’re in great shape.

Reni Benjamin: Perfect. Thanks for taking the questions.

Troy Wilson: Our pleasure.

Operator: We’ve reached the end of the question-and-answer session. I would now like to turn the call back to Dr. Troy Wilson for closing comments.