Curis, Inc. (NASDAQ:CRIS) Q1 2024 Earnings Call Transcript

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Billal Jahangiri : Thanks appreciate it.

Operator: Your next question comes from the line of Sean McCutcheon of Raymond James. Your line is open.

Sean McCutcheon: Hi, guys. Thanks for taking my question. Definitely look forward to the top-line next week. Correct me if I’m wrong, but you said previously that the potential pivotal cohort in the relapsed/refractory AML setting, you are probably going to end up having to go after either FLT3 or spliceosome in a single study with the co-mutations maybe going into the same bucket. So first, is this consistent with your current understanding or your current plan, can you walk us through the decision between FLT3 and spliceosome in that context, what factors you are considering, obviously FLT3 a bit more well established in terms of the scale and scope of the data set that you’ll need. Thanks.

Jim Dentzer: Yes. No, thank you, Sean, and thanks for the question. So yes, you are right. In the past, we have certainly said that, and I would say the same thing today with the very significant caveat that we need guidance from FDA on this issue. Our expectation is that it’s very clear for patients that have a FLT3 mutation only or a splicing factor mutation only. They’re going to go into their respective studies. And as we’ve talked about, it’s roughly one-third of the population in AML has a FLT3 population and roughly 10% have a splicing factor mutation. There are a small number of patients, and we have seen it in our 30 patients, we’ve got two. So there are going to be a small number of patients who would qualify for both studies.

And I suspect again we haven’t had that conversation with FDA. But I suspect what they are going to ask is that we put patients with dual mutation in one study and not in both studies. But we need to have that conversation with them to make sure that that’s what they’d like to see. How you decide which one they go in that’s — again, that’s going to be a subject of discussion with FDA, but those patients would presumably be eligible for both populations.

Sean McCutcheon: Thanks. Yes. And just a quick point of clarification, sorry if I miss this, but will the EHA and ASCO data set be the same data cut?

Jim Dentzer: Yes is the short answer to that question. It’s the same data cut for both populations. We’ll talk about that more next week when the data come out. But absolutely. There are going to be different presenters at both conferences, sort of the behind the scenes — story of working at a biotech company and managing a novel target. Is that you — high-class headache, you get a lot of physicians on both sides of the pond that want to present your data. And so we are going to have different people at different conferences. But the data set, the data cutoff is the same.

Sean McCutcheon: Great. Thank you.

Operator: There are no further questions at this time. I’ll turn the call over to Jim Dentzer. Please continue.

Jim Dentzer: Thank you, operator. And as always, thank you to the patients and families participating in our clinical trials. To our team at Curis for their hard work and commitment and to our partners at Aurigene and the NCI for their ongoing help and support. We look forward to updating you again soon. Operator?

Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.

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