Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q4 2022 Earnings Call Transcript

Michael Metzger: Yes, Phil, thanks for the follow-up. I think we’re going to — well, we haven’t really guided, we’re not planning to guide on a specific number of patients in the combined cohorts. I think what we’ve said is that it’s a sufficient number based on both feedback. We feel that we’re aligned on a strategy to have a sufficient number of patients that will constitute a filing in the — by the end of the year. We’ll have that data, of course, in the third quarter. But we’re — at this point, we’re not guiding specifically to how many patients are in the pooled analysis.

Philip Nadeau: Got it. Okay. And then — last question on revumenib before one question on Axa. In the NPM1 pivotal same data — or sorry, enrollment completion in the second half of the year, that seems to suggest data the first half of ’24, maybe mid-’24 based on your prior guidance for the KMT2A population. Is that a fair assessment? Or is there some reason why there could be a longer interval between enrollment completion and data in the NPM1 patients?

Michael Metzger: I think the same rules apply. I think we said we follow patients for six months. We’re not being specific as to exactly when in the second half, we’ll have the NPM1 enrolled. So I’m going to be a little bit conservative and not project that when we’ll have top line data yet in 2024, but I think we — that’s — it’s the same rules that apply to the KMT2A population as the FDA will be following them all for six months.

Philip Nadeau: Great. And then last question for us on axatilimab. Would you be willing to provide any additional details on the IPF Phase II now? Or will we have to wait until the trial is underway?

Michael Metzger: Yes. Thanks for the question, Phil. We’re excited to obviously get that trial started, and we’ll probably share more details on the trial and the design once we’re underway. I think that’s probably old to say.

Operator: Our next question comes from Anupam Rama with JPMorgan.

Priyanka Grover: This is Priyanka on for Anupam Rama. Just a quick question from us. Between the two KMT2A cohorts, could you provide any color or clarity on enrollment breakdown?

Michael Metzger: Yes. Thank you for the question. As I said previously, we’re not going to give specific guidance on how many patients were contributed from the — either of the two cohorts. What we’re guiding to is that, we have a sufficient number that we can complete the analysis, and we’ll provide that top line data in the third quarter. So I think there’s a lot to be satisfied with that for now. I think that’s the guidance, specifically.

Operator: Our next question comes from Yigal Nochomovitz with Citi.

Ashiq Mubarack: This is Ashiq Mubarack on Yigal. Just on NPM1. Do you have clarity on the number of NPM1 patients you need to enroll to hit your time line guidance? Have you spoken with the FDA on specifically NPM1?

Michael Metzger: Yes, thanks for the question. We had previously disclosed 64 patients, NPM1 patients as we had laid out the three cohorts. 64 patients is the number that we’ll look to enroll. And we have, of course, spoken with the agency about not only NPM1 and KMT2A, we’ve had a fair amount of interaction with them over the several months since we started this program. And we’ve aligned on our — not only our design, but all the statistics that go into each of the cohorts. So yes, nothing really new there. It’s still the same number of patients that we had guided to use.

Ashiq Mubarack: Okay. Are you able to provide any clarity on where you are in terms of fitting the 64 patient number?