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

Michael Metzger: Yes. Thank you for the question, Kalpit. So yes, the combination studies have initiated. So there is the — again, the AUGMENT-102 chemo combination that has been enrolling patients as well as the Beat AML trial that is also enrolling patients, so they both start.

Operator: And our next question comes from Bert Hazlett with BTIG.

Bert Hazlett: Just one or two for me. Could you just remind what the consideration Revumenib post-transplant? Is there a regulatory or an indication strategy there? Or — are you thinking about that as a companion listing or publication strategy? Just could you just frame how you’re thinking about that from a regulatory perspective?

Michael Metzger: Sure. Briggs, do you want to take that question from Bert, please?

Dr. Briggs Morrison: Yes. So Bert, in the ongoing pivotal trials, we allow patients to go back on to Revumenib after their — if they have a response go to transplant, they can go back on Revumenib. That work in the pivotal trial, we don’t anticipate a label indication for that. Best-case scenario is, we might be able to describe in the label that how the trial was conducted. So I think that information will be mostly gotten out into the community through publications. It does set us up for potentially a formal maintenance trial down the road, but the way we’re handling it in the pivotal trial there won’t be a claim regarding maintenance.

Bert Hazlett: Okay. That’s helpful. And then just shifting gears from a corporate perspective, back to axatilimab, I believe you have a co-promote option there, and you’ve hired a Head of Commercial relatively recently. How are you thinking about that decision? And is there a particular timing in which that needs to be executed on your part?

Michael Metzger: Thanks for the question. Good question. You’re correct. Our agreement with Incyte does include a co-promotion option on axatilimab. That election is made in proximity to filing. So it is something that we’ll have to kind of let people understand a little bit better in the coming months as we get closer and closer to that time point. Obviously, we’ll have a filing, as we said before the end of the year. So we’re thinking actively about it. I would just say that we have two programs that, as we described today, as you know, that are really on top of one another in terms of timing, both for filing and then approval. And so the commercial opportunities, while not the same, are — may have some synergy in terms of the doctors that are being called on and how we promote these products.

So the thought potentially that there could be some very nice synergy between what we do with Revumenib and axatilimab, and so that we’re thinking actively about whether the co-promotion option makes sense for us.

Bert Hazlett: Okay. And I know maybe early, but any thoughts on sales force sizing, infrastructure, things like that?

Michael Metzger: Sure. It’s a longer conversation. I would say that we — this is a focused commercial effort, meaning that these are not very large patient populations. More importantly, they are covered by a reasonably focused number of physicians. And so the field force to cover it is somewhere in the order of 40 to 50 physicians — 40 to 50 reps. We’ll refine those estimates and start to give some more color to what the organization looks like that we’re building, but we are actively engaged in bringing in leadership to the Company in order to be ready in time for launch for both of these products.

Operator: Our next question comes from Joel Beatty with Baird.

Joel Beatty: First one just on the pool KMT2A cohort. Do you anticipate that the efficacy will be presented just for the pooled cohort on the label? Or could there also be a breakdown of AML and ALL on the label?