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

Michael Metzger: Thanks, Peter. Thanks for the question. NPM1 enrollment is going well. It’s KMT2A is going well as well. So I think they’re both — there’s great enthusiasm certainly since ASH, I would say that investigators have really engaged with us and have it’s really related to the data that they saw at the meeting. And so NPM1 enrollment is going well. So there’s — and I think that relates to our ability to complete enrollment in the second half of this year. And then you had a follow-up.

Peter Lawson: Yes, just around axatilamab, just with Sanofi’s Rezurock with that launch. Kind of how do you look at that and gauge your own potential launches? How should we think about peak revenues? And whether you think this is ultimately a single agent or combination agent regimen?

Michael Metzger: Thanks for the questions, Peter. So, yes, look, I think we — you heard in my remarks, Rezurock has done well. It’s first year sales upwards of $200 million to $250 million in sales, impressive. This is — our drug has a different mechanism of action, and we think impressive results thus far in its clinical trials. And I think the opportunity here in chronic graft versus host disease is to access patients in the relapsed/refractory setting. I think these patients tend to over there — course of their treatment journey, they tend to get multiple therapies, they cycle through the different therapies. And so our opportunity, we think, is what Rezurock and/or Jakafi experience in the third line, the ability to pick up meaningful share.

Ultimately, this — and that’s as monotherapy — but ultimately, the opportunity here extends itself well beyond just monotherapy into potential combinations. Rezurock is — has its own opportunity for combination potentially. But the mechanism of action of our drug is not overlapping with Jakafi. And so that’s the — as Briggs pointed out, that’s the reason why I think we’re so excited about being able to combine it in the frontline setting and potentially reduce the use of steroids, which could really expand the use of this drug beyond what Rezurock has even shown in relapsed/refractory in the first year. If you think about that a little harder, first year sales to $200 million to $250 million, that’s showing to be a potentially very large opportunity.

Again, that’s just in relapsed/refractory third-line-plus disease. And so the opportunity to go in combination and get the patients earlier in their treatment journey, I think really pretends well for our drug. And I think, was there something else to your question, Peter?

Operator: And our next question comes from Kalpit Patel with B. Riley Securities.

Kalpit Patel: Yes. You mentioned that the enrollment for the NPM1 cohort is going well. So I’m just curious about the timing differences versus the KMT2Ar cohort. Is that just a function of when these trials started enrolling? Just trying to understand the gap there.

Michael Metzger: Yes. Thanks, Kalpit. Good question. Look, as I said, we are pleased with the enrollment for — and the physician enthusiasm for both NPM1 and KMT2A. I do think that BTD has its sort of advantage to our filing strategy for KMT2A and the ability to combine cohorts, may have something to do with our ability to kind of move more — slightly more quickly with KMT2A. So I think that’s part of it. The other part of it is that KMT2A, there’s probably a little less competition for patients with our competitors. And NPM1 may be drawing more patients in various studies. So I do think that there are some competing factors here, some contributing factors here. But ultimately, I think we’re doing quite well with NPM1, and we feel that getting to market as quickly as we can with KMT2A will advantage us greatly as we bring data behind for NPM1 and hopefully get that approved as well.

Kalpit Patel: Okay. And then maybe one question on the combo studies. Has the dosing commenced for the Beat AML study. I think you stated that we’re just expecting safety this year. So I was just wondering if those things started yet.