Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q4 2019 Earnings Conference Call - Final Transcript

Mar 03, 2020 • 04:30 pm ET

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Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q4 2019 Earnings Conference Call - Final Transcript

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Q & A
Executive
Briggs W. Morrison

[Operator Instructions] Our first question comes from Madhu Kumar with Baird.

Analyst
Madhu Kumar

So thinking about the chronic graft versus host disease program, would you imagine the expansion cohort will still require ibrutinib-pretreated patients? Or do you imagine that it will be a kind of a wider swath of the graft versus host population?

Executive
Briggs W. Morrison

Yes, Madhu, it will be a wider population of patients. As you recall, when we first started the trial, we were required maybe post ibrutinib. That inclusion criteria has been softened considerably. So now it is a wider population of patients.

Analyst
Madhu Kumar

Okay. And then thinking about the Menin-MLL program. In terms of PK and PD data, would you wait to get to dose-limiting toxicity to announce kind of PK/PD data? Or would you want to -- if you saw an activity that looked like it was getting good continual Menin-MLL inhibition and good kind of pharmacokinetics that you'd want to report that ahead of really just completing the dose escalation?

Executive
Briggs W. Morrison

Yes. And again, as I pointed out in my prepared remarks, Madhu, I think there's PK, PD and efficacy. If we had a sufficient number of patients that we feel like we've actually adequately characterized the PK and dose proportionality and the ability to cover the target and, let's say, we had that in advance of a significant number of patients with efficacy data, we could potentially present that PK data.

Analyst
Bert Hazlett

Yes. My apologies. I'm intrigued by the commercial launch preparation discussions that are underway. Could you just remind us, assuming success in 2112, what the gating items would be for, first of all, the filing and then actually commercialization of it?

Executive
Briggs W. Morrison

Right. So Bert, let me first take the filing piece, and then I'll turn it over to Michael to talk about some of the commercial work we're doing. So as I said in my prepared remarks, we anticipate that within about 6 months of getting the data from ECOG, we would be in a position to submit the NDA. And then it would depend on FDA decision on whether the timing of how long that review would take. But our base assumption is we'd be in a position to launch the product in 2021. And then maybe I'll turn it over to Michael just to give a couple of comments on how we're getting ready commercially to be prepared for that.

Executive
Michael A. Metzger

Right. Bert, so I think as Briggs mentioned in his prepared remarks, the precommercialization work is a focus for us, has been for some time, and we'll continue with that through getting data and then up to a potential launch. Obviously, putting together the commercial team and the leadership around the commercial launch in the U.S. is important. So we'll be working hard on that, hiring the field force in the U.S. We had talked about launching the drug and being prepared to launch the drug on our own in the U.S. So that will require, of course, a focused field force to do that.

And