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

Michael Metzger: Yes, Joel, great question. I think that was sort of alluded to or part of another question that was asked earlier. The strategy for pooling is that the — we’ll be presenting a total number of patients and they’ll be analyzed. I think the — of course, the agency will look at all the subsets, and we’ll have a breakdown of that, and I think that will be part of our package. But essentially, the analysis, the primary analysis that will be done is on a pooled patient.

Joel Beatty: Okay. And then a question on R&D accounts because it looks like we’ll ramp up over the course of 2023, any priorities that you anticipate will be a part of that increase selling?

Keith Goldan: Yes, Joel, this is Keith. I’ll take that one. So a lot of the increase in 2023 will go towards the initiatives that Michael laid out in his comments. We have a pretty expansive development program for Revumenib to realize the full potential, the current pivotal programs are focused in relapsed/refractory, obviously. But going forward, you heard Michael expand upon all of the work needed to, again, recognize the full potential, looking front line combos, maintenance therapy, et cetera. Additionally, in anticipation of a filing by year-end and to be ready for a launch in 2024, there will be an increase in CMC/tickoff expenses to get our registration batches manufactured. Remember, we do have not only solid tablet formulation that we’ll be bringing to market, but also a liquid formulation as well. So that’s the majority of the increase.

Operator: It appears we have no further questions at this time. I’ll turn the program back to Michael Metzger for any additional or closing remarks.

Michael Metzger: Great. Thank you, operator. Thank you all. We look forward to seeing many of you at the Cowen and Barclays Healthcare Conferences in the next few weeks in March. And with that, I wish you all good night. Thank you.

Operator: This does conclude today’s program. Thank you for your participation and you may disconnect at any time.