Syndax Pharmaceuticals Inc Q4 2023 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Anupam Rama - JPMorgan Chase & Co - Analyst : Hey, guys. Thanks so much for taking the question. Maybe expanding on Keith's comments just now, just remind us of where you are in terms of

Question: Anupam Rama - JPMorgan Chase & Co - Analyst : Thanks so much for taking our questions.

Question: Phil Nadeau - TD Cowen - Analyst : Good afternoon. Thanks for taking our questions and congrats on the progress. A couple on the ASH data and then a follow up on axatilimab. So in terms of the ASH data, there are two controversial aspects that we keep debating with investors and curious to get your thoughts on those. First, in SAVE AML, I know you said that there was no additive toxicity by having adding revumenib to the background revumenib. Not everyone agrees. So could you address the neutropenia rates that you would expect. I think you showed 56% at ASH. What would ASTX727 do alone? And then second on BAML, again, there's some concerns about the combinability, particularly the dose of revumenib going forward in light of the SIP interaction that ven/aza. How will you determine the Phase 2 dose through BAML and what type of dose adjustments would you anticipate once that Phase 2 dose is found?

Question: Phil Nadeau - TD Cowen - Analyst : That's very helpful. Makes it clear. And then last question, just on axatilamab sales and marketing. I think in your prepared remarks, you said Syndax is responsible for 30% of the marketing efforts in the answer, I think to uninformed question, you said 30% of FTEs. How are the marketing efforts? How is 30% of marketing efforts defined? Is that specifically 30% of the fees or are there other metrics that this index needs to deliver as well, such as some touch points with physicians or call points or something else?

Question: Bradley Canino - Stifel Financial Corp. - Analyst : Good afternoon. You've provided peak sales opportunities, but how do you see the KMT2Ar launch playing out this year, things in terms of number of patients that are available in the relapsed refractory setting where they're concentrated and what to back for the pace of uptake?

Question: Michael Schmidt - Guggenheim Securities, LLC - Analyst : Thanks for taking my question. I had one on the first-line setting for every minute in combination with 7+3. In your opinion, what is the right way to come to view our front-line combo data with menin inhibitors and 7+3 and specifically given that one would expect very high CR rates, presumably on top of 7+3 already. What are other benchmarks that you said you're looking for in your own study, including MRD status, for example, transplant rates or any other efficacy measures that are important in your opinion?

Question: Michael Schmidt - Guggenheim Securities, LLC - Analyst : Okay. Thank you.

Question: Ashiq Mubarack - Citigroup - Analyst : Hi, guys. This is Ashiq Mubarack on for Yigal. Thanks for taking my questions. I had a few on axatilimab. I guess first, congrats on the PDUFA date. I'm just wondering how involved you are in the regulatory process from this point out. Obviously, we know Incyte is leading the proceedings, will it be part of the mid-cycle review? Will you be able to weigh in on label negotiations? How should we think about that?

Question: Ashiq Mubarack - Citigroup - Analyst : No, that's very clear. I wanted to ask another one on IPF. Maybe I'm forgetting or simply just don't remember this from prior calls, but we -- I know you're evaluating the 0.3 mg per kg dose, which was obviously the dose that look best and AGAVE-201. I'm just wondering what kind of gives you confidence that's the right dose specifically for IPF. I guess, why didn't you need to do dose optimization work or is the disease biology really similar enough that you felt confident enough not to do that? And obviously, we're dealing with a different endpoint here. So just curious what your thoughts are?

Question: Ashiq Mubarack - Citigroup - Analyst : Very helpful. Thanks very much.

Question: Kalpit Patel - B. Riley Securities, Inc. - Analyst : Yeah, hey, good afternoon and thanks for taking the question. Maybe a couple on the 7+3 combo study. Can you give us some color on what dose of revumenib you're planning to start with? And then second question is, how should we think about the enrollment split between the KMT2A are and the NPM1 population in that combo study, would it be a 50-50 split or are you seeing -- are you anticipating still are you anticipating is skewing of the KMT2A patient as they're more fit.

Question: Jeet Mukherjee - BTIG LLC. - Analyst : Great. Thanks for taking our question. This is Jeet Mukherjee on for Justin, maybe just coming back to axatilimab was, I'm hoping you could provide a little bit of a sense of the opportunity for axatilimab and IPF, subset of patients, perhaps best suited for this therapy and what should we be looking for from an efficacy perspective?

Question: Jeet Mukherjee - BTIG LLC. - Analyst : Got it. That's helpful. And maybe just one more on axatilimab. Just any additional color perspective on the combo studies you're doing with ruxolitinib and steroids in collaboration with Incyte. And just what should be looking there from an efficacy and safety perspective to move one or both of those forward ultimately?

Question: Jeet Mukherjee - BTIG LLC. - Analyst : Thanks for taking (inaudible)