Syndax Pharmaceuticals Inc at Citi Biopharma Back to School Conference Transcript

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

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : So can you just talk a bit about the growth drivers? You've had a few quarters now of sales. How is it looking? And what is the I don't know you've given guidance per se, but just in terms of just qualitatively, how -- what the momentum looks like? And of course, we'll talk about NPM1 as well in a moment.

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Okay. You made a lot of interesting and important points there. So the interesting point, you think from fourth to fifth line to moving to the second to third line, what do you attribute that to? Is that just getting your feet wet with some of the more sicker patients and then doctors getting more comfortable with earlier treatment? And then, of course, the question you could probably anticipate is of the transplant, the ones that go to the transplant, how many of those are coming back, or do you know yet, if they're coming back to Revuforj because that was something that was highlighted? I remember at ASH and many other times.

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Willing to give a preview, not the data itself, but the types of metrics that you would be collecting on that real-world evidence?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : And Steve, you mentioned the 2,000 incident. And you mentioned climbing from the 25% now, which is already a very good start to 1,000. What's the -- to close the gap to get to even above 1,000, what is required there? Is there another level of investment? Or is it just more market awareness, just more experience?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Okay. And Keith, of course, you have a very important FDA date coming up on --?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : October 25. That was about to say. So tell us what that's for and why that's so significant for.

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : And just for those less -- a little bit less familiar, can you just summarize the pivotal data that supports NPM1?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : So October 25, so Steve, the ramp for NPM1, how do you see that? I mean, you already have the drug in the market and people are already using it. And they're probably either maybe using a little bit off label or very much wanting to use it. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 02, 2025 / 8:45PM, SNDX.OQ - Syndax Pharmaceuticals Inc at Citi Biopharma Back to School Conference So is the ramp going to be the same? Or is it going to be steeper for NPM1? But you do have a competitor coming possibly a month later. So there's different pushes and pulls there.

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : So of course, those two relapsed/refractory markets, the KMT2A and the NPM1, that's adding it up, it's 6,500 or so incident, but that's just the start. I'd love to hear more about the earlier studies. There's two. There's BEAT AML, the SAVE AML that are going to try to advance into earlier lines of therapy. So -- and I'd love to understand the market for that as well as the design of the studies and what you're going to show, I believe there will be more data coming at ASH on both of those.

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : And that would be something on the lines of like a minimal residual disease, MRD negativity-type surrogate.

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : And how are things shaping up competitively because there are obviously other companies that are pushing in frontline as well in combination with some of the similar regimens you described. How is it shaking out as far as getting to market in frontline, if you have estimates for that?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Okay. Maybe we could switch gears a little bit and talk about GVHD. So of course, there, you're partnered with Incyte, which I'm sure is helping. So just can you kind of characterize the launch? It's been strong from what I gather. So tell us about the dynamics, and that's in the third line. But similarly, thematically to AML, you're also starting to move into the earlier lines. So it's kind of a different drug, but same concept.

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : In the early days, some people were concerned because obviously, you're an infusion, although you are working on a subcu, right? We can talk about that. But you weren't oral and there were several oral options ahead of you. That doesn't seem -- at least what we've seen in the early innings, doesn't seem to be a limitation.

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : And I mentioned the subcu, but what is the status of that? There is a plan to produce one -- that's being worked on?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : So is that -- was that a controlled study, that one that --

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : And the control is --

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : So it's a combo of Jakafi plus --

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Just axatilimab, not Jakafi?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Okay. Just to clarify. And then the study with Jakafi, I wasn't aware that -- so it's also -- there's a third arm that's just steroids. Okay. I wasn't aware that's interesting. And what is the plan for when that's going to read out? That's up to Incyte?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Okay. But that's all coming. Okay. And which of those you consider to be more significant in terms of the opportunity, the steroid combo with axatilimab or the Jakafi combo? Are they just --

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : But in this practice of GVHD, which is typically first line? Is it steroids or Jakafi or --

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Okay. All right. So you would open the door to that immediately. Okay. And then assuming the Jakafi combo will look good, they would take that forward as well. Okay. Keith, since we have the CFO here, can you just comment briefly as well in terms of the P&L dynamics, how you're thinking about moving towards a profitable enterprise, what that looks like, what the OpEx looks like? Obviously, we're talking about going into some larger studies, earlier line studies, so that will impact the spend.

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Okay. I remember last year, you got the approval for KMT2A. Didn't it come a little bit ahead of schedule, if I recall?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Should we expect something similar for NPM1 or not necessarily?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : But the conduct with the FDA is going well given we've seen a lot of changes with the FDA.

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : So of course, you have the two approved products, which is great. Not many companies can claim two FDA approvals in a six-month period. But are you thinking about anything beyond this in terms of BD? Or are you focused now on these two?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Okay. Excellent. All right. Well, thank you all very much. Great discussion, and we look forward to a good news in a few months.