The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: David Dai - UBS AG - Analyst
: That's great. So with that, for someone who are new to this next story, could you give a quick overview of Syndax, your lead programs as well as
any kind of overall company strategy?
Question: David Dai - UBS AG - Analyst
: That's wonderful. Very exciting, a lot of progress and a lot of excitement happening over the next 12 months, too. So maybe let's start with Revuforj
for a lead program. It's almost a year into launch in the KMT2A space, and you just launched the NPM1. Maybe just help us understand some of the
ramping. How is it going so far? Could you share with us patient also physician feedback and experience on Revuforj so far?
Question: David Dai - UBS AG - Analyst
: Excellent. Excellent. So on KMT2A, right now, more than 750 patients have been treated so far, and a third of them have progressed to transplantation.
As you're treating more patients, as you mentioned before, and the healthier patients, you can imagine, do you envision more patients would
potentially be put on transplantation?
Question: David Dai - UBS AG - Analyst
: Got it. Got it. And so one thing you mentioned was that some patients went into maintenance therapy. And so far, we've seen about 30% to 40%
-- based on the most recent metric, 30% to 40% of patients were put back on to Revuforj after transplantation. How do you think this number would
change over time? And what's your sort of expected percentage at steady state?
Question: David Dai - UBS AG - Analyst
: Is there a number in terms of what the steady state maintenance therapy is going to look like?
Question: David Dai - UBS AG - Analyst
: Okay. That's really good. And tell us a little bit more about those kind of patient journey around that. How quickly do you think these patients can
be put on maintenance therapy based on the current experience with respect to patients getting on the CR and MRD-negative CR and then
transplantation and then eventually get a maintenance? What's sort of timeline look like here?
Question: David Dai - UBS AG - Analyst
: Got it. And do you think this number will also change over time, too, as patients get a little more comfortable with Revuforj, physicians get more
comfortable with Revuforj going forward? Do you think this number will evolve over time as well?
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NOVEMBER 10, 2025 / 4:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc at UBS Global Healthcare Conference
Question: David Dai - UBS AG - Analyst
: Yeah. And I think another question just around the duration of therapy. I think most investors care about right now. Just help us understand where
it is now. And how do you think it's going to evolve after patients or more patients are getting on to maintenance therapy?
Question: David Dai - UBS AG - Analyst
: And how do you think the number will evolve over time as well?
Question: David Dai - UBS AG - Analyst
: Got it. Great. So now you recently got approved for NPM1 patients, but we did see an updated black box warning of Torsades. Maybe just help us
understand the decision of the FDA to include or to update the black box warning to include this Torsades case? And how do you think this might
impact adoption in NPM1 setting?
Question: David Dai - UBS AG - Analyst
: Got you. Got it. And since the approval, you had a couple of weeks, right, of bringing the field team with the (inaudible) label to physicians. I'm
curious, how has the feedback from physicians so far? Maybe Steve, you can talk about this, what has been some of the feedback from the physicians
on the NPM1, especially on the NPM1 setting, how they're viewing the label and how they're treating patients so far on the ramp?
Question: David Dai - UBS AG - Analyst
: That's a great segue to start talking about some of the combination strategies you have for Revuforj, especially moving to frontline. So maybe
making -- just tell us a little more about some of the strategies and clinical development plans you have for Revuforj in combination with various
different therapy standard of care in frontline setting.
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NOVEMBER 10, 2025 / 4:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc at UBS Global Healthcare Conference
Question: David Dai - UBS AG - Analyst
: Very exciting for sure. One thing is for the frontline Phase 3 trials, it seems like surrogate endpoint right now could be -- could use CR or MRD-negative
CR as surrogate endpoints for approval. So I'm curious, have you got buy-in from the FDA on that? And if you're using MRD-negative CR as a
surrogate endpoint, what's the right timeline we should expect in terms of data readout?
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NOVEMBER 10, 2025 / 4:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc at UBS Global Healthcare Conference
Question: David Dai - UBS AG - Analyst
: Yeah. Tell us a little more about that HOVON collaboration that you have. How do you think that you're able to kind of expedite the trial progress,
have more patient enrolled more like more patients, we get to the right kind of number of events or MRD negative? Just tell us a little more about
how you're thinking about using HOVON as a network to help the whole --
Question: David Dai - UBS AG - Analyst
: Got it. Yeah. And just a follow-up on that one. I mean, it seems like a lot of competitors also going after frontline Phase 3 trials, Kura as well as
Johnson & Johnson. So how do you plan to stay ahead of the curve? How do you plan to stay ahead in terms of clinical development?
Question: David Dai - UBS AG - Analyst
: Great. Yeah. Great. And let's switch gears, talk a little bit more about Niktimvo. So launch, of course, has been off to a very strong start. What have
you seen in terms of adoption so far? What are some of the trends that you can share with us?
Question: David Dai - UBS AG - Analyst
: Can you remind us what percentage of patients are currently treated with fourth line and above? And how -- what percentage of patients are
treated essentially off-label in third line in GVHD?
Question: David Dai - UBS AG - Analyst
: Got you. Got you. Great. And so right now, in terms of clinical development, you're moving Niktimvo into IPF, right? So curious about the progress
of the trial so far. And could you share some expectations around the data readout next year?
Question: David Dai - UBS AG - Analyst
: Great. We're almost out of time. Maybe just one last question. So what are some of the near-term catalysts that we should be watching for over
the next 12 to 18 months?
Question: David Dai - UBS AG - Analyst
: Great. Thank you so much, Mike and Steve and Nick. Really appreciate your time. Thank you.
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