Syndax Pharmaceuticals Inc at UBS Global Healthcare Conference Transcript

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

Question: David Dai - UBS - Analyst : Great. And so Syndax is a very interesting story, one of the leaders in the inhibitor space. And so for the audience here who are new to the story maybe give a quick overview of Syndax Therapeutics.

Question: David Dai - UBS - Analyst : Excellent. Yes, great. Many interesting near-term catalyst milestones to watch. Of course, the near-term one that everybody is looking at is going to be the Revumenib approval for the FDA approval in December 26, as you mentioned, I think the already expected pretty much an approval for this one. But there are some questions around this label. So maybe just help us understand what the label is going to looks like. What's the expectation for the label here, Anjali?

Question: David Dai - UBS - Analyst : Got it. And what about things like black box warning, QTc prolongation, if that's -- on that as well?

Question: David Dai - UBS - Analyst : Got it. So very much consistent and there should be any surprises for the label overall.

Question: David Dai - UBS - Analyst : Got it. Great. And of course, the launch everybody is looking at that as well. So ahead of launch, can you just tell us about the commercial -- in the commercial preparations that you're doing right now?

Question: David Dai - UBS - Analyst : That's excellent. So maybe just help us understand some of the initial expectation on the launch, maybe what have you heard so far from physicians on the overall receptivity for Revumenib in KMT2A AML? And what do you think the ramp is going to look like over the first few quarters?

Question: David Dai - UBS - Analyst : Yes. That's great. What about the duration of treatment for Revumenib in KMT2A. What does the number look like for the duration of treatment? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 14, 2024 / 3:15PM, SNDX.OQ - Syndax Pharmaceuticals Inc at UBS Global Healthcare Conference

Question: David Dai - UBS - Analyst : Got it. That's a really helpful commentary here. And maybe just for the audience here, tell us anything about the KMT2A market? How big do you think -- do you estimate that market is?

Question: David Dai - UBS - Analyst : Got a good segway to start talking about the NPM1 data that you just reported a couple of days ago. So maybe for the audience here, just to highlight some of the key updates that we saw from that data update.

Question: David Dai - UBS - Analyst : Got it. Yes. I think the CR, CRh and duration of response was in line with our expectation as well. But I think the [street] was potentially looking at a little bit higher. The expectation was around close about 30% because of the competitor from Kura [itominib]. And so maybe just help level set the 23% CR, CRh and the ORR and duration of response in terms of what it means for the patients here.

Question: David Dai - UBS - Analyst : Got it. Yes, that's really helpful commentary. Just regarding that 75% prior ven population in your trial, how should we think about this in the real world? We just say that's well inconsistent where a lot of patients are being treated with that prior event? Or could that population be lower?

Question: David Dai - UBS - Analyst : Got it. Yes, you alluded to the -- some of the safety things we saw and actually received an e-mail question just regarding that safety. And the question asked when the FDA makes a decision on the KMT2A label for Revumenib for the PDUFA, will they take into consideration the NPM1 safety data, such as the Grade 4 (inaudible) or differentiated syndrome. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 14, 2024 / 3:15PM, SNDX.OQ - Syndax Pharmaceuticals Inc at UBS Global Healthcare Conference

Question: David Dai - UBS - Analyst : Got it. That's really helpful comments. So on that SLA -- or sNDA filing, they plan to do in first half '25. How soon do we think we could actually potentially get an approval? How fast will the review time line look like?

Question: David Dai - UBS - Analyst : Got it. And then based on your experience with the KMT2A filing, you would imagine you've already have the experience like expedite the funding process, right, in getting to the package six months, the thing that will make sense. So the second half 2025, that's when we should be expecting.

Question: David Dai - UBS - Analyst : Great. Now we have about six minutes left. I do want to touch base on the -- on your second program which is quite interesting. The reason you closed the deal with Royalty Pharma $350 million for 13.8% of the royalty from Niktimvo. So just help us understand the structure and the process that went through to actually ultimately get that deal there.

Question: David Dai - UBS - Analyst : Got it. And so just ahead of the launch, any kind of thoughts around the commercial preparation? And between you and partner Incyte, who is going to be driving most of the commercial ramp for Niktimvo?

Question: David Dai - UBS - Analyst : Got it. Just one last question. Maybe just for the next 12, 18 months, what are some of the key catalyst milestones we should be watching for?

Question: David Dai - UBS - Analyst : Okay. Great. Wonderful. Well, with that, we're out of time. Thank you so much, Anjali.