Syndax Pharmaceuticals Inc Q3 2023 Earnings Call Transcript

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

Question: Bradley Canino - Stifel Financial Corp. - Analyst : Hi, and thank you for the questions. Looking forward to ASH. I had a two-parter on the SAVE trial, actually the oral triplet where you had the abstract, it's first, when you speak to AML physicians, do you get the sense they're looking to use off-label combinations in the relapsed refractory setting. Because if we on the street that are anchored to monotherapy data, I guess what that might then mean about the ultimate opportunity in this treatment line in relapse/refractory as we think about efficacy percent to transplant maintenance, et cetera. And then I have a follow-up.

Question: Bradley Canino - Stifel Financial Corp. - Analyst : Great. And then -- yeah, on the safety for the regimen, I guess if it's higher and more prolonged myelosuppression than would be expected from the component? And how are you thinking about this, too? As we think about the frontline [Venza] combo, that might be a different patient population in terms of and how myelosuppression might affect them. Thank you. 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 02, 2023 / 8:30PM, SNDX.OQ - Q3 2023 Syndax Pharmaceuticals Inc Earnings Call

Question: Malcolm Kuno - JP Morgan Securities LLC. - Analyst : Yeah, this is actually Malcolm Kuno on for Anupam and thank you for taking the questions. What additional data are you planning to present at ASH on AUGMENT-101 KMT2A versus what we already know from the topline data? Thank you.

Question: Malcolm Kuno - JP Morgan Securities LLC. - Analyst : Excellent. Thank you.

Question: Chris Shibutani - Goldman Sachs - Analyst : Hi, good afternoon. Thank you so much for taking our questions. This is Charlie on for Chris. Just to kind of follow up on the last question. I'm wondering, do you have the same data cut for the AUGMENT-101 presentation at ASH? So it sounds like we're going to assume the same 57 patients 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 02, 2023 / 8:30PM, SNDX.OQ - Q3 2023 Syndax Pharmaceuticals Inc Earnings Call that we had for the top line results. Just wondering what's the rolling submission with the FDA currently are they going to be looking for those additional 37 patients that are after that data cut? Thank you.

Question: Chris Shibutani - Goldman Sachs - Analyst : Okay, great. Thank you so much.

Question: Phil Nadeau - TD Cowen - Analyst : Good afternoon. A couple of questions from us. First, congrats on the 36% CR/CRh rate with three additional patients in terms of the pivotal trial, NPM1, for revumenib, can you discuss in a bit more detail. What's the implications of the 16% of enrollment coming out of Israel? Is it that the chance of patients will be lost to follow up or the data will be lost? How does that impact the timelines and the number of patients that you need to enroll? 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 02, 2023 / 8:30PM, SNDX.OQ - Q3 2023 Syndax Pharmaceuticals Inc Earnings Call

Question: Phil Nadeau - TD Cowen - Analyst : Got it. That's helpful. And then a follow-up question on the SAFE trial. From the abstract said that enrollment, continued in SAFE and additional on it or updated data will be presented at the meeting. What can we expect in terms of patients at dose level one it at ASH? I think there were two in the abstract. Would there be another four to ASH or could dose level one enrolled beyond the six that were enrolled at dose level zero?

Question: Phil Nadeau - TD Cowen - Analyst : Fair enough. Thanks for taking our questions.

Question: Peter Lawson - Barclays Corporate and Investment Bank - Analyst : Yeah. Thanks for the update for the MRD negative patients. Do you have enough data now to filed for breakthrough designation and we can update this data at the Investor Day and then are patients going to transplant and could that cause a downdraft in the CR CRh rate in a pivotal trial? Thank you.

Question: Peter Lawson - Barclays Corporate and Investment Bank - Analyst : Right exactly.

Question: Peter Lawson - Barclays Corporate and Investment Bank - Analyst : Perfect.

Question: Michael Sachmidt - Guggenheim Partners - Analyst : Hey guys, good afternoon. Thanks for taking my questions. In the NPM1 cohort how many patients had overlapping co-mutations, other genetic alterations and potentially have had received other targeted agents prior to resuming revumenib and how do you expect that dynamic to play out in that pivotal cohort and ultimately on the market? Thank you so much.

Question: Michael Sachmidt - Guggenheim Partners - Analyst : Okay. And in order to how does that affect potential sequencing of therapies? Should the data be replicated in your pivotals study, if approved, in your opinion? 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 02, 2023 / 8:30PM, SNDX.OQ - Q3 2023 Syndax Pharmaceuticals Inc Earnings Call

Question: Michael Sachmidt - Guggenheim Partners - Analyst : Thanks so much.

Question: Kalpit Patel - B. Riley Financial Inc. - Analyst : Yeah, hey. Good afternoon and congrats on all the updates today. Maybe a couple of more questions related to the maintenance use of revumenib. Now that you have all the post-transplant data here. How are you seeing the median duration of treatment for revumenib between the KMT2A populations and the NPM1 populations? Do you expect them to be very similar to each other?

Question: Kalpit Patel - B. Riley Financial Inc. - Analyst : Okay. And then it's nice to see the additional responses in the NPM1 patient population. I'm just curious if you have any more NPM1 patients after that, I believe July cut off in that data in that Phase 1?

Question: Kalpit Patel - B. Riley Financial Inc. - Analyst : Okay, perfect. Thank you.

Question: Justin Zelin - BTIG LLC. - Analyst : Hi. Thanks for taking my question and congrats on the progress here. Maybe a question just on the SAVE AML study, I think the abstract show there wasn't much differentiation syndrome seen here. Can you comment on whether you'd expect the differentiation syndrome to be reduced in the combination setting moving forward? Thank you.

Question: Justin Zelin - BTIG LLC. - Analyst : Great. Thanks. And congrats again on the plenary for axatilimab. Anything additional we should look out for at ASH of beyond what we saw at the top line.

Question: Justin Zelin - BTIG LLC. - Analyst : Great. Thanks for taking my questions.

Question: George Farmer - Scotiabank - Analyst : Hi, good afternoon. Thanks for taking my question. Neil, you mentioned that the 6.4-month DOR in the AUGMENT-1 trial could get better. I'm wondering if it is possible it could get worse. We haven't seen any capital minor curve. So just wondering what your thoughts are there? And then also in the SAVE trial and that alluded to a previous question, about the myelosuppression. Wondering if those patients got any growth factor support and if growth factors were affected, perhaps maybe revumenib had an impact on a recovery or anything like that, if you could comment on. Thanks.

Question: George Farmer - Scotiabank - Analyst : Okay. Great. And then one more, if I could on axatilimab. The IPF study can you just speak kind of high-level about the design of that trial?

Question: George Farmer - Scotiabank - Analyst : Is that a six-month study? 52 weeks? 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 02, 2023 / 8:30PM, SNDX.OQ - Q3 2023 Syndax Pharmaceuticals Inc Earnings Call

Question: George Farmer - Scotiabank - Analyst : Okay. Good thank you.

Question: George Farmer - Scotiabank - Analyst : Thank you George.