Syndax Pharmaceuticals Inc Q3 2024 Earnings Call Transcript

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

Question: Peter Lawson - Barclays - Analyst : Great. Thanks so much. Just with the sale of some of the royalty strength of Niktimvo, does that accelerate any programs under the development?

Question: Peter Lawson - Barclays - Analyst : And then, the timing of the NPM1 data and is that or after a publication, how we should be thinking about that and kind of if it's in the direct NCCN guidelines or you kind of thinking supplemental?

Question: Peter Lawson - Barclays - Analyst : Got you. Okay, perfect. Thank you so much. Thank you.

Question: Chris Shibutani - Goldman Sachs - Analyst : Great. Thank you very much. I think many of us are beginning to turn to 2025 and I realize that with important data readouts coming out, that's a factor. But can you give us any sense early in terms of how we should be thinking about the trajectory of an initial commercialization of Niktimvo? And what we can think about how the results from the NPM1 data may impact the level of spending that you have, particularly from the SG&A aspect? Thank you.

Question: Chris Shibutani - Goldman Sachs - Analyst : That's helpful context. Thank you.

Question: Kelly Shi - Jefferies - Analyst : Congrats on the great progress in the quarter and for the upcoming also very eventful Q4. Firstly, curious your view on the clinical bar for CR/CRh rate for the pivotal NPM1 data? And also, how do we think about the correlation with OS benefit and what is the OS benefit, what is the OS benefit expectation relative to KMT2A subgroup? Thank you

Question: Phil Nadeau - TD Cowen - Analyst : Good afternoon. Thanks for taking our questions. Two questions from us. So first, the updated KMT2A AUGMENT-101 data that we saw in the abstracts today, is that the most recent analysis that the FDA has? Is that what was submitted to the FDA? And is that what the FDA is reviewing? That's first. And then second, we noticed on your slides describing the pivotal trial in combination with ven/aza in the frontline, there was no revumenib dose listed. Have you determined with the FDA's input what that dose is likely to be? Thanks.

Question: Phil Nadeau - TD Cowen - Analyst : That's very helpful. Thank you. You're welcome.

Question: Michael Schmidt - Guggenheim Securities LLC - Analyst : Hey, guys, thanks for taking our questions. Two from us. Just on the KMT2A data on the 13 months duration of response that you've disclosed today in the ASH abstract in AUGMENT-101, would you expect a similar duration in NPM1-treated patients once you have longer follow-up from that cohort? And then, as we think about the menin inhibitor competitive landscape, there's been greater focus recently on differences in drug product characteristics as investors are looking to project how combinable the different agents are, particularly on PK or drug exposure metabolism. And as we continue to look at the emerging combo data at ASH, are there any learnings you can highlight where you feel confident about potential advantages for revumenib over others in the field? Thanks so much.

Question: Michael Schmidt - Guggenheim Securities LLC - Analyst : Thanks, really appreciate it.

Question: Jason Zamansky - Bank of America Merrill Lynch - Analyst : Great. Thank you. Good evening. Congrats on the quarter, and thanks for taking our question, as well as the additional color on ASH. Maybe two quick ones from me. For NPM1, curious as what you're thinking about the potential for breakthrough therapy designation. 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 05, 2024 / 9:30PM, SNDX.OQ - Q3 2024 Syndax Pharmaceuticals Inc Earnings Call Have you requested this? Has FDA given you any indication, particularly given they awarded it in KMT2A? And then, maybe just to circle briefly back on your previous answer regarding the NPM1 efficiency range or efficacy range, certainly, you mentioned for physicians higher the better, but is that 20% floor you mentioned necessary for approval? Does that still apply, or is that higher? Thanks.

Question: Jason Zamansky - Bank of America Merrill Lynch - Analyst : Great. Thanks.

Question: George Farmer - Scotiabank GBM - Analyst : Hi. Good afternoon. Thanks for taking my questions. I really appreciate your decision to disclose the additional KMT2A data. A question on this 6.4 month duration that you showed in 97 patients with the February cutoff. Are you going to be showing anything more mature than that? And is it possible that we could see something closer to the 13 months that you reported from the first 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 05, 2024 / 9:30PM, SNDX.OQ - Q3 2024 Syndax Pharmaceuticals Inc Earnings Call

Question: George Farmer - Scotiabank GBM - Analyst : Okay. And then, the HOVON trial, when do you anticipate that concluding and to be reporting on data? Maybe I missed that in your primary comments.

Question: George Farmer - Scotiabank GBM - Analyst : Okay. And then one more, if you don't mind. With the Royalty Pharma deal, were they looking at the potential of Niktimvo in IPF by any chance when they were contemplating the term?

Question: George Farmer - Scotiabank GBM - Analyst : Okay, good. Thanks very much. 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 05, 2024 / 9:30PM, SNDX.OQ - Q3 2024 Syndax Pharmaceuticals Inc Earnings Call

Question: Kalpit Patel - B. Riley Securities - Analyst : Yeah. Hey. Good afternoon, and thanks for taking the question. Just one more follow-up on that overall survival endpoint in the frontline triplet trial. I guess I understand the rationale for just including NPM1 patients in that analysis, but is there a minimum efficacy threshold that you need for the KMT2Ar patients to make sure that they will be included on the label? Or do you just need to hit the primary endpoint for NPM1 patients?

Question: Kalpit Patel - B. Riley Securities - Analyst : Okay. got it. And then, at ASH, I guess what sort of additional analysis should we expect for the KMT2Ar patients from the pivotal cohort, if any, anything at all? I think a lot of investors have been wondering what the efficacy analysis is like for patients based on the number of priors and the types of priors and just looking at a baseline demographic? Thank you.

Question: Kalpit Patel - B. Riley Securities - Analyst : Got it. Thank you very much. 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 05, 2024 / 9:30PM, SNDX.OQ - Q3 2024 Syndax Pharmaceuticals Inc Earnings Call

Question: Justin Zelin - BTIG, LLC - Analyst : Thanks for taking our question, and congrats on the progress. So, on the revumenib filing, I understand that patients are regularly tested for KMT2A status, but do you expect you'll need a companion diagnostic for approval?

Question: Justin Zelin - BTIG, LLC - Analyst : Great, great. Thanks for taking our question.