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: Peter Lawson - Barclays - Analyst
: And first set of questions I've been asking just to see if there's any kind of impact of the current administration, say, on the supply chain, tariffs. Is
there any worries there from import-export? Is there any worries from -- I guess, you've got prepared from COVID. But just any concerns we should
be thinking about APIs, et cetera?
Question: Peter Lawson - Barclays - Analyst
: Thank you.
Question: Peter Lawson - Barclays - Analyst
: Thank you. And then impact on the FDA. Have you seen any kind of changes in communication?
Question: Peter Lawson - Barclays - Analyst
: Thank you. And then I know it's a long-term impact, but NIH budgetary cuts, does that have any role and effects with clinical trial sites?
Question: Peter Lawson - Barclays - Analyst
: Thank you. And then how should we think about revenue launch and kind of the puts and takes for 2025, so coming back to --?
Question: Peter Lawson - Barclays - Analyst
:
Question: Peter Lawson - Barclays - Analyst
: Thank you. And then how should we think about the new patients coming on? Is that kind of a steady process? Is there seasonality there? Do you
get a kind of initial bolus? And just talk us through your thoughts.
Question: Peter Lawson - Barclays - Analyst
: And then what should we think about growth in that inventory for a couple of weeks or something like that? Is that a sensible number to think
about? And should we think about any more patients coming off of the extended access program?
Question: Peter Lawson - Barclays - Analyst
: And then you talked about these Tier 1 and Tier 2 accounts and what I think 33% penetrated. How quickly can you penetrate the rest? What's the
most addressable kind of population you should think about as regards to those Tier 1 and Tier 2 sites?
Question: Peter Lawson - Barclays - Analyst
: Is there -- as we think about those Tier 1 and Tier 2 accounts, is there kind of a goal by the -- quarter by quarter? Or is that kind of a fluctuating
thing?
Question: Peter Lawson - Barclays - Analyst
: Quarter by quarter, what metrics will you be sharing with the Street?
Question: Peter Lawson - Barclays - Analyst
: Got you. Has there been anything that surprised you in the launch in the first few weeks?
Question: Peter Lawson - Barclays - Analyst
: Yup, encouraging. And then as we think about the NPM1 side of the story, kind of the inclusion in the guidelines, do you think that kind of helps
bolster sales? Or do you expect a change there in the pace?
Question: Peter Lawson - Barclays - Analyst
: Got you. Thank you. Have you been seeing it used off-label, so in the NPM1 percent of patients?
Question: Peter Lawson - Barclays - Analyst
: Would we be able to break that out going forward, the NPM1 versus KMT2A?
Question: Peter Lawson - Barclays - Analyst
: Okay. And will that improve over time? Or do you care at the end of the day, or is that an important metric internally?
Question: Peter Lawson - Barclays - Analyst
: Yeah. Because, initially, you want to track to just make sure there's nothing going wrong with it not being used in NPM1.
Question: Peter Lawson - Barclays - Analyst
: Do you have kind of internal goals of where you think that would be for, like, 2025, the distribution of NPM1 versus --?
Question: Peter Lawson - Barclays - Analyst
: Got you. And just on to some of the clinical trial readouts and initiations, so the ven/aza and UNFIT, so the HOVON study.
Question: Peter Lawson - Barclays - Analyst
: Can you remind us where you are in initiating and kind of the gating steps for the first patients?
Question: Peter Lawson - Barclays - Analyst
: Got you. Okay, so initiated second quarter, you get the first patient.
Question: Peter Lawson - Barclays - Analyst
: And then what's the split you think is going to be US versus ex-US for that trial?
Question: Peter Lawson - Barclays - Analyst
: Just going back to kind of the funding questions, I guess, is there any worry with European funding or external funding?
Question: Peter Lawson - Barclays - Analyst
: Any worries around the ability to control that study, just because it's a HOVON-run study?
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MARCH 13, 2025 / 12:30PM, SNDX.OQ - Syndax Pharmaceuticals Inc at Barclays Global Healthcare Conference
Question: Peter Lawson - Barclays - Analyst
: Okay. Are there any -- what are the pros and cons of working with HOVON? Clearly, you've highlighted some of the benefits of -- they're up and
running. They kind of know what they're doing. But any time delays in getting the data or --?
Question: Peter Lawson - Barclays - Analyst
: Got you. Thank you. And then is there an interim read that we should be thinking about for the HOVON study?
Question: Peter Lawson - Barclays - Analyst
: Is that a seamless process, where you can kind of make those amendments to have an accelerated endpoint integrated into the trial?
Question: Peter Lawson - Barclays - Analyst
: Perfect. Thank you. And then just expectations around CR rates and OS that we should be thinking about for the control level, at least.
Question: Peter Lawson - Barclays - Analyst
: Yes.
Question: Peter Lawson - Barclays - Analyst
: Should we use BEAT AML as a kind of a proxy for what's being run now?
Question: Peter Lawson - Barclays - Analyst
: And then as we think about first-line FIT trials, it sounds like there's other trials being planned and worked through. What should we expect in the
second half as regards to those trials?
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consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
MARCH 13, 2025 / 12:30PM, SNDX.OQ - Syndax Pharmaceuticals Inc at Barclays Global Healthcare Conference
Question: Peter Lawson - Barclays - Analyst
: We've hit the bottom the (inaudible). But thank you so much. Always a pleasure speaking to you.
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