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: Phil Nadeau - Cowen and Company, LLC - Analyst
: Most investor focus is on revumenib or SNDX-5613. Michael, could you give a brief summary of the efficacy data that were presented at ASH 2021
from AUGMENT-101 for those who are less familiar?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: You mentioned the DOR had not been reached. Are you expecting to provide an update on duration of response during 2022?
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JUNE 02, 2022 / 4:30PM, SNDX.OQ - Syndax Pharmaceuticals Inc at Cowen Oncology Innovation Summit:
Insights for ASCO & EHA (Virtual)
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: In terms of the efficacy profile, in light of the improved targeted agents in relapsed/refractory AML, what CR and CRh rate and durability response,
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Investors are also focused on the safety profiles, in particular, differentiation syndrome and QTc prolongation. Maybe starting with differentiation
syndrome, can you remind us of the rate of DS in AUGMENT-101? How is it managed and is there a standard mitigation strategy that you've
employed?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: And in light of the severity of relapsed and refractory AML, do you have an opinion on the rate of Grade 5 DS that would be acceptable? Is there
some tolerance for low rate of fatal cases?
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JUNE 02, 2022 / 4:30PM, SNDX.OQ - Syndax Pharmaceuticals Inc at Cowen Oncology Innovation Summit:
Insights for ASCO & EHA (Virtual)
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Investors have been focused on QTc prolongation for 5613. Can you remind us of the severity in the nature of QTc and the feedback you get from
physicians on how comfortable they are at managing?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Revumenib is in pivotal development today. Can you describe the design of the pivotal trials and maybe give us some idea of when you expect
the first data to be available?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: In the past, you've suggested some arms may enroll -- or some of the individual trials may enroll more quickly than others. Which ones do you think
you'll be in a position to release data from first?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: And can you remind us, have you said how much follow-up you want on the last patient entered into each arm prior to releasing topline data?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Great. And you mentioned that the dose that that's currently being studied is 163 milligrams twice a day for patients on a strong CYP3A4 inhibitor.
What is your strategy for determining the Phase 2 dose for patients who are not on a CYP3A4 inhibitor?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Do you anticipate that the identification of those doses will be rate-limiting to the filing or is it simply to follow up in the trials that's more like
revumenib?
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JUNE 02, 2022 / 4:30PM, SNDX.OQ - Syndax Pharmaceuticals Inc at Cowen Oncology Innovation Summit:
Insights for ASCO & EHA (Virtual)
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: And when do you think you could file? When is the first submission likely?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Perfect. Can you discuss plans to expand the opportunity for revumenib into other lines of therapy in AML? In particular, you've announced three
trials recently: BEAT-AML, AUGMENT-102 and INTERCEPT. What are the purpose of each of those, and how quickly do you think revumenib to move
into other lines of therapy?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: So a lot of interest among investors in the opportunity for revumenib to move into the first line. What data gives you confidence that revumenib
is combinable with Ven/Aza? In particular, are there any overlapping toxicities with Ven/Aza that you are aware of?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Do you believe that there are at least five other menin inhibitors in development for AML? Maybe first question, how do you expect revumenib to
be differentiated from those others? And then second, do you have a sense of when any of the programs other than obviously [Secura] could
release initial data?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: That's very helpful. In terms of the market, how would you quantify the market opportunity for menin inhibitors in AML? How big is the
relapsed/refractory market and how much larger would the first top line opportunity be?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Last five minutes, maybe we can just discuss axatilimab. Can you remind us of the data that were released at ASH 2021 for axatilimab in third-line
GVHD and perhaps provide a brief update on the pivotal trial?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: You've gotten two data from the pivotal study next year. What response rate, duration of response and improvement in the modified Lee Symptom
Scale do you Axa must produce for secure licensure, but then second to be adopted as part of the standard regimen?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Could you quantify the market opportunity for Axa and maybe discuss how the partnership with Incyte could expand its commercial potential?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: To wrap up on -- with some general corporate questions, Syndax has been very productive through its in-licensing capabilities over the last several
years. Would you consider in-licensing or acquiring other oncology pipeline programs? What disease areas would you particularly be interested
in?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Now in the current financing environment, investors are very focused on balance sheets. Remind us of your cash balance as of the end of March
and how long do you expect that to be able to support operations?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Great. It kind of looks like we're out of time. Thank you for a very interesting discussion and congrats on all your programs.
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