Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q3 2023 Earnings Call Transcript

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Michael Metzger: So, with respect to the first question, we have modeled it out in our there is a bit of noise in the line, but with respect to you know, our expectation is that, the median DOR can extend over time with additional follow-up, right? So we have modeled that out, running various, sorry, I’m blanking on the word. But statisticians have modeled it out looking at various different scenarios. And we see multiple different scenarios under which the median Dior could extend over time. The, to the second point, not to the best of my knowledge with respect to stem cell or with respect to growth factor support. You know, that is not our understanding.

George Farmer: Okay, great. And then 1 more if I could on Axtilumab. The IPF study, can you just speak kind of high level about the design of that trial?

Michael Metzger: Sure. I will take that. Yes. As Michael said, in his remarks, it is randomized Phase 2. It is randomized, 135 patients is the target sample size, randomized two to one, active axatilimab to placebo, on a background of best supportive care. So very succinctly, that is the study design. We think that it is an efficient way to address the proof of concept question.

George Farmer: Is that a six-month study, 52-weeks?

Michael Metzger: 26-weeks. That is right, 26-week primary endpoint analysis.

Operator: Our last question is from Joel Beatty at Baird. Your line is open. Please ask your question.

Unidentified Analyst: This is [Ben] (Ph) on for Joel. Thanks for taking the question. What gives you confidence that payers would support or payers would cover post transplant maintenance, revenue management therapy is not in the FDA label?

Michael Metzger: Well, look, I think the experience physicians have in treating patients for AML and providing abatement treatment to those patients who again are at high, high risk of relapse, that is seems to be a very important treatment decision, grant, it is given by the or taken by the physician. And none of these relapsed refractory agents that had been approved have a maintenance label. So it is a sort of a tried and true experience with other agents that gives us confidence that this is something that physicians can do and payers will abide by. I think there is a pharmacoeconomic analysis, of course, that supports this, these are not inexpensive therapies, but these are very seriously ill patients who aren’t able to get to a steady state.

And so, if you can keep them in remission for a long period of time and keep them out of the hospital, that is a very positive driver for any payer. So I also mentioned that this kind of experience can get into the guidelines and you see it in the guidelines as well. And so payers tend to abide by those guidelines in making the reimbursement decision. So I think there are multiple factors in support of this paradigm. And I also mentioned that these are rare diseases. And so payer not one payer is impacted dramatically or disproportionately, I should say, by a high priced therapy being given over an extended period of time. So I think that all kind of factors into the value when we hear from physicians that they do this and they have very little intervention from payers to stop this from happening, there seems to be a supportive setup.

So, that is what I can tell you.

Operator: That completes the Q&A section of the call. I will now hand back to Michael for closing remarks.

Michael Metzger: Thank you, operator. Thank you all. We appreciate you tuning in tonight and we look forward to seeing you at our planned investor events including The Cowen Fall Oncology Summit tomorrow and the Stifel Conference on November 14th, as well as the ASH meeting in December.

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