Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q4 2023 Earnings Call Transcript

Jeet Mukherjee: Thanks for taking our question.

Michael Metzger: Thanks, Jeet.

Operator: Our next question comes from George Farmer with Scotiabank. Your line is now open.

Unidentified Analyst: Hi there. This is Cleo [ph] on for George. Thank you for taking our questions. Two from us on revumenib. So, are — do you have any sense on whether the FDA is intending to hold an ODAC meeting to discuss the approval package in KMT2Ar AML or ALL? And secondly, could you speak to the prospects for other indications for revumenib?

Michael Metzger: Great, Cleo. Thank you for the question. So, in terms of an ODAC, we don’t expect that the FDA will hold an ODAC for revumenib. From time-to-time for new mechanisms, they do that more as a showcase than they do for any other reason. But we don’t expect and we haven’t received any word from the FDA to indicate that we would have an ODAC. So, I think that’s the answer to your first question. And then secondly, you had asked about prospects for additional indications. I presume that means outside of leukemia. And as I mentioned in my previous remarks, we are looking at revumenib in colorectal disease, third-line metastatic colorectal cancer. As a monotherapy agent, it’s obviously a very difficult disease state and we’re going to have some data in the second quarter of this year to first get at whether there’s sufficient activity there as a monotherapy agent and how the drug performs.

There is this thesis that we’re pursuing, a beta-catenin upregulated tumor type, which is a broadly implicated phenomenon through a lot of different cancers. Colorectal cancer is one and so there could be other cancers that we look to see whether they’re susceptible to revumenib treatment. So, stay tuned. There may be more to come. I think the first step here is certainly the colorectal cancer trial that we’re running.

Unidentified Analyst: Okay. Got it. Thank you.

Michael Metzger: Thank you.

Operator: This concludes our question-and-answer session. I will now turn the floor over to Mr. Michael Metzger for any additional comments or closing remarks.

Michael Metzger: Thank you all. We appreciate you tuning in tonight and we look forward to seeing you at our planned investor events, including the upcoming Cowen and Barclays Healthcare Conferences in March. And with that, I wish you all a very pleasant evening. Thank you.

Operator: This concludes today’s conference call. Thank you and you may now disconnect.