Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q1 2024 Earnings Call Transcript

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Chris Shibutani: Thank you. Good morning. A lot of questions on the focus have already been asked. So perhaps if I can ask a bigger-picture, longer-term question, it ties a little bit to your guidance in terms of operating expense spend on R&D. The near term question is it looks as if to reach your full-year guidance, we’ll have a considerable step-up in the second half. Is that primarily attributed to the combination studies. just to give us a sense there, Keith? And then secondly, , I think you’ve done a tremendous amount of work in building this portfolio and the company is now very focused on trying to launch two products but as you know, investors are impatient to trying to figure out what to come next. What is your thought on capital allocation priorities further business development? What are you seeing out there. What’s your appetite? Thank you.

Michael Metzger: Great. Thank you, Chris. Good questions. Maybe, Keith, you want to take the first one on the longer-term?

Keith Goldan: Yeah, sure. So Chris, I wouldn’t necessarily agree that it’s a big step up, to use your words. We did — total operating expenses in 1Q approached to $80 million. The guidance range from second quarter is $80 million, $85 million. So if we were just to stay on that trajectory, we’d be $320 million-ish. So there is some increase that I think we would anticipate in the back half of the year. And I think, yes, certainly as PF ramps as the first line 7+3 combination trial with ramp continues to accrue and as we get ready to launch the pivotal Phase 3 ven/aza combo trial with rev, that’s certainly going to add to some of our R&D expenses in the back half of the year. But also don’t forget, we’re building out a commercial organization. So on the SG&A side, we would expect still some growth there for the sales force of the customer-facing individuals that Steve commented on earlier, as well as the G&A support for field force.

Michael Metzger: And in terms of your second question, Chris, on business development, maybe I’ll start and turn it over to Anjali. So look, I think our strategy has been — and we’ve been pursuing the same business model for quite some time, which is to in-license and develop new molecules with differentiated profiles. I think we’ve been fortunate to have great success with our in-licensing strategy and having these two molecules that are nearing approval. And so the bar is always quite high with regard to new opportunities and it gets incumbent upon us to be thoughtful about how we allocate capital. And so we do think that additional molecules bringing them into the pipeline, backfilling the earlier part of the pipeline is quite important. And we are interested in doing that. And so, I don’t know, if Anjali want to make a comment on our activities, but we remain quite disciplined about what we’re doing.

Anjali Ganguli: No, I think you said it well, Michael. We’re very actively engaged in the market looking across a variety of sources for new opportunities and spending a lot of time on diligence and hopefully we’ll have some exciting news to share. But there is definitely a lot to look at.

Operator: Our next question is from George Farmer with Scotiabank.

George Farmer: Hi, good morning. Thanks for taking my question. A competitor of yours has talked about combining their menin inhibitor with other targeted therapies like inhibitors and the like. Is — there hasn’t been too much conversation on the call about that this morning. Is that something that you’re thinking about as well in a greater detail?

Michael Metzger: George, thanks for the question. So in terms of combinations, maybe I’ll let Neil comment on what else is going on with targeted therapies. Obviously, we have the trials ongoing, the pillars of our strategy being ven/aza in the unfit population, and then [indiscernible] if you will, as another interesting option for patients with relapsed refractory and perhaps in earlier patients as well. So just think about it in terms of — then combos. And then on the fit side of the equation, in combination with that chemotherapy, we’ve already demonstrated the drug’s ability to be combined with chemotherapy in relapsed refractory study. We’ll have data updates on that. We’ll also have additional data, as we talked about on the ven combos this year, which so far, it looks extremely good. But I think there’s options open to us. And Niel, I don’t know if you want to comment on some of those?

Neil Gallagher: Yeah, sure. So we have investigator-initiated trials either planned or ongoing, which were — in which revumenib in combination with [indiscernible] or will be — either are or will be investigated. To Michael’s point on, conducting, for instance, a pivotal program in the frontline fit population in patients with both NPM1 and premutations is technically very challenging. It’s not really core to our strategy. Of course, we haven’t revealed overall what our strategy is, but it’s not core to our strategy. What we’ve said is that, obviously, in addition to the unfit Phase 3 that will initiate — we plan to initiate by yearend that we’re dose ranging in combination with 7+3, which will position us then to initiate a Phase 3 during 2025.

You can anticipate that that will not be in dual mutation patients because that’s a very large and complicated study. So we prefer to generate evidence in that population as opposed to potentially pursuing a registration strategy.

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, operator, and thank you, all, for your questions. Appreciate you tuning in today, and we look forward to seeing you all at our planned investor events, including the Bank of America Conference in May and the Goldman Sachs Conference in June. And with that, we wish you a great day.

Operator: The meeting has now concluded. Thank you for joining. You may now disconnect.

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