Syndax Pharmaceuticals Inc at Citi Virtual Oncology Leadership Summit Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Yigal Nochomovitz - Citi - Analyst : But Michael maybe just to start out, if you could just give us a high level, where you are, what are the lead assets? What are the key catalysts for 2024? I already alluded to two of them. And then we can take it from there and dig into the details.

Question: Yigal Nochomovitz - Citi - Analyst : Okay, awesome. So you're getting, I think you're getting close to the 60 days in terms of acceptance of the NDA for revumenib. What's been the feedback so far to the extent you can comment with the FDA? Are you going to be announcing the acceptance of the filing and the PDUFA date? What can you share at a high level just in terms of the regulatory and then we can move into the clinical data.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. So investors, we should not expect this typical 60 day, the 60 day clock, given the RTOR process, that's important for people to understand.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And then as far as, we've talked a lot at ASH and in other settings regarding the, some of the key clinical metrics in AML, MRD negativity, transplant rates. Of course, the primary endpoint of your trial, which is CR, CRh. What do you think about just in terms of the overall clinical package? How much do you believe the FDA would be weighing in on some of these other endpoints like MRD negativity and transplant rates as they think about how to approve revumenib?

Question: Yigal Nochomovitz - Citi - Analyst : And as we think about how to frame the label in the addressable population, obviously you have data for AML, but you also have some ALL patients, although smaller cohort. My understanding is you're going through the AML, ALL sort of broad label. What can you say about the expectations around not having a ALL included as well?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. We are getting some questions from the listeners. So someone just curious, just in terms of the regulatory, what are the expectations? I mean you mentioned RTOR, so maybe this is not as applicable. You obviously have breakthrough, so you have a very close dialogue, ongoing dialogue. But priority review, is that something that's formally up for discussion? Or how do you think about that?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And then another important question which was discussed with the KOLs at your event and ASH last December. The significance of the post transplant maintenance setting, is that type of language, the resumption of revumenib, post transplant something that could potentially end up in the label? Or how do you see that evolving?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And then with regard to the safety side, are the things that we should be looking out for there in terms of warning language that you might anticipate or not. For example, the QTC prolongation that's something that we should expect to see in the label?

Question: Yigal Nochomovitz - Citi - Analyst : I mean, if it's going to be called out more specifically or not or just as you say, it would just be in the list of AEs as you would typically see.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And then I think it would be helpful if you could spend some time and maybe Anjali could comment as well on the commercial opportunity, what does the market look like in terms of the KMT2A rearranged patient population? What would be the expectations on your duration of therapy at market access, things of that nature, that would be great as we move forward and get closer to the launch? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 21, 2024 / 7:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc at Citi Virtual Oncology Leadership Summit

Question: Yigal Nochomovitz - Citi - Analyst : And for the ones that went to transplant that didn't receive revumenib , what was the reason? I mean, do you think that everyone should kind of go back on assuming the transplant was successful, that everyone should go back on the drug, maybe those ones just didn't have a successful engraftment? What was the reason they didn't get it?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. That makes a lot of sense.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. In the 18 months, that's, is that post-transplant or that's the total duration, just so I'm clear. I'm just could not understand.

Question: Yigal Nochomovitz - Citi - Analyst : Because I remember when I asked the question at your event at ASH, I think they said, one of the KOL said a year post transplant, just for post-transplant. So then the 12 months plus whatever you had pre-transplant gets you more than 18 months. So anyway, that was my math.

Question: Yigal Nochomovitz - Citi - Analyst : Right. Okay. All right. Let's move on and shift a little bit to NPM1. So I think you said the enrollment of the pivotal cohort is you're guiding to sometime sort of towards the end of this quarter, beginning of next quarter and then the top line data at the end of the year, filing in early 2025. What can you tell us in terms of just the latest status on enrollment for the NPM1 pivotal?

Question: Yigal Nochomovitz - Citi - Analyst : And are you going to sort of follow a similar playbook in terms of how you release the KMT2A pivotal last year, a similar setup for NPM1, is that should that be the expectation?

Question: Yigal Nochomovitz - Citi - Analyst : And is there anything you can discuss that's built into the protocol, which could afford an early look, for example in interim? And if so, what might trigger that?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And then in terms of the efficacy on the primary endpoint of CR,CRh. I think you said in the past that you wouldn't expect a difference in response necessarily, but they potentially could see a higher CE, CRh and NPM1, as you pointed out, it's an older population, less likely to get transplant. So you could have a higher probability of the CR, CRh. Would you agree with that statement? And what are your thoughts on what you'd like to see for the CR, CRh?

Question: Yigal Nochomovitz - Citi - Analyst : And while you have the floor, do you want to maybe just go through a little bit on the commercial side and talk about the opportunity. I mean, obviously and NPM1 is a bigger market. What are the dynamics there? Are they similar in terms of KMT2A, as you discussed before, there are some notable differences that we should be aware of?

Question: Yigal Nochomovitz - Citi - Analyst : And then how are you thinking about the durability in NPM1. Because you sort of have two forces that are posing you have the, as you mentioned, the less fit and so they may be less likely to go to transplant. But then you also have a more challenging population. So they may work to balance out. I'm not sure. Do you think there'll be meaningfully different durability on an NPM1 or?

Question: Yigal Nochomovitz - Citi - Analyst : Yeah.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And you got quite a lot of time talking about some very interesting new combo work that you're doing in the earlier line settings across multiple different mechanisms, BEAT AML ,the SAVE AML and the AUGMENT-102 trial I think it would be helpful if you could just kind of recap some of those conclusions, what have you learned about how to advance the menin to earlier line setting? And what will be the next steps to develop combo work? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 21, 2024 / 7:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc at Citi Virtual Oncology Leadership Summit

Question: Yigal Nochomovitz - Citi - Analyst : I think, no, that was great. I think, just for those, maybe less familiar with the story, these are the studies that you're mentioning in combination in the frontline trial are those genotype agnostic? Or are you looking at specific populations? Can you just clarify so people are clear.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And then if you were to venture further into some of the other MOAs in AML, like a FLT3, is that the cards? Are there reasons why that may not work or not or that could work? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 21, 2024 / 7:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc at Citi Virtual Oncology Leadership Summit

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Let's just spend literally a minute or two on menin outside of the AML and ALL. You have a study in CRC. It's, I think you kind of build it as a signal seeking study. What's the quick update there? And then obviously, there are people working on things outside of cancer for the menin space, i.e., diabetes, anything to say there. And then let's talk about axatilimab?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Sounds good. Alright. So axatilimab, let's switch over to the CSF-1R axis of the company. So again, big development with the filing of the BLA by your partner insight. I assume that's insights news to share when the acceptance of the BLA, but can you just confirm that and anything you can say at this point in terms of feedback from the FDA, but I know you may be limited in how much you can talk about that.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And so obviously you also opted in last year, I don't recall exactly when, but quite recently towards the end of last year on the co-commercialization. Tell us about what kind of investment you're going to make in commercial effort in terms of deployment of capital as well as personnel? And will there be any overlap with revumenib or no?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Now, obviously you're entering a space where there is a decent amount of competition. As we all know, with some of the other products for GVHD, chronic GVHD. So it will be great if you could just kind of give us the sales pitch as it were as to as to where you see the differentiation for axatilimab. How could add to the optionality in the therapeutic landscape in addition to what we already have with Jakafi, REZUROCK and Imbruvica? And how you could potentially see taking axatilimab into the earlier settings, earlier lines, which as we know it's important.

Question: Yigal Nochomovitz - Citi - Analyst : Yes. I remember, when we did our KOL checks last year, the comment was that it was very, very good optionality in terms of the mechanism of action of axatilimab playing well with the other mechanisms, given it was kind of orthogonal to whatever all the other ones we're doing. I also got a lot of questions with regard to what Incyte is going to do with the combo with Jakafi. I guess it's not clear or they haven't spelled out in super detail. Are they going to go frontline, meaning real frontline like before steroids? Or is this going to be Jafaki plus axatilimab after some initial attempt with steroids? Just curious or is that now worked out yet?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And you touched on when you're talking about the MOA, and think of fibrotic aspects, you are also developing with Incyte the study in IPF, idiopathic pulmonary fibrosis. What's the latest there as far as the timing and data? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 21, 2024 / 7:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc at Citi Virtual Oncology Leadership Summit

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Understood. And then, Michael, just to round out. Tell us, just quickly on terms of the financial strength of the company, where do you stand with the cash runway. Obviously brought it into two assets we've talked about via in-licensing pathway. Are you thinking about bolting on new assets at this stage? Are you going to focus on the lease late stage opportunities?

Question: Yigal Nochomovitz - Citi - Analyst : Alright, very good. Thank you so much. Congrats on all the progress and we look forward to hopefully very good news soon in terms of the near term approvals for both assets. So thanks again, and I'm sure we'll be chatting soon.