Good afternoon, and welcome once again to TD Cowen's seventh annual Oncology Innovation Summit. I'm Phil Nadeau, one of the biotech analysts here at Cowen, and it's my pleasure to moderate a fireside chat with Syndax. We have with us today Michael Metzger, the CEO, and Nick Botwood, the Head of R&D and CMO. Guys, I'll hand it to you for a brief introduction. Could you give us a state of the company overview, biggest strengths, biggest challenges, and what does Syndax need to do to create shareholder value over the next year? Yeah, thanks, Phil. Great to be with you as always. Look, the company's in a great position, 2026, following after a fantastic 2025 in terms of performance. I think the company's set up for success with two programs, obviously, Revuforj and Niktimvo, trending well, doing very well from a sales perspective. Our ability to not only drive sales, but continue to build these franchises with data being put out at some of these medical meetings, and we'll talk about that today. Really executing on all fronts as we continue to bring the products to more and more patients, and that's going to be predicated on, of course, the data sets that we continue to build on. A lot going on with the company, and the ability to bring as much forward as possible. We'll talk about all of that today. Certainly, the last quarter results showed that we're certainly building on our leadership position with menin and GVHD with Niktimvo and Revuforj. Certainly lots to talk about today. Challenges for us, I would say continue to execute and continue to build our leadership position with both franchises. That's always of importance. Of course, supporting our products with as much new data as possible to make sure physicians have what they need to prescribe the products liberally. That's where we are. That's great. That's a good overview. I think we'll start with a discussion of ASCO and EHA before turning to the commercial franchises. At ASCO, perhaps the most notable abstract is going to be the presentation of data from MD Anderson's experience with Revuforj as a post-maintenance therapy. Could you briefly describe the overall survival and cumulative incidence of relapse data that were disclosed in the abstract, and maybe put those in perspective, how they would compare to what would be expected from standard of care? Yeah, certainly, Certainly, Phil, just to say thank you for having us. Great to be here. As we head into both ASCO and EHA, just high level to say we're very excited about being able to present such a compelling body of evidence. I think it really speaks to the profile of Revuforj and how we're leading in the menin space that we're able to present four abstracts, including this all at ASCO, which I'll talk about, then 12 going into EHA, covering a variety of really important points like the breadth of our profile across KMT2A, NPM1, NUP98r combination data. You'll see updates, more real-world evidence we'll talk about a little bit, then maintenance. Maintenance is really important for us. This is a high focus. It's not an area that we have indicated or we're promoting on, but it's an area we're really continuing to explore and present data to support physician choice. We have some significant investments as well in terms of our research to better define how patients should be optimally treated, and the benefits that maintenance could bring patients. Coming to this MD Anderson data set, firstly, I think it speaks to the very close and ongoing collaboration we have with MD Anderson and their leadership in the hemonc space. We feel very proud to be continuing that collaboration. This is a really meaningful data set, what you've seen in the abstract will actually be updated at ASCO. We'll see slightly more patients and slightly longer follow-up, I think that's important. It'll be a little bit different from what you see in the abstract. The data are equally as compelling, if not more so, I would say, with additional follow-up. What we're seeing across this adult and pediatric population, this is 11 adults and 10 pediatric patients, including a NUP98-r patient, the one and two year OS rates are at 90%. Now, that is really an extraordinary result. For the first time, we've compared this, or MD Anderson have compared and benchmarked this against historical controls that you'd expect to be in the order of 50%-60% one and two year OS rates. That's coupled with really a very low rate of discontinuations. Only around 19% of patients discontinued, and a small percent of patients discontinued because of thrombocytopenias, and we can maybe speak about that a little bit later. Really compelling OS rates. Added to this, you mentioned this cumulative incidence of relapse. You see about a three times level of cumulative incidence of relapse for historical controls compared to what we're seeing with Revumenib in this particular study, which again, I think speaks to the strength of the data and the data that's increasingly supporting the use of Revumenib post-transplant in a maintenance setting. One of the key questions we typically get about MD Anderson data sets are whether they're reproducible by less expert centers. What do you think about the maintenance data that we're seeing here? Is this something that could be replicated by centers that are maybe not as astute as MD Anderson? Well, I think so. There's a few reasons for saying that. I think, one, we are replicating this data at major transplant centers. We're actually presenting another data set at EHA, which is our experience from Augment. It's a smaller data set, 19 patients. You will see data there that has similar one-year and two-year OS rates, so I think that's very much replicating what we're observing at MD Anderson. I think there's a real reason to believe it could be replicated. We're also increasingly learning how to optimally treat patients and manage cytopenias in terms of dose reductions, dose interruptions, and we know revumenib does allow for that flexibility in dosing, and just experience. As physicians get more experienced in treating and patients have a greater ability to manage through that engraftment period and manage the cytopenias and accept they may go low at some point, we're then seeing these long-term benefits in terms of these really compelling one and two-year OS rates. At the end of the day, for a disease that carries a high mortality, that's really what you want to see. You want to see patients getting out to two years not only alive, but ideally event-free. We also see event-free survival of around 84% at one year, which is very encouraging. I think these data are replicable. We will be generating more data. We have just announced on ct.gov a randomized control study. We're collaborating with Dana-Farber, which is a prospective randomized study, really bringing, again a laser focus to addressing this important question around post-transplant maintenance. You mentioned the cytopenias. Thrombocytopenia, in particular, was prominent, with 48% of patients having dose modification and 10% having dose discontinuation. What strategies are being developed to lessen the incidence or severity of thrombocytopenia? I think this is important, I don't think this is a revumenib phenomenon. I think this is a phenomenon of patients having sensitive marrows after engraftment. They have a tendency to get cytopenias, both thrombocytopenia and neutropenia. Judicious use of G-CSF may be helpful for the neutropenias. I think that dose interruptions and dose modifications to allow for thrombocytopenias, understanding when the nadir is going to be, having a break between cycles. We have a controlled phase I experiment we're undertaking with Dr. Ball at City of Hope Hospital. We're hoping to present data from that phase I study, which will show with much more granularity, some of the dynamics of some of these cytopenias that you see and how to optimally manage them. Again, as we continue to pioneer research in this space and generate more data, I think it'll really support physicians and patients on that journey in that post-transplant maintenance. Again, when I come back to the efficacy and you look at the reproducibility of the efficacy in both of these series compared to historical controls, it's really a compelling proposition, and I think both patients and physicians will want to continue to try to support use of revumenib and menin inhibition in general in this post-transplant maintenance setting, because as I say, it's a compelling proposition. More generally, how well understood is the dosing in the maintenance setting? Do you feel like you have an optimal dosing schedule today? I think it'll vary. I think there are a number of factors that contribute to that. I think some patients will tolerate better than others. That depends on the engraftment. It depends on the degree of exposure to menin inhibitions and what they observe before transplant. I think this is going to be an area, as we generate more data, patients will be able to treat in a more bespoke way. I think again that's one of the benefits of revumenib, that we do have these alternate dosing schedules that does allow for dose modifications, and I think that's going to be important in post-transplant, just because we recognize these patients are somewhat fragile after engraftment and they need to be carefully managed, and revumenib allows for that dose titration if you will. As I say, we'll present some actual phase I data looking at this question specifically as we've dose escalated up, and how to optimally manage cytopenias, Phil. It's very much an important question to manage tox, but again, when you have an efficacy proposition of the type we're beginning to see now, OS at one and two years event-free survival, the cumulative incidence of relapse, all very much trending favorably, I would say with revumenib compared to what you'd expect with historical controls. It's a very compelling benefit-risk proposition. Keep in mind is where the adoption of maintenance is today. What proportion of patients are getting Revuforj post-transplant as a maintenance regimen today, and where do you think that could be in a couple of years? Well, I think it depends. For KMT2A, where the intent is clearly to get these patients to transplant, we're probably seeing up to 50% of patients actually going to transplant. That's more than we saw in our original clinical trial AUGMENT-101 pivotal data, but that's because we're increasingly seeing patients treated earlier in their disease and in combination. Of those patients that actually go to transplant, currently, we're seeing about half of them go on to maintenance. Given the data that we'll be presenting and all of the other catalysts, if you will, to support the use of maintenance, we envisage that up to 70%-80% of patients could go on maintenance in the future, and we think that that's probably appropriate. Now, ultimately, our intent is to support guidelines and potentially labeling for maintenance. Again, we're not promoting on it. It's not part of our current indication, but it is becoming part of clinical care. As we continue to generate data, I think that's supportable. You referenced a couple of trials you have ongoing, plus supporting perhaps label expansion or guidelines. Can you remind us of the overall development strategy for Revuforj and post-transplant maintenance? What is the clinical program today? When do you want to label- Yeah. I'd be happy to Phil. There's many components to it. Firstly, and probably most importantly, our pivotal Phase IIIs do allow for maintenance after transplant. That is built in and that will be an analysis we do in those pivotal studies. It's actually quite difficult whether you do two arms or three arms to actually untangle what the contribution of the maintenance after transplant is. Nonetheless, we are allowing for that, and we envisage that quite a few patients will go onto maintenance after transplant, and we'll be able to analyze those patients separately and look at that. That's the first thing. We have, as I've mentioned, a Phase I study with City of Hope, which is really looking at the dynamics of cytopenias and dosing and optimizing dosing, which we're hoping to present data on in the latter part of this year. We have just announced on ClinicalTrials.gov a collaboration with Dana-Farber, a study called MAINTAIN, which is the first randomized control study specifically looking at the impact of maintenance. It's placebo-controlled after transplant, and that will generate very important data, which we just started on and collaborating on. We are, as you've seen here, collating data from our clinical trials experience. This is from MD Anderson's clinical trial experience specifically and our own clinical trial experience from AUGMENT, and indeed real-world data. We will be presenting real-world data, new real-world data at EHA, the so-called RAW study. This is from a collaboration with Dana-Farber, where patients do go on to transplant. As we get more data in the real-world setting and we collate those data, that will also help inform, Phil, that could potentially inform guidelines. When you look at the totality of that data set, we think that that would be sufficient to help inform both labeling and guidelines and clinical practice, and that's our intent. ASCO, there's going to be three other presentations, one analyzing the impact of Revuforj PK, on Revuforj PK of food, two in trial and progress posters. Anything from those other presentations that you'd like to highlight? I think the PK is important, and I think sometimes underestimated from a clinical management perspective. I think it's important that we've been able to demonstrate that Revuforj can be given with a low-fat meal, and also that the PK is largely unimpacted by proton pump inhibitors and H2 antagonists and other common antacids. That's important because many of these patients will be on one of those agents, and so that's important from that. I think that's an important point to highlight. Our trials in progress is important. We have great momentum now with our pivotal phase III programs. EVOLVE-2, you know, is in with venetoclax, patients unfit for intensive chemotherapy. We have our REVEAL study in fit patients in combination with intensive chemotherapy. We will have trials in progress for both of those, so people can look at the design and the inclusion/exclusion criteria, and we think that will really support enrollment. Our focus is just laser now on execution of those pivotal studies. The data we are generating, Phil, and we'll be updating our 708 Phase I intensive chemotherapy data at EHA, is extremely supportive of our REVEAL newly diagnosed intensive chemotherapy, pivotal Phase III. It's important we have that trial in progress posted there. We are excited to update those intensive chemotherapy data because we really think that the efficacy is compelling and highly supportive, if you will, of the probability of technical success in that Phase III. The reason I say that is we are seeing extraordinarily high overall response rates, CR and CRc rates. At dose level one, it's 100% for ORR and CRc, and CR rates of 91% and 71%. That is coupled with very high rates of MRD negativity. It was 100% and 70% for dose level one and dose level two respectively, and we will be updating those data. You'll see a later data cut with more patients and more follow-up in the post at the Congress. Those MRD negativities were assessed using quite sensitive flow cytometry in the main. They were done locally using a combination of both plasma and bone marrow. Those are considerably higher than you would expect from intensive chemotherapy alone, and I think bode very well for that randomized control study, which is compared to intensive chemotherapy alone. The one other point I would make, Phil, or two points maybe about those data with intensive chemotherapy, is one, the PK is unimpacted. That's important when we've looked at PK and the PK of revumenib as you would expect for monotherapy. The second point is that we see very good count recovery, because that's always a concern that you don't see count recovery, and that might impact your ability to assess CR. We really see the time to neutrophil count recovery is 29 days, and that's pretty consistent with what you would expect for intensive chemotherapy alone. The regimen is not only showing compelling efficacy, it's a very tolerable profile, no impact on PK. We will be presenting at EHA in the poster, you don't see it in the abstract, some swimmer plots. The swimmer plots will allow you to see patients going to transplant, and then those patients that go on to maintenance after transplant. We'll also give a little bit more granularity about the genetic subtypes. We'll split it down not just by dose level, but also by NPM1 and KMT2A. I think that will also be important as it guides us towards our pivotal Phase III, which as you know, is in the NPM1 subset. That's really helpful. It's in a great transition to EHA. You mentioned the intensive chemotherapy plus rev data. The other abstract that caught our eye was up to data from the SAVE relapsed refractory trial as well. This is the NUP98-rearranged relapse refractory data. For those less familiar, can you briefly highlight the data that were in the abstract for those trials? Yeah. I'd be very happy to. Very exciting data. We're excited about this. This is SAVE. This is an all-oral regimen from a collaboration we're doing with collaborators at MD Anderson. This is a combination with INQOVI, which as you probably are aware, was recently approved for acute myeloid leukemia for 75-year-olds or more. In May this year it was approved. This is an oral hypomethylating agent with venetoclax and revumenib, all oral, that's quite exciting. The abstract and the poster was a series of 42 patients. Actually, interestingly, the median age was only 40 years old. There was actually five adolescents treated in that series, that's quite interesting. For whatever reason, not considered for intensive chemotherapy. Bear in mind that because this is relapsed refractory disease, half of these patients have actually had prior exposure to Vena and Aza. Despite that, we saw an overall response rate of 88%. I would just call out in the KMT2A subset in particular, it's 100%. This is a very consistent picture now that we see such compelling efficacy outcomes in this KMT2A population, which is a very hard-to-treat population, as you know. eight out of nine patients in the NUP98 subset, and we may not get time to talk about it today, but we will also be presenting some data in NUP98-R with a CRc rate of 28%, which given the very poor prognosis for these patients, is very encouraging. Anyway, back to SAVE, Phil. Very compelling overall response rates. We saw a CR rate of 43%, and interestingly, 24 patients, so that's essentially half of the patients, went on to get a transplant in that relapsed refractory setting. At 18 months, half of the patients were alive and event-free. Very durable outcomes and very high rates of MRD negativity. Again, we're seeing that deep and durable responses. 88% overall response rate, 64% MRD negativity in those responders by flow cytometry done at MD Anderson, so it was a sensitive test. It's a compelling proposition to have this all-oral regimen, I think, again, very well tolerated and very interesting We agree that the data are very interesting, seem quite compelling. Do you think that they're likely to spark more use of the all-oral combo regimen in clinical practice? If that were to happen, how would that impact the duration of therapy in the relapsed refractory space? Yes, I think so, Phil. Especially now that INQOVI has an approval in AML, I think that it is an attractive proposition. I think that these data would support that. I could envisage more uptake in clinical practice. Again, our intent here is simply to provide data and support physicians in efforts to generate data that might inform clinical practice and potentially inform guidelines. That's very much on our mind, given the strength of all of these data sets. There are a number of potential submissions that I think that the NCCN would be interested to consider for inclusion in the guidelines, given the high unmet need and the step change that some of these data sets are now presenting. We're very much thinking about that. I think when you look at the totality of the data, the tolerability, there was no Grade five or 60-day mortality at all from this study, given this is a relatively unfit population in 42 patients. Given the essentially 90% overall response rate and high rates of MRD negative, this is a compelling proposition, and I think very much in our minds in terms of potentially informing NCCN guidelines. There are another 10 or 11 abstracts on Revuforj at EHA that we didn't ask specifically about. Is there anything from those abstracts that you'd like to highlight? Well, I think we covered a lot of it, Phil. Thank you. I would highlight again, our real-world evidence. I think we're very much leading because we've been on the market for so long, our ability to collate actual use of revumenib in the real world. Look out for the data at Dana-Farber, which I think is quite interesting. We will be presenting beyond what you saw in the abstract, a Kaplan-Meier of survival, and I think you'll see a compelling median overall survival compared to what we've seen in our earlier studies. I think that speaks again to earlier use of revumenib, increasing use in combination, getting patients to transplant. When you take all of those things into consideration, you see a median OS, which is a step change from what historically has been presented and what we saw in our earlier studies. I would look out for that. Again, I think the data we've seen in NUP98 speaks to the breadth of our profile and the impact across multiple different genetic subtypes, and that's very encouraging. Again, I think that's a data set that could be helpful to be considered for guidelines because there's such a high unmet need for patients who are NUP98-r. This is about 5% of AML, potentially more. I think now physicians are looking for it more. The prevalence of NUP98 may actually be a little more than 5%, and I think that's important. These patients have traditionally been very chemo-resistant. They share a lot of transcriptional biology with KMT2A. It's a HOXA/MEIS-dependent AML. I think the fact we were able to show nearly 30% CRc, which was detected very early, actually, after just one to three cycles, and patients had a median of nearly seven months, is very encouraging. It's a very full and complete data set that we're really looking forward to the Congress. I think we're going to show up very strongly at both ASCO and EHA this year. Before we leave EHA, there is also an abstract on Niktimvo from the phase II trial in combination with Jakafi newly diagnosed graft-versus-host disease. Can you briefly describe the highlights of that abstract, and what do you think it portends for the top-line data from the trial that are anticipated during the fourth quarter of 2026? Yeah. Phil, just very briefly, just a reminder for everybody, because this is exciting. This is an important randomized study, randomized phase II, looking at the combination of axatilimab and Jakafi. There's a very good mechanistic rationale why those drugs may be synergistic together. This is a potential steroid-sparing regimen. It will look as to whether a JAK and a combination of JAK and axatilimab can offer an alternative to steroids. This is a safety update. This is 66 patients. The entirety of the data, which we've guided towards reporting out in Q4 this year, is in 120 patients. This is safety reported from 66 patients, which is very encouraging. We didn't really see any additive toxicity to JAK alone by adding axatilimab. It looks very comparable to JAK alone when you look at the combination. In fact, the treatment-emergent adverse events were really pretty consistent across the three arms at about 75% and very similar rates of discontinuation. We're looking forward to the efficacy readout on that study in Q4. We think that could be a very important catalyst for frontline GVHD and a potential steroid-sparing regimen, which is really important for patients. We'll look forward to that. Based on these safety readouts, we feel very encouraged by the profile. Perfect. We just have a few minutes left. Maybe we'll turn to the commercial franchises. Revuforj has been launching well in relapsed/refractory AML. Could you guys give us an update on the launch? I think perhaps the biggest question we get from investors along the lines of launch is how much growth is left this year? What is the trajectory for uptake likely to look like through the end of the year? Yeah, Phil, thanks for the question. Certainly, Revuforj is off to a great start. Just keep in mind that we're rolling into our early part of our second year of launch. Trajectory has been good. Quarter growth was about 11%. New scripts revenue was about 13%. I think we're growing well. We have $49 million in the quarter for rev. Growth areas for us, obviously, putting more patients to transplant. I think Nick mentioned it, about 50% of patients going to transplant now, which is significantly higher than we've seen in previous quarters, which is a great precursor of what's to come. About 45%-50% of patients coming back from transplant, and that should meaningfully grow over time to, we believe, 70%-80%, which will be a big growth driver, we think, in the coming quarters as revu continues to stack. That's specifically related to mostly the KMT2A business. NPM1, new patient starts. It's a bigger market, roughly 4,500 patients. We do have best profile leading position there. I think all of our experience with what we've done in the first year, with KMT2A mostly, and now NPM1, will accrue to new patient starts and continue to dominate the field. We think the two areas of growth, of course, KMT2A, new patient starts will continue to penetrate, will bring patients back from transplants, so that maintenance piece is big. Certainly for NPM1, it's new patient starts as it will continue to ramp and penetrate in that part of the market as well. Look, I think we should expect very nice growth from both contributing factors for the year. For Niktimvo, also a lot of growing to do. We're penetrating third line now. About a third of third line is Niktimvo. Fourth line, about 50%. We've been able to really ramp well, tracking as well or maybe better than what we've seen for REZUROCK, which is the prior Sanofi compound. We're doing quite well, and I expect that as patients stay on therapy for months, if not years, that revenue will stack as well. We'll see a similar phenomenon in the relapse refractory setting. Of course, as we get data in the newly diagnosed patients, which Nick mentioned in that trial, we'll read out in the fourth quarter for Niktimvo on top of ruxolitinib. I think that could be very meaningful to unlock the newly diagnosed patient populations. Same goes for Revuforj, of course, all of the combinations that we're doing, answering all the important questions about how the drug can be used in combination and in maintenance. I think that will continue to build meaningfully as drivers of growth for that franchise in the coming months, quarters as well. Lots of opportunity for us. We feel like we're in a really great position to continue to build both franchises aggressively. That's great. With that, we are out of time. I'd like to thank Nick and Michael for coming on and a very interesting discussion. Thanks, guys. Thank you, Phil. Thank you, Phil