All right, we're going to go ahead and get started. I'm Steven Willie, one of the senior biotech analysts here at Stifel, and glad to have with us for the next presentation. CEO Michael Metzger, head of R&D Nick Botwood, Syndax Pharmaceuticals. So we're going to go through a Q&A intended to be somewhat casual, so if there's any questions in the room, feel free to raise your hand. Maybe Michael, before we get started, any kind of introductory comments you want to make before we jump into it? Yeah, thanks for having us, Steve. It's great to be here, great to be with you all. Syndax is at a very interesting and, I think, exciting time for the company. For those of you who do not know, oncology-focused business with two approved products now. In the last year, we have actually had three approvals, which is pretty amazing for a small company like ours. Two different drugs that we are commercializing now. One is called Revuforj. The other is called Niktimvo. Revuforj is a drug for acute AML and ALL, affecting both pediatrics and adults. First of its kind, menin inhibitor, first best-in-class agent, and off to a fantastic start in this category. We will tell you more about it today, quarter, as well as other performance that I am sure Steve will touch on. Niktimvo is for chronic GVHD, third line plus, and this is an area of high medical need as well. Again, this is within the scope of the heme malignancies and heme diseases, and we are using one field force to call on physicians for both agents, which is also rather unique. Chronic GVHD, it's a CSF1R antibody, Niktimvo, and is off to a fantastic start as well. Two drugs being launched in the last year, I think we've sort of reset industry benchmarks for performance around both. We're excited to be here. Of course, these are large market opportunities, $5 billion plus for both. There really is quite a bit of opportunity as we push into the market and, as I said, reset industry benchmarks for performance. Lastly, I'll say we have a very robust set of work ongoing to push both drugs into earlier line patients and really exploit the largest opportunity for both our menin inhibitor, Revuforj, and for Niktimvo in GVHD. Okay. I think there's a number of aspects of the commercial and clinical development programs we want to talk on. Maybe just, I guess, as we kind of look forward to next month at ASH, it seems like the number of Revuforj-related abstracts has kind of grown exponentially, right? Maybe you can just kind of speak to a high level as to how that publication strategy, presentation strategy, coincides with you launching the product, you trying to gain visibility, and how you're marrying these two things. Yeah, maybe I'll start and I'll turn it over to Nick to kind of give you some more breadth and scope around the program and how we're approaching and showcasing it. ASH is a very important meeting for us. This year we have 23 abstracts between the two drugs. Revuforj has three oral presentations, I believe three oral presentations for Revuforj as well. Just a lot going on, really showcasing the full breadth of the program and answering some important questions for physicians and how they could potentially utilize the drug in practice. You want to characterize that? No, thank you. Thank you, Steve. Thanks for having us. Thank you for the question. Very excited about ASH. The depth of our program, I think, will be well reflected there. We're actually going to have 23 abstracts across both Revumenib and Niktimvo. I think this speaks to the very close collaboration we've had with our medical teams and our development teams and our academic collaborators. It's been a very positive collaboration. We really want to drive scientific leadership and continue to be the leaders in the menin class and in the treatment of graft versus host disease. I think our strong presence at ASH will reflect that profile. We're very pleased with the collaboration we've had with multiple sites. When I think about the data we're going to have, I mean, we're going to cover a lot of interesting science. I think there'll be a lot of academic interest in the data we're going to be generating. I'll maybe just try and frame it for you in three buckets. I mean, firstly, I would say we're going to have the first real-world evidence. This is important because this is data based on commercial use of drug at centers and their experience and data they've generated. One series from Moffitt in Florida, an academic center. Dave Solman will present data from a series of 17 patients that shows the breadth of the use of Revumenib now across, of course, KMT2A, now our newly approved indication NPM1, but also other subsets of patients that physicians want to use Revumenib in like NUP98 fusion. We've shown activity across mutations that are driven through the HOX-MEIS upregulation pathway, which could potentially be around 50% of AML. A really very broad profile we have, including KMT2A and NUP98 fusion, and we've been showing that. That is exciting data. Very high use in combination. I think that speaks to the confidence physicians have to combine Revumenib with current standards of care like Vene or Aza or either of those single agents. When you do combine it, you get extraordinarily high response rates. They are going to report 79% overall response rate, high number of patients going to transplant, and a very tolerable regimen. Important real-world evidence. Nice series also from MD Anderson in children. Again, very proud. Indication covers pediatric and children down to one year of age. I think it speaks to the profile of the drug that we got those approvals in both indications. You will see a nice series in maintenance, interestingly. This is in children after transplant with very promising early efficacy data. At one year, 100% of these children were event-free. Given the poor prognosis, that's a really compelling profile. We We will be excited to showcase that. That will really be consolidating our position based on the fact we've been on the market for a year. We will then have some sets of data that are really transitioning us into the frontline setting and again, maintaining our leadership in frontline. Some data in combination with Ven, and in this instance, an oral HMA from the SAVE study, which again shows it's tolerable with a very good profile. We've consistently shown good efficacy with a Vene and a hypomethylating agent from Beat at EHA this year and now SAVE in newly diagnosed patients, which I think sets us up very well for our frontline randomized study, which was the first study to randomize in the frontline. We'll have our first presentation of data in combination with intensive chemotherapy. This is both from a collaboration we have with the National Cancer Institute in the United States and also our own Syndax Monster Study, Study 708. The takeaways from those two data sets, you may have seen the abstracts. We'll have more data at ASH. Are essentially that number one, it's well tolerated in combination with intensive chemotherapy. We have not hit a maximum tolerated dose. We're seeing a compelling efficacy profile in those early data in combination with intensive chemotherapy. 100% of the patients with KMT2A had a complete response, and 100% of those patients had a deep response with MRD negativity. That is really compelling in a subset of patients who otherwise do not have good standards of care. Again, that sets us up very well for our frontline program, which is in combination with intensive chemotherapy called Reveal, which is on ct.gov. We are anticipating enrolling the first patient before the end of the year. We think we will be very competitively positioned. It is going to be a really strong ASH for us. Okay. So on Revuforj, right, I think we're approaching the one-year anniversary here. Maybe you can talk a little bit about what you've learned so far on just kind of the access, prescribing habit, and treatment duration fronts. How does that experience kind of compare relative to what your expectations were when you were presumably up here at this time last year? Yeah, yeah. It's always interesting what a difference a year makes. Look, I think the expectations, we had high expectations of what we could achieve. We built a very formidable team, customer-facing team, medical team to promote and to educate physicians around the use of the product. We've had excellent access, and we've really covered the universe in terms of prescribers. We've gone to all the physicians. Vast majority of them are writing scripts on Revuforj. KMT2A has very high unmet medical need. Physicians, really, as Nick said, they don't have good standard of care, so nothing really works for these patients. That's a great place to start because now we have the only drug on the market that actually has an impact, high impact on these patients. They want to take them to get them to a response. They want to drive them to transplant, and they want to put them back on in a maintenance capacity after they've cleared their engraftment period. We support all that with data and also with the ability to kind of get physicians comfortable with the drug, but also supply the drug. Patients get on drug very quickly, on average less than four days, which is industry best. All of that leads to better access. We have excellent formulary coverage, close to 100% at this stage, and had achieved that within maybe, I think it was about four or five months, six months. That is also industry best. You do not see that very often. We are doing everything from an execution standpoint, but our drug also performs. I think we are seeing physicians utilize the drug, which may be some things that have moved more quickly. Physicians using the drug in second line, third line, so first relapse, second relapse versus what we saw in our clinical trial, which is more like third or fourth line. That actually drives the earlier utilization of these patients. Patients tend to do better, stay on drug longer, and have the opportunity for maintenance in a higher capacity. We're seeing that build throughout the year. Now two-thirds of our patients, about 70% of our patients, are second and third line. We're seeing transplant rates at historically high numbers, about a third of patients getting to transplant versus what we saw in our clinical trial, which was really compelling at 25%. Again, for KMT2A patients in the third line setting, it's usually about 5% or less. We're now at really a very big difference in terms of the number of patients going to transplant. We have seen the amount of patients come back. We said that was going to take some time because you have about one third of patients going to transplant. They need about three to four months to come back on therapy in the maintenance setting. That is starting to materialize in our numbers. We are starting to see scripts for that, and that is going to build over time. All of this starts with treating patients earlier and getting them to transplant in higher numbers. We have been seeing that throughout the year. In terms of how we have performed, I think it is hand in hand with great performance with a field team and a medical team that knows how to support the product and bring it to patients, but also having a product that actually physicians want to utilize to the best of their capacity. Yeah, no, it's certainly been a very successful year. I think interesting that from kind of a targeted therapy comp perspective, right? I mean, you guys have outpaced the other comps while doing so in a smaller incident patient population. I guess as you think about the success you've had thus far in year one, and then you kind of look forward into year two where you'll have the benefit of a broader label, and then you'll have the benefit of this leverage created from post-transplant maintenance. How are you now starting to set expectations for investors who are getting enthusiastic about maybe what a 2026 number or 2026 launch update could look like? It's not easy. It's not easy. It's not hard It's not hard to see the enthusiasm building. We're building something that is unique. KMT2A is a built business now. We've really established it as the foundation for Revuforj. Now we can take that and we're bringing a new indication in NPM1. It's the same treating audience. These physicians have had the experience of writing Revuforj for a very, very sick population of patients. They know how to utilize it. As you said, there are levers for KMT2A, patients coming back. You'll see that build in future quarters. Now you add on a patient population in NPM1 that is two to three times larger. When you think about NPM1, what's compelling about our drug for that population, we have the best efficacy profile, full stop. Physicians are really, really compelled. They want to have the opportunity to give their patients the most efficacious drug. And our drug is now labeled for all the populations. It is a very easy transition. They are enthusiastic to write it. We have the field team immediately out there. Yes, next year should be a great build year for KMT2A as we continue to penetrate that market. We say we will be about half penetrated on an incidence population of about 2,000 patients. We will have about 1,000 KMT2A patients on drug or have taken drug this year. We think we can build on that next year and continue to penetrate that, have additional patients come back for maintenance. That business in itself will be formidable. You add on NPM1 with best-in-class efficacy. It should be a very significant year as we continue to drive that growth. I think everyone's aware that there'll be a competitor reaching market more than likely by the end of this month in the NPM1 subgroup. What proportion of physicians do you think who treat relapsed refractory AML will have had hands-on experience with Revuforj by the time that drug potentially gets approved? All of them. I mean, it's a very high percentage. The ones that are writing have had exposure to Revuforj both commercially and clinically. So they've been involved in clinical trials. They've seen our drug. There's really very few physicians that will not have written Revuforj. Okay. Maybe you can talk a little bit about just kind of your typical prescriber's familiarity with the notion of post-transplant maintenance. I guess their willingness to prescribe this to patients. What your feedback suggests that duration could potentially look like? Yeah, you want to talk about physician experience. Yeah, we hear a lot about this from physicians. I think there's a growing body of evidence that would support the use of maintenance after transplant. We hear it from academic centers and community. They want to do that. If you get a patient to transplant and you're concerned about relapse, in some patients, it may be curative, but for many, they will relapse. If there's an opportunity to use Revumenib for, we hear, up to a year, in some instances, two years, then there's a desire to do it. As I mentioned earlier, there will be a series from MD Anderson, for example, in children, but it could equally be in adults where they are treating patients after transplant and seeing very good event-free survival. We have a program focused on maintenance. We want to generate more data to support the use of Revuforj in maintenance because we think it could bring a real clinical benefit. Our studies do allow for it. It's an option for physicians. One of the advantages of Revuforj for physicians that want to use it in the maintenance setting is that we do have flexibility in dosing. Sometimes when a patient has had a transplant and they're going through engraftment, they're still quite fragile after transplant. The flexibility that Revuforj provides is very good for those patients. Some physicians are exploring lower doses of Revuforj, and it gives them that choice. There is a compelling hypothesis. We hear from them that after engraftment, there's this phenomenon called graft versus leukemia, potentially holding the disease with a targeted agent like Revuforj whilst that graft is getting engrafted and holding and can combat the disease as an attractive proposition. I would say increasing scientific interest in the hypothesis. We are working with the leading sites, generating data, supporting physicians who want to use Revumenib in that capacity. We think it's an important choice for patients after they've had transplant. We are seeing quite significant uptake in that setting. How significant of an opportunity? Maybe I'll reframe this. Do you feel like the notion of post-transplant maintenance therapy and the ROI that you can earn on this as a company, do you still feel like this is widely underappreciated by investors? It's not widely underappreciated from physicians. It's widely underappreciated, I would say, from investors. The main reason is because this is a paradigm that physicians have been interested in. They haven't had the right set of patients or the right therapy to deliver on it. When we started our program, physicians told us that they wanted to put KMT2A patients back on maintenance. This was in the clinical trial setting. We hadn't even designed our trials that way. We had to think about how do we design it into our trials, which we did. They're leading us. They're telling us that they want to do this. The enthusiasm is extremely high. As Nick said, a year to two years of maintenance on average. I haven't met a physician yet that has said they wouldn't put their patient back on maintenance. It is universal that they want to do it. They have the drug to do it. The KMT2A patients are younger. You are seeing it play out in the first year of launch where it is starting to build. This is a very important piece of the business. I cannot emphasize it enough. You have patients who are coming back and can be on for a year to two years, in some cases longer. We have shown this with data. That, in terms of AML, you have not seen that in any of the populations. You really have not seen long-term maintenance in the relapse refractory setting. Once we get to even the frontline setting, that could elongate even more. It starts with the right agent. You have to have the right agent to do it. It's also the right population in KMT2A to start and build that experience. I think the corollary to that is in NPM1, it's a slightly older patient population. You don't see as many transplants. The move from physicians is to try to transplant even the NPM1 patients in higher numbers. We're seeing that in our data. We're seeing in our clinical trial, our pivotal trial, you're seeing around 20%, a little less than 20% of patients get transplanted. That's a lot higher than you would expect. We think this could manifest in the commercial setting as well, where you also get patients to transplant. Not as high numbers as KMT2A, which is now at about a third. We think that could go to probably 50%. NPM1 will also have a component of patients who go to transplant and then potentially take maintenance. Overall, it should really change the way patients are treated in this setting and build to a very large market opportunity. I think that's what's starting to be appreciated by investors. Not totally discounted, but I think they need to see that build, and we do too. Steve, I would just add that we're not promoting it in that setting, but we are providing support and information that we have to investigators that need it and supporting it with ongoing clinical research. You'll see from the real-world series we're presenting at ASH that there is quite a lot of uptake of it. Interestingly, we hear this anecdotally as well. Even sometimes use in the maintenance setting, even if a patient hasn't had Revumenib in relapse refractory, so they go to transplant. Then because of the interest and the scientific rationale to do this, they put them onto maintenance after the transplant. Yeah, that's actually quite interesting. Maybe last commercial question, just how are you thinking about XUS at this point? When or what do you think is the right time for that in terms of an investment if you do choose to invest? Do you see the same kind of prescribing dynamic in Europe post-transplant maintenance as you see in the States, or is it different? Yeah, I mean, our investment now is being made in the development of the drug. Potentially our frontline trials are set up to be global registration trials. We will register the drug outside the U.S. That is, I think, our main thrust at this point. Commercially, we have said that we are not going to commercialize the drug ourselves outside the U.S. We will at some point bring a partner to bear. I think there has been obviously a lot of interest, but our focus has been on development and also commercializing and optimizing the opportunity in the U.S. In terms of maintenance, I think there is absolute utilization outside the United States. A lot of our trials are enrolled globally. We will see what that looks like. We do expect that is a paradigm that will be part of the ex-U.S. environment as well. Okay. On the clinical development side, maybe you can talk a little bit about your frontline development strategy. I know you've initiated a registrational trial with Beneza. You're initiating trials with 7+3. How do these two things kind of, from a strategic perspective, right, maybe talk about how these studies coexist? If you can also maybe speak to which of those studies you think could be the first opportunity for real label expansion. Yeah, great questions. Yeah, very exciting time. We have transformed the standard of care for the majority of patients with AML in relapse refractory setting. That is a remarkable achievement, and we are very proud of that. Obviously, our ambition now is to be the first to do that in the frontline setting as well. It is an incredible opportunity because in the frontline, you have the opportunity to impact the disease even more and potentially get more patients to cure. We will have an incredible opportunity to do that. We are laser-focused on frontline. Very proud that we were the first company to actually randomize patients into a pivotal frontline study, which is being done in collaboration with Hovon. This is a leading European academic group. That study started enrolling early this year. It is enrolling well. It is a well-designed study. Our focus is, of course, on speed. Execution is key. We're in a very competitive space. We want to be first, and we want to be able to bring a new treatment option to patients. We also have a laser focus on quality. We're aware the management of these patients is critical. The dosing with the standards of care in combination with Revumenib is extremely important. We think we're very well positioned strategically working with Hovon to not only deliver flawlessly, but also bring a high degree of quality to that study. In terms of timing and our focus, those patients that get Vene are unfit for intensive chemotherapy. There is a growing interest in the combination of Vene. There'll be some important data at ASH. We think that's a growing and important standard of care. Currently, it's probably about half of patients in frontline get it. We think that proportion may grow based on the compelling evidence that we've shown of Vene in combination with Revumenib whether you use an IV, HMA, or oral. The data is consistently compelling and well tolerated. We think that proportion may grow. We have dual primary endpoints built into that study. We have a complete response rate and an overall survival dual primary endpoint. What that means essentially is they're statistically independently powered. Either of them could be positive in the study. We feel quite confident that if we're able to demonstrate a benefit in complete response rate, that would serve as an accelerated approval in the U.S. and potentially get that treatment option to patients faster. We are very excited about that and, as I say, focused on execution. Steve, as we think about the fit population, this is again an exciting opportunity because intensive chemotherapy does remain a standard of care for many patients. A physician may want to use an intensive chemotherapy combination to either cure the patients or give them a higher probability of getting to stem cell transplant. We will have data at ASH that shows the combinability of Revumenib with standard intensive chemotherapy and also quite compelling efficacy. The complete response rate, so you look at MRD negativity across the spectrum of patients who are eligible for intensive chemotherapy. That is called our Reveal program. We have guided towards starting that program this year, and we are on track to do that. The study 710 is posted on ct.gov. We think, again, that is a well-designed study. We are working with an international CRO, Par Excel. We think that positions us very well to lead in that space also. An important program, transitioning into frontline with the opportunity for greater impact for patients and potentially even cure for some. Great. Maybe we can switch gears to Niktimvo here in the last five minutes. How is this drug launching maybe relative, again, kind of to what your internal expectations were? Maybe you can just kind of talk about how you're economically levered to this asset. Right. So this is Niktimvo with a chronic GVHD. We launched this product in February of this year, off to a fantastic start. The product was actually profitable in its first full quarter. I say that again, in its first full quarter, which does not happen very often in our business. Very, we will talk about expense base, but it is, I think, a very good setup for what this could mean. I think in terms of analogs, the closest analog is a product called REZUROCK, which is Sanofi's product, which has a different mechanism of action. That product is doing about $550 million in its third year of sales. We are tracking on top of that analog and are poised to surpass it. I think usually when you think order of entry of these products, you would think that we would be a step change different in terms of revenue. In fact, we're tracking right on top of it, which means that we think that could be a low benchmark for what we can do. We're taking share from that product. Patients, I mean, this is a new mechanism, as I said. Patients tend to get on the drug quickly and get the response within a month or so and stay on drug for not months, but we're now seeing patients stay on for years. In our clinical trials, we continue to track that. This is a real chronic therapy that makes a new kind of impact for patients and impacts not only inflammation, which has been what the other drugs have been able to impact, but inflammation and fibrosis. We think this is just the start of something tremendous. Big population of patients, 15,000-17,000 patients in the U.S. in chronic GVHD. This segment of the market that we're currently in is about 6,500 patients. We will penetrate that. We think we'll become the standard there. Then we'll expand in combination to frontline in combination with Jakafi, as well as combination with steroids. These are trials that we're running now. The TAM in this space is about $2 billion for the relapse refractory space. When you get to the earlier line, it's a $5 billion + market. Again, I think we're off to a fantastic start. The quarter was $46 million net revenue. We have a collaboration with Insight. We mentioned leverage in this space. Our collaboration revenue is about $14 million for the quarter, 25%-30% in terms of from top line to our contribution, which is very significant. We think that will expand over time. This, as I said, very profitable over time, profitable already. A lot of leverage there on a very, I'd say, focused call point and a focused set of expenses that we think could be at the end of the day, we want contribution. We want to be able to get to profitability. I think we've talked a little bit about that, not today, but one of our important drivers here is to drive to profitability with the two products that we have on very stable expense base. We think over the next few years we can get there and surpass that, which will allow us to have lots of flexibility to continue to build these franchises, but also do other things. Okay. You talked about the opportunity in TAM that steps up as a function from going to third line where you currently sit to frontline. We know there was a competitor trial with Sanofi's REZUROCK that failed in the frontline setting, failed to meet a futility analysis. When you look at that failure, do you ascribe that to kind of trial design specific issues, endpoint specific issues, or do you think that there's something about the frontline biology of chronic graft versus host disease where maybe it's more inflammation driven, where kind of third line plus, it's fibrosis driven? Just any thoughts as to how you view that failure and whether or not you think the reasons for that failure may or may not be applicable to Niktimvo? Yeah, I mean, in the short time we have left, that's a long answer. I would say it may be a combination of things. But look, our drug has hit the macrophage and doesn't have the same impact that REZUROCK does on T cells. That could have something to do with it. The design of their trial, without getting into specifics, may have had some contributors to that, to their ability not to get the drug approved there. So there's a combination of things. I think we're uniquely set up with non-overlapping mechanism of action around steroids to have a positive outcome there. And I'll kind of leave it at that. I think we feel very confident that this will have a significant impact. Have investors started asking you about IPF yet, or do you expect that to be a 2026? That's a good place to end. IPF is a huge opportunity, 150,000-200,000 patients. We think a relatively low bar compared to standard of care. Patients are in dire need of new therapies. Bringing a new mechanism there with really compelling both preclinical and clinical evidence around our GVHD trial with patients who have lung fibrosis really sets that up for success. We have a randomized trial that's reading out next year, which should give us a very important signal in that population. Physicians are excited about it. I think investors are just getting warm to the fact that we're in that space and could have a very meaningful new agent addition as we see that data next year. Okay. Last question. Yes. Balance sheet runway, what that allows you to execute on, and how do you prioritize this notion of achieving sustainable profitability? Balance sheet, $456 million as of the quarter with stable expenses. We've guided over the next few years. You're going to see stable expenses from us. It allows us to really focus our book of work. We're working on frontline trials and supportive trials around both products. That means that we can get there and we can execute with excellence over the next few years. It really allows us, if we can get to profitability, which we believe in that time frame with the cash we have, we can go on and have some flexibility to continue to build the pipeline, which is something else to talk about. At this stage, we're super focused on that and maintaining our leadership position for both assets in these markets where we've started to really make a difference. Very good. Michael, Steve, or Michael and Nick. I really appreciate it. Thanks, Steve. Great to see you. Thank you.