Good day, everyone, and welcome to the Syndax Fourth Quarter and Full Year 2024 Earnings Conference Call. Today's call is being recorded. [Operator Instructions] At this time, I'd like to turn the call over to Sharon Klahre, Head of Investor Relations at Syndax Pharmaceuticals.

Thank you, operator. Welcome, and thank you all for joining us today for a review of Syndax's fourth quarter and full year 2024 financial and operating results. I'm Sharon Klahre. And with me this morning to provide an update on the company's progress and discuss financial results are Michael Metzger, Chief Executive Officer; Dr. Neil Gallagher, President and Head of R&D; Steve Closter, Chief Commercial Officer; and Keith Goldan, Chief Financial Officer. Also joining us for the call today for the question-and-answer session are Dr. Peter Ordentlich, Chief Scientific Officer; and Dr. Anjali Ganguli, Chief Strategy Officer. This call is accompanied by a slide deck that has been posted on the Investor page of the company's website. You can now turn to our forward-looking statements on Slide 2. Before we begin, I'd like to remind you that any statements made during the call that are not historical are considered to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the Risk Factors section in the company's most recent report Form 10-K, as well as other reports filed with the SEC. Any forward-looking statements made represent our views as of today, March 3, 2025, only. A replay of this call will be available on the company's website, www.syndax.com following its completion. With that, I am pleased to turn the call over to Michael Metzger, Chief Executive Officer of Syndax.

Thank you, Sharon. Good morning, everyone, and thank you for joining us on the call today. Starting with Slide 3. We made exceptional progress in 2024 with the FDA approval of two first-in-class medicines that address major unmet needs, a truly remarkable achievement, which puts Syndax in a unique category as a biopharmaceutical company. Today marks another major milestone in the company's evolution as we report our first quarter with product revenue. As a reminder, on November 15, 2024, the FDA approved Revuforj, our first-in-class menin inhibitor for relapsed/refractory acute leukemia patients with a KMT2A translocation. Just five days later, we had product in the channel with immediate ordering, a very fast timeline that highlights the caliber of the team that we have built to support our transition into a leading commercial oncology company. We are off to a strong start with the US launch of Revuforj and are very encouraged by the patient -- the early patient demand, breadth of prescribing and coverage from payers. For the fourth quarter of 2024, we reported $7.7 million in Revuforj net revenue from the initial five weeks of the launch. These early results reflect the high unmet need and demand that Revuforj addresses and the strong execution of our organization to deliver the product. We are very excited about the opportunity we have with Revuforj, especially given the clinical data supporting the significant opportunity for future label expansions. We recently reported the first positive pivotal dataset in relapsed or refractory mutant mNPM1 AML and have continued to report data that shows strong evidence of synergistic activity in combination with standard of care therapies across newly diagnosed and relapsed or refractory patients with KMT2A rearrangements, the mNPM1 mutations, or NUP98 rearrangements. We are preparing to file a supplemental new drug application or sNDA…

Thank you, Michael. It's really a pleasure to be on the call today to provide an update on the launch of Revuforj and Niktimvo, starting with Slide 4. It has been incredibly rewarding for me and our entire team to be a part of bringing Revuforj to patients. We are very encouraged by the progress we have made in the early phase of the launch. As Michael stated in the initial five weeks of launch, we generated $7.7 million in net revenue. We estimate that approximately one-third of the net revenue for this first partial quarter represents inventory at our specialty pharmacies and specialty distributors and the remainder represents patient demand. Patient demand was driven primarily by new patient starts, with only a small number of patients transitioning from our Expanded Access Program, or EAP, to paid drug. All the pre- and post-launch work we have done with HCPs with payers and other stakeholders is truly paying off. We are seeing high product awareness among clinicians and the feedback from our customers has been overwhelmingly positive regarding the product profile and the overall ease of access to the medicine, which really speaks to the efficiency of the limited distribution model that we have established. Our distribution model includes partnerships with two of the leading specialty pharmacies for oncology products as well as a network of specialty distributors and our own dedicated patient support program, known as SyndAccess. Thanks to the systems we have in place, the high quality of our internal team, and the work we've done with payers, we're seeing patients get approved for coverage quickly and a rapid time to first fill, which is the time it takes from initiating a Revuforj prescription to the patient actually starting medication. Turning to Slide 5. As Q4 was a partial…

Thanks, Steve. I'm pleased to provide an update on the revumenib development program starting on Slide 8 with the near-term opportunity we have to expand into relapsed or refractory mutant NPM1 AML. Given the high unmet need and lack of approved therapies that target this population, we are pleased to have reported the first positive pivotal data set. In November 2024, we announced that the primary endpoint was met in the protocol defined efficacy population of 64 adults with relapsed or refractory mutant NPM1 AML in the Phase 2 cohort of the AUGMENT-101 trial. Among a heavily pre-treated population including 75% with prior venetoclax exposure, nearly half of patients achieved a response and 23% achieved CR/CRh. Consistent with other data sets, the responses were deep with 64% of CR/CRh responders achieving MRD negativity. Additionally, 17% of responders proceeded to stem cell transplant, which is a meaningful outcome in a population that is older and less fit for transplant than, for example, patients with KMT2A rearrangements. Overall, the data are compelling and we are confident that they could support regulatory approval, further solidifying our leadership position. Building on the positive pivotal data, we reported results in December 2024 from a larger post hoc analysis, which included additional mutant NPM1 patients from the Phase 2 cohort who met the efficacy evaluable criteria. These results were highly consistent with those for the primary analysis, with an overall response rate of 48% and a CR/CRh rate of 26% among 77 efficacy evaluable patients. Looking ahead, we expect to file the sNDA in the second quarter and believe we could receive approval around year-end. Also in the second quarter, we expect to publish the pivotal NPM1 data and believe this could serve as the basis for the expansion of the listing for revumenib in the…

Thank you, Neil. Earlier this morning, we reported fourth quarter and full year 2024 financial results in our press release. For today's call, I'll touch on a few highlights from our fourth quarter on Slide 11. We're pleased to report $7.7 million of Revuforj net revenue in the fourth quarter of 2024. Operating expenses in the fourth quarter were $104.0 million and included $65.5 million of research and development expenses and $37.7 million of selling, general and administrative expense. Turning to the balance sheet, we continue to maintain a strong financial position with $692.4 million of cash, equivalents and short and long term investments as of the end of the year. We continue to expect that our cash, together with our anticipated product revenue and interest income, will enable the company to reach profitability. For the first quarter of 2025, the company expects R&D expenses to be $65 million to $70 million and total R&D plus SG&A expenses to be $105 million to $110 million. For the full year of 2025, the company expects R&D expenses to be $260 million to $280 million, and total R&D plus SG&A expenses to be $415 million to $435 million, which includes an estimated $45 million in non-cash stock compensation expense. The company is not providing revenue guidance at this time. Ahead of reporting the first sales for Niktimvo with our first quarter 2025 results, I would like to take a moment to briefly review how we will recognize revenue for that partnered product. Slide 12 provides an illustrative example of accounting for sales of Niktimvo and is not intended to provide any margin or other guidance. We will record 50% of the commercial profit defined as net product revenue minus the cost of sales and commercial expenses. During a period where there is…

Yeah. Thank you, Keith. It's been a very successful start to the year for Syndax and we are poised for another exciting period as we advance the launches of Revuforj and Niktimvo and work towards achieving the multiple upcoming milestones that you can see on Slide 13. We are confident that Syndax is well positioned for long term growth. We are very excited about the derisks and very significant market opportunities we have in front of us with the first two differentiated medicines to emerge from our pipeline. We are laser focused on unlocking the full value of both products and are set up for success with a strong balance sheet and a highly experienced team that has done an exceptional job executing to plan throughout the development, approval and commercialization of our first two medicines. In closing, I want to thank everyone who has made it possible for Syndax to bring two novel medicines across the finish line in 2024. I especially want to thank the patients, investigators and study sites who participated in our clinical trials as well as our dedicated and talented Syndax team members. I'd also like to thank our committed long-term investors who continue to share in our vision and support our work in building Syndax into a leading oncology company, an objective that we are well on our way to achieving. And with that, I'd like to open the call for questions. Operator?

[Operator Instructions] The first question will come from Anupam Rama with JPMorgan. Please go ahead.

Hey, guys, thanks so much for taking my question and congrats on all the launch progress here in the early innings. Quick one for me. I know in the press release you talked about a third of the 4Q Revuforj sales were inventory. Just wondering how we should be thinking about inventory levels throughout 2025? And then I know also that you said you're about a-third penetrated into your Tier 1/2 accounts. How have you -- any trends on repeat prescribers from some of the docs, given the aggressive nature of KMT2A? Thanks so much.

Yeah, Anupam. Thanks for the question. So, two questions. So first question I'm going to direct to Keith, which is related to inventory levels. Keith?

Yeah. Morning, Anupam. Good question. Thank you. I think our inventory levels, as you think forward through the -- through 2025, probably be thinking about it similar to other specialty launches or rare disease launches. As a result of our limited distribution channel, which Steve talked about, we're not expecting to see more than two weeks to three weeks of inventory in the channel. We mentioned in our prepared remarks that we saw about approximately one-third stocking. And in five weeks, we're kind of right there in the sweet spot. So we wouldn't expect the inventory level to change in terms of weeks, but as revenue grows, obviously, that inventory level, on an absolute basis, could be expected to grow.

Great. And, Steve, do you want to take the penetration into accounts question?

Yeah. Thanks, Anupam, for the comment. We're pretty pleased with where we are. We've got 33%, as you mentioned, of Tier 1 and 2 accounts, our biggest accounts, that account for two-thirds of the opportunity that are getting on board. We're confident we'll go along the list and get others to write as well. In terms of repeat prescriber, something we're looking at carefully and we're not going to provide numbers yet or estimates on that. But I will say the majority of accounts have used more than once, and that's good, whether that's a patient getting a refill or finding new patients. I mean, this is all about building a habit. The better experience they have upfront, the more likely they are to use the product moving forward. And we feel really good about where we are.

Thanks so much, guys, and congrats.

Thanks, Anupam.

The next question will come from the line of Brad Canino with Stifel. Your line is now open.

Good morning, and nice first commercial quarter. Two-parter for me. For the 66% of Tier 1/2 accounts that have not yet ordered, what do you expect for the cadence and extent of activation over the next 10 months? And then second, now, with the few months of commercial experience under the belt, how do you see Revuforj tracking with some of the historic AML targeted therapy launches? Thank you.

Okay. Thanks, Brad. Appreciate the question. So first I'll direct to Steve.

Yeah. So thanks, Brad, for the question. And I like what you're thinking. I mean, I think for us it's a good start to have a little over a third of accounts activate really early. And it's a good mix of accounts. It's not just the biggest. It's not the smallest. It's a broad range. We think it represents a ton of opportunity moving forward. We're not going to comment on the cadence. I think what we are doing is activating across all 2,000 treatment centers. We're going to focus on the top 200. We think it's just a matter of time for those institutions to get experience. We've got a sales team that is perhaps the most experienced and talented in the industry. They've got great relationships. We still have a ton of momentum. So we expect over the course of the year, one by one, we'll pick each one off. As you can imagine, the 33% is a blend of Tier 1, Tier 2. There's far more Tier 1 accounts that have activated and fewer of the Tier 2 accounts. But over time, with the right type of effort, they will fall. There's unmet need, product is responding well. So we're pretty positive over the course of the coming months.

Great. Maybe the second question relative to analogous.

In terms of analogous, I think we've got a unique setup. I mean I think unlike other targeted therapies in the past, you've got testing for a product like Revuforj, identifying KMT2Ar patients which you may not have had as readily speaking to other targeted therapies. So urgent unmet need is high. Patient diagnostic testing is very high. As mentioned, the product is very well received by clinicians. And on a payer front, things are in a great place. Not all companies look to get paid claims early on in the launch. There's a sense of kind of giving drug away. That not what we're doing. We're developing a habit for physicians to understand the customer experience they can expect, which we believe is a good one. So, too early to say where we are relative to those analogous, but feel great about where we are. Just one partial quarter in and a couple of months in to the start of 2025.

Great. Thank you.

Thanks, Brad.

The next question will come from Peter Lawson with Barclays. Your line is now open.

Great. Thank you so much for taking the questions, and thanks for all the updates. I guess firstly around Revuforj, like how that's being used, if you're seeing off-label use, how much for NPM1 and if you're seeing it being used in combination? And then just regarding the Expanded Access Program, just maybe a clarification for me. You kind of talked about a rapid transition, but I think it mentioned less than 10 patients transitioned. Just kind of how many patients are left on that Extended Access Program? Thank you.

Yeah. Thanks, Peter. Maybe Steve again for you, off-label use, first question.

Yeah. Good question, Peter. Obviously, it's not something we promote against. We're only going to promote against the primary indication as you'd expect. In terms of off-label use, what we can say at this point, it's anecdotal, we know we're getting use -- some use in NPM1, some use in combination treatment, certainly earlier line types of treatment. And that's anecdotal. Over time, we'll be able to better qualify that. But at this early stage, it's a challenge to do that. And in terms of the EAP question, as pointed out, it's -- we're talking EAP transitions were in the single digits. All patients that were eligible to be transferred have been and the EAP remains lightly used for off-label indications and oral solution. It's all lightly used there, but no additional patients to transfer from EAP at this time.

Just maybe a final question. How's momentum going in the first couple of months of '25?

The momentum is good. I mean, I think if you remember we started this back in the fall initially with the NPM1 data release followed by approval, followed by ASH. Believe it or not, institutions are still doing their ASH reviews, which is physicians that didn't make it to the conference. They see the data, so they'll certainly see the data on Revuforj as well as in the menin space. So that momentum that we saw at ASH continues to this day. Very high excitement levels. Our field team, as mentioned, is closely connected to the customer community. So opened -- welcome arms. Physicians see unmet need. They like what they see in the drug. So, I think, we'll ride this wave really probably throughout the rest of the year.

Yeah. And maybe I'd add that the payer coverage seems to be building really very nicely and I think that's a complement to all the hard work that the team is doing to get it through the payer system.

Great. Thanks so much.

Thank you, Peter.

The next question will come from the line of Chris Shibutani with Goldman Sachs. Your line is now open.

Great. Thank you very much. Congratulations on great progress with the initial part of the commercial launch. Many questions have been asked there. Perhaps if I could ask a little bit more of an intermediate or longer term strategic question. Certainly, the company has gotten to this point finding assets, developing them successfully. Now commercializing. What are your thoughts on what's next? What does this company look like in 2030? Many arguments for saying that if you're making these investments in a fully integrated company that we be soon turning to what else is in the pipeline based upon your experience, capabilities and now commercial presence. Do you have a vision to that? Are you going to share that? If not, why not? When might you? And are you and the Board aligned? Thank you.

Well, Chris, what a big question here. So thank you for asking it. I think the vision for the company is ambitious. I think we have done wonderful things to get to this point in not only in-licensing and developing two novel medicines, but bringing them to patients. And I think we'll do quite well commercially. I think the broader vision is to extend these products into earlier line indications and really build on our first-mover advantage. So I think that's a longer term vision for these particular products and I think the extension to additional products, bringing in additional products targeted oncology has been our focus. I think we'll continue to build in oncology and build the pipeline ultimately to be able to leverage the organization that we've developed over time. So I think we have an ambitious vision to have a larger pipeline and to build the company over several years. By 2030, we expect to be an extremely advancing and rapidly advancing company with multiple commercial products in our bag, so to speak, and have the opportunity to continue to get drugs approved. That's the vision, long term vision. As a standalone company, we'll be focused in the US and focused in oncology and look to partner external and ex-US as we build business. But, let's say, I think we would hope to be a formidable specialty oncology company by 2030. And yes, the Board and management are quite aligned in this approach.

Perfect. Thank you for the insights.

Thank you, Chris.

The next question will come from the line of Kelly Shi with Jefferies. Your line is now open.

Congrats on a great quarter, and thank you for taking my questions. Although it's still early days, but curious for patients bearing co-mutations such as FLT3, how physicians sequence the therapies? And what would be the reason that physicians prioritize Revuforj? And also curious, on safety front, could you share about the physician feedback on their real-world experience? Thank you very much.

Sure. Kelly, thanks for the question. So first one related to the prioritization, why would someone -- why would a physician use a menin inhibitor versus some of the other targeted therapies? I'll direct that to Neil.

Yeah. Thanks for the question. So, the answer is in fact two parts, right. So it depends on whether or not the patient is considered to be eligible or ineligible for intensive chemotherapy. So in the Phase 3 trial that we're currently initiating in the unfit population, there is no selection for FLT3. We will include patients, as I mentioned in our -- in the prepared remarks, patients with both NPM1 and KMT2A. There's no approved therapy for patients with, like, three mutations who are unfit for intensive chemotherapy. In the fit setting, it's slightly different. There are approved therapies and therefore until there are approved -- other approved therapies, then physicians will reach for a FLT3 inhibitor for patients who have a FLT3 mutation before anything else. And of course, patients can have both FLT3 and NPM1 mutations at the same time, and this is an area of intense interest for us.

Great. Thank you. And then the second question I'll refer to Steve. I think the question, Kelly, was related to physician feedback on the safety profile so far in real world, so.

Yeah. I mean, I think feedback on the whole profile is great. From an efficacy standpoint, it's got data that's instructive to use in terms of safety and tolerability. As we know we have a black box for DS that's being managed QT. Other aspects of tolerability are understood by physicians. The label is clear. And I'd say the other thing that we do is have a pretty comprehensive customer facing footprint. We have oncology clinical nurse educators that are in accounts within 48 hours of the drug being prescribed. So it's a lot of hand holding and helping physicians and their associated staff through treatment and dosing is clear, white age population, AML, ALL. So I'd say things are very good. There's really nothing getting in the way of physicians putting patients on Revuforj.

Thank you.

Thank you, Kelly.

The next question comes from the line of Michael Schmidt with Guggenheim. Your line is now open.

Hey, guys. Good morning. Thanks for taking our questions. I had a couple more on the Revuforj launch. Keith, perhaps could you comment on early trends in gross to net adjustment as well as potential use of a free drug program, et cetera? And then in terms of early feedback from the market, what have you heard about or seen around transplant dynamics [Technical Difficulty]

Thanks, Michael. Sure. So first question related to gross to net. Maybe I'll direct to Keith.

Yeah. Good morning, Michael. While we're not providing specific numerical figures on gross to net, it's tight. I think if you go back to the comments I made earlier about our limited distribution channel, that allows us to really keep the gross to net very tight. Additionally, we've not seen nor do we foresee the need to rebate. So for those reasons and a few others, the gross to net on Revuforj has been and we expect it to continue to be very tight.

And maybe, Steve, do you want to talk about free -- Michael had asked about free drug program, so why don't you make a comment on that?

Yeah. So we do have a patient assistance program. It's used for basically uninsured or underinsured patients. I mean, our goal as an organization is to make sure every patient has drug. Our first priority is to get the claim paid. If the patient can't qualify for paid drug, there is that patient assistance opportunity. It's in the single digits. I mean you often -- you can't see some pressure at launch. You can see some pressure as deductibles reset for the beginning of the year. I think we've navigated through that incredibly well. It's going to be in the low single digits.

Right. And then maybe early feedback on the transplant dynamic. I think we've -- physicians are obviously very interested in getting patients to transplant, certainly for KMT2A. We've also seen it for NPM1 as well. But most of these patients are on the younger side for KMT2A. And so transplant is an objective and we know patients are going to transplant, so they're going to getting drug and then going to transplant. And then we expect the vast majority of those patients, especially as they're treated earlier in their treatment course, more like first relapse, have the opportunity to potentially go back on transplant -- go back on maintenance after receiving their transplant and the engraftment happens. So I think we're optimistic about how that's unfolding. I think it's early days yet to really say much more about it. But as of today, this is how we're feeling. Very good.

Thank you.

Thanks, Michael.

Our next question comes from Yigal Nochomovitz with Citi. Your line is now open.

Hi, Michael and team. Thank you, and congrats on the first quarter revenues. I have three quick ones, if I may. First, by my math, it seems like you have about 125 to 130 patients on drug net of the inventory, which is about 6% share. Could you just comment on that? Second, if you could be a little more specific regarding how you're defining Tier 1 versus Tier 2 centers? And then third, for Neil perhaps, you mentioned some of the FLT3 dynamics. I'm just curious if you could be a little bit more granular as far as how those Phase 3 trials could look? I could imagine four studies, a KMT2A study for those with a FLT3 and those without. Similarly, NPM1 for those with a FLT3 and those without. This would be in the fit population. So would you have a 7+3 plus FLT3 control arm in those studies, respectively? Thank you.

Great. Good questions, Yigal. Thank You. So let me turn the first to Steve talking about the math that you've done, 125 to 130 patients net of inventory, roughly 6% of the population. That's your math. So make some comments on that, Steve. Go ahead.

Yeah. Appreciate the math, Yigal. And we're just -- we're not going to provide specifics on patient counts just yet. There's really a couple of reasons for it. One is just we have visibility at the patient level in less than half of our limited distribution channel. It's really just to the specialty pharmacy channel. So we want to be accurate, and that'll take us some time to do that. And I think the second is, it's just early from a patient perspective. I think the second question was around Tier 1 and Tier 2 definition, and it's roughly combined about 200 accounts. Those accounts represent about two-thirds of the patient opportunity. So Tier 1, you can think we'll say biggest of the big MD Anderson, Dana-Farber, those are typical Tier 1 accounts. Tier 2 just tend to be a little smaller. It's really just defined by patient opportunity. So these are influential accounts, but may not have the patient volume that the Tier 1s have. So examples, there could be like a St. Jude's or a Tampa General, just to give you some examples to put it in perspective.

Great. And then, I guess, the third question goes to Neil, which is related to the trials in the fit population, specifically around FLT3.

Yeah. So thanks, Yigal. As we referred to in the prepared remarks, our intention is to initiate multiple trials in the fit setting. We also alluded to the fact that speed to date is important. There are, of course, multiple populations within the fit. It's not a homogenous population, including patients with FLT3 and NPM1 commutations. We're not really talking in detail about our strategy. It's a competitive space. But we are working aggressively to start multiple trials starting in the second half of this year.

Okay. Thank you so much.

Thanks, Yigal.

Our next question comes from the line of David Dai with UBS. Your line is now open.

Great. Thanks for taking my questions, and also want to congrats on the great quarter. So two from me as well. So the first one just around the relapsed/refractory NPM1data, you're planning to submit for NCCN guidelines and kudos here. Could you maybe talk about the timing of the inclusion of Revuforj for NPM1 in the NCCN guideline? Do we think about the inclusion of the NCCN before the approval in second half this year? And then the second question just around the [formalization] (ph) of trial in unfit AML, where you said that you're planning to meet with regulators to use MRD negativity as a set of endpoint. Can you just talk a little more about the timing around that and how should we think about your engagement with the FDA or with the regulators on the timing for MRD negative CR? Thank you.

Great, David. Thanks for the question. So the first question is related to relapsed/refractory NPM1 and our timing relative to submission for guidelines and does that -- will that potentially happen before approval? So a couple of steps here. First, we plan to publish the data, I think, we announced in our preparing remarks -- announced -- sorry, submit the data for publication in the second quarter and we hope to get approval on the guidelines that is included in the guidelines sometime in the second quarter as well. So that's certainly in advance of when the drug would be approved towards the end of this year, which would, of course, provide us a very nice advantage for being the first to have guideline coverage for NPM1 and we believe to get the drug approved as well. So I think that's the timing for NPM1 and the strategy there. The second question, I think maybe Neil's going to clarify a little bit related to the MRD and meeting with regulators. Go ahead.

Yeah. Well, so thanks for the question. Typically, we don't discuss the details of our interactions with health authorities. I would just point out that our interest in MRD negativity as a biomarker is long-standing. And as I mentioned in the prepared remarks, we have been part of the consortium led by NIH, which also includes other industry partners as well as the FDA. But as to specifics, we won't get into specifics of discussions with health authorities.

Excellent. Our next question will come from Justin Zelin with BTIG. Your line is now open.

Thanks for taking our question, and congrats on the strong commercial start here. Michael, maybe just to follow up on the prior question, can you speak to your confidence of a broad recommendation by NCCN in the second quarter? And any color on payer discussions regarding reimbursement of patients with NPM mutations with support of a broad NCCN guideline recommendation ahead of the formal potential FDA label expansion later this year?

Yeah. Thanks, Justin. Appreciate it. I think there are couple of questions. So the first around the confidence of broad coverage in NCCN. I think, our -- we'll see -- I mean I think we feel very confident the data is supportive of approval, we think it's practice changing and informative and important. And I think from that perspective we expect that we'll be included in the guidelines and we'll have very good access as a result of that. Second one is related to payer coverage, how I guess that follows on from there and whether we expect that to impact our ability to get the drug covered. And maybe Steve, if you want to make a comment about it.

Yeah. Maybe even take it a step back. We've had a good start. I think in my prepared comments and Michael's comments on market access, we're off to a good start. Payer coverage is growing. It's at 53%. Importantly, claims are being paid really across the continuum. I think because we had such a early start with the payer team calling in probably a year and a half advance of approval calling on payers, the activity on NPM1 and the payer space will proceed that of the customer facing sales team. And what do I mean by that? Once we file, we'll begin talking about NPM1 with payers, making sure they're prepared just like they were for the KMT2Ar launch. I think in the interim, Justin, claims are being paid regardless of indication. From what we can tell, some of this is anecdotal, but payers are not standing in the way of physicians who need a treatment where they otherwise don't have one. And they don't have one whether it's KMT2Ar or NPM1 relapsed/refractory. These are patients in need and they see the need to get patients on drug and are paying the claims. So we feel pretty good about where we are and getting to a better place as we near the launch of that indication.

That makes sense to me. And Steve, if I could just ask a quick follow up. Could you just talk to, in your opinion, the importance of being first in a competitive marketplace like this, the importance of having first to market?

Yeah. I appreciate the question, Justin. I think being first to market and first mover advantage isn't something that Syndax made up. This is just a function of the market and what we expect. The kind of competitive immunity that we're building now, it's about getting drug out. It's having the right customer facing field team, the right trade support, the right medical affairs alignment, doing things right, right out of the gates, which we are doing. Something we didn't -- I mentioned in my prepared comments, but I'd amplify, it's time to first fill the ability to -- from prescription to getting patients on. We're seeing patients get on in a couple of days and anybody who takes longer, it's just because a payer may be giving us some challenges up front which you ultimately get through. So it's that type of great experience, white glove experience that we're trying to provide for physicians and patients, that'll be very challenging for any follow on product if they make it to market to match what we're doing. The kind of experience that physicians will get in a year and possibly more of us being alone on market might as well be 10 years. That's the kind of muscle memory that accounts gain and that's what our goal is.

Thanks for taking my questions, and congrats again.

Thank you, Justin.

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

Hi. Good morning. Thanks for taking my questions. A couple from me. Regarding the strategy for attaining compendia listing in the NPM1 population, can you point to other AML drugs in the space that have secured compendia listing based on a similar dataset than what you have -- with what you have today? And then as a follow-up regarding your strategy in the intensive chemo fit patient population, this data that could come in the second half in combination, can you talk about what do you think the optimal dose is in combination with IC? Thanks.

Great. Thanks, George. So in terms of your question, your first question was strategy for listing for NPM1 and have -- can we point to some other products that were listed in potentially in a similar capacity? I think that was the question. Anjali, maybe you want to take that?

Yeah. Thanks, George. I think a couple examples in the space. So I think the first example is Sorafenib on a Phase 2 dataset. They were granted NCCN guideline listing for FLT3 treatment in frontline. And then I think more recently Gilteritinib in combination with VEN+AZA off a Phase 2 dataset single arm trial was granted compendia listing as well. So I think there is plenty of examples. I mean even our therapy for KMT2A has gotten compendia listening as well. So I think it highlights our confidence for being able to get there.

Right. And maybe this -- thank you. And then the second question.

That's helpful.

Sorry, George. I think the second question relates to the combo for -- with chemotherapy and the dose and how this lecture is going to work. Maybe I'll turn it over to Neil.

Yeah. Look, thanks for the question. As mentioned, we'll present data later in the year. We are -- just to sort of summarize where we are at this point in terms of all of the combinations that we've been testing revumenib in, the drug has been actually well tolerated at both doses tested, both 110 and 160. So we have choices, right, it could be either dose and the data will indicate to us which dose it could be. Currently, we're combining a full dose. That's what we're doing currently and, as I said, we'll report more later in the year.

All right. Excellent. Thanks very much.

Thank you, George.

Our next question will come from Salim Syed with Mizuho. Your line is now open.

Hi. This is Eric on for Salim. Thanks for taking our question, and congrats on the nice ramp for Revuforj. So I wanted to try to get some color on what you think of the timing and the total addressable size of ex-US for Revuforj. What your thoughts there on what the gating factors are that we would need to see for you to go for ex-US regulatory submissions and what that might look like if it's a collaboration, outlicense something like that? Thank you.

Great. Thanks, Eric, for the question. So first I think you had asked about timing for ex-US. And I think the -- we haven't announced all of our plans regulatory and development wise for ex-US. I think they do come together rather nicely around our frontline strategy and getting the draw approved. Ex-US will be tied to not only the frontline trials but there may be other opportunities as well. So we have -- we haven't been specific about the timing. I think the addressable market is probably about half of the US. Ex-US, it's a very appreciable market opportunity for us. So we'll look to address it as soon as possible. And as I mentioned in my earlier remarks, looking for a partner to help us certainly with Revuforj outside the US, that'll come in time as well as we look to commercialize and develop more extensively as outlined. So I think that's a -- that's an ongoing development with our store. As you know, for Niktimvo, we do have a partner in Incyte and they'll commercialize and develop the Niktimvo outside the United States. So over the next couple of years, I think you'll see a lot more development and plans to move globally.

All right. Helpful. Thank you.

Thanks.

Our final question will come from the line of Jason Zemansky with Bank of America. Your line is now open.

Good morning. Congratulations on the launch progress, and thanks for taking our questions. Two, if I may. Somewhat of a follow-up, but regarding the HOVON led trial in the unfit population, is there something in the protocol that could support a potential path to accelerated approval? And what would the timelines look like for that? And then maybe from a broader strategic perspective, how are you prioritizing first line fit versus unfit? What's the more important opportunity for Revu, especially considering the evolving competitive landscape?

Great. Jason, thank you so much for the questions. First one relates to the HOVON trial and accelerated approval and timeline. I'm going to hand that over to Neil.

Yeah. So thanks for the question. As I mentioned in the prepared remarks, we are positioned and will continue to position ourselves to be able to avail of any opportunity for accelerated approval based on intermediate endpoints. However, we're -- it is not our practice to discuss the details of our discussions with health authorities.

Right. And maybe first line fit versus unfit prioritization was the second question. I could take that one. Look, I think we're -- the unfit population, VEN+AZA combination trial with HOVON, I think that addresses the highest unmet need in the frontline population and we will be first to initiate a trial there. We also have the only dataset in that population to distinguish ourselves. So I think that is a very important first trial to initiate. I think we'll have other trials, as Neil pointed out, in the fit population initiated before the end of this year. That will help to kind of drive our strategy in fit. So, I think, in 2025, we'll take a quantum leap forward in initiating trials that will address all the important populations, both fit and unfit. But the first trial to initiate will be the HOVON trial, which again is a global registration trial in that population. So it's again -- it's around unmet need and it's around the opportunities in front of us. And we plan to be first to capitalize on all of these market opportunities.

Great. Thanks, Mike. Appreciate the color.

Thank you.

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

Great. Thank you, operator, and thank you all. We really appreciate you all tuning in today to discuss our recent progress and the exciting milestones ahead. We look forward to seeing many of you at the Cowen, Jefferies and Barclays conferences this month. And with that, have a fantastic day.