Hello everyone, and thank you for joining the HC Wainwright 27th Annual Global Investment Conference. My name is Arabella, and I'm an Associate on the Equity Research Team at HC Wainwright. HC Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions. We're proud to say that more than 600 companies are scheduled to present at our conference today. With that said, I'd like to welcome Syndax Pharmaceuticals, a commercial-stage biopharmaceutical company advancing innovative cancer therapies. From the company, we have Michael Metzger, the CEO. Michael, the floor is yours.
Thank you, Maribel. Morning, everyone. Great to be with you. Thank you, HC Wainwright, for bringing us today, inviting us to the conference. Pleasure to be with you and tell you more about Syndax and give you an update today. These are our forward-looking statements. I direct you to our website where you could read more about it, but I will be making forward-looking statements today and just caution you about that. All right. Syndax is a commercial-stage organization, as we were introduced. We are positioned to really build this company over many years. A very exciting time for the business as we have turned commercial over the last year. We have two first-in-class medicines addressing major needs in hematology. Two products, Revuforj and Nivtemo, together address $5 to $10 billion in market opportunity between the two. Exceptionally large and important markets to address with new medicines.
We have had two very successful early launches with these products. Combined, $100 million in net sales in the first six months of the year, which is significantly exceeding expectations. Importantly, we're on the road to profitability. We have two products contributing significantly to the cash flow of the business. We have $500 million plus in cash, as well as an expense base that is stabilizing over the next few years, which allows us to really drive and build on these multi-billion dollar franchises and get to profitability. We are in a terrific position as a company to go forward to build up the momentum into the second half of 2025 and beyond as we move forward here. Let's get a little bit into our first and only FDA-approved menin inhibitor known as Revuforj. Revuforj was approved as the first to be approved in this class.
It was approved by the FDA in 2024, late 2024, for the treatment of relapsed or refractory acute leukemia with a KMT2A translocation in adult and pediatric patients one year or older. This is an area of high unmet need. Patients with a KMT2A translocation have a very poor prognosis, perhaps the worst prognosis in AML and ALL. This is an area of, again, high unmet need. About 2,000 patients in the U.S. on an incidence basis. That brings us to a $750 million market opportunity in the U.S. Very significant. We are set up for success. Very importantly, the product has first mover advantage. What I mean by that is we, again, are the first to be approved in this class. We'll be on the market ahead of any competition for at least a year, perhaps more. We have a very compelling safety and efficacy profile.
We like to refer to it as best in class. We believe that the efficacy and safety proves that. This is an efficacy-driven market, and everything to date has shown that our efficacy profile is the strongest of all the menin inhibitors. It's the first and only menin inhibitor to have relapsed/refractory KMT2A data, positive data, relapsed/refractory NPM1-positive data in AML. We're also, with our label, with Revuforj and KMT2A, indicated for adults and pediatric patients. Very broad label, which is absolutely essential for this population. We've been included in the NCCN guidelines for AML and ALL, and we have a robust development strategy, which really is designed to unlock the $5 billion total addressable market in not only relapsed/refractory, but also frontline disease. A little bit more about Revuforj. We started strong and the second quarter is no exception.
We've grown from the prior quarter of $20.1 million to $28.6 million in 2Q. 43% growth, which is outstanding. We're off to a fantastic start, something we haven't seen to this extent with other AML targeted therapies. This was all in the phase of having about a third of our patients proceed to stem cell transplant. They took a hiatus from treatment to get their stem cell transplant. The dynamic is many of these patients come back post-transplant and continue on with Revuforj. It's a very important piece of this paradigm and how they treat patients. The drivers of the continued momentum, we're very encouraged by what we're seeing. It's based on a few things here, four things in particular. First, we are able to identify patients. KMT2A patients are tested. The cytogenetics are known when these patients are diagnosed. We're identifying patients, and the uptake has been very strong.
Physicians are very excited about this profile, and they're using the drug. Patients are getting treated earlier in their treatment paradigm. What we saw in our clinical trial is we saw patients that were getting treated in the third and fourth line. Now they're getting treated in the second line and the third line in a lot higher numbers. Third, building transplant rates. We're having success getting patients to transplant. It's part and parcel to the fact that they're getting treated earlier. Patients tend to do better when they're treated earlier. We're seeing more transplants as a result. Of course, now we're starting to see patients come back from transplant and continue on with Revuforj. Fourth, I would say this next term opportunity around AML, which is the extension into NPM1. We have a PDUFA date in October.
At the end of October, we expect to be the first menin inhibitor approved in relapsed/refractory NPM1. This will be the next leg of our growth. We see this momentum continuing for these reasons, not only in the second half of this year, but certainly into 2026 and beyond. Some of the metrics that we've talked about, key metrics that we presented in our quarter, really illustrating why this launch is going so well. I mentioned, of course, the sales growth, 43% from $20 million to $28 million. Impressive, $56 million in net revenue since launch. Beyond that, total prescriptions, over 1,300 prescriptions since launch. More than 500 patients treated. Putting that in perspective, that's about 25% of the incidence population, 2,000 patients. We expect to get to 50% penetrated by the end of this year, which would be a fantastic result for any new therapy that's launched.
The third thing is the 70% use in second and third line. We talked about patients getting treated earlier in their treatment journey. This is very, very important. They have a poor prognosis. If you can get them to a complete response, get them to transplant earlier, get them back on drug, you'll have more success as you move earlier in treatment. About a third of our patients are proceeding to stem cell transplant. Keep in mind that in our clinical trial, we talked about 25% in our pivotal trial getting to transplant, which was more than five times more than you see typically in a third or fourth line population. We're now advancing to second and third line.
Not a big surprise, but an important one that we're seeing the momentum, about a third of the patients going to transplant versus the 25% that we saw in the later lines when we did our clinical trial. Very important metrics really tell you the story of how this is building what we expect to see in the future as this grows. Let's touch on the market for a minute. Large market opportunity, $5 billion plus when you consider all the segments. We're starting on the lower left here with relapsed/refractory acute leukemia, KMT2A, 2,000 patients. Again, incidence population every year, you're going to see roughly 2,000 patients show up again. We expect to own this market. As we discussed, we'll be adding a second indication, about another 4,500 patients. Together, total addressable market between KMT2A and NPM1, about 6,500 patients.
$2 billion really accounts for the segment of patients, the number of patients, high penetration, of course, as well as the fact that you have a drug that patients can stay on for a reasonably long period of time, aided by the use of transplant when they come back for maintenance. You move on to the front line. We are really poised to penetrate the front line. We've started trials. As you see, it really breaks down into the unfit patient population and the fit population. Fit being the younger patients primarily who can sustain chemotherapy treatment, and the unfit population, generally older population that takes standard of care of venetoclax, as they're treated. That is the highest area of unmet need, the unfit patient population. We've already started our trial. Our pivotal trial has kicked off. We're enrolling patients. It's a global registration trial.
Very excited to announce that we are the first there, and we will be, we expect with accelerated approval endpoints for that trial, we'll be able to meet the market need as soon as possible and be there first. Of course, we'll have more data later this year in the fit population as we launch trials for NPM1 and KMT2A into that population. This, as we talk about, $5 billion in total TAM, so there's a very large opportunity, and it's important that we continue our leadership position here as we build not only relapsed/refractory, but into the front line. Okay, let's talk about Nivtemo. Nivtemo is our second product. It's the first and only FDA-approved treatment for chronic graft-versus-host disease targeting the CSF1R receptor. Product was approved, as you know, last year, in 2023, launched early this year in February.
It's approved for chronic graft-versus-host disease after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms. Initial population here, third line plus, about 6,500 patients treated in the U.S. It's a very difficult disease to treat. The hallmarks of the disease are fibrosis and inflammation, and this is a new mechanism that we'll touch on in a moment that really addresses both. The initial indication represents roughly a $2 billion opportunity. As I mentioned, this is a first and best-in-class CSF1R antibody. It's, again, well positioned for success. A novel mechanism in chronic graft-versus-host disease. Other standard of care agents deal mostly with the inflammatory component of this disease. Fibrosis is more of the unmet need. Together with this drug, we address both, which is quite remarkable.
The responses that we've seen in practice, as well as in our clinical experience, have been rapid, durable, really well-observed responses across all organ types, which, again, I'd say best in category results for these patients. We were quickly included into the NCCN guidelines. We're co-commercializing with Incyte. We have a partner in Incyte where we've been partnering for the last couple of years for development and also for commercialization. They built this market. They have Jakafi approved in second line, and it's really been a fantastic partnership to launch our drug with them. Commercial synergies with Revuforj are somewhat unusual for a small company. We find ourselves promoting to the same audience, not just for this product, but also for Revuforj. The commercial synergy is quite important. Have two products in your bag.
Trials, as I mentioned, are underway for chronic graft-versus-host disease and importantly for idiopathic pulmonary fibrosis, another indication outside of chronic graft-versus-host disease to further unlock multi-billion dollar potential around this franchise. Nivtemo's performance, I would say, is quite remarkable. In the first full quarter, the product is profitable. We went the first few months, we went from $13.6 million in the first full quarter, $36.2 million in net sales. This was reported by Incyte. It was profitable to Syndax. We have a 50-50 co-commercialization deal with them. We've split the profit 50-50, $9.4 million in collaboration revenue after expenses to Syndax. That, again, was profitable to us. Very unusual that you see that this early in launch. $50 million in net revenue since that period of time.
When you look at the estimates through the second quarter, some of the key metrics that we've talked about, more than 4,000 administered infusions, more than 700 patients treated. Importantly, 80 to 90% of patients are staying on drug. Persistence is important. You want to get patients to not only feel better, their disease to get better, but also that they are able to stay on drugs, their tolerability and efficacy. This is an important measure. We think that these patients will not be only on drug for a few months, but perhaps several years. This is really turning a chronic disease into something that you can treat over a very long period of time, which is important. Of course, we've had great pull-through at the center level. We've been calling on major centers. More than 80% have ordered already. Very early in launch, we've seen excellent, excellent progress.
Let's talk about the market a little bit. Market for chronic graft-versus-host disease, as I mentioned, is about a $2 billion total addressable market, 6,500 patients treated, third line plus. We're looking to move the molecule into earlier line settings through combinations with standard of care agents. That would unlock a 17,000 U.S. patient population and really get you to a $5 billion market. We talk about not only the number of patients, but also the persistency, the time on therapy. Like Revuforj, we're extending the time on therapy for these patients. We estimate from our trial, it was about 12 months. We think that this could be potentially even several years where patients are on therapy, which would be a fantastic thing to control their disease after such a difficult ordeal in getting to the third line.
Beyond graft-versus-host disease, which we think has a very bright future, we move on to idiopathic pulmonary fibrosis, very large indication, 150,000 patients in the U.S., even more worldwide. This is an area of high unmet need. This would be a new mechanism of action for these patients who definitely need new medicines. We're excited about this. We're currently running a trial, a phase two trial, which will be completed by the end of this year in terms of enrollment, and then we'll have data next year. Let's talk a little bit about this robust pipeline of ours that we are really pushing forward. We're laser-focused on Revuforj and Nivtemo and building these into industry-leading franchises. We feel great about our pipeline and how it's materialized here. I'll touch on a few things that I think are particularly important.
In the relapsed/refractory side of the equation, the SNDA, which is going through priority review now under our tour, our PDUFA target action date of October 25, 2025. That'll be our second approval for Revuforj. We have a couple of very important trials that are kicking off, one that's already started. These are in combination with standard of care moving into the front line. I'd say we're aggressively moving there to be first and not only best in class, but first in the fit and unfit setting. In the unfit combination setting where we have Revuforj plus venetoclax, this is building off of work that we did and you've seen published from the BDA-ML trial. Very strong results there. Enrollment's underway in what we call EVOLVE-2, which is that trial. Dual primary endpoints, CR and OS in the NPM1-mutant patients to support potential accelerated approval and full approval, respectively.
That's an important trial which we'll be following and enrolling aggressively over the next few years. We're working with the Premier Group and HOVON to make sure that that trial comes in on time or hopefully even before. We have another set of trials that'll be starting at the end of the year. These are combinations with chemotherapy. We'll have some supportive data at the medical meetings at the end of the year talking about efficacy, safety, and dose, which will feed into the startup of these trials where we'll be looking at MRD negativities relative to CR and EFS to support accelerated approval and full approval, respectively. These are important trials. We think we're on the forefront of moving there first and building on our leadership position. In terms of axatilimab, we are running combination trials with steroids as well as with Jakafi. Those are phase 3 trials.
We're excited about those results. We're also excited about the MAXIMIZE trial, which is the idiopathic pulmonary fibrosis (IPF) trial, enrolling it this year. Again, phase 2 trial, signal-seeking, robust trial, randomized trial. We should have very important results in the second half of 2026 on that as well. Before I get into Q&A, I'll just mention a couple of things about overall how I see Syndax Pharmaceuticals' position. I think we are probably best positioned, as well positioned as we've been as a company to date. I think this is really a setup where we have not only two products that are contributing significantly, but we also have the cash and the stable expense base to really drive ourselves to a position of controlling our destiny and building a formidable business over many, many years.
Revuforj and Nivtemo both have built themselves on patient demand and physicians really appreciating the opportunity, appreciating the profile of both drugs. A few points on Revuforj in particular. We've spent the first six months of this year really securing our first mover advantage in KMT2A. We've built this market. We will own this market. It's a very important market for Revuforj. Patients have high unmet need. Prognosis is poor for patients who have KMT2A. We can identify these patients through their standard of care tests, and we can bring them the Revuforj medicine quickly. We can get them on drug quickly, and we can bring them to transplant in a higher percentage. They're doing well, and we can bring them back after transplant. That paradigm is what physicians want to do with a medicine like this, and we've been able to fulfill on that.
We feel we've secured our first mover advantage in KMT2A, but we're not done. Of course, we want to build on that. Our second indication really expands with NPM1 in the back half of this year and into next year as we have the first data set and we'll be the first one approved for a larger population in NPM1. Then, of course, building our leadership position to front line. We talked about the trials both in the fit and unfit setting. We really believe that we'll be first, not only first there, but both best profile. The data that we've generated to date with trials like BDA-ML really underpin the opportunity and really show our profile to be really as strong as could be. This is a large market, $5 billion total addressable market.
We do have worldwide rights, I'll remind you, to our product, and we also have long IP. The IP is composition of matter, covers the product until late 2030. We're very well positioned with Revuforj. With Nivtemo, similar story. We wanted to establish ourselves in the third line plus GVHD market. We're making very good headway there. As I said, the product's already profitable and growing significantly. It compares nicely to what we've seen with one of the analogs, Rezurock, which is Sanofi's product, which got off to a good start. This is tracking to be as good or better from a sales perspective than that product, and that product's doing $500 million in its third year of sales. We are in a very good position with establishing this drug as a third line agent, and we hope to move it into earlier lines.
We have trials ongoing with our partner, Incyte. We're well positioned commercially with them, as well as from a development standpoint. Of course, we're going to expand beyond just GVHD and into IPF, and there may be other indications as well where this mechanism, which is very profound and sensitive, we think that we could get really into other diseases to build the franchise. In GVHD alone, $5 billion opportunity. Between the two and with our setup from a corporate perspective, we feel like we have what it takes to really break out and have a strong, not only 2025, but 2026 and beyond. Before we move to Q&A, I just wanted to take a minute to thank not only the patients and their caregivers who have really trusted us to bring these medicines to them. We are connected to them, and we care about them.
It's really just without them, we wouldn't be able to advance our mission. I would like to also thank the Syndax employees and the people who work diligently every day to bring these medicines to patients as well. They've done a remarkable job, and we expect we'll continue on our journey from here. With that, thank you very much, and I'll turn it back for Q&A.
Thank you so much, Michael. We really appreciate the time.