Third Quarter 2026 Earnings Call - SYNDAX PHARMACEUTICALS INC

Good day, everyone, and welcome to the Syndex 3rd Quarter 2026 Earnings Conference Call. Today's call is being recorded. If you'd like to ask a question following the company's prepared remarks, please press star 5 during the call. At this time, I would like to turn the call over to Sharon Clary, Head of Investor Relations at Syndex Pharmaceuticals. Thank you, Operator. Welcome, and thank you all for joining us today for a review of Syndex's 3rd quarter 2026 Financial and Operating Results. I'm Sharon Clary, and with me this afternoon to provide an update on the company's progress and discuss financial results are Michael Metzger, Chief Executive Officer, Steve Kloster, Chief Commercial Officer, Dr. Nick Botwood, Head of R&D and Chief Medical Officer, and Keith Goldan, Chief Financial Officer. These calls 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 two. Before we begin, I'd like to remind you that any statements made during this 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 quarterly report on Form 10Q, as well as other reports filed with the SEC. Any forward-looking statements made represent our views as of today, November 2, 2026 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, and good afternoon, everyone. Let's start on slide three. Syndex delivered another strong quarter of commercial growth and pipeline momentum. Total revenue reached $83 million this quarter, up 82% year-over-year. Demand for both medicines is robust, and we are moving decisively towards profitability. Revuforge net revenue grew to $61 million in the third quarter, underscoring our market leadership in both relapse refractory NPM1 and KMT2A acute leukemia. Similar to prior quarters, we expect Revuforage to account for the vast majority, more than 80% of the revenue for the class this quarter, a leading position we intend to carry forward. We achieved our seventh consecutive quarter of double-digit, quarter-over-quarter Revuforge net revenue growth, driven by a 20% increase in new patients and an increasing number of patients resuming Revuforage after stem cell transplant. Notably, a growing number of both KMT2A and NPM1 patients are proceeding to transplant after receiving Revufourage. As patients pause treatment to receive a transplant, this creates a short-term headwind that will become a long-term tailwind as more patients resume therapy post-transplant, extending the average duration of therapy and driving durable growth for the franchise. Every indicator of Revuforge demand is positive. The latest data are clear. We continue to lead new men and inhibitor starts across every age group, including age groups where NPM1 is predominant. With an unmatched body of clinical trial and real-world evidence and two years of deep clinician experience in the commercial setting, we are confident Reviforge will remain the Menden inhibitor of choice for all Menden-dependent acute leukemias. The clinical impact of our medicine was showcased last week when Reviforge received the prestigious Best Product for Rare Orphan Diseases Award from the Galen Foundation on the heels of being recognized by Time as one of the best innovations of 2026. These awards are a testament to our leadership in Menden Inhibition and the profound difference we've made for patients with some of the most aggressive forms of acute leukemia. Looking ahead, multiple value-driving Revuforge milestones are on deck. As in prior years, Revuforage will have a leading presence at the American Society of Hematology, or ASH, annual meeting in December. New data will be presented from multiple clinical trials and real-world studies spanning the entire acute leukecia treatment continuum, including new frontline combination data that highlight the potential for our ongoing pivotal frontline trials to deliver transformative results. We remain well positioned to be the first to frontline with a Mennon inhibitor, an area of high unmet need, and substantial commercial opportunity. With anticipated frontline indications, we expect Reviforge could exceed $2 billion in peak annual net revenue in the U.S. alone. Nearer term, we except to publish Reviforge data in relapse refractory, NUP98 rearranged acute leukemia in the fourth quarter. This landmark publication will inform clinical practice and could support guideline inclusion in a patient population with high unmet need. NUP 98 rearrangements estimated to be found in approximately 2% to 5% of AML cases are associated with a poor prognosis and resistance to conventional therapies. No targeted treatments have been approved for these patients. As the first and only company to report clinical activity with a Menden inhibitor in this subtype, we have a unique opportunity to pursue a guideline listing that could meaningfully expand the patient population treated with Reviforge. Turning to Nictinvo in chronic graft-versus-host disease, or GVHD, Nictimbo net revenue grew to $67 million in the third quarter, up 47% year-over-year and 12% quarter-over quarter. Our 50% share of Nictinbo net profit delivered $23 million in collaboration revenue, a meaningful contribution to our bottom line. Collaboration revenue to Syndex is now annualizing at over $90 million, and we expect it to keep growing as we further penetrate fourth and third line chronic GVHD. Positive results from the ongoing combination trials of Nictimbo and frontline chronic GVHD could set a new treatment paradigm and unlock another multi-billion dollar opportunity in the near term. Beyond moving Reviforge and Nictinbo into earlier lines of treatment, we are advancing our mutant-selective allosteric EGFR inhibitor for non-small cell-length lung cancer and our next-generation inhibitor for menin from myelofibrosis. Backed by compelling preclinical data and mechanistic insights, both molecules are on track to enter the clinic next year. Each brings a novel mechanism of action to diseases with high unmet need, where we can efficiently generate clinical data that inform and de-risk further development. We took our first two medicines from IND to FDA approval in about five years, and we will leverage that experience to bring innovation to new areas. With a pipeline of promising programs, world-class R&D capabilities, and a solid financial position, Syndex is poised to deliver breakthroughs that improve outcomes for patients and build long-term value. Before I turn the call over to Steve, I want to sincerely thank Keith Goldan for his many contributions, including leading Syndex's financial and capital strategy during an important time in the company's history and spearheading numerous long-term growth initiatives. After more than four years of the company and over 30 years in the industry, Keith Goldan has decided to retire as Chief Financial Officer. I'm pleased to welcome Aaron Andre as our new CFO effective Monday, November 9th. Aaron brings extensive financial and operational leadership experience in biopharmaceutical companies, expanding financial management, corporate strategy, and commercialization. I will now turn the call over to Steve to discuss our commercial results in more detail. Well, thank you, Michael. And starting with RevuForge on slide four, we delivered strong third quarter RevuForge results with double digit quarter over quarter growth across all key demand metrics and growing commercial momentum. Net revenue totaled $61 million up 90% year over year and 11% quarter over quarter. We expect Revuforge to account for the vast majority of all men and inhibitor sales this quarter, highlighting our position as the clear market leader in Menin now and well into the future. Total prescriptions were approximately 1,700, up 13 percent quarter over quarter, primarily driven by growth in new patients and an expanding number of patients on therapy in the post-transplant setting. Compared to Q3 of last year, prescription volume has doubled, highlighting the robust business we are building with multiple drivers. As we expected, new starts returned to growth with about 300 new patients this quarter, up approximately 20% quarter over quarter. This increase reflects growth in both new NPM1 and KMT2A patients and creates strong momentum heading into the end of this year. As highlighted on slide five, we estimate that about 50% of new Rebiforge patients this corner were NPM2 patients. Between the new patients and those who started in prior quarters, we estimate our MPM-1 business accounted for more than 35 percent of the $61 million in net revenue this quarter. That's up more than 30 percent of our net revenue last quarter. Importantly, claims and prescription data indicate we continue to have dominant share of all patients starting a Mennon inhibitor. Notably, Medicare data show revenue forage accounted for the majority of new patients in the third quarter, as well as all prior quarters. This data set provides a view of the split of new patients in an age group that is predominantly MPM1. Claims data also show we continue to have the dominant share of new patience in all age groups, not just the 65 and older group. Turning to the right side of the slide in the latest treatment patterns, as we add more MPM2 patients to our mix, we continue the same pattern. We continue to see Reviforge used early in the relapse refractory treatment paradigm and often in combination with other therapies. Claims data show 75% of use in the second and third line and approximately 40% of abuse is in combination. Notably, we're observing robust transplant rates amongst both relapsed refractory MPM-1 and KMT-2A patients treated with Revuforge. While 11% of MPM1 patients in our pivotal trial underwent a transplant following treatment with Reviforge, recent claims data indicate that about 40% of our MPM1 patients are proceeding to transplant, of which about 50% have resumed therapy afterward. The transplant rate observed with Reviforge is very encouraging and highlights the clinical value of having a medicine with a high overall response rate or ORR. A high ORR is meaningful because it provides increased chance of being able to proceed to a stem cell transplant, the only potentially curative treatment for relapsed refractory MPM-1 and KMT2A patients. Notably, approximately one out of two MPM1 patients achieved an overall response in the pivotal trial of Reviforge, a result others have not matched. Importantly, the ORR observed with Reviforage was also clinically meaningful for patients who are not candidates to receive a transplant. Turning to KMT2A. Claims data indicate that approximately 50% of KMTT2A patients are proceeding to transplant, of which about 60% have resumed therapy afterward, up from about 50% last quarter. We expect the percentage resuming therapy will continue to increase as our colleagues in medical report additional evidence from the post-transplant setting in collaboration with leading treatment centers, building on the encouraging data presented at ASCO and EHA earlier this year. Over time, we expect that up to 70% to 80% of KMT2A patients will ultimately return to therapy for one to two years based on feedback from thought leaders and our clinical trial and real-world experience. We expect the treatment patterns and relapse refractory MPM1 will be relatively similar to the patterns that we see in KMT2A. As the number of KMt2A and MPM1 patients in Revuforge in the post-transplant setting continues to stack, this will have a meaningful impact on the average duration of therapy and drive durable growth. The group of patients in Levuforge and the post transplant setting is already averaging at least nine months of therapy, with this duration expected to increase as we continue to follow patients for time. Importantly, we're also seeing encouraging trends among patients who do not receive a transplant after starting Reviforge. Over half of those patients stay on therapy for a significant period with an average treatment duration of more than seven months. Moving to slide six. We have an excellent commercial foundation to support continued growth in both our indications. Nearly two years after launch, our broad prescriber base continues to expand, including our activation of Tier 1 and Tier 2 accounts. More than 90% of these accounts have now ordered, up from 70% prior to the approval of ReviForge and MPM1. Overall, more than 620 accounts have ordered. That's up about 8% from the prior quarter, reflecting growing adoption centers of all sizes, including community practices. Notably, claims data indicate Reviforge has a substantially larger prescriber base than the other approved Medin inhibitor, and we continue to add more new prescribers and accounts each month in our competition, despite being on the market for twice as long. Patients have reliable access to Reviforge, with formulary coverage in place for nearly 100% of all covered lives for both indications. As we look ahead, we remain confident we will continue to lead this market and deliver for patients. Our conviction is underpinned by the strength of our product profile, the rapidly growing body of clinical trial and real-world evidence that differentiates Reviforge, and the extensive experience and comfort physicians have built over the past two years with nearly 2,000 patients treated with commercial drug and hundreds more treated in clinical trials. Switching gears to Nictinvo on slide seven. Nictinvo net revenue totaled $67 million in the third quarter, up 47% year-over-year, and 12% quarter-over quarter. This performance reflects strong and consistent new patient starts and solid persistency. More than 300 new patients were added, and about 6,350 infusions were administered in the third-quarter. As experience with Nictimvo grows, physicians continue to report impressive activity in multiple organs, with particularly notable responses in the lung. We've captured about one-third of the third-line-plus chronic GVHD market with strong adoption in the fourth line and steadily increasing uptake in the third line, driven by a broad and productive prescriber base. Nictinvo is now annualizing at over $260 million and continues to track with the launch of Resiroc, which reached $500 million in annual U.S. net sales within the first four years of launch in the same indication. Nick Timbo is well-positioned for further growth with steadily increasing uptake in the third line and a profile that allows patients to stay on therapy for extended periods. With that, I'll hand the call over to Nick to talk about our development programs. Thank you, Steve. And I'd like to start with RevuMeneb, which is on slide eight. We've made excellent progress advancing our lifecycle management program designed to unlock the full potential of Revu Meneb. In partnership with leading researchers around the world, we continue to advance the pivotal frontline trials of Revimenib and remain well positioned to be the first to deliver a menin inhibitor for newly diagnosed AML. Global site activation and patient enrollment is well established in these pivotal trials, informed by an extensive body of clinical evidence allowing for optimization of our endpoint assumptions and other aspects of the study designs. We are also advancing an industry-leading portfolio of studies in partnership with clinicians at the forefront of men in research. These studies will provide important practice informing and potentially guidelining enabling evidence across the acute leukemia treatment continuum and multiple patient populations with high unmet need. We will share the latest results from a number of these studies in the fourth quarter. The upcoming presentations will highlight the unique breadth and depth of clinical evidence supporting Revimenib and the vast experience clinicians have established with our medicine. We expect new data in the fourth quarter across three key themes. First is the potential for Revimenab to benefit patients earlier in the treatment paradigm. Second, the ability of Revimenob to bring patients to transplant and its potential in the post-transplant setting. And third, real-world evidence supporting the effectiveness and safety of revimenib, particularly in combination therapy. So I'd like to walk through each of these areas separately. So firstly, we expect new frontline combination data that will provide strong support for our ongoing pivotal frontline trials of revimenid. Updates from the BEAT AML and SAVE trials will provide additional evidence supporting the potential for revimenab in combination with venetoclax and a hypermethylating agent in NPM1 and KMT2A patients who are unfit to receive intensive chemotherapy. Notably, compared to the landmark BEAT-AML data published in June, the upcoming analysis will have significantly longer follow-up and report outcomes in a larger cohort of patients. These updated data will build on the previously reported BEAT AML and SAVE data showing overall response rates approaching 90% and 100% MLD negativity among responders by flow cytometry, along with encouraging early survival data. Additionally, we will provide an update from our Phase 1 frontline trial of Revimenib in combination with intensive chemotherapy in NPM1 and ChemT2A patients. These data will build on the previously reported results showing high rates of remission and MRD negativity with the triplet, along with discouraging durability and tolerability. We also look forward to updated results from Intercept. This is the first trial studying the use of imenin inhibitor as a so-called MRD eraser, a research area of high clinical interest. Intercept explores using rivimenib to intervene early at MRD or early relapse rather than waiting for morphological relapse, which can trail rising MRD by three to four months in MPM1 patients. Results presented at ASH 2024 from the first 11 MPM2 patients were encouraging. 54% of patients achieved a reduction in MRD, including 36% who actually achieved MRD negativity. We anticipate the presentation of more mature data from a larger cohort in the fourth quarter. Positive results could support the use of Revimenib to intervene earlier in the acute leukemia treatment journey. Now turning to the pre- and post-transplant setting, we will present results that highlight the relationship between the robust overall response rate observed with Revumeneb and its ability to enable a meaningful number of relapsed refractory KMT2A and MPM1 patients to proceed to a stem cell transplant. We also expect the first data from a Phase I multicenter trial evaluating Revumaneb as a post-transplant maintenance. This data set will build on the encouraging data from MD Anderson presented at ASCO and EHAR earlier this year. They reported a two-year overall survival rate of 90% among heavily pre-treated KMT2AMPM1 and NUP98 patients who resumed revimenib post-transplant, nearly double the historical rate observed prior to the introduction of revimenid. And then additionally, we will expand the body of real-world evidence supporting clinical decision-making with new data from multiple centers. To date, Syndax is the first and only company to report real-world data supporting the effectiveness and safety of our menin inhibitor as a monotherapy or in combination with other therapies in NPM1, KMT2A, and NUP98 patients with relapsed refractory or MRD-positive disease. Previously reported results were encouraging. Those data showed high rates of response, MRD negativity, and transplant, along with evidence of durable ongoing remissions. Prior data sets also underscored Revimenib's predictable and manageable safety profile, including in combination therapy. Turning to slide 9 now and the other programs in our pipeline. In partnership with Insight, we are advancing a robust life cycle management program for axotilamab. Two trials of axotilimab in newly diagnosed chronic GVHDL are underway. We now expect the top-line results from the phase 2 trial of axatilimab in combination with ruxolitinib to be reported at a medical meeting in the first quarter of 2027. The updated timing reflects the goal of presenting a mature and comprehensive data set that includes not only the primary endpoint of overall response rate, but also key secondary measures such as event-free survival, which will be important for understanding the profile of the regimens. We expect top-line results from the phase 3 trial of axotilumab in combination of corticosteroids in early 2028. Both of these trials have the potential to impact the treatment paradigm for frontline chronic GVHD. We also recently published data from Agave 201 supporting the safety and feasibility of reduced frequency dosing of axotilamab in patients with recurrent or refractory chronic GvHD in blood advances. These data show that transition from axotilimab 0.3 mg per kg every two weeks to 0.6 mg per gig every four weeks was feasible and well tolerated. Patients had a long duration of therapy after the switch with a median of 21 months and 84% remained on treatment at data cut-off suggesting ongoing clinical benefit. This is an important publication that provides physicians with evidence that can inform their treatment decisions. Turning now to our pipeline assets, Syndex 4321 and 62122. 4321 is a novel mutant-selective allosteric inhibitor in development for EGFR-mutated non-small-cell lung cancer. 62122 is a next-generation Menin inhibitor in development from myelofibrosis, or MF. Like Revimenib and Axotilimab, these assets have first- and best-in-class potential in areas of high unmet need. We expect both molecules to be in the clinic next year and remain on track to submit the IND for 4321 by the end of 2026 and the IND for 62122 next year. Both of these clinical development programs are designed to efficiently generate clinical data that can validate the target and the potential for these two approaches. Our development of 6212 will be supported by a phase 1-2 proof-of-principle trial of rebimenibin and MF that we expect will initiate in the fourth quarter of 2027. with initial data anticipated in the second half of next year. This trial conducted in partnership with a group of leading MF researchers will be the first to explore the potential for men in inhibition in MF. With 4-3-2-1, we expect to get the first assessment of monotherapy in lung cancer in early 2028. We look forward to sharing more details on both programs as we get closer to advancing into the clinic next year So in summary, we are executing on a bold R&D vision that aims to deliver novel therapies that transform cancer care with world-class R&B capabilities, strong partnerships with leading scientists and clinicians, and the resources to drive innovation. I have great confidence we will deliver on this vision. With that, I will hand it over to Keith to discuss our financials. Thanks, Nick. Earlier this afternoon, we reported detailed third quarter 2026 financial results, and I'll highlight a few key points on slide 10. Total revenue for the second quarter of 2026 was $83.3 million, up 82% over the same period last year. Revenue-forged net revenue grew to $60.7 million, and Nick Timbo collaboration revenue to $22.6 million. Looking ahead, we expect revenue from both medicines to continue growing and advancing the company towards profitability. The Nick Timbo margin contribution, defined as collaboration revenue recorded by Syndex as a percentage of Nick Timbonet sales, was approximately 34% this quarter. The margin this quarter was slightly benefited by the impact of a one-time non-recurring adjustment. But going forward, we do expect the margin contribution to be in the low to mid-30% range, an increase from the 25% to 30% range we guided to earlier in the launch. Our guidance for total R&D plus SG&A expenses for 2026 remains approximately $400 million, excluding the impact of $50 million in estimated non-cash stock compensation expense. We ended the third quarter in a strong cash position with $551 million in cash, equivalents and investments, and growing revenue from two medicines. We are fully funded to execute our commercial and R&D priorities, including the frontline trials of Revimanivit and Axotilamab, as well as the development of our earlier pipeline assets, just highlighted by Nick. With relatively modest investments in proof-of-principle trials of SNDX 4321 and 62122, we believe we can quickly generate meaningful clinical data that creates significant value for the company. And with that, I will hand the call back to Michael for closing remarks. Thank you, Keith. Moving to slide 11, Syndex is positioned to deliver breakthroughs in cancer care that create long-term value for patients and shareholders. Our first two medicines are improving patient outcomes and generating meaningful revenue to fuel our R&D engine and advance us towards profitability. Revuforge is the market leader in relapsed refractory MPM1 and KMT2A acute leukemia. A growing number of patients we treat are reaching transplant and resuming therapy afterwards, creating a foundation for durable franchise growth. Our next ambition is clear. Be first to frontline AML and establish Revuforage as the menin inhibitor of choice across the acute leukemia treatment continuum. At ASH in December, we will showcase an unmatched and rapidly expanding body of clinical evidence supporting that ambition. Nictimbo is poised to drive continued growth and contribute meaningfully to our bottom line. Beyond that, two ongoing trials and newly diagnosed chronic GVHD could redefine the treatment paradigm and unlock a new multi-billion dollar opportunity. We are working to realize that potential. We are just getting started. Our proven R&D engine, strong financial position, and two innovative pipeline assets entering the clinic next year position Syndex for long-term value creation as we deliver on the milestones shown on slide 12. Our focus is also clear. Deliver first and best-in-class medicines, address major unmet needs, and build shareholder value. To the patients, clinicians, Syndex team members, and everyone who has supported our work, Thank you. You have helped bring two much-needed medicines to thousands of patients. That progress is our foundation, not our finish line, and we are ready to build on that momentum. I'll now open up for questions. At this time, I would like to remind everyone in order to ask a question, press star and then a number five on your telephone keypad. If you'd like to withdraw your question, you can do so by clicking the button on the right-hand side of the screen. Press star and the number five once again. We'll pause for just a moment to compile the Q&A roster. Our first question comes from Anupam Rama with J.P. Morgan. Your line is now open. Hi, this is Duke Tells for Anupama Rama at J. P. Morgan, thank you so much for taking our questions. We have two quick questions. Number one, you mentioned the 50 to 60% rate of patients with KMT2 and NPM1 AML resuming treatment after transplant. We're curious about what you're seeing this patient population? And question number two, what are your expectations for the upcoming first-line combo data readout from the BEAT AML and SAFE trials? Thanks for the question. So first question, we are in fact seeing a very nice, well, resumption of therapy post-transplant, which is something that we've talked about repeatedly. 50% of the patients who have came T2A and gone to transplant, 60% of them are now getting maintenance. And so that's an increase from last quarter. And where we expected to go, 70%, 80% of maturity, that seems to be very much within our reach. So that's a very positive driver of growth for us. And actually, in this quarter, we've seen NPM1 grow from transplant rate, which was much lower, we believe, to now 40% with 50% of patients resuming with maintenance. And that, of course, is a new phenomenon, something that we've seen and are very encouraged by, especially because NPM1 patients are generally older. And this would lead to longer duration of therapy, perhaps. And that is a very encouraging second driver of growth for the business long term. So very encouraging overall. all. And let me turn it over to Nick. Maybe we'll talk about the frontline combo and what to necessarily expect. Yeah. Thank you for the question. We're anticipating presenting a number of frontline data in the fourth quarter. I think you were particularly interested in the BEAT and the SAVE data. So these are combinations with venetoclax and hypermethylating agents. I think we presented these data previously, but I think what's going to be significant from this update is considerably longer follow-up and also an expanded cohort of patients, which is going to give much more meaningful data when we presented the data previously we only have seven months of of median follow-up and therefore the survival data we presented were quite immature so we're really looking forward to updating um the data and what i would you know advise you to watch out for probably three things i mean one is again always we should look towards tolerability and confirm tolerability with an expanded core and longer follow-ups that's always important um that you combine safely. Number two is the CR rate. This is one of the dual primary endpoints in our Evolve 2 pivotal study we're undertaking with Hovon. So look at the CR8 and how it compares with historical controls from, say, Viale in the mid-low 30s. And then I would really encourage you to look at these survival data with an expanded cohort and longer follow-up. I think this is going to be a much more accurate representation of survival. So those are things we're looking forward to updating. And then I would suggest a similar approach to the SAVE frontline data. In this case, it's with an oral hypermethylating agent. But again, similar, you want to focus on tolerability, the CR8s, MRD eradication, and again, the survival. Great. Thank you. Thank You so much. Thank YOU. The next question is from Faisal Khurshid with Jefferies. The line is now open. Hey, guys. Thank you for getting the question. I want to ask about the competitive landscape. I think we're expecting that it might be possible that we see potential registration enabling phase two data sets from J&J and Sumitomo, potentially at ASH. Just curious how you think about those programs and how you recommend it compared to those. Thank You. Yeah, Faisal. Thanks for the question, and I'll let my colleagues jump in. Look, I think we haven't seen data, obviously, yet. So we'll reserve judgment until we do. I'll just point out a couple of things. Revuforge has been on the market for a few years and will be probably on the market for three years by the time the next competitor beyond the one that's on the market today reaches the market. So that's maybe just one fact. Look, I think whether they have data in KMT2A and NPM1 or just one of the subsets will be interesting to us. But, you know, our view on competition is that it's unlikely to be differentiated. We have a very broad profile, believed to be best in class. We have long experience. Physicians are very keen to put their patients on ReviForge with a very strong efficacy profile, which wins in this category. So we are very well positioned to continue our leadership. And we'll see data. We'll have lots of data ourselves at the upcoming medical meeting, which we are excited to uh to talk about and so this will be just one one point uh to to discuss when the data does in fact come out nick anything to add i would just add as if your question is was in relation to frontline again we're we're looking forward to updating the totality of our frontline data including with uh intensive chemotherapy uh we're feeling extremely confident in the profile that we're seeing across the important parameters that inform our phase three um those data have really helped us design, I would suggest, a very innovative and efficient approach to our phase three pivotal studies. You know, we were the first to get a phase three study up and running in the frontline setting back in May 2025. We're feeling very good about the execution of those studies now. We have good momentum sites that were opened up worldwide and tracking quite nicely. So obviously, we'll be interested to see, of course, what data are presented at ASH. You know, competition is good for us, but we're feeling extremely confident about where we are and how we're executing on our programs. Yeah. Lastly, I just said, I think that the bar is quite high for competitors to come behind us. We're feeling quite confident about what we've built and we'll be able to leverage that going forward. But thanks for the question. Got it. Yeah, go ahead. Yeah, thanks for that. For the answer. On that point on frontline, when do you expect to be able to give the street a little more clarity on when to expect frontline data? Because I believe you're not the only company that says that they're first to frontline. Thank you. Sure. Now, look, I think we feel quite confident in our ability to get to frontline first. As Nick mentioned, we have, you know, probably the broadest set of data presented to date, quite compelling data. And we're going to update those data sets at the upcoming medical conference. Our execution is on point, opening up hundreds of sites worldwide, enrolling patients. So the momentum is there. We feel really good about how this is going. You know, in terms of, you know, updating our guidance or informing the street on exactly when we'll complete enrollment and get to, you know, potentially an approval, that will come in time. I think there's, for us, we will obviously, it's a competitive space and doesn't seem to be the right time to necessarily update on that. But we will, of course, do that at the right times. Got it. Thank you. Thank you, sir. Thank you for your time. The next question is from Ellen Horstet with TD Cohen. your line is now unmuted hi guys congrats on the quarter um i'm just wondering with a year or so of commercial use now in the npm1 population uh what can you tell us about the duration of reviforge therapy in this population among the patients that do and do not proceed to transplant and eventual maintenance therapy how should we think about the incremental benefit from use in the post-transplant setting. Thank you. Yeah, Ellen, thanks for the question on NPM1 use. Maybe I'll take a shot at it, and maybe Steve, if you want to chime in here. So look, duration is very encouraging. Overall, I think we've mentioned and guided to that we would expect to be in the 6- to 12-month range for patients who receive a response, and I think мы are, you know, nicely in that range. For NPM 1 patients, what was encouraging this quarter is many of the patients are actually going to transplant 40%, and that half of those patients are resuming maintenance, which as a headwind in terms of a little bit of, in terms of revenue today, will be a tailwind tomorrow, and especially so because they have longer duration when they get maintenance. So that's very encouraging. You know, when we see, we look at the patient population of patients who have not gotten a transplant, but have gotten to response, we're talking about seven plus months of duration. That is for patients who, you know, predominantly NPM1 patients. So they're doing, you know well, and we expect that to continue and build as we go quarter to quarter and more patients come get transplanted and then get maintenance. So I don't know, Steve, anything to add? I think the only thing to add is that the drug is outperforming in the real world than it did in the clinical trials. You know, we've been talking for several quarters on the evolution of the KMT2A patient moving to transplant. We've seen that transplant move up to 50%, possibly could go higher over time. And as Michael mentioned, the increase to 60% of patients returning post-transplant is encouraging. It could certainly go higher than that. But the MPM1 patient, if we looked at the clinical trials, about 11% of patients went to transplant. So we're seeing earlier stage patients, about 75% are first and second line. Combination treatment is in 40% of patients. And the physicians were unlocking. And this may not be just a menin effect. This could be a Revuforge effect in that MPM2 patient. So 40%, first time we revealed that in a quarter. So that's new information of patients moving to transplant that are NPM1 patients and 50% returning post. So as Michael mentioned, short headwind now, but the tailwind is going to be significant. You're seeing patients stay on much longer. The longest duration of treatment is goingto be that transplant, post-transplant start. That group will grow. And as mentioned, if they're not fit to go to transplant, that duration is also increasing over time. So we feel like we're in a very, very, very good spot heading into the end of the year into next year the next question is from Steven Willie with stifle your line is now open yeah congrats on the quarter and also just want to say working with Keith wishing all the best for um quick question on the NPM one transplant rate that you're seeing, I know that you kind of alluded to it. This is the 40% is higher than what was thought for this patient population. I know it's probably more than 2X, what most of the KOLs have told us. Do you think that this is a durable trend? Do you Think this has something to do with just the onboarding of new patients just having a certain phenotype? We'd just be kind of curious how you think about the durability of this 40% getting transplanted and just have follow-up? Yeah, Steve, thanks for the question. No, actually, what I think is happening, what we hear from physicians is that we're treating patients earlier, we're treated them in combination, and they're getting to response. And so I think that's essentially true for KMT2A, but it's also true for MPM1. We're having great success in getting them to a response. Remember in our trial, we treated later line patients and we had a 50% overall response rate. We believe that's You know, by treating them earlier and treating them in combination, you can drive a higher percentage of patients into response. And I think that's what's getting patients to a transplant, the ability to bridge that and get them there quickly. And then ultimately, you know, the fact that they've received less therapy over time, meaning like if you treat them earlier, they don't get as worn down from subsequent therapy, you Can get them onto maintenance. And so I think that coupled with the fact that physicians have told us that transplant techniques have improved, and that allows for more flexibility in how you treat these patients. So the openness to transplant and maintenance seems to be quite real to us and encouraging. And I don't know, Nick, if you have anything to add on that front. Yeah, okay. Steve, that's what we got. Okay. And just a quick follow-up. I know the extension of the frontline Nictinvo Luxor steroid data was pushing the first quarter. I know it sounds like that was a byproduct of wanting to be able to present some durability data. Can you just remind us what the kind of benchmark durability data is in terms of response duration with steroids in the frontline? And I guess just kind of any ballpark estimate of what you think would be clinically meaningful in terms to achieve that. Thank you. Yes, thanks for the second question, Steve. So I'm going to turn it to Nick. Yeah, thank you, Steve, so we're going to, as you heard, we've moved it into Q1 and hope to present it in Q1 in order to present the totality of the data. We've talked previously about the primary endpoint, which is the response rate at six months, where we're anticipating a benchmark historical for steroids of around 40%, the alternative hypothesis being around 60%, so we'll be able to present that, but then I think it's important to present both the duration of response and the EFS. Now, it's not built into the statistics, but if you look at roughly what you'd expect for the EFF for steroids alone, it's probably of the order of six to seven months. And I would anticipate that an increment of that of the older of three to four months would be quite clinically meaningful to physicians and patients to avoid them having to have a steroid regimen and all of the morbidity associated with having to take dexamethasone. So that's the sort of order of magnitude we'd be hoping to see a difference in. But obviously, we'll look forward to reporting those data in totality in Q1. Very helpful. Thanks for taking the questions. Thanks, Steve. The next question is from Edsir Doral with Barclays. Your line is now open. Hi, this is Gustav on for EdsIR. Thanks so much for taking our questions. Two quick ones for us. The first one is on the agave 201 data that showed the transition from 0.3 to 0.6 Q2 to Q4 weeks. What's the significance of this data moving forward? And then number two is around the combination use. So it's about 40% still. At this point, are you able to tell whether the combination used is associated with higher transplant rate or longer duration of treatment or deeper responses in the commercial setting? Thank you. Maybe I'll turn it over. Thanks for the question, Gustav. Let me turn it over to Nick about the agave tool. Thank you for the question. I think this is a very patient-centric approach. I mean, I think the simple clinical benefit is that you're able to transition a patient from a two-weekly IV to a monthly IV with comparable tolerability and prolonged duration of therapy. That's what we've shown in the manuscript and in the publication. And I think that's a benefit to patients. That is something that could ultimately inform guidelines and potentially even inform labeling in due course, which is a consideration. But again, I think it's a patient-centric approach, just requiring less healthcare burden and importantly, less burden for the patients to have a four-weekly infusion as opposed to two-weekling. And the second question, I guess, is about combo use and the 40% that we're seeing and really what's the breakdown of that percentage and what's driving them there? Steve, do you want to make any comments? I'd probably pass to Nick. I think the claims data doesn't really, you know, it's a, yeah, we don't have a subset, but, and we haven't shared data previously, but I think. We've seen, I mean, I think there's a drive. Because we've presented such compelling data of revumenib in combination, I think particularly with Venazer combinations, there is a desire for physicians to use revumenab in a combination with a variety of different chemotherapies. We will be updating later this quarter a few real-world series from multiple centers that I think really emphasizes the desire of centers to use rivumenib combination when they can because you get much higher response rates. And the much higher response rates, including responses like MLFS, give the patients the opportunity to go to transplant. And again, we're hoping to present data demonstrating Revumena bridging patients from responses into transplant and then potentially onto maintenance. And that's really the best opportunity to give patients a durable remission and outcome. So that's Really the drive that you're seeing to combination. Thank you. The next question is from Ego Notumovit with CIDI. You may now unmute yourself. Hi, this is Joanne Kim on for Ego. Thanks for taking our question. On the 20% sequential increase in new reverse-scorch patients, was that growth broad-based across newer accounts or primarily concentrated within the established high-volume centers? And just wondering, are you seeing meaningful repeat prescribing among the newer accounts? Thanks for the questions. First, the 20% quarter-over-quarter growth with accounts, is that kind of falling into a situation? Yeah, I think the exact question was 20% increase in new patients, where are we seeing that from, right? Where's it rising from? It's coming from all over. I mean, two-thirds of our business comes from what we'll call tier one, tier two, and then the rest of the business comes form, we'll say, smaller accounts, of which there are hundreds. You know, we've had over 620 accounts prescribed to date. That is most of the tier ones and tier twos, about 90%. The rest are smaller community practices. That continues to grow. I think we had 8% growth in new accounts. So the business is being spread, and that's how you want it. You want a large foundation of users treating a wide range of patients. That's how You build a big brand, and that's exactly what's happening today, and that'll continue over time. And how would you characterize the repeat business? High repeat business, we'll say this. I mean, patients like this are, in general, challenging to treat, you know, even from early on in the launch, we've got a multifunction type team, including nursing support care to make sure clinicians and their entire staff know how to treat patient success with Revuforge. So from the launch and that continues today, you know, from a, you know, a customer, an account that prescribes for the first time, they're going to get the care. So they repeat rate is incredibly high, assuming they're seeing patients, you Even smaller accounts will continue to use the drug on multiple occasions. And as we know, Revuforge has been the standard of care in KMT-2A and established itself in NPM-1 patients to treat more patients on a continual basis. Gotcha. And if I could just ask one more quick one. On Evolve 2 and Reveal, should we be thinking that the two studies complete enrollment on broadly similar timelines, or are you seeing that one is perhaps tracking ahead of the other? Thanks. Thanks for the final question. We haven't updated our guidance on either one of them, so I don't want to get into that at this point. But both are moving along well and on our schedule, so we feel encouraged. Understood. Thank you very much. Thank you. The next question is from David Dye with UBS. Your line is now open. Great. Thanks for taking my questions. So, they're encouraging new patient starts where, you know, there's about 20 percent quarter-over-quarter growth versus a decline in 2q that you characterize as temporary. I mean, to help us understand more around, you know, whether the improvement reflects a normalization of patient flow, better patient identification, broader count penetration, or shared gains from other main inhibitors, and more importantly, what keeps the confidence that this growth rate can remain positive next several quarters? thanks david so steve you want to want to tackle the new patient start questions yeah we can't david appreciate the question and and uh question right reasonable to ask where where the growth come from and why i think we you know as we just described last quarter which q2 was was a somewhat down quarter for the entire market um things happen i mean there's just variability quarter to quarter there's not any one thing that drives this i think what we're seeing in q3 for us encouraged by the 20% increase in new patient starts. There was growth in both KMT2A and NPM1. We continue to see the number of accounts expand. Formulary coverage is still holding. You know, we obviously, we talk to clinicians and market research and gain insight. So we're encouraged overall by what we see in the business. And just to reiterate, even the dynamic we see in the NPM2A patient moving from transplant and all the patients coming back, these are all good things that are based in the trust in the clinical profile. You We talk about use. There's over 2,000 patients that have used the drug commercially, hundreds more in clinical trials. ASH is going to be great. There's so much data coming. So in the forward, we're optimistic. We're not going to really comment on this quarter, but we gained a lot of steam in Q3 that will continue for the rest of this year. Right. And I would just add that, look, remember, we have 80 plus percent of this business, right? Relapse Refractory is really ours, and we're continuing to build on that momentum. KMT2A, MPM1, we kind of have the dominant share across all age groups. So I think that is a very good place to be as we enter the last part of the year here. Great. Thank you for the question. Thanks, David. The next question is from Celine Saeed with MISUHO. Your line is now open. Great. Thanks for the questions, guys, and congrats on the progress. I guess one from us on the CFO transition, and thanks to Keith for all his help, and welcome to Erin. Keith, so the press release was worded today as retiring. Just curious here why you felt like, first of all, is this the loose definition of retirement that we should be thinking about here, and you plan on doing something else, and why did you feel like right now was the right time to, I guess it looks like it was your decision. Why was it the right time to make that transition at a syntax and maybe to something else? Thank you. Yeah. Salim, thanks. Thanks for the kind words and the question. So yeah, this was purely a personal decision that I made along with my family. Maybe the time was probably right a little earlier in the year. I care tremendously about this company, the patients that we treat, the teams that we built, and wanted to ensure that the transition was as smooth as it could be. So there was to minimize any adverse impact on the business, on the team, on patients. So worked with the leadership team, the board, to find a great replacement. And yeah, this is not a retirement in a loose setting. So I'm looking forward to spending more time with my family, with my friends, pursuing some of my hobbies, doing some philanthropic work. So it's been a good run. I've been a CFO for 26 years and just looking ahead to the future. Okay. All right. Well, we wish you well, and congratulations, and thanks for the additional color, Keith. Thank you. Thanks, Salim. Appreciate it. Thanks. Thanks, Alain. The next question is from Andres Malonado with HC Wainwright. Your line is now open. Hi, everybody. Thanks for taking my questions, and Keith, I wish you the best as well. Maybe circling back to some of the commentary on the transplantation eligibility. You know, in the context of what you guys gave us today, the 40% in MPM1 versus the 50% in KMT2A, was curious on how much of that gap reflects age and fitness versus essentially cohort maturity. And I guess, how realistically can that signal go? And my second question, you know, it's on combination use, you known, given the roughly you stated today that 40% of the use is in combinations, I guess, can you provide a little bit more color about which regimens are driving that outside of the usual suspects? And, you know, are they essentially, how should we think about the breakdown of whether they're extending treatment duration or just primarily getting those patients to transplant? Thank you very much. Great, Andreas. Thanks for the question. So in terms of what we're seeing with transplant and where I essentially took your question is, where is it really going here? You know, the 40% for NPM1 with 50% of the patients returning for maintenance, you know, 40% is a lot higher than we had expected. And so could it get to 40, 50%? I expect it could, just given the momentum we're seeing. And at 50% of those patients resuming, we expect maybe 60, 70% of those patients to resume maintenance. So that is sort of how we see that. And again, it's more of a projection than a hard and fast rule. It's based on physician conversations and some research that we've done and what we're seeing in the real world. And then if you look at KMT2A, that's been creeping up over time, also much higher than we have seen in clinical trials now at 50% transplant rate, 60% resuming maintenance up from about 55% or 50% last quarter. So it's really moving up on the patients returning for maintenance, which is quite encouraging. We've said that the transplant rate for KMT2A could probably go up to maybe 60%, probably not a lot higher. And we expect 70% to 80% of those patients with KMt2A to come back on for maintenance. Again, thinking about how long they can stay on maintenance therapy and reflecting from what physicians have told us and what we've seen in some of our real-world work that we'll report on, even at this upcoming meeting, you see that the desire is to treat them for one to two years in maintenance. And that would be a very good outcome for patients, keep them in remission for a long time, and hopefully move them forward. And I think that is the paradigm that we're pursuing, again, with some estimates for what the rates could be. But Nick, maybe I'll pass to the combination question. Yeah, just a few additional comments on that, including a combination. I mean, one is, I mean I think the drive to transplant, remember in relapse refractor, is really the best chance a patient can have of a durable remission. So it's a little different from a consideration front line. Once you've relapsed, you really want to get a patient's transplant if you can. We're hoping to update some data in the fourth quarter, which looks at our patients that have gone on to get transplant and looks at the role of revimenib as a sort of bridge to transplant. You know, how do you get them there? What kind of response do you need to see, including, you know, all of the contributors to overall response rate, which we know we have the highest overall response rate in the class. So that would include MLFS. And this makes these patients eligible for transplant, which I think is quite promising for patients. Combination use varies. I think what we see most commonly is venaser or single agent ven. occasionally other sorts of chemotherapy only rarely do we see combinations with targeted agents and it's not a it'snot a high priority for our program they tend to be sequenced more but occasionally it might be a combination and then maintenance of course is really important and again i think we have the the most mature and significant data really trying to elucidate how to optimally treat a patient with maintenance revimenib we will be updating some data from a phase one we're doing with Dr. Ball, which I'm excited about, which looks at optimization of dose and managing patients. And then a variety of real-world data, again, you know, optimizing patients, you Know, with revimenab in the maintenance therapy. And as Michael said, physicians tend to want to keep them on if they can for one to two years. Again, we're hoping to update data on the, you Now, MRD erasing MRD, which is really exciting. And I think that'll the first data you know to be presented showing that and and then perhaps the last thing i would say as the data continues to mature we are hearing from physicians now if the patient's done really well and and tolerating the drug well at two years you know sometimes they don't even want to come off for two years and so we are having discussions now with physicians who want to keep a patient on because they're just happy to be you know relapse free out at two years after their transplant and doing well so that's also a trend we're beginning to see as as the data matures. Thank you. The next question is from Jason Zemanski with Bank of America. Your line is now open. Hi, this is Jackie on for Jason. Congrats on the progress and thanks for taking your question. So you've talked about transplant creating in your term headwind, but ultimately becoming a meaningful tailwind as the post-transplant population stacks. So with the KMTT, With the KMT2A restart rate now at 60% and NPM1M already at 50%, how should we think about the timing of that inflection? Is that something you expect to become a more meaningful driver of revenue-forged growth over the course of 2027? Thanks. Jackie, thanks for the question. I think you hit it on the head. Honestly, I think this is a really important phenomenon that takes some time to kind of play out. And basically, it's because you have patients who are going to transplant within, call it three months of being put on Revuforge, and then they pause treatment for a number of months, call It two to four to five months, in some cases, maybe even more, and they pause treatment and then They resume. And so what that means is, you're going to have the tailwind that kicks in quite a bit later. And you need time for the number of patients who drop for transplant to be kind of overcome by patients coming back, meaning in terms of revenue stack. So again, that takes time and it takes time for both now NPM1 and KMT2A. We haven't been kind of thinking about how NPM 1 was part of this equation until recently we saw the data that it's really very much the same, very similar paradigm to what we're seeing with KMT2A. That was a bit of a news to us, but we think it will be ultimately a very good thing for patients as they come back on and can stay on treatment for a long time, as Nick had mentioned earlier. So yeah, so I think 2027 is where you'll see the greatest impact. We have started to see some of that, but will start to see more as it stacks in 27 thank you thank you our final question today is from my young Montani would be rally the line is now open yes from that's been a strong execution quarter and thanks for taking a question and best wishes to keep for the next chapter just a clarification question maybe if you could update us how maybe 4Q to date is progressing on the TRX versus NRX. Obviously NRX did really well quarter over quarter, TRX is lagging a little bit, 20% versus 13%. Is there, again, anything you can comment on 4Q, how that is kind of progressing would be helpful, but more sort of long-term just thinking about how in a sustainable manner we can see TRX accelerating uh that that would be just part one commercial question and then second on the you know uh nick your comments on the newly diagnosed uh phase three program very helpful was just wondering if uh you know you could contextualize on the paradigm vanessa efs and mrd data we recently saw and you know how do you think about mrd negative cr as a as a you know you know, set a good endpoint, and then just your expectation in fit versus unfit, control arm for Revol2 also, and how do you see essentially maintenance being handled, you know? Given you're getting so much deep remission in the frontline setting across fit and unfit. Sorry, that was long-winded, but it would be great to hear your thoughts. Anyway, thanks for the questions. Yeah, so the good news is I get the short question, which is the first one. What are we seeing in the fourth quarter? We're not going to comment on the fourth quarter. I'll say, look, we feel good momentum coming out of third quarter. So, you know, we're very hopeful that business will continue to really ramp from here. But I, you know, that's my answer. I'm going to turn to the second set of questions from Nick. Yeah, great questions. And we can maybe talk a little bit more about the trials when we've presented our data at ASH or at least at the abstracts are open and the relevance of those data to inform the phase threes. But what I would say is they give us a lot of confidence in the assumptions around the endpoints. And just to remind everybody very briefly for the Evolve 2, we have two dual primary endpoints, one is CR, the other is overall survival. So those are relatively simple. And we'll be updating data from both beat and save that I think is very informative to those endpoints and we feel very confident. And the way we've designed those studies, I think, is quite strategically smart. And then for Reveal, which is in fit patients, patients eligible to receive intensive chemotherapy, again, we have dual primary endpoints. One of them is quite stringent, which is looking at MRD negative CR, but assessed in the bone marrow. Again, look for updates for our study 708, which is revumeneb in combination with intensive chemotherapy that informed that study and the relevance of those data for that study. And then the other dual primary endpoint in Reveal is event-free survival, which again, takes a little time to mature, but is it going to be at the definitive endpoint I would say for for potential approvals so more than that to come but the data are very helpful in ensuring we've got the studies designed and executed in the most efficient way we can without with the highest probability of success now are you handling maintenance crossover in these front-line studies sorry can you repeat that just the final part of that question was how are you handling crossover and so the maintenance setting given you're getting deep remissions and some of them might be even going in transplant was just curious how the follow-ups are handled in the study the other studies don't allow for formal crossover for that reason and recall in reveal the dual primary endpoint is event free survival which we're not anticipating to be unduly impacted by any subsequent therapies. Thank you. Thanks for the questions. This concludes our question and answer session. I will now turn the floor over to Michael Metzger for any additional comments or closing remarks. Thank you all. We appreciate everyone tuning in today to discuss our recent progress and the exciting milestones ahead. We look forward to seeing many of you at the upcoming investor conferences in Q4 and at ASH. And before I say good evening, I want to thank Keith Godin for all he's done for us. We wish you all the best in your retirement. Thank you. Have a good evening everyone. This concludes today's call. Thank you and you may now disconnect.