Good day, everyone, and welcome to the Syndax Conference Call to discuss the FDA approval of Revuforj in relapsed/refractory NPM1-mutated AML. Today's call is being recorded. If you would like to ask a question following the company's prepared remarks, please press star five during the call. At this time, I would 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 to discuss the approval of Revuforj for its second indication. Sharon Klahre, I'm joined on the call today by Michael Metzger, Chief Executive Officer, Dr. Nick Botwood, Head of R&D and Chief Medical Officer, and Steve Closter, Chief Commercial Officer. Also joining us on the call today for the question-and-answer session is Keith Goldan, Chief Financial Officer. This call is accompanied by a slide deck that has been posted on the investor page of the Syndax 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 the statements as a result of our various important factors, including those discussed in the risk factor section in the company's most recent quarterly report on Form 10-Q, as well as other reports filed by the SEC. Any forward-looking statements made today represent our views as of today, October 24, 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. Thank you, Sharon, and thank you all for joining us today, starting with slide four. Today is another historic day for the acute leukemia community and Syndax as we continue to deliver on our mission to reimagine cancer care. Earlier today, the U.S. Food and Drug Administration approved Revuforj, our first-in-class menin inhibitor for a second patient population with high unmet need. The Revuforj indication is now expanded to include adults and pediatric patients with relapsed or refractory NPM1 mutated acute myeloid leukemia, or AML. The approval of Revuforj for the most common genetic mutation in AML represents a major breakthrough for patient care. This approval builds upon the first FDA approval of Revuforj in November 2024 for relapsed or refractory acute leukemia patients, including those with AML or ALL who have a KMT2A translocation. Revuforj is now the first and only menin inhibitor approved to treat multiple acute leukemia subtypes in both adults and pediatrics. This broad indication underscores the exceptional strength of the Revuforj efficacy and safety profile. Importantly, today's approval represents another example of Syndax's successful pipeline execution. It also marks the first step in our plan to expand Revuforj into additional indications and further unlock its multi-billion-dollar potential. Turning to slide five, Revuforj is well positioned for near and long-term success with best-in-class efficacy and significant first-mover advantage, building on the success of our launch in KMT2A. The breadth and strength of our clinical data will be key to our success in acute leukemia, a severe disease where physicians' treatment decisions are driven by therapeutic efficacy. Unlike other molecules, clinical trials of Revuforj have shown compelling and consistent efficacy in multiple genetic subtypes of acute leukemia as a single agent and in combination with standard of care agents across the treatment continuum. It is also the only menin inhibitor with positive pivotal data in children, allowing for an indication to treat patients one year of age and older. In relapsed/refractory NPM1-mutated AML specifically, we have pivotal data that surpass the results seen from any other menin inhibitor across multiple efficacy measures, including the overall response rate, or ORR, transplant rate, duration of CR/CRh, and median OS among responders. Particularly notable is the 47% ORR and the 11% transplant rate observed following Revuforj treatment. While CR/CRh is important from a regulatory standpoint, ORR is key from a clinical standpoint. A higher overall response rate gives clinicians the ability to bring more patients into remission and the best chance of bringing their eligible patients to a potentially curative stem cell transplant. In addition to leading efficacy data, we also have a significant first-mover advantage with at least one year head start in commercialization over any other company. Importantly, the same physicians treat both KMT2A and NPM1 patients and have had the opportunity to gain familiarity with Revuforj and see excellent results with it firsthand. We know from other launches in AML and beyond that once a clinician has had a positive experience with the first product in class, that drug becomes very well entrenched. In addition to physicians observing positive clinical results, we also have established a strong track record of delivering a best-in-class HCP and patient experience. As a result, Syndax is already a trusted partner at leading cancer centers across the U.S., positioning us to rapidly expand into this second indication. I will also highlight that the NCCN Guideline Committee added Revuforj as a recommended treatment option for relapsed refractory NPM1-mutated AML on September 18, validating the strength of our data and further solidifying our first-mover advantage. Looking ahead, we are poised to extend our leadership into the frontline setting. We have a comprehensive clinical development plan underway that is designed to unlock the $5 billion-plus U.S. market opportunity across the relapsed refractory and frontline setting. Our pivotal frontline trial in Revuforj, in combination with venetoclax and azacitidine, has been enrolling since earlier this year, and study startup activities are well underway for frontline in combination with intensive chemotherapy. Before I hand the call over to the team to provide more details of the approval, I want to highlight that today's milestone marks the third FDA approval for Syndax in roughly one year across Revuforj and Niktimvo. We advanced both of these novel therapies from first-in-human studies to FDA approval and launch in roughly four years. This is outstanding speed and execution for any biopharma company, especially a biotech of our size. I want to extend my deepest gratitude to everyone who has made this remarkable progress possible, especially the patients, families, investigators, and study teams who participated in our trials. I'm also deeply grateful to the Syndax team for all their hard work that has allowed us to expand the impact we are making for patients and enter the next phase of growth for the company. Congratulations to all of you on a job well done. I will now turn the call over to Nick to discuss the label and supporting data in more detail. Nick? Today is a very exciting day for patients, clinicians, and everyone who's worked to advance Revuforj and menin inhibition. The second approval for Revuforj within 12 months highlights what is possible when leading science and passionate people come together to deliver for patients. I'll start by highlighting on slide 7 the unmet need in relapsed or refractory NPM1-mutated AML. Among the approximately 22,000 patients diagnosed with AML each year, NPM1 mutations are the most common genetic alteration occurring in approximately a third of cases. Compared to patients with KMT2A translocations, patients with NPM1 mutations tend to be older with more comorbidities, making them less likely to be fit enough to receive a potentially curative stem cell transplant. They also tend to be more sensitive to chemotherapy and more likely to have other actionable co-mutations, such as FLT3 mutations. Relapse is common among NPM1-mutated patients, occurring in approximately half of patients treated with intensive chemotherapy and more frequently in patients treated with low-intensity chemotherapy. While NPM1 mutations can be associated with a favorable prognosis in the frontline setting, once a patient relapses or becomes refractory to treatment, they have a poor prognosis with response rates and overall survival declining with each subsequent line of therapy. Prior to today, there were no therapies FDA approved with a relapsed refractory NPM1-mutated AML indication. Slide eight provides an overview of the new Revuforj U.S. prescribing information. Revuforj is now indicated for patients one year and older with relapsed or refractory acute leukemia of a KMT2A translocation or relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. We are very pleased with the additional indication and the flexibility it provides for physicians and for patient choice. The safety section of the updated label is based on the FDA's analysis of nearly 250 patients with relapsed or refractory acute leukemia with a KMT2A translocation or an NPM1 mutation treated with Revuforj in clinical trials. The most common adverse events remain consistent with the prior version of the label and are largely characteristic of symptoms experienced by patients undergoing treatment for AML. The Revuforj label continues to include a boxed warning for differentiation syndrome consistent with other targeted AML therapies that induce differentiation of leukemia cells. The updated label also includes a boxed warning for QTc prolongation and Torsades de Pointes, which is a type of ventricular tachycardia associated with QTc prolongation. This reflects one non-fatal case of non-sustained torsade that was identified during the rigorous review of approximately 250 patients treated with Revuforj in clinical trials. In our broader clinical trial and commercial experience, we have seen that the potential for QTc prolongation has been well managed due to the clear guidance for physicians on mitigating QTc and their familiarity using other drugs that can prolong the QTc interval. Over 1,000 patients have been treated with Revuforj across the clinical trial, expanded access, and commercial setting, with no other cases of torsade reported. Turning now to slide nine and the supporting efficacy data, the expansion of the label is based on data from the phase 1/2 AUGMENT-101 trial, which met the primary endpoint in both the relapsed/refractory NPM1 and KMT2A cohorts. The NPM1 portion of the label includes data from the pre-specified phase 2 primary efficacy analysis population, which consisted of the first 64 adults with relapsed/refractory NPM1-mutated AML who met the efficacy-evaluable criteria, plus one pediatric NPM1 patient. This was an older population with a median age of 65 and a range from 11 up to 84 years. Patients had a median of two prior regimens with a range from one to seven prior regimens, and approximately 75% had prior venetoclax and 23% had received a prior stem cell transplant. In this population, 23% of patients achieved a complete remission or CR, plus complete remission with partial hematologic recovery or CRh. Of the patients who achieved a CR/CRh, the median time to response was only 2.8 months, and the median duration of CR/CRh was 4.5 months. Given the poor prognosis for this patient population, observing a 4.5-month median duration of response with a monotherapy that is generally well tolerated is very encouraging. Notably, seven of the 65 NPM1 patients, or 11% of the total population, underwent a stem cell transplant following treatment with Revuforj. And seeing roughly one out of every 10 patients proceed to a potentially curative transplant is very encouraging, especially when you consider that these patients tend to be older and generally less fit for transplant than patients with KMT2A translocations. As published in the manuscript Blood, nearly half of all relapsed/refractory NPM1 mutated AML patients in AUGMENT-101 achieved a response after receiving Revuforj. A high overall response rate is very impactful because it gives clinicians the ability to bring more patients into remission and the best chance of bringing their eligible patients to a potentially curative stem cell transplant. I also want to highlight that among the nearly 50% of NPM1 patients who achieved a response in AUGMENT-101, the median overall survival observed was nearly two years. Finally, with regards to the depth of the response observed with Revuforj, we have presented data showing an MRD negativity rate of 63% among NPM1 patients with a CR/CRh in the phase two portion of AUGMENT-101. With these clinical data, we are confident in Revuforj's ability to transform the treatment paradigm for relapsed/refractory NPM1 AML. We understand from our interactions with clinicians that they are eager to have Revuforj as a new treatment option for their patients with relapsed/refractory NPM1 leukemia and value having one menin inhibitor that they can use across multiple types of patients. Turning now to slide 10, we've made tremendous progress executing a comprehensive data generation strategy to establish Revuforj as an industry-leading franchise, thanks to the close collaboration across our research and development and medical teams. In recent quarters, we and our clinical collaborators have published and presented multiple data sets that highlight Revuforj's exceptional activity in multiple acute leukemia subtypes across both the relapsed/refractory and frontline setting as a monotherapy and in combination with standards of care. I'll touch on a few highlights. In May, our pivotal data in relapsed/refractory NPM1-mutated AML were published in Blood. This was an important publication which supported the inclusion of revumenib in the NCCN Guidelines as a recommended treatment option for relapsed/refractory NPM1-mutated AML ahead of today's approval. This early inclusion underscores the strength of our data and the benefit physicians believe it could bring to their patients. In June, promising phase 1 data from the BEAT AML trial of revumenib with venetoclax and azacitidine in the frontline setting were published in ASCO's Journal of Clinical Oncology and presented at the European Hematology Association annual meeting. These important data highlight the promising feasibility of combining revumenib with venetoclax and the potential for the triplet to provide high rates of CR and MRD negativity in newly diagnosed patients. Building off the BEAT AML trial, we initiated the pivotal EVOLVE-2 frontline trial of this triplet in early 2025, and enrollment is already well underway. Looking ahead, we have additional data presentations planned before year-end that will further showcase the breadth and strength of revumenib's profile, including the first real-world evidence and phase 1 data in combination with intensive chemotherapy in newly diagnosed patients. In this fit population, study startup activities are well underway for our REVEAL program, with trial initiation expected this quarter. The robust and rapidly growing body of evidence from trials of revumenib spanning different patient populations and settings is of critical importance to hematologists who use these data to inform treatment decisions. I will close by saying that I couldn't be more thrilled to work with the talented Syndax team and the clinical community to help pioneer this new therapeutic class that holds such promise for patients. This is an exciting time for Syndax. We have just begun to scratch the surface of the opportunity to transform patient care with Revuforj and Niktimvo in difficult-to-treat diseases. With that, I will hand the call over to Steve to discuss our commercial plans. Thank you, Nick. It's a real pleasure to be on the call today to discuss yet another milestone that expands our ability to make a big difference for patients. I'll start with the commercial opportunity and then talk about our commercial execution. Slide 13. Today's approval significantly expands our annual total addressable population from approximately 2,000 KMT2A incident patients to a total of 6,500 patients, including NPM1, in the U.S. across the two indications. This represents more than a $2 billion market opportunity in the relapsed/refractory setting. That's important to note that screening for NPM1 mutations and KMT2A translocations is already a routine part of genetic testing that patients undergo, enabling clinicians to identify appropriate patients for Revuforj. Revuforj has the opportunity to address a larger portion of the AML population than other targeted AML therapies, as approximately 40%-45% of AML patients have either an NPM1 mutation or a KMT2A translocation. Pricing and the anticipated duration of therapy, including the potential for significant long-term use post-transplant, positions Revuforj to become the largest targeted AML therapy. The launch of Revuforj is already ahead of other AML analogues with nearly $50 million in net revenue in just the first two full quarters, despite an estimated one-third of KMT2A patients temporarily pausing treatment with Revuforj and proceeding to transplant. Moving to slide 14. Revuforj is positioned to lead in relapsed/refractory NPM1 mutated AML with an industry-leading profile and a solid commercial foundation with HCP and patient experience already established to our launch in KMT2A. We have a strong base of prescribers who have nearly 12 months of experience using Revuforj in clinical practice. Physicians have now treated more than 1,000 patients across the commercial, expanded access, and clinical trial settings, building up strong familiarity with the drug. Importantly, the same physicians treat both KMT2A and NPM1 patients. Beyond building strong familiarity with Revuforj from a clinical standpoint, centers have also built comfort successfully navigating reimbursement and initiating and maintaining usage of the drug, very important factors that create long-lasting and loyal habits. As of the end of June, 65% of the roughly 200 top cancer centers in the U.S. that care for approximately two-thirds of patients with acute leukemia have prescribed Revuforj. Now, beyond those largest institutions, we also have a strong and growing presence in academic centers of all sizes, as well as community practices. Our relationships in the community will give us a significant advantage in NPM1, which is more commonly diagnosed in the community versus KMT2Ar acute leukemia. We've also established excellent access to Revuforj for KMT2A. It is on formulary for 97% of covered lives, and it's already included in the NCCN Guidelines for both KMT2A and NPM1. Addition of this new indication for formulary coverage will be rapid. Further, we have a highly competent infrastructure that delivers best-in-class physician and patient support, including our multidisciplinary customer engagement team, dedicated patient hub, and partnerships with the leading specialty pharmacies in oncology. Our average time from prescription to first fill is less than four days in the specialty pharmacy and hub channels, significantly faster than typical industry benchmarks. This track record of delivering for patients is greatly appreciated by our customers and will be an important driver of brand loyalty. Our strong commercial foundation is a result of the hard work and the talent of our world-class commercial team. These folks are the best of the best. Our field team has over 20 years of experience on average, primarily in hematology and oncology, an average of six product launches under their belt, and strong pre-existing relationships with key clinicians and institutions that treat our target population. They've been focused on serving our accounts for over a year and have developed a deep understanding of how these centers identify and treat patients. Further, our team is equipped with targeting tools that leverage multiple data sources and artificial intelligence to help them identify and engage physicians at a time when they may have an appropriate patient in their care. Importantly, this team has a proven record of success with $56 million in Revuforj net revenue generated in just the first seven months of the launch, exceeding any of the benchmarks set by other AML therapies. Slide 15. With a new indication, our customer-facing team is laser-focused on leveraging our relationships and existing foundation to rapidly execute on our opportunity in NPM1 and capitalize on our well-earned first-mover advantage. We will continue to focus on the three strategic imperatives I discussed on the original Revuforj approval call just about a year ago. Our goals are to leave no appropriate patient behind, engage all key stakeholders involved in treatment and patient care, and deliver a best-in-class experience for patients and clinicians. This strategy has brought us much success and put us in a very strong position to expand into NPM1. I'll also highlight that our significant experience in the market has allowed us to leverage the size and the composition of our field force and allocate our resources where they make the biggest impact. This is another major benefit of our first-to-market position. In summary, we are very well prepared and very excited to immediately expand into the second indication. We've got the right product, the right team, and the right strategy to deliver for patients and all of our stakeholders. And with that, I'm going to hand the call back to Michael. Thank you, Steve. Before we move on to Q&A, I'd like to review on slide 15 the strong position that Syndax is in today. First, we have two first and best-in-class therapies with a combined market opportunity exceeding $10 billion. Second, we are executing two strong product launches with nearly $100 million in combined net product sales generated in the first half of the year, significantly exceeding expectations. And third, we are on the road to profitability, driven by growing contributions from Revuforj and Niktimvo, a strong balance sheet, and an operating expense base that will remain stable over the next few years while fully funding our strategic priorities. Looking to the future, our clinical development plan positions us to be the first to frontline and further expand the Revuforj franchise. We have a similarly compelling opportunity to bring Niktimvo into earlier lines of therapy and additional patient populations. I will close by saying that the future ahead is bright for Syndax. While we have made major strides, we are just getting started, and we'll continue to work with urgency to innovate for patients and drive shareholder value. With that, I would like to open the call for questions. We ask that questions are focused on today's news, as we will not be able to answer questions related to the third quarter, given the proximity of today's call to our quarterly reporting. Operator. At this time, I would like to remind everyone, in order to ask a question, press star, then the number five on your telephone keypad. If you would like to withdraw your question, press star and the number five once again. We'll pause for just a moment to compile the Q&A roster. Our first question will come from Anupam Rama with JPMorgan. Your line is open. Please go ahead. Hey, guys. Thanks for taking the question and congrats on the approval. Quick one from me. What does your market research suggest about the portion of patients that may have some sort of baseline arrhythmia or something like that where the doc might have to think about using Revuforj and how physicians think about managing QTc prolongation as an AE for Revuforj? And then for the patient that had the fatal event that was highlighted in the label, can you remind us, is there anything to note in that patient's baseline characteristics when considering kind of the benefit-risk of Revuforj? Thanks so much. Thanks, Anupam. Appreciate your questions. First question was related to our market research related to QTc and the amount of, I think, as I interpret your question correctly, the amount of potential patients that could be impacted by QTc. Let me turn it over to Nick. Maybe he has a point of view on that, and maybe Steve, if you have a follow-up. Yeah, thank you for the question. Actually, it's a relatively limited number of patients that wouldn't be considered for Revuforj because of a baseline condition. Most patients would be considered eligible. They have obviously baseline ECG to make sure that they're within a normal range, and then they have optimization of electrolytes consistent with the label. So it's a very small proportion of patients, I think, that wouldn't be considered eligible. And then the management of the patient from there on is really quite straightforward with, again, optimization of electrolytes and weekly ECGs for the first month, and are managed accordingly. So it's relatively straightforward to consider a patient. And remembering, of course, the context of relapsed refractory AML, where there are multiple comorbidities and other considerations for treatment. So relatively straightforward. And then maybe I could take the question. I think you were talking about the fatal adverse event. And just to be clear, the case of Torsades that we identified with the FDA in our review of 250 patients, this was a non-sustained episode of Torsades de Pointes. It did not have a fatal outcome. The patient recovered from the event. But again, working with the FDA and with a commitment from both of us towards transparent labeling, it did meet the criteria to put it in a box. The fatal adverse event, which was related to cardiac arrest, this was a case we actually reported in our Blood manuscript. This was a patient with multiple comorbidities and a previous cardiac history. They also had very profound cytopenias, we noted in that manuscript. It's very difficult in a single-arm setting like this in a single-arm study to adjudicate causality to these events. There was no evidence of any ventricular tachycardia prior to the cardiac arrest. And it's because the patient didn't have a postmortem, it's sometimes difficult to ascertain the cause of death. However, again, with a commitment to transparent labeling for physicians and prescribers, we included that case in our section on warnings and precautions. Thanks so much for taking our question. Thanks, Anupam. Your next question will come from Corinne Johnson with Goldman Sachs. Hi, this is Kevin On for Corinne, and congrats on the approval. I just wanted to follow up on that point. If you could just help us understand sort of the change in the black box warning for QTc specifically and why that was added on the back of this approval, and just sort of reiterate what the implications are in your view in terms of adoption in real-world practice? Thank you. Yeah, thanks, Kevin, for the questions. I'm going to turn it over to Nick to talk about the change. I would just say, broadly speaking, implications for adoption, I think don't change, right? The warnings, precautions, the box, patient monitoring doesn't change in any way relative to the label, and physicians have been treating patients for over a year, about a year, with Revuforj successfully, not only in clinical practice, but in commercial practice, thinking about 1,000 patients, so implications of this are really just to highlight for physicians that they need to be thinking about these things, but it doesn't change how we expect practice patterns to go, so we feel fantastic about the label, and it gives us everything we need to be successful, but let me turn it over to Nick to talk about the specific change. Yeah, thank you. And I think it's important to understand, actually, that the safety profile, the totality profile, has not materially changed with this indication. QT prolongation was previously in warnings and precautions. Physicians were aware of it and were managing it very effectively. Recall that we've treated over 1,000 patients now. This is the single and only reported case of Torsades from that very extensive data set. However, as we worked through a very comprehensive review with the FDA and a clinical trial data set of around 250 patients, we did identify this single case of Torsades. Again, it was a non-sustained ventricular tachycardia. Torsades is a type of ventricular tachycardia. It was non-sustained, and the patient did recover from it. However, the FDA guidance, which is very clear on QT, which does include Torsades as a requirement for a boxed w arning, we included a boxed warning in the label, again, in the interest of transparent labeling and to inform physicians, but importantly, the management of patients is not impacted. The management is exactly the same as before, and if you look at the other parameters of QT within the label, it's really largely unchanged from our previous indication as we've expanded from KMT2A to NPM1, and perhaps what I would focus on again is the benefit-risk, because, of course, the benefit-risk considerations are key, and the really compelling efficacy that we have now presented in the label with a compelling CR/CRh, which goes along with our previously reported overall response rate and survival. And I think those are really the considerations that come into a physician's mind when they're selecting a therapy for a relapsed refractory AML setting where the median survival is three months. So we feel extremely confident in the profile, and we feel extremely confident in physicians' continued ability to manage QT in the way they have before with very simple management guidelines, both for the monitoring and management in clinical practice. That's helpful. Thank you. Thanks, Kevin. Your next question will come from Bradley Canino with Guggenheim. Hey, Steve. And great to see the approval come through. Two for me. First, on the warnings change as a follow-up, can you just discuss if the post-marketing data in the 1,000 commercial patients that you outlined was or wasn't a part of this decision to elevate QTc and Torsades to a black box? And then second, could you just talk about how having now both NCCN listing and this specific label heading into ASH-25 positions Syndax to compete in what we're expecting to potentially be a two-player market next year for NPM1? Thank you. Great, Brad. Good questions. Thank you. Let's turn it over to Nick to talk about the, I think it's a very simple follow-up on your first question about whether the commercial experience was part of the FDA's consideration. Yeah. And obviously, we provide periodic safety update reports as part of our regulatory reporting requirements on our commercial use. But as previously stated, in over 1,000 patients, we haven't had another reported case of Torsades. So the FDA review was based on an integrated safety set that you see reflected in the label in around 250 patients with that one reported case, which, again, meets the requirement for a box. But you can see that overall, the profile of the drug, the management of patients is really unchanged from our previous indication. And again, it's been very effectively and well managed by physicians in over a year of commercial use now and 1,000 patients treated. So those were the criteria by which the labeling was decided on. Great. And maybe I'll follow up on your second question, Brad, which is based on the fact that we have a label and listings in the guidelines. How do we see competition? How do we see the, as you say, maybe a two-product race we're here? Look, I think our view on competition remains the same. We have, in an efficacy-driven market, other menin inhibitors that we've seen are inferior in terms of efficacy. They're behind us and, I would say, not differentiated. So we have the best data, as we pointed out in our prepared remarks. You heard that laying out all the data on efficacy measures across the board, the data speaks for itself. And based on that, when physicians are choosing what's best for their patients, they're going to choose the agents that are most efficacious for their patients. And so, look, we expect, as we've done in KMT2A, a fantastic launch where we've dominated that market. We expect to dominate the NPM1 relapsed refractory market as we roll that out. And I think we are off to a fantastic start this year, and we'll be more of the same next year as we get into the NPM1 launch. But we're very much looking forward to it, and we think the label supports everything that we need to be, again, successful for many years. Your next question will come from Clara Dong with Jefferies. Hi. Thanks for taking our question, and congrats on the approval. So just to follow up on the updated label, do you have any plans to update your physician education programs to address the label update? And maybe broadly speaking, do you anticipate any impact on formulary access or peer discussions following the label update, especially on the QTc? Thank you. Thanks, Clara. Good question. Let me turn it over to Nick in terms of how we will educate physicians. And Steve, you may have a comment there. And then the second question is directed to you on payers, so take that. Go ahead, Nick. Yeah. And let me just be clear that there are no additional requirements within the label in terms of any additional procedures or requirements. It's very consistent with previous. The label is very clear on the monitoring and management of QT, and there's nothing additional. We do, of course, have extensive teams in the field supporting education generally around the use of Revuforj in patients with relapsed/refractory AML. They will continue to do that, but there are no additional special requirements around QT. And maybe I can add to maybe the first question. I mean, I think what's great about being in market is we can basically press go with this second indication. So our teams have been hard at work turning around sales materials, other promotional materials, peer-to-peer, and other speaker-type events. So it'll be an immediate turn. We're training our field force immediately. They can begin speaking next week on the new indication. So the impact's going to be very rapid with the new information. In terms of formulary access, as we know, and we've reported previously, formulary coverage is exceptionally high, particularly in the targeted AML category relative to anything out there. It's 97% formulary coverage that we achieved within four-to-five months of launch of KMT2A. Our payer team, because pre-approval of the second indication, we can speak to payers around the NPM1 data. So we've been doing that, delivering pre-approval information exchange presentations. So we'll expect the formulary coverage on NPM1 to be rapid. It's also helpful that we achieved NCCN guideline status category 2A, and I think it was the third, fourth week of September. So that's already impacted payers, and they had already previously been reimbursing some NPM1 prescriptions when written off label. That number of denials has gone down. So we expect the formulary coverage to be very, very quick, and access to the drug for both indications will be fast. Thank you. Super helpful. Thanks, Clara. Your next question will come from Peter Lawson with Barclays. Thanks for taking the questions, and congratulations on the approval. Just to, I guess, continue the theme just around QT and torsades. Does that change in any way what you can combine Revuforj with? The The particular standards of care that also carry a cardiac risk that could preclude any combinations? Thank you. Yeah, Peter, thank you. I'm going to, again, turn it over to Nick. You can address that directly. No, thank you. And the answer is no on the basis that the overall profile has not materially changed. We have already presented data in combination with some standards of care, most notably, I think, venetoclax earlier this year from the BEAT AML study that actually showed no grade 4 QT or discontinuations. We showed it to be very tolerable when combined with standards of care. We're looking forward to updating data later this year in combination with intensive chemotherapy, which will support enrollment in our frontline studies with intensive chemotherapy. So the answer is no. We will, of course, include our current monitoring and management guidelines within those studies. But we have shown that the drug is readily combinable with standards of care in newly diagnosed patients and in other settings. The program, our development program in frontline disease and broader indications in combination with a variety of different therapies is really impacted by this. Gotcha. Are there any therapies that do have cardio toxicity that we should be thinking about more thoroughly? I guess, FLT3? We will be presenting data showing combination therapies later in the year. Again, with the appropriate management and guidance, it's an ongoing phase one, and we'll be updating on data on that later in the year. Great. Thank you so much. Thank you, Peter. Your next question will come from Ellen Horste with TD Cowen. Hi, guys. Congrats on the approval. Just a question on sort of comparing the labels across NPM1 and KMT2A. And it looks like there's slightly increasing rates of grade 5 and serious adverse events across the board. And I'm just wondering if this is correlated with increased exposure time to Revuforj and whether this has any implications for earlier line treatment. Yeah. Nick, another question for you. I think it's quite straightforward as well. Yeah. Actually, the percentages of platelet-adverse reactions is quite consistent across the two populations, 3%-4%. So there's not really a material change in that. What I would add, again, in assessing relapsed/refractory AML in a single-arm setting, the causation of an event is very difficult to ascertain at times. And across now 251 patients that the FDA reviewed extensively, there were a total of nine, now platelet-adverse reactions, 4%. So actually a very consistent rate with previously. But again, in the interest of transparent labeling, we included, although direct association and causality with Revuforj is extremely difficult to establish. As we get more data with randomized control studies with the control arm, I think we'll be able to further ascertain the direct causality if there is one with Revuforj. But it's very consistent across the two populations. And again, a very low rate considering the 251 patients. And of course, reflecting the fact that these patients have refractory AML with untreated has a median overall survival of somewhere in the order of three months. Thanks. That's helpful. Thanks, Ellen. Your next question will come from Justin Zelin with BTIG. Brad, from the approval. Could you share your expectations for duration of therapy for NPM1 patients and also expectations on transplant rates as far as bridging to transplant after to Revuforj versus remaining on the therapy long term? And can you just talk about how it differs meaningfully from the KMT2A population? Sure, Justin. Thanks for the question. Maybe I'll start, and Nick can jump in. So expectations for duration on therapy here, I mean, I think it's consistent with what we saw in our trial. It takes roughly two to three months to get a response, and then duration of response being four and a half months. So time on therapy is in the range of seven, eight months across the different populations. That's, of course, patients who don't respond as well as patients who do respond, stay on therapy, as well as patients and we saw 11% of patients get transplanted here, which is higher than you would expect in this population. Again, third and fourth line patients in our trial, many have received venetoclax, about three-quarters have received prior venetoclax, and about 25%, 20%-25% had a prior stem cell transplant. So we were seeing if you have those patients also going to transplant, the 11%, and you kind of look across those populations, we're talking about roughly seven, eight months is a reasonable expectation in later line patients. But I would also highlight that we expect, as we've seen with Revuforj, patients will be treated likely earlier than fourth line in clinical practice. So I do believe that number could grow and get longer in terms of duration of therapy, which is exciting. We also believe, as your second question indicates, the transplant rates that we're seeing with Revuforj and KMT2A, as we've reported, about a third of patients going to transplant. That's up from our earlier reported clinical experience of 25%. And if you look at NPM1, that's likely in some respects, as patients move earlier in treatment, that number could grow in terms of percentage. So we're very excited about the opportunity, and we think this could be very good for patients long term. Of course, we got to get the drug into the market and into the hands of patients so they can start to utilize it. Excellent. Thanks for taking the questions and congrats again. Yeah, Justin, thank you. Your next question will come from David Dai with UBS. Hey, great. Thanks for taking my questions. And also congrats on the approval. So it's telling me on the fatal adverse reactions we're seeing with nine patients who were included in label. Now, we just see there's out of that nine, there's four patients with sudden deaths, whereas compared to last time, you only have one sudden death. So I just want to understand some detail around those three additional sudden deaths. And does that kind of manifest in some of the characteristics of the NPM1 patients? David, thanks for the question. Again, I'll turn it over to Nick to go through that. Yeah. No, thank you for the question. And again, I would suggest that the adverse event profile is very consistent with the previous label and the current label, both in terms of fatal adverse reactions and overall. And that was not obviously what contributed towards the boxed warning for the case of Torsades. Now, when you are looking at adverse reactions of death, those are not necessarily investigator-assigned causality. Those are cases of, again, fatal reactions that are ultimately adjudicated by the FDA, but where it's not absolutely clear what the cause is. In a setting where there's very high mortality, sometimes deaths without an obvious cause where a patient maybe hasn't had a postmortem, it's very difficult to assign causality. And they are sometimes reported as a fatal adverse reaction where, if there isn't an obvious alternative explanation, it could be included as a sudden death. But what I would say is that it's extremely consistent with the previous labeling. And again, I think in a setting of AML, again, I would focus towards the efficacy. I think that physicians are very much driven by the efficacy and the 48% overall response rate and the nearly two years median overall survival. And that when you're making a decision in a treatment setting with such poor outcomes and comorbidities, that it's often the efficacy that will drive treatment decisions and that we have found the tolerability profile to be well managed in general across the program. Great. Thank you so much for the color. Thanks, David. Your next question will come from Mayank Mamtani with B. Riley Securities. Thanks, team. Congrats on the approval. Appreciate you taking our question. Three quick ones clarifying. So when you say your launch can look different than the AML analogs, could you maybe just comment? Do you mean the curve also versus maybe the end market also that you mean? And then second question on any protocol amendments being considered for the frontline trial, the one already ongoing, or as you think about the intensive chemo trial also starting? And lastly, if you're able to preview the data in some way that you intend to have at ASH and then later this year, and just holistically, what we can learn about the safety of the drug. Thanks for taking our question. Yeah. Thank you so much for your questions. First question, before we move over to the launch and the analog question that you asked, maybe I could just handle the protocol amendments being considered. I would say no. I think we're in good shape, and we're ramping up. Obviously, we've had our frontline trial with venetoclax, the HOVON trial initiate, and that's enrolling nicely, and then in terms of other trials we have, we're starting up. We're well underway and in good shape, so I would just say no in terms of protocol amendments being considered at this point, and then maybe I'll turn it over to Steve to talk about the launch analogs. Yeah, happy to answer the question on analogs. And I think the data I'd provide is really through June. We're not up to next earnings call, which will be in, I guess, a couple of weeks from now. But it doesn't matter what you look at in terms of launch analogs, whether you look at prescriptions, net sales, accounts prescribing, or formulary coverage, Revuforj really has distinguished itself amongst that pack. I think it's been a higher launch base, meaning getting more patients on drug earlier and also driving it much faster. That's where we stand. We think we're in a great position for the rest of the year, and I'll be excited to share performance at an upcoming meeting. Right. I'll just maybe say in terms of the ASH data and whatever we plan to be presenting at ASH, those abstracts will go live in the early part of November, so we're going to reserve judgment until those come out, and we'll have plenty to say about our presence at ASH, which is always robust and exciting for the company, and now that we have two approved agents and we're investigating lots of different new areas to hopefully take them in diseases of importance, we'll have a lot to say at ASH, so let's hold that, but looking forward to discussing that with you soon. Thank you. Once again, if you have a question, you may press star five on your telephone keypad. Our next question will come from Stephen Willey with Stifel. Yeah. Thanks for taking the question and congrats on the label expansion. I know you talked about the difference in patient demographics here between these different subgroups for which you're now labeled, but just wondering if there was a meaningful difference in the number of screen failures in the clinical trial experience as a function of having a baseline QT interval above the 450 threshold. Steve, thanks for the question. I'll turn that over to Nick to answer that. So a couple of comments I would make. Obviously, this is a slightly different population. KMT2A was a younger population. You do tend to see increased QT as you age, and that's something that's accommodated for. So to meet the requirements, there was potentially a higher rate of screen failures. But again, if you look at the overall QT prolongation, and in particular, if you look at the greater than 500 millisecond adverse events in this cohort, and it's that grade three, greater than 500 milliseconds that I think you want to focus on much because that's the one that has the highest association with QT and ventricular tachycardia, then actually it's very comparable across the two populations, KMT and NPM1. So in terms of QT prolongation, quite similar across the two populations. Very consistent profile, interestingly. All right. Thanks for taking the question. Thanks, Steve. Our final question today is from the line of Jason Zemansky with Bank of America. Hi, this is Jackie on for Jason. First off, congrats on the approval, and thanks for taking our question. I'd just like to ask a follow-up on your comments earlier regarding the duration of therapy, at least in the real-world setting. So we've heard from our docs that many of their relapse refractory patients have had prior exposure to a menin via a clinical study, which is likely to grow given the initiation of the pivotal. Can you speak to what you've heard? Is this reflected in your guidance insofar as your duration of therapy assumption? Yeah. Thanks so much for your question, Jackie. I think our duration of therapy calculation is based off of what we've seen in clinical trial. Remember, we're talking about average third, fourth line patients in a clinical trial who had received 75% had received venetoclax, as I mentioned. Many had received a stem cell transplant. So these are heavily pretreated patients who had seen standard of care therapy almost across the board, I would say. And so, yeah, so the calculations that we're talking about here have everything in terms of everything in it. So it has all these assumptions built into it as you're asking about. Okay. Great. Thank you so much. Thank you. This concludes our question and answer session. I'll now turn the floor over to Mr. Michael Metzger for any closing comments or closing remarks. Great. Thank you. Thank you Thank you all for joining us today and to discuss this really exciting milestone for patients, clinicians, and for Syndax. We appreciate your continued support and look forward to connecting with many of you again soon at the upcoming investor conferences at ASH and at our upcoming quarterly call. With that, have a great evening.