Good day, everyone, and welcome to the Syndax Third Quarter 2023 Earnings Conference Call. Today's call is being recorded. At this time, I'd like to turn the call over to Sharon Klahre, Head of Investor Relations at Syndax Pharmaceuticals. Thank you, operator. Welcome, and thank you all for joining us today for a review of Syndax's Third Quarter 2023 Financial and Operating Results. I'm Sharon Klahre, and with me this afternoon to provide an update on the company's progress and discuss financial results are Michael Metzger, Chief Executive Officer, Dr. Neil Gallagher, President and Head of R&D, and Keith Goldan, Chief Financial Officer. Also joining us on the call today for the question and answer session are Dr. Peter Ordentlich, Chief Scientific Officer, and Dr. Anjali Ganguli, Chief Business Officer. This call is accompanied by a slide deck that has been posted on the investor page of the company's website. You can now turn to our forward-looking statements on slide 2. Before we begin, I'd like to remind you that any statements made during 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 10-Q, as well as other reports filed with the SEC. Any forward-looking statements made represent our views as of today, November 2, 2023 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 at Syndax. Thank you, Sharon, and thank you to everyone joining us on the webcast. This continues to be an exciting year for Syndax, and I look forward to sharing a number of updates with you on the significant progress we've made. Throughout the Q3 we delivered on key pipeline milestones that are highlighted on slide 3, including reporting positive top-line AGAVE-201 pivotal data of axatilimab for the treatment of chronic graft-versus-host disease. We also reported positive top-line pivotal AUGMENT-101 data for revumenib in adult and pediatric patients with relapsed refractory KMT2A rearranged acute leukemia. Together, these results put us on a clear path to becoming a commercial-stage biopharmaceutical company in 2024, with two potentially first and best-in-class products. We are also happy to provide data today from additional relapsed or refractory NPM1 patients that were enrolled in the final stages of the phase 1 portion of the AUGMENT-101 trial. Neil will walk us through the data a little later in this call, but in summary, we are encouraged by the 36% CRc rate and deep responses that we are seeing in the NPM1 population. Responses elicited by revumenib in the NPM1 population are durable, with some patients in remission beyond 22 months, further supporting the rationale that revumenib can provide a meaningful benefit to NPM1 patients and emphasizing its blockbuster commercial potential across both KMT2A and NPM1 acute leukemia. We continue our positive momentum heading into the end of 2023, with a primary focus on completing two potential regulatory filings by year-end and launching both drugs in 2024. This will put Syndax in a very unique position to create value as a midcap biotech company. We will have a significant presence at the American Society of Hematology, ASH, annual meeting, including at our planned investor event, and expect to provide several data updates on both these programs at that time. I am pleased to share that as of a few days ago, we initiated the NDA submission of revumenib for KMT2A acute leukemia under the FDA's Real-Time Oncology Review program, or RTOR. We view RTOR as a significant benefit for the revumenib program. It complements our BTD and Fast Track status for KMT2A and provides a more efficient review process to ensure that revumenib is available to patients as early as possible. Under RTOR, the sponsor has consistent engagement with the FDA throughout the submission process. Drugs are accepted for review into this program need to meet specific eligibility criteria, the most important of which is the likelihood of demonstrating substantial improvement over available therapy. In accordance with FDA guidance for AML, and in line with the approvals of other AML agents in the relapsed refractory setting, we anticipate revumenib would be granted full approval based on the results of AUGMENT-101. With our partner, Incyte, we also remain on track to complete the BLA filing for axatilimab by year-end. As you saw from our press release earlier today, data from both the AGAVE-201 and AUGMENT-101 pivotal trials, including post-transplant maintenance data, along with revumenib combination data from the SAVE trial, will be presented at the ASH meeting in December. Beyond the co-Congress presentations, we will also have the opportunity to share additional data from ongoing revumenib combination trials at our ASH investor event, which will further reinforce revumenib's compelling clinical profile and meaningfully add to its value proposition. We are well-funded with $379 million in cash as of September 30. Our current balance sheet not only supports our planned commercial launches and the trials that we have outlined, but also allows us to expand beyond our core registration indications and pursue select business development opportunities. Now let's dive into revumenib, our highly selective menin inhibitor. I'll ask Neil to provide a recap of the results from the AUGMENT-101 pivotal trial, speak to the ASH abstracts and review the data from the NPM1 patients in the phase 1 portion of the AUGMENT-101 trial. Neil? Thank you, Michael. I will now review the AUGMENT-101 pivotal data in relapsed refractory KMT2A acute leukemia, beginning on slide 4. As previously reported, the Independent Data Monitoring Committee reviewed the data and recommended that the trial stop early for efficacy, in accordance with a predefined interim analysis. We are very pleased with the robustness of the data that we reported. Almost two-thirds of these heavily pretreated patients achieved clinically significant responses, enabling many to receive potentially curative transplant. Importantly, a high proportion of responders in the trial were started on revumenib in the post-transplant maintenance setting. The desire for physicians to restart revumenib as post-transplant maintenance speaks to its efficacy and tolerability, and their belief that it may offer a better outcome for their KMT2A acute leukemia patients. Importantly, the ability of these heavily pretreated patients to both respond to and tolerate revumenib therapy also underscores its potential to be adopted into frontline combinations. Turning to slide 5. The majority of patients in the efficacy-evaluable population, which include adults and pediatric AML and ALL patients, achieved clinically significant responses to treatment, with a high overall response rate of 63%. The CR/CRh rate in this population was 23%. The response rates, observed in KMT2A AML specifically were consistent with those in the overall efficacy-evaluable population, with 65% achieving a response and 24.5% achieving CR or CRh. The MRD negative rate among CR/CRh responders was also impressive, at 70%. At the time of the data cut-off, the median duration of CR/CRh response was 6.4 months across both the efficacy-evaluable and AML populations, with 46% or 6 patients remaining in response. Of note, this is a Kaplan-Meier estimate, and the data will continue to mature over time. Therefore, the median DOR may extend beyond 6.4 months with additional follow-up. Turning to Slide 6. Not only did we observe a high overall response rate of 63%, but 39% of responding patients proceeded to bone marrow transplant, which is notably higher than the historical benchmark in this population of less than 5%. Eight patients were transplanted prior to achieving CR/CRh at the discretion of the attending physician. Clearly, if physicians had decided to wait a little longer prior to transplant, then more of these patients could have achieved a best response of CR/CRh. For example, if all 8 of these patients had achieved CR/CRh, then the rate would have been 37%. Seventy-one percent of these patients, 10 of 14, either restarted revumenib or were eligible to restart as maintenance therapy. At the time of data cut-off, some patients were treated in the maintenance portion for as long as 8 months, and several are continuing on therapy, which we believe speaks to revumenib's compelling overall clinical profile and the potential for long-term maintenance in this setting. The ability of revumenib to rapidly induce blast-free responses in heavily pretreated patients, thereby enabling them to undergo potentially curative bone marrow transplant, followed by post-transplant maintenance, represents a potential paradigm shift in the standard of care in this setting. We have a presentation at the ASH meeting that will highlight revumenib for post-transplant maintenance, including patients on therapy in remission beyond 18 months. The data from AUGMENT-101 indicate that revumenib is well tolerated, and the safety profile is consistent with what was previously reported. We believe that the emerging benefit-risk profile of revumenib supports its use, not only as a monotherapy in the relapsed/refractory setting before and after transplant, but also its potential use in combination with frontline standards of care, for which initial data will be forthcoming later this year. Turning to slide 7. Today, we announced encouraging data from 3 additional patients with NPM1-mutated relapsed or refractory AML, included in the phase 1 portion of the AUGMENT-101 trial, for a total of 14 NPM1 patients treated at doses meeting the RP2D criteria. These patients were enrolled in phase 1 to complete the pharmacokinetic characterization of revumenib. Among these 14 patients, 7 achieved a response to treatment for a 50% overall response rate. Five of 14 achieved a CR or CRh, a rate of 36%, and 100% of the CR/CRh responders were MRD negative. On slide 8, you may see that these responses were, are durable, with four of five of the patients remaining in response, three already beyond 6 months, one beyond 22 months, and one over 30 months at the time of the analysis. Revumenib also enabled 43% of NPM1 responders to proceed to transplant. One of the patients who proceeded to transplant had been enrolled following the AUGMENT-101 protocol update, which allowed patients to restart revumenib post, post-transplant. This patient remains on revumenib maintenance at the time of the analysis. Similar to the phase 2 results observed with KMT2A population, revumenib was well tolerated in patients with relapsed refractory NPM1, AML. There were no grade 4 or 5 QT prolongations, no patients experienced more than grade 2 differentiation syndrome, and no patients discontinued due to treatment-related adverse events. As Michael said earlier, these data continue to support our conviction that revumenib will be an important treatment for NPM1 AML, as well as from KMT2A acute leukemias, and we expect that, NPM1 pivotal trial results will be consistent with the data generated to date and highly supportive of a first-to-market approval. The pivotal cohort of the AUGMENT-101 trial continues to enroll relapsed refractory NPM1-mutant AML patients. The trial is designed to enroll 64 patients and up to 20 pediatric patients. While the trial continues to recruit well in the U.S. and internationally, we now forecast completion of enrollment in the late Q1 or early Q2 next year due to a few high-enrolling sites in Europe coming online later than we expected in the Q3, coupled with the recent events in Israel, where we have a high concentration of sites. I would note that Israel accounts for 16% of our enrolling sites, and historically, these have been very high enrolling. We are now looking to make up for any potential shortfall at our sites, but it's difficult for us to predict the impact that the evolving geopolitical situation may have on enrollment. Nonetheless, we expect to be in a position to report data in the Q4 of 2024, and importantly, continue to look forward to a potential approval in 2025 based on an sNDA filing following revumenib's anticipated initial approval in KMT2A. Turning to slide 9. In addition to sharing the AUGMENT-101 pivotal data at ASH, we look forward to Dr. Ghayas Issa highlighting his SAVE trial results in an oral presentation on Saturday morning during the meeting. This is an investigator-sponsored phase 1B trial conducted by Dr. Issa at the MD Anderson Cancer Center, evaluating an all-oral combination of revumenib with venetoclax, and a fixed-dose combination of decitabine and cedazuridine in children and adults with relapsed refractory AML or mixed phenotype acute leukemias. At the time of the data cutoff, the trial was enrolling at the current monotherapy RP2D of 163 mg every 12 hours, with a strong CYP3A4 inhibitor. In total, 8 patients with either NPM1, KMT2A, or NUP98 mutations were enrolled in the trial, having received 2.5 median prior lines of therapy. Approximately two-thirds of patients received prior venetoclax. All patients on a strong CYP3A4 inhibitor were on a strong CYP3A4 inhibitor and were therefore treated with revumenib at either 113 mg Q12 hourly or 163 mg Q12 hourly. Seven of 8 patients were evaluable for response. All 7, 100%, achieved a response. Six of 7 achieved a CRc, and 2 of 7, 28%, achieved a CR or CRh. Importantly, responses were observed across relapsed or refractory NPM1, KMT2A, or NUP98 acute leukemia patients. Three patients transitioned to hematopoietic stem cell transplantation following response, and two continue in remission and have started maintenance as of the data cutoff. We are highly encouraged by the combinability of revumenib with venetoclax and the hypomethylating, hypomethylating agent in this trial. This combination was well tolerated to active doses, including the current monotherapy RP2D. I'll now turn the call back to Michael. Thank you, Neil. Turning to slide 10, we believe that revumenib could form the backbone of treatment for patients with KMT2A-rearranged and NPM1-mutant acute leukemias, and as demonstrated by its compelling efficacy and safety profile, we have expanded our clinical strategy beyond the relapsed or refractory setting into earlier settings and post-transplant maintenance, including combinations with approved therapies. In an attempt to accelerate the generation of evidence of clinical benefits seen with revumenib across various settings of KMT2A and NPM1 acute leukemias, we are collaborating with cooperative groups and leading investigators in addition to the clinical trials that Syndax is conducting. In addition to the SAVE trial that Neil described earlier, we plan to present initial data from the BEAT-AML and AUGMENT-102 trials in the Q4 at our planned investor event at ASH. The phase 1 BEAT-AML trial is part of our collaboration with the Leukemia & Lymphoma Society, and revumenib is being combined with venetoclax and azacitidine to treat newly diagnosed AML patients who are unfit for induction chemotherapy. Enrollment is ongoing in the dose-finding stage of the trial to confirm the RP2D for this combination, and we continue to expect to share data on safety and efficacy from the trial at our ASH investor event. The AUGMENT-102 trial is designed to assess the safety of revumenib in combination with standard salvage chemotherapies for patients with relapse or refractory acute leukemias. We anticipate presenting an update on the initial safety and potential RP2D from the trial at our ASH investor event. We look forward to initiating a trial of revumenib in combination with standard of care intensive chemotherapy, known as 7+3, in newly diagnosed patients with acute leukemia in late 2023 or early 2024. This trial will also include an option for maintenance with revumenib monotherapy. Beyond the acute leukemia trials we've laid out here, we are enrolling a proof of concept, signal-seeking phase 1 clinical trial in metastatic colorectal cancer based on compelling preclinical science, supporting the role of the menin in KMT2A interaction in beta-catenin-driven tumors. The trial is advancing nicely through the dose escalation phase, and we are nearing an RP2D. We would perceive responses or prolonged stable disease as encouraging in this difficult-to-treat patient population with a monotherapy, and we expect to follow these patients to gather sufficient efficacy into 2024. We anticipate being able to provide an update on the progress of the dose escalation phase of the trial in the Q1 of 2024. Now to slide 11. KMT2A and NPM1 acute leukemias represent up to 40% of AML patients, and there are no FDA-approved targeted therapies for this population. Including the expansion opportunities, there is the potential to address upwards of 12,000 NPM1 mutant and KMT2A rearranged acute leukemia patients across various settings. We are committed to bringing these encouraging clinical benefits to even more patients, as this remains an area with significant unmet need. We believe that relapsed or refractory KMT2A acute leukemias alone represent a $650 million-$750 million market opportunity in the U.S. based on the estimated patient population, duration of treatment, and current pricing assumptions. KMT2A rearrangements represent approximately 10% of AML and ALL, which translates into an incidence of approximately 2,600 KMT2A rearranged acute leukemia patients, a very high percentage of whom are refractory to frontline standard of care treatments. Based on the enthusiasm we are hearing from physicians and the potential to shift the treatment paradigm in KMT2A to incorporate maintenance treatment post-transplant, we believe the median duration of therapy across the treatment population would be approximately 9 months, and we believe the data generated in AUGMENT-101 support pricing competitive with or above other targeted therapies in AML, such as FLT3 or IDH inhibitors. With no treatment options approved for these patients and no near-term competition, revumenib could easily become the treatment of choice for all patients with KMT2A acute leukemia, based on obtaining the only age and disease-agnostic label in KMT2A acute leukemia. We expect that our first-mover advantage and experienced physicians will gain treating their patients with revumenib could extend meaningfully beyond KMT2A and allow us to build a formidable franchise in the next few years. Supported by the compelling NPM1 data we presented today, we believe revumenib will also provide meaningful benefit in relapsed or refractory NPM1 patients. Our market research suggests that if approved, oncologists are likely to reach for revumenib as either their second or third-line agent of choice for patients with NPM1 mutant AML. We estimate that this population will be slightly larger than relapsed refractory KMT2A acute leukemia population, and based on our phase I results, we also believe overall efficacy and treatment duration will be consistent between the KMT2A and NPM1 populations. Having first-mover access to two distinct market segments in acute leukemias, KMT2A and NPM1, creates a total accessible population of 5-6,000 patients in the relapsed refractory setting and an addressable market opportunity of approximately $1 to $1.5 billion for revumenib in the U.S. alone. We anticipate that revumenib will begin to carve out a dominant share of the relapsed and refractory NPM1 market starting in 2025. Now, let's dive into axatilimab, our monoclonal antibody targeting the CSF-1R, beginning on slide 12. In collaboration with Incyte, we shared positive results from the global pivotal AGAVE-201 trial, evaluating the efficacy, safety, and tolerability of axatilimab in 241 patients with active chronic GVHD, whose disease had progressed after at least two prior therapies. As a reminder, the trial met its primary endpoint of overall response rate by cycle 7, day 1, using the 2014 NIH consensus criteria for chronic GVHD across all three dose groups. The overall response rate or ORR was 74% at a dose of 0.3 milligrams per kilogram, administered every 2 weeks. The responses were durable, with a median duration of response not yet reached at the time of data cutoff, and 60% of responders were still responding at 1 year. Axatilimab was well tolerated in the trial, with a low 6% discontinuation rate, and the most common adverse events were consistent with the on-target effects that were observed in prior trials. I want to remind you that robust efficacy was observed despite the patients being very advanced and heavily pretreated. As an example, I would highlight that there are meaningful differences in patient populations between the axatilimab AGAVE-201 trial and the Rezurock ROCKstar trial, both of which targeted patients with chronic GVHD who had received two or more prior lines of therapy. Notably, patients in the AGAVE-201 trial had a longer median time since diagnosis, more severe chronic GVHD, and had received more prior lines of therapy, including a greater number of patients that received Jakafi than patients included in the Rezurock trial. We believe these points of differentiation underscore just how impressive the AGAVE-201 trial results are and point to the significant value axatilimab could bring to patients if approved. These results not only support the promise of axatilimab's safety and efficacy profile, but reinforce its potential as a first and best-in-class CSF-1R monoclonal antibody in chronic GVHD. Axatilimab is the first investigational chronic GVHD treatment to target inflammation and fibrosis through the inhibition of disease-associated macrophages, and the AGAVE-201 data demonstrates the potentially pronounced impact this mechanism, alone or in combination with standard of care therapies already available for the management of this disease, may have on patients suffering from chronic graft-versus-host disease. In collaboration with Incyte, we intend to file a BLA by year-end 2023. Additionally, we look forward to showcasing the full results during the plenary session at ASH. Turning to slide 13, approximately 14,000 U.S. patients suffer from chronic graft-versus-host disease, 50% of whom require treatment beyond second-line due to disease progression, inadequate response, or disease manifestations that aren't wholly addressed with current treatments. Unfortunately, there are no cures for this advanced population of chronic GVHD patients. Patients are initially treated with corticosteroids and then cycled through a variety of additional therapies. While patients may be treated with several of the approved therapies, the order in which they are used may depend on the physician's experience with how a given agent may address specific manifestations of the disease. Jakafi and Rezurock have had successful commercial launches, which speaks to the unmet need in chronic GVHD that translates to a substantial commercial opportunity. It is our conviction that axatilimab could provide an effective, differentiated, practice-changing intervention for this underserved population. Axatilimab suppresses monocyte-derived macrophage activation and proliferation, which may provide more comprehensive control of the disease than currently approved therapies. This is a key differentiator and also supports moving axatilimab earlier in the treatment paradigm to potentially prevent organ damage before it occurs. Because axatilimab is an antibody, drug-drug interactions are expected to be minimal, and axatilimab's unique mechanism of action may offer the benefit of being an ideal combination partner with standard of care therapies currently used for the treatment of chronic GVHD. The opportunity to expand to ex-US markets and additional high-value in patients, as well as combinations in earlier settings in chronic GVHD, both in adults and pediatrics, could build significant additional value for axatilimab. We are looking forward to the initiation of additional trials of axatilimab, including a 26-week randomized placebo-controlled phase II trial in 135 idiopathic pulmonary fibrosis patients, expected to begin by year-end, as well as a combination trial to be conducted by Incyte in chronic GVHD patients with Jakafi in mid-2024. I will now turn the call over to Keith to review our financial results. Keith? Thank you, Michael. Let me take a few minutes to discuss our financial results for the quarter ended September 30, 2023. Turning to slide 14, the results of our operations for the Q3 of 2023 and the comparison to the prior year's quarter are included in our press release, so I won't repeat them in these remarks. Additional financial details are available in our Q3 2023 report, which was filed earlier today on Form 10-Q. I'd like to point out that our net loss for the Q3 was $51.1 million, or $0.73 per share, compared to a net loss of $35.4 million, or $0.58 per share, for the comparable period last year. The difference in our net loss was driven largely by an increase in employee-related expenses and professional fees within both SG&A and R&D, combined with increased clinical and manufacturing expenses. We ended the Q3 with $379.3 million in cash equivalents and short- and long-term investments, and 69.9 million shares in pre-funded warrants outstanding. Our balance sheet is expected to provide runway into the second half of 2025, which allows us to appropriately invest to maximize the value of our pipeline, and importantly, it also allows us to transition into a commercial stage organization in 2024. Looking ahead, I'd like to provide financial guidance for the rest of this year. For the full year of 2023, the company expects research and development expenses to be $160 million-$165 million, and total operating expenses to be $225 to $230 million, both of which are inclusive of approximately $30 million of non-cash stock compensation expense. Note that this is a reduction from our prior guidance of $160 to $175 million for R&D expense and $225 to $240 million for total operating expenses. With that, let me now turn the call back over to Michael. Thank you, Keith. Before we open the call for questions, I'd like to provide a summary of what was presented today. In the near term, we remain laser focused on delivering quality data readouts, including the full AUGMENT-101 and AGAVE-201 datasets, as well as data from several other combination trials at the ASH annual meeting and our planned investor event by year-end. We are excited to provide positive final phase 1 results for revumenib treatment in relapsed refractory NPM1 patients, further demonstrating its best-in-class profile in another important indication with high unmet medical need. Pivotal data from these trials will serve as the basis for potential U.S. registrational filings, including an NDA submission in relapsed refractory KMT2A acute leukemia for revumenib, and an Incyte-initiated BLA submission in chronic GVHD for axatilimab by year-end 2023. Both revumenib and axatilimab have significant market opportunities, with the potential to quickly gain considerable market share and have a meaningful impact on the lives of underserved patients in each setting. In addition, we continue to explore ways to capture the maximum value of our current pipeline by expanding into opportunities beyond the initial registration indications, and in doing so, aim to bring the encouraging clinical benefits of our lead candidates to even more patients in need. It has been a transformational year for Syndax, and we expect to maintain this momentum in the coming months with a number of upcoming value-generating milestones that are laid out on slide 15. I remain confident that we have the resources and expertise to execute on our goals and the strategic long-term vision that will enable our successful transition into a commercial stage biopharmaceutical organization. As always, I would like to extend my gratitude to the Syndax team, collaborators, and most importantly, the patients, trial sites, and investigators involved with our clinical programs. Through your integral work, we are advancing our mission of realizing a future with which people with cancer live longer and better than ever before. I'd also like to thank our committed long-term investors, who continue to share in our vision and support us in building Syndax. With that, I would like to open the call for questions. Operator? If you would like to ask a question, please press star five to raise your hand. That's star five to raise your hand to ask a question. Our first question is from Brad Canino at Stifel. Your line is now open. Please ask your question. Hi, and thank you for the questions. Looking forward to ASH. I have a two-parter on the SAVE trial, actually, the all-oral triplet, where you had the abstract.... Yes, first, when you speak to AML physicians, do you get the sense they're looking to use off-label combinations in the relapsed refractory setting? Because if we on the street that are anchored to your monotherapy data, I guess, what might that then mean about the ultimate opportunity in this treatment line in relapsed refractory as we think about efficacy, percent to transplant, maintenance, et cetera? And then I have a follow-up. Yeah, Brad, thanks for the question. I'm going to ask Neil to make a comment. Yeah, look, thanks for the question. Obviously, this is a preliminary dose ranging, and there's more work to be done. We see the value in the data that Dr. Issa is generating in a couple of different ways. So, first of all, you know, the demonstration of the combinability of revumenib with venetoclax and a hypomethylating agent, I think is very important. And the study is ongoing with revumenib being administered at full dose in cycle 1, as was mentioned in the abstract. The other thing to bear in mind is that historically, if you look at this population, you know, they're quite heavily pretreated. Most of them have actually failed venetoclax and a hypomethylating agent. You know, one would expect the response rate, therefore, to venetoclax plus an HMA to be quite low, actually, probably less than 10%. Here we're seeing much, much higher response rates than a 28% CR/CRh rate. So this is actually, you know, incremental progress, albeit based on early data, incremental progress, for those patients. Great. And then- Did you have a second question? Yeah. Go ahead. On the safety for the regimen, I guess, is this higher in more prolonged myelosuppression than would be expected from the components? You know, and how are you thinking about this, too, as, as we think about the frontline Vena combo, that might be a different patient population in terms of, you know, how myelosuppression might affect them? Thank you. Yeah, thanks for the question. Just continuing on. So, well, as the authors themselves conclude, the safety profile is what you would expect from Ven and the hypomethylating agent. So there's no, you know, the triplet, if you can call it a triplet, appears to be extremely well tolerated, right? For among heavily pretreated patients. And just going to your point about what does this mean, as we advance the combinations in earlier-stage patients, I think it signals good things, right? Because if heavily pretreated patients can actually tolerate the combination, then it is highly likely that less heavily pretreated patients will also tolerate the combination well. So we are encouraged. As I mentioned during my prepared remarks, we're... You know, overall, when we look at the data that, that are evolving, some of the data that we've presented today, we're highly encouraged for the opportunity to advance revumenib into earlier-stage combination therapies. Thanks, Brad. Great. Our next question is from Anupam Rama at JP Morgan. Your line is open. Please ask your question. Hi, this is actually Malcolm Kuno on for Anupam. Thank you for taking the question. What additional data are you planning to present at ASH on AUGMENT-101 KMT2A versus what we already know from the top-line data? Thank you. Yeah, Malcolm, thank you for the question. So as we had previously said, and I think we said in the remarks, you know, obviously, we've presented top line in recent days, and we'll be at ASH. We have an abstract that came out today, that explains that we'll have a presentation at ASH at our investor event. I think the data that's been top-lined is the data cut, but we'll have additional analyses that I think go into more specific detail around, around, you know, that particular data cut, whether it's, you know. And then not to speculate specifically around what we're going to present, but I think there are some important analyses that will allow people to get a even deeper feel for what, for what we presented previously. So stay tuned, but we'll have, you know, obviously, more data at ASH and then, again, at our investor event. Excellent. Thank you. Our next question is from- Thank you. Our next question is from Chris Shibutani at Goldman Sachs. Your line is open. Please ask your question. Hi, good afternoon. Thank you so much for taking our questions. This is Charlie on for Chris. Just to kind of follow up on the last question, wondering if we have the same data cut for the AUGMENT-101 presentation at ASH. So it sounds like we're gonna assume the same 57 patients that we had for the top-line results. Just wondering, with the rolling submission with the FDA currently, are they going to be looking for those additional 37 patients that are after that data cut? Thank you. Yeah, Charlie, thank you. You're correct. It is the same data cut at ASH. I mean, we're very focused now on getting our NDA filed, and as you noted, under RTOR, we have a pretty rigorous and short timeline to complete the filing by year-end. So it is a rolling submission. The agency has very specifically agreed to our, you know, data plan, which is again, efficacy on the 57 patients, with safety on the overall 94, which we outlined when we top-lined the data, and confirmed through our pre-NDA meeting and at our RTOR, you know, beginning our RTOR process. So the data will be. They see all the data, but there's no new data cut required from an advocacy standpoint, and the safety obviously will be submitted as such. So that's, that's the way to look at it. ... Okay, great. Thank you so much. Thank you. Our next question is from Yigal Nochomovitz. Please unmute yourself and ask your question. Hi, team. This is Asher on Yigal. Thanks for taking my question. I just had one on the post-transplant setting data you shared. It seems like you're getting some very long durability in terms of patients staying on drug for long periods of time post-transplant, which is great. I guess, how are you thinking about the commercial opportunity sort of on average in terms of duration of treatment in the context of the post-transplant study? Thanks. Yeah, Asher, thanks for the question. I'm gonna turn it over to Anjali to answer that, please. Hi, Asher. Thank you so much for that question. So we've been thinking about and speaking to a number of physicians about how they want to use revumenib based on the data we're generating. And they see that there's an opportunity to treat patients in the post-transplant maintenance setting. The drug is able to get patients to deep durable responses, and they see no downside for continuing them on therapy after transplant. And the goal, I think, would be to keep them on as long as possible, but the standard today is assumed to be close to two years. Obviously, not every patient will achieve that, and not every patient is able to successfully receive a transplant. We estimate that conservatively, duration on average will be close to 18 months. Okay, that's very helpful. I guess a conceptual question on the same topic. What's the decision-making for the physician behind choosing when to end treatment in the post-transplant setting? Is it disease progression, or is there a point at which they kind of determine the benefit, maybe lowering over time? Yeah. Or let's say, the risk of disease progression. Thanks. Yeah, good question. So, Neil, why don't you comment on that? Yeah, thanks. Thanks for the question. As you, as you noted, we're seeing patients actually remaining on the drug for, you know, very protracted periods of time. And, you know, that says to us that, you know, it speaks to the, the tolerability profile of the drug, which, you know, has consistently been very, very good. The feedback... We've obviously talked to investigators and other physicians about this, and, you know, they are very keen when we speak with them. First of all, they wanted this option. Just to remind you, they wanted this option in the study. It wasn't there in the earlier part of the study, and we included it in phase 2, at, at the request of the investigators. So that's, that's one point. The other point is, as we talk to them now, you know, they, they see themselves keeping patients on for protracted periods of time, right? So, you know, they talk about 2 years, right, for instance. But in fact, you know, there's evidence to suggest that patients could stay on longer than that as well. So I don't. I think as long as patients, you know. And remember that these patients are extremely high risk, very heavily pretreated. The KMT2A cohort that we, that we've presented, that we reiterated today, very heavily pretreated, and therefore, you know, there's no. The way the physicians are looking at it is, why take the risk? The drug is getting the patients into response, getting the patients to transplant, well tolerated, and therefore, the patients can go back on it after transplant. Why not just keep the patients on the drug? That's the feedback that we're getting. Got it. Very helpful. Thanks very much. You're welcome. Thank you. Our next question is from Phil Nadeau at TD Cowen. Your line is open. Please ask your question. Good afternoon. A couple questions from us. First, congrats on the 36% CR/CRA rate with the three additional patients. In terms of the, the pivotal trial and NPM1, for revumenib, can you discuss in a bit more detail what, what's the implications of the 16% of enrollment coming out of Israel? Is it that, there's a chance that those patients will be lost to follow-up or, or the data will be lost? How, how does that impact the timelines and the number of patients that you need to enroll? Yeah, thanks for the question, Phil. Look, I think, you know, it's an unfortunate set of events going there. You know, our trial sites are still up and running in Israel. Data is centralized, so we have, you know, obviously good control over the data, not the issue. You know, the implications we think are a little bit hard to predict, but we have a lot of other sites, and we're doing quite well with enrollment elsewhere. So I think that's something we feel very confident we can pick up and complete the trial by the end of the Q1 or very early in the Q2. So it's something that's a little bit unfortunate, but these, you know, as I said, or Neil said in the remarks, these are typically a little bit unfortunate. But we feel very confident that we'll be able to get it done on time. Got it. That's helpful. And then, a follow-up question on the SAVE trial. I believe the abstract said that enrollment continued in SAVE and additional or updated data was presented at the meeting. What can we expect in terms of patients at dose level 1 at ASH? I think there were 2 in the abstract. Would there be another 4 at ASH, or could dose level 1 enroll beyond the 6 that were enrolled at dose level 0? Yeah. Phil, thanks for the question. It's a little bit hard to answer at this point. I think they're continuing to enroll at that dose level. As you know, there were only a few that were enrolled so far. The results have been quite, quite strong and striking. So they're looking forward to expand that to additional patients, and that will be obviously presented at ASH in the presentation. But I can't give you specific numbers on how many patients will be expanded to. I just don't have that detail. Fair enough. Thanks for taking our questions. ... Yeah, thank you so much. Our next question is from Jason Zemansky at Bank of America. Your line is open. Please ask your question. Hi, this is Alex a on for Jason Zemansky. Thank you for taking my question. What sort of data do you think is necessary before the community can start to feel confident about revumenib's combinability profile? What do we need to see in terms of both safety and efficacy? Thank you. Yeah, thanks for the question. Well, look, I think the, the data that we generated to date, both as a monotherapy and now, in NPM1 and for KMT2A, really is, you know, a good source of, you know, or I should say, it underpins well what, we would expect to see as a contribution of components, right? When you think about combining drugs, such as with Venclexta and with chemotherapy. So we, we feel very confident that we have best-in-class, monotherapy data, and that's a good starting point. With combinations, first things first, and Neil made comments about this, you need to be able to combine these drugs safely and effectively, but full dose, monotherapy dose, getting to those levels in a combination is extremely important, and the SAVE information, the SAVE trial information that came out today, really supports that. We'll have data at ASH, for the BEAT-AML trial, which is frontline patients. The SAVE trial. That's in relapsed refractory patients, but BEAT-AML is in newly diagnosed patients, and the opportunity to not only safely dose patients, but dose them at the full, monotherapy dose, as well as drive response rates, as you know, you'd hope to be as good or better than what they see in the doublet. That's what we're looking for. And I would also say, MRD negativity is a big driver of physician choice and how they think about treating their patients. We've been able to show, deep, durable responses signaled by MRD negativity, and that's something we'll look at in these combinations as well, where, patients are not necessarily getting to full MRD, negative status. So there's, you know, those are the types of things that we'll look for, and we expect to have, you know, meaningful data for the end of the year to kind of elucidate all that. Our next question is from Peter Lawson at Barclays. Your line is open. Please ask your question. Great. Thanks so much. Thanks for the update for the NPM1 patients. Just, do you have enough data now to file for a breakthrough designation, and do we get an update this data at the Investor Day? And then, are patients going on to transplant, and could that cause a downdraft in the CR/CRh rate in a pivotal trial? Thank you. Yeah, Peter, thank you. So I think you had a couple different questions here. One was, you know, taking it from in reverse order here. So, you know, could patients go on to, you know, go—do we see patients go to transplant? I think the answer in the NPM1 patient, I think the answer is obviously yes. You see that in the swimmer's lane that we have on our slides, as well as, you know, we mentioned in the remarks. So patients are going to transplant. 3 of the patients of the 14 went to transplant, and many of them are staying on treatment for... And also, you know, in remission. So I think that is an important fact pattern. Also important to note are, you know, what we saw in the phase I, sorry, in the pivotal trial for KMT2A, and Neil mentioned it in his remarks, the number of patients who didn't reach complete count recovery, so didn't reach CR/CRh as best response and were taken to transplant very quickly. That actually ended up penalizing us a bit on the CR/CRh rate, and as Neil remarked, it could have been as high as 37% if all those patients had converted and maybe didn't go to transplant as quickly. What we're seeing with NPM1 is the treatment course is a little bit slower in terms of taking patients to transplant. So these patients are also not necessarily as fit as what you'd see with KMT2A, with younger patients. So we're, we're actually not seeing, if you look at the data, we're not seeing patients at CRp or incomplete hematological recovery points. And so what you're seeing is all of our patients are CR/CRh, and MRD negative, and some of them are going to transplant. So it just tells you the time course probably has an impact in terms of reaching your full potential for CR/CRh as an NPM1 patient. So we don't think actually that's going to be meaningfully impactful in the phase II. In fact, we see it as the opposite. We see that the CR/CRh could actually be more reminiscent of what we're seeing now, which in the mid-30s or higher on NPM1. We'll have to see what the data bears out, but we don't think that same treatment paradigm in terms of the speed at which physicians take their patients to transplant is going to penalize in the same way it did for us on the CRCRh and KMT2A. We will have an update. This is the data. We may have some more to say at our investor event on MPM-001, but this is the data that we have in hand, and so we wanted to get it obviously out to you today. We haven't really bottomed out on what else we would analyze for our R&D day, for our investor day, in and around ASH. Maybe there was another question on it. Oh, BTD. Yeah. Um, right. Exactly. Right, Peter. Thank you. So, so look, I think we've said in the past you need approximately 20-30 patients at the RP2D to file for breakthrough therapy designation. As you see here, this is 14 patients at the RP2D. So, right now, we don't expect that we would be able to make that application. Obviously, that's something that's open to us at some point in time relative to our pivotal data, which is obviously coming. So that's it. Thank you. Perfect. Thank you so much. Thanks, Peter. Our next question is from Michael Schmidt at Guggenheim. Your line is open. Please ask your question. Hey, guys. Good afternoon. Thanks for taking my questions. In the NPM1 cohort, how many patients had overlapping, uh, co-mutations, other, other genetic alterations, and potentially have had received other targeted agents prior to receiving revumenib? And how do you expect the dynamic to play out in the pivotal cohort and ultimately on the market? Thanks so much. Yeah, Michael, thanks for the question. So we didn't break out that data in the swimmer's lane. But I'll tell you, as you noticed, we did say that a lot of, obviously, prior therapy for these patients. In terms of co-mutations, I think the vast majority, if not all, were co-mutated. So there were, you know, obviously, variations on the theme of what we saw, but we didn't break that out. But I think, suffice to say, we had most patients were co-mutated. Yeah, and it's obviously representative of what you would think. Okay. And in order to... You know, how does that affect potential sequencing of therapies, should the data be replicated in your pivotal study, you know, if approved, in your opinion? Yeah, I think what you're getting at is whether or not physicians will look at targeting these specific mutations for, you know, for treatment. And obviously, the paradigm for NPM1, at least in the unfit population or the fit population, they get chemo or they get Venclexta up front, and then physicians look to target their mutations with either a FLT3 or an IDH inhibitor. And we do expect that if these patients have those co-mutations, that's what's going to happen in the real world and in our trial as well. So that what ends up resulting, and I think the remarks that I made suggest this, that physicians will be reaching for second- or third-line revumenib after they've taken action against, obviously, frontline, and then after their, you know, they're going after their targeted mutation to the extent they have one. So I think the data that we presented today shows that, right? It shows that patients do extremely well treated in, call it, the third-line, fourth-line setting on our drug. And as they, you know, progress and get into very, very late lines of therapy, which we've had some patients also like that, they don't do as well. So, you know, I think the targeting of these mutations will likely come before revumenib. Thanks so much. Thank you. Our next question is from Kalpit Patel at B. Riley. Your line is open. Please ask your question. Yeah. Hey, good afternoon, and congrats on all the updates today. Maybe a couple more questions related to the maintenance use of revumenib. Now, now that you have all the post-transplant data here, how are you seeing the median duration of treatment for revumenib, you know, between the KMT2A populations and the NPM1 populations? Do you expect them to be very similar to each other? Yeah, Kalpit, thank you for the question. I think, yes, I think we do think it's gonna be very similar. It's interesting how the data converges a bit, right? So you have patients in the KMT2A population that a great percentage go get a high, you know, overall response rate, get taken to transplant and put back on drug and stay on drug and do very, very well. The speed at which they get a best response, first and best response, and then move to transplant is noteworthy in KMT2A. It's a beat slower with NPM1, which probably allows their counts to recover, as I mentioned earlier. But the paradigm is, seems to be similar, right? At least in relapsed refractory disease, where physicians are interested in putting them back on. Once you get to a CR, you take them to transplant, and you put them back on drug. I think that's also new, and it's a new paradigm, but it's actually a very positive fact pattern for the drug in terms of the ability to treat patients for a long time and keep them in remission. So we're actually very encouraged by what we're seeing, both by, you know, the efficacy standpoint and the tolerability and safety standpoint, to allow this to be the new paradigm. So it's quite interesting how it's turned out to be pretty similar. Okay. And then, you know, it, it's nice to see the additional responses in the NPM1 patient population. I'm just curious if you have any more NPM1 patients after that, I believe July cutoff in that data in that phase 1. Yeah, thanks for the follow-up. We do not. That is it. We are, as you know, this is final data in terms of, you know, patients, that's, that's all we have. We were looking to complete the pharmacokinetic work in the phase one, and we had talked about that in the past, and this was... These are the remaining patients to accomplish that. Okay, perfect. Thank you. Thank you. Our next question is from Justin Zelin at BTIG. Your line is open. Please ask your question. ... Hi, thanks for taking the question, and congrats on the progress here. Maybe a question just on the SAVE AML study. I think the abstract showed there wasn't much differentiation syndrome seen here. Can you comment on whether you'd expect differentiation syndrome to be reduced in the combination setting moving forward? Thank you. Yeah, thanks, Justin. The answer is yes. I mean, the data as we've, as we've discussed, the data are, you know, highly encouraging, and I think that clearly the combination with Venclexta, revumenib with ven and the methylating agent is extremely well tolerated. So there's no reason to suspect that, you know, we would see a different pattern as we advance, for instance, as we advance combinations of ven, the methylating agent, into earlier lines of therapy. So I think it's both expected and gratifying to see. Great, thanks. And congrats again on the plenary for axatilimab. Anything additional we should look out for at ASH beyond what we saw at the top line? Justin, I think yeah, thank you. We obviously have the plenary for axatilimab, which is very exciting. I think we'll, we had five abstracts out today, so a lot of information, SAVE, as we talked about, but also some of the combinations. And so we... Yeah, just a lot of interesting information coming your way, and obviously, we'll have lots, lots to say at our event at ASH as well. So I'm looking forward to seeing everybody there. Great, thanks for taking the questions. Yeah, thank you. Our next question is from George Farmer at Scotiabank. Your line is open. Please ask your question. Hi, good afternoon, thanks for taking my question. Neil, you mentioned that the 6.4-month DOR in the AUGMENT-1 trial could get better. I'm wondering if it is it possible it could get worse? We haven't seen any Kaplan-Meier curves, so just wondering what your thoughts are there. And then also in the SAVE trial, the alluded to a previous question about the myelosuppression. Wondering if those patients got any growth factor support and if growth factors were effective, perhaps maybe revumenib had had an impact on on recovery or anything like that, if you could comment. Thanks. Sure. Thanks for the question. So, with respect to the first question, our, you know, we've modeled it out in our... There's a bit of noise on the line, but, with respect to, you know, our expectation is that, the median DOR can extend over time with, with additional follow-up, right? So we've modeled that out, running, various, sorry, I'm blanking on the word, but so statisticians have modeled it out, looking at various, various different scenarios, and, and, we, see multiple different scenarios under which the median DOR could, could extend over time. The, the, to the second point, not to the best of my knowledge with respect to stem cells, or with respect to growth factor support. You know, that, that's not our understanding. Okay, great. And then one more, if I could, on axatilimab. The IPF study, can you just speak kind of high level about the design of that trial? Sure. I'll take that. Yes. As Michael said, in his remarks, it's randomized phase 2. It's randomized, 135 patients. It's a target sample size, randomized 2 to 1, active axatilimab to placebo on a background of best supportive care. So, you know, very succinctly, that is the study design. We think that it's, you know, an efficient way to address the proof of concept question. All right. Is that a 6-month study? 52 weeks? 26 weeks. That's right, 26-week primary endpoint analysis. Okay, good. Thank you. You're welcome. Thank you, George. Our last question is from Joel Beatty at Baird. Your line is open. Please ask your question. Hi, this is Ben on for Joel. Thanks for taking the question. What gives you confidence that payers would support or payers would cover post-transplant maintenance revumenib therapy, if not in the FDA label? Yeah, thanks for the question. Well, look, I think the experience physicians have in treating patients for AML and providing maintenance treatment to those patients who, again, are at high, high risk of relapse, that is, seems to be a very important treatment decision, you know, given by the or taken by the physician. And none of these, these, relapse refractory agents that have been approved have a maintenance label. So it's a sort of a tried-and-true experience with other agents that gives us confidence that this is something that physicians can do and payers will abide by. I think, you know, there's a pharmacoeconomic analysis, of course, that supports this. The high, you know, these are not inexpensive therapies, but this is, these are very seriously ill patients who aren't able to get to, you know, a steady state. So if you can keep them in remission for a long period of time and keep them out of the hospital, that's a very positive driver for any payer. So, I'll also mention that, you know, this kind of experience can get into the guidelines, and, you see it in the guidelines as well. So payers tend to abide by those guidelines in, in making the reimbursement decisions. So I think there are multiple factors in support of this paradigm. You know, I'll also mention that these are rare diseases, and so payer, not one payer is impacted dramatically or disproportionately, I should say, by a high-price therapy being given over an extended period of time. So I think that's, that all kind of factors into the fact, you know, when we hear from physicians that they do this, and they have very little intervention from payers to stop this from happening, there you know seems to be a supportive setup. So that's what I can tell you. That completes the Q&A section of the call. I will now hand back to Michael for closing remarks. Yeah, thank you, operator. Thank you all. We appreciate you tuning in tonight, and we look forward to seeing you at our planned investor events, including the Cowen Fall Oncology Summit tomorrow and the Stifel Conference on November fourteenth, as well as the ASH meeting in December that we talked a lot about today. So with that, I wish you a great evening. Thank you so much.