Please stand by. Good day, everyone, and welcome to the Syndax third quarter 2022 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. Please go ahead. Great. Thank you, operator. Welcome, and thank you all for joining us today for a review of Syndax's third quarter 2022 financial and operating results. I'm Sharon Klahre, and with me today to provide an update on the company's progress and to discuss financial results are Michael A. Metzger, Chief Executive Officer, Dr. Briggs Morrison, President and Head of R&D, and Keith Goldan, Chief Financial Officer. Also joining us on the call today for this question and answer session is Dr. Peter Ordentlich, Chief Scientific Officer, and Dr. Anjali Ganguli, Chief Business Officer. The 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 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 represent our views as of today, November 3, 2022 only. A replay of this call will be available on the company's website, www.syndax.com, following this call. With that, I'm pleased to turn the call over to Michael Metzger, Chief Executive Officer of Syndax. Thank you, Sharon, and thank you to those joining us on the webcast. We made significant progress during the third quarter, and I look forward to sharing the updates with you today. I expect this momentum to continue as we advance towards two pivotal data readouts and potential registration filings in 2023 for our two lead drug candidates, both of which are first and potentially best-in-class treatments. I want to repeat that for emphasis. We anticipate having both an NDA and BLA filing in 2023, an almost unprecedented accomplishment for a small cap biotechnology company, which speaks to our focus and our determination to realize a future in which people with cancer live longer and better than ever before. We have a strong balance sheet that supports our clinical efforts and enables us to aggressively advance our programs through key near-term milestones. We are also fortunate to have Incyte as a strong partner to help us successfully advance one of our lead molecules, axatilimab. Everyone at Syndax is incredibly excited about the opportunities and important milestones ahead. Turning to slide three, we provide a high-level summary of our current corporate priorities. We have designed a broad development plan for both revumenib and axatilimab that is focused on realizing their full potential given their compelling clinical profiles. Starting with revumenib, our highly selective menin inhibitor. Our pivotal Phase 2 Augment-101 trial evaluating revumenib in patients with relapsed refractory NPM1 mutant or MLL-r acute leukemia is ongoing. We expect to report top-line data from at least one of the cohorts from the Phase 2 portion in the third quarter of 2023, and we continue to expect to file an NDA by the end of 2023. This morning, we published a press release highlighting positive updates from the phase 1 portion of the AUGMENT-101 trial that will be presented during two oral presentations at the American Society of Hematology or ASH annual meeting this December. Beyond the AUGMENT-101 trial, testing the effect of monotherapy in relapsed refractory disease, revumenib is the focus of several ongoing and planned trials that present important expansion opportunities in acute leukemias. In addition to acute leukemias, we are on track to initiate our first solid tumor proof of concept trial in colorectal cancer in the fourth quarter of this year. Moving to axatilimab, our antibody against CSF1R. Enrollment is now complete in our pivotal phase 2 AGAVE-201 trial evaluating axatilimab in patients with chronic graft-versus-host disease, and we expect to report data from the trial in mid-2023. We are working in collaboration with our partner, Incyte, to maximize the value of the axatilimab program, and this includes an expected BLA filing by the end of 2023 as well as initiating a trial testing the combination of axatilimab and ruxolitinib in front-line chronic graft-versus-host disease. Looking beyond cGVHD, we expect to begin a phase 2 trial of axatilimab in idiopathic pulmonary fibrosis or IPF in the fourth quarter of this year. We also continue to assess potential business development opportunities to complement our existing pipeline. While our bar is quite high for in-licensing drug candidates given the strength of our pipeline, we continue to evaluate potential opportunities to in-license earlier-stage targeted oncology compounds that we believe could become high-value differentiated assets. Let's now turn to slide 4, and I'll provide further details on the revumenib program. First, our pivotal phase 2 AUGMENT-101 trial is designed as three single-arm phase 2 trials that enroll independently and could each provide the basis for a co-regulatory filing in the U.S. The AUGMENT-101 2A trial is enrolling patients with relapsed/refractory MLL-r ALL. 2B is enrolling patients with relapsed/refractory MLL-r AML, and 2C is enrolling patients with relapsed/refractory NPM1-mutant AML. Each trial is designed to enroll approximately 64 adult patients, and up to 10 pediatric patients aged 1 month or older. As site staffing issues industry-wide have impacted startup timelines in certain geographies, we have updated our guidance for when our first cohort in this trial will be fully enrolled and expect enrollment to extend into the first quarter of 2023. Interest in the trial remains incredibly high with strong enrollment. Investigators are finding it as challenging as we are to deal with the unfortunate resourcing issues at some of their institutions, and we are working collaboratively to resolve them. We now expect to present top-line data in the third quarter of 2023 for at least one of the three cohorts in the AUGMENT-101 trial, and importantly, we continue to anticipate filing an NDA by the end of 2023. We have agreement with FDA that for each cohort or trial, the primary endpoint will be the percentage of patients achieving CR or CRh, with secondary endpoints including durability of CR/CRh response, transfusion independence, overall survival, and safety. We also have agreement with FDA on the statistical design of each trial. Importantly, the trial design allows patients to be treated again with revumenib after bone marrow transplant, a design feature that provides data on the potential role of revumenib in the post-transplant maintenance setting. I will now hand the call to Briggs to provide an update on the ASH abstracts, which published earlier today. Briggs? Thanks so much, Michael. If we turn to slide five, I'd like to note that we are excited that revumenib will be the focus of two oral presentations at the ASH annual meeting on Saturday, December tenth. Dr. Ghayas Issa from MD Anderson Cancer Center will present updated results from the phase 1 portion of the AUGMENT-101 trial, and will also present a second abstract summarizing the outcomes of patients who achieved a response on revumenib and then went on to bone marrow transplant. A copy of the press release with an overview of the ASH abstracts is available on our website, and I'll take a moment to talk through some of the key highlights of the data that you see on this slide. At ASH in 2021, Dr. Eytan M. Stein from Memorial Sloan Kettering Cancer Center presented the initial phase one data on 51 patients who had either an NPM1 mutation or an MLL-r fusion. This was our efficacy evaluable population. In the abstract release today, there are now 60 patients evaluable for efficacy. The additional patients include 8 patients with MLL-r AML and 1 patient with NPM1 mutant AML. All the patients are from so-called arm A, patients who are enrolled not receiving a concomitant strong CYP3A4 inhibitor. Additionally, all the 9 patients were treated at one of the two doses that had been determined to meet our predefined recommended phase two dose criteria. As you can see, the percentage of patients achieving a complete remission, as defined by the CR/CRh rate, is now 30% versus the 24% previously reported at ASH last year. In addition, at the time of last year's ASH presentation, the median duration of response for patients who had achieved a CR or CRh had not yet been achieved. As the data has matured, we now see a very impressive median duration of CR/CRh response of 9.1 months at the time of the data cutoff. I will also point out that we continue to see a high MRD negative rate, 78% among patients achieving either CR/CRh or a CRp, which is quite meaningful in this patient population as it enables patients to proceed to a potentially curative bone marrow transplant. Indeed, the second abstract described on Slide 6 specifically summarizes the outcomes of the 12 patients who achieved a complete response in revumenib and then went on to receive a stem cell transplant. Impressively, 9 remained in remission as of the data cutoff with a median follow-up of 12.3 months. Two additional transplant patients were treated with revumenib maintenance in the compassionate use setting following a stem cell transplant or non-myeloablative stem cell boost, both of whom remained in remission for over a year as of the data cutoff. Consistent with the data presented last year, revumenib continues to be well-tolerated, and there have been no discontinuations due to treatment-related adverse events. We believe the data continues to support revumenib's compelling clinical profile and position it not only as a first in class, but a best in class treatment and adds to our confidence in the ongoing pivotal trials. Our principal investigators are highly encouraged by the data and believe that revumenib could play an important role in the treatment of not only these relapsed refractory patients, but could also play an important role in earlier treatment lines and in combinations given its clinical profile. I'll hand it back to Michael to talk more about our programs. Thank you, Briggs. Slide 7 highlights a few additional opportunities that we are exploring to move revumenib beyond use as a monotherapy agent in relapsed or refractory acute leukemia. Preclinical data demonstrate the potential benefit of a MEK inhibitor in combination with standard regimens. Revumenib's excellent safety and efficacy profile lends well to expanding its use in earlier settings and in combination with approved therapies. Starting with the phase I Beat AML trial. As part of our collaboration with The Leukemia & Lymphoma Society, revumenib is being combined with venetoclax and cytarabine to treat newly diagnosed AML patients with an NPM1 mutation or MLL rearrangement who are unfit for induction chemotherapy. Revumenib is the first menin inhibitor to be included in the trial, which will assess safety as well as initial efficacy. Enrollment is ongoing, and we expect initial data from this trial to be available in 2023. Longer term, we expect that positive Beat AML trial results would lead to a phase 2/3 trial, which could serve as the basis for our future regulatory filing. We are also currently enrolling patients in the AUGMENT-102 trial designed to assess revumenib in combination with standard established chemotherapies for patients with relapsed or refractory NPM1 mutant or MLL rearranged acute leukemias. We expect to have initial data available from this trial in 2023. Finally, the INTERCEPT trial. This trial is focused on investigating novel therapies to treat early relapse and clonal evolution as a preemptive therapy in AML and is being conducted as part of the INTERCEPT Master clinical trial led by the Australasian Leukaemia & Lymphoma Group. The trial is designed to explore the activity of revumenib as monotherapy in patients with AML who have MRD positive disease following initial treatment, a group of patients at very high risk of relapse. Of note, revumenib is the first menin inhibitor to be included in the Intercept AML Master clinical trial. The Intercept trial is a very creative approach to treating patients early in their disease course. We continue to expect the Australasian Leukaemia & Lymphoma Group to initiate dosing in the fourth quarter of this year. As detailed on slide 8, we are committed to unlocking the full potential of revumenib beyond the relapsed refractory acute leukemia setting by moving it earlier in treatment and in combination. With these expansion opportunities, we see the potential to address upwards of 12,000 NPM1 mutant and MLL-r acute leukemia patients across various settings. These two forms of acute leukemia together represent up to 40% of the overall AML population, which, to our knowledge, will be the largest subpopulation of AML to be addressed by a new targeted therapy. We anticipate that revumenib could be one of the most important new franchises in the leukemia setting, and we are looking to explore revumenib as a treatment in solid tumors as well. We expect to initiate a proof of concept phase I clinical trial in colorectal cancer in the fourth quarter of this year. This trial is designed as a signal-seeking trial in 20-30 patients with refractory colorectal cancer to look for responses or disease stabilization. We are excited about this opportunity, given the compelling preclinical science supporting the role of the menin- MLL1 interaction in beta-catenin-driven tumors such as colorectal cancer. Let me now turn to axatilimab, our potentially best-in-class monoclonal antibody therapy targeting the CSF1R. Slide 9 provides an overview of the pivotal AGAVE-201 dose-ranging trial evaluating axatilimab in patients with cGVHD. We are excited to announce that the trial has now completed enrollment of approximately 240 patients, which exceeds the original enrollment target of 210 patients. We believe this speaks to the enthusiasm that investigators have for axatilimab, as well as the unmet medical need among cGVHD patients. The trial enrolled patients whose disease had progressed after two prior therapies, were at least two years of age and met overall entry criteria. Patients were randomized to one of three treatment groups, each investigating a distinct dose of axatilimab given either once every two weeks or once every four weeks. The primary endpoint is overall response rate using the 2014 NIH consensus criteria for cGVHD, while secondary endpoints include duration of response and validated quality of life assessments using the modified Lee Symptom Scale. As you may recall, the primary endpoint for the AGAVE trial is response by cycle 7, day 1, measured approximately six months after the initial dose. Assuming a few additional weeks for data analysis due to the over-enrollment, we are now comfortable guiding to top-line data in mid-2023. Per the terms of our collaboration agreement, Incyte will be leading the regulatory filing in cGVHD, which we expect will occur in the later part of 2023. This trial is supported by positive Phase 1/2 data in 40 cGVHD patients that we presented at ASH in 2021, where the overall response rate was 68% and the median time on treatment was over 6 months. Along with an excellent safety profile, these results were well received among thought leaders who recognized axatilimab as having the clinical profile that would be beneficial in the treatment of these heavily pretreated patients. In collaboration with our partner, Incyte, we are enthusiastic about expanding the axatilimab program into frontline cGVHD in combination with ruxolitinib. We believe the non-overlapping mechanisms of action of ruxolitinib, suppressing T cell activation, and axatilimab, inhibiting pro-inflammatory monocytes and pro-fibrotic macrophages, may allow for synergistic clinical benefit in patients with cGVHD. The phase I combination trial in patients with newly diagnosed cGVHD is currently in preparation, and we expect the trial to initiate in the first quarter of 2023. Beyond cGVHD, we are excited about the opportunity to expand axatilimab beyond graft-versus-host disease into fibrotic diseases where the monocyte macrophage lineage plays a key role. We continue to expect to initiate a robust phase 2 trial in IPF in the fourth quarter of this year. This multinational trial will enroll 170 patients with IPF randomized 1:1 to receive axatilimab or placebo over a 52-week double-blind treatment period. If successful, we believe this trial, along with one additional phase 3 trial, could form the basis for FDA approval in IPF. Slide 10 highlights the broad clinical and commercial opportunity for axatilimab. We believe cGVHD represents a high unmet medical need and an important commercial opportunity, with approximately 14,000 patients suffering from cGVHD in the U.S. today. The successful commercial launches of Incyte's Jakafi and Sanofi's REZUROCK are encouraging, both posting meaningful early revenues that begin to speak to the commercial opportunity in cGVHD. Despite recent advancements in this area, to our knowledge, axatilimab is the only agent in clinical development that specifically targets the monocyte macrophage lineage. We at Syndax believe the data generated to date with axatilimab suggests it has the potential to play an important role in the treatment of cGVHD, both as a monotherapy and given its safety profile in combination with complementary medicines. Through combinations in the frontline setting as well as the opportunity to expand to ex-U.S. markets, we envision the cGVHD opportunity growing meaningfully. We'll now turn the call over to Keith to review our financial results. Thank you, Michael. I'm going to take a few minutes to discuss our financial results for the third quarter of 2022. Turning to slide 11. The results of operations for the third quarter of 2022 and the comparison to 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 third quarter report, which was filed earlier today on Form 10-Q. I'd like to point out that our net loss for the quarter was $35.4 million, or $0.58 per share, compared to a net loss of $20.6 million or $0.40 per share for the same period last year. This difference is primarily attributed to $12.4 million in non-recurring license revenue recognized in the third quarter of 2021, as well as higher operating expenses in 2022, driven by increased employee-related expenses as well as higher professional fees. This was partially offset by lower third quarter 2022 clinical development and manufacturing expenses, in large part the result of axatilimab cost-sharing benefits from our partner, Incyte. We ended the third quarter with $337.8 million in cash equivalents in marketable securities and 61.3 million shares and pre-funded warrants outstanding. We continue to forecast the cash runway into the second half of 2024. Our current cash on hand supports our development and pre-commercialization plans for both the revumenib and axatilimab programs during this period and provides us flexibility should we decide to engage in business development. I would note that we made a debt repayment in September in connection with the termination of a loan agreement with Hercules. However, this did not have an adverse impact on our cash guidance. Looking ahead, I'd like to provide updated financial guidance for the full year 2022. We now expect R&D expense to be $115 million-$125 million versus our previous guidance of $130 million-$140 million. The reduction is driven largely by higher than expected cost offset from our axatilimab development partner, Incyte. For the full year 2022, we now expect total operating expense to be $145 million-$155 million, including approximately $15 million of non-cash stock compensation expense. The current operating expense guidance is lower than the prior guidance of $160 million-$170 million after accounting for the third quarter financials as well as the updated full year expense guidance. With that, let me now turn the call back over to Michael. Thank you, Keith. As you can see, we continue to make significant progress executing against our ambitious goals and milestones that we have set forth in the beginning of this year. I am confident we have the right plan in place and that we are building the right team to execute on our long-term goals. Syndax has always been focused on delivering new medicines that extend and improve the lives of people with cancer, and we are in a unique position today with two ongoing registration programs with pivotal data within the next 12 months. In addition, both programs offer the potential for broad franchise opportunities beyond their initial registration indications. We believe revumenib could have utility across a wide range of clinical settings in acute leukemia and potentially in solid tumors. Our immediate goal as a company is to be first to market and best in class in NPM1 mutant and MLL-rearranged acute leukemia, and we are pleased to be able to share updated data from the phase 1 portion of AUGMENT-101 at ASH, which continue to support our ambitions. We are actively engaged with physicians, and we are laying the groundwork for potential launches as we seek to take advantage of our leadership position. We plan to have a large presence at the ASH conference, and we are focused on educating physicians through multiple avenues, such as our disease awareness campaign that kicks off in the fourth quarter. Beyond the relapsed refractory setting, we intend to drive additional value potential by expanding its use into newly diagnosed and maintenance settings in NPM1 mutant and MLL-r acute leukemias and perhaps into solid tumors. The same franchise potential holds axatilimab, where broad opportunity exists both in various lines of therapy in cGVHD and across a broad range of fibrotic diseases, starting with IPF. We are indeed in a strong financial position with a balance sheet that allows us to deliver on key near-term milestones. I'd like to close the call by expressing our deep appreciation to the Syndax team, collaborators, and most importantly, the patients, trial sites, and investigators involved with our clinical programs. It is all of you who help us to execute on 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'd like to open the call for questions. At this time, if you'd like to ask a question, please press the star and one on your touch-tone phone. You may remove yourself from the queue at any time by pressing star and two. Once again, that is star and one to ask a question. We'll go right into our first question from Phil Nadeau with TD Cowen. Please go ahead. Your line is open. Hi. Good afternoon. Thanks for taking our questions, and congratulations on the progress. A couple questions on the abstract from this morning. It sounds like most of the patients who are added in the abstract are MLL-r patients with, I think you said, just one NPM1 patient being added. Why is the enrollment of NPM1 patients still so low? It does seem like that's a much larger population. We would have thought maybe you'd get more patients from that genotype in the trial. Then a related question. I think we're all thinking 20% CR/CRh rate is necessary, perhaps for filing in that indication. In any individual genotype, is that a fair assumption? Thanks, Phil. Thanks for the question. I guess I'll take the first one, which, you know, the NPM1 number of NPM1 patients. I think we talked at length about the fact that the enrollment in phase 1, I think, was initially skewed more towards MLL-r patients than NPM1 as the initial patients who came into the trial did quite well and received a response with the MLL-r. Of course, we've seen patients come on as well in the phase 1 and do quite well with having NPM1. Yeah, how the phase 1 was set up, where you have a certain number of slots and so forth, sort of, kind of, and the cadence of enrollment kind of stayed that way throughout the trial. Really no change there with the addition of the new patients. But I would also say importantly, that we do have three phase 2 trials open, individually enrolling, including NPM1, and I think we're prioritizing enrollment in phase 2. I wouldn't expect anything to change, you know, with the ongoing phase 1. I think that's how I would explain that. I don't think I would characterize it as low. I'm just saying that's our phase 1 experience. Phase 2 should be different based on having separate trials. Your second question, what is the 20% CR/CRh rate needed for filing? I think that is an assumption based on precedent, right? I think our trials our statistics are set such that each of the three enrolling cohorts have the same statistical design, same number of patients. We haven't talked much about the actual statistics and the lower bar that we're looking to rule out. You can surmise that the agency has given us similar direction and guidance around you know what statistics we need to achieve and what the point estimates are. I think we feel very confident that, based on precedent of other drugs getting approved, targeted therapies that have been approved, I think that we feel that, you know, at 20% or higher is certainly a decent way to think about it, but it's certainly not a rule, right? I mean, there's been, you know, I'm sure they take into account both not only the safety but also the efficacy of these compounds, the risk-benefit, and certainly we'll have, that'll be part of the package. 20% is sort of a reasonable assumption, but it's not the total situation. That's great. Then one last question from us. Just curious whether you mentioned benefit risk calculation. In your experience with physicians, what risk of differentiation syndrome is acceptable given the efficacy that we're seeing from menin inhibitor? Maybe I'll turn that over to Briggs Morrison. He can address that, please. Yeah. Hi, Phil. Thanks for the question. I don't think we've asked that. We've done sort of market research on that specific question. Obviously, there are other agents that are in clinical use today that have differentiation syndrome as a component of their risk-benefit profile. I think the related question that, you know, we would probably ask is not just what is the percent that might be acceptable, but what is the severity of those events? As you know, we tend not to see very many differentiation syndrome events. The ones we have seen to date in the phase 1 trial are all grade 2. That profile, what we've clearly heard from our investigators at least, is, you know, quite acceptable. That's very helpful. Thanks for your perspectives and congrats on the progress. Thanks so much. Appreciate it. Next we go to the line of Kalpit Patel with B. Riley Securities. Please go ahead. Your line is open. Yeah. Hey, good afternoon and congrats on the ASH data set today. I guess first, starting with the ASH data set, can you confirm that the AE profile was comparable to the prior data set, you know, as the data mature? I think you added maybe 9 more patients of efficacy data, and particularly the grade three or higher, QTc rates, did they stay at the 7% range or so? Yeah, Kalpit, thanks for the question. I think we can confirm that the safety and the new update, and you'll of course see the full safety at ASH, but it was consistent with what we've shown prior. No new safety findings in this data cut. We would expect it to be very similar to what you've seen the last time. Okay. You know, for the efficacy part, for the 9 more patients that you added at the recommended phase 2 doses, if I did the math right, 4 out of 9 patients achieved CR or CRh, which is obviously, you know, a bit better than the overall population numbers. The question is, if you go back and look at just the patients at the recommended phase 2 doses, is the CR/CRh rate higher than the 30% that you have reported at the ASH data set? Yeah. Briggs, do you wanna take that? Unless you have a next question. Yeah. Again, remember that the vast majority of patients treated out of the 60 patients, the vast majority are treated at that one of the doses that met the criteria of recommended phase 2 dose for the protocol. In essence, what you're looking at is the, you know, the sort of efficacy that we would anticipate at our recommended phase 2 dose. Maybe a follow-up on Phil's question. Since you did end up enrolling more patients with MLL-r AML in the phase 1 portion, is it safe to assume that this cohort will likely be the first to read out next year for the pivotal trial? Yeah. Thanks for that question, Kalpit. I think we haven't given any particular guidance on which of the cohorts is going to read out first. I think what we've said consistently is that AML is likely to report before ALL, just based on ALL being a smaller, much smaller patient population. We'll have more to say about that as we get closer, but I would assume that AML will be first. Okay, fantastic. Thanks for taking the questions and congrats on the data set. Thank you so much. Next we go to the line of Madhu Kumar with Goldman Sachs. Please go ahead, your line is open. Yeah, thanks for taking our questions. I wanted to follow up on Phil's questions around differentiation syndrome. I guess one we've been getting a lot recently is, are there differences in your kind of perspective with using revumenib in differentiation syndrome rates in MLL rearranged versus NPM1 mutant disease? Briggs Morrison, would you address Madhu Kumar's question please? Madhu, I would say we haven't actually presented that breakdown. You know, I would say we see relatively little of it, so it's kinda hard to say, you know, what the determinants are or what it correlates with. Given the number, the relatively few cases we've seen, it doesn't seem to be a trend between the different mutations. Okay, great. I guess kind of thinking about the axatilimab program in chronic graft-versus-host disease, how should we think about kind of duration of therapy from the phase 1 trial? Like, could we expect any updates between now and kind of the top-line data middle of next year? Like, how do you think about kind of the duration of use of axatilimab? Yeah. Thanks for the question, Madhu. I think what we had reported data last year, obviously at ASH, and at that point patients had been on six months or longer, and so the duration of therapy looked favorable. As to your question about whether there'll be an update on that, you know, short of putting out our pivotal data, which, of course, we announced today that we've finished the trial, and that data will be coming out in mid-2023. I think the Finished enrollment. Sorry, finished enrollment. We'll have the data mid-2023. You know, I think that would be the next logical time to update other than a potential publication which, you know, could happen along the line, along the way. Right now we're gearing up for the top-line data for the pivotal trial. Okay. I guess one last question is what kind of things should we be focusing on from the ASH presentation that will be different from the abstracts presented earlier this morning? Like, what are kind of key highlights that people should be keeping an eye on? You're asking about what should we be looking for at the ASH presentation itself? Yeah. As distinguished from the abstract, yes. Right. Just to be clear, this is the data cut that we'll have at the presentation, so there's not gonna be a new data cut. If that's a question. In terms of updates and additional details, there of course will be additional details of what we presented today in the presentation. What those are in particular, I'm not at liberty to say now, regarding from the data, but I would expect that there'll be some interesting things that come out of that presentation as well. In fact Okay, great. Two presentations. Just to kinda remind everyone, two presentations. Two oral presentations, one on the transplant data that we presented or we have today, as well as the clinical data. Okay, great. Thanks very much, guys. Thanks, Madhu. Next, we go to the line of Yigal Nochomovitz with Citi. Please go ahead. Your line is open. Hi, team. This is Ashiq Mubarack on for Yigal Nochomovitz. Thanks for taking my questions, and congrats on all the progress. Really great to see. Just kinda going back to the earlier NPM1 enrollment discussion. I guess would you be able to characterize if enrolling NPM1 patients versus MLL-r patients might be different in terms of maybe a competitive dynamic between maybe your trial versus other trials out there? I'm just wondering if there's any potential differences there. Thanks for the question, Ashiq. I think this is, as I mentioned before, this is not the dynamic where we feel like there's a competitive read-through between you know, one trial versus another trial for these phases. I think we have the trial site up and running, and we're enrolling patients well across you know, the three phase 2s, as I mentioned. I think the phase 1 experience was a separate experience for all the reasons I mentioned earlier from the experience that we're seeing in phase 2. You know, there are only a couple sites that overlap with competitors. I think there's much more of the dynamics of phase one and how that was set up to enroll patients versus the phase two, which is obviously, you know, individually enrolling. Okay, all right. That's very clear. Maybe I'll switch over to a question on duration and on the 9.1-month DOR you reported. Can you maybe give some color commentary on how compelling you think that duration is? Maybe you can give us a sense of the contribution of the post-transplant retreatment period for that duration number? Maybe, Briggs, would you like to answer that question for Ashiq please? Yeah, sure. Look, I think if you look at the other examples, I think Phil asked at the beginning about is the 20% required for filing for a CR/CRh. The other question that some have asked is what kind of durability do you need? You know, I think with a 30% CR/CRh rate and a median duration of response, you know, exceeding 9 months, again, looking at other approved drugs, I think that's quite competitive and quite favorable. Of course, our investigators are quite excited about what they're seeing. I think your question of can you separate out what is the duration of response in patients who weren't transplanted versus patients who were transplanted, it's of course difficult to do because so many of the patients were transplanted. I think that's in part why the FDA's AML guidance document recommends that people not censor at the time of transplant. It's essentially unknowable what the duration of response would have been if they hadn't been transplanted. Okay, all right. That's helpful. Maybe last one from me. Seems like you pushed back your expected top line data release for the pivotal cohorts to the third quarter next year. I guess what's driving this slight adjustment? Is it maybe pace of enrollment or is there a need for additional regulatory discussions? Any color there would be very helpful. Yeah, thanks for the follow-up, Ashiq. Let me dive into that a little bit more. I would characterize this as really no shift in timelines. What's important here is that the NDA filing by the end of 2023, which is our prior guidance, data we expect to fall into the third quarter and you know, enrollment in the first quarter. What I explained in my prior remarks related to the fact that there were some site enrollments, a couple sites that didn't come on as quickly as we had projected in the latter part of the year, this part of the year. I think that has you know, put us off a little bit on our expected timeline to fully enroll the first of the three cohorts. Ultimately, I think we, you know, through some good efforts with the sites and the investigators, we will be back on track. Now, I would say that enrollment is strong. I think the enthusiasm for the trial is really very good. I think the results of our trial speak to that and really support that. You know, what you're seeing, what we're seeing across our set of sites that are coming on is just emblematic of what we're, I think, experiencing in the industry. You know, there have been site initiation, resourcing issues that have plagued companies. We really haven't been bitten at all much until we saw a couple sites get delayed coming on in the last few months. I think that's the explanation. I think we're still in excellent shape. Again, we are you know on pace to deliver on what we think is you know obviously the most important, which is top-line data and then of course. Okay, great. Thanks for taking all my questions and congrats again. Thank you so much. Our next question or comment comes from the line of Peter Lawson with Barclays. Please go ahead. Your line is open. Thanks. Thank you for taking the questions. Thanks for the update today. Just wonder if you'd make any commentary around any durability differences between the MLL-r rearranged and the NPM1 patients. As we think about filing an AML, am I right to assume that the FDA is gonna look at these as the two kind of independent, different, separate, genotypes versus that combined number that you've seen so far in the phase 1? Sure, Peter, thanks for the question. Let me address the first one, and then we'll tackle your second question. The first one related to differences that we see in durability between NPM1 and MLL-r. I think, you know, I'll just point out, and we presented this last year, the NPM1 patients are all MRD negative CRs, so very strong responders. I think if you see in the transplant abstract today that 2 of those patients were NPM1 patients that's, you know, done very well and stayed on drugs. I think, you know, both sets of patients have seemed to demonstrate the ability to kinda get to complete responses, and stay in that state for an extended period of time. We don't necessarily see a difference, albeit the number of MLL patients are, as you pointed, as others have pointed out, higher, than the NPM1 patients in terms of aggregates. We don't think that the experience in terms of durability is going to be any different. The second question was related to filing and whether they'll be combined or separate. I think we put the trials together. They're three separate trials. They're enrolling separately, as I pointed out. And, you know, they're set up with separate statistics. And we designed it that way in order to potentially enable three separate filings. If we are in a position to put a few filings, you know, one or more together, due to the timing of when they enrolled, then we could potentially do that. Our view is that we should bring the drug as quickly as possible to the agency to get it potentially approved. We're not gonna wait necessarily to combine datasets in order to avail ourselves of that. That's the overall plan. Are there any other questions related to that, Peter? Yeah. Just really as regards to the ASH update, will we see what additional data we're gonna see? We're gonna see kind of responses broken out by dose, durability potentially, or the MRD negativity between NPM1 and the rearranged patients? Well, as you know, we've presented some of that information in the past. I think, you know, we have tried to be consistent between what we presented from meeting to meeting so that investors can really track what the data looks like and how it's improved over time. What we actually and I did say that we would have some additional things to say, obviously at the ASH presentation in terms of details. I'm not at liberty to say exactly what we will present at the meeting. Suffice to say, you know, I think it's interesting information, and it'll be a great oral presentation. As I said, we're trying to be consistent between the meeting last year and this year in terms of the depth of information that we prepare and then present to the community. Great. Thank you so much. Thanks for taking the questions. Thank you. Next, we go to the line of Joel Beatty with Baird. Please go ahead. Your line is open. Hey, you can press on the data. First question is on AUGMENT-101. Does a cohort need to have efficacy data collected on all 64 adults to read out, or could it read out with a smaller denominator than 64 if enough responses are achieved? Joel, thanks for the question. The way it is set up today, we are targeting 64 patients. That's how it's designed. You know, a lower denominator is not contemplated as part of the current protocol. That's the target number of enrollments. Of course, we could over-enroll it, but I don't believe that there's a you know necessarily an opportunity to under-enroll at this point. Got it. Thanks, man. Can you discuss the status of initiating clinical trials and doing the work to move into the first line setting for revumenib? Right. Great. Maybe do you wanna describe the Beat AML trial a little bit and maybe some of the other things that we're thinking about, please? Sure. Again, I think, Joel, your question about, you know, earlier lines of therapy, we tend to separate those into two buckets. Those who are fit for intensive chemotherapy tend to be younger patients, and those who are unfit for induction chemotherapy, who tend to be older patients or patients with comorbid disease. For the fit patients, the standard of care today, as it's been for decades, is the so-called 7+3 induction consolidation regimen. There's a keen interest to combine our drug there. You know, the safety profile that we've seen, we think is quite favorable for combining with chemotherapy. We're in the process of thinking through how we haven't yet said when that trial will start, what the design is, but we're working hard on it. The second population is the unfit population who are in, you know, combination with venetoclax, and that's the Beat AML trial that's going on now to try to determine in the phase one portion of that, what's the appropriate dose of revumenib to give in combination with the labeled dose of venetoclax. Then the third population of patients that are, you know, again, quite in need of additional therapies are those who still have residual disease by more sophisticated assays and so-called measurable residual disease population. There, you know, as you know, the INTERCEPT trial is essentially a single agent revumenib to see if we can convert those patients to MRD negativity, which would, you know, sort of predict that will be of clinical benefit to them. Great. Thank you. Thank you, Joel. It appears we have no further questions at this time. I'll now turn the program back over to Michael Metzger for any additional or closing remarks. Great. Thank you, operator, and thanks to everybody on the call today. We appreciate the interest in our story. We look forward to seeing many of you at our upcoming investment banking meetings, as well as of course, at the ASH meeting, where we'll be presenting data that we talked about today. Thank you, and have a great rest of your evening. This does conclude today's program. We thank you for your participation. You may disconnect your lines at any time.