Good day, everyone, and welcome to the Syndax second quarter 2022 earnings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Sharon Klahre, Head of Investor Relations at Syndax Pharmaceuticals. Great. Thank you, operator. Welcome and thank you all for joining us today for a review of Syndax's second quarter 2022 financial and operating results. I'm Sharon Klahre, and with me this afternoon to provide you an update on the company's progress and to discuss financial results are Michael 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 for the question and answer session is 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 the 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, August 8, 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. Michael? Thank you, Sharon, and thank you to everyone joining us on today's webcast. I also wanna introduce Keith Goldan, our Chief Financial Officer, who joined us in June. Keith has over 20 years of experience as a CFO in our business, and we look forward to his valuable contributions in the years ahead as a key member of our team. You will hear from Keith during the financial portion of this call. We've made significant progress advancing our pipeline in the second quarter, and I look forward to sharing the details from the quarter and what lies ahead for Syndax. I believe we are in a great position to deliver on the strategic goals and milestones that I set out at the beginning of the year, including delivering pivotal data from both the revumenib and axatilimab clinical programs beginning in the first half of 2023, and continuing the expansion of both molecules into earlier treatment settings and new indications. Our clinical efforts are supported by a strong balance sheet that enables us to aggressively advance our programs through our key near-term milestones, as well as by a strong partner that will help us successfully advance one of our lead molecules. We have designed a broad development plan for both revumenib and axatilimab that is focused on fully realizing the value of each drug candidate given their compelling clinical profiles. We expect regulatory filings for both programs in 2023 and are laying the groundwork to support a strong launch of these first and potentially best-in-class products. We are excited about the opportunities and important milestones ahead. Turning to slide 3, we provide a high-level summary of our current corporate priorities. Starting with revumenib, previously referred to as SNDX-5613, our highly selective menin inhibitor. Our pivotal phase II AUGMENT-101 trial evaluating revumenib in patients with relapsed/refractory NPM1-mutant or MLL-r acute leukemia is enrolling well, and we continue to expect data from one of the three cohorts beginning in the first half of 2023. Data from the phase I portion of this trial continues to mature, and we are looking forward to announcing updated data in the fourth quarter of this year. Beyond the AUGMENT-101 trial in relapsed refractory disease, revumenib is the focus of several ongoing and planned trials that present important expansion opportunities. The ongoing BEAT AML and AUGMENT-102 trials will provide data on safety and initial efficacy of revumenib in combination with approved agents. Additionally, we expect the Australasian Leukaemia and Lymphoma Group to initiate the INTERCEPT trial in the fourth quarter of 2022. This trial explores the activity of revumenib in patients with AML who have MRD-positive disease. Beyond acute leukemia, we have also identified solid tumor indications that could benefit from revumenib, and we are preparing to initiate a proof-of-concept trial in colorectal cancer in the fourth quarter of this year. Moving to axatilimab, our antibody against CSF1R. Our pivotal phase II AGAVE-201 trial evaluating axatilimab in patients with chronic graft-versus-host disease or cGVHD is enrolling well, and we continue to expect data in the first half of 2023. We are actively working with our partner, Incyte, to maximize the value of the axatilimab program, and this includes planning additional trials of axatilimab in earlier lines of cGVHD. We anticipate that Incyte will initiate a trial of axatilimab in combination with Jakafi in the fourth quarter of this year. Beyond cGVHD, we expect to be in a phase II trial of axatilimab in idiopathic pulmonary fibrosis or IPF in the fourth quarter of this year. Briggs will speak to our strategy in IPF, including the trial design later in his remarks. We also continue to assess business development opportunities to complement our existing pipeline. While our bar is 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, we are conducting three single-arm phase II trials that FDA has agreed may each serve as a pivotal trial. Each of these single-arm phase II trials represents an independent path to a separate indication and will serve as the basis for a full 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 open to patients aged one month or older, and each trial will enroll independent of the other two. We have agreement with FDA that for each trial, the primary endpoint will be the percentage of patients achieving CR/CRh, with secondary endpoints including durability of CR/CRh response, transfusion independence, overall survival, and safety. Importantly, the trial design allows patients to be treated with revumenib after bone marrow transplant, a design feature that allows us to start to understand the role of revumenib in the post-transplant maintenance setting. We also have agreement with FDA on the statistical design of each trial. Each trial will enroll approximately 64 adult patients and up to 10 pediatric patients. Patient accrual across the individual trials is going well, and we remain optimistic that we can complete enrollment in one of these trials this year. As we look at the competitive landscape and engage with experts in the field, we believe revumenib's compelling clinical profile, as demonstrated in the robust phase I experience in 59 patients that we presented at ASH in 2021, positions revumenib to not only be the first in class, but also a potentially best in class treatment. Importantly, we have decided to provide updated data from the phase I portion of the AUGMENT-101 trial in the fourth quarter. We are seeing improvements in key metrics of the data since last year's ASH presentation, and we believe this update will further strengthen our leadership position and confidence in the outcome of the pivotal trial. Beyond the AUGMENT-101 pivotal program in relapsed refractory disease, slide 5 highlights some of the additional opportunities that we are exploring with revumenib, all of which build on revumenib's excellent safety and efficacy profile that lends well to the treatment across all settings and in combination with currently approved agents. The phase I BEAT-AML umbrella trial is currently enrolling patients. As part of our collaboration with the Leukemia & Lymphoma Society, revumenib, the first menin inhibitor to be included in this trial, is being combined with venetoclax and azacitidine in newly diagnosed AML patients who are unfit for induction chemotherapy. This trial will assess safety as well as initial efficacy. 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 II/III trial, which could serve as the basis for a regulatory filing. Our other combination trial that is currently enrolling patients, the AUGMENT-102 trial, is designed to assess revumenib in combination with standard salvage chemotherapies for patients with acute leukemias. Both the AUGMENT-102 and BEAT AML trials are supported by preclinical data, which demonstrate the potential benefit of a menin inhibitor used in combination regimens in these settings. Further, revumenib is suitable for use in combination based on its safety profile as seen in the phase I portion of the AUGMENT-101 trial. The INTERCEPT trial is focused on investigating novel therapies to target 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 Leukemia and 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 is that 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, which is important because the general tenet in oncology is that the earlier you treat the patient's disease, the better patients do and the longer patients stay on medicine. We currently expect the Australasian Leukemia and Lymphoma Group to initiate dosing in the fourth quarter of this year. Turning now to slide 6. Our goal is to unlock the full potential of revumenib beyond the relapsed refractory acute leukemia setting. In acute leukemia, we plan to engage patients early in their treatment journey, get them into remission, and hopefully maintain them in that state for months, if not years. 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. Beyond the acute leukemia opportunity, we believe there is significant value in expanding to solid tumors where revumenib could address areas of unmet need. As we mentioned on our first quarter call, we plan to start an initial proof of concept clinical trial in colorectal cancer in the fourth quarter of this year. The phase I 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 signs supporting the role of menin-MLL1 interaction in beta-catenin-driven tumors such as colorectal cancer. We anticipate that revumenib could be one of the most important new franchises in hematology, along with the added potential in solid tumors. We are laying the groundwork for potential launches so that we are well-prepared to get medicine quickly to patients, quickly to physicians and the patients they treat, and take advantage of our leading position. We are educating and building mind share with oncologists as they utilize and gain comfort with the drug while it's in clinical trials. Let me now turn back to axatilimab, our potentially best-in-class monoclonal antibody therapy targeting the CSF1 receptor. Slide 7 outlines our pivotal AGAVE-201 trial evaluating axatilimab in patients with cGVHD. The trial is enrolling patients whose disease has progressed after two prior therapies. Patients must be at least two years of age and have met overall entry criteria. This is a pivotal dose-ranging trial in which 210 patients will be randomized to one of three treatment groups, each investigating a distinct dose of axatilimab given every two weeks or 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 Lee Symptom Scale. Enrollment to the study is going well, and we are on track to complete enrollment by the end of this year and deliver top-line data in the first half of 2023. This trial is supported by positive phase I/II data in 40 cGVHD patients we presented at ASH in 2021, where the overall response rate was 68% and the median time on treatment was over six months. Along with an excellent safety profile, these results were well-received among thought leaders who recognized axatilimab as having a clinical profile that would be beneficial in the treatment of these heavily pretreated patients. In collaboration with our partner, Incyte, we are eager to expand the axatilimab program to include combination therapy as well as to assess its use in other fibrotic diseases, including IPF. The collaboration has brought together two companies with solid track records of innovation, and we are benefiting from Incyte's expertise in GVHD. We are currently planning to assess a novel combination of axatilimab and Jakafi with the goal of establishing axatilimab in earlier settings within cGVHD and expanding its market opportunity. We anticipate this combination trial could begin in the fourth quarter of 2022. As we previously mentioned was our intention, we plan to initiate a robust phase II trial in IPF in the fourth quarter of this year. IPF is the first expansion opportunity that we have committed to pursuing beyond cGVHD, and we believe axatilimab could have a significant impact in this disease. I will now ask Briggs to walk through the biologic rationale, development strategy, and market opportunity for axatilimab in IPF. Briggs? Thanks very much, Michael. Turning to slide 8, axatilimab, you may recall, is an IgG4 monoclonal antibody that binds to the CSF1 receptor and blocks the interaction with its two ligands, CSF1 and IL34, thereby decreasing the proliferation and function of CSF1R-dependent monocytes and macrophages. Preclinical data has indicated that bone marrow-derived monocytes, which are dependent on CSF1, could mediate the inflammatory and fibrotic components of a number of diseases. As I've noted before, our work with experts in the field of fibrotic diseases points to a strong consensus that the scientific basis for the efficacy of axatilimab in chronic graft-versus-host disease is likely to extend to a wide variety of other fibrotic diseases, including IPF. We've established that, axatilimab is active in chronic graft-versus-host disease, and we're excited about the opportunity to expand axatilimab into other fibrotic diseases where the monocyte macrophage lineage plays a key role. Today, we'll focus on our development on IPF. IPF is a chronic fibrosing lung disease for which there are currently very limited treatment options. Only two drugs have been approved, and both have only been shown to slow but not stop or reverse disease progression. The only opportunity for a cure is a lung transplant, which is limited to less than 5% of patients. With the estimated U.S. prevalence of IPF growing to over 180,000 by 2026, we think there is an increasing need for new and safe, effective medications. There are several reasons why we are excited to pursue fibrotic disease outside of GVHD and why we have confidence that axatilimab can have a meaningful benefit in IPF. There is a wealth of emerging preclinical and clinical data indicating that the CSF1 signaling pathway appears to play a significant role in the development of pulmonary fibrosis, and there's a growing understanding of the important role that macrophages play as a master regulator of the fibrotic process. Preclinical data, which I'll review in a minute, supports our planned clinical program. Perhaps of greatest relevance is the data we've generated in patients with pulmonary manifestations of chronic graft-versus-host disease, where we have observed clinically important improvements in lung function. For example, within our phase I/II data that we presented at ASH in 2021 in heavily pretreated patients, we saw lung-specific response rate in 5 of 15 patients. Furthermore, axatilimab has shown good safety and tolerability profile in this phase I/II trial at the doses that we've identified to use in our IPF trial. Slide 9 briefly summarizes some of the data that supports our entry into this proof of concept trial. In the panel on the left, we show data from an experiment in which bleomycin is instilled into the lungs of mice, which is known to induce pulmonary fibrosis. In this case, bleomycin was instilled, and nine days later the animals were treated with an anti-CSF1R antibody or a saline control. The histologic section on the top left shows a normal lung with extensive white airspace. Conversely, the bleomycin lung has extensive fibrosis, the dark-colored material in the slide. Strikingly, the lung treated with bleomycin and then therapeutically treated with an anti-CSF1R antibody on day 9 has significantly less fibrosis and markedly preserved white airspace. A semi-quantitative analysis of these histologic sections yields what's known as an Ashcroft score, and you can see a statistically improved Ashcroft score in the bar graph on the bottom left with the administration of the anti-CSF1R antibody. In the panel on the right, we show data from the COMET investigators. COMET is a trial that aims to correlate outcomes with biochemical markers to estimate time to progression in IPF. The patients were assessed at baseline and then followed over time, and the primary endpoint of the trial was progression-free survival, as determined by the time until any one of the following. Death, acute exacerbation of IPF, lung transplant, or decrease of 10% in FVC or 15% in DLCO. The investigators conducted a screen for biomarkers that would predict IPF progression. The data in the figure on the right shows that patients who have high levels of specific monocytes have a much worse prognosis than patients without these high levels of these monocytes. The table below the graph is a reminder that axatilimab has been shown to specifically deplete the non-classical and intermediate monocytes, the cell type that's correlated with more rapid disease progression in IPF. As we reviewed this data with experts, they are particularly excited about the prospect of axatilimab not simply targeting a specific pathway, but instead targeting and depleting a specific inflammatory cell, thus leaving very little room for redundancy or resistant mechanisms. On slide 10, we've laid out the design of our phase II- B trial in IPF. This is a multinational trial that will enroll 170 patients with IPF randomized one-to-one to receive 75 mg of axatilimab every two weeks or placebo over a 52-week double-blind treatment period. We've leveraged the data from the ongoing chronic graft-versus-host disease program to select an optimal dose that we believe is well suited to the IPF patients, considering an expectation that approximately 80% will be on background medications. In order to maximize the probability of success in the trial, we've worked with experts to design a study that essentially mirrors a pivotal phase III trial. Primary endpoint will measure change from baseline in FVC, which is a current registrational endpoint in IPF. These secondary endpoints include disease progression, St. George's Respiratory Questionnaire, which is a quality of life instrument designed for patients with obstructive airway disease, the six-minute walk test, and diffusing capacity for carbon monoxide. We anticipate enrollment in the IPF trial to initiate in the fourth quarter of this year, and if successful, we believe this trial, along with perhaps one additional phase III trial, could potentially form the basis for FDA approval in IPF. Let me now turn the call back over to Michael. Great. Thank you, Briggs. I'd like to highlight that successful development in IPF would allow us to unlock a very important indication of considerable value. Thus, we're very eager to get this trial up and running and anticipate doing so in the fourth quarter of this year. Slide 11 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. 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 and Incyte believe that 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 front-line setting, as well as the opportunity to expand to ex-U.S. markets, we envision the cGVHD opportunity more than doubling as shown on this slide. I'll now turn the call over to Keith to review our financial results. Thank you, Michael. Let me now take a few minutes to discuss our financial results for the second quarter of 2022. Turning to slide 12. The results of our operations for the second quarter of 2022 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 second quarter report, which was filed earlier today on Form 10-Q. I would like to point out that our net loss for the quarter was $37.6 million or $0.62 per share, compared to a net loss of $22.9 million or $0.44 per share for the same period last year. This difference is primarily attributed to an increase in research and development expense driven by the expansion of both revumenib and axatilimab into registration trials, expansion into new potential indications, and increased manufacturing activities. We ended the second quarter with $378.9 million in cash equivalents and marketable securities, and 60.4 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 it provides us flexibility should we decide to engage in business development. Looking ahead, I'd like to provide financial guidance for the third quarter and full year of 2022. For the third quarter of 2022, we expect R&D expense to be $25 million-$30 million and total operating expense to be $35 million-$40 million. For the full year 2022, consistent with previous guidance, we expect R&D expense to be $130 million-$140 million and total operating expense to be $160 million-$170 million, including approximately $15 million of non-cash stock compensation expense. 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 the ambitious goals and milestones that we set forth in the beginning of this year. Syndax has always been focused on delivering new medicines that extend and improve the lives of people with cancer. Today, with two ongoing registration programs, a notable achievement in its own right, we stand on the precipice of realizing this goal. The potential of these programs extends well beyond their initial registration indications, with both offering broad franchise opportunities that we believe are achievable given their compelling clinical profiles. We believe revumenib could have utility across a wide range of clinical settings in acute leukemia as well as potentially in solid tumors. Our immediate goal as a company is to be the first to market in relapsed refractory acute leukemia and then drive additional value potential by expanding its use into newly diagnosed and maintenance settings in NPM1 mutant and MLL-r acute leukemias. The same franchise potential holds for 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 in a strong financial position with a balance sheet that allows us to deliver on key near-term milestones. We remain confident in our ability to identify and bring in novel molecules to deepen our portfolio. We have a proven track record of delivering on this pillar of our corporate strategy, and I believe this is a core strength of our company and management team. Lastly, we are thankful to our Syndax team, collaborators, and most importantly, the patients, trial sites, and investigators involved with our clinical programs for helping us to execute on our mission of realizing a future in which people with cancer live longer and better than ever before. Further, thank you to our committed long-term investors who 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 would like to ask a question, please press star one on your telephone keypad. If you wish to remove yourself from the queue, please press star two. We'll take our first question from Madhu Kumar with Goldman Sachs. Please go ahead. Hi, this is Ammar on for Madhu. For our first question, we'd like to know what should we be looking for in the updated AUGMENT-101 data in 4Q? What will be the focus, durability of response or other disease features? Second question, how many of the three cohorts from the phase II revumenib cohort will be expected to complete enrollment by year-end? Should we expect an NDA to wait for multiple cohorts? Great. Thank you, Ammar. Let me take your first question related to the update on at the end of the year for revumenib. I think the plan, and we had talked about this as a possibility. The plan is to update the dataset at an opportunity in the fourth quarter. We had presented a fulsome dataset, as you know, as of ASH at last year's meeting. The plan is to present a comprehensive update in similar detail as to what was presented at that meeting. We're not gonna comment specifically on the data, what will be shown, but I think you should assume that it'll be a similar level of detail in that presentation as well. In terms of your second question, sorry, just remind me that question. How many of the three cohorts from the phase II revumenib cohort, which should we expect to be complete enrollment by year-end? Then should we expect- Right. -an NDA to wait for or multiple cohorts? Right. The guidance that we've given is that we'll have at least one cohort we hope to have by the end of the year enrolled, and that we will not necessarily wait to file to get all three cohorts together, but as soon as we have the data together for one cohort, we'll look to file that with the FDA. It could mean an ongoing submission of data for additional cohorts beyond the initial. All right. Thanks for taking our questions. Thank you. We'll move next to Phil Nadeau with Cowen and Company. Please go ahead. Good afternoon, thanks for taking our questions. First, to follow on to the last question. In the prepared remarks, there was an intriguing teaser saying that some of the measures that were disclosed at ASH last year have improved over time. We're curious whether you'd be willing to disclose which of those measures did improve today? Yeah. Thanks for the question, Phil. No, we're not gonna get into the detail there. I think you know, there are lots of detail that was provided in the ASH presentation last year. Some of it maybe are a bit more important to certain investors and others than not. I'd say that it'll be a comprehensive update, and we're looking forward to presenting all the detail, which should further strengthen our position and build confidence in the outcome of the pivotal trials as well. That's understandable. A couple of questions on the earlier stage pipeline. In terms of colorectal cancer, what level of response would you need to see from revumenib to move forward in that indication? Yeah, thanks for the question again. Maybe I'll ask Briggs to address that, please. Right. Phil, you may remember we set the trial up as we could win on one of either a response rate or a disease control rate. As you may recall, the standard of care for this refractory population of patients has a very low, less than 5% response rate. I don't want to go into all the details of the statistics, but you know, if the lower bound exceeds that historical 5%, then that would be intriguing to us. Then the disease control rate, again, for standard of care at six months is probably no greater than 15%. If we saw a disease control rate, you know, exceeding that would also capture our attention. I think what we've outlined is that, if we were to see responses, we could potentially advance more rapidly given that the drug is giving responses. If we saw a disease control rate, the protocol is set up to immediately go into a small randomized phase II to try to confirm that because I think a single-arm disease control rate is a little more challenging to interpret. Could get us excited to do the randomized portion. That's the way the trial is set up. That's very helpful. Last question, kind of a similar question on IPF. What FVC change is the trial powered to detect, if you're willing to disclose? I don't think we're at liberty to talk about that. I mean, I think what we looked at the regulatory precedent for the other two drugs that are approved and tried to power for a degree of a change from baseline in FVC that would be clinically meaningful. Got it. Thanks for taking our questions, and congrats on the progress. Thank you, Phil. We'll move next to Kalpit Patel with B. Riley Securities. Please go ahead. Yeah. Hey, good afternoon, and thanks for taking the questions. For revumenib, you have ongoing efforts to explore the drug in an earlier line setting. I guess, how are you thinking about your strategy for advancing the drug, with the 7 + 3 combo in AML? Would that be a potential future development opportunity? Yeah, thanks for the question. I'd say absolutely. I think there are a number of combinations that we're looking at, and as you're pointing out, 7 + 3 is the fit population, and certainly our drug could be used in that setting. We're looking at, you know, designing trials to address that as well. That's in the planning process. Okay. Diving a little more into the planned updated phase I data from AUGMENT-101. I'm not sure if you'll comment, but should we expect maybe a breakdown of CR/CRh rates based on the dose and on the underlying patient characteristics? For example, you know, which patients progressed on venetoclax and then received a CR or CRh? Thanks for the question. I think you should expect to see a similar level of detail as what we provided at ASH in 2021. Whether or not we're going to provide further breakdown on any subsets and things of that nature, I think we just have to wait to see for the update in the fourth quarter. Okay. One last question for the cGVHD trial with Jakafi. Is there gonna be a comparator arm or has that not been decided for the trial? Yeah. I mean, we're again, we haven't disclosed the details of that trial as of yet, but stay tuned. That will be forthcoming. Okay, fantastic. Thank you very much for taking the question. Thank you. We'll move next to Yigal Nochomovitz with Citi. Please go ahead. Hi, team. This is Ashiq Mubarack on for Yigal. Thanks for taking my questions. I just had a couple on the competitive landscape, the menin competitive landscape. How are you thinking about data from one of your key competitors with a menin inhibitor, which is expected later this year? Ultimately, do you think the NPM1 and MLL-r leukemia spaces, specifically related to menin, is a winner-take-all situation, or do you think it's a little more nuanced than that? Maybe how are you thinking about the first mover advantage part and stickiness with prescribers and so on? Thanks. Yeah. Thanks, Ashiq. I think first to market advantage is important. You know, we feel very good about our current position. We've presented a lot of data at ASH last year, and I think the clinical profile is quite compelling, as I think you'd agree. I think it positions us very nicely, and we'll have an update at the end of this year. We're enrolling our trials very well, and I think we'll have positioned to have one enrolled this year and then data next year. I think we're well set up for success. In terms of you know, NPM1, MLL-r winner take all, you know, that's a tough one to comment on. I think we have a what we think is a very compelling compound and opportunity for us to exploit, and we'll do that to the greatest extent we can. Whether or not there are other competitors in the space, time will tell. As of now, we're really the only ones to present any meaningful data. I think we'll have to see. We like our position, we like our chances, and I think we're well positioned to do that. Okay, great. Maybe if I can ask one more on the competitive space. What are your thoughts generally on strategy of covalent Menin inhibition? Please correct me if I'm wrong, but my understanding is that Menin inhibition results in the Menin protein turning over pretty rapidly. I'm just wondering if you think there is even an advantage to a covalent inhibition or even a longer half-life. Thanks. Yeah, no, thanks for the question, Ashiq. Maybe I'll ask Briggs to comment on that, as well. Yeah. No, I think you captured it correctly. The protein does turn over, so you're gonna need drug on board to inhibit newly synthesized protein. Again, I think our view is we can safely and adequately completely cover the target. You know, we've shown IC90s at trough. I mean, exposures at trough that exceed the IC90. It's not clear to us what covalent will do that would exceed what we can do already with our molecule. Okay, great. Thank you so much for all the color. Thanks, Ashiq. We'll move next to Joel Beatty with Baird. Please go ahead. Hi. Thanks for taking the questions. The first one is on revumenib and the opportunity in the first line unfit patients. The slides show a you know pretty large opportunity in you know increasing number of eligible patients. Could you describe the characteristics of the unfit patients that you know could make them a good market you know good targets for revumenib? And then the second question is on IPF. Based on the preclinical data you've had so far, any hypotheses on how the drug could work on top of one of the two approved drugs versus as a monotherapy? Yeah. Great. Thank you, Joel, for the questions. Maybe I'll ask our Chief Business Officer, Anjali Ganguli, to address the first related to market opportunity in the unfit patient population for revumenib. Sure. Thanks, Michael. In the frontline, as you commented, there are, you know, the two populations, and I think there's an understanding that they're almost evenly split, maybe slight advantage to the fit population. The unfit is treated more and more with ven/aza, and I think our combination in BEAT AML could allow us to justify moving forward into a phase III to get a label in that population. Those patients could potentially see long duration of treatment with revumenib in that setting, as we've seen patients tolerate the drug really well. You know, it could be close to a year of therapy, I think, on average. The ven/aza estimate is over 11 months. The population. You know, if you imagine 20,000-21,000 patients a year with incident AML, 50% in the unfit and then 12 months duration for the population that we're targeting, that could be up to 40% of AML. It starts to be a pretty sizable opportunity. Then the fit, you know, it really depends on how long you can keep them on therapy beyond induction consolidation. We are seeing treatments like with the quizartinib trial, where they're seeing patients being treated up to three years, so that could also get to a very large population. Great. Thanks. Thanks, Anjali. Maybe Briggs, can I ask you to weigh in on the IPF question, please? Yeah, sure. Thanks so much, Joel. You know, again, what I noted in our comments and is very similar to the observations we've made in GVHD. It's the only mechanism that is actually depleting what are potentially the driver cells for the fibrosis, which are these pro-inflammatory macrophages. The pirfenidone and nintedanib work sort of downstream on a specific pathway that are believed to be involved at the fibroblast level of laying down collagen. This is acting more proximal and completely takes out these inflammatory monocytes and macrophages, which probably, as best we can tell from the preclinical work, impacts a much broader set of processes than just the pathways that are impacted by the two approved drugs. That's why we're doing the trial on, as an addition to those two approved drugs, to test that hypothesis. Great, thank you. Thank you, Joel. We'll take our last question from Peter Lawson with Barclays. Please go ahead. Hey, thanks for taking the questions. Just Mike, on the improvement in key metrics, should we assume that that's around efficacy that you're seeing? Yeah, no, thanks for the question, Peter. I think we're pointing out that we, you know, we've seen the data set improve. Obviously key metrics are things that, I would say, you're most paying attention to. Among others, we're excited to present the data in the fourth quarter and probably not gonna say any more than that at this point, but you'll have to just tune in in the fourth quarter. Gotcha. Appreciate that. Thank you. The first time that you think we could see combination data for the menin inhibitor, when do you think that could happen? Thanks, Peter. As I mentioned in my remarks, we have two combination trials ongoing now, AUGMENT-102 and the BEAT AML trial. I think, we expect data to start to accumulate in 2023, and that'll most likely you know, come from the BEAT AML trial first. We don't have specific timing for that just yet, but we'll update as we get a little bit closer how that's materialized. Gotcha. Thank you. I guess just the final question, the decision to have that year-end data, was that driven by the improvement in the key metrics that you were seeing? Look, I think what we you know had said early on and repeatedly was that our focus has been to enroll our trials and really operationally to get done what we needed to get done. If we had the opportunity to update the data set sometime at the end of the year, that we may choose to do that. I think we are encouraged, quite encouraged by what we're seeing. You know, it really gives us the opportunity more so to engage with physicians at ASH. We plan to have a presence there. This is a really, I think, a really good way to get in front of physicians and, you know, have them relate to what we're doing in AML. I think that's those are some of the factors. We are quite excited about the data and what we'll be able to say at the end of the year. Just finally, since I've got the kinda the last set of questions. Business development, just your thoughts around kind of assets, asset pricing, and potential size that you're kind of potentially looking at. Yeah, as you know, Peter, we're completely focused on building value for Syndax shareholders and building this portfolio is part of that strategy. Business development has always been a part of what we do. We have a high bar, as I've said many times, to bring in high quality assets. They're hard to find. We tend to focus on the earlier stage assets because I think that we have the opportunity to bring differentiated assets into Syndax at that stage and really exploit the expertise we have to develop them. That is our focus on business development. It's earlier stage assets, targeted oncology, and that has continued to be the case for quite some time. Hopefully we can add to the portfolio in the future. That's the general, you know, strategy we have. Great. Thank you so much. Thank you. At this time, there are no more questions from the audience. I will now hand it back to the Syndax team. Great. Thank you, operator, and thank you all for joining us on the call today. We look forward to seeing many of you this week at the industry conferences, and I wish you all a great end to the summer and a very pleasant evening. Thank you again. This does conclude today's program. Thank you for your participation. You may disconnect at any time. Have a wonderful afternoon.