Financial Data and Key Metrics Changes - Syndax reported total revenue of $45.9 million for Q3 2025, reflecting a strong 21% growth over the prior quarter [4] - Revyforge net revenue was $32 million in Q3, up 12% from the prior quarter, with a 25% increase in total prescriptions and new patient starts [5][11] - Nictimvo net revenue reached $45.8 million in Q3, marking a 27% increase over the prior quarter [9][19] Business Line Data and Key Metrics Changes - Revyforge has become the standard of care for relapsed refractory KMT2A, with approximately 50% of usage in the second line [5] - Nictimvo is annualizing at nearly $200 million within the first eight months of launch, tracking in line with first-year sales of similar therapies [9] - The approval of Revyforge for relapsed refractory NPM1 mutated AML has expanded the addressable patient population significantly [6][15] Market Data and Key Metrics Changes - The total addressable U.S. population for Revyforge has increased from approximately 2,000 to 6,500 patients with the new indication [15] - Nictimvo is targeting a market opportunity of approximately $2 billion, with 6,500 patients in the U.S. requiring three or more lines of therapy [21] Company Strategy and Development Direction - The company aims to expand Revyforge and Nictimvo into the frontline setting, unlocking a combined market opportunity exceeding $10 billion [10] - Syndax is focused on executing pivotal trials for menin inhibitors, with Evolve 2 being the first frontline trial to start enrolling patients [10][28] - The company is leveraging its strong commercial foundation and prescriber relationships to drive growth in both product lines [16][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching profitability, citing strong performance from both Revyforge and Nictimvo [38] - The company anticipates that the average duration of therapy for KMT2A patients will increase to six to twelve months in 2026 as treatment patterns mature [14][44] - Management highlighted the positive feedback from healthcare providers regarding the efficacy and tolerability of both Revyforge and Nictimvo [20][22] Other Important Information - Syndax has a strong financial position with $456 million in cash equivalents and investments as of September 30, 2025 [38] - The company has received three FDA approvals and is positioned for sustained growth with its current product offerings [39] Q&A Session Summary Question: How has Revyforge's place in lines of therapy evolved? - Management noted that about 70% of Revyforge's business is in the second or third line, a shift from clinical trials where patients were typically in third or fourth line [41][42] Question: What factors will help narrow the duration of therapy range for 2026? - Management indicated that the mix of KMT2A and NPM1 patients will influence the duration of therapy, with expectations for longer durations as more patients return from transplant [44][45] Question: What is the maintenance restart rate for patients who started Revyforge during the launch? - The restart rate has increased to about 35%-40%, with expectations for further growth as more patients return from transplant [46][47] Question: How will revenue per prescription evolve with the inclusion of more NPM1 patients? - Management does not expect significant changes in average revenue per prescription as NPM1 patients are integrated into the prescribing base [49] Question: What has been the impact of the NCCN guidelines on the NPM1 launch? - Management reported strong awareness and excitement among healthcare providers, setting a positive trajectory for the NPM1 launch [54][56]

Financial Data and Key Metrics Changes - Syndax Pharmaceuticals reported net revenue of $20 million for RevuForge in Q1 2025, marking the first full quarter of its launch [6][35] - Nictimvo achieved net revenue of $13.6 million in the first two months of its launch, with Syndax reporting a collaboration loss of only $200,000 for this period [6][36] - The company maintained a strong financial position with $602.1 million in cash and equivalents as of March 31, 2025 [7][39] Business Line Data and Key Metrics Changes - RevuForge's launch has seen strong adoption, with 44% of tier one and tier two accounts ordering the product as of March, up from one-third in February [16] - Nictimvo has been administered in over 1,250 infusions year-to-date, with approximately 95% of top accounts ordering the product [24] Market Data and Key Metrics Changes - The current indication for RevuForge targets an estimated 2,000 patients in the U.S. with relapsed or refractory acute leukemia with a KMT2A translocation, representing a $750 million market opportunity [20] - The total addressable market for Nictimvo is estimated to be between $1.5 billion to $2 billion, targeting 6,500 chronic GVHD patients in the U.S. [10][26] Company Strategy and Development Direction - Syndax aims to position RevuForge as the first menin inhibitor included in clinical guidelines for treating relapsed or refractory mutant NPM1 AML, with plans for a supplemental new drug application (sNDA) to the FDA [8][11] - The company is focused on executing strategic launch imperatives to ensure long-term competitive immunity ahead of potential me-too products entering the market [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong commercial opportunities for both RevuForge and Nictimvo, highlighting the high unmet medical need and the compelling profiles of their medicines [5][6] - The company anticipates that RevuForge will be the first menin inhibitor approved in the frontline setting, with ongoing trials expected to support accelerated approval [11][12] Other Important Information - The EVOLVE-two trial, a pivotal frontline trial for a menin inhibitor, has been initiated, targeting newly diagnosed patients with high unmet medical needs [7][28] - The company has seen robust engagement with the FDA regarding its sNDA filing and overall programs [9] Q&A Session Summary Question: What are you seeing regarding repeat prescribers for RevuForge? - Management noted that 44% of tier one and tier two accounts have ordered RevuForge, with about 80% of those having ordered more than once, indicating a growing user base [44][46] Question: Can you comment on patients receiving RevuForge and their transplant rates? - Management stated that anecdotal information suggests patients are being taken to transplant, and they expect patients to return to RevuForge post-engraftment [52][53] Question: What are the month-over-month trends for new patient adds for RevuForge? - Management indicated that while they are not providing specific numbers yet, they are happy with the steady stream of new patients and refill rates [57][60] Question: Can you provide insights on trends in GVHD and any subgroup details? - Management mentioned that it is still early to provide detailed information on GVHD subgroups, but they are collecting real-world evidence [67][70] Question: What portion of the $20 million revenue for RevuForge stems from refill dynamics? - Management stated that both new patient starts and refill dynamics are building, but specific numbers are not available yet [92][95]