Summary of Syndax Pharmaceuticals FY Conference Call Company Overview - **Company**: Syndax Pharmaceuticals (NasdaqGS:SNDX) - **Event**: 44th Annual JPMorgan Healthcare Conference - **Date**: January 12, 2026 - **Presenting**: CEO Michael Metzger Key Points Company Transformation and Product Launches - 2025 marked a transformational year for Syndax, transitioning to a commercial-stage oncology company with the launch of two first-in-class medicines: Revuforge and Niktimvo [2][3] - Achieved three FDA approvals within 14 months, demonstrating rapid product development and commitment to patient care [2] Financial Performance - The company reported approximately $400 million on the balance sheet, indicating strong financial health to support growth initiatives [3] - Revuforge generated $44 million in preliminary net revenue for Q4 2025, a 38% increase from the previous quarter, and $125 million for the full year [9][11] - Niktimvo generated $56 million in preliminary Q4 2025 net revenue, a 22% increase from the last quarter, and $152 million for the full year [22][23] Revuforge Insights - Revuforge is the first menin inhibitor approved for multiple acute leukemia subtypes, with a total addressable market of approximately $2 billion for relapsed refractory acute leukemia and $5 billion when considering front-line treatment [4][5] - The drug has shown unmatched efficacy and is well-tolerated, allowing for individual dosing and combination therapy with other medications [6][7] - The company has established a strong prescriber base and high reimbursement rates, with 97%-98% coverage from payers for KMT2A indications [8] Market Dynamics and Growth Strategy - The company is witnessing a shift towards earlier lines of therapy, with a growing number of patients being treated in second and third lines, which enhances response rates and treatment duration [12][13] - The approval of NPM1 has tripled the patient population eligible for treatment, further driving brand growth [14][15] - The company plans to advance clinical trials to support front-line use and explore additional indications, including myelofibrosis [18][27] Niktimvo Insights - Niktimvo is the first CSF1R blocking antibody approved for chronic GVHD, with a current market of 6,500 patients and a potential total addressable market of $2 billion [20][21] - The drug is expected to expand into front-line therapy, potentially reaching 15,000-17,000 patients [21] - The company has a robust clinical development plan for Niktimvo, including trials for chronic GVHD and idiopathic pulmonary fibrosis (IPF) [25][26] Future Outlook - Syndax is focused on generating value through data generation and clinical development in 2026, with several anticipated milestones, including top-line data for Axatilimab and pivotal trials for Revuforge [26][27] - The company aims to penetrate the KMT2A market further, targeting a 90% penetration rate over time [35] - The competitive landscape is acknowledged, but Syndax believes its best-in-class profiles and first-mover advantages will allow it to dominate the market [40] Additional Insights - Physicians have expressed strong interest in the combination of Niktimvo with existing therapies, which may drive earlier line utilization [53] - The company is confident in the efficacy of its drugs based on clinical data and physician feedback, with a significant percentage of patients remaining on therapy long-term [48] This summary encapsulates the key insights and strategic direction of Syndax Pharmaceuticals as discussed during the conference call.

Summary of Syndax Pharmaceuticals Conference Call Company Overview - **Company**: Syndax Pharmaceuticals - **Key Products**: RevuForge (Menin inhibitor for AML) and Nictimvo (for chronic GVHD) - **Market Potential**: - RevuForge: Over $5 billion market opportunity - Nictimvo: Over $3 billion market opportunity - **Current Status**: Both products are generating revenue and have FDA approval, with early launches showing positive results [3][4][7]. Core Points and Arguments RevuForge - **Product Profile**: First-in-class Menin inhibitor with a significant first-mover advantage in the market [3]. - **Clinical Data**: - Phase 1b study confirmed a dose of 160 mg in combination with Venaza, showing good tolerability and a 67% complete response (CR) rate compared to 37% historical control [11][13]. - 100% of evaluable patients achieved minimal residual disease (MRD) negativity, indicating strong efficacy [14]. - **Market Position**: Anticipated inclusion in NCCN guidelines ahead of approval, which could enhance market penetration [24][44]. Nictimvo - **Clinical Data**: - Updated data to be presented at EHA, showing a 26% CR rate and a 48% overall response rate in a larger patient population [21][22]. - Rapid symptom improvement across organ systems in chronic GVHD patients [47][48]. - **Sales Performance**: Strong initial sales with $13.6 million in net revenue for the first two months post-launch [49]. Additional Important Insights - **Regulatory Strategy**: Plans to use CR and MRD negativity as potential endpoints for accelerated approval in clinical trials [35][36]. - **Launch Metrics**: - RevuForge generated $20 million in its first full quarter, with 90% of sales from KMT2A patients and expectations for growth as NPM1 reimbursement is secured [37][42]. - High coverage rates with 72% of managed care lives covered, indicating strong market access [39]. - **Competitive Landscape**: Syndax is currently the only approved Menin inhibitor, with a best-in-class profile that physicians favor [29][30][31]. Conclusion Syndax Pharmaceuticals is well-positioned in the oncology market with its innovative products, strong clinical data, and strategic regulatory plans. The company is focused on expanding its market presence and enhancing its product offerings, which could lead to significant growth in the coming years [5][6][34].