Syndax Pharmaceuticals (SNDX) Conference Transcript

Summary of Syndax Pharmaceuticals (SNDX) Conference Call - September 02, 2025 Company Overview - Company: Syndax Pharmaceuticals - Products: Revuforj (for KMT2A-rearranged acute leukemia) and Ictimo (for chronic graft-versus-host disease, cGVHD) - Recent Achievements: Two rapid approvals in succession, with a focus on addressing high unmet medical needs in oncology Key Points on Revuforj - Launch Performance: Revuforj has seen a 43% growth in net sales with over $50 million generated since launch, treating over 500 patients [3][5] - Market Dynamics: - Targeting KMT2A-rearranged patients, with a total addressable market (TAM) of 2,000 new patients annually [5][6] - Currently treating 25% of the available market, with expectations to increase to 50% by year-end [5][6] - Treatment Duration: Average treatment duration expected to increase from 4-6 months to 9 months as more patients are treated earlier in their disease progression [9][10] - Patient Demographics: Shift from treating late-line patients to earlier-line patients, with 70% of current patients being in the second or third line of treatment [7][12] - Transplant Dynamics: Approximately 33% of patients are expected to go for transplant, higher than the 25% seen in clinical trials [7][8] Upcoming Regulatory Milestones - sNDA Submission: An sNDA for Revuforj is under review with a PDUFA date of October 25, 2025 [21][22] - Market Expansion: The NPM1-mutated patient market is larger than KMT2A, with an estimated 4,500 patients [23][24] Key Points on Ictimo - Launch Success: Ictimo has generated nearly $50 million in sales in its first full quarter, with 700 patients treated [42][43] - Patient Retention: 80-90% of patients are remaining on the drug, indicating strong tolerability [42] - Market Coverage: Over 80% of transplant centers have utilized Ictimo, with a majority using it multiple times [43][44] - Partnership with Incyte: Co-promotion with Incyte has been efficient, leveraging their existing infrastructure [44] Future Development Plans - Subcutaneous Formulation: Development of a subcutaneous formulation for Ictimo is underway, which could enhance patient convenience [48] - Clinical Trials: Ongoing studies in combination with dexamethasone and Jakafi for earlier lines of therapy in cGVHD [49][50] Financial Outlook - Profitability Goals: Syndax aims to reach profitability without needing additional financing, with operating expenses expected to remain flat through 2025 [61][62] - Collaboration Revenue: Ictimo is already profitable on a contribution profit basis, with $9 million in collaboration revenue reported [61] Competitive Landscape - Market Position: Syndax is positioned as the only approved menin inhibitor, with a focus on maintaining a competitive edge through efficacy and multiple indications [30][40] Conclusion - Strategic Focus: Syndax is concentrating on successfully commercializing Revuforj and Ictimo, advancing clinical development, and achieving profitability before considering new product investments [68][69]