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]