Summary of Edgewise Therapeutics FY Conference Call Company Overview - **Company**: Edgewise Therapeutics (NasdaqGS:EWTX) - **Event**: 2025 Healthcare Innovations Conference - **Date**: November 11, 2025 Key Points Industry and Product Focus - Edgewise Therapeutics is focused on developing treatments for hypertrophic cardiomyopathy (HCM) and heart failure with preserved ejection fraction (HFpEF) [1][2] PART-D Study Insights - The PART-D data is expected to be released by the end of the year, with ongoing discussions about the efficacy data from the 25 mg dose [7][9] - Initial data from the PART-BC study showed no correlation between ejection fraction changes and drug concentration, indicating a differentiated profile compared to current treatments [2][13] - The company has faced enrollment challenges but has implemented measures to ensure a representative patient group [4][6] Efficacy and Safety Observations - Significant improvements were noted in patient feel and function, as measured by New York Heart Association (NYHA) changes and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores [2][21] - The compound was generally well tolerated, with a few cases of atrial fibrillation observed, which is common in HCM patients [2][3] - The company aims to eliminate the need for multiple echocardiograms in dosing, which is a barrier for many cardiology practices [14][15][20] Competitive Landscape - Edgewise's drug aims to provide a safer alternative to current treatments that require titration and monitoring of ejection fraction [14][15] - The company believes that their drug can be a first-line treatment for patients with borderline ejection fraction, potentially replacing current therapies that have safety concerns [16][17] Future Studies and Registration Plans - Plans for future studies include potentially head-to-head trials against beta blockers and similar studies to previous successful trials [27][30] - The primary endpoints for future studies will likely include KCCQ and NT-proBNP levels, with a focus on achieving significant clinical benefits [33][37] HFpEF Program Development - The company plans to initiate a phase 2A study in HFpEF, focusing on NT-proBNP as a primary measure of efficacy [36][38] - The anticipated timeline for this study is in 2026, with a focus on patient tolerability and dose range [37][38] Sarasantan and DMD Strategy - Discussions are ongoing regarding the registration study for Sarasantan in Duchenne Muscular Dystrophy (DMD), with a focus on patient backgrounds and competitive landscape [39][40] - The company is considering using SV95 as a primary endpoint for DMD studies, pending discussions with regulatory agencies [42][43] Financial Position - Edgewise Therapeutics has $560 million in cash, which is expected to fund operations through 2028, supporting their commercialization plans [47][51] Conclusion - Edgewise Therapeutics is positioned to make significant advancements in the treatment of HCM and HFpEF, with promising data and a strong financial foundation to support ongoing and future studies [52][56]