Edgewise Therapeutics (EWTX) investor relations material

Recent accomplishments and upcoming goals

• Presented key cardiovascular endpoint data from the CANYON study, showing increased ejection fraction in patients with low baseline values and stable NT-proBNP in normal patients.

• Open label extension in Becker muscular dystrophy showed all patients remained progression free, with Phase III data expected by year-end.

• Cardiovascular program 7500 for hypertrophic cardiomyopathy (HCM) is progressing, with 12-week Part D data to be released at the end of Q2 and plans to initiate Phase III by year-end.

• Ongoing discussions with the FDA to finalize Phase III protocols for 7500.

Clinical trial insights and differentiation

• 7500 demonstrated no changes in ejection fraction at increasing doses, supporting a favorable safety profile and potential to avoid REMS requirements.

• The drug's mechanism allows dosing based on patient feel and function rather than ejection fraction, enabling broader use by community cardiologists.

• Responder analysis focuses on achieving normal NT-proBNP, NYHA class I, high KCCQ scores, and low gradients in obstructive patients.

• AFib rates in HCM patients are high and consistent with background rates; Zio Patch monitoring is used to distinguish baseline pathology from drug effects.

Market positioning and operational strategy

• Community cardiologists express strong interest in treating HCM if management is simplified, as current therapies require burdensome echo monitoring.

• 7500's lack of ejection fraction reduction could allow easier adoption in community settings compared to current CMIs.

• Phase III design for non-obstructive HCM leverages learnings from previous studies, focusing on experienced sites to reduce data variability.

• Drug mechanism targets diastolic function, with rapid NT-proBNP reduction preceding hemodynamic changes.