Edgewise Therapeutics (EWTX) investor relations material

Differentiation and mechanism of EDG-7500

• Targets a unique protein in the sarcomere, acting as a partial modulator of contraction, unlike competitors that fully block contraction.

• Demonstrates greater potency on diastolic relaxation, improving the heart's ability to fill with blood and addressing key pathology in HCM and HFpEF.

• Shows robust efficacy in HCM patients without lowering ejection fraction, avoiding black box warnings and REMS required for competitor drugs.

• Enables broader physician adoption and easier administration due to favorable safety and efficacy profile.

Clinical data, safety, and titration approach

• No significant changes in ejection fraction observed, with rapid and robust improvements in diastolic function metrics.

• Atrial fibrillation events are consistent with disease background, not attributed to the drug, and expected to remain stable in future studies.

• Dose titration is based on patient-reported outcomes and tolerability, with minimal reliance on echo monitoring, aligning with AHA guidelines.

• Physicians may use NT-proBNP as a biomarker for dose optimization, focusing on patient well-being rather than frequent imaging.

Efficacy measures and endpoints

• Four-week data show impressive improvements in patient feel and function, with upcoming 12-week data expected to be as good or better than prior results.

• Efficacy is assessed using a combination of NYHA class, NT-proBNP, and gradient relief, emphasizing multi-domain responder analysis.

• The approach aims to simplify real-world use, allowing physicians to optimize care without risking systolic function.