Edgewise Therapeutics (EWTX) investor relations material

Study background and design

• EDG-7500 is a novel cardiac sarcomere modulator that improves diastolic relaxation and reduces LVOT gradients while preserving systolic function, with steady-state achieved in about 4 days.

• The 12-week open-label CIRRUS-HCM study included adults with obstructive (oHCM) and nonobstructive (nHCM) hypertrophic cardiomyopathy, using dose escalation guided by LVOT-G or NT-proBNP.

• By week 12, 65% of oHCM and 84% of nHCM participants received higher doses (100 or 150 mg).

• Baseline characteristics showed oHCM participants were older and had higher LVOT gradients, while nHCM had higher NT-proBNP and more frequent pathogenic mutations.

Efficacy results in oHCM

• 90% of oHCM participants achieved clinically meaningful LVOT gradient improvement, with resting and Valsalva gradients reduced by 55% and 51%, respectively.

• NT-proBNP and hs-cTnI decreased by 56% and 40% from baseline to week 12.

• KCCQ-OSS improved by 24 points at week 12, indicating substantial quality-of-life gains.

• 70% had at least one NYHA class improvement, and 55% reached NYHA Class I by week 12.

• Diastolic function improved, with a 1.2 cm/s (20%) increase in e' lateral velocity.

Efficacy results in nHCM

• NT-proBNP and hs-cTnI decreased by 65% and 33% from baseline to week 12.

• KCCQ-OSS improved by 13 points at week 12.

• 64% had at least one NYHA class improvement, and 52% reached NYHA Class I by week 12.

• Diastolic function improved, with a 1.6 cm/s (37%) increase in e' lateral velocity.