Braveheart Bio (BRVE) investor relations material

Company overview and clinical progress

• Focused on hypertrophic cardiomyopathy (HCM) with $500 million+ in funding, advancing multiple phase III programs for both obstructive and non-obstructive HCM.

• Strong partnership with Hengrui, which is running phase III in China and phase II in HFpEF.

• Initial conviction driven by phase I-B and II data showing rapid, deep gradient reduction, with one-year open label extension data to be presented at AHA.

Differentiation and mechanism of action

• BHB-1893 aims to address efficacy and safety limitations of current agents, offering rapid, deep gradient reduction and minimal ejection fraction (EF) reduction.

• Mechanistically differentiated by consistent potency across myosin mutations and pronounced diastolic improvements, including normalization of left atrial volume index and wall thickness.

• Short half-life and balanced metabolism enable simplified dosing and monitoring, potentially reducing echo burden.

Phase III design and regulatory strategy

• Phase III design features a simple, mostly fixed-dose titration, with 60% of patients served by the starting dose, reducing need for frequent echoes.

• Blinded echoes in Part B aim to support less burdensome monitoring, with regulatory feedback encouraging prospective data to justify this approach.

• Positive regulatory interactions suggest interim analysis plus Hengrui phase III data could support early filing, with additional PK data from Asian patients requested.