Braveheart Bio (BRVE) Corporate presentation summary

Transforming care in hypertrophic cardiomyopathy

• Focus on developing BHB-1893, a next-generation oral cardiac myosin inhibitor for both obstructive (oHCM) and non-obstructive (nHCM) hypertrophic cardiomyopathy, targeting a large, underserved patient population in the U.S. estimated at 700K–960K.

• BHB-1893 is engineered for rapid onset, predictable pharmacokinetics, and a shallow LVEF dose-response, aiming to address safety, efficacy, and ease-of-use gaps left by first-generation CMIs.

• Compelling Phase 2 data show robust efficacy, safety, and simplified dosing, with 86% of oHCM patients achieving target gradient response and significant improvements in diastolic function and biomarkers in nHCM.

• No approved therapies exist for nHCM, highlighting significant unmet need and market opportunity.

• Strong financial position post-IPO supports global Phase 3 trials and continued development.

Clinical development and trial results

• Over 300 subjects have been dosed with BHB-1893 across multiple Phase 1–3 studies, including randomized, double-blind, placebo-controlled trials in both oHCM and nHCM.

• Phase 2 oHCM trials demonstrated rapid, deep LVOT gradient reductions, normalization of NT-proBNP in >80% of patients, and functional improvements in exercise capacity and symptoms.

• Phase 2 nHCM trials showed dose-dependent improvements in cardiac biomarkers, myocardial relaxation, structural remodeling, and patient-reported outcomes, with a favorable safety profile.

• Adverse events were mostly mild or moderate, with no serious events leading to discontinuation or death in either oHCM or nHCM studies.

• Phase 3 global trials (LIONHEART-HCM for oHCM and NOBLE HEART-HCM for nHCM) are designed to simplify titration and focus on functional and structural endpoints.

Differentiation and competitive positioning

• BHB-1893 offers a differentiated profile with rapid onset, minimal titration, and a wide therapeutic index compared to approved CMIs, which require complex titration and monitoring.

• Preclinical and clinical data suggest mechanistic differentiation, with minimal LVEF reduction and improved diastolic function.

• Simplified dosing enables most patients to be managed on starting doses, reducing the need for frequent echocardiograms and dose adjustments.

• BHB-1893 is positioned to address significant unmet needs in both oHCM and nHCM, with potential for disease modification in nHCM.

• Experienced leadership and strategic partnerships support advancement toward regulatory approval and commercialization.