Braveheart Bio — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and investments totaled $503.5 million as of September 30, 2026, compared to $89.2 million as of December 31, 2025.
• Research and development expenses were $17.5 million for the three months ended September 30, 2026, compared to less than $0.1 million for the same period in 2025.
• General and administrative expenses were $12.6 million for the three months ended September 30, 2026, compared to $0.5 million for the same period in 2025.
• G&A expenses included $7.8 million of non-cash stock-based compensation expense, with $6.1 million related to liability-classified modified executive restricted stock awards.
• Net loss was $26.5 million ($0.51 per share, basic and diluted) for the three months ended September 30, 2026, compared to a net loss of $59.1 million ($10.05 per share) for the same period in 2025.
• Total operating expenses were $30.1 million for the three months ended September 30, 2026, compared to $59.3 million for the same period in 2025.
• Total other income was $3.7 million for the three months ended September 30, 2026, compared to $0.2 million for the same period in 2025.
• Total assets were $514.5 million as of September 30, 2026, compared to $89.4 million as of December 31, 2025.
• Total stockholders' equity was $497.6 million as of September 30, 2026, compared to a deficit of $65.9 million as of December 31, 2025.
• No in-process research and development (IPR&D) expense was recorded for the three months ended September 30, 2026, compared to $58.8 million in 2025.

Guidance and Future Outlook:

• The company estimates existing cash, cash equivalents, and investments will fund projected operating expenses and capital requirements into 2029.
• Interim analysis results for the LIONHEART-HCM trial's LVOT gradient at Week 12 are expected in the second half of 2027.
• Topline results from Hengrui Pharma's Phase 3 trial (Study 301) in China are expected in the first half of 2027.
• 52-week data from the nHCM Phase 2 open-label extension are expected in the first half of 2027.
• The NOBLEHEART-HCM Phase 3 trial in non-obstructive HCM is on track to initiate in the first half of 2027.
• The TRUEHEART-HCM Phase 2b fixed-dose trial is expected to initiate in the U.S. in the first half of 2027.

Business Segments and Product Lines:

• BHB-1893 is the lead product candidate, a next-generation oral cardiac myosin inhibitor being developed for obstructive HCM (oHCM) and non-obstructive HCM (nHCM).
• 52-week open-label extension data for BHB-1893 in oHCM showed mean peak oxygen uptake (pVO2) improved by 2.7 mL/kg/min and Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) improved by 17.3 points from baseline.
• In the oHCM open-label extension, 67% of patients achieved a Valsalva left ventricular outflow tract gradient (LVOT-G) below 30 mmHg by Week 1, and 90% reached this threshold at one or more visits during 52 weeks.
• 57% of patients in the oHCM open-label extension remained on the 40 mg twice-daily starting dose at Week 52.
• Preclinical and Phase 2 data indicate BHB-1893 improves diastolic function indices while preserving systolic performance.
• At Week 12 of the Phase 2 study, 59% of BHB-1893-treated patients had normal septal e' velocities compared to 14% of placebo-treated patients, and 57% had normal lateral e' velocities compared to 18% of placebo-treated patients.
• LIONHEART-HCM is a global Phase 3 trial in oHCM enrolling patients, evaluating BHB-1893 against metoprolol with a starting dose of 40 mg twice-daily and a single potential titration step.
• NOBLEHEART-HCM is a planned global Phase 3 trial in nHCM with dual primary endpoints of change in pVO2 and KCCQ-CSS from baseline to Week 36.
• TRUEHEART-HCM is a planned Phase 2b trial evaluating a fixed 40 mg twice-daily dose of BHB-1893 with no titration visits.
• Hengrui Pharma completed enrollment in its Phase 3 trial of HRS-1893 (BHB-1893) in China.

Market and Competitive Landscape:

• Braveheart Bio aims to address limitations of currently available cardiac myosin inhibitors by designing BHB-1893 for rapid onset, consistent depth of response, preservation of systolic function, prompt reversibility, and a straightforward titration approach.
• The company is collaborating with Hengrui Pharma for development in Greater China.

Risks and Challenges:

• Risks include uncertainties related to clinical development activities, the ability to obtain regulatory approvals on expected timelines, and reliance on third parties for manufacturing and clinical trials.
• Specific risks involve dependence on Hengrui for data generation and manufacturing of BHB-1893.
• Risks related to geopolitical developments and U.S. and Chinese laws, including the BIOSECURE Act, are noted.
• The company faces risks related to the competitive landscape for its product candidates.

Management Commentary and Tone:

• Travis Murdoch, President and CEO, stated that BHB-1893 shows a consistent, potentially differentiated profile with rapid, deep responses that continue to improve over time.
• Management highlighted evidence supporting a highly simplified dosing regimen and an updated development strategy to minimize titration while optimizing efficacy.
• The company expressed focus on delivering a potential best-in-disease profile with a simple dosing paradigm for patients with HCM.

Other Key Points:

• Braveheart Bio completed an upsized initial public offering in August 2026, selling 24,437,500 shares at $18.00 per share for gross proceeds of approximately $439.9 million.
• Common stock began trading on the Nasdaq Global Market under the ticker symbol "BRVE" on August 6, 2026.
• A $1.0 million milestone payment under the Hengrui license agreement contributed to the increase in R&D expenses for the quarter.
• The company hosted an investor event on November 6, 2026, titled "HCM Spotlight: Advancing a Next-Generation Cardiac Myosin Inhibitor."