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Braveheart Bio Reports Second Quarter 2026 Financial Results and Provides Business Update

Phase 3 LIONHEART-HCM Trial of BHB-1893 in Obstructive Hypertrophic Cardiomyopathy (oHCM) Initiated

Cash and Cash Equivalents of $122.8 Million as of June 30, 2026, or $527.3 Million After Giving Effect to Braveheart Bio’s Initial Public Offering, Expected to Support Advancement of BHB-1893 Through Late-Stage Clinical Development

SAN FRANCISCO, September 8, 2026: Braveheart Bio, Inc. (Nasdaq: BRVE), a clinical-stage biopharmaceutical company developing next-generation therapeutics for hypertrophic cardiomyopathy (“HCM”) and other serious cardiovascular diseases, today reported unaudited financial results for the second quarter ended June 30, 2026, and provided a business update.

“Our clinical programs continue to advance, and our IPO this summer has provided a strong financial foundation to advance the development of our global Phase 3 programs and evaluate the potential of BHB-1893 as the preferred treatment option in two indications,” said Travis Murdoch, M.D., Chief Executive Officer and President of Braveheart Bio. “Sites are being activated and patients are screening for our LIONHEART-HCM Phase 3 study in obstructive HCM (“oHCM”), and we are on track to dose the first patient this year. We continue to expect results from an interim analysis from LIONHEART-HCM in the second half of 2027. In addition, our program in non-obstructive HCM (“nHCM”) is advancing; we now have an active U.S. investigational new drug application (“IND”) and expect to initiate our NOBLEHEART-HCM Phase 3 study in the first half of 2027.”

Second Quarter and Recent Business Highlights

BHB-1893 Clinical Development

•In May 2026, Braveheart Bio and Hengrui Pharmaceuticals Co., Ltd. announced results from a randomized, double-blind, placebo-controlled Phase 2 trial evaluating HRS/BHB-1893 in nHCM. The results were featured in a late-breaking presentation at the 2026 annual meeting of the Heart Failure Association of the European Society of Cardiology. In this trial, BHB-1893-treated patients were observed to have rapid, substantial, and statistically significant reductions in secondary endpoints that are cardiac biomarkers, which were observed to rapidly reverse during trial drug washout. Patients’ functional status and exercise capacity were also higher at the end of the trial compared to baseline. On echo, BHB-1893 treated patients showed statistically significant, dose-dependent improvements in myocardial relaxation, hemodynamic benefit, and cardiac remodeling compared to placebo-treated patients, including observed improvements in diastolic function. Additionally, no patients in the intervention cohorts required trial drug interruption for LVEF reductions, which, together with BHB-1893’s pharmacokinetic profile, supports a generally favorable profile. Braveheart Bio has an open IND, and expects to initiate NOBLEHEART-HCM, a global Phase 3 trial in nHCM in the first half of 2027.

•Following Phase 2 oHCM results announced in March 2026, Braveheart Bio has initiated LIONHEART-HCM, a Phase 3, multi-region, multi-center, randomized, double-blind, active-comparator-controlled trial, to evaluate the efficacy and safety of BHB-1893 compared to metoprolol in adults with symptomatic oHCM.

Additional Highlights

•In April 2026, Braveheart Bio completed the third closing of its Series A preferred stock financing, issuing an aggregate of 60,000,000 shares at $1.00 per share for gross proceeds of $60.0 million.

•Braveheart Bio completed an initial public offering in August 2026, issuing an aggregate of 24,437,500 shares of common stock at $18.00 per share for gross proceeds of approximately $439.9 million. Braveheart Bio’s common stock began trading on the Nasdaq Global Market under the ticker symbol "BRVE" on August 6, 2026.

Second Quarter 2026 Financial Results

Cash and cash equivalents were $122.8 million as of June 30, 2026, compared to $89.2 million as of December 31, 2025. The June 30, 2026 balance does not reflect the net proceeds from Braveheart Bio's initial public offering (“IPO”), which closed in August 2026. The IPO resulted in aggregate net proceeds of approximately $404.5 million, after deducting underwriting discounts and commissions and offering expenses payable by Braveheart Bio. Including those net proceeds, cash and cash equivalents would have been approximately $527.3 million on an as-adjusted basis. Based on the current operating plan, Braveheart Bio estimates that its existing cash and cash equivalents, together with the net proceeds from its IPO, will be sufficient to fund its projected operating expenses and capital expenditure requirements into 2029.

Research and development (R&D) expenses were $11.1 million for the three months ended June 30, 2026, compared to $0.0 million for the same period in 2025. The increase was primarily due to the advancement of BHB-18