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Item 2.02 Results of Operations and Financial Condition.
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On September 8, 2026, Braveheart Bio, Inc. (the “Company”) announced its financial results and business highlights for the quarter ended June 30, 2026. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information included under Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.
• 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.
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• 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.
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• 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.
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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-1893, preparation for the planned global Phase 3 program, and higher personnel-related costs.
General and administrative (G&A) expenses were $4.8 million for the three months ended June 30, 2026, compared to less than $0.1 million for the same period in 2025. The increase was primarily due to increased headcount and costs incurred to support Braveheart Bio’s increased operations, business development, and preparation for operating as a public company.
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Net loss was $15.0 million, and net loss attributable to common stockholders, after a deemed dividend upon the issuance of Series A preferred stock, was $18.6 million or $2.51 net loss per share, basic and diluted, for the three months ended June 30, 2026, compared to a net loss of $0.4 million, or $0.14 net loss per share, basic and diluted, for the same period in 2025.
The deemed dividend of $3.6 million is a non-cash charge representing the excess of the estimated fair value of the Series A preferred stock issued in April 2026 over the $1.00 per share purchase price. It increased net loss attributable to common stockholders for purposes of computing net loss per share and did not affect net loss or cash flows.
All share and per share amounts for all periods presented have been retroactively adjusted to give effect to the 1-for-4.38 reverse stock split of the Braveheart Bio’s common stock effected on July 29, 2026.
