Healthcare

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, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Braveheart Bio, Inc. (Nasdaq: BRVE), a clinical-stage biopharmaceutical company developing next-generation therapeutic

Braveheart Bio, Inc.September 8, 202613 min read
Braveheart Bio Reports Second Quarter 2026 Financial Results and Provides Business Update

About this update from Braveheart Bio, Inc.

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, Sept. 08, 2026 (GLOBE NEWSWIRE) -- 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 Additional Highlights 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. 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. As of September 3, 2026, Braveheart Bio had 90,038,969 shares of common stock outstanding, reflecting the conversion of all outstanding preferred stock into common stock and the issuance of 24,437,500 shares in Braveheart Bio's IPO, each of which occurred after June 30, 2026. About Braveheart Bio Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Braveheart Bio's lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart Bio is aiming to address the limitations of currently available CMIs by designing BHB-1893 for rapid onset, consistent depth of response, preservation of systolic function, prompt reversibility, and a straightforward approach to titration and monitoring. For more information, please visit www.braveheart.bio. Forward-Looking Statements This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words such as "anticipate," "believe," "expect," "intend," "may," "plan," "potential," "should," "will" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: the clinical development of BHB-1893 and other product candidates, including the initiation, timing, progress, results and future data releases of ongoing and planned clinical trials; the timing of initiation as well as expected results from the NOBLEHEART-HCM global Phase 3 trial; Braveheart Bio's interactions and communications with regulatory authorities and timing as well as anticipated results of submissions; the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of Braveheart Bio's product candidates; its ability to develop and advance its potential future product candidates and programs; and expectations for the Braveheart Bio's uses of capital, expenses and financial results, including its cash runway into 2029. Any forward-looking statements in this press release are based on Braveheart Bio's current expectations and assumptions. These statements are neither promises nor guarantees and involve risks, uncertainties and other important factors that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, risks relating to: Braveheart Bio's research and development activities; Braveheart Bio's ability to obtain the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to clinical development activities; Braveheart Bio's dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Braveheart Bio's ability to attract, integrate and retain key personnel; risks related to Braveheart Bio's financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Braveheart Bio's intellectual property protections; and risks related to the competitive landscape for Braveheart Bio's product candidates; as well as the other risks and uncertainties described under the heading "Risk Factors" section in Braveheart Bio's upcoming Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 and any subsequent filings Braveheart Bio makes with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date of this press release. Except as required by applicable law, Braveheart Bio undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Braveheart Bio intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Braveheart Bio's Investor Relations website, in addition to following Braveheart Bio's press releases, SEC filings, public conference calls, presentations, and webcasts. Investor Relations Contact Alexander Sharif New Street Investor Relations [email protected] Media Contact FGS Global [email protected]

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