Every material Form 8-K Braveheart Bio, Inc. has filed with the SEC since September 08, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Braveheart Bio and Hengrui Pharma presented 52-week open-label extension data from a Phase 2 study of HRS/BHB-1893 in 42 patients with obstructive hypertrophic cardiomyopathy (oHCM) at the American Heart Association Scientific Sessions 2026. The company reported gains in exercise capacity, symptoms and LVOT gradient, and also presented diastolic function data in non-obstructive HCM. The filing contains no financial results, and the company will hold an investor event today to discuss the data and a planned fixed-dose oHCM study.
At Week 52, peak oxygen uptake rose a mean of 2.7 mL/kg/min and KCCQ-CSS rose a mean of 17.3 points from OLE baseline.
At Week 52, 79% (33/42) of patients achieved a Valsalva LVOT gradient below 30 mmHg.
Two patients had transient LVEF reductions below 50%, and no on-treatment severe or serious adverse events were reported.
Investor event and webcast scheduled for November 6, 2026, at 3:35 p.m. CT (4:35 p.m. ET).
Braveheart Bio, a clinical-stage company with no reported revenue, posted a second-quarter 2026 net loss of $15.0 million, up from $0.4 million a year earlier, as R&D and G&A spending rose. Cash was $122.8 million at June 30, 2026, or about $527.3 million on an as-adjusted basis after its August 2026 IPO, which the company says funds operations into 2029.
Net loss attributable to common stockholders was $18.6 million, or $2.51 per share, versus $0.14 per share in Q2 2025; this includes a $3.6 million non-cash deemed dividend.
R&D expenses were $11.1 million and G&A expenses were $4.8 million for the quarter, compared with $0.0 million and less than $0.1 million a year earlier.
Cash and cash equivalents were $122.8 million at June 30, 2026; the IPO closed in August 2026 with aggregate net proceeds of about $404.5 million.
The company said the first patient in the LIONHEART-HCM Phase 3 trial is expected to be dosed this year, and the NOBLEHEART-HCM Phase 3 trial is expected to start in the first half of 2027.
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