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

Quarterly losses narrowed as in-process research expense fell to zero, while clinical development and administrative expenses increased.

Rhea-AI Summary

Braveheart Bio (BRVE) reported a third-quarter net loss of $26.5 million and advanced clinical development of BHB-1893 for hypertrophic cardiomyopathy. Loss per share was $0.51, versus $10.05 a year earlier, when net loss was $59.1 million. Cash, cash equivalents and investments reached $503.5 million at September 30, 2026; the company estimates funding into 2029.

In a 42-patient, 52-week open-label extension in obstructive disease, peak oxygen uptake improved 2.7 mL/kg/min and symptom-related clinical scores improved 17.3 points from extension baseline, with no on-treatment severe or serious adverse events. LIONHEART-HCM Phase 3 is enrolling, with interim results expected in the second half of 2027. Braveheart plans to start NOBLEHEART-HCM Phase 3 and fixed-dose TRUEHEART-HCM Phase 2b in the first half of 2027. Its August IPO raised approximately $439.9 million gross.

21 points · 1 major

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1 major · 8 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointAugust IPO raised approximately $439.9 million gross, including full exercise of the underwriters’ option. 25% of market cap
• Moderate pointCash, cash equivalents and investments rose to $503.5 million from $89.2 million at December 31, 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Existing funds are estimated to cover operating expenses and capital requirements into 2029 under the current plan.
• Moderate pointThird-quarter net loss narrowed to $26.5 million, or $0.51 per share, from $59.1 million, or $10.05.
• Moderate point. Forward-looking: it has not happened yet and may not happen.LIONHEART-HCM Phase 3 is enrolling; interim Week 12 pressure-gradient results are expected in the second half of 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.NOBLEHEART-HCM Phase 3 initiation is planned for first half of 2027 following the completed FDA meeting.
• Moderate point. Forward-looking: it has not happened yet and may not happen.TRUEHEART-HCM fixed-dose Phase 2b initiation is planned for first half of 2027 following supportive FDA feedback.

14 minor points

• Minor pointThird-quarter in-process research expense fell to zero from $58.8 million a year earlier.
• Minor pointThird-quarter other income increased to $3.654 million from $169,000 a year earlier.
• Minor pointObstructive-disease extension showed 2.7 mL/kg/min improved peak oxygen uptake from extension baseline over 52 weeks.
• Minor pointObstructive-disease extension showed 17.3-point improvement in the questionnaire clinical summary score from extension baseline.
• Minor pointHeart outflow pressure gradient fell below 30 mmHg in 67% at Week 1; 90% achieved it during treatment.
• Minor pointStarting dose of 40 mg twice daily was maintained by 57% of patients at Week 52.
• Minor pointBHB-1893 had no on-treatment severe or serious adverse events in the 52-week obstructive-disease extension.
• Minor pointExploratory post-washout measures were lower after 52 weeks than 12 weeks, consistent with potential structural heart improvement.
• Minor pointNormal septal relaxation velocities occurred in 59% versus 14% on placebo at Week 12 in pooled non-obstructive-disease analysis.
• Minor pointNormal lateral relaxation velocities occurred in 57% versus 18% on placebo at Week 12 in pooled non-obstructive-disease analysis.
• Minor point. Forward-looking: it has not happened yet and may not happen.Hengrui’s China Phase 3 completed enrollment; topline results are expected in the first half of 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Non-obstructive-disease Phase 2 extension data at 52 weeks are expected in the first half of 2027.
• Minor pointNine-month net loss narrowed to $55.763 million from $59.598 million a year earlier.
• Minor pointStockholders’ equity reached $497.602 million, versus a $65.872 million deficit at December 31, 2025.

Negative

• Major pointIPO issued 24,437,500 common shares at $18.00 each, diluting existing holders.
• Moderate pointThird-quarter research and development expense rose to $17.542 million from $9,000 a year earlier.
• Moderate pointThird-quarter administrative expense rose to $12.607 million from $508,000, including $7.8 million in non-cash stock compensation.
• Minor pointTRUEHEART-HCM protocol remains under finalization ahead of planned U.S. trial initiation.
• Minor pointNine-month research and development expense rose to $39.581 million from $9,000 a year earlier.

3 minor points

• Minor pointNine-month administrative expense rose to $21.499 million from $540,000 a year earlier.
• Minor pointNine-month deemed preferred-stock dividends were $3.615 million, versus none a year earlier.
• Minor pointTotal liabilities increased to $16.848 million from $5.333 million at December 31, 2025.

News Explained

The release specifies that Braveheart Bio completed its August IPO by selling 24,437,500 common shares at $18 each; this increased the share count and reduced existing holders’ percentage ownership, absent offsetting changes.

Key Figures

Cash, cash equivalents and investments: $503.5 million Cash runway: Into 2029 Net loss: $26.5 million +5 more

Cash, cash equivalents and investments

$503.5 million

As of September 30, 2026

Cash runway

Into 2029

Based on the current operating plan

Net loss

$26.5 million

Q3 2026; compared with $59.1 million in Q3 2025

Net loss per share

$0.51

Q3 2026, basic and diluted; compared with $10.05 in Q3 2025

Peak oxygen uptake change

2.7 mL/kg/min

52-week oHCM Phase 2 open-label extension, from OLE baseline

KCCQ-CSS change

17.3 points

52-week oHCM Phase 2 open-label extension, from OLE baseline

LVOT-G threshold achieved

90%

Reached below 30 mmHg at one or more visits during 52 weeks of treatment

Patients on starting dose

57%

Remained on the 40 mg twice-daily dose at Week 52

Previous Earnings Reports

1 past event · Latest: Sep 08

Same Type 1 event

1. Sep 08

   Q2 earnings

   24h Move

   -1.7%

   Prior quarter reported $122.8M cash, $527.3M IPO-adjusted cash, and runway into 2029.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pvo2, kccq-css, lvot-g, nt-probnp, +1 more

5 terms

pvo2 medical

"Mean peak oxygen uptake (“pVO2”) and Kansas City Cardiomyopathy Questionnaire"

PvO2 is the partial pressure of oxygen in venous blood — a measure of how much oxygen remains in the blood after tissues have taken what they need. Think of it like checking the water level in a used bucket to gauge how much was consumed; low PvO2 can signal poor oxygen delivery or high tissue demand, while high PvO2 can mean reduced uptake. Investors watch PvO2 when it’s used as a clinical measurement or trial endpoint because changes can indicate whether a drug, device, or treatment meaningfully improves patient oxygenation and safety, which affects regulatory decisions and market value.

kccq-css medical

"Clinical Summary Score (“KCCQ-CSS”) improved by 2.7 mL/kg/min and 17.3 points"

The KCCQ-CSS is a patient-reported score that summarizes how heart failure affects a person’s symptoms and physical abilities, producing a 0–100 rating where higher numbers mean better health. Investors should care because this score is commonly used in clinical trials and regulatory reviews to show whether a treatment genuinely improves patients’ day-to-day wellbeing—think of it like a customer satisfaction rating that can influence approval, reimbursement and market uptake.

lvot-g medical

"Valsalva left ventricular outflow tract gradient (“LVOT-G”) below 30 mmHg"

LVOT‑G is the pressure difference across the left ventricular outflow tract, the path blood takes as it leaves the heart. Think of it like the pressure build‑up when water is forced through a narrow part of a hose: a higher gradient means the heart must work harder. For investors, changes in LVOT‑G are a key clinical measure used to judge how well treatments or devices relieve obstruction, affecting regulatory decisions, market acceptance and long‑term revenue potential.

nt-probnp medical

"gradient and NT-proBNP levels after washout were lower following 52 weeks"

A blood test marker released when the heart is under strain; higher NT‑proBNP levels indicate the heart is working harder or may be failing, similar to a dashboard warning light that signals engine stress. Investors watch NT‑proBNP because changes in the marker can drive clinical trial results, treatment approvals, hospital use, and insurance decisions for heart drugs and devices, all of which affect revenue, adoption and valuation in healthcare companies.

open-label extension medical

"presented 52-week open-label extension (“OLE”) data from the Phase 2 study"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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52-week data presented at AHA Scientific Sessions 2026 further strengthen BHB-1893’s potential differentiation, with encouraging clinical activity and support for a highly simplified dosing regimen

LIONHEART-HCM oHCM Phase 3 enrolling with interim analysis expected in second half of 2027; TRUEHEART-HCM fixed-dose oHCM Phase 2b and NOBLEHEART-HCM Phase 3 in nHCM on track to initiate in first half of 2027

Cash, cash equivalents and investments of $503.5 million; cash runway expected into 2029

SAN FRANCISCO, Nov. 10, 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 third quarter ended September 30, 2026, and provided a business update.

“BHB-1893 continues to show a consistent, potentially differentiated profile across multiple clinical studies and our mechanistic work,” said Travis Murdoch, M.D., President and Chief Executive Officer of Braveheart Bio. “The 52-week data presented at AHA showed rapid, deep responses that continued to improve over time, including meaningful improvements in pVO2 and KCCQ-CSS, and evidence supporting a highly simplified dosing regimen. These results inform our updated development strategy, including TRUEHEART-HCM, which will evaluate a fixed dose in oHCM on top of standard of care. With LIONHEART-HCM enrolling, NOBLEHEART-HCM on track to initiate in the first half of 2027 and a strong balance sheet, we are focused on delivering a potential best-in-disease profile with a simple dosing paradigm for patients with HCM.”

Recent Business Highlights

AHA Scientific Sessions 2026 Clinical Data Presentations

• 52-Week Open-Label Extension in Obstructive HCM (“oHCM”): Braveheart Bio and partner Hengrui Pharma presented 52-week open-label extension (“OLE”) data from the Phase 2 study of BHB-1893 in 42 patients with oHCM in a late-breaking oral presentation. Mean peak oxygen uptake (“pVO2”) and Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (“KCCQ-CSS”) improved by 2.7 mL/kg/min and 17.3 points, respectively, from OLE baseline. By Week 1, before any titration, 67% of patients achieved a Valsalva left ventricular outflow tract gradient (“LVOT-G”) below 30 mmHg; 90% reached this threshold at one or more visits during 52 weeks of treatment. At Week 52, 57% of patients remained on the 40 mg twice-daily starting dose. In an exploratory analysis, gradient and NT-proBNP levels after washout were lower following 52 weeks of treatment than following 12 weeks, consistent with potential reverse remodeling. BHB-1893 was generally well tolerated, with no on-treatment severe or serious adverse events.
• New data supporting differentiated mechanism of action: Braveheart Bio presented preclinical mechanistic data from engineered heart tissue models and an ad hoc pooled analysis of the Phase 2 study of BHB-1893 in non-obstructive HCM (“nHCM”). BHB-1893 improved indices of diastolic function while preserving systolic performance, both in vitro and in patients; at Week 12, a majority of BHB-1893-treated patients had normal septal and lateral e′ velocities (59% and 57%, respectively, compared with 14% and 18% of placebo-treated patients). 52-week data from the nHCM Phase 2 OLE are expected in the first half of 2027.

Development Strategy Update

• On November 6, 2026, Braveheart Bio hosted an investor event, “HCM Spotlight: Advancing a Next-Generation Cardiac Myosin Inhibitor,” featuring leading HCM experts, and outlined its updated clinical development strategy for BHB-1893, which is designed to minimize titration while optimizing efficacy. A replay is available in the Investors section of Braveheart Bio’s website.
• LIONHEART-HCM, Global Phase 3 Trial in oHCM: LIONHEART-HCM is enrolling patients. It is a global, randomized, double-blind, active-comparator-controlled Phase 3 trial evaluating the efficacy and safety of BHB-1893 compared to metoprolol in patients with symptomatic oHCM, using a 40 mg twice-daily starting dose with a single potential titration step to 60 mg at Week 4. The primary endpoint is change in pVO2 from baseline to Week 24; secondary endpoints include LVOT gradient, NT-proBNP and KCCQ-CSS. Results from an interim analysis of LVOT gradient at Week 12 are expected in the second half of 2027.
• Hengrui Pharma’s Study 301, a Phase 3 Trial in oHCM in China: Hengrui Pharma, Braveheart Bio’s collaboration partner in Greater China, has completed enrollment in its Phase 3 trial of HRS-1893 on top of standard of care, with topline results expected in the first half of 2027.
• NOBLEHEART-HCM, Global Phase 3 Trial in nHCM: Braveheart Bio has completed its end-of-Phase 2 meeting with the FDA and plans to initiate NOBLEHEART-HCM in the first half of 2027. NOBLEHEART-HCM is a planned global, randomized, double-blind, placebo-controlled Phase 3 trial evaluating BHB-1893 in adults with symptomatic nHCM. The trial design includes a potential single titration step at Week 4. The dual primary endpoints are change in pVO2 and KCCQ-CSS from baseline to Week 36.
• TRUEHEART-HCM, Phase 2b Fixed-Dose Trial in oHCM: TRUEHEART-HCM is a planned Phase 2b trial evaluating a fixed 40 mg twice-daily dose of BHB-1893, with no titration visits, on top of standard of care in patients with symptomatic oHCM. Braveheart Bio has received supportive FDA feedback on the fixed-dose approach and is finalizing the protocol to enable trial initiation in the U.S. in the first half of 2027.
• Braveheart Bio completed its upsized initial public offering in August 2026, selling 24,437,500 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares, 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.

Third Quarter 2026 Financial Results

Cash, cash equivalents and investments were $503.5 million as of September 30, 2026, compared to $89.2 million as of December 31, 2025. Based on the current operating plan, Braveheart Bio estimates that its existing cash, cash equivalents and investments will be sufficient to fund its projected operating expenses and capital expenditure requirements into 2029.

Research and development (R&D) 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. The increase was primarily due to clinical and manufacturing costs to support the initiation and enrollment of LIONHEART-HCM, higher personnel-related costs and a $1.0 million milestone under the Hengrui license agreement.

There was no in-process research and development (“IPR&D”) expense for the three months ended September 30, 2026, compared to $58.8 million for the same period in 2025, which related to the in-license of BHB-1893 from Hengrui.

General and administrative (G&A) expenses were $12.6 million for the three months ended September 30, 2026, compared to $0.5 million for the same period in 2025. The increase was primarily due to personnel-related costs, including stock-based compensation, and consultant and legal costs to support Braveheart Bio's growth and operations as a public company. G&A expenses for the three months ended September 30, 2026 included $7.8 million of non-cash stock-based compensation expense, of which $6.1 million related to liability-classified modified executive restricted stock awards that are remeasured to fair value each reporting period.

Net loss was $26.5 million, or $0.51 net loss per share, basic and diluted, for the three months ended September 30, 2026, compared to a net loss of $59.1 million, or $10.05 net loss per share, basic and diluted, for the same period in 2025.

Braveheart Bio, Inc. Selected Condensed Statements of Operations Data (Unaudited) (in thousands, except share and per share data)
	Three Months Ended September 30,						Nine Months Ended September 30,
		2026			2025			2026			2025
Operating expenses:
Research and development	$	17,542		$	9		$	39,581		$	9
In-process research and development		-			58,770			-			59,218
General and administrative		12,607			508			21,499			540
Total operating expenses		30,149			59,287			61,080			59,767
Loss from operations		(30,149	)		(59,287	)		(61,080	)		(59,767	)
Total other income		3,654			169			5,317			169
Net loss	$	(26,495	)	$	(59,118	)	$	(55,763	)	$	(59,598	)
Deemed dividends upon issuance of redeemable convertible preferred stock		-			-			(3,615	)		-
Net loss attributable to common stockholders	$	(26,495	)	$	(59,118	)	$	(59,378	)	$	(59,598	)
Net loss per share, basic and diluted	$	(0.51	)	$	(10.05	)	$	(2.66	)	$	(20.46	)
Weighted-average shares of common stock outstanding, basic and diluted		52,095,078			5,881,011			22,285,633			2,912,682

Selected Condensed Balance Sheet Data (Unaudited) (in thousands)
	September 30, 2026		December 31, 2025
Cash, cash equivalents and investments	$	503,520	$	89,161
Total assets		514,450		89,350
Total liabilities		16,848		5,333
Redeemable convertible preferred stock		-		149,889
Total stockholders’ equity (deficit)		497,602		(65,872	)

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 http://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 enrollment, progress and expected results from the LIONHEART-HCM global Phase 3 trial; the potential for data from Hengrui’s Phase 3 trial of BHB-1893 in oHCM, together with the LIONHEART-HCM interim analysis, to support a New Drug Application submission; the timing of topline results from Hengrui’s Phase 3 trial and of 52-week data from the Phase 2 nHCM open-label extension; the timing of initiation as well as expected results from the NOBLEHEART-HCM global Phase 3 trial in nHCM; the timing of initiation, progress and expected results from the TRUEHEART-HCM Phase 2b fixed-dose study; 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 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 reliance on clinical data generated by Hengrui and on Hengrui for the manufacture of BHB-1893; 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; risks related to geopolitical developments and U.S. and Chinese laws and regulations, including the BIOSECURE Act; 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 Quarterly Report on Form 10-Q for the quarter ended September 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
Alexander@NewStreetIR.com

Media Contact
FGS Global
Braveheart-bio@fgsglobal.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Braveheart Bio report for third-quarter 2026 earnings?

Braveheart Bio reported a $26.5 million net loss, or $0.51 per share, for the three months ended September 30, 2026. A year earlier, the net loss was $59.1 million, or $10.05 per share. In-process research and development expense fell to zero, while research and administrative expenses increased.

What did Braveheart Bio’s 52-week BHB-1893 obstructive HCM study show?

The 42-patient open-label extension showed improvements from extension baseline of 2.7 mL/kg/min in peak oxygen uptake and 17.3 points in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score. No on-treatment severe or serious adverse events occurred. At Week 52, 57% remained on the 40 mg twice-daily starting dose.

How is Braveheart Bio’s LIONHEART-HCM Phase 3 trial designed?

LIONHEART-HCM compares BHB-1893 with metoprolol in a global, randomized, double-blind trial in symptomatic obstructive HCM. The primary endpoint is change in peak oxygen uptake from baseline to Week 24. Treatment starts at 40 mg twice daily, with one potential increase to 60 mg at Week 4.

What will Braveheart Bio’s NOBLEHEART-HCM and TRUEHEART-HCM trials test?

NOBLEHEART-HCM is planned to test BHB-1893 against placebo in symptomatic non-obstructive HCM, while TRUEHEART-HCM will evaluate a fixed 40 mg twice-daily dose alongside standard care in symptomatic obstructive HCM. NOBLEHEART’s dual primary endpoints measure exercise capacity and questionnaire clinical scores through Week 36; TRUEHEART plans no dose-adjustment visits.