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Edge16 Oct 2026
Winner, Winner: The Chicken McNugget Story
How a 1940s breeding contest, a Cornell food scientist, and a hedge by Ray Dalio helped McDonald's turn the Chicken McNugget into a fast-food icon.
BioCardia
BioCardia (BCDA) investor relations material
BioCardia Q3 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2026 earnings summary12 Nov, 2026
Executive summary
CardiAMP Japan application-material requirements were completed in November 2026 after PMDA consultation; the Shonin submission is targeted for Q4 2026/Q1 2027.
FDA accepted the revised Helix De Novo Pre-Submission; feedback was expected within 70 calendar days.
CardiAMP HF II was recruiting at four sites, with seven additional sites onboarding; no known safety issues were reported.
Financial highlights
Q3 2026 net loss was $1.817M versus $1.483M in Q3 2025; 9M net loss was $5.689M versus $6.244M.
Q3 R&D expense was $1.235M versus $936K; 9M R&D was $3.363M versus $3.834M, reflecting trial closeout partly offset by HF II enrollment and Japan regulatory work.
Q3 SG&A was $600K versus $552K; 9M SG&A was $2.361M versus $2.431M.
Q3 operating loss was $1.835M versus $1.488M; 9M operating loss was $5.724M versus $6.265M.
Outlook and guidance
Japan Shonin submission is targeted for Q4 2026/Q1 2027; approval is expected 12 months after submission.
Helix De Novo submission is expected in Q1 2027, with approval targeted for mid-2027 if FDA meets its 150-day review goal.
September 30 cash of $2.224M was expected to fund planned expenditures and obligations only through January 2027; additional capital is needed beyond then.
Planned funding options include collaborations or licensing, debt, equity, or a combination; R&D spending is expected to rise as pivotal trials and allogeneic programs advance, subject to funding.
Heart3D FDA submission and a partner gene therapy study using Helix and Heart3D are targeted for Q1 2027.
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Latest events from BioCardia
- Regulatory progress, clinical advances, and improved financials highlight late 2026 submissions.BCDA
Q2 2026 - Barinthus pivots to autoimmune therapies, merging with Clywedog and targeting major 2024 milestones.BCDAA.G.P.'s Annual Virtual Healthcare Conference
- Cellular therapies advance for heart failure, with CardiAMP nearing approval and key milestones ahead.BCDACorporate presentation
- CardiAMP cell therapy is safe and may benefit high-risk ischemic heart failure patients.BCDACorporate presentation
- Regulatory milestones achieved, but cash shortfall and going concern risks persist.BCDAQ1 2026
- Positive clinical trial results and regulatory progress, with net loss rising to $8.2 million.BCDAQ4 2025
- Q3 net loss narrowed, but new funding is needed as pivotal trial data and product launches near.BCDAQ3 2024
- Net loss narrowed and cash burn fell, but urgent capital raise is needed to fund late-stage trials.BCDAQ2 2024
- Strong clinical signals and reduced net loss highlight progress despite primary endpoint miss.BCDAQ4 2024
Next BioCardia earnings date
Q4 202631 Mar, 2027
BioCardia
Next BioCardia earnings date
Q4 202631 Mar, 2027
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Frequently asked questions
BioCardia Inc. is a clinical-stage regenerative medicine company focused on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. The company's leading therapeutic candidate, CardiAMP, is an autologous mononuclear cell therapy system designed for treating heart failure and chronic myocardial ischemia, alongside an allogeneic cell therapy for cardiac and pulmonary disease. BioCardia is also advancing an allogeneic cells therapeutic platform, in Phase I/II trial for ischemic heart failure treatment. Additionally, BioCardia offers the Helix biotherapeutic delivery system for precise heart muscle treatments and Morph deflectable guides and sheaths. The company is headquartered in Sunnyvale, California, and its shares are listed on the Nasdaq.