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BioCardia
BioCardia (BCDA) investor relations material
BioCardia Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary12 Nov, 2025
Executive summary
Advanced regulatory submissions for CardiAMP cell therapy and Helix delivery system, with ongoing discussions with FDA and Japan's PMDA for market approval in heart failure indications.
CardiAMP Heart Failure II Phase III trial is accelerating, with four centers enrolling and additional sites onboarding; trial design leverages prior positive data and improved patient selection.
CardiAMP cell therapy for chronic myocardial ischemia showed improved exercise tolerance and reduced angina in trial patients; results being prepared for publication.
CardiALLO allogeneic cell therapy phase 1/2 trial advanced with no safety concerns in the low dose cohort; Phase 2 development planned in the US and Japan.
Partnership with CART-Tech to develop Heart3D Fusion Imaging for biotherapeutic delivery, with promising preclinical results and clinical advancement planned for 2026.
Financial highlights
Net loss for Q3 2025 was $1.5 million, down from $1.7 million in Q3 2024; net loss for nine months ended September 2025 was $6.2 million, up from $5.7 million year-over-year.
Research and development expenses rose to $936,000 in Q3 2025 from $931,000 in Q3 2024, and to $3.8 million for the nine months ended September 2025 from $3.0 million in the prior year period.
Selling, general and administrative expenses decreased to $0.6 million in Q3 2025 from $0.8 million in Q3 2024, and to $2.4 million for the nine months ended September 2025 from $2.8 million in the prior year.
Cash and cash equivalents at September 30, 2025, were $5.3 million, providing runway into Q2 2026.
Accumulated deficit reached $166.4 million as of September 30, 2025.
Outlook and guidance
Cash on hand projected to fund operations into Q2 2026 without additional financing; additional capital will be required for operations beyond that.
Anticipate modest R&D expense increase in 2025 as clinical programs advance in the US and Japan.
SG&A expected to remain close to 2024 levels.
Expect Japan PMDA clinical review and FDA meeting request for CardiAMP in Q4 2025; peer-reviewed publications and further trial enrollment milestones in 2026.
Plans to raise capital through equity, debt, or non-dilutive arrangements; failure to secure funding may require cost reductions or program delays.
Clarify Japan PMDA's key approval hurdle
Detail CardiALLO's Q1 2026 funding plan
Explain the Hawthorne effect's trial impact
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Next BioCardia earnings date
Q4 20251 Apr, 2026
BioCardia
Next BioCardia earnings date
Q4 20251 Apr, 2026
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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.
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