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Investor Relations14 Oct 2025
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BioCardia (BCDA) investor relations material
BioCardia Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary11 Aug, 2025
Executive summary
Presented pivotal two-year clinical data for CardiAMP heart failure, showing reduced all-cause death and non-fatal MACE, with significant benefit in patients with elevated NT proBNP; regulatory submissions are underway in Japan and the US, with key meetings expected in Q4 2025.
Ongoing pivotal and confirmatory trials for CardiAMP HF and refractory angina, with expanded eligibility and improved delivery systems; CardiALLO allogeneic cell therapy trials progressing.
Active partnering and strategic collaboration discussions continue for all technology platforms, including Helix biotherapeutic delivery system.
Multiple financing rounds completed in 2025, but cash runway only extends to October 2025 without additional funding.
Strengthened IP portfolio with a new US patent for the Helix delivery catheter.
Financial highlights
Research and development expenses rose to $1.4M in Q2 2025 from $0.8M in Q2 2024, driven by trial closeout and new trial enrollment.
Net loss increased to $2.0M in Q2 2025 from $1.6M in Q2 2024; six-month net loss was $4.8M versus $3.9M year-over-year.
Cash and equivalents at quarter-end were $980K, with an additional $769K raised post-quarter, providing runway into October 2025.
Revenue was $0 in Q2 2025, down from $3,000 in Q2 2024; $0 for the first half of 2025, down from $58,000 year-over-year.
Accumulated deficit reached $164.9M as of June 30, 2025.
Outlook and guidance
Anticipate FDA submission for Helix system approval in Q3 2025 and key regulatory meetings in Q4 2025.
Project non-dilutive funding for the allogeneic cell therapy program in Q1 2026.
Management expects continued operating losses and negative cash flows for several years as clinical programs advance.
Japan PMDA approval timeline if positive?
CardiAMP HF II trial strategy if FDA supportive?
What makes September financing beneficial?
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Next BioCardia earnings date
Q3 202512 Nov, 2025
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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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