BioCardia, Inc.
BioCardia, Inc. Q3 FY2025 earnings call
November 12, 2025 · fiscal period ended 2025-09
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2025-11-12
Management highlights
• Clinical programs: CardiAmp autologous cell therapy for ischemic heart failure has breakthrough designation, ongoing clinical studies including CardiAmp Heart Failure II trial; CARDI allo allogeneic mesenchymal stem cell therapy advancing in Phase one-two trial. • Helix delivery system: Completed master file update, preparing de novo 05/10 submission. • Partnership: With CAR TECH for Heart 3D Fusion Imaging, advancing to clinic in 2026. • Regulatory: Discussions with FDA and PMDA on approvability of CardiAmp system; positive preliminary clinical consultation with Japan's PMDA.
Segment performance
No distinct product segments with revenue breakdown provided. R&D expenses increased to $936,000 in Q3 2025 from $931,000 in 2024; SG&A expenses decreased to $600,000 in 2025 Q3 from $800,000 in 2024; net loss was $1,500,000 in Q3 2025 compared to $1,700,000 in Q3 2024; net cash used in operations decreased in Q3 2025.
Guidance
• Anticipate Japan PMDA clinical review in Q4 2025, FDA meeting request on approvability also in Q4 2025, and manuscript published in Q1 2026 for BCD01. • Seek peer-reviewed publication of positive results for BCDO2 in Q1 2026. • Anticipate non-dilutive funding for BCDO3 in 2026. • Anticipate FDA submission for Helix biotherapeutic delivery system in Q4 2025.
Risks
• Uncertainties associated with developing new products, technologies, and obtaining regulatory approvals. • Inherent uncertainties that may cause actual results to differ materially from forward-looking statements.
Q&A highlights
Q: For the CardiAmp CMI data announced in September, clarify number of patients in dataset and incremental results to initial cohort.
A: The cardiac CMI data contains 5 patients at primary endpoint out to six months, a modest increase in data with compelling results, wrapping up for publication.
Q: Recruitment in CardiAmp Heart Failure II trial, challenges and enrollment status.
A: Enrollment easier with cell population analysis, resource and bandwidth challenges; 4 centers enrolling, 3 have randomized first patients; expect NIH funding for BCDO3 program.
Q: Interactions with Japanese regulatory authorities and next steps.
A: Process involves clinical consultations, focus on CardiM Heart Failure II program, respect for clinical data sufficiency in Japan
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.24 | $-0.25 | +4.0% | $-0.61 |
| Revenue | — | — | — | $58,000 |
Transcript
November 12, 2025Full transcript unavailable for redistribution
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