earnings
confidence high
sentiment positive
materiality 0.80
BioCardia Q1 2025 net loss $2.7M; CardiAMP HF two-year data shows survival benefit; Helix FDA submission planned
BioCardia, Inc.
2026-Q1 EPS
reported -$0.59
vs consensus -$0.17
▼ miss
(-250.6%)
- Two-year results from Phase 3 CardiAMP HF trial (presented Mar 30) showed increased survival, fewer CV events, improved QoL; significant in NTproBNP-elevated subset (p=0.02).
- CardiAMP HF II confirmatory trial underway with three active sites; primary endpoint based on hierarchical analysis.
- Refractory angina roll-in cohort showed 107 sec increase in exercise tolerance and 82% reduction in angina episodes at 6 months.
- R&D expenses $1.5M, SG&A $1.2M; net loss $2.7M vs $2.3M YoY; cash used in ops $1.6M.
- Plans to submit CardiAMP Cell Therapy for Japan PMDA consultation and Helix delivery system for FDA approval this quarter.