earnings
confidence high
sentiment negative
materiality 0.75
BioCardia Q3 net loss narrows to $2.6M; CardiAMP HF trial paused after DSMB review
BioCardia, Inc.
- Q3 2023 revenue $357K (up 68% YoY); net loss $2.6M improves from $3.1M YoY.
- DSMB recommended pause of CardiAMP HF trial; management agrees primary endpoint unlikely with current design.
- Subset analysis: NT-proBNP>500 patients showed 59% relative risk reduction in mortality (p=0.028).
- Company submitted new protocol (CardiAMP HF II) to FDA targeting responders; Japan PMDA consultation set for Nov 21.
- Cash used in operations $2.4M; anticipates two Helix licensing/development partnerships in Q4 2023.