Regulatory catalysts (Japan PMDA and FDA support) are the primary drivers, potentially outweighing the EPS miss. Monitor upcoming milestones: Euro PCR presentation (May 20) and Japan Shonin submission (Q4 2026). Cash runway is limited; likely need financing within 1-2 quarters.
Price Chart
Executive Summary
BioCardia reported Q1 2026 EPS of -$0.21, missing consensus of -$0.17 by 23.5%, while revenue remained zero. However, the company made significant regulatory progress: Japan's PMDA indicated clinical data is likely sufficient for market clearance, and FDA supported the ongoing CardiAMP HF II trial as a confirmatory study. Cash burn continues with $951K on hand.
Key Financial Metrics
Key Facts
- Q1 2026 EPS -$0.21 vs consensus -$0.17 (23.5% miss)
- Zero revenue; pre-revenue clinical-stage biotech
- Japan PMDA preliminary advisory record indicates likely market clearance for CardiAMP cell therapy
- FDA Q-Sub meeting: no safety concerns, supports CardiAMP HF II trial as confirmatory study
- Cash and cash equivalents $951K, down from $2.5M in Dec 2025
- Net loss $2.3M in Q1 2026 vs $2.7M in Q1 2025
Financial Impact
EPS miss of 23.5% on a small base; cash position low (~$1M)
Risk Factors
- Cash runway only ~$1M; substantial doubt about going concern without additional financing
- Japan approval is not guaranteed; further questions from PMDA could delay
- Dilution risk from potential future equity offerings
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3295791 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 7d ago | 8-K | $0.8975 $1.04 | ▲ +15.88% | ▲ +15.54% | $0.9000 (+0.28%) |
Oct 19, 2026 7d ago | Press Release | $0.9000 $1.04 | ▲ +15.56% | ▲ +15.22% | $0.9000 (−0.00%) |
Oct 7, 2026 19d ago | 8-K | $1.09 $1.06 | ▼ −2.75% | ▼ −2.33% | $0.9000 (−17.43%) |
Oct 1, 2026 25d ago | 8-K | $1.02 $1.04 | ▲ +1.96% | ▲ +1.22% | $0.9000 (−11.76%) |
Oct 1, 2026 25d ago | Press Release | $1.02 $1.04 | ▲ +1.96% | ▲ +1.22% | $0.9000 (−11.76%) |
Sep 23, 2026 4w ago | 8-K | $1.05 $1.07 | ▲ +1.90% | ▲ +1.99% | $0.9000 (−14.29%) |
Sep 23, 2026 4w ago | Press Release | $1.05 $1.07 | ▲ +1.90% | ▲ +1.99% | $0.9000 (−14.29%) |
Sep 10, 2026 6w ago | 8-K | $1.10 $1.08 | ▼ −1.82% | ▼ −2.67% | $0.9000 (−18.18%) |
Aug 24, 2026 9w ago | 8-K | $1.06 $1.13 | ▲ +6.60% | ▲ +6.28% | $0.9000 (−15.09%) |
Aug 5, 2026 11w ago | Press Release | $0.9500 $0.9496 | ▼ −0.04% | ▲ +0.12% | $0.9000 (−5.26%) |
US Market Status
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