The regulatory catalysts (PMDA Shonin submission Q4 2026, FDA PMA pathway clarity) are significant positive milestones for a pre-revenue biotech, but the $951K cash balance creates existential near-term risk. Expect a dilutive equity offering within 2-3 months to fund operations through the Japan submission. The stock will likely trade on cash-runway headlines and regulatory updates rather than quarterly financials.
Price Chart
Executive Summary
BioCardia reported Q1 2026 financial results with a net loss of $2.3M ($0.21 per share), narrower than the $2.7M loss ($0.59 per share) in Q1 2025, driven by lower R&D and SG&A expenses. The company ended the quarter with only $951K in cash, down from $2.5M at year-end 2025, highlighting a critical cash runway concern. The key positive was significant regulatory progress: PMDA determined clinical data likely sufficient for market clearance in Japan (Shonin submission expected Q4 2026), and FDA confirmed PMA pathway for CardiAMP cell therapy while supporting the ongoing confirmatory HF II trial.
Key Financial Metrics
Key Facts
- Net loss of $2.3M in Q1 2026 vs $2.7M in Q1 2025, a $0.4M improvement
- Cash and cash equivalents fell to $951K from $2.5M at Dec 31, 2025 — a 62% decline
- PMDA determined clinical safety and efficacy evidence 'likely sufficient to support market clearance' for CardiAMP Cell Therapy in Japan
- Japan PMDA Shonin submission for approval expected in Q4 2026
- FDA confirmed PMA pathway for CardiAMP Cell Therapy and recommended continuing the CardiAMP HF II confirmatory trial
- FDA agreed on two pathways for Helix delivery catheter marketing clearance, preferred route simultaneous with CardiAMP approval
- No revenue reported in Q1 2026 (pre-revenue clinical-stage biotech)
- Weighted-average shares outstanding increased to 10.8M from 4.6M a year ago, reflecting dilution
Financial Impact
Cash burn of ~$1.7M in operations during Q1 2026; cash runway at $951K likely insufficient beyond Q2 2026 without additional financing
Risk Factors
- Cash runway of $951K likely insufficient beyond Q2 2026 — imminent need for dilutive financing
- Stockholders' equity turned negative at -$1.07M, raising going-concern risk
- CardiAMP HF II trial enrollment still early with only 4 active sites — regulatory approval timelines uncertain
- Japan Shonin submission not expected until Q4 2026, with no guarantee of approval
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-017222 |
| Document: bcda20260515_8k.htm | 0001437749-26-017222 |
| Document: 0001437749-26-017222-index-headers.html | 0001437749-26-017222 |
| Document: 0001437749-26-017222-index.html | 0001437749-26-017222 |
| Document: 0001437749-26-017222.txt | 0001437749-26-017222 |
| 8-K Data (Synthetic) | 0001437749-26-017222 |
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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