The Q1 financials are poor but largely irrelevant for a pre-revenue biotech. The stock will trade on NDA submission timing (Q3 2026) and FDA acceptance risk. Monitor for any FDA feedback or clinical data updates before the NDA filing. The $7M May offering and debt amendment reduce near-term dilution risk but the cash runway only extends to Q4 2026 — additional financing likely needed.
Price Chart
Executive Summary
Clene reported Q1 2026 EPS of -$0.69 (GAAP), a significant miss versus the -$0.50 consensus, driven by $6.0M in other expense from financing-related charges. Revenue collapsed to $15K from $81K YoY. The stock's narrative hinges entirely on the FDA Type C meeting outcome and planned Q3 2026 NDA submission for CNM-Au8 in ALS, not on current financials. Cash runway extended into Q4 2026 via recent financings and debt amendment.
Key Financial Metrics
Key Facts
- Q1 2026 EPS -$0.69 vs consensus -$0.50 (38% miss)
- Q1 2026 revenue $15K vs consensus $34K (56% miss), down from $81K YoY
- Net loss widened to $8.1M from $0.8M YoY, driven by $6.0M in other expense (warrant issuance costs, loss on equity issuance, fair value changes)
- Cash and equivalents $5.9M at March 31, 2026; extended to Q4 2026 via $7M May offering and convertible debt amendment
- FDA Type C meeting confirmed biomarker data (NfL reduction) may support accelerated approval NDA submission in Q3 2026
- R&D expenses cut to $0.3M from $1.5M YoY, reflecting reduced clinical trial spending
Financial Impact
EPS miss of 38% and revenue miss of 56% vs consensus; net loss increased 10x YoY to $8.1M
Risk Factors
- FDA may reject accelerated approval NDA submission despite Type C meeting encouragement
- Cash runway only into Q4 2026; additional dilutive financing likely needed
- Warrant liabilities ($12M) and convertible debt ($12.6M) create significant overhang and potential dilution
- Revenue near zero with no approved products; clinical-stage biotech binary risk
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3294896 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 7d ago | 8-K | $3.73 | awaiting T+20 | — | $3.84 (+2.95%) |
Oct 19, 2026 7d ago | 8-K | $3.29 | awaiting T+20 | — | $3.84 (+16.72%) |
Oct 19, 2026 7d ago | Press Release | $3.29 | awaiting T+20 | — | $3.84 (+16.72%) |
Oct 13, 2026 13d ago | SC 13G/A | $3.39 | awaiting T+20 | — | $3.84 (+13.27%) |
Sep 16, 2026 5w ago | 8-K | $4.15 $3.31 | ▲ +20.36% | ▲ +21.57% | $3.84 (+7.47%) |
Sep 16, 2026 5w ago | 424B5 | $3.86 $3.31 | ▲ +14.25% | ▲ +16.31% | $3.84 (+0.52%) |
Aug 14, 2026 10w ago | 8-K | $4.14 $3.28 | ▼ −20.77% | ▼ −18.78% | $3.84 (−7.25%) |
Aug 14, 2026 10w ago | Press Release | $4.14 $3.28 | ▼ −20.77% | ▼ −18.78% | $3.84 (−7.25%) |
Aug 10, 2026 11w ago | 8-K | $5.16 $3.62 | ▼ −29.84% | ▼ −28.93% | $3.84 (−25.58%) |
May 14, 2026 23w ago | 8-K | $7.05 $5.84 | ▼ −17.16% | ▼ −16.30% | $3.84 (−45.53%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers