Monitor outcome of the FDA Type C meeting in March 2026, which could trigger an NDA filing and potential approval pathway for CNM-Au8 in ALS. The financing reduces near-term dilution risk and supports operations through key regulatory milestones.
Price Chart
Executive Summary
Clene Inc. reported its full year 2025 financial results, showing reduced net loss and operating expenses compared to 2024. The company highlighted progress in its CNM-Au8 program for ALS, including biomarker data supporting an upcoming FDA meeting and planned NDA submission by end of Q2 2026. It also secured over $28 million in an oversubscribed financing, providing cash runway into 2027.
Key Financial Metrics
Key Facts
- Net loss decreased to $26.2M in 2025 from $39.4M in 2024
- R&D expenses dropped to $14.0M from $20.1M year-over-year
- Cash and equivalents were $5.2M as of Dec 31, 2025
- Oversubscribed $28M registered direct offering completed in January 2026
- Initial tranche of $6M provides runway to end of Q3 2026
- Type C FDA meeting scheduled before end of March 2026 for CNM-Au8 in ALS
- Plans to file NDA for CNM-Au8 in ALS by end of June 2026 under accelerated approval
Financial Impact
Reduced net loss by $13.2M year-over-year; $28M financing provides runway into 2027
Risk Factors
- FDA may not accept NDA or may require additional data
- Clinical trial results may not support approval
- Future tranches of financing are milestone-dependent and not guaranteed
- Company has limited revenue and continues to incur losses
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-007828 |
| Document: clnn20251022_8k.htm | 0001437749-26-007828 |
| Document: 0001437749-26-007828-index-headers.html | 0001437749-26-007828 |
| Document: 0001437749-26-007828-index.html | 0001437749-26-007828 |
| Document: 0001437749-26-007828.txt | 0001437749-26-007828 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 8d ago | 8-K | $3.73 | awaiting T+20 | — | $3.97 (+6.43%) |
Oct 19, 2026 8d ago | 8-K | $3.29 | awaiting T+20 | — | $3.97 (+20.67%) |
Oct 19, 2026 8d ago | Press Release | $3.29 | awaiting T+20 | — | $3.97 (+20.67%) |
Oct 13, 2026 14d ago | SC 13G/A | $3.39 | awaiting T+20 | — | $3.97 (+17.11%) |
Sep 16, 2026 5w ago | 8-K | $4.15 $3.31 | ▲ +20.36% | ▲ +21.57% | $3.97 (+4.34%) |
Sep 16, 2026 5w ago | 424B5 | $3.86 $3.31 | ▲ +14.25% | ▲ +16.31% | $3.97 (−2.85%) |
Aug 14, 2026 10w ago | 8-K | $4.14 $3.28 | ▼ −20.77% | ▼ −18.78% | $3.97 (−4.11%) |
Aug 14, 2026 10w ago | Press Release | $4.14 $3.28 | ▼ −20.77% | ▼ −18.78% | $3.97 (−4.11%) |
Aug 10, 2026 11w ago | 8-K | $5.16 $3.62 | ▼ −29.84% | ▼ −28.93% | $3.97 (−23.06%) |
May 14, 2026 23w ago | 8-K | $7.05 $5.84 | ▼ −17.16% | ▼ −16.30% | $3.97 (−43.69%) |
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