The FDA's green light for an NDA submission under accelerated approval is the key catalyst — watch for the actual NDA filing in Q3 2026 and any FDA acceptance decision. The dilutive overhang from the January and May 2026 offerings is partially offset by the convertible debt amendment that removes near-term cash drain. The stock will trade on NDA news, not quarterly financials.
Price Chart
Executive Summary
Clene reported Q1 2026 results with total revenue of $15K (down 81% YoY from $81K) and a net loss of $8.1M ($0.69/share) vs a loss of $0.8M ($0.09/share) in Q1 2025. The wider loss was driven by $4.6M in one-time equity issuance costs and $1.1M in warrant liability fair value changes from the January 2026 financing. Operationally, the company highlighted a successful FDA Type C meeting supporting a planned NDA submission for CNM-Au8 in ALS in Q3 2026, and amended its convertible debt facility to extend maturity to August 2027 with no principal/interest payments before then. The company also completed a $7M registered direct offering in May 2026. Cash of $5.9M at quarter-end, plus the May proceeds and debt amendment, is expected to fund operations into Q4 2026.
Key Financial Metrics
Key Facts
- Total revenue fell 81% YoY to $15K (product revenue $1K, royalty $14K)
- Net loss widened to $8.1M ($0.69/share) from $0.8M ($0.09/share) in Q1 2025
- Operating loss improved to $2.1M from $4.1M YoY on lower R&D and G&A spend
- Cash and cash equivalents $5.9M at March 31, 2026 vs $5.2M at Dec 31, 2025
- Completed $7M registered direct offering in May 2026
- Amended $10M convertible debt facility: maturity extended to Aug 2027, no principal/interest payments before maturity
- FDA Type C meeting confirmed biomarker data may support NDA submission under accelerated approval pathway
- NDA submission for CNM-Au8 in ALS planned for Q3 2026; confirmatory Phase 3 trial (RESTORE-ALS) planned for Q1 2027
- Cash runway extended into Q4 2026 with May proceeds and debt amendment; potential $7M warrant exercises tied to NDA acceptance could extend into 2027
Financial Impact
Net loss of $8.1M in Q1 2026 vs $0.8M in Q1 2025, driven by $4.6M loss on initial equity issuance and $1.1M warrant liability fair value changes
Risk Factors
- NDA submission and FDA acceptance are binary events — rejection or complete response letter would be devastating for a pre-revenue company with $5.9M cash
- Substantial dilution from recent offerings (shares outstanding grew from 10.8M at Dec 2025 to 11.8M at Mar 2026, plus May 2026 offering)
- Stockholders' deficit of $18.8M and accumulated deficit of $316.4M indicate ongoing solvency risk
- Warrant and derivative liabilities of $14.4M create potential for further dilution or cash demands
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-016881 |
| Document: clnn20260116_8k.htm | 0001437749-26-016881 |
| Document: 0001437749-26-016881-index-headers.html | 0001437749-26-016881 |
| Document: 0001437749-26-016881-index.html | 0001437749-26-016881 |
| Document: 0001437749-26-016881.txt | 0001437749-26-016881 |
| 8-K Data (Synthetic) | 0001437749-26-016881 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 6d 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
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