---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-016881"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2026-05-14T12:02:05+00:00"
generated_at: "2026-05-14T12:06:57.227436+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Clene plans Q3 2026 NDA submission for CNM-Au8 ALS; Q1 net loss $8.1M, cash $5.9M

## Summary
- FDA Type C meeting confirmed data may support NDA under accelerated approval for ALS; submission planned Q3 2026.
- May 2026: Amended $10M convertible debt; maturity extended to Aug 2027, monthly payments cancelled.
- Q1 2026 net loss $8.1M ($0.69/share) vs $0.8M loss in Q1 2025; R&D down, other expense up from financing.
- Cash $5.9M at Mar 31; with $7M May offering and $7M warrant exercises, runway expected into 2027.

## SEC filing metadata
- accession: 0001437749-26-016881
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2026-05-14T12:02:05+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 1.01, 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774926016881/0001437749-26-016881-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774926016881/clnn20260116_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-016881
- JSON: https://secwatch.observer/filing/0001437749-26-016881.json
- Plain text: https://secwatch.observer/filing/0001437749-26-016881.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.