---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-005156"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2026-02-24T23:59:59+00:00"
generated_at: "2026-05-16T00:52:26.807500+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Clene announces NDA submission for CNM-Au8 planned for Q2 2026; cash runway into Q4 2026

## Summary
- Raised over $28M in January 2026 registered direct offering; cash runway into Q4 2026 sufficient through NDA acceptance.
- In-person Type C FDA meeting scheduled by end of Q1 2026 to discuss data submitted late 2025.
- NDA for CNM-Au8 via accelerated pathway planned for Q2 2026; PDUFA date possible in H2 2026.
- Confirmatory Phase 3 RESTORE-ALS trial planned to begin later in 2026 after FDA feedback.
- Over 800 patients treated; no CNM-Au8-related SAEs; favorable safety profile across 1,000+ patient-years.

## SEC filing metadata
- accession: 0001437749-26-005156
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2026-02-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774926005156/0001437749-26-005156-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774926005156/clnn20260223_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-005156
- JSON: https://secwatch.observer/filing/0001437749-26-005156.json
- Plain text: https://secwatch.observer/filing/0001437749-26-005156.txt

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