---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-036712"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2025-12-03T23:59:59+00:00"
generated_at: "2026-05-16T15:25:14.862443+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval for CNM-Au8

## Summary
- FDA-recommended analyses show statistically significant reductions in NfL (p=0.0373) and GFAP (p<0.05) in ALS patients treated with CNM-Au8.
- CNM-Au8 treatment associated with 73-77% reduction in risk of death at 1 year in HEALEY ALS Platform Trial open-label extension (p=0.0144).
- Company requested Type C meeting with FDA in Q1 2026 for planned NDA submission under accelerated approval pathway.
- Placebo participants who switched to CNM-Au8 showed NfL decline or stabilization, consistent with active arm trajectory.
- Over 1,000 patient years of exposure data show no drug-related serious adverse events.

## SEC filing metadata
- accession: 0001437749-25-036712
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2025-12-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774925036712/0001437749-25-036712-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774925036712/clnn20251203_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-036712
- JSON: https://secwatch.observer/filing/0001437749-25-036712.json
- Plain text: https://secwatch.observer/filing/0001437749-25-036712.txt

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