---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-005132"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2024-02-22T23:59:59+00:00"
generated_at: "2026-06-05T20:46:31.265665+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Clene reports significant survival benefit with CNM-Au8 in ALS compassionate use programs

## Summary
- 68% decreased risk of all-cause mortality vs PRO-ACT matched controls (HR=0.320, p=0.0001).
- 57% decreased risk of all-cause mortality vs ALS Natural History Consortium matched controls (HR=0.433, p=0.0001).
- Data from 256 EAP participants (220 matched); no serious adverse events attributed to CNM-Au8.
- Results support advancing CNM-Au8 to Phase 3 testing in ALS; $45.1M NIH grant for third EAP.
- CNM-Au8 30 mg well-tolerated with up to 4 years of dosing; EAP enrollment in H1 2024 planned.

## SEC filing metadata
- accession: 0001437749-24-005132
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2024-02-22T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774924005132/0001437749-24-005132-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774924005132/clnn20240221_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-005132
- JSON: https://secwatch.observer/filing/0001437749-24-005132.json
- Plain text: https://secwatch.observer/filing/0001437749-24-005132.txt

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