---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-007120"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2025-03-12T23:59:59+00:00"
generated_at: "2026-05-24T22:41:37.999385+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Clene reports CNM-Au8 survival benefit in ALS: median survival up 198 days vs control

## Summary
- Median survival 951 days for CNM-Au8 30 mg vs 753 days for Regimen A comparator, a 198-day (6.5-month) gain.
- Covariate-adjusted RMST improvement of 124 days (p=0.045); sensitivity analyses including NfL and TRICALS confirm robustness.
- In moderate-to-severe ALS (NfL>33, TRICALS -6.5 to -2.5), median survival gain 11.9 months; mortality risk reduced 44% (p=0.006).
- RESTORE-ALS-eligible subset: median survival 1079 vs 628 days (451-day gain, 14.8 mo), mortality risk reduced 49% (p=0.006).
- Clene to discuss findings with FDA; Phase 3 RESTORE-ALS study launch targeted for mid-2025.

## SEC filing metadata
- accession: 0001437749-25-007120
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2025-03-12T23:59:59+00:00
- event_type: other_material
- 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/1822791/000143774925007120/0001437749-25-007120-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774925007120/clnn20250311_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-007120
- JSON: https://secwatch.observer/filing/0001437749-25-007120.json
- Plain text: https://secwatch.observer/filing/0001437749-25-007120.txt

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