---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-029846"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2025-09-25T23:59:59+00:00"
generated_at: "2026-05-17T05:41:45.370699+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Clene reports CNM-Au8 improves brain NAD+/NADH ratio in MS patients at ECTRIMS 2025; FDA open to cognition endpoints

## Summary
- Mean brain NAD+/NADH ratio increased +0.449 units (p=0.0148) across full REPAIR population (n=39) after 12 weeks of CNM-Au8.
- In REPAIR-MS participants (n=26), NAD+/NADH ratio increased +0.480 units (p=0.058; percent change +9.49%, p=0.0275).
- Baseline EDSS was significantly associated with NAD+/NADH ratio deficit (ρ=0.429, p=0.0127).
- Baseline working memory (SDMT) and upper extremity function (9-HPT) correlated with brain ATP levels (p=0.0009, p=0.0032).
- FDA acknowledged EDSS limitations and expressed openness to broader primary endpoints, including cognition, for MS trials.

## SEC filing metadata
- accession: 0001437749-25-029846
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2025-09-25T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774925029846/0001437749-25-029846-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774925029846/clnn20250923_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-029846
- JSON: https://secwatch.observer/filing/0001437749-25-029846.json
- Plain text: https://secwatch.observer/filing/0001437749-25-029846.txt

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