secwatch.observer — SEC 8-K summary
======================================

Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2025-09-25T23:59:59+00:00
Accession:  0001437749-25-029846
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774925029846/0001437749-25-029846-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774925029846/clnn20250923_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-029846

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer