{"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","discovered_at":"2026-05-14T18:02:45.146211+00:00","generated_at":"2026-05-17T05:41:45.370699+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Clene reports CNM-Au8 improves brain NAD+/NADH ratio in MS patients at ECTRIMS 2025; FDA open to cognition endpoints","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-029846","json":"https://secwatch.observer/filing/0001437749-25-029846.json","markdown":"https://secwatch.observer/filing/0001437749-25-029846.md","text":"https://secwatch.observer/filing/0001437749-25-029846.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:41:45.370699+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}