{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-007543","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2024-03-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.746642+00:00","generated_at":"2026-06-04T22:29:25.250549+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Clene posts FY2023 net loss $49.5M; FDA discussions for CNM-Au8 accelerated approval ongoing","bullets":["Net loss $49.5M ($0.47/share) vs $29.9M ($0.46/share) in FY2022; cash $35.0M, expected to fund ops into Q4 2024.","R&D expenses $26.7M (down from $31.9M); G&A $14.4M (down from $16.9M).","FDA Q4 2023 meeting: initial NfL biomarker data insufficient for accelerated approval; planning supplemental data submission in 2024, potential NDA.","HEALEY ALS OLE: CNM-Au8 reduced plasma NfL at 76 wks (p=0.023) and 60% decreased risk of all-cause mortality (>18 months, p=0.0167).","EAP survival: 68% and 57% reduced mortality risk vs historical controls (p=0.0001); MS trial showed vision and cognition improvements through 35 months."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-007543","json":"https://secwatch.observer/filing/0001437749-24-007543.json","markdown":"https://secwatch.observer/filing/0001437749-24-007543.md","text":"https://secwatch.observer/filing/0001437749-24-007543.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924007543/0001437749-24-007543-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924007543/clnn20231022_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T22:29:25.250549+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":[{"claim_id":"6ad8e09971372f90c3418ca3615f465150bb14be","claim":"Clene Inc. reported financial results for the year ended December 31, 2023.","evidence_excerpt":"On March 13, 2024, Clene Inc. (the “Company”) issued a press release announcing its full year operating and financial results for its year ended December 31, 2023.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924007543/0001437749-24-007543-index.htm","confidence":0.95,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the year ended December 31, 2023"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}