{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-034621","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2025-11-13T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.623216+00:00","generated_at":"2026-05-16T20:31:47.507061+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Clene Q3 net loss $8.8M; plans ALS NDA accelerated approval in Q1 2026","bullets":["Cash $7.9M at Sep 30; +$1.2M raised post-quarter; runway into Q2 2026.","FDA advised Type C meeting to review ALS biomarker data; NDA submission planned Q1 2026.","First patient dosing in confirmatory Phase 3 RESTORE-ALS trial expected H1 2026.","Net loss $8.8M ($0.85/share) vs $8.0M ($1.22/share) in Q3 2024.","Type B end-of-Phase 2 meeting held for MS; FDA open to cognition as primary endpoint."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-034621","json":"https://secwatch.observer/filing/0001437749-25-034621.json","markdown":"https://secwatch.observer/filing/0001437749-25-034621.md","text":"https://secwatch.observer/filing/0001437749-25-034621.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774925034621/0001437749-25-034621-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774925034621/clnn20250821_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T20:31:47.507061+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"}