{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-014917","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2025-05-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.936429+00:00","generated_at":"2026-05-22T08:47:53.357172+00:00","sec_items":["2.02","3.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Clene receives Nasdaq MVLS deficiency notice; reports Q1 2025 net loss of $0.8M, cash $9.8M","bullets":["Nasdaq notified Clene that MVLS of common stock is below $35M minimum; has until Nov 3, 2025 to regain compliance.","Cash and equivalents $9.8M as of Mar 31, 2025, expected to fund operations into Q3 2025.","Net loss of $0.8M ($0.09 per share) vs $11.1M ($1.73) in Q1 2024; decrease due to NIH grant revenue and lower expenses.","Planning to submit NDA for Accelerated Approval of CNM-Au8 in ALS in Q4 2025, pending FDA agreement on SAP in Q2.","Presented new remyelination data from VISIONARY-MS trial at AAN; end-of-Phase 2 meeting with FDA planned in Q3 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-014917","json":"https://secwatch.observer/filing/0001437749-25-014917.json","markdown":"https://secwatch.observer/filing/0001437749-25-014917.md","text":"https://secwatch.observer/filing/0001437749-25-014917.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774925014917/0001437749-25-014917-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774925014917/clnn20250107_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-22T08:47:53.357172+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"}