{"schema_version":"secwatch.filing_event.v1","accession":"0001171843-23-002712","form_type":"8-K","ticker":"FLNA","cik":"0001069530","company_name":"FILANA THERAPEUTICS, INC.","filed_at":"2023-05-01T23:59:59+00:00","discovered_at":"2026-05-14T18:03:37.846909+00:00","generated_at":"2026-06-16T04:36:09.411963+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Q1 net loss $24.3M ($0.58/sh); 1,244+ patients in Phase 3 simufilam trials","bullets":["Net loss widened to $24.3M from $17.5M YoY; R&D expense rose to $22.1M on trial costs.","Cash and equivalents $187.5M, no debt; H1 2023 net cash use guidance reduced to $30-40M from $45-50M.","Over 1,244 Alzheimer's patients enrolled in Phase 3 program (target ~1,750); enrollment completion expected Q4 2023.","Phase 2 open-label study showed long-term safety; mild patients had ADAS-Cog improvement vs historical placebo decline.","Cognition Maintenance Study (randomized withdrawal) results expected Q3 2023; filamin A biological data due Q2 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001171843-23-002712","json":"https://secwatch.observer/filing/0001171843-23-002712.json","markdown":"https://secwatch.observer/filing/0001171843-23-002712.md","text":"https://secwatch.observer/filing/0001171843-23-002712.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1069530/000117184323002712/0001171843-23-002712-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1069530/000117184323002712/f8k_043023.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T04:36:09.411963+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":"0113d8994a855e5a1c3642b978e9212d0396bddd","claim":"FILANA THERAPEUTICS, INC. reported three months ended March 31, 2023 results: net income $24.3 million, EPS $0.58 per share.","evidence_excerpt":"Net loss was $24.3 million, or $0.58 per share, compared to a net loss of $17.5 million, or $0.44 per share, for the same period in 2022.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1069530/000117184323002712/0001171843-23-002712-index.htm","confidence":0.95,"family_label":"Earnings Releases","details":[{"label":"Period","value":"three months ended March 31, 2023"},{"label":"Net income","value":"$24.3 million"},{"label":"EPS","value":"$0.58 per share"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"},{"claim_id":"5d11c321230d9ad7fb7f065facde15b00b0e8a93","claim":"FILANA THERAPEUTICS, INC. updated its first half 2023 guidance (lowered).","evidence_excerpt":"New guidance for net cash use in first half 2023 is expected to be $30 to $40 million, which is revised downward from our previous guidance of $45 to $50 million, due primarily to the timing of certain clinical payment obligations.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1069530/000117184323002712/0001171843-23-002712-index.htm","confidence":0.95,"family_label":"Earnings Releases","details":[{"label":"Period","value":"first half 2023"},{"label":"Guidance","value":"lowered"},{"label":"Result","value":"guidance update"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}