{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-25-000104","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2025-05-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.449338+00:00","generated_at":"2026-05-22T12:54:54.154978+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":"Denali completes BLA submission for Hunter syndrome; Q1 net loss widens to $133M","bullets":["Net loss of $133.0M in Q1 2025 vs $101.8M in Q1 2024; R&D expense rose to $116.2M.","Cash and marketable securities $1.05B as of March 31, 2025.","BLA for tividenofusp alfa (Hunter syndrome) submitted under FDA accelerated approval pathway.","Phase 2b LUMA study for BIIB122 (Parkinson's) fully enrolled; readout expected in 2026.","G&A expenses increased to $29.4M from $25.2M, driven by BLA submission and launch prep."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-25-000104","json":"https://secwatch.observer/filing/0001714899-25-000104.json","markdown":"https://secwatch.observer/filing/0001714899-25-000104.md","text":"https://secwatch.observer/filing/0001714899-25-000104.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000104/0001714899-25-000104-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000104/dnli-20250506.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-22T12:54:54.154978+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"}