{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-24-000215","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2024-11-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.339672+00:00","generated_at":"2026-05-30T04:39:42.592841+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":"Denali Q3 net loss $107.2M; tividenofusp BLA planned early 2025; DNL126 shows biomarker reduction","bullets":["Net loss $107.2M vs $99.4M YoY; no collaboration revenue; cash $1.28B at Sep 30, 2024.","Updated 2024 cash opex guidance: +5-10% vs 2023 (prior: ≤2023) due to BLA prep and commercial readiness.","Tividenofusp alfa (MPS II): FDA agrees CSF HS as surrogate endpoint; BLA submission on track for early 2025.","DNL126 (MPS IIIA): preliminary data show CSF HS reduction and normalization; study expanded for accelerated path.","SAR443820/DNL788 (MS): Sanofi's K2 Phase 2 discontinued after missing primary and key secondary endpoints."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-24-000215","json":"https://secwatch.observer/filing/0001714899-24-000215.json","markdown":"https://secwatch.observer/filing/0001714899-24-000215.md","text":"https://secwatch.observer/filing/0001714899-24-000215.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489924000215/0001714899-24-000215-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489924000215/dnli-20241106.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T04:39:42.592841+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"}