{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-26-000062","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2026-05-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.795700+00:00","generated_at":"2026-05-14T21:53:36.829507+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Denali reports Q1 2026 net loss $128.4M; AVLAYAH approved and launched for Hunter syndrome","bullets":["Net loss of $128.4M for Q1 2026 vs $133.0M in Q1 2025; R&D expenses down $12.4M to $103.8M.","FDA granted accelerated approval for AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome on March 25, 2026; first commercial patients dosed in April.","Cash and marketable securities at $1.05B as of March 31, 2026; $200M gross proceeds received from Royalty Pharma synthetic royalty agreement.","Takeda terminated DNL593 (FTD-GRN) collaboration; Denali retains full rights, Phase 1/2 data expected by end of 2026.","First patient dosed in Phase 1b study of DNL628 (OTV:MAPT) for Alzheimer's disease; data expected in 1H 2027."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-26-000062","json":"https://secwatch.observer/filing/0001714899-26-000062.json","markdown":"https://secwatch.observer/filing/0001714899-26-000062.md","text":"https://secwatch.observer/filing/0001714899-26-000062.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489926000062/0001714899-26-000062-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489926000062/dnli-20260507.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-14T21:53:36.829507+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":"3130ec189b0a50bb043990c162472353f69d43a8","claim":"Denali Therapeutics Inc. reported financial results for the first quarter ended March 31, 2026.","evidence_excerpt":"On May 7, 2026, Denali Therapeutics Inc. (the \"Company\") issued a press release announcing its financial results for the first quarter ended March 31, 2026.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1714899/000171489926000062/0001714899-26-000062-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the first quarter ended March 31, 2026"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}