{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-055612","form_type":"8-K","ticker":null,"cik":"0001029142","company_name":"DYNAVAX TECHNOLOGIES CORP","filed_at":"2024-05-08T23:59:59+00:00","discovered_at":"2026-05-14T18:03:16.941073+00:00","generated_at":"2026-06-02T08:29:59.409209+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Dynavax Q1 HEPLISAV-B revenue up 10% to $47.8M; reaffirms 2024 guidance; FDA clears IND for shingles vaccine","bullets":["HEPLISAV-B net product revenue $47.8M (+10% YoY); total revenue $50.8M; GAAP net loss $8.7M ($0.07/share) vs loss $24.3M ($0.19) YoY.","Reaffirms FY2024 guidance: HEPLISAV-B revenue $265-280M, gross margin ~80%, R&D $60-75M, SG&A $160-180M, cash to increase.","U.S. FDA cleared IND for Z-1018 shingles vaccine; Phase 1/2 trial expected Q2 2024 with top-line data H2 2025.","HEPLISAV-B U.S. market share ~41% (up from 37% YoY); sBLA for hemodialysis under review with PDUFA May 13.","Cash, equivalents, marketable securities $723.5M; plague vaccine contract modification adds $4M from DoD; Phase 2 data Q4 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-055612","json":"https://secwatch.observer/filing/0000950170-24-055612.json","markdown":"https://secwatch.observer/filing/0000950170-24-055612.md","text":"https://secwatch.observer/filing/0000950170-24-055612.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1029142/000095017024055612/0000950170-24-055612-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1029142/000095017024055612/dvax-20240508.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-02T08:29:59.409209+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":"46c822a4856d816cba09b49c1708d43932b21406","claim":"DYNAVAX TECHNOLOGIES CORP reported the quarter ended March 31, 2024 results: revenue $50.8 million. Guidance reaffirmed.","evidence_excerpt":"Total revenues for the first quarter of 2024 were $50.8 million","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1029142/000095017024055612/0000950170-24-055612-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the quarter ended March 31, 2024"},{"label":"Revenue","value":"$50.8 million"},{"label":"Guidance","value":"reaffirmed"},{"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"}