{"schema_version":"secwatch.filing_event.v1","accession":"0001818382-24-000153","form_type":"8-K","ticker":"HUMA","cik":"0001818382","company_name":"Humacyte, Inc.","filed_at":"2024-08-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.647259+00:00","generated_at":"2026-05-31T09:47:09.718181+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA delays ATEV trauma BLA review beyond PDUFA date; Q2 net loss $56.7M","bullets":["FDA notified Humacyte on Aug 9 that additional time needed to complete ATEV BLA review; PDUFA date was Aug 10; no revised action date yet.","Q2 net loss $56.7M vs $22.7M YoY, driven by $27.2M non-cash earnout remeasurement and higher R&D costs.","ATEV V007 Phase 3 trial in hemodialysis showed superior functional patency vs autogenous fistula at 6 and 12 months (p=0.0071).","Cash $93.6M at June 30, 2024; H1 net cash provided $13.1M from $43M public offering and $20M Oberland draw.","R&D expense $23.8M (+16% YoY); G&A $5.7M (-8% YoY); no revenue reported."],"urls":{"canonical":"https://secwatch.observer/filing/0001818382-24-000153","json":"https://secwatch.observer/filing/0001818382-24-000153.json","markdown":"https://secwatch.observer/filing/0001818382-24-000153.md","text":"https://secwatch.observer/filing/0001818382-24-000153.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818382/000181838224000153/0001818382-24-000153-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818382/000181838224000153/huma-20240809.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T09:47:09.718181+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"}