{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-020206","form_type":"8-K","ticker":"PDSB","cik":"0001472091","company_name":"PDS Biotechnology Corp","filed_at":"2025-05-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.402100+00:00","generated_at":"2026-05-20T18:04:02.366333+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"PDS Biotech reports positive extended follow-up data for Versamune HPV Phase 2 in head and neck cancer","bullets":["VERSATILE-002: mOS of 39.3 months (CPS≥20) vs ~15 months for pembrolizumab; median follow-up 18.4 months.","mOS of 30.0 months (CPS≥1) and 29.5 months (CPS 1-19), exceeding historical pembrolizumab results.","Phase 3 VERSATILE-003 (n=351) enrolling; primary endpoint mOS with two interim analyses planned.","Phase 2 window trial: 70% stable disease with Versamune HPV alone; 100% SD/PR with combo; met ctDNA endpoint."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-020206","json":"https://secwatch.observer/filing/0001140361-25-020206.json","markdown":"https://secwatch.observer/filing/0001140361-25-020206.md","text":"https://secwatch.observer/filing/0001140361-25-020206.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125020206/0001140361-25-020206-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125020206/ef20049600_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T18:04:02.366333+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"}