{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-005571","form_type":"8-K","ticker":"PDSB","cik":"0001472091","company_name":"PDS Biotechnology Corp","filed_at":"2025-02-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.720494+00:00","generated_at":"2026-05-26T05:44:33.150122+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"PDS Biotech announces Versamune® HPV ctDNA results: 100% clearance vs 50% CRT alone; Phase 3 HNSCC trial planned Q1 2025","bullets":["Versamune® HPV + CRT achieved 100% HPV16 ctDNA clearance at 3-4 months vs 50% with CRT alone in cervical cancer.","Undetectable ctDNA at 3-4 months linked to 93% 2-year recurrence-free survival vs 30% with detectable ctDNA.","Phase 3 VERSATILE-003 trial in HPV16-positive HNSCC to be initiated in Q1 2025.","Plans to discuss accelerated regulatory pathway (e.g., Breakthrough Therapy) with FDA based on ctDNA-survival correlation.","Median follow-up 23 months; 100% 36-month OS in patients receiving 5 doses of Versamune® HPV + CRT."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-005571","json":"https://secwatch.observer/filing/0001140361-25-005571.json","markdown":"https://secwatch.observer/filing/0001140361-25-005571.md","text":"https://secwatch.observer/filing/0001140361-25-005571.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125005571/0001140361-25-005571-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125005571/ef20044142_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-26T05:44:33.150122+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"}