{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-010575","form_type":"8-K","ticker":"PDSB","cik":"0001472091","company_name":"PDS Biotechnology Corp","filed_at":"2025-03-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.721570+00:00","generated_at":"2026-05-24T03:50:45.368436+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"PDS Biotech reports FY2024 net loss $37.6M; initiates Phase 3 Versamune HPV trial","bullets":["Net loss for FY 2024 was $37.6M ($1.03 per share), compared to $42.9M ($1.39 per share) in 2023; operating expenses decreased to $36.3M from $43.0M.","Initiated Phase 3 VERSATILE-003 trial for Versamune HPV in HPV16-positive first-line recurrent/metastatic HNSCC; ~350 patients, primary endpoint overall survival.","FDA cleared IND for combination of Versamune MUC1 and PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma; Phase 1/2 with NCI.","Cash balance as of Dec 31, 2024 was $41.7M; subsequent $22M registered direct offering in Feb 2025 with $11M upfront proceeds.","FDA granted Fast Track designation for Versamune HPV + pembrolizumab combination in recurrent/metastatic HNSCC."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-010575","json":"https://secwatch.observer/filing/0001140361-25-010575.json","markdown":"https://secwatch.observer/filing/0001140361-25-010575.md","text":"https://secwatch.observer/filing/0001140361-25-010575.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125010575/0001140361-25-010575-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125010575/ef20046266_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T03:50:45.368436+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"}