---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-035211"
form_type: "8-K"
ticker: "PDSB"
cik: "0001472091"
company_name: "PDS Biotechnology Corp"
filed_at: "2024-08-01T23:59:59+00:00"
generated_at: "2026-05-31T13:45:48.014027+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# PDS Biotech aligns with FDA on Phase 3 VERSATILE-003 trial for HPV16-positive HNSCC; initiation in Q4 2024

## Summary
- Received official FDA minutes supporting Phase 3 trial of Versamune HPV + pembrolizumab for first-line recurrent/metastatic HPV16-positive HNSCC.
- FDA agreed to separate PDS01ADC dose optimization to avoid delay; VERSATILE-003 proceeds as a 2-arm double combination registrational trial.
- Phase 3 VERSATILE-003 trial to begin enrollment in Q4 2024; primary endpoint is overall survival.
- Versamune HPV + pembrolizumab combination holds FDA Fast Track designation for this indication.
- Corporate presentation updated; management cites matured VERSATILE-002 survival data supporting revised statistical endpoints.

## SEC filing metadata
- accession: 0001140361-24-035211
- form_type: 8-K
- ticker: PDSB
- cik: 0001472091
- company_name: PDS Biotechnology Corp
- filed_at: 2024-08-01T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1472091/000114036124035211/0001140361-24-035211-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1472091/000114036124035211/ef20033424_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-035211
- JSON: https://secwatch.observer/filing/0001140361-24-035211.json
- Plain text: https://secwatch.observer/filing/0001140361-24-035211.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.