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COMPANY

PDS Biotechnology Corp.

HQ: Princeton, NJ source · pdsbiotech.com ↗ · Mid-Atlantic

Clinical Phase 3

Also known as PDS Biotechnology · 5 sources

Keywords: oncology Recurrent Head and Neck Cancer Metastatic Head and Neck Cancer HPV Positive Oropharyngeal Squamous Cell Carcinoma Head and Neck Neoplasms Unresectable Head and Neck Squamous Cell Carcinoma High-risk HPV Infection and Biopsy-proven CIN1

Location: Princeton, NJ · source · Oct 15, 2026

Profile checked Oct 10, 2026

$16.6MRaised (2 yrs)3Trials (company is sponsor)

Timeline

  1. Raise Private placement: $11.3M (initial closing, as published); deal value up to $22.3M (not counted as received), announced Sep 14, 2026. Source: SEC filing. source ↗
  2. Raise Follow-on offering — Registered direct: $5.3M (total, as published), announced Nov 11, 2025. Source: company release on GlobeNewswire. source ↗
  3. Trial start 3: Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma source ↗
  4. Trial start Phase 2: Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC source ↗
  5. Trial start I: An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101 source ↗

Funding

Raised: $16.6M. Last 2 years.

Clinical trials (lead sponsor) 3

RecordTitlePhaseStatusStartPrimary completion
NCT06790966Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma3TerminatedMay 30, 2025Aug 25, 2026 (actual)
NCT04260126Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCCPhase 2CompletedMar 29, 2021May 14, 2025 (actual)
NCT02065973An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101ICompleted2014-02Dec 30, 2015 (actual)
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