- Trial Phase
- Phase 2 (completed); Phase 3 discontinued)
- Time to Market
- Unknown — the Phase 3 trial has been discontinued and the drug is being shopped for partnership. If partnered, timeline depends on the partner's development plans.
- Why 3/10
- No hard dated catalyst exists for Versamune/PDS0101 in the next ~12 months — the Phase 3 VERSATILE-003 trial was discontinued in August 2026 and the company is seeking a partnership with no announced timeline. ImpactScore is 3 because the drug has strong Phase 2 data but no scheduled binary event, and the company has pivoted to PDS0301 as its lead asset.
PDS0101 (Versamune) is no longer the company's priority — PDS Biotech discontinued its Phase 3 trial in August 2026 and is seeking a partner. Investors should watch for a licensing deal or partnership announcement, but the stock's near-term catalysts now revolve around PDS0301, not Versamune. The company's severe cash constraints (~$5.6M at Q2 2026) and Nasdaq listing deficiency add urgency to finding a partner.
Price Chart
Executive Summary
Versamune is PDS Biotechnology's proprietary T-cell activating platform technology, with PDS0101 as its lead therapeutic cancer vaccine candidate targeting HPV16-positive cancers. PDS0101 showed strong Phase 2 data — a 39.3-month median overall survival when combined with pembrolizumab in first-line head and neck cancer, well above the standard-of-care benchmark. However, in August 2026, PDS Biotech discontinued internal investment in the PDS0101 Phase 3 VERSATILE-003 trial due to cash constraints and pivoted to prioritize PDS0301. The company is now seeking a strategic partnership for PDS0101. With severe liquidity (~$5.6M cash), a Nasdaq deficiency notice, and no hard catalyst scheduled for Versamune/PDS0101, the drug's path forward depends entirely on finding a partner.
How It Works
Versamune is a proprietary T-cell activating platform technology. It works like a targeted training program for the immune system. The drug (PDS0101) uses this platform to create a therapeutic vaccine that trains the body's killer T-cells to recognize and attack cells infected with HPV16 — a virus that causes several cancers including head and neck and cervical cancers. It's given as an injection (not a traditional preventive vaccine) and is designed to work alongside other immunotherapies like pembrolizumab (Keytruda).
Trial Status
Phase 2 VERSATILE-002 trial (NCI-led combination study completed with positive results (39.3-month median OS). Phase 3 VERSATILE-003 trial was discontinued in August 2026. Company seeking partnership for further development.
The Two-Sided Case
Upcoming Catalysts
- Potential partnership/licensing deal for PDS0101 (no timeline), though the company's near-term catalysts are now around PDS0301 data readouts for PDS0301 (Q4 2026-Q2 2028)
Source Filing
The SecBot filing or press-release report that triggered this drug report:
PDS Biotechnology Corp 8-K PDSB ·Originating report