PDS Biotechnology (PDSB) investor relations material

Clinical innovation and results

• Targeted immunotherapy for HPV16-positive head and neck cancers shows a median overall survival of 39.3 months, significantly exceeding the 12–18 month benchmark for current standard of care with pembrolizumab and chemotherapy.

• Disease control rate reached 77.4% and objective response rate was 35.8%, with 11 patients surviving beyond 30 months.

• PDS0101 demonstrated near or complete tumor shrinkage in hard-to-treat patients, including those with low CPS scores.

• Treatment was well-tolerated, with low incidence of severe adverse events and most common side effects being fatigue, headache, and diarrhea.

• Phase 3 VERSATILE-003 pivotal trial is ongoing, with FDA-aligned accelerated approval pathway and progression-free survival as the primary endpoint.

Unmet need and market opportunity

• HPV16-positive head and neck cancers are increasing in the US and EU due to poor HPV vaccine uptake and changing sexual behavior.

• No approved therapies specifically target HPV16-positive cancers, which have worse survival outcomes compared to other groups.

• Estimated US market opportunity exceeds $1 billion for locally advanced HPV16+ HNSCC and $2 billion for HPV16+ anogenital cancers.

Technology and mechanism of action

• Versamune® platform uses lipid nanoparticles (R-DOTAP) to train the immune system to recognize and destroy HPV16-positive tumors.

• PDS0101 recruits, trains, and arms T cells for a targeted attack, increasing production of HPV16-specific CD8+ killer and CD4+ helper T cells.

• Immune checkpoint inhibitors are used in combination to restore pre-existing T cell responses.