PDS Biotechnology (PDSB) Life Sciences Virtual Investor Conference summary

Market opportunity and unmet need

• HPV-16 positive head and neck cancer incidence is rising, representing a $2–3 billion US and $4–5 billion US/EU market opportunity.

• No FDA-approved drugs exist for HPV-16 positive head and neck cancer, creating a significant unmet need.

• Current therapies offer only 12 months median overall survival and high toxicity.

Clinical development and trial results

• Versamune HPV plus Keytruda achieved a median overall survival of 30 months in phase 2, compared to 12 months for standard care.

• Over 20% of patients experienced complete or near-complete tumor shrinkage; nearly 80% had tumor shrinkage or disease stabilization.

• The combination therapy showed durable responses and induced memory immune responses, reducing need for continuous treatment.

• Safety profile was favorable, with only 9% grade 3 toxicity and no compounded toxicity with Keytruda.

Phase 3 trial and pipeline strategy

• Ongoing phase 3 trial (VERSATILE-003) compares Versamune HPV plus Keytruda to Keytruda alone, targeting 351 patients with 85% power to detect a 10-month survival difference.

• Primary endpoint is median overall survival; secondary endpoints include response rates and progression-free survival.

• Final results from the phase 2 VERSATILE-002 study and preliminary neoadjuvant study results are expected in late Q2 or early Q3.

• Additional readouts from NCI-led studies in colorectal, gallbladder, and prostate cancer are anticipated in 2026.