Contradictions Uncovered: Insights from the Latest VERSATILE Clinical Trials Earnings Call

PDS0101's Clinical Progress:
- PDS Biotech advanced its VERSATILE-003 Phase III trial, targeting HPV16-positive head and neck cancer, with approximately 350 patients enrolled in a 2:1 randomization.
- The durable clinical benefit observed in the VERSATILE-002 trial supports the potential of PDS0101 in combination with pembrolizumab to improve outcomes for these patients.
- The company presented positive data at ASCO, reinforcing the clinical benefit and encouraging enrollment in the ongoing trial.

Financial Performance:
- PDS Biotech reported a net loss of approximately $9.4 million for Q2 2025, compared to $8.3 million in Q2 2024.
- The increase in net loss was due to higher net interest expenses, partially offset by lower personnel costs.
- Research and development expenses decreased to $4.2 million, primarily due to lower personnel costs.

Colorectal Cancer Trial Expansion:
- The colorectal cancer cohort of the PDS01ADC Phase II clinical trial met expansion criteria to Stage 2, following positive Stage 1 results.
- The trial showed a promising response rate of at least 6 out of 9 confirmed objective responses by RECIST version 1.1 criteria.
- This expansion allows for further evaluation of the investigational approach to targeting and using antibody fused IL-12 in metastatic colorectal cancer.

Universal Influenza Vaccine Progress:
- PDS Biotech's preclinical data on a novel immune-based universal flu vaccine was featured in presentations at the American Association of Immunologists Annual Meeting.
- The studies were funded by and performed by investigators at the National Institute of Allergy and Infectious Disease.
- The collaborations with NCI, MD Anderson, and Mayo Clinic enable PDS Biotech to advance its pipeline while focusing resources on the VERSATILE-003 trial.