PDS Biotechnology (PDSB) Q4 2025 earnings summary

Executive summary

• Achieved significant clinical progress, including a Phase 3 protocol amendment for VERSATILE-003/PDS0101 to accelerate regulatory submission and reduce trial duration for HPV-16 positive head and neck cancer therapy.

• Early results from the NCI-led trial of PDS-01ADC in metastatic castration-resistant prostate cancer showed a median PFS of 9.6 months, a median PSA decline of 40%, and 6 of 16 patients achieving over 50% PSA reduction.

• Expanded intellectual property portfolio with new patents in the US and Japan, extending market protection for PDS0101 and the Versamune® platform into the 2040s.

Financial highlights

• Net loss for 2025 was $34.5 million ($0.74 per share), improved from $37.6 million ($1.03 per share) in 2024.

• Research and development expenses decreased to $19 million from $22.6 million year-over-year, mainly due to lower manufacturing and personnel costs.

• General and administrative expenses fell to $12.5 million from $13.8 million in 2024.

• Total operating expenses were $31.5 million, down from $36.3 million in 2024.

• Cash and cash equivalents at year-end 2025 were $26.7 million.

Outlook and guidance

• Amended VERSATILE-003/Phase 3 protocol allows for a potentially faster path to accelerated approval using PFS as an interim primary endpoint, with final results expected in about a year and a half.

• R&D expenses for 2026 are expected to increase as the trial restarts, but no specific financial guidance was provided.

• Recruitment for VERSATILE-003 is expected to be robust due to strong site engagement and reduced competition.

• Management remains focused on advancing PDS0101 efficiently for HPV16-positive head and neck cancer.