PDS Biotechnology (PDSB) Q4 2025 earnings summary

Executive summary

• Achieved significant clinical progress, including protocol amendment for VERSATILE-003/PDS0101 to accelerate regulatory submission and reduce trial duration for HPV-16 positive head and neck cancer, and encouraging early Phase 2 data for PDS01ADC in prostate cancer.

• Early results from the NCI-led trial of PDS-01ADC in metastatic castration-resistant prostate cancer showed a median PFS of 9.6 months, 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 Versamune® platform into the 2040s.

Financial highlights

• Net loss for 2025 was $34.5 million ($0.74 per share), improving from a $37.6 million loss ($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 interim PFS readout, with the possibility of accelerated approval and shortened trial duration to about a year for final results.

• R&D expenses expected to increase with trial reinitiation, but no specific financial guidance provided.

• Two interim PFS analyses planned, both powered to detect statistically significant differences, but sample size not disclosed.

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