PDS Biotech refocuses pipeline on PDS0301, halts PDS0101 phase 3 trial

PDS Biotechnology reported second quarter 2026 results on August 13, 2026 alongside a pipeline realignment first disclosed in a shareholder letter dated August 11, 2026. The letter outlined a strategic refocus to make PDS0301, the company's tumor-targeted IL-12 immunocytokine, its lead development program.¹

As part of the shift, PDS Biotech will stop putting internal funding into PDS0101, which includes ending the "VERSATILE-003" Phase 3 trial, and plans to seek outside partners or other externally funded arrangements to keep developing PDS0101.¹ The company said concentrating its resources on PDS0301 while preserving PDS0101's value through partnerships may offer the strongest path to long-term value.¹

The realignment follows new data on PDS0301. The company announced publication of positive clinical and immunological biomarker results from Stage 1 of an NCI-led Phase 2 trial in metastatic colorectal cancer testing PDS0301, an open-label, single-center, non-randomized study.¹ The results, published in the March 2026 issue of Journal of Clinical Oncology Oncology Advances, showed an objective response rate of 77.8% (7 of 9 patients) at six months versus 35% (7 of 20) in a parallel trial without PDS0301, a roughly 80% 24-month survival rate versus about 35% in the comparison arm, and extrahepatic progression-free survival with a median not yet reached at a minimum follow-up of 13.1 months, compared with 8.1 months in the parallel trial.¹

On the financial side, net loss for the quarter ended June 30, 2026 was $9.8 million, or $0.18 per basic and diluted share, compared with $9.4 million, or $0.21 per share, a year earlier.¹ Cash on hand as of June 30, 2026 stood at $5.6 million.¹