Pelareorep in combination with bevacizumab (Avastin) and leucovorin, fluorouracil, irinotecan (FOLFIRI) - (REO 033)

July 13, 2026: Oncolytics Biotech Inc. (NASDAQ: ONCY) provided an operational, clinical, and regulatory update on REO 033, a multi-part randomized controlled trial of pelareorep plus FOLFIRI and bevacizumab vs FOLFIRI and bevacizumab alone in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer. For Part A (n=60), the company said ~half of planned clinical sites will be activated by end of July 2026, remaining sites by end of August, with >20 patients pre-identified and accelerated enrollment expected in 2H 2026; enrollment has opened at Rutgers Cancer Institute of New Jersey.

Regulatory catalyst: the company plans a Type D FDA meeting in 1H August 2026 to discuss adding a registration-directed Part B to REO 033. Part B would increase enrollment and add blinded independent central review, with the goal of supporting potential accelerated approval and traditional full approval within the same study.

Upcoming milestones: initial tumor response update from Part A is expected by year-end 2026; subject to FDA feedback, Part B enrollment is planned to begin in 1Q 2027. The company noted pelareorep has FDA Fast Track designation for this indication, citing prior REO 022 efficacy signals.