ONCOLYTICS BIOTECH INC 8K

Oncolytics Biotech reported operational milestones and an upcoming FDA Type D meeting to potentially convert its REO 033 colorectal cancer trial into a registration-directed study supporting accelerated and full approval of pelareorep.

Oncolytics Biotech Inc. announced clinical and regulatory progress for its randomized REO 033 trial of pelareorep plus FOLFIRI and bevacizumab in second-line RAS‑mutant, microsatellite stable metastatic colorectal cancer, including plans to have roughly half of clinical sites activated by the end of July 2026 and all sites by the end of August 2026, with more than 20 patients already pre-identified across centers. The company will hold a Type D meeting with the FDA in the first half of August 2026 to discuss adding a registration-directed Part B to REO 033 that would increase enrollment and incorporate blinded independent central review, aiming to support both potential accelerated and full approval from the same study infrastructure. Oncolytics expects to report an initial tumor response update from Part A of REO 033 by year-end 2026 and, subject to FDA feedback, to begin enrollment in Part B in the first quarter of 2027, positioning pelareorep’s colorectal program on a potential registrational path while leveraging Fast Track designation and previously favorable REO 022 data.

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1129928

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8K

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sec

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0001129928-26-000043

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6