Oncolytics aligns with FDA on pivotal Part B expansion for REO 033 colorectal cancer study

ONCOLYTICS BIOTECH INC

• FDA written feedback supports potential pivotal Part B expansion of REO 033 in 2L RAS-mutant MSS colorectal cancer.
• Alignment on accelerated approval based on objective response rate; progression-free survival supports full approval.
• Company to skip scheduled Type D meeting; will pursue End-of-Phase meeting for final registration program agreement.
• Part B start-up activities to begin after positive interim Part A data; prior REO 022 data showed improved ORR, PFS, OS.
• Pelareorep combination has FDA Fast Track designation in this patient population.