Company received written feedback from the U.S. Food and Drug Administration ("FDA") regarding the design of a potential pivotal Part B expansion of REO 033, the Company’s ongoing randomized study evaluating pelareorep in second-line RAS-mutant, microsatellite stable ("MSS") metastatic colorectal cancer ("REO 033").

The Company submitted a Type D meeting request to the FDA regarding the potential expansion of REO 033 into a pivotal study. Specifically, Oncolytics sought FDA feedback on the validity of the currently designed REO 033 (Part A) to support expansion of a pivotal Part B, and whether a Part B could support a potential accelerated approval pathway based on objective response rate and duration of response, with progression-free survival serving as the basis for full approval.

The FDA provided written responses that the Company believes represent important alignment regarding the proposed pivotal study design. The FDA also suggested that the Company hold an End-of-Phase meeting to reach final agreement on key elements of the registration program. Based on the substantive written feedback and alignment with the FDA regarding the Company’s immediate development plans for pelareorep in colorectal cancer, Oncolytics elected to forego its scheduled Type D meeting and intends to pursue an End-of-Phase meeting with the FDA as the program advances.

"We are thrilled with the response provided by the FDA and believe this feedback could support a highly efficient path to potentially transition REO 033 from its ongoing randomized Part A directly into a pivotal Part B," said Jared Kelly, Chief Executive Officer of Oncolytics. "Importantly, the feedback provides alignment around the potential use of response rate to support an accelerated approval pathway and progression-free survival to support full approval. We appreciate the FDA’s thoughtful and clear guidance, which allows us to efficiently plan the next stage of development while continuing to generate the Part A clinical data that will inform our decision to launch Part B."

REO 033 is currently evaluating pelareorep in combination with standard-of-care therapy in patients with second-line RAS-mutant, MSS metastatic colorectal cancer. The study was designed to allow for expansion into a pivotal Part B if supported by the clinical results observed in Part A and regulatory feedback. Based on the FDA’s written feedback, Oncolytics plans to minimize the time between the generation of supportive Part A data and initiation of Part B by launching Part B start-up activities as soon as positive interim Part A data are available.

Prior clinical data with pelareorep in metastatic colorectal cancer, including results from REO 022, demonstrated encouraging improvements in objective response rate, duration of response, progression-free survival and overall survival in patients receiving pelareorep-containing therapy combined with the current standard of care. Pelareorep combination therapy has received Fast Track designation from the FDA in this patient population.