Company to leverage strong durability and survival data in second-line and later metastatic squamous cell anal carcinoma

Pivotal study expected to focus on patients in a post-standard-of-care patient population with no FDA-approved therapies

SAN DIEGO, April 27, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced that a Type C meeting with the U.S. Food and Drug Administration ("FDA") has resulted in alignment on the design of a pivotal clinical study to support approval of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal ("SCAC").

"We want to thank the FDA for its very clear guidance and helping us create an efficient pathway for pelareorep in a disease that is desperate for new treatments," said Jared Kelly, Chief Executive Officer of Oncolytics. "While a single-arm study was possible in this setting, following a productive discussion with the FDA and in consideration of recent regulatory decisions regarding similar studies, we have aligned on a randomized controlled trial designed to potentially support both accelerated approval and full approval within the same study. This approach directly addresses relevant and rigorous evidentiary standards while allowing for approval based on multiple endpoint assessments."

SCAC is a rare gastrointestinal malignancy affecting more than 10,000 patients annually in the United States. Patients whose disease progresses following first-line chemotherapy/checkpoint inhibitor treatment have no FDA-approved therapeutic options and limited National Comprehensive Cancer Network recommended treatments. In a recent study combining pelareorep with a checkpoint inhibitor in second-line and later SCAC, the combination achieved a median duration of response of 15.5 months versus 9.5 months and 12-month survival of 82% versus 45.7%, each measured against the current standard of care.1