Oncolytics Biotech® Highlights Transformative Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies

Comparison with multiple landmark first-line metastatic pancreatic ductal adenocarcinoma studies substantiates strong two-year survival benefit of 21.9% vs. 9.2% historical benchmark

Consistent survival benefit compared to standard-of-care chemotherapy in randomized studies in the large HR+/HER2- metastatic breast cancer indication

Data from over 1,100 patients across tumor types reveals a favorable, well-understood safety profile

Excerpt from the Press Release:

SAN DIEGO and CALGARY, AB, July 8, 2025 /PRNewswire/ — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced a strategic update highlighting its compelling clinical data from two tumor types and outlining a sharpened focus on advancing pelareorep, the Company’s intravenously delivered oncolytic virus immunotherapy, into registration-enabling studies.

“We are no longer in the business of funding proof-of-concept studies,” said Jared Kelly, Chief Executive Officer of Oncolytics. “We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology.”

Results from two completed first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trials demonstrate a strong and consistent efficacy signal showing extremely rare 2-year overall survival rates of 21.9% vs. 9.2% based on pooled data from over 100 patients across two studies evaluating pelareorep combined with a chemotherapy backbone.  In addition, a best-in-class 62% objective response rate (ORR) was observed in a single-arm study of pelareorep in combination with a chemotherapy backbone and a checkpoint inhibitor in 13 evaluable patients. These results collectively represent promising efficacy for a therapeutic regimen that includes an immunotherapy in this difficult-to-treat cancer. Currently, there are no approved immunotherapies for first-line treatment of mPDAC.

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