Oncolytics Biotech(r) Reports Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights.

SAN DIEGO and CALGARY, Alberta: Oncolytics Biotech(r) Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the fourth quarter and full year ended December 31, 2022. All dollar amounts are expressed in Canadian currency unless otherwise noted.

"This is a truly exciting time for Oncolytics, as our progress last year provides pelareorep with clear and substantially de-risked paths to registrational studies in both breast and pancreatic cancer," said Dr. Matt Coffey, President and Chief Executive Officer. "Our partner Adlai Nortye recently confirmed pelareorep's ability to combine with paclitaxel and generate sustained clinical responses in HR+/HER2- metastatic breast cancer, which we believe bodes well for BRACELET-1's anticipated readout next quarter. With this readout, we aim to showcase a randomized dataset that shows one or both of the trial's pelareorep-based treatment regimens numerically outperforming the paclitaxel monotherapy arm on key metrics such as overall response rate and progression-free survival. We believe this result would represent a key inflection point, as it would confirm our breast cancer program's prior statistically significant results, accelerate its advancement into a registrational trial, and bolster our business development prospects."

Dr. Coffey continued, "In pancreatic cancer, interim results from pelareorep's GOBLET trial showed an objective response rate that was nearly three times greater than those recorded in historical control trials. These data supported a subsequent Fast Track designation from the FDA, which will be incredibly valuable as we work with the agency and other key stakeholders to identify the optimal path to registration. GOBLET's data also transformed our pancreatic cancer program into our pipeline's second core pillar, thereby adding an important value driver that strengthens our foundation for sustained growth."

Fourth Quarter Highlights

Pancreatic Cancer Program

Reported a 69% ORR and confirmed complete response in phase 1/2 GOBLET trial's pancreatic cancer cohort

A poster presented at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting featured data from the phase 1/2 GOBLET trial's cohort in first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) (link to PR, link to poster). Thirteen patients were evaluable for efficacy as of the poster's cut-off date (October 12, 2022), with one achieving a confirmed...