Oncolytics Biotech (ONCY) investor relations material

Mission and platform overview

• Pelareorep is a first-in-class double-stranded RNA immunotherapeutic agent targeting gastrointestinal (GI) tumors, aiming to address the largest unmet medical need in oncology by providing a tolerable therapy that extends patient survival.

• The platform leverages intravenous delivery, selective infection of tumor cells with RAS pathway mutations, and immune activation to convert "cold" tumors into "hot" tumors, enhancing immune-mediated tumor destruction.

Clinical efficacy and safety

• Pelareorep has demonstrated replication in nearly all evaluated tumor types, including pancreatic, colorectal, breast, and brain cancers, with RNA detected in tumor but not stromal cells.

• Single-agent and combination studies show disease control rates up to 45% in refractory metastatic solid tumors and notable responses in metastatic breast, colorectal, and prostate cancers.

• Over 1,200 patients have been treated, including more than 300 with GI tumors; adverse events are generally mild and manageable, with no maximum tolerated dose identified.

Market opportunity

• GI cancers are the fastest-growing cancer type in people under 50, with significant addressable markets: $20B for metastatic colorectal cancer (mCRC), $3B for metastatic pancreatic ductal adenocarcinoma (mPDAC), and $1B for squamous cell anal carcinoma (SCAC).

• Survival rates remain low across these indications, highlighting the high unmet need and commercial potential.