Michael Freeman

John Newman

Patrick Trucchio

Carvey Leung

Luis Santos

Michael Okunewitch

Rahul Sarugaser

Soumit Roy

- Oncolytics Biotech's proprietary product candidate, **pelareorep**, is an investigational first-in-class double-stranded RNA immunotherapeutic agent targeting gastrointestinal (GI) tumors, which the company believes represent the largest unmet medical need in oncology.  **[1129928_0001104659-25-098796_tm2528273d1_ex99-1.htm:3]** 
- Pelareorep has demonstrated promising clinical efficacy signals, including a **2-year survival rate of 21.9%** in 1L metastatic pancreatic ductal adenocarcinoma (mPDAC) with pela-based therapy compared to 9.2% for comparator arms, and an **Objective Response Rate (ORR) of 30%** in 2L unresectable squamous cell anal carcinoma (SCAC).  **[1129928_0001104659-25-098796_tm2528273d1_ex99-1.htm:6]** **[1129928_0001104659-25-098796_tm2528273d1_ex99-1.htm:7]** 
- The company is pursuing a strategic clinical development pipeline with key milestones including data expected in **Q4 2025** for 2L SCAC (GOBLET cohort 4), and pivotal study launches anticipated in **Q3 2026** for 2L SCAC and **1H 2026** for 2L colorectal cancer (CRC).  **[1129928_0001104659-25-098796_tm2528273d1_ex99-1.htm:5]** 
- Significant market opportunities exist for pelareorep, with estimated total addressable markets of approximately **$3 billion** for 1L mPDAC by 2032, **$12.5 billion** for 2L mCRC by 2033, and **$1.01 billion** for 2L unresectable SCAC by 2032.  **[1129928_0001104659-25-098796_tm2528273d1_ex99-1.htm:4]** 
- Oncolytics Biotech holds **147 patents worldwide** for pelareorep, with new patents expected to extend manufacturing and method of use protection into **2044**, and composition of matter protection through **2028**.  **[1129928_0001104659-25-098796_tm2528273d1_ex99-1.htm:8]**

Oncolytics Biotech Highlights Pelareorep's Clinical Development and Market Opportunity

- Oncolytics Biotech Inc. announced an update on the proposed design for its **registration-directed clinical trial** for **pelareorep** in **first-line pancreatic ductal adenocarcinoma (PDAC)**.  **[1129928_0001129928-25-000079_padcregupdate.htm:0]** 
- The company is scheduled to meet with the **U.S. Food and Drug Administration (FDA) in mid-November 2025** to advance study details.  **[1129928_0001129928-25-000079_padcregupdate.htm:0]** 
- The proposed study features a **three-arm design** with **Overall Survival (OS)** as the primary endpoint and includes a planned interim efficacy analysis.  **[1129928_0001129928-25-000079_padcregupdate.htm:0]** 
- This design builds on a post-hoc analysis where pelareorep combined with chemotherapy achieved an **approximate 22% two-year survival rate**, compared to 9% for chemotherapy alone in historical benchmarks.  **[1129928_0001129928-25-000079_padcregupdate.htm:0]**

Oncolytics Biotech Provides Update on Pancreatic Cancer Registration Study

- Oncolytics Biotech Inc. provided an update on the **GOBLET trial**, which evaluates pelareorep in gastrointestinal cancers, detailing enrollment progress, U.S. site expansion, and anticipated data readouts.  **[1129928_0001129928-25-000077_gobletupdate.htm:0]** 
- Enrollment for **Cohort 4 (SCAC)** is at **20 evaluable patients** and is expected to be completed by the **end of 2025**, with an efficacy update (ORR) anticipated in the **fourth quarter of 2025**.  **[1129928_0001129928-25-000077_gobletupdate.htm:0]** 
- **Cohort 5 (mPDAC)** enrollment is approximately **40% complete** and projected to be fully enrolled by the **end of 2026**, with an interim efficacy update, including overall survival, expected in the **first quarter of 2026**.  **[1129928_0001129928-25-000077_gobletupdate.htm:0]** 
- The GOBLET study is expanding to include **U.S. clinical sites**, with Northwestern University and other academic institutions expected to serve as participants.  **[1129928_0001129928-25-000077_gobletupdate.htm:0]**

Oncolytics Biotech Updates GOBLET Study Progress and U.S. Site Expansion

- Oncolytics Biotech provided an update on the GOBLET trial, which is evaluating **pelareorep** in gastrointestinal cancers.  **[1129928_20250916LN74592:0]** 
- For **Cohort 4 (Squamous Cell Carcinoma of the Anal Canal)**, pelareorep demonstrated a **33% overall response rate (ORR)** in 12 patients, with enrollment of 20 evaluable patients expected to be completed by the **end of 2025** and an efficacy update anticipated in **Q4 2025**.  **[1129928_20250916LN74592:0]** 
- Enrollment for **Cohort 5 (Metastatic Pancreatic Ductal Adenocarcinoma)** is **approximately 40% complete** and projected to be fully enrolled by the **end of 2026**, with an interim efficacy update, including overall survival, expected in **Q1 2026**.  **[1129928_20250916LN74592:0]** 
- The company is expanding the GOBLET study to **U.S. clinical sites**, having submitted a protocol amendment, with Northwestern University expected to serve as one of the sites.  **[1129928_20250916LN74592:0]**

- Oncolytics Biotech Inc. provided an updated safety analysis for **pelareorep**, an intravenously delivered double-stranded RNA immunotherapeutic agent.  **[1129928_0001129928-25-000072_oncypooledsafetypr.htm:0]** 
- The analysis, which includes data from **over 1,200 patients** dosed with pelareorep (including **over 300 gastrointestinal cancer patients**), continues to demonstrate a **favorable safety profile** across multiple indications and treatment combinations.  **[1129928_0001129928-25-000072_oncypooledsafetypr.htm:0]** 
- The most frequent adverse events observed were **Grade 1 and 2 flu-like symptoms** (fever, chills, fatigue) and gastrointestinal issues (nausea, vomiting, diarrhea), with **neutropenia** also noted in GI tumor patients.  **[1129928_0001129928-25-000072_oncypooledsafetypr.htm:0]** 
- The company's CEO stated that pelareorep represents **one of the most de-risked immunotherapies** not yet approved, and Oncolytics is moving towards **registration-enabled studies** and actively pursuing strategic partnerships.  **[1129928_0001129928-25-000072_oncypooledsafetypr.htm:0]**

ONCOLYTICS BIOTECH (ONCY)