About Oncolytics Biotech

Oncolytics Biotech Inc. operates as a clinical-stage biopharmaceutical company. The company is developing pelareorep, a safe and well-tolerated intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. Pelareorep is a proprietary isolate of a naturally occurring, non-pathogenic double-stranded RNA (dsRNA) virus commonly found in environmental waters, known as reovirus. Pelareorep has demonstrated the ability to create a more permissive tumor microenvironment (TME) and conditions the tumor for multiple treatment combinations, including chemotherapies, checkpoint inhibitors and other immuno-oncology drugs, like CAR T therapies, bispecific antibodies, and CDK4/6 and PARP inhibitors. Pelareorep creates a new army of tumor-reactive T cells, helps these cells to infiltrate the tumor through an inflammatory process, and promotes the overexpression of PD-1/PD-L1. In 2022, the company presented clinical biomarker analyses from AWARE-1's first two cohorts at the European Society for Medical Oncology Breast Cancer Meeting (ESMOBC), the Society for Immunotherapy of Cancer Annual Meeting (SITC), and the San Antonio Breast Cancer Symposium (SABCS). In the fourth quarter of 2022, the company’s partner, Adlai Nortye Biopharma Co., Ltd. (Adlai), announced interim results at the 2022 SABCS. Fifteen patients were treated in the bridging clinical trial, with fourteen having had at least one post-baseline tumor assessment (i.e., evaluable for efficacy). In addition to its breast cancer program, the company continued to explore pelareorep in gastrointestinal cancers. Notably, in 2021 enrollment began into the platform study known as GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1). GOBLET is examining combination therapy with pelareorep and atezolizumab (Tecentriq) in four gastrointestinal indications: Patients with first-line locally advanced/metastatic unresectable pancreatic ductal adenocarcinoma (PDAC); Patients with first-line metastatic colorectal cancer (mCRC), limited to microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors; Patients with third-line mCRC independent of microsatellite instability (MSI)/dMMR status; and Patients with second-line or later locally advanced/metastatic unresectable squamous cell carcinoma of the anal canal (SCCA). This study is enrolling patients, and the 3-patient safety run-ins for Cohort 1 and Cohort 3 were completed in the first and second quarter of 2022 (Cohorts 2 and 4 do not require safety run-ins). During 2022, GOBLET’s pancreatic cancer cohort met the efficacy expansion criteria for Stage 1 of the trial and interim clinical results were presented at SITC. Per the study's Simon two-stage design, any cohort meeting a pre-specified efficacy threshold in Stage 1 (defined as achieving a minimum number of objective radiologic responses by week 16) may be expanded to enroll additional patients in an optional Stage 2 study expansion. Finally, the company received the U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of advanced/metastatic PDAC using pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel. Fast Track designation is designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need. Business Strategy The company’s business strategy is to develop and seek regulatory approval to market pelareorep in an effective and timely manner, and access additional technologies at a time and in a manner that is best for its development. The company intends to achieve its business strategy by focusing on these key areas, such as continue to assess the safety and efficacy of pelareorep in human subjects through its clinical development program; maintain existing and establish new collaborations with experts to assist it with scientific and clinical developments of this new potential pharmaceutical product; implement strategic alliances with select biopharmaceutical companies and laboratories, at a time and in a manner whereby such alliances may complement and expand its own research and development efforts. Such alliances may also result in an eventual expansion to include providing additive sales and marketing capabilities; use its broadening patent base and collaborator network as a mechanism to meet its strategic objectives; and develop relationships with companies that could be instrumental in assisting the company to access other innovative therapeutics. As its clinical development program advances, the company anticipates pelareorep's ability to enhance innate and adaptive immune responses within the TME will play an increasingly important role. This greatly increases opportunities for expansion of the company’s clinical program along with business development and partnering opportunities to address a broad range of cancers in combination with a variety of other therapies. The company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) and advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) to phase 3 licensure-enabling studies. In addition, the company is exploring opportunities for registrational programs in gastrointestinal cancers through its GOBLET platform study. The company’s business strategy is based on attaining a number of commercial objectives. The company is pursuing a strategy of establishing relationships with larger companies as strategic partners. It is anticipated that future clinical development into large international or pivotal trials would generally occur in conjunction with a strategic partner or partners, who would contribute expertise and financial assistance. In exchange for certain product rights and commitments to market the company’s products, the strategic partners would be expected to share in proceeds from the sale of its product or products. Patents and Trade Secrets The company relies on its patent portfolio to protect the development of pelareorep. The company has 243 issued patents including 24 issued in the U.S. and 11 in Canada. The company also has 17 patents pending in the U.S., Canada, and other jurisdictions. Regulations The company’s toll manufacturers are subject to periodic inspection by the FDA, the United States Drug Enforcement Administration, or DEA, and other domestic and foreign authorities where applicable, and must comply with cGMP regulations. History Oncolytics Biotech Inc. was founded in 1998. The company was incorporated in 1998 under the Business Corporations Act (Alberta).