Oncolytics Biotech

ONCY

Market cap $92.7M

Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics' regulatory momentum and continues to advance the Company's path toward registration SAN DIEGO, July 20, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to pelareorep in combination with a checkpoint inhibitor for the treatment of patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (“SCAC”) who have progressed on or were intolerant to one or more prior lines of systemic therapy. Fast Track designation is intended to facilitate the development and expedite the review of therapies that treat serious diseases and address significant unmet medical needs.

Half of planned clinical sites will be activated this month; more than 20 patients have been pre-identified across participating centers Company to hold Type D meeting with FDA to discuss a potential registrational pathway through the addition of Part B to the existing REO 033 trial design Part B will be a randomized study designed to support potential accelerated and full approval SAN DIEGO, July 13, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today provided a clinical and regulatory update on REO 033, the Company's randomized controlled study evaluating pelareorep in combination with folinic acid, fluorouracil and irinotecan (“FOLFIRI”) and bevacizumab for the second-line treatment of patients with Rat Sarcoma (“RAS”)-mutant, microsatellite stable (“MSS”) metastatic colorectal cancer. REO 033 builds upon the previously reported REO 022 study, which more than doubled historical standard-of-care benchmarks across progression-free survival, overall survival, duration of response, and objective response rate.1 -4 Based on these data, pelareorep has received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for this indication.

Intellectual property update confirms pelareorep's unique manufacturing process and scalability Previously filed method-of-use patent application expected to provide protection into 2046 Additional patent filings planned in 2026 to further expand the pelareorep intellectual property estate SAN DIEGO, June 16, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today announced that the United States Patent and Trademark Office (“USPTO”) has issued a new patent broadly protecting the Company's proprietary manufacturing process for pelareorep. The newly issued patent covers key aspects of the methods used to manufacture pelareorep and is expected to provide intellectual property protection into 2044.

SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today announced the appointment of Steve Glover to its Board of Directors and the promotion of John McAdory to Chief Operating Officer (“COO”). Mr. Glover brings significant public company leadership and transaction experience to Oncolytics, including serving as Chairman of Ambrx Biopharma during its acquisition by Johnson & Johnson in a transaction valued at approximately $2 billion.

SAN DIEGO, June 01, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, today announced initial data from a preclinical study evaluating pelareorep in combination with RAS inhibitor modalities in a solid tumor model, which demonstrate evidence of greater anti-tumor activity in combination than with the individual approaches alone. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.

Translational data demonstrate induction of both innate and adaptive antiviral and anti-tumor specific immune responses capable of controlling tumor growth

Oncolytics Biotech, Inc. (NASDAQ:ONCY) shares are up on Monday as the company reported promising durability data for its investigational immunotherapy, pelareorep, in treating metastatic colorectal cancer.

2L KRAS-Mutant MSS mCRC Demonstrates ~3–4x Improvement in Duration of Response vs. Historical 4–6 Month Benchmark Company Engaged with FDA to Support Potential Accelerated Approval Pathway in 2L RAS-Mutant MSS mCRC SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced new durability data in metastatic colorectal cancer (“mCRC”), demonstrating meaningful and sustained clinical benefit in patients with RAS-mutant, microsatellite-stable (“MSS”) disease.

Company to leverage strong durability and survival data in second-line and later metastatic squamous cell anal carcinoma Pivotal study expected to focus on patients in a post-standard-of-care patient population with no FDA-approved therapies SAN DIEGO, April 27, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced that a Type C meeting with the U.S. Food and Drug Administration (“FDA”) has resulted in alignment on the design of a pivotal clinical study to support approval of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal (“SCAC”). “We want to thank the FDA for its very clear guidance and helping us create an efficient pathway for pelareorep in a disease that is desperate for new treatments,” said Jared Kelly, Chief Executive Officer of Oncolytics.

Oncolytics is narrowing Pelareorep development toward anal cancer and metastatic colorectal cancer, making its bull case more concrete. Pelareorep may turn “cold” tumors “hot,” potentially improving chemotherapy and checkpoint inhibitor responses across GI cancers. CRC data showed an unusually high 33% ORR versus 6%-11% historical SoC. This is why it received the FDA's Fast Track designation.