ONCY

Pelareorep-driven changes in the tumor microenvironment are associated with tumor responses and shrinkage Immune activation levels more than doubled in nearly all patients after one cycle of treatment Substantial increases in HPV-16-specific T cells and tumor-infiltrating lymphocytes observed when pelareorep is combined with a checkpoint inhibitor SAN DIEGO, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced new translational data from an ongoing study showing pelareorep's ability to increase human papillomavirus (“HPV”)-16-specific T cell clones and tumor-infiltrating lymphocyte (“TIL”) clones in second-line or later squamous cell anal cancer (“SCAC”) patients at the Society for Immunotherapy of Cancer (“SITC”) 2026 Annual Meeting. Pelareorep combined with a checkpoint inhibitor generated promising efficacy signals in second-line or later SCAC, including more than doubling the objective response rate and increasing median duration of response by 50% compared to the current approved therapy in that patient population.

Oncolytics announced durability and survival data in anal cancer from GOBLET study, with 100% of responding patients survived for longer than one year.

SAN DIEGO, Oct. 20, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced the Company is presenting a trial-in-progress abstract and e-poster discussing the REO 033 study at the European Society for Medical Oncology (“ESMO”) Congress 2026. REO 033 is a randomized study evaluating pelareorep in combination with folinic acid, fluorouracil, and irinotecan (“FOLFIRI”) and bevacizumab versus standard-of-care FOLFIRI and bevacizumab as second-line treatment for RAS-mutant, microsatellite-stable (“MSS”) metastatic colorectal cancer (“mCRC”) patients (link to study on ClinicalTrials.gov).

Completion of enrollment earlier this year and expected final PanCAN grant payment this quarter mark successful completion of a key phase of Cohort 5 Final Cohort 4 results expected in Q4 2026; initial Cohort 5 results expected in the first half of 2027 The Company will use the clinical data to focus and guide its strategy to combine pelareorep with a checkpoint inhibitor in gastrointestinal and additional tumors SAN DIEGO, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced an update regarding the status of its GOBLET Phase 1/2 study, including timing for the release of certain clinical data. It also declared that it will receive the final payment under its grant from the Pancreatic Cancer Action Network (“PanCAN”) later this quarter, following the completion of certain activities in Cohort 5 of the study.

New method of use patent covering pelareorep as an immunotherapy for cancer has been issued in several countries, with U.S. issuance expected in the near term Three patent applications are pending, including two method of use with one expected to be converted to a Track One application this quarter Company expects to add a new composition of matter patent covering “next generation” pelareorep SAN DIEGO, Oct. 12, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today provided an update on its intellectual property strategy, outlining progress on new method of use patents and plans to expand its portfolio with composition of matter protection for a modified “next generation” pelareorep. These initiatives build on the Company's existing manufacturing patent protection through 2044 and are intended to extend protection for specified therapeutic uses and future innovations into the late 2040s, subject to patent issuance and applicable patent terms.

SAN DIEGO, Sept. 29, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced data published in the Proceedings of the National Academy of Sciences show pelareorep's ability to change an immunologically inactive liver cancer tumor microenvironment into one that is immunologically active and potentially susceptible to immune-based therapy.

Substantially all planned REO 033 clinical sites are now activated, with multiple patients currently on study Company expects to have sufficient Part A data to provide an interim clinical update by year-end 2026 FDA alignment provides potential path to accelerated approval based on objective response rate and full approval based on progression-free survival SAN DIEGO, Sept. 28, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced continued clinical and operational progress in REO 033, its randomized study evaluating pelareorep in second-line RAS-mutant, microsatellite-stable (“MSS”) metastatic colorectal cancer (“mCRC”).

Oncolytics announced positive preclinical results evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model.

FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full approval Pivotal expansion to follow initial clinical data from the ongoing randomized Part A SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design of a potential pivotal Part B expansion of REO 033, the Company's ongoing randomized study evaluating pelareorep in second-line RAS-mutant, microsatellite stable (“MSS”) metastatic colorectal cancer (“REO 033”). The Company submitted a Type D meeting request to the FDA regarding the potential expansion of REO 033 into a pivotal study.

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.