Oncolytics Biotech

ONCY

Market cap $108M

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.

SAN DIEGO, April 06, 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 it has scheduled a Type C meeting with the U.S. Food and Drug Administration (“FDA”) on April 16, 2026, to discuss a potential registrational development path in anal cancer. The meeting will focus on the potential to initiate a single-arm pivotal study evaluating pelareorep in combination with a checkpoint inhibitor in patients being treated with second-line and later therapy for squamous cell anal carcinoma (“SCAC”).

SAN DIEGO, April 01, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced the completion of the previously announced change in the jurisdiction of incorporation of Oncolytics from the Province of Alberta in Canada to the State of Nevada in the United States (the “Domestication”) through a series of transactions in which the Company first continued its existence from the Province of Alberta in Canada to the Province of British Columbia in Canada on March 17, 2026. The Company will retain its office in Calgary, while the San Diego office will become the Company's new headquarters.

Pelareorep treatment drives coordinated immune activation and tertiary lymphoid structure formation  Translational data suggest potential to boost response to immunotherapy and targeted therapy in RAS-driven tumors Pelareorep's ability to engage the innate and adaptive immune system results in doubling or nearly tripling response rates in breast and gastrointestinal cancers SAN DIEGO, March 19, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced two abstracts across distinct tumor types were accepted for presentation at the American Association for Cancer Research (“AACR”) Annual Meeting 2026, at the San Diego Convention Center from April 17-22, 2026. Pelareorep is an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways via double‑stranded RNA signaling, driving interferon production, dendritic cell activation, and cytotoxic T‑cell priming.

Controlled study designed to confirm previous compelling efficacy with preliminary data expected by the end of 2026 Pelareorep-based treatment regimen recently granted Fast Track Designation in 2L KRAS-mutant MSS metastatic colorectal cancer, confirming its potential in this large indication SAN DIEGO, March 02, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced the initiation of a metastatic colorectal cancer (“mCRC”) Phase 2 study that will be referred to as REO 033. In this trial, second-line (“2L”) RAS-mutated (which includes KRAS), microsatellite-stable (“MSS”) mCRC patients will be randomized to a control arm of bevacizumab (Avastin®) and fluorouracil, leucovorin, irinotecan (“FOLFIRI”) or an experimental arm of pelareorep, bevacizumab, and FOLFIRI.

Company to wind down the GOBLET gastrointestinal study to focus on registration path in the U.S. With sufficient cash on hand to execute near-term milestones, the Company expects to avoid immediate material dilution SAN DIEGO, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has concluded enrollment in the GOBLET study, having generated the necessary clinical and translational data to inform its next phase of development. With sufficient cash on hand to execute near-term milestones, the Company will now focus its efforts and resources on registrational and registration-enabling studies in squamous cell anal cancer (“SCAC”) and metastatic colorectal cancer (“CRC”).

Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population