Announcement • Jul 27
Oncolytics Biotech Inc Announces Notice of Non-Compliance with Nasdaq Listing Requirements On July 20, 2026, Oncolytics Biotech Inc. received a letter (the Letter) from the Nasdaq Listing Qualifications Staff (the Staff) of The Nasdaq Stock Market LLC (Nasdaq) notifying the Company that its common stock, $0.001 par value per share (the Common Stock) had closed below $1.00 per share for 30 consecutive business days and, as a result, the Company was not in compliance with the $1.00 minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement). This Letter has no immediate effect on the listing of the Company's Common Stock which will continue to trade on the Nasdaq Capital Market under the symbol ONCY, subject to the Company's compliance with the other Nasdaq listing requirements. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided a compliance period of 180 calendar days from the date of the Letter, or until January 19, 2027 (the Compliance Period), to regain compliance with the Minimum Bid Price Requirement. If at any time during the Compliance Period, the closing bid price of the Company's Common Stock is at least $1.00 per share for a minimum of ten consecutive business days (unless the Nasdaq staff exercises its discretion to extend this ten business day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H)), Nasdaq will provide the Company written confirmation of compliance with the Minimum Bid Price Requirements, and the matter will be closed. If the Company does not regain compliance during the Compliance Period, the Company may be eligible for an additional 180-calendar day period to regain compliance with the Minimum Bid Price Requirements, provided that it meets the applicable market value of publicly held shares requirement for continued listing and all other applicable standards for initial listing on the Nasdaq Capital Market (except the Minimum Bid Price Requirement), and notifies Nasdaq of its intent to cure the deficiency. If Nasdaq determines that the Company is not eligible for an additional 180 calendar days compliance period or the Company will not be able to cure the deficiency with the Minimum Bid Price Requirement within the allotted compliance period, the Company's stock will be subject to delisting. The Company intends to monitor the closing bid price of the Common Stock and assess its available options to regain compliance with the Minimum Bid Price Requirement and continue listing on the Nasdaq Capital Market. There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other applicable Nasdaq listing rules. Announcement • Jul 20
Oncolytics Biotech Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer Oncolytics Biotech Inc. issued a press release announcing pelareorep in combination with a checkpoint inhibitor was granted Fast Track Designation from the U.S. Food and Drug Administration for the treatment of patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal who 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. The designation provides opportunities for more frequent interactions with the FDA throughout development, rolling review of a future Biologics License Application, and eligibility for Priority Review, if applicable. The Company believes the designation further validates pelareorep's potential to address a significant unmet need in advanced SCAC and follows the positive feedback received during its April 2026 meeting with the FDA regarding a potential registrational development strategy for the program. Based on the FDA's feedback, Oncolytics believes it has a clear regulatory framework in place to advance pelareorep toward a pivotal study in this indication. The designation is supported by encouraging efficacy demonstrated in the Company's GOBLET study evaluating pelareorep in combination with a checkpoint inhibitor in patients with advanced SCAC whose disease had progressed following prior therapy. Previously reported clinical results demonstrated an objective response rate of approximately 30%, more than double historical response rates reported in this setting, a median duration of response of approximately 15.5 months versus 9.5 months, and 12-month overall survival rate of 82% compared to 45.7%. With checkpoint inhibitor plus chemotherapy now established as the first-line standard of care in SCAC, there remains no FDA-approved therapies for patients whose disease progresses following such treatment, representing a significant unmet medical need and an estimated U.S. commercial opportunity approaching $1 billion annually. Although checkpoint therapy is also approved as a single agent following progression or intolerance to platinum-based chemotherapy alone, no checkpoint inhibitor has been approved for patients who progress after receiving the current first-line standard of care regimen. The Fast Track designation in SCAC is the third gastrointestinal cancer designation granted to pelareorep by the FDA, following designations in KRAS-mutated metastatic colorectal cancer in February 2026 and pancreatic cancer in late 2022. Together, these designations underscore pelareorep's potential to address significant unmet medical needs and further validate the Company's strategy of pursuing registration in high-value gastrointestinal cancer indications. Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. Clinical studies have demonstrated pelareorep's potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically cold tumors to hot through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal, anal, and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. Announcement • Jul 13
Oncolytics Biotech Reports Fda Regulatory Milestone and Clinical Progress in Randomized Ras-Mutant Mss Colorectal Cancer Trial Oncolytics Biotech Inc. 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. Based on these data, pelareorep has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for this indication. The multi-part randomized REO 033 study is designed to prospectively validate these encouraging findings against a contemporary control arm while advancing pelareorep toward a potential registration pathway. The Company continues to make rapid operational progress in Part A of REO 033 (n=60 patients), with approximately half of the planned clinical sites activated by the end of July, and more than 20 patients have been pre-identified across participating centers. The remaining sites are expected to be activated by the end of August, positioning the study for accelerated enrollment during the second half of 2026. The Company also announced that it will hold a Type D meeting with the FDA in the first half of August 2026 to discuss the registrational design for REO 033 through the addition of Part B of the study. Building on the currently enrolling Part A of the study, this new registration-directed Part B would preserve the core design elements of REO 033 while increasing enrollment and incorporating blinded independent central review to support both a potential accelerated approval and a traditional full approval within the same study. The Company intends to align with the FDA on a registrational pathway that preserves the operational efficiencies already established through REO 033 while maintaining continuity with the existing clinical program under a prospectively agreed regulatory framework. The Company believes this approach provides the opportunity to generate early randomized efficacy data from Part A while simultaneously positioning Part B as a potential registrational study without the need to initiate a separate registrational trial. It also expects to report an initial tumor response update from patients enrolled in Part A by year-end 2026 and, subject to FDA feedback, initiate enrollment in Part B of the study during the first quarter of 2027. REO 033 is a multi-part randomized controlled clinical trial evaluating pelareorep in combination with FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab alone in patients with second-line RAS-mutant, microsatellite stable metastatic colorectal cancer. The study is designed to confirm the encouraging efficacy signals observed in REO 022 while generating the controlled clinical data necessary to support future regulatory interactions and potential registration. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors to “hot” through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. 
