Every 8-K that Oncolytics Biotech, Inc. (ONCY) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ONCY and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ONCY filings page.
Oncolytics Biotech Inc. (ONCY) reported that preclinical data show its investigational immunotherapy pelareorep maintained antitumor activity when combined with a pan-RAS inhibitor in a RAS-driven colorectal cancer model. During intensive dosing, pelareorep, the RAS inhibitor, and their combination each reduced tumor growth versus control, with the largest reductions in the RAS inhibitor and combination groups, and no evidence of antagonism between the two therapies.
When pelareorep dosing was reduced to once weekly, its incremental activity became less evident, leading the company to pursue additional preclinical work to optimize dosing schedules and further characterize pelareorep’s contribution to RAS inhibitor combinations. Pelareorep has been given to over 1,200 patients and is being advanced in metastatic gastrointestinal cancers, where it has received FDA Fast Track designation in colorectal, anal, and pancreatic cancer.
Oncolytics Biotech Inc. reported that the U.S. FDA has provided written feedback on the design of a potential pivotal Part B expansion of REO 033, a randomized study of pelareorep in second-line RAS-mutant, microsatellite stable metastatic colorectal cancer. The feedback gives what the company views as important alignment on using objective response rate and duration of response to support a potential accelerated approval pathway, with progression-free survival to support full approval. REO 033 was designed with an initial randomized Part A and a potential pivotal Part B. Part A, with 60 patients, will generate the data that inform whether to launch Part B. Based on the FDA’s feedback, Oncolytics plans to begin Part B start-up activities as soon as positive interim Part A data are available and to pursue an End-of-Phase meeting to finalize key elements of the registration program for pelareorep in colorectal cancer.
Oncolytics Biotech Inc. reported receiving a letter from Nasdaq on July 20, 2026 stating that its common stock closed below $1.00 per share for 30 consecutive business days, causing non-compliance with Nasdaq Listing Rule 5550(a)(2), the Minimum Bid Price Requirement for the Nasdaq Capital Market.
The common stock will continue trading on the Nasdaq Capital Market under the symbol ONCY while the company has a 180-calendar day compliance period, until January 19, 2027, to regain compliance. Compliance will be restored if the closing bid price is at least $1.00 per share for a minimum of ten consecutive business days, subject to Nasdaq staff discretion. If compliance is not regained, the company may qualify for an additional 180 days if it meets other initial listing standards (except the minimum bid price) and notifies Nasdaq of its intent to cure; otherwise, the stock will be subject to delisting. The company plans to monitor its share price and evaluate options but notes there is no assurance it will regain compliance or satisfy all Nasdaq rules.
Oncolytics Biotech Inc. reported that the U.S. Food and Drug Administration granted Fast Track designation to pelareorep plus a checkpoint inhibitor for patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal after one or more prior systemic therapies.
The designation, the third Fast Track in gastrointestinal cancers for pelareorep, provides more frequent FDA interactions, rolling Biologics License Application review and potential Priority Review. It is supported by GOBLET study results showing an objective response rate of about 30%, median response duration of 15.5 months, and 82% 12‑month overall survival, in a U.S. market approaching $1 billion annually with no FDA‑approved therapies for patients whose disease progresses after first‑line treatment.
Oncolytics Biotech Inc. reports clinical and regulatory progress for REO 033, a randomized study of pelareorep plus FOLFIRI and bevacizumab for second-line RAS-mutant, microsatellite stable metastatic colorectal cancer. REO 033 builds on the earlier REO 022 trial, which more than doubled historical benchmarks across several efficacy measures, leading to FDA Fast Track designation.
Part A of REO 033 enrolls 60 patients, with about half of planned clinical sites expected to be activated by the end of July 2026 and more than 20 patients pre-identified. Oncolytics plans a Type D meeting with the FDA in the first half of August 2026 to discuss adding a registration-directed Part B designed to support potential accelerated and traditional full approval within the same study. The company expects an initial tumor response update from Part A by year-end 2026 and, subject to FDA feedback, aims to begin enrollment in Part B in the first quarter of 2027.
Oncolytics Biotech Inc. changed its independent auditor, disengaging Ernst & Young LLP and appointing Baker Tilly US, LLP for the 2026 fiscal year, subject to Baker Tilly completing its client acceptance procedures. The company states this change is related to its corporate restructuring.
EY’s audit reports on the financial statements for the years ended December 31, 2025 and December 31, 2024 contained no adverse or disclaimed opinions and were not qualified or modified, other than an explanatory paragraph about Oncolytics Biotech’s ability to continue as a going concern. The company reports no disagreements with EY and no reportable events under Item 304(a) of Regulation S-K, and also notes that it did not consult Baker Tilly on accounting or auditing issues before this engagement.
Oncolytics Biotech Inc. filed an 8-K to share that the U.S. Patent and Trademark Office has issued a new patent covering key aspects of its proprietary manufacturing process for pelareorep. This patent is expected to protect commercial-scale production of the investigational immunotherapy into 2044 and strengthens the company’s intellectual property portfolio.
The company also highlighted a previously filed method-of-use patent application for pelareorep as an immunotherapy that, if granted, is expected to provide protection into 2046, and it plans additional patent filings in 2026. Pelareorep has shown encouraging results in multiple pancreatic, metastatic breast, anal, and colorectal cancer studies and has received Fast Track designation from the FDA for colorectal and pancreatic cancer.
Oncolytics Biotech Inc. announced leadership changes, appointing John McAdory as Chief Operating Officer and adding Steve Glover to its Board of Directors. McAdory, age 49, previously led clinical operations roles at CG Oncology, SillaJen, UCB, and Amgen, and will oversee clinical, preclinical, and development activities as well as strategic partnerships.
Glover, age 66, becomes the ninth director and received an option to purchase 96,000 common shares, vesting in three equal annual installments of 32,000 shares starting one year after June 1, 2026. He brings more than 35 years of biopharma leadership, including chairing Ambrx Biopharma through its approximately $2 billion acquisition by Johnson & Johnson and co-founding Coherus BioSciences. The company emphasizes these appointments as supporting advancement of pelareorep, its investigational immunotherapy platform.
Oncolytics Biotech Inc. filed an 8-K after issuing a press release about early preclinical results for its immunotherapy pelareorep used with RAS inhibitor modalities in a solid tumor model. The combination showed greater anti-tumor activity than either approach alone, supporting further evaluation.
The company plans additional preclinical studies in pancreatic ductal adenocarcinoma and colorectal cancer models, including combinations with KRAS G12C and pan-RAS inhibitors and other next-generation RAS-pathway agents. Full results from these initial studies are expected to be presented in the fall or winter of 2026.
Oncolytics Biotech Inc. is highlighting new translational data on its investigational immunotherapy pelareorep at the 2026 American Society of Clinical Oncology Annual Meeting. The data come from the GOBLET phase 1/2 gastrointestinal cancer trial and the AWARE-1 window-of-opportunity breast cancer study.
Across studies, pelareorep treatment was associated with a multi-step immune activation process: antiviral signaling in tumors, expansion of virus-specific T cells, and subsequent activation of tumor‑specific T cells linked to tumor regression signals. In pancreatic cancer, expansion of pre‑existing tumor‑infiltrating lymphocyte clones in blood correlated with reductions in tumor volume, including mutant KRAS‑specific T‑cell responses.
In breast cancer, serial biopsies showed increased antiviral and immune gene expression, toll‑like receptor 3 activation, CXCL13 induction, and tertiary lymphoid structure formation. AWARE‑1 reported that combining pelareorep, letrozole, and atezolizumab led to 60% of patients achieving at least a 30% increase in CelTIL score, a measure associated with favorable outcomes.
Oncolytics Biotech Inc. reported new clinical data from its REO 022 study in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer. Pelareorep-based combination therapy achieved a 19.5‑month median duration of response, compared with historical benchmarks of about 4–6 months in this setting.
The regimen of pelareorep, bevacizumab, and FOLFIRI showed a 33% objective response rate, versus 6–11% reported for standard care. The company is enrolling a randomized Phase 2 trial in this population and is actively engaged with the FDA to discuss a potential accelerated approval pathway based on response durability and time‑to‑event endpoints.
Oncolytics Biotech Inc. reported that a recent Type C meeting with the U.S. Food and Drug Administration resulted in alignment on the design of a pivotal randomized controlled study of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal.
The planned single pivotal trial is expected to enroll patients whose disease has progressed after standard chemotherapy and checkpoint inhibitor treatment, a setting with no FDA-approved therapies. The study is being structured so accelerated approval and full approval could be pursued at different points using multiple endpoints.
Oncolytics highlighted prior data in second-line and later anal cancer, where pelareorep plus a checkpoint inhibitor showed a median response duration of 15.5 months versus 9.5 months and 12‑month survival of 82% versus 45.7% compared with current standard care. Pelareorep is also being developed in colorectal and pancreatic cancers, where it has FDA Fast Track designation.
Oncolytics Biotech Inc. entered into an Open Market Sale Agreement with Jefferies LLC to sell shares of common stock with an aggregate offering price of up to $75.0 million through an at-the-market program.
Sales will be made from time to time under the company’s effective Form S-3 shelf registration, with Jefferies acting as agent or principal and earning a commission of up to 3.0% of gross proceeds. The company plans to use any net cash raised to fund clinical development of pelareorep, related research and development, operating costs, working capital and general corporate purposes.
Oncolytics Biotech Inc. has scheduled a Type C meeting with the U.S. FDA on April 16, 2026 to discuss a potential single-arm registrational study of pelareorep plus a checkpoint inhibitor in second-line and later squamous cell anal carcinoma (SCAC).
The company plans to propose a pivotal trial enrolling approximately 60–70 patients, using objective response rate as the primary endpoint to support potential full approval. In Cohort 4 of the GOBLET study, pelareorep plus a checkpoint inhibitor achieved an approximately 30% objective response rate and a median duration of response of 17 months in late-line SCAC, compared with real-world response rates of about 10–14% and a median duration of response of roughly 9.5 months.
Oncolytics highlights SCAC as a rare cancer with limited second-line and later treatment options and notes external estimates of about 54,000 anal cancer cases globally each year, with the anal cancer market projected to reach $2.3 billion by 2035.
Oncolytics Biotech Inc. has completed a two-step redomestication, moving its jurisdiction of incorporation from Alberta to British Columbia and then, on March 31, 2026, to Nevada, while keeping its name and Nasdaq listing under the ticker ONCY.
Each outstanding share automatically became one share of Nevada common stock with a $0.001 par value, and a new CUSIP (68237V 103) and ISIN (US68237V1035) now apply. The company adopted new Nevada Articles of Incorporation and Bylaws, entered into indemnification and advancement agreements with directors and executive officers, and designated Nevada and U.S. federal courts as exclusive forums for certain claims.
In connection with the move, the board approved a new 2026 Incentive Award Plan with 6,500,000 shares available plus additional shares from prior plans and an annual increase formula through 2036, while closing prior equity plans to new awards. New risk factors highlight that Nevada law and the governing documents may reduce stockholder rights and make corporate disputes and changes in control more difficult.
Oncolytics Biotech Inc. has completed the first step of its planned two-step redomestication by changing its jurisdiction of incorporation from Alberta to British Columbia, Canada, via a statutory continuance under the ABCA and BCBCA. Shareholders approved the continuance and subsequent U.S. domestication at a special meeting held on January 15, 2026.
All outstanding common shares remain outstanding as common shares of the British Columbia entity, with no change to the company’s name or Nasdaq ticker, which continues as ONCY. The current CUSIP (682310875) and ISIN (CA6823108759) remain in place until the expected second step, when the company plans to domesticate to Nevada on March 31, 2026. Effective April 1, 2026, the CUSIP is expected to change to 68237V103 and the ISIN to US68237V1035 while the stock continues trading on Nasdaq as common stock of a Nevada corporation.
Oncolytics Biotech Inc. reported that two new scientific abstracts featuring its investigational immunotherapy pelareorep have been accepted for presentation at the AACR 2026 Annual Meeting. The data come from the GOBLET study in metastatic pancreatic cancer and the AWARE-1 study in early-stage breast cancer.
GOBLET biomarker analyses suggest that adding pelareorep to atezolizumab and chemotherapy can shift pancreatic tumors toward a more immune-active state, with patients showing immune activation signatures experiencing longer progression-free survival and previously reported higher response rates than with chemotherapy alone. AWARE-1 data show pelareorep can drive coordinated anti-tumor immune responses and tertiary lymphoid structure formation, potentially turning immunologically “cold” breast tumors into more treatment-responsive “hot” tumors, supporting pelareorep as an immune-priming backbone for combination therapies across multiple tumor types.
Oncolytics Biotech Inc. filed an 8-K to highlight the launch of REO 033, a randomized Phase 2 study in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer. Patients will receive either standard bevacizumab plus FOLFIRI or an experimental combination adding pelareorep, with about 30 patients in each arm.
The primary goal is to measure objective response rate, with progression-free survival, overall survival, safety, and biomarker data as additional endpoints. The trial is sponsored by Oncolytics and led by Dr. Sanjay Goel at Rutgers Cancer Institute of New Jersey, with first sites expected to open soon and preliminary data targeted by the end of 2026.
The filing notes earlier REO 022 data in a similar population, where pelareorep-based therapy showed longer median survival and higher response rates than standard care, and that the pelareorep regimen recently received FDA Fast Track Designation in second-line KRAS-mutant MSS metastatic colorectal cancer.
Oncolytics Biotech Inc. is shifting its development strategy to focus on registrational and registration-enabling studies of its immunotherapy pelareorep in squamous cell anal cancer and metastatic colorectal cancer. The company has concluded enrollment in its GOBLET gastrointestinal cancer study, having obtained sufficient clinical and translational data to guide next steps.
Oncolytics plans a mid-April meeting with the U.S. Food and Drug Administration to align on a single-arm registrational study in second-line and later anal cancer, which it believes could enroll well under 100 patients. To concentrate resources and manage spending, the company will wind down GOBLET by stopping new enrollment in the metastatic pancreatic cancer cohorts at approximately 20 patients per arm while continuing to follow existing participants. Management states it has sufficient cash on hand to execute near-term milestones and expects to avoid immediate material dilution.
Oncolytics Biotech Inc. filed a report stating that on February 4, 2026 it issued a press release announcing that the U.S. Food and Drug Administration granted Fast Track Designation for a drug combination including pelareorep, bevacizumab, leucovorin, fluorouracil, and irinotecan (FOLFIRI) in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer.
The company also states that this report, including the press release attached as Exhibit 99.1, is incorporated by reference as an exhibit to its Registration Statement on Form F-3 (File No. 333-289819).
Oncolytics Biotech Inc. held a Special Meeting of Shareholders on January 15, 2026, where investors voted on key corporate changes. Shareholders representing 17,596,480 common shares, or 16.35% of the 107,606,376 shares outstanding as of the December 9, 2025 record date, were present or represented by proxy.
Investors approved a special resolution to continue the company from the Province of Alberta to the Province of British Columbia, and another special resolution to then domesticate the company from British Columbia to the State of Nevada in the United States. They also approved the Oncolytics Biotech Inc. 2026 Incentive Award Plan, each proposal receiving more votes for than against.
The company later issued a press release announcing these results, which has been filed as an exhibit and incorporated by reference into its Form F-3 registration statement.
Oncolytics Biotech, Inc. filed a current report to disclose leadership changes. The company announced that John McAdory has been appointed as Executive Vice President of Strategy and Operations and Yujun Wu has been appointed as Vice President, Head of Biostatistics, signaling additions to its senior management team.
The company also states that this report on Form 8-K, including the attached press release, is incorporated by reference as an exhibit to its Registration Statement on Form F-3 (File No. 333-289819). No financial results or major transactions are described in this report.
Oncolytics Biotech, Inc. filed a Form 8-K to highlight two recent developments related to its cancer therapy pelareorep. On January 8, 2026, the company issued a press release describing updates to its intellectual property portfolio and efforts to extend patent protection for pelareorep as part of its long-term value and development strategy. On January 12, 2026, it released updated clinical data from the GOBLET Cohort 4 study, which showed activity of pelareorep combined with atezolizumab in third-line anal cancer.
The company is also using this report, including the two press releases attached as Exhibits 99.1 and 99.2, as an exhibit to its existing shelf Registration Statement on Form F-3. This helps ensure that the patent and clinical updates are formally included in the broader disclosure framework the company uses for potential future securities offerings.