Welcome to our dedicated page for ONCOLYTICS BIOTECH SEC filings (Ticker: ONCY), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Oncolytics Biotech filings document a clinical-stage oncology company developing pelareorep and reporting material events through Form 8-K disclosures. Recent filings cover pelareorep study updates in metastatic colorectal cancer and squamous cell anal carcinoma, FDA-related development communications, translational data presented from GOBLET and AWARE-1, and incorporation of certain exhibits into a Form F-3 registration statement.
The company's regulatory record also documents capital-structure matters, including Nasdaq-listed ONCY common stock and an open-market sale agreement, as well as corporate-status changes tied to its completed continuance and domestication from Canadian jurisdictions to Nevada. These filings describe governance approvals, registered securities, financing arrangements, and oncology development disclosures for the issuer.
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 a larger net loss as it advanced its immunotherapy pelareorep and expanded corporate activities. For the three and six months ended June 30, 2026, net losses were $9,442 and $18,685 versus $5,277 and $9,988 in 2025, driven by higher research and development and general and administrative expenses. R&D reached $8,814 and G&A $9,846 for the six‑month period as the company launched a randomized Phase 2 second‑line metastatic colorectal cancer trial and prepared potential registrational work in anal cancer. Cash and cash equivalents were $4,115, with operations funded mainly through at‑the‑market equity sales raising $14,385 in net proceeds. Management states that current resources, even with equity distribution capacity, are not sufficient to fund planned operations for 12 months, and discloses substantial doubt about the ability to continue as a going concern, indicating a need for additional financing or strategic arrangements.
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 Chief Operating Officer John Bearden reported holding stock options linked to 500,000 Common Shares. These options have an exercise price of $0.97 per share and expire on January 12, 2031. The option vests 50% on January 12, 2027, 25% on January 12, 2028, and 25% on January 12, 2029, subject to his continued service or employment on each vesting date.
ONCOLYTICS BIOTECH INC director Wayne Pisano received a grant of stock options for 30,000 common shares. The options were granted at an exercise price of $1.06 per share, which equals the closing price of the company’s common stock on June 1, 2026.
The options vest in three equal annual installments, with the first tranche vesting on June 1, 2027, as long as Pisano continues in service or employment on each vesting date. After this grant, he holds 30,000 stock options directly under this award.