Oncolytics Biotech (ONCY) details FDA meeting and registrational plan for REO 033 colorectal cancer trial

Rhea-AI Filing Summary

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.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Part A Enrollment: 60 patients Pre-identified patients: more than 20 patients FDA Meeting Timing: first half of August 2026 +3 more

6 metrics

Part A Enrollment 60 patients Part A of REO 033 is designed to enroll 60 patients (n=60).

Pre-identified patients more than 20 patients More than 20 patients have been pre-identified across participating centers for REO 033.

FDA Meeting Timing first half of August 2026 A Type D meeting with the FDA is planned for the first half of August 2026.

Initial tumor response update year-end 2026 An initial tumor response update from Part A is expected by year-end 2026.

Part B Enrollment Target first quarter of 2027 Subject to FDA feedback, enrollment in Part B is targeted to start in the first quarter of 2027.

Fast Track designation colorectal cancer indication Pelareorep has received Fast Track designation from the FDA for this colorectal cancer indication.

Key Terms

Type D meeting, Fast Track designation, accelerated approval, blinded independent central review, +2 more

6 terms

Type D meeting regulatory

"Company to hold Type D meeting with FDA to discuss a potential registrational pathway"

Fast Track designation regulatory

"pelareorep has received Fast Track designation from the U.S. Food and Drug Administration"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

accelerated approval regulatory

"Part B will be a randomized study designed to support potential accelerated and full approval"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

blinded independent central review regulatory

"incorporating blinded independent central review to support both a potential accelerated approval"

Blinded independent central review is a quality-control step in clinical trials where outside medical experts, who do not know which patients received the experimental therapy, re-examine key measurements (like scans or lab results) to prevent bias. Think of it as neutral referees watching game footage without knowing the teams, which gives investors greater confidence that the trial results are fair, more reliable for regulators, and less likely to be overturned or disputed.

microsatellite stable medical

"patients with Rat Sarcoma (“RAS”)-mutant, microsatellite stable (“MSS”) metastatic colorectal cancer"

Microsatellite stable describes a tumor whose short, repeating DNA sequences (microsatellites) show few or no errors, meaning the cancer’s internal “spell-check” system is largely intact. For investors, this matters because microsatellite stability is a biomarker that helps predict how likely a tumor is to respond to certain therapies and clinical trials, affecting drug development prospects, regulatory decisions, and the size of the potential patient market.

tumor-infiltrating lymphocytes medical

"resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes"

Tumor-infiltrating lymphocytes are immune cells that have moved from the blood into a tumor and are actively interacting with cancer cells. For investors, they matter because their presence and activity can signal how well a patient’s immune system — or an immune-based drug — is likely to fight the tumor, and they are also the basis for a personalized cell therapy approach where these cells are grown and returned to the patient, affecting clinical trial outcomes and commercial potential.

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FAQ

What did Oncolytics Biotech (ONCY) announce regarding the REO 033 trial?

Oncolytics Biotech announced clinical and regulatory progress for REO 033, a randomized study of pelareorep plus FOLFIRI and bevacizumab in RAS-mutant MSS metastatic colorectal cancer, and outlined plans to transition the trial toward a potential registrational pathway.

What is the design and size of Part A of the REO 033 study for ONCY?

Part A of REO 033 is a randomized controlled study with 60 patients (n=60). About half of planned clinical sites are expected to be activated by the end of July 2026, with more than 20 patients already pre-identified across participating centers.

What FDA interactions did Oncolytics Biotech (ONCY) disclose for REO 033?

Oncolytics plans to hold a Type D meeting with the FDA in the first half of August 2026. The goal is to discuss adding Part B to REO 033 as a registration-directed component supporting potential accelerated and full approval in the same study.

How does REO 033 relate to the earlier REO 022 study for Oncolytics Biotech (ONCY)?

REO 033 is designed to prospectively validate REO 022 results, which more than doubled historical standard-of-care benchmarks for key efficacy endpoints. Based on these data, pelareorep received Fast Track designation from the FDA for this colorectal cancer indication.

What future milestones did Oncolytics Biotech (ONCY) outline for REO 033?

Oncolytics expects an initial tumor response update from Part A by year-end 2026. Subject to FDA feedback, the company aims to initiate enrollment in registration-directed Part B of REO 033 during the first quarter of 2027, maintaining continuity with the existing trial infrastructure.

FALSE0001129928A000011299282026-01-082026-01-08

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

___________________________________

FORM 8-K

___________________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 13, 2026

___________________________________

Oncolytics Biotech Inc.

(Exact name of registrant as specified in its charter)

___________________________________

Nevada (State or other jurisdiction of incorporation)			001-38512 (Commission File Number)						98-0541667 (IRS Employer Identification No.)
4350 Executive Drive, Suite 325 San Diego, CA 92121						92121
(Address of principal executive offices)						(Zip Code)
(403) 670-7377
(Registrant's telephone number, including area code)
N/A
(Former name or former address, if changed since last report)

___________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class			Trading Symbol(s)			Name of each exchange on which registered
Common stock, par value $0.001 per share			ONCY			The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Exchange Act (§240.12b-2 of this chapter).

Emerging growth company    ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01. Other Events.

On July 13, 2026, Oncolytics Biotech Inc. (the “Company”) issued a press release announcing certain updates and progress relating to the REO 033 study. The Company will also hold a Type D meeting with the U.S. Food and Drug Administration to discuss plans for registrational expansion and other study design elements. The information set forth in this Item 8.01 and in Exhibit 99.1 is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.						Description
99.1						Press Release issued by Oncolytics Biotech Inc., dated as of July 13, 2026.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: July 13, 2026

ONCOLYTICS BIOTECH INC.
By:			/s/ Kirk Look
Name:			Kirk Look
Title:			Chief Financial Officer

Oncolytics Biotech® Reports FDA Regulatory Milestone and Strong Clinical Progress in Randomized RAS-Mutant MSS Colorectal Cancer Trial

Half of planned clinical sites will be activated this month; more than 20 patients have been pre-identified across participating centers

Company to hold Type D meeting with FDA to discuss a potential registrational pathway through the addition of Part B to the existing REO 033 trial design

Part B will be a randomized study designed to support potential accelerated and full approval

SAN DIEGO, CA, July 13, 2026 – Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today 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.1-4 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. Most recently, global lead principal investigator Dr. Sanjay Goel and his team opened enrollment at Rutgers Cancer Institute of New Jersey.

“The magnitude and durability of the efficacy observed in REO 022 warrant earnest evaluation in a randomized setting,” said Dr. Sanjay Goel, Global Lead Principal Investigator for REO 033 and Professor of Medicine and Director of the Phase I Program at Rutgers Cancer Institute of New Jersey. “It is encouraging to see REO 033 expanding rapidly across leading academic centers, and I believe this study has the potential to further define the role of pelareorep in RAS-mutant MSS metastatic colorectal cancer.”

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.

“Launching a global randomized study with multiple high-quality sites in a short period of time reflects the operational capabilities of our clinical organization and our investigators,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Just as importantly, our ongoing interactions with the FDA have enabled us to focus on efficiently transitioning REO 033 into a registration-directed program built upon the existing trial infrastructure. We believe this strategy has the potential to significantly reduce development timelines while maintaining scientific rigor as we work to bring a much-needed immunotherapeutic option to patients in a treatment landscape that desperately needs innovation.”

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.

About REO 033

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 (link to study on ClinicalTrials.gov). 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.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. 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. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on LinkedIn and on X @oncolytics.

References

1.Goel S, et al. Elucidation of Pelareorep Pharmacodynamics in A Phase I Trial in Patients with KRAS-Mutated Colorectal Cancer. Mol Cancer Ther. 2020 May;19(5):1148-1156. doi: 10.1158/1535-7163.MCT-19-1117.

2.FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C–mutated colorectal cancer. Published June 21, 2024. Accessed April 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-cetuximab-kras-g12c-mutated-colorectal-cancer

3.Bennouna J. Lancet Oncol (14):29-37, 2013

4.Iwamoto S. Ann Oncol. Jul;26(7):1427-33, 2015

Forward-looking statements

This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-

looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies, its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers; the expansion, data, and progress of the randomized REO 033 study; the activation of clinical sites; and plans for future disclosure of clinical trial results. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.

Company Contact

Jon Patton

Director of IR & Communication

jpatton@oncolytics.com

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 17.5 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT 1.8 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT 21.1 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT 12.2 KB