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Oncolytics preclinical RAS combo data in colorectal model

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.

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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.

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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, or exhibit attachments filed with this report.
Announcement date September 10, 2026 Date of press release and 8-K disclosure of pelareorep and pan-RAS inhibitor preclinical results
Patients treated with pelareorep Over 1,200 patients Total number of patients to whom pelareorep has been administered in clinical studies
Fast Track indications 3 cancers (colorectal, anal, pancreatic) Pelareorep has received FDA Fast Track designation for these gastrointestinal cancers
pan-RAS inhibitor medical
"evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven"
A pan-RAS inhibitor is a drug designed to block activity of the RAS family of proteins (such as KRAS, NRAS and HRAS) that often drive uncontrolled cell growth in cancers. For investors, it matters because a single medicine that works across multiple RAS types can address a larger group of patients and reduce the risk that a tumor will bypass the drug, much like cutting power to several faulty switches instead of just one.
pelareorep medical
"Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy"
Fast Track designation regulatory
"pelareorep has received Fast Track designation from the FDA for colorectal, anal,"
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.
tertiary lymphoid structures medical
"resulting in the formation of tertiary lymphoid structures and the expansion of"
Clusters of immune cells that form in non-lymph node tissues, acting like pop-up immune hubs where white blood cells gather, communicate and organize a local defense. They matter to investors because their presence or absence can change how a disease progresses and how well immunotherapies work, so they can serve as biomarkers or influence the commercial prospects and regulatory outlook of drugs and diagnostics.
tumor-infiltrating lymphocytes medical
"and the expansion of tumor-infiltrating lymphocytes. It has been administered to"
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.

FAQ

What did Oncolytics Biotech Inc. (ONCY) announce in this 8-K filing?
Oncolytics Biotech Inc. announced positive preclinical results showing that pelareorep maintained activity when combined with a pan-RAS inhibitor in a RAS-driven colorectal cancer model, with both the RAS inhibitor and the combination reducing tumor growth compared to control.

How did pelareorep perform with a pan-RAS inhibitor in the colorectal cancer model?
During intensive dosing every other day, pelareorep, the pan-RAS inhibitor, and their combination each reduced tumor growth versus control. The greatest reductions were in the RAS inhibitor and combination groups, and pelareorep activity was maintained without evidence of antagonism with RAS inhibition.

What are Oncolytics Biotech’s next steps for pelareorep and RAS inhibitors?
Oncolytics plans to expand preclinical evaluation of pelareorep with RAS inhibitors across additional dosing schedules and RAS-driven tumor models to further assess pelareorep’s contribution, including its potential impact on response depth, durability, and resistance to RAS-targeted therapy.

What is pelareorep, the therapy being developed by ONCY?
Pelareorep is an intravenously delivered, systemically active investigational immunotherapy that selectively replicates in tumor cells and activates innate and adaptive anti-tumor immune responses, including upregulation of inflammatory cytokines, formation of tertiary lymphoid structures, and expansion of tumor-infiltrating lymphocytes.

In which indications has pelareorep shown encouraging clinical results according to Oncolytics Biotech?
Pelareorep has shown 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, and is being advanced in metastatic gastrointestinal cancers.

What regulatory status does pelareorep have in gastrointestinal cancers?
Pelareorep has received Fast Track designation from the FDA for colorectal, anal, and pancreatic cancer in the metastatic gastrointestinal cancer setting, supporting its ongoing clinical development in these indications.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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): September 10, 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 September 10, 2026, Oncolytics Biotech Inc. (the “Company”) issued a press release announcing results from a preclinical study evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model. 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 September 10, 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: September 10, 2026
ONCOLYTICS BIOTECH INC.
By:
/s/ Kirk Look
Name:
Kirk Look
Title:
Chief Financial Officer





Oncolytics Biotech® Announces Positive Preclinical Results Combining Pelareorep with a Pan-RAS Inhibitor in Colorectal Cancer

Preclinical results demonstrate pelareorep activity is maintained in the presence of RAS inhibition

Findings support further evaluation of pelareorep’s potential to deepen and prolong responses to RAS-targeted therapy

SAN DIEGO, CA, September 10, 2026 – Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced positive preclinical results evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model.

During the initial treatment period, when pelareorep was administered every other day, pelareorep, the pan-RAS inhibitor and the combination each reduced tumor growth compared to the control. The greatest tumor reductions were observed in the RAS inhibitor and combination groups, demonstrating that pelareorep activity was maintained in the presence of RAS inhibition without evidence of antagonism between the two therapies.

Following the transition to less frequent weekly pelareorep dosing, the incremental activity associated with pelareorep became less evident. Together, these findings support further evaluation of optimized pelareorep dosing with RAS inhibitors and the hypothesis that sustained pelareorep activity could potentially deepen or prolong responses to RAS-targeted therapy and thereby delay the emergence of treatment resistance.

Importantly, the findings are consistent with previously published independent research demonstrating that RAS inhibitors do not interfere with the mechanism through which pelareorep selectively infects tumor cells. This biological compatibility provides a rationale for further evaluating whether pelareorep’s tumor-selective and immunologic activity can complement the direct antitumor effects of RAS inhibition and potentially delay the development of resistance.

“These results provide an encouraging first look at combining pelareorep with one of the most important emerging classes of targeted cancer therapies,” said Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics. “We observed pelareorep activity during the initial intensive dosing period as well as biologic compatibility between pelareorep and RAS inhibition, supporting the continued evaluation of pelareorep/RAS inhibitor combination therapy. Because acquired resistance remains a major limitation of RAS-targeted therapies, we believe these findings provide a compelling rationale to investigate whether sustained pelareorep activity can deepen and prolong responses to RAS inhibition and potentially delay the emergence of resistance. Similarly, pelareorep, because of its unique mechanism of action, may offer a treatment option for patients who become resistant to RAS inhibitors.”

Oncolytics plans to expand its preclinical evaluation of pelareorep with RAS inhibitors across additional dosing schedules and RAS-driven tumor models. These studies will be designed to further characterize pelareorep’s contribution to the combination, including its potential impact on the depth and durability of tumor response and the development of resistance to RAS-targeted therapy.

About Pelareorep


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. It has been administered to over 1,200 patients, and clinical studies have demonstrated pelareorep’s potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types.

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, anal, 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.


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 the potential benefits of combining pelareorep with RAS inhibitors; the potential ability of pelareorep to delay or help overcome resistance to RAS-targeted therapies; plans for additional preclinical studies involving RAS inhibitors; and the potential clinical development and commercialization of pelareorep. Preclinical results may not be predictive of results observed in clinical studies. Additional forward-looking statements include those 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; the Company’s belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; and the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers. 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




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