# EDGAR Filing Document

**Accession Number:** 0001129928
**File Stem:** 0001129928-26-000028
**Filing Date:** 2026-5
**Character Count:** 12228
**Document Hash:** 3aacee2739b271f05db8b16f739d42a0
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001129928-26-000028.hdr.sgml**: 20260504

**ACCESSION NUMBER**: 0001129928-26-000028

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20260504

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20260504

**DATE AS OF CHANGE**: 20260504

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ONCOLYTICS BIOTECH INC
- **CENTRAL INDEX KEY:** 0001129928
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 980541667
- **STATE OF INCORPORATION:** NV
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38512
- **FILM NUMBER:** 26934865

**BUSINESS ADDRESS:**
- **STREET 1:** SUITE 325, 4350 EXECUTIVE DRIVE
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121
- **BUSINESS PHONE:** 4036707377

**MAIL ADDRESS:**
- **STREET 1:** SUITE 325, 4350 EXECUTIVE DRIVE
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121

?xml version='1.0' encoding='ASCII'? oncy-20260504

**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): **May 4, 2026**

**___________________________________**

**Oncolytics Biotech Inc.**

(Exact name of registrant as specified in its charter)

**___________________________________**

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

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

---

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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&nbsp;&nbsp;&nbsp;&nbsp;☐

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. ☐

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**Item 8.01. Other Events.**

On May 4, 2026, Oncolytics Biotech Inc. (the "Company") issued a press release announcing certain updates from the REO 022 study in metastatic colorectal cancer. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated into this Item 8.01 by reference.

**Item 9.01. Financial Statements and Exhibits.**

(d) Exhibits.

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| | |
|:---|:---|
| <u>Exhibit No.</u> | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Description</u> |
| 99.1 | <u>[Press Release issued by Oncolytics Biotech Inc., dated as of](crcupdate.htm)[May](crcupdate.htm)[4](crcupdate.htm)[, 2026](crcupdate.htm)</u>. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

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**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: May 4, 2026

---

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

---

## Exhibit 99.1

**Oncolytics Biotech**<sup>®</sup> **Reports Durable Responses in Second-Line RAS-Mutant MSS Colorectal Cancer**

*2L KRAS-Mutant MSS mCRC Demonstrates ~3–4x Improvement in Duration of Response vs. Historical 4–6 Month Benchmark*

*Company Engaged with FDA to Support Potential Accelerated Approval Pathway in 2L RAS-Mutant MSS mCRC*

**SAN DIEGO, CA, May 4, 2026 –** Oncolytics Biotech<sup>®</sup> Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced new durability data in metastatic colorectal cancer ("mCRC"), demonstrating meaningful and sustained clinical benefit in patients with RAS-mutant, microsatellite-stable ("MSS") disease.

Pelareorep-based combination therapy demonstrated a 19.5-month median duration of response in second-line ("2L") KRAS-mutant MSS mCRC patients in the REO 022 study, compared to historical benchmarks of approximately 4–6 months in this setting.<sup>1</sup> Additional data from this study include an objective response rate of 33% for patients receiving pelareorep, bevacizumab, and FOLFIRI, tripling the 6-11% for the standard of care.<sup>2, 3</sup>

"We believe these data demonstrate a compelling durability signal for pelareorep in colorectal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics. "A 19.5-month median duration of response in second-line patients—representing a three- to four-fold improvement over historical expectations—highlights pelareorep's potential to deliver sustained benefit in a population with few effective options. We believe these results support a path toward accelerated approval in second-line RAS-mutant MSS metastatic colorectal cancer, and we are actively engaging with the FDA to align on a regulatory strategy leveraging our ongoing randomized study."

Oncolytics is currently enrolling patients in its randomized Phase 2 study evaluating pelareorep in combination with FOLFIRI and bevacizumab in second-line RAS-mutant MSS mCRC (link to study on ClinicalTrials.gov). The Company is actively engaging with the U.S. Food and Drug Administration ("FDA") to discuss a potential accelerated approval pathway based on response durability and time-to-event endpoints from this study.

Colorectal cancer remains one of the largest oncology markets globally, with significant unmet need in later-line settings. RAS-mutant MSS mCRC represents a particularly difficult-to-treat population, where patients typically experience rapid disease progression and limited durability of response on standard therapies. The magnitude and consistency of durability and patient response observed with pelareorep-based combinations suggest the potential to meaningfully extend clinical benefit in this setting.

**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 "hot" through the activation of innate and adaptive immune responses.

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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 social media on LinkedIn and on X @oncolytics.

**References**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.Bennouna J. Lancet Oncol (14):29-37, 2013

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.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, and projected outcomes of the Company's planned clinical study of pelareorep, including the potential for accelerated regulatory approval; its 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.ca

<br>