Oncolytics Biotech (ONCY) secures FDA Fast Track for pelareorep colorectal cancer combination

Rhea-AI Filing Summary

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).

Positive

• FDA Fast Track Designation for a combination including pelareorep, bevacizumab, leucovorin, fluorouracil, and irinotecan (FOLFIRI) in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, signaling regulatory support for development in a serious oncology indication.

Negative

• None.

Insights

Biotech regulatory and pipeline analyst

FDA Fast Track Designation highlights regulatory support for Oncolytics Biotech’s colorectal cancer combination therapy.

The company reports U.S. FDA Fast Track Designation for a combination regimen including pelareorep, bevacizumab, leucovorin, fluorouracil, and irinotecan (FOLFIRI) in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer. Fast Track status is intended to facilitate development and review of therapies for serious conditions.

This designation can allow more frequent FDA interactions and potential eligibility for expedited review pathways, depending on future data. The report also links this update to the company’s Form F-3 registration statement by incorporating the press release as an exhibit, aligning the regulatory milestone with existing capital markets documentation.

FALSE0001129928A000011299282026-02-042026-02-04

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): February 4, 2026

___________________________________

Oncolytics Biotech Inc.

(Exact name of registrant as specified in its charter)

___________________________________

Alberta, Canada (State or other jurisdiction of incorporation)			001-38512 (Commission File Number)						n/a (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 shares, no par value 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 February 4, 2026, Oncolytics Biotech, Inc. (the “Company”) issued a press release announcing Fast Track Designation from the U.S. Food And Drug Administration for the combination of pelareorep, bevacizumab, leucovorin, fluorouracil, irinotecan (FOLFIRI) in second-line KRAS-mutant microsatellite-stable metastatic colorectal caner. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated into this Item 8.01 by reference.

In addition to any of the Company’s filings with the U.S. Securities and Exchange Commission that automatically incorporate all filings made by the Company pursuant to Sections 13(a), 13(c), 14, and 15(d) of the U.S. Securities and Exchange Act of 1934, as amended, this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is hereby incorporated by reference as an exhibit to the Company’s Registration Statement on Form F-3 (File No. 333-289819).

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.						Description
99.1						Press Release issued by Oncolytics Biotech, Inc., dated as of February 4, 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: February 4, 2026

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

FAQ

What did Oncolytics Biotech Inc. (ONCY) announce in this 8-K filing?

Oncolytics Biotech announced that the U.S. FDA granted Fast Track Designation for a combination regimen including pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer. The company disclosed this via a press release attached as Exhibit 99.1 to the report.

Which treatment regimen received FDA Fast Track Designation for Oncolytics Biotech (ONCY)?

The designation covers a combination of pelareorep, bevacizumab, leucovorin, fluorouracil, and irinotecan (FOLFIRI). It is intended for use in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, a difficult-to-treat form of colorectal cancer with specific genetic characteristics.

For which patient population is Oncolytics Biotech’s Fast Track Designation targeted?

The Fast Track Designation is for patients with second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer. This population has tumors with KRAS mutations and microsatellite stability, and the therapy is intended for use after first-line treatment has already been given.

How is this regulatory update linked to Oncolytics Biotech’s Form F-3 registration?

The company states that this report, including Exhibit 99.1, is incorporated by reference as an exhibit to its Form F-3 Registration Statement (File No. 333-289819). This formally connects the Fast Track Designation disclosure to its existing securities registration document.

What exhibit in the Oncolytics Biotech (ONCY) 8-K contains more detail on the Fast Track news?

Exhibit 99.1 to the 8-K is a press release dated February 4, 2026. That press release provides additional detail regarding the U.S. FDA’s Fast Track Designation for the pelareorep-based combination in metastatic colorectal cancer.

Does the Oncolytics Biotech 8-K mention any financial statements or earnings data?

No. The 8-K focuses on an FDA Fast Track Designation and related press release. The filing lists exhibits, including the press release and an Inline XBRL cover page data file, but does not present financial statements or earnings metrics.