Oncolytics Biotech® Launches Randomized Colorectal Cancer Study

Rhea-AI Summary

Oncolytics Biotech (Nasdaq: ONCY) launched a randomized Phase 2 study (REO 033) testing pelareorep plus bevacizumab and FOLFIRI versus bevacizumab and FOLFIRI in 2L RAS‑mutant, MSS metastatic colorectal cancer. Each arm is planned to enroll 30 patients; primary endpoint is objective response rate, with preliminary data expected by year‑end 2026.

Prior REO 022 results reported median OS 27 months, median PFS 16.6 months, and ORR 33% versus ~11.2, 5.7 months, and ~10% for standard therapy; pelareorep combo has FDA Fast Track Designation.

Positive

• Median OS reported at 27 months in prior REO 022
• Median PFS reported at 16.6 months in prior REO 022
• Objective response rate 33% versus ~10% standard therapy
• FDA Fast Track Designation granted for pelareorep combo
• Randomized Phase 2 study powered for statistical significance

Negative

• Small planned enrollment of 30 patients per arm
• Preliminary data expected only by end of 2026

Key Figures

Planned enrollment: 30 patients per arm Median OS: 27 months Median PFS: 16.6 months +5 more

8 metrics

Planned enrollment 30 patients per arm Randomized Phase 2 mCRC study REO 033

Median OS 27 months REO 022 pelareorep + bevacizumab + FOLFIRI

Median PFS 16.6 months REO 022 pelareorep + bevacizumab + FOLFIRI

SOC median OS 11.2 months Standard-of-care benchmark cited in article

SOC median PFS 5.7 months Standard-of-care benchmark cited in article

ORR pelareorep arm 33% REO 022 pelareorep-containing therapy

SOC ORR 10% Standard-of-care ORR benchmark in article

Study line of therapy 2L Second-line RAS-mutated MSS mCRC population

Market Reality Check

Price: $1.13 Vol: Volume 1,195,359 vs 20-da...

low vol

$1.13 Last Close

Volume Volume 1,195,359 vs 20-day avg 1,936,164 (relative volume 0.62) shows sub-average activity into the news. low

Technical Shares at $1.13 are trading above the 200-day MA of $0.99, sitting 25.17% below the 52-week high and 246.84% above the 52-week low.

Peers on Argus

ONCY gained 5.61% while close biotech peers showed mixed moves: GNLX +4.56%, HUR...

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ONCY gained 5.61% while close biotech peers showed mixed moves: GNLX +4.56%, HURA +7.74%, ACTU -3.86%, CRDF -0.51%, ZURA -1.93%. Momentum scanner flagged GLSI -6.02% with no news. Overall trading points to a stock-specific reaction rather than a coordinated sector move.

Historical Context

5 past events · Latest: Feb 24 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 24	Strategy shift	Positive	+6.6%	Prioritized registrational pelareorep programs in anal and colorectal cancer.
Feb 04	Fast Track news	Positive	+2.5%	FDA Fast Track for pelareorep combo in 2L KRAS-mutant MSS mCRC.
Jan 14	Leadership hires	Positive	+5.0%	Added strategy and biostatistics leaders for late-stage pelareorep programs.
Jan 12	Anal cancer data	Positive	+2.5%	GOBLET Cohort 4 showed meaningful ORR and durable responses in anal cancer.
Jan 09	Domestication plan	Neutral	-2.4%	Proposed move of incorporation from Alberta to Nevada and SEC status change.

Pattern Detected

Recent ONCY news, especially clinical and strategic updates, has typically been followed by positive 24-hour price reactions, with only the domicile change headline drawing a modest negative move.

Recent Company History

Over the past several months, Oncolytics has advanced pelareorep across multiple indications. A Jan 12 anal cancer update showed durable responses, followed by senior hires on Jan 14 to support late-stage development. The company then outlined a U.S. domestication plan on Jan 9. In early Feb, FDA granted Fast Track for 2L KRAS-mutant MSS mCRC with strong ORR, PFS, and OS benchmarks, and on Feb 24 ONCY committed to registration-focused programs in anal and colorectal cancer. Today’s randomized mCRC study launch operationalizes that strategy.

Market Pulse Summary

This announcement details the initiation of REO 033, a randomized Phase 2 trial in 2L RAS‑mutated MS...

Analysis

This announcement details the initiation of REO 033, a randomized Phase 2 trial in 2L RAS‑mutated MSS metastatic colorectal cancer, powered with 30 patients per arm and ORR as the primary endpoint. It builds directly on REO 022 results, where pelareorep combinations showed improved ORR, PFS 16.6 months, and OS 27 months versus standard benchmarks. Investors may watch enrollment progress, timing of preliminary data by end of 2026, and how outcomes compare with the Fast Track–supporting dataset.

Key Terms

fast track designation, microsatellite-stable, objective response rate, progression-free survival, +4 more

8 terms

fast track designation regulatory

"Pelareorep-based treatment regimen recently granted Fast Track Designation in 2L..."

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

microsatellite-stable medical

"RAS-mutated (which includes KRAS), microsatellite-stable (“MSS”) mCRC patients..."

Microsatellite-stable describes tumors whose short, repeated stretches of DNA remain unchanged, meaning the cell’s internal “proofreader” is effectively catching copying errors. Investors care because this molecular trait affects which therapies and clinical trials are likely to work — some immunotherapies and targeted drugs perform differently in stable versus unstable tumors, influencing a drug’s market potential, trial success and regulatory path.

objective response rate medical

"The primary endpoint of the study is objective response rate (“ORR”)..."

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

progression-free survival medical

"with progression-free survival (“PFS”), overall survival (“OS”), safety..."

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"with progression-free survival (“PFS”), overall survival (“OS”), safety..."

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

biomarker medical

"overall survival (“OS”), safety, and biomarker analysis as other endpoints."

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

bevacizumab medical

"control arm of bevacizumab (Avastin®) and fluorouracil, leucovorin, irinotecan..."

A targeted cancer and eye‑disease drug that works by blocking a protein tumors and abnormal eye tissue use to grow new blood vessels, effectively 'cutting off the supply lines' they need to expand. Investors watch it because sales, patent status, regulatory approvals, and competing copies (biosimilars) can drive significant revenue shifts, affect treatment standards, and influence the maker’s stock and competing firms’ market prospects.

FOLFIRI medical

"bevacizumab (Avastin®) and fluorouracil, leucovorin, irinotecan (“FOLFIRI”)..."

FOLFIRI is a chemotherapy combination used to treat certain cancers, made from the drugs fluorouracil (5-FU), leucovorin, and irinotecan — think of it as a three‑ingredient recipe designed to attack cancer cells in different ways. Investors care because its use affects demand for related drugs, influences clinical trial and approval outcomes, and can drive revenue or cost pressures for companies involved in manufacturing, supplying supportive care, or developing competing therapies.

AI-generated analysis. Not financial advice.

Controlled study designed to confirm previous compelling efficacy with preliminary data expected by the end of 2026

Pelareorep-based treatment regimen recently granted Fast Track Designation in 2L KRAS-mutant MSS metastatic colorectal cancer, confirming its potential in this large indication

SAN DIEGO, March 02, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech^® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced the initiation of a metastatic colorectal cancer (“mCRC”) Phase 2 study that will be referred to as REO 033.

In this trial, second-line (“2L”) RAS-mutated (which includes KRAS), microsatellite-stable (“MSS”) mCRC patients will be randomized to a control arm of bevacizumab (Avastin^®) and fluorouracil, leucovorin, irinotecan (“FOLFIRI”) or an experimental arm of pelareorep, bevacizumab, and FOLFIRI. The study is powered for statistical significance, with each study arm expected to enroll 30 patients. All participants will have failed their initial treatment with platinum-based chemotherapy. The primary endpoint of the study is objective response rate (“ORR”), with progression-free survival (“PFS”), overall survival (“OS”), safety, and biomarker analysis as other endpoints. The trial will be sponsored by Oncolytics with Sanjay Goel, M.D., M.S., FASCO, Professor of Medicine at Rutgers Cancer Institute of New Jersey, as the Lead Investigator. The Company is expecting to initiate the first study site later this month and provide preliminary data by year-end.

“I am honored to lead this study as I have a long track record working with pelareorep and have witnessed its ability to improve patient outcomes in a meaningful way,” said Dr. Goel. “The colorectal cancer data we recorded in the REO 022 study continues to be compelling to this day, as evidenced by the Fast Track Designation, and I hope we can generate additional exciting data in this new trial to support registration.”

The previous REO 022 clinical study of pelareorep, bevacizumab, and FOLFIRI in this population demonstrated a median OS of 27 months and a median PFS of 16.6 months, both of which substantially exceed the median 11.2- and 5.7-month OS and PFS, respectively, observed for standard-of-care therapy. Similarly, ORR in the same study was 33% for pelareorep-containing therapy compared to approximately 10% for standard-of-care treatment.^1-2 Last month, the Company announced that pelareorep in combination with bevacizumab and FOLFIRI was granted Fast Track Designation by the U.S. Food & Drug Administration in 2L KRAS-mutant, MSS mCRC.

“The potential to improve clinical outcomes compared to the standard-of-care in the second-line setting would have the potential to benefit patients around the world who are affected by colorectal cancer,” said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX, and member of the Oncolytics Biotech Gastrointestinal Scientific Advisory Board. “An immunotherapy with the potential to improve outcomes would improve treatment options in colorectal cancer and would be highly welcomed, especially as we are seeing more and more younger patients being diagnosed with colorectal cancer.”

References

1. Bennouna J. Lancet Oncol (14):29-37, 2013
2. Iwamoto S. Ann Oncol. Jul;26(7):1427-33, 2015

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.

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.

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 anticipated design, size, management, timelines, milestones, and outcomes of current and future studies; the Company’s goals, strategies, and objectives; and its belief in the clinical promise of pelareorep in colorectal and other 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

Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com

Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
oblaschak@lifescicomms.com

FAQ

What is the design of Oncolytics (ONCY) REO 033 colorectal cancer study?

REO 033 is a randomized Phase 2 trial comparing pelareorep plus bevacizumab and FOLFIRI to bevacizumab and FOLFIRI. According to the company, each arm is expected to enroll 30 patients and the primary endpoint is objective response rate.

When will Oncolytics (ONCY) report preliminary REO 033 data?

The company expects to provide preliminary data by year‑end 2026. According to the company, the first study site is planned to open later in March 2026 with interim readouts targeted before 2027.

What prior clinical results support Oncolytics' (ONCY) REO 033 trial?

Prior REO 022 showed median OS of 27 months and median PFS of 16.6 months. According to the company, ORR was 33% versus approximately 10% for standard‑of‑care comparators in that study.

What regulatory status does pelareorep have for 2L KRAS‑mutant MSS mCRC?

Pelareorep combined with bevacizumab and FOLFIRI has received FDA Fast Track Designation. According to the company, the designation applies specifically to second‑line KRAS‑mutant, MSS metastatic colorectal cancer.

How many patients will be enrolled in the Oncolytics (ONCY) REO 033 study?

The study is expected to enroll 30 patients per arm, for a total of about 60 patients. According to the company, all participants will have failed first‑line platinum‑based chemotherapy.