Take a Quick Look at (ONCY) While It’s Still Early

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Trading Ideas Initiates Coverage of Oncolytics Biotech® Inc. (Nasdaq: ONCY) This Morning—Monday, July 13, 2026.

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Pull Up (ONCY) While It’s Still Early…

July 13, 2026
Take a Quick Look at (ONCY) While It’s Still Early

Dear Reader,

A biotech candidate can spend years being judged almost entirely on its clinical data. But at a certain point, the story has to become bigger than the trial results.

That is where Oncolytics Biotech® Inc. (Nasdaq: ONCY) appears to be heading with pelareorep.

The company is now building around the program on several fronts at once, strengthening patent protection, advancing randomized clinical studies, defining a potential regulatory path, and exploring new combination strategies.

Most recently, Oncolytics secured a new U.S. patent covering key aspects of pelareorep’s proprietary manufacturing process, extending protection into 2044. The company also has a separate method-of-use patent application under review that, if issued, is expected to provide protection into 2046.

That matters because the (ONCY) story is no longer centered on early clinical signals alone.

In colorectal cancer, a pelareorep-based combination previously produced a 33% objective response rate and a 19.5-month median duration of response in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer. The company is now advancing a randomized Phase 2 study designed to further evaluate those findings.

(ONCY) has also reached alignment with the FDA on a planned pivotal study in metastatic anal cancer, while new preclinical work is evaluating pelareorep alongside RAS-targeted approaches. Initial findings reported in June showed greater anti-tumor activity from the combination than from the individual approaches alone in the model studied, with additional research planned in colorectal and pancreatic cancer.

The result is a development story that now stretches well beyond a single data point, and analyst coverage adds another layer to the picture…

H.C. Wainwright maintained a Buy rating and $10 target on (ONCY) on May 26, 2026, representing approximately 1,027% upside potential from recent levels around $0.89. While Zacks Small-Cap Research published a $6 valuation in its May 19 report, representing approximately 576% upside potential from those same levels.

With its clinical programs advancing, a broader intellectual property position taking shape, and additional research expected later in 2026, (ONCY) is a name we are keeping a close eye on.

To understand why these developments matter, it is worth taking a closer look at pelareorep and the gastrointestinal cancer programs now driving the company’s strategy.

Inside the (ONCY) Story

Oncolytics Biotech Inc. (Nasdaq: ONCY) is a clinical-stage biotechnology company developing pelareorep, an investigational immunotherapy designed to help stimulate an anti-tumor immune response.

The company is advancing pelareorep across several gastrointestinal cancers, including colorectal, anal, and pancreatic cancer, where it is being evaluated alongside chemotherapy, checkpoint inhibitors, and other targeted treatments.

Pelareorep has received FDA Fast Track designation in colorectal and pancreatic cancer, while Oncolytics continues moving its clinical programs forward, refining potential regulatory pathways, and evaluating strategic partnership opportunities.

More recently, the company added another layer to the story by securing a new U.S. patent covering key aspects of pelareorep’s commercial manufacturing process, extending protection into 2044.

(ONCY) Is Targeting a Global Oncology Market Forecast to Reach $732B

Cancer remains one of the world’s largest healthcare challenges, and the commercial market surrounding its diagnosis and treatment continues to expand. The global oncology market is estimated at approximately $279.7B in 2026 and projected to reach $732.5B by 2035, according to Precedence Research.

Oncolytics is focused on pelareorep across colorectal, anal, and pancreatic cancer—three gastrointestinal cancers with significant unmet treatment needs.

Colorectal cancer: The latest GLOBOCAN 2024 estimates report approximately 2.04M new cases and 917,895 deaths worldwide. The global colorectal cancer therapeutics market is estimated at $14.1B in 2026 and projected to reach $21.1B by 2035. In the U.S., five-year relative survival for distant disease is just 13% for colon cancer and 18% for rectal cancer.

Anal cancer: IARC estimates approximately 54,000 new cases worldwide annually. Across the seven major pharmaceutical markets, the anal cancer market was valued at approximately $697.6M in 2025 and is projected to reach nearly $1.18B by 2036. Treatment options can remain limited once the disease progresses or returns after prior therapy.

Pancreatic cancer: The latest GLOBOCAN 2024 estimates report approximately 531,000 new cases and 490,786 deaths worldwide. For patients diagnosed with distant disease, the five-year relative survival rate remains just 3%. Current standard treatment remains centered on surgery, chemotherapy, radiation, targeted therapy, or combinations of these approaches, while immunotherapy continues to be investigated in clinical trials.

Taken together, these are large disease areas where meaningful treatment gaps remain—helping explain why (ONCY)’s gastrointestinal cancer strategy continues to draw attention.

Recent Developments Moving the (ONCY) Story Forward

Throughout 2026, (ONCY) has continued expanding the pelareorep story across several fronts, including clinical development, regulatory progress, intellectual property, new research, and leadership.

New U.S. Patent Protection Into 2044: (ONCY) announced a new U.S. patent covering key aspects of its proprietary manufacturing process for pelareorep. The company said the patent is expected to provide protection into 2044 and support the consistent production of pelareorep at commercial scale. A separate method-of-use patent application remains under review and, if issued, is expected to provide protection into 2046.
Leadership Expanded for the Next Stage of Development: (ONCY) appointed former Ambrx executive Steve Glover to its Board of Directors and promoted John McAdory to Chief Operating Officer. McAdory is overseeing clinical operations, development, preclinical research, and supporting strategic partnership and business development efforts.
New RAS-Targeted Combination Research Underway: Initial preclinical findings announced June 1 showed greater anti-tumor activity when pelareorep was combined with RAS-targeted approaches than with the individual approaches alone in the model studied. Additional work is planned in pancreatic and colorectal cancer models, with the full dataset expected to be presented later in 2026.
Durable Colorectal Cancer Data Reported: In May, (ONCY) reported a 19.5-month median duration of response in second-line KRAS-mutant, MSS metastatic colorectal cancer, alongside a previously reported 33% objective response rate. The company is now evaluating pelareorep in an ongoing randomized Phase 2 study and has said it is engaging with the FDA regarding a potential accelerated approval pathway.
FDA Alignment on Planned Pivotal Anal Cancer Study: Following a Type C meeting, (ONCY) announced alignment with the FDA on a planned randomized pivotal study in metastatic anal cancer. The proposed study is intended to evaluate a pathway that could potentially support accelerated and full approval, depending on the results.

7 Developments Putting (ONCY) on Our Radar for Monday, July 13, 2026…

1. Patent Protection Now Extends Into 2044: A newly issued U.S. patent adds protection around key aspects of pelareorep’s commercial manufacturing process.

2. REO 033 Is Now in Motion: The randomized Phase 2 colorectal cancer study is underway, with preliminary data expected by the end of 2026.

3. Earlier Data Showed Durable Responses: Previous colorectal cancer results included a 33% objective response rate and a 19.5-month median duration of response.

4. Fast Track Status Adds Regulatory Support: Pelareorep has received FDA Fast Track designation in second-line KRAS-mutant, MSS metastatic colorectal cancer.

5. A Pivotal Anal Cancer Path Is Taking Shape: Following a Type C meeting, the company aligned with the FDA on the design of a planned randomized pivotal study.

6. RAS-Targeted Research Is Broadening the Program: New preclinical work is exploring pelareorep alongside RAS-targeted approaches in colorectal and pancreatic cancer models.

7. Several GI Cancer Programs Are Advancing at Once: The broader pelareorep strategy now spans colorectal, anal, and pancreatic cancer across clinical development, regulatory planning, and partnership efforts.

Keep (ONCY) on Your Radar While It’s Still Early…

(ONCY) remains a clinical-stage biotech, which means the risks are real. Clinical results can change the outlook quickly, regulatory timelines may shift, and additional capital could be needed to support future development.

But there is now more to follow than there was just a few months ago.

The company has added new U.S. patent protection around pelareorep’s manufacturing process, advanced a randomized colorectal cancer study, reported durable response data, secured FDA Fast Track designation, outlined a regulatory path in anal cancer, and expanded research into new RAS-targeted combinations.

That is why (ONCY) remains firmly on our radar this Monday morning.

Take a look at (ONCY) while it’s still early.

Also, keep a look out for our next update—it could be here any moment.

Sincerely,

Dean Knightly

Senior Editor

Trading Ideas