The Silent Killer Just Met Its Match

ISSUED ON BEHALF OF ONCOLYTICS BIOTECH

Oncolytics Biotech (NASDAQ: ONCY) is advancing a virus-based immunotherapy that turns “cold” pancreatic and gastrointestinal (GI) tumors “hot.” The data show survival gains that more than double the standard of care. The CEO just sold his last company for $2 billion.

And the stock is trading at a market cap of just ~$100M.

Gastrointestinal cancers are where immunotherapy goes to die.

Pancreatic cancer. Anal cancer. Colorectal tumors. These are the places where drugs that work in many other cancers simply stop working.

The tumors are unable to be penetrated by standard of care treatments, commonly referred to as being “cold.” The immune system can’t see them.

Checkpoint inhibitors, which have revolutionized melanoma and lung cancer, barely move the needle here.

The reason is simple. GI tumors hide. They don’t express the biomarkers that make them visible to immune attack.

PD-L1 levels are low. T-cell infiltration is minimal. The tumor microenvironment is hostile. These cancers have built a fortress.

And for decades, that fortress has been unbreachable.

But what if the problem isn’t the immune system? What if the problem is that no one has handed it the key?

Oncolytics Biotech Inc. (NASDAQ: ONCY) isn’t developing another checkpoint inhibitor.

It’s developing the key. The company’s lead asset, pelareorep, doesn’t attack the tumor directly.

It turns the tumor “hot” so it is receptive to therapeutic intervention, and the immune system can finally do its job.

The mechanism is elegant. Pelareorep is an oncolytic virus delivered intravenously.

It selectively replicates inside cancer cells, triggering a cascade of immune activation. T-cells mobilize. NK cells infiltrate.

The tumor, once invisible, becomes a target.

This isn’t theory. The company has spent years proving the mechanism works. Now it’s proving the mechanism translates into survival.

The Validation

Before you can unlock a fortress, you need to prove the key actually works.

Oncolytics ran that experiment in breast cancer. Specifically, HR+/HER2- metastatic breast cancer.

This is a large indication, heavily studied, with well-established benchmarks.

It’s also a tumor type that doesn’t respond well to immunotherapy.

The BRACELET-1 trial combined pelareorep with paclitaxel and pelareorep, paclitaxel, and avelumab. The control arm received paclitaxel alone. The results were unambiguous.

Median overall survival in the pelareorep arm was estimated at 32.1 months. In the control arm, 18.2 months. That’s a 76% improvement.[1]

The company didn’t just extend survival. It has also demonstrated proof of mechanism. Biopsies confirmed what the data suggested.

In the AWARE-1 breast cancer study, pelareorep increased PD-L1 expression. It activated interferon signaling. It generated and expanded tumor-infiltrating lymphocytes in the blood and in the tumor. The “cold” tumor became “hot.”

That was the validation. Pelareorep works. The key turns.

Now the question is whether it can unlock the fortress.

The Data (The Evidence)

The fortress is GI cancer. Pancreatic, colorectal, and anal. These are the indications where immunotherapy has consistently failed.

Oncolytics is systematically working through them.

Pancreatic Cancer

Start with pancreatic cancer. First-line metastatic pancreatic ductal adenocarcinoma.

Standard chemotherapy delivers a two-year survival rate of approximately 9%.[2]

That’s the benchmark. It hasn’t moved in decades.

Oncolytics ran a pooled analysis across multiple first-line pancreatic cancer studies. Patients who received pelareorep in combination with chemotherapy achieved a two-year survival rate of approximately 22%.[3]

That’s more than double the benchmark.

The company also reported a 62% objective response rate in patients receiving pelareorep, chemotherapy, and a checkpoint inhibitor.[4]

For context, standard chemotherapy alone typically generates response rates in the low 20% range.

This is not incremental improvement. This is a step-function change.

Anal Cancer

Now look at anal cancer. Squamous cell anal carcinoma. Second-line or later.

This is a rare, deadly disease with virtually no treatment options after first-line therapy fails.

The only FDA-approved immunotherapy for this indication delivers a 13.8% objective response rate.[5]

Pelareorep combined with atezolizumab achieved a 30% objective response rate. That’s more than double the benchmark.[6]

The median duration of response was 15.5 months, compared to 9.5 months for standard care.[7]

Two patients achieved complete responses, one ongoing beyond two years.

The data are consistent. Pelareorep turns cold tumors hot. And when the tumor becomes visible, the immune system attacks.

Colorectal Cancer

Finally, the largest commercial opportunity of this group, colorectal cancer. KRAS-mutant, microsatellite-stable. Second-line.

Adding pelareorep to standard of care treatment dramatically improved progression-free survival and overall survival.

The combination of pelareorep, FOLFIRI, and bevacizumab achieved 16.6 months progression-free survival compared to 5.7 months for FOLFIRI and bevacizumab. That is more than double.[8]

For overall survival, pelareorep, FOLFIRI, and bevacizumab came in at 27 months, while FOLFIRI and bevacizumab recorded 11.2 months. Once again, adding pelareorep more than doubled the standard of care.

Additional colorectal clinical studies demonstrate the consistent translational data we have seen in the previously mentioned indications. The REO 022 and REO 013 studies showed immune activation, including dendritic cell maturation and CD8+ T cell activation.

Once again, pelareorep is proving its potential in another GI tumor, one that is estimated to affect 1.9 million people annually[9]. The potential benefit is significant for patients and for the prospects of Oncolytics.

The Architect (The People)

You don’t join a $105-million micro-cap company to run a science lab.

Jared Kelly became CEO of Oncolytics in mid-2025.

Prior to that, he served as head of legal and corporate strategy at Ambrx Biopharma.[10]

That company was acquired by Johnson & Johnson for $2 billion. Kelly played a central role in orchestrating that transaction.

He didn’t join Oncolytics to publish papers. He joined to package an asset.

The playbook is straightforward. Demonstrate clinical proof of concept. Secure regulatory alignment.

Build the data package that makes the asset strategic. Then execute.

Oncolytics is advancing toward a registration-directed trial in first-line pancreatic cancer.

The company has met with the FDA to finalize study design and aligned on plans.

The proposed trial is a three-arm study powered for overall survival. Pelareorep plus chemotherapy. Pelareorep plus chemotherapy plus checkpoint inhibitor as an optional experimental arm. Chemotherapy control.

If that trial succeeds, pelareorep becomes the first approved immunotherapy in first-line pancreatic cancer. That’s not a niche indication.

That’s a multi-billion-dollar market.

Kelly’s job isn’t to discover the science. The science is already discovered.

His job is to translate the data into value.

The Dream Team

It’s not just the CEO. The scientific validation is world-class.

In November 2025, Oncolytics formed a Gastrointestinal Tumor Scientific Advisory Board.[11]

It is comprised of three of the field’s leading investigators:

Dr. Sanjay Goel (Rutgers Cancer Institute) – Director of Phase I Program
Dr. Deva Mahalingam (Northwestern University) – Director of Developmental Therapeutics
Dr. Dirk Arnold (Asklepios Tumorzentrum Hamburg) – Principal Investigator of the GOBLET study

These aren’t advisory board seats for show. All three have led clinical trials evaluating pelareorep. They have seen the data firsthand.

“Pelareorep has shown remarkable immune activation and durable efficacy across multiple GI tumor types,” said Dr. Goel. “I believe pelareorep has the potential to change how we approach immunotherapy in GI cancers.”

The Scientific Advisory Board will guide the registration-enabling study designs. They will define the accelerated approval pathways.

These are critical steps as Oncolytics pivots from proof-of-concept to pursuit of regulatory approval.

The Gap

Markets price uncertainty.

Right now, the market is pricing Oncolytics Biotech as a “Maybe.”

The company has just over a $105-million market cap [as of December 9, 2025]. That valuation reflects doubt. Doubt that the data will replicate…

Doubt that the FDA will grant approval. Doubt that a Big Pharma partner will step in.

But look at the data. A 22% two-year survival rate in pancreatic cancer versus 9% for chemotherapy alone.

A 30% response rate in anal cancer versus 13.8% for the approved drug. These aren’t marginal signals.

These are categorical improvements in diseases with no effective immunotherapy.

The market is pricing this as a “Maybe.” The data suggest it’s a “Likely.”

The difference between those two is the investment opportunity.

Big Pharma doesn’t wait for registration trials to finish.

Ambrx was acquired pre-Phase 3.[12]

Trillium Therapeutics was bought for $2.26 billion based on mid-stage data.[13]

Kite Pharma went for $11.9 billion between pivotal data and full approval.[14]

Oncolytics is entering that same window. The company has late-stage survival data.

It has FDA Fast Track designations in both pancreatic and breast cancer.[15],[16]

It has a CEO who has already executed a multi-billion-dollar exit.

The fortress has been unbreachable for decades. Oncolytics has the key. The question isn’t whether the key works.

The question is how long it stays overlooked.

The answer is simple. The market hasn’t caught up yet.

But it will.

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