Monday, 1 June 2026

(Nasdaq: ONCY) Has Our Full Focus This Morning After Key FDA Milestone Announced

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Krypton Street Just Put Oncolytics Biotech® Inc. (Nasdaq: ONCY) On This Morning’s Watchlist—Monday, June 1, 2026

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ONCY Could Be Hard to Ignore This Morning…

June 1, 2026

(Nasdaq: ONCY) Has Our Full Focus This Morning After Key FDA Milestone Announced

Dear Reader,

Gastrointestinal cancers are the fastest growing cancer in the world for people under 50 — and the treatment landscape has barely moved in years.

That's the backdrop against which Oncolytics Biotech® Inc. (Nasdaq: ONCY) is advancing pelareorep, a novel dsRNA immunotherapy that has now generated clinical data across three separate GI tumor indications, all clearing historical benchmarks by roughly 2–3 times on key endpoints.

With the global oncology market on a path from $279B to over $732B this decade and multiple data readouts slated for the second half of 2026, (ONCY) is a story we believe readers should be aware of right now.

And it's just one of the reasons why (ONCY) is topping our watchlist this morning—Monday, June 1, 2026.

Over the last two weeks, ONCY has made an approximate 38% move, from around $.77 on May 20 to $1.07 this past Friday afternoon, on May 29, according to Barchart.

Beyond the recent move, ONCY has also drawn coverage from analysts with targets well above its recent $1 range.

Analyst Targets Suggest 200% to 500% Upside Potential…

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In May 2026, David Bautz, PhD from Zacks SCR set a $6 valuation on ONCY, which suggests 500% upside potential from its recent $1 range.

Additionally, Jason McCarthy from Maxim Group reiterated a bullish rating with a $3 target, which suggests 200% upside potential.

With ASCO 2026 data on the immediate horizon, fresh FDA alignment on a pivotal anal cancer study, and recent momentum over the past two weeks, ONCY is a name we're keeping a very close eye on this week.

The combination of upcoming clinical readouts, recent regulatory progress, and favorable analyst coverage could help place ONCY on the radar of many biotech followers heading into June.

To understand why these developments matter, it's worth taking a closer look at the company, its lead immunotherapy candidate, and the gastrointestinal cancer programs driving its strategy.

Company Overview

San Diego-based Oncolytics Biotech® Inc. (Nasdaq: ONCY) is a clinical-stage immunotherapy company with a singular mission: to establish pelareorep — branded "pela" — as a platform immunotherapy for gastrointestinal (GI) tumors, the fastest-growing cancer category in the world in people under 50 years old.

Pelareorep is a first-in-class, intravenously administered double-stranded RNA (dsRNA) immunotherapeutic agent derived from the naturally occurring Reovirus.

When administered IV, pela evades immune neutralization by associating with mononuclear cells in the blood, is delivered directly to the tumor, selectively infects and replicates in tumor cells with RAS pathway mutations, and triggers a coordinated innate and adaptive immune response — effectively converting a "cold" tumor into a "hot" one primed for immune attack.

Oncolytics has built its pipeline around three difficult gastrointestinal cancers where patients still have limited treatment choices: colorectal cancer, anal cancer, and pancreatic cancer.

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Its lead candidate, pelareorep, has already been evaluated in more than 20 company-sponsored studies and in over 1,200 patients across multiple cancer types.

That includes more than 300 patients with GI tumors, with the company reporting a manageable safety profile and no maximum tolerated dose identified.

In April 2026, Oncolytics also completed its move to the United States, bringing its corporate base to San Diego, California.

The company also reports 137 issued patents worldwide, with newer filings expected to extend manufacturing protection to 2044 and method-of-use protection to 2046.

A $732B Oncology Market Coming Into View

Cancer treatment is one of the biggest and fastest-growing parts of healthcare. The global oncology market is projected to rise from approximately $279B in 2026 to more than $732B within the next decade.

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ONCY is focused on three hard-to-treat gastrointestinal cancers where patients still need better options: colorectal cancer, anal cancer, and pancreatic cancer.

Colorectal cancer affects approximately 1.9M people worldwide.

The market tied to ONCY’s target area is estimated at approximately $20B and is projected to grow at a 4.7% annual rate through 2033. For patients with metastatic colorectal cancer, the five-year survival rate is just 15%.

Anal cancer is smaller, but still represents an area with serious unmet need. It affects roughly 54,000 people globally, and the market is projected to reach approximately $2.3B by 2035.

For patients who have already gone through prior treatment, choices remain limited.

Pancreatic cancer may be the toughest of the three. It affects approximately 500,000 people globally, and its treatment market is projected at approximately $3B, growing at a 15% annual rate through 2032.

For metastatic pancreatic cancer, the five-year survival rate is only 3%, and there is currently no approved immunotherapy included in standard care.

The Data Behind ONCY’s Story

Here’s what caught our attention: Oncolytics has reported encouraging data across all three of its main gastrointestinal cancer programs.

In colorectal cancer, one study showed patients on a pelareorep-based treatment lived a median of 27.0 months, compared with 11.2 months for a historical benchmark.

The same study also showed 16.6 months before the cancer worsened, compared with 5.7 months for the benchmark.

In anal cancer, Oncolytics reported a 30% response rate in evaluable patients who had already received prior therapy, with responses lasting 17 months compared with 9.5 months for the current approved therapy.

In pancreatic cancer, pelareorep-based therapy showed an approximately 21.9% two-year survival rate across multiple studies, compared with approximately 9.2% for selected comparator treatment arms.

These results come from different studies and are not head-to-head comparisons, so future data will be important.

Still, the consistency across colorectal, anal, and pancreatic cancer is one of the key reasons ONCY remains on our radar.

FDA Milestones and an Experienced Team

In April 2026, Oncolytics announced alignment with the FDA on the design of a key anal cancer study for pelareorep.

In simple terms, the company and FDA have agreed on the general study plan Oncolytics intends to use as it works toward possible approval in this indication.

That matters because anal cancer is a rare area with limited treatment choices, and Oncolytics believes this study could support a faster approval route if the data is strong enough.

The company is also advancing in colorectal cancer.

In March 2026, Oncolytics launched a randomized study in second-line RAS-mutated colorectal cancer, with preliminary data expected by Q4 2026.

Pelareorep has also received Fast Track Designation in this setting.

Oncolytics is led by CEO Jared Kelly, who has led more than 50 deals, including the $2B Ambrx sale to Johnson & Johnson in 2024.

Its leadership team also includes CMO Thomas Heineman, M.D., Ph.D., with nearly 30 years of development experience in virology and oncology, and CBO Andrew Aromando, with over 30 years in oncology portfolio strategy.

7 Reasons We Have All Eyes on ONCY This Morning

—Monday, June 1, 2026…

1. Analyst Coverage: ONCY has attracted favorable analyst coverage, with Zacks SCR assigning a $6 valuation that suggests approximately 500% potential upside from its recent $1 range and Maxim Group maintaining a $3 target that suggests approximately 200% potential upside.

2. Recent Momentum: Over the last two weeks, ONCY moved approximately 38%, rising from around $0.77 on May 20 to $1.07 on May 29, according to Barchart.

3. Fast Track: Pelareorep has received Fast Track Designation in second-line RAS-mutated colorectal cancer, giving ONCY another regulatory marker to monitor.

4. ASCO Ahead: With ASCO 2026 data on the immediate horizon, ONCY could draw added attention from biotech watchers this week.

5. Cancer Pipeline: ONCY is advancing pelareorep across colorectal cancer, anal cancer, and pancreatic cancer.

6. Clinical Signals: In anal cancer, ONCY reported responses lasting 17 months, including one complete response lasting 15 months and another response lasting 28 months that became a complete response.

7. FDA Alignment: Recent FDA alignment on a key anal cancer study gives ONCY a clear regulatory item for readers to track.

ONCY Could Be Hard to Ignore This Morning…

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ONCY has a lot lining up at once: ASCO 2026 data ahead, FDA alignment on a key anal cancer study, Fast Track status in colorectal cancer, and analyst coverage from Zacks SCR and Maxim Group.

With pelareorep being evaluated across three difficult cancer areas and ONCY already showing an approx. 38% move over the last two weeks, this is a name we believe deserves close attention as the week begins.

ONCY is near the very top of our screen this morning.

Give ONCY a closer look while it’s still early.

Sincerely,

Alex Ramsay

Co-Founder / Managing Editor

Krypton Street Newsletter

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Pursuant to an agreement between Media 1717 LLC and TD Media LLC, Media 1717 LLC has been hired for a period beginning on 05/31/2026 and ending on 06/01/2026 to publicly disseminate information about (ONCY:US) via digital communications. Under this agreement, TD Media LLC has paid Media 1717 LLC seven thousand five hundred USD (“Funds”). To date, including under the previously described agreement, Media 1717 LLC has been paid fifteen thousand USD (“Funds”). These Funds were part of the one hundred thousand USD funds that TD Media LLC received from Oncolytics Biotech Inc., the issuer of (ONCY:US).

Neither Media 1717 LLC, TD Media LLC and their member own shares of (ONCY:US).

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