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Jeff Ackerman Just Put Oncolytics Biotech® Inc. (Nasdaq: ONCY) Front and Center for This Morning
—Monday, June 1, 2026
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Take A Look At ONCY This Morning While It’s Still Early…
June 1, 2026
After Its Latest FDA Update (Nasdaq: ONCY) is Topping Our Watchlist This Morning
Dear Reader, What would it mean for cancer patients — and for the biotech world — if a single intravenous agent could transform "cold" GI tumors into immune-primed targets and deliver survival data that is 2-3 times better than the current standard of care? That's not a hypothetical: it describes what Oncolytics Biotech® Inc. (Nasdaq: ONCY) has been building toward its lead candidate pelareorep, a first-in-class dsRNA immunotherapy targeting gastrointestinal tumors. 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. Analyst Coverage
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. 
The company is currently advancing a focused pipeline across three high-unmet-need GI indications: second-line (2L) RAS-mutated metastatic colorectal cancer (mCRC), second-line or later (≥2L) unresectable Squamous Cell Anal Carcinoma (SCAC), and first-line (1L) metastatic Pancreatic Ductal Adenocarcinoma (mPDAC). Pelareorep has been evaluated in over 20 Oncolytics-sponsored studies and in more than 1,200 patients across multiple cancer types, including more than 300 patients with GI tumors — all with a manageable safety profile and no maximum tolerated dose identified. In April 2026, Oncolytics completed its domicile change to the United States, consolidating its operations in San Diego, California. The company holds 137 patents issued worldwide, with new filings expected to extend manufacturing protection to 2044 and method-of-use protection to 2046.
A Massive and Underserved Market Cancer treatment is one of the largest and fastest-growing areas in healthcare. The global oncology market is projected to grow from approximately $279B in 2026 to more than $732B within the next decade. 
ONCY is focused on three difficult gastrointestinal cancers where patients still have limited options: colorectal cancer, anal cancer, and pancreatic cancer. Colorectal cancer affects approximately 1.9M people globally, and the market tied to ONCY’s target setting is estimated at approximately $20B, growing at a 4.7% annual rate through 2033. In metastatic colorectal cancer, the five-year survival rate is just 15%. Anal cancer is a smaller but highly underserved area, affecting roughly 54,000 people globally. That market is projected to reach approximately $2.3B by 2035, yet patients who have already received prior therapy still have very few choices. Pancreatic cancer may be the most urgent of the three. It affects approximately 500,000 people globally, and the 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 as part of standard care. Clinical Data That Stands Out Here’s what caught our attention: Oncolytics has reported encouraging clinical data across all three of its main gastrointestinal cancer programs. While these results come from different studies and should not be viewed as head-to-head comparisons, the numbers compare favorably with historical benchmarks. In colorectal cancer, one study showed that patients receiving pelareorep with a commonly used treatment combination had a median overall survival of 27.0 months, compared with 11.2 months for a historical benchmark. The same study also reported 16.6 months of progression-free survival, compared with 5.7 months for the benchmark, and a 33% response rate, compared with 6–11%. In May 2026, Oncolytics also reported new colorectal cancer data showing that responses lasted 3–4 times longer than the historical 4–6 month benchmark. In anal cancer, pelareorep combined with atezolizumab produced a 30% response rate in evaluable patients who had already received prior therapy. The company also reported responses lasting 17 months, compared with 9.5 months for the current approved therapy, including one complete response lasting 15 months and another long-running response lasting 28 months that eventually became a complete response. In pancreatic cancer, data across multiple studies showed that pelareorep-based therapy produced an approximately 21.9% two-year survival rate, compared with approximately 9.2% for selected comparator treatment arms. Taken together, these results help explain why pelareorep has attracted growing attention across multiple gastrointestinal cancer programs. Additional studies and future data readouts will be important, but the consistency of the results across colorectal, anal, and pancreatic cancer is one of the key reasons ONCY remains on our radar. Regulatory Progress 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 plain English, that means 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 moving forward 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 colorectal cancer setting, a status the FDA uses for programs aimed at serious conditions with unmet medical need. Leading the company is CEO Jared Kelly, a transactional expert who has led more than 50 deals, including the $2B Ambrx sale to Johnson & Johnson in 2024. CMO Thomas Heineman, M.D., Ph.D. brings nearly 30 years of drug development experience with expertise in virology and oncology, and CBO Andrew Aromando contributes over 30 years in oncology portfolio optimization.
7 Reasons Why ONCY is Topping Our Watchlist This Morning—Monday, June 1, 2026…1. 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. 2. Analyst Targets: ONCY has attracted favorable analyst coverage, with Zacks SCR assigning a $6 valuation that suggests approximately 500% potential upside from the recent $1 range and Maxim Group maintaining a $3 target that suggests approximately 200% potential upside. 3. FDA Alignment: Recent FDA alignment on a key anal cancer study gives ONCY a clear regulatory item for readers to track. 4. ASCO Ahead: With ASCO 2026 data on the immediate horizon, ONCY could draw added attention from biotech watchers this week. 5. Three Programs: ONCY is advancing pelareorep across colorectal cancer, anal cancer, and pancreatic cancer. 6. Durable Responses: 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. Fast Track: Pelareorep has received Fast Track Designation in second-line RAS-mutated colorectal cancer, giving ONCY another regulatory marker to monitor. Take A Look At ONCY This Morning While It’s Still Early…
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. We have all eyes on ONCY this morning. Take a look at ONCY while it’s still early. Sincerely, Jeff Ackerman
Managing Editor
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