Recent FDA Milestone Just Put (Nasdaq: ONCY) on Our Watchlist for Tomorrow Morning

Any content you receive is for information purposes only. Always conduct your own research.  *Sponsored See Why Market Crux is Highlighting Oncolytics Biotech® Inc. (Nasdaq: ONCY) Tomorrow Morning—Monday, June 1, 2026 Get Real-Time Alerts Sent Directly To Your Phone. Up To 10X Faster Than Email. ONCY May Be One to Watch Closely Tomorrow Morning… May 31, 2026 Recent FDA Milestone Just Put (Nasdaq: ONCY) on Our Watchlist for Tomorrow Morning Dear Reader, A clinical-stage immunotherapy platform with consistent 2–3x efficacy improvements over standard of care across three separate cancer indications — and analyst targets that suggest between 200% and 500% upside potential from its recent range. That's the profile of Oncolytics Biotech® Inc. (Nasdaq: ONCY), a San Diego-based company developing pelareorep, a first-in-class dsRNA immunotherapy targeting GI tumors. With an approximate 32% move over the last two weeks and a slate of potential catalyst events converging in H2 2026, (ONCY) has earned a spot on the Market Crux radar this coming week. And it's just one of the reasons why (ONCY) will be topping our watchlist tomorrow morning—Monday, June 1, 2026. Over the last two weeks, ONCY has gone 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 Coverage Adds to the ONCY Story… 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. Meet Oncolytics Biotech San Diego-based Oncolytics Biotech® Inc. (Nasdaq: ONCY) is a clinical-stage immunotherapy company focused on gastrointestinal cancers, including some of the toughest areas of cancer care. Its lead candidate, pelareorep, also known as “pela,” is designed to help the immune system recognize and attack cancer more effectively. The company’s goal is to use pelareorep as a broad platform for treating GI tumors, a cancer category that has been growing quickly among people under 50. In simple terms, pelareorep is given through an IV and is designed to reach tumors through the bloodstream. Once there, it may help turn tumors that are harder for the immune system to detect into tumors that are more visible and easier for the body’s immune defenses to target. ONCY’s Pipeline Takes Shape Oncolytics has built its pipeline around three difficult gastrointestinal cancers where patients still have limited treatment choices: colorectal cancer, anal cancer, and pancreatic cancer. 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. ONCY’s Focus Inside a $732B Oncology Market Cancer treatment is one of the biggest and fastest-growing areas in healthcare, with the global oncology market projected to rise from approximately $279B in 2026 to more than $732B within the next decade. ONCY is focused on three hard-to-treat gastrointestinal cancers where patients still need better options: Colorectal cancer: Affects approximately 1.9M people worldwide. ONCY’s target area is estimated at approximately $20B and projected to grow at a 4.7% annual rate through 2033. In metastatic colorectal cancer, the five-year survival rate is just 15%. Anal cancer: Affects roughly 54,000 people globally, with the market projected to reach approximately $2.3B by 2035. Patients who have already gone through prior treatment still have limited choices. Pancreatic cancer: Affects approximately 500,000 people globally, with the treatment market projected at approximately $3B and 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. Here’s 7 Reasons ONCY Is Back in Focus Tomorrow Morning —Monday, June 1, 2026… 1. Market Scale: ONCY is targeting three hard-to-treat GI cancers within a global oncology market projected to grow from approximately $279B in 2026 to more than $732B within the next decade. 2. Analyst Coverage: Zacks SCR set a $6 valuation and Maxim Group maintained a $3 target, suggesting approximately 500% and 200% upside potential, respectively. 3. Fast Track: Pelareorep has received Fast Track Designation in second-line RAS-mutated colorectal cancer, giving ONCY another regulatory marker to monitor. 4. Cancer Pipeline: ONCY is advancing pelareorep across colorectal cancer, anal cancer, and pancreatic cancer. 5. 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. 6. FDA Update: Recent FDA alignment on a key anal cancer study gives ONCY a clear regulatory item for readers to track. 7. 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. ONCY May Be One to Watch Closely Tomorrow Morning… ONCY is heading into the week with several items worth tracking: 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 showing an approx. 38% move over the last two weeks, we believe this is one to watch closely. ONCY will be on our screen first thing tomorrow morning—Monday, June 1, 2026. Make sure you keep an eye out for my next update, it could be hitting early. Sincerely, Gary Silver Managing Editor, Market Crux   MarketCrux.com (“MarketCrux” or “MC” ) is owned by Headline Media LLC, MC is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile MC brings to your attention. Any emojis used do not have a specific defined meaning, and may be used inconsistently. We do not provide personalized in-vest-ment advice, are not in-vest-ment advisors, and any profiles we mention are not suitable for all in-vest-ors. Pursuant to an agreement between Headline Media LLC and TD Media LLC, Headline Media 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 Headline Media LLC seven thousand five hundred USD (“Funds”). To date, including under the previously described agreement, Headline Media 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 Headline Media LLC, TD Media LLC and their member own shares of (ONCY:US). Please see important disclosure information here: https://marketcrux.com/disclosure/oncy-x06lE/#details

Headline Media | 7901 4th Street N, Suite 300, St. Petersburg, FL 33702 Unsubscribe Update Profile | About our service provider Sent by gary@marketcrux.net