Tuesday's Radar: (Nasdaq: ONCY) Grabs Our Full Focus With 7 Key Potential Catalysts

On September 10th, Oncolytics Biotech Inc. (Nasdaq: ONCY)

Any content you receive is for information purposes only. Always conduct your own research. *Sponsored Tuesday's Radar: (Nasdaq: ONCY) Grabs Our Full Focus With 7 Key Potential Catalysts *Get Our Updates Faster—Tap Here To Receive SMS Alerts* September 15th Greetings, Friend! On September 10th, Oncolytics Biotech Inc. (Nasdaq: ONCY) released preclinical findings almost nobody outside oncology noticed. Pelareorep, the company’s lead therapy, was paired with a pan-RAS inhibitor in colorectal cancer models. Tumors shrank, and, more to the point, neither agent got in the other’s way. Chief Medical Officer Dr. Thomas Heineman called it “an encouraging first look at combining pelareorep with one of the most important emerging classes of targeted cancer therapies.” That quiet release capped a busy eight months. Since March, ONCY has launched a randomized colorectal trial, reported durable responses in a hard-to-treat population, won a manufacturing patent running into 2044, collected a third Fast Track designation, and obtained written FDA feedback supporting a pivotal expansion of a trial already enrolling patients. The record behind that run is specific. In REO 022, a study of second-line KRAS-mutant, microsatellite-stable metastatic colorectal cancer, pelareorep with bevacizumab and FOLFIRI produced a 33% objective response rate against a 6% to 11% historical benchmark, a 19.5-month median duration of response against four to six months, and 27-month median overall survival against 11.2 months. The anal carcinoma data carry a similar shape. In the GOBLET study, pelareorep paired with a checkpoint inhibitor delivered roughly a 30% objective response rate, a 15.5-month median duration of response versus 9.5 months historically, and 82% survival at twelve months versus 45.7%. Patients who progress after first-line treatment have no FDA-approved options today, a gap the company sizes near $1Bn in annual U.S. spending. All three programs sit on one asset. Pelareorep is described by the company as a first-in-class double-stranded RNA immunotherapeutic agent, with a safety profile demonstrated in over 1,300 patients. Sources: Oncolytics Biotech Press Releases May 4th & March 2nd Behind The Scenes The shift shows up in management’s own words. When the agency’s written response landed in August, CEO Jared Kelly said the company was “thrilled with the response provided by the FDA” and believed the feedback “could support a highly efficient path to potentially transition REO 033 from its ongoing randomized Part A directly into a pivotal Part B.” A month earlier, the operational update read less like a science bulletin and more like a build-out report. Half the planned sites were active by the end of July, more than 20 patients had been pre-identified, and Rutgers Cancer Institute of New Jersey came online under study lead Dr. Sanjay Goel. An initial Part A response update is guided for year-end 2026, with Part B enrollment anticipated in early 2027. About The Company: Oncolytics Biotech Inc. Oncolytics Biotech is a clinical-stage biopharmaceutical company based in San Diego, California, with shares listed on Nasdaq as ONCY. It has one clinical asset, pelareorep, and no commercial revenue today. The model is direct: carry pelareorep through late-stage testing in gastrointestinal indications, then reach registration alone or with a partner. Their pipeline spans three registration-directed settings: second-line RAS-mutant MSS colorectal cancer, later-line unresectable squamous cell anal carcinoma, and first-line metastatic pancreatic ductal adenocarcinoma. Their anal and pancreatic pivotal studies are listed as seeking partnership. Collaborators include Roche, Pfizer, Merck Serono, Incyte and Adlai Nortye. More Report Sources: ONCY Website. ONCY Presentation. The Shift Now Underway The change at ONCY is one of posture. For most of its history the company produced proof-of-concept signals. Over the past year it has converted them into agreed trial designs. The FDA aligned on a pivotal pancreatic design with overall survival as the primary endpoint (pancreatic alignment), on a randomized pivotal design in anal carcinoma (April 27th, 2026), and now on a registration-directed expansion in colorectal cancer. In June, a new U.S. patent extended protection over commercial-scale manufacturing into 2044, with a pending method-of-use filing that could reach 2046. The September pan-RAS work hints at where the platform travels next. Sources: Market.us Media (colorectal, 2025), Fortune Business Insights (pancreatic, 2025), Market Research Future (anal, 2025). 7 Potential Catalysts Putting (Nasdaq: ONCY) At The Top Of Our Watchlist #1. FDA Feedback Opens A Direct Line To A Pivotal Study. August feedback confirmed response rate and duration can support accelerated approval in second-line RAS-mutant MSS colorectal cancer, letting ONCY carry an enrolling trial into a registration-directed expansion rather than start over. #2. First Tumor Response Data Expected Before Year-End. Management has guided to an initial Part A response update by the end of 2026, putting ONCY on a defined near-term news calendar rather than an open-ended one. #3. Three Fast Track Designations Across Gastrointestinal Cancers. July’s designation in anal carcinoma was the third granted to pelareorep, giving ONCY earlier and more frequent agency contact across all three programs. #4. Manufacturing Patent Extends Commercial Coverage Into 2044. A new U.S. patent covers the methods used to produce pelareorep at commercial scale, and ONCY has said a pending method-of-use filing could stretch coverage into 2046. #5. Analyst Targets Sit Well Above Recent Chart Levels. TipRanks has compiled a list of analyst targets that have all been reiterated over the past year and stand at or above $3.00 each. Each of those targets point to a potential triple-digit upside. #6. A Combination Path Into The RAS-Targeted Therapy Class. September preclinical work showed no antagonism when pelareorep was paired with a pan-RAS inhibitor, placing ONCY beside one of the fastest-moving target classes in oncology. #7. Partnership Framework Already Built With Large Pharmaceutical Names. Collaborations with Roche, Pfizer, Merck Serono, Incyte and Adlai Nortye give ONCY access to partner agents, and its pipeline page lists two pivotal programs as seeking partnership. In Closing Clinical-stage biotechnology runs on long odds and longer timelines, and nothing here changes that arithmetic. What has changed at Oncolytics Biotech Inc. (Nasdaq: ONCY) is the shape of the questions in front of it. A year ago the open question was whether regulators would accept the company’s reading of its data. Today the designs are agreed, the sites are active and the readouts are scheduled. The next marker is close. For readers who track emerging themes before they reach consensus, ONCY should earn a slot on your watchlist and a closer read of the filings while the calendar is still ahead of it. We’re initiating coverage on Oncolytics Biotech Inc. (Nasdaq: ONCY). Be on the lookout for updates heading out soon. Talk again shortly. All the best, Dane James Editor Market Pulse Today (Remember: St-ock Prices Could Be Significantly Lower Now From The Original Dates I Provided.) *MarketPulseToday.com (“MarketPulseToday” or “MPT” ) is owned by Thousand Sun Media LLC, MPT is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile MPT 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 Thousand Sun Media LLC and TD Media LLC, Thousand Sun Media LLC has been hired for a period beginning on 09/14/2026 and ending on 09/15/2026 to publicly disseminate information about (ONCY:US) via digital communications. Under this agreement, TD Media LLC has paid Thousand Sun Media LLC seven thousand five hundred USD ("Funds"). To date, including under the previously described agreement, Thousand Sun Media LLC has been paid thirty thousand USD ("Funds"). These Funds were part of the ninety thousand USD funds that TD Media LLC received from Oncolytics Biotech Inc., the issuer of (ONCY:US). Neither Thousand Sun Media LLC, TD Media LLC and their member own shares of (ONCY:US). Please see important disclosure information here: https://marketpulsetoday.com/disclosure/oncy-2gfeg/#details

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