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Oncolytics Biotech Inc. (Nasdaq: ONCY) Is Topping The Krypton Street Watchlist This Morning
—Monday, September 14, 2026…
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September 14, 2026 Dear Reader, The opening bell is nearly here, and Oncolytics Biotech Inc. (Nasdaq: ONCY) is still topping our watchlist. With regulatory progress, encouraging clinical benchmarks, and another major data point expected later this year, this morning’s setup deserves a close look. Gastrointestinal cancers are the fastest-growing cancer category among adults under 50 worldwide… And yet, for some of the most aggressive subtypes — second-line metastatic colorectal cancer, advanced anal cancer, metastatic pancreatic cancer — the treatment options remain startlingly thin. Colorectal cancer alone accounts for roughly 1.9M new diagnoses globally each year. Pancreatic cancer carries a five-year metastatic survival rate of just 3%. And in advanced squamous cell anal carcinoma, patients whose disease progresses after front-line therapy currently have zero FDA-approved options. These are indications where the unmet need is enormous, the patient populations are well-defined, and the current standard-of-care options leave significant room for improvement. That's the backdrop one clinical-stage company has been building into for years… Oncolytics Biotech Inc. (Nasdaq: ONCY) is a San Diego-based immunotherapy company developing pelareorep, a first-in-class double-stranded RNA immunotherapy with a dual mechanism of action. Pelareorep selectively replicates inside tumor cells while simultaneously activating both innate and adaptive immune responses — converting immunologically "cold" tumors to "hot." It's a fundamentally different approach to treating solid tumors… And across three separate gastrointestinal cancer programs, the clinical data is stacking up in ways that warrant serious attention. Which is just some of the reasons why (ONCY) is topping our watchlist this morning—Monday, September 14, 2026.
Three analysts currently cover (ONCY) with bullish ratings… Jason McCarthy of Maxim Group carries a $3 target, while Patrick Trucchio of H.C. Wainwright and Chad Messer of Lake Street each carry $5 targets — suggesting more than 500% upside from the recent $.75 range. The Numbers Behind the Momentum
The clinical signal from pelareorep is not subtle. In second-line KRAS-mutant metastatic colorectal cancer (mCRC), the REO 022 study showed a progression-free survival of 16.6 months compared to 5.7 months for standard-of-care benchmarks. Overall survival reached 27 months versus 11.2 months. The objective response rate came in at 33%, compared to just 6-11% for benchmarks… And the median duration of response reached 19.5 months — compared to 4 to 6 months for recently approved targeted therapies in the space. Those represent 2-3x improvements across nearly every key endpoint. This is a patient population defined by RAS mutations — the same mutations that drive resistance to many existing therapies and have historically made these tumors among the hardest to treat. When a clinical-stage compound produces that kind of separation from established benchmarks in a second-line setting, the data warrants a hard look. In advanced squamous cell anal carcinoma (SCAC), the GOBLET study showed a 30% objective response rate — more than double the historical benchmarks in that setting. Duration of response hit approximately 15.5 months versus 9.5 months for the current approved therapy. The 12-month overall survival rate was 82% compared to 45.7%. And this is in a patient population where no FDA-approved therapies exist after the current front-line regimen. Then there's pancreatic cancer, widely regarded as oncology's toughest challenge… In first-line metastatic pancreatic ductal adenocarcinoma, pelareorep-based therapy demonstrated a 2-year survival rate of approximately 22% versus roughly 9.2% across multiple comparator arms from landmark studies — a ~2.5x improvement that stands out in an indication where no immunotherapy has been approved. The compound has now been administered to more than 1,200 patients across multiple cancer types. Preclinical biopsy data has confirmed pelareorep replication in nearly all evaluated tumor types, and a pooled safety analysis of over 500 patients found no maximum tolerated dose — with the therapy described as "generally well-tolerated." That safety profile matters. It means pelareorep can be layered onto existing standards of care without adding a significant burden on patients — a critical feature for a compound designed to work in combination across multiple tumor types and treatment settings. Three Fast Tracks and a Registrational Path the FDA Agreed To
What distinguishes Oncolytics Biotech Inc. (Nasdaq: ONCY) at this stage is the density of regulatory milestones packed into a remarkably short window. Pelareorep now holds three separate Fast Track designations from the FDA — in colorectal cancer (February 2026), anal cancer (July 2026), and pancreatic cancer (late 2022). Each designation validates the FDA's recognition that pelareorep addresses serious diseases with significant unmet medical needs. It also opens pathways for more frequent regulatory interactions, rolling review of a future application, and potential Priority Review eligibility — tools that can meaningfully compress the timeline from late-stage development to a potential approval decision. But the August 18th announcement may carry the most weight for anyone watching this name… The FDA provided written alignment on a potential pivotal Part B expansion of REO 033, the company's ongoing controlled study in second-line RAS-mutant MSS metastatic colorectal cancer. That feedback included alignment around the potential use of objective response rate to support an accelerated approval pathway… With progression-free survival supporting full approval. "We are thrilled with the response provided by the FDA and believe this feedback could support a highly efficient path to potentially transition REO 033 from its ongoing randomized Part A directly into a pivotal Part B," said Jared Kelly, CEO of Oncolytics Biotech Inc. (Nasdaq: ONCY). REO 033 is currently enrolling patients at 15-20 U.S. sites, with preliminary data expected in Q4 2026. For the anal cancer program, final GOBLET cohort 4 data is expected in the second half of 2026, and the company is seeking a partnership to advance toward a pivotal controlled study in that indication. A Platform That Keeps Expanding
Beyond the near-term clinical readouts, pelareorep is increasingly being developed as a platform immunotherapy with applications reaching well past its three lead programs… And the most recent preclinical data adds a new dimension to the story. On September 10th, Oncolytics Biotech Inc. (Nasdaq: ONCY) announced positive preclinical results combining pelareorep with a pan-RAS inhibitor in a RAS-driven colorectal cancer model. The results showed pelareorep activity was maintained in the presence of RAS inhibition without evidence of antagonism between the two therapies. That matters because acquired resistance remains a major limitation of RAS-targeted therapies… And pelareorep's unique mechanism may offer a way to deepen and prolong responses to that entire emerging class of targeted cancer therapy — potentially delaying the development of resistance that currently limits patient outcomes. "These results provide an encouraging first look at combining pelareorep with one of the most important emerging classes of targeted cancer therapies," said Thomas Heineman, MD, PhD, Chief Medical Officer. The company is expanding its preclinical evaluation across additional dosing schedules and tumor models, while also advancing combination programs with CAR-T therapies, bispecific antibodies, and antibody-conjugate platforms. The manufacturing profile adds another layer of appeal. Pelareorep is a non-genetically modified reovirus produced in Carlsbad, California, with high yield, low cost-of-goods, and no special handling requirements — characteristics that could translate to straightforward commercial-scale production across multiple indications. The intellectual property portfolio stands at 139 patents issued worldwide, with a new manufacturing patent extending protection to 2044 and method-of-use filings expected to provide coverage into 2046. The addressable market across pelareorep's three lead GI indications tells its own story… Colorectal cancer therapeutics represent approximately $20B growing at 4.7% CAGR to 2033, with immunotherapy holding the largest segment share. The U.S. anal cancer market represents an estimated $1B annual commercial opening with no approved second-line therapies. And the pancreatic cancer treatment space is projected to reach $3B with a 15% CAGR to 2032, per Fortune Business Insights. Combined, that's a platform targeting over $25B in addressable end markets — with pelareorep as the common thread. The leadership team brings relevant transactional and development experience to the table, including CEO Jared Kelly, who has led more than 50 transactions including a $2B acquisition, and CMO Thomas Heineman, with nearly 30 years of virology and oncology development expertise. 7 Reasons Why We Have (ONCY) Pulled Up Early This Morning—Monday, September 14, 2026…
1. FDA-Aligned Registrational Path: The FDA provided written alignment on a potential pivotal Part B expansion of REO 033 in second-line RAS-mutant MSS colorectal cancer, including a potential accelerated approval pathway based on objective response rate. 2. Three GI Fast Track Designations: Pelareorep has received Fast Track designation from the FDA in colorectal, anal, and pancreatic cancer — three high-unmet-need gastrointestinal indications that together represent a combined addressable market exceeding $25B. 3. Compelling REO 022 Data: In second-line KRAS-mutant mCRC, pelareorep combination therapy showed progression-free survival of 16.6 months versus 5.7 months, overall survival of 27 months versus 11.2 months, and a 33% objective response rate — a 2-3x improvement across key endpoints. 4. Strong Anal Cancer Signal: In advanced SCAC, the GOBLET study demonstrated a 30% objective response rate and 15.5-month duration of response — more than doubling historical benchmarks in a setting with no approved therapies following front-line standard of care. 5. Preclinical RAS Combination Data: September 2026 results confirmed pelareorep's biological compatibility with RAS inhibitors, opening the door to combination approaches aimed at delaying treatment resistance in one of oncology's most important emerging therapy classes. 6. Deep Safety and Patient Database: Pelareorep has been administered to more than 1,200 patients across multiple cancer types, with a well-characterized tolerability profile and no maximum tolerated dose identified — supporting its use in broad combination regimens. 7. Analyst Coverage: three analysts currently covering ONCY carry targets ranging from $3 to $5, pointing to significant upside potential from the recent $.75 range. Get Focused On (ONCY) This Morning…
For anyone following the oncology space for clinical-stage names with deep data, mounting regulatory momentum, and a clear registrational framework across multiple high-need indications… Oncolytics Biotech Inc. (Nasdaq: ONCY) is worth a closer look. We are fully focused on (ONCY) this morning. Get this one on your radar while it’s still early. My next update could be coming very shortly, keep an eye out for it. Sincerely, Alex Ramsay Co-Founder / Managing Editor Krypton Street Newsletter |
