Oncolytics Biotech announced that enrollment in its GOBLET gastrointestinal study, a phase 1/2 program investigating pelareorep in advanced gastrointestinal cancers, has concluded. The study enrolled patients across five cohorts and the company will now reallocate resources to registration‑ready programs in squamous cell anal cancer (SCAC) and metastatic colorectal cancer (mCRC), while pausing further enrollment in the pancreatic cohort.
The decision follows strong clinical signals from the GOBLET cohorts. In mCRC, pelareorep‑based therapy achieved a 33% objective response rate versus roughly 10% for standard care, and produced a median progression‑free survival of 16.6 months and a median overall survival of 27 months. In SCAC, the combination of pelareorep with atezolizumab yielded a 29% objective response rate and a median duration of response of about 17 months, markedly exceeding historical benchmarks of 10% or less.
Oncolytics’ financial position is constrained, with negative free cash flow of $19 million in the last twelve months and a current ratio of 1.84. To conserve cash, the company has halted enrollment in the pancreatic cohort, which had reached approximately 20 patients per arm, and is focusing on indications with a clearer regulatory path.
Management emphasized that the GOBLET data have provided “invaluable insights into the efficacy and safety of pelareorep in gastrointestinal cancers” and that the company is “turning the corner from proof‑of‑concept studies and will be sprinting toward regulatory clarity for the remainder of the year.” The CEO noted that the data in SCAC, particularly in patients with two prior lines of therapy, point to a registration study in an indication with no approved therapies.
The company has a Fast Track designation from the FDA for pelareorep in KRAS‑mutant, microsatellite‑stable metastatic colorectal cancer in the second‑line setting, and a similar designation for pancreatic cancer. The pause in the pancreatic arm does not signal a loss of confidence but reflects a prioritization of resources toward indications with a more rapid path to market.
Analysts have noted that Oncolytics’ share price has risen 48.5% over the past year, driven by the strong clinical data and the company’s strategic focus on registration‑ready programs. However, the stock appears on an “Most Overvalued stocks list” according to InvestingPro, indicating that valuation concerns may temper enthusiasm.
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