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Business Update
Seeking Alignment on Turning REO 033 Into a Registration-Directed Trial
On July 13, 2026, Oncolytics Biotech, Inc. (NASDAQ: ONCY) provided a regulatory update for REO 033, an ongoing randomized study evaluating pelareorep, the company’s lead development product, in combination with folinic acid, fluorouracil, and irinotecan (FOLFIRI) and bevacizumab for the second-line treatment of patients with RAS-mutant, microsatellite stable (MSS) metastatic colorectal cancer (mCRC). Pelareorep is a systemically delivered oncolytic virus designed to selectively replicate in cancer cells and enhance anti-tumor immunity
Oncolytics intends to leverage the existing clinical infrastructure for the multi-part REO 033 study to potentially accelerate development of pelareorep. The company expects approximately half of planned clinical sites to be activated by the end of July 2026, with remaining sites to be activated by the end of August 2026. We anticipate Part A of the study, which is planned to enroll 60 patients, could achieve accelerated enrollment during the second half of 2026, with Oncolytics reporting that more than 20 patients having already been pre-identified at participating trial sites.
The company will be conducting a Type D meeting with the FDA to discuss the addition of Part B to the REO 033 study. Part B is expected to be a larger randomized cohort intended to potentially support registration while preserving the core elements of the ongoing study. Key areas for regulatory alignment include trial size, endpoint strategy, statistical considerations, and the appropriate approval pathway.
Alignment with the FDA could enable Oncolytics to expand the existing randomized study into a registration-directed program rather than initiating a separate Phase 3 trial, potentially reducing timelines for pelareorep in second-line RAS-mutant MSS mCRC. The FDA has up to 30 days to provide feedback following the meeting, and we anticipate additional clarity from the company following receipt of the formal meeting minutes.
The REO 033 study builds upon results generated in the prior REO 022, for which Oncolytics recently provided updated durability data. Those results demonstrated a 19.5-month median duration of response in second-line RAS-mutant MSS mCRC patients, in addition to previously reported median overall survival (OS) of 27.0 months. These results compare favorably to established benchmarks for FOLFIRI plus bevacizumab in the second-line setting. Across prospective trials and real-world studies, objective response rates for FOLFIRI-based regimens in previously treated mCRC are typically in the range of ~6–11%, with median PFS of approximately 5–7 months and median OS of approximately 11–13 months (Bennouna et al., 2013; Iwamoto et al., 2015). While cross-trial comparisons should be interpreted with caution, the magnitude of improvement observed with pelareorep, particularly in a molecularly defined, poor-prognosis RAS-mutant population, suggests the potential for meaningful clinical benefit beyond cytotoxic therapy alone.
Conclusion
We view the upcoming Type D meeting with the FDA regarding the potential expansion of REO 033 into a registration-directed study as an important inflection point for Oncolytics. FDA feedback will be critical in determining the trial design, endpoint strategy, and regulatory pathway required to support potential registration. Importantly, a successful regulatory alignment could allow Oncolytics to leverage an ongoing randomized trial rather than restart development with a de novo pivotal study, potentially preserving time and capital. We look forward to an update from the company following the receipt of the meeting minutes. With no changes to our model, our valuation remains at $6 per share.
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