Oncolytics Biotech® to Prioritize Registration-Focused Programs in Anal and Colorectal Cancer
Rhea-AI Summary
Oncolytics (Nasdaq: ONCY) will prioritize registrational development of pelareorep in squamous cell anal cancer (SCAC) and metastatic colorectal cancer (CRC) after concluding GOBLET enrollment. The company plans an FDA meeting in mid-April to align on a single‑arm SCAC registrational study, believes a trial well under 100 subjects could support approval, and has sufficient cash to avoid immediate material dilution.
Oncolytics stopped further enrollment in GOBLET Cohort 5 PDAC arms at approximately 20 patients per arm and will continue to follow enrolled patients for mature results.
Positive
- Planned FDA meeting in mid-April 2026 to align on registrational design
- Company believes a SCAC registrational trial of well under 100 subjects could support approval
- Sufficient cash on hand to execute near-term milestones and avoid immediate dilution
- GOBLET Cohort 4 showed a promising efficacy signal defining a clear registrational path
Negative
- Stopped further enrollment in GOBLET Cohort 5 PDAC at ~20 patients per arm, limiting PDAC development
- Winding down GOBLET enrollment shifts resources away from broader GI indications
News Market Reaction – ONCY
On the day this news was published, ONCY gained 6.60%, reflecting a notable positive market reaction. Argus tracked a peak move of +7.2% during that session. Argus tracked a trough of -2.7% from its starting point during tracking. Our momentum scanner triggered 14 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $8M to the company's valuation, bringing the market cap to $128M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
ONCY is up 9.96% while close oncology peers show mixed moves: GNLX (+2.66%), HURA (+9.73%), ZURA (+6.87%) versus ACTU (-10.9%) and CRDF (-1.89%). Scanner momentum flags other biotech names (GLSI, AVTX) but ONCY’s move appears stock-specific.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 04 | Fast Track designation | Positive | +2.5% | FDA Fast Track for pelareorep regimen in 2L KRAS-mutant MSS mCRC. |
| Jan 14 | Leadership appointments | Positive | +5.0% | New EVP Strategy and Head of Biostatistics for late-stage programs. |
| Jan 12 | GOBLET Cohort 4 data | Positive | +2.5% | Updated anal cancer data showing durable responses with pelareorep combo. |
| Jan 09 | Jurisdiction change plan | Neutral | -2.4% | Proposal to domesticate from Alberta to Nevada for U.S. alignment. |
| Jan 08 | IP strategy update | Positive | +3.2% | Patent strategy aiming to extend pelareorep protection and support launches. |
Recent ONCY news, especially clinical and strategic updates, has generally been followed by positive share reactions, indicating a pattern of market support for pelareorep development milestones.
Over the past months, Oncolytics has steadily advanced pelareorep. On Jan 12, 2026, updated GOBLET Cohort 4 data in third-line anal cancer showed activity that supported further development. Two days later, on Jan 14, 2026, the company strengthened late-stage capabilities with senior strategy and biostatistics hires. On Feb 4, 2026, pelareorep combinations in KRAS‑mutant MSS metastatic colorectal cancer received FDA Fast Track Designation. Additional updates on IP strategy and U.S. domestication rounded out a transition toward U.S.-focused, registration-directed programs, consistent with today’s GI cancer prioritization.
Market Pulse Summary
The stock moved +6.6% in the session following this news. A strong positive reaction aligns with Oncolytics’ pattern of share gains following clear pelareorep milestones. The company highlighted a registration-focused path in SCAC and CRC, winding down broader GOBLET work while noting sufficient cash to avoid near-term dilution. Prior Fast Track news and GOBLET data also drew constructive moves. Investors may weigh this focus against modest trading volume of 1,138,804 shares and the stock’s position below its $1.51 52-week high.
Key Terms
squamous cell anal cancer medical
metastatic colorectal cancer medical
metastatic pancreatic ductal adenocarcinoma medical
overall survival medical
single-arm technical
AI-generated analysis. Not financial advice.
Company to wind down the GOBLET gastrointestinal study to focus on registration path in the U.S.
With sufficient cash on hand to execute near-term milestones, the Company expects to avoid immediate material dilution
SAN DIEGO, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has concluded enrollment in the GOBLET study, having generated the necessary clinical and translational data to inform its next phase of development. With sufficient cash on hand to execute near-term milestones, the Company will now focus its efforts and resources on registrational and registration-enabling studies in squamous cell anal cancer (“SCAC”) and metastatic colorectal cancer (“CRC”).
“GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution.”
The promising efficacy signal observed in GOBLET Cohort 4 has defined a clear registrational path for pelareorep-based therapy in second-line and later SCAC, a setting in which available therapies offer only limited benefit. The Company is planning to move quickly to pursue regulatory approval through a U.S.-based study to ensure the enrollment of patients representative of the current standard of care.
Oncolytics expects to meet with the U.S. Food and Drug Administration (“FDA”) in mid-April. The objective of this meeting is to align on the design of a single-arm SCAC registrational study. Based on the observed efficacy signal in GOBLET Cohort 4, the Company believes a clinical trial of well under 100 subjects will be sufficient to secure FDA approval in this rare cancer indication.
Given its strategic focus on SCAC and CRC, and the desire to deploy capital efficiently, Oncolytics has elected to stop further enrollment in the GOBLET Cohort 5 metastatic pancreatic ductal adenocarcinoma (“PDAC”) cohorts at approximately 20 patients per arm. The Company believes the available data are sufficient to inform its future PDAC strategy while limiting additional spend on this indication at this time.
Current enrollment in GOBLET Cohort 5 allows responses to therapy, including overall survival, to be analyzed. The Company will continue to follow Cohort 5 patients currently on study, monitor their responses, and plan to report results once the data reach maturity.
“The GOBLET study has provided invaluable insights into the efficacy and safety of pelareorep in gastrointestinal cancers,” said Thomas Heineman, MD, Chief Medical Officer of Oncolytics. “These data have provided crucial support for our platform approach in GI cancers. They have, in fact, allowed us to identify a clear and efficient path forward as we move into registration-focused development of pelareorep in GI cancers.”
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
- Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
- Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
- Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
- Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
- Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the anticipated design, size, protocols strategy, priorities, timelines, milestones, and outcomes of current and future studies; the Company’s expectations regarding its cash position, liquidity, and funding requirements; the Company’s goals, strategies, and objectives; anticipated timelines and objectives for future meetings with regulatory bodies, including the FDA; and its belief in the clinical promise of pelareorep in anal, colorectal and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
oblaschak@lifescicomms.com
FAQ
What did Oncolytics (ONCY) announce on February 24, 2026 about trial focus?
When will Oncolytics (ONCY) meet the FDA to discuss the SCAC registrational study?
How large does Oncolytics (ONCY) expect the SCAC registrational trial to be?
What change did Oncolytics (ONCY) make to GOBLET Cohort 5 PDAC enrollment?
Will Oncolytics (ONCY) report additional GOBLET results after stopping enrollment?
Does Oncolytics (ONCY) expect immediate shareholder dilution after this strategy shift?
