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ONCOLYTICS BIOTECH (ONCY)

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Recent press releases and 8-K filings for ONCY.

Oncolytics Biotech Receives FDA Fast Track Designation for Pelareorep
ONCY
New Projects/Investments
  • Oncolytics Biotech Inc. announced it has received FDA Fast Track Designation for its drug pelareorep in combination with bevacizumab and FOLFIRI for the treatment of second-line KRAS-mutant, microsatellite-stable metastatic colorectal cancer (mCRC). This designation allows for more frequent communication with the FDA and potential eligibility for Accelerated Approval and Priority Review.
  • The designation is supported by clinical data demonstrating significant improvements over standard-of-care, including a 33% objective response rate, 16.6-month progression-free survival, and 27-month overall survival.
  • The company estimates the annual total addressable market for this subgroup of patients to be approximately $3-5 billion.
  • Oncolytics plans to initiate a controlled clinical study in March, with interim data anticipated by year-end 2026.
3 days ago
Oncolytics Biotech's Pelareorep Receives FDA Fast Track Designation for Colorectal Cancer
ONCY
New Projects/Investments
  • Oncolytics Biotech Inc. (ONCY) has been granted FDA Fast Track Designation for its investigational therapy, pelareorep, in combination with bevacizumab and FOLFIRI for second-line KRAS-mutant, MSS metastatic colorectal cancer.
  • The designation is supported by clinical data demonstrating strong efficacy signals, including a 33% objective response rate (ORR), 16.6 months median progression-free survival (PFS), and 27 months median overall survival (OS), which represent a 2-3 times improvement over standard-of-care.
  • The annual total addressable market for the 2L KRAS-mutant MSS mCRC subgroup is estimated to be approximately $3-5 billion.
  • The company plans to initiate a controlled clinical study in March, with interim data anticipated by the end of 2026.
3 days ago
Oncolytics Biotech Strengthens Leadership and Advances Pelareorep in Late-Stage GI Cancer Trials
ONCY
Management Change
New Projects/Investments
  • Oncolytics Biotech Inc. is strengthening its leadership team with key hires, including John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, to support late-stage clinical trials for its cancer treatment, pelareorep.
  • The company's lead candidate, pelareorep, has shown compelling clinical data in gastrointestinal cancers, achieving a 33% response rate in colorectal cancer patients with KRAS mutations (three times better than standard therapy) and a 29% response rate in third-line anal cancer patients with responses lasting approximately 17 months.
  • Oncolytics Biotech has secured FDA agreement on its Phase 3 trial design for pancreatic cancer, positioning it to launch what would be the only immunotherapy registration trial currently planned for this disease.
8 days ago
Oncolytics Biotech Announces Executive Appointments and Clinical Milestones
ONCY
Management Change
New Projects/Investments
  • Oncolytics Biotech Inc. has strengthened its leadership team with the appointments of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, bringing deep expertise in late-stage oncology trial execution and regulatory strategy.
  • The company reported breakthrough efficacy data for pelareorep, achieving a 33% objective response rate in second-line KRAS-mutant metastatic colorectal cancer when combined with standard chemotherapy, tripling historical rates of 6-11%.
  • Pelareorep also showed a 29% objective response rate in third-line anal cancer, nearly tripling historical benchmarks, with a median duration of response of approximately 17 months.
  • Oncolytics has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease.
Jan 27, 2026, 3:50 PM
Oncolytics Biotech Reports Positive Clinical Data and Strengthens Scientific Advisory Board
ONCY
New Projects/Investments
  • Oncolytics Biotech Inc. (ONCY) recently released updated clinical data showing significant activity of its lead asset, pelareorep, in third-line metastatic anal cancer.
  • The company previously reported a 33% response rate in colorectal cancer on December 16.
  • Oncolytics expanded its Scientific Advisory Board on January 7 with experts from Memorial Sloan Kettering, signaling preparation for registration.
Jan 26, 2026, 3:13 PM
Oncolytics Biotech Shareholders Approve Corporate Restructuring and Incentive Plan
ONCY
Proxy Vote Outcomes
Executive Compensation
  • Oncolytics Biotech Inc. shareholders approved all items of business at a Special Meeting held on January 15, 2026.
  • Shareholders approved the Continuance Resolution with 85.21% For, authorizing the company to move from Alberta to British Columbia, and the Domestication Resolution with 86.98% For, authorizing the company to move from British Columbia to Nevada, USA.
  • The 2026 Incentive Award Plan Resolution was also approved with 76.77% For, which will become effective upon the completion of the Continuance and Domestication.
  • The company expects to consummate the Continuance and Domestication, and for the 2026 Incentive Award Plan to become effective, by the end of the first quarter of 2026.
Jan 15, 2026, 9:01 PM
Oncolytics Biotech Announces Updated Clinical Data for Pelareorep
ONCY
New Projects/Investments
  • Oncolytics Biotech Inc. announced updated clinical data demonstrating the activity of pelareorep in third-line metastatic anal cancer.
  • The findings from the GOBLET trial indicate that pelareorep is effective in gastrointestinal tumors, turning "cold" cancers into targets for the immune system.
  • This efficacy signal follows the company's recent recruitment of top oncologists from Memorial Sloan Kettering to its advisory board.
Jan 14, 2026, 3:15 PM
Oncolytics Biotech Provides Update on Intellectual Property Strategy and Patent Filings
ONCY
New Projects/Investments
  • Oncolytics Biotech, Inc. filed a Track 1 prioritized examination patent application in early Q3 2025 with the USPTO, focusing on manufacturing-related innovations for pelareorep.
  • If granted, this patent application could extend patent protection for pelareorep until 2044.
  • The company received initial feedback from the USPTO in Q4 2025 and expects a final action in Q3 2026 regarding this application.
  • Oncolytics plans to file additional patent applications for manufacturing and novel method-of-use covering therapeutic uses of pelareorep, which could provide IP protection beyond 2044.
Jan 12, 2026, 9:05 PM
Oncolytics Biotech Announces Updated Clinical Data from GOBLET Cohort 4 in Anal Cancer
ONCY
New Projects/Investments
  • In third-line metastatic squamous cell anal carcinoma (SCAC) patients, pelareorep-atezolizumab achieved an objective response rate (ORR) of approximately 29% and a median duration of response (DOR) of approximately 17 months (67 weeks).
  • This ORR compares favorably to historical third-line SCAC studies, which typically show an ORR of approximately 10% or less.
  • Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss guidance on a development plan for potential accelerated approval in this indication, which currently has no FDA-approved therapies.
  • In the second-line setting, pelareorep and atezolizumab achieved a 30% ORR and a median DOR of 15.5 months, outperforming the current standard of care.
Jan 12, 2026, 2:00 PM
Oncolytics Biotech Outlines Rationale for Proposed Jurisdiction Change to Nevada
ONCY
Proxy Vote Outcomes
New Projects/Investments
M&A
  • Oncolytics Biotech proposes to change its jurisdiction of incorporation from Alberta, Canada, to the State of Nevada in the United States.
  • The company's operations, management, shareholder base, and capital markets activity have become predominantly U.S.-based, and effective January 1, 2026, Oncolytics became a domestic issuer under SEC rules, leading to increased regulatory complexity.
  • This proposed domestication is intended to simplify regulatory structure, improve operational efficiency, and enhance access to U.S. capital markets, better positioning the company for future growth and strategic opportunities, including partnerships and potential M&A activity.
  • Shareholders of record as of December 9, 2025, will vote on the proposal at a special meeting scheduled for January 15, 2026.
Jan 9, 2026, 2:00 PM

Quarterly earnings call transcripts for ONCOLYTICS BIOTECH.