Pelareorep treatment drives coordinated immune activation and tertiary lymphoid structure formation Translational data suggest potential to boost response to immunotherapy and targeted therapy in RAS-driven tumors Pelareorep’s ability to engage the innate and adaptive immune system results in doubling or nearly tripling response rates in breast and gastrointestinal cancers SAN DIEGO, March 19, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage ...

Core Insights - Oncolytics Biotech Inc. has initiated a Phase 2 study for pelareorep in metastatic colorectal cancer, aiming to confirm previous efficacy data with preliminary results expected by the end of 2026 [1][2] Study Design and Objectives - The trial will involve second-line RAS-mutated, microsatellite-stable mCRC patients, randomized to either a control arm (bevacizumab and FOLFIRI) or an experimental arm (pelareorep, bevacizumab, and FOLFIRI) [2] - Each arm is expected to enroll 30 patients who have failed initial platinum-based chemotherapy, with the primary endpoint being objective response rate (ORR) [2] - Secondary endpoints include progression-free survival (PFS), overall survival (OS), safety, and biomarker analysis [2] Previous Study Results - The prior REO 022 study showed promising results with a median OS of 27 months and median PFS of 16.6 months for pelareorep, significantly better than the standard-of-care median OS of 11.2 months and PFS of 5.7 months [3] - The ORR for pelareorep-containing therapy was 33%, compared to approximately 10% for standard treatment [3] Regulatory Designation - Pelareorep in combination with bevacizumab and FOLFIRI has received Fast Track Designation from the U.S. FDA for second-line KRAS-mutant, MSS mCRC [3][6] Clinical Implications - The potential to improve clinical outcomes in the second-line setting could significantly benefit patients globally affected by colorectal cancer [4] - An effective immunotherapy could enhance treatment options, especially as younger patients are increasingly diagnosed with colorectal cancer [4] Company Overview - Oncolytics Biotech Inc. is a clinical-stage biotechnology company focused on developing pelareorep, an investigational immunotherapeutic agent designed to activate immune responses against cancer [5] - The company is also pursuing strategic partnerships to accelerate development and maximize commercial impact [6]

Core Viewpoint - Oncolytics Biotech Inc. has decided to wind down the GOBLET gastrointestinal study to concentrate on the registration path for its investigational drug pelareorep in the U.S. for specific cancer indications [2][3]. Group 1: Study Conclusion and Focus Shift - The company has concluded enrollment in the GOBLET study, having gathered sufficient clinical and translational data to inform its next development phase [2]. - Oncolytics will now focus its resources on registrational studies for squamous cell anal cancer (SCAC) and metastatic colorectal cancer (CRC) [2][3]. - The promising efficacy signal observed in GOBLET Cohort 4 has defined a clear path for regulatory approval in second-line and later SCAC, where current therapies provide limited benefits [3]. Group 2: Regulatory Plans - Oncolytics plans to meet with the U.S. Food and Drug Administration (FDA) in mid-April to align on the design of a single-arm SCAC registrational study [4]. - The company believes that a clinical trial involving fewer than 100 subjects will be sufficient to secure FDA approval for this rare cancer indication [4]. Group 3: Enrollment and Data Analysis - The company has decided to stop further enrollment in GOBLET Cohort 5 for metastatic pancreatic ductal adenocarcinoma (PDAC) at approximately 20 patients per arm, believing the existing data is adequate to inform future strategies [5]. - Current enrollment in GOBLET Cohort 5 will allow for analysis of therapy responses, including overall survival, and the company will continue to monitor these patients [6]. Group 4: Insights from GOBLET Study - The GOBLET study has provided valuable insights into the efficacy and safety of pelareorep in gastrointestinal cancers, supporting the company's platform approach in this area [7]. - The study is a phase 1/2 multiple indication study conducted at 17 centers in Germany, focusing on various treatment combinations for advanced or metastatic gastrointestinal tumors [7][10]. Group 5: About Oncolytics Biotech Inc. - Oncolytics is a clinical-stage biotechnology company developing pelareorep, which has shown encouraging results in multiple cancer studies and is designed to activate immune responses against tumors [10][11]. - The company is actively pursuing strategic partnerships to accelerate development and maximize commercial impact [11].

Market Overview - Gold prices have surpassed $5,000 per ounce, indicating a significant increase in value [1] - The White House has allocated $12 billion for critical mineral stockpiling, reflecting a strategic move towards resource security [2] - The FDA approved over 50 oncology treatments in 2025, showcasing rapid advancements in the healthcare sector [3] Company Highlights - **VisionWave Holdings (NASDAQ: VWAV)**: The company is developing an AI-controlled intelligent radar system with a distributed mesh decoy architecture, which could enhance operational efficiency compared to traditional radar systems [3][4] - **Starfighters Space (NYSE-A: FJET)**: The company is progressing to the Critical Design Review for STARLAUNCH 1, supported by GE Aerospace. This follows successful wind tunnel tests at speeds of Mach 0.85 and Mach 1.3 [5][6] - **Ares Strategic Mining (CSE: ARS / OTCQX: ARSMF)**: Ares holds the only permitted domestic source of fluorspar in the U.S. and has secured a $168.9 million contract with the Pentagon, with potential task orders reaching $250 million [6][7] - **Lake Victoria Gold (TSXV: LVG / OTCQB: LVGLF)**: The company reported drilling results confirming mineralization at its Imwelo Gold Project, with notable gold grades of 11.88 g/t over 1.33m and continuity extending beyond historical limits [8][9] - **Oncolytics Biotech (NASDAQ: ONCY)**: The company received FDA Fast Track Designation for its treatment in colorectal cancer, showing a 33% response rate compared to ~10% with standard chemotherapy, significantly improving patient outcomes [10][11]

Core Insights - The FDA has granted Fast Track Designation to Oncolytics Biotech's pelareorep for treating KRAS-mutant MSS metastatic colorectal cancer, indicating its potential as an immunotherapeutic platform in gastrointestinal cancers [1][2][3] Clinical Data - Pelareorep-based therapy shows a 33% objective response rate (ORR), significantly higher than the approximately 10% ORR with standard-of-care (SOC) [2] - The median progression-free survival (PFS) for pelareorep is 16.6 months, compared to 5.7 months with SOC, and the median overall survival (OS) is 27 months, compared to 11.2 months with SOC [2] Market Potential - There are approximately 2 million new colorectal cancer cases globally each year, with a total addressable market of $3-5 billion for the second-line KRAS-mutant MSS mCRC subgroup [2] Future Plans - The company plans to initiate a controlled clinical study comparing SOC alone versus SOC plus pelareorep, with the first clinical site expected to be activated in March 2026 and interim data anticipated by year-end [1][2] Regulatory Benefits - Fast Track Designation allows for more frequent communication with the FDA, potentially leading to Accelerated Approval and Priority Review if criteria are met [3]

Core Viewpoint - Oncolytics Biotech Inc. announced the results of its Special Meeting of Shareholders, where all proposed resolutions were approved, facilitating the company's transition and incentive plan [1][2]. Group 1: Voting Results - The Continuance Resolution was approved with 14,994,075 votes (85.21%) in favor and 2,602,405 votes (14.79%) against [3]. - The Domestication Resolution received 15,304,574 votes (86.98%) for and 2,291,905 votes (13.02%) against [3]. - The 2026 Incentive Award Plan Resolution was supported by 13,508,657 votes (76.77%) while 4,087,822 votes (23.23%) were against [3]. Group 2: Company Developments - The approval of the resolutions allows Oncolytics to transition from Alberta to British Columbia and then to Nevada, with the 2026 Incentive Award Plan expected to take effect by the end of Q1 2026 [4]. - Oncolytics is focused on developing pelareorep, an investigational immunotherapeutic agent, which has shown promising results in various cancer studies [5]. - The company is advancing pelareorep in combination with chemotherapy and checkpoint inhibitors for metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA [6].

Group 1 - Oncolytics Biotech, Inc. held a Special Meeting of Shareholders, chaired by Chief Financial Officer Kirk Look [2][3] - The meeting included participation from key management members, including CEO Jared Kelly and other directors [3] - The virtual platform used for the meeting ensures shareholder rights are protected and allows for participation similar to past in-person meetings [5] Group 2 - Voting will be conducted by a poll, allowing every registered shareholder and proxy holder with a control number to vote on each matter [5] - The meeting acknowledged the possibility of unexpected technical glitches and expressed appreciation for shareholder patience [4] - The service providers for the virtual platform are experienced in managing such meetings [4]

Financial Data and Key Metrics Changes - The meeting discussed the approval of the Continuance Resolution and Domestication Resolution, which were passed by a majority of not less than two-thirds of the votes cast [19] - The 2026 Incentive Award Plan was also approved by a majority of the votes cast [19] Business Lines Data and Key Metrics Changes - No specific data or metrics related to individual business lines were provided during the meeting Market Data and Key Metrics Changes - No specific market data or metrics were discussed during the meeting Company Strategy and Development Direction - The company is transitioning from Alberta to British Columbia and then domesticate to Nevada, indicating a strategic shift in its operational base [9][12] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting Other Important Information - The meeting was conducted virtually, ensuring shareholder rights were protected and allowing participation similar to in-person meetings [3][4] - The voting results will be filed on SEDAR and made available on the company's website [20] Q&A Session Summary - No specific questions were raised during the meeting regarding the motions presented [12][15][18][22]

Financial Data and Key Metrics Changes - The meeting discussed the approval of the Continuance Resolution and Domestication Resolution, which were passed by a majority of not less than 2/3 of the votes cast [19] - The 2026 Incentive Award Plan also received majority approval from the votes cast [19] Business Line Data and Key Metrics Changes - No specific business line data or key metrics were provided during the meeting Market Data and Key Metrics Changes - No specific market data or key metrics were discussed during the meeting Company Strategy and Development Direction and Industry Competition - The company is transitioning from Alberta to British Columbia and then to Nevada, indicating a strategic move to potentially enhance operational flexibility and regulatory advantages [9][12] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting Other Important Information - The meeting was conducted virtually, ensuring shareholder rights were protected and participation was facilitated [3][4] - The voting results will be filed on SEDAR and made available on the company's website [20] Q&A Session All Questions and Answers - No specific questions were raised during the meeting regarding the motions presented [12][15][18][22]

Financial Data and Key Metrics Changes - The meeting discussed the approval of the Continuance Resolution and Domestication Resolution, which were passed by a majority of not less than two-thirds of the votes cast [20] - The 2026 Incentive Award Plan was also approved by a majority of the votes cast [20] Business Line Data and Key Metrics Changes - No specific business line data or key metrics were provided during the meeting Market Data and Key Metrics Changes - No specific market data or key metrics were discussed during the meeting Company Strategy and Development Direction - The company is transitioning from Alberta to British Columbia and then domesticated to Nevada, indicating a strategic move to align with favorable business regulations [9][12] Management Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting Other Important Information - The meeting was conducted virtually, ensuring shareholder rights were protected and participation was similar to past in-person meetings [3][4] - The voting process was outlined, allowing registered shareholders to vote on resolutions [5][6] Q&A Session Summary - No specific questions were raised during the meeting regarding the motions presented [12][15][18][23]