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Oncolytics Biotech® to Prioritize Registration-Focused Programs in Anal and Colorectal Cancer
Globenewswire· 2026-02-24 14:00
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 tr ...
THE INFRASTRUCTURE REALIGNMENT: 5 Stocks Positioning for the 2026 Supply Imperative
Markets.Businessinsider.Com· 2026-02-20 15:10
VANCOUVER, British Columbia, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Equity InsiderMarket Intelligence Brief —WHAT’S HAPPENING:Gold above $5,000 per ounce[1]. The White House mobilized $12 billion for critical mineral stockpiling[2]. The FDA approved more than 50 oncology treatments in 2025 alone[3].Things are truly moving fast, and this report is going to help you see what’s driving the market so early in 2026.These five companies are positioned where defense, computation, infrastructure, and resource security i ...
Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer
Globenewswire· 2026-02-04 13:50
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]
Oncolytics Biotech® Announces Results of Special Meeting of Shareholders
Globenewswire· 2026-01-15 21:01
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].
Oncolytics Biotech Inc. (ONCY) Shareholder/Analyst Call Prepared Remarks Transcript
Seeking Alpha· 2026-01-15 16:16
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]
Oncolytics Biotech (ONCY) - 2026 FY - Earnings Call Transcript
2026-01-15 16:02
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]
Oncolytics Biotech (ONCY) - 2026 FY - Earnings Call Transcript
2026-01-15 16:02
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]
Oncolytics Biotech (ONCY) - 2026 FY - Earnings Call Transcript
2026-01-15 16:00
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]
The $185B Cancer Surge: Why the FDA's Fast-Track Pivot is Scaling a New Immunotherapy Era
Financialpost· 2026-01-14 15:40
Core Viewpoint - The article discusses the advertising and promotional efforts for Oncolytics Biotech Inc., highlighting its potential in the biotech sector and the associated financial implications for investors [1]. Group 1: Company Overview - Oncolytics Biotech Inc. is currently engaged in advertising and digital media efforts to enhance its visibility in the market [1]. - The company has been involved in the development of innovative cancer therapies, which positions it favorably within the biotech industry [1]. Group 2: Financial Implications - The article indicates that there may be third parties holding shares of Oncolytics Biotech Inc. who could liquidate their shares, potentially impacting the stock price negatively [1]. - The owner/operator of Market IQ Media Group, which promotes Oncolytics Biotech Inc., owns shares of the company and reserves the right to buy and sell shares at any time, indicating a potential conflict of interest [1].
Oncolytics Biotech® Appoints John McAdory as EVP of Strategy and Operations and Yujun Wu to Lead Biostatistics
Globenewswire· 2026-01-14 14:00
Core Viewpoint - Oncolytics Biotech Inc. has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics to enhance its operational, clinical, and regulatory capabilities as it advances registration-directed development programs in gastrointestinal cancers [1][4]. Group 1: Appointments and Roles - John McAdory will oversee clinical development execution, operational strategy, and regulatory readiness across the Company's portfolio, bringing extensive experience in leading late-stage oncology programs [2][3]. - Yujun Wu will lead Biostatistics, contributing expertise in statistical strategy, regulatory interactions, and late-stage trial design, having previously supported multiple clinical programs through late-stage development [3][4]. Group 2: Strategic Focus - The appointments support Oncolytics' strategic focus on advancing pelareorep through efficient regulatory pathways, prioritizing indications with high unmet medical need, including squamous cell anal cancer, pancreatic cancer, and KRAS-mutant colorectal cancer [4][10]. - The Company is actively pursuing accelerated approval strategies and pivotal trials, emphasizing the importance of high-quality statistical leadership at this critical time [4][10]. Group 3: Inducement Awards - In connection with their appointments, the Company granted inducement equity awards to Mr. McAdory and Mr. Wu, including stock options with an exercise price of US$0.97 [5][6]. - Mr. McAdory received an award of 300,000 restricted share units that will vest upon a material transaction, while he also received 500,000 stock options [7][8].