Core Insights - Pelareorep demonstrates significant potential in enhancing immune responses in RAS-driven tumors, particularly in breast and gastrointestinal cancers, with response rates doubling or tripling [1][2] Group 1: Treatment Efficacy - Pelareorep, in combination with atezolizumab and chemotherapy, shows a 62% objective response rate in first-line metastatic pancreatic cancer patients, more than double the historical response rates observed with chemotherapy alone [7][8] - New biomarker data from the Phase 1/2 GOBLET trial indicates that pelareorep can shift tumors towards a more immune-active state, leading to longer median progression-free survival of 7.5 months for patients with immune activation signatures compared to 5.6 months for those without [6] Group 2: Mechanism of Action - Pelareorep activates innate immune pathways through double-stranded RNA signaling, resulting in interferon production, dendritic cell activation, and cytotoxic T-cell priming [1] - The treatment promotes the formation of tertiary lymphoid structures (TLS), which enhance anti-tumor immune responses and may convert immunologically cold tumors into hot tumors, making them more susceptible to immunotherapy [3][10] Group 3: Clinical Trials and Studies - The GOBLET study is a Phase 1/2 trial exploring pelareorep in advanced or metastatic gastrointestinal tumors, focusing on objective response rates, disease control rates, and safety [11] - AWARE-1 is a window-of-opportunity study evaluating pelareorep in early-stage breast cancer, showing that 60% of patients experienced significant increases in their CelTIL score, indicating enhanced immune activity [13] Group 4: Market Potential and Unmet Needs - RAS mutations are prevalent in aggressive cancers, with approximately 95% of pancreatic cancers and 45% of colorectal cancers affected, highlighting a significant unmet clinical need that pelareorep aims to address [2] - The company is actively pursuing strategic partnerships to accelerate the development of pelareorep and maximize its commercial impact in the oncology market [17]

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].

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].

Oncolytics Biotech PELAREOREP a transformative dsRNA immunotherapy platform for gastrointestinal tumors January 2026 Forward-Looking Statements Oncolytics Biotech Confidential This presentation is strictly confidential. Neither the Securities and Exchange Commission nor any state or foreign securities commission or regulatory authority has passed upon the adequacy or accuracy of this presentation. Any representation to the contrary is a criminal offense. This presentation does not constitute an offer to sel ...

Core Insights - The combination of pelareorep and atezolizumab has shown a nearly tripled objective response rate (ORR) compared to historical benchmarks, achieving an ORR of approximately 29% in a heavily pretreated population of third-line metastatic squamous cell anal carcinoma (SCAC) patients [1][3][5] - The median duration of response (DOR) for this combination therapy is approximately 17 months, indicating significant clinical benefit in a setting with no FDA-approved therapies [1][3][5] Clinical Data Summary - In the updated GOBLET Cohort 4, four out of 14 evaluable patients achieved objective responses, including two complete responses and two partial responses [3][4] - Historical studies in third-line SCAC typically report an ORR of around 10% or less, highlighting the potential of pelareorep plus atezolizumab in addressing unmet medical needs [4][5] Development Strategy - Oncolytics plans to pursue a registration study based on the promising data from GOBLET Cohort 4, aiming for accelerated approval from the FDA [7] - The company has received initial positive feedback from key opinion leaders (KOLs) and the FDA, with a Type C meeting scheduled for Q1 2026 to discuss the development plan [7]

Group 1: Leadership and Strategic Developments - Oncolytics Biotech Inc. has strengthened its leadership by appointing Dr. Eileen O'Reilly, Dr. Neil Segal, and Dr. Van Morris to its Gastrointestinal Tumor Scientific Advisory Board, enhancing clinical and strategic oversight as the company advances pelareorep toward registration-enabling trials in pancreatic, colorectal, and anal cancers [2] - The expanded advisory board is expected to sharpen the late-stage development strategy for a GI-focused immunotherapy platform, which targets large addressable markets [2] Group 2: Clinical and Translational Momentum - Recent data from trials in second-line KRAS-mutant, microsatellite-stable metastatic colorectal cancer showed a 33% objective response rate, significantly higher than the historical rate of 6-11% [3] - The trials also indicated more than double the progression-free and overall survival compared to standard therapy, highlighting the potential effectiveness of pelareorep [3] - Increased KRAS-specific T-cell responses were reported in translational analyses, reinforcing the mechanistic differentiation of pelareorep [3] Group 3: Company Focus and Technology - Oncolytics Biotech Inc. is focused on developing pelareorep, an immune-oncolytic virus platform that targets solid tumors and hematologic malignancies [4] - The technology leverages tumor-selective viral replication to stimulate both innate and adaptive anti-cancer immune responses [4]