Core Insights - Oncolytics Biotech Inc. has presented biomarker and translational data supporting the efficacy of pelareorep, an oncolytic virus that enhances immune responses in cancer treatment [1][2][3] - The data indicates that pelareorep can convert "cold" tumors into "hot" tumors, making them more responsive to immunotherapy [1][5] - The company is advancing towards registration-enabling trials for pelareorep in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA [4] Group 1: Mechanism of Action - Pelareorep demonstrates the ability to replicate in cancer cells, activate immune pathways, and drive T cell expansion and infiltration in tumors resistant to immunotherapy [1][2] - The treatment has shown consistent immune activation signatures across various studies, confirming its immune-mediated mechanism of action [2][5] - The upregulation of interferons and PD-L1, along with the mobilization of tumor-infiltrating lymphocytes, correlates with tumor size reduction [5] Group 2: Clinical Studies and Data - The GOBLET study is currently enrolling patients with pancreatic ductal adenocarcinoma (PDAC) and anal carcinoma, with additional data expected next year [2] - Previous studies have shown promising results in metastatic breast cancer and pancreatic cancer, reinforcing pelareorep's potential as a versatile immunotherapeutic agent [3][4] - The company anticipates that the clinical data will support its regulatory path and serve as a foundation for future studies in immunotherapy-resistant solid tumors [2][4]

Core Viewpoint - Oncolytics Biotech Inc. is hosting a KOL webinar on July 22, 2025, to discuss the immunotherapeutic agent pelareorep in the context of metastatic pancreatic ductal adenocarcinoma and other gastrointestinal cancers [1][2]. Company Overview - Oncolytics Biotech Inc. is a clinical-stage biotechnology company focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that has shown promising results in clinical studies for metastatic breast cancer and pancreatic cancer [10][11]. - Pelareorep works by inducing anti-cancer immune responses and transforming "cold" tumors into "hot" tumors, enhancing the effectiveness of various cancer treatments [10]. Webinar Details - The webinar will feature key opinion leaders (KOLs) including Dirk Arnold, Alexander Eggermont, Sanjay Goel, and Devalingam Mahalingam, who will discuss existing clinical data and the potential of pelareorep in treating mPDAC and other gastrointestinal cancers [2][4][5][6][8]. - A live Q&A session will follow the formal presentation and roundtable discussion [3]. KOL Profiles - Dirk Arnold, M.D., Ph.D., is a prominent figure in gastrointestinal cancers and immunotherapy, with extensive experience in clinical trials [4]. - Alexander Eggermont, M.D., Ph.D., has a strong background in clinical and translational immunotherapy, having authored over 900 peer-reviewed papers [5]. - Sanjay Goel, M.D., M.S., FASCO, focuses on drug development and health disparities, with over 150 research publications [6][7]. - Devalingam Mahalingam, M.D., Ph.D., specializes in early-phase clinical studies and has been involved in numerous clinical trials [8][9].

Core Insights - Oncolytics Biotech Inc. has reported compelling clinical data for its oncolytic virus immunotherapy, pelareorep, showing a significant two-year survival benefit of 21.9% in metastatic pancreatic ductal adenocarcinoma (mPDAC) compared to a historical benchmark of 9.2% [1][2] - The company is shifting its strategy to focus on advancing pelareorep into registration-enabling trials, leveraging its fast-track status to expedite the regulatory process [2][7] - Pelareorep has demonstrated a favorable safety profile across over 1,100 patients, with common treatment-related adverse events being manageable and transient [6][8] Clinical Data Summary - In mPDAC trials, pelareorep combined with chemotherapy showed a 2-year overall survival rate of 21.9% versus 9.2% from historical data, with a 62% objective response rate (ORR) in a single-arm study [2][3] - In HR+/HER2- metastatic breast cancer, pelareorep has shown a median overall survival benefit of over 10 months compared to standard chemotherapy, with specific studies indicating mOS of 21.0 months versus 10.8 months [5][6] - The disease control rate (DCR) for pelareorep in combination with gemcitabine was reported at 83%, significantly higher than the 33% benchmark [3] Regulatory and Developmental Status - Pelareorep has received Fast Track designations from the FDA for both metastatic breast cancer and mPDAC, indicating its potential as a significant therapeutic option [7][9] - The company is planning combination clinical trials with pelareorep in various solid tumors as it moves towards registrational studies [9]

Core Insights - Oncolytics Biotech Inc. has appointed Andrew Aromando as Chief Business Officer to lead global business development and corporate strategies [1][2][3] - Aromando's previous experience includes a significant role in the $2 billion acquisition of Ambrx Biopharma by Johnson & Johnson, highlighting his expertise in navigating complex transactions [2][3] - The company aims to optimize the value of its clinical data for pelareorep, an immunotherapeutic agent, targeting multiple cancer types including pancreatic, breast, and anal cancers [2][5] Company Overview - Oncolytics Biotech Inc. is a clinical-stage biotechnology company focused on developing pelareorep, which has shown promising results in clinical studies for metastatic breast cancer and pancreatic cancer [5][6] - Pelareorep works by inducing anti-cancer immune responses and transforming "cold" tumors into "hot" tumors, enhancing treatment efficacy [5][6] - The company is advancing towards registrational studies for pelareorep in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA [6] Executive Compensation - As part of Aromando's appointment, he received an initial stock option grant for 750,000 shares at an exercise price of CAD$0.93, vesting over three years [4] - Additionally, he was granted 500,000 restricted stock units that will vest upon the company entering into a definitive agreement for certain transactions [4]

Company Overview - Oncolytics Biotech Inc. is a clinical-stage biotechnology company focused on developing pelareorep, an intravenously delivered immunotherapeutic agent with promising results in treating various cancers [6][7] - Pelareorep has received FDA Fast Track designation for metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) [3][6] Leadership Appointment - Jared Kelly has been appointed as the Chief Executive Officer and a member of the Board of Directors, bringing extensive experience in biotech and corporate strategy [1][2] - Kelly's previous role included orchestrating the $2 billion sale of Ambrx Biopharma to Johnson & Johnson, showcasing his expertise in transformative deals [2] Clinical Data and Development - Pelareorep has shown a greater than 60% objective response rate in mPDAC patients, significantly outperforming historical control trials [3] - In mBC, pelareorep demonstrated meaningful survival benefits in two randomized Phase 2 studies involving over 100 patients [4] - The agent has a favorable safety profile based on data from over 1,100 patients across multiple tumor types [4] Strategic Focus - The company aims to advance pelareorep through a renewed clinical development plan, targeting partnerships to enhance its market potential [3][4] - Oncolytics is conducting combination clinical trials with pelareorep in solid malignancies, moving towards registrational studies in mBC and pancreatic cancer [7] Incentives for Leadership - As part of his appointment, Kelly received stock options for 2,850,000 shares and performance-based options for 1,900,000 shares, aligning his incentives with shareholder value creation [5]

Core Insights - Oncolytics Biotech Inc. presented new data on pelareorep's mechanism of action in pancreatic ductal adenocarcinoma (PDAC) at the 2025 ASCO Annual Meeting, highlighting its ability to stimulate immune responses and prime tumors for treatment [1][2] Group 1: Mechanism of Action - Pelareorep initiates a pro-inflammatory tumor microenvironment (TME) and induces both innate and adaptive immune responses, allowing circulating tumor-infiltrating lymphocytes (TILs) to attack tumors [1] - The treatment expands anti-reovirus T cells and upregulates chemokines that facilitate the expansion of pre-existing TIL clones in the blood, which can return to the tumor and reduce its size [2] - The presence of TIL clones in the blood before treatment and their expansion post-treatment correlate with favorable clinical responses [4] Group 2: Clinical Trial Insights - The GOBLET study is a Phase 1/2 trial evaluating pelareorep in combination with other therapies for advanced or metastatic gastrointestinal tumors, focusing on objective response rate (ORR) and disease control rate [3] - Efficacy results from GOBLET Cohort 1 showed a 62% overall response rate, an 85% disease control rate, and a 45% 12-month survival rate in first-line metastatic PDAC patients [4] Group 3: Combination Therapies - Pelareorep is being tested in combination with atezolizumab, gemcitabine, and nab-paclitaxel for advanced/metastatic pancreatic cancer, as well as in other cancer types such as MSI-high metastatic colorectal cancer and anal cancer [5][12] - The company is advancing towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA [9]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported cash and cash equivalents of CAD 15.3 million, providing runway through key value-driving milestones and into the third quarter of 2025 [18] - Net cash used in operating activities for the quarter was CAD 6.5 million, a decrease from CAD 7.5 million in the same period last year, reflecting lower net operating expenditures [18][20] - The net loss for the quarter was CAD 6.7 million or CAD 0.08 per basic and diluted share, compared to a net loss of CAD 6.9 million or CAD 0.09 per share in Q1 of 2024 [20] Business Line Data and Key Metrics Changes - Research and development expenses totaled CAD 4.1 million, down from CAD 5.7 million in Q1 of 2024, primarily due to reduced manufacturing and clinical trial costs [20] - General and administrative expenses remained consistent at CAD 3 million for the first quarter [19] Market Data and Key Metrics Changes - The company is actively pursuing a new CEO to lead the development of its asset, pelareorep, which has potential in various cancer indications, including pancreatic and breast cancer [5][6] - The company showcased the versatility of pelareorep in gastrointestinal cancers at ASCO GI, presenting data on pancreatic and anal cancers [8] Company Strategy and Development Direction - The company aims to find a leader focused on clinical trial execution for pelareorep, which is seen as a valuable treatment option for patients with high unmet medical needs [5][6] - The company is exploring multiple registrational opportunities for pelareorep, including studies in advanced metastatic HR positive, HER2 negative breast cancer [6][12] - The company is considering various pathways for regulatory approval, including studies in patients at different stages of breast cancer treatment [13][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data for pelareorep, which continues to exceed expectations, and highlighted the potential for the asset in treating difficult malignancies [5][7] - The company is optimistic about the ongoing enrollment in clinical trials and the potential for regulatory approval in various indications [10][11] Other Important Information - The company announced a USD 20 million share purchase agreement with Alumni Capital, providing access to capital at its discretion [21][44] - The company has received Fast Track approval from the FDA for its pancreatic cancer program, indicating regulatory support for its initiatives [25] Q&A Session Summary Question: What can you share about the potential trial design for the breast cancer study? - The primary endpoint for the next breast cancer study is anticipated to be progression-free survival, and discussions with the FDA have occurred regarding the study design [24] Question: Have there been any recent interactions with the FDA regarding the pancreatic cancer program? - The FDA is aware of the pancreatic cancer program and has granted Fast Track approval, but there have been no recent discussions [25][26] Question: What areas are being prioritized in business development activities? - The company is looking for partners to maximize the value of pelareorep across multiple indications, with breast and pancreatic cancer as top priorities [29] Question: Are there plans to explore additional combination approaches with immune checkpoint inhibitors? - The company has shown that pelareorep potentiates the activity of checkpoint inhibitors, particularly in pancreatic cancer, and will continue to explore this on an indication-by-indication basis [31][32] Question: Can you discuss the share purchase agreement and its benefits? - The share purchase agreement allows the company to access capital at its discretion, with a minimum purchase notice set at CAD 750,000, providing flexibility to move programs forward [44][45]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported cash and cash equivalents of CAD 15.3 million, providing runway through key value-driving milestones and into the third quarter of 2025 [21] - Net cash used in operating activities for the quarter was CAD 6.5 million, compared to CAD 7.5 million in the same period last year, reflecting lower net operating expenditures [21][22] - The net loss for the quarter was CAD 6.7 million or CAD 0.08 per basic and diluted share, compared to a net loss of CAD 6.9 million or CAD 0.09 per share in Q1 of 2024 [22] Business Line Data and Key Metrics Changes - Research and development expenses totaled CAD 4.1 million, down from CAD 5.7 million in Q1 of 2024, primarily due to reduced manufacturing and clinical trial costs [22] - General and administrative expenses remained consistent at CAD 3 million for the first quarter [22] Market Data and Key Metrics Changes - The company is actively pursuing a CEO search to lead the development of pelareorep, which has potential in various cancer indications, including pancreatic and breast cancer [6][8] - The company showcased the versatility of pelareorep in gastrointestinal cancers at ASCO GI, with promising data presented for pancreatic and anal cancers [9][11] Company Strategy and Development Direction - The company aims to find a leader focused on clinical trial execution for pelareorep, which is seen as a valuable treatment option for difficult-to-treat malignancies [6][8] - There are plans for a registration-enabling study evaluating pelareorep in combination with paclitaxel for advanced metastatic HR positive, HER2 negative breast cancer [6][8] - The company is exploring various pathways for regulatory approval, including studies in different stages of breast cancer treatment [16][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data for pelareorep, which continues to exceed expectations, and highlighted the high unmet medical need in targeted cancer indications [6][8] - The company is optimistic about the potential for pelareorep to fulfill its promise as a treatment option for patients with several malignancies [6][8] Other Important Information - The company announced a USD 20 million share purchase agreement with Alumni Capital, providing access to capital at its discretion [23][44] - The company has received Fast Track approval from the FDA for its pancreatic cancer program, indicating regulatory support for its development efforts [27] Q&A Session All Questions and Answers Question: What can you share about the potential trial design for the breast cancer study? - The primary endpoint for the next breast cancer study is anticipated to be progression-free survival, and discussions with the FDA have been ongoing regarding the study design [26] Question: Have there been any recent interactions with the FDA regarding the pancreatic cancer program? - The FDA is aware of the pancreatic cancer program and has granted Fast Track approval, but there have been no recent discussions [27][28] Question: What areas are being prioritized in business development activities? - The company is looking for partnerships that could maximize the value of pelareorep across multiple indications, with breast and pancreatic cancer as top priorities [30] Question: Are there plans to explore additional combination approaches with immune checkpoint inhibitors? - The company has shown that pelareorep potentiates the activity of checkpoint inhibitors, particularly in pancreatic cancer, and will continue to explore this synergy [32][33] Question: Can you discuss the structure of the share purchase agreement with Alumni Capital? - The agreement provides access to capital at the company's discretion, with a minimum purchase notice set at CAD 750,000, allowing flexibility in capital management [44][45]

Core Insights - Pelareorep shows significant clinical benefits in treating anal and pancreatic cancers, with ongoing studies demonstrating its versatility and potential to improve patient outcomes [2][9][20] - The company has entered a US$20 million share purchase agreement to support its clinical development efforts, providing a flexible funding source [6] - Financial results for Q1 2025 indicate a net loss of CAD 6.7 million, a slight improvement from CAD 6.9 million in Q1 2024, with cash and cash equivalents reported at CAD 15.3 million [10][15] Clinical Developments - Pelareorep has demonstrated promising results in multiple studies, including randomized Phase 2 studies in breast cancer and ongoing studies in pancreatic cancer and anal cancer [2][18] - The GOBLET study's interim results show an objective response rate of 33% in patients with unresectable squamous cell anal carcinoma, with some patients achieving a complete response lasting over 15 months [9] - Upcoming presentations at the ASCO Annual Meeting will highlight pelareorep's role in activating anti-tumor immunity [3][4] Financial Performance - As of March 31, 2025, the company reported CAD 15.3 million in cash and cash equivalents, projecting a cash runway through key milestones into Q3 2025 [10] - Research and development expenses decreased to CAD 4.1 million in Q1 2025 from CAD 5.7 million in Q1 2024, primarily due to lower manufacturing and clinical trial costs [10][13] - The basic and diluted loss per share improved to CAD 0.08 in Q1 2025 from CAD 0.09 in Q1 2024 [10][15] Strategic Initiatives - The company is focused on optimizing the development pathway for pelareorep, emphasizing its ability to combine with existing therapies while maintaining a favorable safety profile [2][20] - Key opinion leaders have discussed the need for new treatment options and pelareorep's potential to activate the immune system against tumors [5] - The company is advancing towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA [20]

Conference Call & Webcast Date: Wednesday, May 14, 2025 Time: 4:30 p.m. ET Dial In – North American Toll-Free: (888) 510-2154 Dial In – International: (437) 900-0527 RapidConnect: to join the conference call without operator assistance, please click here Conference ID (if needed): 28038 Webcast: please click here Conference call and webcast to take place on Wednesday, May 14, 2025, at 4:30 p.m. ET SAN DIEGO and CALGARY, AB, May 6, 2025 Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-s ...