Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically "cold" tumors "hot"Â through the activation of inna ...

Core Insights - Oncolytics Biotech Inc. is advancing its clinical-stage immunotherapy, pelareorep, with updates on enrollment, U.S. site expansion, and data readouts from the GOBLET trial focused on gastrointestinal cancers [1][2][6] Enrollment Progress - The GOBLET trial is evaluating pelareorep's efficacy in gastrointestinal cancers, with a specific focus on Cohort 4 (SCAC) and Cohort 5 (mPDAC) [2][4] - Enrollment in Cohort 4 is currently at 20 evaluable patients, with completion expected by the end of 2025 [2] - Cohort 5 is approximately 40% enrolled, with full enrollment anticipated by the end of 2026 [4][5] Efficacy Data - In Cohort 4, pelareorep combined with atezolizumab showed a 33% overall response rate (ORR) in 12 patients, significantly higher than the 11% ORR achieved by retifanlimab [2] - In Cohort 5, pelareorep combined with chemotherapy achieved a 62% ORR in 13 evaluable patients [4] U.S. Site Expansion - The company has submitted a protocol amendment to open U.S. clinical sites for the GOBLET study, with Northwestern University expected to participate [6][7] - This expansion aims to provide novel immunotherapy strategies to U.S. patients with pancreatic cancer [7] Future Updates - An efficacy update for Cohort 4 is expected in Q4 2025, while an interim efficacy update for Cohort 5 is anticipated in Q1 2026 [3][5] Company Overview - Oncolytics is developing pelareorep, an intravenously delivered double-stranded RNA immunotherapeutic agent, which has shown promise in various cancer studies [8] - The company is pursuing strategic partnerships to enhance development and commercial impact [9]

Core Insights - Oncolytics Biotech Inc. has reported that pelareorep demonstrates a significant survival benefit in KRAS mutant metastatic colorectal cancer (mCRC), with median progression-free survival (PFS) of 16.6 months compared to 5.7 months for the current standard of care, and median overall survival (OS) of 27.0 months versus 11.2 months [6]. Group 1: Clinical Efficacy - In the REO 022 trial, pelareorep combined with FOLFIRI and bevacizumab showed promising results in platinum refractory 2L mCRC KRAS mutant patients [2]. - The GOBLET study's 3L mCRC Cohort 3 demonstrated that pelareorep combined with atezolizumab and TAS-102 met its predefined efficacy endpoint, achieving durable disease control and survival rates exceeding historical benchmarks [2]. Group 2: Mechanism of Action - Studies including REO 022 and REO 013 confirmed pelareorep's mechanism of action, showing viral replication and immune activation in mCRC tumors, including dendritic cell maturation and CD8+ T cell activation [3]. - The findings indicate that pelareorep can modify mCRC tumors to become immune responsive, making them more amenable to checkpoint inhibition [3]. Group 3: Future Development Plans - The company plans to initiate an investigator-sponsored trial to further explore pelareorep's potential in KRAS mutant mCRC, leveraging the robust immune activation and survival benefits observed in previous studies [4]. - Oncolytics aims to define a regulatory pathway for pelareorep and engage with leading investigators to establish a clear path to registration in mCRC, including the design of a confirmatory study [4].

Core Insights - Pelareorep demonstrates a favorable safety profile across multiple indications and treatment combinations, with over 1,200 patients dosed, including more than 300 gastrointestinal cancer patients [1][3] - The most common adverse events associated with pelareorep are Grade 1 and 2 symptoms such as fever, chills, fatigue, nausea, vomiting, and diarrhea, with no significant modification of Grade 3 or 4 adverse events from chemotherapy when combined with pelareorep [2][3] - Oncolytics Biotech is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors for metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA [5] Company Overview - Oncolytics Biotech Inc. is a clinical-stage biotechnology company focused on developing pelareorep, an intravenously delivered double-stranded RNA immunotherapeutic agent [4] - Pelareorep has shown promising results in various cancer studies, including first-line pancreatic cancer, metastatic breast cancer, and early-phase studies in anal and colorectal cancer [4] - The company is actively pursuing strategic partnerships to enhance development and commercial impact [5]

Financial Data and Key Metrics Changes - The company presented its financial statements for the fiscal year ended December 31, 2024, but did not seek shareholder approval for them, indicating a focus on transparency and engagement with shareholders [12][13][26]. Business Line Data and Key Metrics Changes - The company is shifting its focus entirely on the commercialization of its immunotherapy candidate, pelareorep, rather than exploratory studies, aiming to unlock its full potential [32][34]. Market Data and Key Metrics Changes - The industry is increasingly recognizing the need for effective immunotherapy in pancreatic and gastrointestinal cancers, with several high-profile companies also pursuing this indication, indicating a competitive landscape [33]. Company Strategy and Development Direction - The company aims to accelerate pelareorep into a registration-enabled study for first-line pancreatic cancer, positioning itself to create significant shareholder value [32][34]. - The strategic vision includes a focus on gastrointestinal cancer, with plans to extend intellectual property protection and regulatory clarity on studies [36]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's unique position in the market and its potential for a transformational transaction, drawing parallels to the success of Ambrex [34][35]. - The company does not expect to raise additional dilutive capital until clarity on key milestones is achieved, indicating a cautious approach to funding [36]. Other Important Information - The company plans to provide more regular updates to shareholders, moving away from quarterly discussions focused solely on financial statements [36]. Q&A Session Summary - No specific questions were raised during the formal part of the meeting regarding the financial statements or motions presented, indicating a smooth process [16][20][24].

Core Opinion - Oncolytics Biotech is advancing its clinical-stage immunotherapy pelareorep, focusing on regulatory clarity and pivotal studies for pancreatic cancer treatment [2][6][7] Company Developments - New management team members, including CEO Jared Kelly and CBO Andrew Aromando, bring extensive biotech experience to enhance pelareorep's development [3] - The company is committed to limiting dilution by terminating its At-the-Market and Equity Line of Credit facilities, indicating confidence in its current capital to reach key milestones [8] Clinical Data and Research - Recent presentations at the American Society of Clinical Oncology Annual Meeting highlighted pelareorep's mechanism of action and its potential to improve survival rates in metastatic pancreatic ductal adenocarcinoma (mPDAC) [2][4] - In a review of landmark studies, pelareorep demonstrated a two-year survival rate of 21.9% in mPDAC patients, significantly higher than the historical benchmark of 9.2% for chemotherapy regimens [4] Strategic Initiatives - The company is pursuing a registration-enabling pivotal study for pelareorep in first-line mPDAC, with discussions ongoing with regulators to finalize the approval pathway [6][7] - Pelareorep has received Fast Track and Orphan Drug designations from the FDA, underscoring its potential in addressing high unmet medical needs in pancreatic cancer [7] Financial Performance - As of June 30, 2025, Oncolytics reported cash and cash equivalents of CAD 14.6 million, projecting a cash runway through key milestones into Q1 2026 [12] - The net loss for Q2 2025 was CAD 6.2 million, an improvement from CAD 7.3 million in Q2 2024, with R&D expenses decreasing to CAD 2.8 million from CAD 4.6 million year-over-year [12][15] Future Milestones - The company plans to initiate start-up activities for the pivotal study in Q4 2025, with updated clinical data expected by the end of 2025 [10][12]

Core Viewpoint - Oncolytics Biotech Inc. will voluntarily delist its common shares from the Toronto Stock Exchange (TSX) effective August 22, 2025, while maintaining its listing on the Nasdaq [1][2]. Group 1: Delisting Details - The delisting from TSX is deemed beneficial for the company and its shareholders, allowing shares to continue trading on Nasdaq under the symbol "ONCY" [2]. - Canadian shareholders can trade their shares on Nasdaq through U.S.-registered broker-dealer affiliates [2]. - Oncolytics will remain a reporting issuer in Canada, and shareholder approval for the delisting is not required under TSX regulations [2]. Group 2: Company Overview - Oncolytics is a clinical-stage biotechnology company focused on developing pelareorep, an immunotherapeutic agent that has shown promising results in treating various cancers, including pancreatic and breast cancers [3][4]. - Pelareorep works by converting "cold" tumors into "hot" tumors, thereby activating immune responses against cancer [3]. Group 3: Strategic Focus - 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 [4]. - Oncolytics is actively seeking strategic partnerships to enhance development and commercial impact [4]. Group 4: Future Considerations - Oncolytics will cease to be treated as a Foreign Private Issuer under U.S. federal securities laws effective January 1, 2026, and is contemplating re-domiciling to the U.S. [6]. - The company believes that the costs associated with maintaining a secondary listing on TSX do not justify the benefits, given its focus on the U.S. market and shareholder base [6].

Core Insights - Oncolytics Biotech Inc. is initiating regulatory discussions with the FDA for a pivotal study in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), aiming to start study activities by the end of 2025 [1][4] - The company believes in the differentiated mechanism of action of pelareorep and its potential to improve survival rates in mPDAC, a highly lethal cancer [2][3] - Oncolytics is considering an adaptive study design that may involve collaboration with a third party, focusing on overall survival as the primary endpoint [2][4] Company Overview - Oncolytics is a clinical-stage biotechnology company developing pelareorep, an immunotherapeutic agent that has shown promising results in metastatic breast cancer and early-phase studies in pancreatic and colorectal cancer [5][6] - Pelareorep works by converting "cold" tumors into "hot" tumors, activating both innate and adaptive immune responses [5] - The company has received Fast Track and Orphan Drug designations for pelareorep in mPDAC, positioning it well for strategic partnerships in gastrointestinal oncology [4][6] Strategic Goals - The CEO of Oncolytics emphasizes the importance of execution and focus in moving down a clear regulatory path, with the goal of enhancing shareholder value and attracting pharmaceutical partnerships [3][4] - The upcoming regulatory discussions and trial initiation are seen as major catalysts for collaboration and long-term value creation [4] - Oncolytics aims to leverage its clinical promise in mPDAC and other gastrointestinal cancers to engage potential partners looking to enhance their oncology pipelines [3][4]

Core Insights - Oncolytics Biotech Inc. hosted a key opinion leader (KOL) webinar discussing the clinical data of pelareorep and its role in treating pancreatic and gastrointestinal cancers [1][2] - The CEO emphasized pelareorep as a compelling immunotherapy platform suitable for combination strategies, aiming for registrational development in collaboration with pharmaceutical partners [2] Company Overview - Oncolytics is a clinical-stage biotechnology company focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that has shown promising results in metastatic breast cancer and pancreatic cancer [3][4] - Pelareorep works by inducing anti-cancer immune responses and converting "cold" tumors into "hot" tumors, enhancing treatment efficacy [3] Clinical Development - Pelareorep has demonstrated synergies with multiple approved oncology treatments, and Oncolytics is advancing combination clinical trials in solid malignancies, particularly in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA [4] - The treatment has shown meaningful survival benefits in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) patients, highlighting an unmet need for effective immunotherapies in this area [6] Mechanism of Action - Translational data from clinical trials indicate that pelareorep replicates in tumors, stimulates chemokine expression, and promotes the expansion of tumor-infiltrating lymphocytes (TILs), correlating with tumor size reduction [6]

Summary of Oncolytics Biotech Key Opinion Leader Webinar Company and Industry - **Company**: Oncolytics Biotech - **Industry**: Oncology, specifically focusing on pancreatic cancer and other gastrointestinal cancers Core Points and Arguments 1. **Introduction of Pelareorep**: Pelareorep is an oncolytic virus that selectively targets cancer cells and is administered intravenously, making it easier for widespread application compared to other oncolytic viruses that require intratumoral administration [6][7][8] 2. **Efficacy in Pancreatic Cancer**: Pelareorep has shown strong efficacy signals in pancreatic cancer, with a 62% overall response rate observed in clinical studies, which is significantly higher than traditional chemotherapy combinations [15][34] 3. **Unmet Need in Pancreatic Cancer**: Pancreatic cancer is the 10th most common cancer but the second leading cause of cancer death, highlighting the urgent need for effective treatments [10][11] 4. **Current Treatment Landscape**: Standard treatments include gemcitabine and FOLFIRINOX, with limited overall survival rates. Pelareorep combined with chemotherapy has shown improved survival rates compared to historical controls [12][13][22] 5. **Safety Profile**: Over 1,100 patients have been treated with Pelareorep, showing a favorable safety profile with mild side effects such as flu-like symptoms, indicating it is well-tolerated [66][70] 6. **Combination Therapy Potential**: Pelareorep can be combined with various chemotherapy regimens and checkpoint inhibitors, enhancing its therapeutic potential across multiple cancer types [86] 7. **Goblet Trial**: The Goblet trial is a significant study evaluating Pelareorep in combination with gemcitabine, nab-paclitaxel, and atezolizumab, showing promising early results [34][35] 8. **Biomarker Insights**: Tumor-infiltrating lymphocyte expansion has been identified as a potential biomarker correlating with treatment response, suggesting a mechanism of action that enhances immune response [40][41] Other Important but Possibly Overlooked Content 1. **Durability of Response**: The durability of responses in patients treated with Pelareorep is a notable characteristic, indicating potential long-term benefits [15] 2. **Mechanism of Action**: Pelareorep induces endoplasmic reticulum stress in pancreatic cancer cells, leading to apoptosis, which supports its mechanism of action [20] 3. **Future Directions**: There is a strong interest in exploring Pelareorep in registration-enabling studies for first-line treatment in pancreatic cancer, given the promising efficacy and safety data [57][69] 4. **Cross-Tumor Potential**: Pelareorep has demonstrated efficacy across various tumor types, including breast and colorectal cancers, indicating its potential as a versatile therapeutic agent [86] This summary encapsulates the key insights and discussions from the Oncolytics Biotech webinar, focusing on the promising role of Pelareorep in treating pancreatic cancer and its potential applications in other cancers.