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Oncolytics Biotech (ONCY) - 2025 FY - Earnings Call Transcript
2025-08-08 15:00
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].
Oncolytics Biotech® Reports Second Quarter Financial Results and Details Clinical Program Plans for Pelareorep
Prnewswire· 2025-08-08 13:05
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]
Oncolytics Biotech® Announces Voluntary Delisting from the Toronto Stock Exchange
Prnewswire· 2025-08-08 13:00
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].
Oncolytics Biotech® to Engage FDA for Potential Registration-Enabled Study in First-Line Pancreatic Cancer with Goal to Launch Trial Activities by Year-End
Prnewswire· 2025-07-29 12:30
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]
Key Opinion Leader Event Highlights Pelareorep's Compelling Pancreatic and Gastrointestinal Data And Future Potential
Prnewswire· 2025-07-23 13:39
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]
Oncolytics Biotech (ONCY) Update / Briefing Transcript
2025-07-22 18:00
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.
Oncolytics Biotech® Presents Aggregated Translational Data Providing Evidence of Pelareorep's Effectiveness Across Multiple Tumor Types
Prnewswire· 2025-07-16 12:30
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]
Oncolytics Biotech® to Host Key Opinion Leader Discussion Focusing on Pancreatic and Gastrointestinal Cancers
Prnewswire· 2025-07-10 12:30
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].
Oncolytics Biotech® Highlights Transformative Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies
Prnewswire· 2025-07-08 12:30
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]
Oncolytics Biotech® Appoints Former Ambrx Executive as Chief Business Officer to Drive Business Development Strategy
Prnewswire· 2025-06-30 11:00
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]