Oncolytics Biotech (US:ONCY) Prnewswire·2025-08-08 13:05Core 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]