Oncolytics Biotech® Reports Second Quarter 2024 Financial Results and Operational Highlights

Core Insights - Oncolytics Biotech Inc. is advancing its immunotherapeutic agent, pelareorep, towards registration-enabling studies for breast and pancreatic cancers, with positive feedback from the FDA regarding the study design for HR+/HER2- metastatic breast cancer [1][2][3] - The company has initiated the GOBLET study for pancreatic cancer, evaluating pelareorep in combination with modified FOLFIRINOX, supported by a $5 million grant from the Pancreatic Cancer Action Network (PanCAN) [1][4] - Oncolytics has a cash position of $24.9 million, providing a runway through key milestones into 2025 [1][7] Regulatory and Clinical Developments - The FDA has supported the use of progression-free survival as the primary endpoint and overall survival as a secondary endpoint for the pelareorep study in HR+/HER2- metastatic breast cancer [3] - The GOBLET study's fifth cohort will assess pelareorep combined with mFOLFIRINOX, with or without atezolizumab, in newly diagnosed pancreatic ductal adenocarcinoma patients [4][5] - A collaboration with the Global Coalition for Adaptive Research (GCAR) is underway to evaluate pelareorep in first-line metastatic pancreatic cancer, which has received Fast Track Designation from the FDA [5][6] Financial Performance - For Q2 2024, Oncolytics reported a net loss of $7.3 million, slightly improved from a net loss of $7.4 million in Q2 2023, with a basic and diluted loss per share of $0.10 [7][11] - Research and development expenses increased to $4.6 million in Q2 2024 from $3.7 million in Q2 2023, primarily due to higher clinical trial costs [7][11] - The company’s total assets as of June 30, 2024, were $32.1 million, down from $38.8 million at the end of 2023 [10] Upcoming Milestones - Overall survival results from the BRACELET-1 trial in HR+/HER2- metastatic breast cancer are expected in the second half of 2024 [9] - Finalization of the master protocol for the adaptive registration-enabling trial for pelareorep in first-line pancreatic cancer is anticipated in H2 2024 [9] - An update on the safety run-in for the GOBLET mFOLFIRINOX cohort is expected in H1 2025 [9]