Oncolytics Biotech® Reports Highlights and Financial Results for Q4 and Year-End 2024

Core Insights - Oncolytics Biotech Inc. reported strong efficacy signals for its lead candidate, pelareorep, in treating HR+/HER2- metastatic breast cancer, pancreatic cancer, and anal cancer, indicating potential for redefining treatment landscapes in these high-need areas [1][2][16] - The company has a cash position of $15.9 million, providing a runway through critical milestones into the third quarter of 2025 [1][11] - Management is focused on advancing pelareorep towards registration-enabling studies, with significant data supporting its efficacy in multiple cancer types [2][4][6] Clinical Development - The BRACELET-1 trial demonstrated robust improvements in progression-free survival (PFS) and overall survival (OS) for patients receiving pelareorep combined with paclitaxel compared to paclitaxel alone [4][6] - The GOBLET study showed a 33% objective response rate in anal cancer patients treated with pelareorep and atezolizumab, including a complete response lasting over 15 months [5][15] - Ongoing combination studies in pancreatic cancer have cleared safety milestones, allowing for continued enrollment in the GOBLET study [5][15] Financial Performance - For Q4 2024, the company reported a net loss of $8.0 million, compared to a net loss of $3.9 million in Q4 2023, with a basic and diluted loss per share of $0.10 [11][14] - Research and development expenses for Q4 2024 were $4.6 million, slightly down from $4.7 million in Q4 2023, primarily due to lower personnel-related expenses [11][14] - The total assets as of December 31, 2024, were $20.2 million, down from $38.8 million in 2023, reflecting the company's ongoing investment in clinical trials [12][14] Anticipated Milestones - In H1 2025, the company plans to finalize the protocol for an adaptive registration-enabling trial for pelareorep in first-line pancreatic ductal adenocarcinoma and submit it to the FDA [11][19] - In H2 2025, the first patient is expected to be enrolled in the registration-enabling study for pelareorep and paclitaxel in advanced or metastatic HR+/HER2- breast cancer [11][19] - Initial efficacy results from Cohort 5 of the GOBLET study are anticipated in H2 2025, investigating pelareorep combined with modified FOLFIRINOX in newly diagnosed metastatic pancreatic cancer [11][19]