Oncolytics Biotech (ONCY) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported cash and cash equivalents of CAD 15.3 million, providing runway through key value-driving milestones and into the third quarter of 2025 [18] - Net cash used in operating activities for the quarter was CAD 6.5 million, a decrease from CAD 7.5 million in the same period last year, reflecting lower net operating expenditures [18][20] - The net loss for the quarter was CAD 6.7 million or CAD 0.08 per basic and diluted share, compared to a net loss of CAD 6.9 million or CAD 0.09 per share in Q1 of 2024 [20] Business Line Data and Key Metrics Changes - Research and development expenses totaled CAD 4.1 million, down from CAD 5.7 million in Q1 of 2024, primarily due to reduced manufacturing and clinical trial costs [20] - General and administrative expenses remained consistent at CAD 3 million for the first quarter [19] Market Data and Key Metrics Changes - The company is actively pursuing a new CEO to lead the development of its asset, pelareorep, which has potential in various cancer indications, including pancreatic and breast cancer [5][6] - The company showcased the versatility of pelareorep in gastrointestinal cancers at ASCO GI, presenting data on pancreatic and anal cancers [8] Company Strategy and Development Direction - The company aims to find a leader focused on clinical trial execution for pelareorep, which is seen as a valuable treatment option for patients with high unmet medical needs [5][6] - The company is exploring multiple registrational opportunities for pelareorep, including studies in advanced metastatic HR positive, HER2 negative breast cancer [6][12] - The company is considering various pathways for regulatory approval, including studies in patients at different stages of breast cancer treatment [13][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data for pelareorep, which continues to exceed expectations, and highlighted the potential for the asset in treating difficult malignancies [5][7] - The company is optimistic about the ongoing enrollment in clinical trials and the potential for regulatory approval in various indications [10][11] Other Important Information - The company announced a USD 20 million share purchase agreement with Alumni Capital, providing access to capital at its discretion [21][44] - The company has received Fast Track approval from the FDA for its pancreatic cancer program, indicating regulatory support for its initiatives [25] Q&A Session Summary Question: What can you share about the potential trial design for the breast cancer study? - The primary endpoint for the next breast cancer study is anticipated to be progression-free survival, and discussions with the FDA have occurred regarding the study design [24] Question: Have there been any recent interactions with the FDA regarding the pancreatic cancer program? - The FDA is aware of the pancreatic cancer program and has granted Fast Track approval, but there have been no recent discussions [25][26] Question: What areas are being prioritized in business development activities? - The company is looking for partners to maximize the value of pelareorep across multiple indications, with breast and pancreatic cancer as top priorities [29] Question: Are there plans to explore additional combination approaches with immune checkpoint inhibitors? - The company has shown that pelareorep potentiates the activity of checkpoint inhibitors, particularly in pancreatic cancer, and will continue to explore this on an indication-by-indication basis [31][32] Question: Can you discuss the share purchase agreement and its benefits? - The share purchase agreement allows the company to access capital at its discretion, with a minimum purchase notice set at CAD 750,000, providing flexibility to move programs forward [44][45]