Oncolytics Biotech (US:ONCY)2025-05-14 21:30Financial 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 [21] - Net cash used in operating activities for the quarter was CAD 6.5 million, compared to CAD 7.5 million in the same period last year, reflecting lower net operating expenditures [21][22] - 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 [22] 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 [22] - General and administrative expenses remained consistent at CAD 3 million for the first quarter [22] Market Data and Key Metrics Changes - The company is actively pursuing a CEO search to lead the development of pelareorep, which has potential in various cancer indications, including pancreatic and breast cancer [6][8] - The company showcased the versatility of pelareorep in gastrointestinal cancers at ASCO GI, with promising data presented for pancreatic and anal cancers [9][11] 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 difficult-to-treat malignancies [6][8] - There are plans for a registration-enabling study evaluating pelareorep in combination with paclitaxel for advanced metastatic HR positive, HER2 negative breast cancer [6][8] - The company is exploring various pathways for regulatory approval, including studies in different stages of breast cancer treatment [16][37] 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 high unmet medical need in targeted cancer indications [6][8] - The company is optimistic about the potential for pelareorep to fulfill its promise as a treatment option for patients with several malignancies [6][8] Other Important Information - The company announced a USD 20 million share purchase agreement with Alumni Capital, providing access to capital at its discretion [23][44] - The company has received Fast Track approval from the FDA for its pancreatic cancer program, indicating regulatory support for its development efforts [27] Q&A Session All Questions and Answers 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 been ongoing regarding the study design [26] 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 [27][28] Question: What areas are being prioritized in business development activities? - The company is looking for partnerships that could maximize the value of pelareorep across multiple indications, with breast and pancreatic cancer as top priorities [30] 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 synergy [32][33] Question: Can you discuss the structure of the share purchase agreement with Alumni Capital? - The agreement provides access to capital at the company's discretion, with a minimum purchase notice set at CAD 750,000, allowing flexibility in capital management [44][45]