23-05-2025
Oncolytics Biotech Inc (ONCY) Q1 2025 Earnings Call Highlights: Strategic Advances Amid ...
Cash and Cash Equivalents: $15.3 million as of March 31, 2025.
Net Cash Operating Activities: $6.5 million for the quarter, down from $7.5 million in the same period last year.
General and Administrative Expenses: $3 million for the first quarter, consistent with the prior year.
Research and Development Expenses: $4.1 million, down from $5.7 million in Q1 of 2024.
Net Loss: $6.7 million or $0.08 per basic and diluted share, compared to $6.9 million or $0.09 per share in Q1 of 2024.
Share Purchase Agreement: USD20 million agreement with Alumni Capital to extend financial runway.
Warning! GuruFocus has detected 1 Warning Sign with ONCY.
Release Date: May 14, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Oncolytics Biotech Inc (NASDAQ:ONCY) reported promising clinical data for pelareorep, showing a 33% objective response rate in relapsed anal carcinoma, including a complete response lasting over 15 months.
The company is actively enrolling patients in the GOBLET Cohort 5 study for metastatic pancreatic cancer, supported by a $5 million grant from the Pancreatic Cancer Action Network.
Pelareorep demonstrated a favorable safety profile across multiple studies, allowing for combination with various chemotherapies and checkpoint inhibitors.
The company has secured a USD20 million share purchase agreement with Alumni Capital, providing financial flexibility and extending the runway through key milestones.
Oncolytics Biotech Inc (NASDAQ:ONCY) is exploring multiple registrational opportunities for pelareorep in breast cancer, supported by positive data from two randomized Phase 2 studies showing significant clinical benefits.
The company is still in the process of searching for a new CEO, which may impact strategic decision-making and leadership continuity.
Despite promising data, regulatory approval for pelareorep in anal carcinoma is not guaranteed and the commercial opportunity is smaller compared to other indications.
Research and development expenses decreased due to reduced manufacturing and clinical trial costs, which could indicate a slowdown in certain development activities.
The net loss for the quarter was $6.7 million, reflecting ongoing financial challenges despite a slight improvement from the previous year.
There have been no recent interactions with the FDA regarding the pancreatic cancer program, which could delay potential registrational pathways.
Q: Regarding the anticipated start of the registrational trial in HR positive HER2 negative metastatic breast cancer, what can you share about the potential trial design for the study? Will PFS be a primary endpoint? And have there been any recent interactions with the FDA regarding the pancreatic cancer program? A: Thomas Heineman, Chief Medical Officer, explained that the primary endpoint for the breast cancer study is anticipated to be progression-free survival. The FDA has been informed of the pancreatic cancer program, and while there have been no recent discussions, the FDA granted Fast Track approval in pancreatic cancer.
Q: Are there specific areas like regional rights or co-development opportunities being prioritized in business development activities? Are there plans to explore additional combination approaches with immune checkpoint inhibitors? A: Christophe Degois, VP of Business Development, stated that they are exploring both global and regional partnerships, particularly for breast and pancreatic cancer. Thomas Heineman added that they are exploring combinations with checkpoint inhibitors, especially in pancreatic cancer, where there is strong synergy.
Q: Could you discuss the rationale and potential registration paths for treating patients at different stages of the breast cancer journey? A: Thomas Heineman clarified that while they are not shifting focus to earlier stages, there are opportunities in treating patients who have failed antibody-drug conjugate therapy. This could further de-risk the program and stimulate interest from partners and investors.
Q: Can you describe the basic structure of the share purchase agreement with Alumni Capital and the flexibility it offers? A: Kirk Look, CFO, explained that the agreement provides access to capital at their discretion, with a minimum purchase notice set at $750,000. This structure helps reduce the cost of capital and supports strategic program advancements.
Q: Have you utilized the share purchase agreement since its announcement? A: Kirk Look confirmed that they have tapped into the agreement strategically to ensure it functions as intended.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
