Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Oncolytics Biotech Inc (ONCY, Financial) reported promising final data from the Bracelet One breast cancer study, showing substantial improvements in progression-free survival and overall survival when combining their therapeutic agent with paclitaxel.
- The company is planning a registration-enabling Phase II study for HR-positive, HER2-negative metastatic breast cancer, aiming for accelerated approval based on positive clinical benefits observed.
- Oncolytics Biotech Inc (ONCY) is advancing its gastrointestinal cancer program, with promising efficacy signals in pancreatic cancer, supported by collaborations with GCAR and a $5 million grant from the Pancreatic Cancer Action Network.
- The company has ongoing collaborations with major pharmaceutical companies like Roche and Pfizer, indicating strong industry interest and potential for strategic partnerships.
- Financially, Oncolytics Biotech Inc (ONCY) has managed to decrease its net cash used in operating activities compared to the previous year, reflecting efficient cash management as they ramp up efforts for registration.
Negative Points
- The company faces uncertainties and risks related to the execution of their clinical trials and the potential for delays in achieving regulatory approvals.
- Oncolytics Biotech Inc (ONCY) reported a net loss of $9.5 million for the third quarter of 2024, indicating ongoing financial challenges.
- There is no guarantee of regulatory approval, as the FDA requires compelling data, and the company acknowledges that the FDA will not commit to approval before seeing final results.
- The company is still in the early stages of engaging potential partners for their breast cancer program, with significant outreach efforts planned for the future.
- Enrollment timelines for their pancreatic cancer trial remain uncertain, as they need to finalize the protocol and seek FDA guidance, which could impact the speed of trial progression.
Q & A Highlights
Q: Can you provide details on the upcoming San Antonio breast cancer update?
A: Thomas Heineman, Chief Medical Officer, stated that the data presented in the call are the final results. Due to timing, there will be no further updates at the San Antonio meeting.
Q: Could you elaborate on the potential for accelerated approval in your breast cancer registration enabling study?
A: Thomas Heineman explained that the study is designed to provide a clinically meaningful benefit. If results are comparable to the Bracelet study, it could lead to accelerated approval. The study aims to meet FDA criteria for clinical benefit, statistical significance, and safety.
Q: How quickly do you expect to complete patient enrollment for the first-line PDAC trial?
A: Thomas Heineman mentioned that once the protocol is finalized and discussed with the FDA, they expect efficient enrollment due to the commonality of the cancer and the involvement of high-potential recruiting sites.
Q: Can you describe your partnering and business development approach following the metastatic breast cancer data?
A: Christophe Degois, Vice President of Business Development, noted that they are preparing for a large outreach to potential partners, including big pharma and regional companies, to accelerate drug development and prepare for market launch.
Q: What pricing assumptions are you using for market sizing?
A: Christophe Degois stated they are using pricing similar to Enhertu, with a slight premium, considering the post-Enhertu positioning for most patients. Pricing varies between the US and international markets.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
