Oncolytics Biotech (ONCY) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Strategic vision and development plans

• Aims to extend survival for cancer patients using pelareorep in metastatic breast and pancreatic cancers.

• Pursuing two main approval pathways: accelerated approval in breast cancer and full approval in pancreatic cancer.

• Plans to enroll patients in pivotal studies within 3–5 years, targeting regulatory submissions within five years if data are positive.

• Confident in the plan to seek accelerated approval and expand into additional indications like anal carcinoma.

Key clinical data and outcomes

• BRACELET study in HR-positive, HER2-negative breast cancer showed median overall survival not reached for pelareorep arm, with conservative estimates over 32 months vs. 18.2 months for control.

• Two-year survival rate was 64% for pelareorep vs. 33% for control; median progression-free survival was 12.1 months vs. 6.4 months.

• Safety profile consistent with prior studies, mostly mild to moderate flu-like symptoms, rare severe events.

Regulatory and study design updates

• Next step is a large phase 2 study in breast cancer, aiming for accelerated approval, focusing on patients who failed antibody-drug conjugate therapy.

• FDA endorsed progression-free survival as the primary endpoint and provided guidance on clinically meaningful effect size.

• Study modeled to cost $30 million, with a 24-month timeline to readout; current cash covers operations into Q2 2025, additional funding required.