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

Strategic vision and development plans

• Focus on extending survival for cancer patients using pelareorep in metastatic breast and pancreatic cancer.

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

• Large phase 2 study planned for breast cancer aiming for accelerated approval; phase 3 program in pancreatic cancer with GCAR.

• Confident in submitting for approval in one or both indications within five years, pending positive data.

• Additional opportunities being explored in anal carcinoma.

Key clinical data and safety

• BRACELET study in HR-positive, HER2-negative inoperable breast cancer showed pelareorep combo therapy led to median overall survival not reached (>32 months conservatively), vs. 18.2 months for chemotherapy.

• Two-year survival rate was 64% for pelareorep combo 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

• FDA discussions in May provided guidance on study population and endorsed PFS as primary endpoint for breast cancer phase 2.

• FDA advised on clinically meaningful effect size to ensure adequate statistical power.

• Adaptive study design with GCAR in pancreatic cancer aims for efficiency, faster endpoints, and access to top investigators.