Oncolytics Biotech, Inc. Q3 FY2024 earnings call

Wayne Pisano

• Highlighted critical milestone in BRACELET-1 breast cancer study with pelareorep plus paclitaxel showing substantial improvement in PFS, OS, and 24-month OS. Continuing enrollment in GOBLET cohort 5 and working with GCAR on pancreatic cancer study.

Tom Heineman

• BRACELET-1 study results: median PFS nearly doubled, median OS not calculable in pelareorep arm (conservative estimate 32.1 months), 24-month OS rate nearly doubled. Plan for registration-enabling breast cancer study using PFS as primary endpoint. GOBLET study in gastrointestinal cancers, collaboration with GCAR and PanCAN grant for pancreatic cancer, ongoing enrollment in GOBLET cohort 5.

Christophe DeGois

• Discussed business development, market opportunity for pelareorep in breast cancer with addressable population and potential sales, collaborations with GCAR and PanCAN.

Kirk Look

• Reviewed Q3 2024 financials: $19.6M cash and cash equivalents, net loss $9.5M, lower G&A expenses, higher R&D expenses due to manufacturing and clinical trial costs, upcoming milestones including registration-enabling study in breast cancer, GCAR collaboration progress, and GOBLET study enrollment.

No detailed product segment financial performance with revenue contributions provided; focus is on pelareorep development.

• Pursue accelerated approval pathway for breast cancer via registration-enabling study.
• Collaborate with GCAR to finalize master protocol for pancreatic cancer trial and seek FDA guidance.
• Continue enrollment in GOBLET cohort 5, expect safety data from it in early 2025 and efficacy later, and updated efficacy data from cohort 4 next year.

Q: Soumit Roy asked about the upcoming San Antonio Breast Cancer update and HER2 status.

A: Tom Heineman responded that the data presented are final results, no update at San Antonio, and patients were HER2 low (IHC 2 and below).

Q: Louise Chen inquired about the breast cancer registration-enabling study and master protocol for PDAC trial.

A: Tom Heineman and Kirk Look discussed the breast cancer study's accelerated approval potential and timeline, and the PDAC trial's enrollment expectation to be efficient due to common cancer and potential recruiting sites.

Q: Michael Freeman asked about partnering and business development.

A: Christophe DeGois talked about reengaging pharma companies, ongoing discussions with current partners and new ones, and ideal partner being one to accelerate development and prepare for launch.