Oncolytics Biotech, Inc. Q2 FY2024 earnings call

Wayne Pisano welcomed participants, mentioned Matt Coffey's recovery and confidence in the team. Tom Heineman discussed clinical advancements including Type C meeting with FDA for breast cancer, anticipation of BRACELET-1 survival results, and pancreatic cancer program with GOBLET study. Christophe Degois talked about collaboration with GCAR. Kirk Look reviewed financial results for Q2 2024, including cash position, expenses, net loss, etc.

No detailed product segment financial performance with revenue contributions provided in the transcript.

Anticipate reporting overall survival results from BRACELET-1 study in the second half of 2024. Expect to finalize the master protocol for the pancreatic cancer combination therapy in the second half of 2024 and initiate the adaptive registration enabling trial in the first half of 2025. Dosed the first patient in the GOBLET modified FOLFIRINOX pancreatic cancer cohort and expect a safety update in the second half of 2024.

Factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions by regulatory agencies, and other factors detailed in the company's filings with SEDAR and the SEC.

Q: Can you remind us of the size of the commercial opportunity for pelareorep in HR+/HER2- metastatic breast cancer and what the registration trial design would look like?

A: Christophe Degois discussed the changing market and ongoing update of commercial opportunity, while Tom Heineman explained the registration enabling large Phase 2 study with progression-free survival as primary endpoint.

Q: About the registration enabling study for pelareorep in breast cancer, specificity of patients who enrolled and geography?

A: Wayne Pisano and Tom Heineman mentioned majority likely failed antibody-drug conjugate therapy and study would have substantial enrollment in North America with possible sites in Western Europe.

Q: BRACELET-1 trial P-Value and differences in Phase 2/3 trial?

A: Tom Heineman said P-value for PFS comparison was 0.03, and Phase 2/3 would include patients who failed ADC therapy not in BRACELET.

Q: Nature of additional registrational opportunity from GOBLET study cohort 5 and size of pivotal study in breast cancer?

A: Tom Heineman said cohort 5 data is signal finding, not for accelerated approval, but could be part of registrational study; pivotal study would be sub-200 patients similar to Ibrance and Enhertu approvals.

Q: Patient recruitment for breast cancer trial and confidence?

A: Tom Heineman anticipated reasonable enrollment as there are patients who need better options than standard chemo.

Q: Destination for partners in GOBLET study and outreach plans?

A: Kirk Look said would leverage GCAR study readout and cohort 5 results to outreach to partners, with BRACELET survival analysis providing earlier outreach opportunity