Oncolytics Biotech (ONCY) Q3 2024 earnings summary

Executive summary

• Final BRACELET-1 data showed pelareorep plus paclitaxel nearly doubled progression-free and 24-month overall survival rates in metastatic breast cancer compared to paclitaxel alone, with a 14-month overall survival benefit; plans for registration-enabling studies and accelerated approval are underway.

• Ongoing development in gastrointestinal cancers, including pancreatic and anal cancer, with upcoming data from GOBLET study cohorts addressing significant unmet needs.

• Collaborations with GCAR and PanCAN support clinical development and trial execution in pancreatic cancer.

Financial highlights

• Cash and cash equivalents stood at $19.6 million (CAD 19.6 million) as of September 30, 2024, with a projected runway into 2025.

• Net cash used in operating activities for the nine months ended September 30, 2024, was $19.1 million, down from $22.3 million in the prior year period.

• Q3 2024 general and administrative expenses were $3.1 million, down from $5.2 million in Q3 2023, mainly due to lower investor relations and transaction costs.

• Research and development expenses rose to $6.8 million in Q3 2024 from $5.8 million in Q3 2023, driven by higher manufacturing and clinical trial costs.

• Net loss for Q3 2024 was $9.5 million (C$9.5 million), with a loss per share of $0.12 (C$0.12), compared to $9.9 million (C$9.9 million) and $0.14 (C$0.14) per share in Q3 2023.

Outlook and guidance

• Registration-enabling phase 2 breast cancer study to enroll approximately 180 patients, targeting primary endpoint results within two years of enrollment start.

• H1 2025: Finalize master protocol and submit to FDA for adaptive registration-enabling trial in first-line pancreatic ductal adenocarcinoma; safety run-in data from GOBLET cohort 5 and updated efficacy data from cohort 4 expected.

• Mid 2025: First patient enrollment in registration-enabling study for metastatic HR+/HER2- breast cancer.

• H2 2025: Initial efficacy results from GOBLET study cohort 5 (pancreatic cancer) anticipated.

• Anticipate accelerated approval submission for breast cancer if clinical benefit mirrors BRACELET-1 outcomes.