Oncolytics Biotech (ONCY) Q3 2024 earnings summary

Executive summary

• Final BRACELET-1 data showed pelareorep plus paclitaxel nearly doubled progression-free survival and 24-month overall survival rate in HR-positive, HER2-negative metastatic breast cancer compared to paclitaxel alone, confirming pelareorep's potential and supporting a registration-enabling study for accelerated approval.

• Ongoing development in gastrointestinal cancers, with GOBLET Cohort 5 enrolling for pancreatic cancer and upcoming data from anal and pancreatic cancer cohorts addressing significant unmet needs.

• Collaboration with GCAR for an adaptive registration-enabling pancreatic cancer trial, with master protocol submission to FDA planned for H1 2025.

• Business development efforts intensified, including outreach to pharma partners and strategic events such as the J.P. Morgan conference.

Financial highlights

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

• Net loss for Q3 2024 was $9.5 million, with a loss per share of $0.12, improving from $9.9 million and $0.14 per share in Q3 2023.

• Research and development expenses rose to $6.8 million from $5.8 million year-over-year, mainly due to higher manufacturing and clinical trial costs.

• General and administrative expenses decreased to $3.1 million from $5.2 million, reflecting lower investor relations and transaction costs.

• 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.

Outlook and guidance

• Registration-enabling breast cancer study expected to enroll over 18 months, with data maturity six months after last patient; filing position anticipated soon after.

• H1 2025: Finalize master protocol and submit to FDA for adaptive registration-enabling trial in first-line pancreatic ductal adenocarcinoma.

• H1 2025: Safety run-in data from GOBLET study cohort 5 (pancreatic cancer) and updated efficacy data from cohort 4 (anal cancer) expected.

• Anticipates accelerated approval for pelareorep in breast cancer by 2027, targeting a US addressable population of 55,000.

• Projected $2.4 billion annual sales potential in US and EU5 by 2033 with 15–20% market penetration.