Oncolytics Biotech, Inc.
Oncolytics Biotech, Inc. Q2 FY2023 earnings call
August 14, 2023 · fiscal period ended 2023-06
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2023-08-14
Management highlights
• Progress in CAR T programs for pelareorep in pancreatic and breast cancer, with BRACELET-1 trial in breast cancer showing 50% improvement in progression-free survival and nearly threefold increase in confirmed overall response rate for pelareorep plus paclitaxel vs paclitaxel alone. This program is Phase 3 ready. • Pela included in Precision Promise adaptive Phase 3 clinical trial for pancreatic cancer, expected to reduce Phase 3 costs by ~50% and support approval for pela in combination with checkpoint inhibitor and chemotherapies. Plan to finalize agreements with Precision Promise team by Q4 2023 and open trial in early 2024. • Successfully raised $15M in equity offering, with $42.7M pro forma cash balance and financial runway extending to end of 2024. General and administrative expenses increased due to investor relations and annual meeting costs; R&D expenses increased due to manufacturing and personnel costs partly offset by lower BRACELET-1 study costs. • Preclinical research on pelareorep plus CAR T combination shows promising results, but details on presentation timing depend on licensing agreements.
Segment performance
No detailed breakdown of financial performance by product segments in terms of absolute revenue and contribution % provided in the transcript.
Guidance
• Plan to provide updates at ESMO in H2 2023 from GOBLET study pancreatic and colorectal cancer cohorts. • Provide guidance on registrational pathways for breast and pancreatic programs later in 2023. • BRACELET-1 overall survival data maturing, with update on timeline once reasonable expectation is possible. • Anticipate sufficient pool of patients for breast cancer registration trial mid next year, with regulatory filings expected to be pursued this year.
Risks
• Risks associated with clinical trials, including results of current or pending trials not meeting expectations. • Intellectual property protection risks. • Regulatory actions by agencies that could impact development and commercialization timelines. • Factors detailed in company filings with SEDAR and SEC that may cause actual results to differ from forward-looking statements.
Q&A highlights
Q: Can you talk about the pace of enrollment in the Precision Promise program and how it accelerates the registrational pathway for pelareorep? Also, regarding accelerated approval pathway for pancreatic and when first data cut might be.
A: Precision Promise protocol is vetted by FDA, uses established sites with experienced pancreatic cancer experts, enhancing enrollment and regulatory path. Enrollment expected to be fast due to top sites. First data cut around first half of 2025.
Q: On the breast cancer front, how stringent was the enrollment criteria for HER-2 negatives and confidence in registration trial enrollment?
A: Enrollment included HER-2 negative patients, with confidence due to strong objective response rate and PFS benefit in the trial, and relevance of HER-2 low patients in future. Registration trial enrollment criteria expected to be definable with FDA and stakeholders.
Q: When should we expect update on breast cancer registration trial and primary endpoint for pancreatic trial?
A: Update on breast cancer registration trial expected late 2023/early 2024 as OS matures. Pancreatic trial primary endpoint is overall survival.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.09 | $-0.09 | +0.0% | $-0.07 |
| Revenue | — | — | — | — |
Transcript
August 14, 2023Full transcript unavailable for redistribution
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