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ONCY

Oncolytics Biotech, Inc.

Oncolytics Biotech, Inc. Q4 FY2023 earnings call

March 9, 2024 · fiscal period ended 2023-12

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Summary

Generated 2024-03-09

Management highlights

  • Clinical results in 2023: Positive data from GOBLET study cohorts in pancreatic, colorectal, anal cancer; BRACELET-1 breast cancer data. Translational data showed correlation between response rates and T cell expansion. - 2024 plans: Initiate first registrational studies for pelareorep; provide guidance on breast cancer registrational path in H1; initiate pancreatic cancer registration study with adaptive design; report OS data from BRACELET-1; expand anal cancer cohort enrollment. - Manufacturing: Well-established supply chain; scaled up drug substance production; working with CDMO; pela has long shelf life. - Partnerships: Received $5 million PanCAN grant for modified FOLFIRINOX PDAC cohort and GOBLET.
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Segment performance

Kirk Look reviewed financial results. In Q4 2023, net loss was $3.9 million vs $8.6 million in Q4 2022, net loss per share $0.05 vs $0.14. Full year 2023 net loss was $27.8 million vs $24.8 million in 2022, net loss per share $0.41 vs $0.43. Cash at year end was $34.9 million. G&A expenses in Q4 2023 were $4.2 million vs $3.7 million in Q4 2022. Full year 2023 G&A was $16.1 million vs $11.5 million. R&D expenses in Q4 2023 were $4.7 million vs $4.8 million in Q4 2022. Full year 2023 R&D was $17.7 million vs $15.4 million, driven by higher manufacturing expenses offset by lower clinical study costs.

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Guidance

  • In H1 2024, provide guidance on registrational path for pelareorep in breast cancer. - Initiate registration study for pelareorep in pancreatic cancer using adaptive design. - Expect to report overall survival data from BRACELET-1 breast cancer study in 2024. - Expand enrollment in GOBLET anal carcinoma cohort.
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Risks

  • Factors including results of current or pending clinical trials, risks associated with intellectual property protection, financial protections, actions by regulatory agencies, and other factors detailed in company filings with SEDAR and the SEC.
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Q&A highlights

Q: Question on breast cancer trial patient characteristics and manufacturing virus characteristics A: Tom Heineman said breast cancer population similar to BRACELET study with some standard of care differences; Allison Hagerman said no changes to virus characteristics, raw materials same, products tested for comparability Q: Question on pivotal study design in pancreatic cancer A: Matt Coffey said study uses adaptive design, primary endpoint overall survival, similar to PanCAN's design to expedite approval Q: Question on anal cohort expansion timing A: Tom Heineman said study submitted to German regulators, hoping to start enrollment in May Q: Question on BRACELET-1 OS data expectations and OpEx for 2024 A: Tom Heineman said OS results expected in third quarter, optimistic overall survival will validate PFS benefit; Kirk Look said 2024 OpEx more in line with 2021 levels, dependent on clinical plan progress

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Transcript

March 9, 2024

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