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IO Biotech (IOBT) investor relations material
IO Biotech Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Piper Sandler 37th Annual Healthcare Conference summary3 Dec, 2025
Key clinical results and data updates
Phase III trial of IO102-IO103 plus pembrolizumab in metastatic melanoma showed median PFS of 19.4 months vs. 11 months for control, with a hazard ratio of 0.77 and favorable safety profile.
Subgroup analyses revealed consistent drug effect across all stratification markers, with no added safety concerns.
Overall survival is trending positively (hazard ratio 0.79), with more mature OS data expected next year.
First time a therapeutic cancer vaccine has shown clear benefit in metastatic disease in a randomized phase III trial.
Longer-term data in NSCLC and SCCHN cohorts showed primary endpoint hit in head and neck and encouraging lung data.
Regulatory and trial strategy
FDA recommended against BLA submission due to not meeting statistical significance on the primary endpoint, despite clinical benefit.
New global adaptive phase II/III trial planned, evaluating IO102-IO103 with Opdualag in first-line advanced melanoma, reflecting changes in standard of care.
Trial will be a randomized one-to-one study, with PFS and OS as key endpoints.
EU regulatory engagement ongoing, with potential for MAA submission in 2026, possibly focusing on subgroups with clear benefit.
Pipeline and future directions
Phase II basket study in neoadjuvant/adjuvant melanoma and SCCHN ongoing, aiming to prolong time to recurrence; initial data expected by year-end, with presentation in 2026.
IO102-IO103 shows potential pan-tumor effect, with immune modulatory signatures being explored for patient enrichment.
Early pipeline assets IO112 (Arginase 1) and IO170 (TGF-beta) have generated strong interest, with IO112 nearing IND readiness.
Focus remains on melanoma, with plans to revisit other indications and potential partnerships after progress in lead program.
How does new trial design mitigate FDA concerns?
What's the capital raise strategy for new trial?
How will pan-tumor potential be realized?
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Next IO Biotech earnings date
Q4 20256 Mar, 2026
Next IO Biotech earnings date
Q4 20256 Mar, 2026
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Frequently asked questions
IO Biotech Inc. is a biotechnology company focused on developing immunotherapies for cancer. The company specializes in therapeutic cancer vaccines designed to stimulate the immune system to target and eliminate tumor cells. Its pipeline includes investigational treatments for various cancers, advancing through clinical trials and regulatory evaluations. The company is headquartered in Copenhagen, Denmark, and its shares are listed on the NASDAQ.
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