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IO Biotech (IOBT) investor relations material
IO Biotech H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Key clinical results and product positioning
SilentBio™ (IO102/IO103) demonstrated a median PFS of 19.4 months vs. 11.0 months for pembrolizumab alone in first-line advanced melanoma, with a hazard ratio of 0.77 and a p-value of 0.056.
Subgroup analysis excluding prior anti-PD-1 exposure showed median PFS of 24.8 months and a nominal p-value of 0.037.
PD-L1 negative group saw a dramatic effect: 16.6 months median PFS vs. 3 months for control, nominal p-value 0.006, hazard ratio 0.54.
No added systemic toxicity observed; only injection site reactions reported.
Overall survival trends favor the combination arm, with hazard ratio 0.79 and curves widening post nine months.
Regulatory and commercialization plans
BLA submission to FDA planned for end of 2025, with a meeting scheduled for end of Q3 and briefing package already submitted.
EU MAA submission targeted for early 2026, with first launch opportunities anticipated in Europe.
Commercial-scale manufacturing and distribution are established, with supply chain readiness for launch.
Agreement reached with FDA on pediatric development plan.
Cash runway extends into Q1 2026, with a Q2 cash balance of $28 million and additional funding from the European Investment Bank.
Market opportunity and strategic focus
First-line advanced melanoma market in the US includes 15,000 patients, growing at 9% annually, with a significant unmet need as 50% of patients do not benefit from current standard of care.
SilentBio™ is positioned as a differentiated, off-the-shelf, subcutaneous cancer vaccine with broad applicability across tumor types.
Plans to expand into head and neck, lung, and earlier-stage indications, with ongoing Phase 2 trials in these areas.
Platform technology (T-win®) enables development of products for multiple indications and future potential beyond immuno-oncology.
Growing awareness and positive feedback from key opinion leaders and stakeholders.
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