IO Biotech (IOBT) investor relations material

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.