Ono Pharmaceutical (4528) Investor presentation summary

Strategic priorities and pipeline progress

• Three global Phase 3 trials initiated and seven POC study data readouts planned for FY2026 in oncology, immunology & inflammation, and neurology.

• Four new pipeline assets entered Phase 1, with a focus on global expansion and specialty product launches through 2028.

• Peak sales projections for key assets such as ONO-4578 and ONO-2808 exceed ¥100 billion each.

• Open innovation and external collaborations drive drug discovery, especially in neurology and oncology.

• Emphasis on disease-modifying therapies and targeting glial cells in neurology.

ONO-4578 clinical development and results

• ONO-4578, an EP4 antagonist, combined with nivolumab and chemotherapy, showed significant PFS improvement in first-line HER2-negative advanced gastric cancer (median PFS: 9.0 vs 6.9 months, HR 0.67, p=0.040).

• OS data favored ONO-4578 (median OS: 18.6 vs 14.2 months, HR 0.68), with more pronounced benefit in PD-L1 CPS ≥1 subgroup.

• Higher ORR (62.0% vs 48.7%) and longer DOR (8.5 vs 6.6 months) observed in ONO-4578 group.

• Safety profile was manageable; most common TRAEs included sensory neuropathy and cytopenias.

• Phase 3 gastric cancer trial in preparation; additional Phase 2 studies ongoing in colorectal cancer.

ONO-2808 clinical development and results

• ONO-2808, a selective S1P5 agonist, targets multiple system atrophy (MSA) with Phase 2 data showing potential to slow disease progression.

• Exploratory efficacy analyses indicated less impairment and brain atrophy in both MSA-P and MSA-C subtypes compared to placebo.

• Safety profile was acceptable, with reversible transaminase elevations and no new safety signals.

• Phase 3 trial preparations underway in Japan, US, and EU.

• Biomarker and imaging collaborations support translational research and clinical development.