• 75% 2.5-year overall survival for OST-HER2 vs. 47% pooled historical control (p = 0.003), with no new patient deaths reported since the 2-year overall survival data (75% vs. 60%, p = 0.034)
  • Updated clinical efficacy data being added to regulatory dossiers as Company seeks early market authorizations in U.S., U.K., Europe and Australia in 2nd half of 2026
  • EMA and Australia TGA (TGA) alignment achieved on early Q4-2026 3-year overall survival data, supported by biomarker data, as key approvable clinical efficacy endpoint
  • Upcoming U.S. FDA and U.K. MHRA meetings seek alignment with EMA and TGA on Phase 2b 3-year overall survival and biomarker data to support early market access
  • Confirmatory Phase 3 study, required to have commenced prior to grant of early market access in U.S., U.K., Europe or Australia, expected to initiate in late Q3-2026 in Australia