Summit reports Q2 2026 results, ivonescimab OS data consistent across regions ahead of Nov FDA decision

Filed July 23, 2026 · Period ending July 23, 2026 · ~2 min read

Key Changes

• high

  Updated HARMONi analysis shows consistent OS benefit (HR 0.76) in both Western and Asian patients with 23.2 and 32.7 months median follow-up, strengthening case ahead of November 14, 2026 FDA PDUFA date for ivonescimab BLA.

  Exhibit 99.1 view on EDGAR →
• high

  HARMONi-6 Phase III showed ivonescimab plus chemo achieved statistically significant OS improvement vs tislelizumab plus chemo in squamous NSCLC (HR 0.66, p=0.0017), first head-to-head win over anti-PD-(L)1 regimen in any tumor type.

  Exhibit 99.1 view on EDGAR →
• high

  Q2 2026 GAAP net loss $215.7M ($0.28/share), down from $565.7M year-ago on lower stock comp; non-GAAP loss $147.0M ($0.19/share), up from $86.9M on expanded ivonescimab development. Cash and investments $690.7M at quarter-end.

  Exhibit 99.1 view on EDGAR →