Summit Therapeutics (SMMT) investor relations material

Executive summary

• Ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, has demonstrated statistically significant and clinically meaningful overall survival benefit in Phase III trials, including the HARMONI-6 trial for 1L squamous NSCLC, and has received two approvals in China, with a BLA accepted by the FDA and a PDUFA date set for November 14, 2026.

• Over 4,000 patients have been dosed in clinical studies globally, and more than 70,000 patients have received ivonescimab commercially in China.

• The global clinical pipeline includes multiple ongoing or completed Phase III trials in lung, colorectal, head and neck, and other solid tumors, with positive efficacy and safety profiles across regions.

• Ongoing collaborations with Akeso, Arcus Biosciences, GSK, Revolution Medicines, and others are accelerating clinical development and expanding the pipeline.

• Expanded Akeso license to include Latin America, Middle East, and Africa.

Financial highlights

• Cash, cash equivalents, and short-term investments totaled $690.7 million at June 30, 2026, with no debt.

• GAAP operating expenses for Q2 2026 were $220.5 million, up from $195.2 million in Q1 2026; non-GAAP operating expenses were $151.8 million, up from $122.4 million.

• GAAP net loss for Q2 2026 was $215.7 million ($0.28/share), improved from $565.7 million ($0.76/share) in Q2 2025; non-GAAP net loss was $147.0 million ($0.19/share).

• Raised $230.8 million in Q2 2026 and $68.4 million post-quarter via ATM facility.

• Net cash used in operating activities for H1 2026 was $263.4 million.

Outlook and guidance

• FDA decision on ivonescimab expected in Q4 2026, with commercial launch preparations underway.

• HARMONi-3 PFS analysis for the squamous cohort expected in H2 2026, with interim OS analysis; non-squamous PFS analysis expected in H1 2027.

• Additional Phase III studies and expansion into new tumor types planned, with further details to be provided in coming months.

• Data from collaborations with Arcus Biosciences and Revolution Medicines expected by mid-2027.

• Plans to raise additional funds through equity, debt, collaborations, or licensing; failure to secure funding may delay or reduce R&D and commercialization.