Summit Therapeutics — Q3 2026 Earnings Summary

Financial Performance:

• Cash and cash equivalents plus short-term investments totaled $629.8 million as of September 30, 2026, compared to $713.4 million at December 31, 2025.
• GAAP operating expenses for the third quarter of 2026 were $214.6 million, a decrease from $234.2 million in the same period of 2025.
• Non-GAAP operating expenses for the third quarter of 2026 were $166.9 million, an increase from $103.4 million in the same period of 2025.
• GAAP research and development (R&D) expenses were $169.1 million for the third quarter of 2026, compared to $131.1 million in the prior year period.
• Non-GAAP R&D expenses were $145.2 million for the third quarter of 2026, compared to $90.5 million in the prior year period.
• GAAP general and administrative (G&A) expenses were $45.5 million for the third quarter of 2026, down from $103.1 million in the prior year period.
• Non-GAAP G&A expenses were $21.7 million for the third quarter of 2026, up from $12.9 million in the prior year period.
• GAAP net loss for the third quarter of 2026 was $208.4 million ($0.26 per share), compared to $231.8 million ($0.31 per share) in the prior year period.
• Non-GAAP net loss for the third quarter of 2026 was $160.7 million ($0.20 per share), compared to $101.0 million ($0.13 per share) in the prior year period.
• For the nine months ended September 30, 2026, GAAP net loss was $613.5 million ($0.78 per share), compared to $860.4 million ($1.16 per share) in the prior year period.
• Net cash used in operating activities for the nine months ended September 30, 2026, was $423.2 million, compared to $221.0 million in the prior year period.
• Net cash provided by financing activities for the nine months ended September 30, 2026, was $330.3 million, compared to $43.7 million in the prior year period.
• The company raised $94.1 million in gross proceeds through its ATM facility during the third quarter of 2026.

Guidance and Future Outlook:

• The FDA set a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026, for the Biologics License Application (BLA) for ivonescimab in EGFR-mutated NSCLC.
• Enrollment in the HARMONi-3 squamous cohort is complete, with the number of PFS events expected to be reached in the fourth quarter of 2026.
• An interim analysis for overall survival (OS) in the HARMONi-3 squamous cohort is expected in conjunction with the primary PFS analysis in Q4 2026.
• Enrollment in the HARMONi-3 non-squamous cohort is ongoing, with the number of PFS events expected to be reached in the first half of 2027.
• HARMONi-7 enrollment is expected to be completed in 2027.
• HARMONi-GI3 enrollment is expected to complete in Q3 2027.
• The company plans to host a conference call following the FDA's action on the BLA.

Business Segments and Product Lines:

• Summit holds exclusive rights to develop and commercialize ivonescimab in North America, South America, Europe, the Middle East, Africa, and Japan.
• Over 5,000 patients have been treated with ivonescimab in global clinical studies, and over 100,000 patients have been treated commercially in China.
• The HARMONi study met its primary endpoint for progression-free survival (PFS) in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC.
• Updated OS results from HARMONi showed a hazard ratio of 0.76 (95% CI: 0.61 – 0.95; nominal p=0.0151) in the global intention-to-treat population.
• HARMONi-2 results presented at WCLC 2026 showed ivonescimab monotherapy achieved a statistically significant OS improvement versus pembrolizumab with a hazard ratio of 0.73 (95% CI: 0.57, 0.95; p=0.009).
• HARMONi-GI1 results presented at ESMO 2026 showed ivonescimab plus chemotherapy achieved a statistically significant OS improvement versus durvalumab plus chemotherapy with a hazard ratio of 0.75 (95% CI: 0.61, 0.92; p=0.0031).
• New clinical trials announced include HARMONi-GU1 (bladder cancer), SMT112-216 (kidney cancer), and collaborations with AstraZeneca, Daiichi Sankyo, GSK, Arcus, and GORTEC.
• Summit has agreed to support more than 65 investigator-sponsored trials (ISTs), with 26 actively enrolling.

Market and Competitive Landscape:

• The FDA noted that a statistically significant OS benefit is necessary to support marketing authorization for ivonescimab in the EGFR-mutated NSCLC setting, though no current FDA-approved options in this setting have demonstrated such a benefit.
• Western patients in the HARMONi study replicated the survival improvement seen in Asian patients, reinforcing regional consistency.
• Ivonescimab is a novel bispecific antibody combining PD-1 blockade and VEGF inhibition, designed to target tumor tissue with higher avidity than prior approved drugs.
• There are currently 17 Phase III clinical studies studying ivonescimab globally.

Risks and Challenges:

• The FDA requires a statistically significant OS benefit to support marketing authorization in the EGFR-mutated NSCLC setting, which HARMONi did not achieve in its primary analysis.
• Actual results may differ materially from forward-looking statements regarding clinical trial timing, regulatory approvals, and financial performance.
• Risks include the potential for future sales by AstraZeneca to dilute existing stockholders and adverse effects on the market price of common stock.
• The company relies on third parties for the supply of third-party products and contributions to certain combination clinical trials.
• Uncertainties exist regarding the initiation of future clinical trials, availability and timing of data, and the success of trials.

Management Commentary and Tone:

• Robert W. Duggan, Chairman and Co-CEO, stated the quarter marked meaningful momentum highlighted by AstraZeneca's $2 billion investment and expanded collaborations.
• Dr. Maky Zanganeh, President and Co-CEO, expressed encouragement regarding statistically significant OS results from Akeso's studies and anticipation for upcoming HARMONi-3 data.
• Management believes ivonescimab is a potential treatment option with a favorable benefit-risk profile despite the primary OS analysis not reaching statistical significance in HARMONi.

Analyst Questions and Answers:

• No specific analyst questions and answers are included in the press release text.

Other Key Points:

• AstraZeneca completed a $2.0 billion strategic equity investment in Summit on October 5, 2026.
• AstraZeneca purchased approximately 108,955 shares of preferred stock convertible into common stock at a 1:1,000 ratio.
• The investment represents a common stock price equal to $18.36, a premium over the closing trading price on the announcement day.
• Summit entered into a clinical trial collaboration with AstraZeneca to evaluate ivonescimab with sone-ve in gastrointestinal cancer settings.
• Summit executed a non-binding Memorandum of Understanding with AstraZeneca to conduct clinical trials combining ivonescimab with multiple AstraZeneca cancer medicines.
• Summit announced a clinical trial collaboration with AstraZeneca and Daiichi Sankyo to evaluate ivonescimab with Datroway® across multiple solid tumor settings, starting with a Phase III trial in first-line triple-negative breast cancer.
• Stock-based compensation expense decreased significantly due to modifications to performance-based stock option awards in the second quarter of 2025.