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Earnings

Summit Reports Narrower Q3 2026 Loss; AstraZeneca Completes $2 Billion Equity Investment in Summit

The oncology company reported third-quarter 2026 GAAP operating expenses of $214.6 million and ended September with $629.8 million in cash and investments, before AstraZeneca completed a $2.0 billion preferred-stock purchase on October 5.

Summit Therapeutics Inc. (SMMT) reported a third-quarter 2026 GAAP net loss of $208.4 million and GAAP operating expenses of $214.6 million. It closed the quarter with $629.8 million in cash and cash equivalents and short-term investments, down from $690.7 million at June 30, 2026, after raising $94.1 million in gross proceeds through its ATM facility.

On October 5, 2026, AstraZeneca completed a $2.0 billion strategic equity investment, purchasing about 108,955 shares of preferred stock convertible 1:1,000 into common stock, a conversion price equal to $18.36 of common stock. The company said the investment will support continued acceleration of ivonescimab development.

GAAP net loss was $208.4 million, or $(0.26) a share, compared with $231.8 million, or $(0.31) a share, a year earlier. Non-GAAP net loss was $160.7 million, or $(0.20) a share, versus $101.0 million, or $(0.13) a share.

GAAP operating expenses were $214.6 million. The company attributed the year-over-year decline to an $83.1 million drop in stock-based compensation tied to a second-quarter 2025 modification of performance-based stock option awards, offset by higher R&D from expanded ivonescimab clinical studies. Non-GAAP operating expenses were $166.9 million, which the company said was primarily driven by expansion of clinical studies and development costs related to ivonescimab.

GAAP R&D expenses were $169.1 million, compared with $131.1 million a year earlier, driven by expanded ivonescimab clinical studies and offset by a $16.7 million decrease in stock-based compensation. Non-GAAP R&D expenses were $145.2 million, compared with $90.5 million a year earlier. GAAP G&A expenses were $45.5 million, compared with $103.1 million a year earlier, due to a $66.4 million decrease in stock-based compensation. Non-GAAP G&A expenses were $21.7 million, compared with $12.9 million a year earlier, which the company said was primarily driven by expansion of infrastructure and headcount to support ivonescimab development.

The global ivonescimab program expanded beyond NSCLC and colorectal cancer. In August 2026 Summit announced planned initiation of Phase II/III HARMONi-GU1 in urothelial carcinoma, with Phase II site activations and enrollment begun. In October 2026 it announced initiation of Phase II SMT112-216 in first-line metastatic clear-cell renal cell carcinoma, planning to enroll about 100 patients in the U.S. and China.

HARMONi-3 enrollment in both squamous and non-squamous NSCLC cohorts is complete. The squamous cohort’s PFS events for primary analysis are expected in the fourth quarter of 2026 with a planned early interim OS analysis, and non-squamous PFS events are expected in the first half of 2027. HARMONi-GI3 enrollment in first-line unresectable metastatic CRC is expected to include 900 patients, with completion now expected in Q3 2027.

Updated June 2026 HARMONi OS analysis showed an OS hazard ratio of 0.76 (95% CI 0.61–0.95; nominal p=0.0151) in the global ITT population and 0.76 (95% CI 0.52–1.10) in the western subgroup, with western patients replicating the survival improvement seen in Asian patients. The FDA accepted Summit’s BLA for ivonescimab plus chemotherapy in EGFR-mutated non-squamous NSCLC after prior TKI therapy in January 2026, with a PDUFA goal action date of November 14, 2026. HARMONi met its PFS primary endpoint; the primary OS analysis showed a positive trend without a statistically significant result, and the FDA noted that a statistically significant OS benefit is necessary to support marketing authorization.

Akeso’s HARMONi-2 interim OS analysis in PD-L1–positive advanced NSCLC showed ivonescimab monotherapy versus pembrolizumab with an HR of 0.73 (95% CI 0.57–0.95; p=0.009). HARMONi-GI1 in biliary tract cancer showed ivonescimab plus chemotherapy versus durvalumab plus chemotherapy with an OS HR of 0.75 (95% CI 0.61–0.92; p=0.0031).

In September 2026 Summit entered a clinical trial collaboration with AstraZeneca on ivonescimab plus sonesitatug vedotin in GI cancers and a non-binding MOU for additional AstraZeneca ADC combinations. In October 2026 it announced a collaboration with AstraZeneca and Daiichi Sankyo on ivonescimab plus Datroway, intended to begin with a Phase III trial in first-line triple-negative breast cancer. None of those collaborations include upfront, milestone, or royalty-sharing payments. In October 2026 Summit also announced ECOG-ACRIN Phase II/III EA2251 in advanced biliary tract cancer, with U.S. site activation expected to begin in the fourth quarter of 2026. The company said it has agreed to support more than 65 investigator-sponsored trials, of which 26 have started and are actively enrolling.

Over 5,000 patients have been treated with ivonescimab in clinical studies globally, and over 100,000 patients have been treated commercially in China.

Given the FDA’s November 14 PDUFA goal action date for the pending BLA, Summit plans to host a conference call and webcast following the FDA’s action.

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