Summit Therapeutics Reports Q4 and 2024 Full-Year Financial and Operational Results
Summit Therapeutics Inc. (NASDAQ: SMMT) has provided an update on its operational progress and financial results for the fourth quarter and full year ending December 31, 2024. The company continues to advance its clinical development programs, particularly for ivonescimab (SMT112), a bispecific antibody that combines immunotherapy with anti-angiogenesis effects into a single molecule. Summit’s focus remains on the progress of this novel investigational treatment in non-small cell lung cancer (NSCLC) and other oncology settings.
Operational and Corporate Updates
Summit made significant strides in advancing ivonescimab’s clinical development during 2024. The company closed a Collaboration and License Agreement with Akeso Inc. in January 2023. Through this collaboration, ivonescimab has been administered to over 2,300 patients worldwide across several clinical studies. Summit holds the rights to develop and commercialize ivonescimab in multiple regions, including the United States, Canada, Europe, Japan, Latin America, the Middle East, and Africa, while Akeso retains rights for other regions, including China.
The company has focused its clinical development efforts on treating non-small cell lung cancer (NSCLC), with several Phase III clinical trials ongoing. These studies include:
- HARMONi: Ivonescimab combined with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after third-generation EGFR tyrosine kinase inhibitor (TKI) therapy.
- HARMONi-3: Ivonescimab combined with chemotherapy for first-line metastatic NSCLC patients.
- HARMONi-7: Ivonescimab monotherapy for first-line metastatic NSCLC patients with high PD-L1 expression.
In October 2024, Summit completed enrollment for the HARMONi trial and expects to report topline results by mid-2025, depending on data maturation. The U.S. Food and Drug Administration (FDA) granted Fast Track designation for ivonescimab in combination with platinum-based chemotherapy for treating adults with locally advanced or metastatic NSCLC who have progressed after EGFR-TKI therapy.
Summit has also amended the HARMONi-3 protocol to expand eligibility to patients with both squamous and non-squamous histologies, significantly broadening the potential patient population for the study. Enrollment for patients with squamous tumors has already begun, and the protocol amendment is now active for patients with non-squamous tumors in the U.S.
Additionally, in late 2024, Summit entered a clinical trial collaboration with Pfizer to evaluate the combination of ivonescimab with Pfizer’s antibody-drug conjugates (ADCs) in solid tumor settings. Under the agreement, Pfizer will oversee the clinical studies, and Summit will provide ivonescimab for use in these trials. The collaboration aims to explore potentially groundbreaking therapeutic combinations to improve the standard of care for patients with serious unmet medical needs. These studies are set to begin in mid-2025.
Furthermore, Summit plans to explore ivonescimab’s clinical development beyond NSCLC in other solid tumor indications, with investigator-sponsored trials across various oncology settings already underway.
Financial Results
Summit’s financial performance for the year reflects its ongoing investments in clinical development and operational activities:
- Cash Position: Summit ended 2024 with $412.3 million in cash and cash equivalents and short-term investments, compared to $186.2 million at the end of 2023. This strong cash position supports the company’s ongoing development programs.
- Research and Development (R&D) Expenses: GAAP R&D expenses for the full year 2024 totaled $150.8 million, up from $59.4 million in 2023. Non-GAAP R&D expenses were $134.8 million in 2024, compared to $55.0 million the previous year. The increase is largely due to the expansion of clinical trials for ivonescimab.
- General and Administrative (G&A) Expenses: GAAP G&A expenses for 2024 were $60.5 million, compared to $30.3 million in 2023. Non-GAAP G&A expenses rose to $25.5 million from $20.6 million, reflecting increased administrative costs as the company scaled operations.
- Operating Expenses: GAAP operating expenses for 2024 totaled $226.3 million, down from $610.6 million in 2023. Non-GAAP operating expenses were $175.3 million in 2024, compared to $596.5 million in 2023. The decrease in operating expenses was primarily due to a reduction in acquired in-process R&D expenses, offset by higher clinical development costs and staffing increases related to ivonescimab’s expansion.
- Net Loss: Summit reported a GAAP net loss of $221.3 million for 2024, or $(0.31) per share, compared to a GAAP net loss of $614.9 million, or $(0.99) per share, for 2023. Non-GAAP net loss for 2024 was $170.3 million, or $(0.24) per share, compared to a non-GAAP net loss of $600.8 million, or $(0.97) per share, in 2023.
Non-GAAP Financial Measures
Summit’s financial results include Non-GAAP measures, which exclude certain items such as acquired in-process R&D expenses, to provide a clearer view of the company’s ongoing operations. Management believes these measures are useful for comparing financial performance across periods and analyzing business trends.
