Summit Therapeutics Q1 2024 Financial Results and Operational Progress

Summit Therapeutics Inc. has announced significant advancements in its clinical and corporate operations for the first quarter ending March 31, 2024. The company is advancing the development of ivonescimab (SMT112), a novel bispecific antibody that combines immunotherapy and anti-angiogenesis effects, aimed at treating non-small cell lung cancer (NSCLC).

The collaboration with Akeso Inc., initiated in January 2023, has allowed Summit to develop and commercialize ivonescimab in the US, Canada, Europe, and Japan. Akeso retains rights in other parts of the world, including China. Since this partnership began, over 1,600 patients have been treated with ivonescimab in various clinical trials globally. Summit is currently enrolling patients in two Phase III registrational trials: the HARMONi trial and the HARMONi-3 trial.

The HARMONi Phase III trial focuses on patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). The trial combines ivonescimab with chemotherapy, with enrollment expected to complete in the second half of 2024. The HARMONi-3 Phase III trial targets first-line metastatic squamous NSCLC patients, with initial patient treatments commencing in the fourth quarter of 2023.

In January 2024, Akeso updated Phase II AK112-201 trial data. For patients with advanced or metastatic squamous NSCLC, a median progression-free survival (mPFS) of 11.1 months and a median overall survival (mOS) that was not yet reached were noted. For patients with EGFR mutations who progressed after EGFR TKI treatment, mPFS was 8.5 months, and mOS was 22.5 months. Treatment-related adverse events led to discontinuation in 11% and 0% of patients in the two cohorts, respectively, with no treatment-related deaths reported.

At the 2024 European Lung Cancer Congress, Summit and Akeso presented data on ivonescimab’s efficacy in NSCLC patients with brain metastases. Among 35 patients with brain metastases, an intracranial response rate of 34% was observed, including 23% complete responses. The median intracranial progression-free survival was 19.3 months, with no cases of intracranial bleeding complications. This data supports the ongoing HARMONi and HARMONi-3 Phase III trials.

In April 2024, Summit appointed Dr. Mostafa Ronaghi to its Board of Directors. Dr. Ronaghi co-founded Cellanome and previously served as Chief Technology Officer at Illumina, Inc., and co-founded GRAIL, a platform for cancer detection.

Financially, Summit reported cash and equivalents of $157.0 million as of March 31, 2024, down from $186.2 million at the end of 2023. Operating cash outflows for the first quarter of 2024 were $30.1 million, with research and development expenses increasing significantly to $30.9 million compared to $9.9 million in the same period of the previous year. This increase is attributed to expanded clinical study and development costs for ivonescimab.

Summit’s GAAP net loss for Q1 2024 was $43.5 million, lower than the $542.3 million loss in Q1 2023, which included substantial in-process research and development expenses related to the Akeso agreement. Non-GAAP net loss for Q1 2024 was $34.0 million, compared to $18.6 million in Q1 2023.

Summit Therapeutics continues to focus on the development and commercialization of therapies intended to improve and extend the lives of cancer patients. With ongoing clinical trials and strong financial guidance, the company aims to advance its promising drug candidates towards regulatory approvals and potential market entry.