In This Story
Adicet Bio Inc. (ACET+8.60%) has filed its 10-K filing for the fiscal year ended December 31, 2024.
The filing outlines the company's focus on developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet Bio's lead product candidate, ADI-001, is being developed for the treatment of autoimmune diseases, while ADI-270 targets renal cell carcinoma and other CD70+ solid tumors.
In December 2023, the FDA cleared Adicet Bio's IND application for ADI-001 in lupus nephritis. The company has since expanded its clinical development program to include additional autoimmune diseases such as systemic lupus erythematosus and systemic sclerosis.
Adicet Bio reported dosing its first lupus nephritis patient in November 2024 and plans to report preliminary clinical data in the first half of 2025. The company also received Fast Track Designation from the FDA for ADI-001 in lupus nephritis and systemic sclerosis.
ADI-270, targeting renal cell carcinoma, received FDA clearance for its IND application in June 2024. Adicet Bio dosed its first RCC patient in December 2024 and plans to share preliminary clinical data in the first half of 2025.
The company acknowledges its reliance on third-party manufacturers and suppliers for the production of its product candidates. Adicet Bio is also dependent on its collaboration with Regeneron Pharmaceuticals, which could impact its business if terminated.
Adicet Bio faces various risks, including the potential for adverse developments in the financial services industry, regulatory challenges in China, and the need for substantial additional financing to develop its product candidates.
The filing also highlights Adicet Bio's strategy to expand its pipeline and develop additional product candidates using its gamma delta T cell platform. The company plans to file one new IND every 12-18 months.
Adicet Bio's financial performance is influenced by its collaboration with Regeneron and its ability to secure additional financing. The company reported a net loss of $117.1 million for the year ended December 31, 2024.
The filing details various risks and uncertainties, including potential changes in U.S. and Chinese regulations, data privacy and security compliance, and the impact of global conflicts on supply chains.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Adicet Bio Inc. annual 10-K report dated March 6, 2025. To report an error, please email earnings@qz.com.