CARGO Therapeutics Reports $167.5 Million Net Loss for 2024, Discontinues FIRCE-1 Study

CARGO Therapeutics, Inc. reported a net loss of $167.5 million for the year ended December 31, 2024, compared to a net loss of $98.1 million in 2023. Research and development expenses increased by $67.6 million, primarily due to higher manufacturing costs ($29.4 million increase), increased preclinical and clinical costs ($10.9 million increase) related to the firi-cel Phase 2 trial, and higher employee-related costs ($19.1 million increase). General and administrative expenses rose by $23.1 million, mainly due to increased employee-related costs ($16.2 million increase) and higher outside services costs ($3.0 million increase) associated with operating as a public company. The company's cash and cash equivalents and marketable securities totaled $368.1 million as of December 31, 2024.

A significant development during the period was the January 29, 2025, decision to discontinue the FIRCE-1 Phase 2 study of firicabtagene autoleucel (firi-cel), the company's lead program at the time. This decision followed an analysis of FIRCE-1 data indicating the product did not demonstrate a competitive benefit-risk profile. Concurrently, the company implemented a workforce reduction of approximately 50%, anticipating restructuring costs between $31 million and $37 million. The company is now focusing on evaluating strategic options for firi-cel while advancing its CRG-023 program and allogeneic platform. As of December 31, 2024, CARGO Therapeutics employed approximately 167 full-time employees.

In January 2025, the FDA allowed the IND for CRG-023 to proceed. The company plans a Phase 1 dose escalation study in 3L+ large B-cell lymphoma (LBCL), including CAR T-naïve patients, with enrollment expected to begin in the second quarter of 2025. Preclinical data for CRG-023, presented at the 2024 American Society of Hematology (ASH) Conference, demonstrated sustained anti-tumor activity. The company is also developing a novel allogeneic platform, aiming to select a lead vector candidate in the first half of 2025 and subsequently pursue an allogeneic vectorized CRG-023. The company's manufacturing process for CRG-023 utilizes a lentiviral vector produced using a modern suspension cell culture platform.

CARGO Therapeutics' strategy centers on developing next-generation cell therapies to address limitations of approved CAR T-cell therapies, such as limited durability, safety concerns, and unreliable supply. The company holds exclusive rights to develop and commercialize its product candidates. The company's pipeline includes both autologous and allogeneic programs and platforms. The company's financial projections indicate that existing cash resources should be sufficient to fund operations through mid-2028, based on current assumptions. However, the company acknowledges the inherent uncertainties in biotechnology product development and the need for future funding to achieve profitability.

The company's 10-K filing details several license agreements with Stanford University, Oxford Biomedica, and the National Cancer Institute (NCI), outlining milestone payments, royalties, and other obligations. The filing also extensively discusses the risks associated with clinical-stage biotechnology development, including regulatory hurdles, competition, intellectual property protection, and market acceptance. The company notes that it is an "emerging growth company" under the JOBS Act and may utilize exemptions from certain reporting requirements.