Adicet Bio Reports $117.1 Million Net Loss for 2024, FDA Clears IND Applications for ADI-001 and ADI-270

Adicet Bio, Inc., a clinical-stage biotechnology company, reported a net loss of $117.1 million for the year ended December 31, 2024, compared to a net loss of $142.7 million in 2023. Total operating expenses decreased by $24.4 million (16%) year-over-year, primarily due to a $6.7 million (6%) reduction in research and development expenses, offset by a $1.8 million (7%) increase in general and administrative expenses. The decrease in research and development costs stemmed from lower expenses related to contract development and manufacturing organizations (CDMOs), partially offset by increased lab expenses and professional fees. The company's goodwill impairment charge was eliminated in 2024, following a $19.5 million charge in 2023.

Significant developments during the year included the FDA's clearance of an Investigational New Drug (IND) application for ADI-001 in lupus nephritis (LN) in December 2023, and subsequent expansion of the ADI-001 clinical development program to include other autoimmune diseases. The company also received FDA clearance for its IND application for ADI-270 in renal cell carcinoma (RCC) in June 2024. By February 2025, three patients had been dosed in the Phase 1 clinical trial for ADI-001 in autoimmune diseases and three patients in the Phase 1 trial for ADI-270 in RCC. Adicet Bio also terminated its loan agreement with Banc of California in November 2024, repaying all outstanding indebtedness.

The company's lead product candidate, ADI-001, is an allogeneic gamma delta T cell therapy targeting CD20, currently in Phase 1 clinical trials for various autoimmune diseases. ADI-270, another allogeneic gamma delta CAR T cell therapy, targets CD70 and is being developed for RCC and other cancers. Adicet Bio plans to file one new IND application every 12-18 months. The company's pipeline also includes several additional gamma delta T cell therapy programs in preclinical development. As of December 31, 2024, Adicet Bio employed 152 full-time employees.

Adicet Bio's financial performance was impacted by significant research and development expenses, reflecting the company's clinical-stage status and ongoing development efforts. The company's cash, cash equivalents, and short-term investments totaled $176.3 million as of December 31, 2024, which the company believes will fund operations for at least twelve months. The company anticipates continued losses for the foreseeable future and will require substantial additional funding to support its development and commercialization plans.

The company's 10-K filing also detailed various risk factors, including those related to the inherent uncertainties of clinical trials, regulatory approvals, competition, manufacturing, intellectual property protection, and market conditions. The filing highlighted the company's reliance on third-party manufacturers and collaborators, the potential for adverse events in clinical trials, and the challenges associated with obtaining and maintaining regulatory approvals in multiple jurisdictions. The company also noted the risks associated with its operations in China, including regulatory uncertainties and compliance requirements.