Financial outcomes for the second quarter of 2025 revealed by Adicet Bio, accompanied by company updates.
In a series of announcements made in July and August 2025, Adicet Bio has shared updates on its ongoing operations and clinical trials. The biotech company is extending its cash runway into the fourth quarter of 2026, thanks to strategic expense reductions, including a workforce reduction.
Active Phase 1 Clinical Trial Expands Enrollment
The Phase 1 clinical trial for ADI-001, Adicet Bio's innovative treatment for autoimmune diseases, is currently active and enrolling patients. The trial, which began in 2025, has already made significant strides, with the first systemic sclerosis patient dosed in July 2025, marking a key milestone.
The trial is now expanding enrollment to include patients with lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy, stiff person syndrome, and anti-neutrophil cytoplasmic autoantibody associated vasculitis. The trial is designed to evaluate safety and preliminary efficacy across these autoimmune conditions.
Preliminary Data Expected in 2H 2025
Preliminary clinical data from this Phase 1 trial is expected to be released in the second half of 2025. This means that initial results may be reported between July and December 2025. The trial has also received FDA Fast Track designation for LN and SLE, highlighting the urgency and potential impact of this therapy.
Pipeline Prioritization and Financial Outlook
Adicet Bio has announced a strategic prioritization of its pipeline, which includes discontinuing the development of ADI-270 for patients with metastatic/advanced clear renal cell carcinoma and closing enrollment in the ADI-270 Phase 1 clinical trial. This move is part of a broader cost-cutting strategy that is expected to extend Adicet Bio's cash runway into the fourth quarter of 2026.
The company's cash, cash equivalents, and short-term investments decreased from $176.3 million as of December 31, 2024, to $125.0 million as of June 30, 2025. Despite this decrease, Adicet Bio expects that its current resources will be sufficient to fund its operating expenses into the fourth quarter of 2026.
Focus on ADI-212 for Prostate Cancer
Adicet Bio is also prioritizing the preclinical development of ADI-212 for prostate cancer. The company is advancing the development of ADI-212, an optimized next-generation gene-edited and armored clinical candidate, for enhancing potency in solid tumors and delivering multiple anti-tumor mechanisms of action to the tumor microenvironment. Adicet Bio expects to submit a regulatory filing for ADI-212 for the treatment of metastatic castration-resistant prostate cancer in the first quarter of 2026.
Financial Highlights
For the three months ended June 30, 2025, Adicet Bio reported R&D expenses of $28.4 million, an increase from $25.9 million during the same period in 2024. This increase was due to a $1.4 million increase in expenses related to contract development and manufacturing organizations and contracted R&D services, a $1.6 million increase in facility-related expenses, and a $0.2 million increase in lab supplies and materials.
G&A expenses for the same period were $4.0 million, a decrease from $6.9 million during the same period in 2024. This decrease was due to a $1.8 million decrease in payroll and personnel expenses primarily related to a decrease in stock-based compensation expense and a $1.1 million decrease in facility-related expenses.
Adicet Bio reported a net loss of $31.2 million for the three months ended June 30, 2025, or a net loss of $0.34 per basic and diluted share. This represents a slight increase from the net loss of $29.9 million for the same period in 2024. The company reduced its workforce by approximately 30% in connection with its strategic pipeline prioritization.
In conclusion, Adicet Bio is making significant strides in the development of its innovative treatments for autoimmune diseases and cancer. The company's strategic pipeline prioritization and cost-cutting measures are expected to extend its cash runway into the fourth quarter of 2026, providing a stable foundation for its ongoing operations. Preliminary clinical data for ADI-001 is expected in the second half of 2025, and Adicet Bio is also focusing on the preclinical development of ADI-212 for prostate cancer.
The upcoming preliminary clinical data from ADI-001, an innovative treatment for autoimmune diseases by Adicet Bio, will provide insights into its efficacy against medical conditions like lupus nephritis, systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, stiff person syndrome, and anti-neutrophil cytoplasmic autoantibody associated vasculitis. While Adicet Bio is reducing its expenses and workforce to extend its cash runway into the fourth quarter of 2026, it is simultaneously focusing on the preclinical development of ADI-212 for prostate cancer, aiming to submit a regulatory filing for its treatment of metastatic castration-resistant prostate cancer in the first quarter of 2026.
