Fractyl Health, Inc., a clinical-stage metabolic therapeutics company, reported a net loss of $141.0 million for the year ended December 31, 2025, compared to a net loss of $68.7 million for the year ended December 31, 2024. The company generated no revenue in 2025, a decrease from the $93,000 in revenue reported in 2024, which was related to a limited commercial pilot launch in Germany that has since been paused. The company's cost of goods sold also decreased to zero in 2025 from $50,000 in 2024, aligning with the absence of revenue.
Research and development expenses increased to $74.5 million in 2025 from $70.5 million in 2024, primarily driven by advancements in the Revita and Rejuva programs. Revita-related expenses increased by $3.0 million due to a $6.1 million increase in clinical-related expenses, offset by decreases in collaborative medical research and engineering expenses. Rejuva-related expenses increased by $4.5 million as the company advanced preclinical CMC activities and clinical preparation work for the RJVA-001 first-in-human study. Selling, general, and administrative expenses decreased to $22.3 million in 2025 from $23.1 million in 2024, mainly due to lower personnel-related expenses, offset by increases in offering costs and legal, audit, and investor relations expenses.
The company's strategic developments in 2025 included the completion of enrollment in the REMAIN-1 Pivotal Cohort, a study evaluating Revita's efficacy in maintaining weight loss after GLP-1 therapy discontinuation. Fractyl also announced a strategic reprioritization, pausing investment in Revita for T2D, including the REVITALIZE-1 study and the Germany Real-World Registry study. The company submitted CTAs for RJVA-001 in T2D to regulators in the EU and Australia, advancing the program toward its anticipated first-in-human study.
As of December 31, 2025, Fractyl Health had $81.5 million in cash and cash equivalents. The company believes this will be sufficient to fund operating expenses and capital expenditure requirements into early 2027. However, management has concluded that substantial doubt exists about the company's ability to continue as a going concern for at least one year after the issuance of these financial statements. The company plans to seek additional funding through equity or debt financings or through collaboration or licensing transactions. Fractyl Health is targeting several key milestones in 2026, including data readouts from the REMAIN-1 study and the potential submission of a De Novo marketing application for Revita.
About Fractyl Health, Inc.
Fractyl Health develops innovative, disease-modifying therapies targeting the gut and pancreas to treat obesity and type 2 diabetes. Its lead products, Revita and Rejuva, aim to provide durable weight management and metabolic remission through procedural and gene therapy approaches. Focused on long-term benefits, the company targets large markets with solutions designed to address root causes, reduce treatment burden, and shift care from symptom management to disease elimination.
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