FRACTYL HEALTH, INC.

Fractyl Health, Inc. (Nasdaq: FRYL) is a clinical-stage metabolic therapeutics company focused on developing novel disease-modifying treatments for obesity and type 2 diabetes. The company's website is www.fractylhealth.com.

Fractyl's lead product candidate is Revita, an investigational outpatient procedural therapy designed to remodel the duodenal lining through hydrothermal ablation to reverse damage to intestinal nutrient sensing caused by chronic high-fat and high-sugar diets. Revita has received FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1 based therapy. The company has evaluated Revita in over 500 participants across multiple clinical studies in South America, Europe, and the United States, demonstrating favorable safety and tolerability data. Fractyl anticipates submitting a potential De Novo marketing application for Revita in late 2026 and is currently evaluating the device in the REMAIN-1 weight maintenance program, which includes three distinct participant cohorts designed to establish the clinical and regulatory foundation for the therapy.

The company is also developing Rejuva, a novel pancreatic gene therapy platform utilizing adeno-associated virus delivery designed to enable long-term remission of type 2 diabetes and obesity by reprogramming pancreatic islet cells to endogenously produce metabolic hormones. The lead candidate from this platform, RJVA-001, is designed to enable pancreatic beta cells to express GLP-1 locally via nutrient-responsive control through a single endoscopic intervention. A second candidate, RJVA-002, is a dual GIP/GLP-1 gene therapy currently in preclinical development targeting obesity.

Fractyl operates as a smaller reporting company and emerging growth company. The company has not yet obtained marketing authorization for any product candidate in the United States and remains in clinical development stages. The company's business model focuses on developing disease-modifying therapies that provide long-term metabolic benefits from single administrations, positioning treatments toward prevention and remission rather than chronic symptom management. Fractyl's strategy includes establishing practice-changing clinical evidence, executing targeted commercialization approaches, and expanding applications across the metabolic disease spectrum.