Fractyl Health, Inc. reported a net loss of $68.7 million for the year ended December 31, 2024, compared to a net loss of $77.1 million in 2023. Revenue for 2024 was $93,000, a decrease of 22.5% from $120,000 in 2023. This revenue was generated from a pilot commercial launch of the Revita DMR System in Germany, which has since been paused. Research and development expenses increased by 85.3% to $70.5 million in 2024, primarily due to advancements in the Revita and Rejuva programs and increased personnel costs. Selling, general, and administrative expenses also rose by 79.9% to $23.1 million, largely attributed to increased professional services and higher public company insurance premiums.
A significant development was the announcement of a strategic reprioritization on January 31, 2025. This involved pausing investment in Revita programs for Type 2 diabetes (T2D), including the REVITALIZE-1 pivotal study and the Germany Real-World Registry study. The company cited positive preliminary results from the REVEAL-1 open-label cohort of the REMAIN-1 study, strong patient and physician interest, and the urgent need for durable weight maintenance solutions after GLP-1 drug discontinuation as the drivers for this decision. As of February 15, 2025, over 189 patients were enrolled in the REMAIN-1 study across 13 clinical sites. The company also announced a workforce reduction impacting 22 employees (approximately 17% of the workforce).
Fractyl Health is developing two key product candidates: Revita, an investigational outpatient procedural therapy for weight maintenance after GLP-1 discontinuation in patients with obesity, and Rejuva, a novel pancreatic gene therapy platform for the treatment of T2D and obesity. The REMAIN-1 study for Revita is ongoing, with a midpoint analysis anticipated in the second quarter of 2025 and full enrollment expected in the summer of 2025. For Rejuva, the company anticipates submitting the first clinical trial application module for RJVA-001 by the first half of 2025. Preclinical data for RJVA-001, presented at the World Congress Insulin Resistance, Diabetes and Cardiovascular Disease in December 2024, demonstrated safe and precise pancreatic delivery in Yucatan pigs.
The company's financial statements show a cash and cash equivalents balance of approximately $67.5 million as of December 31, 2024. The filing notes that this amount is insufficient to fund the current operating plan for at least twelve months and that substantial doubt exists about the company's ability to continue as a going concern. Fractyl Health intends to seek additional funding through equity or debt financings, collaborations, or licensing transactions. The company's commercialization strategy for Revita, if approved, involves a targeted sales force initially focusing on centers of excellence with metabolically focused gastroenterologists.
Fractyl Health's 10-K filing highlights numerous risks, including those related to clinical trial success, regulatory approvals, market competition, manufacturing and supply chain, intellectual property protection, and financial resources. The company's future success hinges on the successful development, regulatory approval, and commercialization of its product candidates, along with securing adequate funding to support its operations. The company's outlook is contingent upon achieving key clinical milestones and securing additional financing.
About Fractyl Health, Inc.
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