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Fractyl Health, Inc. (Nasdaq: GUTS) is a pioneering metabolic therapeutics company based in Burlington, MA, dedicated to transforming the treatment of metabolic diseases such as type 2 diabetes (T2D) and obesity. The company aims to shift the paradigm from chronic symptomatic management to durable disease-modifying therapies that address the root causes of these conditions at the organ level.
Fractyl Health's leading product candidate, Revita®, focuses on remodeling the duodenal lining through hydrothermal ablation, known as duodenal mucosal resurfacing (DMR). This innovative approach aims to correct abnormal intestinal nutrient sensing and signaling mechanisms, which are potential root causes of metabolic diseases like T2D and obesity. Revita has received a CE mark in Europe and reimbursement authorization in Germany for T2D treatment. In the United States, Revita is for investigational use only. The company is currently enrolling patients in pivotal studies such as Revitalize-1 and Remain-1 to further investigate the efficacy of Revita.
Additionally, Fractyl Health's Rejuva® platform is in the preclinical development stage, focusing on next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies. The platform aims to offer novel, disease-modifying therapies that target the pancreas, leveraging advanced delivery systems and proprietary screening methods.
Recently, Fractyl Health presented new preclinical data from its Rejuva platform at the Digestive Disease Week (DDW) 2024, showcasing the potential of GLP-1 based pancreatic gene therapy to reduce liver fat in diet-induced obesity models. The company also shared impressive 6-month follow-up data from its German real-world registry study of Revita for T2D, highlighting significant improvements in blood sugar levels, body weight, and medication burden among participants.
Fractyl Health continues to advance its mission with promising research and active participation in major medical conferences. The company’s strategic goals include progressing towards regulatory approvals and expanding clinical studies to validate their innovative therapies.
For more information, visit www.fractyl.com or follow Fractyl Health on Twitter.
Fractyl Health presented preclinical data on its Rejuva GLP-1 pancreatic gene therapy at Digestive Disease Week 2024. The therapy showed significant reductions in liver weight (42%), liver triglycerides (67%), total cholesterol (36%), and LDL cholesterol (51%) compared to placebo two months post-administration. These results highlight the potential for profound metabolic benefits from a single administration. The company plans to nominate its first GLP-1 PGTx candidate for obesity in H2 2024. The therapy aims to address metabolic dysfunction-associated liver diseases such as MASLD and MASH, which are major causes of liver transplants in the U.S. Rejuva utilizes a proprietary delivery method to target the pancreas, aiming for durable effects on glucose and weight control.
Fractyl Health (Nasdaq: GUTS) announced its Q1 2024 financial results, highlighting several key developments and milestones. The company reported revenues from its pilot commercial launch in Germany but faced increased R&D and SG&A expenses, leading to a net loss of $3.3 million. However, this was a significant improvement from the $11.9 million loss in Q1 2023, primarily due to a $17.1 million non-cash gain.
Fractyl expects to initiate the Remain-1 pivotal study for weight maintenance in H2 2024 and anticipates topline data from the Revitalize-1 study in Q4 2024. The company is also progressing with its Rejuva gene therapy program, aiming to present new preclinical data in May 2024 and complete IND-enabling studies by H2 2024. Additionally, Fractyl appointed Adrian Kimber as Chief Commercial Officer to lead launch readiness for Revita.
Fractyl’s cash position as of March 31, 2024, was $121.4 million, which is expected to fund operations through 2025. The company will discuss these updates in a conference call on May 13, 2024.
Fractyl Health, Inc. presented promising 6-month follow-up data from its German real-world registry study of Revita for advanced Type 2 Diabetes (T2D). Participants showed sustained improvements in blood glucose, weight loss, and reduced T2D medication use after a single treatment. No serious adverse events related to the device or procedure have been reported. These results indicate the potential of Revita for durable weight loss maintenance.
Fractyl Health, Inc. (Nasdaq: GUTS) will present at BofA Securities 2024 Health Care Conference. Dr. Harith Rajagopalan, CEO, will participate in a fireside chat on May 15, 2024. The Company focuses on innovative treatments for obesity and type 2 diabetes.
Fractyl Health, Inc. (Nasdaq: GUTS) will report Q1 2024 financial results and business updates on May 13, 2024. The company focuses on metabolic therapeutics for obesity and T2D, hosting a conference call at 4:30 p.m. ET.
Fractyl Health, Inc. (Nasdaq: GUTS) will present new data at the German Diabetes Association (DDG) Annual Meeting on its real-world registry study of Revita for T2D and at the Digestive Disease Week (DDW) on the potential of Rejuva in reducing liver fat. The presentations include clinical updates and preclinical data demonstrating the effectiveness of their metabolic therapeutics in treating obesity and T2D.
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