Core Insights - Fractyl Health, Inc. is set to report its financial results for Q3 2025 on November 12, 2025, at 4:30 p.m. ET [1] - The company focuses on innovative treatments for obesity and type 2 diabetes (T2D), aiming to address the root causes of these metabolic diseases [3] Company Overview - Fractyl Health is dedicated to developing new therapeutic approaches for metabolic diseases, particularly obesity and T2D, which are significant contributors to morbidity and mortality in the 21st century [3] - The company aims to shift the treatment paradigm from chronic symptomatic management to durable disease-modifying therapies that target organ-level causes [3] - Fractyl Health has a strong intellectual property portfolio, including 33 granted U.S. patents and around 40 pending U.S. applications, along with various foreign patents [3] - The company is headquartered in Burlington, Massachusetts [3]

Core Viewpoint - Fractyl Health, Inc. has announced a pricing of an underwritten offering of 60 million shares of common stock at $1.00 per share, aiming to raise approximately $60 million in gross proceeds before expenses [1][8]. Company Overview - Fractyl Health is a metabolic therapeutics company focused on innovative treatments for metabolic diseases, particularly obesity and type 2 diabetes (T2D) [5][12]. - The company aims to shift the treatment paradigm from chronic symptomatic management to durable disease-modifying therapies that address the root causes of metabolic diseases [5][12]. - Fractyl has a strong intellectual property portfolio, including 33 granted U.S. patents and around 40 pending U.S. applications, along with numerous foreign patents [5][12]. Offering Details - The underwritten offering is expected to close on or about September 29, 2025, subject to customary closing conditions [1][8]. - BofA Securities and Evercore ISI are serving as joint book-running managers, while Ladenburg Thalmann is the lead manager for the offering [2][9]. - A shelf registration statement for the offering was filed with the SEC on March 3, 2025, and was declared effective on March 18, 2025 [3][10].

Core Insights - Fractyl Health, Inc. announced significant results from the REMAIN-1 Midpoint Cohort, indicating that the Revita procedure may be the first therapy to maintain weight loss after discontinuation of GLP-1 drugs, with Revita-treated patients losing an additional 2.5% total body weight compared to a 10% regain in sham-treated patients [2][3][10] Study Results - The REMAIN-1 Midpoint Cohort study involved 45 participants who had achieved at least 15% total body weight loss with tirzepatide, randomized to receive either Revita or a sham procedure [4][5] - At the 3-month mark, the study met its primary efficacy endpoint with a statistically significant p-value of 0.014, demonstrating the effectiveness of Revita in promoting further weight loss [8][10] - Safety and tolerability were excellent, with no serious adverse events related to Revita observed, and side effects were mild and transient [8] Future Outlook - The ongoing REMAIN-1 Midpoint Cohort is expected to provide 6-month data in Q1 2026, while the Pivotal Cohort aims to complete randomization in early 2026, with topline primary endpoint data and potential PMA filing anticipated in H2 2026 [11] - These milestones are crucial for establishing Revita as a potential first-in-class treatment for post-GLP-1 weight maintenance, opening a new therapeutic category in obesity care [11] Company Background - Fractyl Health focuses on innovative metabolic therapeutics targeting the root causes of obesity and type 2 diabetes, aiming to transform treatment from chronic management to durable disease-modifying therapies [13][15] - The company holds a robust intellectual property portfolio, including 33 granted U.S. patents and approximately 40 pending applications, positioning it well in the metabolic disease treatment landscape [13]

Company Overview - Fractyl Health, Inc. is a metabolic therapeutics company focused on innovative approaches to treat obesity and type 2 diabetes (T2D) [3] - The company aims to shift the treatment of metabolic diseases from chronic symptomatic management to durable disease-modifying therapies targeting organ-level root causes [3] - Fractyl has a strong intellectual property portfolio with 32 granted U.S. patents and approximately 40 pending U.S. applications, along with numerous foreign patents [3] Upcoming Events - The company will report its financial results for the second quarter of 2025 and provide business updates on August 12, 2025, at 4:30 p.m. ET [1] - Harith Rajagopalan, M.D., Ph.D., Co-Founder and CEO, will present at the Canaccord Genuity 45th Annual Growth Conference on August 13, 2025, at 11:30 a.m. ET [2] - A live webcast of the conference call and presentation will be available on Fractyl Health's website, with an archived version for later access [2]

Core Insights - Fractyl Health, Inc. has strengthened its intellectual property portfolio with the issuance of two new U.S. patents, enhancing its leadership in metabolic innovation and duodenal resurfacing technologies [1][2][3] Intellectual Property Developments - The company has built a robust patent portfolio since 2011, now comprising 31 granted U.S. patents and approximately 40 pending U.S. applications, along with numerous foreign patents [2][5] - The newly issued patents focus on electrical energy ablation systems for treating tissue, specifically targeting duodenal mucosa with thermal and non-thermal energy applications [3][4] Product and Clinical Development - Fractyl's lead product candidate, Revita, aims to remodel the duodenal lining to reverse damage caused by high-fat and high-sugar diets, which are root causes of metabolic diseases [6][7] - Revita has received U.S. FDA Breakthrough Device designation for weight maintenance in patients who discontinue GLP-1-based drugs [6][7] - The company is preparing for three key data readouts from its pivotal study of Revita, with significant milestones expected in June 2025, Q3 2025, and the second half of 2026 [4][5]