BURLINGTON, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced the appointment of Lara Smith Weber as Chief Financial Officer, effective January 12, 2026. Ms. Smith Weber will oversee finance, accounting, and investor relations; and will serve as a key strategic partner to the Company’s executive leaders ...

Core Insights - Fractyl Health, Inc. is focused on innovative treatments for obesity and type 2 diabetes (T2D), aiming to address the root causes of these metabolic diseases rather than just managing symptoms [2][3] - The company will participate in the 8th Annual Evercore Healthcare Conference, highlighting its commitment to engaging with investors and stakeholders [1][2] Company Overview - Fractyl Health is based in Burlington, Massachusetts, and specializes in metabolic therapeutics [2] - The company has developed a significant intellectual property portfolio, including 33 granted U.S. patents and approximately 45 pending U.S. applications, along with various foreign patents [2] Industry Context - Obesity and T2D are increasingly recognized as major health challenges in the 21st century, contributing to rising morbidity and mortality rates [2] - The company aims to shift the treatment paradigm from chronic management to durable, disease-modifying therapies that target the organ-level causes of metabolic diseases [2]

Financial Data and Key Metrics Changes - For Q3 2025, research and development expenses decreased to $17.5 million from $19.0 million in Q3 2024, primarily due to reduced spending on the Revitalize One study and lower stock-based compensation [17] - Selling, general, and administrative expenses increased to $5.2 million from $4.8 million in the same period last year, reflecting one-time costs associated with the issuance of warrants [17] - The company reported a net loss of $45.6 million, compared to a net loss of $23.2 million in Q3 2024, largely driven by a $23.5 million non-cash accounting change in the fair value of warrants [17] - As of September 30, 2025, cash and cash equivalents stood at approximately $77.7 million, bolstered by $83 million from recent underwritten offerings, extending the cash runway into early 2027 [18] Business Line Data and Key Metrics Changes - Revita, the company's endoscopic procedural therapy, demonstrated significant clinical results, with treated patients losing an additional 2.5% of total body weight while sham group patients regained about 10% after discontinuing tirzepatide [6][8] - Enrollment in the Remain One pivotal cohort was completed in Q2 2025, with over 60% of patients randomized as of October 31, 2025, ahead of schedule [7] Market Data and Key Metrics Changes - The company anticipates nearly 1 million annual procedures at peak adoption for Revita, translating to a substantial revenue opportunity [13] - Revita's unit economics are expected to create strong incentives for adoption at clinical sites, with gross margins comparable to or better than other advanced endoscopic interventions [13] Company Strategy and Development Direction - The company is focused on advancing clinical programs and regulatory milestones, with a clear path for multiple catalysts expected within the next 12 months, including pivotal data and potential PMA submission [19] - Revita is positioned as a transformative therapy for obesity, particularly in post-GLP-1 weight maintenance, complementing existing chronic drug therapies [9][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical and regulatory milestones, emphasizing the strong data supporting Revita and the growing market need for effective obesity treatments [4][19] - The company is optimistic about the potential for Revita to significantly reduce weight regain rates, which is a critical challenge for patients discontinuing GLP-1 therapies [9][22] Other Important Information - The company has established a ready-to-activate commercial model with experienced physicians at major clinical centers across the U.S. [12] - Revita's durable activity is expected to provide economic advantages by potentially reducing the need for ongoing drug therapy and associated health risks [11] Q&A Session Summary Question: What are the expectations for the six-month updates for Reveal One and Remain One Midpoint? - Management expects the six-month Reveal dataset to show consistency in results, with a goal of less than 5% weight regain, which would be a compelling outcome [21][23] Question: Can you clarify the German registry data regarding weight loss maintenance? - The average weight loss at one year was 8%, and at two years was 8.9%, indicating no waning of effect [26][27] Question: What are the manufacturing needs for Revita? - The company is confident in its current manufacturing capabilities to support clinical studies and is preparing for scale [41]

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]