Core Insights - Fractyl Health, Inc. has appointed Lara Smith Weber as Chief Financial Officer, effective January 12, 2026, to oversee finance, accounting, and investor relations, and to support the executive leadership team and Board of Directors [1][3] Company Overview - Fractyl Health is a metabolic therapeutics company focused on innovative treatments for obesity and type 2 diabetes (T2D), aiming to shift from chronic management to durable disease-modifying therapies [5] - The company has a strong intellectual property portfolio, with 35 granted U.S. patents and approximately 45 pending U.S. applications, alongside numerous foreign patents [5] Leadership Transition - Lara Smith Weber brings over 20 years of financial leadership experience in medtech and biotech, with a proven track record in building financial organizations and guiding companies through operational scaling [2][3] - Ms. Smith Weber's previous roles include CFO at Inari and ONWARD Medical, where she strengthened capital structures and financial systems [3] - Lisa Davidson, the former CFO, resigned effective December 31, 2025, after ten years with the company, during which she played a key role in its growth and IPO [4][5]

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]