Fractyl Health(GUTS) - 2025 Q2 - Quarterly Results

Business Highlights and Clinical Pipeline Update The company reports positive clinical progress for its Revita® program and advancements in the preclinical Rejuva® gene therapy platform Revita® Program The Revita® procedure is advancing through the REMAIN-1 pivotal study to evaluate its efficacy post-GLP-1 drug discontinuation REVEAL-1 Cohort - Positive 3-month data showed that 12 of 13 participants maintained or further reduced their weight after discontinuing GLP-1 medication and receiving a single Revita procedure[5][6] - Median weight remained stable through 3 months (0.46% change), compared to a typical 5-6% weight rebound seen in other clinical studies after GLP-1 withdrawal[6] - Upcoming data releases for the REVEAL-1 Cohort are expected for the 6-month follow-up in Q4 2025 and the 1-year follow-up in Q2 2026[6] REMAIN-1 Midpoint Cohort - Enrollment is complete for the 45-participant randomized, double-blind REMAIN-1 Midpoint Cohort, designed to provide an early readout on Revita's potential for weight maintenance post-GLP-1[7][10] - Key data readouts are anticipated in September 2025 (3-month data) and Q1 2026 (6-month data)[1][10] REMAIN-1 Pivotal Cohort - Enrollment is complete for the 315-participant randomized, double-blind REMAIN-1 Pivotal Cohort, which will evaluate the safety and efficacy of Revita for weight maintenance[8][11] - The company expects to report 6-month primary endpoint data and submit a Premarket Approval (PMA) application to the FDA in the second half of 2026[1][11] Germany Real-World Registry Study - Data from the first 9 patients with 2 years of follow-up showed that a single Revita procedure led to a median 9.6% weight loss and a 1.6% reduction in HbA1c in participants with obesity and advanced T2D[9] - These effects were sustained through two years with no device- or procedure-related serious adverse events reported, supporting Revita's potential for durable, long-term metabolic control[9] Rejuva® Gene Therapy Platform The Rejuva® gene therapy platform is advancing its lead candidate, RJVA-001, toward first-in-human studies for T2D and obesity - Preclinical data presented at ADA and ASGCT showed a single dose of Rejuva prevented weight gain and hyperglycemia in animals, demonstrating durable metabolic improvements and supporting readiness for clinical trials[14] - The company submitted the first module of its CTA in Europe for RJVA-001 in May 2025 for a Phase 1/2 study in adults with inadequately controlled T2D[14] - Pending regulatory authorization, Fractyl expects to dose the first patients with RJVA-001 and report preliminary data in 2026[14] Corporate Developments The company strengthened its financial position, expanded its IP portfolio, and explored a potential commercial collaboration for Revita - Completed a $23 million underwritten public offering in August 2025, which is expected to extend the cash runway through key upcoming clinical data readouts from the REMAIN-1 Midpoint Cohort[2][14] - Was issued two new U.S. patents, expanding protection for its duodenal mucosal resurfacing platform and bringing its portfolio to 32 granted U.S. patents[14] - Entered into a non-binding Letter of Intent with Bariendo Inc to evaluate a potential collaboration for Revita as a post-GLP-1 weight maintenance intervention, pending FDA approval[14] Second Quarter 2025 Financial Results The company reported a wider net loss driven by increased R&D expenses, while maintaining a cash runway into 2026 Q2 2025 Financial Highlights (vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change Driver | | :--- | :--- | :--- | :--- | | R&D Expenses | $21.2M | $16.8M | Advancement of REMAIN-1 study and Rejuva program | | SG&A Expenses | $4.9M | $6.2M | Lower stock-based compensation expenses | | Net Loss | ($27.9M) | ($17.2M) | Fluctuation in fair value of notes/warrants & higher operating expenses | | Cash & Equivalents | $22.3M | N/A | As of June 30, 2025 | - The company believes its cash position, including proceeds from the August 2025 offering, is sufficient to fund operations into 2026[17] Financial Statements This section presents selected consolidated balance sheet and statement of operations data for the period ending June 30, 2025 Selected Consolidated Balance Sheet Data The balance sheet shows a significant decrease in cash and total assets, resulting in a stockholders' deficit as of June 30, 2025 Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $22,291 | $67,464 | | Total assets | $62,006 | $108,077 | | Total liabilities | $80,218 | $79,653 | | Total stockholders' equity (deficit) | ($18,212) | $28,424 | Consolidated Statements of Operations and Comprehensive Loss The statement of operations reveals a wider net loss for Q2 2025 compared to Q2 2024, driven by higher R&D spending Statement of Operations Highlights (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $21,151 | $16,762 | | Selling, general and administrative | $4,928 | $6,242 | | Loss from operations | ($26,079) | ($22,985) | | Net loss and comprehensive loss | ($27,889) | ($17,229) | About the Company and Products This section provides an overview of Fractyl Health's mission and its key investigational product platforms, Revita® and Rejuva® About Fractyl Health Fractyl Health is a metabolic therapeutics company developing disease-modifying therapies for obesity and Type 2 Diabetes - The company's goal is to transform metabolic disease treatment from chronic symptomatic management to durable therapies that target the root causes of disease[19] About Revita® Revita® is an investigational duodenal remodeling procedure designed to maintain weight loss after GLP-1 drug discontinuation - Revita is designed to reverse damage to intestinal nutrient sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets[20] About Rejuva® The Rejuva® platform is a preclinical gene therapy program targeting the pancreas to provide durable treatment for T2D and obesity - Rejuva aims to offer novel, disease-modifying therapies by developing locally delivered gene therapies that address the underlying root causes of metabolic diseases[21]