Fractyl Health(GUTS) - 2025 Q3 - Quarterly Results

Financial Performance - Fractyl Health reported a net loss of $45.6 million for Q3 2025, compared to a net loss of $23.2 million in Q3 2024, primarily due to a $23.5 million non-cash accounting change[13]. - The company reported no revenue for the three months ended September 30, 2025, compared to $14,000 for the same period in 2024[24]. - The net loss for the three months ended September 30, 2025, was $45,603,000, significantly higher than the loss of $23,173,000 for the same period in 2024[24]. - Total operating expenses for the nine months ended September 30, 2025, were $73,532,000, an increase from $68,361,000 in the same period of 2024[24]. - Research and development expenses for the three months ended September 30, 2025, were $17,457,000, compared to $19,004,000 for the same period in 2024[24]. - The company's total liabilities increased to $117,450,000 as of September 30, 2025, from $79,653,000 as of December 31, 2024[22]. - Cash and cash equivalents increased to $77,657,000 as of September 30, 2025, up from $67,464,000 as of December 31, 2024[22]. - The company reported a working capital of $61,021,000 as of September 30, 2025, compared to $51,988,000 as of December 31, 2024[22]. - The company continues to incur significant net losses and expects this trend to continue for the foreseeable future[19]. Research and Development - Research and Development expenses for Q3 2025 were $17.5 million, down from $19.0 million in Q3 2024[13]. - Fractyl's RJVA-002 gene therapy candidate for obesity demonstrated approximately 30% weight loss in preclinical studies after a single administration[13]. - Positive 3-month data from the REMAIN-1 Midpoint Cohort showed Revita-treated patients lost an additional 2.5% of total body weight after stopping tirzepatide, while sham-treated patients regained 10% (p=0.014)[9]. - The REMAIN-1 Pivotal Cohort is fully enrolled with over 60% of the 315 planned participants randomized as of October 31, 2025[9]. - Fractyl expects to report 6-month data from the REVEAL-1 Cohort in Q4 2025 and 1-year data in Q2 2026[5]. - The company anticipates reporting 6-month primary endpoint data from the REMAIN-1 Pivotal Cohort in H2 2026 and potentially filing a PMA application with the FDA in H2 2026[9]. Funding and Cash Position - The company completed $83 million in underwritten offerings, extending its cash runway into early 2027[2]. - Fractyl's cash position as of September 30, 2025, was approximately $77.7 million, expected to fund operations into early 2027[13]. Regulatory and Operational Risks - The company relies on third parties for conducting certain aspects of its preclinical and clinical studies, which may introduce additional risks[19]. - The regulatory approval process for the company's product candidates is lengthy and unpredictable, impacting the timeline for potential commercialization[19]. - The company aims to transform metabolic disease treatment from chronic management to durable disease-modifying therapies[15].