Financial Data and Key Metrics Changes - In Q1 2025, the company reported a net loss of $23.7 million, compared to a net loss of $3.3 million in Q1 2024, largely due to fluctuations in the non-cash change in fair value of notes and warrants and increased operating expenses [18] - Research and development expenses increased to $19.4 million from $14.4 million in the same period last year, reflecting advancements in the REMAIN one study and the Rejuva program [17] - Cash and cash equivalents as of March 31, 2025, were approximately $42.1 million, which is expected to fund operations into Q4 2025 [18] Business Line Data and Key Metrics Changes - The REMAIN one pivotal cohort has completed full enrollment, evaluating Revita for durable weight maintenance after GLP-1 discontinuation, significantly ahead of schedule [7] - The REVEAL one cohort showed promising initial results, with participants experiencing only a 1.2% average weight regain after GLP-1 cessation, compared to the typical 3% [9] Market Data and Key Metrics Changes - The company is addressing a significant unmet need in obesity care, as real-world evidence indicates that GLP-1 drugs do not deliver the expected weight loss seen in clinical trials [5] - There is a clear demand for non-drug options to enhance efficacy in weight maintenance after discontinuation of GLP-1 therapy, as patients express a strong interest in alternatives like Revita [11] Company Strategy and Development Direction - The company aims to redefine obesity treatment by offering patient-friendly solutions for durable improvements in weight and metabolic control, focusing on scalable outpatient solutions [4] - The Rejuva platform is designed to deliver a best-in-class GLP-1 based therapy for obesity and metabolic disease, emphasizing potency, durability, and convenience [12] Management's Comments on Operating Environment and Future Outlook - Management anticipates 2025 to be a year of acceleration, with multiple data readouts and regulatory filings expected [4] - The company is confident in its ability to deliver key milestones, including pivotal data from the REMAIN one study and the first CTA module submission for Rejuva [21] Other Important Information - The company has developed a large-scale cGMP manufacturing process for Rejuva, which could significantly lower costs compared to current systemic gene therapy products [15] - Management does not foresee any material impact from current tariff policies on its business operations [19] Q&A Session Summary Question: Regarding the midpoint analysis of REMAIN one - Management confirmed that over 45 patients have achieved the required 15% total body weight loss and anticipates the dataset in Q3 [27][28] Question: Upcoming REVEAL one update - The three-month data will include the majority of previously reported patients, with additional data expected from new participants [31][33] Question: Concerns about FDA shakeup - Management stated that there are no current concerns affecting regulatory interactions, and preparations for the CTA are on track [40][41] Question: Enrollment progress in REMAIN one - Enrollment was approximately three months ahead of schedule, driven by higher than expected demand at individual sites [47] Question: Sham procedure details - The sham procedure involves an upper endoscopy and randomization, ensuring rigorous controls to limit placebo effects [50][52]

Core Insights - Fractyl Health is advancing its metabolic therapeutics, particularly focusing on maintaining weight loss after discontinuation of GLP-1 therapy, with promising early clinical data from its Revita treatment [3][7][15] - The company anticipates significant milestones in 2025, including data updates from various cohorts and the submission of its first Clinical Trial Application for its Rejuva gene therapy platform [2][4][16] Company Updates - Fractyl Health reported first quarter 2025 financial results, highlighting rapid clinical and operational momentum [2] - The company has completed enrollment for the REMAIN-1 Pivotal Cohort ahead of schedule, with 6-month primary endpoint data expected in the second half of 2026 [9] - The REVEAL-1 Cohort has shown encouraging results, with an average weight regain of only 1.2% after GLP-1 discontinuation, compared to the typical 3% [7][8] Clinical Trials and Data - The REVEAL-1 Cohort is designed to provide real-world insights on Revita's performance after GLP-1 therapy cessation, with early data expected in June 2025 [5][7] - The REMAIN-1 Midpoint Cohort, which includes 45 participants, aims to assess Revita's efficacy in maintaining weight loss post-GLP-1 therapy, with initial efficacy analysis planned after 12 weeks of follow-up [6][8] - The Rejuva gene therapy platform is progressing towards first-in-human studies, with the first CTA module submission for RJVA-001 expected in June 2025 [10][16] Financial Performance - For Q1 2025, Fractyl reported a net loss of $23.7 million, an increase from $3.3 million in Q1 2024, primarily due to higher operating expenses [11][23] - Research and development expenses for the quarter were $19.4 million, up from $14.4 million in the same period last year, reflecting ongoing advancements in clinical programs [11][23] - As of March 31, 2025, the company had approximately $42.1 million in cash and cash equivalents, which is expected to fund operations into Q4 2025 [11][20]

Core Insights - Fractyl Health, Inc. is set to report its financial results for Q1 2025 and provide business updates on May 13, 2025, at 4:30 p.m. ET [1] - The CEO, Harith Rajagopalan, will present at the BofA Securities 2025 Health Care Conference on May 14, 2025, at 5:00 p.m. PT [2] Company Overview - Fractyl Health is a metabolic therapeutics company focused on innovative treatments for metabolic diseases, particularly obesity and type 2 diabetes (T2D) [4] - The company aims to shift the treatment paradigm from chronic symptomatic management to durable disease-modifying therapies that address the root causes of these diseases [4] - Fractyl Health is headquartered in Burlington, Massachusetts [4]