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]

Financial Performance - For the nine months ended September 30, 2025 and 2024, the company incurred net losses of $97.2 million and $43.7 million, respectively, with an accumulated deficit of $512.5 million as of September 30, 2025[130]. - The net loss for the three months ended September 30, 2025, was $45.6 million, a 96.8% increase from a loss of $23.2 million in 2024[166]. - Net loss for the nine months ended September 30, 2025, was $97.2 million, an increase of $53.5 million or 122.4% from a loss of $43.7 million in 2024[175]. - The company reported a net loss of $97.2 million for the nine months ended September 30, 2025, adjusted for non-cash expenses of $28.4 million[212]. - The company may face substantial doubt about its ability to continue as a going concern for at least one year after the issuance of its financial statements due to liquidity concerns[202]. Revenue and Expenses - Revenue for the nine months ended September 30, 2025, was $0, a decrease of $90,000 or 100.0% compared to $90,000 in 2024[175]. - Cost of goods sold for the same period was $0, down from $50,000, representing a 100.0% decrease[175]. - Research and development expenses totaled $17.5 million for the three months ended September 30, 2025, a decrease of 8.1% compared to $19.0 million in 2024[166]. - Research and development expenses increased by $7.9 million, or 15.6%, to $58.0 million compared to $50.2 million in 2024, driven by advancements in Revita and Rejuva programs[177]. - Selling, general and administrative expenses increased by $0.4 million, or 9.2%, during the three months ended September 30, 2025, primarily due to professional service fees[171]. - Selling, general and administrative expenses decreased by $2.7 million, or 14.8%, to $15.5 million, primarily due to a $3.7 million decrease in stock-based compensation[181]. - Other expense, net, was $22.9 million for the three months ended September 30, 2025, primarily due to a $21.2 million loss from the change in fair value of warrant liabilities[172]. - Other net expense was $23.7 million for the nine months ended September 30, 2025, compared to other income of $24.6 million in 2024, reflecting a change of $48.3 million or 196.3%[182]. Cash Flow and Financing - The net cash used in operating activities for the nine months ended September 30, 2025, was $68.992 million, compared to $48.487 million for the same period in 2024[211]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $79.739 million, primarily from common stock issuances, while for the same period in 2024, it was $101.159 million[215][216]. - The company received approximately $20.7 million in net proceeds from the August 2025 Offering, which included the issuance of 19,047,619 shares of common stock[196]. - The September 2025 Offering generated approximately $56.0 million in net proceeds from the sale of 60,000,000 shares at $1.00 per share[199]. - The company expects to seek additional funds through equity or debt financings, collaborations, or licensing transactions to support its operations[203]. - The company expects to incur substantial operating losses and negative cash flows for the foreseeable future, necessitating additional funding to achieve business objectives[200]. Clinical Trials and Research - The Revita DMR System has received reimbursement authorization in Germany and a CE mark in Europe, with a limited commercial pilot initiated in Düsseldorf, Germany[121]. - The REMAIN-1 Midpoint Cohort (n=45) demonstrated a statistically significant 2.5% further weight loss with Revita after GLP-1 discontinuation, compared to a 10% weight regain in sham-treated patients (n=16) with a p-value of 0.014[136]. - The REMAIN-1 Pivotal Cohort has completed enrollment of 315 participants, with randomization of 194 participants as of October 31, 2025, and no serious adverse effects reported[139]. - The first Clinical Trial Application module for RJVA-001 has been submitted, with preliminary data expected in 2026[128]. - RJVA-002 showed a robust, dose-dependent reduction in body weight in preclinical studies, with mid- and high-dose cohorts losing a mean of 18% (p<0.01) and 29% (p<0.0001) of body weight, respectively[144]. - The company anticipates presenting 6-month data for the REVEAL-1 Cohort in Q4 2025 and 1-year data in Q2 2026[135]. - The company expects to complete randomization for the REMAIN-1 Pivotal Cohort in early 2026, with 6-month topline primary endpoint data anticipated in the second half of 2026[140]. Weight Loss Outcomes - After a single Revita procedure, participants achieved a mean total body weight loss of 8.0%, decreasing from 102 kg to 94 kg at 3 months, sustained at 94 kg for 1 year[152]. - Mean HbA1c decreased by 1.0% at 3 months, from 8.8% at baseline to 7.7%, and this improvement was maintained at 7.9% throughout 1 year post-procedure[152]. - Among 30 participants, 28 lost weight, with 20 experiencing at least a 5% reduction and 12 achieving 10% or more[152]. - For 14 participants followed for 2 years, mean weight loss was 7.9% at 1 year, from 104 kg to 95 kg, maintained at 94 kg after 2 years[155]. - The Germany Real-World Registry study initiated in 2023 included participants with a mean age of 60 years, mean weight of 102 kg (225 lbs), and mean HbA1c of 8.8% despite treatment with up to three glucose-lowering agents[151]. Patent and Market Risks - The company has built a patent portfolio that includes 33 issued U.S. patents and approximately 45 pending U.S. applications as of September 30, 2025[149]. - The company is exposed to various market risks, including interest rate risk and credit risk, which could impact its financial condition[224]. - Future contractual commitments for leases as of September 30, 2025, totaled $53.8 million, with $52.8 million related to operating leases[218]. - The company may need to implement cost reduction strategies if it is unable to obtain additional financing[203].

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].

Core Insights - Fractyl Health, Inc. reported positive results from the REMAIN-1 Midpoint Cohort, indicating that the Revita procedure can maintain weight loss after discontinuation of GLP-1 therapy, with 6-month data expected in Q1 2026 [1][11] - The company completed $83 million in underwritten offerings, which is anticipated to extend its cash runway through early 2027, supporting upcoming clinical and regulatory milestones [3][20] Company Updates - Fractyl Health is focused on innovative treatments for obesity and type 2 diabetes (T2D), with ongoing momentum in its Revita and Rejuva platforms [3][18] - The REMAIN weight maintenance program includes three cohorts: REVEAL-1, REMAIN-1 Midpoint, and REMAIN-1 Pivotal, aimed at evaluating Revita's effectiveness in sustaining weight loss [5][21] - The REMAIN-1 Midpoint Cohort showed that Revita-treated patients lost an additional 2.5% of total body weight after stopping tirzepatide, while sham-treated patients regained 10% [11] Financial Performance - For Q3 2025, Fractyl reported a net loss of $45.6 million, compared to $23.2 million in Q3 2024, primarily due to a non-cash accounting change related to warrants [20][27] - Research and development expenses were $17.5 million for Q3 2025, down from $19.0 million in the same period of 2024 [20][27] - As of September 30, 2025, the company had approximately $77.7 million in cash and cash equivalents, which is expected to fund operations into early 2027 [20][26] Upcoming Milestones - The company expects to report 6-month data from the REVEAL-1 Cohort in Q4 2025 and pivotal data from the REMAIN-1 Pivotal Cohort in H2 2026 [1][12] - Fractyl anticipates filing a Premarket Approval (PMA) application with the FDA in H2 2026 [12] Research and Development - The Rejuva platform is advancing gene therapies for T2D and obesity, with RJVA-002 showing promising preclinical results, including approximately 30% weight loss in a mouse model [10][13] - The company has submitted the first Clinical Trial Application (CTA) module for RJVA-001, with preliminary data expected in 2026 [22][13]

Core Insights - Fractyl Health, Inc. is set to report its financial results for Q3 2025 on November 12, 2025, at 4:30 p.m. ET [1] - The company focuses on innovative treatments for obesity and type 2 diabetes (T2D), aiming to address the root causes of these metabolic diseases [3] Company Overview - Fractyl Health is dedicated to developing new therapeutic approaches for metabolic diseases, particularly obesity and T2D, which are significant contributors to morbidity and mortality in the 21st century [3] - The company aims to shift the treatment paradigm from chronic symptomatic management to durable disease-modifying therapies that target organ-level causes [3] - Fractyl Health has a strong intellectual property portfolio, including 33 granted U.S. patents and around 40 pending U.S. applications, along with various foreign patents [3] - The company is headquartered in Burlington, Massachusetts [3]

Core Insights - Fractyl Health, Inc. announced promising preclinical data for RJVA-002, indicating a potential for significant weight loss in obesity treatment, achieving approximately 30% weight loss over five weeks in a mouse model, with no observed adverse effects [1][2][3] Company Overview - Fractyl Health is focused on innovative metabolic therapeutics aimed at addressing the root causes of obesity and type 2 diabetes (T2D) [9] - The company has a robust intellectual property portfolio with 33 granted U.S. patents and around 40 pending applications [9] Product Development - RJVA-002 is the second candidate from the Rejuva Smart GLP-1 platform, which aims to provide a durable treatment for obesity and T2D [1][7] - The Rejuva platform utilizes gene therapy to enable long-term remission of metabolic diseases by reprogramming pancreatic islet cells to produce metabolic hormones [7][10] - RJVA-001, the first candidate from the Rejuva platform, is expected to enter clinical trials in 2026 for T2D patients [7][10] Preclinical Study Results - In a diet-induced obesity mouse model, a single administration of RJVA-002 resulted in a mean weight loss of 18% and 29% for mid- and high-dose cohorts, respectively, by day 35 [3][2] - The weight loss trajectory for RJVA-002 has not yet plateaued, indicating potential for sustained effects [2][3] Future Directions - The company plans to present further results from ongoing studies at upcoming scientific congresses, which will include metabolic measurements [4] - Fractyl Health aims to transform the treatment paradigm for obesity and T2D from chronic disease management to durable remission [3][10]

Core Points - Fractyl Health held a conference call to discuss the REMAIN-1 Midpoint Cohort Data, indicating a focus on sharing important data and insights with investors [1][2]. Group 1 - The call was led by Brian Luque, Head of Investor Relations and Corporate Development, who introduced the session and highlighted the availability of a press release on the company's website [2]. - Dr. Harith Rajagopalan, Co-Founder and CEO of Fractyl Health, was the main presenter during the call, suggesting a leadership role in communicating the company's developments [2]. Group 2 - The company made forward-looking statements during the call, which are subject to risks and uncertainties that could lead to actual results differing from those statements [3][4]. - A comprehensive list of risk factors is available in the company's SEC filings, specifically referencing the quarterly report on Form 10-Q filed on August 12, 2025, which is encouraged for review by stakeholders [3].

Summary of Fractyl Health's REMAIN1 Midpoint Cohort Data Call Company Overview - **Company**: Fractyl Health (NasdaqGM: GUTS) - **Industry**: Obesity treatment and metabolic disease management Key Points and Arguments 1. **Milestone Presentation**: Fractyl Health presented the first prospective randomized double-blind control data from the REMAIN1 midpoint cohort, demonstrating that Revita prevented weight regain three months after discontinuation of GLP-1 drugs [5][6] 2. **Therapeutic Category**: The results indicate a new potential therapeutic category in obesity post-GLP-1 weight maintenance, positioning Fractyl to lead in this area [5][6] 3. **Future Milestones**: The company anticipates four weight maintenance data readouts in the next year, with pivotal data and potential PMA filing expected in the second half of 2026 [5][18] 4. **Cash Flow**: Fractyl expects to have sufficient cash to fund operations into early 2027 [5] 5. **Revita's Mechanism**: Revita targets duodenal dysfunction as a root cause of obesity, aiming to restore normal signaling and create a durable metabolic reset [6][15] 6. **Clinical Efficacy**: In the REMAIN1 midpoint cohort, Revita patients lost 2.5% more body weight compared to sham patients, who regained 10% of their weight, resulting in a clinically significant treatment difference of 12.5% [9][14] 7. **Safety Profile**: Revita demonstrated an excellent safety and tolerability profile, with no serious device-related adverse events reported [10][15] 8. **Patient Demographics**: The study included 45 adults with obesity, mirroring the real-world GLP-1 population, with an average BMI of 37.1 kg/m² [13] 9. **Weight Loss Maintenance**: Revita patients lost an additional 2 kg after stopping tirzepatide, while sham patients regained 8 kg, highlighting Revita's effectiveness in maintaining weight loss [14][15] 10. **Market Demand**: There is significant demand for a durable alternative to GLP-1 drugs, with many patients eager to find solutions for weight maintenance after stopping medications [19][20] Additional Important Content 1. **Regulatory Designation**: Revita received FDA Breakthrough Device designation for post-GLP-1 weight maintenance, emphasizing its potential in a hard-to-treat patient population [7][10] 2. **Commercial Strategy**: If approved, Revita could fit seamlessly into existing endoscopy practices, with a sales model targeting hospitals and endoscopy centers [20][21] 3. **Payer Interest**: Early feedback from health plans indicates interest in a sustainable solution for long-term weight maintenance, which Revita could provide [20] 4. **Clinical Trial Design**: The REMAIN-1 program was designed to replicate pivotal cohort protocols, ensuring consistency in patient selection and treatment [10][18] 5. **Future Data Expectations**: Upcoming data releases include six-month results from the midpoint cohort and open-label data from the REVEAL-1 cohort, which will further validate Revita's efficacy [22][36] This summary encapsulates the critical insights from Fractyl Health's recent conference call, highlighting the company's innovative approach to obesity treatment and the promising data surrounding its product, Revita.

Core Insights - Fractyl Health's experimental outpatient procedure has demonstrated the ability to preserve weight loss even after the discontinuation of a GLP-1 drug, leading to a significant increase in the company's stock price by 23% in premarket trading on Friday [1] Company Summary - The outpatient procedure developed by Fractyl Health is positioned as a potential alternative for patients who may discontinue GLP-1 medications, which are commonly used for weight management [1] - The positive market reaction indicates strong investor interest and confidence in the company's innovative approach to weight loss solutions [1] Industry Context - The development of outpatient procedures that can maintain weight loss effects post-medication aligns with growing trends in the healthcare industry focused on sustainable weight management solutions [1] - The success of Fractyl Health's procedure could influence future research and investment in similar therapeutic approaches within the weight loss and metabolic health sectors [1]

Core Viewpoint - Fractyl Health, Inc. has announced a pricing of an underwritten offering of 60 million shares of common stock at $1.00 per share, aiming to raise approximately $60 million in gross proceeds before expenses [1][8]. Company Overview - Fractyl Health is a metabolic therapeutics company focused on innovative treatments for metabolic diseases, particularly obesity and type 2 diabetes (T2D) [5][12]. - The company aims to shift the treatment paradigm from chronic symptomatic management to durable disease-modifying therapies that address the root causes of metabolic diseases [5][12]. - Fractyl has a strong intellectual property portfolio, including 33 granted U.S. patents and around 40 pending U.S. applications, along with numerous foreign patents [5][12]. Offering Details - The underwritten offering is expected to close on or about September 29, 2025, subject to customary closing conditions [1][8]. - BofA Securities and Evercore ISI are serving as joint book-running managers, while Ladenburg Thalmann is the lead manager for the offering [2][9]. - A shelf registration statement for the offering was filed with the SEC on March 3, 2025, and was declared effective on March 18, 2025 [3][10].