Randomized 6-month data from the REMAIN-1 Midpoint Cohort expected in late January 2026 Topline 6-month data from the REMAIN-1 Pivotal Cohort and potential PMA submission expected in H2 2026 Approximately $85.6 million in cash and cash equivalents on hand, supporting execution across planned 2026 milestones Received gross proceeds of $23.0 million from exercises of Tranche A warrants from August 2025 financing, with cash runway into early 2027 BURLINGTON, Mass., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Fractyl He ...

Fractyl Health, Inc. (NASDAQ:GUTS) is one of the 10 Best New Penny Stocks to Invest In. On December 19, Canaccord Genuity reiterated its Buy rating on Fractyl Health, Inc. (NASDAQ:GUTS) with a price target of $8. This comes after a series of virtual meetings with the company’s leadership, including Co-founder and Chief Executive Officer, Dr. Harith Rajagopalan, along with Head of Investor Relations and Corporate Development, Brian Luque. During the meetings, many key areas of the business were discussed, ...

Summary of Fractyl Health FY Conference Call (December 03, 2025) Company Overview - **Company**: Fractyl Health (NasdaqGM:GUTS) - **Focus**: Development of Revita, a treatment targeting obesity and type 2 diabetes through an outpatient endoscopic procedure Key Industry Insights - **Obesity and GLP-1 Drugs**: There are approximately 10 million people using GLP-1 medications for weight loss, with an estimated 6 million expected to stop treatment this year, leading to significant weight regain risks for many patients [1][2] - **Market Opportunity**: The potential market for Revita includes nearly 1 million patients annually who are already undergoing endoscopies for other reasons, making it easier to integrate the Revita procedure into existing healthcare practices [8] Core Findings from Clinical Studies - **Reveal-1 Study**: - Patients who lost an average of 24% body weight (over 50 pounds) on GLP-1s and then underwent Revita maintained a weight regain of only 1.5% over six months, compared to an expected regain of over 10% [4][5] - The study demonstrated that 40% of patients continued to lose weight after the procedure, indicating a stable weight maintenance profile [14] - Hemoglobin A1c levels remained stable, with only a 0.04% change, suggesting effective glucose control alongside weight maintenance [15][16] - **Remain-1 Study**: - In a pilot study with 45 subjects, those who received Revita lost an average of 2 kg after stopping tirzepatide, while the sham group regained approximately 8 kg, highlighting a significant treatment difference of about 10 kg [21] - The pivotal Remain-1 study, which includes 315 patients, is expected to provide further data in the second half of 2026, with a focus on post-GLP-1 weight maintenance [24][23] Important Data Points - **Endoscopy Statistics**: Approximately 20 million endoscopies are performed annually in the U.S., with 800,000 of those being patients on GLP-1s [7] - **Patient Cohorts**: Fractyl is studying three patient cohorts: Reveal-1 (open-label), Remain Midpoint (pilot randomized), and Remain pivotal [13][20] - **FDA Designation**: The company has received Breakthrough Device Designation from the FDA, which may expedite the approval process for Revita [25] Additional Considerations - **Market Expectations**: A 50% reduction in weight regain is considered a significant win for the market, with stability in weight maintenance being a critical factor for patient outcomes [30][32] - **Clinical Consistency**: The data from both Reveal-1 and Remain-1 studies show a consistent signal of stability in weight maintenance, which is crucial for the therapeutic potential of Revita [33] This summary encapsulates the key points discussed during the Fractyl Health FY Conference Call, highlighting the company's innovative approach to addressing obesity and the promising clinical data supporting its treatment.

Core Insights - Fractyl Health, Inc. announced positive results from the REVEAL-1 Cohort, showing that participants who lost 24% of total body weight on GLP-1 drugs maintained stable weight and glycemic control six months after a single Revita treatment [1][3][6] - Revita demonstrated a mean weight change of 1.5% after six months, significantly lower than the ~10% weight regain observed in third-party studies following GLP-1 withdrawal [1][6] - The company anticipates key clinical data releases in 2026, including the REMAIN-1 Midpoint Cohort data in January and potential PMA filing in H2 2026 [1][13] Company Overview - Fractyl Health focuses on innovative treatments for obesity and type 2 diabetes, aiming to transform metabolic disease management from chronic symptomatic treatment to durable, disease-modifying therapies [11] - The company has a robust intellectual property portfolio with 35 granted U.S. patents and approximately 45 pending applications [11] - Revita, the company's lead product, is designed to remodel the duodenal lining to reverse damage caused by unhealthy diets, and has received FDA Breakthrough Device designation for weight maintenance after GLP-1 drug discontinuation [12] Study Details - The REVEAL-1 Cohort included 22 participants who had lost at least 15% of their body weight on GLP-1 medications and chose to discontinue therapy [9][10] - Participants maintained stable weight and minimal change in HbA1c levels after the Revita procedure, indicating potential for long-term metabolic health [6][8] - The study reported excellent tolerability, with no serious adverse events and mild, transient treatment-emergent adverse events in 36% of participants [6][8] Future Outlook - Fractyl Health is preparing for multiple clinical readouts in 2026, including 1-year data from the REVEAL-1 Cohort and the REMAIN-1 Pivotal Cohort [13] - The company is experiencing rapid clinical enrollment in its pivotal studies, reflecting a strong demand for non-drug alternatives in obesity treatment [8]

Core Insights - Fractyl Health, Inc. announced positive results from the REVEAL-1 Cohort, indicating that participants who lost 24% of total body weight on GLP-1 drugs maintained stable weight and glycemic control for 6 months after a single Revita treatment [1][3][5] - Revita shows potential as a first-in-class therapy for weight maintenance post-GLP-1 therapy, with minimal weight change of 1.5% observed [1][5][7] Study Results - Participants in the REVEAL-1 Cohort lost an average of 24% of total body weight (>50 lbs.) on GLP-1 drugs before receiving Revita treatment [5][9] - After the Revita procedure, participants maintained stable weight with a mean total body weight change of 1.5% ± 1.3% at 6 months [5][9] - Glycemic control was also sustained, with minimal change in HbA1c levels (0.04% ± 0.08%) compared to a ~0.4% increase seen in other studies post-GLP-1 withdrawal [5][9] Safety and Efficacy - The study included 22 participants, with safety data available for all and efficacy data for 17 [5][9] - No serious adverse events were reported, and 36% of participants experienced mild, transient adverse events consistent with prior Revita experiences [5][7] - The average ablation length during the procedure was approximately 16 cm, aligning with previous real-world experiences [5][7] Future Developments - Upcoming clinical data from the REMAIN-1 Midpoint Cohort is expected in January 2026, with additional pivotal data anticipated in H2 2026 [1][12] - Revita has received FDA Breakthrough Device designation for post-GLP-1 weight maintenance, highlighting its potential as a scalable, non-drug alternative for obesity treatment [7][11] Company Overview - Fractyl Health focuses on innovative treatments for metabolic diseases, including obesity and type 2 diabetes, aiming to transform treatment from chronic management to disease-modifying therapies [10][11] - The company has a robust intellectual property portfolio with 35 granted U.S. patents and approximately 45 pending applications [10]

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]

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. 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]

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, Inc. announced significant results from the REMAIN-1 Midpoint Cohort, indicating that Revita may be the first therapy to maintain weight loss after discontinuation of GLP-1 drugs, with Revita-treated patients losing an additional 2.5% total body weight compared to a 10% regain in sham-treated patients, achieving statistical significance (p=0.014) [2][3][8] Study Design and Results - The REMAIN-1 Midpoint Cohort involved 45 participants who had lost at least 15% of their body weight with tirzepatide, randomized to receive either Revita or a sham procedure after stopping the drug [4] - The study met its primary efficacy endpoint at 3 months, showing Revita's effectiveness in promoting further weight loss while ensuring excellent safety and tolerability, with no serious adverse events reported [8][10] Future Milestones - The ongoing REMAIN-1 Midpoint Cohort is expected to provide 6-month data in Q1 2026, while the Pivotal Cohort aims to complete randomization in early 2026, with topline primary endpoint data and potential PMA filing anticipated in H2 2026 [11]