BURLINGTON, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced the appointment of Lara Smith Weber as Chief Financial Officer, effective January 12, 2026. Ms. Smith Weber will oversee finance, accounting, and investor relations; and will serve as a key strategic partner to the Company’s executive leaders ...

Financial Position - As of December 31, 2025, the company's preliminary unaudited cash and cash equivalents were approximately $81.5 million, which increased to $85.6 million after receiving an additional $4.1 million from Tranche A warrants[9]. - The company anticipates that its current cash position will fund operations through early 2027, supporting planned clinical and regulatory milestones for 2026[9]. - The company had 153,372,044 shares of common stock outstanding as of December 31, 2025, with no Tranche A warrants remaining[10]. - The company’s financial information is preliminary and unaudited, subject to completion of financial closing procedures for the fiscal year ended December 31, 2025[17]. Clinical and Regulatory Milestones - The company plans to advance its Revita program through key clinical and regulatory milestones in 2026, focusing on validation in post-GLP-1 weight maintenance[11]. - The anticipated milestones for the Revita program include 6-month randomized data from the REMAIN-1 Midpoint Cohort in late January 2026 and a potential PMA filing in H2 2026[14]. - The Rejuva gene therapy platform is expected to progress toward clinical validation in 2026, with first-in-human dosing of RJVA-001 anticipated in H2 2026, subject to regulatory authorization[12]. - The company is aligning its clinical development with regulatory strategy and real-world implementation considerations for Revita as it moves through a registrational year[11]. - The company has completed Clinical Trial Applications for RJVA-001 in the EU and Australia, setting the stage for expected dosing of first patients in 2026[12]. - The company’s strategic outlook for 2026 includes anticipated clinical and regulatory milestones across its Revita and Rejuva programs[8].

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, ...

U.S. stock futures were lower this morning, with the Dow futures falling around 0.2% on Tuesday.Shares of Lightwave Logic Inc (NASDAQ:LWLG) fell sharply in pre-market trading after the company announced pricing of $35 million public offering of common stock.Lightwave Logic shares dipped 14.5% to $3.22 in pre-market trading.Here are some other stocks moving lower in pre-market trading.Ascent Solar Technologies, Inc. (NASDAQ:ASTI) shares dipped 15.1% to $3.54 in pre-market trading after jumping 34% on Monday. ...

U.S. stock futures were lower this morning, with the Dow futures falling around 0.2% on Tuesday.Shares of Lightwave Logic Inc (NASDAQ:LWLG) fell sharply in pre-market trading after the company announced pricing of $35 million public offering of common stock.Lightwave Logic shares dipped 14.5% to $3.22 in pre-market trading.Here are some other stocks moving lower in pre-market trading.Ascent Solar Technologies, Inc. (NASDAQ:ASTI) shares dipped 15.1% to $3.54 in pre-market trading after jumping 34% on Monday. ...

Holders will have until December 30, 2025 to exercise Tranche A Warrants at $1.05 per share, enabling up to $17.9 million in potential gross proceedsBURLINGTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pioneering pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced that it will call all of its outstanding Tranche A Common Stock Purchase Warrants ...

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]