Positive randomized 3-month REMAIN-1 Midpoint Cohort data showed single Revita procedure maintained weight loss after GLP-1 discontinuation; 6-month data expected in Q1 2026

6-month data from open-label REVEAL-1 Cohort expected in Q4 2025

Topline 6-month data from REMAIN-1 Pivotal Cohort and potential PMA filing expected in H2 2026

$83M in underwritten offerings expected to extend cash runway through upcoming clinical and regulatory milestones and into early 2027

Conference call today at 4:30 p.m. ET

BURLINGTON, Mass., Nov. 12, 2025 (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 third quarter 2025 financial results and provided business updates highlighting continued momentum across its Revita and Rejuva$(R)$ platforms. During the third quarter, the Company reported positive randomized data from the REMAIN-1 Midpoint Cohort, expanded its Rejuva Smart GLP-1$(TM)$ platform into obesity with potent preclinical results from RJVA-002, strengthened its Board of Directors with industry leaders, and completed $83M in underwritten offerings, which it expects will extend its cash runway through upcoming clinical and regulatory milestones and into early 2027.

"The third quarter marked a major inflection point for Fractyl," said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. "With positive randomized data from our Revita program showing that durable, drug-free weight maintenance may be attainable, we are pushing the boundaries of what is possible in metabolic disease. We aim to move beyond chronic management and toward durable remission, potentially transforming care for the hundreds of millions of people living with obesity and T2D. With pivotal Revita data and our first-in-human Rejuva study ahead, we believe Fractyl is well positioned for a series of meaningful catalysts that could reshape the future of metabolic medicine."

Recent Highlights and Upcoming Milestones

Revita(R)

The Company is studying Revita in the REMAIN weight maintenance program, which is designed to evaluate Revita's potential to sustain weight loss following GLP-1 discontinuation. The REMAIN program includes three distinct patient cohorts: the REVEAL-1 Cohort, the REMAIN-1 Midpoint Cohort, and the REMAIN-1 Pivotal Cohort.

REVEAL-1 Cohort

The REVEAL-1 Cohort (n=22) is an open-label study in individuals living with obesity who have lost at least 15% of their total body weight on a GLP-1 medication and who either need or choose to discontinue GLP-1 therapy. After stopping the GLP-1 drug, participants receive the Revita treatment in an open-label setting. REVEAL-1 is designed to provide early, real-world insights on how Revita performs after GLP-1 discontinuation.

   -- Fractyl expects to report 6-month data from the REVEAL-1 Cohort in Q4 
      2025, and 1-year data in Q2 2026. 

REMAIN-1 Midpoint Cohort

The REMAIN-1 Midpoint Cohort (n=45) is a randomized, double-blind, sham-controlled pilot study to assess the potential of Revita to maintain weight loss after GLP-1 discontinuation. Participants are individuals with obesity who have not yet taken GLP-1 drugs, are initiated on tirzepatide at the time of enrollment, and treated with the drug to achieve at least 15% total body weight loss. Participants then discontinue tirzepatide and are randomized to undergo either Revita or a sham procedure with a 2:1 treatment allocation. The key efficacy endpoint was total body weight change in Revita versus sham at 3 months. This Cohort is intended to provide an important early, randomized readout of Revita's potential to maintain weight loss after GLP-1 discontinuation.

   -- In September 2025, Fractyl reported positive 3-month randomized data from 
      the REMAIN-1 Midpoint Cohort. The study met its key efficacy endpoint, 
      showing that Revita-treated patients lost an additional 2.5% of total 
      body weight after stopping tirzepatide, while sham-treated patients 
      regained 10% (p=0.014). The Revita procedure was well-tolerated with no 
      related serious adverse events reported, consistent with prior clinical 
      studies. These data provide the first randomized, blinded evidence that 
      drug-free, durable weight maintenance is possible and strengthens 
      confidence in the ongoing REMAIN-1 Pivotal Cohort. 
 
   -- Fractyl expects to report 6-month randomized data from the REMAIN-1 
      Midpoint Cohort in Q1 2026. 

REMAIN-1 Pivotal Cohort

The REMAIN-1 Pivotal Cohort (n=315) is a randomized, double-blind, sham-controlled pivotal study to evaluate the safety and efficacy of Revita in maintaining weight loss after GLP-1 discontinuation. The first co-primary endpoint is defined as the percent of total body weight regain from the time of tirzepatide discontinuation in Revita versus sham patients through 6-month follow-up. The primary objective is to demonstrate the benefit of Revita versus sham for weight maintenance after GLP-1 discontinuation.

   -- The Pivotal Cohort is fully enrolled, and as of October 31, 2025, 
      randomization was complete in over 60% of 315 planned participants. The 
      procedure was well-tolerated, with no unanticipated or device/procedure 
      related serious adverse effects reported, and no new safety concerns were 
      observed. The Company expects to complete randomization in early 2026. 
 
   -- Fractyl anticipates reporting 6-month primary endpoint data from the 
      REMAIN-1 Pivotal Cohort in H2 2026 and potentially filing a Premarket 
      Approval (PMA) application with the U.S. Food and Drug Administration 
      (FDA) in H2 2026. 

Germany Real-World Registry Study

The Germany Real-World Registry study is a prospective, post-market, clinical follow-up study to evaluate the Revita procedure in patients with inadequately controlled T2D. Entry criteria included a baseline Hemoglobin A1c (HbA1c) between 7-10% (inclusive), a BMI of <=45 kg/m(2) , and use of at least one glucose-lowering agent (GLA).

   -- As of October 31, 2025, the first 30 participants have now reached one 
      year of follow-up, and 14 participants have reached two years of 
      follow-up. The first 14 participants with two-year follow-up maintained 
      an average total body weight loss of 8.9% and a 1.7% reduction in HbA1c. 
      3-month results were highly predictive of outcomes at 6, 12, and 24 
      months. 

Rejuva(R)

Rejuva is Fractyl's gene therapy platform designed to achieve long-term remission of T2D and obesity by durably reprogramming pancreatic islet cells to endogenously produce metabolic hormones. The lead product candidate, RJVA-001, is being advanced for patients with inadequately controlled T2D. The second candidate, RJVA-002, is a dual GIP/GLP-1 gene therapy designed to address obesity.

   -- In October 2025, Fractyl announced potent new preclinical data from 
      RJVA-002, its dual GIP/GLP-1 gene therapy candidate for obesity, at the 
      Cell & Gene Meeting on the Mesa 2025. A single administration of RJVA-002 
      led to approximately 30% weight loss over five weeks in a translational 
      obesity model in male mice, with weight loss not yet plateaued and no 
      observed adverse effects. These findings highlighted the potential for a 
      durable, one-time gene therapy approach to obesity that could match or 
      exceed best-in-class chronic drug therapy. Results from this ongoing 
      study at longer time points and with associated metabolic measurements 
      will be presented at an upcoming scientific congress. 
 
   -- Fractyl has completed preclinical chemistry, manufacturing, and controls 
      $(CMC)$ activities and lot release for its RJVA-001 drug product. 
 
   -- Fractyl has submitted the first Clinical Trial Application $(CTA)$ module 
      for RJVA-001 in T2D to regulators, and if the CTA is authorized, the 
      Company expects to dose the first patients with RJVA-001 and report 
      preliminary data in 2026. 

Business Updates

   -- In September 2025, Fractyl announced a $60 million underwritten offering 
      of common stock. The financing, together with the Company's $23 million 
      underwritten public offering in August, further strengthens its balance 
      sheet and extends its estimated cash runway through upcoming clinical and 
      regulatory milestones into early 2027. 
 
   -- In September 2025, Fractyl expanded its Board of Directors with the 
      appointment of Christopher Thompson, M.D., Professor of Medicine at 
      Harvard Medical School and a pioneer in bariatric endoscopy, and Ian 
      Sheffield, an experienced healthcare investor and former medtech 
      executive. Their combined clinical and financial expertise strengthens 
      the Company's leadership as it advances Revita through late-stage 
      development and prepares for its first-in-human Rejuva study. 

Third Quarter 2025 Financial Results

   -- Research and Development Expenses: R&D expenses were $17.5 million for 
      the quarter ended September 30, 2025, compared to $19.0 million for the 
      same period in 2024, primarily due to reduced spending on the 
      REVITALIZE-1 study and lower stock-based compensation expenses. 
 
   -- Selling, General and Administrative Expenses: SG&A expenses were $5.2 
      million, compared to $4.8 million in the third quarter of 2024, primarily 
      driven by costs incurred related to the issuance of the warrants in 
      connection with the underwritten public offering in August 2025. 
 
   -- Net Loss: For the quarter ended September 30, 2025, Fractyl reported a 
      net loss of $45.6 million, compared to $23.2 million for the same period 
      in 2024. The variance was driven by a $23.5 million non-cash accounting 
      change in fair value related to the warrants and does not reflect a 
      change in underlying operating performance. Operating expenses this 

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