Fractyl Health SEC Filings

GUTS NASDAQ

Welcome to our dedicated page for Fractyl Health SEC filings (Ticker: GUTS), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.

Reading Fractyl Health’s biotech disclosures can feel like dissecting a medical journal. Clinical trial protocols, FDA Breakthrough updates, and detailed R&D expenses sprawl across dense exhibits, leaving even seasoned analysts asking, “How do I find Revita progress or Rejuva spend in this 10-K?” If you have typed “Fractyl Health SEC filings explained simply” or hunted for “Fractyl Health insider trading Form 4 transactions,” you know the challenge.

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06/23/2025 07:45 AM

Filing

[8-K] Fractyl Health, Inc. Reports Material Event

Rhea-AI Summary

Fractyl Health (NASDAQ: GUTS) announced positive 3-month data from the REVEAL-1 cohort of its REMAIN-1 pivotal study, showing promising results for weight management after GLP-1 discontinuation:

12 out of 13 participants maintained or lost weight after stopping GLP-1 treatment and receiving a single Revita procedure
6 participants achieved additional weight loss
Median weight remained stable through 3 months, contrasting with typical 5-6% rebound in studies like SURMOUNT-4
Procedure demonstrated strong safety profile with no serious adverse effects

Additionally, the company revealed new preclinical data for its Rejuva® Smart GLP-1™ pancreatic gene therapy platform. A single dose prevented obesity and hyperglycemia in animals on high-fat diets. The company expects REMAIN-1 Midpoint Cohort data in Q3 2025 and RJVA-001 preliminary clinical data in 2026.

Rhea-AI Impact

Rhea-AI Sentiment

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FAQ

What is the current stock price of Fractyl Health (GUTS)?

The current stock price of Fractyl Health (GUTS) is $1.62 as of June 30, 2025.

What is the market cap of Fractyl Health (GUTS)?

The market cap of Fractyl Health (GUTS) is approximately 78.9M.

What is the primary focus of Fractyl Health?

Fractyl Health is focused on developing metabolic therapeutics that target the root causes of obesity and type 2 diabetes through innovative interventions rather than chronic symptom management.

How does Fractyl Health’s Revita procedure work?

Revita uses an endoscopic, outpatient procedure to remodel the duodenal lining via hydrothermal ablation, aiming to restore normal nutrient sensing and improve metabolic health.

What distinguishes the Rejuva platform?

Rejuva is a novel gene therapy platform that leverages AAV-based vectors to induce localized production of therapeutic proteins in the pancreas, targeting long-term metabolic regulation.

How does Fractyl Health address weight maintenance after GLP-1 therapy?

The company designs its treatments to offer durable effects that maintain weight loss after discontinuation of GLP-1 drugs, addressing a significant unmet need in obesity care.

What regulatory achievements has Fractyl Health accomplished?

Fractyl Health has obtained CE marking for its Revita system in Europe and received FDA Breakthrough Device Designation for weight maintenance, validating its innovative approach.

Who can benefit from Fractyl Health's therapies?

The therapies are designed for patients with obesity and type 2 diabetes, particularly those who have experienced challenges with conventional chronic medication-based treatments.

How does the company ensure its research and therapies are scientifically robust?

Fractyl Health adheres to rigorous clinical study protocols, regulatory requirements, and employs advanced scientific methods to validate the safety and efficacy of its therapeutic approaches.

What potential advantages do Fractyl Health's treatments offer over traditional therapies?

Their treatments aim to provide lasting metabolic improvements by addressing the underlying causes of disease, potentially reducing the need for continuous medication and overcoming issues like weight regain.