Fractyl Health, Inc. - Common Stock (GUTS)

Participants who lost 24% total body weight (>50 lbs.) on GLP-1 drugs maintained stable weight 6 months after GLP-1 discontinuation and single Revita treatment

BURLINGTON, Mass., Dec. 01, 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 that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of the Company, will be participating in a fireside chat at the 8th Annual Evercore Healthcare Conference, being held December 2-4, 2025, in Coral Gables, FL.

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

BURLINGTON, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics company focused on pattern-breaking approaches to treat the root causes of obesity and type 2 diabetes (T2D), today announced it will report financial results for the third quarter 2025 and provide business updates on Wednesday, November 12, 2025, at 4:30 p.m. ET.

RJVA-002 achieved ~30% weight loss at five weeks in a translational obesity model; weight loss not yet plateauedPreclinical results show that a single point-in-time treatment with RJVA-002 has the potential to achieve significant weight loss that can match or exceed best-in-class chronic drug therapy

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Pilot study met key 3-month efficacy endpoint with strong statistical significance (p=0.014); Revita-treated patients lost an additional 2.5% total body weight after stopping GLP-1 drugs vs. 10% regain in sham-treated patients

Appointments include Christopher Thompson, M.D. and Ian Sheffield as Independent Directors

Randomized 3-month REMAIN-1 Midpoint Cohort data expected in September 2025

Offering included participation from leading institutional investors, including Nantahala Capital, ADAR1 Capital Management, Second Line Capital, 683 Capital, and SilverArc Capital

BURLINGTON, Mass., Aug. 06, 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 it will report financial results for the second quarter 2025 and provide business updates on Tuesday, August 12, 2025, at 4:30 p.m. ET.

BURLINGTON, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company pioneering pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced the pricing of its underwritten public offering of 19,047,619 shares of common stock and accompanying Tranche A and Tranche B warrants, for gross proceeds of $20 million before deducting underwriting discounts, commissions, and offering expenses.

BURLINGTON, Mass., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company pioneering pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock, in an underwritten public offering. Each share of common stock or pre-funded warrant will be sold with accompanying common warrants to purchase shares of common stock (or a pre-funded warrant in lieu thereof). The purchase price of each pre-funded warrant will equal the price per share at which shares of common stock are being sold to the public in the offering, minus $0.00001, the per share exercise price of each pre-funded warrant. In addition, Fractyl expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock and/or pre-funded warrants to purchase shares of its common stock offered in the public offering at the public offering price, less the underwriting discounts and commissions. All of the shares of common stock, pre-funded warrants and common warrants are being offered by Fractyl. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Two-year follow-up in Germany Real-World Registry study showed median 9.6% weight loss and 1.6% HbA1c reduction after a single Revita procedure in participants with type 2 diabetes, with no device- or procedure-related serious adverse events to date

12 of 13 participants maintained or lost weight at 3 months, with 6 of 13 losing additional weight after stopping GLP-1 therapy and undergoing Revita procedure

New findings demonstrated that a single dose of Rejuva was well tolerated in healthy animals, with no evidence of toxicity

Robust intellectual property portfolio, built over more than a decade, designed to protect core innovations for treating metabolic diseases

BURLINGTON, Mass., June 13, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics company focused on pattern-breaking approaches to treat the root causes of obesity and type 2 diabetes (T2D), today announced it will present a poster of new preclinical data from its Rejuva Smart GLP-1 pancreatic gene therapy platform at the American Diabetes Association’s (ADA) 85th Scientific Sessions being held June 20-23, 2025, in Chicago, Illinois.

Collaboration is designed to implement a highly scalable clinical pathway for Revita in post GLP-1 weight maintenance, pending FDA approval, potentially benefiting millions of eligible patients

First-in-human study will evaluate safety, tolerability, and early efficacy of a one-time, pancreas-targeted smart GLP-1TM gene therapy for patients with inadequately controlled T2D and obesity

Data suggests that single dose of RJVA-001 leads to durable metabolic improvements with low systemic GLP-1 exposure in db/db mouse model of T2D— potentially simultaneously addressing durability, adherence, and tolerability challenges seen with current GLP-1 drugs

REVEAL-1 Cohort 3-month open-label data update expected in June 2025; early clinical signals reinforce Revita’s potential to maintain weight loss after GLP-1 discontinuation in the real world

BURLINGTON, Mass., May 06, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced it will report financial results for the first quarter 2025 and provide business updates on Tuesday, May 13, 2025, at 4:30 p.m. ET.

BURLINGTON, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pattern-breaking approaches to treat the root causes of obesity and type 2 diabetes (T2D), today announced that it will deliver an oral presentation of compelling preclinical data from its Rejuva single-administration Smart GLP-1 pancreatic gene therapy platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting, taking place May 13-17, 2025, in New Orleans, Louisiana.