Fractyl Health

GUTS

Market cap $171M

RJVA-002 achieved ~30% weight loss at five weeks in a translational obesity model; weight loss not yet plateaued Preclinical 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 BURLINGTON, Mass., Oct. 07, 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 potent new preclinical data from RJVA-002, the second candidate from the Company's Rejuva® Smart GLP-1™ platform, at the 2025 Cell & Gene Meeting on the Mesa.

Fractyl Health delivered best-case results from its REMAIN-1 trial, with Revita patients continuing weight loss after GLP-1 discontinuation while placebo significantly rebounded. GUTS is still ~$230 million market cap, given de-risked Revita data and a robust cash position following recent financings. Revita's unique, durable weight loss profile and minimal side effects position it as a one-time solution for GLP-1 discontinuation, addressing a major market need.

Fractyl Health, Inc. - Special Call Company Participants Brian Luque Harith Rajagopalan - Co-Founder, CEO & Director Conference Call Participants Umer Raffat - Evercore ISI Institutional Equities, Research Division Whitney Ijem - Canaccord Genuity Corp., Research Division Jason Gerberry - BofA Securities, Research Division Joseph Pantginis - H.C. Wainwright & Co, LLC, Research Division William Wood - B.

Fractyl Health said its experimental outpatient procedure helped preserve weight loss after discontinuation of a GLP-1 drug, sending the company's shares 23% higher in premarket trading on Friday.

Fractyl Health Announces Pricing of $60 Million Underwritten Offering of Common Stock BURLINGTON, Mass., September 26, 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 the pricing of an underwritten offering of 60 million shares of its common stock at a price of $1.00 per share.

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

Fractyl Health's Revita offers a one-time procedure to maintain GLP-1 weight loss, with pivotal 45-patient trial data expected imminently. Early open-label results show Revita may significantly reduce post-GLP-1 weight regain. Despite past "OK" results in T2D, Revita's may have found its killer application in GLP-1 discontinuation patient; awarded FDA Breakthrough Device Designation.

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

Fractyl Health, Inc. (NASDAQ:GUTS ) Q2 2025 Earnings Conference Call August 12, 2025 4:30 PM ET Company Participants Brian Luque - Corporate Participant Harith Rajagopalan - Co-Founder, CEO & Director Lisa A. Davidson - CFO & Treasurer Conference Call Participants Jason Matthew Gerberry - BofA Securities, Research Division Jeffrey Scott Cohen - Ladenburg Thalmann & Co. Inc., Research Division Whitney Glad Ijem - Canaccord Genuity Corp., Research Division William McKinnie Wood - B.

Randomized 3-month REMAIN-1 Midpoint Cohort data expected in September 2025 Positive 3-month REVEAL-1 Cohort data showed single Revita ® procedure sustained weight loss after GLP-1 discontinuation; incremental 6-month open-label data expected in Q4 2025 Top-line REMAIN-1 Pivotal Cohort 6-month data and PMA filing expected in H2 2026 $23M underwritten public offering expected to extend cash runway through key upcoming 3-and 6-month randomized data readouts from REMAIN-1 Midpoint Cohort Conference call today at 4:30 p.m. ET BURLINGTON, Mass.