Fractyl Health - GUTS STOCK NEWS

Fractyl Health (NASDAQ: GUTS) has reported promising early data from its REVEAL-1 study, suggesting that its Revita® procedure may help prevent weight regain after patients discontinue GLP-1 medications. The study shows that at 1-month post-procedure, 7 patients experienced an average weight regain of just 1.2%, compared to the typical 3% regain observed after GLP-1 discontinuation.

The REVEAL-1 cohort, part of the ongoing REMAIN-1 pivotal study, has treated 15 patients to date, with no safety or tolerability concerns reported. This safety profile aligns with previous data from over 100 treated patients. The company's REMAIN-1 pivotal study is now more than 50% enrolled, with a midpoint data analysis expected in Q3 2025.

Revita, which holds FDA Breakthrough Device designation, is being studied under an open Investigational Device Exemption. The company aims to position it as the first approved intervention specifically for post-GLP-1 weight maintenance, addressing a growing unmet need in obesity treatment.

Fractyl Health (NASDAQ: GUTS) reported its Q4 and full year 2024 financial results, highlighting strong progress in its REMAIN-1 pivotal study for weight maintenance post-GLP-1 therapy. The study has enrolled 189 patients across 13 clinical sites in six months, with midpoint data analysis expected in Q2 2025 and full enrollment by summer 2025.

Key financial metrics for Q4 2024 include:

• R&D expenses increased to $20.3M (vs $10.1M in Q4 2023)
• SG&A expenses rose to $4.9M (vs $2.8M in Q4 2023)
• Net loss widened to $25.0M (vs $19.2M in Q4 2023)
• Cash position of $67.5M as of December 31, 2024

The company plans to submit its first Clinical Trial Application module for RJVA-001 in type 2 diabetes in H1 2025, with preliminary data expected in 2026. Fractyl has strategically focused on weight maintenance and extended its cash runway into 2026.

Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company specializing in treatments for obesity and type 2 diabetes (T2D), has announced it will release its fourth quarter and full year 2024 financial results on March 3, 2025, at 4:30 p.m. ET. The company will also provide business updates during the event.

A live webcast of the conference call will be available in the 'Events' section of Fractyl's investor relations website, with a replay option available after the event.

Fractyl Health (NASDAQ: GUTS) announced strategic changes focusing on two key programs: the Revita® weight maintenance program and Rejuva® pancreatic gene therapy. The company is prioritizing its REMAIN-1 pivotal study for weight maintenance post-GLP-1 withdrawal, with midpoint data analysis expected in Q2 2025 and full enrollment by summer 2025.

Initial results from the REVEAL-1 cohort showed promising outcomes in weight maintenance after GLP-1 discontinuation, with over 145 patients enrolled across 10 clinical sites in 5 months. The company will pause investment in Revita programs for Type 2 Diabetes, including the REVITALIZE-1 study and German Real-World Registry.

The Rejuva gene therapy program has completed key preclinical studies, with first-in-human studies for RJVA-001 planned for H1 2025. To optimize resources, Fractyl is implementing a 17% workforce reduction, extending its cash runway into 2026.

Fractyl Health (NASDAQ: GUTS) has announced promising initial results from the REVEAL-1 cohort of its REMAIN-1 study, showing successful weight maintenance after GLP-1 drug discontinuation and Revita procedure. The first patient maintained a 15% total body weight loss one month after stopping tirzepatide and receiving the Revita treatment, compared to typical 3% weight regain within four weeks of GLP-1 discontinuation.

The company reports strong enrollment progress in the REMAIN-1 pivotal study, with over 100 patients enrolled across 8 clinical sites in less than 4 months, demonstrating high demand from both patients and physicians. The study's mid-point analysis remains on track for Q2 2025. Full REVEAL-1 cohort data presentation is expected in Q1 2025, following slight delays due to holiday scheduling.

Fractyl Health (NASDAQ: GUTS) presented promising preclinical data for RJVA-001, their Rejuva® Smart GLP-1™ pancreatic gene therapy, at WCIRDC. The study demonstrated successful delivery in Yucatan pig models using an endoscopic ultrasound-guided system. Key findings include:

- Achieved therapeutically relevant GLP-1 expression in pancreatic beta cells at low viral doses (6e13 vg per pig)
- Expression levels were five times higher in treated vs untreated animals (p< 0.02)
- No adverse safety effects observed
- Pancreatic lipase remained in normal range

The company plans to initiate first-in-human studies in the first half of 2025. Previous mouse studies showed RJVA-001's potential to maintain improvements in weight and blood glucose levels after discontinuing semaglutide treatment.

Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company, announced it will present new preclinical data from its Rejuva® platform at the 2024 Poster Session of the 22nd World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC). The presentation will focus on the feasibility and safety of novel endoscopic ultrasound-guided delivery of human GLP-1 pancreatic gene therapy in pigs. The session is scheduled for December 12, 2024, from 6:30 pm to 7:30 pm (PST).

The company specializes in developing new approaches to treat root causes of obesity and Type 2 Diabetes (T2D) through their single-administration Smart GLP-1 Pancreatic Gene Therapy Platform.

Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company specializing in obesity and Type 2 Diabetes treatments, has announced its participation in two upcoming investor conferences. The company's Co-Founder and CEO, Harith Rajagopalan, M.D., Ph.D., will present at:

- The 7th Annual Evercore ISI HealthCONx Conference (Fireside Chat) on December 3, 2024, at 7:30 AM ET

- The Piper Sandler 36th Annual Healthcare Conference (Fireside Chat) on December 4, 2024, at 1:30 PM ET

Webcast replays will be available on the company's investor relations website.

Fractyl Health reported Q3 2024 financial results, highlighting progress in its obesity and Type 2 Diabetes treatments. The company's REMAIN-1 weight maintenance study is advancing rapidly, with mid-point analysis expected in Q2 2025. Revenue was generated from German commercial launch, while R&D expenses increased to $19.0M from $9.4M year-over-year. Net loss widened to $23.2M from $15.7M. The company maintains $84.7M in cash, expected to fund operations through Q4 2025.

Key developments include the nomination of RJVA-002, a smart GIP/GLP-1 pancreatic gene therapy candidate for obesity treatment, and plans to initiate first-in-human studies for RJVA-001 in H1 2025, pending CTA approval.