Fractyl Health Stock Price, News & Analysis

Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focusing on obesity and Type 2 Diabetes treatments, has announced its participation in two upcoming investor conferences. Dr. Harith Rajagopalan, Co-founder and CEO, will represent the company at these events:

1. Morgan Stanley Global Healthcare Conference on 09/06/2024 at 10:45 AM ET (Fireside Chat format)

2. H.C. Wainwright 26th Annual Global Investment Conference on 09/09/2024 at 2:00 PM ET (Company Presentation format)

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

Fractyl Health (GUTS) reported Q2 2024 financial results and provided business updates. Key highlights include:

1. Updated clinical results from German Real-World Registry showing Revita®'s potential for sustained weight loss and blood sugar reduction for at least one year post-treatment.

2. FDA Breakthrough Device designation for Revita in weight maintenance after GLP-1 drug discontinuation.

3. Initiation of REMAIN-1 pivotal study for Revita in weight maintenance, with data readouts expected from Q4 2024.

4. REVITALIZE-1 study on track to report topline data in mid-2025 for an expanded Type 2 Diabetes patient population.

5. Presentation of preclinical data comparing Rejuva® to semaglutide at ADA 2024 Conference.

6. Q2 2024 financial results: R&D expenses $16.8M, SG&A expenses $6.2M, net loss $17.2M, cash position $102.4M.

Fractyl Health (Nasdaq: GUTS) announced promising clinical results from its German Real-World Registry for the Revita® endoscopic procedure. After 12 months, patients experienced:

• A median weight decrease from 111 kg to 97 kg (13% total body weight loss)
• A median HbA1c reduction from 9.6% to 7.2%
• Stable or decreased glucose-lowering medications in 10 out of 11 patients

The study involved 11 hard-to-treat patients with obesity and Type 2 Diabetes. Revita, designed to resurface the duodenal lining, shows potential as a durable weight maintenance solution. The procedure was well-tolerated with no reported adverse safety events.

Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focusing on innovative treatments for obesity and type 2 diabetes, has announced it will release its second quarter 2024 financial results and provide business updates on August 14, 2024, at 4:30 p.m. ET. The company will host a live webcast of the conference call, which can be accessed through the 'Events' section of Fractyl's investor relations website. For those unable to attend the live event, an archived version of the webcast will be made available for replay on the company's website.

Fractyl Health (Nasdaq: GUTS) has received FDA Breakthrough Device Designation for its Revita System in weight maintenance for people with obesity who discontinue GLP-1 drugs. Revita is an outpatient endoscopic procedure targeting the duodenal lining to potentially treat root causes of obesity and type 2 diabetes. The designation will enable priority FDA review upon completion of the REMAIN-1 study, with data readouts expected from Q4 2024.

Key points:

• Revita aims to address high discontinuation rates and substantial weight regain after stopping GLP-1 drugs
• Breakthrough status may accelerate development, assessment, and review processes
• Previous studies suggest potential for durable weight maintenance after a single Revita procedure
• Revita is already approved in Germany for T2D treatment

Fractyl Health will participate in the Piper Sandler 2nd Annual Virtual Obesity Day on June 26, 2024, at 9:30 a.m. EDT. CEO Dr. Harith Rajagopalan and CSO Dr. Timothy Kieffer will discuss recent corporate updates. Key highlights include the acceleration of their weight maintenance clinical study and compelling preclinical data from their Rejuva® pancreatic gene therapy. This data, presented at the American Diabetes Association’s 84th Scientific Session, demonstrated greater and more durable weight loss compared to semaglutide. Rejuva’s data was recognized as the top abstract out of 8,000 submissions. For more details and access to the webcast, please contact your Piper Sandler representative.

Fractyl Health (Nasdaq: GUTS) announced the acceleration of its REMAIN-1 clinical study, focusing on Revita's effectiveness in maintaining weight loss post-GLP-1 therapy discontinuation. Open label data from the REVEAL-1 cohort is expected in Q4 2024, with mid-point analysis by Q2 2025. The FDA approved an amendment expanding the Revita study (REVITALIZE-1) to include patients inadequately controlled on any glucose-lowering agent, significantly increasing the eligible U.S. treatment population. Additionally, Fractyl presented preclinical data at the ADA's 84th Scientific Sessions, showing greater and more durable weight loss with Rejuva® therapy compared to semaglutide. The company aims to address the high weight regain rates post-GLP-1 therapy and enhance glucose regulation for T2D patients.

Fractyl Health presented new preclinical data on its Rejuva® GLP-1 pancreatic gene therapy at the ADA's 84th Scientific Sessions. The studies showed that a single administration of Rejuva reduced fat mass by 21%, improved glycemia, and retained lean mass in a diet-induced obesity (DIO) mouse model. Post-semglutide withdrawal, Rejuva maintained a 17% reduction in fat and 22% weight loss. These findings suggest Rejuva can mimic natural GLP-1 release and sustain weight and glycemic improvements, addressing a critical need for a long-lasting obesity and T2D treatment.

Fractyl Health (Nasdaq: GUTS) will present new preclinical obesity data from its Rejuva® platform at the American Diabetes Association's (ADA) 84th Scientific Sessions in Orlando, FL, on June 23, 2024. The study, titled "Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia after Semaglutide Withdrawal in a Murine Model of Obesity," has been selected as one of eight Presidents' Select abstracts. CEO Dr. Harith Rajagopalan will present the findings. Additionally, Fractyl will host an in-person Key Opinion Leader (KOL) event on June 24, 2024, featuring Dr. David A. D’Alessio from Duke University School of Medicine. The event will be webcast live for those unable to attend.