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. Poster Presentation Detail ...

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 Rising interest from patients and payers for an off-ramp from GLP-1 drugs is fueling significant demand for endoscopic alternatives designed to restore health rather than manage disease BURLINGTON, Mass. and SAN FRANCISCO, June 04, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), ...

Core Insights - Fractyl Health, Inc. announced promising preclinical data for its RJVA-001 gene therapy, which shows potential for durable metabolic improvements in type 2 diabetes (T2D) with low systemic GLP-1 exposure [1][2][3] - The therapy mimics natural hormone regulation, achieving significant metabolic benefits while minimizing side effects associated with current GLP-1 drugs [1][3][4] Group 1: RJVA-001 Efficacy and Mechanism - A single dose of RJVA-001 resulted in over 200 mg/dL reduction in fasting blood sugar and more than 2-fold increase in fasting insulin levels in db/db mice, demonstrating its efficacy in metabolic control [3][4] - RJVA-001 achieved glycemic control with circulating GLP-1 levels more than 5-fold lower than those seen with pharmacologic GLP-1 drugs, indicating a lower risk of side effects [3][4] - The therapy showed nutrient-responsive GLP-1 secretion, activating glucose-dependent expression in human beta cells, which reflects a more physiological response compared to constant drug stimulation [3][4] Group 2: Safety and Delivery Method - Endoscopic ultrasound-guided delivery of RJVA-001 in large animal models demonstrated targeted pancreatic expression with no observed toxicity, reinforcing its safety profile [4] - The procedure time for delivery was under 20 minutes, and biodistribution studies indicated minimal systemic distribution, with no adverse safety findings even at high doses [4] Group 3: Future Development and Regulatory Plans - Fractyl Health plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 by June 2025, with preliminary human data expected in 2026 [1][6] - The company aims to transform the treatment of metabolic diseases by shifting from chronic management to durable disease-modifying therapies targeting root causes [5][6]

Fractyl Health (GUTS) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Brian Luque - Head - IR & Corporate DevelopmentHarith Rajagopalan - Co-Founder, CEO & DirectorLisa Davidson - CFO & TreasurerChi Fong - VP - Equity ResearchAvraham Novick - Biotech Equity Research AssociateMichael Difiore - Managing DirectorWhitney Ijem - Managing Director Operator Good afternoon, and welcome to Fractal Health's First Quarter twenty twenty five Financial Results and Business Updates Call. As a reminder ...

Fractyl Health (GUTS) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome to Fractal Health's First Quarter twenty twenty five Financial Results and Business Updates Call. As a reminder, this conference call is being recorded. At this time, all participants are in listen only mode. There will be a question and answer session following management's prepared remarks. I'll now turn the call over to Brian Lucay, Head of Investor Relations and Corporate Development at Fractal. Bri ...

Exhibit 99.1 Fractyl Health Announces First Quarter 2025 Financial Results and Business Updates 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 REMAIN-1 Midpoint Cohort data expected in Q3 2025; first randomized data on post-GLP-1 weight maintenance REMAIN-1 Pivotal Cohort has completed enrollment ahead of schedule; 6-month primary endpoint data anticipated in H2 20 ...

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 REMAIN-1 Midpoint Cohort data expected in Q3 2025; first randomized data on post-GLP-1 weight maintenance REMAIN-1 Pivotal Cohort has completed enrollment ahead of schedule; 6-month primary endpoint data anticipated in H2 2026 Rejuva gene therapy platform advancing toward first-in-human studies; first CTA module submis ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-41942 Fractyl Health, Inc. (Exact Name of Registrant as Specified in its Charter) (State ...

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- ...

Financial Data and Key Metrics Changes - In Q4 2024, revenue was generated from the commercial pilot in Germany, contributing to the financial position of the company [33] - Research and development expenses increased to $20.3 million in Q4 2024 from $10.1 million in Q4 2023, primarily due to progress in clinical studies and increased personnel-related expenses [34] - Selling, general and administrative expenses rose to $4.9 million in Q4 2024 from $2.8 million in Q4 2023, attributed to costs associated with being a publicly traded company [34] - The net loss for Q4 2024 was $25 million, compared to a net loss of $19.2 million in Q4 2023, mainly due to increased operating expenses [35] - As of December 31, 2024, the company had approximately $67.5 million in cash and cash equivalents, expected to fund operations through key clinical milestones into 2026 [36] Business Line Data and Key Metrics Changes - The Revita program is focused exclusively on weight maintenance post GLP-1 withdrawal, with the REMAIN-1 pivotal study prioritized [14] - Over 189 patients have enrolled in the REMAIN-1 study across 13 clinical sites, indicating strong demand for effective off-ramps from GLP-1 therapy [14] - Initial results from the REVEAL-1 cohort showed a patient maintaining weight loss during a challenging period, suggesting potential effectiveness of the Revita procedure [15] Market Data and Key Metrics Changes - The obesity market is under pressure, with over 70% of U.S. adults affected, leading to an estimated $170 billion in annual medical costs [16] - Public payers are reassessing coverage for GLP-1 treatments due to rising costs, with some states discontinuing coverage [17] Company Strategy and Development Direction - Fractyl aims to lead in the obesity treatment market by providing durable solutions for weight maintenance, focusing on both Revita and Rejuva platforms [37] - The company plans to leverage relationships with GI endoscopists to build a scalable commercial model for Revita [25] - The Rejuva platform is designed for physiologically regulated expression of GLP-1, aiming to reshape treatment paradigms in metabolic disease [27] Management's Comments on Operating Environment and Future Outlook - Management believes 2025 will be a pivotal year, with expectations for key clinical milestones and regulatory filings [12] - The company is confident in its ability to deliver long-term metabolic health solutions, addressing significant unmet needs in obesity care [37] - There is a growing recognition among public payers of the need for effective obesity treatments, which is expected to enhance the value proposition of Fractyl's offerings [84] Other Important Information - The REMAIN-1 study is the first of its kind to evaluate the efficacy of the Revita procedure in sustaining weight loss after GLP-1 drug discontinuation [19] - The FDA has granted Breakthrough Device designation for Revita, highlighting its potential in the weight maintenance market [10] Q&A Session Summary Question: Update on REMAIN-1 midpoint analysis and patient dropout rates - Nearly 100 patients have achieved the prespecified 15% total body weight loss, with a substantial number randomized for the study, and no dropouts due to lack of interest in the procedure [44] Question: Expectations for REVEAL-1 data presentation - The company plans to share data from about 10 patients in the REVEAL-1 study, with a focus on translating findings to the REMAIN study [59] Question: Gating items for Rejuva CTA submission - The company is on track to submit the first CTA module in the first half of 2025, with necessary preclinical verification testing and final testing ongoing [53] Question: Update on the first patient in REVEAL-1 - No additional information is available at this time, but the company plans to follow up with longer-term data on the patient [69] Question: Plans for strategic partnerships for commercialization - The company is in discussions with major players in the space regarding potential collaborations to bolster commercialization efforts [71] Question: Data collection for REVEAL-1 and weight regain analysis - The company is collecting various biomarker data and expects to share findings later in the year, with weight regain not significantly dependent on the specific GLP-1 drug used [79]