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Fractyl Health to Present 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

1. Fractyl Health will present preclinical data on gene therapy for diabetes. 2. The presentation is scheduled for May 17, 2025, at ASGCT. 3. Fractyl aims to change diabetes treatment from symptomatic to disease-modifying. 4. Rejuva platform is preclinical and targets obesity and type 2 diabetes. 5. If approved, initial results of CTO for RJVA-001 expected in 2026.

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Why Bullish?

The upcoming presentation of preclinical data positions GUTS favorably among investors, similar to other biotech firms that see price growth after promising announcements.

How important is it?

The presentation signals potential advancements in treatment, attracting attention and investment in GUTS. Investors usually respond positively to innovative therapeutic developments.

Why Long Term?

As regulatory submissions and results unfold, GUTS could see sustained investor interest, similar to companies that experience increasing value from successful trials.

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BMYNVTAEDIT
April 28, 2025 16:30 ET  | Source: Fractyl Health, Inc. 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. Oral Presentation Details: Title: Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibility in a Porcine ModelSession: AAV Preclinical and Proof-of-Concept StudiesDate and Time: Saturday, May 17, 2025, 9:15 a.m. – 9:30 a.m. CTLocation: NOLA Theater A The presentation will be available via the Presentations & Publications section of the Fractyl website once it concludes on May 17, 2025.About Fractyl HealthFractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington, MA. For more information, visit www.fractyl.com. About Rejuva®Fractyl Health’s Rejuva platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of obesity and T2D. The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas. The program aims to transform the management of metabolic diseases by offering novel, disease-modifying therapies that address the underlying root causes of disease. The Company plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 in type 2 diabetes to regulators in H1 2025, and if the CTA is authorized, expects to report preliminary data in 2026. Contacts  Media Contact Jessica Cotrone, Head of Corporate Communications jcotrone@fractyl.com, 978.760.5622 Investor Contact Brian Luque, Head of Investor Relations and Corporate DevelopmentIR@fractyl.com, 951.206.1200

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