Fractyl Health Inc

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

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Fractyl Health, Inc. is a metabolic therapeutics company. It develops medical device solutions for the treatment of metabolic diseases, which includes type 2 diabetes and obesity. The company was founded by Harith Rajagopalan and Jay D. Caplan on August 30, 2010 and is headquartered in Burlington, MA.

Fractyl Health, Inc. (NASDAQ:GUTS ) Q1 2024 Earnings Conference Call May 13, 2024 4:30 PM ET Company Participants Stephen Jasper - Gilmartin Group Harith Rajagopalan - Co-founder and CEO Lisa Davidson - CFO Timothy Kieffer - Chief Scientific Officer Adrian Kimber - Chief Commercial Officer Conference Call Participants Michael DiFiore - Evercore ISI Michael Ulz - Morgan Stanley Operator Good afternoon, and welcome to Fractyl Health's First Quarter Financial Results and Business Updates Call. As a reminder, this conference call is being recorded.

Fractyl Health, Inc. (GUTS) Q1 2024 Earnings Call Transcript

Initiation of Remain-1 pivotal study for weight maintenance in patients with obesity after discontinuation of GLP-1 based drugs expected in the second half of 2024 Topline data from Revitalize-1 pivotal study in patients with inadequately controlled T2D anticipated in the fourth quarter 2024 Update from real-world Germany registry study of Revita in patients with T2D at DDG Annual Meeting Appointed Adrian Kimber as Chief Commercial Officer to lead Revita launch readiness activities Conference call today at 4:30 p.m. ET BURLINGTON, Mass.

Fractyl Health Reports First Quarter 2024 Financial Results and Provides Business Updates

First 14 participants with at least six months of follow up continue to demonstrate sustained improvements in blood glucose and weight with reduction in T2D medication utilization after a single Revita treatment No device- or procedure-related serious adverse events have been observed to date in any registry participant BURLINGTON, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced 6-month follow-up data from its enrolling German real-world registry study of Revita for T2D.

Fractyl Health Presents Clinical Update on Revita® German Real-World Registry for Patients With Advanced Type 2 Diabetes (T2D)

BURLINGTON, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced that Dr. Harith Rajagopalan, CEO of Fractyl Health, will participate in a fireside chat at the upcoming BofA Securities 2024 Health Care Conference on Wednesday, May 15, 2024, at 4:20 p.m.

Fractyl Health to Present at BofA Securities 2024 Health Care Conference

BURLINGTON, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced it will report financial results for the first quarter 2024 and provide business updates after market close on Monday, May 13, 2024.

Fractyl Health to Report First Quarter 2024 Financial Results and Provide Business Updates on May 13, 2024

At DDG, Fractyl Health will present new clinical updates on its ongoing real-world registry study of Revita ® in patients with T2D in Germany At DDW, Fractyl Health will provide an oral presentation from its Rejuva ® platform with new preclinical data demonstrating the potential of GLP-1 based pancreatic gene therapy (GLP-1 PGTx) to durably reduce liver fat in the diet-induced obesity model BURLINGTON, Mass., April 30, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced that it will present new data from its ongoing real-world registry study of Revita for T2D at the upcoming German Diabetes Association (DDG) Annual Meeting taking place May 8-11, 2024, in Berlin, Germany.

Fractyl Health Announces Multiple Presentations at the Upcoming Digestive Disease Week (DDW) 2024 Conference and the German Diabetes Association (DDG) Annual Meeting

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BURLINGTON, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced the appointment of Adrian Kimber as Chief Commercial Officer.

Fractyl Health Expands Leadership with Appointment of Adrian Kimber as Chief Commercial Officer to Spearhead Anticipated Launch Preparation as the Company Conducts Two Pivotal Studies for Revita in Obesity and Type 2 Diabetes

Received IDE approval for the Revita® Remain-1 pivotal study for weight maintenance in patients with obesity after discontinuation of GLP-1 Based Drugs Completion of enrollment in pivotal Revitalize-1 study in patients with inadequately controlled T2D expected in second quarter of 2024 and anticipated topline data in fourth quarter of 2024 Announced nomination of RJVA-001 as first clinical candidate in the Rejuva® GLP-1 gene therapy platform; completion of IND-enabling studies expected in second half of 2024 Completed initial public offering of common stock raising $110 million in gross proceeds; cash on hand expected to fund operations through 2025 BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and obesity, today reported its fourth quarter and full year 2023 financial results and provided a business update.

Fractyl Health Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs

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Fractyl Health today announced promising new preclinical findings for the first clinical candidate in its Rejuva® pancreatic gene therapy platform.

UPDATE -- Fractyl Health Announces New Results From Its Rejuva® Platform Demonstrating Potent and Durable Effects of a Single Dose of a Human GLP-1 Pancreatic Gene Therapy Transgene Compared to Semaglutide in the db/db Mouse Model of Diabetes and Obesity

Fractyl Health Announces New Results From Its Rejuva® Platform Demonstrating Potent and Durable Effects of a Single Dose of a Human GLP-1 Pancreatic Gene Therapy Transgene Compared to Semaglutide in the db/db Mouse Model of Diabetes and Obesity

LEXINGTON, Mass., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“Fractyl Health” or the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of Type 2 Diabetes (T2D) and obesity, today announced the appointment of Samuel Conaway to its Board of Directors.

Fractyl Health Appoints Samuel Conaway to Its Board of Directors, Bolstering New Product Commercial Expertise During Revita® Pivotal Clinical Trials

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Shares of Fractyl Health fell 8.3% on their market debut on Friday, giving the obesity and diabetes drug developer a market capitalization of $654.6 million.

Fractyl Health valued at $654.6 mln in tepid debut

Obesity and diabetes drug developer Fractyl Health on Thursday priced its U.S. initial public offering (IPO) below an indicated range to raise $110 million.

Fractyl Health prices US IPO below range to raise $110 mln

LEXINGTON, Mass., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and obesity, today announced the pricing of its initial public offering of 7,333,333 shares of common stock at a public offering price of $15.00 per share, for total gross proceeds of approximately $110.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Fractyl Health.

Fractyl Health Announces Pricing of Initial Public Offering

Thus far, 2024 has been a mixed year for initial public offerings (IPOs). Various IPOs in 2023 performed well, but many underperformed expectations.

GUTS IPO News: 5 Things to Know as Fractyl Health Plans to Go Public

Fractyl Health, Inc. has filed for a $100 million IPO to raise funds for its treatments for Type 2 Diabetes and obesity, although the final figure may differ. The company's lead procedural approach, Revita DMR System, is already approved in Europe. The global market for Type 2 diabetes drug treatments is expected to reach $61.6 billion by 2030.

Fractyl Health Aims For $100 Million IPO Raise

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