Fractyl Health Inc

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

Fractyl Health reports Q3 loss, highlights Revita and Rejuva

Fractyl Health showcased positive outcomes with Revita and Rejuva but faces challenges regarding drug durability and financial performance. The company's focus on innovative therapies presents growth opportunities in the future.

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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.

RJVA-001 was successfully delivered in large animal Yucatan pig models at low total viral dose Results confirm ability to directly target pancreas with novel delivery catheter and route of administration Local delivery of RJVA-001 achieved therapeutically relevant GLP-1 expression within pancreatic beta cells with no adverse safety effects observed Company plans to initiate first-in-human studies with RJVA-001 in first half of 2025 BURLINGTON, Mass., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering pattern breaking approaches for the treatment of obesity and type 2 diabetes (T2D), will present new data from its preclinical Rejuva Smart GLP-1 pancreatic gene therapy program in a poster titled “Feasibility and Safety of Novel Endoscopic Ultrasound-Guided Delivery of Human GLP-1 Pancreatic Gene Therapy in Pigs” at the 22nd World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC).

Fractyl Health Unveils Promising Preclinical Data Demonstrating Safety and Feasibility of Local Delivery of RJVA-001 Rejuva® Smart GLP-1™ Pancreatic Gene Therapy at the World Congress Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC)

BURLINGTON, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today 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) taking place December 12-14, 2024.

Fractyl Health to Present New Preclinical Data from its Rejuva® Single-Administration Smart GLP-1 Pancreatic Gene Therapy Platform at the World Congress Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC)

BURLINGTON, Mass., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of the Company, will present at two upcoming investor conferences.

Fractyl Health to Participate in the Upcoming December Conferences

Fractyl Health, Inc. (NASDAQ:GUTS ) Q3 2024 Earnings Conference Call November 12, 2024 4:30 PM ET Company Participants Stephen Jasper - Gilmartin Group Harith Rajagopalan - Co-Founder and CEO Lisa Davidson - CFO Conference Call Participants Michael Ulz - Morgan Stanley Michael DiFiore - Evercore ISI William Wood - B. Riley Securities Operator Good afternoon, and welcome to Fractyl Health's Third Quarter Financial Results and Business Updates Call.

Fractyl Health, Inc. (GUTS) Q3 2024 Earnings Call Transcript

REMAIN-1 weight maintenance pivotal study enrollment progressing rapidly; mid-point data analysis expected in Q2 2025 Anticipate reporting data from REVEAL-1 open-label cohort beginning in Q4 2024 Topline data from REVITALIZE-1 pivotal study expected in mid-2025 Company presented compelling weight maintenance data from both Revita ® and Rejuva ® platforms at ObesityWeek ® 2024 Conference call today at 4:30 p.m. ET BURLINGTON, Mass, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today reported its third quarter 2024 financial results and provided business updates.

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

13-week follow-up represents the longest data to-date demonstrating durable efficacy of RJVA-001 on weight and blood sugar in the diet-induced obesity (DIO) mouse model

Fractyl Health to Present New Preclinical Data on Sustained Weight Maintenance and Blood Sugar from its Rejuva® RJVA-001 Single-Administration GLP-1 Pancreatic Gene Therapy Candidate at ObesityWeek® 2024

BURLINGTON, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced it will report financial results for the third quarter 2024 and provide business updates on Tuesday, November 12, 2024, at 4:30 p.m. ET.

Fractyl Health to Report Third Quarter 2024 Financial Results and Provide Business Updates on November 12, 2024

BURLINGTON, Mass., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced that it will present compelling weight maintenance data from both its Revita and Rejuva platforms at The Obesity Society's Annual Meeting at ObesityWeek 2024, held from November 2-6, 2024, in San Antonio, Texas.

Fractyl Health to Present Compelling Weight Maintenance Data from both Revita® and Rejuva® Platforms at ObesityWeek® 2024

BURLINGTON, Mass., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D)), today announced that Harith Rajagopalan, M.D.

Fractyl Health to Present at Chardan's 8th Annual Genetic Medicines Conference

BURLINGTON, Mass., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced that Harith Rajagopalan, M.D.

Fractyl Health to Participate in Upcoming September Investor Conferences

Fractyl Health, Inc. (NASDAQ:GUTS ) Q2 2024 Earnings Conference Call August 14, 2024 4:30 PM ET Company Participants Stephen Jasper - Gilmartin Group Harith Rajagopalan - Co-founder and CEO Lisa Davidson - CFO Conference Call Participants Michael Ulz - Morgan Stanley Umer Raffat - Evercore Operator Good afternoon, and welcome to Fractyl Health's Second Quarter Financial Results and Business Updates Call. As a reminder, this conference call is being recorded.

Fractyl Health, Inc. (GUTS) Q2 2024 Earnings Call Transcript

Updated clinical results from German Real-World Registry demonstrate potential for Revita ® to meaningfully sustain weight loss and lower blood sugar for at least one-year post-treatment in a real-world setting Granted U.S. FDA Breakthrough Device designation for Revita in weight maintenance after discontinuation of GLP-1 based drugs REMAIN-1 pivotal study for Revita in weight maintenance now initiated with anticipated data readouts beginning in Q4 2024 REVITALIZE-1 on-track to report topline data in mid-2025 in expanded Type 2 Diabetes patient population Presented head-to-head preclinical data comparing Rejuva ® versus semaglutide in #1 abstract at ADA 2024 Conference call today at 4:30 p.m. ET BURLINGTON, Mass.

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

BURLINGTON, Mass., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced it will report financial results for the second quarter 2024 and provide business updates on Wednesday, August 14, 2024, at 4:30 p.m.

Fractyl Health to Report Second Quarter 2024 Financial Results and Provide Business Updates on August 14, 2024

Fractyl Health Receives FDA Breakthrough Device Designation for Revita in Weight Maintenance for People with Obesity Who Discontinue GLP-1 Based Drugs

BURLINGTON, Mass., June 25, 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, and Dr. Timothy Kieffer, CSO of Fractyl Health, will participate in a virtual fireside chat at the upcoming Piper Sandler 2nd Annual Virtual Obesity Day on Wednesday, June 26, 2024 at 9:30 a.m.

Fractyl Health to Present at Piper Sandler 2nd Annual Virtual Obesity Day

Company will accelerate Revita® weight maintenance clinical study REMAIN-1; open label data from REVEAL-1 cohort expected in Q4 2024 and mid-point data analysis for REMAIN-1 anticipated in Q2 2025 Company expands Revita type 2 diabetes clinical study REVITALIZE-1, expanding eligibility; increases potential U.S. treatment population for Revita by over 6x (from ~4 to ~25 million patients) Company presented preclinical data showing greater, more durable weight loss for its GLP-1 pancreatic gene therapy Rejuva® vs. semaglutide in one of eight President Select Abstracts at the American Diabetes Association's 84 th Scientific Sessions BURLINGTON, Mass.

Fractyl Health Announces Advancement in Weight Maintenance Pipeline and Business Updates

Single administration of Rejuva reduced fat mass and improved glycemia in the well-validated diet-induced obesity (DIO) mouse model Rejuva also prevented weight and glycemic rebound after semaglutide withdrawal Data provide first demonstration that Rejuva treatment has potential to mimic natural release of GLP-1 from pancreas BURLINGTON, Mass., June 23, 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 presented new data from its preclinical Rejuva pancreatic gene therapy program in an oral presentation at the American Diabetes Association (ADA)'s 84th Scientific Sessions in Orlando, FL.

Fractyl Health Presents New Preclinical Data on Sustained Weight Maintenance and Improved Body Composition from its Rejuva® Single-Administration GLP-1 Pancreatic Gene Therapy in President's Select Oral Presentation at the American Diabetes Association's 

Results showed single-administration GLP-1 pancreatic gene therapy candidate reduced liver weight by 42% (p

Fractyl Health Presents Compelling Preclinical Data from Single-Administration GLP-1 Pancreatic Gene Therapy Rejuva® at Digestive Disease Week 2024

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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