Breakthrough Device Designations are granted by the U.S. FDA to expedite review of promising technologies that address high unmet needs and may improve the lives of people with life-threatening or debilitating conditions BURLINGTON, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company"), a metabolic therapeutics company focused on pioneering new approaches that treat the root cause of obesity and type 2 diabetes (T2D), today announced that the U.S. Food and Drug Administ ...

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, th ...

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, 2024 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 ...

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 Exhibit 99.1 Fractyl Health Reports First Quarter 2024 Financial Results and Provides Business Updates Appointed Adrian ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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) Delaware 27-3553477 (State or ot ...

临床试验进展 - 公司获得Revita® Remain-1 临床试验的IDE批准，用于评估在停用GLP-1类药物后维持体重的患有肥胖症的患者[3] - 预计2024年第二季度完成Revitalize-1 临床试验的患有未得到充分控制的2型糖尿病患者的入组，并于2024年第四季度公布临床试验结果[8] - 公司计划2024年下半年启动Remain-1临床试验并开始报告Reveal-1队列的数据[9] 新药研发 - 公司提名RJVA-001作为Rejuva® GLP-1基因疗法平台的首个临床候选药物，预计2024年下半年完成IND使能研究[12] - 公司计划2024年下半年提名首个用于治疗肥胖症的GLP-1基因疗法候选药物[15] 商业化进展 - 公司在德国开展Revita系统的有限商业试点,并获得NUB报销授权[7] - 在Revita系统的临床试验中,患者接受治疗后3个月HbA1c中位数下降1.9%,体重中位数下降17.6磅[4][5] - 公司发布Revita系统在体重维持方面的长期数据,单次治疗后4周平均总体体重下降3.4%,48周维持4.0%的体重下降[6] 财务状况 - 公司完成首次公开募股,筹集1.1亿美元资金,预计现金储备可支持公司运营至2025年[16] - 公司2023年全年收入为0.1百万美元,研发费用为38.0百万美元,销售及管理费用为12.8百万美元,净亏损为77.1百万美元[18][19][20][21] - 公司2023年12月31日的现金及现金等价物为33,209千美元[30] - 公司2023年12月31日的总资产为76,212千美元[30] - 公司2023年12月31日的长期债务为55,152千美元[30] - 公司2023年12月31日的总负债为113,944千美元[30] - 公司2023年12月31日的总股东赤字为325,062千美元[30] - 公司2023年第四季度的收入为7千美元[30] - 公司2023年第四季度的研发费用为10,166千美元[30] - 公司2023年第四季度的销售、一般及管理费用为2,820千美元[30] - 公司2023年第四季度的净亏损为19,180千美元[30] - 公司2023年第四季度的每股基本和稀释亏损为11.18美元[30]