0000000000-23-013915.txt : 20240301 0000000000-23-013915.hdr.sgml : 20240301 20231220153607 ACCESSION NUMBER: 0000000000-23-013915 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20231220 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Fractyl Health, Inc. CENTRAL INDEX KEY: 0001572616 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 273553477 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD SEC FILE NUMBER: 377-05668 BUSINESS ADDRESS: STREET 1: 17 HARTWELL AVENUE CITY: LEXINGTON STATE: MA ZIP: 02421 BUSINESS PHONE: 781-902-8800 MAIL ADDRESS: STREET 1: 17 HARTWELL AVENUE CITY: LEXINGTON STATE: MA ZIP: 02421 FORMER COMPANY: FORMER CONFORMED NAME: Fractyl Laboratories Inc. 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filename2.txt United States securities and exchange commission logo December 20, 2023 Harith Rajagopalan, M.D., Ph.D. Chief Executive Officer Fractyl Health, Inc. 17 Hartwell Avenue Lexington, MA 02421 Re: Fractyl Health, Inc. Registration Statement on Form S-1 Filed December 14, 2023 File No. 333-276046 Dear Harith Rajagopalan: We have reviewed your registration statement and have the following comment. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to this letter, we may have additional comments. Registration Statement on Form S-1 Prospectus Summary Overview, page 1 1. Please revise to provide the source for your statement that up to two-thirds of patients discontinue weekly GLP-1RA therapy within the first year. In your revisions, please disclose the drugs that were discontinued and the dates covered by the study or studies showing the discontinuation. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration Harith Rajagopalan, M.D., Ph.D. Fractyl Health, Inc. December 20, 2023 Page 2 statement. Please contact Michael Fay at 202-551-3812 or Brian Cascio at 202-551-3676 if you have questions regarding comments on the financial statements and related matters. Please contact Tyler Howes at 202-551-3370 or Alan Campbell at 202-551-4224 with any other questions. Sincerely, FirstName LastNameHarith Rajagopalan, M.D., Ph.D. Division of Corporation Finance Office of Industrial Applications and Comapany NameFractyl Health, Inc. Services December 20, 2023 Page 2 cc: Nathan Ajiashvili, Esq. FirstName LastName