GUTS / Fractyl Health, Inc. - Pengajuan SECLaporan Tahunan, Pernyataan Proksi

FORM 8-K Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 29, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission Fi

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. )

TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. )         Filed by the Registrant ☒     Filed by a Party other than the Registrant  ☐         Check the appropriate box:  ☐ Preliminary

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. )

TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. )         Filed by the Registrant ☒     Filed by a Party other than the Registrant  ☐         Check the appropriate box: ☒ Preliminary P

FORM 8-K Item 2.02 Results of Operations and Financial Condition. Item 9.01 Financial Statements and Exhibits.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 12, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission Fi

Fractyl Health Announces Second Quarter 2025 Financial Results and Business Updates Randomized 3-month REMAIN-1 Midpoint Cohort data expected in September 2025 Positive 3-month REVEAL-1 Cohort data showed single Revita® procedure sustained weight los

Exhibit 99.1 Fractyl Health Announces Second Quarter 2025 Financial Results and Business Updates Randomized 3-month REMAIN-1 Midpoint Cohort data expected in September 2025 Positive 3-month REVEAL-1 Cohort data showed single Revita® procedure sustained weight loss after GLP-1 discontinuation; incremental 6-month open-label data expected in Q4 2025 Top-line REMAIN-1 Pivotal Cohort 6-month data and

BASIS OF PRESENTATION TRADEMARKS AND TRADENAMES FORWARD-LOOKING STATEMENTS SUMMARY RISK FACTORS Table of Contents PART I—FINANCIAL INFORMATION PART II—OTHER INFORMATION

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 June 30, 2025 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.

Warrant Agency Agreement

EX-4.1 Exhibit 4.1 WARRANT AGENCY AGREEMENT WARRANT AGENCY AGREEMENT, dated as of August 7, 2025 (“Agreement”), between Fractyl Health, Inc., a Delaware corporation (the “Company”), and Equiniti Trust Company, LLC (the “Warrant Agent”). W I T N E S S E T H WHEREAS, pursuant to a registered offering (the “Offering”) by the Company of 21,904,761 shares of common stock, par value $0.00001 per share (

Form of Tranche B Warrant

EX-4.3 Exhibit 4.3 TRANCHE B COMMON STOCK PURCHASE WARRANT FRACTYL HEALTH, INC. Issue Date: August 7, 2025 Warrant Shares: [ ] THIS TRANCHE B COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [ ] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the d

19,047,619 Shares of Common Stock Tranche A Warrants to Purchase Up to 19,047,619 Shares of Common Stock Tranche B Warrants to Purchase Up to 19,047,619 Shares of Common Stock

424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-285522 PROSPECTUS SUPPLEMENT (To Prospectus Dated March 18, 2025) 19,047,619 Shares of Common Stock Tranche A Warrants to Purchase Up to 19,047,619 Shares of Common Stock Tranche B Warrants to Purchase Up to 19,047,619 Shares of Common Stock We are offering 19,047,619 shares of our common stock, par value $0.00001 per sh

Form of Tranche A Warrant

EX-4.2 Exhibit 4.2 TRANCHE A COMMON STOCK PURCHASE WARRANT FRACTYL HEALTH, INC. Issue Date: August 7, 2025 Warrant Shares: [ ] THIS TRANCHE A COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [ ] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the d

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 6, 2025 Fractyl Health, In

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 6, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission Fil

Underwriting Agreement, dated as of August 6, 2025, by and between the Company and Ladenburg Thalmann & Co. Inc.

EX-1.1 Exhibit 1.1 19,047,619 SHARES OF COMMON STOCK, TRANCHE A WARRANTS EXERCISABLE INTO 19,047,619 SHARES OF COMMON STOCK, AND TRANCHE B WARRANTS EXERCISABLE INTO 19,047,619 SHARES OF COMMON STOCK OF FRACTYL HEALTH, INC. UNDERWRITING AGREEMENT August 6, 2025 Ladenburg Thalmann & Co. Inc. As the Representative of the Several underwriters, if any, named in Schedule I hereto 640 Fifth Avenue, 4th F

Form of Voting Agreement by and among the Company and its directors, its officers and Mithril, dated August 6, 2025

EX-10.1 Exhibit 10.1 DATE: [], 2025 TO: Fractyl Health, Inc. Ladenburg Thalmann & Co. Inc. To Whom It May Concern: Reference is made to that certain Underwriting Agreement, dated as of August 6, 2025 (the “Agreement”), by and between Fractyl Health, Inc. (the “Company”) and Ladenburg Thalmann & Co. Inc. as representative of the underwriters named therein (the “Representative”), which provides for

Subject to Completion, dated August 5, 2025

424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-285522 The information in this preliminary prospectus supplement is not complete and may be changed. This preliminary prospectus supplement and the accompanying prospectus are not an offer to sell the securities and are not soliciting an offer to buy the securities in any jurisdiction where the offer or sale is not permi

Regulation FD Disclosure, Financial Statements and Exhibits, Other Events

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 23, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission File

Fractyl Health Reports Positive 3-Month REVEAL-1 Cohort Data Showing Revita® Sustained Weight Loss After GLP-1 Discontinuation, Supporting its Potential as a First-in-Class Weight Maintenance Therapy 12 of 13 participants maintained or lost weight at

Exhibit 99.1 Fractyl Health Reports Positive 3-Month REVEAL-1 Cohort Data Showing Revita® Sustained Weight Loss After GLP-1 Discontinuation, Supporting its Potential as a First-in-Class Weight Maintenance Therapy 12 of 13 participants maintained or lost weight at 3 months, with 6 of 13 losing additional weight after stopping GLP-1 therapy and undergoing Revita procedure Median weight remained stab

Fractyl Health Presents New Data at the American Diabetes Association’s 85th Scientific Sessions Demonstrating its Rejuva® Smart GLP-1TM Pancreatic Gene Therapy Platform Prevents Obesity and Type 2 Diabetes in Preclinical Models New findings demonstr

Exhibit 99.2 Fractyl Health Presents New Data at the American Diabetes Association’s 85th Scientific Sessions Demonstrating its Rejuva® Smart GLP-1TM Pancreatic Gene Therapy Platform Prevents Obesity and Type 2 Diabetes in Preclinical Models New findings demonstrated that a single dose of Rejuva was well tolerated in healthy animals, with no evidence of toxicity Rejuva-treated healthy animals expo

Fractyl Health Reinforces Intellectual Property Leadership in Metabolic Disease with Two New U.S. Patents Directed to Duodenal Resurfacing Robust intellectual property portfolio, built over more than a decade, designed to protect core innovations for

Exhibit 99.1 Fractyl Health Reinforces Intellectual Property Leadership in Metabolic Disease with Two New U.S. Patents Directed to Duodenal Resurfacing Robust intellectual property portfolio, built over more than a decade, designed to protect core innovations for treating metabolic diseases New U.S. patents strengthen Fractyl’s leadership in metabolic innovation by expanding its patent coverage of

Regulation FD Disclosure, Financial Statements and Exhibits, Other Events

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 18, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission File

Submission of Matters to a Vote of Security Holders

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 11, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission File

Regulation FD Disclosure, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 19, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission File

First-in-human study will evaluate safety, tolerability, and early efficacy of a one-time, pancreas-targeted smart GLP-1TM gene therapy for patients with inadequately controlled T2D and obesity Expect to dose first patients and report preliminary dat

Exhibit 99.1 Fractyl Health Advances Rejuva® Gene Therapy Platform with Submission of First Clinical Trial Application Module in Europe for RJVA-001 in Type 2 Diabetes First-in-human study will evaluate safety, tolerability, and early efficacy of a one-time, pancreas-targeted smart GLP-1TM gene therapy for patients with inadequately controlled T2D and obesity Expect to dose first patients and repo

Regulation FD Disclosure, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 17, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission File

Fractyl Health Unveils New Rejuva® Smart GLP-1TM Pancreatic Gene Therapy Preclinical Data Highlighting Durable Potency and Safety with Limited Systemic GLP-1 Exposure at ASGCT 2025 Data suggests that single dose of RJVA-001 leads to durable metabolic

Exhibit 99.1 Fractyl Health Unveils New Rejuva® Smart GLP-1TM Pancreatic Gene Therapy Preclinical Data Highlighting Durable Potency and Safety with Limited Systemic GLP-1 Exposure at ASGCT 2025 Data suggests that single dose of RJVA-001 leads to durable metabolic improvements with low systemic GLP-1 exposure in db/db mouse model of T2D— potentially simultaneously addressing durability, adherence,

Financial Statements and Exhibits, Results of Operations and Financial Condition

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 13, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission File

BASIS OF PRESENTATION TRADEMARKS AND TRADENAMES FORWARD-LOOKING STATEMENTS SUMMARY RISK FACTORS Table of Contents PART I—FINANCIAL INFORMATION PART II—OTHER INFORMATION

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, 2025 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.

Fractyl Health Announces First Quarter 2025 Financial Results and Business Updates REVEAL-1 Cohort 3-month open-label data update expected in June 2025; early clinical signals reinforce Revita’s potential to maintain weight loss after GLP-1 discontin

Exhibit 99.1 Fractyl Health Announces First Quarter 2025 Financial Results and Business Updates REVEAL-1 Cohort 3-month open-label data update expected in June 2025; early clinical signals reinforce Revita’s potential to maintain weight loss after GLP-1 discontinuation in the real world REMAIN-1 Midpoint Cohort data expected in Q3 2025; first randomized data on post-GLP-1 weight maintenance REMAIN

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.  )

TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.  ) Filed by the Registrant ☒ Filed by a Party other than the Registrant  ☐ Check the appropriate box:  ☐ Preliminary Proxy Statement  ☐

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.  )

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.  ) Filed by the Registrant ☒ Filed by a Party other than the Registrant  ☐ Check the appropriate box:  ☐ Preliminary Proxy Statement  ☐ Confidential, for

Regulation FD Disclosure, Financial Statements and Exhibits, Other Events

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 01, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission Fil

Fractyl Health Reports Positive Early Data Showing Revita® Has Potential to Prevent Weight Regain After GLP-1 Discontinuation New REVEAL-1 study results show early signs of weight maintenance after GLP-1 discontinuation REMAIN-1 pivotal study now mor

Exhibit 99.1 Fractyl Health Reports Positive Early Data Showing Revita® Has Potential to Prevent Weight Regain After GLP-1 Discontinuation New REVEAL-1 study results show early signs of weight maintenance after GLP-1 discontinuation REMAIN-1 pivotal study now more than 50% enrolled; midpoint data analysis anticipated in Q3 2025 BURLINGTON, Mass., April 1, 2025 (GLOBE NEWSWIRE) – Fractyl Health, In

Other Events, Shareholder Director Nominations

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 13, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission Fil

As filed with the Securities and Exchange Commission on March 13, 2025

Table of Contents As filed with the Securities and Exchange Commission on March 13, 2025 Registration No.

Fractyl Health, Inc. 3 Van de Graaff Drive, Suite 200 Burlington, MA 01803

Fractyl Health, Inc. 3 Van de Graaff Drive, Suite 200 Burlington, MA 01803 March 13, 2025 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Fractyl Health, Inc. Amendment No. 1 to Registration Statement on Form S-3 Filed March 13, 2025 File No. 333-285522 To whom it may concern: Pursuant to Rule 461(a)

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Fractyl Health, Inc.

Fractyl Health Announces Fourth Quarter and Full Year 2024 Financial Results and Business Updates Strong patient and physician demand for pivotal REMAIN-1 study highlights urgent need for post-GLP-1 withdrawal weight maintenance solutions; midpoint d

Exhibit 99.1 Fractyl Health Announces Fourth Quarter and Full Year 2024 Financial Results and Business Updates Strong patient and physician demand for pivotal REMAIN-1 study highlights urgent need for post-GLP-1 withdrawal weight maintenance solutions; midpoint data analysis anticipated in Q2 2025 and full study enrollment expected in summer 2025 Company plans to submit first Clinical Trial Applic

Financial Statements and Exhibits, Results of Operations and Financial Condition

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 03, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission Fil

Sales Agreement, dated March 3, 2025, by and between Fractyl Health, Inc. and Jefferies LLC.

Exhibit 1.2 Execution Version OPEN MARKET SALE AGREEMENTSM March 3, 2025 JEFFERIES LLC 520 Madison Avenue New York, New York 10022 Ladies and Gentlemen: Fractyl Health, Inc., a Delaware corporation (the “Company”), proposes, subject to the terms and conditions stated herein, to issue and sell from time to time through Jefferies LLC, as sales agent and/or principal (the “Agent”), shares of the Comp

Form of Indenture between the Registrant and one or more trustees to be named.

Exhibit 4.4 FRACTYL HEALTH, INC. INDENTURE Dated as of , 20 [ • ] Trustee TABLE OF CONTENTS Page ARTICLE I. DEFINITIONS AND INCORPORATION BY REFERENCE 1 Section 1.1. Definitions 1 Section 1.2. Other Definitions 4 Section 1.3. Incorporation by Reference of Trust Indenture Act 4 Section 1.4. Rules of Construction 5 ARTICLE II. THE SECURITIES 5 Section 2.1. Issuable in Series 5 Section 2.2. Establish

Form 10-K

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, 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: 001-41

Powers of Attorney (incorporated by reference to the signature page hereto).

Table of Contents As filed with the Securities and Exchange Commission on March 3, 2025 Registration No.

Fractyl Health, Inc. Insider Trading Compliance Policy

Exhibit 19.1 FRACTYL HEALTH INC. Insider Trading Compliance Policy and Procedures I. Summary Federal and state laws prohibit trading in the securities of a company while in possession of material nonpublic information and in breach of a duty of trust or confidence. These laws also prohibit anyone who is aware of material nonpublic information from providing this information to others who may trade

Fractyl Health Announces Increased Focus on Groundbreaking Revita® Weight Maintenance and Rejuva® Pancreatic Gene Therapy Programs with Potential to Deliver Key Clinical Milestones Across Multiple Studies in 2025 Prioritizing Revita’s clinical develo

Exhibit 99.1 Fractyl Health Announces Increased Focus on Groundbreaking Revita® Weight Maintenance and Rejuva® Pancreatic Gene Therapy Programs with Potential to Deliver Key Clinical Milestones Across Multiple Studies in 2025 Prioritizing Revita’s clinical development on weight maintenance post-GLP-1 withdrawal in response to significant patient and physician demand in ongoing REMAIN-1 pivotal stu

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 31, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission F

Fractyl Health Announces Positive Initial Clinical Results Demonstrating Weight Maintenance Following GLP-1 Discontinuation and Revita Procedure in First Patient of the REVEAL-1 Cohort Company also announces strong enrollment progress for REMAIN-1 we

Exhibit 99.1 Fractyl Health Announces Positive Initial Clinical Results Demonstrating Weight Maintenance Following GLP-1 Discontinuation and Revita Procedure in First Patient of the REVEAL-1 Cohort Company also announces strong enrollment progress for REMAIN-1 weight maintenance pivotal study High demand from patients and physicians indicates significant interest in REMAIN-1 study and GLP-1 discon

Regulation FD Disclosure, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 13, 2025 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission F

GUTS / Fractyl Health, Inc. / MAVERICK CAPITAL LTD - SC 13G Passive Investment

SC 13G 1 d891783dsc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Fractyl Health, Inc. (Name of Issuer) Common Stock, par value $0.00001 per share (Title of Class of Securities) 35168W103 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Check the

Power of Attorney

EX-99.B 3 d891783dex99b.htm EX-99.B EXHIBIT B Power of Attorney KNOW ALL MEN BY THESE PRESENTS, that I, Lee S. Ainslie III, hereby make, constitute and appoint Trevor Wiessmann as my agent and attorney-in-fact for the purpose of executing (i) in my personal capacity or (ii) in my capacity as manager or other officer or representative of Maverick Capital Management, LLC, Maverick Capital, Ltd. or a

JOINT FILING AGREEMENT

EX-99.A 2 d891783dex99a.htm EX-99.A EXHIBIT A JOINT FILING AGREEMENT The undersigned hereby agree that the statement on Schedule 13G with respect to the Common Stock of Fractyl Health, Inc., dated as of November 14, 2024, is, and any amendments thereto (including amendments on Schedule 13D) signed by each of the undersigned shall be, filed on behalf of each of us pursuant to and in accordance with

JOINT FILING AGREEMENT

EX-99.1 2 d863183dex991.htm EX-99.1 Exhibit 1 JOINT FILING AGREEMENT The undersigned hereby agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned, and any amendments thereto executed by the undersigned shall be filed on behalf of each of the undersigned without the necessity of filing any additional joint filing agreement. The undersigned acknowledge that

GUTS / Fractyl Health, Inc. / Mithril LP - SC 13G Passive Investment

SC 13G 1 d863183dsc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1 (b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO 13d-2 (b) (Amendment No.  ) Fractyl Health, Inc. (Name of Issuer) Common Stock, par value $0.00001 per share (Title of Class of Securitie

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

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 September 30, 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.

Fractyl Health Reports Third Quarter 2024 Financial Results and Provides Business Updates REMAIN-1 weight maintenance pivotal study enrollment progressing rapidly; mid-point data analysis expected in Q2 2025 Anticipate reporting data from REVEAL-1 op

Exhibit 99.1 Fractyl Health Reports Third Quarter 2024 Financial Results and Provides Business Updates 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 weigh

Financial Statements and Exhibits, Results of Operations and Financial Condition

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 12, 2024 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission

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 13-week follow-up represents the longest data

Exhibit 99.1 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 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 Company plans

Regulation FD Disclosure, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 04, 2024 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission

Fractyl Health Reports Second Quarter 2024 Financial Results and Provides Business Updates Updated clinical results from German Real-World Registry demonstrate potential for Revita® to meaningfully sustain weight loss and lower blood sugar for at lea

Exhibit 99.1 Fractyl Health Reports Second Quarter 2024 Financial Results and Provides Business Updates 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 afte

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

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 June 30, 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.

Financial Statements and Exhibits, Results of Operations and Financial Condition

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 14, 2024 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission Fi

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 30, 2024 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission File

Fractyl Health Receives FDA Breakthrough Device Designation for Revita in Weight Maintenance for People with Obesity Who Discontinue GLP-1 Based Drugs Breakthrough Device Designations are granted by the U.S. FDA to expedite review of promising techno

Exhibit 99.1 Fractyl Health Receives FDA Breakthrough Device Designation for Revita in Weight Maintenance for People with Obesity Who Discontinue GLP-1 Based Drugs 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 REMAIN-1 pivota

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 24, 2024 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission File

Fractyl Health Announces Advancement in Weight Maintenance Pipeline and Business Updates 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

Exhibit 99.1 Fractyl Health Announces Advancement in Weight Maintenance Pipeline and Business Updates 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

Master Services Agreement as Amended and Statement of Work dated April 25, 2024 by and between Velocity Global, LLC. and Fractyl Heath, Inc.

Exhibit 10.8 MASTER SERVICES AGREEMENT This Master Services Agreement is entered into and effective as of April 25, 2024 ("Effective Date") between Velocity Global, LLC, a Colorado limited liability company, located at 1701 Platte Street, Suite 210, Denver, CO 80202 ("Velocity Global"), and Fractyl Health, Inc. ("Client"), located at 3 Van de Graaff Drive, Suite 200, Burlington, Massachusetts, Uni

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

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.

Employment Agreement dated May 10, 2024 by and between Velocity Global International Ltd., and Timothy Kieffer.

Exhibit 10.9 EMPLOYMENT AGREEMENT This employment agreement (this "Agreement") is made as of the 10th day of May, 2024 BETWEEN: Velocity Global International Ltd., (the "Employer") and Timothy Kieffer, (the "Employee"). WHEREAS the Employer is engaged in the business of, among other things, providing payroll, human resources, and payment services to clients (the “Business”); AND WHEREAS the Employ

Financial Statements and Exhibits, Results of Operations and Financial Condition

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 13, 2024 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission File

Fractyl Health Reports First Quarter 2024 Financial Results and Provides Business Updates 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 2

Exhibit 99.1 Fractyl Health Reports First Quarter 2024 Financial Results and Provides Business Updates 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 Upda

Fractyl Health, Inc. Amended and Restated 2011 Stock Incentive Plan and forms of award agreements thereunder

Exhibit 10.1 Fractyl Health, Inc. 2011 Stock Incentive Plan (as amended and restated June 9, 2021) 1. Purpose The purpose of this 2011 Stock Incentive Plan (the “Plan”) of Fractyl Health, Inc., a Delaware corporation (the “Company”), is to advance the interests of the Company’s stockholders by enhancing the Company’s ability to attract, retain and motivate persons who are expected to make importan

Employment Letter Agreement, dated March 8, 2024, by and between Fractyl Health, Inc. and Adrian Kimber.

Exhibit 10.7 Employment Agreement This Employment Agreement (this “Agreement”), dated as of March 8, 2024, is made by and between Fractyl Health, Inc. a Delaware corporation (together with any successor thereto, the “Company”), and Adrian Kimber (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), and will become effective on the Effective Date

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 01, 2024 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission Fil

Fractyl Health Receives FDA IDE Approval for the Revita

EX-99.1 Exhibit 99.1 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 Revita aims to be the first approved therapeutic option for durable weight maintenance after discontinuation of GLP-1 based drugs, as an adjunct to diet and exercise With this FDA IDE approval, Fractyl Health will initiate

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

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: 001-41

Exhibit 4.3

Exhibit 4.3 DESCRIPTION OF REGISTRANT’S SECURITIES Capital Structure The following summary describes the material provisions of the common stock of Fractyl Health, Inc. (“we”, “us”, “our”, the “Company”) that is registered under Section 12 of the Securities Exchange Act of 1934, as amended, and does not purport to be complete. For a complete description of the terms and provisions of our common st

Fractyl Health, Inc. Policy for Recovery of Erroneously Awarded Compensation

Exhibit 97.1 FRACTYL HEALTH, INC. POLICY FOR RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION Fractyl Health, Inc. (the “Company”) has adopted this Policy for Recovery of Erroneously Awarded Compensation (the “Policy”), effective as of the date shares of the Company’s common stock are first listed on the Nasdaq Stock Market (the “Effective Date”). Capitalized terms used in this Policy but not otherwis

Fractyl Health, Inc. 2024 Incentive Award Plan and forms of award agreements thereunder.

Exhibit 10.14 FRACTYL HEALTH, INC. 2024 INCENTIVE AWARD PLAN ARTICLE I. Purpose The Plan’s purpose is to enhance the Company’s ability to attract, retain and motivate persons who make (or are expected to make) important contributions to the Company by providing these individuals with equity ownership opportunities and/or equity-linked compensatory opportunities. Capitalized terms used in the Plan

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 1, 2024 Fractyl Health, Inc

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 1, 2024 Fractyl Health, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41942 27-3553477 (State or Other Jurisdiction of Incorporation) (Commission File

Fractyl Health Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Received IDE approval for the Revita® Remain-1 pivotal study for weight maintenance in patients with obesity after discontinuation of GLP-1 Based

Exhibit 99.1 Fractyl Health Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update 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 2

Joint Filing Agreement

EX-99.1 2 d775588dex991.htm EX-99.1 Exhibit 99.1 Joint Filing Agreement Pursuant to Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, the undersigned hereby agree that only one statement containing the information required by Schedule 13G need be filed with respect to the ownership by each of the undersigned of shares of Fractyl Health, Inc. EXECUTED this 16th day of February 2024. GENER

GUTS / Fractyl Health, Inc. / General Catalyst GP V, LLC - SC 13G Passive Investment

SC 13G 1 d775588dsc13g.htm SC 13G SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO § 240.13d-1(b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO § 240.13d-2 Under the Securities Exchange Act of 1934 (Amendment No. )* Fractyl Health, Inc. (Name of Issuer) Common Stock, par value $0.00001 per share

Joint Filer Agreement

EX-99.1 2 d789098dex991.htm EX-99.1 Exhibit 99.1 Joint Filer Agreement The undersigned hereby agree and acknowledge that the statement containing the information required by Schedule 13G, to which this agreement is attached as an exhibit, is filed on behalf of each of them, and any amendments or supplements to the Schedule 13G shall also be filed on behalf of each of them. Dated: 2/14/2024 CVF, LL

GUTS / Fractyl Health, Inc. / CVF, LLC - SC 13G Passive Investment

SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Fractyl Health, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 35168W 108 (CUSIP Number) February 6, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which t

Amended and Restated Certificate of Incorporation of Fractyl Health, Inc.

Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF FRACTYL HEALTH, INC. Fractyl Health, Inc. (the “Corporation”), a corporation organized and existing under the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify as follows: 1. The name of the Corporation is Fractyl Health, Inc. The Corporation was incorporated under the name MedCatalyst, Inc. by the fi

Current Report

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 6, 2024 FRACTYL HEALTH, INC. (Exact name of registrant as specified in its charter) Delaware 001-41942 27-3553477 (State or other jurisdiction of incorporation ) (Commission

As filed with the Securities and Exchange Commission on February 6, 2024

As filed with the Securities and Exchange Commission on February 6, 2024 Registration No.

Amended and Restated Bylaws of Fractyl Health, Inc.

Exhibit 3.2 Amended and Restated Bylaws of Fractyl Health, Inc. (a Delaware corporation) as of February 6, 2024 Table of Contents Page Article I - Corporate Offices 1    1.1 Registered Office 1 1.2 Other Offices 1 Article II - Meetings of Stockholders 1 2.1 Place of Meetings 1 2.2 Annual Meeting 1 2.3 Special Meeting 1 2.4 Advance Notice of Business to be Brought before a Meeting 2 2.5 Advance Not

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Fractyl Health, Inc.

7,333,333 Shares Common Stock

Table of Contents Filed Pursuant to Rule 424(b)(4) Registration No. 333-276046 P R O S P E C T U S 7,333,333 Shares Common Stock This is Fractyl Health, Inc.’s initial public offering. We are selling 7,333,333 shares of our common stock. The initial public offering price is $15.00 per share. Prior to this offering, no public market existed for our common stock. Our common stock has been approved f

January 30, 2024

January 30, 2024 Via EDGAR Division of Corporation Finance Office of Life Sciences U.

[signature page follows]

VIA EDGAR January 30, 2024 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.

As filed with the Securities and Exchange Commission on January 29, 2024.

S-1/A Table of Contents Index to Financial Statements As filed with the Securities and Exchange Commission on January 29, 2024.

Employment Letter Agreement, dated January 26, 2024, by and between Fractyl Health, Inc. and Sarah Toomey.

Exhibit 10.8 Employment Agreement This Employment Agreement (this “Agreement”), dated as of January 26, 2024, is made by and between Fractyl Health, Inc. a Delaware corporation (together with any successor thereto, the “Company”), and Sarah Toomey (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), and will become effective, if at all, upon th

Employment Letter Agreement, dated January 26, 2024, by and between Fractyl Health, Inc. and Lisa A. Davidson.

Exhibit 10.6 Employment Agreement This Employment Agreement (this “Agreement”), dated as of January 26, 2024, is made by and between Fractyl Health, Inc. a Delaware corporation (together with any successor thereto, the “Company”), and Lisa Davidson (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), and will become effective, if at all, upon t

Form of Amended and Restated Bylaws of the Registrant (to be in effect upon the consummation of this offering).

Exhibit 3.4 Amended and Restated Bylaws of Fractyl Health, Inc. (a Delaware corporation) as of [ • ], 2024 Table of Contents Page Article I - Corporate Offices 1 1.1 Registered Office 1 1.2 Other Offices 1 Article II - Meetings of Stockholders 1 2.1 Place of Meetings 1 2.2 Annual Meeting 1 2.3 Special Meeting 1 2.4 Advance Notice of Business to be Brought before a Meeting 2 2.5 Advance Notice of N

Form of Underwriting Agreement.

Exhibit 1.1 FRACTYL HEALTH, INC. (a Delaware corporation) [●] Shares of Common Stock UNDERWRITING AGREEMENT Dated: [●], 2024 FRACTYL HEALTH, INC. (a Delaware corporation) [●] Shares of Common Stock UNDERWRITING AGREEMENT [●], 2024 BofA Securities, Inc. Morgan Stanley & Co. LLC Evercore Group L.L.C. as Representatives of the several Underwriters c/o BofA Securities, Inc. One Bryant Park New York, N

Form of Amended and Restated Certificate of Incorporation of the Registrant (to be in effect upon the consummation of this offering).

Exhibit 3.3 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF FRACTYL HEALTH, INC. Fractyl Health, Inc. (the “Corporation”), a corporation organized and existing under the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify as follows: 1. The name of the Corporation is Fractyl Health, Inc. The Corporation was incorporated under the name MedCatalyst, Inc. by the fi

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Tables Form S-1 (Form Type) FRACTYL HEALTH, INC.

Form 8-A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-A FOR REGISTRATION OF CERTAIN CLASSES OF SECURITIES PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 FRACTYL HEALTH, INC. (Exact name of registrant as specified in its charter) Delaware 27-3553477 (State of incorporation or organization) (I.R.S. Employer Identification No.) 17 Hartwell Avenue, Lex

Fractyl Health, Inc. 2024 Incentive Award Plan and forms of award agreements thereunder.

Exhibit 10.15 FRACTYL HEALTH, INC. 2024 INCENTIVE AWARD PLAN ARTICLE I. PURPOSE The Plan’s purpose is to enhance the Company’s ability to attract, retain and motivate persons who make (or are expected to make) important contributions to the Company by providing these individuals with equity ownership opportunities and/or equity-linked compensatory opportunities. Capitalized terms used in the Plan

First Amendment to Offer Letter, dated September 12, 2024, by and between Fractyl Health, Inc. and Timothy Kieffer, Ph.D.

Exhibit 10.10 FIRST AMENDMENT TO OFFER LETTER AGREEMENT THIS FIRST AMENDMENT TO OFFER LETTER AGREEMENT (this “Amendment”) is entered into by and between Fractyl Health, Inc. (the “Company”) and Tim Kieffer (the “Executive”) and will become effective, if at all, as of the date of the Company’s initial public offering of stock (“IPO”) pursuant to an effective registration statement filed under the S

1271 Avenue of the Americas

1271 Avenue of the Americas New York, New York 10020-1401 Tel: +1.212.906.1200 Fax: +1.212.751.4864 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh January 29, 2024 Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo Los Angeles Wash

Employment Letter Agreement, dated January 26, 2024, by and between Fractyl Health, Inc. and Harith Rajagopalan, M.D., Ph.D.

Exhibit 10.5 Employment Agreement This Employment Agreement (this “Agreement”), dated as of January 26, 2024, is made by and between Fractyl Health, Inc. a Delaware corporation (together with any successor thereto, the “Company”), and Harith Rajagopalan (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), and will become effective, if at all, u

Employment Letter Agreement, dated January 26, 2024, by and between Fractyl Health, Inc. and Jay D. Caplan.

Exhibit 10.7 Employment Agreement This Employment Agreement (this “Agreement”), dated as of January 26, 2024, is made by and between Fractyl Health, Inc. a Delaware corporation (together with any successor thereto, the “Company”), and Jay Caplan (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), and will become effective, if at all, upon the

Amended and Restated Certificate of Incorporation of the Registrant (as amended and currently in effect).

Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF FRACTYL LABORATORIES INC. (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware) Fractyl Laboratories Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), DOES HEREBY CERTIFY: 1. Tha

Fractyl Health, Inc. 2024 Employee Stock Purchase Plan.

Exhibit 10.16 FRACTYL HEALTH, INC. 2024 EMPLOYEE STOCK PURCHASE PLAN ARTICLE I. PURPOSE The purpose of this Plan is to assist Eligible Employees of the Company and its Designated Subsidiaries in acquiring a stock ownership interest in the Company. The Plan consists of two components: (i) the Section 423 Component and (ii) the Non-Section 423 Component. The Section 423 Component is intended to qual

First Amendment to Severance Agreement and Change in Control Agreement, by and between the Registrant and Timothy Kieffer, Ph.D. (to be in effect upon the effectiveness of this registration statement).

Exhibit 10.12 FIRST AMENDMENT TO SEVERANCE AGREEMENT AND CHANGE IN CONTROL AGREEMENT THIS AMENDMENT TO SEVERANCE AGREEMENT AND CHANGE IN CONTROL AGREEMENT (this “Amendment”) is entered into by and between Fractyl Health, Inc. (the “Company”), and Tim Kieffer (the “Executive”) and will become effective, if at all, as of the date of the Company’s initial public offering of stock (“IPO”) pursuant to

Offer Letter, dated September 12, 2023, by and between Fractyl Health, Inc. and Timothy Kieffer, Ph.D.

Exhibit 10.9 Tim Kieffer Delivered by email September 12, 2023 Dear Tim: On behalf of Fractyl Health, Inc. (the “Company”), I am pleased to offer you the position of Chief Scientific Officer, contingent upon the successful completion of reference and background checks as applicable. Your anticipated start date is on or about September 12, 2023 (“Start Date”). In this position, you will report to H

Fractyl Health, Inc. Non-Employee Director Compensation Program.

Exhibit 10.17 FRACTYL HEALTH, INC. NON-EMPLOYEE DIRECTOR COMPENSATION PROGRAM Non-employee members of the board of directors (the “Board”) of Fractyl Health, Inc. (the “Company”) shall receive cash and equity compensation as set forth in this Non-Employee Director Compensation Program (this “Program”). The cash and equity compensation described in this Program shall be paid or be made, as applicab

Severance Agreement and Change in Control Agreement, dated September 12, 2023, by and between Fractyl Health, Inc. and Timothy Kieffer, Ph.D.

Exhibit 10.11 FRACTYL HEALTH, INC. SEVERANCE AGREEMENT AND CHANGE IN CONTROL AGREEMENT This Severance Agreement and Change in Control Agreement (the “Agreement”) is made and entered into by and between Timothy Kieffer (“Employee”) and Fractyl Health, Inc. (the “Company”), effective as of the latest date set forth by the signatures of the parties hereto below (the “Effective Date”). R E C I T A L S

Credit Agreement and Guaranty, dated September 7, 2023, by and among the Registrant, Symbiotic Capital Opportunities Holding, L.P. and Catalio Structured Opportunities AIV LLP.

Exhibit 10.1 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. CREDIT AGREEMENT AND GUARANTY dated as of September 7, 2023 by and among FRACTYL HEALTH, INC., as the Borrower, THE SUBSIDIARY GUARANTORS FROM TIME TO TIME PA

Second Amendment to Credit Agreement and Guaranty, dated December 9, 2023, by and among Fractyl Health, Inc., Symbiotic Capital Opportunities Holding, L.P. and Symbiotic Capital Agency LLC.

Exhibit 10.3 SECOND AMENDMENT TO CREDIT AGREEMENT AND GUARANTY This SECOND AMENDMENT TO CREDIT AGREEMENT AND GUARANTY (this “Amendment”) is entered into as of December 9, 2023, by and among FRACTYL HEALTH, INC., a Delaware corporation (the “Borrower”), the lenders party hereto, and SYMBIOTIC CAPITAL AGENCY LLC, as administrative agent for the Lenders (in such capacity, the “Administrative Agent”).

Fractyl Health, Inc. Amended and Restated 2011 Stock Incentive Plan and forms of award agreements thereunder.

Exhibit 10.4 Fractyl Health, Inc. 2011 Stock Incentive Plan (as amended and restated June 9, 2021) 1. Purpose The purpose of this 2011 Stock Incentive Plan (the “Plan”) of Fractyl Health, Inc., a Delaware corporation (the “Company”), is to advance the interests of the Company’s stockholders by enhancing the Company’s ability to attract, retain and motivate persons who are expected to make importan

Lease Agreement, dated August 10, 2022, by and between Fractyl Health, Inc. (f/k/a Fractyl Laboratories, Inc.) and BP 17 Hartwell LLC.

Exhibit 10.11 LEASE by and between 3 VDG Owner LLC, a Delaware limited liability company and Fractyl Health, Inc., a Delaware corporation Table of Contents 1. Lease of Premises 1 2. Basic Lease Provisions 3 3. Term 6 4. Tenant’s Improvements 6 5. Condition of Premises 7 6. Reserved 7 7. Rent 7 8. Rent Adjustments 8 9. Operating Expenses 9 10. Taxes on Tenant’s Property 13 11. Security Deposit 13 1

As filed with the Securities and Exchange Commission on December 14, 2023.

Table of Contents Index to Financial Statements As filed with the Securities and Exchange Commission on December 14, 2023.

Fifth Amended and Restated Investors’ Rights Agreement, dated June 9, 2021, by and among Fractyl Health, Inc. and certain of its stockholders.

Exhibit 4.2 Execution Version FIFTH AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT THIS FIFTH AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT (this “Agreement”) is made as of June 9th, 2021 by and among Fractyl Health, Inc., a Delaware corporation (the “Company”), and each of the investors listed on Schedule A hereto, each of which is referred to in this Agreement as an “Investor,” and any Addi

Form of Indemnification Agreement by and among the Registrant and its directors and officers.

Exhibit 10.15 FRACTYL HEALTH, INC. INDEMNIFICATION AGREEMENT THIS INDEMNIFICATION AGREEMENT (the “Agreement”) is made and entered into as of , 2023 between Fractyl Health, Inc., a Delaware corporation (the “Company”), and [Name] (“Indemnitee”). WITNESSETH THAT: WHEREAS, highly competent persons have become more reluctant to serve corporations as directors, officers or in other capacities unless th

Bylaws of the Registrant (currently in effect).

Exhibit 3.2 AMENDED AND RESTATED BYLAWS OF FRACTYL LABORATORIES INC. (a Delaware corporation) TABLE OF CONTENTS Page ARTICLE I—CORPORATE OFFICES 1 1.1 REGISTERED OFFICE 1 1.2 OTHER OFFICES 1 ARTICLE II—MEETINGS OF STOCKHOLDERS 1 2.1 PLACE OF MEETINGS 1 2.2 ANNUAL MEETING 1 2.3 SPECIAL MEETING 1 2.4 ADVANCE NOTICE PROCEDURES FOR BUSINESS BROUGHT BEFORE A MEETING 2 2.5 ADVANCE NOTICE PROCEDURES FOR

List of Subsidiaries

Exhibit 21.1 Subsidiaries of Fractyl Health, Inc. Subsidiary Jurisdiction Fractyl Laboratories Ltd. United Kingdom Fractyl Securities Corporation Massachusetts

1271 Avenue of the Americas

1271 Avenue of the Americas New York, New York 10020-1401 Tel: +1.212.906.1200 Fax: +1.212.751.4864 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh December 14, 2023 Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo Los Angeles Was

Lease Agreement, dated November 17, 2015, by and between the Registrant (f/k/a Fractyl Laboratories, Inc.) and BP 17 Hartwell LLC.

Exhibit 10.10 LEASE 17 HARTWELL AVENUE LEXINGTON, MASSACHUSETTS Lease Dated November 17, 2015 THIS INSTRUMENT IS AN INDENTURE OF LEASE in which the Landlord and the Tenant are the parties hereinafter named, and which relates to space in a certain building (the “Building”) known as, and with an address at, 17 Hartwell Avenue, Lexington, Massachusetts 02421. The parties to this Indenture of Lease he

First Amendment to Credit Agreement and Guaranty, dated October 16, 2023, by and among the Fractyl Health, Inc., Symbiotic Capital Opportunities Holding, L.P. and Symbiotic Capital Agency LLC.

Exhibit 10.2 FIRST AMENDMENT TO CREDIT AGREEMENT AND GUARANTY This FIRST AMENDMENT TO CREDIT AGREEMENT AND GUARANTY (this “Amendment”) is entered into as of October 16, 2023, by and among FRACTYL HEALTH, INC., a Delaware corporation (the “Borrower”), the lenders party hereto, and SYMBIOTIC CAPITAL AGENCY LLC, as administrative agent for the Lenders (in such capacity, the “Administrative Agent”). R

Specimen Stock Certificate evidencing the shares of common stock.

Exhibit 4.1 FH INCORPORATED UNDER THE CUSIP 000000 00 0 LAWS OF THE STATE SEE REVERSE FOR CERTAIN OF DELAWARE DEFINITIONS AND LEGENDS This certifies that BY: AMERICAN COUNTERSIGNED is the record holder of STOCK AND FULLY PAID AND NONASSESSABLE SHARES OF COMMON STOCK, $0.00001 PAR VALUE PER SHARE, OF (BROOKLYN, FRACTYL HEALTH, INC. TRANSFER transferable on the books of the Corporation in person or

Amended and Restated Certificate of Incorporation of the Registrant (as amended and currently in effect).

Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF FRACTYL LABORATORIES INC. (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware) Fractyl Laboratories Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), DOES HEREBY CERTIFY: 1. Tha

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Tables Form S-1 (Form Type) FRACTYL HEALTH, INC.

September 21, 2023

September 21, 2023 VIA EDGAR Division of Corporation Finance Office of Life Sciences U.

As confidentially submitted to the Securities and Exchange Commission on September 21, 2023.

Table of Contents As confidentially submitted to the Securities and Exchange Commission on September 21, 2023.

As confidentially submitted to the Securities and Exchange Commission on August 22, 2023.

Table of Contents As confidentially submitted to the Securities and Exchange Commission on August 22, 2023.

As confidentially submitted to the Securities and Exchange Commission on April 4, 2022.

Table of Contents As confidentially submitted to the Securities and Exchange Commission on April 4, 2022.

AMENDED AND RESTATED CERTIFICATE OF INCORPORATION FRACTYL LABORATORIES INC. (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware)

Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF FRACTYL LABORATORIES INC. (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware) Fractyl Laboratories Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), DOES HEREBY CERTIFY: 1. Tha

AMENDED AND RESTATED FRACTYL LABORATORIES INC. (a Delaware corporation)

Exhibit 3.2 AMENDED AND RESTATED BYLAWS OF FRACTYL LABORATORIES INC. (a Delaware corporation) TABLE OF CONTENTS Page ARTICLE I—CORPORATE OFFICES 1 1.1 REGISTERED OFFICE 1 1.2 OTHER OFFICES 1 ARTICLE II—MEETINGS OF STOCKHOLDERS 1 2.1 PLACE OF MEETINGS 1 2.2 ANNUAL MEETING 1 2.3 SPECIAL MEETING 1 2.4 ADVANCE NOTICE PROCEDURES FOR BUSINESS BROUGHT BEFORE A MEETING 2 2.5 ADVANCE NOTICE PROCEDURES FOR

FIFTH AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT

Exhibit 4.2 Execution Version FIFTH AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT THIS FIFTH AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT (this “Agreement”) is made as of June 9th, 2021 by and among Fractyl Health, Inc., a Delaware corporation (the “Company”), and each of the investors listed on Schedule A hereto, each of which is referred to in this Agreement as an “Investor,” and any Addi

Fractyl Health, Inc. 2011 Stock Incentive Plan (as amended and restated June 9, 2021)

Exhibit 10.1 Fractyl Health, Inc. 2011 Stock Incentive Plan (as amended and restated June 9, 2021) 1. Purpose The purpose of this 2011 Stock Incentive Plan (the “Plan”) of Fractyl Health, Inc., a Delaware corporation (the “Company”), is to advance the interests of the Company’s stockholders by enhancing the Company’s ability to attract, retain and motivate persons who are expected to make importan

Subsidiaries of Fractyl Health, Inc. Subsidiary Jurisdiction Fractyl Laboratories Ltd. United Kingdom Fractyl Securities Corporation Massachusetts

Exhibit 21.1 Subsidiaries of Fractyl Health, Inc. Subsidiary Jurisdiction Fractyl Laboratories Ltd. United Kingdom Fractyl Securities Corporation Massachusetts

LEASE 17 HARTWELL AVENUE LEXINGTON, MASSACHUSETTS Lease Dated November 17, 2015

Exhibit 10.6 LEASE 17 HARTWELL AVENUE LEXINGTON, MASSACHUSETTS Lease Dated November 17, 2015 THIS INSTRUMENT IS AN INDENTURE OF LEASE in which the Landlord and the Tenant are the parties hereinafter named, and which relates to space in a certain building (the “Building”) known as, and with an address at, 17 Hartwell Avenue, Lexington, Massachusetts 02421. The parties to this Indenture of Lease her

1271 Avenue of the Americas

1271 Avenue of the Americas New York, New York 10020-1401 Tel: +1.212.906.1200 Fax: +1.212.751.4864 www.lw.com FIRM / AFFILIATE OFFICES Austin Moscow Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Shanghai Hong Kong Silicon Valley Houston Singapore London Tel Aviv Los Angeles Tokyo Madrid Wash

As confidentially submitted to the Securities and Exchange Commission on February 3, 2022.

Table of Contents As confidentially submitted to the Securities and Exchange Commission on February 3, 2022.

FRACTYL HEALTH, INC. INDEMNIFICATION AGREEMENT

Exhibit 10.10 FRACTYL HEALTH, INC. INDEMNIFICATION AGREEMENT THIS INDEMNIFICATION AGREEMENT (the “Agreement”) is made and entered into as of , 2022 between Fractyl Health, Inc., a Delaware corporation (the “Company”), and [Name] (“Indemnitee”). WITNESSETH THAT: WHEREAS, highly competent persons have become more reluctant to serve corporations as directors, officers or in other capacities unless th

FH INCORPORATED UNDER THE CUSIP 000000 00 0 LAWS OF THE STATE SEE REVERSE FOR CERTAIN OF DELAWARE DEFINITIONS AND LEGENDS This certifies that BY: AMERICAN COUNTERSIGNED is the record holder of STOCK AND FULLY PAID AND NONASSESSABLE SHARES OF COMMON S

Exhibit 4.1 FH INCORPORATED UNDER THE CUSIP 000000 00 0 LAWS OF THE STATE SEE REVERSE FOR CERTAIN OF DELAWARE DEFINITIONS AND LEGENDS This certifies that BY: AMERICAN COUNTERSIGNED is the record holder of STOCK AND FULLY PAID AND NONASSESSABLE SHARES OF COMMON STOCK, $0.00001 PAR VALUE PER SHARE, OF (BROOKLYN, FRACTYL HEALTH, INC. TRANSFER transferable on the books of the Corporation in person or

As confidentially submitted to the Securities and Exchange Commission on January 11, 2022.

Table of Contents As confidentially submitted to the Securities and Exchange Commission on January 11, 2022.

FIFTH AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT

Exhibit 4.2 Execution Version FIFTH AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT THIS FIFTH AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT (this “Agreement”) is made as of June 9th, 2021 by and among Fractyl Health, Inc., a Delaware corporation (the “Company”), and each of the investors listed on Schedule A hereto, each of which is referred to in this Agreement as an “Investor,” and any Addi

Subsidiaries of Fractyl Health, Inc. Subsidiary Jurisdiction Fractyl Laboratories Ltd. United Kingdom Fractyl Securities Corporation Massachusetts

Exhibit 21.1 Subsidiaries of Fractyl Health, Inc. Subsidiary Jurisdiction Fractyl Laboratories Ltd. United Kingdom Fractyl Securities Corporation Massachusetts

LEASE 17 HARTWELL AVENUE LEXINGTON, MASSACHUSETTS Lease Dated November 17, 2015

Exhibit 10.6 LEASE 17 HARTWELL AVENUE LEXINGTON, MASSACHUSETTS Lease Dated November 17, 2015 THIS INSTRUMENT IS AN INDENTURE OF LEASE in which the Landlord and the Tenant are the parties hereinafter named, and which relates to space in a certain building (the “Building”) known as, and with an address at, 17 Hartwell Avenue, Lexington, Massachusetts 02421. The parties to this Indenture of Lease her

AMENDED AND RESTATED CERTIFICATE OF INCORPORATION FRACTYL LABORATORIES INC. (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware)

Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF FRACTYL LABORATORIES INC. (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware) Fractyl Laboratories Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), DOES HEREBY CERTIFY: 1. Tha

FH INCORPORATED UNDER THE CUSIP 000000 00 0 LAWS OF THE STATE SEE REVERSE FOR CERTAIN OF DELAWARE DEFINITIONS AND LEGENDS This certifies that BY: AMERICAN COUNTERSIGNED is the record holder of STOCK AND FULLY PAID AND NONASSESSABLE SHARES OF COMMON S

Exhibit 4.1 FH INCORPORATED UNDER THE CUSIP 000000 00 0 LAWS OF THE STATE SEE REVERSE FOR CERTAIN OF DELAWARE DEFINITIONS AND LEGENDS This certifies that BY: AMERICAN COUNTERSIGNED is the record holder of STOCK AND FULLY PAID AND NONASSESSABLE SHARES OF COMMON STOCK, $0.00001 PAR VALUE PER SHARE, OF (BROOKLYN, FRACTYL HEALTH, INC. TRANSFER transferable on the books of the Corporation in person or

Fractyl Health, Inc. 2011 Stock Incentive Plan (as amended and restated June 9, 2021)

Exhibit 10.1 Fractyl Health, Inc. 2011 Stock Incentive Plan (as amended and restated June 9, 2021) 1. Purpose The purpose of this 2011 Stock Incentive Plan (the “Plan”) of Fractyl Health, Inc., a Delaware corporation (the “Company”), is to advance the interests of the Company’s stockholders by enhancing the Company’s ability to attract, retain and motivate persons who are expected to make importan

AMENDED AND RESTATED FRACTYL LABORATORIES INC. (a Delaware corporation)

Exhibit 3.2 AMENDED AND RESTATED BYLAWS OF FRACTYL LABORATORIES INC. (a Delaware corporation) TABLE OF CONTENTS Page ARTICLE I—CORPORATE OFFICES 1 1.1 REGISTERED OFFICE 1 1.2 OTHER OFFICES 1 ARTICLE II—MEETINGS OF STOCKHOLDERS 1 2.1 PLACE OF MEETINGS 1 2.2 ANNUAL MEETING 1 2.3 SPECIAL MEETING 1 2.4 ADVANCE NOTICE PROCEDURES FOR BUSINESS BROUGHT BEFORE A MEETING 2 2.5 ADVANCE NOTICE PROCEDURES FOR

January 11, 2022

January 11, 2022 VIA EDGAR AND KITEWORKS Division of Corporation Finance Office of Life Sciences U.

As confidentially submitted to the Securities and Exchange Commission on December 20, 2021.

Table of Contents As confidentially submitted to the Securities and Exchange Commission on December 20, 2021.

December 20, 2021

December 20, 2021 VIA EDGAR AND HAND DELIVERY Division of Corporation Finance Office of Life Sciences U.

As confidentially submitted to the Securities and Exchange Commission on November 9, 2021.

Table of Contents As confidentially submitted to the Securities and Exchange Commission on November 9, 2021.