Correspondence 0001193125-24-017326 from FRACTYL HEALTH, INC. (GUTS)
FRACTYL HEALTH, INC.
Date: Jan. 29, 2024 · CIK: 0001572616 · Accession: 0001193125-24-017326
AI Filing Summary & Sentiment
File numbers found in text: 333-276046
Referenced dates: December 20, 2023
Letter
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
Washington, D.C.
VIA EDGAR
Madrid
Division of Corporation Finance
Office of Life Sciences
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-6010
Attention:
Tyler Howes
Alan Campbell
Michael Fay
Brian Cascio
Re: Fractyl Health, Inc.
Registration Statement on Form S-1
Filed December 14, 2023
File No. 333-276046
To the addressees set forth above:
On behalf of our client, Fractyl Health, Inc. (the “Company”), set forth below is the Company’s response to the comment of the Staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) in its letter dated December 20, 2023, relating to the Company’s registration statement on Form S-1 filed on December 14, 2023 (the “Registration Statement”).
The Company has filed today Amendment No. 1 to the Registration Statement (“Amendment No. 1”), together with this letter, via EDGAR submission. For convenience of reference, the text of the comment in the Staff’s letter has been reproduced in bold and italics herein. The Company has also provided its response immediately after the comment. Capitalized terms used but not otherwise defined herein have the meanings assigned to such terms in Amendment No. 1.
January 29, 2024
Page 2
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.
Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 1, 101, 122 and 130 of Amendment No. 1.
*********
We hope that the foregoing has been responsive to the Staff’s comment and look forward to resolving any outstanding issues as quickly as possible. Please do not hesitate to contact me at (212) 906-2916 with any questions or further comments you may have regarding this filing or if you wish to discuss the above.
Sincerely,
/s/ Nathan Ajiashvili
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CORRESP 1 filename1.htm CORRESP 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 Washington, D.C. VIA EDGAR Madrid Division of Corporation Finance Office of Life Sciences U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549-6010 Attention: Tyler Howes Alan Campbell Michael Fay Brian Cascio Re: Fractyl Health, Inc. Registration Statement on Form S-1 Filed December 14, 2023 File No. 333-276046 To the addressees set forth above: On behalf of our client, Fractyl Health, Inc. (the “Company”), set forth below is the Company’s response to the comment of the Staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) in its letter dated December 20, 2023, relating to the Company’s registration statement on Form S-1 filed on December 14, 2023 (the “Registration Statement”). The Company has filed today Amendment No. 1 to the Registration Statement (“Amendment No. 1”), together with this letter, via EDGAR submission. For convenience of reference, the text of the comment in the Staff’s letter has been reproduced in bold and italics herein. The Company has also provided its response immediately after the comment. Capitalized terms used but not otherwise defined herein have the meanings assigned to such terms in Amendment No. 1. January 29, 2024 Page 2 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. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 1, 101, 122 and 130 of Amendment No. 1. ********* We hope that the foregoing has been responsive to the Staff’s comment and look forward to resolving any outstanding issues as quickly as possible. Please do not hesitate to contact me at (212) 906-2916 with any questions or further comments you may have regarding this filing or if you wish to discuss the above. Sincerely, /s/ Nathan Ajiashvili Nathan Ajiashvili of LATHAM & WATKINS LLP Enclosures cc: (via e-mail) Harith Rajagopalan, M.D., Ph.D., Chief Executive Officer, Fractyl Health, Inc. Johan Brigham, Latham & Watkins LLP Evan Smith, Latham & Watkins LLP Jonathan Sarna, Latham & Watkins LLP Edwin O’Connor, Goodwin Procter LLP Alicia Tschirhart, Goodwin Procter LLP