SEC Comment Letter 0000000000-23-010905 to FRACTYL HEALTH, INC. (GUTS)
FRACTYL HEALTH, INC.
Date: Oct. 3, 2023 · CIK: 0001572616 · Accession: 0000000000-23-010905
AI Filing Summary & Sentiment
Letter
United States securities and exchange commission logo October 3, 2023 Harith Rajagopalan, M.D., Ph.D. Chief Executive Officer Fractyl Health, Inc. 17 Hartwell Avenue Lexington, MA 02421 Re:Fractyl Health, Inc. Amendment No. 6 to Draft Registration Statement on Form S-1 Submitted September 21, 2023 CIK 0001572616 Dear Harith Rajagopalan: We have reviewed your amended draft registration statement and have the following comment. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. 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 the information you provide in response to this letter and your amended draft registration statement or filed registration statement, we may have additional comments. Amendment No. 6 to Draft Registration Statement on Form S-1 Prospectus Summary Our Development Pipeline, page 2 1.We note your response to prior comment 2 and reissue in part. Please further clarify if both the "CE Mark" approval arrow and "Insulin-Treated T2D" arrow are for separate indications. To the extent both both of these arrows are targeting the same indication, revise the Revita section of your pipeline table so that the same indication does not appear twice. 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.
FirstName LastNameHarith Rajagopalan, M.D., Ph.D. Comapany NameFractyl Health, Inc. October 3, 2023 Page 2 FirstName LastName Harith Rajagopalan, M.D., Ph.D. Fractyl Health, Inc. October 3, 2023 Page 2 Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Nathan Ajiashvili, Esq.
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United States securities and exchange commission logo
October 3, 2023
Harith Rajagopalan, M.D., Ph.D.
Chief Executive Officer
Fractyl Health, Inc.
17 Hartwell Avenue
Lexington, MA 02421
Re:Fractyl Health, Inc.
Amendment No. 6 to Draft Registration Statement on Form S-1
Submitted September 21, 2023
CIK 0001572616
Dear Harith Rajagopalan:
We have reviewed your amended draft registration statement and have the following
comment.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. 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 the information you provide in response to this letter and your amended
draft registration statement or filed registration statement, we may have additional comments.
Amendment No. 6 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Development Pipeline, page 2
1.We note your response to prior comment 2 and reissue in part. Please further clarify if
both the "CE Mark" approval arrow and "Insulin-Treated T2D" arrow are for separate
indications. To the extent both both of these arrows are targeting the same
indication, revise the Revita section of your pipeline table so that the same indication does
not appear twice.
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.
FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
Comapany NameFractyl Health, Inc.
October 3, 2023 Page 2
FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
October 3, 2023
Page 2
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Nathan Ajiashvili, Esq.