SEC Comment Letter 0000000000-23-013915 to FRACTYL HEALTH, INC. (GUTS)
FRACTYL HEALTH, INC.
Date: Dec. 20, 2023 · CIK: 0001572616 · Accession: 0000000000-23-013915
AI Filing Summary & Sentiment
File numbers found in text: 333-276046
Letter
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
FirstName LastNameHarith Rajagopalan, M.D., Ph.D. Comapany NameFractyl Health, Inc. December 20, 2023 Page 2 FirstName LastName 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, 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
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
FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
Comapany NameFractyl Health, Inc.
December 20, 2023 Page 2
FirstName LastName
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,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Nathan Ajiashvili, Esq.