SEC Comment Letter 0000000000-23-010221 to FRACTYL HEALTH, INC. (GUTS)
FRACTYL HEALTH, INC.
Date: Sept. 15, 2023 · CIK: 0001572616 · Accession: 0000000000-23-010221
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United States securities and exchange commission logo
September 15, 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. 5 to Draft Registration Statement on Form S-1
Submitted August 22, 2023
CIK 0001572616
Dear Harith Rajagopalan:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
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 comments apply 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 these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 5 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note your statements here and elsewhere regarding your expected timing to initiate a
first-in-human clinical study of Rejuva. Please remove this disclosure as it appears to be
premature given your disclosure indicates that you have yet to nominate a candidate,
complete preclinical studies and submit an IND for this program.
Our Development Pipeline, page 2
2.Please revise the Revita section of your pipeline table so that the same indication does not
appear twice. In that regard, we note that you have included arrows for both "Germany
FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
Comapany NameFractyl Health, Inc.
September 15, 2023 Page 2
FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
September 15, 2023
Page 2
Real World Registry" and "Insulin-Treated T2D", which appear to be duplicative. Please
also revise your pipeline table with respect to Rejuva to show Phase 1, Phase 2 and Phase
3 columns to clearly represent what development stages must be completed prior to
commercialization of this candidate.
3.Please revise this subsection or elsewhere in the Prospectus Summary, as appropriate, to
disclose why you did not commercially launch Revita in Europe prior to the first half of
2023.
What Sets Us Apart, page 3
4.We note that your disclosure here and elsewhere indicates that your product candidates are
designed to target dysfunction with "one-time" treatments. However, your disclosure
throughout the prospectus also indicates that the Revita system is designed to enable
"repeatable" metabolic improvement. Please reconcile your disclosure.
You may 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.