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SEC Comment Letter 0000000000-22-013585 to Mineralys Therapeutics, Inc. (MLYS) (CIK 0001933414) (MLYS)

Mineralys Therapeutics, Inc. (MLYS) (CIK 0001933414)
Date: Dec. 16, 2022 · CIK: 0001933414 · Accession: 0000000000-22-013585

AI Filing Summary & Sentiment

Date
December 16, 2022
Author
Not clearly detected
Form
UPLOAD
Company
Mineralys Therapeutics, Inc. (MLYS) (CIK 0001933414)

Letter

United States securities and exchange commission logo December 16, 2022 Jon Congleton Chief Executive Officer Mineralys Therapeutics, Inc. 150 N. Radnor Chester Road, Suite F200 Radnor, PA 19087 Re:Mineralys Therapeutics, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted December 7, 2022 CIK No. 0001933414 Dear Jon Congleton: We have reviewed your amended draft registration statement and have the following comment. In our comment, 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 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 the comment and your amended draft registration statement or filed registration statement, we may have additional comments. Amendment No. 1 to Draft Registration Statement on Form S-1 Business Phase 1 Clinical Trial Results, page 107 1.We note your response to our prior comment 4 and the added reference to your open IND. Please further revise your disclosure to clarify when the IND was submitted and accepted by the FDA, and briefly disclose any interactions the company has had with the FDA in relation to its trials.

FirstName LastNameJon Congleton Comapany NameMineralys Therapeutics, Inc. December 16, 2022 Page 2 FirstName LastName Jon Congleton Mineralys Therapeutics, Inc. December 16, 2022 Page 2 You may contact Garry Newberry at 202-551-3761 or Angela Connell at 202-551-3426 if you have questions regarding comments on the financial statements and related matters. Please contact Doris Stacey Gama at 202-551-3188 or Laura Crotty at 202-551-7614 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Matt Bush, Esq.

Show Raw Text
United States securities and exchange commission logo
December 16, 2022
Jon Congleton
Chief Executive Officer
Mineralys Therapeutics, Inc.
150 N. Radnor Chester Road, Suite F200
Radnor, PA 19087
Re:Mineralys Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted December 7, 2022
CIK No. 0001933414
Dear Jon Congleton:
            We have reviewed your amended draft registration statement and have the following
comment.  In our comment, 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 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 the comment and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1
Business
Phase 1 Clinical Trial Results, page 107
1.We note your response to our prior comment 4 and the added reference to your open IND.
Please further revise your disclosure to clarify when the IND was submitted and accepted
by the FDA, and briefly disclose any interactions the company has had with the FDA in
relation to its trials.

 FirstName LastNameJon Congleton
 Comapany NameMineralys Therapeutics, Inc.
 December 16, 2022 Page 2
 FirstName LastName
Jon Congleton
Mineralys Therapeutics, Inc.
December 16, 2022
Page 2
            You may contact Garry Newberry at 202-551-3761 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters.  Please
contact Doris Stacey Gama at 202-551-3188 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Matt Bush, Esq.