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December 1, 2022
Jon Congleton
Chief Executive Officer
Mineralys Therapeutics, Inc.
150 N. Radnor Chester Road, Suite F200
Radnor, PA 19087
Re:Mineralys Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted November 4, 2022
CIK No. 0001933414
Dear Jon Congleton:
            We have reviewed your 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.
Draft Registration Statement on Form S-1 filed November 4, 2022
Cover Page
1.Please disclose whether your offering is contingent upon final approval of your NASDAQ
listing on your cover page. Please ensure the disclosure is consistent with your
underwriting agreements.
Prospectus Summary
Overview, page 2
2.We note your references to your Phase 2 clinical trial evaluating subjects with uHTN and
rHTN where MLS-101 was well tolerated with "favorable safety data". Please revise the
references to "favorable safety data", here and throughout the prospectus, as such phrase

 FirstName LastNameJon Congleton
 Comapany NameMineralys Therapeutics, Inc.
 December 1, 2022 Page 2
 FirstName LastNameJon Congleton
Mineralys Therapeutics, Inc.
December 1, 2022
Page 2
implies a conclusion regarding safety of the product candidate, which determination is
within the sole authority of the FDA and comparable foreign regulators.
3.You state that multiple large-scale studies have demonstrated that patients who fail to
achieve their BP goal have a significantly elevated risk of developing heart disease,
stroke, and kidney disease. Please revise your disclosure to cite the referenced studies,
where appropriate.
Our Product Candidate, MLS-101, page 3
4.We note your statement that Mitsubishi Tanabe Pharmaceutical Company
progressed MLS-101 through Phase 1 clinical development. Please add footnotes to your
pipeline table to show which columns relate to work conducted by the company and
which relate to the work of Mitsubishi Tanabe. In addition, please disclose where
Mitsubishi Tanabe conducted the Phase 1 clinical trial and discuss, where appropriate, any
interaction the company has had with the FDA regarding its ability to rely on such trial
data in the event the trial was not conducted in the United States.
5.You state that you intend to use the observations from MLS-101's complete Phase 1 trial
in healthy volunteers and Phase 2 in uHTN and rHTN to inform the development of MLS-
101 in uHTN related to obesity and obstructive sleep apnea. You also state that you intend
to develop MLS-101 for the treatment of chronic kidney disease. We note that your
pipeline table shows completion of Phase 1 for both the use of MLS-101 in uHTN related
to obesity and obstructive sleep apnea and chronic kidney disease. Please revise your
disclosure to clearly state, if true, that you may rely on the Phase 1 data obtained by
Mitsubishi Tanabe for these additional indications.
6.We note the use of p-values on page 4. At first use, please explain how "p-value" is used
to measure statistical significance and the relevance of statistical significance to the FDA's
evidentiary standards for drug approval.
Our Team and Investors, page 5
7.Please limit the disclosure of specific investors to those identified in the Principal
Shareholder table on page 144.  Additionally, indicate that prospective investors should
not rely on the named investors’ investment decision, that these investors may have
different risk tolerances and the recent offering was conducted as a significant discount to
the IPO price.

Summary of Risks Associated with Our Business, page 6
8.We note your summarized risk factor regarding your exclusive license with Mitsubishi
Tanabe, which if terminated would cause you to lose the right to develop and
commercialize MLS-101. Please also include the effects this would have on the business
as you have done on page 24.

 FirstName LastNameJon Congleton
 Comapany NameMineralys Therapeutics, Inc.
 December 1, 2022 Page 3
 FirstName LastName
Jon Congleton
Mineralys Therapeutics, Inc.
December 1, 2022
Page 3
Implications of Being an Emerging Growth Company, page 7
9.Your disclosure here and on the cover page indicates that you have elected not to avail
yourselves of the extended transition period for complying with new or revised accounting
standards. Your risk factor disclosure on page 67, discussion of the JOBS Act on page 90,
and Emerging Growth Company status on page F-8, however, indicates the opposite.
Please revise to address this apparent inconsistency.
Risk Factors
We intend to conduct some of our clinical trials for MLS-101 outside of the United States...,
page 22
10.We note the above listed risk factor. Please revise your disclosure to indicate the countries
in which you intend to conduct clinical trials and discuss whether or not the equivalency
standards that you reference in this risk factor will be implicated.
Use of Proceeds, page 75
11.We note your statement that you will require substantial additional capital in order to
advance MLS-101 through clinical trials, regulatory approval and commercialization. In
accordance with Item 504 of Regulation S-K, please revise your disclosure on page 75 to
clarify where the company intends to obtain such additional capital, as you have done on
page 14, or provide an appropriate cross-reference.
Intellectual Property, page 109
12.Please revise your disclosure regarding your patent portfolio to clarify the ownership
status of each patent where referenced. In this regard it may be useful to
provide tabular disclosure.
General
13.Please provide us with supplemental copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
have presented or expect to present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain, copies of those
communications.

 FirstName LastNameJon Congleton
 Comapany NameMineralys Therapeutics, Inc.
 December 1, 2022 Page 4
 FirstName LastName
Jon Congleton
Mineralys Therapeutics, Inc.
December 1, 2022
Page 4
            You may contact Gary 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.