United States securities and exchange commission logo
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
Jon Congleton
FirstName LastNameJonInc.
Congleton
Mineralys Therapeutics,
Comapany1,
December NameMineralys
2022 Therapeutics, Inc.
December
Page 2 1, 2022 Page 2
FirstName LastName
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.
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,
FirstName LastNameJon Congleton
have presented or expect to present to potential investors in reliance
on Section 5(d) of the
Comapany NameMineralys
Securities Therapeutics,
Act, whether Inc.
or not you retained, or intend to retain, copies
of those
communications.
December 1, 2022 Page 3
FirstName LastName
Jon Congleton
FirstName LastNameJonInc.
Congleton
Mineralys Therapeutics,
Comapany1,
December NameMineralys
2022 Therapeutics, Inc.
December
Page 4 1, 2022 Page 4
FirstName LastName
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.