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October 4, 2019
Todd Franklin Watanabe
Chief Executive Officer
Arcutis, Inc.
2945 Townsgate Rd., Suite 110
Westlake Village
CA 91361
Re: Arcutis, Inc.
Draft Registration Statement on Form S-1
Submitted September 9, 2019
CIK No. 0001787306
Dear Mr. Watanabe:
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
Overview, page 1
1. Please expand the disclosure in the discussion of unmet need to clarify
that there are
numerous available therapies for the conditions that you are proposing
to treat. Further,
since conclusions regarding the efficacy and safety of available
treatments are uniquely
within the purview of the FDA, please revise your disclosure throughout
your prospectus
to eliminate conclusory statements regarding safety and efficacy.
2. Please tell us the basis for your statement at the bottom of page 1 that
traditional therapies
"offer inadequate efficacy."
Todd Franklin Watanabe
FirstName LastNameTodd Franklin Watanabe
Arcutis, Inc.
Comapany 2019
October 4, NameArcutis, Inc.
Page 2
October 4, 2019 Page 2
FirstName LastName
3. Please expand your description of "IC50 values" to provide context for
the term. In
addition, please define technical terms and terms of art (e.g.
"hematopoietic adverse
effects," p. 7) where they first appear in the prospectus.
4. We note the inclusion of Vitiligo and Alopecia Areata in the pipeline
table on page 2, and
references to your product candidate ARQ-252 having applications for
hand eczema "and
potentially vitiligo and alopecia areata." Please expand your pipeline
table and your
disclosure to provide more information about the company's progress
with respect to pre-
clinical trials for these applications. If you have undertaken IND
enabling studies,
describe these studies in the disclosure. Alternatively, please delete
these applications
from the pipeline table and throughout your document.
5. Considering your stage of development, tell us the basis for your
belief that your pipeline
of therapeutics will be "best in class in immune-dermatology."
Implications of Being an Emerging Growth Company, page 8
6. Please supplementally provide us with 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,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
Risk Factors, page 14
7. We note that there are references to foreign regulators and foreign
markets throughout the
Risk Factors and other sections of your prospectus. Please revise to
explain what non-US
markets, if any, you plan to enter, and what steps you have taken to
attain the necessary
regulatory and patent approvals.
Use of Proceeds, page 72
8. Please clarify whether you believe the net proceeds of the offer will
be sufficient to
complete the Phase 1 clinical trials for the products disclosed in
your pipeline table, or in
the case of ARQ-151, Phase 2 and 3 clinical trials, and if not, how
far into those trials you
expect the proceeds to last.
Management's Discussion and Analysis of Financial Condition and Results of
Operations, page
82
9. We note your reference on page 82 to "potential collaboration
agreements." Please
confirm that all material information regarding collaboration
agreements and discussions
of such agreements has been disclosed.
Todd Franklin Watanabe
Arcutis, Inc.
October 4, 2019
Page 3
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Use of Estimates
Stock Based Compensation
Common Stock Valuation, page 94
10. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances including stock
compensation and
beneficial conversion features.
Notes to Condensed Financial Statements
6. Related Party Transactions
Hawkeye Collaboration Agreement, page F-44
11. Please revise to disclose the significant terms of the Hawkeye
Collaboration Agreement,
including any upfront payments made or received and any future
milestones or royalties.
General
12. Please provide us mockups of any pages that include any additional
pictures or graphics to
be presented, including any accompanying captions. Please keep in
mind, in scheduling
your printing and distribution of the preliminary prospectus, that we
may have comments
after our review of these materials.
You may contact Christine Torney at 202-551-3652 or Angela Connell at
202-551-3426
if you have questions regarding comments on the financial statements and
related
matters. Please contact Julia Griffith at 202-551-3267 or Dietrich King at
202-551-8071 with
any other questions.
FirstName LastNameTodd Franklin Watanabe Sincerely,
Comapany NameArcutis, Inc.
Division of
Corporation Finance
October 4, 2019 Page 3 Office of Life
Sciences
FirstName LastName