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United States securities and exchange commission logo
January 4, 2021
Berndt Modig
Chief Executive Officer
Pharvaris, B.V.
J.H. Oortweg 21
2333 CH Leiden, The Netherlands
Re: Pharvaris, B.V.
Amendment No. 1 to
Draft Registration
Statement on Form F-1
Submitted December
18, 2020
CIK No. 0001830487
Dear Mr. Modig:
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. 1 to Draft Registration Statement on Form F-1 submitted
December 18, 2020
Prospectus Summary
Overview, page 1
1. We note your revised
disclosure in response to prior comment 2. You continue to describe
your potential product
candidates as "potent," a "potent inhibitor," "potent antagonist" or
"a potent and selective
treatment for acute" HAE" on pages 1, 3, 94, 95 and
elsewhere. Your
disclosure continues to inappropriately indicate your conclusions
regarding the efficacy
of your product candidate by stating that your product candidate
was observed to be
potent. Please delete such references here and throughout your
registration statement.
Berndt Modig
Pharvaris, B.V.
January 4, 2021
Page 2
2. We note your response to our prior comments 3, 15 and 17. Despite your
revised
disclosure, we continue to believe that it is not appropriate for you
to compare PHA121
with icatibant where the trials were not head-to-head. In addition,
statements that your
early-stage product candidate is "more potent" than an FDA approved
drug, such as your
statement, "[PHA121 is] more potent inhibitor than icatibant" and
"PHA121 was shown to
be consistently 25-fold more potent at inhibiting the effects of
administered bradykinin
than icatibant on a molar basis," are inappropriate. Please revise
your disclosure
throughout your prospectus accordingly to remove such comparisons. You
can discuss
your Bradykinin Challenge Study as well as the fact that you believe
it establishes a proof
of concept; however, you should not make comparison statements that
imply that your
product candidate is more effective or more potent than an approved
product candidate
unless the results were derived from a head-to-head study.
Pipeline, page 4
3. We note your response to our prior comment 7 and disagree with your
reasons for
continuing to show that you have completed Phase 1 for PHVS416 in your
pipeline table
given your disclosure elsewhere that you have ongoing Phase 1 studies.
The table should
depict your material product candidates and their current stage of
development. You may
include a narrative discussion regarding the fact that you anticipate
beginning a Phase 2
study prior to the completion of your ongoing Phase 1 studies.
Business, page 88
4. We note your MD&A disclosure that "[i]n 2019, a milestone payment of
300,000 was
paid to a third-party upon commencement of Phase 1 development." In
your Business
section please disclose the material terms of your material
agreements, such as the name
of the third party, potential aggregate milestone payments, expiration
term and termination
provisions related to this agreement. In addition, please file the
agreement as an exhibit or
tell us why you believe such agreement is not required to be filed.
See Item 601(b)(10) of
Regulation S-K.
PHA121
Overview,
FirstName page 100
LastNameBerndt Modig
Comapany
5. NamePharvaris,
We note your revisedB.V.
graphic on page 101 as well as the inclusion of a
legend. However,
Januaryplease include
4, 2021 Page narrative
2 disclosure to explain the graphic on page 101.
FirstName LastName
Berndt Modig
FirstName LastNameBerndt Modig
Pharvaris, B.V.
Comapany
January NamePharvaris, B.V.
4, 2021
January
Page 3 4, 2021 Page 3
FirstName LastName
You may contact Julie Sherman at 202-551-3640 or Kate Tillan at
202-551-3604 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jason L. Drory at 202-551-8342 or Chris Edwards at 202-551-6761 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Sophia Hudson, Esq.