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United States securities and exchange commission logo
January 15, 2021
Berndt Modig
Chief Executive Officer
Pharvaris, B.V.
J.H. Oortweg 21
2333 CH Leiden, The Netherlands
Re: Pharvaris, B.V.
Amendment No. 2 to
Draft Registration
Statement on Form F-1
Submitted January
11, 2021
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.
Draft Registration Statement on Form F-1 submitted January 11, 2021
Prospectus Summary, page 1
1. We note your revised
disclosure in response to prior comments 1 and 2 and your
disclosures that
"[p]otency as used in this prospectus refers to the amount of drug required
to produce a
pharmacological effect of given intensity and is not a measure of therapeutic
efficacy" and that you,
"have not conducted a head-to-head comparison of icatibant or any
other drug candidate to
PHA121 in a clinical trial." Please include clarifying language on
page 3 when you state
your belief that PHVS416 is "More potent inhibitor than icatibant"
and "Longer half-life
than icatibant." Specifically, include disclosure that your beliefs are
not based on
head-to-head studies but on your models and that potency is not a measure of
Berndt Modig
FirstName LastNameBerndt Modig
Pharvaris, B.V.
Comapany
January 15,NamePharvaris,
2021 B.V.
January
Page 2 15, 2021 Page 2
FirstName LastName
efficacy.
Our Pipeline, page 4
2. We note your response to our prior comment 3 and reissue in part. The
pipeline table
should clearly depict your material product candidates and their
current stage of
development. For example, text that reflects upcoming milestones
should not be included
in the "Phase 1" and "Phase 2" columns, but should be in the "Upcoming
Milestone"
column. In addition, please include narrative disclosure here and
elsewhere you include
the pipeline table to make clear that the sole active pharmaceutical
ingredient in PHA121
is the same active pharmaceutical ingredients in PHVS416 and PHVS719
and discuss how
you plan to rely on trial data from PHA121 to advance PHVS416 and
PHVS719. Also, we
note your disclosure on page 1, where you state you "are developing
PHA121 for the on-
demand setting as PHVS416, which is delivered in a soft capsule
designed to rapidly treat
symptoms with a single dose." However, your pipeline table indicates
that you are
developing PHVS416 for both the on-demand and prophylactic treatments
of HAE. Please
revise your pipeline table or otherwise advise.
PHA121, page 101
3. We note your revised statement on page 101 where you state, "PHA121
combines the
preclinical effectiveness and selectivity of bradykinin-B2-receptor
antagonism with oral
bioavailability and extended exposure upon a single dose." Please
revise this
statement and any similar statements throughout your prospectus that
state or imply that
your product candidates are safe or effective as these determinations
are solely within the
authority of the FDA and comparable regulatory bodies.
License Agreement, page 113
4. We note your response to our prior comment 4, including your updated
disclosure on page
113. Please expand your disclosure to (i) identify your product
candidates that are
dependent on the license agreement; (ii) disclose when the latest to
expire patents is
scheduled to expire; (iii) aggregate amounts paid to date under the
license agreement; and
(iv) aggregate potential milestone payments outstanding.
Material United States and Dutch Income Tax Considerations, page 176
5. We note that the tax opinions filed as Exhibit 8.2 and Exhibit 8.1 are
short-form tax
opinions. Please revise the tax disclosure in your tax section to
clearly identify and
articulate the opinion being rendered and state clearly that it is the
opinion of the named
counsel. Please also revise opinion itself to state, if true, that the
statements made in the
prospectus constitute counsel's opinion, as opposed to summaries. For
guidance, refer to
Section III.B of Staff Legal Bulletin No. 19.
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
Berndt Modig
Pharvaris, B.V.
January 15, 2021
Page 3
contact Jason L. Drory at 202-551-8342 or Chris Edwards at 202-551-6761 with
any other
questions.
Sincerely,
FirstName LastNameBerndt Modig
Division of
Corporation Finance
Comapany NamePharvaris, B.V.
Office of Life
Sciences
January 15, 2021 Page 3
cc: Sophia Hudson, Esq.
FirstName LastName