View:
United States securities and exchange commission logo
December 9, 2020
Berndt Modig
Chief Executive Officer
Pharvaris, B.V.
J.H. Oortweg 21
2333 CH Leiden, The Netherlands
Re: Pharvaris, B.V.
Draft Registration
Statement on Form F-1
Submitted November
12, 2020
CIK No. 0001830487
Dear Mr. Modig:
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 F-1 submitted November 12, 2020
Market and Industry Data, page ii
1. Your statement that you
have not independently verified third-party market and industry
information may imply
an inappropriate disclaimer of responsibility with respect to the
third party
information. Please either delete the statement or specifically state that you
are
liable for such
information.
Prospectus Summary
Overview, page 1
2. Here and elsewhere
throughout your prospectus you refer to your product candidate,
PHA121, as being
"highly potent," "a potent antagonist" and a "potent and selective
Berndt Modig
FirstName LastNameBerndt Modig
Pharvaris, B.V.
Comapany9,
December NamePharvaris,
2020 B.V.
December
Page 2 9, 2020 Page 2
FirstName LastName
treatment for acute HAE." Given the stage of your product development,
it appears
premature to describe your product candidates as potent, which implies
they are effective.
Similarly, we note your reference to your product candidates'
"anticipated therapeutic
profile." Please revise your disclosure to remove such statements
throughout your
prospectus.
3. We refer to the comparisons here and elsewhere in your prospectus
where you state
that: "PHA121 was shown to be consistently 25-fold more potent than
icatibant on a molar
basis," "more potent than icatibant," "observed greater potency for
PHA121 compared to
icatibant," and "observed that PHA121 was more potent in blocking the
effects of BK in
humans than icatibant, when comparing the PHA121 results of the trial
to published data
on icatibant." Please remove these comparisons as they do not appear
to be based on
a head-to-head studies or tell us why you believe such comparisons are
appropriate.
4. We note your disclosure in this section and in the Business section
that you plan to initiate
a "pivotal" trial in the on-demand setting following your planned
RAPIDe-1 trial. Please
revise the disclosure in these sections to make it clear that even if
you receive positive
data from RAPIDe-1 trial, the U.S. Food and Drug Administration (FDA)
or other
regulators may require you to conduct additional trials.
5. Please place your discussion of the bradykinin challenge in
appropriate context with
reference to your limited trial data to date and indicate that you
have not yet conducted a
Phase 2 study. Additionally, we note your disclosure on page 3 that
you expect your
planned trials of PHVS416 and PHVS719 will support a regulatory
application for
PHVS719 in prophylaxis for HAE. Please remove this disclosure as it is
premature and
speculative given the current stage of development.
Differentiation of PHA121, page 3
6. We note your statements here and throughout your document that your
product candidates
are designed or have the potential to be "best-in-class." This term
suggests that the product
candidate is effective and likely to be approved. Please delete these
references throughout
your registration statement. If your use of this term was intended to
convey your belief
that the product is based on a novel technology or approach and/or is
further along in the
development process, you may discuss how your technology differs from
technology used
by competitors and, if applicable, that you are not aware of competing
products that are
further along in the development process. Statements such as these
should be
accompanied by cautionary language that the statements are not
intended to give any
indication that the product candidate has been proven effective or
that it will receive
regulatory approval.
Our Pipeline, page 4
7. Please revise the pipeline table on page 4, which also appears on page
91, so that it
reflects the current status of your product candidates. For example,
we note your
disclosure on page 97 that you still have ongoing and planned Phase 1
studies for your
Berndt Modig
FirstName LastNameBerndt Modig
Pharvaris, B.V.
Comapany9,
December NamePharvaris,
2020 B.V.
December
Page 3 9, 2020 Page 3
FirstName LastName
product candidate, such that it does not appear that you have
completed your Phase 1
studies. In addition, we note your disclosure on page 103 that you
plan to conduct a Phase
1 bridging study in 2021 for PHVS719 and that you only have a
"prototype formulation
for extended release." Accordingly, please remove the dashed box from
your pipeline
chart for PHVS719.
Recent Developments
COVID-19, page 6
8. We note your disclosure that the COVID-19 pandemic caused you to
experience a delay
in enrollment in your Phase 1 study of PHA121. Please revise to
discuss in greater detail
the extent of the delay and also disclose if any of your other
clinical trials have been
affected. Please also revise any associated risk factors to
specifically discuss the impact
COVID-19 has actually had on your clinical trials to date given the
amount of time that
has passed since the initial outbreak.
Implications of Being an Emerging Growth Company and a Foreign Private
Issuer, page 9
9. 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
10. Please update your risk factor disclosure by relocating risks that
could apply generally to
any company or offering of securities to the end of the risk factor
section under the
caption General Risk Factors. Refer to Item 105 of Regulation
S-K and
SEC Release Nos. 33-10825; 34-89670.
Use of Proceeds, page 67
11. We note your disclosure that you intend to use a portion of the net
proceeds to fund the
clinical development of PHVS416 and PHVS719. Please revise to specify
how far in the
clinical development of the associated product candidates you expect
to reach with the net
proceeds. In this regard, we note that you have a number of clinical
trials planned for the
associated product candidates. Also, to the extent material amounts of
other funds are
necessary to accomplish your specified purposes, state the amounts of
such other funds
and the sources thereof.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Estimates and Judgments
Share-Based Payments, page 85
12. 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
Berndt Modig
FirstName LastNameBerndt Modig
Pharvaris, B.V.
Comapany9,
December NamePharvaris,
2020 B.V.
December
Page 4 9, 2020 Page 4
FirstName LastName
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.
Business
Current Treatments and Their Limitations, page 94
13. We note your disclosure that "four other angioedema-specific oral
medications for acute,
as well as prophylactic, use are in clinical development." Please
provide additional
disclosure about these potential competitors, including the stage of
development.
PHA121
Overview, page 95
14. We note your statement here that "PHA121 showed efficacy and clear
dose-dependent
activity." You also state on page 97 that, "PHA121 was safe and well
tolerated when
administered orally up to single doses of 22 mg." Please revise these
and all 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.
15. We note your disclosure that "PHA121 demonstrated longer duration and
faster onset of
activity than injected icatibant in the same study." Please expand
your disclosure to
describe the icatibant study, including who completed the study, how
the 0.6 mg/kg dose
of icatibant compares to the doses depicted in PHA121, and discuss the
vehicle in the
icatibant study. To the extent the icatibant study is not a
head-to-head study please remove
this disclosure or tell us why you believe your comparison is
appropriate.
16. The graphic provided on the bottom of page 95 contains text that is
illegible. Please revise
this figure accordingly. In addition, the graphic contains
abbreviations such as "HMWK"
that are not defined. Please define abbreviations in all graphics here
and
elsewhere. Additionally, all graphics throughout the prospectus should
be accompanied
by narrative disclosure that clearly explains the context for the
graphic.
Bradykinin Challenge Study, page 98
17. We note your comparison of the results of PHA121 observed in your
Bradykinin
Challenge Study to published reports of clinical trial data for
icatibant as well as your
related predictions on page 2. As these comparisons are not based on
head-to-head studies,
please tell us why you believe it is appropriate to include them.
Address in your response
whether you expect to be able to rely on such comparisons to support
an application for
marketing approval.
Berndt Modig
FirstName LastNameBerndt Modig
Pharvaris, B.V.
Comapany9,
December NamePharvaris,
2020 B.V.
December
Page 5 9, 2020 Page 5
FirstName LastName
PHA121-C002 (SAD extension), page 100
18. We note your disclosure regarding the occurrence of treatment-related
adverse events
related to PHA121. Please expand your disclosure to provide the number
of patients who
experienced each such treatment-related adverse event.
Intellectual Property, page 104
19. Please expand your disclosure to clarify the patent term for your sole
granted U.S. patent
for PHA121. In addition, please identify the material jurisdictions
that are included in
your "27 pending non-U.S. applications."
Corporate Structure, page 127
20. In order to provide appropriate context for your disclosure, please
revise to include an
organizational chart that identifies the significant subsidiaries of
the Company. Refer
to Item 4(a) of Form F-1 and Item 4.C of Form 20-F.
Employees, page 127
21. Please provide a breakdown of each main category of activity and
geographic location for
each of your employees. Refer to Item 4(a) of Form F-1 and Item 6.D of
Form 20-F.
Related Party Transactions, page 140
22. We note your disclosure that you issued shares of Series C preferred
stock in November
2020. Please identify the related parties and describe the related
party interest.
Financial Statements
Note 21. Events After the Reporting Period, page F-26
23. We see from your disclosure herein that you granted 600,000 share
options on January 1,
2020. Please reconcile this disclosure with that on page II-2 that
indicates that 600,000
share options were granted on December 13, 2019.
General
24. At first use, please define abbreviations. For example only, we note
that "DDI," "SAD"
and "GLP" on page 97 and "DBP" on page 99 are not defined at first
use.
Berndt Modig
Pharvaris, B.V.
December 9, 2020
Page 6
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 Christine Westbrook at 202-551-5019
with any other
questions.
Sincerely,
FirstName LastNameBerndt Modig
Division of
Corporation Finance
Comapany NamePharvaris, B.V.
Office of Life
Sciences
December 9, 2020 Page 6
cc: Sophia Hudson, Esq.
FirstName LastName