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United States securities and exchange commission logo
May 17, 2021
Theis Terwey, PD, Dr. Med.
Chief Executive Officer
GH Research PLC
28 Baggot Street Lower
Dublin 2
D02 NX43
Ireland
Re: GH Research PLC
Draft Registration
Statement on Form F-1
Submitted April 20,
2021
CIK No. 0001855129
Dear Dr. Terwey:
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
Prospectus Summary, page 1
1. Please disclose that
your GH001 product candidate is delivered via inhalation of aerosols
from a vaporization
device produced by a third-party.
Our Pipeline, page 1
2. Please revise the last
two items under GH001 in your pipeline table to identify the
indications or tell us
why you believe these items are sufficiently material to warrant
inclusion in the table
despite not having identified an indication. The statement that you
Theis Terwey, PD, Dr. Med.
FirstName LastNameTheis Terwey, PD, Dr. Med.
GH Research PLC
Comapany
May NameGH Research PLC
17, 2021
May 17,
Page 2 2021 Page 2
FirstName LastName
will plan to explore additional indications through collaborations
with academic
institutions and commercial contract research organizations, or CROs,
where you appear
not to have yet entered into any material collaborations, suggests
that these are not
currently material and do not warrant disclosure in the chart. Please
also provide similar
disclosure of the indication under GH002. We note that GH002 is in the
preclinical stage
and there is little discussion of GH002 in your submission separate
from the discussion of
GH001.
5-MeO-DMT Mechanism of Action in Psychiatric and Neurological Disorders, page 2
3. We note your statement here that the administration of your product
candidates correlate
with clinical improvement across various psychiatric and neurological
disorders and your
statement on page 130 that the SSG concluded that all single doses
were safe to
administer. Please revise this 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.
Our Market Opportunity, page 2
4. Please disclose the source of your statement that there are an
estimated number of
approximately 48 million MDD patients in the United States and Europe,
of which about
50% receive treatment with pharmacotherapy or pharmacotherapy and
psychotherapy, we
estimate that there are approximately nine million TRD patients in the
United States and
Europe who would be candidates for treatment.
Our 5-MeO-DMT Therapies: GH001 and GH002, page 3
5. Please disclose the percentage of patients in your clinical trials
that experienced at least
one adverse drug reaction, the duration of your clinical trials and
that your clinical trials
were conducted in the Netherlands.
Risk Factors
We depend on third-party suppliers..., page 77
6. Please identify the manufacturer that is the sole supplier of your
vaporization device.
Provisions of our Constitution could delay..., page 93
7. Please revise your statement that a supermajority of the voting power
is required to amend
your constitution to clarify that such an amendment requires the
approval of 75% of the
voting power.
Use of Proceeds, page 100
8. Please revise your disclosure to indicate the portion of proceeds to
be allocated to each
product candidate. Please also disclose how far the funds from this
offer and existing cash
will allow you to proceed with the continued development of each of
your product
Theis Terwey, PD, Dr. Med.
GH Research PLC
May 17, 2021
Page 3
candidates with respect to each indication you are pursuing.
Management's Discussion and Analysis, page 107
Results of Operations, page 111
9. Given your disclosure on page 112 that you expect research and
development costs to
"increase materially in the near future, consistent with our plan to
advance our GH001 and
GH002 product candidates through clinical development", please revise
to disclose costs
by product candidate as well as by the nature of expense for each
period presented. To the
extent that you do not track expenses by product candidate, please
disclose as such.
10. Please revise to disclose the extent to which any stock-based
compensation has been
awarded during 2021 and provide the fair market valuation of each
award. 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 initial
public offering 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. Please discuss with the staff how to
submit your response.
Business
Economic and Societal Burden, page 118
11. Please disclose the source of your statements in this section.
Intellectual Property, page 134
12. Please disclose the jurisdictions in which you have filed your patent
applications and the
specific products, product groups and technologies to which such
patent applications
relate. Also, briefly describe the agreements with third parties you
refer to on page 71
under which you grant or are granted rights to intellectual property.
Management
Equity Incentive Plans, page 160
13. Please file the 2021 equity incentive plan and the employment
agreements with your
executive officers as exhibits to your registration statement. Refer
to Item
601(b)(10)(iii)(A) or advise.
Tax Considerations,
FirstName page 193
LastNameTheis Terwey, PD, Dr. Med.
Comapany
14. NameGH
Please file the Research
consent ofPLC
Davis Polk & Wardwell LLP as an exhibit to
your registration
May 17,statement.
2021 PageFor3 guidance, refer to Section III.A.2 of Staff Legal
Bulletin No. 19.
FirstName LastName
Theis Terwey, PD, Dr. Med.
FirstName LastNameTheis Terwey, PD, Dr. Med.
GH Research PLC
Comapany
May NameGH Research PLC
17, 2021
May 17,
Page 4 2021 Page 4
FirstName LastName
Underwriting, page 200
15. Please disclose the exceptions to the lock-up agreements with your
directors, officers and
existing stockholders.
General
16. 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.
You may contact Jenn Do at 202-551-3743 or Kevin Kuhar at 202-551-3662
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Jeffrey Kauten at 202-551-3447 or Mary Beth Breslin at 202-551-3625 with any
other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Yasin Keshvargar, Esq.