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United States securities and exchange commission logo
July 31, 2020
George Goldsmith
Chief Executive Officer
Compass Rx Ltd.
COMPASS Rx Limited
3rd Floor
1 Ashley Road
Cheshire WA14 2DT
United Kingdom
Re: Compass Rx Ltd.
Draft Registration
Statement on Form F-1
Submitted July 2,
2020
CIK No. 0001816590
Dear Mr. Goldsmith:
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
Overview, page 1
1. We refer to the fourth
sentence under the heading. Please revise to clarify, if true, that
these academic studies
did not involve use of your COMP360 formulation.
2. We note your disclosure
that you observed that COMP360 had no negative effects on
cognitive and emotional
functioning in your Phase I clinical trial. Please disclose what
George Goldsmith
Compass Rx Ltd.
July 31, 2020
Page 2
you mean by "no negative effects" and how that was determined. With
reference to your
disclosure on page 165, also tell us why you believe it is appropriate
to highlight these
positive Phase 1 results without also discussing the two unexpected
serious adverse
reactions observed in your on-going Phase IIb trial.
3. We note your disclosure that you believe that a single dose of your
COMP360
monotherapy with psychological support from specially trained
therapists could
fundamentally change depression care. Please revise the Overview
section to clarify, if
true, that you do not have clinical data concerning your therapy that
would support the
statement.
Risks Associated with Our Business, page 4
4. With reference to your disclosures on pages 20 and 70, please revise
to highlight the risks
that (i) regulatory authorities could require you to generate more
clinical or other data than
you currently anticipate to establish whether or to what extent the
substance has an abuse
potential and (ii) that patent protection for certain methods of
treating drug-resistant
depression with your psilocybin formulation may never be adequately or
sufficiently
protected because the use of psilocybin and psilocin remains illegal.
With reference to
your disclosure on page 93, also revise the Summary to highlight your
belief that you
were a PFIC in 2019 and discuss briefly the attendant risks to
shareholders.
5. Please revise the sixth bullet point on page 5 to clarify briefly the
nature of the
"investigator-initiated" studies you reference and your
role/responsibility, if any, in the
these studies.
6. We note your disclosure on page 33 concerning your belief that the
prior use of other
drugs and therapies may interfere with the mechanism of action or
response to your
investigational COMP360 psilocybin therapy. Please revise the Business
section to
discuss in greater detail the basis for this concern and also
highlight it briefly as a risk in
the Summary section.
Implications of Being an Emerging Growth Company and a Foreign Private Issuer,
page 6
7. 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.
We have broad
FirstName discretion in the
LastNameGeorge use of proceeds..., page 88
Goldsmith
Comapany
8. NameCompass
We note Rx to
the references Ltd.
a global offering on page 88 but do not see
references in any
July 31,other
2020sections
Page 2 of the prospectus. Please advise or revise.
FirstName LastName
George Goldsmith
FirstName LastNameGeorge Goldsmith
Compass Rx Ltd.
Comapany
July NameCompass Rx Ltd.
31, 2020
July 31,
Page 3 2020 Page 3
FirstName LastName
Critical Accounting Policies and Significant Judgments and Estimates
Share-Based Compensation, page 134
9. Once you have an estimated offering price or range, please explain to
us the reasons for
any differences between the recent valuations of your common shares
leading up to the
IPO, the estimated offering price, and the consideration of
convertible preferred
share issuances. This information will help facilitate our review of
your accounting for
stock compensation.
Psilocybin Academic Studies, page 154
10. We note several references to "clinically significant" reductions or
decreases in certain
symptoms as well as a reference to "clinical remission" in this
section. Please revise to
define these terms at first use.
Business
Statistically Significant Decrease in HADS Depression Scores at 26 Weeks Post
Treatment, page
156
11. We note your statement below the chart that closed symbols indicate
significant within-
group differences versus baseline. Please clarify which symbols are
closed in the graph
and provide the range of differences for each closed symbol. Please
provide similar
information for the groups denoted by an asterisk and a cross in the
chart on page 157.
Significant Reduction in Depressive Symptoms Observed up to Three Months Post
Treatment,
page 158
12. We note your disclosure that the data in the chart is from the first
12 patients dosed and
that only 19 of the 20 patients completed the entire follow-up period.
Please tell us
why data for all 19 patients who completed the trial is not disclosed
and, if known, why
one patient did not complete the trial.
Intellectual Property, page 170
13. Please disclose the expiration dates for your patents. Also, please
provide the basis for
your statement that psilocybin is one of the safest psychoactive
substances.
14. Please revise to discuss in greater detail the substance of the
Petition for Post Grant
Review. Also, please identify the party who filed the petition.
Principal Shareholders, page 207
15. Please revise footnote 4 to disclose the names of the other two
Managing Members of the
General Partner of each of The Founders Fund VII, LP, The Founders
Fund VII Principals
Fund, LP and The Founders Fund VII Entrepreneurs Fund, LP.
George Goldsmith
FirstName LastNameGeorge Goldsmith
Compass Rx Ltd.
Comapany
July NameCompass Rx Ltd.
31, 2020
July 31,
Page 4 2020 Page 4
FirstName LastName
Differences in Corporate Law, page 226
16. We note that you refer, in part, to Delaware law and English law. It
is not appropriate to
qualify your disclosure by reference to information that is not
included in the filing or
filed as an exhibit. Please revise accordingly.
You may contact Kristin Lochhead at (202) 551-3664 or Angela Connell at
(202) 551-
3426 if you have questions regarding comments on the financial statements and
related
matters. Please contact Ada Sarmento at (202) 551-3798 or Joe McCann at (202)
551-6262 with
any other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences