View:
United States securities and exchange commission logo
June 11, 2020
James McCullough
Chief Executive Officer
Renalytix AI plc
Avon House 19 Stanwell Road
Penarth, Cardiff CF64 2EZ
United Kingdom
Re: Renalytix AI plc
Draft Registration
Statement on Form F-1
Filed May 15, 2020
CIK No. 0001811115
Dear Mr. McCullough:
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.
DRS of Form F-1
Prospectus Summary
Overview, page 1
1. Please remove the
characterization of your company as "commercial-stage" given that you
have yet to
commercialize any product candidates.
2. Please revise to
provide the sources for the statistic you cite in the following sentence
concerning the amount
of Medicare spending: "CKD affects approximately 37 million
individuals in the
United States, significantly impacting their quality of life and resulting
in Medicare spending of
over $120 billion per year."
James McCullough
FirstNameAI plc
Renalytix LastNameJames McCullough
Comapany NameRenalytix AI plc
June 11, 2020
June 11, 2020 Page 2
Page 2
FirstName LastName
3. Please clarify here and throughout your prospectus, if your $12
billion initial launch
market opportunity estimate is based on "patients 21 years of age or
older with earlier
stage DKD (Stages 1 through 3)." It appears your disclosure that DKD
affecting approximately 12.6 million people, may be a more expansive
number than the
population planned for your initial commercial launch.
Implications of being an emerging growth company., page 9
4. 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.
FractalDx spin-off, page 10
5. We note that you may spin off FractalDx in June, 2020. Please advise
us if this spin-off
will involve the distribution of shares, and if so, the consideration
you gave to the
registration requirements of the Securities Act of 1933, and the
Exchange Act of 1934.
Our articles of association to be in effect upon completion of the global
offering will provide that
the U.S. federal district courts,, page 74
6. We note that your proposed forum selection provision in your articles
of association
identifies the federal courts of the United States as the exclusive
forum for the resolution
of any claim arising under the Securities Act of 1933. Please disclose
that there is
uncertainty as to whether a court would enforce such provision. In
that regard, we note
that Section 22 of the Securities Act creates concurrent jurisdiction
for federal and state
courts over all suits brought to enforce any duty or liability created
by the Securities Act
or the rules and regulations thereunder. We note that you describe the
effect of the federal
forum selection provision from the company's perspective. Please
revise your disclosure
to also describe the effect of the amendment on shareholders. For
example, the effects
may include, but are not limited to, these provisions can discourage
claims or limit
investors' ability to bring a claim in a judicial forum that they find
favorable.
Industry and Market Data, page 78
7. Please revise to clarify whether you commissioned any of the
third-party data that you cite
in the prospectus. To the extent that you commissioned any such data,
also provide the
consent of the third-party in accordance with Rule 436.
Use of Proceeds, page 79
8. Please revise at paragraph three to indicate the amount estimated to
be allocated for each
use you identify. Please clarify whether the proceeds allocated for
the "development of the
KidneyIntelIX platform" will be sufficient to obtain FDA clearance for
the platform, or
whether additional sources of funding will be necessary.
James McCullough
Renalytix AI plc
June 11, 2020
Page 3
Management's Discssion and Analysis of Financial Condition and Results of
Operations
Our License Agreements, page 86
9. Please state the date of the last to expire licensed patents under your
Mount Sinai
agreement.
In-licensed intellectual property., page 137
10. With respect to those patents that have been issued, please indicate the
type of patent
protection in each instance, be it composition of matter, use, or
process.
You may contact Jeanne Bennett at 202-551-3606 or Kate Tillan at
202-551-3604 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Paul Fischer at 202-551-3415 or Celeste M. Murphy at 202-551-3257 with
any other
questions.
Sincerely,
FirstName LastNameJames McCullough
Division of
Corporation Finance
Comapany NameRenalytix AI plc
Office of Life
Sciences
June 11, 2020 Page 3
cc: Alison Haggerty, Esq.
FirstName LastName