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United States securities and exchange commission logo
May 14, 2021
Olivier Taelman
Chief Executive Officer
Nyxoah SA
Rue Edouard Belin 12
1435 Mont-Saint-Guibert, Belgium
Re: Nyxoah SA
Draft Registration
Statement on Form F-1
Submitted April 16,
2021
CIK No. 0001857190
Dear Dr. Taelman:
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 April 16, 2021
Cover Page
1. When referencing the
last reported sales price of your ordinary shares on Euronext
Brussels, please
disclose the price as converted into U.S. dollars at the most recent
exchange rate.
Summary
Overview, page 1
2. We note your statement
on page 2: We continue to develop a substantial body of clinical
evidence to demonstrate
the safety and efficacy of the Genio system and your statement
on page 4 referring to
the Genio system as a clinically proven solution. You also refer on
Olivier Taelman
Nyxoah SA
May 14, 2021
Page 2
page 5 to the Genio system being a [s]afe, effective and
patient-centric therapeutic
option that demonstrated compelling safety and effectiveness
data. Please revise these
statements 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 in other
jurisdictions.
3. On page 2 you state: We believe that positive results from this
trial may eliminate the
need for Genio system patients to undergo the DISE procedure prior to
implantation of the
Genio system, thereby leading to a potential indication expansion in
Europe. Please
revise to balance these statements concerning the need to undergo the
DISE
procedure given on page 103 you indicated a different procedure would
still be required
with the Genio system, specifically that a post-surgery sleep study
will need to be
conducted to optimize the Genio system device, or advise.
4. We note your statement on page 3 that you plan to investigate and
provide new
neurostimulation technologies for OSA patients through your
partnership with Vanderbilt
University. Please revise to describe this partnership.
The Genio System Market Opportunity, page 3
5. Please revise page 3 to explain how you calculated an $11 billion
European, Australian
and New Zealand market opportunity and $10 billion US market
opportunity.
Additionally, explain how you estimated non-compliance rates. Lastly,
you state that
approximately 70% of those non-compliant patients are eligible for
hypoglossal nerve
stimulation based on their anatomical characteristics. Please also
revise to explain in the
Summary the anatomical limitations of your device or hypoglossal nerve
stimulation
devices generally.
Use of Proceeds, page 68
6. With respect to the first three bullets on page 68, please revise to
specify an estimate of
how far the proceeds from this offering will allow you to reach with
respect to your
development and commercialization of your Genio program in the various
jurisdictions in
which you seek or have obtained regulatory approval, and the
additional technologies in
your pipeline.
Capitalization, page 70
7. Please revise to provide the information required by Item 3.B of Form
20-F regarding
indebtedness.
Our Competitive
FirstName Strengths, page
LastNameOlivier 90
Taelman
Comapany
8. NameNyxoah
Please revise page SA
90 to explain the significance of receiving CE-Mark
conditional
labeling for
May 14, 2021 Page 2 1.5T and 3T full-body MRI scan.
FirstName LastName
Olivier Taelman
FirstName
Nyxoah SALastNameOlivier Taelman
Comapany
May NameNyxoah SA
14, 2021
May 14,
Page 3 2021 Page 3
FirstName LastName
Clinical Results and Studies, page 103
9. Please revise to provide a brief explanation of the disclosed p-values
and how p-values are
used to measure statistical significance.
10. By presenting your trial results on page 105 and then your competitor
s results on page
106 your disclosure operates as a comparison. Such comparisons are not
permissible
where, as is the case here, these are not head-to-head trials. Please
remove the data from
page 106 showing your competitors trial results.
Business
Manufacturing and Supply, page 110
11. Please provide the sources and names of principal suppliers as
applicable. See Item
101(h)(4)(v) of Regulation S-K.
Intellectual Property, page 111
12. Please revise pages 111-112 to provide the following with respect to
the Cochlear
Collaboration Agreement, the Man & Science SA license agreement and
the Vanderbilt
University license agreement, as applicable:
the nature and scope of intellectual property transferred;
Each parties rights and obligations;
Duration of agreement and duration of royalty term, if any;
Termination provisions;
Up-front or execution payments received or paid;
Aggregate amounts paid or received to date under agreement;
Aggregate future potential milestone payments to be paid or
received, if any;
Royalty rates or a royalty range, if any.
Please also file the Man & Science SA and the Vanderbilt University
license agreements
as exhibits pursuant to Item 601 of Regulation S-K, and ensure all
material contracts are
described as required by Item 10.C of Form 20-F.
13. Please revise page 111 to state the types of patents you own and the
foreign jurisdictions
in which you have granted or pending patent applications.
Principal Shareholders, page 143
14. Please revise your disclosure to identify the natural person or
persons who have voting
and/or investment control of the shares held by Cochlear Investments
Pty Ltd, Gilde
Healthcare, TOGETHER Partnership and Resmed Inc. on page 143.
Olivier Taelman
FirstName
Nyxoah SALastNameOlivier Taelman
Comapany
May NameNyxoah SA
14, 2021
May 14,
Page 4 2021 Page 4
FirstName LastName
Certain Relationships and Related Party Transactions, page 145
15. Here or in the Business section, please clarify whether you have
exclusive access to the
patents covered by the Man & Science SA license agreement in the Sleep
Disordered
Breathing field and define the scope of this field and Shared
Patents.
Description of Share Capital and Articles of Association
Articles of Association and Other Share Information, page 149
16. Please revise to disclose the exclusive forum provision of your
Articles of Association,
and note any enforceability or other concerns associated therewith.
Exhibits
17. Please file your agreement with the Walloon Region.
General
18. 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 Julie Sherman at 202-551-3640 or Kevin Kuhar at
202-551-3662 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Samuel Kluck at 202-551-3233 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: John Rudy, Esq.