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Nyxoah SA
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Nyxoah SA
Response Received
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SEC wrote to company
2022-12-29
Nyxoah SA
Summary
UPLOAD · 2022-12-29
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Company responded
2023-01-04
Nyxoah SA
Summary
CORRESP · 2023-01-04
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Nyxoah SA
Response Received
3 company response(s)
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SEC wrote to company
2021-06-22
Nyxoah SA
Summary
UPLOAD · 2021-06-22
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Company responded
2021-06-28
Nyxoah SA
Summary
CORRESP · 2021-06-28
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Company responded
2021-06-28
Nyxoah SA
Summary
CORRESP · 2021-06-28
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Company responded
2021-06-28
Nyxoah SA
Summary
CORRESP · 2021-06-28
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Nyxoah SA
Response Received
1 company response(s)
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SEC wrote to company
2021-06-25
Nyxoah SA
Summary
UPLOAD · 2021-06-25
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Company responded
2021-06-25
Nyxoah SA
References: May 24, 2021
Summary
CORRESP · 2021-06-25
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Nyxoah SA
Response Received
1 company response(s)
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SEC wrote to company
2021-06-08
Nyxoah SA
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UPLOAD · 2021-06-08
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Company responded
2021-06-10
Nyxoah SA
Summary
CORRESP · 2021-06-10
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Nyxoah SA
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SEC wrote to company
2021-05-14
Nyxoah SA
Summary
UPLOAD · 2021-05-14
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-28 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2025-03-26 | SEC Comment Letter | Nyxoah SA | Belgium | 333-285982 | Read Filing View |
| 2023-01-04 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2022-12-29 | SEC Comment Letter | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-28 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-28 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-28 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-25 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-25 | SEC Comment Letter | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-22 | SEC Comment Letter | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-10 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-08 | SEC Comment Letter | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-05-14 | SEC Comment Letter | Nyxoah SA | Belgium | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-26 | SEC Comment Letter | Nyxoah SA | Belgium | 333-285982 | Read Filing View |
| 2022-12-29 | SEC Comment Letter | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-25 | SEC Comment Letter | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-22 | SEC Comment Letter | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-08 | SEC Comment Letter | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-05-14 | SEC Comment Letter | Nyxoah SA | Belgium | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-28 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2023-01-04 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-28 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-28 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-28 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-25 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
| 2021-06-10 | Company Response | Nyxoah SA | Belgium | N/A | Read Filing View |
2025-03-28 - CORRESP - Nyxoah SA
CORRESP 1 filename1.htm Nyxoah SA Rue Edouard Belin 12 1435 Mont-Saint-Guibert, Belgium March 28, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention : Robert Augustin Re: Nyxoah SA Registration Statement on Form F-3 Filed March 20, 2025 File No. 333-285982 Acceleration Request Ladies and Gentlemen: In accordance with Rule 461 of the Rules and Regulations promulgated under the Securities Act of 1933, as amended, Nyxoah SA, a limited liability company organized and existing under the laws of Belgium (the “Registrant”), hereby respectfully requests that the Securities and Exchange Commission accelerate the effective date of the above-referenced Registration Statement on Form F-3 to Tuesday, April 1, 2025, at 4:00 p.m., Eastern time, or as soon as thereafter practicable. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please contact John T. Rudy of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (617) 348-3050 with any questions regarding this request. Very truly yours, NYXOAH SA /s/ John Landry John Landry Chief Financial Officer cc: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. John T. Rudy Jason McCaffrey
2025-03-26 - UPLOAD - Nyxoah SA File: 333-285982
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 26, 2025 Olivier Taelman Chief Executive Officer Nyxoah SA Rue Edouard Belin 12 B-1435 Mont-Saint-Guibert Belgium Re: Nyxoah SA Registration Statement on Form F-3 Filed March 20, 2025 File No. 333-285982 Dear Olivier Taelman: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Robert Augustin at 202-551-8483 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Jason McCaffrey </TEXT> </DOCUMENT>
2023-01-04 - CORRESP - Nyxoah SA
CORRESP
1
filename1.htm
Nyxoah
SA
Rue Edouard Belin 12
1435 Mont-Saint-Guibert, Belgium
January 4, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Benjamin Richie
Re:
Nyxoah SA
Registration Statement on Form F-3
Filed December 22, 2022
File No. 333-268955
Acceleration Request
Ladies and Gentlemen:
In accordance with Rule 461
of the Rules and Regulations promulgated under the Securities Act of 1933, as amended, Nyxoah SA, a limited liability company organized
and existing under the laws of Belgium (the “Registrant”), hereby respectfully requests that the Securities and Exchange Commission
accelerate the effective date of the above-referenced Registration Statement on Form F-3 to Friday, January 6, 2023, at 4:00
p.m., Eastern time, or as soon as thereafter practicable.
The cooperation of the staff
in meeting the timetable described above is very much appreciated.
Please contact John T. Rudy of Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (617) 348-3050 with any questions regarding this request.
Very truly yours,
NYXOAH SA
/s/ Olivier Taelman
Olivier Taelman
Chief Executive Officer
cc:
Mintz, Levin, Cohn, Ferris, Glovsky
and Popeo, P.C.
Jonathan L. Kravetz
John T. Rudy
2022-12-29 - UPLOAD - Nyxoah SA
United States securities and exchange commission logo
December 29, 2022
Olivier Taelman
Chief Executive Officer
Nyxoah SA
Rue Edouard Belin 12
B-1435 Mont-Saint-Guibert
Belgium
Re:Nyxoah SA
Registration Statement on Form F-3
Filed December 22, 2022
File No. 333-268955
Dear Olivier Taelman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Benjamin Richie at 202-551-7857 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: John Rudy
2021-06-28 - CORRESP - Nyxoah SA
CORRESP
1
filename1.htm
Nyxoah SA
Rue Edouard Belin 12
1435 Mont-Saint-Guibert, Belgium
June 28, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Margaret Schwartz
Re:
Nyxoah SA
Registration Statement on Form F-1
File No. 333-257000
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations under the Securities Act of 1933, as amended, Nyxoah SA, a limited liability company organized and
existing under the laws of Belgium (the “Registrant”), hereby respectfully requests that the effective date of the above-captioned
registration statement on Form F-1 (Registration No. 333-257000) be accelerated so that the registration statement may become effective
at 4:00 p.m., Eastern time, on Wednesday, June 30, 2021, or as soon thereafter as practicable, or at such later time as the Registrant
may orally request via telephone call to the staff. This request for acceleration is subject, however, to your receiving a telephone call
prior to such time from our legal counsel, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., confirming this request. The Registrant
hereby authorizes John T. Rudy of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, to make such request
on its behalf.
Please call John T. Rudy (617-348-3050) of Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, with any comments or questions regarding this matter.
Very truly yours,
NYXOAH SA
/s/ Olivier Taelman
Olivier Taelman
Chief Executive Officer
cc:
Securities and Exchange Commission
Julie Sherman
Kevin Kuhar
Margaret Schwartz
Samuel Kluck
Nyxoah
SA
Olivier Taelman
Fabian Suarez Gonzalez
Robert Taub
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Jonathan L. Kravetz
John T. Rudy
Latham & Watkins LLP
Shayne Kennedy
2021-06-28 - CORRESP - Nyxoah SA
CORRESP
1
filename1.htm
One Financial Center
Boston, MA 02111
617 542 6000
mintz.com
June 28, 2021
CONFIDENTIAL – VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Julie Sherman
Kevin Kuhar
Margaret Schwartz
Samuel Kluck
Re: Nyxoah SA
Amendment No. 1 to Registration Statement
on Form F-1
Filed June 25, 2021
File No. 333-257000
Ladies and Gentlemen:
This letter sets forth the
response of Nyxoah SA (the “Company”) to the comment letter, dated June 25, 2021, of the staff of the Division of Corporation
Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect
to the Company’s Amendment No. 1 to the Registration Statement on Form F-1 publicly filed with the Commission on June 25, 2021.
Concurrently, the Company is filing publicly an Amendment No. 2 to the Registration Statement on Form F-1 (the “Amendment”).
Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in the Amendment.
In order to facilitate your
review, we have repeated each comment in its entirety in italicized text in the original numbered sequence and followed by the Company’s
response. When indicated, the responses below are contained in the Amendment. References to page numbers in this letter refer to the pagination
of the Amendment.
1. Please revise the tax opinion to state clearly the material tax consequences and, if filing a short
form, please revise the opinion and related disclosure in the prospectus to state clearly the opinion that the disclosure in the tax consequences
section of the prospectus is the opinion of NautaDutilh BV/SRL or advise. Refer to Sections III.B.2 and III.C.2 of Staff Legal Bulletin
No. 19.
Response: The
Company respectfully acknowledges the Staff's comment and has re-filed the revised tax opinion as Exhibit 8.1 to the Amendment.
2. We note that both opinions indicate that counsel’s services shall be governed by its General
Terms and Conditions, including a limitation of liability and a nomination of competent jurisdiction. Please tell us why such statement
is both necessary and appropriate. In the alternative, please have counsel remove such statement from the opinions.
Response: The Company
respectfully acknowledges the Staff’s comment. The Company respectfully advises the Staff that the “General Terms
and Conditions of NautaDutilh BV/SRL” (the “Terms and Conditions”) referenced in the legal opinions delivered by
NautaDutilh BV/SRL, filed as Exhibits 5.1 and 8.1 to the Company’s registration statement on Form
F-1, do not contain (i) any assumptions or qualifications that limit, qualify or otherwise impact the legal opinions expressed in
each letter, (ii) any exclusion or carve out of the laws of the relevant jurisdiction for the legal opinions expressed in each
letter, or (iii) any limitation on the ability of purchasers to rely on the legal opinions expressed in each letter. As a
result of the foregoing, the Company believes that the reference to the Terms and Conditions in the legal opinions delivered by
NautaDutilh is appropriate and consistent with the requirements of Item 601 of Regulation S-K and Staff Legal Bulletin No. 19 (CF),
Legality and Tax Opinions in Registered Offerings (October 14, 2011). The Terms and Conditions do contain the arrangements
pursuant to which NautaDutilh is acting as counsel to the Company. The Company believes that reference to the Terms and
Conditions is necessary in order to make clear the arrangements pursuant to which NautaDutilh has been engaged by the Company.
For these reasons, the Company believes that the references to the Terms and Conditions in both legal opinion letters are
appropriate and necessary. The Company would also note that NautaDutilh has previously delivered legal opinion letters for
other issuers that have been filed as Exhibits 5.1 and/or 8.1 to the registration statements of other issuers, each of which has
contained the same language referencing the general terms and conditions of NautaDutilh. Examples of such legal opinions
delivered by NautaDutilh with reference to the firm’s Terms and Conditions include: Galapagos NV, Exhibit 5.1 and 8.1 opinions
as to Belgian law (Form F-1/A, File No. 333-203435, filed May 12, 2015 and May 5, 2015, respectively); LAVA Therapeutics B.V.,
Exhibit 5.1 opinion as to Dutch law (Form F-1/A, File No. 333-253795, filed March 18, 2021); Pharvaris B.V., Exhibit 5.1 opinion as
to Dutch law (Form F-1/A, File No. 333-252157, filed February 1, 2021); and Centogene N.V., Exhibit 5.1 opinion as to Dutch law
(Form F-1/A, File No. 333-234177, filed October 28, 2019).
Boston London Los
Angeles New York San Diego San
Francisco Washington
MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C.
MINTZ
June 28, 2021
Page 2
If you have any questions
or comments in connection with this letter or the Registration Statement, please contact the undersigned by phone at (617) 348-3050 or
via e-mail at jrudy@mintz.com.
Very truly yours,
/s/ John
Rudy
John Rudy
cc: Olivier Taelman, Chief Executive Officer and Executive Director (Nyxoah SA)
2021-06-28 - CORRESP - Nyxoah SA
CORRESP
1
filename1.htm
Piper Sandler & Co.
800 Nicollet Mall
Minneapolis, Minnesota 55402
Stifel, Nicolaus & Company, Incorporated
787 7th Ave., 11th Floor
New York, NY 10019
Cantor Fitzgerald & Co.
499 Park Avenue, 6th Floor
New York, NY 10022
June 28, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Margaret Schwartz
Re:
Nyxoah SA
Registration Statement on Form F-1
File No. 333-257000
Acceleration Request
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended
(the “Act”), we, as representatives of the several underwriters, hereby join in the request of Nyxoah SA (the “Company”)
for acceleration of the effective date of the above-referenced Registration Statement, requesting effectiveness as of 4:00 P.M. Eastern
Time, on Wednesday, June 30, 2021, or as soon thereafter as practicable, or at such later time as the Company may orally request via telephone
call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission.
Pursuant to Rule 460 under the Act, we, as representatives of the several
underwriters, wish to advise you that there will be distributed to each underwriter or dealer, who is reasonably anticipated to participate
in the distribution of the securities, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure
adequate distribution of the preliminary prospectus.
We, the undersigned, as representatives of the several underwriters,
have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with
the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
[Signature page follows]
Very truly yours,
Piper Sandler & Co.
By:
/s/ Neil Riley
Name: Neil Riley
Title: Managing Director
Stifel, Nicolaus & Company, Incorporated
By:
/s/ Nathan Thompson
Name: Nathan Thompson
Title: Director
Cantor Fitzgerald & Co.
By:
/s/ Sage Kelly
Name: Sage Kelly
Title: Global Head of Investment Banking
2021-06-25 - CORRESP - Nyxoah SA
CORRESP
1
filename1.htm
One Financial Center
Boston, MA 02111
617 542 6000
mintz.com
June 25, 2021
CONFIDENTIAL – VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Julie Sherman
Kevin Kuhar
Margaret Schwartz
Samuel Kluck
Re: Nyxoah SA
Registration Statement on Form F-1
Submitted June 10, 2021
CIK No. 0001857190
Ladies and Gentlemen:
This letter sets forth the
response of Nyxoah SA (the “Company”) to the comment letter, dated June 22, 2021, of the staff of the Division of Corporation
Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect
to the Company’s Registration Statement on Form F-1 publicly filed with the Commission on June 10, 2021. Concurrently, the Company
is filing publicly an Amendment No. 1 to the Registration Statement on Form F-1 (the “Amendment”). Defined terms used
but not otherwise defined herein have the meanings ascribed to such terms in the Amendment.
In order to facilitate your
review, we have repeated each comment in its entirety in italicized text in the original numbered sequence and followed by the Company’s
response. When indicated, the responses below are contained in the Amendment. References to page numbers in this letter refer to the pagination
of the Amendment.
1. We note that certain existing investors have indicated an interest to purchase in the offering. Please
revise to provide the aggregate amount the investors have indicated they would be interested in purchasing and name any such investors
that are affiliated with you or if such purchase by such investor would materially affect the beneficial ownership table (i.e., such investor
would hold over 3% ownership), and if so state the percentage change.
Response: The
Company respectfully acknowledges the Staff's comment and has revised the disclosure on the cover page and pages 9, 54, 72, 147, 148,
150 and 184 of the Amendment.
2. We note your response to prior comment 3 and your revised disclosure of the minimum annual royalty
payments you will make to Vanderbilt that are creditable against the earned royalties. Please revise your disclosure to include the earned
royalty payment that you will make to Vanderbilt. Also please file as an exhibit any related agreements between the company and Vanderbilt.
Boston London Los
Angeles New York San Diego San
Francisco Washington
MINTZ, LEVIN, COHN, FERRIS, GLOVSKY
AND POPEO, P.C.
MINTZ
June
25, 2021
Page 2
Response: The Company respectfully
acknowledges the Staff's comment and has revised the disclosure on pages 115 and F-51 of the Amendment. Additionally, the Company respectfully
refers the Staff to the twelfth response in its Response Letter, dated May 24, 2021, as it pertains to the Vanderbilt Agreement, which
is also included below for ease of reference:
However, with respect to the Vanderbilt
University license agreement, the Company respectfully advises the Staff that the partnership with Vanderbilt University is in its very
early stages, development of potential new technologies is just commencing, and only one patent has been issued in the United States.
As a result, the Company has determined that the Vanderbilt University license agreement is not material as it has very little effect
on the Company’s business. Further, to the extent that it were to become material in the future, it was entered into by the Company
in the ordinary course of business (the agreement is such as ordinarily accompanies the kind of business conducted by Company, which includes
the ongoing development of potential new technologies), and the Company is not and does not expect to become substantially dependent on
the agreement. As a result, the Company believes that the Vanderbilt University license agreement does not fall under item 601(b)(10)(ii)(B)
of Regulation S-K and, accordingly, need not be filed.
If you have any questions
or comments in connection with this letter or the Registration Statement, please contact the undersigned by phone at (617) 348-3050 or
via e-mail at jrudy@mintz.com.
Very truly yours,
/s/ John Rudy
John Rudy
cc: Olivier Taelman, Chief Executive Officer
and Executive Director (Nyxoah SA)
2021-06-25 - UPLOAD - Nyxoah SA
United States securities and exchange commission logo
June 25, 2021
Olivier Taelman
Chief Executive Officer
Nyxoah SA
Rue Edouard Belin 12
1435 Mont-Saint-Guibert, Belgium
Re:Nyxoah SA
Amendment No. 1 to Registration Statement on Form F-1
Filed June 25, 2021
File No. 333-257000
Dear Dr. Taelman:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our June 22, 2021 letter.
Amendment No. 1 to Registration Statement on Form F-1, Filed June 25, 2021
Exhibits
1.Please revise the tax opinion to state clearly the material tax consequences and, if filing a
short form, please revise the opinion and related disclosure in the prospectus to state
clearly the opinion that the disclosure in the tax consequences section of the prospectus is
the opinion of NautaDutilh BV/SRL or advise. Refer to Sections III.B.2 and III.C.2 of
Staff Legal Bulletin No. 19.
2.We note that both opinions indicate that counsel’s services shall be governed by its
General Terms and Conditions, including a limitation of liability and a nomination of
FirstName LastNameOlivier Taelman
Comapany NameNyxoah SA
June 25, 2021 Page 2
FirstName LastName
Olivier Taelman
Nyxoah SA
June 25, 2021
Page 2
competent jurisdiction. Please tell us why such statement is both necessary and
appropriate. In the alternative, please have counsel remove such statement from the
opinions.
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 Tom Kluck at 202-551-3233 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: John Rudy, Esq.
2021-06-22 - UPLOAD - Nyxoah SA
United States securities and exchange commission logo
June 22, 2021
Olivier Taelman
Chief Executive Officer
Nyxoah SA
Rue Edouard Belin 12
1435 Mont-Saint-Guibert, Belgium
Re:Nyxoah SA
Registration Statement on Form F-1
Filed June 10, 2021
File No. 333-257000
Dear Dr. Taelman:
We have reviewed your 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-1, Filed June 10, 2021
Cover Page
1.We note that certain existing investors have indicated an interest to purchase in the
offering. Please revise to provide the aggregate amount the investors have indicated they
would be interested in purchasing and name any such investors that are affiliated with you
or if such purchase by such investor would materially affect the beneficial ownership table
(i.e., such investor would hold over 3% ownership), and if so state the percentage change.
FirstName LastNameOlivier Taelman
Comapany NameNyxoah SA
June 22, 2021 Page 2
FirstName LastName
Olivier Taelman
Nyxoah SA
June 22, 2021
Page 2
Intellectual Property, page 114
2.We note your response to prior comment 3 and your revised disclosure of the minimum
annual royalty payments you will make to Vanderbilt that are creditable against the earned
royalties. Please revise your disclosure to include the earned royalty payment that you
will make to Vanderbilt. Also please file as an exhibit any related agreements between
the company and Vanderbilt.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
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 Tom Kluck at 202-551-3233 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: John Rudy, Esq.
2021-06-10 - CORRESP - Nyxoah SA
CORRESP
1
filename1.htm
One Financial Center
Boston, MA 02111
617 542 6000
mintz.com
June 10, 2020
CONFIDENTIAL – VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Julie Sherman
Kevin Kuhar
Margaret Schwartz
Samuel Kluck
Re: Nyxoah SA
Amendment No. 1 to Draft Registration
Statement on Form F-1
Submitted May 24, 2021
CIK No. 0001857190
Ladies and Gentlemen:
This letter sets forth the
response of Nyxoah SA (the “Company”) to the comment letter, dated June 8, 2021, of the staff of the Division of Corporation
Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect
to the Company’s Amendment No. 1 to the Draft Registration Statement on Form F-1 confidentially submitted to the Commission on May
24, 2021 for confidential non-public review pursuant to the Jumpstart Our Business Startups Act, as amended (the “JOBS Act”).
Concurrently, the Company is filing publicly a Registration Statement on Form F-1 (the “Registration Statement”). Defined
terms used but not otherwise defined herein have the meanings ascribed to such terms in the Registration Statement.
In order to facilitate your
review, we have repeated each comment in its entirety in italicized text in the original numbered sequence and followed by the Company’s
response. When indicated, the responses below are contained in the Registration Statement. References to page numbers in this letter refer
to the pagination of the Registration Statement.
1. We note your response to our prior comment number 4 and your reference to continuing to prosecute patent
applications. Please revise to clarify whether you will own any patents arising from this partnership or will you simply license Vanderbilt’s
patents. Additionally, on page 93 please revise to disclose any upfront material payments and the termination provisions of the agreement.
Response:
The Company respectfully acknowledges the Staff's comment and has revised the disclosure on pages 94 and 116 of the Registration
Statement.
2. We note your response
to our prior comment number 10. We understand the language on page 109 and the related charts
are intended to allow investors to be able to understand the market in which the Company
operates and to show the clinical data generated by the principal hypoglossal nerve stimulation
therapies. However, these charts are the same charts used in the prior filing showing the
results of third party studies of that were not head-to-head trials and the corresponding
Company’s chart appears on the page before. Therefore, the graphics showing the results
for your competitors on page 109 are understood to be a comparison. You may note the types
of metrics used in these studies and the features of these other devices, such as number
of incisions required, but please remove the results of the competitor’s trials.
Response: The Company respectfully
acknowledges the Staff's comment and has revised the disclosure on page 109 of the Registration Statement.
Boston London Los
Angeles New York San Diego San
Francisco Washington
MINTZ, LEVIN, COHN, FERRIS, GLOVSKY
AND POPEO, P.C.
MINTZ
June 10, 2021
Page 2
3. We note your response to our prior comment number 12. You state that the Clarification confirms that
the license granted by Man & Science SA will continue in effect until the last to expire patent. Please revise to state when these
patents are expected to expire. With respect to the Man & Science SA and Cochlear Limited agreements, please also state whether you
have any ongoing or future financial obligations under either such agreement. To the extent you take the position that the agreement with
Vanderbilt University is not material, please remove all references to such agreement in the Summary. If you wish to retain such description
then you must file such agreement.
Response: The Company respectfully
acknowledges the Staff's comment and has revised the disclosure in the Summary and on pages 114, 115, and 150 of the Registration
Statement.
4. We note your response to our prior comment number 15. With respect to the description of the Man &
Science Agreement on page 149 and elsewhere, please revise to explain the scope of the sleep disordered breathing field.
Response: The Company respectfully
acknowledges the Staff's comment and has revised the disclosure on pages 115 and 150 of the Registration Statement.
5. We see from your disclosures that you entered into a collaboration agreement with Vanderbilt University
pursuant to which you are exploring additional neurostimulation technologies and under this agreement, you are responsible for product
development, while Vanderbilt University is responsible for patent prosecution. Please revise to disclose the significant terms of this
in-licensing agreement, including the term of the agreement, any significant milestones, and any royalties due under the agreement.
Response: The Company respectfully
acknowledges the Staff's comment and has revised the disclosure on pages 116, F-51 and F-52 of the Registration Statement.
If you have any questions
or comments in connection with this letter or the Registration Statement, please contact the undersigned by phone at (617) 348-3050 or
via e-mail at jrudy@mintz.com.
Very truly yours,
/s/ John Rudy
John Rudy
cc: Olivier Taelman, Chief Executive Officer
and Executive Director (Nyxoah SA)
2021-06-08 - UPLOAD - Nyxoah SA
United States securities and exchange commission logo
June 8, 2021
Olivier Taelman
Chief Executive Officer
Nyxoah SA
Rue Edouard Belin 12
1435 Mont-Saint-Guibert, Belgium
Re:Nyxoah SA
Amendment No. 1 to Draft Registration Statement on Form F-1
Submitted May 24, 2021
CIK No. 0001857190
Dear Dr. Taelman:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form F-1, Submitted May 24, 2021
Business
Our Competitive Strengths, page 92
1.We note your response to our prior comment number 4 and your reference to continuing
to prosecute patent applications. Please revise to clarify whether you will own any patents
arising from this partnership or will you simply license Vanderbilt’s patents. Additionally,
on page 93 please revise to disclose any upfront material payments and the termination
provisions of the agreement.
FirstName LastNameOlivier Taelman
Comapany NameNyxoah SA
June 8, 2021 Page 2
FirstName LastName
Olivier Taelman
Nyxoah SA
June 8, 2021
Page 2
Clinical Results and Studies , page 106
2.We note your response to our prior comment number 10. We understand the language on
page 109 and the related charts are intended to allow investors to be able to understand the
market in which the Company operates and to show the clinical data generated by the
principal hypoglossal nerve stimulation therapies. However, these charts are the same
charts used in the prior filing showing the results of third party studies of that were not
head-to-head trials and the corresponding Company’s chart appears on the page before.
Therefore, the graphics showing the results for your competitors on page 109 are
understood to be a comparison. You may note the types of metrics used in these studies
and the features of these other devices, such as number of incisions required, but please
remove the results of the competitor’s trials.
Intellectual Property, page 114
3.We note your response to our prior comment number 12. You state that the Clarification
confirms that the license granted by Man & Science SA will continue in effect until the
last to expire patent. Please revise to state when these patents are expected to expire. With
respect to the Man & Science SA and Cochlear Limited agreements, please also state
whether you have any ongoing or future financial obligations under either such agreement.
To the extent you take the position that the agreement with Vanderbilt University is not
material, please remove all references to such agreement in the Summary. If you wish to
retain such description then you must file such agreement.
Certain Relationships and Related Party Transactions , page 149
4.We note your response to our prior comment number 15. With respect to the description
of the Man & Science Agreement on page 149 and elsewhere, please revise to explain the
scope of the sleep disordered breathing field.
2. Significant accounting policies
Significant Events and Transactions of the Interim Period, page F-50
5.We see from your disclosures that you entered into a collaboration agreement with
Vanderbilt University pursuant to which you are exploring additional neurostimulation
technologies and under this agreement, you are responsible for product development,
while Vanderbilt University is responsible for patent prosecution. Please revise to disclose
the significant terms of this in-licensing agreement, including the term of the agreement,
any significant milestones, and any royalties due under the agreement.
FirstName LastNameOlivier Taelman
Comapany NameNyxoah SA
June 8, 2021 Page 3
FirstName LastName
Olivier Taelman
Nyxoah SA
June 8, 2021
Page 3
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 Tom Kluck at 202-551-3233 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: John Rudy, Esq.
2021-05-14 - UPLOAD - Nyxoah SA
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
FirstName LastNameOlivier Taelman
Comapany NameNyxoah SA
May 14, 2021 Page 2
FirstName LastName
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 Strengths, page 90
8.Please revise page 90 to explain the significance of receiving CE-Mark conditional
labeling for 1.5T and 3T full-body MRI scan.
FirstName LastNameOlivier Taelman
Comapany NameNyxoah SA
May 14, 2021 Page 3
FirstName LastName
Olivier Taelman
Nyxoah SA
May 14, 2021
Page 3
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.
FirstName LastNameOlivier Taelman
Comapany NameNyxoah SA
May 14, 2021 Page 4
FirstName LastName
Olivier Taelman
Nyxoah SA
May 14, 2021
Page 4
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.