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Valneva SE
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Valneva SE
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Valneva SE
Response Received
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SEC wrote to company
2023-08-03
Valneva SE
Summary
UPLOAD · 2023-08-03
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Company responded
2023-08-10
Valneva SE
References: August 3, 2023
Summary
CORRESP · 2023-08-10
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Valneva SE
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-08-16
Valneva SE
Summary
UPLOAD · 2022-08-16
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Company responded
2022-08-17
Valneva SE
Summary
CORRESP · 2022-08-17
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Valneva SE
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2021-10-25
Valneva SE
Summary
UPLOAD · 2021-10-25
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Company responded
2021-10-26
Valneva SE
Summary
CORRESP · 2021-10-26
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Company responded
2021-10-26
Valneva SE
Summary
CORRESP · 2021-10-26
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Valneva SE
Response Received
3 company response(s)
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SEC wrote to company
2021-04-20
Valneva SE
References: February 5,
2021
Summary
UPLOAD · 2021-04-20
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Company responded
2021-04-21
Valneva SE
References: April 20, 2021 | February 5, 2021
Summary
CORRESP · 2021-04-21
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Company responded
2021-05-03
Valneva SE
Summary
CORRESP · 2021-05-03
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Company responded
2021-05-03
Valneva SE
Summary
CORRESP · 2021-05-03
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Valneva SE
Awaiting Response
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SEC wrote to company
2021-02-11
Valneva SE
Summary
UPLOAD · 2021-02-11
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-31 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2025-03-28 | SEC Comment Letter | Valneva SE | France | 333-286071 | Read Filing View |
| 2023-08-14 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| 2023-08-10 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2023-08-03 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| 2022-08-17 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2022-08-16 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| 2021-10-26 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2021-10-26 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2021-10-25 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| 2021-05-03 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2021-05-03 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2021-04-21 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2021-04-20 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| 2021-02-11 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-28 | SEC Comment Letter | Valneva SE | France | 333-286071 | Read Filing View |
| 2023-08-14 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| 2023-08-03 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| 2022-08-16 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| 2021-10-25 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| 2021-04-20 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| 2021-02-11 | SEC Comment Letter | Valneva SE | France | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-31 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2023-08-10 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2022-08-17 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2021-10-26 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2021-10-26 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2021-05-03 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2021-05-03 | Company Response | Valneva SE | France | N/A | Read Filing View |
| 2021-04-21 | Company Response | Valneva SE | France | N/A | Read Filing View |
2025-03-31 - CORRESP - Valneva SE
CORRESP 1 filename1.htm March 31, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Chris Edwards Re: Valneva SE Registration Statement on Form F-3 Filed March 25, 2025 File No. 333- 286071 Acceleration Request Requested Date: April 2, 2025 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the " Registrant ") hereby requests that the Securities and Exchange Commission (the " Commission ") take appropriate action to cause the above-referenced Registration Statement on Form F-3 (File No. 333-286071) (the " Registration Statement "), to become effective on April 2, 2025, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the Commission's staff. The Registrant hereby authorizes Katie Kazem of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Katie Kazem of Cooley LLP at (703) 456-8043. [Signature page follows] Very truly yours, Valneva SE By: /s/ Peter Bühler Peter Bühler Chief Financial Officer cc: Marc Recht, Cooley LLP Katie A. Kazem, Cooley LLP Florent Bouyer, Jones Day William Magioncalda, Paul Hastings LLP Seo Salimi, Paul Hastings LLP
2025-03-28 - UPLOAD - Valneva SE File: 333-286071
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 28, 2025 Thomas Lingelbach Chief Executive Officer Valneva SE 6 rue Alain Bombard 44800 Saint-Herblain France Re: Valneva SE Registration Statement on Form F-3 Filed March 25, 2025 File No. 333-286071 Dear Thomas Lingelbach: 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 Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Katie Kazem </TEXT> </DOCUMENT>
2023-08-14 - UPLOAD - Valneva SE
United States securities and exchange commission logo
August 14, 2023
Peter Bühler
Chief Financial Officer
Valneva SE
6 rue Alain Bombard
44800 Saint-Herblain, France
Re:Valneva SE
Form 20-F for the Fiscal Year Ended December 31, 2022
Filed March 30, 2023
File No. 001-40377
Dear Peter Bühler:
We have completed our review of your filing. 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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2023-08-10 - CORRESP - Valneva SE
CORRESP
1
filename1.htm
Document
Katie Kazem
+1 703 456-8043
kkazem@cooley.com
VIA EDGAR
August 10, 2023
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Eric Atallah
Lyn Dicker
Re: Valneva SE
Form 20-F for the fiscal year ended December 31, 2022
Filed March 30, 2023
File number 001-40377
Ladies and Gentlemen:
This letter is submitted on behalf of Valneva SE (the “Company”) in response to the comment of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2022, filed on March 30, 2023 (the “20-F”), as set forth in the Staff’s letter dated August 3, 2023 (the “Comment Letter”). The Company is concurrently filing its Amendment No. 1 to the 20-F to address the Staff’s comment in the Comment Letter.
For the Staff’s convenience, we have incorporated your comment into this response letter in italics.
Form 20-F filed March 30, 2023
Exhibits 12.1 and 12.2, page 182
1.We note the certifications provided in Exhibits 12.1 and 12.2 do not include paragraph 4(b) and the introductory language in paragraph 4 referring to internal control over financial reporting after the end of the transition period that allows these omissions. Please file an amendment that is limited to the cover page, explanatory note, signature page, and paragraphs 1, 2, 4 and 5 of the certifications. Refer to Instruction 12 to the Form 20-F Exhibits and Question 246.13 of the Compliance and Disclosure Interpretations of Regulation S-K.
Response:
The Company respectfully advises the Staff that it has filed an Amendment No. 1 to the 20-F to include in the officer certifications provided in Exhibits 12.1 and 12.2 paragraph 4(b) and the reference to internal control over financial reporting in the introductory language of paragraph 4.
* * *
Please contact me at (703) 456-8043 or Marc Recht at (617) 937-2316 or with any questions or further comments regarding the enclosed matters or our response to the Staff’s comment.
Sincerely,
/s/ Katie Kazem
Katie Kazem
cc: Thomas Lingelbach, Valneva SE
Marc Recht, Cooley LLP
David Boles, Cooley LLP
2023-08-03 - UPLOAD - Valneva SE
United States securities and exchange commission logo
August 3, 2023
Peter Bühler
Chief Financial Officer
Valneva SE
6 rue Alain Bombard
44800 Saint-Herblain, France
Re:Valneva SE
Form 20-F for the Fiscal Year Ended December 31, 2022
Filed March 30, 2023
File No. 001-40377
Dear Peter Bühler:
We have limited our review of your filing to the financial statements and related
disclosures 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 comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Form 20-F for the Fiscal Year Ended December 31, 2022
Item 19. Exhibits
Exhibit 12.1 and 12.2, page 182
1.We note the certifications provided in Exhibits 12.1 and 12.2 do not include paragraph
4(b) and the introductory language in paragraph 4 referring to internal control over
financial reporting after the end of the transition period that allows these omissions.
Please file an amendment that is limited to the cover page, explanatory note, signature
page, and paragraphs 1, 2, 4 and 5 of the certifications. Refer to Instruction 12 to the
Form 20-F Exhibits and Question 246.13 of the Compliance and Disclosure
Interpretations of Regulation S-K.
In closing, 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.
FirstName LastNamePeter Bühler
Comapany NameValneva SE
August 3, 2023 Page 2
FirstName LastName
Peter Bühler
Valneva SE
August 3, 2023
Page 2
You may contact Eric Atallah at (202) 551-3663 or Lynn Dicker, Senior Accountant, at
(202) 551-3616 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-08-17 - CORRESP - Valneva SE
CORRESP
1
filename1.htm
August 17, 2022
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Daniel Crawford
Re:
Valneva SE
Registration Statement on Form F-3
Filed August 12, 2022
File No. 333- 266839
Acceleration Request
Requested Date: August 19, 2022
Requested Time: 4:00 p.m. Eastern Time
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended,
the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the
“Commission”) take appropriate action to cause the above-referenced Registration Statement on Form F-3 (File
No. 333-266839) (the “Registration Statement”), to become effective on August 19, 2022, at 4:00 p.m. Eastern
Time, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the Commission’s
staff. The Registrant hereby authorizes Katie Kazem and David Boles of Cooley LLP, counsel to the Registrant, to make such request on
its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Katie Kazem or David Boles
of Cooley LLP at (703) 456-8043 and +44 20 7556 4446, respectively.
[Signature page follows]
Very truly yours,
Valneva SE
By: /s/ Thomas Lingelbach
Thomas Lingelbach
Chief Executive Officer and President
cc:
David Boles, Cooley LLP
Marc Recht, Cooley LLP
Katie A. Kazem, Cooley LLP
Jean-Marc Franceschi, Hogan Lovells
Paris LLP
Robert E. Puopolo, Goodwin Procter
LLP
Edwin O’Connor, Goodwin Procter
LLP
Seo Salimi, Goodwin Procter LLP
Arnaud Duhamel, Gide Loyrette Nouel
A.A.R.P.I.
Guilhem Richard, Gide Loyrette Nouel
A.A.R.P.I.
2022-08-16 - UPLOAD - Valneva SE
United States securities and exchange commission logo
August 16, 2022
Thomas Lingelbach
Chief Executive Officer
Valneva SE
910 Clopper Road, Suite 160S
Gaithersburg, MD 20878
Re:Valneva SE
Registration Statement on Form F-3
Filed August 12, 2022
File No. 333-266839
Dear Mr. Lingelbach:
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 Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Marc Recht, Esq.
2021-10-26 - CORRESP - Valneva SE
CORRESP 1 filename1.htm CORRESP 6 rue Alain Bombard 44800 Saint-Herblain, France VIA EDGAR October 26, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Abby Adams Re: Valneva SE Registration Statement on Form F-1 File No. 333-260507 Acceleration Request Requested Date: October 28, 2021 Requested Time: 4:00 P.M. Eastern Time All: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form F-1 to become effective on October 28, 2021, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as its counsel may orally request via telephone call to the staff. The Registrant hereby authorizes each of David Boles and Katie Kazem of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with David Boles of Cooley LLP at +44 7556 4446, or in his absence, Katie Kazem at +1 703 456 8043. Thank you for your assistance with this matter. [Signature Page Follows] Sincerely, Valneva SE By: /s/ Thomas Lingelbach Thomas Lingelbach Chief Executive Officer and President cc: David Boles, Cooley LLP Marc Recht, Cooley LLP Katie A. Kazem, Cooley LLP Jean-Marc Franceschi, Hogan Lovells Paris LLP Robert E. Puopolo, Goodwin Procter LLP Edwin O’Connor, Goodwin Procter LLP Seo Salimi, Goodwin Procter LLP Arnaud Duhamel, Gide Loyrette Nouel A.A.R.P.I. Guilhem Richard, Gide Loyrette Nouel A.A.R.P.I.
2021-10-26 - CORRESP - Valneva SE
CORRESP 1 filename1.htm CORRESP October 26, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Valneva SE Registration Statement on Form F-1 Registration No. 333-260507 Acceleration Request Requested Date: October 28, 2021 Requested Time: 4:00 PM, Eastern Daylight Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Goldman Sachs Bank Europe SE, Jefferies LLC, Jefferies International Limited and Jefferies GmbH, as representatives of the several underwriters, hereby join Valneva SE in requesting that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form F-1 (File No. 333-260507) (the “Registration Statement”) to become effective on October 28, 2021, at 4:00 PM, Eastern Daylight Time, or as soon as practicable thereafter. Pursuant to Rule 460 under the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement. We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable. [Signature Page Follows] Very truly yours, Goldman Sachs Bank Europe SE By: /s/ Ben Thorpe Name: Ben Thorpe Title: Managing Director Jefferies LLC By: /s/ Kevin Sheridan Name: Kevin Sheridan Title: Managing Director Jefferies International Limited By: /s/ Luca Erpici Name: Luca Erpici Title: Managing Director Jefferies GmbH By: /s/ Oliver Diehl Name: Oliver Diehl Title: Managing Director By: /s/ Luca Erpici Name: Luca Erpici Title: Managing Director cc: Thomas Lingelbach, Valneva SE Robert Puopolo, Goodwin Procter LLP Edwin O’Connor, Goodwin Procter LLP Seo Salimi, Goodwin Procter LLP Katie A. Kazem, Cooley LLP [Signature Page to Acceleration Request]
2021-10-25 - UPLOAD - Valneva SE
United States securities and exchange commission logo
October 25, 2021
Thomas Lingelbach
Chief Executive Officer
Valneva SE
6 rue Alain Bombard
44800 Saint-Herblain, France
Re:Valneva SE
Draft Registration Statement on Form F-1
Submitted October 20, 2021
CIK No. 0001836564
Dear Mr. Lingelbach:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. 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 Abby Adams at (202) 551-6902 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Boles
2021-05-03 - CORRESP - Valneva SE
CORRESP 1 filename1.htm UW Acceleration Request May 3, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Valneva SE Registration Statement on Form F-1 Registration No. 333-255155 Acceleration Request Requested Date: May 5, 2021 Requested Time: 4:00 PM, Eastern Daylight Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Goldman Sachs Bank Europe SE, Jefferies LLC, Jefferies International Limited and Jefferies GmbH, as representatives of the several underwriters, hereby join Valneva SE in requesting that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form F-1 (File No. 333-255155) (the “Registration Statement”) to become effective on May 5, 2021, at 4:00 PM, Eastern Daylight Time, or as soon as practicable thereafter. Pursuant to Rule 460 under the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement. We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable. [Signature Page Follows] Very truly yours, Goldman Sachs Bank Europe SE By: /s/ B. W. R. Thorpe Name: B. W. R. Thorpe Title: Managing Director Jefferies LLC By: /s/ Kevin Sheridan Name: Kevin Sheridan Title: Managing Director Jefferies International Limited By: /s/ Luca Erpici Name: Luca Erpici Title: Managing Director Jefferies GmbH By: /s/ Oliver Diehl Name: Oliver Diehl Title: Managing Director By: /s/ Luca Erpici Name: Luca Erpici Title: Managing Director cc: Thomas Lingelbach, Valneva SE Robert Puopolo, Goodwin Procter LLP Edwin O’Connor, Goodwin Procter LLP Seo Salimi, Goodwin Procter LLP Katie A. Kazem, Cooley LLP [Signature Page to Acceleration Request]
2021-05-03 - CORRESP - Valneva SE
CORRESP 1 filename1.htm Acceleration Request 6 rue Alain Bombard 44800 Saint-Herblain, France VIA EDGAR May 3, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Laura Crotty Tracey McKoy Lynn Dicker Re: Valneva SE Registration Statement on Form F-1 File No. 333-255155 Acceleration Request Requested Date: May 5, 2021 Requested Time: 4:00 P.M. Eastern Time Ladies: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form F-1 to become effective on May 5, 2021, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as its counsel may orally request via telephone call to the staff. The Registrant hereby authorizes each of David Boles, Katie Kazem and Darah Protas of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with David Boles of Cooley LLP at +44 7556 4446, or in his absence, Katie Kazem at +1 703 456 8043. Thank you for your assistance with this matter. [Signature Page Follows] Sincerely, Valneva SE By: /s/ Thomas Lingelbach Thomas Lingelbach Chief Executive Officer and President cc: David Boles, Cooley LLP Marc Recht, Cooley LLP Divakar Gupta, Cooley LLP Katie A. Kazem, Cooley LLP Jean-Marc Franceschi, Hogan Lovells Paris LLP Robert E. Puopolo, Goodwin Procter LLP Edwin O’Connor, Goodwin Procter LLP Seo Salimi, Goodwin Procter LLP Arnaud Duhamel, Gide Loyrette Nouel A.A.R.P.I. Guilhem Richard, Gide Loyrette Nouel A.A.R.P.I.
2021-04-21 - CORRESP - Valneva SE
CORRESP 1 filename1.htm CORRESP David Boles T: +44 20 7556 4446 dboles@cooley.com VIA EDGAR April 21, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.W. Washington, DC 20549 Attn: Ada D. Sarmento Laura Crotty Tracey McKoy Lynn Dicker Re: Valneva SE Amendment No. 1 to Registration Statement on Form F-1 Filed April 21, 2021 File No. 333-255155 Ladies: On behalf of our client, Valneva SE (the “Company”), we are responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated April 20, 2021 (the “Comment Letter”), relating to the above referenced Registration Statement on Form F-1 (the “Registration Statement”). In response to the comments set forth in the Comment Letter (the “Comments”), the Company has revised the Registration Statement and is publicly filing Amendment No. 1 to its Registration Statement (the “Amendment”) with this response letter. For the Staff’s reference, we have included both a clean copy of the Amendment and a copy marked to show all changes from the Registration Statement publicly filed on April 9, 2021. Set forth below are the Company’s responses to the Comments. The numbering of the paragraphs below corresponds to the numbering of the Comments, which for your convenience we have incorporated into this response letter. Page references in the text of this response letter correspond to page numbers of the Amendment. Registration Statement on Form F-1 Prospectus Summary Overview, page 1 1. We note your disclosure that you believe that your flexible approach to the clinical and manufacturing development of VLA2001 will facilitate your ability to meet the needs of future customers, including playing a key role in providing supply for any potential booster programs. Please balance your disclosure in this section with the risk identified on page 17 that you may need to redevelop your manufacturing process to produce a booster dose, which could result in additional time and expense and divert your manufacturing resources away from production of other products. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 17 of the Amendment to clarify that the risk related to redeveloping our manufacturing process relates to the potential adaptation of VLA2001 to address new variants, rather than the potential to produce a booster dose. Our Portfolio and Pipeline, page 2 2. Please remove references to “positive” data from your Phase 1/2 clinical trial of VLA2001 here and on pages 21, 124, 125, 127, 147 and 148 as this may create an inference that your vaccine is more likely to be found safe and effective, which is a determination solely in the authority of regulatory agencies such as the FDA. Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 4, 21, 124, 125, 127, 147 and 148 of the Amendment. Principal Shareholders, page 206 3. We note your revisions in response to prior comment 12 from our letter dated February 5, 2021. With respect to the shares held by Groupe Grimaud La Corbière SAS, please revise to identify the natural person or persons who have voting and investment control over such shares. Please also revise to disclose how voting and investment control of the shares held by Bpifrance Participations SA is managed by Caisse des Dépôts and EPIC Bpifrance and identify any natural persons at such entities who have voting and investment control over such shares. Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 207 and 208 of the Amendment. * * * * Please direct any questions or comments concerning the Amendment or this response letter to either the undersigned at +44 20 7556 4446 or Katie Kazem at (703) 456-8043. Yours very truly /s/ David Boles David Boles cc: Thomas Lingelbach, Valneva SE Katie A. Kazem, Cooley LLP Robert E. Puopolo, Goodwin Procter LLP Edwin O’Connor, Goodwin Procter LLP Seo Salimi, Goodwin Procter LLP
2021-04-20 - UPLOAD - Valneva SE
United States securities and exchange commission logo
April 20, 2021
Thomas Lingelbach
Chief Executive Officer
Valneva SE
6 rue Alain Bombard
44800 Saint-Herblain, France
Re:Valneva SE
Registration Statement on Form F-1
Filed April 9, 2021
File No. 333-255155
Dear Mr. Lingelbach:
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
Prospectus Summary
Overview, page 1
1.We note your disclosure that you believe that your flexible approach to the clinical and
manufacturing development of VLA2001 will facilitate your ability to meet the needs of
future customers, including playing a key role in providing supply for any potential
booster programs. Please balance your disclosure in this section with the risk identified on
page 17 that you may need to redevelop your manufacturing process to produce a booster
dose, which could result in additional time and expense and divert your manufacturing
resources away from production of other products.
FirstName LastNameThomas Lingelbach
Comapany NameValneva SE
April 20, 2021 Page 2
FirstName LastName
Thomas Lingelbach
Valneva SE
April 20, 2021
Page 2
Our Portfolio and Pipeline, page 2
2.Please remove references to "positive" data from your Phase 1/2 clinical trial of VLA2001
here and on pages 21, 124, 125, 127, 147 and 148 as this may create an inference that your
vaccine is more likely to be found safe and effective, which is a determination solely in
the authority of regulatory agencies such as the FDA.
Principal Shareholders, page 206
3.We note your revisions in response to prior comment 12 from our letter dated February 5,
2021. With respect to the shares held by Groupe Grimaud La Corbière SAS, please revise
to identify the natural person or persons who have voting and investment control over
such shares. Please also revise to disclose how voting and investment control of the
shares held by Bpifrance Participations SA is managed by Caisse des Dépôts and EPIC
Bpifrance and identify any natural persons at such entities who have voting and
investment control over such shares.
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 Tracey McKoy at 202-551-3772 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Ada D. Sarmento at 202-551-3798 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Marc Recht, Esq.
2021-02-11 - UPLOAD - Valneva SE
United States securities and exchange commission logo
February 11, 2021
Thomas Lingelbach
Chief Executive Officer
Valneva SE
6 rue Alain Bombard
44800 Saint-Herblain, France
Re:Valneva SE
Draft Registration Statement on Form F-1
Submitted January 15, 2021
CIK No. 0001836564
Dear Mr. Lingelbach:
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
Cover Page
1.We note that you intend to disclose the last reported sale price of your ordinary shares on
Euronext Paris on the cover page, and your disclosure that the final offering price will be
determined through negotiations with the underwriters by reference to the prevailing
market prices of your ordinary shares on Euronext Paris after taking into account market
conditions and other factors. Please confirm that the U.S. IPO price will be substantially
similar to the Euronext Paris trading price, converted to U.S. dollars at the most recent
exchange rate. If you intend to price the securities based on the Euronext Paris market
price, you may also disclose a percentage range based on that price (for example, 10% of
the home market price) within which you intend to price the securities. Alternatively, if
FirstName LastNameThomas Lingelbach
Comapany NameValneva SE
February 11, 2021 Page 2
FirstName LastNameThomas Lingelbach
Valneva SE
February 11, 2021
Page 2
you expect that the U.S. IPO price will not be substantially similar to the Euronext
Paris trading price, please disclose on the cover page a bona fide price range of the offered
securities. See Item 501(b)(3) of Regulation S-K.
Prospectus Summary
Overview, page 1
2.Please revise the third paragraph in this section to disclose that you currently do not have
a commercial license for the specific virus strain that you use in VLA2001 and are in the
process of negotiating a license agreement with the World Health Organization.
Our Portfolio and Pipeline, page 2
3.We note that you have included your parvovirus and norovirus programs in your pipeline
table, which appear to be in the discovery phase. Given the early-stage development of
these programs, please explain why each program is sufficiently material to your business
to warrant inclusion in your pipeline table.
4.Please revise the narrative description regarding VLA15 on page 3 to disclose that Pfizer
will lead late-stage development of VLA15 and will have sole control over its
commercialization pursuant to your collaboration agreement with Pfizer.
5.Please revise to provide balance and context to your references to "positive" initial results,
"positive" data, "encouraging" preclinical results, a "promising" Phase 1 dataset
and "promising" clinical data from your trials both here and in the Business
section. In this regard, we note your risk factor on page 20 concerning the limitations of
pre-clinical and earlier clinical data. Please also clarify, if true, that the data you present is
not statistically significant.
Implications of Being an Emerging Growth Company, page 8
6.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.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Material Weaknesses, page 117
7.You disclose that you have begun to develop a remediation plan to address
certain material weaknesses and strengthen your controls in those areas. Please revise
your filing to state the estimated time period to develop and execute your remediation
plan.
FirstName LastNameThomas Lingelbach
Comapany NameValneva SE
February 11, 2021 Page 3
FirstName LastNameThomas Lingelbach
Valneva SE
February 11, 2021
Page 3
Business
Phase 1 Clinical Trial and Results, page 130
8.We note your statement on page 130 that VLA15 demonstrated a "favorable" safety
profile. Please revise this statement to remove implication that your product
candidate is safe, as this determination is solely within the authority of the FDA.
Material Agreements
Department of Defense Contracts, page 154
9.Please file the agreements with the U.S. Department of Defense as exhibits to the
registration statement, or, in the alternative, please tell us why you believe that you are not
required to file the agreements. See Item 601(b)(10) of Regulation S-K.
UK Supply Agreement, page 155
10.Please revise to disclose the aggregate amounts received to date under the agreement.
Intellectual Property
Patents and Patent Applications, page 159
11.We note your disclosure on page 42 that two of your patents have been limited in scope in
opposition proceedings in Europe and the patents could ultimately be revoked. It appears
that you only discuss one of the two patents in the IXIARO section on page 160. Please
revise to identify the other patent or clarify whether both patents pertain to
IXIARO. Please also revise to disclose if you expect the potential revocation of
these patents to have any material impact on your plans for further commercialization of
IXIARO, your development plans for your product candidates, if applicable, your patent
portfolio and your business.
Principal Shareholders, page 203
12.Please revise your disclosure to identify the natural person or persons who have voting
and investment control of the shares held by each of your 5% shareholders.
Description of American Depositary Shares
Governing Law/Waiver of Jury Trial, page 242
13.We note your disclosure that the deposit agreement requires ADS holders to waive the
right to a jury trial of any claim they may have against you or the depositary arising out of
or relating to your ordinary shares, the ADSs or the deposit agreement, including any
claim under U.S. federal securities laws. Please add a risk factor to the prospectus
describing this provision, the risks of the provision or other impacts on shareholders, any
uncertainty about enforceability, the impact on claims arising under other laws, and
whether or not the provision applies to purchasers in secondary transactions.
FirstName LastNameThomas Lingelbach
Comapany NameValneva SE
February 11, 2021 Page 4
FirstName LastName
Thomas Lingelbach
Valneva SE
February 11, 2021
Page 4
You may contact Tracey McKoy at 202-551-3772 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Ada D. Sarmento at 202-551-3798 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Marc Recht