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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.
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 Corbi re 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 D p
ts 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,
FirstName LastNameThomas Lingelbach
Division of
Corporation Finance
Comapany NameValneva SE
Office of Life
Sciences
April 20, 2021 Page 2
cc: Marc Recht, Esq.
FirstName LastName