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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
Thomas Lingelbach
FirstName
Valneva SELastNameThomas Lingelbach
Comapany11,
February NameValneva
2021 SE
February
Page 2 11, 2021 Page 2
FirstName LastName
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.
Thomas Lingelbach
FirstName
Valneva SELastNameThomas Lingelbach
Comapany11,
February NameValneva
2021 SE
February
Page 3 11, 2021 Page 3
FirstName LastName
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.
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,
FirstName LastNameThomas Lingelbach
Division of Corporation
Finance
Comapany NameValneva SE
Office of Life Sciences
February 11, 2021 Page 4
cc: Marc Recht
FirstName LastName