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United States securities and exchange commission logo
November 18, 2020
Lars Staal Wagner, M.D.
Chief Executive Officer
Evaxion Biotech A/S
Bredgade 34E
1260 Copenhagen K
Denmark
Re: Evaxion Biotech A/S
Draft Registration
Statement on Form F-1
Submitted October
22, 2020
CIK No. 0001828253
Dear Dr. Wagner:
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
Prospectus Summary
Overview, page 1
1. Please revise your
product pipeline table on pages 2, 116 and 126 to include separate
columns for Phase 2 and
Phase 3.
2. We note certain
statements in this section and in the Business section that preliminary data
from your EVX-01
clinical trial shows "early signs of potential efficacy" in combination
with check point
inhibitor therapy, that you have demonstrated that development and
iterative training of
your AI platform "directly translates into improved antitumor effect in
Lars Staal Wagner, M.D.
FirstName LastNameLars Staal Wagner, M.D.
Evaxion Biotech A/S
Comapany 18,
November NameEvaxion
2020 Biotech A/S
November
Page 2 18, 2020 Page 2
FirstName LastName
pre-clinical studies" and EVX-03 "has shown highly encouraging data in
inducing an
antitumor effect." Efficacy is a determination that is solely within
the authority of the
FDA or similar foreign regulators. You may present clinical trial end
points and objective
data resulting from trials without concluding efficacy. Please revise
these statements
accordingly.
3. We note your disclosure that EDEN is able to identify novel and highly
protective vaccine
antigens within 48 hours and new product candidates can be produced to
be tested in pre-
clinical studies in weeks, that EDEN can identify vaccine candidates
in a matter of weeks
instead of years thus lowering the overall development time and that
you have the ability
to rapidly move from target identification to clinical development in
as little as 18 months
as demonstrated in your EVX-02 program. Please balance this disclosure
by noting, if
true, that there is no guarantee that you will be able to identify
potential drug candidates in
this timeframe in the future and revise these statements to remove any
implication that
you will be able to accelerate the development of your product
candidates as such
statements are speculative.
Our PIONEER Platform, page 2
4. Please briefly explain what the GAMP5 approach is on page 3 and what
GxP compliance
is on page 4.
Our EDEN Platform, page 4
5. Please provide the basis for your statement that "the ability of EDEN
to predict protective
vaccine antigens has been confirmed in pre-clinical models."
Implications of Being an Emerging Growth Company and a Foreign Private Issuer,
page 9
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.
Material Internal Control Weakness, page 20
7. Please expand the risk factor to disclose the number of additional
accounting personnel
you believe are needed to remediate your internal control weakness.
Also, please state the
estimated time period during which you plan to hire the additional
personnel.
Critical Accounting Policies and Estimates
Ordinary Share Valuation, page 113
8. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the awards underlying your warrants
and/or options and the
reasons for any differences between the recent valuations of your
units leading up to the
IPO and the estimated offering price. This information will help
facilitate our review of
Lars Staal Wagner, M.D.
FirstName LastNameLars Staal Wagner, M.D.
Evaxion Biotech A/S
Comapany 18,
November NameEvaxion
2020 Biotech A/S
November
Page 3 18, 2020 Page 3
FirstName LastName
your accounting for equity issuances including unit-based
compensation. Please discuss
with the staff how to submit your response.
Our PIONEER Derived Immuno-Oncology Programs, page 126
9. We note that you do not appear to disclose p-values associated with
the results shown in
the graphics on pages 127, 131 and 133. If the results shown could be
due to chance,
please revise to make that clear.
Our Adaptive Vaccine Approach and RAVEN Process, page 145
10. We note your disclosure that you believe that your platform, once
developed, will allow
you "to rapidly identify, design and manufacture a best in class,
second wave vaccine
against COVID-19 that offers increased efficacy in a larger part of
the human population."
Please delete this statement as it appears to be speculative.
In-Licensing, page 170
11. Please disclose the upfront licensing fee paid, the aggregate future
milestone payments
and the royalty term for the Pharma Jet agreement and file the
agreement as an exhibit or
tell us why you don't believe it is required to be filed. Once you
have entered into the SSI
agreement, please disclose the upfront licensing fee paid, the
aggregate future milestone
payments, the royalty rate on net sales and the royalty term and file
the agreement as an
exhibit or tell us why you do not believe it is required to be filed.
Principal Shareholders, page 188
12. Please revise your disclosure to identify the natural person or
persons who have voting
and investment control of the shares held by Punga Punga C.V.
Description of Share Capital, page 190
13. We note that you refer shareholders to, in part, applicable Danish
law. It is not appropriate
to qualify your disclosure by reference to information that is not
included in the filing or
filed as an exhibit. Please revise accordingly.
Underwriting, page 222
14. We note your disclosure on page 92 that the initial public offering
price for the ADSs was
determined through negotiations with the underwriters. Please discuss
the various factors
considered in such determination. Refer to Item 9(A)(2) of Form 20-F.
Lars Staal Wagner, M.D.
Evaxion Biotech A/S
November 18, 2020
Page 4
You may contact Christine Torney at 202-551-3652 or Al Pavot at
202-551-3738 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Ada D. Sarmento at 202-551-3798 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
FirstName LastNameLars Staal Wagner, M.D.
Division of
Corporation Finance
Comapany NameEvaxion Biotech A/S
Office of Life
Sciences
November 18, 2020 Page 4
cc: Dwight A. Kinsey, Esq.
FirstName LastName