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December 7, 2020
Lars Staal Wagner, M.D.
Chief Executive Officer
Evaxion Biotech A/S
Bredgade 34E
1260 Copenhagen K
Denmark
Re: Evaxion Biotech A/S
Amendment No. 1 to
Draft Registration Statement on Form F-1
Submitted November
25, 2020
CIK No. 0001828253
Dear Dr. Wagner:
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. Our references to prior comments are to comments in our
November 18, 2020 letter.
Amendment No. 1 to Draft Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1. We note your revisions
in response to prior comment 2. Please remove the references to
"encouraging" results
and "highly encouraging" and "strong" preclinical data here and in
the Business section.
Please also revise the statement in the MD&A section that
preliminary data from
your EVX-01 clinical trial shows "early signs of potential efficacy"
in combination with
check point inhibitor therapy.
Lars Staal Wagner, M.D.
FirstName LastNameLars Staal Wagner, M.D.
Evaxion Biotech A/S
Comapany7,
December NameEvaxion
2020 Biotech A/S
December
Page 2 7, 2020 Page 2
FirstName LastName
Our EDEN Platform, page 4
2. We note your revisions in response to prior comment 5. Please remove
the references to
preclinical "confirmation" of EDEN's predictive ability here and in
the Business section.
To the extent that you have not already done so, please revise to
discuss the specific
results of these preclinical models and why you believe those results
indicate that EDEN
may have the ability to predict protective vaccine antigens. Please
also revise the
references to "high efficacy and reduced attrition" in the discussion
of the key strengths of
the EDEN platform on page 5 and in the Business section. Given the
current stage of
development of your product candidates and the number of product
candidates that never
receive FDA approval, such assertions do not seem appropriate.
Liquidity and Capital Resources, page 110
3. Please file the EIB loan agreement, as amended, the form of the
warrants, and the lease
agreement as exhibits to your registration statement. Alternatively,
please explain why
the filing of such documents is not required.
4. We note your disclosure that you are working to obtain new long-term
sources of funding
and believe it is probable that new funding will be obtained in due
time to enable you to
continue your activities as planned at least until September 30, 2021.
Please revise to
clarify if this funding is in addition to the expected proceeds from
your anticipated initial
public offering.
Business
In-Licensing, page 177
5. Please revise to disclose when the royalty term is currently expected
to end for the
PharmaJet agreement or how it is determined.
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,
Division of
Corporation Finance
Office of Life
Sciences
cc: Dwight A. Kinsey, Esq.