View:
United States securities and exchange commission logo
May 17, 2024
Christian Kanstrup
Chief Executive Officer
Evaxion Biotech A/S
Dr. Neergaards Vej 5F
2970 H rsholm
Denmark
Re: Evaxion Biotech A/S
Registration
Statement on Form F-1
Filed May 6, 2024
File No. 333-279153
Dear Christian Kanstrup:
We have conducted a limited review of your registration statement
and have the
following comment.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.
Registration Statement on Form F-1 filed May 6, 2024
General
1. We note certain
statements regarding safety and efficacy in your business overview that is
incorporated into your
prospectus by reference to your most recent annual report on Form
20-F for the year ended
December 31, 2023. For example only and without limitation, you
state in the "Business
overview" section that is incorporated into your prospectus by
reference to your Form
20-F that:
"In addition, the
data showed induction of neoantigen-specific T cells in 100% of
patients and a
favorable safety profile." (page 95)
"Our five AI
models...have allowed us to generate numerous pipeline candidates
within both cancer
and infectious diseases, all with first-in-class potential." (page 97)
"The initial data
demonstrated that the EVX-01 treatment appeared safe and well
tolerated." (page
115)
Christian Kanstrup
Evaxion Biotech A/S
May 17, 2024
Page 2
"Final data from a first-in-human Phase 1/2a clinical
trial...substantiated a promising
safety profile...as well as indicated encouraging clinical outcome
data of our first-
generation neoantigen DNA therapy." (page 116)
"EVX-B2 was developed using our, proprietary AI model EDEN for
B-cell antigen
discovery, to identify novel and, we believe, highly efficacious
B-cell antigen vaccine
targets." (page 135)
"GLA-SE was identified to have the highest adjuvating capacity on
the antigens,
resulting in a formulation with high immunogenicity and protective
efficacy in
vivo and in vitro." (page 136)
"EVX-B2 demonstrates broad protection in a bactericidal assay using
a panel of 50
different relevant clinical isolates with >50% bactericidal killing
recognized as
efficacy." (page 139)
Although we do not object to disclosure regarding the objective results
of a product
candidate study, safety and efficacy determinations are solely within
the authority of the
FDA. Therefore, please revise your registration statement to remove any
statements
regarding safety or efficacy determinations from the "Business overview"
disclosures
required by Part I, Item 4.a of Form F-1. In addition, please remove
references to your
product candidates potentially being "first-in-class" as these
descriptions imply an
expectation of regulatory approval and are inappropriate given the
length of time and
uncertainty with respect to securing marketing approval.
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.
Please contact Jessica Dickerson at 202-551-8013 or Jason Drory at
202-551-8342 with
any other questions.
Sincerely,
FirstName LastNameChristian Kanstrup
Division of
Corporation Finance
Comapany NameEvaxion Biotech A/S
Office of Life
Sciences
May 17, 2024 Page 2
cc: Michael D. Baird, Esq.
FirstName LastName