Correspondence 0001104659-24-081497 from Evaxion A/S (EVAX)
Evaxion A/S
Date: July 22, 2024 · CIK: 0001828253 · Accession: 0001104659-24-081497
AI Filing Summary & Sentiment
Referenced dates: May 17, 2024
Letter
NEW YORK
LONDON
SINGAPORE
PHILADELPHIA
CHICAGO
WASHINGTON, DC
SAN FRANCISCO
SILICON VALLEY
SAN DIEGO
LOS ANGELES
BOSTON
HOUSTON
DALLAS
FORT WORTH
AUSTIN
FIRM and AFFILIATE OFFICES
www.duanemorris.com
HANOI
HO CHI MINH CITY
SHANGHAI
ATLANTA
BALTIMORE
WILMINGTON
MIAMI
BOCA RATON
PITTSBURGH
NEWARK
LAS VEGAS
CHERRY HILL
LAKE TAHOE
MYANMAR
ALLIANCES IN MEXICO
July 22, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington D.C. 20549-4720
Attn: Jessica Dickerson
Jason Drory
Re: Evaxion Biotech A/S
Draft Registration Statement on Form F-1
Submitted May 6, 2024
CIK No. 0001828253
Ladies and Gentleman:
On behalf of our client, Evaxion Biotech A/S (the “Company”), we are responding to the comments from the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in the Staff’s letter dated May 17, 2024 (the “Comment Letter”) relating to the Company’s Draft Registration Statement on Form F-1 submitted to the Commission on May 6, 2024 (the “Draft Registration Statement”).
In response to the comments set forth in the Comment Letter, the Company has revised the Draft Registration Statement and is submitting a revised draft of the Draft Registration Statement (the “Amended DRS”) together with this response letter. The Amended DRS also contains certain additional updates and revisions.
In addition, we are providing the following responses to your Comment Letter. To assist your review, we have retyped the text of the Staff’s comments in italics below. The responses and information described below are based upon information provided to us by the Company.
Duane Morris llp
865 South Figueroa STREET, SUITE 3100 LOS ANGELES, CA 90017-5450 PHONE: +1 213 689 7400 FAX: +1 213 689 7401
Securities and Exchange Commission
Page 2
Draft Registration Statement on Form F-1 Submitted May 6,
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)
· "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.
In response to the Staff’s comment, the Company has revised the disclosure 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, including all the examples above. The Company has also revised its disclosure to remove any reference to its product candidates potentially being “first-in-class”.
Please do not hesitate to contact Michael D. Baird at (212) 404-8771 or mdbaird@duanemorris.com with any questions you may have regarding this submission or if you wish to discuss any of the above responses.
Securities and Exchange Commission
Page 3
Very
truly yours,
/s/
Michael D. Baird
Show Raw Text
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filename1.htm
NEW
YORK
LONDON
SINGAPORE
PHILADELPHIA
CHICAGO
WASHINGTON, DC
SAN FRANCISCO
SILICON VALLEY
SAN DIEGO
LOS ANGELES
BOSTON
HOUSTON
DALLAS
FORT WORTH
AUSTIN
FIRM and AFFILIATE OFFICES
www.duanemorris.com
HANOI
HO CHI MINH CITY
SHANGHAI
ATLANTA
BALTIMORE
WILMINGTON
MIAMI
BOCA RATON
PITTSBURGH
NEWARK
LAS VEGAS
CHERRY HILL
LAKE TAHOE
MYANMAR
ALLIANCES IN MEXICO
July 22, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington D.C. 20549-4720
Attn: Jessica
Dickerson
Jason Drory
Re: Evaxion
Biotech A/S
Draft Registration Statement on Form F-1
Submitted May 6, 2024
CIK No. 0001828253
Ladies and Gentleman:
On behalf of our client, Evaxion Biotech A/S (the
“Company”), we are responding to the comments from the Staff (the “Staff”) of the Securities and Exchange Commission
(the “Commission”) contained in the Staff’s letter dated May 17, 2024 (the “Comment Letter”) relating
to the Company’s Draft Registration Statement on Form F-1 submitted to the Commission on May 6, 2024 (the “Draft
Registration Statement”).
In response to the comments set forth in the Comment
Letter, the Company has revised the Draft Registration Statement and is submitting a revised draft of the Draft Registration Statement
(the “Amended DRS”) together with this response letter. The Amended DRS also contains certain additional updates and revisions.
In addition, we are providing the following responses
to your Comment Letter. To assist your review, we have retyped the text of the Staff’s comments in italics below. The responses
and information described below are based upon information provided to us by the Company.
Duane
Morris llp
865 South Figueroa STREET, SUITE
3100 LOS ANGELES, CA 90017-5450
PHONE: +1 213 689 7400 FAX:
+1 213 689 7401
Securities and Exchange Commission
Page 2
Draft Registration Statement on Form F-1 Submitted 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)
· "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.
In response to the Staff’s comment, the Company has
revised the disclosure 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, including all the examples above. The Company has also revised its disclosure
to remove any reference to its product candidates potentially being “first-in-class”.
Please
do not hesitate to contact Michael D. Baird at (212) 404-8771 or mdbaird@duanemorris.com with any questions you may have
regarding this submission or if you wish to discuss any of the above responses.
Securities and Exchange Commission
Page 3
Very
truly yours,
/s/
Michael D. Baird
Michael
D. Baird
cc: Christian
Kanstrup, Evaxion Biotech, Inc.