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Evaxion A/S
Response Received
1 company response(s)
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Evaxion A/S
Response Received
1 company response(s)
High - file number match
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Company responded
2025-01-28
Evaxion A/S
Summary
CORRESP · 2025-01-28
Generating summary...
Evaxion A/S
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-05-17
Evaxion A/S
Summary
UPLOAD · 2024-05-17
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Company responded
2024-08-20
Evaxion A/S
Summary
CORRESP · 2024-08-20
Generating summary...
Evaxion A/S
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2024-07-22
Evaxion A/S
References: May 17, 2024
Summary
CORRESP · 2024-07-22
Generating summary...
Evaxion A/S
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-01-18
Evaxion A/S
Summary
UPLOAD · 2024-01-18
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Company responded
2024-01-30
Evaxion A/S
Summary
CORRESP · 2024-01-30
Generating summary...
Evaxion A/S
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-07-12
Evaxion A/S
Summary
UPLOAD · 2022-07-12
Generating summary...
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Company responded
2022-08-24
Evaxion A/S
Summary
CORRESP · 2022-08-24
Generating summary...
Evaxion A/S
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-05-27
Evaxion A/S
Summary
UPLOAD · 2022-05-27
Generating summary...
↓
Company responded
2022-06-01
Evaxion A/S
Summary
CORRESP · 2022-06-01
Generating summary...
Evaxion A/S
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2021-11-03
Evaxion A/S
References: October 29, 2021
Summary
CORRESP · 2021-11-03
Generating summary...
Evaxion A/S
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2021-11-03
Evaxion A/S
References: October 29, 2021
Summary
CORRESP · 2021-11-03
Generating summary...
Evaxion A/S
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2021-10-29
Evaxion A/S
Summary
CORRESP · 2021-10-29
Generating summary...
Evaxion A/S
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2021-10-29
Evaxion A/S
Summary
CORRESP · 2021-10-29
Generating summary...
Evaxion A/S
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-06-29
Evaxion A/S
Summary
UPLOAD · 2021-06-29
Generating summary...
Evaxion A/S
Response Received
4 company response(s)
High - file number match
Company responded
2021-01-22
Evaxion A/S
References: November 18, 2020
Summary
CORRESP · 2021-01-22
Generating summary...
↓
SEC wrote to company
2021-01-28
Evaxion A/S
Summary
UPLOAD · 2021-01-28
Generating summary...
↓
Company responded
2021-02-01
Evaxion A/S
References: January 28, 2021
Summary
CORRESP · 2021-02-01
Generating summary...
↓
Company responded
2021-02-02
Evaxion A/S
Summary
CORRESP · 2021-02-02
Generating summary...
↓
Company responded
2021-02-02
Evaxion A/S
Summary
CORRESP · 2021-02-02
Generating summary...
Evaxion A/S
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2020-12-22
Evaxion A/S
References: November 18, 2020
Summary
UPLOAD · 2020-12-22
Generating summary...
Evaxion A/S
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2020-12-07
Evaxion A/S
Summary
UPLOAD · 2020-12-07
Generating summary...
Evaxion A/S
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2020-11-18
Evaxion A/S
Summary
UPLOAD · 2020-11-18
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-20 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2025-03-19 | SEC Comment Letter | Evaxion A/S | Denmark | 333-285778 | Read Filing View |
| 2025-01-28 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2024-11-22 | SEC Comment Letter | Evaxion A/S | Denmark | 333-283304 | Read Filing View |
| 2024-08-20 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2024-07-22 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2024-05-17 | SEC Comment Letter | Evaxion A/S | Denmark | 333-279153 | Read Filing View |
| 2024-01-30 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2024-01-18 | SEC Comment Letter | Evaxion A/S | Denmark | 333-276505 | Read Filing View |
| 2022-08-24 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2022-07-12 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2022-06-01 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2022-05-27 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-11-03 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-11-03 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-10-29 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-10-29 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-06-29 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-02-02 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-02-02 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-02-01 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-01-28 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-01-22 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2020-12-22 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2020-12-07 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2020-11-18 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-19 | SEC Comment Letter | Evaxion A/S | Denmark | 333-285778 | Read Filing View |
| 2024-11-22 | SEC Comment Letter | Evaxion A/S | Denmark | 333-283304 | Read Filing View |
| 2024-05-17 | SEC Comment Letter | Evaxion A/S | Denmark | 333-279153 | Read Filing View |
| 2024-01-18 | SEC Comment Letter | Evaxion A/S | Denmark | 333-276505 | Read Filing View |
| 2022-07-12 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2022-05-27 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-06-29 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-01-28 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2020-12-22 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2020-12-07 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2020-11-18 | SEC Comment Letter | Evaxion A/S | Denmark | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-20 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2025-01-28 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2024-08-20 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2024-07-22 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2024-01-30 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2022-08-24 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2022-06-01 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-11-03 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-11-03 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-10-29 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-10-29 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-02-02 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-02-02 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-02-01 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
| 2021-01-22 | Company Response | Evaxion A/S | Denmark | N/A | Read Filing View |
2025-03-20 - CORRESP - Evaxion A/S
CORRESP 1 filename1.htm Evaxion Biotech A/S Dr. Neergaards Vej 5F 2970 Hørsholm Denmark Telephone: +45 31 31 97 53 March 20, 2025 U.S. Securities and Exchange Commission Office of Life Sciences Division of Corporation Finance 100 F Street, N.E. Mail Stop 4546 Washington, D.C. 20549 Attn: Mr. Tyler Howes Re: Evaxion Biotech A/S Registration Statement on Form F-3 (File No. 333- 285778) Acceleration Request Requested Date: March 24, 2025 Requested Time: 4:30 P.M. Eastern Time Dear Mr. Howes: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned registrant (the " Registrant ") hereby requests that the Securities and Exchange Commission (the " Commission ") take appropriate action to cause the above-referenced Registration Statement on Form F-3 (File No. 333-285778) (the "Registration Statement ") to become effective on Monday, March 24, 2025, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff (the " Staff "). Once the Registration Statement has been declared effective, please orally confirm that event with Michael D. Baird of Duane Morris LLP by telephone at (215) 870-6771, or if you have any questions or require additional information regarding this matter. Thank you for your assistance and cooperation in this matter. The Company understands that the Staff will consider this request as confirmation by the Company of its awareness of its responsibilities under the federal securities laws as they relate to the offering of the securities covered by the Registration Statement. Very truly yours, Evaxion Biotech A/S By: /s/ Christian Kanstrup Christian Kanstrup Chief Executive Officer cc: Michael D. Baird, Duane Morris LLP Lars Lüthjohan Jensen, Mazanati-Andersen 2
2025-03-19 - UPLOAD - Evaxion A/S File: 333-285778
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 19, 2025 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-3 Filed March 13, 2025 File No. 333-285778 Dear Christian Kanstrup: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. 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. Please contact Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Michael D. Baird, Esq. </TEXT> </DOCUMENT>
2025-01-28 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
Evaxion Biotech A/S
Dr. Neergaards
Vej 5F
2970 Hørsholm
Denmark
Telephone: +45 31 31
97 53
January 28, 2025
U.S. Securities and Exchange Commission
Office of Life Sciences
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 4546
Washington, D.C. 20549
Attn:
Mr. Tyler Howes
Re: Evaxion Biotech A/S
Registration Statement on Form F-1 (File
No. 333-283304)
Acceleration Request
Requested Date: January 29, 2025
Requested Time: 5:00 P.M. Eastern Time
Dear Mr. Howes:
In accordance with Rule 461 of
Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned registrant (the
“Registrant”) hereby requests that the Securities and Exchange Commission (the
“Commission”) take appropriate action to cause the above-referenced Registration Statement on
Form F-1 (File No. 333-283304) (the “Registration Statement”) to become effective on Wednesday,
January 29, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time as the Registrant or its
counsel may orally request via telephone call to the staff (the “Staff”).
Once the Registration Statement has been declared
effective, please orally confirm that event with Michael D. Baird of Duane Morris LLP by telephone at (215) 870-6771, or if you have any
questions or require additional information regarding this matter. Thank you for your assistance and cooperation in this matter.
The Company understands that the Staff will consider
this request as confirmation by the Company of its awareness of its responsibilities under the federal securities laws as they relate
to the offering of the securities covered by the Registration Statement.
Very truly yours,
Evaxion Biotech A/S
By:
/s/ Christian Kanstrup
Christian Kanstrup
Chief Executive Officer
cc:
Michael D. Baird, Duane Morris LLP
Lars
Lüthjohan Jensen, Mazanati-Andersen
2
2024-11-22 - UPLOAD - Evaxion A/S File: 333-283304
November 22, 2024
Christian Kanstrup
Chief Executive Officer
Evaxion Biotech A/S
Dr. Neergaards Vej 5F
2970 Hørsholm
Denmark
Re:Evaxion Biotech A/S
Registration Statement on Form F-1
Filed November 18, 2024
File No. 333-283304
Dear Christian Kanstrup :
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Michael D. Baird, Esq.
2024-08-20 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
Evaxion Biotech A/S
Dr. Neergaards
Vej 5F
2970 Hørsholm
Denmark
Telephone: +45 31 31
97 53
August 20, 2024
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
Registration Statement on Form F-1 (File
No. 333-279153)
Acceleration Request
Requested Date: August 22, 2024
Requested Time: 4:30 P.M. Eastern Time
Dear Ms. Dickerson:
In accordance with Rule 461 of Regulation
C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”)
hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause
the above-referenced Registration Statement on Form F-1 (File No. 333-279153) (the “Registration Statement”)
to become effective on Thursday, August 22, 2024, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable, or at such later
time as the Registrant or its counsel may orally request via telephone call to the staff (the “Staff”).
Once the Registration Statement has been declared
effective, please orally confirm that event with Michael D. Baird of Duane Morris LLP by telephone at (215) 870-6771, or if you have any
questions or require additional information regarding this matter. Thank you for your assistance and cooperation in this matter.
The Company understands that the Staff will consider
this request as confirmation by the Company of its awareness of its responsibilities under the federal securities laws as they relate
to the offering of the securities covered by the Registration Statement.
Very truly yours,
Evaxion Biotech A/S
By:
/s/ Christian Kanstrup
Christian Kanstrup
Chief Executive Officer
cc:
Michael D. Baird, Duane Morris LLP
Lars Lüthjohan
Jensen, Mazanati-Andersen
2
2024-07-22 - CORRESP - Evaxion A/S
CORRESP
1
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.
2024-05-17 - UPLOAD - Evaxion A/S File: 333-279153
United States securities and exchange commission logo
May 17, 2024
Christian Kanstrup
Chief Executive Officer
Evaxion Biotech A/S
Dr. Neergaards Vej 5F
2970 Hørsholm
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)
FirstName LastNameChristian Kanstrup
Comapany NameEvaxion Biotech A/S
May 17, 2024 Page 2
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: Michael D. Baird, Esq.
2024-01-30 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
Evaxion Biotech A/S
Dr. Neergaards
Vej 5F
2970 Hørsholm
Denmark
Telephone: +45 31 31
97 53
January 30, 2024
U.S. Securities and Exchange Commission
Office of Life Sciences
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 4546
Washington, D.C. 20549
Attn:
Mr. Alan Campbell
Re: Evaxion Biotech A/S
Registration Statement on Form F-1 (File No. 333-276505)
Acceleration Request
Requested Date: January 31, 2024
Requested Time: 5:15 P.M. Eastern Time
Dear Mr. Campbell:
In accordance with Rule 461 of Regulation C of
the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”)
hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause
the above-referenced Registration Statement on Form F-1 (File No. 333-276505) (the “Registration Statement”)
to become effective on Wednesday, January 31, 2024, at 5:15 p.m., Eastern Time, or as soon thereafter as practicable, or at such later
time as the Registrant or its counsel may orally request via telephone call to the staff (the “Staff”).
Once the Registration Statement has been
declared effective, please orally confirm that event with Michael D. Baird of Duane Morris LLP by telephone at (215) 870-6771, or in
his absence you can also contact Dwight A. Kinsey of Duane Morris LLP by telephone at (917) 620-3675, or if you have any questions
or require additional information regarding this matter. Thank you for your assistance and cooperation in this matter.
The Company understands that the Staff will
consider this request as confirmation by the Company of its awareness of its responsibilities under the federal securities laws as they
relate to the offering of the securities covered by the Registration Statement.
Very truly yours,
Evaxion Biotech A/S
By:
/s/ Christian Kanstrup
Christian Kanstrup
Chief Executive Officer
cc:
Dwight A. Kinsey, Duane Morris LLP
Michael D. Baird, Duane Morris LLP
Lars Lüthjohan Jensen, Mazanati-Andersen
2
2024-01-18 - UPLOAD - Evaxion A/S File: 333-276505
United States securities and exchange commission logo
January 18, 2024
Christian Kanstrup
Chief Executive Officer
Evaxion Biotech A/S
Dr. Neergaards Vej 5F
2970 Hørsholm
Denmark
Re:Evaxion Biotech A/S
Registration Statement on Form F-1
Filed January 12, 2024
File No. 333-276505
Dear Christian Kanstrup:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael D. Baird
2022-08-24 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
Evaxion Biotech A/S
Dr. Neergaards Vej 5F, 2970
Hørsholm, Denmark
August 24, 2022
U.S. Securities and Exchange Commission
Office of Life Sciences
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Tim Buchmiller
Re: Evaxion Biotech A/S – Registration Statement on Form F-1 Filed on July 7, 2022, as amended (File No. 333-266050)
Acceleration Request
Requested Date: August 26, 2022
Requested Time: 4:30 P.M. Eastern Time
Dear Mr. Buchmiller:
In accordance with Rule 461 of Regulation C of
the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”)
hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause
the above-referenced Registration Statement on Form F-1 filed on July 7, 2022, as amended (File No. 333-266050) (the “Registration
Statement”), to become effective on Friday, August 26, 2022, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable,
or at such later time as the Registrant or its counsel, Duane Morris LLP, may orally request via telephone call to the staff (the “Staff”).
Once the Registration Statement has been declared effective, please orally confirm that event with Dwight A. Kinsey of Duane Morris LLP
by telephone at (917) 620-3675, or in his absence you can also contact Rina R. Patel of Duane Morris LLP by telephone at (212) 404-8736,
or if you have any questions or require additional information regarding this matter. Thank you for your assistance and cooperation in
this matter.
The Registrant understands that the Staff will consider this request as confirmation by the Registrant of its awareness of its responsibilities
under the federal securities laws as they relate to the offering of the securities covered by the Registration Statement.
Very truly yours,
Evaxion Biotech A/S
By:
/s/ Lori Hollander
Lori Hollander
Vice President,
Financial Planning and Analysis
cc:
Lars Wegner, Evaxion Biotech A/S
Jesper Nyegaard Nissen, Evaxion Biotech A/S
Bo Karmark, Evaxion Biotech A/S
Dwight A. Kinsey, Duane Morris LLP
Rina R. Patel, Duane Morris LLP
Lars Lüthjohan Jensen, Mazanti-Andersen
Gyrithe Falck, Mazanti-Andersen
2
2022-07-12 - UPLOAD - Evaxion A/S
United States securities and exchange commission logo
July 12, 2022
Bo Karmark
Chief Financial Officer
Evaxion Biotech A/S
Dr. Neergaards Vej 5F
2970 Hørsholm
Denmark
Re:Evaxion Biotech A/S
Registration Statement on Form F-1
Filed July 7, 2022
File No. 333-266050
Dear Mr. Karmark:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Dwight A. Kinsey, Esq.
2022-06-01 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
Evaxion Biotech A/S
Dr. Neergaards Vej 5F, 2970
Hørsholm, Denmark
June
1, 2022
U.S.
Securities and Exchange Commission
Office of Life Sciences
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 4546
Washington, D.C. 20549
Attn:
Christopher Edwards
Re: Evaxion Biotech A/S
Registration Statement on Form F-3 (File No. 333-265132)
Acceleration Request
Requested Date: June 3, 2022
Requested Time: 4:30 P.M. Eastern Time
Dear Mr. Edwards:
In accordance with Rule 461 of Regulation
C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”)
hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause
the above-referenced Registration Statement on Form F-3 (File No. 333-265132) (the “Registration Statement”)
to become effective on Friday, June 3, 2022, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time
as the Registrant or its counsel, Duane Morris LLP, may orally request via telephone call to the staff (the “Staff”).
Once the Registration Statement has been declared
effective, please orally confirm that event with Dwight A. Kinsey of Duane Morris LLP by telephone at (917) 620-3675, or in his absence
you can also contact Rina R. Patel of Duane Morris LLP by telephone at (212) 404-8736, or if you have any questions or require additional
information regarding this matter. Thank you for your assistance and cooperation in this matter.
The Company understands that the Staff will consider
this request as confirmation by the Company of its awareness of its responsibilities under the federal securities laws as they relate
to the offering of the securities covered by the Registration Statement.
Very truly yours,
Evaxion Biotech A/S
By:
/s/
Lori Hollander
Lori Hollander
Vice President, Financial Planning and Analysis
cc:
Lars Wegner, Evaxion Biotech A/S
Jesper Nyegaard Nissen, Evaxion Biotech A/S
Bo Karmark, Evaxion Biotech A/S
Dwight A. Kinsey, Duane Morris LLP
Rina R. Patel, Duane Morris LLP
Lars Lüthjohan
Jensen, Mazanati-Andersen
2
2022-05-27 - UPLOAD - Evaxion A/S
United States securities and exchange commission logo
May 27, 2022
Jesper Nyegaard Nissen
Chief Operating Officer
Evaxion Biotech A/S
Dr. Neergaards Vej 5F
2970 Hørsholm
Denmark
Re:Evaxion Biotech A/S
Registration Statement on Form F-3
Filed May 20, 2022
File No. 333-265132
Dear Mr. Nissen:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Rina R. Patel
2021-11-03 - CORRESP - Evaxion A/S
CORRESP
1
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Evaxion Biotech A/S
Dr. Neergaards Vej 5F, 2970
Hørsholm, Denmark
November
3, 2021
U.S. Securities and Exchange Commission
Office of Life Sciences
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 4546
Washington, D.C. 20549
Attn:
Ms. Ada Sarmento
Re: Evaxion Biotech A/S
Amendment No. 1 to Registration Statement on
Form F-1 (File No. 333-260493)
Acceleration Request
Requested Date: November 4,
2021
Requested Time: 4:30 P.M. Eastern
Time
Dear Ms. Sarmento:
In accordance with Rule 461 of
Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned registrant (the
“Registrant”) hereby requests that the Securities and Exchange Commission (the
“Commission”) take appropriate action to cause the above-referenced Amendment No. 1 to Registration
Statement on Form F-1 (File No. 333-260493) (the “Registration Statement”) to become effective
on Thursday, November 4, 2021, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time as the
Registrant or its counsel may orally request via telephone call to the staff (the “Staff”). This letter supersedes our previous acceleration request joinder letter dated October 29, 2021; please disregard that letter in favor
of this one.
Once the Registration Statement, as amended,
has been declared effective, please orally confirm that event with Dwight A. Kinsey of Duane Morris LLP by telephone at (917)
620-3675, or in his absence you can also contact Rina R. Patel of Duane Morris LLP by telephone at (212) 404-8736, or if you have
any questions or require additional information regarding this matter. Thank you for your assistance and cooperation in this
matter.
The Company understands that the Staff will consider
this request as confirmation by the Company of its awareness of its responsibilities under the federal securities laws as they relate
to the offering of the securities covered by the Registration Statement.
Very truly yours,
Evaxion Biotech A/S
By:
/s/
Lars Staal Wegner, M. D.
Name: Lars Staal Wegner, M. D.
Title: Chief Executive
Officer
cc:
Dwight A. Kinsey, Duane Morris LLP
Rina R. Patel, Duane Morris LLP
Lars Lüthjohan Jensen, Mazanati-Andersen
Ivan Blumenthal, Mintz, Levin; Cohn,
Ferris, Glovsky and Popeo LLP
Keunjung Cho, Mintz Levin Cohn,
Ferris Glovsky and Popeo LLP
2
2021-11-03 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
Oppenheimer
& Co. Inc.
85 Broad Street
New York, New York 10004
November 3, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Evaxion Biotech A/S
Registration Statement on Form F-1
File No. 333-260493
Ladies and Gentlemen:
In accordance with the
above-referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations of the Securities and Exchange
Commission under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as the representative of
the several underwriters (the “Representative”), hereby joins in the request of Evaxion Biotech A/S that the effective date
of the above-referenced Registration Statement be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time, on
Thursday, November 4, 2021, or as soon thereafter as practicable. This letter supersedes our previous acceleration request joinder letter
dated October 29, 2021; please disregard that letter in favor of this one.
Pursuant to Rule 460
under the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably anticipated
to be invited to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears
to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned, as the
representative of the several underwriters, represents that the several underwriters have and will comply with the requirements of Rule 15c2-8 under
the Securities Exchange Act of 1934, as amended.
Very truly yours,
OPPENHEIMER &
CO. INC.
As representative of the
several Underwriters
OPPENHEIMER & CO. INC.
By:
/s/ Michael Margolis R.Ph.
Name:
Michael Margolis R.Ph.
Title:
Senior Managing Director, Co-Head Healthcare Investment Banking
2021-10-29 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
Evaxion Biotech A/S
Dr. Neergaards Vej 5F, 2970
Hørsholm, Denmark
October 29,
2021
U.S. Securities and Exchange Commission
Office of Life Sciences
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 4546
Washington, D.C. 20549
Attn:
Ms. Ada Sarmento
Re: Evaxion Biotech A/S
Registration Statement on Form F-1 (File No. 333-260493)
Acceleration Request
Requested Date: November 2,
2021
Requested Time: 4:30 P.M. Eastern
Time
Dear Ms. Sarmento:
In accordance with Rule 461 of Regulation
C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”)
hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause
the above-referenced Registration Statement on Form F-1 (File No. 333-260493) (the “Registration Statement”)
to become effective on Tuesday, November 2, 2021, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable, or at such
later time as the Registrant or its counsel may orally request via telephone call to the staff (the “Staff”).
Once the Registration Statement has been declared
effective, please orally confirm that event with Dwight A. Kinsey of Duane Morris LLP by telephone at (917) 620-3675, or in his absence
you can also contact Rina R. Patel of Duane Morris LLP by telephone at (212) 404-8736, or if you have any questions or require additional
information regarding this matter. Thank you for your assistance and cooperation in this matter.
The Company understands that the Staff will consider
this request as confirmation by the Company of its awareness of its responsibilities under the federal securities laws as they relate
to the offering of the securities covered by the Registration Statement.
Very truly yours,
Evaxion Biotech A/S
By:
/s/
Glenn S. Vraniak
Glenn S. Vraniak
Chief Financial Officer
cc:
Lars Wegner, Evaxion Biotech A/S
Dwight A. Kinsey, Duane Morris LLP
Rina R. Patel, Duane Morris LLP
Lars Lüthjohan Jensen, Mazanati-Andersen
Ivan Blumenthal, Mintz, Levin; Cohn,
Ferris, Glovsky and Popeo LLP
Keunjung Cho, Mintz Levin Cohn,
Ferris Glovsky and Popeo LLP
2
2021-10-29 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
Oppenheimer &
Co. Inc.
85 Broad Street
New York,
New York 10004
October 29, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Evaxion Biotech A/S
Registration Statement on Form F-1
File No. 333-260493
Ladies and Gentlemen:
In accordance with the above-referenced
Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations of the Securities and Exchange Commission
under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as the representative of the several
underwriters (the “Representative”), hereby joins in the request of Evaxion Biotech A/S that the effective date of the above-referenced
Registration Statement be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time, on Tuesday, November 2,
2021, or as soon thereafter as practicable.
Pursuant to Rule 460
under the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably anticipated
to be invited to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears
to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned, as the representative
of the several underwriters, represents that the several underwriters have and will comply with the requirements of Rule 15c2-8 under
the Securities Exchange Act of 1934, as amended.
Very truly yours,
OPPENHEIMER & CO. INC.
As representative of the
several Underwriters
OPPENHEIMER & CO. INC.
By:
/s/ Michael Margolis R.Ph.
Name: Michael Margolis R.Ph.
Title: Senior Managing Director, Co-Head
Healthcare Investment Banking
2021-06-29 - UPLOAD - Evaxion A/S
United States securities and exchange commission logo
June 29, 2021
Lars Staal Wegner, MD
Chief Executive Officer
Evaxion Biotech A/S
Dr. Neergaards vej 5F
2970 Hørsholm
Denmark
Re:Evaxion Biotech A/S
Draft Registration Statement on From F-1
Submitted June 25, 2021
CIK No. 0001828253
Dear Dr. Wegner:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. 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.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Dwight A. Kinsey, Esq.
2021-02-02 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
Evaxion Biotech A/S
Bredgade 34E, 1260 Copenhagen K, Denmark
February 2, 2021
U.S. Securities and Exchange Commission
Office of Life Sciences
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Ms. Ada Sarmento
Mr. Tim Buchmiller
Re: Evaxion Biotech A/S
Registration Statement on Form F-1, as
amended (File No. 333-251982)
Acceleration Request
Requested Date:
February 4, 2021
Requested Time:
4:00 P.M. Eastern Time,
Ladies and Gentlemen:
In accordance with Rule 461 of Regulation
C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”)
hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action
to cause the above-referenced Registration Statement on Form F-1 (File No. 333-251982) (the “Registration Statement”)
to become effective on Thursday, February 4, 2021, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, or at such
later time as the Registrant or its counsel may orally request via telephone call to the staff (the “Staff”).
Once the Registration Statement has
been declared effective, please orally confirm that event with Dwight A. Kinsey of Duane Morris LLP by telephone at (917)
620-3675, or in his absence you can also contact Rina R. Patel of Duane Morris LLP by telephone at (212) 404-8736, or if you
have any questions or require additional information regarding this matter. Thank you for your assistance and cooperation in
this matter.
The Company understands that the Staff will
consider this request as confirmation by the Company of its awareness of its responsibilities under the federal securities laws
as they relate to the offering of the securities covered by the Registration Statement.
Very truly yours,
Evaxion Biotech A/S
By:
/s/
Glenn S. Vraniak
Glenn S. Vraniak
Chief Financial Officer
cc:
Lars Wegner, Evaxion Biotech A/S
Dwight A. Kinsey, Duane Morris LLP
Rina R. Patel, Duane Morris LLP
Lars Lüthjohan Jensen, Mazanati-Andersen
Ivan Blumenthal, Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo, P.C.
Cliff M. Silverman, Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo, P.C.
2021-02-02 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
Oppenheimer &
Co. Inc.
85
Broad Street
New
York, New York 10004
February 2,
2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Evaxion
Biotech A/S
Registration
Statement on Form F-1, as amended
File
No. 333-251982
Ladies
and Gentlemen:
In
accordance with the above-referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations
of the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), the
undersigned, as the representative of the several underwriters (the “Representative”), hereby joins in the request
of Evaxion Biotech A/S that the effective date of the above-referenced Registration Statement be accelerated so that it will be
declared effective at 4:00 p.m., Eastern Time, on February 4, 2021, or as soon thereafter as practicable.
Pursuant
to Rule 460 under the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who
is reasonably anticipated to be invited to participate in the distribution of the security, as many copies of the proposed form
of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The
undersigned, as the representative of the several underwriters, represents that the several underwriters have and will comply
with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very
truly yours,
OPPENHEIMER &
CO. INC.
As
representative of the
several
Underwriters
OPPENHEIMER & CO. INC.
By:
/s/ Michael Margolis R.Ph.
Name:
Michael Margolis R.Ph.
Title:
Managing Director, Co-Head of Healthcare Investment Banking
2021-02-01 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
NEW YORK
LONDON
SINGAPORE
PHILADELPHIA
CHICAGO
WASHINGTON, DC
SAN FRANCISCO
SILICON VALLEY
SAN DIEGO
LOS ANGELES
TAIWAN
BOSTON
HOUSTON
AUSTIN
HANOI
HO CHI MINH CITY
SHANGHAI
ATLANTA
BALTIMORE
WILMINGTON
MIAMI
BOCA RATON
PITTSBURGH
NEWARK
LAS VEGAS
CHERRY HILL
LAKE TAHOE
MYANMAR ALLIANCES IN
MEXICO
AND SRI LANKA
FIRM and AFFILIATE OFFICES
Dwight A. Kinsey
DIRECT DIAL: +1 212 404 8727
PERSONAL FAX: +1 212 818 9606
E-MAIL: DAKinsey@duanemorris.com
www.duanemorris.com
February 1, 2021
VIA EDGAR
Ms. Ada D. Sarmento
Tom Buchmiller
Office of Healthcare & Insurance
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
Re. Evaxion Biotech A/S
Amendment No. 1 to Registration Statement
on
Form F-1 Filed January 19, 2021
Amendment No. 2 to Registration Statement
on
Form F-1 Filed January 25, 2021
File No. 333-251982
Dear Ms. Sarmento:
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 January 28, 2021 (the
“Comment Letter”) relating to the Company’s Amendment No. 1 to Registration Statement on Form F-1 filed
with the Commission on January 19, 2021, and Amendment No. 2 to Registration Statement on Form F-1 filed with the Commission on
January 25, 2021 (File No. 333-251982) (collectively referred to herein as the “Amended Registration Statement”).
January 4, 2021
Page 2
In response to the comments set forth in
the Comment Letter, the Company has revised the Amended Registration Statement and is filing an Amendment No. 3 to
Registration Statement (the “Amendment No. 3”) together with this response letter. The Amendment No. 3
also contains certain additional updates and revisions.
Set forth below are the Company’s responses
to the Staff’s comments. The responses below are based on information provided to us by the Company. The headings and paragraph
numbers of this response letter correspond to the headings and paragraph numbers contained in the Comment Letter and, to facilitate
the Staff’s review, we have reproduced the text of the Staff’s comments below in bold italics. Capitalized terms used
but not defined herein have the meanings given to them in Amendment No. 3. All references to page numbers and captions (other than
those in the Staff’s comments) correspond to the page numbers and captions in Amendment No. 3.
Amendment No. 1 to Registration Statement
on Form F-1
In-Licensing, page 178
1. We note your revisions in response to prior comment one and reissue in part. Please revise to disclose the royalty term.
RESPONSE: In response to the Staff’s
comment, the Company respectfully advises the Staff that it has revised the disclosure on page 178 to include the royalty term
of the SSI license agreement.
Amendment No. 2 to Registration Statement
on Form F-1
Danish Tax Considerations, page 223
2. We note that the tax opinion filed as Exhibit 8.1 appears to be a short-form tax opinion. Please revise to clearly identify
that the "Taxation – Danish Tax Considerations" disclosure is the opinion of the counsel or accountant. Please
also revise the opinion to include a similar statement and to provide the consent of counsel or of the accountant to being named
in the registration statement. Counsel or the accountant must opine on the tax consequences of the offering, not the manner in
which those consequences are described in the prospectus. For guidance, refer to Sections III.B.2 and III.C.2 of Staff Legal Bulletin
No. 19.
RESPONSE: In response to the
Staff’s comment, the Company respectfully advises the Staff that it has revised the disclosure on page 224 to indicate
that to the extent that the discussion in the section entitled “Taxation – Danish Tax Considerations”
relates to matters of Danish tax law, it represents the opinion of PricewaterhouseCoopers Statsautoriseret
Revisionspartnerselskab. In addition, a new Exhibit 8.1 has been added to include a similar statement that such
statements are the opinion of PricewaterhouseCoopers Statsautoriseret Revisionspartnerselska and to include their consent to
being named in the registration statement.
****
January 4, 2021
Page 3
We thank the Staff in advance for its consideration
of the Amendment No. 3 and hope the Staff finds that the foregoing answers are responsive to its comments. Please do not hesitate
to contact the undersigned by telephone at 917-620-3675, by fax at (212) 818-9606 or by email at dakinsey@duanemorris.com
or you can also contact Rina R. Patel of our office by telephone at (212) 404-8736, by fax at (212) 818-9607 or by email at rrpatel@duanemorris.com
with any questions or comments regarding this response letter or Amendment No. 3.
Very truly yours,
/s/ Dwight A. Kinsey
Dwight A. Kinsey
DAK/jr
2021-01-28 - UPLOAD - Evaxion A/S
United States securities and exchange commission logo
January 28, 2021
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 Registration Statement on Form F-1
Filed January 19, 2021
Amendment No. 2 to Registration Statement on Form F-1
Filed January 25, 2021
File No. 333-251982
Dear Dr. Wagner:
We have reviewed your amended registration statements 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to oral comments issued on January 14, 2021.
Amendment No. 1 to Registration Statement on Form F-1
In-Licensing, page 178
1.We note your revisions in response to prior comment one and reissue in part. Please
revise to disclose the royalty term.
FirstName LastNameLars Staal Wagner, M.D.
Comapany NameEvaxion Biotech A/S
January 28, 2021 Page 2
FirstName LastName
Lars Staal Wagner, M.D.
Evaxion Biotech A/S
January 28, 2021
Page 2
Amendment No. 2 to Registration Statement on Form F-1
Danish Tax Considerations, page 223
2.We note that the tax opinion filed as Exhibit 8.1 appears to be a short-form tax opinion.
Please revise to clearly identify that the "Taxation – Danish Tax
Considerations" disclosure is the opinion of the counsel or accountant. Please also revise
the opinion to include a similar statement and to provide the consent of counsel or of the
accountant to being named in the registration statement. Counsel or the accountant must
opine on the tax consequences of the offering, not the manner in which those
consequences are described in the prospectus. For guidance, refer to Sections III.B.2 and
III.C.2 of Staff Legal Bulletin No. 19.
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.
2021-01-22 - CORRESP - Evaxion A/S
CORRESP
1
filename1.htm
NEW YORK
LONDON
SINGAPORE
PHILADELPHIA
CHICAGO
WASHINGTON, DC
SAN FRANCISCO
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NEWARK
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MYANMAR
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AND SRI LANKA
Dwight A. Kinsey
DIRECT DIAL: +1 212 404 8727
PERSONAL FAX: +1 212 818 9606
E-MAIL: DAKinsey@duanemorris.com
www.duanemorris.com
January 22,
2021
VIA EDGAR
Ms. Ada D. Sarmento
Office of Healthcare and Insurance
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Mail Stop 4311
Washington, D.C. 20549
Re: Evaxion Biotech A/S -
Anticipated Price Range/
Registration Statement on Form F-1 (File No. 333-251982)
Dear Ms. Sarmento:
On behalf of Evaxion Biotech A/S (the “Company”),
we submit this supplemental letter in response to Comment No. 8 from the staff (the “Staff”) of
the Securities and Exchange Commission (the “Commission”) in its letter dated November 18, 2020
(the “Comment Letter”), relating to the Draft Registration Statement on Form S-1 (CIK No. 0001828253),
originally submitted on a confidential basis by the Company to the Commission on October 22, 2020, and as revised and further
submitted on a confidential basis on November 25, 2020, December 16, 2020 and January 4, 2021 and publicly filed
on January 8, 2021 (as amended, the “Registration Statement”).
Because of the commercially sensitive nature
of information contained herein, certain information has been omitted and has been marked by [****] to show the portions redacted
in the version filed via EDGAR and for which the Company is seeking confidential treatment.
[****] Certain information in this letter
has been omitted and submitted separately with the Securities and Exchanges Commission. Confidential treatment has been requested
by Evaxion Biotech A/S with respect to such portions of this letter.
Duane Morris LLP
January 22, 2021
Page 2
Set forth below are the Company’s
responses to the Staff’s Comment No. 8 in the Comment Letter. The responses below are based on information provided
to us by the Company. The headings and paragraph numbers of this response letter correspond to the headings and paragraph numbers
contained in the Comment Letter and, to facilitate the Staff’s review, we have reproduced below in bold italics the text
of the Staff’s comments in the Comment Letter. Capitalized terms used but not defined herein have the meanings given to them
in the Registration Statement. All references to page numbers and captions (other than those in the Staff’s comments)
correspond to the page numbers and captions in the Registration Statement.
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 your accounting for equity issuances including unit-based compensation. Please
discuss with the staff how to submit your response.
RESPONSE:
Determination of Estimated Preliminary
Initial Public Offering Price Range
The Company supplementally advises the Staff
that, although not yet reflected in the Registration Statement, based on (i) discussions with the Company’s Board of
Directors (the “Board”), with the lead underwriters (the “Underwriters”) for
the Company’s initial public offering (“IPO”), (ii) over ten testing-the-water meetings with
professional investors and (iii) current market conditions, if the Company were to commence marketing of the IPO today the
Company anticipates that the estimated price range would be $[****] to $[****] per share (the “Preliminary Price Range”),
resulting in a midpoint of the Preliminary Price Range of $[****] per share (the “Midpoint Price”).
The Company advises the Staff that the
Preliminary Price Range represents the Company’s belief of what the bona fide price range to be disclosed in an
amendment to the Registration Statement and the preliminary prospectus will be. Furthermore, the actual bona fide price range
to be included in an amendment to the Registration Statement and preliminary prospectus is subject to further change, which
may result from various factors, including but not limited to then-current market conditions and subsequent business, market
and other developments affecting the Company and its markets. For clarity, the Company advises the Staff that, given the
volatility of the public trading markets and the uncertainty of the timing of the offering, the price range for the IPO
remains under discussion between the Company and the Underwriters. The Company advises the Staff that the final range to be
included in a pre-effective amendment to the Registration Statement will include a price range of no more than $2.00 or 10%
of the low end of the range, unless otherwise approved by the Staff.
[****] Certain information in this letter
has been omitted and submitted separately with the Securities and Exchanges Commission. Confidential treatment has been requested
by Evaxion Biotech A/S with respect to such portions of this letter.
Duane Morris LLP
January 22, 2021
Page 3
The Company advises the Staff that a bona
fide price range will be included in an amendment to the Registration Statement prior to any distribution of the preliminary prospectus
in connection with the Company’s road show.
Purpose
The purpose of this
letter is to provide support the Company’s Ordinary Shares (“Ordinary Shares”) values used by management in the
determination of the share-based compensation expense recognized in the consolidated financial statements of the Company and the
disclosures included in the consolidated financial statements and Management’s Discussion and Analysis of Financial Condition
and Results of Operations section of the Registration Statement and any subsequent amendments. This letter focuses on warrants
issued from January 1, 2019 through December 31, 2020, a period of 24 months prior to the anticipated effective date
of the Company’s Registration Statement.
The Company’s
remuneration philosophy has historically been one in which employees are offered annual performance-based remuneration through
the issuance of warrants, with an exercise price equal to the then nominal value of the Ordinary Shares. This exercise price has
historically been significantly below the then current valuation as determined by sales of the Company’s Ordinary Shares
in arms-length transactions with unrelated third-party investors. This allowed the Company to conserve cash that would normally
be expended through an annual cash bonus plan. This effort to conserve cash has also historically applied to some external consultants
and board members.
Since its inception
in 2008, the Company has granted warrants during annual performance evaluations based on a formalized grid describing the “bonus
amount” for annual performance and title level, which is then converted into warrants to each individual grantee. The conversion
into the number of warrants is based on the value per share received by the Company in the latest capital increase. For accounting
purposes, the expense recognized related to the warrants has been based on an interpolation between capital increase dates or a
valuation performed on the Company’s Ordinary Shares.
Duane Morris LLP
January 22, 2021
Page 4
Relevant
Accounting Guidance
For purposes
of this letter, the Company considered the following accounting guidance:
· International Financial Reporting Standards (“IFRS”) 2, Share-based Payment
(“IFRS 2”);
· American Institute of Certified Public Accountants (“AICPA”) Accounting and
Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (“AICPA Practice
Aid”); and
· Deloitte Financial Reporting Alert – Interpolation Considerations for Valuing Share-Based
Compensation, March 2017 (“DT Interpolation Guide”)
Overview
The Company has evaluated
the fair value of its warrants for all grants made since January 1, 2019 through December 31, 2020 to support the critical
accounting estimates disclosed in the Company’s Registration Statement. As noted above, the Registration Statement included
the Company’s audited statements of financial position as of December 31, 2018 and 2019 and unaudited statement of financial
position as of September 30, 2020. In addition, the Company has disclosed detailed information on warrants issued through
December 31, 2020 in the Registration Statement under the sections entitled “Management – Warrant Incentive Plan”
and “Description of Share Capital – Our Warrants – Our EIB Warrants.” Warrants granted since the inception
of the Company on August 11, 2008 through the date of this letter are as follows (Note – the Company effected a 2-for-1
stock split and an issuance of 17-for-1 bonus shares as of January 4, 2021 which are reflected in the table below in the right
column:
Date
No. of Warrants
Granted (pre-
Split)
No. of Warrants
Granted (post-
Split)
Inception (August 11, 2008) to January 1, 2018
41,161
1,481,796
December 2018 *
5,348
192,528
January 2019 **
1,256
45,216
February 2019 *
221
7,956
September 2019 *
1,500
54,000
October 2019 *
4,185
150,660
December 2020
10,088
363,168
Total
63,759
2,295,324
* 11,254 pre-split (or 405,144
post-split) warrants were issued in 2020 in accordance with the established criteria in the employment contracts. The Company
accounts for these warrants when the employee begins providing the requisite service required to receive the award. The fair value
of the award is estimated based on the underlying Ordinary Share value on this date.
** 1,256 pre-split (or 45,276
post-split) warrants had not been authorized for issuance by the board of directors when warrant holder forfeited. Accordingly,
the Company recognized an expense for the services delivered when the employee began providing requisite service required but accounted
for the forfeiture when the employee left the Company. No formal authorization was obtained from the board of directors as the
warrants were not ultimately issued.
Duane Morris LLP
January 22, 2021
Page 5
No other warrants have
been approved by the Board from and after December 31, 2020 through the date of this letter and no warrants have been exercised
as of the date of this letter.
Summary of Evaluation Methodology
a. Background
The value of the Company’s
Ordinary Shares is ultimately based on the fair value of the Company’s equity1.
To determine the value of the equity, the Company can either estimate the total value of its equity and calculate an appropriate
per share value for the Ordinary Shares, or it could use public market transactions. As the Company has been a private company
since its inception, there are no public market data available to use in valuing the Ordinary Shares underlying the Company’s
warrants. Thus, while estimating the underlying fair value of the Company’s equity and Ordinary Shares, the management has
exercised significant judgement.
b. Equity Valuation – Capital Transactions
The Company considered
several potential data points when determining the appropriate value of its Ordinary Shares2.
These included both capital transactions in which the Company sold Ordinary Shares to unrelated third-party investors in arms-length
negotiated transactions, as well as other financing transactions that could potentially be settled in Ordinary Shares and for which
an Ordinary Share value was established.
1
The Company’s equity value could be derived from its enterprise value. An enterprise value incorporates all
of an entity’s capital (both debt and equity) and thus equals an entity’s equity value plus debt less cash. One could
utilize an enterprise value to derive an entity’s equity value. Both the market approach and income approach directly estimate
an entity’s enterprise value. This would then be adjusted by any debt and/or cash to arrive at the entity’s equity
value.
2
The Company has one share class. All observable transactions were for the same share class.
Duane Morris LLP
January 22, 2021
Page 6
Capital Transactions:
The Company has had a series of capital transactions where the Company’s Ordinary Shares were sold to unrelated third
parties in arms-length negotiated transactions. These transactions have occurred throughout the period in which the Company’s
warrants have been granted and accrued. There were four capital transactions which the Company considered when estimating its Ordinary
Share value between January 1, 2019 and December 31, 2020. Since these transactions involved the sale of Ordinary Shares
to unrelated third-party investors in arms-length negotiated transactions, the Company concluded that these values represented
the best available evidence to support the fair value of the Company’s equity on the dates of such transactions.
In each of these transactions,
the relative ownership of the Company was affected, and a share value was established. The fair values of the warrants based on
actual share prices as of the dates of each capital transactions with a reduction for the exercise price. Below the actual share
prices are as follows:
Valuation Date
(As of Date)
Fair
Value Price
Per Ordinary Share
(Post-Split)
Fair
Value Price
Per Ordinary Share
(Post-Split)
(DKK)
(USD)
July 17, 2019
[****]
[****]
December 19, 2019
[****]
[****]
September 17, 2020
[****]
[****]
October 15, 2020
[****]
[****]
The Company concluded
that these transactions provide the strongest evidence of the Ordinary Share values on these specific dates and used these values
as the basis to estimate the fair value of the Ordinary Shares underlying the Company’s warrants on their respective grant
dates for the purposes of determining the compensation expense associated with the issuance of such warrants.
Except for the
EIB Warrants (as defined in the Registration Statement), all of the Company’s warrants are exercisable for DKK 1 per
warrant (post-split) and accordingly, management has concluded that the exercise price thereof is nominal and, therefore, the
warrants are effectively “penny” warrants. As such, the Company values the warrants using the intrinsic value
method, defined as the fair value of the underlying Ordinary Share on the grant date less the exercise price. This approach
is similar to the methodology commonly used to value restricted stock awards or restricted stock units. While the warrants
have characteristics similar to options (exercise price, contractual term, etc.), the Company considers them to be
deeply “in the money” and, as a result, there is a minimal time value. The Company considered using other
valuation methods, such as the Black-Scholes-Merton Model, but noted that the output from such valuation models would be
materially consistent with the award value calculated using the intrinsic value method. All warrants granted have a
contractual expiration in 2036 and given the long life of the awards and the nominal exercise price, the Company has chosen
to value these awards in a similar fashion to
2020-12-22 - UPLOAD - Evaxion A/S
United States securities and exchange commission logo
December 22, 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. 2 to Draft Registration Statement on Form F-1
Submitted December 16, 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 December 7, 2020 letter.
Amendment No. 2 to Draft Registration Statement on Form F-1
Business
Key Findings to Date from Our EVX-01 Phase 1/2a Clinical Trial, page 133
1.We note your revisions in response to prior comment 1. Please remove the references to
"encouraging" results and a "favorable" safety profile in this section. Please also revise
the references to a "favorable safety profile" in the Key Advantages of Our PIONEER
Platform sections in the Summary and the Business sections to better describe your belief
that PIONEER has the potential to identify potentially harmful neoepitopes.
FirstName LastNameLars Staal Wagner, M.D.
Comapany NameEvaxion Biotech A/S
December 22, 2020 Page 2
FirstName LastName
Lars Staal Wagner, M.D.
Evaxion Biotech A/S
December 22, 2020
Page 2
In-Licensing, page 177
2.We refer to prior comment 11 from our letter dated November 18, 2020. Now that 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.
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.
2020-12-07 - UPLOAD - Evaxion A/S
United States securities and exchange commission logo
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.
FirstName LastNameLars Staal Wagner, M.D.
Comapany NameEvaxion Biotech A/S
December 7, 2020 Page 2
FirstName LastName
Lars Staal Wagner, M.D.
Evaxion Biotech A/S
December 7, 2020
Page 2
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.
2020-11-18 - UPLOAD - Evaxion A/S
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
FirstName LastNameLars Staal Wagner, M.D.
Comapany NameEvaxion Biotech A/S
November 18, 2020 Page 2
FirstName LastNameLars Staal Wagner, M.D.
Evaxion Biotech A/S
November 18, 2020
Page 2
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
FirstName LastNameLars Staal Wagner, M.D.
Comapany NameEvaxion Biotech A/S
November 18, 2020 Page 3
FirstName LastNameLars Staal Wagner, M.D.
Evaxion Biotech A/S
November 18, 2020
Page 3
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.
FirstName LastNameLars Staal Wagner, M.D.
Comapany NameEvaxion Biotech A/S
November 18, 2020 Page 4
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: Dwight A. Kinsey, Esq.