0000000000-24-005751.txt : 20240920 0000000000-24-005751.hdr.sgml : 20240920 20240517133602 ACCESSION NUMBER: 0000000000-24-005751 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20240517 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Evaxion Biotech A/S CENTRAL INDEX KEY: 0001828253 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: G7 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD SEC FILE NUMBER: 333-279153 BUSINESS ADDRESS: STREET 1: DR NEERGAARDS VEJ 5F CITY: HOERSHOLM STATE: G7 ZIP: 2970 BUSINESS PHONE: 004531262615 MAIL ADDRESS: STREET 1: DR NEERGAARDS VEJ 5F CITY: HOERSHOLM STATE: G7 ZIP: 2970 PUBLIC REFERENCE ACCESSION NUMBER: 0001104659-24-057512 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]#;VQO7!E+UA/8FIE8W0O5VED=&@@,30R."],96YG=&@@,S8U+T)I='-097)# M;VUP;VYE;G0@.#X^7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to this letter, we may have additional comments. Registration Statement on Form F-1 filed May 6, 2024 General 1. We note certain statements regarding safety and efficacy in your business overview that is incorporated into your prospectus by reference to your most recent annual report on Form 20-F for the year ended December 31, 2023. For example only and without limitation, you state in the "Business overview" section that is incorporated into your prospectus by reference to your Form 20-F that: "In addition, the data showed induction of neoantigen-specific T cells in 100% of patients and a favorable safety profile." (page 95) "Our five AI models...have allowed us to generate numerous pipeline candidates within both cancer and infectious diseases, all with first-in-class potential." (page 97) "The initial data demonstrated that the EVX-01 treatment appeared safe and well tolerated." (page 115) Christian Kanstrup Evaxion Biotech A/S May 17, 2024 Page 2 "Final data from a first-in-human Phase 1/2a clinical trial...substantiated a promising safety profile...as well as indicated encouraging clinical outcome data of our first- generation neoantigen DNA therapy." (page 116) "EVX-B2 was developed using our, proprietary AI model EDEN for B-cell antigen discovery, to identify novel and, we believe, highly efficacious B-cell antigen vaccine targets." (page 135) "GLA-SE was identified to have the highest adjuvating capacity on the antigens, resulting in a formulation with high immunogenicity and protective efficacy in vivo and in vitro." (page 136) "EVX-B2 demonstrates broad protection in a bactericidal assay using a panel of 50 different relevant clinical isolates with >50% bactericidal killing recognized as efficacy." (page 139) Although we do not object to disclosure regarding the objective results of a product candidate study, safety and efficacy determinations are solely within the authority of the FDA. Therefore, please revise your registration statement to remove any statements regarding safety or efficacy determinations from the "Business overview" disclosures required by Part I, Item 4.a of Form F-1. In addition, please remove references to your product candidates potentially being "first-in-class" as these descriptions imply an expectation of regulatory approval and are inappropriate given the length of time and uncertainty with respect to securing marketing approval. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Jessica Dickerson at 202-551-8013 or Jason Drory at 202-551-8342 with any other questions. Sincerely, FirstName LastNameChristian Kanstrup Division of Corporation Finance Comapany NameEvaxion Biotech A/S Office of Life Sciences May 17, 2024 Page 2 cc: Michael D. Baird, Esq. FirstName LastName