<SEC-DOCUMENT>0001104659-22-130983.txt : 20221229
<SEC-HEADER>0001104659-22-130983.hdr.sgml : 20221229
<ACCEPTANCE-DATETIME>20221229170034
ACCESSION NUMBER:		0001104659-22-130983
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20221229
FILED AS OF DATE:		20221229
DATE AS OF CHANGE:		20221229

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Evaxion Biotech A/S
		CENTRAL INDEX KEY:			0001828253
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			G7
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39950
		FILM NUMBER:		221499394

	BUSINESS ADDRESS:	
		STREET 1:		BREDGADE 34E
		CITY:			COPENHAGEN K
		STATE:			G7
		ZIP:			1260
		BUSINESS PHONE:		4531262615

	MAIL ADDRESS:	
		STREET 1:		BREDGADE 34E
		CITY:			COPENHAGEN K
		STATE:			G7
		ZIP:			1260
</SEC-HEADER>
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<TYPE>6-K
<SEQUENCE>1
<FILENAME>tm2233711d1_6k.htm
<DESCRIPTION>FORM 6-K
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<P STYLE="text-align: center; margin-top: 0; margin-bottom: 0">&nbsp;</P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, D.C. 20549</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;&nbsp;</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;<B>&nbsp;</B></P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM&nbsp;6-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>REPORT OF FOREIGN PRIVATE ISSUER</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>PURSUANT TO SECTION&nbsp;13a-16 OR 15d-16</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>For the&nbsp;month of December&nbsp;2022</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Commission File Number: 001-39950</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Evaxion Biotech A/S</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Exact Name of Registrant as Specified in Its
Charter)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Dr.&nbsp;Neergaards Vej 5f</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>DK-2970 Hoersholm</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Denmark</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Address of principal executive offices)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Indicate by check mark whether the registrant files or will file annual
reports under cover of Form&nbsp;20-F or Form&nbsp;40-F.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif">Form&nbsp;20-F
</FONT><FONT STYLE="font-family: Wingdings">x</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form&nbsp;40-F
</FONT><FONT STYLE="font-family: Wingdings">&uml;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 206pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">Indicate by
check mark if the registrant is submitting the Form&nbsp;6-K in paper as permitted by Regulation S-T Rule&nbsp;101(b)(1): </FONT><FONT STYLE="font-family: Wingdings">&uml;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">Indicate by
check mark if the registrant is submitting the Form&nbsp;6-K in paper as permitted by Regulation S-T Rule&nbsp;101(b)(7): </FONT><FONT STYLE="font-family: Wingdings">&uml;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>INCORPORATION BY REFERENCE</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">This report on Form&nbsp;6-K&nbsp;shall be deemed to be&nbsp;incorporated
by reference&nbsp;in Evaxion Biotech A/S&rsquo;s registration statements on&nbsp;Form&nbsp;S-8&nbsp;(File&nbsp;No.&nbsp;333-255064), on
Form F-3 (File No. 333-265132) and on Form F-1 (File No. 333-266050), including any prospectuses forming a part of such registration statements
and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently
filed or furnished.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>FDA Indicates Phase 2b Study for EVX-01 May Proceed</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
previously announced on September 21, 2022, </FONT>Evaxion Biotech A/S (the &ldquo;Company&rdquo;) reached an important milestone when
it enrolled its first patient in Perth, Australia in the Company&rsquo;s global Phase 2b clinical trial of EVX-01, the Company&rsquo;s
personalized, peptide-based cancer immunotherapy targeting melanoma, in combination with KEYTRUDA&reg; an anti-PD-1 inhibitor developed
by Merck &amp;Co., Inc. (&ldquo;Merck&rdquo;).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
November 2022, the Company submitted an Investigational New Drug Application (&ldquo;IND&rdquo;) along with a Fast Track designation request
</FONT>to the U.S. Food and Drug Administration (&ldquo;FDA&rdquo;) for the Phase 2b clinical trial of EVX-01 in combination with
KEYTRUDA&reg; for the treatment of patients with metastatic melanoma. On December 22, 2022, the FDA notified the Company that it had reviewed
the Company&rsquo;s IND <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT> and determined that the
Company may proceed with its Phase 2b trial. The Company anticipates a reply from the FDA on its Fast Track designation submission in
the first quarter of 2023.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">It
is anticipated that the trial will be conducted globally at clinical sites across the United States, Europe, and Australia in collaboration
with Merck, which is supplying the trial with its PD-1 inhibitor, KEYTRUDA<SUP>&reg;</SUP>.&nbsp;Patients enrolled in the Phase 2b clinical
trial will receive standard of care treatment along with KEYTRUDA<SUP>&reg;</SUP>&nbsp;in combination with EVX-01, or in the event of
progression, another standard of care treatment in combination with EVX-01. The Company is responsible for the conduct of the trial</FONT>.
The Company and Merck will continue to collaborate as the data mature. The Phase 2b clinical trial is a single arm trial evaluating the efficacy and safety of EVX-01 in combination with KEYTRUDA&reg; (pembrolizumab)
in adults with unresectable or metastatic melanoma. The trial will evaluate if EVX-01 improves the best overall response (BOR) in
patients with an initial assessment of stable disease (SD) or partial response (PR) after initiating KEYTRUDA&reg; treatment, as compared
to historical outcomes with KEYTRUDA&reg; alone in metastatic or unresectable melanoma.<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company has received approval of its Clinical Trial Applications for the </FONT>Phase 2b trial from regulatory authorities in Australia,
Italy and France. The Company subsequently informed the French regulators that it currently does not intend to conduct the trial in France.
In addition, the Company submitted a CTA in Spain and is awaiting approval by the Spanish regulatory authorities.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Pursuant to the requirements of the Securities Exchange Act of 1934,
as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Evaxion Biotech A/S</B></FONT></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 50%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date: December 29,&nbsp;&nbsp;2022</FONT></TD>
    <TD STYLE="width: 4%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:</FONT></TD>
    <TD STYLE="width: 46%; border-bottom: black 1pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/ Bo Karmark</FONT></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Bo Karmark</P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Chief Financial Officer</P></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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