<SEC-DOCUMENT>0001193125-21-266749.txt : 20210907
<SEC-HEADER>0001193125-21-266749.hdr.sgml : 20210907
<ACCEPTANCE-DATETIME>20210907171230
ACCESSION NUMBER:		0001193125-21-266749
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20210907
FILED AS OF DATE:		20210907
DATE AS OF CHANGE:		20210907

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Ascendis Pharma A/S
		CENTRAL INDEX KEY:			0001612042
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			G7
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36815
		FILM NUMBER:		211239983

	BUSINESS ADDRESS:	
		STREET 1:		TUBORG BOULEVARD 12
		CITY:			HELLERUP
		STATE:			G7
		ZIP:			DK-2900
		BUSINESS PHONE:		45 70 22 22 44

	MAIL ADDRESS:	
		STREET 1:		TUBORG BOULEVARD 12
		CITY:			HELLERUP
		STATE:			G7
		ZIP:			DK-2900
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d198217d6k.htm
<DESCRIPTION>6-K
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B><FONT
STYLE="white-space:nowrap">FORM&nbsp;6-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF
FOREIGN PRIVATE ISSUER </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO <FONT STYLE="white-space:nowrap">SECTION&nbsp;13a-16</FONT> OR
<FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of September, 2021 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number: <FONT STYLE="white-space:nowrap">001-36815</FONT> </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>Ascendis Pharma A/S </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact Name of Registrant as Specified in Its Charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Tuborg
Boulevard 12 </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><FONT STYLE="white-space:nowrap">DK-2900</FONT> Hellerup </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Denmark </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of
principal executive offices) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the registrant files or will file annual reports under cover of Form <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT
STYLE="white-space:nowrap">40-F.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form
<FONT STYLE="white-space:nowrap">20-F&nbsp;&nbsp;&#9746;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form</FONT> <FONT STYLE="white-space:nowrap">40-F&nbsp;&nbsp;&#9744;</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if the registrant is submitting the <FONT STYLE="white-space:nowrap">Form&nbsp;6-K</FONT> in paper as permitted by Regulation <FONT
STYLE="white-space:nowrap">S-T</FONT> Rule&nbsp;101(b)(1):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if the registrant is submitting the <FONT
STYLE="white-space:nowrap">Form&nbsp;6-K</FONT> in paper as permitted by Regulation <FONT STYLE="white-space:nowrap">S-T</FONT> Rule&nbsp;101(b)(7):&nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>INCORPORATION BY REFERENCE </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This report on <FONT STYLE="white-space:nowrap">Form&nbsp;6-K</FONT> shall be deemed to be incorporated by reference into the registration statements on <FONT
STYLE="white-space:nowrap">Form&nbsp;S-8</FONT> (Registration Numbers <FONT STYLE="white-space:nowrap">333-203040,</FONT> <FONT STYLE="white-space:nowrap">333-210810,</FONT> <FONT STYLE="white-space:nowrap">333-211512,</FONT> <FONT
STYLE="white-space:nowrap">333-213412,</FONT> <FONT STYLE="white-space:nowrap">333-214843,</FONT> <FONT STYLE="white-space:nowrap">333-216883,</FONT> <FONT STYLE="white-space:nowrap">333-228576</FONT> and
<FONT STYLE="white-space:nowrap">333-254101)</FONT> and <FONT STYLE="white-space:nowrap">Form&nbsp;F-3</FONT> (Registration Numbers <FONT STYLE="white-space:nowrap">333-209336,</FONT> <FONT STYLE="white-space:nowrap">333-211511,</FONT> <FONT
STYLE="white-space:nowrap">333-216882,</FONT> <FONT STYLE="white-space:nowrap">333-223134,</FONT> <FONT STYLE="white-space:nowrap">333-225284</FONT> and <FONT STYLE="white-space:nowrap">333-256571)</FONT> of Ascendis Pharma A/S (the
&#147;Company&#148;) (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-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On September&nbsp;3, 2021, the Company submitted an investigational new drug application with the U.S. Food and Drug Administration to initiate the
Company&#146;s clinical program of TransCon IL-2 &szlig;/<FONT STYLE="FONT-FAMILY:SYMBOL">&#103;</FONT>, a long-acting prodrug which is designed for prolonged exposure of an <FONT STYLE="white-space:nowrap">IL-2</FONT> variant that selectively
activates the <FONT STYLE="white-space:nowrap">IL-2R&szlig;/</FONT><FONT STYLE="FONT-FAMILY:SYMBOL">&#103;</FONT> with minimal binding to <FONT STYLE="white-space:nowrap">IL-2R&#945;.</FONT> </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I>Forward-Looking Statements </I></B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This report contains
forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this report regarding Ascendis&#146; future plans and objectives of management are forward-looking
statements. Examples of such statements include, but are not limited to, statements relating to the design of TransCon <FONT STYLE="white-space:nowrap">IL-2</FONT> &szlig;/<FONT STYLE="FONT-FAMILY:SYMBOL">&#103;</FONT> for prolonged exposure of an <FONT
STYLE="white-space:nowrap">IL-2</FONT> variant that selectively activates the <FONT STYLE="white-space:nowrap">IL-2R&szlig;/</FONT><FONT STYLE="FONT-FAMILY:SYMBOL">&#103;</FONT> with minimal binding to
<FONT STYLE="white-space:nowrap">IL-2R&#945;.</FONT> Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations disclosed in the forward-looking statements and you should not place undue reliance on these
forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially
from the forward-looking statements that Ascendis makes, including the following: unforeseen safety or efficacy results in its TransCon <FONT STYLE="white-space:nowrap">IL-2</FONT> &szlig;/<FONT STYLE="FONT-FAMILY:SYMBOL">&#103;</FONT> or other
development programs; unforeseen expenses related to the development of its TransCon <FONT STYLE="white-space:nowrap">IL-2</FONT> &szlig;/<FONT STYLE="FONT-FAMILY:SYMBOL">&#103;</FONT> or other development programs, selling, general and
administrative expenses, other research and development expenses and Ascendis&#146; business generally; delays in the development of its TransCon <FONT STYLE="white-space:nowrap">IL-2</FONT> &szlig;/<FONT STYLE="FONT-FAMILY:SYMBOL">&#103;</FONT> or
other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug; Ascendis&#146; ability to obtain additional funding,
if needed, to support its business activities and the effects on its business from the <FONT STYLE="white-space:nowrap">worldwide&nbsp;COVID-19&nbsp;pandemic.</FONT> For a further description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis&#146; business in general, see Ascendis&#146; Annual Report on <FONT STYLE="white-space:nowrap">Form&nbsp;20-F&nbsp;filed</FONT> with
the U.S. Securities and Exchange Commission (&#147;SEC&#148;) on March&nbsp;10, 2021 and Ascendis&#146; other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any <FONT
STYLE="white-space:nowrap">future&nbsp;in-licensing,&nbsp;collaborations,</FONT> acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any
forward-looking statements, except as required by law. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" COLSPAN="3"><B>Ascendis Pharma A/S</B></TD></TR>
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<TD VALIGN="top">Date: September&nbsp;7, 2021</TD>
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<TD VALIGN="top">By:</TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Michael Wolff Jensen</P></TD></TR>
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<TD VALIGN="top">Michael Wolff Jensen</TD></TR>
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<TD VALIGN="top">Senior Vice President, Chief Legal Officer</TD></TR>
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