<SEC-DOCUMENT>0001193125-25-237841.txt : 20251014
<SEC-HEADER>0001193125-25-237841.hdr.sgml : 20251014
<ACCEPTANCE-DATETIME>20251014060211
ACCESSION NUMBER:		0001193125-25-237841
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20251013
FILED AS OF DATE:		20251014
DATE AS OF CHANGE:		20251014

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			IMMUTEP Ltd
		CENTRAL INDEX KEY:			0001506184
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				000000000
		STATE OF INCORPORATION:			C3
		FISCAL YEAR END:			0630

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35428
		FILM NUMBER:		251389184

	BUSINESS ADDRESS:	
		STREET 1:		LEVEL 32, SUITE 32.07 AUSTRALIA SQUARE
		STREET 2:		264 GEORGE STREET
		CITY:			SYDNEY,
		STATE:			C3
		ZIP:			NSW 2000
		BUSINESS PHONE:		612 8315 7003

	MAIL ADDRESS:	
		STREET 1:		LEVEL 32, SUITE 32.07 AUSTRALIA SQUARE
		STREET 2:		264 GEORGE STREET
		CITY:			SYDNEY,
		STATE:			C3
		ZIP:			NSW 2000

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Prima BioMed Ltd
		DATE OF NAME CHANGE:	20101119
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d94471d6k.htm
<DESCRIPTION>6-K
<TEXT>
<HTML><HEAD>
<TITLE>6-K</TITLE>
</HEAD>
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<Center><DIV STYLE="width:8.5in" align="left">
<DIV STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;
</DIV><DIV STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</DIV> <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><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM&nbsp;6-K </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; 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 RULE&nbsp;13a-16 OR 15d-16 </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>Date as October 13, 2025 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number&nbsp;001-35428 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>IMMUTEP LIMITED </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact
Name as Specified in its Charter) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>N/A </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of
Registrant&#8217;s Name) </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Level&nbsp;32, Australia Square </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>264 George Street, Sydney </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>NSW 2000, Australia </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 office) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></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&nbsp;20-F or Form&nbsp;40-F. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form 20-F&#8194;&#9746;&#8195;&#8195;&#8195;Form 40-F&#8194;&#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 Form&nbsp;6-K in paper as permitted by Regulation&nbsp;S-T Rule&nbsp;101(b)(1):&#8194;&#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 Form&nbsp;6-K in paper as permitted by Regulation&nbsp;S-T Rule&nbsp;101(b)(7):&#8194;&#9744; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the
Commission pursuant to Rule&nbsp;12g3-2(b) under the Securities Exchange Act of 1934. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Yes&#8194;&#9744;&#8195;&#8195;&#8195;No&#8194;&#9746; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If &#8220;Yes&#8221; is marked, indicated below the file number assigned to the registrant in connection with Rule&nbsp;12g3-2(b): Not applicable. </P>
<P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;
</DIV><DIV STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</DIV>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>EXHIBIT INDEX </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="94%"></TD></TR>
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<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; "><B>Exhibit</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; "><B>Description&nbsp;of&nbsp;Exhibit</B></P></TD></TR>


<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">99.1</P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"><A HREF="d94471dex991.htm">Immutep Announces Successful Completion of FDA Project Optimus Requirements </A></TD></TR>
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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; text-indent:4%; font-size:10pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Date: October 13, 2025 </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" COLSPAN="3">IMMUTEP LIMITED</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">By:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<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/ Marc Voigt</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Name:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Marc Voigt</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Title:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Chief Executive Officer</TD></TR>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d94471dex991.htm
<DESCRIPTION>EX-99.1
<TEXT>
<HTML><HEAD>
<TITLE>EX-99.1</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt;margin-bottom:0pt" ALIGN="right">


<IMG SRC="g94471g1013155222405.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Immutep Announces Successful Completion of FDA Project Optimus Requirements </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Confirmation of 30mg efti as optimal biological dose relevant for Immutep&#8217;s oncology pipeline and potential
future Biological License Applications (BLA) </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Registrational <FONT STYLE="white-space:nowrap">TACTI-004</FONT>
<FONT STYLE="white-space:nowrap">(KEYNOTE-F91)</FONT> Phase III trial in first line <FONT STYLE="white-space:nowrap">non-small</FONT> cell lung cancer now in process of opening clinical sites in the United States </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>SYDNEY, AUSTRALIA &#8211; October</B><B></B><B>&nbsp;13, 2025 &#8211;</B> <U>Immutep Limited</U> (ASX: IMM; NASDAQ: IMMP) (&#8220;Immutep&#8221; or
&#8220;the Company&#8221;), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces that positive and straightforward feedback has been received from the US Food and Drug Administration (&#8220;FDA&#8221;)
regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Immutep&#8217;s Chief Development Officer, Christian Mueller</B>, said, &#8220;We are very thankful for the FDA&#8217;s positive feedback and productive
discussions over the past few years. The alignment on efti&#8217;s optimal biologic dose has strategic relevance to our efti oncology programs and is a major <FONT STYLE="white-space:nowrap">de-risking</FONT> event and building block towards future
BLA filings. We are excited to successfully conclude this chapter of efti&#8217;s clinical development and are intently focused on bringing this novel immunotherapy to market to help address the needs of cancer patients worldwide.&#8221; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The agreement with the FDA on efti&#8217;s optimal biological dosing carries strategic importance in the ongoing and future clinical development of this <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> immunotherapy, including the global <FONT STYLE="white-space:nowrap">TACTI-004</FONT> <FONT STYLE="white-space:nowrap">(KEYNOTE-F91)</FONT> Phase III trial
evaluating efti in combination with MSD&#8217;s (Merck&nbsp;&amp; Co., Inc., Rahway, NJ, USA) <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">anti-PD-1</FONT></FONT> therapy
KEYTRUDA<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (pembrolizumab), and chemotherapy as first-line treatment for advanced or metastatic <FONT STYLE="white-space:nowrap">non-small</FONT> cell lung cancer (1L NSCLC), regardless of <FONT
STYLE="white-space:nowrap">PD-L1</FONT> expression. With the conclusion of <U>Project Optimus</U>, this registrational study is now in process of opening sites in the United States. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Eftilagimod Alfa (Efti) </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Efti is a novel
immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class&nbsp;II pathway to fight cancer. As an MHC Class&nbsp;II agonist, its activation of APCs engages the adaptive and innate
immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important <FONT STYLE="white-space:nowrap">co-stimulatory</FONT> signals&nbsp;&amp; cytokines that further
boost the immune system&#8217;s ability to combat cancer. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Efti is under evaluation for a variety of solid tumours including <FONT
STYLE="white-space:nowrap">non-small</FONT> cell lung cancer (NSCLC) in a pivotal Phase III trial called <FONT STYLE="white-space:nowrap">TACTI-004</FONT> <FONT STYLE="white-space:nowrap">(KEYNOTE-F91),</FONT> as well as head and neck squamous cell
carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">anti-PD-[L]1</FONT></FONT> immunotherapy, radiotherapy,
and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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<TD VALIGN="middle" ALIGN="center"><B>Immutep Limited</B>, Level&nbsp;32, Australia Square, 264 George Street, Sydney NSW 2000, Australia; ABN: 90 009 237 889</TD>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Immutep </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease<I>.</I> The Company is a pioneer in the
understanding and advancement of therapeutics related to Lymphocyte Activation <FONT STYLE="white-space:nowrap">Gene-3</FONT><B> </B><FONT STYLE="white-space:nowrap">(LAG-3),</FONT> and its diversified product portfolio harnesses <FONT
STYLE="white-space:nowrap">LAG-3&#8217;s</FONT> ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders.
For more information, please visit <U>www.immutep.com.</U> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>KEYTRUDA<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> is a registered
trademark of Merck Sharp&nbsp;&amp; Dohme LLC, a subsidiary of Merck&nbsp;&amp; Co., Inc., Rahway, NJ, USA. </I></P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Australian Investors/Media: </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Eleanor Pearson, Sodali&nbsp;&amp; Co. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+61 2 9066 4071;
<U>eleanor.pearson@sodali.com</U> </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>U.S. Investors/Media: </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Chris Basta, VP, Investor Relations and Corporate Communications </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+1 (631) 318 4000; <U>chris.basta@immutep.com</U> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This
announcement was authorised for release by the Board of Immutep Limited. </P>
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<TD VALIGN="middle" ALIGN="center"><B>Immutep Limited</B>, Level&nbsp;32, Australia Square, 264 George Street, Sydney NSW 2000, Australia; ABN: 90 009 237 889</TD>
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