<SEC-DOCUMENT>0001213900-25-033493.txt : 20250421
<SEC-HEADER>0001213900-25-033493.hdr.sgml : 20250421
<ACCEPTANCE-DATETIME>20250421083215
ACCESSION NUMBER:		0001213900-25-033493
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20250421
FILED AS OF DATE:		20250421
DATE AS OF CHANGE:		20250421

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Enlivex Therapeutics Ltd.
		CENTRAL INDEX KEY:			0001596812
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36578
		FILM NUMBER:		25851365

	BUSINESS ADDRESS:	
		STREET 1:		37 DEREH MENACHEM BEGIN ST.
		STREET 2:		15TH FLOOR
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			6522042
		BUSINESS PHONE:		972 (0) 3 7326616

	MAIL ADDRESS:	
		STREET 1:		37 DEREH MENACHEM BEGIN ST.
		STREET 2:		15TH FLOOR
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			6522042

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Bioblast Pharma Ltd.
		DATE OF NAME CHANGE:	20160919

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	BIO BLAST PHARMA LTD.
		DATE OF NAME CHANGE:	20140113
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>ea023888801-6k_enlivex.htm
<DESCRIPTION>CURRENT REPORT
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<!-- Field: Rule-Page --><DIV STYLE="margin: 0pt; width: 100%"><DIV STYLE="font-size: 1pt; border-top: Black 2pt solid; border-bottom: Black 1pt solid">&nbsp;</DIV></DIV><!-- Field: /Rule-Page -->

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center">Form 6-K</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center">Pursuant to Rule 13a-16 or 15d-16</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center">under the Securities Exchange Act of 1934</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center">For the month of: April 2025</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center">Commission file number: 001-36578</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center">(Translation of registrant&rsquo;s name into English)</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><U>14 Einstein Street, Nes Ziona, Israel 7403618</U></P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center">Form 20-F&nbsp;&#9746;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form
40-F&nbsp;&#9744;</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">On April 21, 2025, Enlivex Therapeutics Ltd., a
company organized under the laws of the State of Israel (&ldquo;Enlivex&rdquo;), issued a press release announcing that Enlivex had completed
enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra&trade; in patients
with moderate to severe knee osteoarthritis. A copy of such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and
incorporated herein by reference.</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top; background-color: white">
    <TD STYLE="border-bottom: black 1.5pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Exhibit No.</B></FONT></TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: white">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD STYLE="width: 10%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1</FONT></TD>
    <TD STYLE="width: 90%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: blue"><U><A HREF="ea023888801ex99-1_enlivex.htm">Press Release issued by Enlivex Therapeutics Ltd. on April 21, 2025.</A></U></FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><B>&nbsp;&nbsp;</B></P>

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

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

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

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR>
    <TD>&nbsp;</TD>
    <TD COLSPAN="2" STYLE="border-bottom: black 1.5pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Enlivex Therapeutics Ltd.</FONT></TD></TR>
  <TR>
    <TD>&nbsp;</TD>
    <TD COLSPAN="2"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(Registrant)</FONT></TD></TR>
  <TR>
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 60%">&nbsp;</TD>
    <TD STYLE="width: 5%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:</FONT></TD>
    <TD STYLE="width: 35%; border-bottom: black 1.5pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/ Oren Hershkovitz</FONT></TD></TR>
  <TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt">Name:&nbsp;</P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt">Title:</P></TD>
    <TD STYLE="vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Oren Hershkovitz<BR>
Chief Executive Officer</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt">Date: April 21, 2025</P>

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

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

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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ea023888801ex99-1_enlivex.htm
<DESCRIPTION>PRESS RELEASE ISSUED BY ENLIVEX THERAPEUTICS LTD. ON APRIL 21, 2025.
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Exhibit 99.1</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"><IMG SRC="ex99-1_001.jpg" ALT="" STYLE="height: 42px; width: 150px"></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: justify"><B>Enlivex Announces Completion of Enrollment
In The Phase II stage Of Its Phase I/II Trial Evaluating Allocetra In Patients With Moderate To Severe Knee Osteoarthritis</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; text-align: justify">Nes-Ziona, Israel, April 21, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the &ldquo;Company&rdquo;), a clinical-stage macrophage
reprogramming immunotherapy company, today announced that the Company completed enrollment of all patients in the Phase II stage of its
randomized, controlled, blinded Phase I/II trial of Allocetra&trade; in patients with moderate to severe knee osteoarthritis. Overall,
133 patients were randomized and treated in the Phase II stage.&nbsp;&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Oren Hershkovitz, Ph.D, CEO of Enlivex, commented,
&ldquo;We are pleased to have completed the recruitment of patients in the Phase II stage of this trial, which follows the recently announced
promising initial efficacy data from the Phase I stage. We therefore reiterate our timeline objective to obtain 3-month topline data by
August 2025. We believe Allocetra&trade; has the potential to transform the way osteoarthritis patients are being treated today, and we
are eager to receive the topline data of the trial.&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>ABOUT THE PHASE I/II CLINICAL TRIAL IN MODERATE TO SEVERE KNEE OSTEOARTHRITIS</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The multi-center Phase I/II clinical trial
consists of two stages. The first stage was a Phase I safety run-in, open-label dose escalation phase to characterize the safety and
tolerability of Allocetra&trade; injections to the target knee, in order to identify the dose and injection regimen for the
subsequent Phase II stage. Recently the Company announced <FONT STYLE="background-color: white">positive interim 3-month and 6-month
efficacy data for the first 12 patients treated in this Phase I stage, demonstrating marked statistically significant improvements
in all key efficacy endpoints and no safety issues. </FONT>The Phase II stage, which completed its patient enrollment, is a
double-blind, randomized, placebo-controlled multi-center trial. In addition to evaluating safety, the study design includes an
interim statistical evaluation, conducted by an independent third party and blinded to the Company, to assess the potential value of
the enrollment of up to 50 patients in addition to the originally targeted randomized sample size, and its marginal impact on the
p-value of the statistical estimation of the total group and/or specific sub-group. In addition, the study incorporates an
independent data safety and monitoring board (DSMB) that reviews the safety data at predefined time points.&nbsp;The trial&rsquo;s
key efficacy end points will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and post
treatment, including 12 month follow up. The Company expects a topline data readout from the Phase II stage, including full 3-month
endpoints, by August 2025.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>ABOUT KNEE OSTEOARTHRITIS</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; text-align: justify">Osteoarthritis is by far the most common form
of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL
injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic
knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their
lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement.
The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis
is critical. There are currently no medications approved by either the U.S. Food and Drug Administration (FDA) or the European Medicines
Agency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint.</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"></P>

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<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>ABOUT ENLIVEX</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; text-align: justify">Enlivex is a clinical stage macrophage reprogramming
immunotherapy company developing Allocetra&trade;, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their
homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution
of life-threatening and life debilitating conditions. For more information, visit&nbsp;https://enlivex.com/.</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: justify"><I>Safe Harbor Statement: This press release contains
forward-looking statements, which may be identified by words such as &ldquo;expects,&rdquo; &ldquo;plans,&rdquo; &ldquo;projects,&rdquo;
&ldquo;will,&rdquo; &ldquo;may,&rdquo; &ldquo;anticipates,&rdquo; &ldquo;believes,&rdquo; &ldquo;should,&rdquo; &ldquo;would,&rdquo; &ldquo;could,&rdquo;
&ldquo;intends,&rdquo; &ldquo;estimates,&rdquo; &ldquo;suggests,&rdquo; &ldquo;has the potential to&rdquo; and other words of similar
meaning, including statements regarding expected cash balances, expected clinical trial results, market opportunities for the results
of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA<SUP>TM</SUP>&nbsp;programs.
All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of
1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex&rsquo;s business
and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that
the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support
the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue
to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth
in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results
of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed,
later-stage trials. The development of any products using the ALLOCETRA<SUP>TM</SUP>&nbsp;product line could also be affected by a number
of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision
making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and
other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should
consider the economic, competitive, governmental, technological and other factors discussed in Enlivex&rsquo;s filings with the Securities
and Exchange Commission, including in the Company&rsquo;s most recent Annual Report on Form 20-F filed with the Securities and Exchange
Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we
do not undertake any obligation to update forward-looking statements, except as required under applicable law.</I></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>ENLIVEX CONTACT</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">Shachar Shlosberger, CFO<BR>
Enlivex Therapeutics, Ltd.<BR>
shachar@enlivexpharm.com</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>INVESTOR RELATIONS CONTACT</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">Dave Gentry, CEO<BR>
RedChip Companies Inc.<BR>
1-407-644-4256<BR>
ENLV@redchip.com</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">&nbsp;</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"></P>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
