<SEC-DOCUMENT>0001213900-25-086674.txt : 20250911
<SEC-HEADER>0001213900-25-086674.hdr.sgml : 20250911
<ACCEPTANCE-DATETIME>20250911081442
ACCESSION NUMBER:		0001213900-25-086674
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20250911
FILED AS OF DATE:		20250911
DATE AS OF CHANGE:		20250911

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:		251307261

	BUSINESS ADDRESS:	
		ADDRESS IS A NON US LOCATION: 	YES
		STREET 1:		37 DEREH MENACHEM BEGIN ST.
		STREET 2:		15TH FLOOR
		CITY:			TEL AVIV
		PROVINCE COUNTRY:   	L3
		BUSINESS PHONE:		972 (0) 3 7326616

	MAIL ADDRESS:	
		ADDRESS IS A NON US LOCATION: 	YES
		STREET 1:		37 DEREH MENACHEM BEGIN ST.
		STREET 2:		15TH FLOOR
		CITY:			TEL AVIV
		PROVINCE COUNTRY:   	L3

	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>ea0256928-6k_enlivex.htm
<DESCRIPTION>REPORT OF FOREIGN PRIVATE ISSUER
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">UNITED STATES</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Washington, D.C. 20549</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">Form 6-K</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">Report of Foreign Private Issuer</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">under the Securities Exchange Act of 1934</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">For the month of: September 2025</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">Commission file number: 001-36578</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"><U>ENLIVEX THERAPEUTICS LTD.</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Translation of registrant&rsquo;s name into English)</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"><U>14 Einstein Street, Nes Ziona, Israel 7403618</U></P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Form 20-F&nbsp;&#9746;&nbsp;&nbsp;&nbsp;&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 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"></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; text-align: left">On September 11, 2025, Enlivex Therapeutics Ltd.,
a company organized under the laws of the State of Israel (&ldquo;Enlivex&rdquo;), issued a letter from its Chief Executive Officer to
shareholders outlining Enlivex&rsquo;s strategic roadmap following positive Phase IIa Allocetra&trade; results. A copy of such letter
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 0"><B>&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>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="width: 9%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1</FONT></TD>
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 90%"><A HREF="ea025692801ex99-1_enlivex.htm"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Letter issued by Enlivex Therapeutics Ltd. on September 11, 2025.</FONT></A></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

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

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <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 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">(Registrant)</FONT></TD>
    <TD STYLE="width: 35%">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:</FONT></TD>
    <TD STYLE="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 STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Name: </FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Oren Hershkovitz</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Title:</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Executive Officer</FONT></TD></TR>
  </TABLE>

<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">Date: September 11, 2025</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="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">2</P>

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

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

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ea025692801ex99-1_enlivex.htm
<DESCRIPTION>LETTER ISSUED BY ENLIVEX THERAPEUTICS LTD. ON SEPTEMBER 11, 2025
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<P STYLE="text-align: right; margin: 0"><B>Exhibit 99.1</B></P>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Enlivex CEO Issues Letter to Shareholders Outlining Strategic Roadmap
Following Positive Phase IIa Allocetra&trade; Results </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in"><B><I>Allocetra&trade; demonstrated statistically significant
and clinically meaningful improvements in pain and function in Phase IIa trial in primary osteoarthritis patients</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in"><B><I>Six-month data expected November 2025; Phase IIb trial
initiation planned for Q2 2026</I></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">Nes-Ziona, Israel, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics
Ltd. (Nasdaq: ENLV, the &ldquo;Enlivex&rdquo;), a clinical-stage macrophage reprogramming immunotherapy company, today issued the following
update to shareholders from Chief Executive Officer, Oren Hershkovitz, highlighting the strength of its recently announced Phase IIa topline
results for Allocetra&trade; in knee osteoarthritis (KOA) and detailing the next steps planned for its clinical development roadmap.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Dear fellow shareholders,</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">I would like to take this opportunity to provide you with our perspective
on our recent Phase IIa (ENX-CL-05-001) 3-month topline data readout for Allocetra&trade; in patients with moderate-to-severe KOA.</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">We believe that these three-month results represent a key positive
milestone for Enlivex. After a careful analysis of the data and discussions with multiple physicians and experts who are among the world-leaders
in the area of KOA, we believe that Allocetra&trade; has the potential to become a leading therapy of choice for the tens of millions
of patients with primary (idiopathic, age-related) KOA, who currently have few and poor treatment options for this debilitating disease.</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">Having received many calls from investors after announcing the positive
3-month data, we would like to reiterate that we believe that, notwithstanding recent stock price movements, the clinical data and expert
validation are clear. We further believe Allocetra&trade; is well positioned to advance toward late-stage development and ultimately address
a major unmet need in KOA.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Positive Feedback from Analysts and Key Opinion Leaders Reinforce
Confidence in Allocetra&trade;</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">To underscore this, it is important to highlight the enthusiasm not
only from our team but also from respected industry analysts and key opinion leaders. One of those analysts is Jason Kolbert, M.Sc., a
long-time biotech analyst who covers Enlivex. He started his August 22, 2025, report by stating, &ldquo;Enlivex reported what we, <B>along
with every expert we consulted</B>, viewed not just as good but <B>truly exceptional data</B> in its knee osteoarthritis program&rdquo;.
He continues to provide insight into what has technically transpired, and I highly recommend that you obtain a full copy of his research
report, as well as the recent H.C. Wainwright research report from Raghuram Selvaraju, Ph.D., a notable veteran life sciences analyst,
dated September 2, 2025 discussing the positive results.</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">Highly positive and encouraging feedback came up during our discussions
of the 3-month results with key opinion leaders in KOA. Prof. Ali Mobasheri, a Professor of Musculoskeletal Biology in the Faculty of
Medicine, University of Oulu, Finland, is one of world&rsquo;s leading experts on osteoarthritis and has been serving as a clinical advisor
to Enlivex for the last two years. He is the former President of the Osteoarthritis Research Society International (OARSI), the leading
medical society for advancing the understanding, early detection, treatment and prevention of osteoarthritis. Prof. Mobasheri participated
in, and consulted on, most clinical trials in osteoarthritis during the last 15 years. When we asked for Prof. Mobasheri&rsquo;s insight
on the trial&rsquo;s 3-month data, he stated, &ldquo;this positive effect that you have seen in the older patient population is quite
intriguing, and it fits nicely with the distinct type of age-related osteoarthritis that is highly prevalent in that population. It is
very impressive to obtain such statistical significance in a relatively small patient population, and I highly recommend that you move
forward into the next Phase IIb. You may have something here that could change the life of OA idiopathic patients, and I urge you to continue
to explore this.&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Key Study Findings Highlight Allocetra&trade;&rsquo;s Potential
in Patients with Age-Related 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">I would like to reiterate some of the key 3-month findings of the
study. In addition to assessing the overall safety and efficacy of Allocetra, the study included assessments aiming to find a high-responder
patient population, because the term &ldquo;osteoarthritis&rdquo; represents a collection of clinical conditions rather than one molecular
disease. This means there are multiple pathways for inflammation in osteoarthritis, and Allocetra<FONT STYLE="font-family: Times New Roman, Times, Serif"><SUP>TM</SUP></FONT>
may be suitable for specific pathways, taking into consideration its proposed mechanism of action. This objective was met, and in primary
idiopathic age-related osteoarthritis patients (&ge;60 years), a population representing more than half of the total KOA market and 54%
of the study population, Allocetra&trade; achieved substantial, clinically meaningful and highly statistically significant improvement
compared to the control placebo group in pain and function. Efficacy was assessed by the FDA-accepted questionnaire assessing knee pain,
function and stiffness (WOMAC -Western Ontario and McMaster Universities Arthritis Index, a validated patient reported questionnaire
assessing pain, function and stiffness).</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">The treatment effect as represented in the reduction of pain and improvement
in function comprises potential Phase III primary endpoints are commonly accepted by the FDA. The following results were observed:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9675;</FONT></TD><TD STYLE="font-family: Times New Roman, Times, Serif; text-align: left">72%
                                            reduction in pain vs. placebo and absolute reduction of 49% from baseline in the Allocetra<FONT STYLE="font-family: Times New Roman, Times, Serif"><SUP>TM</SUP></FONT>
                                            arm</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9675;</FONT></TD><TD STYLE="font: normal 10pt Times New Roman, Times, Serif; text-align: left">109%
                                            improvement in function vs. placebo and absolute reduction of 50% from baseline in the Allocetra<FONT STYLE="font-family: Times New Roman, Times, Serif"><SUP>TM</SUP></FONT>
                                            arm</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9675;</FONT></TD><TD STYLE="text-align: left">Efficacy exceeding FDA thresholds for Phase III trials</TD></TR></TABLE>

<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">These improvements demonstrated even greater effects and statistical
significance with aging, as we further enrich the responder primary idiopathic age-related osteoarthritis patients.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><IMG SRC="ex99-1_001.jpg" ALT="">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Allocetra&trade; was well tolerated, with no drug-related serious adverse
events, and mostly mild-to-moderate, transient local reactions were observed.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Significance for the Knee Osteoarthritis Market</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">KOA is one of the most prevalent and disabling diseases globally, affecting
more than 32 million Americans today and projected to impact 78 million by 2040. Despite this enormous burden, there are no approved disease-modifying
treatments, with current options limited to pain relief, steroids, or surgery. The prevalence of KOA increases with age, as the progressive
degeneration of the joint surface evolves. By the age of 60 years, the prevalence increases to 30% of the entire population, and 50% of
patients with knee OA are aged 60 and above. The prevalence of KOA is expected to grow significantly due to the rising geriatric population
worldwide and the associated increase in the prevalence of osteoarthritis. This strengthens the importance of the clinical effect observed
by Allocetra<SUP>TM</SUP> in the age-related primary idiopathic aging population, as a promising therapy that may change the life of a
substantial OA population, which is expected to increase over time.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Next Steps and Key Milestones</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">Building on these strong results, Enlivex is advancing Allocetra&trade;
toward late-stage development with a planned roadmap of catalysts:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: left"><B>November 2025:</B> Six-month readout from the ongoing Phase IIa trial</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: left"><B>2026 (Q1&ndash;Q2):</B> Expected regulatory approval of Phase IIb protocol</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: left"><B>2026 (Q2&ndash;Q3):</B> Expected dosing of first patient in Phase IIb trial focused on primary KOA patients</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: left"><B>2027 (Q2&ndash;Q3):</B> Expected three- and six-month topline data from Phase IIb trial</TD></TR></TABLE>

<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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    <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
    <!-- Field: /Page -->

<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">We believe that the positive 3-month topline data from the Phase IIa
trial position Enlivex as a strong candidate for a potential partnership with a larger company that has an interest in osteoarthritis,
as well as for securing other non-dilutive funding opportunities. We are currently pursuing both.</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">We remain focused on rapidly executing our clinical roadmap and look
forward to potentially unlocking the significant medical and market opportunity, while delivering enduring value for patients and shareholders.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>About ENX-CL-05-001</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B>NX-CL-05-001 is a multi-center Phase I/II clinical trial
consisting 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 IIa stage. The Phase IIa stage is a double-blind, randomized, placebo-controlled multi-centered trial. In addition to evaluating
safety, the study protocol was designed to efficiently find a strong signal in a responder population to guide future development, and
includes an interim statistical evaluation, conducted by an independent third party and blinded to Enlivex, to assess the potential
value of enrollment of up to 50 patients in addition to the original randomized sample size of 130, and its marginal impact on the p-value
of the statistical estimation of the total group and specifically to identify a potential responder sub-group. The trial&rsquo;s key
efficacy endpoints evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months post treatment.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></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">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. Osteoarthritis is an heterogenous
complex condition and not a single molecular derived disease.&nbsp;This heterogeneity stems from diverse underlying pathologies, such
as inflammatory, metabolic, and genetic factors.&nbsp;Recognizing these variations is crucial for developing more personalized oriented
treatment rather than a &ldquo;one-size-fits-all&rdquo; approach. 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"><B>&nbsp;</B></P>

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

<!-- Field: Page; Sequence: 4; Value: 2 -->
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    <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
    <!-- Field: /Page -->

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></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">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">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;target,&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, ALLOCETRATM&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 ALLOCETRATM&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 Enlivex&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.</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">ENLIVEX CONTACT</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">INVESTOR RELATIONS CONTACT</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="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">5</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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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
