UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

 

For the month of: July 2025

 

Commission file number: 001-36578

 

ENLIVEX THERAPEUTICS LTD.

(Translation of registrant’s name into English)

 

14 Einstein Street, Nes Ziona, Israel 7403618

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annualreports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒        Form40-F ☐

 

 

 

 

 

 

On July 28, 2025, Enlivex Therapeutics Ltd., acompany organized under the laws of the State of Israel, issued a press release announcing that that all 134 patients in its Phase IIstage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis,have completed a follow-up period of at least three months, the trial’s primary timepoint for measurement of key endpoints. A copyof such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference.

 

1

 

 

Exhibit No.    
     
99.1   Press Release issued by Enlivex Therapeutics Ltd. on July 28, 2025.

  

2

 

 

SIGNATURES

 

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.

 

  Enlivex Therapeutics Ltd.
  (Registrant)
   
  By: /s/ Oren Hershkovitz
  Name:  Oren Hershkovitz
  Title: Chief Executive Officer

 

Date: July 28, 2025

 

 

3

 

 

Exhibit 99.1

 

 

Enlivex Reaffirms August 18, 2025 As TargetDate For Announcement of Phase II Topline Data

 

Nes-Ziona, Israel, July 28, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogrammingimmunotherapy company, today announced that all 134 patients in its Phase II stage of its randomized, controlled, blinded Phase I/IItrial of Allocetra™ in patients with moderate to severe knee osteoarthritis, have completed a follow-up period of at leastthree months, the trial’s primary timepoint for measurement of key endpoints. The data are being analyzed and audited, with atarget date of August 18, 2025 for the public release of audited topline results for three-month key endpoints, including safety andchange from baseline in knee pain and function.

  

The multi-center Phase I/II clinical trial consistsof two stages. The first stage was a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerabilityof Allocetra™ injections to the target knee, in order to identify the dose and injection regimen or the subsequent Phase IIa stage.This stage is a double-blind, randomized, placebo-controlled multi-centered trial. In addition to evaluating safety, the study protocolis designed to efficiently find a strong signal in a responder population to guide future development, and includes an interim statisticalevaluation, conducted by an independent third party and blinded to the Company, to assess the potential value of enrollment of up to 50patients in addition to the original randomized sample size of 130, and its marginal impact on the p-value of the statistical estimationof the total group and specifically to identify a potential responder sub-group. The trial’s key efficacy endpoints evaluate joint-painand joint-function in comparison to placebo at three months, six months and 12 months post treatment.

 

ABOUT KNEE OSTEOARTHRITIS

 

Osteoarthritis is by far the most common formof arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACLinjuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomaticknee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in theirlifetimes. 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 osteoarthritisis critical. There are currently no medications approved by either the U.S. Food and Drug Administration (FDA) or the European MedicinesAgency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint.

 

ABOUT ENLIVEX

 

Enlivex is a clinical stage macrophage reprogrammingimmunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into theirhomeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolutionof life-threatening and life debilitating conditions. For more information, visit https://enlivex.com/.

 

Safe Harbor Statement: This press release containsforward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,”“will,” “may,” “anticipates,” “believes,” “should,” “would,” “could,”“intends,” “estimates,” “suggests,” “target,” “has the potential to” and otherwords of similar meaning, including statements regarding expected cash balances, expected clinical trial results, market opportunitiesfor the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs.All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s businessand prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; thatthe products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would supportthe approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continueto show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forthin the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the resultsof 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 product line could also be affected by a numberof other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decisionmaking, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents andother proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors shouldconsider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securitiesand Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and ExchangeCommission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and wedo not undertake any obligation to update forward-looking statements, except as required under applicable law.

 

ENLIVEX CONTACT

 

Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
shachar@enlivexpharm.com

 

INVESTOR RELATIONS CONTACT

 

Dave Gentry, CEO
RedChip Companies Inc.
1-407-644-4256
ENLV@redchip.com