6-K

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: April 2024

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 annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒        Form 40-F ☐

On April 22, 2024, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (“Enlivex”), issued a press release announcing that the first two patients have been dosed in Enlivex’s multi-country, randomized, controlled Phase I/II trial evaluating Allocetra^TM^ in up to 160 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.

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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.

Date: April 22, 2024

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Exhibit 99.1

Enlivex Announces Dosing of First Two Patientsin its Randomized, Controlled Phase I/II Trial Evaluating Allocetra™ in Patients with Knee Osteoarthritis

Nes-Ziona, Israel, April 22, 2024 (GLOBE NEWSWIRE)-- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first two patients have been dosed in the Company’s multi-country, randomized, controlled Phase I/II trial evaluating Allocetra^TM^ in up to 160 patients with moderate to severe knee osteoarthritis.

The Phase I/II multi-center trial is composed of two stages. The first stage is a safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra™ injections to the target knee in order to identify the dose and injection regimen for the second, randomized stage. The second stage is a double-blind, randomized, placebo-controlled stage, which the Company expects to initiate following the completion of the safety run-in stage and confirmation by the independent Data and Safety Monitoring Board. In addition to evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra™ injections into the knee. The Company expects that the primary measurements will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment.

Einat Galamidi, MD., Vice President, Medical of Enlivex, stated “We are pleased with the enrollment and dosing of the first two patients in the open-label stage of the trial. This stage is designed to identify the dose and injection regimen for the randomized stage, and we look forward to the continued enrollment of additional patients.”

ABOUT KNEE OSTEOARTHRITIS^1^

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 or the European Medicines Agency that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint.

ABOUT ALLOCETRA™

Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as “unmet medical needs”, as a stand-alone therapy or in combination with leading therapeutic agents.

ABOUT ENLIVEX

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, 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 http://www.enlivex.com.

Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,”“projects,” “will,” “may,” “anticipates,” “believes,” “should,”“would”, “could,” “intends,” “estimates,” “suggests,” “has the potentialto” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the resultsof current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA^TM^ 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;that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that wouldsupport the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies maynot continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from thoseset forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly fromthe results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of moredeveloped, later-stage trials. The development of any products using the ALLOCETRA^TM^ product line could also be affectedby a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements fordata analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing andthe impact of patents and other proprietary rights held by competitors and other third parties.  In addition to the risk factorsdescribed above, investors should consider the economic, competitive, governmental, technological and other factors discussedin Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent AnnualReport on Form 20-F filed with the Securities and Exchange Commission.  The forward-looking statements contained in this press releasespeak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, exceptas 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