Enlivex Ltd 6-K, filed Aug 16, 2021

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: August 2021

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 ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7): ☐

On August 15, 2021, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel, issued a press release announcing that the Israeli Ministry of Health has authorized the initiation of a proposed Company-sponsored, multi-center, placebo-controlled, randomized, blinded, Phase IIb clinical trial evaluating Allocetra^TM^ in severe and critical COVID-19 patients with acute respiratory distressed syndrome (ARDS). A copy of such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference.

1

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: August 16, 2021

2

Exhibit 99.1

Enlivex: After Review of Phase II Data, Israeli Ministry of Health Authorizes Initiation of a Multi-Center, Randomized Phase IIb Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients

Nes Ziona, Israel, August 15, 2021 (GLOBE NEWSWIRE) --Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today reported that after reviewing previously-reported Phase II trial data, the Israeli Ministry of Health has authorized the initiation of a proposed Company-sponsored, multi-center, placebo-controlled, randomized, blinded, Phase IIb clinical trial evaluating Allocetra^TM^ in severe and critical COVID-19 patients with acute respiratory distressed syndrome (ARDS).

The Phase IIb trial is expected to recruit up to 152 severe or critical COVID-19 patients in clinical centers in Israel and certain European countries, and is designed to assess the safety and efficacy of Allocetra^TM^ when administered in addition to standard of care treatment.

Enlivex previously reported positive top-line results from Phase Ib and Phase II investigator-initiated clinical trials of Allocetra^TM^ in COVID-19 patients in severe and critical condition. Aggregate data from the two trials demonstrated that Allocetra^TM^ was safe and well tolerated. Moreover, at the end of the 28-day follow-up period, a 0% (0/21) mortality rate was observed and 90.5% (19/21) of patients recovered from their respective severe/critical condition and were discharged from the hospital after an average of 5.6 days following Allocetra^TM^administration.

The planned Phase IIb clinical trial will have two primary endpoints: ventilation-free survival and recovery for each of the two sub-populations of patients in the study (severe and critical). In addition, the trial will assess several secondary endpoints, including evaluation of long-COVID-19 symptoms.

Oren Hershkovitz, Ph.D., CEO of Enlivex, and Prof. Dror Mevorach, Chief Scientific Officer of Enlivex, stated in a joint comment: “We would like to thank the Israeli Ministry of Health for the expedited review and for authorizing a Phase IIb clinical trial of Allocetra^TM^ in COVID-19 patients in severe and critical condition.”

ABOUT ALLOCETRA^TM^

Allocetra^TM^ 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, COVID-19 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^TM^ 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 immunotherapy company developing Allocetra^TM^, 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 conditions. For more information, visit http://www.enlivex.com.

Safe Harbor Statement:  Thispress 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, the expected timing of clinical trials’ results for,and market opportunities for, ALLOCETRA^TM^ programs, as well as potential changes in the severity level of the COVID-19pandemic (including due to new variants of the virus) and the effect of such changes on pace of patient recruitment into clinical trials,manufacturing delays, and changes in market opportunities. All such forward-looking statements are made pursuant to the safe harbor provisionsof the Private Securities Litigation Reform Act of 1995.  Investors are cautioned that forward-looking statements involve risks anduncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating anyrevenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectivenessand/or may not generate data that would support the approval or marketing of these products for the indications being studied or for otherindications; that ongoing studies may be delayed and/or not continue to show substantial or any activity; and other risks and uncertaintiesthat may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials inhumans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stagetrials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA^TM^ productline could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional timerequirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive productsand pricing and the impact of patents and other proprietary rights held by competitors and other third parties.  In addition to therisk factors described 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 Annual Report onForm 20-F filed with the Securities and Exchange Commission.  The forward-looking statements contained in this press release speakonly as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as requiredunder applicable law.

ENLIVEX CONTACT

Shachar Shlosberger, CFO

Enlivex Therapeutics, Ltd.

shachar@enlivexpharm.com

INVESTOR RELATIONS CONTACT

Eric Ribner

LifeSci Advisors

eric@lifesciadvisors.com