Enlivex Ltd 6-K, filed Mar 8, 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: March 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 March 8, 2021, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel, issued a press release announcing that the Japan Patent Office issued a notice of allowance for a new patent application covering Allocetra^TM^. 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: March 8, 2021

2

Exhibit 99.1

EnlivexReceives Notice of Allowance for Japanese Patent Application

Coveringthe use of Allocetra in Combination with CAR-T Therapies

Nes-Ziona,Israel, March 8, 2021 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today announced that the Japan Patent Office issued a notice of allowance for a new patent application (number 2017-543802) covering Allocetra^TM^, the Company’s immunotherapy product candidate. Upon issuance, the patent, titled “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment”, will provide added intellectual property protection in Japan with respect to certain methods, uses and pharmaceutical compositions for Allocetra^TM^ in combination with CAR-T therapies. The company expects that this new patent will be issued in Japan in the second quarter of 2021.

Enlivex is developing Allocetra^TM^ 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 other therapeutic agents.

ABOUTENLIVEX

Enlivex is a clinical stage macrophage reprogramming 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.

SafeHarbor 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 potential to” and other words of similar meaning, including statements regarding expected cash balances,market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and marketopportunities for, ALLOCETRA^TM^ programs. All such forward-looking statements are made pursuant to the safe harborprovisions of the Private Securities Litigation Reform Act of 1995.  Investors are cautioned that forward-looking statementsinvolve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may notsucceed in generating any revenues or developing any commercial products; that the products in development may fail, may not achievethe expected results or effectiveness and/or may not generate data that would support the approval or marketing of these productsfor 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 othertrials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stagetrials. The development of any products using the ALLOCETRA^TM^ product line could also be affected by a numberof other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analysesand decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and theimpact 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 Annual Reporton 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,except as required under applicable law.

ENLIVEXCONTACT

Shachar Shlosberger, CFO

Enlivex Therapeutics, Ltd.

shachar@enlivexpharm.com

INVESTORRELATIONS CONTACT

Eric Ribner

LifeSci Advisors

eric@lifesciadvisors.com