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: September 2022

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 September 6, 2022, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (the “Company”), issued a press release announcing that the U.S. Patent and Trademark Office issued a Notice of Allowance for patent application number 15/551,284, and the resulting patent, once issued, will provide the Company with added intellectual property protection through at least 2036 with claims covering methods of using Allocetra™ to inhibit or reduce cytokine release syndrome in patients undergoing chimeric antigen receptor (CAR) T-cell therapy. 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: September 6, 2022

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Exhibit 99.1

Enlivex Receives Notice of Allowance for U.S.Patent Application Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome in Patients Receiving CAR T Cell Therapy

Nes-Ziona, Israel, Sept. 06, 2022 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, today announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for patent application number 15/551,284. Once issued, the resulting patent will provide Enlivex with added intellectual property (IP) protection through at least 2036 with claims covering methods of using Allocetra™ to inhibit or reduce cytokine release syndrome in patients undergoing chimeric antigen receptor (CAR) T-cell therapy. The Company expects that this new patent will be issued in the United States by the end of the first quarter of 2023.

Oren Hershkovitz, PhD, CEO of Enlivex commented, “We look forward to the anticipated issuance of this patent, which will broaden the robust IP portfolio protecting Allocetra™ and our various development programs. This IP portfolio is a key source of value for Enlivex, and we remain committed to its maintenance and continued expansion.”

CAR T cells are T cells that have been genetically engineered to include a receptor that allows them to specifically target and destroy cancerous cells. While several CAR T cell treatments were recently approved by the FDA in several cancer indications, such treatments have been associated, in many patients, with a side effect named cytokine release syndrome, which describes a collection of potentially severe or life-threatening symptoms that stem from over-activation of immune pathways. Preclinical data indicate that Allocetra™ has the potential to prevent or reduce cytokine release syndrome associated with CAR T-cell therapies.

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 conditions. For more information, visit http://www.enlivex.com.

Safe Harbor Statement:  This pressrelease 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 similarmeaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinicalexperiments, the effectiveness of, and market opportunities for, ALLOCETRA^TM^ programs. All such forward-looking statementsare made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Investors are cautionedthat forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, includingthe risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products indevelopment may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approvalor marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to showsubstantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in theforward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results ofclinical and other trials 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 number of otherfactors, 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 proprietaryrights held by competitors and other third parties.  In addition to the risk factors described above, investors should consider theeconomic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with theSecurities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securitiesand Exchange Commission.  The forward-looking statements contained in this press release speak only as of the date the statementswere made, and we do 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

Eric Ribner

LifeSci Advisors

eric@lifesciadvisors.com