Enlivex Ltd 6-K, filed May 18, 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: May 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 May 18, 2021, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel, issued a press release announcing that the Israel Innovation Authority selected Enlivex’s ongoing sepsis clinical program to receive a second non-dilutive grant of approximately $1.1 million for 2021. 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: May 18, 2021

2

Exhibit 99.1

Enlivex Awarded Second Israel InnovationAuthority Grant to Support the Clinical Development of Allocetra in Sepsis

Grant provides $1.1 millionin non-dilutive funding for 2021

Nes Ziona, Israel, May 18, 2021 (GLOBE NEWSWIRE) --Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today announced that the Israel Innovation Authority (IIA) selected Enlivex’s ongoing sepsis clinical program to receive a second non-dilutive grant of approximately $1.1 million for 2021. To date, Enlivex has received a total of approximately $6.6 million in non-dilutive grants from the IIA for clinical trials and product development, excluding this newly approved grant.

The IIA is an independent, publicly funded agency charged with fostering the development of industrial R&D within the State of Israel. It provides non-dilutive grants in the form of reimbursement for actual expenses pre-approved by the IIA. The grants become repayable only through royalties from future sales of products developed with the support of the IIA, and the repayment, if any, is limited to the original grant amount plus interest.

Enlivex is currently recruiting patients to its Phase IIb trial of Allocetra^TM^ for the treatment of organ dysfunctions associated with sepsis.

ABOUT ALLOCETRA^TM^

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 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, 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; 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 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 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, investorsshould consider the economic, 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