Enlivex Ltd 6-K, filed Apr 13, 2020

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 2020

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 April 13, 2020, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (the “Company”), issued a press release with respect to the selection of the Company by the Israel Innovation Authority to receive a $1.5 million grant to fund the Company’s planned COVID-19 and sepsis clinical programs. 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: April 13, 2020

2

Exhibit 99.1

EnlivexSelected by the Israel Innovation Authority to Receive $1.5 Million Grant to Fund COVID-19 and Sepsis Clinical Trials

**NesZiona, Israel, April 13, 2020 (GLOBE NEWSWIRE) —**Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today announced that the Israel Innovation Authority (IIA) selected the Company’s planned COVID-19 and sepsis clinical programs to receive, in the aggregate, a non-dilutive grant of approximately $1.5 million for the period through the first quarter of 2021. To date, Enlivex has received a total of approximately $4.31 million in grants from the IIA for its historical clinical trials and development.

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 that 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.

Following the positive results of Enlivex’s Phase Ib clinical trial in severe sepsis patients, Enlivex currently plans to initiate this year a Phase IIb/III trial of Allocetra^TM^ for the treatment of organ dysfunction associated with sepsis, and, subject to regulatory approvals, initiate a clinical trial of Allocetra^TM^ in COVID-19 patients.

ABOUTENLIVEX

Enlivex is a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions which involve hyper-expression of cytokines (Cytokine Release Syndrome) and for which there are no approved treatments (unmet medical needs), as well as solid tumors immune-checkpoint rebalancing.  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