Enlivex Ltd 6-K, filed Oct 27, 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: October 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 October 27, 2020, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel, issued a press release announcing that it will host a COVID-19 webinar on Thursday, November 5, 2020, at 10:00 a.m. Eastern Time. A copy of such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference.

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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: October 27, 2020

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Exhibit 99.1

Enlivex to Host COVID-19 Webinar: The Staging of a New Disease and Its Implications for Treatment Options, with Mount Sinai Key Opinion Leader

*Findings and Analyses On 68,000 COVID-19 Patients Discussed in the Webinar on Thursday, November 5^th^ @ 10amET *

NesZiona, Israel, October 27, 2020 (GLOBE NEWSWIRE) --Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage immunotherapy company, today announced that it will host a Key Opinion Leader (KOL) webinar on COVID-19 and its implications for treatment options on Thursday, November 5, 2020 at 10am Eastern Time.

The webinar will feature a presentation by KOL Carlos Cordon-Cardo, MD, PhD, from Mount Sinai hospital, who will discuss his team’s findings in more than 68,000 COVID-19 patients, including more than 100 autopsies, a proposed framework for optimized treatment options for treating COVID-19 patients in severe and critical condition, and a short discussion regarding Allocetra™ by Enlivex as a product candidate for consideration. Dr. Cordon-Cardo with be available to answer questions following the formal presentations.

Enlivex's management team will discuss the recently reported positive top-line results of a Phase Ib investigator-initiated clinical trial of Allocetra™ in five COVID-19 patients in severe and critical condition, and the on-going Phase II investigator-initiated clinical trial, which is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition. The clinical trial has been designed to assess Allocetra™ in combination with standard of care treatment, and plans to evaluate safety, tolerability, cytokine profile and efficacy parameters.

To register for the webinar, please click here.

Enlivex recently reported positive top-line results of a previously announced Phase Ib investigator-initiated clinical trial of Allocetra™^^ in COVID-19 patients in severe and critical condition in Hadassah Hospital, one of the largest hospitals in Israel. The Phase Ib clinical trial included five COVID-19 patients, three in severe condition and two in critical condition. All five patients completely recovered from their respective severe/critical condition and were released from the hospital after an average of 5 days (severe) and 9 days (critical), following administration of Allocetra™, at which time they were all COVID-19 PCR negative. There were no reported severe adverse events relating to the administration of Allocetra™^^ in the patients, and the therapy was well-tolerated.

ABOUTTHE ALLOCETRA COVID-19 PHASE II CLINICAL TRIAL

The COVID-19 study is a multi-center investigator-initiated, Phase II clinical trial. The trial is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition, as defined by the U.S. National Institute of Health (NIH), and is designed to assess Allocetra™^^ in combination with standard of care treatment. Safety, tolerability, cytokine profile and efficacy parameters are planned to be evaluated. Up to twenty-four patients are expected to be recruited, subject to each patient’s eligibility and signing of an informed consent to participate and receive treatment. Eligibility criteria include an existing illness with at least one of (a) radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or (b) Sp/O2 ratio lower or equal to 94% on room air, or (c) requiring supplemental oxygen (low flow or high flow), with a P/F ratio of below 350 but higher than 150. Exclusion criteria include (a) pregnancy, lactation and childbearing potential woman who are not willing to use acceptable contraceptives measures for the entire study duration, (b) Illness combined with other organ failure requiring organ support other than a respirator, including Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30), (c) intubated patients (due to inability to sign an informed consent), (d) patients with malignant tumor, other serious systemic diseases and psychosis, (e) patients who are participating in other clinical trials or treated with any experimental agents that may contradict this trial, (f) co-infection of HIV or tuberculosis, (g) known immunocompromised state or medications known to be immunosuppressive, and (h) patients with P/F ratio or S/F ratio of <150 or a change in status of eligibility manifested by a rapid decline of P/F ratio between eligibility status and actual drug delivery.

ABOUT ENLIVEX

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) such as sepsis and COVID-19, as well as enhancement of immune activity against solid tumors in combination with CAR-T or immune checkpoint therapies.

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

Safe Harbor Statement:  This press release containsforward-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 resultsof current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA™^^ programs.All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation ReformAct of 1995.  Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’sbusiness and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercialproducts; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generatedata that would support the approval or marketing of these products for 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 resultsto differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produceresults that differ significantly from the results of clinical and other trials in animals. The results of early-stage trialsmay differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA™^^ product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturingissues, 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 proprietary rights held by competitors andother third parties.  In addition to the risk factors described above, investors should consider the economic, competitive,governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission,including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do notundertake any obligation to update forward-looking statements, except as required under applicable law.

ENLIVEX CONTACTShachar Shlosberger, CFOEnlivex Therapeutics, Ltd.shachar@enlivexpharm.com

INVESTOR RELATIONS CONTACT

Eric Ribner

LifeSci Advisors

eric@lifesciadvisors.com