Enlivex Ltd 6-K, filed Aug 2, 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: August 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 August 2, 2021, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel, issued a press release announcing the hiring of Tzvi Palash as project manager for the design and construction of Enlivex’s new cGMP Allocetra^TM^ manufacturing plant. 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: August 2, 2021

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Exhibit 99.1

Enlivex Hires Biotech Industry Veteran Tzvi Palash to Lead the Design and Construction of its New cGMP Allocetra Manufacturing Plant

Mr.Palash joins Enlivex from Gamida Cell, where he served as Chief Operating Officer, and previously served as Chief Operating Officer ofProtalix Biotherapeutics, and as General Manager of ColBar LifeScience, a Johnson & Johnson company

Nes Ziona, Israel, August 2, 2021 (GLOBE NEWSWIRE) --Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the hiring of Tzvi Palash as Project Lead to manage the design and construction of the Company’s new cGMP Allocetra^TM^manufacturing plant.

“Tzvi is a highly talented industry veteran, and we are thrilled that he is joining our team,” said Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex. “He has successfully led the construction of multiple manufacturing plants, with experience specifically in the cell therapy space, leaving him well suited for his new role. I look forward to working with him to increase our manufacturing capacity in preparation for upcoming clinical trials and the potential commercialization of Allocetra^TM^, if approved.”

Mr. Palash brings over 35 years of experience in the healthcare industry to Enlivex and has extensive expertise leading the construction of pharmaceutical manufacturing plants. Mr. Palash joins Enlivex from Gamida Cell where, as Chief Operating Officer (COO), he was responsible for overseeing operational activities including the recently completed construction of a cell therapy manufacturing plant. Prior to that, Mr. Palash was the COO of Protalix Biotherapeutics, Inc., where he led all operational activities through the approval of Elelyso®, the company’s plant cell culture-derived protein product, by the U.S. Food and Drug Administration (FDA). Prior to joining Protalix, Mr. Palash led the planning, construction, scale-up and regulatory oversight of an Israel-based manufacturing facility as a COO and General Manager at ColBar LifeScience Ltd, a biomaterials company acquired by Johnson & Johnson. He also successfully led FDA audits for Evolence® and Ossix®, and was a member of the Global Aesthetic Management Team within the Consumer Group of Johnson & Johnson. Earlier in his career, Mr. Palash held operational roles at Teva Pharmaceutical Industries and Interpham Laboratories.

Mr. Palash added, “The opportunity to lead the design and construction of Enlivex’s new manufacturing plant is truly exciting. I believe that the Company has generated compelling clinical data in sepsis and COVID-19, preclinical data in solid tumors, and Allocetra’s broadly applicable mechanism of action positions Enlivex as a future leader in cell therapies for infectious, inflammatory and oncologic diseases. I am eager to begin working with my new colleagues and believe that our complementary skill sets will serve us well as we continue to advance Allocetra^TM^’s development.”

ABOUT ALLOCETRA^TM^

Allocetra^TM^ 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, 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:  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, including therisks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in developmentmay fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketingof these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantialor any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-lookingstatements. 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-stage trials.The development of any products using the ALLOCETRA^TM^ product line could also be affected by a number of other factors,including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, theimpact 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 the Securities and ExchangeCommission, 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 not undertakeany 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