Enlivex Ltd 6-K, filed Nov 17, 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: November 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 November 15, 2020, the Board of Directors (the “Board”) of Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (the “Company”), appointed Dr. Brian Schwartz, M.D. to serve as a Director for a term expiring at the Company’s 2021 Annual Meeting of Shareholders.

Dr. Schwartz will participate in the standard non-employee director compensation arrangements described in the Company’s 2020 Proxy Statement furnished as Exhibit 99.1 to the Company’s Report on Form 6-K filed with the Securities and Exchange Commission on May 19, 2020.

There are no arrangements or understandings between Dr. Schwartz, on the one hand, and any other person, on the other hand, pursuant to which he was appointed to the Board. Since the beginning of the Company’s last fiscal year, the Company has not engaged in any transactions, and there are no proposed transactions, or series of similar transactions, in which Dr. Schwartz was or is to be a participant and in which any related person had a direct or indirect material interest in which the amount involved exceeds or exceeded $120,000

In connection with his appointment to the Board, Dr. Schwarz will receive ten-year options to purchase an aggregate of 40,500 of the Company’s ordinary shares, at a price of $9.02 per share, vesting ratably over a period of four years, commencing on the first anniversary of the date of grant.

On November 17, 2020, the Company issued a press release announcing Dr. Schwartz’s appointment to the Board. 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: November 17, 2020

2

Exhibit 99.1

Enlivex Appoints Former ArQule, Inc. Executive Dr. Brian Schwartz to

the Company’s Board of Directors

*Dr. Schwartz Served as ArQule’s Chief Medical Officer and Head of Research andDevelopment Prior to the $2.7 billion Acquisition of ArQule by Merck in February 2020 *

NesZiona, Israel, November 17, 2020 (GLOBE NEWSWIRE) --Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage immunotherapy company, today announced that Brian Schwartz, MD, who served for twelve years as Chief Medical Officer of ArQule, Inc. and led ArQule’s research and development programs through its $2.7 billion acquisition by Merck earlier this year, joined the Enlivex Board of Directors on November, 15, 2020.

Dr. Schwartz commented, “I am excited to be joining the Board of Directors of Enlivex. After carefully reviewing the scientific basis and data for Allocetra^TM^, which is currently in clinical development for sepsis and COVID-19, and in preclinical development for solid cancers, I believe that this innovative immunotherapy approach has the potential to significantly impact life-threatening, high-mortality diseases. Additionally, I believe that the planned and ongoing clinical program, coupled with a management team that has a track-record of creating shareholder value, leaves the Company well positioned for sustained near- and long-term growth.”

Dr. Schwartz brings significant experience in drug development in both the biotechnology and pharmaceutical industries. Dr. Schwartz most recently served as Chief Medical Officer and head of Research and Development of ArQule, Inc. where he served as a key member of the management team and spearheaded a number of preclinical and clinical drug development programs in oncology and rare diseases. Prior to joining ArQule in 2008, Dr. Schwartz served as Chief Medical Officer and Senior Vice President, Clinical and Regulatory Affairs, at Ziopharm Oncology, Inc., where he built and led clinical, regulatory, and quality assurance departments responsible for the development of new cancer drugs. Earlier in his career, Dr. Schwartz held a number of positions at Bayer Healthcare and Leo Laboratories. At Bayer, Dr. Schwartz was a key physician responsible for the global clinical development of sorafenib (Nexavar®) and has extensive regulatory experience working with the FDA’s Oncology Division, the European Medicines Evaluation Agency (EMEA), and numerous other health authorities. Dr. Schwartz received his medical degree from the University of Pretoria, South Africa, practiced medicine, and worked at the University of Toronto prior to his career in the biopharmaceutical industry. Dr Schwartz is currently serves as a board member of Mereo Biopharma and LifeSci Acquisition Corp.

Shai Novik, Executive Chairman of the Board of Enlivex, stated, “We are excited to have Dr. Schwartz on our Board. He has significant relevant experience in all aspects of the product development lifecycle and shareholder value creation. We look forward to working together.”

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) 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.

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

INVESTORRELATIONS CONTACT

Eric Ribner

LifeSci Advisors

eric@lifesciadvisors.com