Form 6-K Enlivex Therapeutics For: May 25

May 25, 2022 8:06 AM EDT

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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 2022

 

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 25, 2022, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (the “Company”), issued a press release announcing that the Israel Innovation Authority selected the Company’s ongoing sepsis clinical program to receive a third non-dilutive grant of approximately $1.2 million for 2022. A copy of such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference.

 

  

Exhibit No.  
   
99.1 Press Release issued by Enlivex Therapeutics Ltd. on May 25, 2022.

  

 

 

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.

 

  Enlivex Therapeutics Ltd.
  (Registrant)
   
  By: /s/ Oren Hershkovitz
 

Name: 

Title:

Oren Hershkovitz
Chief Executive Officer

 

Date: May 25, 2022

 

 

 

Exhibit 99.1

 

 

Enlivex Awarded Its Third Non-Dilutive Israel Innovation Authority Grant

to Support the Clinical Development of Allocetra in Sepsis Patients

 

Grant provides $1.2 million in non-dilutive funding for 2022 sepsis clinical trial expenses

 

To date, Enlivex has received a total of $7.8 million in non-dilutive grants from the Israel Innovation Authority, excluding this new grant

 

Nes Ziona, Israel, May 25, 2022 (GLOBE NEWSWIRE) --  Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, today announced that the Israel Innovation Authority (IIA) selected Enlivex’s ongoing sepsis clinical program to receive a thirdnon-dilutive grant of approximately $1.2 million for 2022. To date, Enlivex has received a total of approximately $7.8 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 research and development 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 AllocetraTM for the treatment of organ dysfunction associated with sepsis.

 

ABOUT ALLOCETRA™

 

Enlivex is developing AllocetraTM as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, 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, AllocetraTM 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 macrophage reprogramming immunotherapy company developing Allocetra™, 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 https://enlivex.com/.

 

Safe Harbor 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 market opportunities for, ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data 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 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 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 ALLOCETRATM 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, 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 and other 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 not undertake any obligation to update forward-looking statements, except as required under applicable law.

 

ENLIVEX CONTACT:
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd. 
[email protected]



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