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Enlivex Awarded Second Israel Innovation Authority Grant to Support the Clinical Development of Allocetra in Sepsis

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Enlivex Therapeutics has received a $1.1 million grant from the Israel Innovation Authority, bringing its total non-dilutive funding to approximately $6.6 million for clinical trials and product development. This funding supports Enlivex's ongoing Phase IIb clinical trial of Allocetra for treating organ dysfunctions related to sepsis. Allocetra is designed to reprogram macrophages into their homeostatic state to combat severe diseases, including sepsis and COVID-19, addressing unmet medical needs.

Positive
  • Received $1.1 million non-dilutive funding from the Israel Innovation Authority.
  • Total funding from the IIA now amounts to approximately $6.6 million.
  • Currently recruiting patients for Phase IIb trial of Allocetra.
Negative
  • None.

Grant provides $1.1 million in non-dilutive funding for 2021

Nes Ziona, Israel, May 18, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today announced that the Israel Innovation Authority (IIA) selected Enlivex’s ongoing sepsis clinical program to receive a second non-dilutive grant of approximately $1.1 million for 2021.  To date, Enlivex has received a total of approximately $6.6 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 R&D 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 dysfunctions associated with sepsis.

ABOUT ALLOCETRATM

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, 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, 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 immunotherapy company developing AllocetraTM, 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 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.                                                                      
shachar@enlivexpharm.com


FAQ

What is the purpose of the $1.1 million grant for Enlivex (ENLV)?

The grant supports Enlivex's Phase IIb clinical trial for Allocetra, aimed at treating organ dysfunctions related to sepsis.

How much total funding has Enlivex (ENLV) received from the Israel Innovation Authority?

Enlivex has received approximately $6.6 million in non-dilutive grants from the Israel Innovation Authority to date.

What is Allocetra being developed for by Enlivex (ENLV)?

Allocetra is developed to reprogram macrophages into their homeostatic state, targeting diseases like sepsis and COVID-19.

What stage is the Allocetra trial at for Enlivex (ENLV)?

Enlivex is currently in the patient recruitment phase for its Phase IIb clinical trial of Allocetra.

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