Enlivex Awarded Its Third Non-Dilutive Israel Innovation Authority Grant to Support the Clinical Development of Allocetra in Sepsis Patients

Rhea-AI Summary

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has been awarded a grant of approximately $1.2 million from the Israel Innovation Authority for its ongoing sepsis clinical trial in 2022. This brings the total non-dilutive funding from the IIA to about $7.8 million since the inception of their partnership. Enlivex is currently recruiting patients for its Phase IIb trial of Allocetra^TM, aimed at treating organ dysfunction associated with sepsis. Allocetra^TM is designed to reprogram macrophages, potentially addressing unmet medical needs in critical conditions.

Positive

• Secured additional funding of $1.2 million for sepsis clinical trial in 2022.
• Total funding from Israel Innovation Authority now at $7.8 million, supporting clinical trials and product development.
• Active recruitment for Phase IIb trial of Allocetra^TM signifies progress in clinical development.

Negative

• None.

• 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 Allocetra^TM for the treatment of organ dysfunction associated with sepsis.

ABOUT ALLOCETRA™

Enlivex is developing Allocetra^TM 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, 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 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, ALLOCETRA^TM 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 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, 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 Enlivex's clinical trial for Allocetra?

The trial aims to evaluate Allocetra's effectiveness in treating organ dysfunction associated with sepsis.

How much funding has Enlivex received for its clinical trials?

Enlivex has received a total of approximately $7.8 million in non-dilutive grants from the Israel Innovation Authority.

What stage is the Allocetra trial currently in?

Enlivex is currently recruiting patients for its Phase IIb trial.

What is Allocetra designed to do?

Allocetra is designed to reprogram macrophages to restore their homeostatic state, potentially improving outcomes in critical conditions like sepsis.