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: December 2023
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 ☐
On
December 20, 2023, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (“Enlivex”), issued
a press release announcing the completion of enrollment of all 120 patients in its Phase II trial of Allocetra in patients with sepsis.
A copy of such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference.
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: |
Oren Hershkovitz |
| |
Title: |
Chief Executive Officer |
Date: December
20, 2023
2
Exhibit 99.1
Enlivex Announces Completion of Enrollment of Its
Phase II Trial Evaluating Allocetra In Patients With Sepsis
| · | Enrollment completed in placebo-controlled,
randomized, dose-finding, multi-country, multi-center Phase II sepsis study |
| · | Topline Data Expected in late Q1 2024 |
Nes-Ziona, Israel, Dec. 19, 2023 (GLOBE NEWSWIRE)
-- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company,
today announced that the Company completed enrollment of all 120 patients in its Phase II trial of Allocetra™ in patients with sepsis.
The Phase II trial is a placebo-controlled, randomized,
dose-finding, multi-country, multi-center study, evaluating frozen-formulation Allocetra™ in addition to standard of care in patients
with sepsis associated with pneumonia, biliary, urinary tract, or peritoneal infections. Sepsis is a life-threatening disease with no
therapies approved by the U.S. Food and Drug Administration and a high unmet need. Each year, more than 1.7 million adults in the United
States develop sepsis, with annual mortality of more than 270,000 due to the disease.
“The completion of the enrollment in our Phase
II trial of Allocetra™ in patients with sepsis is an important execution milestone for Enlivex, meeting our enrollment timeline”
stated Einat Galamidi, Medical Vice President of Enlivex. “We expect, in line with our prior timeline guidance, to report the top-line
data readout from the trial by the end of Q1 2024. We appreciate the hard work of the investigators involved in this trial across multiple
medical centers, and the patients who have helped us achieve this key milestone.”
ABOUT ALLOCETRA™
Allocetra™ 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, 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™ 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 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
INVESTOR RELATIONS CONTACT
Eric Ribner
LifeSci Advisors
eric@lifesciadvisors.com
Enlivex Therapeutics (NASDAQ:ENLV)
Historical Stock Chart
From Oct 2024 to Nov 2024
Enlivex Therapeutics (NASDAQ:ENLV)
Historical Stock Chart
From Nov 2023 to Nov 2024
