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: September 2024
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
September 26, 2024, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (“Enlivex”),
issued a press release announcing that the Danish Medicines Agency authorized the initiation of the Phase II stage of
Enlivex’s multi-country Phase I/II trial in moderate and severe knee osteoarthritis. 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:
Title: |
Oren Hershkovitz
Chief Executive Officer |
Date:
September 26, 2024
2
Exhibit 99.1
Enlivex
Receives Authorization from the Danish Medicines Agency to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients
with Moderate to Severe Knee Osteoarthritis
Nes-Ziona,
Israel, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage
reprogramming immunotherapy company, today announced that the Danish Medicines Agency authorized the initiation of the Phase II stage
of the Company’s multi-country Phase I/II trial in moderate and severe knee osteoarthritis. This approval follows the recently
announced recommendation by the independent Data and Safety Monitoring Board (DSMB) that the Company may move forward to the Phase II
stage of the trial.
The
Phase I/II multi-center clinical trial is composed of two stages. The first stage is a Phase I safety run-in, open-label dose escalation
phase to characterize the safety and tolerability of Allocetra™ injections to the target knee in order to identify the dose and
injection regimen for the subsequent Phase II stage. The Phase II stage is a double-blind, randomized, placebo-controlled stage, which
the Company is now initiating following the completion of the safety run-in stage and the safety confirmation by the DSMB, which the
Company recently announced. In addition to evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy
of Allocetra™ injections into the knee. The Company expects that the primary measurements will evaluate joint-pain and joint-function
in comparison to placebo at three months, six months and 12 months after treatment.
Einat
Galamidi, MD, Medical Vice President of Enlivex, commented, “We are pleased with the safety profile of Allocetra™ following
three sequential intra-articular knee injections, as demonstrated in the first twelve patients in the Phase I safety run-in stage of
this trial, and the approval to progress into the double-blind, randomized, placebo controlled Phase II stage.”
ABOUT
KNEE OSTEOARTHRITIS1
Osteoarthritis
is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide.
About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis
by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing
knee osteoarthritis in their lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States,
primarily for total joint replacement. The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant
disability for persons with osteoarthritis is critical. There are currently no medications approved by either the U.S. Food and Drug
Administration (FDA) or the European Medicines Agency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural
damage in the joint.
| 1 | Source:
The Arthritis Foundation; Disease modification in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis and Cartilage
Open (2) (2020) |
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 and life debilitating 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.
shachar@enlivexpharm.com
INVESTOR
RELATIONS CONTACT
Dave
Gentry, CEO
RedChip
Companies Inc.
1-407-644-4256
ENLV@redchip.com
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