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: July 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 July 23, 2024, Enlivex Therapeutics Ltd., a
company organized under the laws of the State of Israel (“Enlivex”), issued a press release announcing that the Israeli Ministry
of Health authorized the initiation of a Phase I clinical trial to evaluate the safety and tolerability of AllocetraTM following
injection into an affected joint in patients with psoriatic arthritis. 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 |
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Title: |
Chief Executive Officer |
Date: July 23, 2024
2
Exhibit 99.1
Enlivex
Receives Regulatory Authorization For The Initiation Of A Phase I
Clinical Trial To Evaluate Allocetra In Patients With Psoriatic Arthritis
| ● | First
study of AllocetraTM in psoriatic arthritis, a chronic inflammatory condition
that causes joint pain, swelling and stiffness, affects as many as 30% of people with psoriasis1,
and has limited treatment options |
Nes-Ziona,
Israel, July 23, 2024 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage
macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of Health has authorized the initiation of
a Phase I clinical trial to evaluate the safety and tolerability of Allocetra™ following injection into an affected joint in patients
with psoriatic arthritis.
The
trial currently plans to recruit six patients who have insufficiently responded to conventional therapies for psoriatic arthritis. The
primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and secondary endpoints
will include assessments of change from baseline in pain and other parameters of disease activity for up to 12 months following administration
of Allocetra™.
“There
are many psoriatic arthritis patients with poor response to existing treatments. The mode of action of AllocetraTM may become
a new modality in treating these patients. We are pleased to announce the initiation of a new clinical program in psoriatic arthritis
and are looking forward to commencing the study as a first step to our future development of a potentially effective treatment option
for these patients” stated Oren Hershkovitz, Ph.D., CEO of Enlivex.
ABOUT
PSORIATIC ARTHRITIS1
Psoriatic
arthritis (PsA) is a chronic inflammatory arthritis that typically occurs in individuals with psoriasis, a skin condition characterized
by red, scaly patches. PsA can affect any joint in the body, leading to pain, stiffness, and swelling. It can also cause inflammation
in other parts of the body, including the eyes, heart, and gastrointestinal tract. The global market for psoriatic arthritis (PsA) treatments,
valued at approximately $10.8 billion in 2023, is estimated to grow substantially. Certain projections indicate the market will reach
$20.5 billion by 2032, growing at a compound annual growth rate (CAGR) of 7.4% from 2024 to 2032. Other analysis anticipates the PsA
treatment market will increase from $9.97 billion in 2023 to $24.87 billion by 2031, representing a CAGR of 12.1% from 2024 to 2031.
The current landscape of PsA treatment is marked by significant challenges, including limited efficacy, side effects, high costs, long-term
safety concerns, underdiagnosis, and issues with patient adherence. Addressing these challenges requires ongoing research and development
of more effective, safer, and affordable treatments, along with efforts to improve diagnosis and patient education.
1 | https://www.yalemedicine.org/conditions/psoriatic-arthritis |
https://www.reportsandinsights.com/report/psoriatic-arthritis-psa-treatment-market
https://www.snsinsider.com/reports/psoriatic-arthritis-treatment-market-3223
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 sepsis, osteoarthritis’ psoriatic arthritis 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, and harnessing the healing power of these cells, Allocetra™ has the potential to provide a novel
immunotherapeutic mechanism of action for life-threatening and life-debilitating 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 and life-debilitating 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
Dave
Gentry, CEO
RedChip
Companies Inc.
1-407-644-4256
ENLV@redchip.com
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