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: October 2026
Commission file number: 001-36578
ENLIVEX 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 October
28, 2026, Enlivex Ltd., a company organized under the laws of the State of Israel (the “Company”), issued
a press release announcing that 135 patients, out of a total planned 182, have been randomized and were administered the first injection
of AllocetraTM in the Company’s Phase 2b clinical trial of Allocetra™ for the treatment of patients with moderate-to-severe
age-related symptomatic primary knee osteoarthritis. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated
herein by reference.
| Exhibit No. |
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| 99.1 |
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Press Release |
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.
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Enlivex Ltd. |
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(Registrant) |
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By: |
/s/ Oren Hershkovitz |
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Name: Title: |
Oren Hershkovitz
Chief Executive Officer |
Date: October 28, 2026
Exhibit 99.1
Enlivex Announces Randomization of 135 Patients
in Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis
| ● | 135 patients, out of a total
planned 182, have been randomized and were administered the first injection of AllocetraTM; enrollment actively ongoing at
clinical sites in the United States and in Europe |
| ● | Topline six-month data expected
by mid-2027 |
| ● | Phase 2b builds on positive
three- and six-month Phase 1/2a data, which supported FDA Regenerative Medicine Advanced Therapy (RMAT) designation granted in July 2026 |
Nes-Ziona, Israel, Oct. 28, 2026 (GLOBE NEWSWIRE)
-- Enlivex Ltd. (Nasdaq: ENLV) (“Enlivex” or the “Company”), a quality longevity company powered by a prediction
markets treasury, today announced that 135 patients, out of a total planned 182, have been randomized and were administered the first
injection of AllocetraTM in the Company’s Phase 2b clinical trial of Allocetra™ for the treatment of patients
with moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA). The trial is actively recruiting at clinical sites
in the United States, Denmark and Poland, and the Company expects to report topline six-month data by mid-2027.
The global, multicenter, randomized, double-blind,
placebo-controlled Phase 2b trial is designed to evaluate the efficacy and safety of intra-articular injections of Allocetra™ in
patients aged 64 and older with moderate-to-severe age-related symptomatic primary knee OA, the population for which the U.S. Food and
Drug Administration (FDA) granted RMAT designation. Key efficacy endpoints include changes from baseline in pain and function compared
with placebo, measured at three and six months following treatment. Additional endpoints include changes in quality-of-life measures and
functional mobility assessments.
Einat Galamidi, M.D., Chief Medical Officer of
Enlivex, commented, “We are very excited by the progress of our Phase 2b trial. Reaching more than 70% of randomization in the trial
reflects strong engagement from our investigators and patients across the United States and Europe. Our team is committed to executing
this study to the highest standards of quality and in accordance with our stated timelines, and we look forward to reporting topline six-month
data by mid-2027.
About Enlivex (Nasdaq: ENLV)
Enlivex is a quality longevity company powered
by a prediction markets treasury. The Company is advancing Allocetra™, an advanced clinical-stage immunotherapy targeting inflammatory
conditions associated with aging, with a primary focus on age-related osteoarthritis. In addition to its clinical programs, Enlivex operates
a prediction markets treasury strategy built around the Rain protocol, the leading decentralized prediction markets infrastructure on
Arbitrum. This dual strategy combines the development of quality longevity therapeutics with exposure to the emerging prediction markets
ecosystem.
About Knee Osteoarthritis
Knee osteoarthritis (KOA) is one of the most prevalent
and disabling diseases worldwide, affecting more than 32 million Americans today and projected to impact 78 million Americans by 2040.
There are currently no approved disease-modifying therapies; treatment is largely limited to pain relief, intra-articular steroids, or
surgery, and the burden increases sharply with age. By age 60, KOA affects roughly 30% of the population, and about half of knee OA patients
are 60 years and older. This demographic is expanding with global aging trends, underscoring the need for new, durable therapies.
Forward-Looking Statements
This press release contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements may be identified by words such as “expects,” “plans,” “projects,”
“will,” “may,” “anticipates,” “believes,” “should,” “would,” “could,”
“intends,” “estimates,” “suggests,” “target,” “has the potential to,” “goal,”
and other words of similar meaning, including statements relating to the anticipated benefits of the Company’s digital asset treasury
strategy; the assets to be held by the Company; the expected future market, price, trading activity, and liquidity of the RAIN token;
the impact of expanded exchange listings and increased token liquidity on market participation and accessibility; the potential effects
of digital asset liquidity on the liquidity of the Company’s ordinary shares; macroeconomic, political, and regulatory conditions surrounding
digital assets; the Company’s plans for value creation and strategic positioning; market size and growth opportunities; regulatory conditions;
competitive position; technological and market trends; future financial condition and performance; expected clinical trial results; market
opportunities for the results of current clinical studies and preclinical experiments; and the effectiveness of, and market opportunities
for, ALLOCETRA™ programs. Each forward-looking statement contained in this press release is subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties
include, among others, the risk of failure to realize the anticipated benefits of the Company’s digital asset treasury strategy; changes
in business, market, financial, political, and regulatory conditions; risks relating to the Company’s operations and business, including
the highly volatile nature of the price, trading volume, and liquidity of RAIN and other cryptocurrencies; risks associated with digital
asset exchange listings, trading venues, and market infrastructure; the risk that the price and liquidity of the Company’s ordinary shares
may be correlated with the price or liquidity of the digital assets it holds; risks related to increased competition in the industries
in which the Company operates; risks relating to significant legal, commercial, regulatory, and technical uncertainty regarding digital
assets generally; risks relating to the treatment of crypto assets for U.S. and foreign tax purposes; and those risks and uncertainties
identified in the Company’s filings with the Securities and Exchange Commission. The forward-looking statements in this press release
speak only as of the date of this document, and the Company undertakes no obligation to update or revise any of these statements, except
as required by applicable law.
ENLIVEX CONTACT
Shachar Shlosberger, CFO
Enlivex Ltd.
shachar@enlivex.com
