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: November 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 November
2, 2026, Enlivex Ltd., a company organized under the laws of the State of Israel (“Enlivex” or the “Company”),
issued a press release announcing 12-month topline data from the randomized, double-blind, placebo-controlled Phase IIa stage of the Company’s
multi-country Phase I/IIa trial (ENX-CL-05-001) evaluating Allocetra™ in patients with moderate to severe knee osteoarthritis. A
copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
The information contained in the four bullets immediately under the heading “Summary of the 12-month Topline Data, Age Group 64+”
in the press release is hereby incorporated by reference into the Company’s registration statements on Forms S-8, F-3 and F-3MEF
(File No. 333-256799,
File No. 333-232413,
File No. 333-232009,
File No. 333-252926,
File No. 333-286956,
File No. 333-292417,
File No. 333-294284,
File No. 333-295215
and File No. 333-298071),
filed with the SEC.
| Exhibit No. |
|
Description |
| 99.1 |
|
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.
| |
Enlivex Ltd. |
| |
(Registrant) |
| |
|
| |
By: |
/s/ Oren Hershkovitz |
| |
Name: Title: |
Oren Hershkovitz
Chief Executive Officer |
Date: November 2, 2026
Exhibit 99.1
Enlivex Announces Favorable 12-Month Topline Data from
Phase I/IIa Allocetra Trial, Demonstrating Durable Treatment Response
| ● | In
patients aged 64+: 79.2% of patients achieved a clinically meaningful response (reduced pain
and improved knee function) in the Allocetra™ group vs. 47.6% in the placebo group
at 12 months (p=0.027)1 |
| ● | Allocetra™ treatment benefit at 12 months was consistent with the response
rates observed at 3 and 6 months, demonstrating a durable effect from a single treatment cycle |
| ● | The 12-month data will be presented at the American College of Rheumatology
(ACR) Convergence in a poster presentation on November 8, 2026 |
Nes-Ziona, Israel, Nov. 02, 2026 (GLOBE NEWSWIRE)
-- Enlivex Ltd. (Nasdaq: ENLV) (“Enlivex” or the “Company”), a quality longevity company powered by a prediction
markets treasury, today announced favorable 12-month topline data from the randomized, double-blind, placebo-controlled Phase IIa stage
of the Company’s multi-country Phase I/IIa trial (ENX-CL-05-001) evaluating Allocetra™ in patients with moderate to severe
knee osteoarthritis. With 12-month follow-up now complete, the data show that a single three-injection treatment cycle of Allocetra™
produced a sustained treatment response through one year in patients with primary age-related knee osteoarthritis, the population being
evaluated in the Company’s ongoing Phase IIb trial. The one-year safety and efficacy results have been selected for a poster presentation
at the American College of Rheumatology (ACR) Convergence 2026 (details below).
Summary of the 12-month Topline Data, Age Group 64+
| ● | Sustained
responder benefit at one year: The proportion of patients (age 64+) achieving a clinically
meaningful response2 (reduced pain and increased knee function) was 66% higher
for the Allocetra™ group than for the placebo group at 12 months, consistent with the
treatment benefit observed at the earlier 3- and 6-month timepoints: |
| o | At 12 months: 79.2% responders in the Allocetra™ group
vs. 47.6% in the placebo group (p=0.027) |
| o | This substantial treatment benefit was consistent with the
response rates observed at 3 months (80% higher for the Allocetra™ group than for the placebo group; p=0.019) and 6 months (39%
higher for the Allocetra™ group than for the placebo group; p=0.168). |
| ● | Improvement in pain and function
maintained through 12 months: Allocetra™ produced statistically significant and clinically meaningful improvements versus
placebo at 3 and 6 months. At 12 months, treatment differences continued to favor Allocetra™ and were reasonably maintained
throughout one year (scale 0–100; difference vs. placebo in change from baseline), in the 64+ age group: |
| o | WOMAC3
pain: -17.5 points at 3 months (p=0.004), -15.4 points at 6 months (p=0.012), and -12.2 points
at 12 months (p=0.113) |
| o | WOMAC function: -19.3 points at 3 months (p=0.0008), -19.5
points at 6 months (p=0.0008), and -13.1 points at 12 months (p=0.067) |
| ● | Consistent age-related effect: Across
analyses, patient age was the strongest predictor of treatment response, with the treatment effect increasing with age. Improvements in
patient-reported outcomes were supported by objective physical performance tests and by exploratory serum biomarker and imaging analyses
consistent with Allocetra™’s proposed macrophage-reprogramming mechanism of action. |
| ● | Favorable safety profile through 12 months: No treatment-related serious
adverse events were observed. Adverse events were predominantly transient, mild to moderate local knee reactions, consistent with previously
reported data. |
| 1 | Summary of the 12-month Topline Data, Age Group 64+ |
| 2 | Under the OMERACT-OARSI responder criteria, the established
standard for osteoarthritis trials |
| 3 | WOMAC: a widely used, standardized questionnaire to evaluate
the condition and quality of life of patients with osteoarthritis of the hip and knee |
12-month data presentation at the ACR convergence
ACR Convergence 2026 is taking place November 6–11, 2026 at the
Orange County Convention Center in Orlando, Florida.
The poster will be presented by Prof. Philip Conaghan, Consultant Rheumatologist
and Director of the NIHR Leeds Biomedical Research Centre. Prof. Conaghan is an international leader in osteoarthritis and musculoskeletal
imaging who has authored more than 700 publications and chaired multiple global guideline and clinical trial initiatives.
Poster Presentation
| ● | Title: Durable Clinical Efficacy of an Innovative Intra-Articular
Apoptotic Cell Therapy in Knee Osteoarthritis: Age-Related Effect Through One Year |
| ● | Session: Poster Session A (0632–0644): Osteoarthritis –
Clinical Poster A |
| ● | Date & Time: November 8, 2026 | 10:30 AM – 12:30
PM ET |
“The 12-month results show that a single treatment cycle of Allocetra™
delivered a clinically meaningful benefit in older patients with knee osteoarthritis that was sustained through one year. In a disease
with no approved disease-modifying therapies, where treatment is largely limited to symptom management or surgery, a durable response
from a single treatment cycle could offer a differentiated profile for patients, physicians and payers. We are pleased that these data
were selected for presentation at ACR Convergence 2026, and we look forward to topline data from our Phase IIb trial, which is enrolling
this same population, by the end of the second quarter of 2027,” said Dr. Oren Hershkovitz, Chief Executive Officer of Enlivex.
About ENX-CL-05-001
ENX-CL-05-001 is a multi-center Phase I/IIa clinical trial consisting
of two stages. The first stage was 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 IIa stage.
The Phase IIa stage was a double-blind, randomized, placebo-controlled multi-centered trial where 134 patients were randomized and treated.
About Knee Osteoarthritis
Osteoarthritis (OA) is one of the most prevalent and disabling diseases
worldwide, affecting more than 32 million Americans today and projected to continue and grow substantially, with knee OA (KOA) being the
most prevalent form. 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 KOA patients are 60 years of age or older. This demographic is expanding with global aging trends, underscoring the need for new, durable
therapies.
About Enlivex
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.
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 that results from subgroup analyses and small patient populations, including those
described in this press release, may not be replicated in larger trials, including the Company’s ongoing Phase IIb trial; the risk
that topline data may change following a more comprehensive review of the data; the risk that RMAT designation may not lead to a faster
development or regulatory review process and does not increase the likelihood of approval; risks related to the timing, conduct and outcome
of clinical trials and regulatory submissions; 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
