Full Press Release Details
Enlivex Announces Second
Regulatory Approval for Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis
Israel, April 21, 2026 - Enlivex Ltd. (Nasdaq: ENLV) ("Enlivex" or the "Company"), a quality longevity
company, today announced that it has received Clinical Trial Application (CTA) approval by the Danish Medicines Agency (DKMA) for
the Phase 2b trial of Allocetra , the Company's
clinical-stage immunotherapy, for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis
planned global, multicenter, randomized, double-blind, placebo-controlled Phase 2b clinical trial, recently approved by the FDA, has
been designed to evaluate the efficacy and safety of intra-articular injections of Allocetra
in patients with moderate-to-severe age-related symptomatic
primary knee osteoarthritis, which 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. The clinical trial is designed to enroll patients from clinical centers in
the United States, Denmark and Poland.
Hershkovitz, Ph.D, CEO of Enlivex, commented, "Following the recent FDA clearance, the approval in Denmark marks another key step
in executing our global Phase 2b strategy for Allocetra .
Expanding into Europe reflects our commitment to advancing a unified, multinational development program designed to generate robust clinical
data. Osteoarthritis remains a highly prevalent and disabling condition with limited disease-modifying treatment options, and we believe
Allocetra 's unique immunomodulatory mechanism
has the potential to address the underlying drivers of inflammation and improve the quality of life for aging patients with knee osteoarthritis.
We look forward to initiating patient enrollment and further evaluating Allocetra 's
potential to reduce pain, increase function, and improve quality of life for patients."
The Phase 2b trial has been
designed to be statistically powered to evaluate key efficacy endpoints, including change from baseline in pain and physical function
compared with placebo, measured at three- and six-months periods following treatment. Additional endpoints include changes in quality-of-life
measures and functional mobility assessments.
About Enlivex (Nasdaq:
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
Shachar Shlosberger, CFO