First U.S. patient dosed in Enlivex (Nasdaq: ENLV) Phase 2b knee OA trial
Rhea-AI Filing Summary
Enlivex Ltd. reports dosing the first patient at a United States clinical site in its global Phase 2b trial of Allocetra™ for moderate-to-severe age-related primary knee osteoarthritis. This marks the start of U.S. enrollment in a randomized, double-blind, placebo-controlled study.
The multicenter trial spans sites in the United States, Denmark and Poland and evaluates intra-articular Allocetra™ injections. Key efficacy measures track pain and physical function at three and six months, with additional quality-of-life and mobility endpoints. Enlivex positions Allocetra™ within a broader strategy that combines longevity-focused immunotherapy development with a prediction markets treasury built around the Rain protocol.
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Insights
First U.S. dosing advances Enlivex’s Phase 2b OA program within a dual biotech–crypto strategy.
Enlivex has dosed the first U.S. patient in its global Phase 2b Allocetra™ trial for moderate-to-severe knee osteoarthritis. The study is randomized, double-blind and placebo-controlled, enrolling across the United States, Denmark and Poland to test intra-articular injections.
Knee osteoarthritis affects more than 32 million Americans today and is projected to impact 78 million by 2040, with no approved disease-modifying therapies. The trial’s primary endpoints focus on pain and physical function at three and six months, with added quality-of-life and mobility measures.
Alongside clinical development, Enlivex operates a prediction markets treasury strategy using the Rain protocol on Arbitrum. This links its longevity drug programs with exposure to digital-asset markets, while the press release highlights extensive forward-looking risks around both clinical outcomes and crypto-related activities.
Key Figures
Key Terms
Phase 2b clinical trial medical
randomized, double-blind, placebo-controlled medical
intra-articular injections medical
prediction markets treasury financial
Rain protocol technical
forward-looking statements regulatory
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: May 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 May 18, 2026, Enlivex Ltd., a company organized under the laws of the State of Israel, issued a press release announcing the dosing of the first patient at a United States clinical site in the 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. | ||
| 99.1 | Press Release |
1
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: | Oren Hershkovitz | |
| Title: | Chief Executive Officer | |
Date: May 18, 2026
2
Exhibit 99.1
Enlivex Announces Dosing Of First Patient In The United States As Part Of Its Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis
| ● | Enrollment milestone follows FDA IND clearance received in March 2026 and Danish Medicines Agency (DKMA) approval received in April 2026 |
Nes-Ziona, Israel, May 18, 2026 (GLOBE NEWSWIRE) --Enlivex Ltd. (Nasdaq: ENLV) (“Enlivex” or the “Company”), a quality longevity company powered by a prediction markets treasury, today announced the dosing of the first patient at a United States clinical site in the Phase 2b clinical trial of Allocetra™ for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA).
The global, multicenter, randomized, double-blind, placebo-controlled Phase 2b clinical trial is 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 trial is enrolling patients from clinical centers in the United States, Denmark and Poland. Key efficacy endpoints include changes from baseline of pain and physical function compared with placebo, measured at three- and six-month periods following treatment. Additional endpoints include changes in quality-of-life measures and functional mobility assessments.
Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, “Dosing the first patient in the United States marks a significant step in the execution of our global Phase 2b strategy for Allocetra™. The United States represents the largest clinical site network for this trial, and initiating enrollment there reflects the momentum we have built following FDA IND clearance and DKMA approval. Our Phase 1/2a data demonstrated a robust, durable, and clinically meaningful treatment effect in the patient population that is the center focus of this Phase 2b trial, and we believe that we are positioned to generate the data needed to move forward to the last stages of clinical development and offer a therapy that will address a significant unmet need for aging patients with this debilitating disease.”
| Enlivex (Nasdaq: ENLV) | www.enlivex.com |
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
| Enlivex (Nasdaq: ENLV) | www.enlivex.com |