6-K
Enlivex Ltd. (ENLV)
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: March 2025
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 March 17, 2025, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (“Enlivex”), issued a press release announcing that the China National Intellectual Property Administration issued a notice of allowance for patent application number 2020800620493, and the resulting patent, once issued, will provide Enlivex with added intellectual property protection in China through at least 2040 with claims covering methods of using Allocetra™ to treat subjects with osteoarthritis. A copy of such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference.
| Exhibit No. | |
|---|---|
| 99.1 | Press Release issued by Enlivex Therapeutics Ltd. on March 17, 2025. |
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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 |
| Title: | Chief Executive Officer |
Date: March 17, 2025
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Exhibit 99.1

Enlivex Receives Notice of Allowance for ChinesePatent Application Covering the Use of Allocetra in Patients with Osteoarthritis
Nes-Ziona, Israel, March 17, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the China National Intellectual Property Administration (CNIPA) issued a notice of allowance for patent application number 2020800620493. Once issued, the resulting patent will provide Enlivex with added intellectual property protection in China through at least 2040 with claims covering methods of using Allocetra™ to treat subjects with osteoarthritis. The Company expects that this new patent will be issued in China during the first half of 2025.
Enlivex recently reported positive interim six (6) months efficacy data from the first stage of its ongoing randomized, multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis.
Key highlights:
| ● | Statistically<br>significant, 47.0% average reduction of reported pain (P=0.0001), compared to average pain level at baseline |
|---|---|
| ● | 46%<br>improvement in joint function and 40% improvement in joint stiffness |
| --- | --- |
| ● | 83%<br>of the patients were still considered as responders to treatment^1^after 6 months |
| --- | --- |
| ● | No<br>serious adverse events |
| --- | --- |
| ● | Efficacy<br>continues to display strong persistence and durability over time, maintaining the 3-month positive effect |
| --- | --- |
Oren Hershkovitz, Ph.D, CEO of Enlivex, commented, “We are very pleased to receive the first patent allowance for the use of Allocetra^TM^ as a potential treatment in patients with osteoarthritis. We believe that this allowance provides high assurance that similar patent allowances will be obtained across all major jurisdictions as part of our IP portfolio rollout.”
ABOUT KNEE OSTEOARTHRITIS^2^
Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement. The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis is critical. There are currently no medications approved by either the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint.
| ^1^ | According to the OMERACT-OARSI criteria (Outcome Measures<br>in Arthritis Clinical Trials-Osteoarthritis Research Society International) |
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| ^2^ | Source: The Arthritis Foundation, Disease modification<br>in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis and Cartilage Open (2) (2020) |
| --- | --- |
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 https://enlivex.com/.
Safe Harbor Statement: This press release containsforward-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 similarmeaning, including statements regarding expected cash balances, expected clinical trial results, market opportunities for the resultsof current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA^TM^ programs.All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s businessand prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; thatthe products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would supportthe approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continueto show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forthin the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the resultsof 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 ALLOCETRA^TM^ product line could also be affected by a number ofother factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decisionmaking, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents andother proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors shouldconsider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securitiesand Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and ExchangeCommission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and wedo 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