Enlivex Reaffirms

Enlivex Reaffirms August 18, 2025 As Target

Date For Announcement of Phase II Topline Data

Nes-Ziona, Israel, July 28, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming

immunotherapy company, today announced that all 134 patients in its Phase II stage of its randomized, controlled, blinded Phase I/II

trial of Allocetra in patients with moderate to severe knee osteoarthritis, have completed a follow-up period of at least

three months, the trial's primary timepoint for measurement of key endpoints. The data are being analyzed and audited, with a

target date of August 18, 2025 for the public release of audited topline results for three-month key endpoints, including safety and

change from baseline in knee pain and function.

The multi-center Phase I/II clinical trial consists

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 or the subsequent Phase IIa stage.

This stage is a double-blind, randomized, placebo-controlled multi-centered trial. In addition to evaluating safety, the study protocol

is designed to efficiently find a strong signal in a responder population to guide future development, and includes an interim statistical

evaluation, conducted by an independent third party and blinded to the Company, to assess the potential value of enrollment of up to 50

patients in addition to the original randomized sample size of 130, and its marginal impact on the p-value of the statistical estimation

of the total group and specifically to identify a potential responder sub-group. The trial's key efficacy endpoints evaluate joint-pain

and joint-function in comparison to placebo at three months, six months and 12 months post treatment.

ABOUT KNEE OSTEOARTHRITIS

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.

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 contains

forward-looking statements, which 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" and other

words of similar meaning, including statements regarding expected cash balances, expected clinical trial results, market opportunities

for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs.

All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of

1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex's business

and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that

the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support

the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue

to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth

in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results

of 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 ALLOCETRATM product line could also be affected by a number

of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision

making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and

other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should

consider the economic, competitive, governmental, technological and other factors discussed in Enlivex's filings with the Securities

and Exchange Commission, including in the Company's most recent Annual Report on Form 20-F filed with the Securities and Exchange

Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we

do not undertake any obligation to update forward-looking statements, except as required under applicable law.

Shachar Shlosberger, CFO

Enlivex Therapeutics, Ltd.

INVESTOR RELATIONS CONTACT

RedChip Companies Inc.