Enlivex CEO Issues Letter to Shareholders - Perspectives on Recent Events Nes-Ziona, Israel

Enlivex CEO Issues Letter to Shareholders -

Perspectives on Recent Events

Nes-Ziona, Israel, April 29, 2024 (GLOBE NEWSWIRE) - Enlivex

Therapeutics Ltd. (Nasdaq: ENLV, the "Company" or "Enlivex"), a clinical-stage macrophage reprogramming immunotherapy

company, today issued the following update to shareholders from Chief Executive Officer, Oren Hershkovitz.

Dear fellow shareholders,

I have been serving as the Chief Executive Officer of Enlivex for the

last four and a half years. During that period, we have been working diligently to develop our drug product candidate, AllocetraTM,

as a first-in-kind modulator of a spectrum of negative immune reactions from low, chronic, debilitating inflammation to high-grade, life-threatening

To-date, we have completed numerous pre-clinical studies across multiple

disease models, infused AllocetraTM in more than 100 patients and witnessed the encouraging safety profile and potential effect

of AllocetraTM. We saw a patient with COVID-19 in critical condition saying goodbye to his loved ones via a video call, as

the consensus in the ICU was that he would not last through the night, and that patient received an infusion of AllocetraTM

and within hours had a complete reversal of his condition, resulting in his release from the hospital several days later. We also saw

a patient with an ultra-rare condition, vanishing bone disease in the shoulder joint. In this case, not only was the joint cartilage completely

eroded, but the shoulder bone itself had completely disintegrated. After four years of escalation and nine months of continued hospitalization,

the patient received a compassionate treatment of injections of matched AllocetraTM to the shoulder joint. We witnessed the

outstanding recovery of the inflammatory condition resulting in hospital discharge after five weeks and no re-hospitalization in the

following three years. We have witnessed, first-hand, the potential effect of AllocetraTM as a life-changer, and all of us

at Enlivex are committed to translate that first-hand experience into a global one.

On April 11, 2024, we released the top-line data from a placebo-controlled,

randomized, dose-finding, multi-country, multi-center Phase II trial, which evaluated frozen-formulation Allocetra in addition

to standard of care in patients with sepsis associated with pneumonia, biliary, urinary tract, or peritoneal infections.

The trial randomization resulted in a higher risk profile of the AllocetraTM

group as compared to the control group, making some of the data challenging to interpret. In small clinical trials, these things happen

from time to time. While we are not happy that this occurred, we are pleased that AllocetraTM demonstrated (i) a potential

indication of effect not only stand-alone but also as compared to the control group in high-risk urinary tract infection (UTI) sepsis

patients, and (ii) a favorable safety and tolerability profile.

We believe that these results have increased the likelihood of AllocetraTM

to eventually change the lives of millions of people around the world, whether in sepsis or osteoarthritis. We believe that each

of these two market segments represents a potential multi-billion dollar commercial opportunity for Enlivex. The Phase II sepsis study

also demonstrated the giant leap we made in transforming AllocetraTM into a completely off-the-shelf drug that can be easily

shipped and stored in clinical sites globally and easily administered by physicians, including in complex environments, such as in intensive

care units. As we continue to analyze the data from the sepsis study, we will also assess whether collaborators may seek to work with

us on a larger sepsis study, which could be in high-risk UTI sepsis patients or across multiple patient populations.

Some asked us recently what the link is between a potential indication

of effect in sepsis and the treatment of osteoarthritis. We note that the basic mechanism of action of AllocetraTM is to positively

modulate macrophages that are at the core of the particular inflammatory cause. We chose osteoarthritis after careful review of the scientific

literature that showed high correlation between inflamed macrophages and osteoarthritis severity and clinical manifestation. Therefore,

the potential indication of effect and the favorable safety and tolerability profile of AllocetraTM as demonstrated in the

sepsis trial are very important, in our opinion, and we expect that these increase the probability of success in osteoarthritis.

We announced earlier this week that the

first two patients had been dosed in the Company's multi-country, randomized, controlled Phase I/II trial evaluating

AllocetraTM in up to 160 patients with moderate to severe knee osteoarthritis. We anticipate two significant milestones

relating to osteoarthritis, the first of which being results from the ongoing clinical trial of AllocetraTM in patients

with end-stage knee osteoarthritis, which we expect in Q3 2024. These patients have been suffering from knee osteoarthritis for many

years, and, following various treatments, eventually have reached the stage requiring knee replacement surgery. We are offering

them, as a last resort, a single injection of AllocetraTM to the knee. We started with the first patient approximately

seven months ago, and we are continuing to enroll patients. Our second milestone, which we expect in Q3 2025, is top-line results

from the Company's multi-country, randomized, controlled Phase I/II trial evaluating AllocetraTM in up to 160

patients with moderate to severe knee osteoarthritis.

We expect that our existing cash resources will provide adequate coverage,

plus a safety margin, for obtaining the data from these two important trials. I am privileged to lead such an enthusiastic and dedicated

team at Enlivex who accomplished and executed so much in the past four and a half years The team at Enlivex is genuinely excited about

the prospect of AllocetraTM to be a game changer in the world of medicine. We appreciate your continued support. It takes time,

courage and tenacity to change the world, and we hope to do just that.

Oren Hershkovits, Ph.D., CEO

Sepsis is a life-threatening disease with no therapies approved by

the U.S. Food and Drug Administration ("FDA") and a high unmet medical need. According to the U.S. Centers for Disease Control

and Prevention, each year, at least 1.7 million adults in the United States develop sepsis, with approximately 270,000 dying of the disease.

Urinary tract infection is the second most common infectious disease

affecting more than 150 million people globally annually. Up to 31% of sepsis cases start as UTIs, representing up to 9.8 million cases

annually worldwide, leading to as many as 1.6 million deaths.1

ABOUT KNEE OSTEOARTHRITIS2

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 FDA or the European Medicines Agency that have been demonstrated to arrest, slow or reverse

progression of structural damage in the joint.

Allocetra is being developed as a universal, off-the-shelf cell

therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram

macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective

diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action

for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination

with leading therapeutic agents.

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 http://www.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," "has the potential to" and other words of similar

meaning, including statements regarding expected cash balances, 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