Enlivex Reports Positive Top-Line Results from Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients and Provides a Program Update Phase II (16 patients treated, 9/16 (56%) with severe ill

Enlivex Reports Positive Top-Line Results from Phase II Clinical

Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients and Provides a Program Update

Nes Ziona, Israel, February 3, 2021 (GLOBE NEWSWIRE) -- Enlivex

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

diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today reported positive top-line results from a multi-center,

investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients. Based

on the positive results and in consultation with the trial's principal investigator, the Company has completed the trial

early and plans to submit a summary of the data for review by the relevant regulatory bodies. Submission of the data summary to

regulators is expected later this month and will serve as the basis for a discussion with regulators on the next steps in Allocetra's

regulatory pathway in COVID-19 patients with severe or critical illness.

Sixteen COVID-19 patients were treated with AllocetraTM

in the Phase II clinical trial, which originally was expected to enroll twenty-four patients. The clinical trial was completed

early in support of anticipated accelerated regulatory filings of the trial's positive safety and efficacy data. Of the sixteen

patients enrolled in the Phase II trial, nine (9/16, 56%) were in severe condition and seven (7/16, 44%) were in critical condition.

Key results and conclusions from both the Phase II clinical

trial, as well as a previously reported investigator-initiated Phase Ib study of AllocetraTM in severe and critical

COVID-19 patients, include:

Data from the investigator-initiated Phase II trial, as well

as an audited analysis of the Phase Ib trial are shown below:

Prof. Vernon van Heerden, Head of the General Intensive

Care Unit at Hadassah Medical Center in Israel and the lead investigator of both the prior Phase Ib and the now-completed

Phase II clinical trials of AllocetraTM in severe and critical COVID-19 patients stated, "The results we

have seen from the twenty-one COVID-19 patients treated to date with AllocetraTM are exciting. The Phase II

patients who have been discharged from the hospital are currently healthy. We believe that these compelling results have

demonstrated the safety and efficacy of AllocetraTM in these complicated patients, highlighting the potential

of Enlivex's product candidate to benefit severe and critical COVID-19 patients as well as others suffering from

cytokine storms and organ dysfunctions across various clinical indications."

Prof. Dror Mevorach, M.D., Chief Scientific and Medical Officer

of Enlivex, added, "We believe the results from the COVID-19 clinical trials of AllocetraTM represent a unique

opportunity for severe and critical COVID-19 patients, on top of standard of care. The data suggest that AllocetraTM may

have utility as a safe and efficacious treatment for reprogramming macrophages and resolving states of organ failures both in this

COVID-19 patient population, regardless of the specific coronavirus mutation that inflicted

the patients, and across different life-threatening, high mortality clinical indications with high unmet medical

Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex

commented, "We are pleased with the top-line results of this Phase II clinical trial. We believe that AllocetraTM,

if approved, could potentially cover the void that currently exists for the treatment of severe and critical COVID-19 patients.

COVID-19 vaccines are game-changers in the fight against the pandemic, yet with various surveys demonstrating 25-32% of the population

in the United States and major European countries unwilling to get vaccinated1, and concerns surrounding various mutant

strains of the SARS-CoV-2 virus, our commercial model estimates continued demand for the treatment of severe and critical COVID-19

patients for years to come."

ABOUT THE ALLOCETRA COVID-19 PHASE II CLINICAL TRIAL

The COVID-19 study is a multi-center, investigator-initiated,

Phase II clinical trial. The trial was designed to recruit up to twenty-four COVID-19 patients in severe or critical condition,

as defined by the U.S. National Institute of Health (NIH), in order to assess AllocetraTM in combination with standard

of care treatment. Safety, tolerability, cytokine profile and efficacy parameters are planned to be evaluated. Up to twenty-four

patients were expected to be recruited, subject to each patient's eligibility and signing of an informed consent to participate

and receive treatment. However, due to a positive safety and efficacy top-line analysis of the results from the first sixteen (16)

patients, the study is now completed and closed and will not recruit additional patients. Twelve (12) patients were recruited at

Hadassah Medical Center, three (3) patients at Barzilai Medical Center, and one (1) patient at Ziv Medical Center. Eligibility

criteria included an existing illness with at least one of (a) radiographic infiltrates by imaging (chest x-ray, CT scan, etc.),

or (b) Sp/O2 ratio lower than or equal to 93% on room air, or (c) requiring supplemental oxygen (low flow or high flow),

with a P/F ratio of below 350 but higher than 150. Exclusion criteria included (a) pregnancy, lactation and childbearing potential

woman who are not willing to use acceptable contraceptives measures for the entire study duration, (b) illness combined with other

organ failure requiring organ support other than a respirator, including Stage 4 severe chronic kidney disease or requiring dialysis

(i.e. estimated glomerular filtration rate (eGFR) < 30), (c) intubated patients (due to inability to sign an informed consent),

(d) patients with malignant tumor, other serious systemic diseases and psychosis, (e) patients who are participating in other clinical

trials or treated with any experimental agents that may contradict this trial, (f) co-infection of HIV or tuberculosis, (g) known

immunocompromised state or medications known to be immunosuppressive, and (h) patients with P/F ratio or S/F ratio of <150 or

a change in status of eligibility manifested by a rapid decline of P/F ratio between eligibility status and actual drug delivery.

AllocetraTM is a universal,

off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers,

sepsis, COVID-19 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, AllocetraTM 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.

1 Nature: A global survey

of potential acceptance of a COVID-19 vaccine, Oct 20, 2020

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing AllocetraTM, 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 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 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.

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