Enlivex Reports Positive Interim Results From Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients Nes Ziona, Israel

Reports Positive Interim Results From Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients

Nes Ziona, Israel, December 3, 2020 (GLOBE NEWSWIRE) -- Enlivex

Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage immunotherapy company, today reported positive interim

results of an investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19

The interim clinical results relate to eight COVID-19 patients

who were treated with AllocetraTM in the Phase II clinical trial , six of whom were in severe condition and two of whom

were in critical condition. Key results and conclusions from both the ongoing Phase II clinical trial, as well as a previously-reported

investigator-initiated Phase Ib study include:

Data from both the previously-reported investigator-initiated

Phase Ib study and the ongoing investigator-initiated Phase II COVID-19 trials are shown below:

Prof. Vernon van Heerden, Head of the Critical Care Medicine

Unit at Hadassah Hospital in Israel and the lead investigator of both the prior Phase Ib and the current Phase II COVID-19 clinical

trials stated, "Thirteen COVID-19 patients have been treated to date with AllocetraTM. The Phase II patients that

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

safety and an indication of 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 Enlivex in this COVID-19 patient population, and suggest that AllocetraTM may have utility as a

safe and efficacious treatment for resolving states of organ failures across different life-threatening, high mortality clinical

indications with high unmet medical needs."

Oren Hershkovitz, Ph.D., CEO of Enlivex commented, "We

are pleased with the interim results of this COVID-19 Phase II clinical trial. We believe that AllocetraTM, if approved,

could potentially cover the void that currently exists in treatments for severe or critical COVID-19 patients. The upcoming anticipated

regulatory approval of various COVID-19 vaccines is a game-changer in the fight against the pandemic, yet with various surveys

demonstrating 33% of the U.S. population unwilling to get vaccinated, and studies showing that vaccines are not 100% effective,

our commercial model estimates continued demand for the treatment of severe or 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 is expected 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), and is designed 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 are expected to be recruited, subject to each patient's eligibility and signing of an informed consent to participate

and receive treatment. Eligibility criteria include 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 or equal to 94% 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 include (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.

Enlivex is a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune

system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions which involve hyper-expression

of cytokines (Cytokine Release Syndrome) and for which there are no approved treatments (unmet medical needs) such as sepsis and

COVID-19, as well as solid tumors' immune-checkpoint rebalancing. 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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