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Exhibit 99.1 ENLIVEX immune rebalancing Enlivex Announces Third Quarter 2021 Financial Results and Provides a Business Update Initiated dosing in placebo - controlled Phase IIb clinical trial evaluating Allocetra ™ in severe and critical COVID - 19 patients with ARDS Received authorization to expand ongoing sepsis and COVID - 19 trials into Spain Initiated design and construction process for a new cGMP AllocetraTM manufacturing plant Nes Ziona , Israel , November 22 , 2021 ( GLOBE NEWSWIRE ) -- Enlivex Therapeutics Ltd. ( Nasdaq : ENLV , the " Company " ) , a clinical - stage macrophage reprogramming immunotherapy company , today announced that it filed its financial results and related discussion for the third quarter ended September 30 , 2021 with the SEC on November 19 , 2021 . " We are advancing towards 2022 with a strong balance sheet , expanded leadership team , and compelling clinical and preclinical data that we believe demonstrate Allocetra's potential as a next generation cell therapy for infectious , inflammatory and oncologic diseases , " said Oren Hershkovitz , Ph.D. , CEO of Enlivex . " Our ongoing sepsis and COVID - 19 trials were recently granted authorization for expansion into sites in Spain , which positions us to broaden our therapeutic impact while also providing important regulatory validation for our study designs and manufacturing process . To support these and our other programs , we also initiated the design and construction process for a new cGMP manufacturing plant . This plant will importantly allow us to be prepared for larger clinical trials and the potential commencement of commercial activities . " Dr. Hershkovitz continued , " Alongside this recent regulatory and corporate progress , we have continued to advance our solid tumor program towards the initiation of two planned clinical trials . Through the advancement of these trials , we aim to clinically demonstrate Allocetra's potential to combine synergistically with currently available cancer therapies and improve response rates for difficult - to - treat cancer patients . Looking ahead , we expect our solid tumor , sepsis , and COVID - 19 programs to gain momentum as we work to address life - threatening conditions through Allocetra's clinical development . " Business Highlights and Upcoming Milestones Sepsis : • • Enlivex's immunotherapy product candidate Allocetra ™ is being evaluated in a placebo - controlled , randomized , dose - finding , multi - center , Phase II trial in patients with pneumonia - associated sepsis . The trial , which has multiple sites currently open for enrollment in Israel , is expected to enroll 120 to 160 patients across four cohorts receiving varying doses of Allocetra ™ or placebo , all in addition to standard - of - care therapy . The trial's two primary endpoints are safety ( number and severity of adverse events and severe adverse events ) and efficacy ( change from baseline in sequential organ failure ( SOFA ) score ) , which will be assessed throughout a 28 - day follow - up period . The trial is supported by previously reported positive results from a Phase Ib trial that demonstrated a positive safety profile and vastly improved clinical outcomes , including SOFA scores , duration of hospitalization , and mortality , in Allocetra - treated sepsis patients compared to a group of matched historical controls that received standard - of - care therapy . Sepsis is a life - threatening disease with no FDA approved therapies and a high unmet need . Each year , more than 1.7 million adults in the United States develop sepsis , with more than 270,000 dying of the disease . Subsequent to the quarter end , Enlivex announced that the Spanish Agency of Medicines and Medical Devices ( AEMPS ) authorized the expansion of its ongoing sepsis trial to clinical sites in Spain following a review of the Company's clinical and preclinical data , study design , and manufacturing process . Enlivex also continues to work with additional regulatory agencies in an effort to further expand the trial in Europe as part of its regulatory strategy . Due to the impact of COVID - 19 pandemic on trial enrollment to - date , and the potential impact on enrollment going forward , Enlivex currently expects that interim results from the trial will be reported in the first half of 2022 , and top - line data will be reported by year - end 2022 . Subsequent to the quarter end , Enlivex announced the peer - reviewed publication of clinical data from its Phase Ib trial showing a robust safety profile and substantial improvements in state of organ failure , duration of ICU stay , and mortality in 10 Allocetra - treated severe sepsis patients vs. matched historical controls . Additionally , results from the trial showed that all evaluated patients had elevated pro- and anti - inflammatory cytokines , chemokines , and additional immune modulators that steadily decreased following Allocetra ™ treatment . Findings from the trial were published in collaboration with researchers at Hadassah - Hebrew University Medical Center and The Wohl Institute for Translational Medicine in Frontiers in Immunology , a leading journal in its field publishing rigorously peer - reviewed research articles . COVID - 19 : . Enlivex believes that COVID - 19 will transition from a pandemic to an endemic , with multiple variants continuing to circulate throughout the population . Allocetra ™ has demonstrated the potential to address a critical unmet need for COVID - 19 patients in severe or critical condition , who do not have many effective treatment options available today . Previously reported aggregate data from Phase Ib and Phase II investigator - initiated clinical trials in COVID - 19 patients in severe and critical condition demonstrated that Allocetra TM , was safe and well tolerated . Moreover , at the end of the 28 - day follow - up period , a 0 % ( 0/21 ) mortality rate was observed and 90.5 % ( 19/21 ) of patients recovered from their respective severe / critical condition and were discharged from the hospital after an average of 5.6 days following Allocetra ™ administration . In September 2021 , Enlivex announced the initiation of dosing in a multi - center , placebo - controlled , randomized , blinded , Phase IIb clinical trial evaluating Allocetra ™ in severe and critical COVID - 19 patients with acute respiratory distress syndrome ( ARDS ) . The trial , which is currently enrolling patients at clinical trial sites in Israel , is expected to recruit up to 152 severe or critical COVID - 19 patients . It is designed to assess the safety and efficacy of Allocetra TM when administered in addition to standard - of - care treatment . The trial's two primary endpoints are ventilation - free survival and recovery for each of the two sub - populations of patients in the study ( severe and critical ) , and could potentially be sufficient for obtaining emergency or conditional marketing authorization for either patient sub - population , though no guidance as to the potential for such emergency or conditional marketing authorization has been provided by the Israeli Ministry of Health or European regulators .