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ENLIVEX immune rebalancing Enlivex Announces Second Quarter 2021 Financial Results and Provides a Business Update • Top - line results from Phase IIb sepsis trial expected in Q2 2022 • Phase IIb trial in severe and critical COVID - 19 patients planned for initiation in Q3 2021 • Initiation of a Phase Ib trial evaluating AllocetraTM in combination with chemotherapy in solid peritoneal tumors planned for Q4 2021 • Phase Ib trial evaluating Allocetra aTM in combination with immune checkpoint inhibitors planned for initiation in the first half of 2022 Initiated design and construction process for a new cGMP AllocetraTM manufacturing plant Exhibit 99.1 • Nes Ziona , Israel , August 9 , 2021 ( GLOBE NEWSWIRE ) -- Enlivex Therapeutics Ltd. ( Nasdaq : ENLV , the " Company " ) , a clinical - stage macrophage reprogramming immunotherapy company , today announced that financial results for the second quarter ended June 30 , 2021 were filed with the SEC on August 6 , 2021 and provided a business update . " We are very pleased with our recent progress , which has placed us on track to achieve a steady cadence of value creating milestones , ” said Oren Hershkovitz , CEO of Enlivex . " Our placebo - controlled Phase IIb sepsis trial is ongoing , with top - line data expected in the second quarter of 2022. We are also on track to initiate a Phase IIb trial evaluating Allocetra TM as a treatment for severe / critical COVID - 19 patients in Israel in Q3 of this year , and we plan to expand the trial to include European sites thereafter . These trials are each supported by compelling clinical data that highlight the broad applicability of Allocetra's immunotherapeutic mechanism of action . " Dr. Hershkovitz continued , " Alongside our clinical progress , we have also generated preclinical data highlighting Allocetra's potential to synergistically enhance the efficacy of TM . cancer therapies . By combining Allocetra with these therapies , we believe we can improve response rates and provide effective therapeutic options to patients who currently have none available . We look forward to evaluating this hypothesis through our planned Phase Ib solid tumor trial . With a strong financial position and talented leadership team , we believe we are well positioned to advance these and our other clinical studies as we work to become a leader in cell therapies for infectious , inflammatory and oncologic diseases . " Business Highlights and Upcoming Milestones Sepsis : • 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 . Enlivex's immunotherapy product candidate Allocetra TM is being evaluated in a placebo - controlled , randomized , dose- finding , multi - center , Phase IIb trial in patients with pneumonia - associated sepsis . The trial , which has multiple sites currently open for enrollment , is expected to include 120 to 160 patients across four cohorts receiving varying doses of Allocetra TM or placebo , all in addition to standard - of - care therapy . The trial's two primary endpoints include both safety ( number and severity of adverse events and severe adverse events ) , and efficacy ( change from baseline in sequential organ failure ( SOFA ) score ) assessments throughout a 28 - day follow - up period . The trial is supported by previously reported positive results from a Phase Ib investigator - initiated trial showing vastly improved clinical outcomes , including SOFA scores , duration of hospitalization , and mortality , in Allocetra TM - treated sepsis patients compared to a group of matched historical controls that received standard - of - care therapy . Top - line results from the Phase IIb study are expected in Q2 2022 . COVID - 19 : Enlivex believes that COVID - 19 will migrate from a pandemic to an endemic , with multiple variants continuing to circulate throughout the population . Further , Allocetra ™ M has demonstrated the potential to address a critical unmet need for COVID - 19 patients in severe or critical condition , who don't have many effective treatment options available today . In late 2020 and early 2021 , Enlivex reported positive top - line results in 21 patients from Phase Ib and Phase II investigator - initiated trials in COVID - 19 patients in severe / critical condition . Aggregate data from the two trials showed a 0 % ( 0/21 ) mortality rate at the end of the 28 days follow - up period and that 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 . To facilitate the advancement of its COVID - 19 program , Enlivex has submitted a regulatory filing with the Israeli Ministry of Health to initiate a placebo - controlled , double- blinded , randomized , multi - center Phase IIb trial in COVID - 19 patients in severe / critical condition with associated acute respiratory distress syndrome ( ARDS ) . The trial TM will be designed to recruit up to 152 patients ( 76 Allocetra plus standard - of - care , 76 placebo plus standard - of - care ) . In addition , the Company plans to add several European clinical sites as part of this study , and is in discussions with the European Medicines Agency ( EMA ) and certain local European regulators for this purpose . The Phase IIb clinical trial will have two primary endpoints : 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 per the potential for such emergency or conditional marketing authorization has been provided by the Israeli Ministry of Health or European regulators . Solid tumors : Alongside some industry experts , Enlivex believes that one of the main problems with the lack of efficacy of immunotherapies targeted at patients with various solid tumor malignancies is the negative reprogramming of macrophages in the tumor microenvironment . This negative reprogramming results in proliferation of pro - tumor macrophages , contributing to drug resistance , preventing disease resolution , and promoting disease severity . Data from initial preclinical solid tumor models suggest that Allocetra TM has the potential to reprogram such macrophages back to their respective homeostatic state , and thereby may assist in disease resolution and offer patients