Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Enlivex Therapeutics — ISCT 2020, Paris (Virtual)
14 slides from Enlivex's conference presentation, May 28, 2020
Slide 1: Resolution of cytokine storm associated with sepsis by apoptotic cells (Allocetra-OTS) administration
Resolution of cytokine storm associated with sepsis by apoptotic cells (Allocetra-OTS) administration * ISCT 2020, Paris (Virtual) ¢ Dror Mevorach, MD
Slide 2: Conflict of Interest
Conflict of Interest: DM is the Founder, CSO and CMO of Enlivex Therapeutics, Ltd
Slide 3: Sepsis background and study methods (Phase IB, NCT03925857)
Sepsis has no proven specific pharmacologic treatment. Reported mortality in sepsis ranges from 30%—45%. This study was designed to determine the safety preliminary efficacy of allogenic apoptotic cells administered for immunomodulation in septic patients. Methods. ClinicalTrials.gov Identifier: NCT
Slide 4: Inflammation: WBC & CRP
Resolution of inflammation: WBC & CRP WBC count HOd¢HS Neutrophil count Normal values Patient 001 *F Patient 008 Patient 002 -% *Patient 009 Patient 003 ~<- *Patient 010 Patient 006 -@- *Patient 011 Patient 007 -® *Patient 012 (chronic dialysis patient)
Slide 5: Kaplan-Meier survival curve: Allocetra-OTS treated group vs historical controls
Kaplan-Maier survival curve: Comparison between Allocetra-OTS treated group and historical controls Total patients Pneumonia-only 100 1.00 u———_, —S 075 ee 075: 2 2 3 8 & os & os 3 a Log ank Log-ank ows 025 0078 peos owe 0 3 7 i ® 7 % i % 3 7 3 7 6 % Fo Fo Das ofelonup Days offolow-up Number at risk
Slide 6: Sequential Organ Failure Assessment (SOFA) score progression during sepsis
Sequential Organ Failure Assessment (SOFA) score progression during sepsis 15- 10 Delta SOFA Score Maximum SOFA a 1 ' H.Controls Treatment
Slide 7: Sequential Organ Failure Assessment (SOFA) score progression during sepsis
Sequential Organ Failure Assessment (SOFA) score progression during sepsis Delta SOFA Score Day 1-5 Delta SOFA score before Allocetra-OTS Delta SOFA score before Allocetra-OTS Delta SOFA score before Allocetra-OTS and at day 5 and at day 7 and at day 7 ’ 15 p<0.0001 p<0.0001 p<0.0005 T-test 7 . T-te
Slide 8: Sequential Organ Failure Assessment (SOFA) score progression during sepsis
Sequential Organ Failure Assessment (SOFA) score progression during sepsis Area Under the Curve (AUC) of SOFA at 5 days Area Under the Curve (AUC) of SOFA at 7 days AUC 1-5 10- H.Controls Group p<0.0001 T-test eo Treatment AUC 1-7 10- . H.Controls Group p<0.0001 T-test — Treatment
Slide 9: Kaplan-Meier curve describing time to leave the hospital and ICU
Kaplan-Maier curve describing time to leave the hospital and ICU proportion of hospitalized patients fortion of hospitalized patients Hospital ICU ‘Sata + Hons “+ Treatment Sia + Cons Trane 1.00 1.00 7 I 2 € 075: conn S07 5 a 2 i tH, 8 050: o 050: La] 2 ° 5 Log-rank é Log-rank 025: B02 p= 0.00085 5
Slide 10: Cytokine storm in sepsis following Allocetra-OTS: Pro-inflammatory cytokines
Resolution of the cytokine storm in sepsis following Allocetra-OTS administration: Pro-inflammatory cytokines 5000- IL-6 150- TNF-a 20- IL-18 IN te A 38 as =¢ 2 30 23 20- 2. 10: 4 0 eS VHA we ” ; NY Ob A no P & Day & Day Ce & E ‘eof EN ~® Normal values 198 -* Patient 001 -# Patient 008 = 40 —@ Patie
Slide 11: Cytokine storm in sepsis: Anti-inflammatory cytokines and hemopoietic growth factors
Resolution of the cytokine storm in sepsis, following Allocetra-OTS administration: Anti-inflammatory cytokines and hemopoietic growth factors A B c -® Normal values 50 IL-0 40000 IL-ARa 50000. TNERA 30- ae seo sate *———* 3 Patient 001 4 Patient 008 10000 ze asi Phas -@ Patient 002 4% *Patient 009 2
Slide 12: Cytokine storm in sepsis: Chemokines
Resolution of the cytokine storm in sepsis, following Allocetra-OTS administration: Chemokines wor R MCP Ls MPH, -® Normal values ’ 80 -® Patient 001 4 Patient 008 Eo -@ Patient 002 -—% *Patient 009 2 & Patient 003 - *Patient 010 20 + Patient 006 -@ *Patient 011 & Patient 007 -® *Patient 012 (chroni
Slide 13: Cytokine storm in sepsis: Immunomodulators and stress hormones
Resolution of the cytokine storm in sepsis, following Allocetra-OTS administration: Immunomodulators and stress hormones 4200 TREM-1 0000 Osteopontin seeeegg. eA aa00 <o0000 |e 4988888 On 288888 80000 £1288 = = sooce i z Glucagon Normal values Cortisol Patient 001 -W Patient 008 o> ~ -—® Patient 002
Slide 14: Summary
Summary * Ten patients were treated with Allocetra-OTS, administered as a single dose or two sequential doses. All 10 patients had mild to moderate sepsis with a SOFA score range of 2-6 upon entering the study. No serious adverse events (SAEs) and no related AEs were reported. All 10 study subjects