Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Enlivex Therapeutics — Investor Presentation (September 2019)
26 slides from Enlivex's investor presentation, Sep 9, 2019
Slide 1: ENLIVEX
ENLIVEX immune rebalancing NASDAQ: ENLV Life-saving
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS These slides and the accompanying oral presentation contain forward-looking statements and information. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activi
Slide 3: Enlivex, Executive Summary
Enlivex, Executive Summary Paradigm shifting immunotherapy For complex, life-threatening indications without therapies A/\~ Short regulatory approval pathway Specialized life-threatening regulation in Europe potentially enabling post- Phase II marketing approval; Advanced clinical-stage pipeline Mul
Slide 4: Slide 4
Slide 5: Allocetra™
Allocetra™ Matched or unmatched Selection of Chemically inducing Billions of semi-apoptotic (off-the-shelf) donor mononuclear cells ONLY programmed cell death (dying) ALLOCETRA cells
Slide 6: Rebalancing the immune responses
Rebalancing the immune responses CX B 2S) oo) KR (1) Cytokine Storm > (2) Allocetra™ infusion > © Macrophage feeding > @ Aeertsignals decrease > (5) Normal immune state
Slide 7: Therapeutic product pipeline of live-saving therapies for out-of-control immune indications
Therapeutic product pipeline of live-saving therapies for out-of-control immune indications Indication tion of post-B complications Adjunctive treatment for prevention of cytokine storms and organ dysfunction in Sepsis Treatment of post-BMT complications for steroid refractory patients Solid tumor “
Slide 8: Preventing & treating complications post bone-marrow transplantations
Preventing & treating complications post bone-marrow transplantations
Slide 9: Bone marrow transplants (BMT) are susceptible to GVHD and other material complications
Bone marrow transplants (BMT) are susceptible to GVHD and other material complications POST TRANSPLANTATION ALL CAUSE MORTALITY ~ Graft-vs-host disease (GVHD), a hyperimmune response, occurs when the donor T-cells register the host body's Primary ; tissues and organs as foreign antigens and initiate
Slide 10: Phase IIa clinical data — prevention of complications
Phase IIa clinical data — prevention of complications Preventing GvHD, leading to expedited hospital discharge overall improved outcomes ACUTE GVHD GRADE II-IV (%) 60% 50% 40% 30% 20% 10% 0% 60% 50% UZo 50% 43% GvHD 40% 30% 28% 20% 16% 10% NON RELPASE MORTALITY 200 DAYS 0% ™) Hadassah Hospital BMT u
Slide 11: Phase IIa clinical data - immune activity
IL-6 concentration (pg/ml) Phase IIa clinical data - immune activity Preventing uncontrolled signaling levels (cytokine storm) -------= UNCONTROLLED Upper-threshold of “normal” range ‘==IL-6 levels in patients who received LOW Dose (35mm - 70mm cells/kg) of Allocetra IL-6 levels in patients who rece
Slide 12: Phase II/III endpoints vs Phase IIa data
Phase II/III endpoints vs Phase IIa data 6-Months GvHD-Free Survival Endpoints 30-Day Engraftment (GES) Historical averages* 94.4% 30% Phase lla 4 ethene (study results’) ays 100% (n=6) Phase II/IIl io eave tnos) (required to show statistical >=95% nar al significance’) >= 70% (n=15) = 100% (n=8) 1
Slide 13: Allocetra™ adjunctive therapy for prevention of sepsis-related cytokine storms
Allocetra™ Adjunctive therapy for the prevention of sepsis- related cytokine storms & organ dysfunction
Slide 14: Sepsis is the 3rd leading cause of death in the U.S.
Sepsis is the 3'¢ leading cause of death in the U.S. #1 Cardiovascular #2 Cancer SEPSIS CATEGORIES qeeenerernitititt Each year, at least 1.7 million adults in America develop sepsis. OUTCOME Nearly 270,000 Americans die as a result of sepsis each year. 50% 50% im Organ Damage (3 Cy m Mortality in On
Slide 15: Sepsis severity & cytokine storm
Sepsis severity & cytokine storm Magnitude Cytokine Storm Problem Zone — __ Treatment Unmet medical need Organ Failure Zone Viral/Bacterial f?. wameny Treatment Problem Zone — — Anti-Viral/Antibiotics Fluids, Vasopressors Zone
Slide 16: Post induction survival, severe sepsis model (pre-clinical)
Post induction survival, severe sepsis model (pre-clinical) | CLP (cecum ligation and puncture) only 100 + Uj —CIP + Ertapenem + vehicle CLP + Ertapenem + Allocetra-OTS 80 n= 20 p< 0.001 3 60 [4 5 a x 40 20 6% Survival i) oO 25 50 75 100 125 150 175. 200 Hours post CLP (Sepsis Induction) Survival ra
Slide 17: Immune activity profile, severe sepsis model (pre-clinical)
Immune activity profile, severe sepsis model (pre-clinical) TNFa 1,400 64X Wie 1,167 aad INCREASE 4,649 100 400 SS 366 247 700 = 5,469 ‘TNFa (pg/ml) IL-6 (pg/ml) 3 1,000 50 pre-ClP 24h pre-ClP 24h mCLP mCLP+Ertapenem CLP + Ertapenem+ OTS-ALLOCETRA ALLOCETRA™ prevents uncontrolled signaling levels (c
Slide 18: Positive outcome from safety committee review in severe sepsis
VS ENLIVEX Enlivex Therapeutics Announces Positive Outcome From Safety Committee’s Review Of Six Patients With Severe Sepsis Patients; Enrollment Of Last Study Cohort Approved Nes Ziona, Israel, August 19, 2019 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunother
Slide 19: Sepsis Market
Sepsis Market . ; Suitability Lies Game Addressable Mechanism ee Significant demand, no approved drug issue of action causes Regulatory Number of Annual Approvals Patients RERRING Is tees caoa eect (1) Us - 1.7M BETTS rrctmonia moult EU = 1.0M cau © verall Immune ©ENLIVEX ALL Relaxation Severe sepsi
Slide 20: Solid Tumor Treatment
Solid Tumor Treatment
Slide 21: Solid tumors' micro-environment modulation
Solid tumors’ micro-environment modulation © Enlivex discovered a proprietary ae \ “immune checkpoint” pathway a for solid tumors, which is activated by the engulfment of © Allocetra™ ate : \ 7K OVERALL RESPONSE TO CAR-T
Slide 22: Substantial increase in survival & remission
Substantial increase in survival & remission (pre-clinical) % Survival 100 Complete Remission Survival Duration 120 CAR-T CAR-T + Alone ALLOCETRA™ 0% 20% +83% +233% n=40 (p<0.001) 140 160
Slide 23: Clinical milestones planned timeline
Clinical milestones planned timeline Phase II/III study initiation (EU/ISR) Prevention of GvHD & = -—_o—_0—__0-0—__‘"_ Full 6-months GCFS efficacy data Transplant # Patients: 3 ay 30 40 | Complications patients’ interim clinical data Full 12-months mortality data Ss 30-Day CRS & 6M GCFS endpoints Pr
Slide 24: Accelerated regulatory pathways for life-saving, unmet medical need indications
Accelerated regulatory pathways for life-saving, unmet medical need indications Phase II Single arm Phase II Single arm Open-label Small # of patients Open-label Small # of patients oT oT ALLOCETRA™ has received FDA & EU orphan drug designations for GVHD
Slide 25: Cell-therapy breakthroughs are disruptive in nature
Cell-therapy breakthroughs are disruptive in nature Players : 7 [Ss Pharma | JUNO | ENLIVEX THERAPEUTICS i immune rebalancing : + + : i+ Sepsis Recurring blood cancers | Recurring blood cancers i * Post BMT complications i Solid tumors Hard to treat i i VVV History of failure | VVV i VVV >50% mortal
Slide 26: Thank You
Enlivex Therapeutics — Investor Presentation (September 2019) on 6ix