Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Enlivex Therapeutics — Investor Presentation (June 2020)
35 slides from Enlivex's investor presentation, June 2020
Slide 1: Life-saving immunomodulating cell therapies
Ticker: ENLV Life-saving immunomodulating cell therapies June 2020
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 Company Overview
Enlivex Company Overview We develop intelligent immunomodulating cell therapies to rebalance life-threatening hyperimmune responses, in complex indications with unmet medical need. NASDAQ GS ENLV Cash & equivalents $32MM (Mar 31, 2020) Shares Outstanding 13.4MM HQ Nes Ziona, Israel 2020 Corporate Pr
Slide 4: Investment Highlights
Investment Highlights Paradigm shifting Advanced clinical-stage Short regulatory approval immunotherapy pipeline pathway For complex, life-threatening indications Promising results of PhIb (sepsis) and Specialized regulation in Europe without therapies PhIIa (GvHD) studies, initiating Sepsis potenti
Slide 5: Management
Management Shai Novik Founder of Prolor Biotech, Sold in 2013 ($560mm transaction). Lead product partnered to Pfizer, $295 Executive Chairman million down payment, $275 upon FDA approval. Phase III endpoint met Oct 2019. Oren Hershkovitz Former Director of CMC, VP R&D and CEO of OPKO Biologics (PROL
Slide 6: ALLOCETRA Pipeline
ALLOCETRA™ Pipeline of life-saving therapies for complex immune-modulated indications Global EU Conditional Post EU Marketing Indication Pre-Clinical Phase Ib Phase IIb Market Size Marketing Approval US Phase 3 Treatment of organ failure Phase IIb Initiation $33B Completed associated with Sepsis Q3-
Slide 7: Allocetra Mechanism of Action
AllocetraTM Mechanism of Action
Slide 8: The role of macrophages and dendritic cells
The role of macrophages and dendritic cells Immune system Macrophage & dendritic And release signals to triggered cells activated recruit special forces Immune Triggering Immune system Macrophages & dendritic cells The more dying cells they “eat”, Immune system relaxing “eat” the dying cells the les
Slide 9: Abnormal immune response: cytokine storms
Abnormal immune response: cytokine storms Trigger attacks of immune cells on healthy organs, and may result in organ damage, failure and mortality Immune system Macrophages & dendritic cells release triggered signals to recruit special forces Special forces arrive Kill infected cells Macrophages & d
Slide 10: Macrophages/DCs/Monocytes
• ALLOCETRA is a next-generation immunomodulating therapy for diseases associated with complex immune modulation Macrophages/DCs/Monocytes Designed By Evolution To Be Pivotal • Allows control of Immune Regulators, Controlling macrophages/DCs/monocytes, to induce: Triggering & Relaxation Of Multiple
Slide 11: Allocetra
Allocetra™ Proprietary, early-apoptotic, stable formulation of mononuclear cells Selection of Chemically inducing Billions of semi-apoptotic Matched or unmatched (off- mononuclear cells ONLY programmed cell death (dying) ALLOCETRA cells the-shelf) donor blood Lymphocytes, Monocytes of the selected c
Slide 12: Allocetra's MOA
Allocetra’s MOA Restoring immune homeostasis through modulation of macrophage/DC activity 01 02 03 04 05 Cytokine Storm Allocetra™ infusion Macrophage feeding Alert signals decrease Normal immune state 2020 Corporate Presentation I1212
Slide 13: Treatment of organ failure associated with sepsis
AllocetraTM Treatment of organ failure associated with sepsis
Slide 14: Sepsis is the 3rd leading cause of death in the U.S.
Sepsis is the 3rd leading cause of death in the U.S. SEPSIS is a body’s overwhelming, life-threatening response to infection, involving hyperactivation of multiple immune pathways and a resulting cytokine storm. It can lead to tissue damage, organ failure, and death. SEPSIS CATEGORIES Each year, at
Slide 15: Allocetra is well positioned to treat the complex pathophysiology of sepsis
AllocetraTM is well positioned to treat the complex pathophysiology of sepsis ALLOCETRA’s Homeostatic Effect on: • Well-characterized MOA Macrophages I Monocytes I DCs • Activates natural immune rebalancing pathways • Modulation at the core (macrophages, DCs, monocytes) results in homeostasis OF EAC
Slide 16: Phase Ib Clinical Trial in Severe Sepsis Patients
AllocetraTM Phase Ib Clinical Trial in Severe Sepsis Patients with an Off-The-Shelf Universal Product
Slide 17: Sequential Organ Failure Assessment (SOFA) Score
Sequential Organ Failure Assessment (SOFA) Score The sequential organ failure assessment score (SOFA score), previously known as the sepsis- related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person'
Slide 18: High degree of matching: treated vs controls
High degree of matching: treated vs controls Treated (n=10) Matched Controls (n=37) Average age 71.5 (51-83) 71.25 (50-83) Male/female 80/20 80/20 Average diagnosis SOFA 3.4 (2-6) 3.47 (2-7) Average diagnosis Apache II score 12.3 (8-21) 14.25 (5-24) Sepsis source Pneumonia 50% 53% Biliary infections
Slide 19: Allocetra treatment leads to improved patient outcomes
AllocetraTM treatment leads to improved patient outcomes Maximal SOFA Score Treated (n=10) Matched Controls (n=37) Maximal change in SOFA score, diagnosis to day 28 Diagnosis SOFA (Avg.) 3.4 (2-6) 3.47 (2-7) p<0.0001 T-test MAX SOFA (Avg.) 3.4 (2-6) 7.04 (2-18) MAX SOFA Delta from 0% 102% diagnosis
Slide 20: Statistically significant improvement in hospitalization vs. matched controls
Statistically significant improvement in hospitalization vs. matched controls Time to ICU discharge Average duration of hospitalization ICU stay 100 Percent ICU stay (%) 80 60 40 20 p<0.0001 0 0 4 8 12 16 20 24 28 Day Historical Control (N=34) Allocetra-OTS-treated (N=10) 2020 Corporate Presentation
Slide 21: Phase Ib results show Allocetra treatment was well tolerated
Phase Ib results show AllocetraTM treatment was well tolerated All patients recovered No SAEs, 44 AEs, no No dose limiting No evidence of from the septic related AEs, six toxicity was observed autoimmunity or condition and were possibly related AEs autoantibodies discharged alive 2020 Corporate Pres
Slide 22: Complete recovery from any organ failure for all 10 patients
Clinical summary: complete recovery from any organ failure for all 10 patients and 100% 28-day survival Sepsis characteristics and organ recovery Organ Dysfunction Each patient had at least 2 organ dysfunctions, maximum of 5 Kidney 3/9 patients (33%) had new-onset acute kidney injury, all have compl
Slide 23: Sepsis - Phase IIb clinical plan
Sepsis - Phase IIb clinical plan Sepsis Phase IIb Addressable global market $33 Billion market (severe Sepsis only) Type Controlled, randomized, multi-center (5 centers) Patients 120 (75 treated, 40 control) , SOFA < 10, Pneumonia-sourced Duration 28 days / patient Recruitment 12 Months End-points S
Slide 24: Sepsis treatment is a $33 billion market with no approved drug
Sepsis treatment is a $33 billion market with no approved drug Significant demand, no approved drug Addressable Mechanism of Status Company issue action Regulatory Number of Annual Approvals Patients Terminated Prevent Vascular Increase Arterial 2018 Leakage Pressure US None 1.7M Unclear, no Severe
Slide 25: Sepsis go-to-market strategy
Sepsis go-to-market strategy Sepsis Phase IIb, 120 patients, expected initiation by Q4 2020 Pending study results, apply Initiate a post-marketing global for conditional marketing Phase III, targeting regulatory Q3/2021 interim data, authorization in Europe approval in the U.S. and Q1/2022 top-line
Slide 26: Preventing & treating COVID-19 organ failure & mortality
Preventing & treating COVID-19 organ failure & mortality
Slide 27: COVID-19 patients cause of death: sepsis, typically associated lung failure
COVID-19 patients cause of death: sepsis, typically associated lung failure 191 severe COVID-19 patients in the Wuhan area 54 mortalities All 54 mortalities (100%) had sepsis Majority of sepsis was lung-associated – 92% of the 54 patients had ARDS. Zhou et al., Clinical course and risk factors for m
Slide 28: Controlling macrophages in the lungs may prevent lung failure (I)
Controlling macrophages in the lungs may prevent lung failure in SARS-CoV- 1/2 infections (I) SARS-CoV-1 Channappannavar et al. Pathogenic human coronavirus infections: causes and consequences of cytokine storms and immunopathology . Semin Immunol 2017 “Accumulation of inflammatory monocytes/macroph
Slide 29: Controlling macrophages in the lungs may prevent lung failure in SARS-CoV-2
Controlling macrophages in the lungs may prevent lung failure in SARS-CoV-2 infections SARS-CoV-2 Liao et al. The landscape of lung bronchoalveolar immune cells in COVID-19 revealed by single-cell RNA sequencing. Nature Medicine May 2020 “monocyte-derived FCN1+ macrophages …. overwhelm in the severe
Slide 30: Peer-reviewed, robust science
Peer-reviewed, robust science Apoptotic Cells induced Apoptotic cell clearance: Single Infusion of Donor iC3b-opsonized apoptotic Signaling for immune basic biology and Mononuclear Early Apoptotic cells mediate a distinct anti- Homeostasis in therapeutic potential Cells as Prophylaxis for inflammato
Slide 31: Intellectual property
Intellectual property Target Territory Status Filing Term Immune disease medicament comprising A modulator of the binding between US, EU Granted 2009 2027 A heparin binding domain of thrombospondin-1 & A beta1 integrin ROW Granted 2006 2026 US, EU, IL Granted 2014 2026 Disease therapy using dying or
Slide 32: Planned milestones
Planned milestones Q2 2020 Q4 2020 Q3 2021 Initiation of Final data Interim data COVID-19 Phase II COVID-19 Phase II sepsis Phase IIb Q3 2020 Q4 2020 Q1 2022 Interim data Initiation of sepsis Top line data COVID-19 Phase II Phase IIb, 120 patients sepsis Phase IIb 2020 Corporate Presentation I32
Slide 33: Financial Summary
Financial Summary NASDAQ GS ENLV Cash $32MM (Mar 31, 2020) Debt None Shares 13.4MM Outstanding Funded Q1-2023 Through 33
Slide 34: Board Of Directors
Board Of Directors Shai Novik Founder of Prolor Biotech, Sold in 2013 Abraham Havron,Ph.D. Former CEO of Prolor Biotech. Founding team Executive Chairman ($560mm transaction). Lead product Director and Director of R&D of Interpharm (Merck partnered to Pfizer, $295 million down Serono) ,VP CMC of Bio
Slide 35: Thank You
Ticker: ENLV Thank You www.enlivex.com May 2020
Enlivex Therapeutics — Investor Presentation (June 2020) on 6ix