Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Enlivex Therapeutics — Investor Presentation (December 2020)
38 slides from Enlivex's investor presentation, December 2020
Slide 1: Life-saving immunomodulating cell therapies
Ticker: ENLV Life-saving immunomodulating cell therapies December 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 1 Cash & equivalents $36MM (Sep 30, 2020 ) Shares Outstanding 14.3MM HQ Nes Ziona, Israel 1 Cash balance
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 Phase Ib in Specialized regulation in Europe with no available therapies sepsis, initiating Sepsis Phase IIb, potent
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: Cytokine storms and organ failures
Cytokine storms and organ failures • Cytokine storms trigger attacks on healthy organs, and may result in organ failure and mortality • Triggered by macrophages who are out of control Immune system Macrophages & dendritic cells release triggered signals to recruit special forces Special forces arriv
Slide 7: Enlivex: control cytokine storms at the core
Enlivex: control cytokine storms at the core • Common approach: identify primary cytokines and neutralize them • Problem: cytokine storms are heterogeneous across patients • Result: No approved therapy to date, despite numerous attempts Enlivex approach Control macrophages & dendritic cells vs. Comm
Slide 8: ALLOCETRA
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 Q4
Slide 9: Allocetra Mechanism of Action
AllocetraTM Mechanism of Action
Slide 10: 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 11: 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 12: 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 13: 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 I1313
Slide 14: Treatment of organ failure associated with sepsis
AllocetraTM Treatment of organ failure associated with sepsis
Slide 15: Sepsis is the 3rd leading cause of death in the U.S. – $33 BN target market
Sepsis is the 3rd leading cause of death in the U.S. – $33 BN target market* 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 C
Slide 16: 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 17: 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 18: 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 19: 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 20: 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 21: 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 22: 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 23: Clinical summary: 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 24: 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 120-160, SOFA < 10, Pneumonia-sourced Duration 28 days / patient Recruitment 12 Months End-points Safety, Change in SOFA
Slide 25: 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 26: 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 27: Preventing & treating COVID-19 organ failure & mortality
Preventing & treating COVID-19 organ failure & mortality
Slide 28: 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 29: COVID-19 – ongoing Phase II clinical trial
COVID-19 – ongoing Phase II clinical trial COVID-19 Phase II Addressable global market $2.5 Billion market (critical/severe COVID-19 only) Type Open-label, multi-center Patients 24, severe or critical, subject to NIH classifications Duration 28 days / patient Recruitment 3 Months End-points Safety S
Slide 30: Positive clinical outcomes for Allocetra treatment, Phase Ib final and Phase II interim results
Positive clinical outcomes for Allocetra treatment, investigator-initiated Phase Ib TM final results and Phase II interim results December 3, 2020 Patient classification as defined by the NIH classification guide Clinical Trial # Patients Disease Clinical Outcome Hospitalization Post Administration
Slide 31: Preventing & treating Joint diseases without effective therapies
Preventing & treating Joint diseases without effective therapies
Slide 32: Long-term positive outcomes for Allocetra compassionate treatment of erosive osteoarthritis
Substantial long-term positive clinical outcomes for Allocetra compassionate TM treatment of patient with erosive osteoarthritis • A 70-year-old patient experienced a four-year inflammatory and erosive process of the right shoulder • Resulting in complete destruction of the humeral head on X-ray, si
Slide 33: 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 34: 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 35: Planned/executed milestones
Planned/executed milestones Q3 2020 Late Q4 2020 Q1 2021 Q3 2021 Top-line data from Interim data from Top-line data Interim data COVID-19 Phase Ib COVID-19 Phase II COVID-19 Phase II sepsis Phase IIb Early Q4 2020 Late Q4 2020 Late Q4 2020 Q1 2022 Initiation of COVID-19 24-months follow-up Initiatio
Slide 36: Financial Summary
Financial Summary NASDAQ GS ENLV Cash $36MM (Sep 30, 20201) Debt None Shares 14.3MM Outstanding Q1-2023 Funded (without ATM use or Through warrant exercises) 1 Cash balance as reported for Sep 30 2020 plus Q4 warrant exercises 36
Slide 37: Board Of Directors
Board Of Directors Shai Novik Founder of Prolor Biotech, Sold in 2013 Brian Schwartz, M.D. Former CMO of Arqule through its $2.7 billion Executive Chairman ($560mm transaction). Lead product Director acquisition by Merck in 2020. Previously, partnered to Pfizer, $295 million down responsible for the
Slide 38: Thank You
Ticker: ENLV Thank You www.enlivex.com May 2020
Enlivex Therapeutics — Investor Presentation (December 2020) on 6ix