Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Enlivex Therapeutics — Investor Presentation (April 2024)
34 slides from Enlivex's investor presentation, Apr 11, 2024
Slide 1: Company Presentation April 2024
Nasdaq: ENLV COMPANY PRESENTATION April 2024
Slide 2: Forward-Looking Statements
2 | Nasdaq: ENLV 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 re
Slide 3: Macrophage Modulation for the Treatment of Inflammatory Diseases
3 | Nasdaq: ENLV MACROPHAGE MODULATION FOR THE TREATMENT OF INFLAMMATORY DISEASES Enlivex is a clinical stage pharmaceutical company developing Allocetra , a universal, off - the - shelf cell therapy designed to reprogram macrophages into their homeostatic state, for treatment of inflammatory diseas
Slide 4: Driving Innovation with Balanced Scientific and Business Expertise
4 | Nasdaq: ENLV DRIVING INNOVATION WITH BALANCED SCIENTIFIC AND BUSINESS EXPERTI SE Shai Novik Executive Chairman Iris Tavor Senior Director of RA/QA 26 years of experience $560M company sale 20 years of experience A Einat Galamidi VP Medical 20 years of experience Oren Hershkovitz Chief Executive
Slide 5: Board of Directors
5 | Nasdaq: ENLV BOARD OF DIRECTORS Former CMO of Arqule through its $ 2.7 billion acquisition by Merck in 2020 . Previously, responsible for the global clinical development of sorafenib (Nexavar ® ) at Bayer. Former CEO of PROLOR Biotech. Founding team and Director of R&D of Interpharm (Merck Seron
Slide 6: Cellular First Responders: Macrophages and Their Critical Role in Inflammation
6 | Nasdaq: ENLV CELLULAR FIRST RESPONDERS: MACROPHAGES AND THEIR CRITICAL ROLE IN INFLAMMATION Recruit other immune cells Defend against pathogens Cleanup senescent or dead cells Control tissue homeostasis and repair Macrophages, which are found in abundance throughout the body, are immune cells th
Slide 7: Promoting Balance: Apoptotic Cells Facilitate Macrophage Homeostasis
7 | Nasdaq: ENLV PROMOTING BALANCE: APOPTOTIC CELLS FACILITATE MACROPHAGE HOMEOST ASIS MACROPHAGE Eat me TSP - 1 PtdSer TAM AMP The interaction between apoptotic cells and macrophages contributes to the pro - resolution and immune - modulating effects of Allocetra , promoting macrophage and immune h
Slide 8: Allocetra: An Off the Shelf Cell Therapy Designed to Restore Macrophage Homeostasis
8 | Nasdaq: ENLV ALLOCETRA : AN OFF THE SHELF CELL THERAPY DESIGNED TO RESTORE MACROPHAGE HOMEOSTASIS PtdSer Apoptotic cell • harnesses the same biological activity seen in naturally occurring apoptotic cells; • presents a highly - differentiated, off - the - shelf, cellular therapy modality. Alloce
Slide 9: Allocetra Pipeline: Building Momentum
9 | Nasdaq: ENLV ALLOCETRA TM PIPELINE: BUILDING MOMENTUM Indication Administration Pre - clinical Phase I/II Phase II Phase III Organ failure associated with Sepsis Moderate knee osteoarthritis ENX - CL - 05 - 001 ENX - CL - 02 - 002 End - stage knee osteoarthritis Randomized/controlled, 160 patien
Slide 10: A Comprehensive Picture: Inflammatory Disease Treatment Informed by Extensive Research
10 | Nasdaq: ENLV A COMPREHENSIVE PICTURE: INFLAMMATORY DISEASE TREATMENT INFORMED BY EXTENSIVE RESEARCH Sepsis * Phase / trials Administration method Safety Efficacy 1 completed trial: 2 completed trials: Compassionate case Systemic administration Local injection No drug related SAE s or drug relat
Slide 11: Allocetra for the Treatment of Sepsis
11 | Nasdaq: ENLV ALLOCETRA FOR THE TREATMENT OF SEPSIS
Slide 12: Sepsis: A Global Health Challenge with Substantial Market Opportunity
12 | Nasdaq: ENLV SEPSIS: A GLOBAL HEALTH CHALLENGE WITH SUBSTANTIAL MARKET OPPORT UNITY Market Standard of care Disease Antibiotics Vasopressors Currently there are no FDA/EMA approved drugs to treat sepsis. SOC only treats complications of sepsis and does not address core dysregulated immune respo
Slide 13: A Treatment for Sepsis Is an Unmet Medical Need
13 | Nasdaq: ENLV A TREATMENT FOR SEPSIS IS AN UNMET MEDICAL NEED 4 3 2 1 0 1 - Polkki et al. Association of Sequential Organ Failure Assessment (SOFA) components with mortality. Acta Anaesthesiol Scand. 2022;66:731 – 741. Respiratory Renal Neurologic Hepatic Hematological SOFA 1 is a scoring system
Slide 14: Sepsis Phase I/II: Indication of Effect of Allocetra
14 | Nasdaq: ENLV SEPSIS PHASE I/II: INDICATION OF EFFECT OF ALLOCETRA at least 2 organ dysfunctions (kidney, lungs, cardiovascular, hematological, liver). Allocetra macrophage reprogramming led to dramatic improvement, when compared with historical matched controls that received standard of care on
Slide 15: Sepsis Phase I/II: Allocetra Treatment Leads to Improved Patient Outcomes
15 | Nasdaq: ENLV day 28 day 14 3.4 4.4 H istorical matched controls N= 37 0.1 0.0 Treated N=10 3.3 4.4 Difference SEPSIS PHASE I/II: ALLOCETRA TREATMENT LEADS TO IMPROVED PATIENT OUTCOMES Statistically significant improvement in duration of hospitalization and SOFA score vs. matched controls Averag
Slide 16: Sepsis 28-Day Mortality Rate Remains High in Recent Clinical Trials
16 | Nasdaq: ENLV SEPSIS 28 - DAY MORTALITY RATE REMAINS HIGH AS DEMONSTRATED IN RECENT CLINICAL TRIALS IN SEPSIS WORLDWIDE 1 - Pickkers , P., Angus, D.C., Bass, K. et al. Intensive Care Med 50 , 68 – 78 ( 2024 ). https://pubmed.ncbi.nlm.nih.gov/ 38172296 / 2 - François B. et al. ASTONISH investigat
Slide 17: ENX-CL-02-002 Sepsis Phase II Randomized Controlled Study
17 | Nasdaq: ENLV ENX - CL - 02 - 002 SEPSIS PHASE II RANDOMIZED CONTROLLED STUDY Primary: Safety /change in SOFA score. Secondary: Mortality. Endpoints: Control (placebo) 1 Allocetra : 10 x 10 6 cells with option for a 2 nd dose SOFA 2 - 9 Standard of care + SOFA 5 - 13 pneumonia pneumonia, urinary
Slide 18: Allocetra Group Presented a Higher Mortality Risk
18 | Nasdaq: ENLV ENX - CL - 02 - 002 SEPSIS PHASE II RANDOMIZED CONTROLLED STUDY ALLOCETRA GROUP PRESENTED A HIGHER MORTALITY RISK 1 - Analysis of modified intent - to - treat ( mITT ) population for all patients who were randomized, received the high dose of Allocetra TM or placebo, had a screenin
Slide 19: Allocetra Cohort Stand-Alone Analysis Demonstrates Substantial Reduction in Organ Failure Scores
19 | Nasdaq: ENLV ENX - CL - 02 - 002 PHASE II: ALLOCETRA COHORT STAND - ALONE ANALYSIS DEMONSTRATES SUBSTANTIAL REDUCTION IN ORGAN FAILURE SCO RES 1 - Analysis of modified intent - to - treat (mITT) placebo population for all patients who were randomized, had a screening total S OFA score ≥ 5 point
Slide 20: Phase II: UTI High-Risk Patients, Potential Indication of Effect
20 | Nasdaq: ENLV ENX - CL - 02 - 002 PHASE II: UTI HIGH - RISK PATIENTS, POTENTIAL INDICATION OF EFFECT, SUBSTANTIAL MARKET 1 - Management of Urosepsis in 2018 , Bonkat et. Al. , European Urology Focus Volume 5 , Issue 1 , ( 2019 ). Potential indication of effect in high - risk UTI patients Despite
Slide 21: Phase II: Control Cohort Results Not Aligned with Expected Mortality
21 | Nasdaq: ENLV ENX - CL - 02 - 002 PHASE II: CONTROL COHORT RESULTS ARE NOT ALIGNED WITH EXPECTED MORTALITY The control cohort , which was relatively small, exhibited uncharacteristically high organ recovery rates and low mortality, that are not aligned with recent clinical trials data1. This unu
Slide 22: Phase II: 28 Days, Allocetra Favorable Safety Profile
22 | Nasdaq: ENLV ENX - CL - 02 - 002 PHII: 28 DAYS, ALLOCETRA FAVORABLE SAFETY PROFILE 1 Allocetra TM ( N=75) Control ( N=45) TEAE = Treatment Emergent Adverse Event 82.7% (n=62) 80.0% (n=36) Patients with at least one TEAE 50.7% (n=38) 55.6% (n=25) TEAEs CTCAE Grade ≥ 3 9.3% (n=7) 15.6% (n=7) TEAE
Slide 23: Phase II: Summary and Conclusions
23 | Nasdaq: ENLV ENX - CL - 02 - 002 PHII: SUMMARY AND CONCLUSIONS 1 - Compared with recently - completed sizable clinical trials – Revival Phase III (2024), Astonish Phase IIb (2023), Karakike (2019) – in which mortality rates were in the range of 23% – 30%. 2 - Management of Urosepsis in 2018, Bo
Slide 24: Allocetra for the Treatment of Osteoarthritis
24 | Nasdaq: ENLV ALLOCETRA FOR THE TREATMENT OF OSTEOARTHRITIS
Slide 25: Osteoarthritis: A Growing Market with Significant Potential
25 | Nasdaq: ENLV OSTEOARTHRITIS: A GROWING MARKET WITH SIGNIFICANT POTENTIAL Standard of care Disease overview Disease manifestation: cartilage damage, abnormal bone remodeling , and inflammation of the synovium. Today 2023 2040 2030 32.5M M $ 6.8 B 78MM $ 15.7 B Market Lifestyle changes Physiother
Slide 26: Macrophages Are an Emerging New Target for Osteoarthritis Treatment
26 | Nasdaq: ENLV MACROPHAGES ARE AN EMERGING NEW TARGET FOR OSTEOARTHRITIS TREATMENT Synovial macrophages in osteoarthritis: the key to understanding pathogenesis? Amanda Thomson and Catharien M. U. Hilkens Frontiers in Immunology 2021 Imbalance of M1/M2 macrophages is linke d to severity level of
Slide 27: Allocetra Compassionate Case Results
27 | Nasdaq: ENLV Complete destruction of the humeral head on X - ray; Significant inflammatory reaction on MRI; Significantly elevated ESR & CRP ; Extended hospitalization: 4 years of hospital visits, including 9 months continuous hospitalization with permanent shoulder port. Treatment: 5 intra - j
Slide 28: Investigator Initiated Trial for End-Stage Knee Osteoarthritis
28 | Nasdaq: ENLV 0189 - 22 - KMC INVESTIGATOR INITIATED TRIAL FOR END - STAGE KNEE OSTEOARTHRITIS Primary: safety and tolerability. Secondary: change from baseline in pain . Endpoints: N= ϭϴ ClinicalTrials.gov Registration: NCT06208241 End stage osteoarthritis indicated for knee replacement surgery
Slide 29: Clinical Trial Design: Moderate Knee Osteoarthritis
29 | Nasdaq: ENLV ENX - CL - 05 - 001 CLINICAL TRIAL DESIGN Primary: safety and tolerability. Secondary: Change in Weekly NRS Pain and WOMAC assessments . Endpoints: Local knee Injection Multi - country, multi - center Patient criteria: patients with symptomatic knee OA who have failed to respond to
Slide 30: Milestones Met & Planned
30 | Nasdaq: ENLV MILESTONES MET & PLANNED 2023 Q3 2024 Q 1 April 2024 2024 EO Q 3 (planned) 2025 Q 3 (planned) Initiation of Phase I/II in end - stage knee osteoarthritis. Initiation of Phase I/II in moderate knee osteoarthritis. Top line data macrophage reprogramming Sepsis Phase II (randomized, c
Slide 31: Extensive IP Protection
31 | Nasdaq: ENLV EXTENSIVE IP PROTECTION Australia Canada China France Germany Israel Japan United Kingdom 11 Patents USA 22 Patents Expected protection up to 2043
Slide 32: Financial Summary
32 | Nasdaq: ENLV FINANCIAL SUMMARY NASDAQ GS: ENLV Cash & equivalence : $ 27.3 MM ( Dec. 31 , 202 ϯ ) Debt: none Shares outstanding: 18. 6 MM Estimated cash runway through: Dec. 31, 2025 2024 Phase II topline data Phase I/II topline data Readouts 2025 Q 2 Q1 Q3 Q3 Q2 Q 4 Q4 Estimated c ash runway t
Slide 33: Investment Summary
33 | Nasdaq: ENLV INVESTMENT SUMMARY Management team with a track record of creating shareholder value and getting drug products through marketing approvals globally in multi - billion dollar market segments Cost - effective, novel therapeutic modality with strong IP protection Targeted at high and
Slide 34: Thank You
THANK YOU
Enlivex Therapeutics — Investor Presentation (April 2024) on 6ix