Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Enlivex Therapeutics — Investor Presentation (June 2024)
36 slides from Enlivex's investor presentation, June 2024
Slide 1: Company Presentation
COMPANY PRESENTATION June 2024 Nasdaq: ENLV
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS These slides and the accompanying oral presentation contain forward- looking and (vii) our expectations regarding our ability to obtain and maintain statements and information. Forward-looking statements are subject to known intellectual property protection for our product
Slide 3: Macrophage Modulation for the Treatment of Inflammatory Diseases
MACROPHAGE MODULATION FOR THE TREATMENT OF INFLAMMATORY DISEASES Enlivex is a clinical stage pharmaceutical company developing Allocetra ™, What’s new: a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state, for treatment of inflammatory Announced posi
Slide 4: Driving Innovation with Balanced Scientific and Business Expertise
DRIVING INNOVATION WITH BALANCED SCIENTIFIC AND BUSINESS EXPERTISE Shai Novik Oren Hershkovitz Dror Mevorach Executive Chairman CEO Scientific Founder 26 years of experience $560M company sale 16 years of experience 20 years of experience 140+ publications A A A Shachar Shlosberger Einat Galamidi Ve
Slide 5: Board of Directors
BOARD OF DIRECTORS Shai Novik Roger Pomerantz Gili Hart, Ph.D Executive Chairman Vice Chairman Director Founder and President of PROLOR Biotech, Former Worldwide Head of Licensing and Formerly with PROLOR Biotech, led the pre-clinical, Sold in 2013 ($560mm transaction). Lead product, Acquisition and
Slide 6: Cellular First Responders: Macrophages and Their Critical Role in Inflammation
CELLULAR FIRST RESPONDERS: MACROPHAGES AND THEIR CRITICAL ROLE IN INFLAMMATION Macrophages, which are found in abundance Macrophages orchestrate inflammation and its resolution. throughout the body, are immune cells that reside in or infiltrate human tissue. Main functions: Role in inflammation: 1 I
Slide 7: Promoting Balance: Apoptotic Cells Facilitate Macrophage Homeostasis
PROMOTING BALANCE: APOPTOTIC CELLS FACILITATE MACROPHAGE HOMEOSTASIS Prof. Dror Mevorach How apoptotic cells Scientific Founder influence macrophages Eat Apoptotic Cells Induce NF-kB PtdSer me TAM and Inflammasome Negative Signaling Enlivex's Allocetra™ mechanism Amir Grau, Adi Tabib, Inna Grau, Inn
Slide 8: Allocetra: An Off the Shelf Cell Therapy Designed to Restore Macrophage Homeostasis
ALLOCETRA™: AN OFF THE SHELF CELL THERAPY DESIGNED TO RESTORE MACROPHAGE HOMEOSTASIS Process: PtdSer A A A Eat me A A A A Apoptotic cell collect cells from proprietary cells express cells are off the shelf, healthy donors apoptotic cell “eat me” signal frozen cost effective cell modification process
Slide 9: Allocetra Pipeline: Building Momentum
ALLOCETRATM PIPELINE: BUILDING MOMENTUM Indication Administration Pre-clinical Phase I/II Phase Phase III II ENX-CL-02-002 NCT04612413 Randomized, controlled, Phase II, 120 patients, ongoing. Organ failure Efficacy stage completed; safety follow-up continues Systemic associated with administration S
Slide 10: A Comprehensive Picture: Inflammatory Disease Treatment Led by Extensive Research
A COMPREHENSIVE PICTURE: INFLAMMATORY DISEASE TREATMENT LED BY EXTENSIVE RESEARCH Sepsis* complete COVID-19* complete Vanishing bone disease complete at least 2 organ severe 4-year inflammatory Patient population N=10 dysfunctions, N=21 and critical N=1 and erosive process of maximum of 5 patients t
Slide 11: Allocetra for the Treatment of Sepsis
ALLOCETRA™ FOR THE TREATMENT OF SEPSIS 11 | Nasdaq: ENLV
Slide 12: Sepsis: A Global Health Challenge with Substantial Market Opportunity
SEPSIS: A GLOBAL HEALTH CHALLENGE WITH SUBSTANTIAL MARKET OPPORTUNITY Disease Market Standard of care Global market Currently there are no FDA/EMA Affected areas: $33B (severe Sepsis only2) approved drugs to treat sepsis. SOC only treats complications of sepsis and does not address core Brain dysreg
Slide 13: A Treatment for Sepsis Is an Unmet Medical Need
A TREATMENT FOR SEPSIS IS AN UNMET MEDICAL NEED SOFA1 is a scoring system that assesses the severity Specific organ system SOFA score of failure of the key organ systems involved in sepsis, predicts the estimated mortality risk1 scoring 0-4 for each body system, and a maximum of 24 points. Respirato
Slide 14: Sepsis Phase I/II: Indication of Effect of Allocetra
SEPSIS PHASE I/II: INDICATION OF EFFECT OF ALLOCETRA™ Indication: organ failure associated with sepsis Patient criteria: Treatment: Day 28 treatment outcomes: Result: 100% 100% Day 28 mortality. N=10 Allocetra™ + SOC Day 28 still with All 10 patients organ failures. 80% Hospital discharge. treated h
Slide 15: Sepsis Phase I/II: Allocetra Treatment Leads to Improved Patient Outcomes
SEPSIS PHASE I/II: ALLOCETRA™ TREATMENT LEADS TO IMPROVED PATIENT OUTCOMES Statistically significant improvement in duration of hospitalization and SOFA score vs. matched controls Time to ICU discharge: Average SOFA score during 28 days: Drastic difference in organ failure resolution Treated N=10 Hi
Slide 16: Sepsis 28-Day Mortality Rate Remains High in Recent Clinical Trials
SEPSIS 28-DAY MORTALITY RATE REMAINS HIGH AS DEMONSTRATED IN RECENT CLINICAL TRIALS IN SEPSIS WORLDWIDE REVIVAL1 ASTONISH2 Analysis of 2 randomized Phase III (AM-PHARMA) Phase IIb (INOTREM) controlled trials3 Pickkers et al, 2024 Francois et al, 2023 (VARIOUS ACADEMIA) Karakike et al, 2019 Patient p
Slide 17: ENX-CL-02-002 Sepsis Phase II Randomized Controlled Study
ENX-CL-02-002 SEPSIS PHASE II RANDOMIZED CONTROLLED STUDY Phase II study design: Patient distribution: Treatment Follow-up period Treated mITT Day 0 Day 28 3 months 6 months 12 months Allocetra™ Control 45 37 Follow up Follow up Follow up Follow up Control All Allocetra™ 75 50 Initial protocol: Amen
Slide 18: Allocetra Group Presented a Higher Mortality Risk
ENX-CL-02-002 SEPSIS PHASE II RANDOMIZED CONTROLLED STUDY ALLOCETRA™ GROUP PRESENTED A HIGHER MORTALITY RISK Demographics and baseline characteristics: mITT population1 Control Allocetra™ N=37 N=40 Age 64.2 (30-89) 65.1 (30-89) BMI 27.2 (17-38) 26.3 (17-39) Screening SOFA 8.1 (5-12) 8 (5-13) Allocet
Slide 19: Allocetra Cohort Stand-Alone Analysis Demonstrates Substantial Reduction in Organ Failure Scores
ENX-CL-02-002 PHASE II: ALLOCETRA™ COHORT STAND-ALONE ANALYSIS DEMONSTRATES SUBSTANTIAL REDUCTION IN ORGAN FAILURE SCORES 28-day analysis: SOFA by infectious origin of sepsis1 28-day mortality rate: Patient population UTI Respiratory Internal by origin of sepsis2 abdominal ENX-CL-02-002 PhII: Alloce
Slide 20: Phase II: UTI High-Risk Patients, Potential Indication of Effect
ENX-CL-02-002 PHASE II: UTI HIGH-RISK PATIENTS, POTENTIAL INDICATION OF EFFECT, SUBSTANTIAL MARKET Potential indication of effect in high-risk UTI patients Despite higher risk of the Allocetra™-treated group UTI Population: screening SOFA 7 D1-14 D1-28 Septic Respiratory Coagulation Cardiovascular
Slide 21: Phase II: Control Cohort Results Not Aligned with Expected Mortality
ENX-CL-02-002 PHASE II: CONTROL COHORT RESULTS ARE NOT ALIGNED WITH EXPECTED MORTALITY Control cohort Control cohort stand-alone analysis, day 28: organ failure score (SOFA) by infectious origin of sepsis Patient UTI Respiratory Internal Cholangiti Skin/Soft population2 abdominal s tissue The contro
Slide 22: Phase II: Allocetra Favorable Safety Profile
ENX-CL-02-002 PHII: 28 DAYS, ALLOCETRA™ FAVORABLE SAFETY PROFILE1 Control AllocetraTM Patients TEAE = Treatment Emergent Adverse Event (N=45) (N=75) Treated mITT distribution Patients with at least one TEAE 80.0% (n=36) 82.7% (n=62) Control 45 37 All Allocetra™ TEAEs CTCAE Grade ≥ 3 55.6% (n=25) 50.
Slide 23: Phase II: Summary and Conclusions
ENX-CL-02-002 PHII: SUMMARY AND CONCLUSIONS The efficacy (mITT) population presented a 20% higher frequency of septic shock in Allocetra TM-treated patients compared to placebo, and a 35% higher frequency of invasive ventilation – both key determinants of disease severity, potentially indicating ris
Slide 24: Allocetra for the Treatment of Osteoarthritis
ALLOCETRA™ FOR THE TREATMENT OF OSTEOARTHRITIS 24 | Nasdaq: ENLV
Slide 25: Osteoarthritis: A Growing Market with Significant Potential
OSTEOARTHRITIS: A GROWING MARKET WITH SIGNIFICANT POTENTIAL Disease overview Market Standard of care U.S. Cases1: Femur Today 2040 Lifestyle changes Joint space Subchondral narrowing bone cysts/ sclerosis 32.5MM 78MM Synovitis Physiotherapy Cartilage loss Market size2: Fibula Tibia 2023 2030 Pain me
Slide 26: Macrophages Are an Emerging New Target for Osteoarthritis Treatment
MACROPHAGES ARE AN EMERGING NEW TARGET FOR OSTEOARTHRITIS TREATMENT The role of innate immunity Imbalance of M1/M2 macrophages is linked in osteoarthritis: when our first line to severity level of knee osteoarthritis. of defense goes on the offensive. Baolong Liu, Maoquan Zhang, Jingming Zhao, Eric
Slide 27: Allocetra Compassionate Case Results
ALLOCETRA™ COMPASSIONATE CASE RESULTS Patient with Complete destruction Result: vanishing bone of the humeral head on X-ray; disease Significant inflammatory Fluid drainage declined CRP declined reaction on MRI; (normal range 0.5) Significantly elevated ESR & CRP; Extended hospitalization: 4 years
Slide 28: End-Stage Knee Osteoarthritis Trial Design
0189-22-KMC - END-STAGE KNEE OSTEOARTHRITIS TRIAL DESIGN Investigator-initiated Phase I/II study Study initiated enrolment in Q3-2023. Endpoints: N=18 local knee injection Primary: Treatment safety and tolerability. End stage osteoarthritis Follow-up period period indicated for knee Day 1 1M 3M 6M 1
Slide 29: End-Stage Knee Osteoarthritis Positive Interim Data
END-STAGE KNEE OSTEOARTHRITIS POSITIVE INTERIM DATA Three-month interim data from 9 patients showed a significant reduction 10.0 in pain and a favorable safety profile. 9.0 Pain reduction: patients reported an average pain reduction of 8.0 7.78 64% from baseline. 7.0 Complete Pain Resolution: 33
Slide 30: Basal Thumb OA Clinical Trial Design
0006-24-KMC BASAL THUMB OA CLINICAL TRIAL DESIGN Investigator initiated Phase I/II randomized, double-blind, placebo-controlled study Patient criteria: Part 1: Safety (run-in) 6 patients 1 N=3 Dose 1 0 N=6 Escalating doses patients with basal thumb joint Endpoints: (first carpometacarpal (CMC) 2 N=3
Slide 31: Moderate Knee OA Clinical Trial Design
ENX-CL-05-001 - MODERATE KNEE OA CLINICAL TRIAL DESIGN Phase I/II randomized, double-blind, placebo-controlled study Patient criteria: Part 1: Safety (run-in) 6 patients 1 N=3 Dose 1: repeated dosing N=3-6 Escalating doses Dose 2: repeated 0 2 N=3 dosing patients with symptomatic Endpoints: knee OA
Slide 32: Milestones Met & Planned
MILESTONES MET & PLANNED Top line data End-stage knee End-stage knee Basal thumb Moderate knee Moderate knee macrophage osteoarthritis osteoarthritis Phase osteoarthritis osteoarthritis osteoarthritis reprogramming Phase I/II I/II 6m Topline (18 Phase I/II Topline Phase I/II Phase I/II Sepsis Phase
Slide 33: Extensive IP Protection
EXTENSIVE IP PROTECTION Australia Canada China Expected protection up to 11 Patents USA 22 Patents France Germany 2043 Israel Japan United Kingdom 33 | Nasdaq: ENLV
Slide 34: Financial Summary
FINANCIAL SUMMARY 2024 2025 Q2 Q3 Q4 Q1 Q2 Q3 Q4 ENX-CL-02-002 NCT04612413 Phase II topline Organ failure data NASDAQ GS: ENLV associated with Sepsis ENX-CL-05-001 Cash & equivalents: $23.4MM (March. 31, NCT06233474 Phase I/II Phase I/II 2024) Interim Topline Moderate knee Readouts data Debt: none o
Slide 35: Investment Summary
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 low grade inflammation
Slide 36: Thank You
THANK YOU
Enlivex Therapeutics — Investor Presentation (June 2024) on 6ix