Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Enlivex Therapeutics — Investor Presentation (September 2025)
39 slides from Enlivex's investor presentation, September 2025
Slide 1: Company Presentation
COMPANY PRESENTATION Sept 2025 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 intellectual statements and information. Forward-looking statements are subject to known and property protection for our pro
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 , a universal, What’s new: off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state, for treatment of inflammatory diseases. Annou
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 $590M 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 ($590mm 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 throughout the Macrophages orchestrate inflammation and its resolution. 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 and PtdSer me TAM Inflammasome Negative Signaling Amir Grau, Adi Tabib, Inna Grau, Inna Enlivex's Allocetra mechanism
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: A A PtdSer 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 Study # Administration Pre-clinical Phase I/II Phase II Phase III Organ failure associated ENX-CL-02-002 Systemic Randomized, controlled, Phase II, 120 patients, ongoing. with sepsis NCT04612413 administration Efficacy stage completed; safety follow
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 and Patient population N=10 dysfunctions, N=21 and critical N=1 erosive process of the maximum of 5 patien
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 Affected areas: $33B Global market (severe Sepsis only2) Currently there are no FDA/EMA 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, scoring 0-4 for predicts the estimated mortality risk1 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 had
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 His
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 (VARIOUS Pickkers et al, 2024 Francois et al, 2023 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: Amende
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) Allocetra
Slide 19: Allocetra Cohort Stand-Alone Analysis Demonstrates 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: Allocet
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 Cholangitis Skin/Soft population2 abdominal tissue The control
Slide 22: Phase II: 28 Days, Allocetra Favorable Safety Profile
ENX-CL-02-002 PHII: 28 DAYS, ALLOCETRA FAVORABLE SAFETY PROFILE1 Control AllocetraTM TEAE = Treatment Emergent Adverse Event (N=45) (N=75) Patients distribution Treated mITT Patients with at least one TEAE 80.0% (n=36) 82.7% (n=62) Control 45 37 TEAEs CTCAE Grade ≥ 3 55.6% (n=25) 50.7% (n=38) All Al
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 AllocetraTM-treated patients compared to placebo, and a 35% higher frequency of invasive ventilation – both key determinants of disease severity, potentially indicating risk
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 of defense to severity level of knee osteoarthritis. 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 o
Slide 28: End-Stage Knee Osteoarthritis Trial Design
0189-22-KMC - END-STAGE KNEE OSTEOARTHRITIS TRIAL DESIGN Investigator-initiated Phase I/II study 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 12M Secondary: replacement surgery. Cha
Slide 29: End-Stage Knee Osteoarthritis Positive Interim Data, 50% Reduction in Pain
END-STAGE KNEE OSTEOARTHRITIS POSITIVE INTERIM DATA, 50% REDUCTION IN PAIN Investigator-initiated Phase I/II study: End-stage osteoarthritis indicated for knee replacement surgery Target enrollment = 18 Three-month interim data from 9 patients showed a significant reduction in pain and a favorable s
Slide 30: Moderate Knee OA Clinical Trial Design
ENX-CL-05-001 - MODERATE KNEE OA CLINICAL TRIAL DESIGN Phase I/II randomized, double-blind, placebo-controlled, multi-country study Patient criteria: Part 1: Safety (run-in) 15 patients 1 Dose 1: repeated dosing 2 Dose 2: repeated dosing 0 Escalating doses patients with symptomatic knee 3 Dose 3: re
Slide 31: Positive Interim Data, Durable and Substantial Reduction in Pain
ENX-CL-05-001 - MODERATE KNEE OA CLINICAL TRIAL DESIGN: POSITIVE INTERIM DATA , DURABLE AND SUBSTANTIAL REDUCTION IN PAIN AT 3-AND 6-MONTHS Interim data from 12 patients showed a durable and Improvement in Pain, Function and Stiffness4 significant reduction in pain and function, and a favorable safe
Slide 32: 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 33: Trial for Psoriatic Arthritis (PsA)
ENX-CL-06-001 TRIAL FOR PSORIATIC ARTHRITIS (PSA) ENX Phase I study Endpoints: Treatment Follow up period Primary: 1 On systemic therapy with an unresponsive Day 0 2W 1M 3M 6M 12M Safety. Patients with PsA with at least N=3 joint one joint unresponsive to Follow Follow Follow Follow Follow Secondary
Slide 34: Temporomandibular Osteoarthritis (TMJ-OA)
1400-24-SMC TEMPOROMANDIBULAR OSTEOARTHRITIS (TMJ-OA) Investigator-initiated Phase I study Endpoints: Local Injection Treatment Follow up period to TMJ Primary: 1 N=3 Day 0 2W 1M 2-6M 6-10M 12M Failed IA TMJ Safety. Patients with TMJ-OA steroid injection unresponsive to conventional Follow Follow Mo
Slide 35: Milestones Met & Planned
MILESTONES MET & PLANNED Moderate knee Basal thumb Moderate knee Basal thumb Moderate knee osteoarthritis Phase osteoarthritis Phase osteoarthritis Phase osteoarthritis osteoarthritis I/II - Phase I stage 3m I/II Topline 3m I/II 3m Readout Phase I/II 6m Phase I/II readout Readout (randomized, (rando
Slide 36: Extensive IP Protection
EXTENSIVE IP PROTECTION Australia Canada China 11 22 Expected protection up to 2043 France USA Germany Patents Patents Israel Japan United Kingdom 36 | Nasdaq: ENLV
Slide 37: Financial Summary
FINANCIAL SUMMARY 2024 2025 2026 Q4 Q1 Q2 Q3 Q4 Q1 Q2 NASDAQ GS ENX-CL-02-002 ENLV Organ failure associated with Sepsis Cash & equivalents $19.5 MM (June. 30, 2025) ENX-CL-05-001 Phase I/II Phase I Phase I Phase I/II Debt Moderate knee interim 3m interim 6m Interim Topline data osteoarthritis Readou
Slide 38: 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 39: Thank You
THANK YOU
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