Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Investor Presentation (October 2025)
37 slides from Enlivex's investor presentation, October 2025
Slide 1: Enlivex – Company Presentation
ENLIVEX – COMPANY PRESENTATION October 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, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state, for treatment of inflammatory diseases. About: ON A A All
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 exit 17 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 Moderate knee Local knee Randomized/controlled, ENX-CL-05-001 injection osteoarthritis NCT06233474 149 patients, enrollment completed Moderate knee Local knee Randomized, controlled,
Slide 10: Allocetra for the Treatment of Osteoarthritis
ALLOCETRA FOR THE TREATMENT OF OSTEOARTHRITIS 10 | Nasdaq: ENLV
Slide 11: 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 12: 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 13: Knee Osteoarthritis (KOA) Market
KNEE OSTEOARTHRITIS (KOA) MARKET 1 Prevalence of Osteoarthritis increases with age 60 • High prevalence & burden: • 32M Americans today; projected 78M by 2040 50 Prevalence (%) • One of the most disabling diseases globally 40 • Unmet medical need: • No approved disease-modifying treatments 30 • Curr
Slide 14: ENX-CL-05-001 – Phase IIa Study Designed A Priori to Identify Correlation of Treatment Effect
ENX-CL-05-001 – PHASE IIa STUDY DESIGNED A PRIORI TO IDENTIFY CORRELATION OF TREATMENT EFFECT AND BASELINE FACTORS Heterogeneous patient Inflammation OA leading experts forewarned population included indiscriminately us prior to study design Purpose was to assess safety, efficacy, and potentially fi
Slide 15: ENX-CL-05-001: Phase I/IIa 2-stage trial design
ENX-CL-05-001: PHASE I/IIa 2-stage trial design - randomized, double-blind, placebo-controlled, multi-country study Patient criteria: Phase I: Dose escalation & safety 15 patients Independent safety committee→ no negative safety signal, highest dose selected for Phase IIa Phase IIa: Randomized, doub
Slide 16: ENX-CL-05-001 – Phase IIa Objectives Met
ENX-CL-05-001 – PHASE IIa OBJECTIVES MET: (a) FAVORABLE SAFETY PROFILE & POSITIVE EFFECT, (b) HIGH RESPONDERS WERE IDENTIFIED (REPRESENTING 50% OF THE KOA MARKET) • We had clear success in isolating the key molecular disease for which our drug works well • This finding directly illustrates that our
Slide 17: 24% Improvement of WOMAC Pain Overall; 72% Improvement Primary OA Patients
24% IMPROVEMENT OF WOMAC PAIN OVERALL; 72% IMPROVEMENT PRIMARY OA PATIENTS – STATISTICALLY SIGNIFICANT AND CLINICALLY MEANINGFUL • 54% of the study’s population are Primary OA patients (n=69 out of 129) • The data shows substantial, clinically meaningful, and highly statistically significant differe
Slide 18: Allocetra Effect in Primary OA: Reduction in Pain
ALLOCETRA EFFECT IN PRIMARY OA: CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT, IRRESPECTIVE OF AGE THRESHOLD (REDUCTION IN PAIN) WOMAC pain change 3 months, Primary OA population Age >= 60 (54% of patients) Age >= 63 (40% of patients) Age >= 65 (33% of patients) WOMAC pain change, 3 months Placeb
Slide 19: Allocetra Effect in Primary OA: Change in Pain, Stiffness & Function
ALLOCETRA EFFECT IN PRIMARY OA: CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT, IRRESPECTIVE OF AGE THRESHOLD (CHANGE IN PAIN, STIFFNESS & FUNCTION) WOMAC total change 3 months, Primary OA population Age >= 60 (54% of patients) Age >= 63 (40% of patients) Age >= 65 (33% of patients) Placebo Alloce
Slide 20: Clinically Meaningful, Statistically Significant Across Efficacy Endpoints in Primary Osteoarthritis Patients
CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT ACROSS EFFICACY ENDPOINTS IN PRIMARY OSTEOARTHRITIS PATIENTS 3-month endpoints, Primary OA subjects (age >=60, n=69, 54% of enrolled subjects) % Reduction from p-value Efficacy measure Allocetra Placebo Difference Better than baseline in Allocetra pla
Slide 21: Phase III Endpoints: Clinically Meaningful, Statistically Significant, Trending with Age
PHASE III ENDPOINTS: CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT, SUBSTANTIAL EFFECT SIZE, TRENDING WITH AGE % Excess reduction of pain, pain & function in Allocetra group vs reduction in the placebo group 450% 379% 400% p-value=0.0003 350% 256% % Better Than Placebo, 250% p-value=0.0008 217% W
Slide 22: Safety Profile: Allocetra Demonstrated a Favorable Safety Profile
SAFETY PROFILE: ALLOCETRATM DEMONSTRATED A FAVORABLE SAFETY PROFILE, NO RELATED SERIOUS ADVERSE EVENTS WERE REPORTED • As observed also in earlier clinical data in severe OA subjects, some patients injected with Allocetra experienced local responses following injection (84% of patients treated with
Slide 23: Summary: 3-Month Topline Data – ENX-CL-05-001
SUMMARY: 3-MONTH TOPLINE DATA – ENX-CL-05-001 • Study objectives met • AllocetraTM demonstrated a favorable safety profile, no related serious adverse events were reported • 72% avg positive effect in pain reduction, 99% in increased function (Phase III endpoints) for Primary OA patients ▪ Clinicall
Slide 24: ENX-CL-05-002: Phase IIb
ENX-CL-05-002: PHASE IIb Randomized, double-blind, placebo-controlled, multi-country study Phase IIb: Randomized, double-blind, placebo-controlled Patient criteria: • AllocetraTM (1 or 2 doses) Vs. Placebo , 3 injections in total, each injection 2 weeks from the previous injection • 75 patients per
Slide 25: Additional Clinical Studies in OA
ADDITIONAL CLINICAL STUDIES IN OA 25 |
Slide 26: 0006-24-KMC 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 27: 1400-24-SMC Temporomandibular Osteoarthritis (TMJ-OA)
1400-24-SMC TEMPOROMANDIBULAR OSTEOARTHRITIS (TMJ-OA) Investigator-initiated Phase I study Endpoints: Local Injection to TMJ Treatment Follow up period 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 Allocetra Follow
Slide 28: Allocetra for the Treatment of Sepsis
ALLOCETRA FOR THE TREATMENT OF SEPSIS 28 | Nasdaq: ENLV
Slide 29: 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 Affected areas: $33B (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 30: 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 31: Sepsis Phase II: 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 32: 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 33: Short and Long Term Target Milestones
SHORT AND LONG TERM TARGET MILESTONES Phase IIa Phase IIb Phase IIb Phase IIb Phase IIa Phase IIb Phase IIb Moderate knee Primary OA Primary OA Primary OA Moderate knee Primary OA Primary OA osteoarthritis Moderate knee Moderate knee Moderate knee osteoarthritis Moderate knee Moderate knee 6m readou
Slide 34: 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 34 | Nasdaq: ENLV
Slide 35: Financial Summary
FINANCIAL SUMMARY NASDAQ GS ENLV Cash & equivalents Shares outstanding $19.5 MM (June. 30, 2025) 23.8 MM (June 2025) Debt Estimated cash runway through none Dec. 31, 2026 35 | Nasdaq: ENLV
Slide 36: 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 37: Thank You
THANK YOU