Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Enlivex Therapeutics — Investor Presentation (August 2025)
26 slides from Enlivex's investor presentation, Aug 18, 2025
Slide 1: Enlivex Therapeutics Phase IIa Topline Results Aug 2025
ENLIVEX THERAPEUTICS PHASE IIA TOPLINE RESULTS Aug 2025
Slide 2: 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 activity, performance or achi
Slide 3: Macrophage Modulation for the Treatment of Inflammatory Diseases
MACROPHAGE MODULATION FOR THE TREATMENT OF INFLAMMATORY DISEASES Novel therapeutic modality: macrophage modulation. Cost - effective cell therapy: simple manufacturing process yielding a ready - to - use off - the - shelf cell therapy. Substantial market: unmet need in inflammatory and autoimmune di
Slide 4: Driving Innovation with Balanced Scientific and Business Expertise
Shai Novik Executive Chairman Iris Tavor VP RA/QA years of 26 experience $590M company exit 20 years of experience A Einat Galamidi CMO 20 years of experience Veronique Amor - Baroukh VP Operations 10 years of experience Shachar Shlosberger CFO 15 years of experience A A A Oren Hershkovitz CEO 17 ye
Slide 5: Former CEO of PROLOR Biotech. Founding team and Director of R&D of Interpharm (Merck
Former CEO of PROLOR Biotech. Founding team and Director of R&D of Interpharm (Merck Serono), where he led the development of REBIF, a multi - billion multiple sclerosis drug. Formerly, VP CMC of BioTechnology General Ltd., and VP of Clal Biotechnology Industries Ltd. Former EVP and CFO of Epizyme a
Slide 6: Knee Osteoarthritis Phase IIa Results 3-Month Topline Data Analysis
ENX - CL - 05 - 001 KNEE - OSTEOARTHRITIS PHASE IIa RESULTS 3 - MONTH TOPLINE DATA ANALYSIS
Slide 7: Osteoarthritis: A Growing Market with Significant Potential and Unmet Medical Need
OSTEOARTHRITIS: A GROWING MARKET WITH SIGNIFICANT POTENTIAL AND UNMET MEDICAL NEED 7 | Standard of care Disease overview Disease manifestation: cartilage damage, abnormal bone remodeling, and inflammation of the synovium. Today 2023 2040 2030 32.5MM $6.8B 78MM $15.7B Lifestyle changes Physiotherapy
Slide 8: Prevalence of Osteoarthritis Increases with Age
PREVALENCE OF OSTEOARTHRITIS INCREASES WITH AGE 1 1 Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population - based studies, A. Cui et al. / EClinicalMedicine 2930 (2020) 100587 60 50 40 30 20 10 0 30 – 39 40 – 49 50 – 59 60 – 69 70 – 79 80+ Prevalence (%) OA Pre
Slide 9: Phase I/IIa Multi-Country Randomized Double-Blind Controlled Trial in Knee Osteoarthritis
ENX - CL - 05 - 001 PHASE I/IIa 9 | MULTI - COUNTRY, MULTI - CENTER, RANDOMIZED, DOUBLE - BLIND, CONTROLLED TRIAL EVALUATING ALLOCETRA TM IN PATIENTS WITH MODERATE TO SEVERE KNEE OSTEOARTHRITIS
Slide 10: Phase IIa Study Designed A Priori to Identify Correlation of Treatment Effect and Baseline Factors
ENX - CL - 05 - 001 – PHASE IIa STUDY DESIGNED A PRIORI TO IDENTIFY CORRELATION OF TREATMENT EFFECT AND BASELINE FACTORS Key baseline covariates to be examined in the study Inflammation Pain Other covariates BMI Heterogeneous patient population included indiscriminately Purpose was to assess safety,
Slide 11: Heterogeneous Patient Population
HETEROGENEOUS PATIENT POPULATION Treatment effect may differ due to baseline factors (E.G., BMI, PAIN, INFLAMMATION, etc.) ENROLL 134 PATIENTS Regardless of baseline factors RANDOMIZE BASED ONLY ON BASELINE PAIN LEVELS Conduct an INTERIM ANALYSIS after 90 patients recruited 3M DATA TREATMENT PLACEBO
Slide 12: Phase IIa Objectives Met: Safety Profile and High Responders Identified
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) Specific responder profile • More than 50% of the patients in the study • Representing more than 50% of the KOA market • Aligned wi
Slide 13: Phase I/IIa 2-Stage Trial Design
Patient criteria: Patients with symptomatic moderate to severe knee OA who have failed to respond to conventional OA therapy; Age 45 - 80 years; Kellgren - Lawrence (K - L) Grade 2 or 3. Phase I: Dose escalation & safety Randomized, double - blind, placebo - controlled, multi - country study 15 pati
Slide 14: Well-Balanced Baseline Demographics & Characteristics
WELL - BALANCED BASELINE DEMOGRAPHICS & CHARACTERISTICS 14 | Placebo (N=67) Allocetra (N=67) ALL RANDOMIZED & TREATED Age (years) 61.54 (8.26) 60.72 (8.31) Mean (SD) 61.00 (55.50, 67.00) 60.00 (54.00, 66.50) Median (Q1, Q3) 46.00 - 80.00 46.00 - 80.00 Min - Max Sex 37 (55.2%) 36 (53.7%) Female 30 (4
Slide 15: Primary vs Secondary OA: Difference in Mediation of Inflammation
PRIMARY VS SECONDARY OA: DIFFERENCE IN MEDIATION OF INFLAMMATION • Primary OA • As individuals age, the cumulative effects of wear and tear on joint tissues become increasingly evident and induce low grade inflammation mainly mediated by resident macrophages and fibroblasts, and the regenerative cap
Slide 16: Positive Effect on WOMAC Pain Across Study Patients; Primary OA Patients
24% POSITIVE EFFECT ON WOMAC PAIN ACROSS STUDY PATIENTS; 72% IN 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 significan
Slide 17: Clinically Meaningful, Statistically Significant Across Efficacy Endpoints in Primary OA
CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT ACROSS EFFICACY ENDPOINTS IN PRIMARY OSTEOARTHRITIS PATIENTS Delta between groups expressed as % from FDA’s threshold for clinical significance ( - 10% to - 15%) Reduction from baseline in Allocetra group p - value % Better than placebo Difference Pla
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 ) Age >= 60 (54% of patients) WOMAC pain change 3 months, Primary OA population Age >= 63 (40% of patients) Age >= 65 (33% of patients) Positive effect difference : 72%
Slide 19: Allocetra Effect in Primary OA: Pain, Stiffness and Function
ALLOCETRA EFFECT IN PRIMARY OA: CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT, IRRESPECTIVE OF AGE THRESHOLD ( CHANGE IN PAIN, STIFFNESS & FUNCTION ) Age >= 60 (54% of patients) WOMAC total change 3 months, Primary OA population Age >= 63 (40% of patients) Age >= 65 (33% of patients) Positive eff
Slide 20: Phase III Endpoints: Substantial Effect Size, Trending with Age
72% p - value=0.0300 91% p - value=0.0128 140% p - value=0.0035 183% p - value=0.0029 172% p - value=0.0036 217% p - value=0.0017 99% p - value=0.0083 130% p - value=0.0024 210% p - value=0.0005 250% p - value=0.0010 256% p - value=0.0008 379% p - value=0.0003 450% 400% 350% 300% 250% 200% 150% 100%
Slide 21: Superior Activity in Primary OA Consistent with Mechanism of Action
SUPERIOR ACTIVITY IN PRIMARY OA CONSISTENT WITH THE PROPOSED MECHANISM OF ACTION OF ALLOCETRA TM T T T N N N R C C R N N T N T T T T Secondary Osteoarthritis Inflammation - mediation via multiple cell types R T T T C Resident macrophage, interacts well with Allocetra TM Circulating macrophage, may i
Slide 22: Safety Profile: Favorable, No Related Serious Adverse Events
SAFETY PROFILE: ALLOCETRA TM DEMONSTRATED A FAVORABLE SAFETY PROFILE, NO RELATED SERIOUS ADVERSE EVENTS WERE REPORTED 22 | • 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
Slide 23: Planned Phase IIb
Patient criteria: Primary OA patients with symptomatic moderate to severe knee OA who have failed to respond to conventional OA therapy; Age 60/65 - 80 years; Kellgren - Lawrence (K - L) Grade 2 or 3. NRS=numerical rating scale. WOMAC= Standard knee questionnaire evaluating pain, stiffness & physica
Slide 24: Short and Long Term Target Milestones
2025 November Phase IIa Moderate knee osteoarthritis 6m readout 2026 Q2/3 2026 Q2 2026 Q3 2027 Q1 Phase IIb Primary OA Moderate knee osteoarthritis Regulatory Approval Phase IIb Primary OA Moderate knee osteoarthritis First Patient Dosed Phase IIb Primary OA Moderate knee osteoarthritis Complete Enr
Slide 25: Summary of Phase IIa Results
• Study objectives met • Allocetra tm 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 ▪ Clinically meaningful with high statistical significan
Slide 26: Thank You
THANK YOU
Enlivex Therapeutics — Investor Presentation (August 2025) on 6ix