Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Enlivex Therapeutics — Investor Presentation (September 2023)
32 slides from Enlivex's investor presentation, September 2023
Slide 1: Off-the-shelf, universal, macrophage reprogramming cell therapies
Off-the-shelf, universal, macrophage reprogramming cell therapies for life- threatening diseases NASDAQ Ticker: ENLV
Slide 2: Forward-Looking Statements
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 activi
Slide 3: Enlivex: reprioritization plan, impact
Enlivex: repriotization plan, impact • Inflammatory and autoimmune indications • Knee osteoarthritis vertical • Randomized, controlled, statistically-powered Phase I/II, 120-150 patients, top-line data readout Q2-25 • Oncology indications • ~50% workforce reductions • Cash runway extended through en
Slide 4: Enlivex: next-generation, differentiated cell therapies
Enlivex: next-generation, differentiated cell therapies PAST FUTURE • Autologous • Off-the-shelf • Not scalable • Scalable • High COGS • Low COGS & • Engineered T-cells • New cell modalities • NKs • Gamma-delta • Macrophages 4
Slide 5: Immune system balance: macrophages are key player
Immune system balance: macrophages are key player • Macrophages PAST are primary immune cells that FUTURE regulate immune activity • They are the first-responders to pathogenic challenge, engulf infected cells, cancer cells, and increase/decrease overall immune activity in response to these various
Slide 6: Macrophage homeostasis implies proper function for its specific tissue
Macrophage homeostasis implies proper function for its specific tissue, environment and challenge Reprogramming imbalanced macrophage populations can lead to disease resolution Sepsis, COVID-19 ARDS, Macrophage population homeostasis ARF post heart surgery Pro-homeostasis Pro-inflammatory Pro-organ
Slide 7: Allocetra
AllocetraTM • First-ever cell therapy designed to restore macrophage homeostasis, overall immune rebalancing • Provide a highly-differentiated new modality that may offer effective treatment to sepsis and cancer patients who do not respond to standard-of-care
Slide 8: Allocetra for macrophage reprogramming: the manufacturing process
Allocetra™ for macrophage reprogramming: the manufacturing process Proprietary, universal, off-the-shelf, frozen-formulation, macrophage-reprogramming cells Allocetra™ characteristics Allocetra™ delivery into macrophages via engulfment Allocetra™ cell “eat me” signals PtdSer • Mononuclear cells coll
Slide 9: Allocetra for macrophage reprogramming – reprioritized pipeline
Allocetra™ for macrophage reprogramming – reprioritized pipeline Pipeline of reprogrammable macrophage-modulated indications Potential support Global for EU Conditional Post EU Marketing Indication Pre-Clinical Phase Ib Phase IIb Market Size Marketing Approval US Phase 3 Submission Randomized, Organ
Slide 10: Reprogramming macrophages responsible for organ failure in sepsis
AllocetraTM Reprogramming macrophages responsible for organ failure in sepsis
Slide 11: Cytokine/Chemokine network in sepsis
Cytokine/Chemokine network in sepsis: the impossible task of resolving sepsis with inhibition of a certain cytokine or signaling pathway Ghrelin G-CSF MΦ: Macrophages GM-CSF TREM-1 sTNFR1 Activation Inhibition Gro-α/β MCP-1 Chemotaxis Bacterial TNFα infection Downregulated in most of the patients IL
Slide 12: Phase Ib clinical trial of macrophage reprogramming in sepsis patients
AllocetraTM Phase Ib clinical trial of macrophage reprogramming in sepsis patients
Slide 13: Sequential Organ Failure Assessment (SOFA) Score
Sequential Organ Failure Assessment (SOFA) Score The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's
Slide 14: High degree of matching: treated vs controls
High degree of matching: treated vs controls Treated (n=10) Matched Controls (n=37) Average age 71.5 (51-83) 71.25 (50-83) Male/female 80/20 80/20 Average diagnosis SOFA 3.4 (2-6) 3.47 (2-7) Average diagnosis Apache II score 12.3 (8-21) 14.25 (5-24) Sepsis source Pneumonia 50% 53% Biliary infections
Slide 15: Day 28 treatment outcomes
Allocetra™ macrophage reprogramming leads to improved outcomes for sepsis patients Alive and organs recovered on day 28: 100% vs 41% 120% Day 28 treatment outcomes Day 28, Mortality 100% 100% Day 28 mortality 80% Day 28 still with organ failures 60% 41% 40% 32% Hospital discharge 27% 20% 0% 0% 0% Al
Slide 16: Avg. SOFA Scores
Allocetra™ macrophage reprogramming leads to improved outcomes for sepsis patients Statistically significant improvement in hospitalization and SOFA vs. matched controls Time to ICU discharge Average SOFA score during 28 days Drastic difference in organ failure resolution 5 4.4 4.1 4.1 4.0 4 3.47 Av
Slide 17: Clinical summary of macrophage reprogramming in sepsis Phase Ib
Clinical summary of macrophage reprogramming in sepsis Phase Ib: complete recovery from any organ failure for all 10 patients and 100% 28-day survival Sepsis clinical characteristics and organ recovery Organ Dysfunction Each patient had at least 2 organ dysfunctions, maximum of 5 Kidney 3/9 patients
Slide 18: Sepsis Phase II clinical plan
Sepsis AllocetraTM macrophage reprogramming Phase II clinical plan Sepsis Phase II Addressable global market $33 Billion market (severe Sepsis only) Type Controlled, randomized, multi-country, multi-center Patients 80-160, SOFA < 10, Source: pneumonia, biliary, urinal tract, and peritoneal infection
Slide 19: Phase Ib & II Clinical Trials in COVID-19
AllocetraTM Phase Ib & II Clinical Trials in COVID-19 Patients in Severe or Critical Condition
Slide 20: COVID-19 business opportunity is de-prioritized
Despite strong clinical results, COVID-19 business opportunity is de-prioritized • Primary reasons: • Availability of therapeutics for mild/moderate patients • Dominance of Omicron variants, who seem to cause less severe disease in most patients • Regulators “step-back” and reluctance to provide eme
Slide 21: Positive Phase Ib and top line Phase II results in COVID-19
AllocetraTM: Positive Phase Ib and top line Phase II results in COVID-19 Hospitalization Clinical Outcome # Patients Post Administration of AllocetraTM Clinical Trial Disease Severity enrolled Recovered Mortality Discharged Duration Day 28 Day 28 Day 28 (days, avg.) Phase Ib 5 2 Severe, 3 Critical 5
Slide 22: Macrophage reprogramming in solid tumor microenvironment
AllocetraTM Macrophage reprogramming in solid tumor microenvironment Unique & differentiated value proposition
Slide 23: Studies evaluating Allocetra + anti-cancer drugs in solid tumors
Studies for evaluating the synergistic effect of Allocetra™ + anti-cancer drugs in solid tumors Model Anti-cancer drug used Syngeneic peritoneal mesothelioma 1. Anti-CTLA4 (AB12) in immunocompetent mice Syngeneic peritoneal mesothelioma 2. Anti-PD1 (AB12) immunocompetent mice Syngeneic peritoneal me
Slide 24: Synergistic effect of Allocetra + anti-CTLA4 in mesothelioma
Synergistic effect of Allocetra™ + anti-CTLA4 in peritoneal mesothelioma solid tumor Legend Initial cancer spread advanced cancer spread mouse dead mouse alive Mortality 100% 75% 71.5% 33% 0% Survival 0% 25% 28.5% 67% 100% Complete 0% 25% 28.5% 67% 100% cure IVIS imageing, AB12-137 study 24
Slide 25: Reprioritization and impact on oncology vertical
Allocetra™: reprioritization and impact on oncology vertical • Phase I/II Allocetra + chemotherapy (ClinicalTrials.gov Identifier: NCT05431907) • First & second cohort ongoing, injections of Allocetra intraperitoneally with Chemo • Phase I/II Allocetra monotherapy and in combination with anti-PD1 (C
Slide 26: Osteoarthritis vertical, severe compassionate case
Osteoarthritis vertical, severe compassionate case as basis for potential ● 70-year old patient who suffered for many years from vanishing bone disease (Gorham-Stout syndrome) ● A rare disease characterized by destruction of osseous matrix and proliferation of vascular structures, resulting in compl
Slide 27: Osteoarthritis vertical, ongoing and planned clinical trials
Osteoarthritis vertical, ongoing and planned clinical trials ● End-stage knee osteoarthritis ● Investigator-initiated Phase I/II, 12 patients ● Patients have already been scheduled for knee replacement surgeries ● Offered an injection of AllocetraTM in lieu of surgery ● First patient dosed ● Data re
Slide 28: Planned milestones (24 months)
Planned milestones (24 months) Q1-24 Q2-25 Q4 2022 Top line data macrophage Moderate knee Received FDA approval for IND reprogramming sepsis osteoarthritis Phase I/II (Phase I/II in advanced-stage Phase II (randomized, top-line data solid tumors patients) controlled) (randomized, controlled, powered
Slide 29: Financial Summary
Financial Summary NASDAQ GS ENLV Cash $36MM (Jun 30, 2023) Debt None Shares Outstanding 18.4 MM Dec 31 2025 (due to Funded Through reprioritization plan) 29
Slide 30: Management
Management Founder and President of PROLOR Biotech through a $560mm sale in 2013. Lead product Shai Novik partnered to Pfizer, $295 million down payment, $275 upon FDA & other regulatory approvals. Executive Chairman Now named Ngenla® by Pfizer, received marketing authorizations starting 2022 in Aus
Slide 31: Board Of Directors
Board Of Directors Shai Novik Founder and President of PROLOR Biotech, Sold in 2013 ($560mm transaction). Lead product partnered to Pfizer, Executive Chairman $295 million down payment, $275 upon FDA & other regulatory approvals. BLA filed by Pfizer late 2020. Former Worldwide Head of Licensing and
Slide 32: Thank You
Thank You
Enlivex Therapeutics — Investor Presentation (September 2023) on 6ix