Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Enlivex Therapeutics — Investor Presentation (February 2024)
30 slides from Enlivex's investor presentation, February 2024
Slide 1: Off-the-shelf, universal, macrophage reprogramming cell therapies
Off-the-shelf, universal, macrophage reprogramming cell therapies for life- threatening and debilitating 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: 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 3
Slide 4: Immune system balance: macrophages are key player
Immune system balance: macrophages are key player In some diseases, Primary immune cells that macrophages are negatively- regulate immune activity reprogrammed and become non-homeostatic Non-homeostatic macrophages First-responders to pathogenic cause excess damage and challenge and orchestrate the
Slide 5: Macrophage homeostasis implies proper function for its specific tissue, environment, and challenge
Macrophage homeostasis implies proper function for its specific tissue, environment, and challenge. Reprogramming imbalanced macrophage populations can lead to disease resolution Non-homeostatic, Homeostatic Macrophages pro-inflammatory Macrophages TM Pro-homeostasis Allocetra Pro-inflammatory Pro-o
Slide 6: 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 osteoarthritis patients.
Slide 7: 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 Allocetra PtdSer Allocetra • Mononuclear cells collected
Slide 8: Allocetra for macrophage reprogramming
Allocetra for macrophage reprogramming 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 failure associated with $
Slide 9: Allocetra: Reprogramming macrophages responsible for organ failure in Sepsis
AllocetraTM Reprogramming macrophages responsible for organ failure in Sepsis
Slide 10: 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 11: Phase Ib clinical trial of macrophage reprogramming in Sepsis patients
AllocetraTM Phase Ib clinical trial of macrophage reprogramming in Sepsis patients
Slide 12: 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 13: 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 14: Allocetra macrophage reprogramming leads to improved outcomes for sepsis patients
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% All
Slide 15: Allocetra macrophage reprogramming leads to improved outcomes for Sepsis patients
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 Avg
Slide 16: 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 17: Sepsis: Allocetra 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 18: Phase Ib & II Clinical Trials in COVID-19
AllocetraTM Phase Ib & II Clinical Trials in COVID-19 Patients in Severe or Critical Condition
Slide 19: Despite strong clinical results, 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 20: Allocetra: 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
Slide 21: Allocetra and Osteoarthritis
Allocetra and Osteoarthritis Pro-inflammatory macrophages lead to a chronic low-grade inflammation and eventually cartilage degradation • Osteoarthritis (OA) is a worldwide highly prevalent chronic joint disease that causes pain, disability, and loss of function. • Globally, prevalent cases of OA in
Slide 22: Osteoarthritis vertical - severe compassionate case
Osteoarthritis vertical - severe compassionate case as basis for Allocetra 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, resulti
Slide 23: 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 indicated for knee replacement surgeries ● Offered an injection of AllocetraTM in lieu of surgery ● First patient dosed ● Data re
Slide 24: Macrophage reprogramming in solid tumor microenvironment
AllocetraTM Macrophage reprogramming in solid tumor microenvironment Unique & differentiated value proposition
Slide 25: Synergistic effect of Allocetra + anti-CTLA4 in peritoneal 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 imaging, AB12-137 study 25
Slide 26: Enlivex - Planned Milestones (24 months)
Enlivex - Planned Milestones (24 months) April-24 Q3-25 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, contro
Slide 27: Financial Summary
Financial Summary NASDAQ GS ENLV Cash $30MM (Sep 30, 2023) Debt None Shares Outstanding 18.4 MM Funded Through Dec 31, 2025. 27 27
Slide 28: 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 29: 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 30: Thank You
Thank You
Enlivex Therapeutics — Investor Presentation (February 2024) on 6ix