Enlivex Therapeutics Ltd. (NASDAQ: ENLV) Stock Information | RedChip
Enlivex Therapeutics Ltd. NASDAQ: ENLV logo small-cap
NASDAQ: ENLV

Enlivex Therapeutics Ltd.

$1.41 -0.0050 -0.35% 15.8K

Company Overview


Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram macrophages, which are primary immune cells, into their homeostatic state. Diseases such as osteoarthritis, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action and resolution for conditions which are life-threatening and debilitating “unmet medical needs”.

Value Proposition


Enlivex presents a compelling investment opportunity in the biopharmaceutical sector with its innovative approach to treating life-threatening and debilitating conditions through macrophage reprogramming. The company's leading product Allocetra™ is a groundbreaking off-the-shelf, cost-effective cell therapy platform designed to reset the body's immune cells (macrophages) to their optimal functioning state. This technology addresses a critical need for rebalancing the immune system, offering potential treatments for a range of inflammatory and autoimmune diseases with high unmet medical needs. With macrophages playing a vital role as the body's first line of defense, Enlivex's focus on converting these cells from a "disease setting" back to their "resolution settings" opens the door to addressing complex conditions like osteoarthritis and sepsis, tapping into multi-billion-dollar markets.

The company is at an advanced clinical stage with Phase I/II trials in osteoarthritis aiming at a combined market opportunity of $9 billion and a Phase IIb trial for sepsis showing promise for a $33 billion market opportunity. Enlivex's strong leadership team, proven by their successful $560 million exit event with PROLOR Biotech and a significant partnership with Pfizer, underscores the company's potential for high returns. With a robust cash balance ensuring an operational runway through the end of 2026 and a buy recommendation with a $6 per share price target, Enlivex stands out as a promising investment for investors seeking to capitalize on the next wave of innovations in immunotherapy and cell reprogramming technologies.

Pipeline


“Pipeline”

Investor Presentation

Investment Highlights


  • Macrophage reprogramming targeting unmet medical need indications
    • Off-the-shelf, universal cell therapy for resetting macrophages back to their ”resolution settings” and away from “disease settings”
    • A type of immune cell, macrophages act as the body's first line of defense, engulfing and destroying pathogens and debris
    • Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions
  • Advanced clinical-stage pipeline addressing multi-billion-dollar markets
    • Phase I/II in osteoarthritis (OA)
      • Positive interim readouts for Phase I/II end-stage knee osteoarthritis showed a significant reduction in pain and a favorable safety profile.
      • Top-line data for end-stage knee osteoarthritis expected in Q1 2025; $2B global market opportunity
      • Top-line data from moderate knee osteoarthritis expected in Q3 2025; $7B global market opportunity
      • w Phase I/II trial for basal thumb joint osteoarthritis authorized; early-stage safety run-in and randomized stages planned. Topline data expected in Q2 2025
    • Phase IIb macrophage reprogramming for sepsis
      • Topline 28 days - potential indication of relative efficacy demonstrated in a population of high-risk UTI patients; ~$10B global market opportunity
  • Strong leadership
    • Previously founded and managed PROLOR Biotech; a $560M exit event; signed partnership with Pfizer, including $295 million down payment; and drug (NGenla) approved in 43 countries (incl. US); leading product in $4 billion market
    • Vice Chairman Roger Pomerantz: former Head of Business Development at Merck and former Venture Parter at Flagship Pioneering
  • Cash balance supporting multiple clinical milestones within 18-24 months
    • $23.4 million cash (as of March. 31, 2024) provides runway through year end 2026
  • Buy recommendation from H.C. WAINWRIGHT & CO with $6 per share price target

Allecetra™ Compassionate Case Results


“Allocetra™

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