Enlivex Therapeutics (ENLV) Company Presentation summary

Business overview and leadership

• Developing Allocetra, an off-the-shelf cell therapy targeting macrophage modulation for inflammatory diseases, with a focus on sepsis and osteoarthritis.

• Management and board have extensive experience in biotech, drug development, and successful exits, including multi-billion dollar transactions and global product approvals.

• Strong intellectual property protection with patents in major markets, expected through 2043.

• Cash and equivalents of $20.6M as of March 31, 2025, with no debt and an estimated runway through December 2026.

• Platform supports multiple indications, with simple, scalable, and cost-effective manufacturing.

Allocetra mechanism and scientific rationale

• Allocetra uses allogeneic apoptotic cells to reprogram macrophages, restoring immune homeostasis and resolving inflammation.

• Therapy leverages natural immune processes, presenting a differentiated, ready-to-use cell therapy.

• Macrophage modulation is a novel approach for treating both classical and non-classical inflammatory diseases.

• Extensive research supports the role of macrophages in inflammation and disease resolution.

Clinical pipeline and trial results

• Active clinical programs in sepsis, moderate and end-stage knee osteoarthritis, basal thumb osteoarthritis, psoriatic arthritis, and TMJ osteoarthritis.

• Sepsis Phase II trial showed Allocetra-treated patients had higher baseline risk but demonstrated substantial SOFA score reduction and low mortality in high-risk UTI subgroup.

• Moderate knee osteoarthritis interim data showed 47-50% pain reduction and 42-46% improvement in function at 3 and 6 months, with no severe adverse events.

• End-stage knee osteoarthritis interim data showed 51% pain reduction and 89% surgery avoidance at 3 months.

• Compassionate use in vanishing bone disease led to hospital discharge and sustained recovery.