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The Market Opportunity:
A Multi-Billion-Euro Potential

  • €10B+ combined market opportunity in oLP & aGvHD

  •  No competing Treg-targeting therapies in these high-unmet-need areas

  •  Expansion into additional autoimmune indications

A doctor and a businessman are walking together and talking inside a modern medical facility. The doctor is wearing a white

Investor Value Proposition: A De-Risked, High-Impact Opportunity

  • Clinically Validated & De-Risked – PoC achieved, accelerating development

  • First-in-Class Science – No direct competition in Treg activation

  • Multi-Billion-Euro Market Potential – Addressing severe, underserved diseases

  • Strong Leadership – Proven biotech entrepreneurs with successful regulatory approvals and exits

  • Strategic Expansion – Beyond oLP & aGvHD, unlocking new high-value indications

A scientist wearing a lab coat, protective mask, and safety goggles is using a dropper to transfer blue liquid into a row of

1. Oral Lichen Planus (oLP) – A Game-Changer with Curative Intent

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  • 3M+ patients suffer from chronic, pre-malignant inflammation

  • 60,000+ progress to oral cancer annually

  • No approved therapies – Existing treatments fail to control inflammation, therefore do not prevent malignancy potential

  • €5B+ market potential


Why Tregalizumab?
Tregalizumab targets and controls chronic inflammation, offering the first curative therapy for oLP.

 


2. Acute Graft-versus-Host Disease (aGvHD) – A Life-Saving Breakthrough

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  •  60% of patients develop aGvHD post stem cell transplant

  • >50% failure rate with first-line steroids

  • Severe complications, long hospitalizations, high costs

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Why Tregalizumab?
Unlike existing treatments, Tregalizumab prevents aGvHD at its source by activating Tregs—while preserving the Graft-vs-Leukemia (GvL) effect.

 


 Prof. Dr. Robert Zeiser, GvHD Expert:
❝ Tregalizumab directly addresses the core pathophysiology of aGvHD, setting it apart from current treatments. ❞

Our Target Indications: High-Value, High-Impact

Why Tregalizumab? A First-in-Class Breakthrough

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  • Restores Immune Tolerance – Activates Tregs to reduce harmful inflammation without broad immunosuppression

  • Addresses Core Disease Pathophysiology – Modulates immunity at its source rather than just managing symptoms

  • Proven Clinical Activity – PoC in RA &; Psoriasis, paving the way for broader autoimmune applications

  • Biomarker-Driven Development – targeted patient selection, reducing trial risk

How It Works: A Differentiated Mechanism

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  • Treg activation → Enhances immune regulation in inflammatory diseases

  • Reduces effector T-cell activity → Controls harmful immune responses

  • Balances immune modulation → Avoids immunosuppression seen in existing biologics

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Competitive Advantage: Unlike current therapies that block inflammatory cytokines (e.g.TNF, IL-6, IL-23), Tregalizumab rebalances the immune system, creating a first-in-class solution with high commercial defensibility.

Verschneite Berge

Research & Development

Targeting the Root Cause: A Paradigm Shift in Immune Modulation

 

Unlike traditional biologics that suppress the immune system, Tregalizumab is the first and only monoclonal antibody designed to selectively activate regulatory T-cells (Tregs), restoring immune balance and addressing high-unmet-need diseases more effectively.

Revolutionizing Autoimmune Oncology Treatment

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