EXORPHIA, Inc. | Pioneering Next-Generation EV Therapeutics & DDS Platform.

About EXORPHIA

EXORPHIA is dedicated to overcoming the limits of existing treatments through extracellular vesicle innovation. Underpinned by strong intellectual property and extensive CMC expertise (over 1,000 EV batches produced), our proprietary platform is built on three core pillars:

1. Prime-EV™ Platform: Cell pre-conditioning technology that enriches key biological cargo in naive EVs for superior therapeutic potency.

2. Engineered EV Platform: Proprietary cargo-loading technology for precise delivery of proteins, nucleic acids, and small molecules, as well as surface antigen display.

3. Advanced CMC & QC Platform: A scalable, high-purity manufacturing process integrated with mechanism-linked QC biomarkers (FDA pre-IND reviewed) ensuring high batch-to-batch consistency and room-temperature stability.

Pipeline & Platform Overview

1. EXP01-AD: Atopic Dermatitis (Dermatology)

• Profile: A differentiated MSC-EV candidate designed to restore the broken skin barrier (TEWL reduction) and modulate local skin inflammation without systemic immunosuppression.

• Current Status: Nonclinical PoC achieved at low doses (1/100 of conventional dose).

• Strategy: Prioritizing a once-weekly subcutaneous (S.C.) injection as the lead route for systemic therapy, with a topical formulation maintained as an optional complementary local treatment.

2. EXP01: Lung Injury — ARDS & IPF (Respiratory)

• Profile: An anti-inflammatory and anti-fibrotic therapy targeting Acute Respiratory Distress Syndrome (ARDS) and Idiopathic Pulmonary Fibrosis (IPF).

• Current Status: FDA Pre-IND consultation completed. Demonstrates superior anti-fibrotic efficacy, respiratory function recovery, and improved survival in pre-clinical models without the toxicity or weight-loss side effects of standard therapies.

3. EXP03-INF: Intranasal EV Vaccine (Infectious Diseases)

• Profile: An engineered mucosal vaccine platform enabling multi-valent antigen presentation via nasal administration, inducing strong mucosal and systemic immune responses.

4. EXP03-AI: Immune Tolerance EV Therapy (Autoimmune Diseases)

• Profile: Engineered EVs modified to induce antigen-specific immune tolerance for refractory autoimmune disorders.

5. Advanced DDS Platform: CNS-DDS & Oncology

• Profile: A versatile drug delivery platform leveraging engineered EVs for targeted delivery of nucleic acids (mRNA/siRNA), proteins, and small molecules.

• Applications: Focused on crossing challenging biological barriers (e.g., Blood-Brain Barrier for CNS-DDS) and targeted delivery in Oncology.

6. Reproductive Health: POF / DOR & Infertility (IVF Adjunct)

• Profile: An EV-based therapeutic adjunct targeting Premature Ovarian Failure (POF) and Diminished Ovarian Reserve (DOR) to improve high-quality blastocyst acquisition rates in assisted reproductive technology (ART).

• Target Launch: Commercial launch in Japan planned for 2027–2028, followed by global expansion.

Partnering Opportunities (The Ask)

We are actively seeking partnering discussions with pharma and biotech companies interested in:

• Out-Licensing & Co-Development: Regional or global rights for EXP01-AD (S.C. / Topical), EXP01 (ARDS/IPF), and Reproductive Health / IVF Adjunct assets.

• Vaccine & Autoimmune Collaborations: Co-development opportunities for the EXP03 mucosal vaccine and autoimmune tolerance platforms.

• DDS Platform Partnerships: Joint development leveraging our Engineered EV platform for targeted CNS delivery or oncology cargo loading.