/NurExone Biologic Inc.
NurExone Biologic Inc.

NurExone Biologic Inc.

TSXV:NRX.VBiotechnology

Developing biologically guided exosome therapies for central nervous system injuries.

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Investor Insight

Why this opportunity matters now

NurExone Biologic Inc. is a biopharmaceutical innovator advancing a proprietary, non-invasive exosome platform ('ExoTherapy') for central nervous system (CNS) injuries and neurological regeneration.

Supported by Orphan Drug Designations from both the U.S. FDA and European Medicines Agency (EMA) for its lead drug candidate, ExoPTEN, NurExone is progressing toward first-in-human clinical trials. The company's platform model offers dual upside through proprietary biopharmaceutical development and near-term commercial revenue via naïve exosome production and licensing through its U.S. subsidiary, Exo-Top Inc.

Company Overview

Who NurExone Biologic Inc. is and what they do

NurExone Biologic Inc. (TSXV: NRX) is a pharmaceutical technology company headquartered in Toronto, Canada, with scientific operations in Israel. The company develops off-the-shelf, targeted exosome-based therapeutics engineered to promote nerve regeneration and functional recovery in patients with traumatic spinal cord injury, optic nerve damage, and facial nerve conditions.

Through exclusive worldwide licenses from the Technion - Israel Institute of Technology and Tel Aviv University, NurExone leverages membrane-bound extracellular vesicles loaded with active therapeutic agents, such as siRNA, to cross biological barriers and deliver targeted treatment via simple intranasal administration.

Company Highlights

Key competitive advantages at a glance

Lead Drug Candidate ExoPTEN

Proprietary exosome-loaded siRNA therapy for acute spinal cord injury showing significant motor recovery and tissue repair in preclinical models.

FDA & EMA Orphan Drug Designations

Granted Orphan Drug Status by both U.S. and European regulators, offering regulatory pathways, fee waivers, and potential market exclusivity.

Non-Invasive Intranasal Delivery

Biologically guided intranasal spray enables off-the-shelf, targeted delivery directly to the central nervous system without systemic surgery.

Commercial Exosome Manufacturing Strategy

Expanding US-based manufacturing capabilities via subsidiary Exo-Top Inc. to supply clinical-grade exosomes and generate licensing revenues.

Key Assets

The flagship project driving value

ExoPTEN Therapy — project overview

ExoPTEN Therapy

Biologically Guided Exosome Nanodrug for Acute Spinal Cord Injury

ExoPTEN is NurExone's flagship therapeutic candidate, composed of MSC-derived exosomes loaded with a proprietary PTEN-inhibiting siRNA sequence. Administered intranasally shortly after spinal cord trauma, ExoPTEN delivers siRNA directly to injured spinal tissue to suppress PTEN expression, enabling axon regrowth, structural repair, and functional motor rehabilitation.

PRIMARY INDICATION
Acute Spinal Cord Injury (SCI)
REGULATORY STATUS
FDA & EMA Orphan Drug Designation
ADMINISTRATION
Intranasal Spray (Non-Invasive)
MECHANISM
PTEN-siRNA Loaded Exosomes for Axonal Growth
STAGE
Advanced Preclinical / IND Preparation

Management Team

Experienced leadership driving results

Leadership Team in Biotechnology, R&D, and Corporate Finance

Dr. Lior Shaltiel

Chief Executive Officer & Director

Biotech executive with broad experience leading R&D, corporate development, and technology commercialization in life science companies.

Profile

David Stolick

Director

Experienced corporate governance and executive leader serving on the board of directors.

Profile

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Disseminated on behalf of NurExone Biologic Inc.. This profile is spotlight content and does not constitute investment advice. Please review the full disclaimer and do your own due diligence before making any investment decisions.