Neurogenesis

What Neurogenesis does

NeuroGenesis Bio Inc. is a clinical-stage cellular therapy company developing autologous cell therapies for neurodegenerative diseases of the central nervous system. The company's proprietary NG CELL™ platform isolates a unique subpopulation of bone marrow-derived stem cells, enhances them into remyelinating and regenerative biofactory cells, and expands them under cGMP and CMC standards into tens of millions of cells for intrathecal or intravenous administration. NG Cells home in on damaged CNS areas, reside for up to three months, and secrete remyelinating, neuroprotective, and regenerative proteins including CNTF and BDNF. The lead product NG01 is in Phase IIb clinical development for Secondary Progressive Multiple Sclerosis and Amyotrophic Lateral Sclerosis (ALS), with over 140 patients dosed across open-label, long-term extension, and placebo-controlled studies, and Phase 2 data showing an 84% reduction in relative risk of treatment failure versus placebo. The second product NG02 is in preclinical development for Parkinson's disease, Alzheimer's disease, and other CNS degenerative conditions.

The company's go-to-market model centers on the clinical trial and regulatory pathway. NG01 is distributed exclusively through a multi-center Phase IIb network at five KOL-managed academic medical centers — Mass General, Brigham & Women's Hospital, University of Miami, NYU Langone, and Hadassah Medical Center in Jerusalem — with world-renowned principal investigators. An Expanded Access / compassionate use program provides treatment access to patients who have exhausted available therapies and cannot enroll in trials, and the company reserves the right to charge for product supplied under that program. The company is headquartered at 410 White Spruce Blvd., Rochester, NY, with clinical and research operations in Jerusalem, and is establishing a GMP cell therapy manufacturing facility in Rochester. It currently has 1-10 employees and is private, with funding to date from grants (NMSS Fast Forward, BIRD Foundation $7.5M with OrganaBio) and prior equity rounds from Excell Partners, New York Ventures, and Rhodium.

The revenue model is pre-commercial: NeuroGenesis has no approved product and no disclosed product revenue. Future revenue is expected to come from commercialization of NG01 following regulatory approval, with pricing and reimbursement yet to be determined. The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to NG01 for Secondary Progressive Multiple Sclerosis in March 2026 based on Phase 2 data, supporting an accelerated approval pathway. The company is led by Co-Founder and CEO Tal Gilat, Co-Founder and CSO Dr. Dimitrios Karussis (director of the MS Center at Hadassah Medical Center), Co-Founder and CTO Dr. Ibrahim Kassis, COO Dr. Nir Netzer, CMO Dr. Mark Freedman, and SVP Quality and Regulatory Affairs Dorit Harati.

Name

Neurogenesis

Legal name

NeuroGenesis Bio Inc.

Website

https://neurogenesis-cell.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

NeuroGenesis is a clinical-stage biotech developing autologous bone marrow-derived cell therapies (NG CELL™ platform) that deliver remyelinating and neuroprotective proteins to treat progressive multiple sclerosis and ALS, with FDA RMAT designation for lead candidate NG01.

Ownership category

akta.pro rank

Product category

Cellular Therapy / Regenerative Medicine

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell Therapy Developers (Autologous) (HLAAABAA)

akta.pro secondary industries

Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE), Neural & Spinal Cord Regeneration (HLAAAGAI), Multiple Sclerosis & Neuroimmunology (HLAKAIAF)

Keywords

• Autologous cell therapy
• Regenerative medicine
• Neurodegenerative disease therapy
• Remyelinating cell therapy
• Stem cell biofactory

Headquarters

HQ city

Rochester

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D

Revenue model

1. Cell Therapy Product Revenue: Pre-revenue clinical stage company. Revenue will be generated through commercialization of NG01 cell therapy upon regulatory approval. The company has an Expanded Access policy that reserves the right to charge for NG01 provided under expanded access/compassionate use programs.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

NeuroGenesis develops an autologous cell therapy platform called NG CELL™ that uses a proprietary subpopulation of a patient's own bone marrow-derived stem cells, which are selected, enhanced, and expanded into remyelinating and regenerative biofactory cells (NG Cells). Its lead product NG01 is in Phase IIb clinical trials for progressive multiple sclerosis and ALS, while NG02 is under preclinical development for Parkinson's disease and Alzheimer's. The cells are administered intrathecally, home in on damaged CNS areas, and reside there for up to three months producing sustained remyelinating, neuroprotective, and regenerative proteins.

Product overview

NeuroGenesis is a clinical-stage cellular therapy company developing a unified platform approach using its proprietary NG CELL™ platform. The platform supports two main products: NG01 (lead product in Phase 2/3 clinical trials for progressive multiple sclerosis and ALS) and NG02 (in preclinical development for Parkinson's disease and Alzheimer's). The NG CELL™ platform enables the identification, enhancement, and expansion of patient-derived bone marrow cells into remyelinating biofactory cells that are administered via intrathecal or intravenous injection to treat neurodegenerative diseases.

Differentiator

Problem solved

Functional benefit

Products and services

• NG CELL™ Platform Proprietary technology platform that identifies, isolates, and enhances a unique subpopulation of patient-derived bone marrow cells into remyelinating and neuroregenerative biofactory cells (NG Cells), expanded to tens of millions under cGMP and CMC practices for patient administration.
• NG01 Lead cell therapy product candidate in Phase IIb clinical trials for progressive multiple sclerosis (Secondary Progressive MS) and ALS. NG01 cells are autologous remyelinating and neuroprotective biofactory cells administered intrathecally that home to damaged CNS areas and secrete remyelinating, neuroprotective, and anti-apoptotic proteins (CNTF, BDNF, others) for up to three months.
• NG02 Second cell therapy product under development, leveraging the NG CELL™ platform with enhanced neuroprotective and neuroregenerative properties and the potential to differentiate into neuronal cell types based on preclinical studies. Intended indications include Parkinson's disease, Alzheimer's disease, and other central nervous system degenerative diseases.

Quantifiable outcome

• 84% reduction in relative risk of treatment failure versus placebo
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Six partnerships are on record, tiered core.

• OrganaBiocoreStrategic or Co-development Partner · 5 May 2026Joint project partnership with OrganaBio as part of BIRD Foundation's $7.5 million grant program for U.S.-Israel collaborative projects. The BIRD Foundation approved approximately $20 million total investment across seven joint projects spanning healthcare, mental health, and pharmaceuticals sectors.
• Mass GeneralcoreStrategic or Co-development PartnerClinical trial site for Phase IIb studies in secondary progressive MS and ALS, managed by world-renowned Key Opinion Leaders.
• Brigham & Women's HospitalcoreStrategic or Co-development PartnerClinical trial site for Phase IIb studies in secondary progressive MS and ALS, managed by world-renowned Key Opinion Leaders.
• University of MiamicoreStrategic or Co-development PartnerClinical trial site for Phase IIb studies in secondary progressive MS and ALS, managed by world-renowned Key Opinion Leaders.
• NYU LangonecoreStrategic or Co-development PartnerClinical trial site for Phase IIb studies in secondary progressive MS and ALS, managed by world-renowned Key Opinion Leaders.
• Hadassah Medical CentercoreStrategic or Co-development PartnerClinical trial site for Phase IIb studies in secondary progressive MS and ALS, managed by world-renowned Key Opinion Leaders. Home to company's Co-Founder and Chief Scientific Officer Dr. Dimitrios Karussis who directs the MS Center and department of Neuroimmunology.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• Athersys: Clinical-stage regenerative medicine company developing MultiStem cell therapy for neurological and inflammatory indications. Comparable in cell-based approach to CNS/inflammatory disease and clinical-stage positioning.

Broad incumbents

• Mesoblast: Commercial-stage cell therapy company with remestemcel-L and broader allogeneic MSC platform; larger and more diversified than NeuroGenesis but operates in overlapping cell therapy regulatory and commercial landscape.
• BlueRock Therapeutics: Bayer-owned cell therapy developer with programs in Parkinson's disease and other CNS indications using iPSC-derived dopaminergic neurons. Comparable in CNS cell therapy platform and pipeline overlap with NeuroGenesis' NG02 program.

Direct peers

• Pluristem Therapeutics: Cell therapy developer using placenta-derived stem cells; NeuroGenesis COO Nir Netzer previously led preclinical and first cell therapy program there. Comparable in technology platform category (cell-based regenerative medicine) and clinical-stage positioning.
• Gamida Cell: Commercial-stage cell therapy company (Omisirge approved); NeuroGenesis SVP Dorit Harati previously led QA/Manufacturing/Logistics at Gamida Cell. Comparable in cell therapy manufacturing, regulatory expertise, and clinical-stage operational model.
• BrainStorm Cell Therapeutics: Clinical-stage autologous cell therapy developer (NurOwn) for ALS and progressive MS, the most directly comparable competitor with overlapping indications and similar autologous MSC-based platform targeting the same neurodegenerative markets.
• Lineage Cell Therapeutics: Allogeneic cell therapy developer with CNS and ophthalmology programs; Neurgain team includes alumni of CellCure Neurosciences (acquired by Lineage). Direct competitor in CNS cell therapy with overlapping platform approach.
• Saneron CCEL Therapeutics: Early-stage cell therapy company developing stem cell treatments for neurological conditions including MS; listed investor in NeuroGenesis. Highly comparable in therapeutic area (MS/CNS), platform (umbilical cord blood-derived cells), and clinical-stage positioning.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/neurogenesis-cell

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds3 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Neurogenesis