Neuraly

What Neuraly does

Neuraly is a clinical-stage biotechnology company developing disease-modifying drug candidates for neurodegenerative diseases. Founded in 2018 as a spinout from Johns Hopkins University School of Medicine, the company focuses on inhibiting pathological glial activation in microglia and astrocytes as an upstream driver of neuronal cell death. The lead asset NLY01 (pegsebrenatide) is a first-in-class long-acting pegylated exendin-4 analogue GLP-1 receptor agonist that crosses the blood-brain barrier and has demonstrated neuroprotective activity in preclinical models of Parkinson's disease and Alzheimer's disease. The company serves patients in indications where no approved disease-modifying therapies currently exist, including Parkinson's disease, Alzheimer's disease, and progressive multiple sclerosis.

The technology platform is anchored on NLY01, which is currently in Phase 2 clinical development for both Parkinson's disease (topline results announced March 2023) and Alzheimer's disease (Phase 2B, IND cleared November 2020), with a Phase 2 investigator-initiated trial in progressive multiple sclerosis initiated in May 2026 enrolling approximately 120 patients over 96 weeks. The pipeline is supplemented by NLY02, an orally bioavailable small molecule kinase inhibitor in IND-enabling studies, and NLY03, a parthanatos-pathway neuroprotective agent in lead optimization for stroke and Parkinson's disease. Neuraly has also developed PMI04, a PET imaging biomarker of neuroinflammation, which it licensed to Enigma Biomedical USA in January 2025 for research and potential commercialization. Scientific co-founders include Dr. Ted Dawson of Johns Hopkins, elected to the National Academy of Medicine in 2021.

Neuraly operates as a wholly-owned subsidiary of D&D Pharmatech Inc. (KOSDAQ: 347850), a South Korean clinical-stage biotech that funds development through disease-specific subsidiaries. Aggregate funding attributed to Neuraly and its parent totals approximately $224M, including $36M raised at Neuraly's launch in July 2018, a $137.1M Series B by D&D Pharmatech in August 2019, and a $51M Series C in October 2021, with investors including Octave Life Sciences, Smilegate Investment, InterVest, Magna Investment, and LB Investment. The revenue model is pharmaceutical development and commercialization: the company is pre-revenue and will generate revenue through product sales following FDA approval, with pricing and commercial channels not yet disclosed. Clinical operations rely on academic medical institution partnerships, primarily Johns Hopkins and the University of Pennsylvania.

Name

Neuraly

Legal name

Neuraly Inc.

Website

https://neuralymed.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

51–100 employees

Short description

Neuraly is a clinical-stage biotechnology company developing first-in-class GLP-1 receptor agonist therapies that target neuroinflammation to treat Parkinson's disease, Alzheimer's disease, and progressive multiple sclerosis. The company is a wholly-owned subsidiary of D&D Pharmatech Inc.

Ownership category

akta.pro rank

Product category

Neurodegenerative Disease Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

In Vivo Discovery & Translational Models Platforms (humanized models, PK/PD, efficacy) (HLAAAIAK)

akta.pro secondary industries

Translational & Pharmacodynamic Biomarkers (MOA, target engagement, PD/PK-linked markers) (HLAAAMAD), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Neurodegenerative disease therapeutics
• GLP-1 receptor agonists
• Parkinson's disease drugs
• Alzheimer's disease drugs
• Clinical-stage biotechnology

Headquarters

HQ city

Germantown

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Infrastructure

Revenue model

1. Pharmaceutical Development and Commercialization: As a clinical-stage biotech company, Neuraly is pre-revenue. The company develops proprietary drug candidates through clinical trials with the goal of obtaining regulatory approval and commercializing disease-modifying therapies for neurodegenerative diseases. Revenue would be generated through product sales following FDA approval.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Neuraly is a clinical-stage biotechnology company developing a pipeline of disease-modifying drug candidates for neurodegenerative diseases, including Parkinson's disease, Alzheimer's disease, and progressive multiple sclerosis. The lead asset NLY01 (pegsebrenatide) is a long-acting, pegylated GLP-1 receptor agonist that penetrates the blood-brain barrier and targets microglia and astrocyte-mediated neuroinflammation. Additional pipeline assets include orally bioavailable small-molecule candidates (NLY02, NLY03) and the PMI04 PET imaging biomarker of neuroinflammation.

Product overview

Neuraly is a clinical-stage biotechnology company developing a pipeline of disease-modifying drug candidates for neurodegenerative diseases. The core product is NLY01 (pegsebrenatide), a first-in-class long-acting GLP-1 receptor agonist currently in Phase II trials for Parkinson's Disease and Alzheimer's Disease. The company is advancing follow-on candidates including NLY02 (small molecule, IND-enabling) and NLY03 (neuronal survival pathway targeting, preclinical) to diversify its portfolio. Additionally, Neuraly has developed PMI04, a PET imaging biomarker of neuroinflammation.

Differentiator

Problem solved

Functional benefit

Products and services

• NLY01 (Pegsebrenatide) A first-in-class, long-acting pegylated exendin-4 analogue GLP-1 receptor agonist (GLP-1R) that penetrates the blood-brain barrier and targets microglia and astrocyte-mediated neuroinflammation. Currently in Phase II clinical trials for Parkinson's disease, Alzheimer's disease, and progressive multiple sclerosis.
• NLY02 An orally active, microglia/astrocyte-targeted small molecule kinase inhibitor targeting glial activation for Parkinson's and Alzheimer's disease. Currently in IND-enabling studies.
• NLY03 An orally active neuroprotective agent targeting the parthanatos cascade for stroke and Parkinson's disease. Currently in lead optimization/discovery stage.
• PMI04 PET Imaging Biomarker A PET (Positron Emission Tomography) imaging biomarker of neuroinflammation developed by Neuraly and licensed to Enigma Biomedical USA for research and commercialization.

Quantifiable outcome

• Phase 2 trial results in Parkinson's disease announced March 2023
• +1 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core.

• D&D PharmatechcoreOthers · 19 October 2021Neuraly is a wholly owned subsidiary of D&D Pharmatech, Inc. (KOSDAQ: 347850), a clinical-stage global biotech company that funds development through disease-specific subsidiary companies founded and guided by top-tier medical research faculty and biotechnology veterans.
• Enigma Biomedical USAcoreTechnology or Integration · 17 January 2021Neuraly and Enigma Biomedical USA announced a research license and commercialization option agreement for PMI04, a PET imaging biomarker of neuroinflammation developed by Neuraly. This partnership enables Enigma to commercialize the biomarker while Neuraly retains research capabilities.
• University of PennsylvaniacoreStrategic or Co-development Partner · 10 November 2020Neuraly announced a strategic sponsored research agreement with the University of Pennsylvania to explore use of NLY01 to therapeutically target a neuroinflammatory mechanism of glaucoma. The study was based on research published in Cell Reports demonstrating NLY01's potential for clinical use in treating glaucoma and other retinal diseases.
• 1st BiotherapeuticscoreStrategic or Co-development Partner · 30 October 2018Neuraly and South Korea-based 1st Biotherapeutics agreed to co-develop brain penetrant c-Abl inhibitors for Parkinson's disease with aims to file an investigational new drug (IND) application with the FDA.
• Johns Hopkins School of MedicinecoreStrategic or Co-development PartnerNeuraly was founded based on groundbreaking research from a team of world-class neuroscientists led by Neuraly co-founder Dr. Ted Dawson at Johns Hopkins University School of Medicine. The company originated from this academic collaboration with ongoing clinical trial operations at Johns Hopkins.

Scale indicators7 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Alector: Alector is a clinical-stage biotech developing immuno-neurology therapeutics that target microglia and other immune cells in the brain to treat neurodegenerative diseases including Alzheimer's and frontotemporal dementia. Directly comparable to Neuraly in mechanism (microglial modulation) and indication focus.
• Denali Therapeutics: Denali Therapeutics is a clinical-stage biotech developing therapeutics for neurodegenerative diseases, leveraging insights into lysosomal function, glial biology, and BBB-penetrant biologic delivery. Closely comparable to Neuraly in target indication, stage, and platform approach.
• Anavex Life Sciences: Anavex is a clinical-stage biotech developing small molecules (e.g., ANAVEX 2-73/blarcamesine) for Alzheimer's, Parkinson's, and Rett syndrome. Comparable in clinical-stage status, neurodegenerative disease focus, and pursuit of disease-modifying mechanisms.
• Cassava Sciences: Cassava Sciences is a clinical-stage biotech developing simufilam for Alzheimer's disease. Directly comparable in being a small-cap, clinical-stage, disease-modifying therapy developer for neurodegeneration.
• Prothena: Prothena is a clinical-stage biotech developing antibody-based protein immunotherapies for neurodegenerative diseases including Parkinson's, Alzheimer's, and ATTR amyloidosis. Comparable in biologic platform, disease focus, and stage.
• BioVie: BioVie is a clinical-stage biotech developing therapies for neurodegenerative and neuroinflammatory disorders including Alzheimer's and Parkinson's. Comparable in small-cap, late-preclinical/early-clinical stage and indication overlap.

Emerging players

• Vigil Neuroscience: Vigil Neuroscience is an early-stage biotech developing TREM2-activating antibodies to boost microglial function in neurodegenerative diseases. Comparable in glial-focused mechanism for neurodegeneration, though at earlier stage than Neuraly.
• Cognition Therapeutics: Cognition Therapeutics is a clinical-stage biotech developing small molecules (e.g., CT1812) for Alzheimer's disease and dementia with Lewy bodies. Comparable in clinical-stage status and neurodegenerative focus.

Broad incumbents

• Eli Lilly: Eli Lilly is a global pharmaceutical incumbent with a leading GLP-1 franchise (Mounjaro/Zepbound) and is running large Phase 3 trials of GLP-1 in Alzheimer's disease (EVOKE/EVOKE+). Highly relevant incumbent entering the same GLP-1 + neurodegeneration strategic intersection as Neuraly.
• Novo Nordisk: Novo Nordisk is the global leader in GLP-1 therapeutics (semaglutide/Ozempic) and is exploring GLP-1 in Parkinson's disease. Highly relevant broad incumbent whose resources and brand could overshadow Neuraly's microglia-targeted GLP-1 approach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds2 records

Investors10 records

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M&A

Investments

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

Frequently asked questions about Neuraly