Clene Nanomedicine

What Clene Nanomedicine does

Clene Inc. (NASDAQ: CLNN) is a publicly traded clinical-stage biopharmaceutical company founded in 2013 and headquartered in Salt Lake City, Utah, developing nanocrystal therapeutics for neurodegenerative diseases using its proprietary Clean-Surfaced Nanocrystal (CSN) platform. The platform uses a patented electro-crystal-chemistry process to produce clean-surfaced nanocrystals of pure transition elements. Its lead candidate CNM-Au8 is an oral suspension of catalytically-active gold nanocrystals that catalyze NAD+ to drive ATP production, reduce oxidative stress, and lower misfolded protein levels, targeting the cellular energy impairments underlying amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson's disease. The pipeline also includes CNM-ZnAg (antiviral/antimicrobial), CNM-AgZn17 (wound healing), and CNM-PtAu7 (oncology). The company holds 30+ U.S. patents and hundreds of foreign patents covering the CSN platform and CNM-Au8 manufacturing.

Clene is pre-revenue with no approved products and operates a regulatory-driven go-to-market model centered on its planned New Drug Application (NDA) for CNM-Au8 in ALS under the FDA accelerated approval pathway by end of June 2026. Today, the investigational drug is distributed through NIH-funded Expanded Access Programs (EAPs) and clinical trials at academic medical centers including Columbia University, Massachusetts General Hospital, Duke, Northwestern, NOVA, Texas Neurology, Penn State, and the University of Iowa, with the HEALEY-ALS Platform Trial running across 54 NEALS consortium sites. A virtual tele-neurology partnership with Synapticure extends enrollment across all 50 U.S. states. Clinical data shows a median survival extension of up to 14.8 months in ALS patients and over 1,000 patient-years of CNM-Au8 exposure without identified safety signals; new analyses indicate a 9-10% reduction in neurofilament light chain (NfL) levels is associated with 8-13% lower mortality risk.

The company has funded operations through a mix of equity financings (over $42M raised in 2024-2026), a $45.1M NIH/NINDS grant, and state-backed debt and grant facilities in Maryland supporting its Elkton manufacturing facility. FY2025 net loss was $26.2M (down from $39.4M in 2024) and R&D expense was $14.0M (down from $20.1M). As of May 2026, total debt was $22.05M against a market capitalization of approximately $85.23M.

Name

Clene Nanomedicine

Legal name

Clene Nanomedicine, Inc.

Website

https://clene.com

Company type

Public

Founded year

2013

Operating status

Operating

Headcount range

51–100 employees

Short description

Clene Inc. is a clinical-stage biopharmaceutical company developing Clean-Surfaced Nanocrystal (CSN) therapeutics, with lead candidate CNM-Au8, an oral gold nanocrystal suspension for ALS, MS, and Parkinson's disease, pursuing FDA accelerated approval with an NDA planned by June 2026.

Ownership category

akta.pro rank

Product category

Neurodegenerative Disease Therapeutics

NAICS

Research and Development in Nanotechnology (541713)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industry

Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)

Keywords

• Nanotherapeutic drug development
• Neurodegenerative disease therapeutics
• Clean-surfaced nanocrystals
• Clinical-stage biopharmaceutical
• ALS drug development

Headquarters

HQ city

Salt Lake City

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Pharmaceutical Drug Sales (Future): Clene is pre-revenue. The company plans to commercialize CNM-Au8 upon FDA approval. Revenue would be generated through prescription drug sales, likely via specialty pharmacy and distribution channels targeting ALS patients and neurologists.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Clene Nanomedicine is a clinical-stage biopharmaceutical company developing therapeutics based on its Clean-Surfaced Nanocrystal (CSN) platform. Its lead candidate, CNM-Au8, is an oral suspension of catalytically-active gold nanocrystals designed to address cellular energy impairment in neurodegenerative diseases including ALS, MS, and Parkinson's disease. The pipeline also includes CNM-ZnAg (antiviral/antimicrobial), CNM-AgZn17 (wound healing), and CNM-PtAu7 (oncology).

Product overview

Clene Inc. is a clinical-stage biopharmaceutical company developing a pipeline of nanotherapeutics based on its Clean-Surface Nanocrystal (CSN™) platform. The company's lead product is CNM-Au8®, an oral suspension of catalytically-active gold nanocrystals targeting neurodegenerative diseases including ALS, MS, and Parkinson's disease. The broader pipeline includes CNM-ZnAg (zinc-silver ionic solution), CNM-AgZn17 (topical gel for infections/wound healing), and CNM-PtAu7 (gold-platinum nanotherapeutic for oncology). The company also operates expanded access programs (EAPs) such as ACT-EAP with CNM-Au8 to provide investigational drug access to ALS patients outside of clinical trials.

Differentiator

Problem solved

Functional benefit

Products and services

• CNM-Au8® An oral suspension of clean-surfaced, catalytically-active gold nanocrystals developed as a disease-modifying treatment for amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson's disease. The drug candidate targets cellular energy impairments to restore and protect neuronal health by catalyzing NAD+ to drive ATP production.
• CNM-ZnAg A proprietary zinc-silver ionic solution that has demonstrated both antiviral and antimicrobial properties, developed using Clene's Clean-Surfaced Nanocrystal (CSN) platform for infectious disease applications.
• CNM-AgZn17 A topical gel polymer suspension of silver and zinc ions being developed for the treatment of infectious diseases and to accelerate wound healing.
• CNM-PtAu7 A gold-platinum nanotherapeutic whose initial in vitro research has demonstrated broad-spectrum efficacy across a variety of tumor cell lines, developed using Clene's CSN platform for oncology applications.
• ACT-EAP with CNM-Au8® A compassionate use expanded access program providing people with amyotrophic lateral sclerosis (ALS) access to CNM-Au8, run as a collaboration between Clene, Columbia University, and Synapticure across all 50 U.S. states and supported by NIH ACT for ALS funding.

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

Four partnerships are on record, tiered core.

• Columbia UniversitycoreStrategic or Co-development Partner · 1 June 2024Columbia University is a key collaborator in Clene's ACT-EAP (Access for ALS Expanded Access Program) for CNM-Au8. Dr. Jinsy Andrews serves as Principal Investigator at Columbia's ALS research site in New York, NY. The program provides people with ALS access to CNM-Au8 while generating real-world evidence. Funded by NIH as part of the ACT for ALS.
• SynapticurecoreChannel Partner/ Reseller/ Distributor · 1 June 2024Synapticure is a specialty tele-neurology clinic partnering with Clene to enable virtual participation in the ACT-EAP across all 50 US states. Eric Anderson serves as Principal Investigator. Synapticure conducts all visits virtually, sending vendors to participants' homes for assessments, with CNM-Au8 shipped directly to patients.
• NEALS Consortium (Northeast ALS Consortium)coreStrategic or Co-development Partner · 1 July 2020The HEALEY ALS Platform Trial enrolled 653 participants across 54 NEALS consortium sites testing four investigational regimens concurrently (Zilucoplan, Verdiperstat, CNM-Au8, and Pridopidine) within approximately two years, demonstrating significant operational efficiencies with sIRB approval times of 21-120 days.
• Massachusetts General Hospital (MGH)coreStrategic or Co-development Partner · 1 January 2019MGH collaborates on multiple EAPs with Clene, including a program started in 2019 in collaboration with Dr. Merit Cudkowicz of Harvard University to grant ALS patients access to CNM-Au8. A second EAP with MGH and 16 centers across the US started in 2023 for patients completing the Healey Platform Trial's long-term extension.

Scale indicators11 records

Recent moves6 records

Expansion highlights5 records

Market position

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/clenenano
• Facebookfacebook.com/CleneNanomedicine
• LinkedInlinkedin.com/company/clene-nanomedicine

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds15 records

Investors9 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 Clene Nanomedicine