Clene Nanomedicine
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.
- Company typePublic
- Founded2013
- HeadquartersSalt Lake City, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Clene Nanomedicine firmographics
Firmographics- 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
Clene Nanomedicine industry classification
Industry- 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
Where Clene Nanomedicine is headquartered
LocationHeadquarters
- HQ city
- Salt Lake City
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Clene Nanomedicine business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- 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
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Expanded Access Program - NIH funded, no cost to participants |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels6 records
Clene Nanomedicine product offering
Product offeringCore 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.
Companies that use Clene Nanomedicine
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles2 records
Clene Nanomedicine technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Clene Nanomedicine partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core.
- Columbia UniversitycoreColumbia 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.
- SynapticurecoreSynapticure 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)coreThe 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)coreMGH 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
Clene Nanomedicine competitors and assessment
Company assessmentMarket position
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Clene Nanomedicine social profiles
Digital presenceClene Nanomedicine financial estimates
Financial estimateRevenue estimate
Valuation estimate
Clene Nanomedicine leadership team
Management profileNumber of profiles
Profiles8 records
Clene Nanomedicine funding detail
Funding detailFunding overview
Funding rounds15 records
Investors9 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Clene Nanomedicine M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Clene Nanomedicine
What does Clene Nanomedicine do?
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).
Is Clene Nanomedicine a public or private company?
Clene Nanomedicine is a public company. It is classified as public and is currently operating.
When was Clene Nanomedicine founded?
Clene Nanomedicine was founded in 2013. It employs 51 to 100 people.
Where is Clene Nanomedicine based?
Clene Nanomedicine is headquartered in Salt Lake City, United States, in the North America region.
How does Clene Nanomedicine make money?
One revenue line is on record: pharmaceutical Drug Sales (Future).
Does Clene Nanomedicine have an API?
No public API is recorded for Clene Nanomedicine.
What industry is Clene Nanomedicine in?
Clene Nanomedicine's product category is Neurodegenerative Disease Therapeutics. Its primary akta.pro industry code is HLAIACAC, Neurology & CNS Specialty Pharmaceuticals, with a secondary code of HLAIAAAF, Neurology & Psychiatry (CNS) Pharmaceuticals. Its NAICS code is 541713 and its SIC code is 2836.