Clene Inc. (NASDAQ: CLNN)

Clene Inc. is a clinical-stage pharmaceutical company pioneering the discovery development and commercialization of novel clean-surfaced nanotechnology therapeutics. CSN® therapeutics are comprised of atoms of transition elements that when assembled in nanocrystal form possess unusually high unique catalytic activities not present in those same elements in bulk form. These catalytic activities drive support and maintain beneficial metabolic and energetic cellular reactions within diseased stressed and damaged cells. Clene innovated an electro-crystal-chemistry drug development platform that draws from advances in nanotechnology plasma and quantum physics materials science and biochemistry. The company's development and clinical efforts are dedicated to revolutionizing the treatment of neurodegenerative diseases to restore and protect neuronal health and function by targeting cellular energy impairments common to many diseases with a current focus on amyotrophic lateral sclerosis multiple sclerosis and Parkinson’s disease.

Clene generates revenue primarily through the development and potential commercialization of its lead drug asset CNM-Au8 a highly concentrated aqueous suspension of catalytically-active clean-surfaced faceted gold nanocrystals for the treatment of ALS MS and PD. The company also has other therapeutic assets in early stages of development including CNM-ZnAg a broad-spectrum antiviral and antibacterial agent comprised of zinc and silver ions in an aqueous solution and CNM-AgZn17 a similar agent in a gel polymer formulation for topical application. Additionally Clene develops very low concentration dietary supplements through its wholly-owned subsidiary dOrbital Inc. or through an exclusive license with 4Life Research LLC including rMetx™ and KHC46 (Gold Factor™). Revenue is expected to arise from future product sales licensing agreements and potential collaborations once therapeutics receive regulatory approval.

The company operates through the following segments:

• Clean-Surfaced Nanotechnology Therapeutics Segment. This segment encompasses the discovery development and potential commercialization of Clene’s proprietary CSN® therapeutics including CNM-Au8 for neurodegenerative diseases and other ionic solutions such as CNM-ZnAg and CNM-AgZn17 for antiviral antibacterial and wound healing applications. The segment leverages the company’s electro-crystal-chemistry platform to produce clean-surfaced highly faceted catalytically-active nanocrystals and ionic solutions of transition elements.

• Dietary Supplements Segment. This segment involves the development and distribution of very low concentration dietary supplements utilizing Clene’s patented electrochemistry manufacturing platform. These supplements include rMetx™ (ZnAg Immune Boost) sold through dOrbital and a substantially similar product Zinc Factor™ sold by 4Life Research LLC under a supply agreement and KHC46 (Gold Factor™) an aqueous gold dietary supplement licensed exclusively to 4Life for worldwide marketing and distribution.

Clene positions itself as an industry leader in the development of therapeutic catalytic nanocrystals with a proprietary knowledge base in producing clean-surfaced highly faceted catalytically-active nanocrystals. The company believes it has established a first mover advantage in the innovation of new therapeutic candidates for diseases that have proven extremely difficult to target using traditional methods due to its deep understanding of the chemical properties safety profiles and catalytic abilities of transitional metal nanocrystals. Clene’s competitive advantages include its proprietary electro-crystal-chemistry platform which avoids toxic organic residues and stabilizing surfactants common in traditional nanoparticle synthesis resulting in nanocrystals with substantially higher catalytic activity and lower toxicity. The company’s CSN therapeutics represent a novel approach to drug development substantially different from standard small molecule drugs and biologics by offering multi-modal activities across multiple cell types and disease states through cellular catalysis that supports energetic reactions reduces oxidative stress and promotes protein homeostasis.

Clene serves patients suffering from neurodegenerative diseases including those with amyotrophic lateral sclerosis multiple sclerosis and Parkinson’s disease. The company also provides dietary supplements to broad populations seeking immune support and general health and well-being through its subsidiary dOrbital and its licensing partner 4Life Research LLC. Additionally Clene’s early-stage antiviral and antibacterial agents CNM-ZnAg and CNM-AgZn17 are intended for individuals requiring treatment of infectious diseases and wound or burn healing applications.