Salt Lake City— Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced that it has secured $42.5 million in a Series D financing. The round was led by SymBiosis II, LLC, a biotech-focused investment vehicle. Participants in the round included existing investors, as well as new institutional investors from South Korea and Japan.

Proceeds from the financing will be used to advance Clene’s clinical pipeline—particularly the lead nanocatalyst, CNM-Au8—through its ongoing Phase 3 study for the treatment of amyotrophic lateral sclerosis (ALS), and multiple Phase 2 clinical trials for the treatment of progressive neurologic impairment seen in people suffering from multiple sclerosis, Parkinson’s disease, and ALS.

“This financing further validates our scientific approach and the significant progress we have made across our Phase 2 clinical trials evaluating the first potential therapeutic nanocatalyst CNM-Au8 for the treatment of neurodegenerative diseases,” said Rob Etherington, President and CEO of Clene. “We welcome our new shareholders and thank them, as well as our existing investors, for their commitment to Clene and our unique bioenergetic approach.”

About CNM-Au8

CNM-Au8 is a concentrated, aqueous suspension of clean-surfaced faceted nanocrystalline gold (Au) that acts catalytically to support important intracellular biological reactions. CNM-Au8 consists solely of gold atoms organized into faceted, geometrical crystals held in suspension in sodium bicarbonate-buffered, pharmaceutical grade water. CNM-Au8 has demonstrated safety in Phase 1 studies in healthy volunteers, and both remyelination and neuroprotection effects in multiple preclinical models.  Preclinical data presented at scientific congresses demonstrated that treatment with CNM-Au8 in neuronal cultures improved survival of neurons, protected neurite networks, decreased intracellular levels of reactive oxygen species, and improved mitochondrial capacity in response to cellular stress induced by multiple disease-relevant neurotoxins. Oral treatment with CNM-Au8 improved functional behaviors in rodent models of ALS, multiple sclerosis, and Parkinson’s disease versus vehicle (placebo). CNM-Au8 has received regulatory approval to initiate Phase 2 and 3 clinical studies for neuroprotection and remyelination in patients with multiple sclerosis, amyotrophic lateral sclerosis (ALS), and Parkinson’s disease.

About Clene

Clene Nanomedicine, Inc. is a privately held, clinical-stage biopharmaceutical company focused on the development of unique therapeutics for neurodegenerative diseases. Clene has innovated a novel nanotechnology drug platform for the development of a new class of orally-administered neurotherapeutic drugs. Clene has also advanced into the clinic an aqueous solution of ionic zinc and ionic silver for anti-viral and anti-microbial uses.  Founded in 2013, the company is based in Salt Lake City, Utah with R&D and manufacturing operations located in North East, Maryland. For more information, please visit www.clene.com.