Clene has innovated a novel nanotechnology drug platform to develop a new class of orally-administered neurotherapeutic drugs.
FREMONT, CA: Clene Nanomedicine, a Salt Lake City, UT-based clinical-stage biopharmaceutical company, secured $42.5 million in Series D financing. The round was led by SymBiosis II, LLC, a biotech-focused investment vehicle. Participants in the round included existing investors and new institutional investors from South Korea and Japan.
The capital 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 who have 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."
Clene Nanomedicine is a clinical-stage biopharmaceutical company focused on the development of therapeutics for neurodegenerative diseases. CNM-Au8 is a concentrated, aqueous suspension of clean-surfaced faceted nanocrystalline gold (Au) that catalytically supports important intracellular biological reactions. It consists solely of gold atoms organized into faceted, geometrical crystals held in suspension in sodium bicarbonate-buffered, pharmaceutical grade water. It has demonstrated safety in Phase 1 studies in healthy volunteers and 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 ALS models, 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.
Founded in 2013, the company is based in Salt Lake City, Utah with R&D and manufacturing operations located in North East, Maryland.