Clene is a clinical-stage pharmaceutical company developing what it calls Clean-Surfaced Nanotechnology (CSN) therapeutics — catalytically-active metallic nanocrystals that act as biological catalysts inside diseased cells. Its lead drug, CNM-Au8, is an oral suspension of gold nanocrystals designed to cross the blood-brain barrier and enter neurons, where the nanocrystals catalyze cellular energy reactions, reduce oxidative stress, and promote clearance of misfolded proteins. Clene is developing CNM-Au8 across three neurodegenerative diseases: ALS, multiple sclerosis, and Parkinson's disease. ALS is the most advanced indication, with two Phase 2 trials completed and an NDA submission planned under an accelerated approval pathway by mid-2026. In MS, Clene positions CNM-Au8 as a remyelinating and neuroprotective complement to existing therapies, with Phase 3 discussions ongoing with the FDA. In Parkinson's, early-stage clinical work demonstrated target engagement but remains early. Clene has no approved products and no product revenue; the company funds operations through equity raises, grants — including a substantial NIH grant supporting its ALS expanded access program — and a nominal dietary supplement business selling low-concentration gold and zinc-silver products through a related-party licensing arrangement. Clene manufactures CNM-Au8 in-house at a GMP facility in Maryland using proprietary electrocrystallization equipment, and holds over 160 issued patents covering its manufacturing processes and nanocrystal compositions.
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