Recent Updates — CLNN

Clene Inc. entered into a subaward amendment with New York University on October 15, 2026, securing funding of up to $7.2 million for the fourth year of an NIH Grant supporting an Expanded Access Program for CNM-Au8 treatment of amyotrophic lateral sclerosis. The agreement covers the period from September 1, 2026, to August 31, 2027. Clene Inc. is a biotechnology company focused on developing therapies for neurological diseases.

Clene Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking accelerated approval of CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS). The submission is based on neurofilament light chain biomarker data and clinical outcomes. Clene remains focused on advancing CNM-Au8 through the regulatory process while preparing for a confirmatory Phase 3 RESTORE-ALS study. Clene Inc. is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health to treat neurodegenerative diseases.

Clene Inc. entered into a securities purchase agreement on September 15, 2026, to issue and sell 1,219,513 shares of common stock at $3.28 per share in a registered direct offering led by Chairman David Matlin and founding investor Kensington Capital Holdings. The transaction generates approximately $4 million in gross proceeds with an expected closing date of September 17, 2026. Clene intends to use the net proceeds alongside existing cash to fund general corporate purposes, including regulatory dialogue, New Drug Application preparation for its lead candidate CNM-Au8, expanded access protocols, and manufacturing expansion. The company is a clinical-stage biotechnology firm focused on developing therapies for neurodegenerative diseases such as ALS.