Clene (NASDAQ: CLNN), a late clinical-stage biopharma company developing treatments for neurodegenerative diseases, reported Q2 2025 results and said it has sufficient cash runway into Q1 2026. The company plans to meet with the FDA this quarter to review survival data for lead candidate CNM-Au8 in amyotrophic lateral sclerosis (ALS) and is preparing analyses of NIH-sponsored Expanded Access Program neurofilament light biomarker data, expected in Q4. These steps are intended to support a potential New Drug Application submission under the FDA’s accelerated approval pathway for ALS by year-end 2025. Management said its focus remains on delivering an impactful therapy to the ALS community.
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About Clene Inc.
Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8(R)is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8(R)is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on X (formerly Twitter) and LinkedIn .
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN
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