Clene (NASDAQ: CLNN) announced first quarter 2025 financial results and progress on its CNM-Au8 program for ALS and MS. The company is preparing for a potential NDA submission under the FDA’s Accelerated Approval pathway for ALS in Q4 2025, supported by survival data and upcoming biomarker analysis. New data also showed CNM-Au8 significantly improved survival in patients with more severe ALS. In MS, Clene presented Phase 2 extension results demonstrating remyelination and neuronal repair. The company reported a Q1 net loss of $0.8 million on reduced expenses and $9.8 million in cash, funding operations into Q3 2025.
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About Clene Inc.
Clene (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® 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® 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.
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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