BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Plans 2025 NDA Submission Following Positive ALS Trial Data 

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, reported a full-year 2024 net loss of $39.4 million, or $5.67 per share, compared to a loss of $49.5 million in 2023. Revenue remained limited, but Clene highlighted regulatory progress and survival data supporting CNM-Au8, its gold nanocrystal suspension for ALS. The company expects to meet with the FDA in Q2 2025 to finalize analysis plans for biomarker data, with a potential accelerated NDA submission in the second half of 2025. Clene ended the year with $12.2 million in cash and expects to begin enrollment for its confirmatory Phase 3 RESTORE-ALS trial in mid-2025. 

To view the full press release, visit https://ibn.fm/uA4y1 

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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