Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, will be meeting in-person with the U.S. Food and Drug Administration (“FDA”) before the end of November 2024. The company announced that the meeting, which will focus on discussions about the development of the company’s proprietary CNM-Au8 for the treatment of amyotrophic lateral sclerosis (“ALS”), will include key FDA representatives, including the organization’s director of the Office on New Drugs and director of the Office of Neuroscience, as well as the Division of Neurology 1 (“DN1”) review team and key opinion leaders in the ALS, biostatistics and biomarkers space.

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About Clene Inc.

Clene and its wholly owned subsidiary, Clene Nanomedicine, 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 the survival and function of central nervous system cells via a mechanism that targets mitochondrial function and the nicotinamide adenine dinucleotide (“NAD”) pathway while reducing oxidative stress. CNM-Au8 is a federally registered trademark of Clene Nanomedicine. 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.

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