Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), is in the process of submitting a briefing book to the U.S. Food and Drug Administration (“FDA”). The company anticipates submitting the book by July 13, 2024, in advance of the FDA granting a Type C interaction. According to the announcement, the purpose of the interaction between Clene and the FDA is to obtain key feedback on the potential path to submission of a new drug application (‘NDA’) for Clene’s CNM-Au8(R) as a potential treatment for ALS. The briefing book, which is focused on addressing comments from the FDA made in a December 2023 meeting, will contain analyses of data from completed clinical studies. “Clene believes these new analyses serve to further demonstrate the potential for CNM-Au8 as a treatment in people living with ALS, consistent with the accelerated approval standards,” said the company in the press release. “Clene also included data addressing the agency’s request to provide additional information concerning the relationship between CNM-Au8’s proposed mechanism of action and reduction in NfL, as well as the association between observed NfL reductions and improved clinical outcomes in ALS patients, including survival.”

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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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