Clene (NASDAQ: CLNN) has entered into an agreement with Germany-based APST Research GmbH to utilize its extensive neurofilament light chain (NfL) database in FDA-recommended analyses of CNM-Au8® for treating amyotrophic lateral sclerosis (ALS). APST’s repository includes biomarker data from over 4,300 ALS patients, which will help Clene compare NfL changes in NIH-sponsored Expanded Access Protocol participants to matched controls. The results could support Clene’s planned New Drug Application submission for CNM-Au8 under the FDA’s Accelerated Approval pathway in the second half of 2025. CEO Rob Etherington emphasized the importance of leveraging real-world evidence to advance potential treatments for ALS.

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

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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