Clene (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) 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, has announced several key updates on its National Institutes of Health (“NIH”) funded Accelerating Access to Critical Therapies Expanded Access Program for CNM-Au8® compassionate use (“EAP”) in ALS. Late last year, in collaboration with Columbia University and Synapticure, Clene announced the award of a four-year grant from the National Institute of Neurological Disorders and Stroke (“NINDS”), part of the NIH, to support an EAP for Clene’s investigational drug CNM-Au8 in ALS. “CNM-Au8 treatment has been associated with lowered risk of death and delayed clinical worsening, all while being very well-tolerated, in both of our independent Phase 2 clinical studies,” said Rob Etherington, CEO of Clene. “Data from EAP programs, which usually include a broader ALS population than clinical trials, can supplement the safety and other meaningful data gathered from clinical studies. We are grateful for the NIH’s recognition to fund this important initiative and are pleased to provide this EAP for the ALS community. We are also grateful to the FDA for approving this EAP, working alongside Columbia University and Synapticure, to enable people who are living with this devastating disease access to our investigational drug CNM-Au8.”

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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(R) 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(R) 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.

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