• Clene, a company targeting the treatment of neurodegenerative diseases that severely impact people’s lives, is currently focusing on amyotrophic lateral sclerosis (“ALS”) alongside other neurodegenerative diseases
• The company’s wholly owned subsidiary, Clene Nanomedicine, and two collaborators, Columbia University and Synapticure, are the recipients of a four-year grant totaling $45.1 million
• The grant will support an Expanded Access Protocol (“EAP”) study for Clene’s investigational product, CNM-Au8(R)
• CNM-Au8 is an orally administered gold nanocrystal suspension that is thought to improve mitochondrial health and protect neuronal function to treat neurodegenerative diseases, including ALS
• The EAP study will give patients who did not initially meet the criteria to enroll in a clinical trial an opportunity to try CNM-Au8, which, besides being well tolerated, has improved the survival of ALS patients

In late December of 2021, President Biden signed into law H.R. 3537, the Accelerated Access to Critical Therapies for ALS Act (“Act for ALS”) (https://ibn.fm/oQbSk). The Act for ALS (amyotrophic lateral sclerosis), now public law, directs the Department of Health and Human Services through the Secretary to, among others, “award grants to participating entities for the purposes of scientific research utilizing data from expanded access to investigational drugs for individuals who are not otherwise eligible for clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of ALS” (https://ibn.fm/A2Tuu).

During the financial year 2023, the National Institutes of Health (“NIH”) made strides to implement the Act for ALS, extending its commitment to advancing research on ALS, which currently has no cure. Through its division, the National Institute of Neurological Disorders and Stroke (“NINDS”), the…

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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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