Clene Inc. (NASDAQ: CLNN) Applies Patented Nanotechnology to Development of CNM-Au8(R), its Investigational Drug for ALS

• In line with recent emphasis on the growing importance of nanotechnology in the US, Clene Nanomedicine innovated its investigational drug, CNM-Au8(R), using nanotechnology for the treatment of neurodegenerative disease
• Clene’s nanotechnological approach was recently recognized by the NINDS of NIH with a substantial grant to conduct an Expanded Access Protocol in ALS with CNM-Au8(R)
• Clene aims to file a New Drug Application for CNM-Au8(R) for ALS indications in the first half of 2024

October 2023 has turned into a month for the celebration of nanotechnology. On Wednesday, Oct. 4, 2023, three U.S.-based scientists, Moungi Bawendi, Louis Brus, and Aleksey Ekimov, were awarded the 2023 Nobel Prize in Chemistry for their discovery and synthesis of tiny clusters of atoms known as quantum dots, which are widely used today in applications as diverse as digital flat screens to surgery. On Friday, Oct. 6, the White House Office of Science and Technology Policy tweeted, “Happy #NationalNanoDay! #Nanotechnology is at the heart of many recent and emerging technologies, such as #NobelPrize winning #QuantumDots, higher energy density #batteries, hardware for #AI, and #QuantumComputers. What will nanotechnology enable in the future?”  Clene Nanomedicine believes that its lead asset, CNM-Au8(R), holds one such key to the future: the future of medicines to treat neurodegenerative disease.

Clene (NASDAQ: CLNN) is a biopharmaceutical company that aims to revolutionize the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”), Parkinson’s Disease, and multiple sclerosis (“MS”). CNM-Au8 is manufactured by Clene using patented nanotechnology that results in an investigational drug with catalytic activity that targets mitochondrial health to improve neuronal function and survival. By increasing energy production and utilization inside cells, CNM-Au8 has been shown to enable neuroprotection and remyelination in multiple independent preclinical studies.

CNM-Au8 has now been investigated in two independent, Phase 2, randomized, double-blind, placebo-controlled,clinical trials, RESCUE-ALS, conducted at sites in Australia, and the Healey Platform Trial, led by Massachusetts General Hospital and conducted at clinical sites across the US in conjunction with the NEALS Consortium. In RESCUE-ALS, the survival difference for 30mg CNM-Au8 ALS-treated participants exhibited a 19.3-month survival rate versus the placebo. During the double-blind portion of the HEALEY ALS Platform Trial, participants on the 30mg CNM-Au8 dose demonstrated a 98% decreased risk of death over the Regimen’s placebo group, a benefit that is sustained during the trial’s open label extension. These promising results were used to support a grant application to NINDS/NIH to support an Expanded Access Protocol for CNM-Au8 in ALS, which was subsequently awarded to Clene in collaboration with Columbia University and Synapticure, and announced on Oct. 5, 2023. Clene plans to file a New Drug Application for CNM-Au8 for ALS indications with the FDA in the first half of 2024. As of January 2023, Clene has over 150 issued patents worldwide with approximately 20 more patents pending, on top of trade secrets.

The global ALS treatment market was valued at $647.9 million in 2020 and is expected to reach $885.5 million, growing at a CAGR of 5.8%. The market is driven by the prevalence of the disease among geriatric patients. Still, this neurodegenerative disease affects patients at different rates and presents with varying symptoms, making it difficult to control and diagnose (https://ibn.fm/Ij5Q9).

CNM-Au8 has accumulated over 500 years of exposure in patients with ALS, MS, and Parkinson’s Disease with no serious adverse event attributed to the drug. CNM-Au8 is federally registered and trademarked to Clene Inc.

For more information, visit the company’s website at 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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