Clene Inc. (NASDAQ: CLNN) Presents Updates on CNM-Au8(R) at Emerging Growth Conference 73 – Biotech Feature

• CNM-Au8(R) works by improving cellular energy production and utilization, which is crucial for maintaining neuronal health
• Clene has conducted several clinical trials to evaluate the safety and efficacy of CNM-Au8 in neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”)
• The global ALS treatment market is expected to grow significantly, driven by the increasing prevalence of the disease among the aging population
• Clene has submitted a briefing book to the FDA to seek feedback on a potential pathway for accelerated approval for CNM-Au8 to treat ALS

Clene (NASDAQ: CLNN), a biopharmaceutical company, is at the forefront of transforming the treatment of neurodegenerative disorders like ALS (amyotrophic lateral sclerosis) and multiple sclerosis (“MS”). In a recent Emerging Growth Conference 73 – Biotech Feature, Clene presented new findings and information pertinent to current and potential investors.

Under the leadership of CEO Rob Etherington, the company focuses on improving mitochondrial health, which is crucial for neurological functions. Mitochondria play a vital role in cellular metabolism and energy production. In neurodegenerative diseases, impaired mitochondrial function is a significant issue. Clene’s lead agent, CNM-Au8, targets the nicotinamide adenine dinucleotide (NAD+) pathway to restore and protect neurological function.

CNM-Au8 works by improving cellular energy production and utilization, which is crucial for maintaining neuronal health. Mitochondrial dysfunction is a common pathway leading to neuronal death in neurodegenerative diseases. By targeting this dysfunction, CNM-Au8 aims to provide neuroprotection and promote remyelination, potentially altering the course of these debilitating conditions.

Clene has conducted extensive clinical trials to evaluate the safety and efficacy of CNM-Au8. In Phase 2 trials for ALS, the treatment has been associated with improved survival rates and delayed clinical worsening. The drug has demonstrated a a favorable safety profile, with over 650 years of cumulative patient exposure without any serious adverse events attributed to it. These trials have also demonstrated significant improvements in biomarkers and in measures of clinical function.

Key studies include:

HEALEY ALS Platform Trial with Harvard’s Massachusetts General Hospital: Focused on ALS, this study showed statistically significant survival benefits in the double-blind phase.

RESCUE-ALS Study: A nine-month double-blind study that continues to follow patients for over three years through an open-label long-term extension, demonstrating promising survival and functional preservation outcomes.

VISIONARY Multiple Sclerosis Study: Despite being half-enrolled due to the COVID pandemic, CNM-Au8 treatment on top of standard-of-care MS drugs showed significant improvements in vision and cognitive function, which are critical unmet needs in MS treatment.

The global ALS treatment market is expected to grow significantly, driven by the increasing prevalence of the disease among the aging population. CNM-Au8 holds promise not only for ALS but also for other neurodegenerative diseases like MS and Parkinson’s, where current treatment options are limited. Its ability to penetrate the blood-brain barrier and its neuroprotective properties make it a strong candidate for addressing the high unmet needs in these markets​.

With over 650 years of cumulative subject exposure, CNM-Au8 has shown a strong safety profile with no serious adverse events linked to the drug. This robust safety data coupled with efficacy and biomarker results from two independent Phase 2 clinical trials in ALS has been instrumental in the company’s engagement with the FDA. Clene has submitted a briefing book to the FDA to seek feedback on a potential pathway for accelerated approval for #CNMAU8.

Clene is gearing up for phase three programs for both ALS and MS. The company’s innovative approach, backed by strong intellectual property with over 150 patents worldwide, positions it as a leader in addressing neurodegenerative diseases. The anticipated FDA interactions and ongoing studies will be crucial steps towards potentially bringing a transformative treatment to patients suffering from these devastating conditions.

Clene’s commitment to improving mitochondrial health offers a beacon of hope for patients with neurodegenerative diseases. With its promising clinical data, strong safety profile, and strategic regulatory engagements, the company is well-positioned to make significant strides in this challenging field.

A replay of the presentation can be found on the Emerging Growth Conference YouTube channel (https://ibn.fm/wCwsg).

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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