Clene (CLNN) Conference Transcript

Summary of Clene (CLNN) Conference Call - May 21, 2025 Company Overview - Clene Inc. (CLNN) is a late clinical stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases [1] Core Drug and Therapeutic Areas - The primary drug discussed is CMA-eight, targeting neurodegenerative diseases, specifically amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS) [3][4] - CMA-eight has shown potential in remyelination and neuron protection in MS, with data presented at the American Academy of Neurology [4] Regulatory Pathway and FDA Meetings - Clene has a meeting scheduled with the FDA in June to discuss the statistical analysis plan for neurofilament data, a biomarker indicative of neuron damage [6][10] - The company is preparing to file a New Drug Application (NDA) under the accelerated approval pathway, potentially by Q4 2025 [12][13] - The FDA's evaluation will include data from a $45 million NIH-funded compassionate use program involving 170 participants with ALS [8][9] Clinical Trial Insights - The ALS study duration was shorter (6-9 months) due to the urgent needs of patients, while the MS study is planned for 12 months [19][20] - The ALS study focuses on global functional scales and survival, whereas the MS study looks at visual and cognitive changes [20] Current Market Landscape - The main approved drug for ALS is riluzole, which has been available since 1995, providing limited clinical benefit [21][22] - Clene's drug aims to improve neuronal energy and function, potentially offering significant advantages over existing treatments [23] Market Potential and Comparables - Clene believes it could achieve sales of up to $400 million in the first year post-approval, which would significantly increase its market capitalization [24][25] - A comparable ALS company previously achieved a market cap of over $2 billion after FDA approval, highlighting the potential for Clene [24] Additional Insights - The company is also exploring strategic partnerships related to its MS program, although commercialization for MS is still years away [16] - The focus remains primarily on ALS due to a quicker regulatory path [16] Conclusion - Clene is positioned to make significant advancements in the treatment of neurodegenerative diseases, with ongoing discussions with the FDA and promising clinical data supporting its drug candidates [26]