Summary of Clene Inc. FY Conference Call (September 05, 2025) Company Overview - **Company**: Clene Inc. (Ticker: CLNN) - **Industry**: Clinical-stage biopharmaceutical company focused on developing nanotherapeutics for neurodegenerative diseases, specifically targeting ALS (Amyotrophic Lateral Sclerosis) and MS (Multiple Sclerosis) [1][2] Core Points and Arguments - **Product Development**: Clene is pioneering a catalytic nanotherapeutic called CNM-Au8 aimed at treating ALS and MS, focusing on improving mitochondrial function [3][4] - **Clinical Trials**: - Completed two Phase II proof of concept studies: HEALEY and RESCUE, both of which missed primary endpoints but provided valuable insights [4][9] - Achieved significant secondary endpoints, including a 94% risk reduction in time to death (p=0.04) and a 71% reduction in clinical worsening for RESCUE-ALS [10][11] - Neural filament levels, a biomarker for neuron damage, showed a p=0.04 reduction, indicating potential for disease progression monitoring [12][14] - **Regulatory Engagement**: Clene is in discussions with the FDA regarding the potential for accelerated approval based on neural filament data and survival benefits [16][19] Financial Position - **Cash Position**: As of the end of June, Clene reported $7.3 million in cash, with an additional $1.9 million raised subsequently, leading to a pro forma cash position of approximately $11 million [25] Additional Important Information - **Safety Profile**: Over 1,000 participant-years of exposure to CNM-Au8 with no serious adverse events reported, although some mild side effects like nausea and headache were noted [7][8] - **Market Need**: Emphasis on the importance of cognitive and functional improvements in MS, with ongoing discussions for a Phase III trial focused on cognition [23][24] - **Future Outlook**: Clene aims for commercialization of CNM-Au8 by late 2026, contingent on successful regulatory filings and clinical outcomes [24] Conclusion - Clene Inc. is positioned at a critical juncture with promising clinical data and a solid financial runway to advance its innovative therapies for ALS and MS, with significant regulatory discussions on the horizon [26][27]