- Clene Inc. announced on **September 25, 2025**, the presentation of new clinical data at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2025), showing that **CNM-Au8® improves brain energy metabolism** in multiple sclerosis (MS) patients.  **[1822791_0001437749-25-029846_ex_863757.htm:0]** **[1822791_0001437749-25-029846_clnn20250923_8k.htm:1]** **[1822791_0001437749-25-029846_clnn20250923_8k.htm:2]** 
- The REPAIR studies demonstrated a **significant increase in the mean NAD+/NADH ratio** in the brain, a measure of energetic capacity, by **+0.449 units (8.65% change, p=0.0148)** after 12 weeks of CNM-Au8 treatment in the full REPAIR population.  **[1822791_0001437749-25-029846_ex_863757.htm:1]** 
- The U.S. Food and Drug Administration (FDA) has indicated **openness to considering other potential primary endpoints**, such as cognition, for evaluating broader treatment effects in MS clinical trials, acknowledging the limitations of the Expanded Disability Status Scale (EDSS).  **[1822791_0001437749-25-029846_ex_863757.htm:0]** **[1822791_0001437749-25-029846_ex_863757.htm:1]** 
- CNM-Au8 treatment was found to be **safe and well tolerated**, with adverse events characterized as transient and predominantly mild-to-moderate in severity.  **[1822791_0001437749-25-029846_ex_863757.htm:1]**

Clene (CLNN)