CNM-Au8 Therapeutic Potential - Clene is pioneering catalytic nanotherapeutics to treat neurodegenerative diseases like ALS, Parkinson's, and MS[13] - CNM-Au8 is a nanocrystal suspension administered orally, targeting energy metabolism and oxidative stress, and can penetrate the blood-brain barrier[27] - CNM-Au8 contains >100 trillion nanocrystals per 60 mL dose (at 30 mg)[24] - Over 800 participant-years of exposure to CNM-Au8 with predominantly mild-to-moderate TEAEs and no related SAEs across all clinical programs[36] ALS Clinical Trial Outcomes - In the HEALEY ALS Platform Trial, CNM-Au8 30 mg showed a 94% risk reduction in time to death or PAV during the double-blind period[41] - During the OLE to Month 12 of the HEALEY ALS Platform Trial, CNM-Au8 30 mg showed a 78% risk reduction in time to death or PAV[46] and a 62% risk reduction in time to death[48] - A 71% risk reduction in delayed time to clinical worsening was observed in two independent Phase 2 trials[50] - Participants with NfL decline at Week 24 in the HEALEY ALS Platform Trial showed a 91% risk reduction in time to death or PAV[92] MS Clinical Trial Outcomes - In MS patients on DMTs, CNM-Au8 demonstrated significantly improved vision as measured by Change in Low Contrast Letter Acuity (LCLA)[124] - CNM-Au8 demonstrated global neurological improvement in stable MS patients on DMTs[123] Financial Status - As of March 31, 2025, Clene Inc had $9.8 million in cash and equivalents on hand (unaudited)[178]
Clene (CLNN) Earnings Call Presentation