Clene Inc.'S (NASDAQ: CLNN) CNM-Au8(R) Delivers Significant Survival Benefits In New Analyses Of Healey ALS Platform Trial Data

• Clene's CNM-Au8^® treatment was demonstrated to improve survival in ALS patients by up to 14.8 months.
• The findings come from a post hoc analysis of the HEALEY ALS platform Trial, comparing CNM-Au8 to a concurrently enrolled control.
• Strong survival benefit was observed in patients meeting the planned criteria for Clene's upcoming Phase 3 RESTORE-ALS trial.
• The company is preparing to submit a New Drug Application (“NDA”) to the FDA later this year for potential accelerated approval, and further regulatory discussions and a confirmatory Phase 3 trial are planned for mid-2025.

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), has released new data showing that its lead drug candidate, CNM-Au8, significantly extends survival in patients with ALS. The findings were derived from a cross-regimen post hoc analysis of long-term survival in HEALEY ALS Platform Trial participants ( ).

The study compared participants treated with CNM-Au8 30 mg (Regimen C) against those in Regimen A, which served as a large concurrent control group. Survival data was tracked over 48 months using public records and site reporting. The majority (78%) of patients in both groups received standard...

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