Clene reports biomarker analyses showing CNM-Au8 survival benefit in NfL responders for ALS NDA

Clene Inc.

• CNM-Au8 30 mg cut death risk 74% at 12 months vs controls in HEALEY (p=0.0124); 38% lower risk over full follow-up (HR 0.621, p=0.037).
• Causal analysis: 41% lower death risk in predicted NfL responders (HR 0.593, p=0.026); no benefit in non-responders.
• RESCUE-ALS: NfL responders had 76% lower adjusted death risk vs non-responders (HR 0.24, p=0.008); median survival 43.5 vs 19.9 months.
• 10% NfL decline linked to 6-10% lower death risk in >2,000 untreated ALS patients (APST, ANSWER ALS).
• NDA for ALS accelerated approval planned for early Q4 2026; FDA acknowledged NfL as reasonably likely surrogate in March 2026.