Clene Q3 net loss $8.8M; plans ALS NDA accelerated approval in Q1 2026

Clene Inc.

Cash $7.9M at Sep 30; +$1.2M raised post-quarter; runway into Q2 2026.
FDA advised Type C meeting to review ALS biomarker data; NDA submission planned Q1 2026.
First patient dosing in confirmatory Phase 3 RESTORE-ALS trial expected H1 2026.
Net loss $8.8M ($0.85/share) vs $8.0M ($1.22/share) in Q3 2024.
Type B end-of-Phase 2 meeting held for MS; FDA open to cognition as primary endpoint.

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