---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-034621"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2025-11-13T23:59:59+00:00"
generated_at: "2026-05-16T20:31:47.507061+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-25-034621
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2025-11-13T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774925034621/0001437749-25-034621-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774925034621/clnn20250821_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-034621
- JSON: https://secwatch.observer/filing/0001437749-25-034621.json
- Plain text: https://secwatch.observer/filing/0001437749-25-034621.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.