secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2025-11-13T23:59:59+00:00
Accession:  0001437749-25-034621
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774925034621/0001437749-25-034621-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774925034621/clnn20250821_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-034621

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer