secwatch.observer — SEC 8-K summary
======================================

Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2026-02-24T23:59:59+00:00
Accession:  0001437749-26-005156
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene announces NDA submission for CNM-Au8 planned for Q2 2026; cash runway into Q4 2026
--------------------------------------------------------------------------------

- Raised over $28M in January 2026 registered direct offering; cash runway into Q4 2026 sufficient through NDA acceptance.
- In-person Type C FDA meeting scheduled by end of Q1 2026 to discuss data submitted late 2025.
- NDA for CNM-Au8 via accelerated pathway planned for Q2 2026; PDUFA date possible in H2 2026.
- Confirmatory Phase 3 RESTORE-ALS trial planned to begin later in 2026 after FDA feedback.
- Over 800 patients treated; no CNM-Au8-related SAEs; favorable safety profile across 1,000+ patient-years.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774926005156/0001437749-26-005156-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774926005156/clnn20260223_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-005156

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