secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2025-05-07T23:59:59+00:00
Accession:  0001437749-25-014917
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 2.02, 3.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene receives Nasdaq MVLS deficiency notice; reports Q1 2025 net loss of $0.8M, cash $9.8M
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- Nasdaq notified Clene that MVLS of common stock is below $35M minimum; has until Nov 3, 2025 to regain compliance.
- Cash and equivalents $9.8M as of Mar 31, 2025, expected to fund operations into Q3 2025.
- Net loss of $0.8M ($0.09 per share) vs $11.1M ($1.73) in Q1 2024; decrease due to NIH grant revenue and lower expenses.
- Planning to submit NDA for Accelerated Approval of CNM-Au8 in ALS in Q4 2025, pending FDA agreement on SAP in Q2.
- Presented new remyelination data from VISIONARY-MS trial at AAN; end-of-Phase 2 meeting with FDA planned in Q3 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774925014917/0001437749-25-014917-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774925014917/clnn20250107_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-014917

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