---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-014917"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2025-05-07T23:59:59+00:00"
generated_at: "2026-05-22T08:47:53.357172+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Clene receives Nasdaq MVLS deficiency notice; reports Q1 2025 net loss of $0.8M, cash $9.8M

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-25-014917
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2025-05-07T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 3.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774925014917/0001437749-25-014917-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774925014917/clnn20250107_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-014917
- JSON: https://secwatch.observer/filing/0001437749-25-014917.json
- Plain text: https://secwatch.observer/filing/0001437749-25-014917.txt

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