regulatory
confidence high
sentiment negative
materiality 0.85
Clene receives Nasdaq MVLS deficiency notice; reports Q1 2025 net loss of $0.8M, cash $9.8M
Clene Inc.
- 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.