earnings
confidence high
sentiment positive
materiality 0.85
Clene plans Q3 2026 NDA submission for CNM-Au8 ALS; Q1 net loss $8.1M, cash $5.9M
Clene Inc.
- FDA Type C meeting confirmed data may support NDA under accelerated approval for ALS; submission planned Q3 2026.
- May 2026: Amended $10M convertible debt; maturity extended to Aug 2027, monthly payments cancelled.
- Q1 2026 net loss $8.1M ($0.69/share) vs $0.8M loss in Q1 2025; R&D down, other expense up from financing.
- Cash $5.9M at Mar 31; with $7M May offering and $7M warrant exercises, runway expected into 2027.