earnings
confidence high
sentiment negative
materiality 0.75
SeaStar Medical Q1 net loss $5.3M; FDA non-approvable letter for pediatric SCD HDE
SeaStar Medical Holding Corp
2023-Q1 EPS reported
-$0.40
- Net loss of $5.3M ($0.40/sh) vs $1.0M ($0.14/sh) in Q1 2022; cash $725,000 as of Mar 31, 2023.
- FDA issued non-approvable letter for pediatric AKI HDE; 90-120 day plan to resubmit, targeting late 2023 approval.
- Adult NEUTRALIZE-AKI trial site activated; first patient enrollment expected soon; topline results expected in 2025.
- Closed first $3.3M tranche of $9.8M convertible debt; second tranche $2.2M closed after quarter-end.