secwatch.observer — SEC 8-K summary
======================================

Issuer:     SeaStar Medical Holding Corp (ICU)
CIK:        0001831868
Form:       8-K
Filed at:   2023-05-16T23:59:59+00:00
Accession:  0001193125-23-146082
Event type: earnings
Sentiment:  negative
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

SeaStar Medical Q1 net loss $5.3M; FDA non-approvable letter for pediatric SCD HDE
--------------------------------------------------------------------------------

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1831868/000119312523146082/0001193125-23-146082-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1831868/000119312523146082/d496122d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-146082

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