Seelos Therapeutics, Inc. Announces Receipt of Minutes from its End of Phase II Meeting with the United States Food and Drug Administration Highlighting Modifications to the Primary and Secondary Endpoints of its Phase II Study of SLS-002

Seelos Therapeutics, Inc. announced the receipt of minutes from its End of Phase II Meeting with the FDA. In the meeting minutes, the FDA agreed that the primary endpoint in a Phase III trial could be the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 16, rather than the 24-hour timepoint that was selected in the Phase II SLS-002-201 study. This agreement with the FDA gives Seelos further confidence for its Phase III development of SLS-002 as data in the Phase II study showed clinically significant treatment differences from placebo on both the Day 16 MADRS (p-value: 0.012) and the 24-hour Sheehan- Suicidality Tracking Scale (S-STS) (p-value: 0.,008).