Lipocine LPCN 1154 Phase 3 PPD trial: 1/3 randomized; topline 2Q26; DSMB review 4Q25

Lipocine Inc.

One-third of planned patients randomized in LPCN 1154 Phase 3 trial for postpartum depression.
Topline results expected in second quarter 2026.
Independent DSMB safety review planned for fourth quarter 2025; update post-DSMB.
Trial conducted entirely outpatient; no medical monitoring by HCP required per FDA feedback.
CEO Mahesh Patel states LPCN 1154 can become standard of care; 505(b)(2) NDA submission targeted in 2026.

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