Lipocine reports near-breakeven 2024; FDA requires Phase 3 for oral brexanolone

Lipocine Inc.

Net income of ~$8,400 vs net loss of $16.4M in 2023; revenue of $11.2M from license/royalty fees.
Cash and securities $21.6M at Dec 31, 2024, vs $22.0M at Dec 31, 2023.
FDA meeting for LPCN 1154 requires safety/efficacy study for NDA; Phase 3 start expected Q2 2025.
TLANDO license agreements generated $10M in 2024; Verity milestones up to $259M plus tiered royalties.
FDA removed Boxed Warning on cardiovascular risk for testosterone products in Feb 2025.

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