Lipocine Inc. announced the initiation of the BLOOM Phase 3 study for LPCN 1154, an oral formulation of brexanolone intended to treat postpartum depression (PPD). The placebo-controlled outpatient trial will enroll approximately 120 participants with severe PPD, with first dosing expected in early Q4 2026. This study aims to generate evidence for a potential New Drug Application under the 505(b)(2) pathway, incorporating FDA feedback and strengthened site controls following a prior Phase 3 trial that missed its primary endpoint but showed promising exploratory results. Lipocine expects average monthly cash burn of approximately $1 million during execution, supported by $23.3 million in unrestricted cash as of June 30, 2026. Lipocine is a biopharmaceutical company developing oral therapeutics using proprietary drug-delivery technology.

Lipocine Inc. reported financial results for the quarter ended June 30, 2026, showing a net loss of $2.6 million, or ($0.32) per diluted share, compared to a net loss of $2.2 million in the prior year period. Cash and equivalents increased to $23.3 million from $14.9 million at year-end 2025. The company announced that its Phase 3 trial for LPCN 1154 (BRLIZIO) in postpartum depression missed its primary endpoint, though a post hoc analysis excluding an outlier site showed clinically meaningful improvement. Lipocine has requested an FDA guidance meeting scheduled for the third quarter of 2026 and initiated a new Phase 3 trial to complement existing data. Additionally, Pharmalink received marketing authorization for TLANDO in the UAE on July 8, 2026. Lipocine Inc. is a biopharmaceutical company focused on developing novel oral therapeutics.

Lipocine Inc. appointed Michael J. Grissinger to its Board of Directors, effective August 3, 2026, expanding the board to five members. Mr. Grissinger is classified as an independent director and will receive an annual retainer of $55,000 plus an initial stock option grant for 2,000 shares. He brings over two decades of experience in pharmaceutical licensing, corporate development, and M&A from Johnson & Johnson and currently serves on the boards of Aprea Therapeutics and Adicet Bio. This appointment is not material to investor value.