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Lipocine To Focus On Central Nervous System Conditions; Explores Partnerships For Non-Core Assets

  • Lipocine Inc (NASDAQ: LPCNannounced its plans to focus on treating Central Nervous System (CNS) disorders. The company's priority is to advance its endogenous neuroactive steroids (NAS) pipeline.

  • The CNS development portfolio includes LPCN 1154, a fast-acting oral antidepressant for postpartum depression (PPD) with potential for outpatient use; LPCN 2101 for women with epilepsy; and additional undisclosed CNS-focused candidates.

  • Lipocine's most advanced NAS candidate is LPCN 1154, a non-invasive, oral formulation of the neurosteroid brexanolone. Lipocine said the pilot PK bridge study (a prelude to a pivotal study required for an application filing) is ongoing, with results expected in Q1 of 2023.

  • Lipocine has developed a portfolio of non-CNS candidates, including LPCN 1144 for non-cirrhotic NASH, LPCN 1148 for decompensated liver cirrhosis, LPCN 1107 for prevention of pre-term birth, and LPCN 1111, a once-a-day therapy for TRT.

  • The company intends to advance these programs further through partnerships. As a result, no further significant investment is expected for these programs.

  • Lipocine had a cash balance of $37.4 million, sufficient to support operations and capital expenditure until at least September 2023.

  • In addition, LPCN plans to explore strategic partnerships and other opportunities for non-core assets.

  • Price Action: LPCN shares are down 3.53% at $0.48 on the last check Monday.

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