Lipocine Inc Stock Price, News & Analysis

Lipocine Inc. (NASDAQ: LPCN) announced the dosing of the first participant in a pilot clinical bridge study of LPCN 1154, an oral formulation of brexanolone aimed at treating postpartum depression (PPD). The FDA supports Lipocine's proposal to validate LPCN 1154's efficacy through a pharmacokinetic bridge to intravenous brexanolone. The pilot study, involving 12 participants, seeks to compare the safety and tolerability of LPCN 1154 with the approved injectable form. Results are anticipated in the first half of 2023, with the potential for a pivotal study and NDA filing based on these findings.

Lipocine Inc. (NASDAQ: LPCN) announced its financial results for the year ended December 31, 2022, highlighting a strategic shift towards developing neuroactive steroids for CNS disorders. The company reported a net loss of $10.8 million, or ($0.13) per diluted share, compared to a loss of $634,399, or ($0.01) per diluted share in 2021. License revenue significantly declined to $500,000 from $16.1 million in 2021. Research and development expenses rose to $8.6 million, driven by increased clinical study costs. As of December 31, 2022, the company had $32.5 million in cash, down from $46.6 million in 2021.

Lipocine Inc. (NASDAQ: LPCN) announced a dividend distribution of one one-thousandth of a share of newly designated Series B Preferred Stock for each outstanding share of common stock, effective March 24, 2023. This preferred stock will grant significant voting rights on matters including a potential reverse stock split. Uncertificated and non-transferable, the Series B Preferred Stock can be redeemed if not represented at the stockholder meeting. The company aims to maintain its capitalization structure post-distribution. Further details will follow in a Form 8-K filing with the SEC.

Lipocine Inc. (NASDAQ: LPCN) announced its management team will present at the Biotech Showcase and participate in the LifeSci Partners Corporate Access Event from January 9-11, 2023, in San Francisco. The presentation is scheduled for January 11 at 9 AM PT at the Hilton Hotel Union Square. Investors can attend in person or via webcast. Lipocine focuses on CNS disorder treatments and is exploring partnerships for various product candidates, including LPCN 1154 for postpartum depression and LPCN 2101 for epilepsy.

Lipocine Inc. (NASDAQ: LPCN) has completed enrollment in its Phase 2 proof-of-concept study for LPCN 1148, targeting decompensated cirrhosis, with top-line results expected in mid-2023. The study focuses on the effects of LPCN 1148 on improving muscle function and outcomes in cirrhotic patients. This condition affects over 500,000 Americans annually, with high mortality rates. The ongoing research is vital as it addresses a significant unmet medical need, and the company plans to explore potential partnerships for LPCN 1148.

Lipocine Inc. (NASDAQ: LPCN) announced its Q3 and nine-month financial results for 2022, reporting a net loss of $2.4 million ($0.03 per diluted share) for Q3, an improvement from $3.1 million ($0.04 per diluted share) in Q3 2021. Revenues remained flat at $0, down from $55,000 in the previous year. R&D expenses decreased to $2.1 million, while G&A expenses fell to $0.8 million. As of September 30, 2022, cash reserves stood at $34.3 million, down from $46.6 million at year-end 2021. The company is shifting focus to CNS disorders, notably postpartum depression treatment LPCN 1154.

Lipocine Inc. (NASDAQ: LPCN) has announced key leadership appointments, with George Nomikos, M.D., Ph.D. appointed Chief Medical Officer and Spyros Papapetropoulos, M.D., Ph.D. as Lead Director and Chairman of the Board. The FDA has agreed to Lipocine's plan to establish the efficacy of LPCN 1154 for postpartum depression via a pivotal pharmacokinetic study. A pilot study has started, with results expected in the first half of 2023. LPCN 1154 aims to be the fastest acting oral treatment for postpartum depression, enhancing Lipocine's focus on CNS disorders.

Lipocine Inc. (NASDAQ: LPCN) announced its participation in the H.C. Wainwright 6th Annual NASH Investor Conference on October 17, 2022, at 3:30 p.m. EST. The conference will be held virtually, and interested investors can arrange 1x1 meetings with representatives. Lipocine focuses on developing oral delivery products for CNS disorders using its proprietary Lip'ral platform. Key clinical candidates include LPCN 1154 for postpartum depression and LPCN 2101 for epilepsy. Lipocine also explores partnerships for several other treatment candidates.