Business
Lipocine Announces Financial Results for the First Quarter Ended March 31, 2023
SALT LAKE CITY, May 11, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS)
About this update from Lipocine Inc.
[{"type":"text","content":"SALT LAKE CITY, May 11, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the first quarter ended March 31, 2023, and provided a corporate update.\n\n \n \n \n \n \n \n\n \nFirst Quarter HighlightsNeuroactive Steroid for DepressionDosing was initiated in a pilot clinical bridge study of LPCN 1154 (oral brexanolone) a neuroactive steroid product candidate that Lipocine is developing for postpartum depression (\"PPD\"). LPCN 1154 is targeted to be a differentiated oral treatment option as a mono or add-on therapy for patients with unresolved symptoms needing fast onset with high response in short treatment duration.\nResults are expected in the second quarter of the year. The FDA has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 via the 505(b)(2) pathway. The proof-of-concept study is a prelude to a single confirmatory Pivotal PK study in place of an efficacy study for NDA submission.LPCN 1148 in liver cirrhosisLPCN 1148 is being evaluated in an ongoing Phase 2 proof-of-concept (\"POC\") study for the management of decompensated cirrhosis of various etiologies. Topline results are expected mid-2023.\nLipocine continues to explore partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1148, for the management of decompensated cirrhosis, LPCN 1144, our candidate for treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day therapy candidate for testosterone replacement therapy (TRT).\nQuarter Ended March 31, 2023 Financial ResultsLipocine reported a net loss of $3.9 million, or ($0.04) per diluted share, for the three months ended March 31, 2023, compared with a net loss of $3.5 million or ($0.04) per diluted share, in the three months ended March 31, 2022.\nLipocine recognized license revenue for payments receivable from Spriaso under a licensing agreement in the cough and cold field of approximately $55,000 during the three months ended March 31, 2023. There was no revenue during the three months ended March 31, 2022.\nResearch and development expenses were $3.1 million and $1.9 million, respectively, for the three months ended March 31, 2023, and 2022. The increase...