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Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2023
SALT LAKE CITY, Nov. 8, 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, Nov. 8, 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 third quarter and nine months ended September 30, 2023, and provided a corporate update.\n\n \n \n \n \n \n \n\n \nClinical Program Highlights\nNeuroactive Steroids\nOn October 18, Lipocine completed a successful meeting with the FDA on LPCN 1154, which is in development for postpartum depression (PPD). The FDA agreed on Lipocone's proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanoloneLipocine anticipates initiating the pivotal study program in Q1 2024 with the LPCN 1154 \"to be marketed\" formulationTop line results from the study are expected by Q2 2024, with a goal of filing a New Drug Application (NDA) in 2024If approved, LPCN 1154, has the potential to be a differentiated preferred treatment option for PPD with rapid and high remission/response rates with short treatment durationLPCN 1148 in liver cirrhosis\nIn July, Lipocine announced positive topline results from its Phase 2 proof-of-concept (\"POC\") study evaluating LPCN 1148 in cirrhosisStudy met primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P 1 in the LPCN 1148 treatment arm relative to placebo (P More patients on LPCN 1148 reported symptom improvement compared to placebo (P LPCN 1148 was well-tolerated, with AE rates and severities similar to placeboLipocine plans to meet with the FDA to discuss the development path to NDA filingQuarter Ended September 30, 2023 Financial Results\nLipocine reported a net loss of $6.7 million, or ($1.27) per diluted share, for the three months ended September 30, 2023, compared with a net loss of $2.4 million or ($0.52) per diluted share, in the three months ended September 30, 2022.\nDuring the three months ended September 30, 2023, the Company recognized a non-cash minimum guaranteed royalties revenue reversal of variable consideration revenue of $3.1 million related to the termination of the Antares License Agreement. The reversal of revenue is due to the fact that Lipoocine will not receive anticipated royalt...