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Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2023
SALT LAKE CITY, Aug. 10, 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, Aug. 10, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced financial results for the second quarter and six months ended June 30, 2023, and provided a corporate update.\n\n \n \n \n \n \n \n\n \nClinical Program Highlights\nNeuroactive Steroids\nLipocine announced positive topline results from a pilot pharmacokinetics (\"PK\") bridge study of LPCN 1154 (oral brexanolone). Lipocine is developing LPCN 1154 for postpartum depression (\"PPD\")The bridge study results demonstrated comparative pharmacokinetics of LPCN 1154 to an approved IV brexanoloneThe study identified a dosing regimen of LPCN 1154 to be tested in a single confirmatory pivotal PK study required for NDA filingLPCN 1154 treatment was well-tolerated with no hypoxia or sedation-related adverse eventsLPCN 1148 in liver cirrhosis\nLipocine 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 filingPosters on LPCN 1148 and LPCN 1144 were presented at the European Association for the Study of the Liver (EASL) Congress 2023, in Vienna, Austria, June 21 – 24, 2023Quarter Ended June 30, 2023 Financial Results\nLipocine reported a net loss of $3.6 million, or ($0.68) per diluted share, for the three months ended June 30, 2023, compared with a net loss of $2.6 million or ($0.61) per diluted share, in the three months ended June 30, 2022.\nLipocine did not recognize any revenue during the three months ended June 30, 2023. During the three months ended June 30, 2022, we recognized revenue related to a non-refundable cash fee of $0.5 million received from Antares for consideration of a 90-day extension for Antares to exercise its option to license LPCN 1111.\nResearch and development expenses were $2.5 million and $2.9 million, respectively, for the three months ended June 30, 2023, and 2022. The de...