Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2024

Core Insights - Lipocine Inc. reported financial results for Q3 and the first nine months of 2024, highlighting advancements in its drug development pipeline, particularly LPCN 1154 for postpartum depression and LPCN 2401 for obesity management [1][5][9]. Drug Development Updates - LPCN 1154, an oral formulation of brexanolone, is being developed for postpartum depression, with NDA submission targeted by the end of 2024. Positive results from a qEEG study confirmed its CNS activity [1]. - LPCN 2401, an oral anabolic androgen receptor agonist, showed promising Phase 2 study results for obesity management, with plans to meet the FDA regarding further studies [2]. - LPCN 1148 is under evaluation for managing decompensated cirrhosis, with a successful Phase 2 study completed [3]. Financial Performance - For Q3 2024, Lipocine reported a net loss of $2.2 million, a significant reduction from a net loss of$6.7 million in Q3 2023 [5]. - No revenues were recorded in Q3 2024, compared to a non-cash revenue reversal of $3.1 million in Q3 2023 [6]. - For the nine months ended September 30, 2024, the company reported a net loss of$1.8 million, compared to a net loss of 14.1 million for the same period in 2023 [9]. Research and Development Expenses - R&D expenses for Q3 2024 were 1.6 million, down from 2.9 million in Q3 2023, attributed to reduced costs related to TLANDO and the LPCN 1148 study [7]. - For the nine-month period, R&D expenses were 6.3 million, down from $8.5 million in 2023, reflecting decreased costs in various areas [11]. General and Administrative Expenses - General and administrative expenses remained stable at$1.0 million for Q3 2024, compared to Q3 2023 [8]. - For the nine months ended September 30, 2024, these expenses increased to $4.1 million from$3.8 million in 2023, driven by higher business development and legal fees [12]. Cash Position - As of September 30, 2024, Lipocine had $19.8 million in unrestricted cash and marketable securities, down from$22.0 million at the end of 2023 [8].