Second Drug Safety Monitoring Board (DSMB) meeting update planned for mid-January 2026 Topline results on track for the second quarter of 2026 SALT LAKE CITY, Dec. 16, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced 80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment ...

Core Insights - Lipocine Inc. reported its financial results for Q3 2025, highlighting ongoing clinical trials and product development efforts, particularly for LPCN 1154 aimed at treating postpartum depression [1][5][9]. Financial Performance - As of September 30, 2025, Lipocine had $15.1 million in unrestricted cash and equivalents, down from $21.6 million at the end of 2024 [5]. - The company reported a net loss of $3.2 million, or ($0.59) per diluted share, for Q3 2025, compared to a net loss of $2.2 million, or ($0.44) per diluted share, for Q3 2024 [5][9]. - Total revenues for the nine months ended September 30, 2025, were $831,000, significantly lower than $7.7 million for the same period in 2024, primarily due to a decrease in license revenue [10]. Research and Development - Research and development expenses increased to $2.7 million in Q3 2025 from $1.6 million in Q3 2024, driven by costs associated with the LPCN 1154 Phase 3 clinical trial [7]. - The company is advancing LPCN 1154, an oral formulation for postpartum depression, with top-line data expected in Q2 2026 [3][5]. - LPCN 2101, a candidate for epilepsy, is under evaluation for a potential Phase 2 proof-of-concept study, with promising pre-clinical results [3][5]. Product Development and Partnerships - Lipocine is exploring partnerships for LPCN 1154 and LPCN 2401, which targets obesity management [3][5]. - LPCN 2401 is designed as a once-daily oral formulation and may enter a proof-of-concept Phase 2 study pending regulatory guidance [3][5]. Market Presence - The company has an exclusive license agreement with Verity Pharma for TLANDO, its oral testosterone replacement therapy, which has generated royalty revenue of $115,000 in Q3 2025 [6][10].

Core Insights - Lipocine Inc. is progressing with its pivotal Phase 3 clinical trial for LPCN 1154, an oral formulation of brexanolone aimed at treating postpartum depression (PPD), with one-third of the planned patients already randomized and topline results expected in Q2 2026 [1][3][2] Company Overview - Lipocine Inc. is a biopharmaceutical company focused on developing innovative products with effective oral delivery using its proprietary technology platform [7][8] - The company has multiple drug candidates in development, including LPCN 1154 for PPD, LPCN 2101 for epilepsy, and LPCN 2203 for essential tremor, among others [9] Clinical Trial Details - The Phase 3 trial is a randomized, double-blind study comparing LPCN 1154 to placebo in women aged 15 and older diagnosed with severe PPD, conducted entirely in an outpatient setting without the need for medical monitoring [3][6] - A Data Safety Monitoring Board (DSMB) meeting is scheduled for Q4 2025 to review safety data from the one-third of patients randomized [2] Product Characteristics - LPCN 1154 is designed for a 48-hour dosing schedule, offering potential rapid and meaningful clinical benefits for women suffering from PPD, with no significant risk of adverse reactions to breastfed infants [5][3] - The product aims to address the unmet needs in PPD treatment, as traditional antidepressants have slow onset and various side effects [6] Market Context - Postpartum depression is a significant issue, with estimates suggesting that 20-40% of obstetricians believe their patients may suffer from it, highlighting a substantial market opportunity for effective treatments [6]

Company Overview - Lipocine Inc. is a biopharmaceutical company focused on developing innovative products utilizing its proprietary technology platform for effective oral delivery [3][4] - The company has several drug candidates in development targeting large addressable markets with significant unmet medical needs [3][4] Clinical Development Candidates - LPCN 1154: Oral brexanolone for potential treatment of postpartum depression [4] - LPCN 2101: Candidate for potential treatment of epilepsy [4] - LPCN 2203: Oral candidate aimed at managing essential tremor [4] - LPCN 2401: Oral anabolic androgen receptor agonist for obesity management [4] - LPCN 1148: Novel androgen receptor agonist prodrug for managing symptoms associated with liver cirrhosis [4] - LPCN 1107: Candidate for prevention of preterm birth, exploring partnership opportunities [4] - LPCN 1144: Candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH) [4] Recent Events - Company management will present and meet with investors at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 [1][2]

Core Viewpoint - Lipocine Inc. reported its financial results for the second quarter of 2025, highlighting a decrease in net loss compared to the same period in 2024, alongside updates on its product development and clinical studies [1][2][6]. Financial Results - As of June 30, 2025, Lipocine had $17.9 million in unrestricted cash and equivalents, down from $21.6 million at the end of 2024 [2]. - The company reported a net loss of $2.2 million, or ($0.41) per diluted share, for Q2 2025, an improvement from a net loss of $3.1 million, or ($0.57) per diluted share, in Q2 2024 [2][6]. - Total revenues for the six months ended June 30, 2025, were $717,000, a significant decrease from $7.7 million in the same period of 2024, primarily due to a drop in license revenue [7]. Revenue Breakdown - Royalty revenue from TLANDO sales was $123,000 in Q2 2025, up from $90,000 in Q2 2024 [3]. - License revenue recognized in Q2 2025 was $500,000, with no license revenue reported in Q2 2024 [3]. Expenses - Research and development expenses increased to $2.1 million in Q2 2025 from $1.9 million in Q2 2024, attributed to costs related to LPCN 2401 clinical studies [4]. - General and administrative expenses decreased to $0.9 million in Q2 2025 from $1.5 million in Q2 2024, due to reduced business development fees and legal costs [5]. Clinical Development Updates - Lipocine is advancing LPCN 1154, an oral brexanolone candidate for postpartum depression, with a pivotal Phase 3 study initiated in Q2 2025 [8]. - The company plans to start a proof-of-concept Phase 2 study for LPCN 2401 in Q3 2025, targeting obesity management [8]. - Lipocine is exploring potential partnerships for both LPCN 1154 and LPCN 2401 to enhance commercialization efforts [8]. Licensing Agreements - Lipocine has an exclusive license agreement with Verity Pharma for TLANDO in the U.S. and Canada, with additional agreements in South Korea and the GCC countries [8]. - Verity Pharma filed a New Drug Submission for TLANDO in Canada in June 2025, and a license and supply agreement was established with Aché Laboratórios for Brazil [8].

Core Insights - Lipocine Inc. has initiated a pivotal Phase 3 clinical trial for LPCN 1154, an oral treatment for postpartum depression (PPD), with the first patient dosed [1][3] - The trial aims to support a New Drug Application (NDA) submission in mid-2026, following FDA feedback that allows for an outpatient study without medical monitoring [2][5] - LPCN 1154 is designed to provide rapid relief for PPD, addressing a significant unmet medical need in the treatment landscape [5][6] Company Overview - Lipocine is a biopharmaceutical company focused on developing innovative products with effective oral delivery, targeting large markets with significant unmet medical needs [9][10] - The company has multiple drug candidates in development, including LPCN 2101 for refractory epilepsy and LPCN 2203 for essential tremor, alongside LPCN 1154 for PPD [10] Clinical Trial Details - The Phase 3 trial is a two-arm, randomized, blinded study involving women aged 15 and older with severe PPD, assessing the efficacy of LPCN 1154 compared to a placebo [3][4] - The primary endpoint is the change in the Hamilton Depression Rating Scale (HAM-D), with secondary endpoints including the Montgomery-Åsberg Depression Rating Scale (MADRS) and Hamilton Anxiety Rating Scale (HAM-A) [4] Market Context - Postpartum depression is a major depressive disorder that can affect 20-40% of obstetric patients, with traditional antidepressants having slow onset and side effects [7] - LPCN 1154 aims to offer a differentiated treatment option with a 48-hour dosing regimen, potentially becoming the standard of care for PPD [5][6]

Summary of Lipocene's Conference Call Company Overview - **Company Name**: Lipocene - **Ticker**: LPCN - **Market Cap**: Approximately $20 million - **Focus**: Biopharmaceutical company developing treatments for postpartum depression and obesity management [1][2] Core Products and Pipeline LPCN 1150 (Postpartum Depression Treatment) - **Mechanism**: Brexanolone (allopregnanolone), a bioidentical hormone that stabilizes mood, is a GABA positive allosteric modulator [24][25] - **Market Potential**: Approximately 250,000 mothers suffer from postpartum depression, with 60,000 to 80,000 seeking intervention [30][31] - **Clinical Development**: - Phase III study initiated, outpatient design, 48-hour treatment duration, targeting 80 patients [25][27] - Expected ANDA filing in about a year, with low clinical risk due to established efficacy of the molecule [26][27] - **Market Share Potential**: Estimated 30% to 50% market share, with market size projected between $500 million to $1 billion in the US [31][32] LPCN 2401 (Obesity Management) - **Target Population**: GLP-1 users, with nearly 30 million Americans expected to use GLP-1s [5][6] - **Mechanism**: A bioidentical myostatin inhibitor that works on fat, muscle, and bone, showing positive Phase II results [7][12] - **Clinical Development**: - Upcoming Phase II proof of concept study as an adjunct to GLP-1, with first patient dosing expected in Q3 of the current year [13][18] - Focus on weight loss and fat loss, with a goal to maintain or improve GLP-1 related weight loss [9][10] - **Market Opportunity**: Addresses unmet needs in quality weight loss and fat loss, particularly for patients concerned about weight rebound after stopping GLP-1 [12][15] Financial Overview - **Cash Management**: - Current spending is approximately $3 million per quarter, with cash runway expected for at least 12 months [33] - Focused and frugal spending strategy to support ongoing studies [33] Key Takeaways - **Investor Interest**: Both LPCN 1150 and LPCN 2401 are seen as valuable assets, with significant market potential in their respective fields [4][5] - **Regulatory Perspective**: Positive regulatory feedback for LPCN 1150, allowing for outpatient studies, which is favorable for product labeling [27] - **Partnership Opportunities**: The company is open to partnerships for LPCN 2401 post-proof of concept [19][20] Additional Insights - **Market Trends**: Increasing diagnosis rates for postpartum depression and obesity management create a favorable environment for Lipocene's products [31][21] - **Clinical Efficacy**: Previous studies indicate strong efficacy for both LPCN 1150 and LPCN 2401, with a focus on quality weight loss and maintaining lean mass [15][16][17]