SALT LAKE CITY, Jan. 20, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that enrollment and participant dosing have been completed in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). A total of 90 patients were randomized in the study. To date, LPCN 1154 has demonstrated a favorable saf ...

Core Viewpoint - Lipocine Inc. has completed a scheduled independent Data Safety Monitoring Board (DSMB) review of its Phase 3 clinical trial for LPCN 1154, which is aimed at treating postpartum depression (PPD), and the trial will continue without modifications [1][2]. Group 1: Clinical Trial Details - The DSMB's recommendation was based on safety data from 82 randomized participants, with 74 completing dosing, and no serious adverse events or treatment discontinuations reported [2][7]. - The study is no longer screening new participants but continues to enroll eligible participants, with topline safety and efficacy results expected in early Q2 2026 [3][4]. - The Phase 3 study is a pivotal, randomized, double-blind trial comparing LPCN 1154 to placebo in women aged 15 and older diagnosed with severe PPD, conducted entirely in an outpatient setting [4][5]. Group 2: Product Overview - LPCN 1154 is an oral formulation of brexanolone designed for rapid relief of PPD, potentially becoming a first-line treatment option for women, with no significant risk of adverse reactions to breastfed infants [5][6]. - The product aims to address the unmet medical needs in PPD treatment, as traditional antidepressants have slow onset and side effects [6]. Group 3: Company Background - Lipocine is a biopharmaceutical company focused on developing innovative products with effective oral delivery, targeting large markets with significant unmet medical needs [8][9]. - The company's development pipeline includes several candidates for various conditions, including LPCN 2201 for major depressive disorder and LPCN 2101 for epilepsy, among others [9].

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 - The Drug Safety Monitoring Board (DSMB) has reviewed the ongoing Phase 3 clinical trial of LPCN 1154 and has recommended that the study continue as planned [1] - More than half of the planned participants have completed dosing without any reported dose reductions, discontinuations, drug-related serious adverse events (SAEs), loss of consciousness, or excessive sedation [1] - Topline results are expected to be available in the second quarter of 2026 [1] Company Summary - Lipocine Inc. is a biopharmaceutical company focused on developing innovative products with effective oral delivery using its proprietary technology platform [1] - The ongoing Phase 3 clinical trial is evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of postpartum depression (PPD) [1] - The DSMB review was conducted after approximately one-third of the planned 80 participants (n=30) completed at least the day seven follow-up visit [1]

Core Insights - Lipocine (LPCN) reported a quarterly loss of $0.59 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.56, and compared to a loss of $0.44 per share a year ago, indicating a negative earnings surprise of -5.36% [1] - The company generated revenues of $0.12 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 15.00%, a significant improvement from zero revenues a year ago [2] - Lipocine's stock has declined approximately 47.5% year-to-date, contrasting with the S&P 500's gain of 15.6% [3] Company Performance - Over the last four quarters, Lipocine has consistently failed to meet consensus EPS estimates [2] - The current consensus EPS estimate for the upcoming quarter is -$0.55 on revenues of $0.1 million, while for the current fiscal year, it is -$1.87 on revenues of $0.92 million [7] - The estimate revisions trend for Lipocine was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6] Industry Context - The Medical - Drugs industry, to which Lipocine belongs, is currently ranked in the top 39% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - As of September 30, 2025, Lipocine had $15.1 million in unrestricted cash, down from $21.6 million at December 31, 2024, representing a decrease of approximately 30.3%[7] - The net loss for the third quarter ended September 30, 2025, was $3.2 million, or ($0.59) per diluted share, compared to a net loss of $2.2 million, or ($0.44) per diluted share, for the same period in 2024, indicating an increase in loss of 45.5%[7] - For the nine months ended September 30, 2025, Lipocine reported a net loss of $7.3 million, or ($1.35) per diluted share, compared to a net loss of $1.8 million, or ($0.33) per diluted share, for the same period in 2024, representing an increase in loss of 305.6%[13] - Total revenues for the three months ended September 30, 2025, were $114,574, compared to $0 in the same period of 2024, indicating a significant increase[26] - Total revenue for the nine months ended September 30, 2025, was $831,000, a significant decrease from $7.7 million in the same period of 2024, primarily due to a drop in license revenue from $7.5 million to $500,000[14] - License revenue for the nine months ended September 30, 2025, was $500,000, down from $7,500,000 in the same period of 2024[26] - The net loss attributable to common shareholders for the three months ended September 30, 2025, was $3,186,832, compared to a loss of $2,218,818 in the same period of 2024[26] - Comprehensive loss for the three months ended September 30, 2025, was $(3,180,962), compared to $(2,199,157) in the same period of 2024[26] Expenses - Research and development expenses increased to $2.7 million for the third quarter of 2025 from $1.6 million in the same quarter of 2024, reflecting a rise of 68.8% primarily due to ongoing clinical trials[9] - Operating expenses for the three months ended September 30, 2025, totaled $3,475,614, an increase from $2,630,473 in the same period of 2024[26] - Research and development expenses for the three months ended September 30, 2025, were $2,707,777, up from $1,585,233 in the same period of 2024[26] - General and administrative expenses decreased to $0.8 million for the third quarter of 2025 from $1.1 million in the same quarter of 2024, a reduction of 27.3%[11] - General and administrative expenses for the three months ended September 30, 2025, were $767,837, down from $1,045,240 in the same period of 2024[26] Assets and Cash Position - Lipocine's total assets decreased to $16.1 million as of September 30, 2025, from $22.5 million at December 31, 2024, a decline of approximately 28.5%[24] Product Development - Lipocine is developing LPCN 1154 for postpartum depression, with top-line data expected in Q2 2026 and plans for a 505(b)(2) NDA submission in the U.S. in 2026[4] - The company is exploring partnerships for LPCN 1154 and LPCN 2401, which targets obesity management and is expected to enter a proof-of-concept Phase 2 study[10] Revenue Sources - Royalty revenue from TLANDO sales was $115,000 during the quarter ended September 30, 2025, with no royalty revenue recorded in the comparable period in 2024[8]

Regulatory Approvals and Product Launches - TLANDO received FDA approval on March 28, 2022, and was commercially launched on June 7, 2022[95][109]. - The FDA requires an efficacy and safety study of oral LPCN 1154 in the target population for 505(b)(2) NDA submission[120]. - FDA granted orphan drug designation to LPCN 1107, providing development incentives including tax credits and waiver of user fees[174]. Licensing Agreements and Financials - Verity Pharma paid an initial payment of $2.5 million upon signing the Verity License Agreement and an additional $5 million on February 1, 2024[111]. - The company is eligible to receive milestone payments of up to $259 million based on sales and development milestones under the Verity License Agreement[111]. - The company entered into multiple licensing agreements for TLANDO, including a $2.5 million initial payment from Verity Pharma and potential milestone payments of up to $259 million[208]. - Revenue generated from license fees, royalties, and milestone payments totaled $53.9 million since inception through September 30, 2025[177]. - Total revenue for the nine months ended September 30, 2025 was $831,287, a decrease of $6.9 million compared to $7.7 million in 2024[196]. Research and Development - LPCN 1154 is being developed as a fast-acting oral antidepressant for postpartum depression with a 48-hour treatment duration[103]. - The company aims to leverage its Lip'ral drug delivery technology platform to develop differentiated products for conditions with large unmet medical needs[102]. - LPCN 2101 is being evaluated for epilepsy, including drug-resistant epilepsy and women with epilepsy[103]. - LPCN 2401 demonstrated a 4.4% increase in lean mass and a 6.7% decrease in fat mass in a Phase 2 study, indicating its potential for improving body composition in patients using GLP-1 therapies[154]. - LPCN 1148 met its primary endpoint by increasing skeletal muscle index (L3-SMI) relative to placebo (P<.01) in male cirrhotic patients, showing its efficacy in managing sarcopenia[164]. Clinical Studies and Outcomes - Positive data from a qEEG study of oral brexanolone indicated robust CNS activity, suggesting effective oral delivery of endogenous GABAA receptor PAMs[118]. - As of the end of Q3 2025, one-third of planned participants have been randomized in the Phase 3 safety and efficacy study for LPCN 1154[120]. - The Phase 2 study of LPCN 1148 showed fewer occurrences of hepatic encephalopathy (OHE) events in treated patients, suggesting improved clinical outcomes[165]. Market Opportunities and Unmet Needs - Approximately 600,000 women are affected by postpartum depression (PPD) annually, with about 240,000 diagnosed and 144,000 treated with prescription medication[126]. - LPCN 1154 aims to provide rapid relief with a 48-hour duration through a convenient oral therapy, addressing the unmet need for fast-acting treatments for PPD[128]. - Drug-resistant epilepsy (DRE) affects 30-40% of epilepsy patients in the U.S., contributing to $24.5 billion in annual healthcare costs[131]. - Approximately 74% of U.S. adults aged 20 and older are either obese or overweight, highlighting a significant market opportunity for obesity management solutions[157]. Financial Performance and Expenses - Research and development expenses amounted to approximately $160.5 million since inception through September 30, 2025[178]. - Research and development expenses for the three months ended September 30, 2025 increased by $1.35 million primarily due to LPCN 1154 Phase 3 clinical trial costs[190]. - General and administrative expenses for the three months ended September 30, 2025 decreased by $277,403 compared to the same period in 2024[191]. - As of September 30, 2025, the company had $15.1 million in unrestricted cash, down from $21.6 million as of December 31, 2024[203]. Cash Flow and Liquidity - For the nine months ended September 30, 2025, net cash used in operating activities was $6.8 million, compared to $2.9 million for the same period in 2024[217]. - The company expects to continue incurring operating losses as it advances the clinical development of multiple product candidates, including LPCN 1154 and LPCN 2401[202]. - The company has sufficient liquidity to meet projected operating requirements through at least November 6, 2026, but may need to raise additional capital[214]. Market Risks and Accounting Policies - The company is exposed to various market risks, including potential losses from adverse changes in interest rates, but does not engage in derivatives for trading or speculative purposes[227]. - There have been no material changes to the company's market risk during the first nine months of 2025, as noted in the 2024 Form 10-K[228].

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]