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]

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].

[Corporate Update & Product Pipeline](index=1&type=section&id=Corporate%20Update%20%26%20Product%20Pipeline) Lipocine is advancing its Neuroactive Steroids program with LPCN 1154 and LPCN 2401, while expanding TLANDO™'s global commercial reach through new licensing agreements [Neuroactive Steroids Program](index=1&type=section&id=Neuroactive%20Steroids%20Program) Lipocine's Neuroactive Steroids program is advancing two key product candidates: LPCN 1154 for postpartum depression (PPD) and LPCN 2401 for obesity management, both of which are in clinical development with potential for third-party partnerships [LPCN 1154 (Postpartum Depression)](index=1&type=section&id=LPCN%201154%20(Postpartum%20Depression)) LPCN 1154, an oral brexanolone product candidate for rapid PPD symptom relief, initiated its pivotal Phase 3 safety and efficacy study in Q2 2025, with topline results expected in Q2 2026 and a U.S. NDA submission in mid-2026. The company is also exploring partnering opportunities for commercialization - Pivotal Phase 3 safety and efficacy study for LPCN 1154 initiated in **Q2 2025**[4](index=4&type=chunk) - Topline results for LPCN 1154 expected in **Q2 2026**, with a 505(b)(2) New Drug Application (NDA) submission in the U.S. expected in **mid-2026**[4](index=4&type=chunk) - LPCN 1154 is a non-invasive, 48-hour oral treatment option targeted for rapid symptom relief of postpartum depression (PPD)[4](index=4&type=chunk) - Lipocine may explore partnering LPCN 1154 with a third party for commercialization[4](index=4&type=chunk) [LPCN 2401 (Obesity Management)](index=1&type=section&id=LPCN%202401%20(Obesity%20Management)) LPCN 2401, an oral anabolic androgen receptor agonist, is targeted as an adjunct to GLP-1 receptor agonists for quality weight loss or as monotherapy for weight maintenance, with a proof-of-concept Phase 2 study targeted for initiation in Q3 2025. Partnering opportunities are also being explored - Lipocine plans to initiate a proof-of-concept Phase 2 study for LPCN 2401 in obese and overweight GLP-1 eligible patients, with first patient dosing targeted for **Q3 2025**[4](index=4&type=chunk) - LPCN 2401 is a once-daily oral formulation comprising a proprietary anabolic androgen receptor agonist, expected to improve body composition for quality weight loss as an adjunct to GLP-1 receptor agonists, or as a monotherapy for weight maintenance[4](index=4&type=chunk) - Lipocine may explore partnering LPCN 2401 with a third party[4](index=4&type=chunk) [TLANDO™ Program](index=2&type=section&id=TLANDO%E2%84%A2%20Program) The TLANDO™ program focuses on commercializing Lipocine's FDA-approved oral testosterone replacement therapy through exclusive licensing and distribution agreements in various global markets, expanding its reach to Canada, South Korea, GCC countries, and Brazil [Commercialization & Licensing Updates](index=2&type=section&id=Commercialization%20%26%20Licensing%20Updates) Lipocine has expanded TLANDO™'s global commercialization through new licensing agreements, including an exclusive license with Aché Laboratórios Farmacêuitcos S.A. for Brazil in April 2025, and Verity Pharma filing a New Drug Submission for TLANDO in Canada in June 2025 - Lipocine has an exclusive License Agreement with Verity Pharma (entered **2024**) for TLANDO in the United States and Canada[11](index=11&type=chunk) - In **June 2025**, Verity Pharma filed a New Drug Submission (NDS) for TLANDO in Canada[11](index=11&type=chunk) - In **April 2025**, Lipocine entered a license and supply agreement with Aché Laboratórios Farmacêuitcos S.A., granting an exclusive license to commercialize TLANDO in Brazil, with expected fees upon regulatory milestones and royalties on net sales[11](index=11&type=chunk) - TLANDO is expected to be the first oral testosterone product to be registered in Brazil[11](index=11&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Lipocine's financial performance for Q2 and H1 2025 shows a net loss, primarily driven by changes in license revenue and operating expenses compared to the prior year [Second Quarter Ended June 30, 2025](index=2&type=section&id=Second%20Quarter%20Ended%20June%2030%2C%202025) For Q2 2025, Lipocine reported a reduced net loss of $2.2 million compared to $3.1 million in Q2 2024, with an EPS of ($0.41). The company's unrestricted cash, cash equivalents, and marketable investment securities decreased to $17.9 million as of June 30, 2025, from $21.6 million at December 31, 2024 Q2 2025 Financial Highlights | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :---------------------------------------------------------------- | :---------- | :---------- | :----------- | | Net Loss | $(2.2) million | $(3.1) million | $(0.9) million decrease | | Diluted EPS | $(0.41) | $(0.57) | $0.16 increase | | Unrestricted Cash, Cash Equivalents & Marketable Investment Securities (as of period end) | $17.9 million (June 30, 2025) | $21.6 million (Dec 31, 2024) | $(3.7) million decrease | [Revenue Analysis (Q2 2025)](index=2&type=section&id=Revenue%20Analysis%20(Q2%202025)) Total revenues significantly increased in Q2 2025 to $622,849 from $89,565 in Q2 2024, primarily due to $500,000 in license revenue recognized in 2025, which was absent in the prior year, alongside a modest increase in TLANDO royalty revenue Q2 2025 Revenue Breakdown | Revenue Type | Q2 2025 | Q2 2024 | Change (YoY) | | :------------- | :---------- | :---------- | :----------- | | License revenue | $500,000 | $0 | $500,000 increase | | Royalty revenue | $122,849 | $89,565 | $33,284 increase | | **Total Revenues** | **$622,849** | **$89,565** | **$533,284 increase** | [Operating Expenses (Q2 2025)](index=2&type=section&id=Operating%20Expenses%20(Q2%202025)) Research and development expenses increased to $2.1 million in Q2 2025 due to the initiation of LPCN 2401 clinical studies, while general and administrative expenses decreased to $0.9 million, driven by lower business development, legal, and professional fees, and reduced Delaware franchise tax Q2 2025 Operating Expenses | Expense Type | Q2 2025 | Q2 2024 | Change (YoY) | | :----------------------- | :---------- | :---------- | :----------- | | Research and development | $2,136,769 | $1,874,721 | $262,048 increase | | General and administrative | $890,433 | $1,507,412 | $(616,979) decrease | - Increase in R&D expenses was due to increased costs related to the initiation of LPCN 2401 clinical studies and other R&D costs[8](index=8&type=chunk) - Decrease in G&A expenses was primarily due to lower business development fees, consulting expenses, legal fees, Delaware franchise tax (due to reduced authorized common stock), and corporate insurance premiums[9](index=9&type=chunk) [Six Months Ended June 30, 2025](index=2&type=section&id=Six%20Months%20Ended%20June%2030%2C%202025) For the first half of 2025, Lipocine reported a net loss of $4.1 million, or ($0.76) per diluted share, a significant shift from a net income of $0.4 million in the comparable period of 2024, primarily due to a substantial decrease in license revenue H1 2025 Financial Highlights | Metric | H1 2025 | H1 2024 | Change (YoY) | | :---------------- | :---------- | :---------- | :----------- | | Net Loss (Income) | $(4.1) million | $0.4 million | $(4.5) million decrease | | Diluted EPS | $(0.76) | $0.10 | $(0.86) decrease | [Revenue Analysis (H1 2025)](index=3&type=section&id=Revenue%20Analysis%20(H1%202025)) Total revenues for the six months ended June 30, 2025, decreased significantly to $716,713 from $7.7 million in H1 2024, mainly due to a substantial reduction in license revenue from $7.5 million in 2024 (Verity Licensing Agreement) to $500,000 in 2025, partially offset by a slight increase in TLANDO royalty revenue H1 2025 Revenue Breakdown | Revenue Type | H1 2025 | H1 2024 | Change (YoY) | | :------------- | :---------- | :---------- | :----------- | | License revenue | $500,000 | $7,500,000 | $(7,000,000) decrease | | Royalty revenue | $216,713 | $206,738 | $9,975 increase | | **Total Revenues** | **$716,713** | **$7,706,738** | **$(6,990,025) decrease** | [Operating Expenses (H1 2025)](index=3&type=section&id=Operating%20Expenses%20(H1%202025)) Research and development expenses decreased to $3.2 million in H1 2025 from $4.7 million in H1 2024, primarily due to lower costs for LPCN 1154 studies in 2025 compared to 2024, despite increased costs for LPCN 2401 studies. General and administrative expenses also decreased to $2.0 million from $3.1 million, mainly due to one-time business development fees incurred in 2024 H1 2025 Operating Expenses | Expense Type | H1 2025 | H1 2024 | Change (YoY) | | :----------------------- | :---------- | :---------- | :----------- | | Research and development | $3,198,341 | $4,693,646 | $(1,495,305) decrease | | General and administrative | $2,012,910 | $3,083,131 | $(1,070,221) decrease | - Decrease in R&D expenses was a result of lower costs related to the initiation of the LPCN 1154 Phase 3 clinical study in 2025 compared to 2024, and a decrease in other R&D related costs, offset by increased costs for LPCN 2401 clinical studies and personnel[13](index=13&type=chunk) - Decrease in G&A expenses was due to one-time business development fees incurred in 2024 in conjunction with the Verity Pharmaceutical license agreement, as well as decreases in other business development expenses, legal fees, corporate insurance premiums, and professional fees[14](index=14&type=chunk) [Other Income (H1 2025)](index=3&type=section&id=Other%20Income%20(H1%202025)) Interest and investment income decreased to $0.4 million in H1 2025 from $0.6 million in H1 2024, attributed to lower interest rates and reduced cash and marketable investment securities balances H1 2025 Other Income | Metric | H1 2025 | H1 2024 | Change (YoY) | | :-------------------------- | :---------- | :---------- | :----------- | | Interest and investment income | $424,149 | $640,209 | $(216,060) decrease | - The decrease in interest and investment income was due to lower interest rates and lower cash and marketable investment securities balances in 2025 compared to 2024[15](index=15&type=chunk) [About Lipocine](index=3&type=section&id=About%20Lipocine) Lipocine is a biopharmaceutical company leveraging its proprietary oral drug delivery technology to develop a diverse pipeline of clinical candidates for unmet medical needs, including its FDA-approved TLANDO [Company Overview and Pipeline](index=3&type=section&id=Company%20Overview%20and%20Pipeline) Lipocine is a biopharmaceutical company utilizing its proprietary technology platform for effective oral drug delivery, developing a pipeline of candidates for significant unmet medical needs such as PPD, refractory epilepsy, essential tremor, obesity, and liver cirrhosis, while also exploring partnering opportunities for several assets. TLANDO, an FDA-approved oral testosterone replacement therapy, is also part of its portfolio - Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, targeting large addressable markets with significant unmet medical needs[16](index=16&type=chunk) - Clinical development candidates include LPCN 1154 (PPD), LPCN 2101 (refractory epilepsy), LPCN 2203 (essential tremor), LPCN 2401 (obesity management), and LPCN 1148 (liver cirrhosis)[17](index=17&type=chunk) - Lipocine is exploring partnering opportunities for LPCN 1107 (preterm birth), LPCN 1154 (PPD), LPCN 2401 (obesity management), LPCN 1148 (decompensated cirrhosis), and LPCN 1144 (MASH)[17](index=17&type=chunk) - TLANDO, a novel oral prodrug of testosterone, is approved by the FDA for conditions associated with hypogonadism in adult males[17](index=17&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents Lipocine's condensed consolidated balance sheets and statements of operations, detailing assets, liabilities, equity, revenues, and expenses for the reported periods [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Lipocine's total assets were $18.6 million, a decrease from $22.5 million at December 31, 2024, primarily driven by a reduction in marketable investment securities and cash. Total stockholders' equity also decreased to $17.1 million from $21.0 million over the same period Condensed Consolidated Balance Sheets Highlights | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------------------------------ | :------------ | :---------------- | :------- | | Cash and cash equivalents | $6,043,980 | $6,205,926 | $(161,946) | | Marketable investment securities | $11,891,702 | $15,427,385 | $(3,535,683) | | Total current assets | $18,420,043 | $22,321,673 | $(3,901,630) | | Total assets | $18,577,193 | $22,510,501 | $(3,933,308) | | Total current liabilities | $1,448,773 | $1,512,936 | $(64,163) | | Total stockholders' equity | $17,128,420 | $20,997,565 | $(3,869,145) | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) The statements detail the company's revenues, operating expenses, and net income/loss for the three and six months ended June 30, 2025, and 2024, showing a net loss for both periods in 2025 compared to a net income for the six months in 2024, primarily driven by changes in license revenue Condensed Consolidated Statements of Operations Highlights | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :------------------------------------------------ | :---------- | :---------- | :---------- | :---------- | | Total revenues | $622,849 | $89,565 | $716,713 | $7,706,738 | | Total operating expenses | $3,027,202 | $3,382,133 | $5,211,251 | $7,776,777 | | Operating loss | $(2,404,353) | $(3,292,568) | $(4,494,538) | $(70,039) | | Net income (loss) attributable to common shareholders | $(2,205,716) | $(3,068,634) | $(4,070,589) | $444,987 | | Basic earnings (loss) per share | $(0.41) | $(0.57) | $(0.76) | $0.08 | | Diluted earnings (loss) per share | $(0.41) | $(0.56) | $(0.76) | $0.10 | [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section provides a cautionary disclaimer regarding forward-looking statements, outlining inherent risks and uncertainties in product development and commercialization [Disclaimer and Risk Factors](index=4&type=section&id=Disclaimer%20and%20Risk%20Factors) This section serves as a cautionary note regarding forward-looking statements in the release, highlighting inherent risks and uncertainties associated with product development, clinical trials, regulatory approvals, commercialization, and financial resources, and advises investors to refer to SEC filings for detailed risk factors - The release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[18](index=18&type=chunk) - Investors are cautioned that all such statements involve risks and uncertainties, including potential lack of success in developing product candidates, insufficient capital, inability to secure partnerships, unsuccessful safety and efficacy studies, and failure to obtain FDA approval[18](index=18&type=chunk) - Lipocine assumes no obligation to update or revise publicly any forward-looking statements, except as required by law[18](index=18&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) This section provides essential contact details for media inquiries and investor relations for Lipocine Inc [Media and Investor Relations](index=4&type=section&id=Media%20and%20Investor%20Relations) This section provides contact details for media inquiries and investor relations for Lipocine Inc - Media Contact: Krista Fogarty, Phone: **(801) 994-7383**, Email: **kf@lipocine.com**[20](index=20&type=chunk) - Investors Contact: PJ Kelleher, Phone: **(617) 430-7579**, Email: **pkelleher@lifesciadvisors.com**[20](index=20&type=chunk)