● LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist, a regulator of myostatin. It is expected to have a favorable benefit to risk profile as a non-invasive option as an adjunct to GLP-1 receptor agonist use for quality weight loss though improved body composition and/or as a monotherapy for weight maintenance and/or newly achieved glycemic status post cessation of GLP-1 receptor agonist use with demonstrated liver benefits. ● Lipocine plans ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or other jurisdiction of incorporation or organization) 675 Arapeen Drive, Suite 202, Salt Lake City, Utah 84108 (Address of principal executive offices) (Zip Code) (I.R.S. Employer Identification ...

Summary of Lipocine (LPCN) Update / Briefing July 09, 2025 Company Overview - **Company**: Lipocine (LPCN) - **Focus**: Development of LPCN 1154, an oral treatment for postpartum depression (PPD) currently in Phase III clinical trials Industry Context - **Postpartum Depression (PPD)**: A serious condition affecting approximately 250,000 women annually in the US, with around 80,000 seeking treatment - **Current Treatment Landscape**: Traditional treatments include SSRIs and SNRIs, which have slow onset times and often inadequate dosing and duration for many patients Key Points and Arguments PPD Treatment Landscape - **Prevalence**: PPD affects 1 in 5 women in the US and 1 in 4 globally, leading to significant economic costs estimated at $14.2 billion annually due to untreated cases [13] - **Screening Recommendations**: The American College of Obstetricians and Gynecologists (ACOG) updated guidelines in 2023 to recommend routine screening for depression and anxiety during pregnancy and postpartum [15] - **Treatment Gaps**: Despite increased screening, many women do not receive adequate treatment, with only 70% starting treatment but fewer receiving adequate doses [15][16] LPCN 1154 Development - **Product Profile**: LPCN 1154 is designed as a rapid-acting oral treatment for PPD, utilizing proprietary drug delivery technology to enhance absorption [8][39] - **Clinical Advantages**: The 48-hour outpatient dosing regimen eliminates the need for hospital stays, addressing significant barriers to access seen with IV brexanolone [39][56] - **Expected Submission**: Anticipated NDA submission for LPCN 1154 in mid-2026, with positive efficacy findings expected from ongoing Phase III trials [53][59] Clinical Efficacy and Safety - **Efficacy of Brexanolone**: Previous studies have shown brexanolone's efficacy in reducing HAM-D scores, with high response rates across various severities of PPD [37][81] - **Safety Profile**: LPCN 1154 has shown a favorable safety profile with no serious adverse events reported in clinical studies, contrasting with IV brexanolone's side effects [64][66] Market Dynamics - **Shifting Prescribing Practices**: There is a growing trend among healthcare providers to consider newer treatments like LPCN 1154, driven by the need for faster relief and better safety profiles compared to traditional SSRIs [35][92] - **Potential for Broader Applications**: If proven effective, LPCN 1154 could also be explored for other forms of major depressive disorder (MDD) and treatment-resistant depression, addressing a significant unmet need [60] Future Outlook - **Regulatory Pathway**: The FDA has indicated that a single Phase III study could support NDA submission, contingent on positive results [53] - **Market Opportunity**: LPCN 1154 represents a significant market opportunity due to its unique attributes and the growing recognition of PPD as a critical health issue [57][58] Additional Important Insights - **Patient Perspectives**: Many patients express concerns about side effects and stigma associated with antidepressant use, which can hinder treatment adherence [36] - **Healthcare Provider Insights**: Obstetricians are increasingly involved in the screening and treatment of PPD, reflecting a shift towards integrated care models [68][75] This summary encapsulates the critical aspects of Lipocine's developments and the broader context of postpartum depression treatment, highlighting the potential impact of LPCN 1154 on patient care and market dynamics.

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]

Core Insights - Lipocine Inc. announced that its candidate LPCN 1148 for men with cirrhosis is featured in the "Hepatology Highlights" section of the June 2025 edition of Hepatology, indicating its potential as a "First in Class" product for hepatic encephalopathy and sarcopenia [1][3] - The Phase 2 trial results for LPCN 1148 were published in the same issue, showcasing its efficacy and safety in treating cirrhosis patients [2][9] - The US FDA has granted fast track designation to LPCN 1148 for treating sarcopenia in patients with decompensated cirrhosis, highlighting its significance in addressing unmet medical needs [4][11] Company Overview - Lipocine is a biopharmaceutical company focused on developing therapeutics with effective oral delivery, targeting significant unmet medical needs in various conditions [12] - The company is exploring partnerships for LPCN 1148 and other drug candidates, aiming to enhance patient outcomes and quality of life for those with liver diseases [4][12][13] Industry Context - Cirrhosis is a severe liver disease affecting over 382,000 patients in the US, with limited treatment options available, primarily liver transplantation [6][5] - Hepatic encephalopathy is a common and debilitating complication of cirrhosis, with a high recurrence rate and significant impact on patient quality of life [7][8] - The need for effective treatments for sarcopenia and hepatic encephalopathy in cirrhosis patients is critical, as current management options are limited to diet and exercise [3][5]

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]

Product Development and Approvals - TLANDO received FDA approval on March 28, 2022, and was commercially launched on June 7, 2022[92][104]. - The company entered into multiple licensing agreements for TLANDO, including an exclusive license with Verity Pharma for the U.S. and Canada, and additional agreements with SPC, Pharmalink, and Aché for other territories[93][94][106][109]. - The company is developing LPCN 1154 for postpartum depression, LPCN 2401 for obesity management, LPCN 2101 for epilepsy, and LPCN 2203 for essential tremor, targeting significant unmet medical needs[95][102]. - LPCN 1111, a next-generation oral testosterone replacement therapy, completed a Phase 2b study demonstrating good dose-response relationships and safety[112]. - The company aims to leverage its Lip'ral drug delivery technology platform to develop differentiated products for conditions with large unmet medical needs[98]. - The company is exploring partnerships for its pipeline assets, including LPCN 1144 and LPCN 1148, to advance their development[101]. - The FDA requires an efficacy and safety study of oral LPCN 1154 in the target population for NDA submission, with a Phase 3 study initiated[117]. - LPCN 2101 is being evaluated for women with epilepsy, with promising PK results and plans for a Phase 2 proof-of-concept study[126]. - LPCN 2203 is an oral candidate for managing essential tremor, with successful completion of oral pharmacokinetics and plans for a Phase 2 study[139]. - 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 obesity management[149]. - LPCN 1148 met its primary endpoint by increasing skeletal muscle index (L3-SMI) relative to placebo (P<.01) in patients with cirrhosis[159]. - LPCN 1107 aims to be the first oral hydroxyprogesterone caproate product for reducing preterm birth risk, addressing an unmet need as approximately 11% of U.S. pregnancies result in preterm birth[179]. Financial Performance and Revenue - The company has generated $53.2 million in revenue from license fees, royalties, and milestone payments since inception through March 31, 2025[185]. - Revenue for the three months ended March 31, 2025, was $93,864, a decrease of $7,523,310 compared to $7,617,174 in the same period of 2024[196]. - Royalty revenue from TLANDO sales was $94,000 for the three months ended March 31, 2025, down from $117,000 in the same period of 2024[197]. - Research and development expenses totaled approximately $155.7 million since inception through March 31, 2025[186]. - Research and development expenses decreased by $1.76 million to $1,061,571 for the three months ended March 31, 2025, compared to $2,818,926 in 2024[198]. - General and administrative expenses decreased by $453,242 to $1,122,477 for the three months ended March 31, 2025, compared to $1,575,719 in 2024[199]. - As of March 31, 2025, the company had $19.7 million in unrestricted cash, cash equivalents, and marketable investment securities, down from $21.6 million at December 31, 2024[203]. Strategic Partnerships and Licensing - Verity Pharma made an initial payment of $2.5 million upon signing the Verity License Agreement, with additional payments totaling $5 million and potential milestone payments of up to $259 million based on sales and development milestones[106]. - The company plans to support its partners in the commercialization of TLANDO, ensuring timely availability to patients while receiving milestone and royalty payments[100]. - The company is responsible for supporting its partners in obtaining regulatory approvals for TLANDO in their respective territories[105]. - The company entered into the Aché License and Supply Agreement in April 2025, granting Aché an exclusive license to commercialize TLANDO in Brazil, with potential fees and royalties based on sales[204]. - The Verity License Agreement, executed in January 2024, includes potential milestone payments of up to $259 million and tiered royalty payments ranging from 12% to 18% of net sales[207]. - The company is exploring partnering opportunities for LPCN 2401 and LPCN 1148, although no agreements have been finalized[151][156]. Market Needs and Patient Demographics - Approximately 600,000 women in the U.S. are affected by postpartum depression (PPD) annually, with 1 in 8 mothers suffering from this condition[119]. - Approximately 900,000 childbearing-aged women in the U.S. suffer from active epilepsy, facing unique challenges related to hormonal influences and seizure control[129]. - Essential tremor affects an estimated 7 million people in the U.S., with significant impacts on daily activities and emotional well-being[140]. - Approximately 74% of US adults aged 20 and older are either obese or overweight, highlighting a significant market opportunity for obesity management therapies[152]. - It is estimated that 20% to 30% of the U.S. population suffers from NAFLD, with 15% to 20% progressing to MASH, indicating a growing patient population[165]. Clinical Study Results - The qEEG study of oral brexanolone indicated robust central nervous system activity with concentration- and time-dependent post-dose changes[114]. - LPCN 1154 demonstrated bioequivalence with IV brexanolone in the definitive PK study, meeting standard bioequivalence criteria and Ctrough criteria[116]. - LPCN 1154 is being developed for PPD and has shown promising results in clinical studies, with no sedation or somnolence events observed[116][117]. - LPCN 2401 could potentially be used as a monotherapy post-discontinuation of GLP-1 agonists to manage weight regain and improve diabetes remission durability[148]. - LPCN 1144 treatment resulted in significant liver fat reduction and improvement in liver injury markers, with no tolerability issues observed[170]. - Both treatment arms of LPCN 1144 met the pre-specified regulatory endpoint of MASH resolution with no worsening of fibrosis[172]. - The LiFT Phase 2 clinical study enrolled 56 biopsy-confirmed male MASH subjects, with a treatment period of 36 weeks[168]. Financial Outlook and Capital Needs - The company expects to incur operating losses into the foreseeable future as it advances clinical development for multiple product candidates[202]. - The company believes existing capital resources will be sufficient to meet projected operating requirements through at least May 8, 2026[214]. - The company may need to raise additional capital through equity or debt markets or out-licensing activities to support operations beyond May 8, 2026[215]. - For the three months ended March 31, 2025, net cash used in operating activities was $2.0 million, compared to a cash inflow of $2.4 million for the same period in 2024[219]. - Cash used in investing activities for the three months ended March 31, 2025, was $882,000, significantly lower than $4.1 million in 2024[221]. - No cash was used in financing activities during the three months ended March 31, 2025, while $8,000 was used in the same period in 2024[222]. - The net cash used in operating activities in 2025 was primarily due to ongoing operational support, while the 2024 cash inflow included $7.5 million from the Verity License Agreement[220]. Operational and Market Risks - The company has contractual commitments with clinical research organizations and vendors for clinical trials and research studies, which are generally cancellable obligations[223]. - The lease for the corporate headquarters in Salt Lake City, Utah, was modified and extended through February 28, 2026[224]. - There have been no significant changes in critical accounting policies during the three months ended March 31, 2025, compared to the previous year[226]. - The company is exposed to market risks, including potential losses from adverse changes in interest rates, but does not engage in derivatives for trading purposes[227]. - There were no material changes to the company's market risk during the first three months of 2025[228]. - The company may face dilution of existing stockholders' ownership if additional capital is raised through public or private equity offerings[217].

Core Viewpoint - Lipocine Inc. has initiated a Phase 3 trial for LPCN 1154, an oral formulation of brexanolone, aimed at treating postpartum depression (PPD) [1][2][3] Company Overview - Lipocine Inc. is a biopharmaceutical company focused on developing effective oral delivery systems for therapeutics [7] - The company is exploring partnerships for various drug candidates, including LPCN 1154 for PPD and others targeting conditions like epilepsy and obesity [9] Clinical Trial Details - The Phase 3 trial for LPCN 1154 is a randomized, blinded, placebo-controlled study designed to evaluate safety and efficacy in women aged 15 and older diagnosed with severe PPD [3][4] - The trial will involve a 48-hour dosing period, with the first patient expected to be dosed in Q2 2025 [2][8] - Primary endpoint includes the change from baseline in the Hamilton Depression Rating Scale (HAM-D), with secondary endpoints assessing anxiety symptoms and safety measures [4] Product Information - LPCN 1154 is designed for rapid relief of PPD and is a bioidentical formulation of the neuroactive steroid allopregnanolone [5] - The product aims to address significant unmet medical needs in PPD treatment, particularly for patients with acute symptoms and elevated suicide risk [5][6] Market Context - Postpartum depression is a major depressive disorder affecting 20-40% of obstetric patients, with 64% of women with PPD also experiencing anxiety symptoms [6] - Traditional antidepressants are not approved for PPD and have slow onset and side effects, highlighting the need for effective treatments like LPCN 1154 [6]

Regulatory Approvals and Licensing - TLANDO received FDA approval on March 28, 2022, and was commercially launched on June 7, 2022[29]. - The company entered into a license agreement with Verity Pharmaceuticals for TLANDO, which includes an initial payment of $2.5 million and additional payments totaling $5 million by February 1, 2024[31]. - The Verity License Agreement allows for milestone payments of up to $259 million based on sales and development milestones, with tiered royalty payments ranging from 12% to 18% of net sales in the Licensed Verity Territory[31]. - The company is responsible for supporting its licensees in obtaining regulatory approvals for TLANDO in their respective territories[30]. - The FDA granted Fast Track Designation for LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis due to its clinical effectiveness[83]. - The FDA granted Fast Track Designation to LPCN 1144 as a treatment for non-cirrhotic MASH, aimed at expediting the development and review process[96]. - The FDA acknowledged that no additional non-clinical studies are needed to support an NDA submission for LPCN 1144[97]. - The FDA requires 2 adequate and well-controlled Phase 3 clinical trials for NDA approval[136]. - The NDA review process by the FDA usually takes 8 months to 1 year, with potential for additional data requests[140]. - Orphan drug designation is granted for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[142]. - If granted orphan drug exclusivity, a product is protected from competition for 7 years for the same indication[143]. - Priority Review designation allows for an expedited review process, targeting 8 months for new molecular entities[144]. Clinical Development Pipeline - The clinical development pipeline includes LPCN 1154 for postpartum depression, LPCN 2101 for epilepsy, LPCN 2203 for essential tremor, and LPCN 2401 for obesity management[21][26]. - LPCN 1154, an oral formulation of brexanolone for postpartum depression (PPD), has completed clinical PK studies and demonstrated bioequivalence with IV brexanolone[40]. - Approximately 600,000 women in the U.S. are affected by PPD annually, highlighting a significant unmet medical need for effective oral therapies[43]. - LPCN 2101 is being evaluated for women with epilepsy, with promising PK results from pre-clinical and Phase 1 studies[48]. - The company plans to initiate a Phase 2 IND opening proof-of-concept study for LPCN 2101, subject to resource prioritization[48]. - No epilepsy drug has been specifically approved for women of child-bearing age, indicating a gap in the market for targeted treatments[58]. - LPCN 1154 is expected to initiate a Phase 3 safety and efficacy study in the second quarter of 2025, following FDA guidance[41]. - LPCN 2203 is an oral candidate for managing essential tremor, with a planned submission for a proof-of-concept phase 2 study to the FDA[60]. - Essential tremor affects an estimated 7 million people in the U.S., with 90% of patients reporting emotional impacts and 75% experiencing tremor-related anxiety[61][62]. - LPCN 2401 demonstrated a placebo-adjusted increase in lean mass of 4.4%, a decrease in fat mass of 6.7%, and a reduction in trunk fat mass of 2.5% in a Phase 2 study[69]. - LPCN 1148 met its primary endpoint by increasing skeletal muscle index (L3-SMI) relative to placebo (P<.01) in patients with cirrhosis[82]. - LPCN 2401 has potential as an adjunct to GLP-1 receptor agonists, improving body composition while preserving lean mass[68]. - LPCN 2401 could potentially be used as monotherapy post-discontinuation of GLP-1 agonists to manage weight regain and improve diabetes remission durability[70]. - LPCN 1144 treatment resulted in robust liver fat reduction, assessed by MRI-PDFF, and showed improvement of liver injury markers with no observed tolerability issues[92]. - The LiFT clinical study enrolled 56 biopsy-confirmed male MASH subjects, with a treatment period of 36 weeks[90]. - Both LPCN 1144 treatment arms met the pre-specified accelerated approval regulatory endpoint of MASH resolution with no worsening of fibrosis[94]. - Approximately 20% to 30% of the U.S. population is estimated to suffer from NAFLD, with 15% to 20% progressing to MASH, which lacks effective therapy[88]. - The average steady state HPC levels for LPCN 1107 were comparable or higher than for injectable HPC, demonstrating effective dosing[100]. Financials and Market Considerations - The company spent $7.4 million and $10.2 million on research and development in 2024 and 2023, respectively[106]. - Xifaxan® sales for the 12-month period ending November 2024 totaled approximately $2.5 billion[111]. - The company may receive a potential cash royalty of 20% of net proceeds from Spriaso, capped at $10 million, under a related party transaction[156]. - Coverage and reimbursement from third-party payers are critical for the commercial success of approved products[151]. - The company has not disclosed any quantitative and qualitative market risk information as it qualifies as a "smaller reporting company"[394]. Corporate Structure and Employee Relations - As of December 31, 2024, the company had 16 full-time employees, with 11 engaged in drug development and 5 in general administration[158]. - The company maintains good relations with its employees, who are not represented by labor unions[158]. - The company is committed to workplace diversity, equality, and inclusion[159]. - The company utilizes consultants regularly to balance in-house expertise with outsourced capabilities[158]. - The company has outsourced substantial clinical trial work and certain drug manufacturing to contract manufacturers[158]. Product Development and Market Trends - The proprietary Lip'ral drug delivery technology platform is designed to improve the absorption of poorly bioavailable drugs, enhancing patient compliance and safety[18][27]. - The testosterone replacement therapy market includes various forms, with intramuscular injections holding the highest market share in terms of annual prescriptions[117]. - LPCN 1111 is targeted to meet the unmet need for a once-a-day convenient oral testosterone replacement therapy[119]. - The patent portfolio includes various issued patents and applications related to Oral TU and other products, with expiration dates between 2029 and 2041[123]. - Reformulated Rifaximin SSD is in a Phase 3 study for reduction of early decompensation in cirrhosis, with topline data anticipated in the first half of 2026[114]. - GB 1211, an oral galectin-3 inhibitor for advanced liver cirrhosis, is targeted for initiation of a long-term trial in the first half of 2024[113]. Recent Developments and Market Withdrawals - Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for treatment of patients with MASH in March 2024[115]. - Akero Therapeutics reported statistically significant reversal of compensated cirrhosis (F4) due to MASH at week 96 in their Phase 2b SYMMETRY study[115]. - The only previously approved therapy for prevention of preterm birth, Makena®, was withdrawn from the market effective April 6, 2023, due to lack of clinical benefit[121]. - The FDA has granted a therapeutic equivalence rating of AB to "generic" versions of approved testosterone products, indicating their bioequivalence[118]. Stock and Financial Management - On May 10, 2023, the company approved a reverse stock split of 1-for-17, effective May 11, 2023, with shares trading on a split-adjusted basis from May 12, 2023[160].

Core Insights - Lipocine Inc. reported financial results for the year ended December 31, 2024, showing a net income of approximately $8,400 compared to a net loss of $16.4 million in 2023, indicating a significant turnaround in financial performance [6][19] - The company is advancing its product candidates, including LPCN 1154 for postpartum depression, LPCN 2401 for obesity management, and LPCN 1148 for decompensated cirrhosis, with ongoing clinical studies and potential partnerships [2][3][12] Financial Performance - As of December 31, 2024, Lipocine had $21.6 million in unrestricted cash and equivalents, a slight decrease from $22.0 million in 2023 [6] - The company recognized revenue of $11.2 million in 2024, a significant increase from a net reversal of variable consideration revenue of $2.9 million in 2023, primarily driven by license and royalty revenue [7][18] - Research and development expenses decreased to $7.4 million in 2024 from $10.2 million in 2023, attributed to the completion of certain clinical studies and reduced costs in other areas [8] Product Development - LPCN 1154, an oral formulation of brexanolone, is being developed for postpartum depression, with a Phase 3 safety and efficacy study expected to start in Q2 2025 following FDA guidance [2] - LPCN 2401 is positioned as a once-daily oral treatment for obesity management, showing positive Phase 2 study results and potential for partnership [2][12] - LPCN 1148 is aimed at treating decompensated cirrhosis, with positive Phase 2 trial results published, and has received fast track designation from the FDA [3][12] Partnerships and Licensing - Lipocine entered into a license agreement with Verity Pharma for the marketing of TLANDO, with expected total license fees of $11 million, and potential milestone payments of up to $259 million [11] - The company is exploring additional partnerships for its product candidates, including LPCN 1154, LPCN 2401, and LPCN 1148, to enhance commercialization efforts [2][12]