Accessibility StatementSkip Navigation One-Third of Patients Randomized; Topline Results Expected in 2Q 2026 DSMB Safety Review Update Planned for 4Q 2025 SALT LAKE CITY, Sept. 30, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum d ...

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)

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section provides Lipocine Inc.'s unaudited condensed consolidated financial statements and comprehensive notes for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This table presents the company's financial position, including assets, liabilities, and equity, as of June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | **Assets** | | | | Cash and cash equivalents | $6,043,980 | $6,205,926 | | Marketable investment securities | $11,891,702 | $15,427,385 | | Total current assets | $18,420,043 | $22,321,673 | | Total assets | $18,577,193 | $22,510,501 | | **Liabilities & Equity** | | | | Total current liabilities | $1,448,773 | $1,512,936 | | Total stockholders' equity | $17,128,420 | $20,997,565 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) This table details the company's revenues, expenses, and net income or loss for the three and six months ended June 30, 2025, and 2024 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $622,849 | $89,565 | $716,713 | $7,706,738 | | Research and development | $2,136,769 | $1,874,721 | $3,198,341 | $4,693,646 | | General and administrative | $890,433 | $1,507,412 | $2,012,910 | $3,083,131 | | 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 | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) This section outlines changes in stockholders' equity, reflecting net loss, stock-based compensation, and common stock transactions - Total stockholders' equity decreased from **$20,997,565** at December 31, 2024, to **$17,128,420** at June 30, 2025, primarily due to a net loss of **$4,070,589** and an unrealized net loss on marketable investment securities of **$10,381**, partially offset by stock-based compensation and common stock sales through ATM offering[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This table summarizes cash flows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net income (loss) | $(4,070,589) | $444,987 | | Cash used in operating activities | $(3,855,491) | $(90,258) | | Net cash provided by investing activities | $3,617,927 | $662,531 | | Cash provided by financing activities | $75,618 | $209,340 | | Net increase (decrease) in cash and cash equivalents | $(161,946) | $781,613 | | Cash and cash equivalents at end of period | $6,043,980 | $5,553,371 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [Basis of Presentation](index=9&type=section&id=(1)%20Basis%20of%20Presentation) The financial statements are unaudited, prepared in accordance with SEC rules and U.S. GAAP, and include all necessary recurring adjustments. The Company estimates sufficient capital resources through at least August 5, 2026, but acknowledges the need for additional capital through equity, debt, or out-licensing to support long-term operations and potential new clinical studies - The Company believes existing capital resources are sufficient through at least August 5, 2026, but will need to raise additional capital for long-term operations[23](index=23&type=chunk) - On January 12, 2024, Lipocine entered into the Verity License Agreement, granting exclusive rights to commercialize the TLANDO product in the US and Canada, with an **$11.0 million** license fee (partially received) and potential milestones up to **$259 million**, plus tiered royalties (12-18%)[24](index=24&type=chunk)[25](index=25&type=chunk) [Revenue](index=10&type=section&id=(2)%20Revenue) Revenue is primarily generated from license and royalty arrangements. Upfront license fees are recognized upon transfer of technology rights, while contingent milestone payments are recognized when achieved and collectability is probable. Sales-based royalties are recognized when products are sold by the licensee - For the three months ended June 30, 2025, **80% of revenue was from Aché** and **20% from Verity Pharma**; for the six months ended June 30, 2025, **70% was from Aché** and **30% from Verity Pharma**[31](index=31&type=chunk) - For the three months ended June 30, 2024, **100% of revenue was from Verity Pharma**; for the six months ended June 30, 2024, **99% of revenue was from Verity Pharma**, including **$7.5 million** in license revenue[31](index=31&type=chunk) [Earnings (Loss) per Share](index=11&type=section&id=(3)%20Earnings%20(Loss)%20per%20Share) Basic and diluted earnings per share calculations are provided, showing a net loss for both three and six months ended June 30, 2025, compared to a loss and income respectively in the prior year. Certain stock options and warrants were antidilutive and excluded from diluted EPS calculations | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net income (loss) | $(2,205,716) | $(3,068,634) | $(4,070,589) | $444,987 | | Basic EPS | $(0.41) | $(0.57) | $(0.76) | $0.08 | | Diluted EPS | $(0.41) | $(0.56) | $(0.76) | $0.10 | - Stock options (**354,908** for 3M/6M 2025, **295,517** for 3M 2024, **173,443** for 6M 2024) and unvested restricted stock units (**19,346** for 3M/6M 2025, **21,762** for 3M 2024, **14,508** for 6M 2024) were antidilutive and excluded from diluted EPS[33](index=33&type=chunk) [Marketable Investment Securities](index=12&type=section&id=(4)%20Marketable%20Investment%20Securities) The Company classifies marketable investment securities as available-for-sale debt securities, carried at fair value with unrealized gains/losses in comprehensive income. All securities are government treasury bills due within one year | Metric | June 30, 2025 | December 31, 2024 | | :----------------------- | :-------------- | :---------------- | | Amortized Cost | $11,892,945 | $15,418,247 | | Aggregate Fair Value | $11,891,702 | $15,427,385 | | Gross Unrealized Gains | $646 | $9,138 | | Gross Unrealized Losses | $(1,889) | $- | - No sales of marketable investment securities occurred, thus no realized gains or losses for the three or six months ended June 30, 2025 or 2024; maturities of **$4.5 million** (3M 2025) and **$8.7 million** (6M 2025) were recorded[34](index=34&type=chunk) [Fair Value](index=12&type=section&id=(5)%20Fair%20Value) The Company values financial instruments using observable inputs, primarily Level 1 (quoted prices in active markets). Cash equivalents (money market funds) and government treasury bills are classified as Level 1 | Asset | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :-------------------------- | :------------------------- | :--------------------------- | | Cash equivalents - money market funds | $5,755,118 | $6,155,167 | | Government treasury bills | $11,891,702 | $15,427,385 | | Total | $17,646,820 | $21,582,552 | - All fair value measurements are classified within Level 1 of the fair value hierarchy[36](index=36&type=chunk) [Income Taxes](index=13&type=section&id=(6)%20Income%20Taxes) The Company determines interim tax provisions using an estimated annual effective tax rate. As of June 30, 2025, and December 31, 2024, a full valuation allowance was maintained against deferred tax assets, indicating uncertainty about their realization - A full valuation allowance is maintained against deferred tax assets as of June 30, 2025, and December 31, 2024, due to uncertainty of realization[40](index=40&type=chunk) [Contractual Agreements](index=14&type=section&id=(7)%20Contractual%20Agreements) Lipocine has several key license and distribution agreements for its TLANDO product across various territories, including the Verity License Agreement (US/Canada), SPC License Agreement (South Korea), Pharmalink Distribution Agreement (GCC), and Aché License Agreement (Brazil). These agreements involve upfront fees, milestone payments, and tiered royalties - Verity License Agreement (January 2024): Granted exclusive rights for TLANDO in US/Canada, includes **$11.0 million** license fee (partially received), up to **$259 million** in development/sales milestones, and **12-18%** tiered royalties on net sales[41](index=41&type=chunk)[42](index=42&type=chunk)[44](index=44&type=chunk) - SPC License Agreement (September 2024): Granted exclusive rights for TLANDO in South Korea, includes a one-time upfront fee, additional payments for inventory, marketing authorization, sales milestones, and royalties on net sales[45](index=45&type=chunk) - Pharmalink Distribution Agreement (October 2024): Granted exclusive rights for TLANDO in GCC countries, includes a one-time upfront fee and eligibility for regulatory authorization milestones[46](index=46&type=chunk) - Aché License Agreement (April 2025): Granted exclusive rights for TLANDO in Brazil, entitled to fees upon regulatory milestones, royalties on net sales, and supply price for TLANDO[47](index=47&type=chunk) - Abbott Products, Inc.: Company owes a perpetual **1% royalty** on TLANDO net sales, capped at **$1.0 million** for the first two years post-launch (June 7, 2022); royalty expense was **$10,000** (3M 2025) and **$18,000** (6M 2025)[48](index=48&type=chunk)[103](index=103&type=chunk) [Leases](index=15&type=section&id=(8)%20Leases) The Company has a non-cancelable operating lease for office and laboratory facilities in Salt Lake City, Utah, extended through February 28, 2026 | Year | Operating Lease Payments | | :--- | :----------------------- | | 2025 | $188,639 | | 2026 | $62,880 | | Total | $251,519 | - Rent expense was **$94,000** (3M 2025) and **$187,000** (6M 2025)[51](index=51&type=chunk) [Stockholders' Equity](index=15&type=section&id=(9)%20Stockholders'%20Equity) Shareholders approved a reduction in authorized common stock from 200,000,000 to 75,000,000 shares. The Company continues to issue common stock through an ATM offering and maintains a Rights Agreement. Stock-based compensation expense is recognized for various awards, and common stock warrants from the November 2019 offering expired in November 2024 - Authorized common stock reduced from **200,000,000** to **75,000,000** shares, effective June 4, 2025[52](index=52&type=chunk) - Sold **23,739 shares** of common stock through A.G.P. Sales Agreement for net proceeds of **$76,000** during the three and six months ended June 30, 2025[56](index=56&type=chunk)[215](index=215&type=chunk) - Stock-based compensation expense was **$65,205** (3M 2025) and **$136,207** (6M 2025)[63](index=63&type=chunk) - As of June 30, 2025, **354,908 stock options** were outstanding with a weighted average exercise price of **$21.26**, and **197,655 shares** remained available for grant under the 2014 Plan[69](index=69&type=chunk)[70](index=70&type=chunk) - Common stock warrants from the November 2019 Offering expired in November 2024, extinguishing the related liability; no warrants were outstanding as of June 30, 2025[73](index=73&type=chunk)[76](index=76&type=chunk) [Commitments and Contingencies](index=22&type=section&id=(10)%20Commitments%20and%20Contingencies) The Company is involved in various legal matters in the ordinary course of business but is not currently aware of any material litigation that could significantly impact its financial condition. It also enters into agreements with standard guarantee and indemnification provisions - No current litigation is expected to have a material adverse effect on financial condition, liquidity, or results of operations[77](index=77&type=chunk) [Agreement with Spriaso, LLC](index=22&type=section&id=(11)%20Agreement%20with%20Spriaso,%20LLC) Lipocine has a license and services agreement with Spriaso, a related party. Lipocine assigned intellectual property rights for cough and cold products to Spriaso in exchange for a 20% royalty on net proceeds up to $10.0 million. Lipocine did not receive revenue from Spriaso during the reported periods and does not consolidate Spriaso as it is not the primary beneficiary - Lipocine assigned intellectual property for cough and cold products to Spriaso, a related party, in exchange for a **20% royalty** on net proceeds up to **$10.0 million**[79](index=79&type=chunk) - No revenue was received from Spriaso during the three and six months ended June 30, 2025, and 2024[79](index=79&type=chunk) [Segment Reporting](index=22&type=section&id=(12)%20Segment%20Reporting) The Company operates as a single reporting segment, focusing on its proprietary technology platform for oral drug delivery. The CEO manages resources and assesses performance on a total company basis using consolidated financial information - The Company operates as a single reporting segment, focused on leveraging its proprietary technology platform for oral drug delivery[80](index=80&type=chunk) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $622,849 | $89,565 | $716,713 | $7,706,738 | | Program expenses (LPCN 1154) | $1,042,929 | $1,024,607 | $1,049,621 | $2,677,093 | | Non-program expenses | $735,511 | $1,252,539 | $1,736,128 | $2,759,176 | | Personnel costs | $1,028,142 | $1,033,638 | $2,112,907 | $1,999,836 | | Stock-based compensation | $65,205 | $102,265 | $136,207 | $201,571 | | Total segment operating income (loss) | $(2,404,353) | $(3,292,568) | $(4,494,538) | $(70,039) | | Net income (loss) | $(2,205,716) | $(3,068,634) | $(4,070,589) | $444,987 | [Recent Accounting Pronouncements](index=23&type=section&id=(13)%20Recent%20Accounting%20Pronouncements) The FASB issued ASU 2024-03 in November 2024, requiring disaggregation of certain income statement expense captions in financial statement notes. The Company is currently evaluating the impact of this guidance, which is effective for annual periods beginning after December 15, 2026 - FASB issued ASU 2024-03 (November 2024) requiring disaggregation of income statement expenses, effective for annual periods after December 15, 2026; the Company is evaluating its impact[84](index=84&type=chunk)[85](index=85&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses Lipocine's business overview, corporate strategy, pipeline, financial performance, liquidity, and critical accounting policies [Overview of Our Business](index=24&type=section&id=Overview%20of%20Our%20Business) Lipocine is a biopharmaceutical company utilizing its proprietary Lip'ral platform for oral drug delivery, focusing on differentiated products for CNS disorders, liver diseases, and hormone supplementation. TLANDO®, an oral testosterone replacement therapy, received FDA approval in March 2022 and has been licensed to multiple partners globally - Lipocine is a biopharmaceutical company leveraging its proprietary Lip'ral platform for oral delivery of difficult-to-deliver molecules, focusing on CNS disorders, liver diseases, and hormone supplementation[90](index=90&type=chunk) - TLANDO®, an oral testosterone replacement therapy, was FDA approved on March 28, 2022, and commercially launched on June 7, 2022; it has since been licensed to Verity Pharma (US/Canada), SPC (South Korea), Pharmalink (GCC), and Aché (Brazil)[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) [Corporate Strategy](index=25&type=section&id=Corporate%20Strategy) Lipocine's corporate strategy centers on leveraging its Lip'ral drug delivery technology, advancing CNS product candidates like LPCN 1154 for PPD, supporting partners in TLANDO commercialization, and seeking partnerships for other pipeline assets such as liver programs (LPCN 1144, LPCN 1148) and LPCN 2401 and LPCN 1107 - Key strategies include leveraging the Lip'ral drug delivery platform, advancing CNS candidates (priority on LPCN 1154 for PPD), supporting TLANDO commercialization partners (Verity Pharma, SPC, Pharmalink, Aché), and developing partnerships for pipeline assets (LPCN 1144, LPCN 1148, LPCN 2401, LPCN 1107)[97](index=97&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) [Our Pipeline Product Candidates](index=26&type=section&id=Our%20Pipeline%20Product%20Candidates) Lipocine's pipeline includes TLANDO (oral TRT) with multiple international licenses, and several CNS disorder candidates (LPCN 1154 for PPD, LPCN 2101 for epilepsy, LPCN 2203 for essential tremor). Other candidates like LPCN 2401 (obesity management), LPCN 1148 (decompensated cirrhosis), LPCN 1144 (MASH), and LPCN 1107 (preterm birth prevention) are being explored for partnerships [TRT Franchise – TLANDO and LPCN 1111 (TLANDO XR)](index=26&type=section&id=TRT%20Franchise%20%E2%80%93%20TLANDO%20and%20LPCN%201111%20(TLANDO%20XR)) TLANDO, an FDA-approved oral testosterone replacement therapy, is licensed to Verity Pharma (US/Canada), SPC (South Korea), Pharmalink (GCC), and Aché (Brazil). These partners are responsible for development, commercialization, and regulatory approvals in their respective territories, with Lipocine receiving license fees, milestones, and tiered royalties - TLANDO is licensed to Verity Pharma (US/Canada), SPC (South Korea), Pharmalink (GCC), and Aché (Brazil); partners are responsible for regulatory approvals and commercialization[102](index=102&type=chunk)[104](index=104&type=chunk) - Verity Pharma payments include **$11.0 million** license fee (partially received), up to **$259 million** in milestones, and **12-18%** tiered royalties[105](index=105&type=chunk) - SPC, Pharmalink, and Aché agreements include upfront fees, potential milestones, and royalties/supply prices[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) [Oral Programs for CNS Disorders](index=27&type=section&id=Oral%20Programs%20for%20CNS%20Disorders) Lipocine is developing oral neuroactive steroids (NASs) for CNS disorders, leveraging its technology for effective oral delivery. LPCN 1154 for PPD is in Phase 3, LPCN 2101 for epilepsy has an accepted IND for Phase 2, and LPCN 2203 for essential tremor is planning a Phase 2 study - Oral brexanolone (NAS) qEEG study showed robust CNS activity, supporting development for neuropsychiatric disorders[111](index=111&type=chunk)[112](index=112&type=chunk) - LPCN 1154 (oral brexanolone for PPD) met bioequivalence with IV brexanolone in a definitive PK study and is now in a Phase 3 safety and efficacy study[113](index=113&type=chunk)[114](index=114&type=chunk) - LPCN 2101 (NAS for epilepsy) IND accepted for Phase 2 study; LPCN 2203 (NAS for essential tremor) is planning a Phase 2 study[123](index=123&type=chunk)[137](index=137&type=chunk) - Unmet need in PPD for rapid-acting oral therapies, especially after Zulresso withdrawal and ZURZUVAE's CNS depressant effects; LPCN 1154 aims for robust, rapid relief with good tolerability[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - Unmet need in epilepsy for women of childbearing age due to ASM teratogenic effects, contraception failure, and comorbidities; oral endogenous NASs like LPCN 2101 could offer benefits without these downsides[132](index=132&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk) [Other Pipeline Candidates](index=33&type=section&id=Other%20Pipeline%20Candidates) Lipocine is seeking partnerships for LPCN 2401 (obesity), LPCN 1148 (cirrhosis), LPCN 1144 (MASH), and LPCN 1107 (preterm birth), all showing promising clinical results - LPCN 2401 (anabolic androgen receptor agonist for obesity management) showed **4.4% increase in lean mass** and **6.7% decrease in fat mass** in a Phase 2 study; a proof-of-concept Phase 2 study as an adjunct to GLP-1 agonists is planned for Q3 2025[145](index=145&type=chunk)[148](index=148&type=chunk) - LPCN 1148 (testosterone laurate for decompensated cirrhosis) Phase 2 study met primary endpoint (increased skeletal muscle index) and showed improvements in clinical outcomes like OHE prevention and hospitalizations[157](index=157&type=chunk)[158](index=158&type=chunk) - LPCN 1144 (oral prodrug of testosterone for MASH) Phase 2 study met MASH resolution endpoint with no worsening of fibrosis and received FDA Fast Track Designation; FDA recommended a Phase 2 dose ranging study prior to pivotal study[169](index=169&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) - LPCN 1107 (oral HPC for prevention of preterm birth) completed a multi-dose PK study showing comparable or higher HPC levels than injectable HPC; received FDA Orphan Drug Designation[176](index=176&type=chunk)[178](index=178&type=chunk) - Significant unmet need for muscle-preserving options in GLP-1 obesity management, as current therapies cause substantial lean mass loss; LPCN 2401 aims to address this[150](index=150&type=chunk)[152](index=152&type=chunk) - Makena, an injectable HPC for preterm birth, was withdrawn by the FDA in April 2023 due to lack of verified clinical benefit, highlighting the unmet need LPCN 1107 aims to address[179](index=179&type=chunk) [Financial Operations Overview](index=40&type=section&id=Financial%20Operations%20Overview) Lipocine's revenue to date primarily comes from license fees, royalties, and milestone payments, not product sales. Research and development expenses, which are expensed as incurred, have been significant ($157.8 million since inception) and are expected to continue increasing due to ongoing clinical trials. General and administrative expenses are also expected to rise as a public company - Revenue primarily from license fees, royalties, and milestones; no product sales to date[180](index=180&type=chunk) - Incurred **$157.8 million** in R&D expenses since inception through June 30, 2025, with significant future costs expected for pipeline development[181](index=181&type=chunk)[182](index=182&type=chunk) - General and administrative expenses are expected to increase as a public company, covering legal, consulting, audit, and intellectual property costs[189](index=189&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) This section compares Lipocine's financial performance for the three and six months ended June 30, 2025, and 2024, across key revenue and expense categories [Comparison of the Three Months Ended June 30, 2025 and 2024](index=42&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares Lipocine's financial results for the three months ended June 30, 2025, and 2024 | Metric | 3M Ended June 30, 2025 | 3M Ended June 30, 2024 | Variance | | :------------------------------ | :--------------------- | :--------------------- | :------- | | Revenue | $622,849 | $89,565 | $533,284 | | R&D expenses | $2,136,769 | $1,874,721 | $262,048 | | G&A expenses | $890,433 | $1,507,412 | $(616,979) | | Interest & investment income | $198,637 | $308,845 | $(110,208) | | Unrealized loss on warrant liability | $- | $(84,430) | $84,430 | - Revenue increased by **$533,284**, driven by **$500,000** in license revenue in 2025 (vs. $0 in 2024) and higher royalty revenue from TLANDO sales (**$123,000** in 2025 vs. **$90,000** in 2024)[192](index=192&type=chunk) - R&D expenses increased by **$262,048** due to a **$153,000** increase for LPCN 2401 clinical studies and an **$81,000** increase in other R&D costs[193](index=193&type=chunk) - G&A expenses decreased by **$616,979**, primarily from lower business development fees (**$350,000**), legal fees (**$184,000**), and Delaware franchise tax (**$40,000**)[194](index=194&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=43&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares Lipocine's financial results for the six months ended June 30, 2025, and 2024 | Metric | 6M Ended June 30, 2025 | 6M Ended June 30, 2024 | Variance | | :------------------------------ | :--------------------- | :--------------------- | :------- | | Revenue | $716,713 | $7,706,738 | $(6,990,025) | | R&D expenses | $3,198,341 | $4,693,646 | $(1,495,305) | | G&A expenses | $2,012,910 | $3,083,131 | $(1,070,221) | | Interest & investment income | $424,149 | $640,209 | $(216,060) | | Unrealized loss on warrant liability | $- | $(124,502) | $124,502 | - Revenue decreased by **$6,990,025**, primarily due to **$7.5 million** in license revenue from the Verity License Agreement in 2024, with only **$500,000** in license revenue in 2025[199](index=199&type=chunk) - R&D expenses decreased by **$1,495,305**, mainly due to a **$1.6 million** decrease in LPCN 1154 Phase III clinical study costs in 2025 compared to 2024, partially offset by increased LPCN 2401 study costs[200](index=200&type=chunk) - G&A expenses decreased by **$1,070,221**, primarily from a **$512,000** decrease in one-time business development fees related to the Verity License Agreement in 2024 and a **$410,000** decrease in other business development expenses[201](index=201&type=chunk) [Liquidity and Capital Resources](index=44&type=section&id=Liquidity%20and%20Capital%20Resources) Lipocine's operations are financed through equity sales, debt, and license agreements. As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $17.9 million, down from $21.6 million at December 31, 2024. The Company expects existing capital to fund operations through August 5, 2026, but will require additional capital for long-term needs and further product development. Cash used in operating activities increased significantly in 2025 due to R&D for LPCN 1154 Phase III - Unrestricted cash, cash equivalents, and marketable investment securities were **$17.9 million** as of June 30, 2025, down from **$21.6 million** at December 31, 2024[206](index=206&type=chunk) - Existing capital resources are projected to be sufficient through at least August 5, 2026, but additional capital will be needed for long-term operations and further product development[216](index=216&type=chunk) - Net cash used in operating activities increased from **$90,258** (6M 2024) to **$3,855,491** (6M 2025), primarily due to cash required for LPCN 1154 Phase III clinical trial[220](index=220&type=chunk)[221](index=221&type=chunk) - Net cash provided by investing activities was **$3.6 million** (6M 2025) and **$663,000** (6M 2024), mainly from maturities of marketable investment securities[222](index=222&type=chunk) - Net cash provided by financing activities was **$76,000** (6M 2025) from ATM sales and **$209,000** (6M 2024) from Cantor Sales Agreement[223](index=223&type=chunk)[224](index=224&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=48&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) The Company's financial statements rely on estimates and assumptions in accordance with U.S. GAAP, particularly for revenue recognition from license agreements. No significant material changes to critical accounting policies occurred during the six months ended June 30, 2025 - No significant material changes to critical accounting policies during the six months ended June 30, 2025[228](index=228&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=48&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The Company is exposed to market risks, primarily from changes in interest rates, but does not use derivatives for speculative purposes. No material changes to market risk occurred during the first six months of 2025 - No material changes to the Company's market risk during the first six months of 2025[230](index=230&type=chunk) [Item 4. Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) Lipocine's management, including the CEO and Principal Financial Officer, evaluated the effectiveness of its disclosure controls and procedures as of June 30, 2025, concluding they were effective. No material changes in internal control over financial reporting occurred during the quarter - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2025[232](index=232&type=chunk) - No material changes in internal control over financial reporting occurred during the most recent fiscal quarter[233](index=233&type=chunk)[234](index=234&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) Lipocine is involved in routine legal matters but is not currently a party to any material litigation that could significantly impact its financial condition, liquidity, or results of operations - The Company is not currently a party to any material litigation or other material legal proceedings[236](index=236&type=chunk) [Item 1A. Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors from the 2024 Form 10-K, focusing on development and commercialization risks for LPCN 1154, potential patent infringement, reliance on third-party suppliers, influence of management/directors, stock price volatility, and the Company's history of operating losses and future capital requirements - LPCN 1154 development and NDA submission face risks, including uncertainty of clinical trial results, FDA acceptance, and the need for additional studies[239](index=239&type=chunk) - Commercialization of LPCN 1154 is dependent on finding a partner, and there's no assurance of favorable terms or successful partnership; labeling requirements (warnings) could negatively impact commercialization[240](index=240&type=chunk) - Risks include third-party patent infringement proceedings and reliance on third-party vendors for brexanolone supply[241](index=241&type=chunk)[242](index=242&type=chunk) - Management and directors beneficially own approximately **6.5%** of common stock, potentially influencing corporate affairs[243](index=243&type=chunk) - The market price of common stock has been volatile (traded between **$2.83** and **$7.83** over the past year) and may continue to be so[244](index=244&type=chunk) - The Company has incurred significant operating losses in most years since inception (accumulated deficit of **$203.8 million** as of June 30, 2025) and expects continued losses due to R&D expenses for pipeline candidates[245](index=245&type=chunk)[246](index=246&type=chunk) [Item 5. Other Information](index=51&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted or terminated any Rule 10b5-1 trading arrangements during the second quarter of 2025 - No directors or executive officers adopted or terminated Rule 10b5-1 trading arrangements during Q2 2025[247](index=247&type=chunk) [Item 6. Exhibits](index=52&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including amendments to the Certificate of Incorporation, Certificate of Designation, certifications (Sarbanes-Oxley Act), and XBRL interactive data files - Includes amendments to Certificate of Incorporation (e.g., reduction of authorized common stock), Certificate of Designation of Preferred Stock, and various certifications (e.g., Sarbanes-Oxley Act)[250](index=250&type=chunk)

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. is hosting a virtual R&D investor event on July 9, 2025, focusing on postpartum depression (PPD) and featuring Dr. Kristina M. Deligiannidis [1][4] - LPCN 1154 (BRLIZIO™) is being developed as a potential first-line treatment for rapid symptom relief in women with PPD, with a 48-hour treatment duration in an outpatient setting [3][9] - The event will provide updates on clinical, regulatory, and development aspects, including a Phase 3 registrational study expected to read out in Q2-2026 [4] Company Overview - Lipocine is a biopharmaceutical company that utilizes a proprietary technology platform for effective oral delivery of therapeutics, targeting large markets with significant unmet medical needs [12] - The company has multiple drug candidates in development, including LPCN 2101 for epilepsy and LPCN 2203 for essential tremor, alongside LPCN 1154 for PPD [13] Postpartum Depression Insights - PPD is a serious mood disorder that can have adverse effects on maternal and infant health, with symptoms persisting up to 12 months after childbirth [2][10] - A survey indicated that obstetricians believe 20-40% of their patients may suffer from PPD, with 64% of affected women reporting comorbid anxiety symptoms [11]

Core Viewpoint - Lipocine Inc. announced that its licensing partner, Verity Pharma, has filed a New Drug Submission (NDS) for TLANDO® in Canada, marking a significant step towards making this oral testosterone replacement therapy available in the Canadian market [1][2]. Company Overview - Lipocine is a biopharmaceutical company focused on developing effective oral delivery of therapeutics using its proprietary technology platform [5]. - The company has several drug candidates in development, including LPCN 1154 for postpartum depression and LPCN 2101 for epilepsy, among others [6]. Product Information - TLANDO is the first and only oral testosterone replacement therapy approved by the FDA that does not require dose titration, targeting conditions associated with a deficiency of endogenous testosterone in adult males [4][6]. - The product was developed using Lipocine's proprietary Lip'ral drug delivery technology platform [4]. Market Opportunity - Canada has over 700,000 annual prescriptions for testosterone replacement therapy (TRT), with approximately 50% of patients covered by private insurance, indicating a substantial market opportunity for TLANDO [2][8]. - Limited promotional activities for existing TRTs in Canada may allow TLANDO to capture a significant market share [2].

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]