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]

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].

Company Overview - Lipocine Inc. is a biopharmaceutical company focused on effective oral delivery of therapeutics, leveraging its proprietary technology platform [7] - TLANDO is a testosterone replacement therapy approved by the US FDA for adult males with testosterone deficiency, developed using Lipocine's Lip'ral drug delivery technology [4][8] Partnership and Market Opportunity - Lipocine has entered into a license and supply agreement with Aché Laboratórios Farmacêuticos S.A, granting exclusive rights to market TLANDO in Brazil [1][3] - The Brazilian market for prescription testosterone products is substantial, with a compound annual growth rate (CAGR) of 34% from 2019 to 2023, and currently no oral testosterone therapy registered in Brazil [2] Aché's Profile - Aché is a leading Brazilian pharmaceutical company with nearly 60 years of experience, focusing on improving lives through a diverse portfolio that includes prescription medications, generics, and OTC products [5][6] - Aché has over 350 brands and 900 drug presentations across more than 150 therapeutic categories, reaching over 20 countries [6] Financial Terms of the Agreement - Under the agreement, Lipocine received an upfront payment and is eligible for additional payments upon achieving regulatory milestones, as well as royalties on net sales [3] - Aché will handle the regulatory submission and approval process in Brazil, leveraging its established commercial capabilities and regulatory expertise [3]

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]