Lipocine(LPCN) - 2023 Q2 - Quarterly Report

PART I—FINANCIAL INFORMATION This part covers Lipocine Inc.'s unaudited financial statements and management's analysis for the first half of 2023 ITEM 1. FINANCIAL STATEMENTS Presents Lipocine Inc.'s unaudited condensed consolidated financial statements and accompanying notes for H1 2023 and FY 2022 Condensed Consolidated Balance Sheets Provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific dates Condensed Consolidated Balance Sheets Summary | Metric | June 30, 2023 | December 31, 2022 | | :-------------------------------- | :-------------- | :---------------- | | Assets | | | | Cash and cash equivalents | $5,014,695 | $3,148,496 | | Marketable investment securities | $20,775,275 | $29,381,410 | | Total current assets | $27,084,528 | $34,135,080 | | Total assets | $30,483,460 | $37,542,922 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $1,827,182 | $1,678,126 | | Warrant liability | $104,267 | $229,856 | | Total liabilities | $1,931,449 | $1,907,982 | | Total stockholders' equity | $28,552,011 | $35,634,940 | | Total liabilities and stockholders' equity | $30,483,460 | $37,542,922 | - Total assets decreased from $37.5 million at December 31, 2022, to $30.5 million at June 30, 2023, primarily driven by a reduction in marketable investment securities[10] - Cash and cash equivalents increased from $3.1 million at December 31, 2022, to $5.0 million at June 30, 2023[10] Condensed Consolidated Statements of Operations and Comprehensive Loss Presents the company's financial performance, including revenues, expenses, and net loss over specific periods Condensed Consolidated Statements of Operations and Comprehensive Loss Summary | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenues | $0 | $500,000 | $54,990 | $500,000 | | Research and development expenses | $2,515,211 | $2,898,012 | $5,621,521 | $4,785,965 | | General and administrative expenses | $1,440,394 | $1,129,519 | $2,727,708 | $2,373,205 | | Operating loss | $(3,955,605) | $(3,527,531) | $(8,294,239) | $(6,659,170) | | Net loss | $(3,548,629) | $(2,631,777) | $(7,418,859) | $(6,119,558) | | Basic loss per share | $(0.68) | $(0.50) | $(1.42) | $(1.17) | | Diluted loss per share | $(0.68) | $(0.61) | $(1.44) | $(1.20) | - Revenue for the three months ended June 30, 2023, was $0, a decrease from $500 thousand in the same period of 2022. For the six months, revenue decreased from $500 thousand in 2022 to $54,990 in 2023[12] - Net loss increased for both the three-month period (from $(2.6 million) to $(3.5 million)) and the six-month period (from $(6.1 million) to $(7.4 million)) year-over-year[12] Condensed Consolidated Statements of Changes in Stockholders' Equity Details changes in the company's equity, including net loss and stock-related transactions Condensed Consolidated Statements of Changes in Stockholders' Equity Summary | Metric | June 30, 2023 | December 31, 2022 | | :-------------------------- | :-------------- | :---------------- | | Total Stockholders' Equity | $28,552,011 | $35,634,940 | | Accumulated Deficit | $(190,843,991) | $(183,425,043) | - Total stockholders' equity decreased by approximately $7.1 million from December 31, 2022, to June 30, 2023, primarily due to the net loss incurred during the period[15] - The accumulated deficit increased by approximately $7.4 million during the first six months of 2023, reflecting the ongoing net losses[15] Condensed Consolidated Statements of Cash Flows Summarizes cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows Summary | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(7,418,859) | $(6,119,558) | | Cash used in operating activities | $(7,237,654) | $(6,931,731) | | Cash provided by investing activities | $9,115,069 | $11,083,460 | | Cash used in financing activities | $(11,216) | $(2,121,088) | | Net increase in cash and cash equivalents | $1,866,199 | $2,030,641 | | Cash and cash equivalents at end of period | $5,014,695 | $4,981,193 | - Cash used in operating activities increased slightly from $(6.9 million) in H1 2022 to $(7.2 million) in H1 2023[17] - Cash provided by investing activities decreased from $11.1 million in H1 2022 to $9.1 million in H1 2023, primarily due to changes in marketable investment securities[17] - Cash used in financing activities significantly decreased from $(2.1 million) in H1 2022 to $(11 thousand) in H1 2023, largely due to the full repayment of the SVB loan in 2022[17] (1) Basis of Presentation Outlines the accounting principles and assumptions used in preparing the financial statements - The unaudited condensed consolidated financial statements are prepared in accordance with SEC rules and U.S. GAAP, including normal recurring adjustments[20] - Management believes existing capital resources are sufficient to meet operating requirements through at least August 10, 2024, but additional capital will be needed to support operations beyond this period[23] - A 1-for-17 reverse stock split was approved by stockholders on May 10, 2023, and became effective on May 11, 2023, to meet Nasdaq listing requirements[24][25] (2) Revenue Details the company's revenue recognition policies and sources of revenue - Revenue is primarily generated from license and royalty arrangements, recognized when performance obligations are satisfied or milestones are achieved[27][29][30] Revenue by Period and Source | Period | 2023 Revenue | 2022 Revenue | | :-------------------------- | :----------- | :----------- | | Three Months Ended June 30 | $0 | $500,000 | | Six Months Ended June 30 | $54,990 | $500,000 | | Source (2023) | Spriaso (related-party) | N/A | | Source (2022) | N/A | Antares | - A contract asset of $579,428 as of June 30, 2023, is related to minimum royalty revenue from the Antares License Agreement, with an estimated payment expected in Q3 2023[31] (3) Earnings (Loss) per Share Presents basic and diluted earnings per share calculations for the reporting periods Earnings (Loss) per Share Summary | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Basic loss per share | $(0.68) | $(0.50) | $(1.42) | $(1.17) | | Diluted loss per share | $(0.68) | $(0.61) | $(1.44) | $(1.20) | | Weighted average common shares outstanding, basic | 5,234,830 | 5,234,141 | 5,234,830 | 5,228,608 | | Weighted average common shares outstanding, diluted | 5,234,830 | 5,263,389 | 5,234,830 | 5,262,993 | - Stock options (264,150) and warrants (49,433) were antidilutive and excluded from diluted EPS computation for the periods ended June 30, 2023 and 2022[34] (4) Marketable Investment Securities Describes the company's marketable investment securities and their fair value classification - Marketable investment securities are classified as available-for-sale debt securities, carried at fair value with unrealized gains/losses in accumulated other comprehensive income (loss)[35] Marketable Investment Securities Summary | Security Type | June 30, 2023 Fair Value | December 31, 2022 Fair Value | | :-------------------------------- | :----------------------- | :------------------------- | | Government treasury bills | $2,357,632 | $5,959,000 | | Corporate bonds, notes and commercial paper | $9,697,393 | $20,041,620 | | U.S. government agency securities | $8,720,250 | $3,380,790 | | Total | $20,775,275 | $29,381,410 | - No sales of marketable investment securities occurred, and no realized gains or losses were reported for the three and six months ended June 30, 2023 and 2022[35] (5) Fair Value Explains the fair value measurement of financial instruments using a three-level hierarchy - Financial instruments are valued using observable inputs, categorized into Level 1 (quoted prices in active markets), Level 2 (similar instruments/observable inputs), and Level 3 (unobservable inputs)[36] Fair Value Measurements Summary | Asset/Liability | June 30, 2023 Fair Value | Level 1 | Level 2 | Level 3 | | :-------------------------------- | :----------------------- | :-------- | :-------- | :-------- | | Cash equivalents - money market funds | $4,897,774 | $4,897,774 | $0 | $0 | | Government treasury bills | $2,357,632 | $2,357,632 | $0 | $0 | | Commercial paper | $7,339,702 | $0 | $7,339,702 | $0 | | Corporate bonds and notes | $2,357,691 | $0 | $2,357,691 | $0 | | U.S. Government agency securities | $8,720,250 | $0 | $8,720,250 | $0 | | Warrant liability | $104,267 | $0 | $0 | $104,267 | - The warrant liability is a Level 3 liability, valued using a Black-Scholes option-pricing model with assumptions including 100% volatility, 5.25% risk-free interest rate, $8.50 strike price, $5.04 common stock fair value, and 1.4 years expected life as of June 30, 2023[42] (6) Loan and Security Agreements Details the company's loan agreements, including repayment status - The $10.0 million Loan and Security Agreement with Silicon Valley Bank (SVB) was fully paid on June 1, 2022, including a $650 thousand Final Payment Charge[44] (7) Income Taxes Discusses the company's income tax position, including deferred tax assets and valuation allowances - The Company maintains a full valuation allowance against its deferred tax assets, as it is more likely than not that these benefits will not be realized[46] (8) Contractual Agreements Outlines key contractual obligations and agreements impacting the company's operations - The Company owes Abbott Products, Inc. a perpetual 1% royalty on net sales of TLANDO, capped at $1.0 million for the first two calendar years post-launch (June 7, 2022)[47] - Under the Antares License Agreement, the Company granted exclusive U.S. rights for TLANDO to Antares (now Halozyme), receiving an initial $11.0 million payment and eligible for $10.0 million in additional payments (2025, 2026) and up to $160.0 million in sales milestones, plus tiered royalties (mid-teens to 20%)[48][49] - Research and development expenses under contract agreements were $1.7 million and $2.1 million for the three months ended June 30, 2023 and 2022, respectively, and $3.8 million and $3.2 million for the six months ended June 30, 2023 and 2022, respectively[52] (9) Leases Describes the company's operating lease commitments for facilities - The Company has a non-cancelable operating lease for office and laboratory facilities in Salt Lake City, Utah, extended through February 28, 2024[53] Operating Lease Payments | Year Ending December 31 | Operating Lease Payments | | :------------------------ | :----------------------- | | 2023 | $178,678 | | 2024 | $59,559 | | Total | $238,237 | (10) Stockholders' Equity Details changes in stockholders' equity, including stock splits, offerings, and stock-based compensation - A 1-for-17 reverse stock split became effective on May 11, 2023, to maintain Nasdaq listing, with all common stock data retroactively adjusted[55][56][57] - The Company has an At-the-Market (ATM) Offering agreement with Cantor Fitzgerald & Co. to sell up to $50.0 million in common stock, with $15.7 million currently available for sale as of June 30, 2023, due to S-3 limitations[59][62] - Series B Preferred Stock was issued as a dividend on March 7, 2023, to facilitate the reverse stock split vote, and all shares were redeemed by June 30, 2023[63][65] Stock-Based Compensation Expense | Stock-Based Compensation Expense | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $83,229 | $63,021 | $178,742 | $142,673 | | General and administrative | $81,636 | $76,548 | $163,895 | $167,924 | | Total | $164,865 | $139,569 | $342,637 | $310,597 | Stock Option Activity | Stock Option Activity | Number of Shares | Weighted Average Exercise Price | | :---------------------- | :--------------- | :------------------------------ | | Balance at Dec 31, 2022 | 277,225 | $38.44 | | Options granted | 26,467 | $6.19 | | Options forfeited | (7,352) | $6.91 | | Options cancelled | (32,190) | $47.77 | | Balance at June 30, 2023 | 264,150 | $34.95 | | Options exercisable at June 30, 2023 | 167,770 | $48.55 | - The warrant liability from the November 2019 Offering, classified as a Level 3 liability, decreased from $229,856 at December 31, 2022, to $104,267 at June 30, 2023, primarily due to a decrease in stock price[86] (11) Commitments and Contingencies Summarizes the company's legal and contractual commitments and potential liabilities - The lawsuit against Clarus was resolved through a Global Agreement, amended in April 2022, settling all outstanding claims for a total payment of $1.25 million, with no future royalties[90] - A shareholder class action lawsuit (Solomon Abady v. Lipocine Inc. et al.) was dismissed with prejudice on April 14, 2023[91] (12) Agreement with Spriaso, LLC Details the license and services agreement with related-party Spriaso, LLC, and associated revenue - The Company has a license and services agreement with Spriaso, a related-party, for intellectual property in the cough and cold field, entitling the Company to a 20% royalty on net proceeds up to $10.0 million[94] - Licensing revenue from Spriaso was approximately $55 thousand for the six months ended June 30, 2023, with no revenue recognized for the three months ended June 30, 2023 or for either period in 2022[94] ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Management's discussion and analysis of Lipocine Inc.'s financial condition, operational results, product pipeline, liquidity, and capital resources Overview of Our Business Provides an overview of Lipocine's biopharmaceutical focus, proprietary platform, and product pipeline - Lipocine is a biopharmaceutical company leveraging its proprietary Lip'ral platform for oral delivery of difficult-to-deliver molecules, focusing on CNS disorders[98] - TLANDO®, an oral testosterone replacement therapy, was licensed to Antares (now Halozyme) and received FDA approval on March 28, 2022, with commercial launch on June 7, 2022[99] - Key pipeline candidates include LPCN 1154 for postpartum depression (PPD), LPCN 2101 for epilepsy, and LPCN 1148 for decompensated cirrhosis, with other assets (LPCN 1144, LPCN 1111, LPCN 1107) being explored for partnerships[100] Corporate Strategy Outlines the company's strategic focus on advancing CNS candidates and seeking partnerships for other assets - The Company's strategy focuses on advancing LPCN 1154 and other CNS product candidates, supporting TLANDO® commercialization by its licensee, and seeking partnerships for non-core pipeline assets (LPCN 1144, LPCN 1148, LPCN 1111, LPCN 1107, and TLANDO outside the U.S.)[103][104][105] - The Lip'ral drug delivery technology platform aims to improve bioavailability, reduce dose, and enhance absorption consistency for insoluble drugs[107] Our Development Pipeline Product Candidates Presents key product candidates in the development pipeline, including those for PPD, epilepsy, and cirrhosis LPCN 1154: Product Candidate for PPD Details the development of LPCN 1154, an oral brexanolone formulation for postpartum depression - LPCN 1154, an oral brexanolone formulation for PPD, is advancing to a pivotal PK study in Q4 2023, following positive pilot PK bridge study results in May 2023[110] - PPD affects approximately 500 thousand women annually in the U.S., with a significant unmet need for convenient, fast-acting oral therapies due to limitations of existing treatments like injectable brexanolone (Zulresso™) and the recently approved oral Zurzuvae™[111][113][114] LPCN 2101: NAS for Epilepsy Describes LPCN 2101, a neuroactive steroid candidate for women with epilepsy, and its development status - LPCN 2101, an NAS candidate for women with epilepsy (WWE), has completed pre-clinical and Phase 1 studies with promising PK results, safety, and tolerability; a Phase 2 proof-of-concept study is planned, subject to resource availability[118] - Epilepsy affects approximately 900 thousand childbearing-age women in the U.S., with 30% being refractory to current anti-seizure medications (ASMs) and facing challenges like hormonal influences on seizures, teratogenic risks of ASMs, and comorbidities like depression[121][122][124] - There is an unmet need for epilepsy treatments specifically for WWE of childbearing age that offer uncompromised ASM efficacy, minimal drug-drug interactions, low fetal-neonatal toxicity, and potential benefits for associated psychiatric comorbidities[127][129][130] LPCN 1148: Oral Product Candidate for the Management of Decompensated Cirrhosis Highlights LPCN 1148, an oral testosterone formulation for decompensated cirrhosis, and its clinical trial results - LPCN 1148, a testosterone laurate formulation for decompensated cirrhosis, met its primary endpoint in a Phase 2 POC study in July 2023, showing increased skeletal muscle index (L3-SMI) and improvements in clinical outcomes like prevention of new decompensation events and hospitalizations[132][134] - The study demonstrated LPCN 1148 was well-tolerated with adverse event rates similar to placebo, no mortality, and no drug-induced liver injury[134] - Cirrhosis affects over 2 million worldwide, with 500 thousand decompensated cases in the U.S., leading to significant mortality and economic burden, and common complications including sarcopenia and hepatic encephalopathy[135][137][138] Our Partnership Pipeline Product Candidates Discusses product candidates for which the company is seeking partnerships for further development or commercialization - The Company is actively seeking partnerships for the continued development and/or marketing of LPCN 1144, LPCN 1148, LPCN 1111, LPCN 1107, and TLANDO outside the U.S., as it does not anticipate significant internal development activities for these without a partner[139] TLANDO: An Oral Product for Testosterone Replacement Therapy Provides an update on TLANDO, an oral testosterone replacement therapy licensed for U.S. commercialization - TLANDO, an oral TRT, is exclusively licensed to Antares (now Halozyme) for U.S. commercialization, with the Company eligible for future payments and tiered royalties (mid-teens to 20%) on net sales[140][143][194] - The Company incurred royalty expense of approximately $9 thousand and $13 thousand for the three and six months ended June 30, 2023, respectively, to Abbott Products, Inc. for TLANDO net sales[141] - Antares is responsible for FDA-required post-marketing studies and Pediatric Research Equity Act (PREA) requirements for TLANDO[142] LPCN 1144: An Oral Prodrug of Bioidentical Testosterone Product Candidate for the Treatment of NASH Details LPCN 1144, a testosterone prodrug for NASH, including its clinical trial results and regulatory status - LPCN 1144, for non-cirrhotic NASH, completed a Phase 2 LiFT study where both treatment arms met the accelerated approval endpoint of NASH resolution with no worsening of fibrosis, showing robust liver fat reduction and improved liver injury markers[148][150][152] - The FDA granted Fast Track Designation to LPCN 1144 in November 2021 and agreed to a 505(b)2 regulatory pathway and the proposed primary surrogate endpoint for accelerated approval, recommending a Phase 3 trial of 72 weeks[153][154] - NASH is a rapidly increasing liver disease strongly correlated with obesity and metabolic syndrome, affecting 15-20% of the NAFLD population in the U.S., with no currently approved therapy[146] LPCN 1111: A Next-Generation Long-Acting Oral Product Candidate for TRT Describes LPCN 1111, a next-generation oral testosterone replacement therapy candidate, and its development path - LPCN 1111, a next-generation oral TRT candidate, completed a Phase 2b dose-finding study in 2016, demonstrating good dose-response and tolerability[156] - The Company is scaling up manufacturing for potential partners to conduct pivotal studies, with FDA feedback indicating a Phase 3 trial design following ICH guidelines, including a 3-month efficacy and 1-year safety component for approximately 100 subjects[155][157] - Antares' option to license LPCN 1111 expired on June 30, 2022, and was not exercised, retaining all development and commercialization rights with Lipocine[157] LPCN 1107: An Oral Product Candidate for the Prevention of Preterm Birth Presents LPCN 1107, an oral hydroxyprogesterone caproate product for preventing preterm birth - LPCN 1107, an oral hydroxyprogesterone caproate (HPC) product for preventing preterm birth (PTB), completed a multi-dose PK study in pregnant women, showing comparable or higher HPC levels than injectable HPC (Makena®)[159][160] - The FDA granted orphan drug designation to LPCN 1107, qualifying it for development incentives[162] - The FDA withdrew approval for Makena® (injectable HPC) in April 2023 due to lack of verified clinical benefit, highlighting an urgent unmet need for effective PTB treatments and potentially impacting the development path for LPCN 1107[163][164] Financial Operations Overview Provides an overview of the company's revenue sources, research and development, and general and administrative expenses - The Company has not generated product sales revenue to date, relying on license fees, royalties, and milestone payments, with $44.8 million in total revenue since inception through June 30, 2023[165] - Research and development expenses, totaling approximately $142.7 million since inception through June 30, 2023, are expensed as incurred and are expected to remain significant due to ongoing clinical studies for CNS candidates and LPCN 1148[166][167] - General and administrative expenses are expected to increase as a public company, including legal, accounting, and business development fees, but may be reduced if additional capital cannot be raised[172][174] - Other income and expense primarily includes interest and investment income, warrant liability gains/losses, and litigation settlement gains[175] Results of Operations Compares financial performance metrics for the three and six months ended June 30, 2023, versus 2022 Results of Operations (Three Months Ended June 30) Three Months Ended June 30, 2023 vs. 2022: | Metric | 2023 | 2022 | Variance | | :-------------------------------- | :----------- | :----------- | :----------- | | Revenue | $0 | $500,000 | $(500,000) | | Research and development expenses | $2,515,211 | $2,898,012 | $(382,801) | | General and administrative expenses | $1,440,394 | $1,129,519 | $310,875 | | Interest and investment income | $379,521 | $69,877 | $309,644 | | Gain on warrant liability | $27,455 | $583,445 | $(555,990) | | Gain on litigation settlement | $0 | $250,000 | $(250,000) | Results of Operations (Six Months Ended June 30) Six Months Ended June 30, 2023 vs. 2022: | Metric | 2023 | 2022 | Variance | | :-------------------------------- | :----------- | :----------- | :----------- | | Revenue | $54,990 | $500,000 | $(445,010) | | Research and development expenses | $5,621,521 | $4,785,965 | $835,556 | | General and administrative expenses | $2,727,708 | $2,373,205 | $354,503 | | Interest and investment income | $749,991 | $111,453 | $638,538 | | Gain on warrant liability | $125,589 | $205,457 | $(79,868) | | Gain on litigation settlement | $0 | $250,000 | $(250,000) | - Interest and investment income significantly increased in both periods due to higher interest rates and imputed interest on the Antares License Agreement asset[180][188] - Research and development expenses increased by $835,556 for the six months ended June 30, 2023, primarily due to increased costs for LPCN 1148 and LPCN 1154 clinical studies and personnel, partially offset by decreases in LPCN 1144, LPCN 1111, and LPCN 1107 related costs[186] Liquidity and Capital Resources Assesses the company's cash position, capital resources, and future funding needs for operations and clinical studies - As of June 30, 2023, the Company had $25.8 million in unrestricted cash, cash equivalents, and marketable investment securities, down from $32.5 million at December 31, 2022[193] - Existing capital resources are projected to be sufficient for operating requirements through at least the next twelve months, but additional capital will be needed for future operations and clinical studies[201] - The Company has an At-the-Market (ATM) Offering with $15.7 million currently available for sale, but funding may not be available on favorable terms, potentially requiring delays or reductions in development programs[199][202] Sources and Uses of Cash Analyzes cash flows from operating, investing, and financing activities for the first half of 2023 and 2022 Cash Flow Activities Summary | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash used in operating activities | $(7,237,654) | $(6,931,731) | | Cash provided by investing activities | $9,115,069 | $11,083,460 | | Cash used in financing activities | $(11,216) | $(2,121,088) | - Net cash used in operating activities increased to $7.2 million in H1 2023, primarily for LPCN 1148 and LPCN 1154 clinical studies[205][206] - Net cash provided by investing activities decreased to $9.1 million in H1 2023, mainly from marketable investment securities maturities[207][208] - Net cash used in financing activities significantly decreased to $11 thousand in H1 2023, compared to $2.1 million in H1 2022, due to the prior year's SVB loan repayment[209][210] Contractual Commitments and Contingencies Summarizes the company's contractual obligations and potential liabilities - The SVB Loan and Security Agreement was fully paid in June 2022[211] - The Company enters into cancellable contracts and purchase orders for clinical trials, manufacturing, and research services[212] - The operating lease for its Salt Lake City facility was extended through February 28, 2024[213] Critical Accounting Policies and Significant Judgments and Estimates Confirms no material changes to critical accounting policies during the first six months of 2023 - No significant material changes occurred in critical accounting policies during the six months ended June 30, 2023, compared to those disclosed in the 2022 Form 10-K[214][215] ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS Details Lipocine Inc.'s exposure to market risks, primarily from interest rate fluctuations, with no material changes reported - The Company is exposed to market risks, including potential losses from adverse changes in interest rates[217] - No material changes to the Company's market risk occurred during the first six months of 2023[218] ITEM 4. CONTROLS AND PROCEDURES Confirms the effectiveness of Lipocine Inc.'s disclosure controls and internal control over financial reporting as of June 30, 2023 - The Company's disclosure controls and procedures were evaluated and deemed effective as of June 30, 2023[219][220] - No material changes in internal control over financial reporting occurred during the most recent fiscal quarter[221] PART II—OTHER INFORMATION This part includes legal proceedings, risk factors, equity sales, defaults, mine safety, and exhibits ITEM 1. LEGAL PROCEEDINGS Refers to Note 11 for details on the Company's legal proceedings arising in the ordinary course of business - Information regarding legal proceedings is detailed in Note 11 – Commitments and Contingencies to the condensed consolidated financial statements[223] ITEM 1A. RISK FACTORS Updates risk factors related to common stock ownership, financial position, warrant volatility, and Nasdaq listing compliance - The value of outstanding warrants from the November 2019 Offering is subject to material fluctuations based on the Company's common stock price and other Black-Scholes model assumptions[225][226] - The market price of the Company's common stock has been volatile, trading between $3.53 and $13.99 per share over the past year (post-reverse stock split), and may continue to fluctuate significantly[228] - The Company has incurred significant operating losses since inception, with an accumulated deficit of $190.8 million as of June 30, 2023, and expects continued losses, which could adversely affect stockholders' equity and working capital[229] - Failure to maintain compliance with Nasdaq listing rules, including the minimum bid price of $1.00 per share, could result in delisting, leading to reduced liquidity and trading activity for its securities[232][233] ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS Reports no unregistered sales of equity securities or use of proceeds for the period - No unregistered sales of equity securities or use of proceeds to report[234] ITEM 3. DEFAULTS UPON SENIOR SECURITIES States no defaults upon senior securities occurred during the reporting period - No defaults upon senior securities to report[235] ITEM 4. MINE SAFETY DISCLOSURES Confirms no mine safety disclosures are applicable to the Company - No mine safety disclosures to report[236] ITEM 5. OTHER INFORMATION Indicates no other information to report for the period - No other information to report[237] ITEM 6. EXHIBITS Provides a comprehensive list of exhibits filed with the Form 10-Q, including various corporate documents, certifications, and XBRL-related files - The report includes an index of exhibits, such as Amended and Restated Bylaws, Certificates of Incorporation, Certificates of Designation for Preferred Stock, and various certifications (e.g., Sarbanes-Oxley Act)[239] - XBRL (eXtensible Business Reporting Language) documents, including the instance document, schema, calculation, definition, labels, and presentation linkbase documents, are filed as part of the exhibits[239]