Financial Performance - As of September 30, 2021, the company had an accumulated deficit of $185.3 million, with a net loss of $13.3 million for the nine months ended September 30, 2021, compared to $16.5 million for the same period in 2020[89]. - The company has not generated any revenues from product sales and does not expect to do so until regulatory approval is obtained for TLANDO or other products[88]. - The company recorded a litigation settlement expense of $4.0 million during the nine months ended September 30, 2021, related to the Global Agreement with Clarus[162]. - The company has generated $28.1 million in revenue from license fees, royalties, and government grants since inception through September 30, 2021[138]. - Cash used in operating activities for the nine months ended September 30, 2021, was $13.4 million, compared to $11.6 million for the same period in 2020[178]. - Cash used in investing activities increased significantly to $34.1 million in 2021 from $1.5 million in 2020[177]. - Financing activities provided $27.8 million in cash during the nine months ended September 30, 2021, compared to $16.3 million in 2020[177]. - The company anticipates needing to raise additional capital to support operations, including ongoing clinical studies and regulatory compliance[174]. Product Development and Regulatory Approvals - The company received tentative approval from the FDA for TLANDO on December 8, 2020, but final approval is contingent upon the expiration of Clarus Therapeutics' exclusivity period for JATENZO®, which ends on March 27, 2022[84][94]. - TLANDO's resubmission to the FDA will be a Class 1 resubmission, which includes a two-month review goal period[84][94]. - The FDA granted Fast Track Designation to LPCN 1144 for non-cirrhotic NASH, aimed at expediting its development and review[119]. - The FDA granted tentative approval for TLANDO as a testosterone replacement therapy (TRT) in adult males, but final approval is pending until March 27, 2022[140]. - The company plans to initiate a Phase 2 proof-of-concept study for LPCN 1148 in male cirrhotic subjects, targeting approximately 48 to 60 patients[126]. - LPCN 1107 aims to become the first oral product indicated for the reduction of preterm birth risk, addressing a significant unmet need as 11.7% of U.S. pregnancies result in preterm birth[129]. - The FDA has granted orphan drug designation to LPCN 1107, qualifying the company for various development incentives[134]. Clinical Trials and Research - LPCN 1144, currently in Phase 2 testing, showed robust liver fat reduction and improvement in liver injury markers in the LiFT clinical study, with positive results released in January and August 2021[87]. - The LiFT Phase 2 clinical study enrolled 56 male subjects with confirmed non-cirrhotic NASH, showing significant liver fat reduction at Week 12: Treatment A had a -7.7% change and Treatment B had a -9.2% change compared to placebo's -1.7%[106][110]. - In subjects with liver fat ≥ 5% at baseline, Treatment A and B showed a mean relative liver fat reduction of -40.0% and -46.9%, respectively, both statistically significant[111]. - 66.7% of subjects in Treatment A and 63.2% in Treatment B achieved over 30% relative reduction in liver fat at Week 12, compared to 15.8% in the placebo group[112]. - Both treatment arms of LPCN 1144 met the pre-specified regulatory endpoint of NASH resolution with no worsening of fibrosis, with 54% and 69% responders in Treatments A and B, respectively[114]. - A previous 16-week POC study showed that 48% of treated NAFLD subjects achieved resolution, with a mean liver fat reduction of 55% in this group[120]. - TLANDO XR, a next-generation oral testosterone product, completed a Phase 2b study, identifying the Phase 3 dose with good dose-response relationships observed[121]. - TLANDO XR was well tolerated in clinical studies, with no severe or serious drug-related adverse events reported[121]. Licensing and Agreements - The Antares License Agreement includes an initial payment of $11.0 million and potential milestone payments of up to $160.0 million, along with tiered royalty payments ranging from mid-teens to 20% of net sales of TLANDO in the U.S.[96]. - The company entered into the Antares License Agreement, granting Antares exclusive rights to develop and commercialize TLANDO, with an initial payment of $11.0 million and potential milestone payments of up to $160.0 million[165]. - The company is exploring licensing LPCN 1107 to a third party, although no agreements have been finalized[133]. Financial Position and Expenses - Research and development expenses totaled approximately $126.3 million since inception through September 30, 2021[139]. - Research and development expenses for the three months ended September 30, 2021, were $2,366,521, a decrease of $121,340 compared to $2,487,861 in 2020[149]. - Total research and development expenses for the nine months ended September 30, 2021, were $5,411,748, down from $7,268,599 in 2020, reflecting a decrease of $1,856,851[156]. - General and administrative expenses for the three months ended September 30, 2021, were $1,222,146, a decrease of $665,049 from $1,887,195 in 2020[149]. - The company expects research and development expenses to increase in the future as ongoing clinical studies are completed, including studies for LPCN 1144, LPCN 1148, LPCN 1154, and LPCN 1107[144]. - The company anticipates a decrease in general and administrative expenses due to reduced legal fees from the settlement with Clarus, although this may be offset by increases in other areas[147]. Cash Flow and Capital Management - As of September 30, 2021, the company had $38.7 million in unrestricted cash, cash equivalents, and marketable investment securities, compared to $19.7 million at December 31, 2020[164]. - The gross proceeds from the January 2021 public offering were approximately $28.7 million, after deducting underwriter fees and expenses of $1.9 million[166]. - The company had no capital expenditures for the nine months ended September 30, 2021, and 2020[180]. - The net proceeds from the sale of 16,428,571 shares of common stock in January 2021 generated $26.8 million[182]. - The company received a PPP loan of $234,000 at a 1.0% interest rate, which was fully forgiven by the Small Business Administration[167]. - The company received a PPP Loan of approximately $234,000, which was forgiven as per the terms of the CARES Act[185]. Risk Factors - The company is subject to various risks regarding the realization of milestone and royalty payments from the Antares License Agreement[165]. - The fair value of the investment portfolio is subject to interest rate risk, but a hypothetical ten percent increase in interest rates would have an insignificant impact on the consolidated financial statements[191]. - The company does not hedge interest rate exposures and invests in highly liquid, investment-grade securities[191]. - A one percent increase in the prime rate would result in a $10,000 increase in interest expense, while a one percent decrease would lead to an $11,000 decrease[192].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarterly Period ended June 30, 2021 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarterly Period ended March 31, 2021 ¨ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorp ...

For Quarterly Period ended September 30, 2020 ¨ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . FORM 10-Q x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporatio ...

WASHINGTON, D.C. 20549 FORM 10-Q x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION For Quarterly Period ended June 30, 2020 ¨ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or Organization) 675 Arapeen Drive, Suite 202, Salt Lake City, Utah 84108 (Address of Principal Executive Offices) (Zip Code) FORM 10-Q x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarterly Period ended March 31, 2020 ¨ T ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or Organization) 675 Arapeen Drive, Suite 202, Salt Lake City, Utah 84108 (Address of Principal Executive Offices) (Zip Code) FORM 10-K (IRS Employer Identification No.) Commission File Number: 001-36357 801-994-7383 LIPOCINE INC. (Registrant's telephone number, including area code) (Exact name of registrant as specified in its charter) Securities registered pursuant to S ...

[PART I—FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss and decreased assets for the period, with a significant regulatory setback for its lead drug candidate TLANDO Condensed Consolidated Balance Sheet (Unaudited) | | September 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Total current assets** | $17,310,742 | $20,809,203 | | **Total assets** | $17,341,910 | $20,851,953 | | **Total current liabilities** | $5,234,733 | $4,491,748 | | **Total liabilities** | $9,836,570 | $11,418,280 | | **Total stockholders' equity** | $7,505,340 | $9,433,673 | Condensed Consolidated Statements of Operations (Unaudited) | | Three Months Ended Sep 30, 2019 | Three Months Ended Sep 30, 2018 | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | **Total revenues** | $164,990 | $0 | $164,990 | $428,031 | | **Operating loss** | $(2,975,688) | $(2,353,056) | $(9,451,538) | $(8,154,451) | | **Net loss** | $(3,060,200) | $(2,459,072) | $(9,715,269) | $(8,434,543) | | **Basic and Diluted loss per share** | $(0.12) | $(0.12) | $(0.40) | $(0.40) | Condensed Consolidated Statements of Cash Flows (Unaudited, Nine Months Ended) | | September 30, 2019 | September 30, 2018 | | :--- | :--- | :--- | | **Cash used in operating activities** | $(8,358,175) | $(9,845,998) | | **Cash provided by investing activities** | $2,440,822 | $6,347,294 | | **Cash provided by financing activities** | $4,504,322 | $10,090,761 | | **Net (decrease) increase in cash** | $(1,413,031) | $6,592,057 | - The company received a **Complete Response Letter (CRL)** from the FDA regarding its New Drug Application (NDA) for TLANDO on November 8, 2019[75](index=75&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company discusses the FDA's rejection of its lead candidate TLANDO, pipeline progress, and significant going concern risks due to limited capital [Overview of Our Business](index=23&type=section&id=Overview%20of%20Our%20Business) The company's lead candidate TLANDO received a CRL from the FDA due to efficacy endpoint failures, while its NASH candidate LPCN 1144 advances - On November 8, 2019, the company received a **Complete Response Letter (CRL)** from the FDA for its TLANDO New Drug Application (NDA)[79](index=79&type=chunk) - The CRL identified one deficiency: the efficacy trial **did not meet the three secondary endpoints** for maximal testosterone concentrations (Cmax)[80](index=80&type=chunk) - The company's pipeline includes LPCN 1144 for pre-cirrhotic NASH, TLANDO XR (next-gen TRT), LPCN 1148 for NASH cirrhosis, and LPCN 1107 for prevention of preterm birth[81](index=81&type=chunk) [Our Product Candidates](index=26&type=section&id=Our%20Product%20Candidates) The pipeline is led by TLANDO, which received a CRL, while LPCN 1144 for NASH shows progress and other candidates face funding-dependent delays - **TLANDO**: Received a CRL on November 8, 2019, because the efficacy trial did not meet three Cmax secondary endpoints[90](index=90&type=chunk) - **LPCN 1144 (NASH)**: Currently in the LiFT Phase 2 clinical study, with top-line liver fat reduction data expected in mid-2020 and 36-week biopsy data by late 2020 or early 2021[120](index=120&type=chunk) - **LPCN 1107 (Preterm Birth)**: The company does not anticipate initiating a Phase 3 study in 2019 unless additional capital is secured or the product is out-licensed[130](index=130&type=chunk)[131](index=131&type=chunk) - **LPCN 1148 (NASH Cirrhosis)**: The company expects to file an Investigational New Drug (IND) application by December 31, 2019[127](index=127&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Operating expenses increased year-over-year, driven by higher R&D costs for the LPCN 1144 study and increased G&A legal fees Comparison of Operations (Three Months Ended Sep 30) | | 2019 | 2018 | Variance | | :--- | :--- | :--- | :--- | | **License revenue** | $164,990 | $0 | $164,990 | | **Research and development expenses** | $1,713,417 | $1,422,919 | $290,498 | | **General and administrative expenses** | $1,427,261 | $930,137 | $497,124 | Comparison of Operations (Nine Months Ended Sep 30) | | 2019 | 2018 | Variance | | :--- | :--- | :--- | :--- | | **License revenue** | $164,990 | $428,031 | $(263,041) | | **Research and development expenses** | $5,626,883 | $4,282,823 | $1,344,060 | | **General and administrative expenses** | $3,989,645 | $4,299,659 | $(310,014) | - The increase in Q3 2019 R&D expenses was primarily due to costs related to the **LPCN 1144 LiFT Phase 2 clinical study**[147](index=147&type=chunk) - The increase in Q3 2019 G&A expenses was primarily due to a **$565,000 increase in legal fees**, mainly from the patent infringement lawsuit against Clarus[148](index=148&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) Existing capital is only sufficient through March 2020, creating substantial doubt about its ability to continue as a going concern - The company believes its existing capital resources will be sufficient to meet projected operating requirements **only through at least March 31, 2020**[163](index=163&type=chunk) - The company will need to raise additional capital to support operations, and if unsuccessful, its ability to continue as a **going concern will become a risk**[163](index=163&type=chunk) - As of September 30, 2019, the company had sold 6,261,342 shares under its ATM Sales Agreement, resulting in **net proceeds of approximately $18.2 million** since program inception[162](index=162&type=chunk) - The company has a $10.0 million loan with Silicon Valley Bank, which requires maintaining **$5.0 million of restricted cash** as collateral until TLANDO is approved by the FDA[157](index=157&type=chunk)[158](index=158&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) The company is exposed to interest rate risk from its investment portfolio and variable-rate debt with Silicon Valley Bank - The company's investment portfolio is subject to interest rate risk, but a hypothetical 10% increase in rates is **not expected to have a significant impact** on the fair value of its marketable securities[181](index=181&type=chunk) - The company's **$10.0 million loan from SVB** bears interest at a variable rate, and a 1% increase in the prime rate would result in a $79,000 increase in future annual interest expense[182](index=182&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective as of September 30, 2019**[185](index=185&type=chunk) - **No material changes** in internal control over financial reporting occurred during the most recent fiscal quarter[186](index=186&type=chunk) [PART II—OTHER INFORMATION](index=47&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in multiple legal proceedings, including patent litigation with Clarus and a shareholder derivative lawsuit - On April 2, 2019, Lipocine filed a lawsuit against Clarus Therapeutics alleging that its JATENZO® product **infringes six of Lipocine's U.S. patents**[190](index=190&type=chunk) - A **shareholder derivative complaint** was filed on February 15, 2019, against certain officers and directors for alleged breaches of fiduciary duty[189](index=189&type=chunk) - Clarus has appealed a December 2018 PTAB ruling that was in favor of Lipocine, which had **canceled all claims in a Clarus patent**[188](index=188&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.Risk%20Factors) Key risks include the uncertain approval of TLANDO, significant going concern risk due to funding needs, ongoing litigation, and stock price volatility - The company's business depends primarily on the success of TLANDO, which recently received its **third Complete Response Letter (CRL)** from the FDA[192](index=192&type=chunk)[193](index=193&type=chunk) - The company will need substantial additional capital as existing resources are only projected to last through **March 31, 2020**, creating a going concern risk[203](index=203&type=chunk) - The company is engaged in **patent litigation with Clarus** and defending a shareholder derivative lawsuit, which will require substantial costs and resources[199](index=199&type=chunk)[202](index=202&type=chunk) - The company's common stock is **thinly traded**, with an average daily volume of approximately 147,000 shares in Q3 2019, which can lead to significant price volatility[207](index=207&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported[209](index=209&type=chunk) [Exhibits](index=53&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including officer certifications and XBRL data files

[PART I—FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section provides the company's unaudited financial statements, management's analysis of financial condition and operations, market risk disclosures, and internal controls [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Lipocine Inc. as of June 30, 2019, including the balance sheet, statement of operations, statement of changes in stockholders' equity, and statement of cash flows Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2019 ($) | December 31, 2018 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,664,319 | $8,077,539 | | Total current assets | $19,641,755 | $20,809,203 | | Total assets | $19,676,783 | $20,851,953 | | **Liabilities & Equity** | | | | Total current liabilities | $4,442,820 | $4,491,748 | | Total liabilities | $9,826,577 | $11,418,280 | | Total stockholders' equity | $9,850,206 | $9,433,673 | Condensed Consolidated Statements of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2019 ($) | Six Months Ended June 30, 2019 ($) | | :--- | :--- | :--- | | Total revenues | $0 | $0 | | Research and development | $1,964,146 | $3,913,466 | | General and administrative | $1,386,457 | $2,562,385 | | Operating loss | ($3,350,603) | ($6,475,851) | | Net loss | ($3,430,597) | ($6,655,069) | | Basic and Diluted loss per share | ($0.14) | ($0.28) | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2019 ($) | Six Months Ended June 30, 2018 ($) | | :--- | :--- | :--- | | Cash used in operating activities | ($5,560,807) | ($6,486,336) | | Cash used in investing activities | ($3,530,190) | ($122,334) | | Cash provided by financing activities | $4,677,777 | $10,000,000 | | Net (decrease) in cash | ($4,413,220) | $3,391,330 | - The company believes its existing capital resources are sufficient to meet operating requirements through at least March 31, 2020, but will need to raise additional capital to support long-term operations and commercialization of TLANDO, if approved[22](index=22&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Lipocine is a clinical-stage biopharmaceutical company focused on oral drug delivery for metabolic and endocrine disorders, with its lead candidate TLANDO having an FDA PDUFA goal date of November 9, 2019 [Overview of Our Business](index=21&type=section&id=Overview%20of%20Our%20Business) - Lipocine is a clinical-stage biopharmaceutical company developing oral drug products for metabolic and endocrine disorders using its proprietary delivery technologies[72](index=72&type=chunk) - The most advanced product candidate, TLANDO™, is an oral testosterone replacement therapy, with its New Drug Application (NDA) accepted by the FDA and a Prescription Drug User Fee Act (PDUFA) goal date of November 9, 2019[72](index=72&type=chunk) - The company has incurred losses in most years since inception, with an accumulated deficit of **$145 million** as of June 30, 2019, and a net loss of **$6.7 million** for the first six months of 2019[77](index=77&type=chunk) [Our Product Candidates](index=22&type=section&id=Our%20Product%20Candidates) - The FDA accepted the NDA for TLANDO with a PDUFA goal date of November 9, 2019, following a previous Complete Response Letter (CRL) in May 2018, which the company believes has been addressed through an ABPM clinical study and a definitive phlebotomy study[82](index=82&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk) - LPCN 1144, an oral testosterone product for pre-cirrhotic non-alcoholic steatohepatitis (NASH), has completed a Proof-Of-Concept study showing significant liver fat reduction, and a Phase 2 paired-biopsy study (LiFT) has been initiated[74](index=74&type=chunk)[75](index=75&type=chunk)[115](index=115&type=chunk) - Other pipeline candidates include TLANDO XR (LPCN 1111) for once-daily TRT, LPCN 1148 for NASH cirrhosis, and LPCN 1107 for prevention of preterm birth, with development of LPCN 1107 paused pending additional capital or out-licensing[74](index=74&type=chunk)[79](index=79&type=chunk)[127](index=127&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Comparison of Operating Results (Three Months Ended June 30) | Expense Category | 2019 ($) | 2018 ($) | Variance ($) | | :--- | :--- | :--- | :--- | | Research and development | $1,964,146 | $1,482,378 | $481,768 | | General and administrative | $1,386,457 | $1,682,031 | ($295,574) | - R&D expenses increased in Q2 2019 primarily due to costs for the LPCN 1144 Phase 2 study and activities related to the TLANDO NDA filing[144](index=144&type=chunk) - G&A expenses decreased in Q2 2019 mainly due to lower personnel costs following the elimination of the commercial sales and marketing team in 2018[145](index=145&type=chunk) Comparison of Operating Results (Six Months Ended June 30) | Category | 2019 ($) | 2018 ($) | Variance ($) | | :--- | :--- | :--- | :--- | | License revenue | $0 | $428,031 | ($428,031) | | Research and development | $3,913,466 | $2,859,905 | $1,053,561 | | General and administrative | $2,562,385 | $3,369,522 | ($807,137) | [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2019, the company had **$14.5 million** in unrestricted cash, cash equivalents, and marketable securities, plus **$5.0 million** in restricted cash[153](index=153&type=chunk) - The company believes existing capital is sufficient to fund operations through at least March 31, 2020, but will require additional capital for long-term development and commercialization[159](index=159&type=chunk) - During the first six months of 2019, the company raised net proceeds of **$6.3 million** from its "at the market" (ATM) offering and made **$1.7 million** in debt principal repayments[168](index=168&type=chunk) - The company has a **$10.0 million** loan with Silicon Valley Bank (SVB), which requires maintaining **$5.0 million** in restricted cash as collateral until TLANDO is approved by the FDA[154](index=154&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) The company's primary market risk exposure is to interest rate fluctuations, affecting its investment portfolio and variable-rate debt, with a hypothetical 10% interest rate increase having an insignificant impact on marketable securities - The company's main market risk is interest rate risk on its investment portfolio and variable-rate debt[176](index=176&type=chunk) - The investment portfolio consists of high-quality, liquid, investment-grade securities, with a hypothetical **10% increase** in interest rates deemed to have an insignificant impact on the portfolio's fair value[177](index=177&type=chunk) - The company has a **$10.0 million** variable-rate loan with SVB, where a **one percent change** in the prime rate would result in a change of approximately **$96,000 to $119,000** in future interest expense[178](index=178&type=chunk) [Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2019, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2019[181](index=181&type=chunk) - There were no changes in internal control over financial reporting during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, internal controls[182](index=182&type=chunk) [PART II—OTHER INFORMATION](index=44&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section details legal proceedings, updated risk factors, and other required disclosures including equity sales, defaults, and exhibits [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in several legal matters, including an appeal by Clarus Therapeutics regarding a PTAB judgment, a shareholder derivative complaint, and a patent infringement lawsuit filed by Lipocine against Clarus - Clarus Therapeutics has appealed a December 2018 PTAB ruling that canceled all claims in its '428 patent after an interference proceeding where Lipocine was granted priority of invention[184](index=184&type=chunk) - A shareholder derivative complaint was filed in February 2019 against certain current and former officers and directors, alleging breaches of fiduciary duty related to statements about the TLANDO NDA filing[185](index=185&type=chunk) - In April 2019, Lipocine filed a patent infringement lawsuit against Clarus, alleging that its JATENZO® product infringes six of Lipocine's U.S. patents[186](index=186&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) This section highlights updated risks, emphasizing the company's primary dependence on the success of its lead product candidate, TLANDO, and the need for substantial additional capital - The company's success is primarily dependent on TLANDO, which has received two Complete Response Letters (CRLs) from the FDA, and despite an NDA resubmission with a PDUFA date of November 9, 2019, there is no guarantee of approval[188](index=188&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk) - The company faces risks from ongoing litigation, including a shareholder derivative suit and patent disputes, which could require substantial costs and divert management attention[197](index=197&type=chunk)[199](index=199&type=chunk) - Substantial additional capital is needed to fund operations beyond March 31, 2020, and failure to secure financing could force the company to delay, reduce, or cease operations[204](index=204&type=chunk) - The company's common stock is thinly traded, which can lead to significant price volatility and may make it difficult for stockholders to sell shares[202](index=202&type=chunk)[203](index=203&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=50&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[209](index=209&type=chunk) [Defaults Upon Senior Securities](index=50&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[210](index=210&type=chunk) [Mine Safety Disclosures](index=50&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[211](index=211&type=chunk) [Other Information](index=50&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - None[212](index=212&type=chunk) [Exhibits](index=51&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer, and XBRL data files - The exhibits filed include CEO and CFO certifications under Sections 302 and 906 of the Sarbanes-Oxley Act, and XBRL interactive data files[215](index=215&type=chunk)