UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-K WASHINGTON, D.C. 20549 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 ...

PART I—FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's total assets decreased to $39.4 million as of September 30, 2022, from $52.5 million at year-end 2021, primarily due to a reduction in cash and marketable securities used to fund operations. For the nine months ended September 30, 2022, the company reported a net loss of $8.5 million, an improvement from a $13.3 million net loss in the prior-year period, mainly due to a gain on litigation settlement and lower general and administrative expenses. Cash used in operating activities was $10.1 million Condensed Consolidated Balance Sheets Highlights | Account | September 30, 2022 ($) | December 31, 2021 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,396,960 | $2,950,552 | | Marketable investment securities | $31,858,842 | $43,689,205 | | Total current assets | $36,110,540 | $46,379,675 | | **Total assets** | **$39,424,228** | **$52,482,439** | | **Liabilities & Equity** | | | | Total current liabilities | $1,511,306 | $5,616,625 | | Total liabilities | $1,775,405 | $6,912,421 | | **Total stockholders' equity** | **$37,648,823** | **$45,570,018** | Condensed Consolidated Statements of Operations Highlights | Metric | Three Months Ended Sep 30, 2022 ($) | Three Months Ended Sep 30, 2021 ($) | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $54,994 | $500,000 | $54,994 | | Research and development | $2,100,432 | $2,366,521 | $6,886,398 | $5,411,748 | | General and administrative | $798,939 | $1,222,146 | $3,172,144 | $4,281,690 | | Operating loss | $(2,899,371) | $(3,533,673) | $(9,558,542) | $(9,638,444) | | **Net loss** | **$(2,409,165)** | **$(3,081,297)** | **$(8,528,723)** | **$(13,258,420)** | | Basic loss per share | $(0.03) | $(0.03) | $(0.10) | $(0.15) | Condensed Consolidated Statements of Cash Flows Highlights | Cash Flow Activity | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | | Cash used in operating activities | $(10,129,905) | $(13,405,843) | | Cash provided by (used in) investing activities | $11,697,357 | $(34,057,767) | | Cash provided by (used in) financing activities | $(2,121,044) | $27,763,333 | | **Net decrease in cash and cash equivalents** | **$(553,592)** | **$(19,700,277)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Lipocine is a biopharmaceutical company focused on developing oral therapies for Central Nervous System (CNS) disorders using its proprietary Lip'ral platform. Its lead product, TLANDO®, an oral testosterone replacement therapy, was approved by the FDA and is commercialized by its licensee, Halozyme (via Antares). The development pipeline is led by CNS candidates LPCN 1154 for postpartum depression and LPCN 2101 for epilepsy, along with LPCN 1148 for decompensated cirrhosis. For the nine months ended September 30, 2022, the company's net loss narrowed to $8.5 million from $13.3 million year-over-year, primarily due to a gain on litigation settlement and lower G&A expenses. The company believes its existing cash of $34.3 million is sufficient to fund operations through at least September 30, 2023, but will require additional capital for long-term operations - The company's primary focus is on leveraging its proprietary Lip'ral platform to develop oral treatments for **Central Nervous System (CNS) disorders**[95](index=95&type=chunk) - TLANDO®, an oral testosterone replacement therapy, received **FDA approval on March 28, 2022**, and was **commercially launched** by licensee Halozyme/Antares on **June 7, 2022**. Lipocine is eligible for up to **$160.0 million** in sales milestones and tiered royalties from **mid-teens to 20%**[95](index=95&type=chunk)[139](index=139&type=chunk) Key Development Pipeline Status | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | **LPCN 1154** | Postpartum Depression (PPD) | Pilot PK bridge study initiated; results expected H1 2023 | | **LPCN 2101** | Epilepsy | IND accepted; Phase 2 proof-of-concept study planned for 2023 | | **LPCN 1148** | Decompensated Cirrhosis | Phase 2 proof-of-concept study ongoing; enrollment completion expected Q4 2022, top-line results H1 2023 | | **LPCN 1144** | Non-cirrhotic NASH | Phase 2 completed; seeking partnership | | **LPCN 1111** | Once-daily TRT | Phase 2 completed; seeking partnership | | **LPCN 1107** | Prevention of Preterm Birth | Dose finding study completed; seeking partnership | - The company believes its existing capital resources of **$34.3 million** (as of Sep 30, 2022) are sufficient to fund projected operating requirements through at least **September 30, 2023**[192](index=192&type=chunk)[200](index=200&type=chunk) Comparison of Results of Operations (Nine Months Ended Sep 30) | Metric | 2022 ($) | 2021 ($) | Variance ($) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $500,000 | $54,994 | $445,006 | $500k fee from Antares for LPCN 1111 option extension | | R&D Expenses | $6,886,398 | $5,411,748 | $1,474,650 | Increased costs for LPCN 1148, 1154, and 1111 studies, offset by completion of LPCN 1144 study | | G&A Expenses | $3,172,144 | $4,281,690 | $(1,109,546) | Decrease in legal fees related to 2021 Clarus settlement and Antares agreement | | Gain (Loss) on Litigation | $250,000 | $(4,000,000) | $4,250,000 | Gain from amended Clarus settlement in 2022 vs. initial settlement expense in 2021 | | **Net Loss** | **$(8,528,723)** | **$(13,258,420)** | **$4,729,697** | Primarily due to litigation settlement gain and lower G&A expenses | [Quantitative and Qualitative Disclosures About Market Risks](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) The company states that there have been no material changes to its market risk during the first nine months of 2022. It refers to the more detailed disclosures in its 2021 Form 10-K - There have been **no material changes** to the Company's market risk during the first nine months of 2022[217](index=217&type=chunk) [Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and Principal Financial Officer, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2022. There were no material changes in internal control over financial reporting during the quarter - The company's Chief Executive Officer and Principal Financial Officer concluded that disclosure controls and procedures were **effective as of September 30, 2022**[219](index=219&type=chunk) - **No changes** in internal control over financial reporting occurred during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, internal controls[220](index=220&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal matters. The report references Note 11 of the financial statements for details, which discusses the settlement with Clarus Therapeutics and an ongoing purported shareholder class action lawsuit filed in 2019 - The company is involved in a purported shareholder class action lawsuit, ***Solomon Abady v. Lipocine Inc. et al.***, filed in **November 2019**, alleging false and misleading statements regarding the NDA for TLANDO. The company intends to vigorously defend itself[84](index=84&type=chunk) - All outstanding litigation with Clarus Therapeutics, including a patent infringement lawsuit and a USPTO interference proceeding, was **resolved via a global settlement agreement in July 2021**[83](index=83&type=chunk)[85](index=85&type=chunk) [Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) This section highlights material changes to risk factors, focusing on the potential for Nasdaq to delist the company's common stock due to its failure to maintain a minimum bid price of $1.00. Other risks discussed include difficulties in managing growth, the volatility of the stock price, and the financial impact of warrant liability fluctuations - On **June 7, 2022**, the company received a notice from Nasdaq for non-compliance with the minimum bid price requirement (**$1.00** per share). The company has until **December 5, 2022**, to regain compliance[232](index=232&type=chunk) - Failure to regain compliance with Nasdaq listing rules could result in **delisting**, which would lead to **reduced liquidity**, **limited market quotations**, and a potential classification as a "**penny stock**"[234](index=234&type=chunk) - The company's common stock has been volatile, trading between **$0.39** and **$1.85** per share over the past year[230](index=230&type=chunk) - The company has incurred significant operating losses since inception, with an accumulated deficit of **$181.2 million** as of **September 30, 2022**, and expects to incur continued losses[235](index=235&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=54&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[236](index=236&type=chunk) [Defaults Upon Senior Securities](index=54&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[237](index=237&type=chunk) [Mine Safety Disclosures](index=54&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[238](index=238&type=chunk) [Other Information](index=55&type=section&id=Item%205.%20Other%20Information) There was no other information to report during the period - None[240](index=240&type=chunk) [Exhibits](index=56&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 as required by the Sarbanes-Oxley Act - The exhibits filed include **CEO and CFO certifications** pursuant to **Sections 302 and 906 of the Sarbanes-Oxley Act of 2002**[241](index=241&type=chunk)

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) (IRS Employer Identification No.) FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarter ...

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 March 31, 2022 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or Organization) (IRS Employer Identification No.) 675 Arapeen Drive, Suite 202, Salt ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 ...

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 ...