Lipocine Inc. 10-Q

ITEM 1. FINANCIAL STATEMENTS LIPOCINE INC. AND SUBSIDIARIES Condensed Consolidated Balance Sheets (Unaudited) June 30, December 31, 2026 2025 Assets Current assets: Cash and cash equivalents $ 4,979,430 $ 5,205,842 Marketable investment securities 18,287,179 9,724,545 Accrued interest income 101,065 14,189 License fee and royalties receivable 190,099 1,145,390 Prepaid and other current assets 179,004 787,600 Total current assets 23,736,777 16,877,566 Property and equipment, net of accumulated depreciation of $ 1,313,541 and $ 1,284,079 respectively 74,831 104,293 Other assets 23,753 23,753 Total assets $ 23,835,361 $ 17,005,612 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 680,525 $ 971,822 Accrued expenses 1,067,432 1,236,374 Deferred revenue 320,000 320,000 Total current liabilities 2,067,957 2,528,196 Total liabilities 2,067,957 2,528,196 Commitments and contingencies (notes 8 and 10) Stockholders’ equity: Common stock, par value $ 0.0001 per share, 75,000,000 shares authorized; 8,244,589 and 6,158,779 issued and 8,244,253 and 6,158,443 outstanding, respectively 9,153 8,944 Additional paid-in capital 237,503,220 223,901,106 Treasury stock at cost, 336 shares ( 40,712 ) ( 40,712 ) Accumulated other comprehensive income ( 13,401 ) 4,445 Accumulated deficit ( 215,690,856 ) ( 209,396,367 ) Total stockholders’ equity 21,767,404 14,477,416 Total liabilities and stockholders’ equity $ 23,835,361 $ 17,005,612 See accompanying notes to consolidated financial statements 3 LIPOCINE INC. AND SUBSIDIARIES Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) 2026 2025 2026 2025 Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Revenues: License revenue $ - $ 500,000 $ - $ 500,000 Royalty revenue 190,099 122,849 309,496 216,713 Total revenues 190,099 622,849 309,496 716,713 Operating expenses: Research and development 2,041,389 2,136,769 4,805,782 3,198,341 General and administrative 990,956 890,433 2,195,425 2,012,910 Total operating expenses 3,032,345 3,027,202 7,001,207 5,211,251 Operating loss ( 2,842,246 ) ( 2,404,353 ) ( 6,691,711 ) ( 4,494,538 ) Other income: Interest and investment income 219,851 198,637 397,422 424,149 Total other income 219,851 198,637 397,422 424,149 Loss before income tax expense ( 2,622,395 ) ( 2,205,716 ) ( 6,294,289 ) ( 4,070,389 ) Income tax expense ( 200 ) - ( 200 ) ( 200 ) Net loss attributable to common shareholders $ ( 2,622,595 ) $ ( 2,205,716 ) $ ( 6,294,489 ) $ ( 4,070,589 ) Basic loss per share attributable to common stock $ ( 0.32 ) $ ( 0.41 ) $ ( 0.84 ) $ ( 0.76 ) Weighted average common shares outstanding, basic 8,216,988 5,351,957 7,509,923 5,350,267 Diluted loss per share attributable to common stock $ ( 0.32 ) $ ( 0.41 ) $ ( 0.84 ) $ ( 0.76 ) Weighted average common shares outstanding, diluted 8,216,988 5,351,957 7,509,923 5,350,267 Comprehensive loss: Net loss $ ( 2,622,595 ) $ ( 2,205,716 ) $ ( 6,294,489 ) $ ( 4,070,589 ) Net unrealized loss on marketable investment securities ( 6,207 ) ( 6,764 ) ( 17,846 ) ( 10,381 ) Comprehensive loss $ ( 2,628,802 ) $ ( 2,212,480 ) $ ( 6,312,335 ) $ ( 4,080,970 ) See accompanying notes to consolidated financial statements 4 LIPOCINE INC. AND SUBSIDIARIES Condensed Consolidated Statements of Changes in Stockholders’ Equity For the Three and Six Months Ended June 30, 2026 and 2025 (Unaudited) Number of Shares Amount Number of Shares Amount Paid-In Capital Comprehensive Loss Accumulated Deficit Stockholders’ Equity Stockholders’ Equity Common Stock Treasury Stock Additional Accumulated Other Total Number of Shares Amount Number of Shares Amount Paid-In Capital Comprehensive Loss Accumulated Deficit Stockholders’ Equity Balances at March 31, 2025 5,350,356 $ 8,863 336 $ ( 40,712 ) $ 220,860,140 $ 5,521 $ ( 201,633,735 ) $ 19,200,077 Net loss - - - - - - ( 2,205,716 ) ( 2,205,716 ) Unrealized net loss on marketable investment securities - - - - - ( 6,764 ) - ( 6,764 ) Unrealized net loss on marketable investment securities - - - - - ( 6,764 ) - ( 6,764 ) Stock-based compensation - - - - 65,205 - - 65,205 Common stock sold through ATM offering, net of costs 23,739 2 - - 75,616 - - 75,618 Balances at June 30, 2025 5,374,095 $ 8,865 336 $ ( 40,712 ) $ 221,000,961 $ ( 1,243 ) $ ( 203,839,451 ) $ 17,128,420 Stockholders’ Equity Common Stock Treasury Stock Additional Accumulated Other Total Number of Shares Amount Number of Shares Amount Paid-In Capital Comprehensive Loss Accumulated Deficit Stockholders’ Equity Balances at December 31, 2024 5,347,940 $ 8,863 336 $ ( 40,712 ) $ 220,789,138 $ 9,138 $ ( 199,768,862 ) $ 20,997,565 Net loss - - - - - - ( 4,070,589 ) ( 4,070,589 ) Unrealized net loss on marketable investment securities - - - - - ( 10,381 ) - ( 10,381 ) Unrealized net loss on marketable investment securities - - - - - ( 10,381 ) - ( 10,381 ) Stock-based compensation - - - - 136,207 - - 136,207 Vesting of restricted stock units 2,416 - - - - - - - Common stock sold through ATM offering, net of costs 23,739 2 - - 75,616 - - 75,618 Balances at June 30, 2025 5,374,095 $ 8,865 336 $ ( 40,712 ) $ 221,000,961 $ ( 1,243 ) $ ( 203,839,451 ) $ 17,128,420 5 Stockholders’ Equity Common Stock Treasury Stock Additional Accumulated Other Total Number of Shares Amount Number of Shares Amount Paid-In Capital Comprehensive Loss Accumulated Deficit Stockholders’ Equity Balances at March 31, 2026 7,475,115 $ 9,076 336 $ ( 40,712 ) $ 235,937,414 $ ( 7,194 ) $ ( 213,068,261 ) $ 22,830,323 Net loss - - - - - - ( 2,622,595 ) ( 2,622,595 ) Unrealized net loss on marketable investment securities - - - - - ( 6,207 ) - ( 6,207 ) Unrealized net loss on marketable investment securities - - - - - ( 6,207 ) - ( 6,207 ) Stock-based compensation - - - - 58,145 - - 58,145 Option exercises - - - - - - - - Vesting of restricted stock units - - - - - - - - Common stock sold through ATM offering, net of costs 769,138 77 - - 1,507,661 - - 1,507,738 Balances at June 30, 2026 8,244,253 $ 9,153 336 $ ( 40,712 ) $ 237,503,220 $ ( 13,401 ) $ ( 215,690,856 ) $ 21,767,404 Stockholder’s Equity Common Stock Treasury Stock Additional Accumulated Other Total Number of Shares Amount Number of Shares Amount Paid-In Capital Comprehensive Loss Accumulated Deficit Stockholders’ Equity Balances at December 31, 2025 6,158,443 $ 8,944 336 $ ( 40,712 ) $ 223,901,106 $ 4,445 $ ( 209,396,367 ) $ 14,477,416 Balances 6,158,443 $ 8,944 336 $ ( 40,712 ) $ 223,901,106 $ 4,445 $ ( 209,396,367 ) $ 14,477,416 Net loss - - - - - - ( 6,294,489 ) ( 6,294,489 ) Unrealized net loss on marketable investment securities - - - - - ( 17,846 ) - ( 17,846 ) Unrealized net loss on marketable investment securities - - - - - ( 17,846 ) - ( 17,846 ) Stock-based compensation - - - - 123,543 - - 123,543 Option exercises 1,325 - - - 6,986 - - 6,986 Vesting of restricted stock units 1,209 - - - - - - - Common stock sold through ATM offering, net of costs 2,083,276 209 - - 13,471,585 - - 13,471,794 Balances at June 30, 2026 8,244,253 $ 9,153 336 $ ( 40,712 ) $ 237,503,220 $ ( 13,401 ) $ ( 215,690,856 ) $ 21,767,404 Balances 8,244,253 $ 9,153 336 $ ( 40,712 ) $ 237,503,220 $ ( 13,401 ) $ ( 215,690,856 ) $ 21,767,404 See accompanying notes to condensed consolidated financial statements 6 LIPOCINE INC. AND SUBSIDIARIES Condensed Consolidated Statements of Cash Flows (Unaudited) 2026 2025 Six Months Ended June 30, 2026 2025 Cash flows from operating activities: Net loss $ ( 6,294,489 ) $ ( 4,070,589 ) Adjustments to reconcile net loss to cash used in operating activities: Depreciation expense 29,462 31,678 Stock-based compensation expense 123,543 136,207 Amortization of discounts on marketable investment securities ( 160,852 ) ( 92,625 ) Changes in operating assets and liabilities: Accrued interest income ( 86,876 ) ( 1,285 ) License and royalties receivable 955,291 ( 28,985 ) Prepaid and other current assets 608,596 234,271 Accounts payable ( 291,297 ) 171,298 Accrued expenses ( 168,942 ) ( 235,461 ) Cash used in operating activities ( 5,285,564 ) ( 3,855,491 ) Cash flows from investing activities: Purchases of marketable investment securities ( 20,219,628 ) ( 5,082,073 ) Maturities of marketable investment securities 11,800,000 8,700,000 Net cash provided by (used in) investing activities ( 8,419,628 ) 3,617,927 Cash flows from financing activities: Net proceeds from sale of common stock through ATM 13,471,794 75,618 Proceeds from stock option exercises 6,986 - Cash provided by financing activities 13,478,780 75,618 Net decrease in cash and cash equivalents ( 226,412 ) ( 161,946 ) Cash and cash equivalents at beginning of period 5,205,842 6,205,926 Cash and cash equivalents at end of period $ 4,979,430 $ 6,043,980 Supplemental disclosure of non-cash investing and financing activity: Net unrealized loss on available-for-sale securities $ ( 17,846 ) $ ( 10,381 ) Supplemental disclosure of cash flow information: Income taxes paid $ 200 $ 200 See accompanying notes to consolidated financial statements 7 LIPOCINE INC. Notes to Condensed Consolidated Financial Statements (Unaudited) (1) Basis of Presentation The accompanying unaudited condensed consolidated financial statements included herein have been prepared by Lipocine Inc. (“Lipocine” or the “Company”) in accordance with the rules and regulations of the United States Securities and Exchange Commission (“SEC”). The unaudited condensed consolidated financial statements are comprised of the financial statements of Lipocine and its subsidiaries, collectively referred to as the Company. In management’s opinion, the interim financial data presented includes all adjustments (consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by U.S. generally accepted accounting principles (“U.S. GAAP”) has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the three and six months ended June 30, 2026 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2026. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2025. The preparation of the unaudited condensed consolidated financial statements requires management to make estimates and assumptions relating to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with U.S. GAAP. Actual results could differ from these estimates. The Company believes that its existing capital resources, together with interest thereon, will be sufficient to meet its projected operating requirements through at least August 4, 2027. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could utilize its available capital resources sooner than it currently expects. While the Company believes it has sufficient liquidity and capital resources to fund our projected operating requirements through at least August 4, 2027, the Company will need to raise additional capital through the equity or debt markets or via out-licensing activities to support its operations. If the Company is unsuccessful in raising additional capital, its long-term ability to continue as a going concern will become a risk. Further, the Company’s operating plan may change, and the Company may need additional funds to meet operational needs and capital requirements for product development, regulatory compliance and clinical trial activities sooner than planned. In addition, the Company’s capital resources may be consumed more rapidly if it pursues additional clinical studies for LPCN 1154, LPCN 2201, LPCN 2203, LPCN 2101, LPCN 2401, LPCN 1148, and/or LPCN 1107. Conversely, the Company’s capital resources could last longer if the Company reduces expenses, reduces the number of activities currently contemplated under its operating plan, or terminates, modifies the design of or suspends on-going clinical studies. On January 12, 2024, the Company entered into a License Agreement (the “Verity License Agreement”) with Gordon Silver Limited (“GSL”) and Verity Pharmaceuticals, Inc. (“Verity Pharma”), pursuant to which the Company granted to GSL (an affiliate of Verity Pharma) an exclusive, royalty-bearing, sublicensable right and license to commercialize the TLANDO product with respect to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, as indicated in a New Drug Application (“NDA”) No. 208088, treatment of Klinefelter syndrome, and pediatric indications relating to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (the “Field”), in each case within the United States and Canada (the “Licensed Verity Territory”). The Verity License Agreement also provides GSL with a license to develop and commercialize TLANDO XR (LPCN 1111), the Company’s potential once-daily oral product candidate for testosterone replacement therapy in the Licensed Verity Territory. The Company retains development and commercialization rights for TLANDO and TLANDO XR (LPCN 1111) outside of the Licensed Verity Territory, and with respect to applications outside of the Field inside or outside the Licensed Verity Territory. Upon execution of the Verity License Agreement, GSL agreed to pay the Company a license fee of $ 11.0 million consisting of an initial payment of $ 2.5 million which was received on signing of the Verity License Agreement, $ 5.0 million which was received on February 1, 2024, $ 2.5 million which was received on December 30, 2024, and $ 1.0 million which was received on January 5, 2026. The Company is also eligible to receive development and sales milestone payments of up to $ 259 million in the aggregate, depending primarily on the achievement of certain sales milestones in a single calendar year with respect to all products licensed by GSL under the Verity License Agreement. In addition, the Company is eligible to receive tiered royalty payments at rates ranging from 12 % up to 18 % of net sales of licensed products in the Licensed Verity Territory. 8 In addition to the Verity License Agreement, the Company entered into a license agreement in the territories of South Korea, the Gulf Cooperation Council, or GCC, and Brazil. The Company retains development and commercialization rights for TLANDO outside of the United States, Canada, South Korea, the GCC, and Brazil and retains the development and commercialization rights for TLANDO XR (LPCN 1111) outside the United States and Canada, and with respect to applications outside of the Field inside or outside the Licensed Verity Territory. On July 8, 2026, Pharmalink received product marketing authorization approval for TESTYRA ® (TLANDO) in the UAE. (2) Revenue The Company generates most of its revenue from license and royalty arrangements. At inception of each contract, the Company identifies the goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company reassesses its reserves for variable consideration at each reporting date and makes adjustments, if necessary, which may affect revenue and earnings in periods in which any such changes become known. See Note 7 for a description of the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement, and the Aché License Agreement. See Note 11 for a description of the agreement with Spriaso, a related party. License Fees For distinct license performance obligations, upfront license fees are recognized when the Company satisfies the underlying performance obligation. Performance obligations under these licenses, which consist of the right to use the Company’s proprietary technology, are satisfied at a point in time corresponding with delivery of the underlying technology rights to the licensee, which is generally upon transfer of the licensed technology/product to the customer. In addition, license arrangements may include contingent milestone payments, which are due following achievement by our licensee of specified sales or regulatory milestones and the licensee and/or Company will fulfill its performance obligation prior to achievement of these milestones. Because of the uncertainty of the milestone achievement, and/or the dependence on sales of our licensee, variable consideration for contingent milestones is fully constrained and is not recognized as revenue until the milestone is achieved by our licensee, to the extent collectability is reasonably certain. Royalties Royalty revenue consists of sales-based and minimum royalties earned under license agreements for our products. Sales-based royalty revenue represents variable consideration under license agreements and is recognized in the period a customer sells products incorporating the Company’s licensed technologies/products. The Company estimates sales-based royalty revenue earned but unpaid at each reporting period using information provided by the licensee. The Company’s license arrangements may also provide for minimum royalties, which the Company recognizes upon the satisfaction of the underlying performance obligation, which generally occurs with delivery of the underlying technology rights to the licensee. Sales-based and minimum royalties are generally due within 45 days after the end of each quarter in which they are earned. Deferred Revenue – Customer Prepayment for Inventory As of June 30, 2026 and December 31, 2025, the Company has recorded deferred revenue of $ 320,000 related to a one-time non-refundable, non-creditable upfront prepayment received from SPC Korea (“SPC”) in consideration for TLANDO product inventory that has not yet been delivered or transferred. This prepayment is recognized as a contract liability in accordance with ASC 606, Revenue from Contracts with Customers , because the Company has an obligation to transfer inventory in the future. Revenue associated with this advance payment will be recognized when the inventory is transferred to the customer, which will occur upon shipment of the inventory. The deferred revenue is expected to be recognized as revenue within 60 days of SPC’s receipt of marketing authorization for TLANDO in South Korea (the “SPC Territory”), which is expected to occur in 2027. The Company periodically evaluates deferred revenue balances to ensure they appropriately reflect remaining performance obligations and expected fulfillment timelines. 9 Revenue Concentration A major partner is considered to be one that comprises more than 10 % of the Company’s total revenues. For the three months ended June 30, 2026, the Company recognized royalty revenue of approximately $ 190,000 relating to the Verity License Agreement. For the three months ended June 30, 2025, the Company recognized licensing revenue of $ 500,000 from one customer and royalty revenue of approximately $ 123,000 relating to the Verity License Agreement. For the six months ended June 30, 2026, the Company recognized royalty revenue of $ 309,000 relating to the Verity License Agreement. For the six months ended June 30, 2025, the Company recognized license revenue of $ 500,000 from one customer and royalty revenue of approximately $ 217,000 relating to the Verity License Agreement. (3) Loss per Share Basic loss per share is calculated by dividing net loss available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted loss per share is based on the weighted average number of common shares outstanding plus, where applicable, the additional potential common shares that would have been outstanding related to dilutive options, warrants and unvested restricted stock units to the extent such shares are dilutive. The following table sets forth the computation of basic and diluted loss per share of common stock for the three and six months ended June 30, 2026 and 2025: Schedule of Computation of Basic and Diluted Earnings (Loss) Per Share of Common Stock 2026 2025 2026 2025 Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Basic loss per share attributable to common stock: Numerator Net loss $ ( 2,622,595 ) $ ( 2,205,716 ) $ ( 6,294,489 ) $ ( 4,070,589 ) Denominator Weighted avg. common shares outstanding 8,216,988 5,351,957 7,509,923 5,350,267 Basic loss per share attributable to common stock $ ( 0.32 ) $ ( 0.41 ) $ ( 0.84 ) $ ( 0.76 ) Diluted loss per share attributable to common stock: Numerator Net loss $ ( 2,622,595 ) $ ( 2,205,716 ) $ ( 6,294,489 ) $ ( 4,070,589 ) Total net loss for purpose of calculating diluted net loss per common share Denominator $ ( 2,622,595 ) $ ( 2,205,716 ) $ ( 6,294,489 ) $ ( 4,070,589 ) Weighted avg. common shares outstanding 8,216,988 5,351,957 7,509,923 5,350,267 Diluted loss per share attributable to common stock $ ( 0.32 ) $ ( 0.41 ) $ ( 0.84 ) $ ( 0.76 ) The computation of diluted loss per share for the three and six months ended June 30, 2026 and 2025 does not include the following stock options or unvested restricted stock units in the computation of diluted loss per share because these instruments were antidilutive: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Stock options 485,038 354,908 485,038 354,908 Unvested restricted stock units 16,928 19,346 16,928 19,346 10 (4) Marketable Investment Securities The Company has classified its marketable investment securities as available-for-sale securities, all of which are debt securities. These securities are carried at fair value with unrealized holding gains and losses, net of the related tax effect, included in accumulated other comprehensive income (loss) in stockholders’ equity until realized. Gains and losses on investment security transactions are reported on the specific-identification method. Dividend income is recognized on the ex-dividend date and interest income is recognized on an accrual basis. The amortized cost, gross unrealized holding gains, gross unrealized holding losses, and fair value for available-for-sale securities by major security type and class of security as of June 30, 2026, and December 31, 2025, were as follows: Schedule of Available for Sale Securities June 30, 2026 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Aggregate Fair Value Government treasury bills $ 18,300,580 $ 9 $ ( 13,410 ) $ 18,287,179 $ 18,300,580 $ 9 $ ( 13,410 ) $ 18,287,179 December 31, 2025 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Aggregate Fair Value Government treasury bills $ 9,720,100 $ 4,445 $ - $ 9,724,545 $ 9,720,100 $ 4,445 $ - $ 9,724,545 Maturities of debt securities classified as available-for-sale securities as of June 30, 2026 are as follows: Schedule of Maturities of Debt Securities Classified as Available-for-Sale Securities June 30, 2026 Amortized Cost Aggregate Fair Value Due within one year $ 18,300,580 $ 18,287,179 $ 18,300,580 $ 18,287,179 There were no sales of marketable investment securities during the three or six months ended June 30, 2026 or 2025 and therefore no realized gains or losses. Additionally, during the three months ended June 30, 2026 and 2025, $ 6.5 million and $ 4.5 million of marketable investment securities matured, respectively and during the six months ended June 30, 2026 and 2025, $ 11.8 million and $ 8.7 million of marketable investment securities matured, respectively. The Company evaluates its available-for-sale debt securities for credit losses at each reporting date. As of June 30, 2026, the Company’s available-for-sale portfolio consisted of U.S. Treasury bills with maturities due within one year. The Company concluded that any unrealized losses were not attributable to credit and, accordingly, no allowance for credit losses was recorded and no impairment was recognized in earnings during the three or six months ended June 30, 2026 or 2025. (5) Fair Value The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: ● Level 1 Inputs: Quoted prices for identical instruments in active markets. ● Level 2 Inputs: Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-derived valuation in which all significant inputs and significant value drivers are observable in active markets. ● Level 3 Inputs: Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. 11 All of the Company’s financial instruments are valued using quoted prices in active markets or based on other observable inputs. For accrued interest income, prepaid and other current assets, accounts payable, and accrued expenses, the carrying amounts approximate fair value because of the short maturity of these instruments. The following table presents the placement in the fair value hierarchy of assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2026 and December 31, 2025: Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis Fair value measurements at reporting date using June 30, 2026 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 4,872,027 $ 4,872,027 $ - $ - Government treasury bills 18,287,179 18,287,179 - - $ 23,159,206 $ 23,159,206 $ - $ - Fair value measurements at reporting date using December 31, 2025 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 4,459,687 $ 4,459,687 $ - $ - Government treasury bills 9,724,545 9,724,545 - - $ 14,184,232 $ 14,184,232 $ - $ - The following methods and assumptions were used to determine the fair value of each class of assets and liabilities recorded at fair value in the balance sheets: Cash equivalents: Cash equivalents primarily consist of highly rated money market funds and treasury bills with original maturities to the Company of three months or less and are purchased daily at par value with specified yield rates. Cash equivalents related to money market funds and treasury bills are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices or broker or dealer quotations for similar assets. Government treasury bills: The Company uses a third-party pricing service to value these investments. United States treasury bills are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets for identical assets and reportable trades. The Company’s accounting policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or changes in circumstances that caused the transfer. There were no transfers into or out of Level 1, Level 2, or Level 3 for the three or six months ended June 30, 2026. (6) Income Taxes The tax provision for interim periods is determined using an estimate of the Company’s effective tax rate for the full year adjusted for discrete items, if any, that are taken into account in the relevant period. Each quarter the Company updates its estimate of the annual effective tax rate, and if the estimated tax rate changes, the Company makes a cumulative adjustment. At June 30, 2026 and December 31, 2025, the Company had a full valuation allowance against its deferred tax assets, net of expected reversals of existing deferred tax liabilities, as it believes it is more likely than not that these benefits will not be realized. 12 (7) Contractual Agreements (a) Verity Pharmaceuticals, Inc. On January 12, 2024, the Company entered into the Verity License Agreement with GSL and Verity Pharma, pursuant to which the Company granted to GSL (an affiliate of Verity Pharma) an exclusive, royalty-bearing, sublicensable right and license to commercialize the Company’s TLANDO ® product with respect to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, as indicated in NDA No. 208088, treatment of Klinefelter syndrome, and pediatric indications relating to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (the “Field”), in each case within the United States and Canada (the “Licensed Verity Territory”). The Verity License Agreement also provides GSL with a license to develop and commercialize TLANDO XR (LPCN 1111), the Company’s potential once-daily oral product candidate for testosterone replacement therapy in the Licensed Verity Territory. Under the Verity License Agreement, the Company retains rights to TLANDO in applications outside of the Field and to the development and commercialization rights outside of the United States and Canada. The Company retains rights to TLANDO XR in applications outside of the Field and to development and commercialization rights in the field outside of the United States and Canada. Upon execution of the Verity License Agreement, GSL agreed to pay the Company a license fee of $ 11.0 million consisting of an initial payment of $ 2.5 million which was received on signing of the Verity License Agreement, $ 5.0 million which was received on February 1, 2024, $ 2.5 million which was received on December 30, 2024, and $ 1.0 million was received on January 5, 2026. The Company is also eligible to receive development and sales milestone payments of up to $ 259.0 million in the aggregate, depending primarily on the achievement of certain sales milestones in a single calendar year with respect to all products licensed by GSL under the Verity License Agreement. Under the Verity License Agreement, GSL is generally responsible for expenses relating to the development (including the conduct of any clinical trials) and commercialization of licensed products in the Field in the Licensed Verity Territory, while the Company is generally responsible for expenses relating to development activities outside of the Field and/or the Licensed Verity Territory. The Company concluded that licensing revenue recognized in conjunction with the Verity License Agreement met the requirements under ASC 606, Revenue from Contracts with Customers. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. License revenue from payments to be received in the future will be recognized when it is probable that we will receive license payments under the terms of the Verity License Agreement. Under the Verity License Agreement with Verity Pharma, during the three months ended June 30, 2026 and 2025, the Company recognized royalty revenue of approximately $ 190,000 and $ 123,000 , respectively and for the six months ended June 30, 2026 and 2025, the Company recognized royalty revenue of approximately $ 309,000 and $ 217,000 , respectively. (b) SPC Korea In September 2024, the Company entered into a Distribution and License Agreement (the “SPC License Agreement”) with SPC, pursuant to which the Company granted to SPC a non-transferable, exclusive, royalty-bearing license to commercialize the Company’s TLANDO product with respect to the Field, specific to the SPC Territory. SPC paid the Company a one-time non-refundable, non-creditable upfront fee in October 2024. The Company also received an additional payment for a non-refundable prepayment in consideration for TLANDO product inventory, and is eligible to receive additional payments for various marketing authorization and sales milestones, and the Company will supply TLANDO to SPC and receive a supply price. In addition, the Company will receive royalties on net sales in the SPC Territory. 13 (c) Pharmalink In October 2024, the Company entered into a distribution and supply agreement (the “Pharmalink Distribution Agreement”) with Pharmalink, pursuant to which the Company granted to Pharmalink a non-transferable, exclusive, license to commercialize the Company’s TLANDO product with respect to the Field, specific to the Gulf Cooperation Council Countries (“GCC”), including Saudi Arabia, Kuwait, the United Arab Emirates (“UAE”), Qatar, Bahrain, and Oman (the “GCC Territory”). Pharmalink paid the Company a one-time non-refundable, non-creditable upfront fee. The Company is eligible to receive additional payments in regulatory authorization milestones related to the marketing approval in countries in the GCC Territory under the Pharmalink Distribution Agreement and the Company will supply TLANDO to Pharmalink at an agreed transfer price. On July 8, 2026, Pharmalink received product marketing authorization approval for TESTYRA ® (TLANDO) in the UAE. (d) Aché Laboratórios Farmacêuticos S.A . In April 2025, the Company entered into a License and Supply Agreement (the “Aché License Agreement”) with Aché, pursuant to which the Company granted to Aché an exclusive license to commercialize the Company’s TLANDO product with respect to the Field, specific to Brazil (the “Aché Territory”). Under the agreement, the Company is entitled to receive fees upon the achievement of certain regulatory milestones, royalties on net sales and will supply TLANDO to Aché at an agreed transfer price. (e) Abbott Products, Inc. On March 29, 2012, the Company terminated its collaborative agreement with Solvay Pharmaceuticals, Inc. (later acquired by Abbott Products, Inc. (“Abbott”) for TLANDO. As part of the termination, the Company reacquired the rights to the intellectual property from Abbott. All obligations under the prior license agreement have been completed except that Lipocine will owe Abbott a perpetual 1 % royalty on net sales. Such royalties are limited to $ 1.0 million in the first two calendar years following product launch, after which period there is not a cap on royalties and no maximum aggregate amount. If generic versions of any such product are introduced, then royalties are reduced by 50 %. TLANDO was commercially launched on June 7, 2022. The Company incurred royalty expense of approximately $ 16,000 and $ 10,000 during the three months ended June 30, 2026 and 2025, respectively and incurred royalty expense of approximately $ 26,000 and $ 18,000 during the six months ended June 30, 2026 and 2025, respectively. (f) Contract Research and Development The Company has entered into agreements with various contract organizations that conduct pre-clinical, clinical, analytical and manufacturing development work on behalf of the Company as well as a number of independent contractors and clinical researchers who serve as advisors to the Company. The Company incurred expenses of $ 1.2 million and $ 1.3 million for the three months ended June 30, 2026 and 2025, respectively, and incurred expenses of $ 3.0 million and $ 1.4 million for the six months ended June 30, 2026 and 2025, respectively, under these agreements and has recorded these expenses in research and development expenses. (8) Leases The Company has a non-cancelable operating lease for office space and laboratory facilities in Salt Lake City, Utah. The term of the lease has been extended through February 28, 2027. Future minimum lease payments under the non-cancelable operating lease as of June 30, 2026 are: Schedule of Future Minimum Rental Payments for Operating Leases Operating Lease 2026 $ 193,355 2027 64,452 Total minimum lease payments $ 257,807 The Company’s rent expense was $ 97,000 and $ 94,000 for the three months ended June 30, 2026 and 2025, respectively. The Company’s rent expense was $ 192,000 and $ 187,000 for the six months ended June 30, 2026 and 2025, respectively. 14 (9) Stockholders’ Equity On June 4, 2025, the Company held its annual general meeting of shareholders, at which a proposal to amend the Company’s Amended and Restated Certificate of Incorporation (the “Restated Certificate”) to reduce the number of authorized shares of the Company’s common stock from 200,000,000 to 75,000,000 shares was approved. The Company filed the amendment to the Restated Certificate with the Secretary of State of the State of Delaware on June 4, 2025. The amendment to the Restated Certificate became effective upon filing with the Secretary of State of the State of Delaware. The Company is authorized to issue up to 75,000,000 shares of its common stock, par value $ 0.0001 . (a) Issuance of Common Stock On April 26, 2024, the Company entered into a sales agreement with A.G.P. /Alliance Global Partners (“A.G.P.”) (the “A.G.P. Sales Agreement”) pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to the amount the Company registered on an effective registration statement pursuant to which the offering is being made. As of February 26, 2026, the Company has registered $ 50,000,000 of common shares for sale under the A.G.P. Sales Agreement, pursuant to the Registration Statement on Form S-3, as amended (File No. 333-275716) (the “Form S-3”), through A.G.P. as the Company’s sales agent. A.G.P. may sell the Company’s common stock by any method permitted by law deemed to be an “at the market offering” (“ATM”) as defined in Rule 415(a)(4) of the Securities Act, including sales made directly on or through the Nasdaq Capital Market or any other existing trade market for our common stock, in negotiated transactions at market prices prevailing at the time of sale or at prices related to prevailing market prices, or any other method permitted by law. A.G.P. will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable law and regulations to sell shares under the A.G.P. Sales Agreement. The Company will pay A.G.P. 3.0 % of the aggregate gross proceeds from each sale of shares under the A.G.P. Sales Agreement. In addition, the Company has also provided A.G.P. with customary indemnification rights. The shares of the Company’s common stock to be sold under the A.G.P. Sales Agreement will be sold and issued pursuant to the Form S-3, as amended, which was previously declared effective by the Securities and Exchange Commission, and the related prospectus and one or more prospectus supplements. The Company is not obligated to make any sales of its common stock under the A.G.P. Sales Agreement. The offering of common stock pursuant to the A.G.P. Sales Agreement will terminate upon the termination of the A.G.P. Sales Agreement as permitted therein. The Company and A.G.P. may each terminate the A.G.P. Sales Agreement at any time upon ten days’ prior notice. During the three months ended June 30, 2026, the Company sold 769,138 shares of common stock at a weighted average price of $ 2.02 per share under the A.G.P. Sales Agreement, for aggregate gross proceeds of $ 1.6 million and net proceeds of $ 1.5 million, after deducting sales agent commissions, discounts and other offering costs. During the six months ended June 30, 2026, the Company sold 2,083,276 shares of common stock at a weighted average price of $ 6.67 per share under the A.G.P. Sales Agreement, for aggregate gross proceeds of $ 13.9 million and net proceeds of $ 13.5 million, after deducting sales agent commissions, discounts and other offering costs. (b) Rights Agreement On November 13, 2015, the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent, entered into a Rights Agreement (the “Rights Agreement”). Also on November 12, 2015, the Board of the Company authorized and the Company declared a dividend of one preferred stock purchase right (each a “Right” and collectively, the “Rights”) for each outstanding share of common stock of the Company. The dividend was payable to stockholders of record as of the close of business on November 30, 2015 and entitles the registered holder to purchase from the Company one one-thousandth of a fully paid non-assessable share of Series A Junior Participating Preferred Stock of the Company at a price of $ 63.96 per one-thousandth share (the “Purchase Price”). The Rights will generally become exercisable upon the earlier to occur of (i) 10 business days following a public announcement that a person or group of affiliated or associated persons has become an Acquiring Person (as defined below) or (ii) 10 business days (or such later date as may be determined by action of the Board prior to such time as any person or group of affiliated or associated persons becomes an Acquiring Person) following the commencement of, or announcement of an intention to make, a tender offer or exchange offer the consummation of which would result in the beneficial ownership by a person or group of 15% or more of the outstanding common stock of the Company. Except in certain situations, a person or group of affiliated or associated persons becomes an “Acquiring Person” upon acquiring beneficial ownership of 15% or more of the outstanding shares of common stock of the Company. 15 In general, in the event a person becomes an Acquiring Person, then each Right not owned by such Acquiring Person will entitle its holder to purchase from the Company, at the Right’s then current exercise price, in lieu of shares of Series A Junior Participating Preferred Stock, common stock of the Company with a market value of twice the Purchase Price. In addition, if after any person has become an Acquiring Person, (a) the Company is acquired in a merger or other business combination, or (b) 50% or more of the Company’s assets, or assets accounting for 50% or more of its earning power, are sold, leased, exchanged or otherwise transferred (in one or more transactions), proper provision shall be made so that each holder of a Right (other than the Acquiring Person, its affiliates and associates and certain transferees thereof, whose Rights became void) shall thereafter have the right to purchase from the acquiring corporation, for the Purchase Price, that number of shares of common stock of the acquiring corporation which at the time of such transaction would have a market value of twice the Purchase Price. The Company will be entitled to redeem the Rights at $ 0.001 per Right at any time prior to the time an Acquiring Person becomes such. The terms of the Rights are set forth in the Rights Agreement, which is summarized in the Company’s Current Report on Form 8-K dated November 13, 2015. The rights plan was originally set to expire on November 12, 2018; however, on November 5, 2018 our Board approved an Amended and Restated Rights Agreement pursuant to which the expiration date was extended to November 5, 2021, and again on November 2, 2021, the Company adopted a Second Amended and Restated Rights Agreement pursuant to which the expiration date was extended to November 1, 2024. On October 22, 2024, the Company adopted a Third Amended and Restated Rights Agreement pursuant to which the expiration date was extended to October 22, 2027, unless the rights are earlier redeemed or exchanged by the Company. (c) Share-Based Payments The Company recognizes stock-based compensation expense for grants of stock option awards, restricted stock units and restricted stock under the Company’s Incentive Plan to employees, nonemployees and nonemployee members of the Company’s Board based on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award’s requisite service period. In addition, the Company has granted performance-based stock option awards and restricted stock units, which vest based upon the Company satisfying certain performance conditions. Potential compensation cost, measured on the grant date, related to these performance options will be recognized only if, and when, the Company estimates that these options or units will vest, which is based on whether the Company considers the performance conditions to be probable of attainment. The Company’s estimates of the number of performance-based options or units that will vest will be revised, if necessary, in subsequent periods. The Company uses the Black-Scholes model to compute the estimated fair value of stock option awards. Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of the Company’s common stock price, (ii) the periods of time over which employees and members of the board of directors are expected to hold their options prior to exercise (expected term), (iii) expected dividend yield on the common stock, and (iv) risk-free interest rates. Stock-based compensation expense also includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Stock-based compensation cost for stock option and restricted stock awards that has been expensed in the statements of operations amounted to approximately $ 58,000 and $ 65,000 , for the three months ended June 30, 2026 and 2025, respectively, and approximately $ 124,000 and $ 136,000 , for the six months ended June 30, 2026 and 2025, respectively. The expense is allocated as follows: Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs 2026 2025 2026 2025 Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Research and development $ 36,015 $ 31,016 $ 51,777 $ 66,989 General and administrative 22,130 34,189 71,766 69,218 Total $ 58,145 $ 65,205 $ 123,543 $ 136,207 The Company issued 58,073 and 8,820 stock options during each of the three months ended June 30, 2026 and 2025, respectively, and 97,073 and 25,191 stock options during each of the six months ended June 30, 2026 and 2025. The Company did not issue any restricted stock awards during the three or six months ended June 30, 2026 or 2025. 16 Key assumptions used in the determination of the fair value of stock options granted are as follows: Expected Term : The expected term represents the period that the stock-based awards are expected to be outstanding. The expected term was estimated using the simplified method in accordance with the provisions of Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment , for awards with stated or implied service periods. The simplified method defines the expected term as the average of the contractual term and the vesting period of the stock option. For awards with performance conditions, and that have the contractual term to satisfy the performance condition, the contractual term was used. Risk-Free Interest Rate: The risk-free interest rate used was based on the implied yield currently available on U.S. Treasury issues with an equivalent remaining term. Expected Dividend : The expected dividend assumption is based on management’s current expectation about the Company’s anticipated dividend policy. The Company does not anticipate declaring dividends in the foreseeable future. Expected Volatility : The volatility factor is based solely on the Company’s trading history. For options granted during the six months ended June 30, 2026 and 2025, the Company calculated the fair value of each option grant on the respective dates of grant using the following weighted average assumptions: Schedule of Key Assumption of Fair Value of Stock Options Granted 2026 2025 Expected term 5.83 years 5.73 years Risk-free interest rate 4.04 % 4.30 % Expected dividend yield — — Expected volatility 90.87 % 94.19 % FASB Accounting Standards Codification (“ASC”) 718, Stock Compensation, requires the Company to recognize compensation expense for the portion of options that are expected to vest. Therefore, the Company applied estimated forfeiture rates that were derived from historical employee termination behavior. If the actual number of forfeitures differs from those estimated by management, additional adjustments to compensation expense may be required in future periods. As of June 30, 2026, there was approximately $ 687,000 of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the Company’s stock plan, of which $ 628,000 relates to unvested stock options and $ 59,000 relates to unvested restricted stock units. Share-based compensation related to options is expected to be recognized over a weighted average period of 1.3 years. The cost will be adjusted for subsequent changes in estimated forfeitures. The weighted average fair value of stock options granted during the six months ended June 30, 2026 and 2025 was approximately $ 3.39 and $ 3.32 per share, respectively. (d) Stock Option Plan In April 2014, the Board of Directors adopted the 2014 Stock and Incentive Plan (“2014 Plan”) subject to shareholder approval which was received in June 2014. The 2014 Plan provides for the granting of nonqualified and incentive stock options, stock appreciation rights, restricted stock units, restricted stock and dividend equivalents. An aggregate of 58,823 shares were authorized for issuance under the 2014 Plan. Additionally, 15,994 remaining authorized shares under the 2011 Equity Incentive Plan were issuable under the 2014 Plan at the time of the 2014 Plan adoption. Upon receiving shareholder approval in June 2016, the 2014 Plan was amended and restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted under the 2014 Plan from 74,817 to 145,405 . Additionally, upon receiving shareholder approval in June 2018, the 2014 Plan was further amended and restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted under the 2014 Plan from 145,405 to 189,522 . Upon receiving shareholder approval in June 2020, the 2014 Plan was further amended and restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted under the 2014 Plan from 189,522 to 336,582 . In June 2024, the 2014 Plan was further amended and restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted from 336,582 to 600,000 . In June 2026, the 2014 Plan was further amended and restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted from 600,000 to 1,000,000 . The Board, on an option-by-option basis, determines the number of shares, exercise price, term, and vesting period for options granted. Options granted generally have a ten-year contractual life. The Company issues shares of common stock upon the exercise of options with the source of those shares of common stock being either newly issued shares or shares held in treasury. An aggregate of 1,000,000 shares of common stock are authorized for issuance under the 2014 Plan, with 466,200 shares remaining available for grant as of June 30, 2026. 17 A summary of stock option activity is as follows: Schedule of Stock Option Activity Outstanding stock options Number of shares Weighted average exercise price Balance at December 31, 2024 335,258 $ 23.59 Options granted 100,994 4.22 Options exercised - - Options forfeited ( 8,327 ) 4.62 Options cancelled ( 10,616 ) 48.83 Balance at December 31, 2025 417,309 18.64 Options granted 97,073 4.66 Options exercised ( 1,325 ) 5.27 Options forfeited ( 22,053 ) 116.04 Options cancelled ( 5,966 ) 3.66 Balance at June 30, 2026 485,038 11.64 Options exercisable at June 30, 2026 279,159 16.89 The following table summarizes information about stock options outstanding and exercisable: Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable As of June 30, 2026 Options outstanding Options exercisable Number outstanding Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value Number exercisable Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value 485,038 7.01 $ 11.64 $ 1,588 279,159 5.20 $ 16.89 $ - As of June 30, 2025 Options outstanding Options exercisable Number outstanding Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value Number exercisable Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value 354,908 6.60 $ 21.26 $ - 256,738 5.59 $ 27.57 $ - The intrinsic value for stock options is defined as the difference between the current market value and the exercise price. 18 (e) Restricted Stock Units A summary of restricted stock unit activity is as follows: Summary of Restricted Stock Unit Activity Number of Unvested Restricted Stock Units Balance at December 31, 2025 18,137 Granted - Vested ( 1,209 ) Cancelled - Balance at June 30, 2026 16,928 (f) Common Stock Warrants In an offering in February 2020, the Company issued 296,593 common stock warrants to shareholders which allowed the shareholder the option to purchase shares of common stock. However, because these warrants did not provide the warrant holder the option to put the warrant back to the Company, the warrants were classified as equity. As of March 31, 2025, the warrants that had been outstanding from the offering done in February 2020 to purchase an equal number of shares of common stock had expired. No common stock warrants were exercised during the three months ended March 31, 2025. (10) Commitments and Contingencies Litigation The Company is involved in various lawsuits, claims and other legal matters from time to time that arise in the ordinary course of conducting business. The Company records a liability when a particular contingency is probable and estimable. The Company is not currently aware of any matter, individually or in the aggregate, that could have a material adverse effect on our financial condition, liquidity, or results of operations. Guarantees and Indemnifications In the ordinary course of business, the Company enters into agreements, such as lease agreements, licensing agreements, clinical trial agreements, and certain services agreements, containing standard guarantee and / or indemnification provisions. Additionally, the Company has indemnified its directors and officers to the maximum extent permitted under the laws of the State of Delaware. (11) Agreement with Spriaso, LLC The Company has a license and a services agreement with Spriaso, a related-party that is majority-owned by certain current and former directors of Lipocine Inc. and their affiliates. Under the license agreement, the Company assigned and transferred to Spriaso all of the Company’s rights, title and interest in its intellectual property to develop products for the cough and cold field. In addition, Spriaso received all rights and obligations under the Company’s product development agreement with a third-party. In exchange, the Company will receive a royalty of 20 percent of the net proceeds received by Spriaso, up to a maximum of $ 10.0 million. Spriaso also granted back to the Company an exclusive license to such intellectual property to develop products outside of the cough and cold field. The Company also agreed to continue providing up to 10 percent of the services of certain employees to Spriaso for a period of time. The agreement to provide services expired in 2021 ; however, it may be extended upon written agreement of Spriaso and the Company. During the three and six months ended June 30, 2026 and 2025, the Company did not receive any revenue from Spriaso. Spriaso filed its first NDA and as an affiliated entity of the Company, using up the one-time waiver for user fees for a small business submitting its first human drug application to the FDA. Spriaso is considered a variable interest entity under the FASB ASC Topic 810-10, Consolidations, however the Company is not the primary beneficiary and has therefore not consolidated Spriaso. 19 (12) Segment Reporting Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company operates as a 1 single reporting segment, focused on leveraging its proprietary technology platform to augment therapeutics through effective oral delivery of products and product candidates. The Company’s measure of segment profit or loss is net income (loss). The CODM is the chief executive officer (“CEO”). The CODM manages and allocates resources to the operations of the Company on a total company basis. Managing and allocating resources on a consolidated basis enables the CEO to assess the overall level of resources available and how to best deploy these resources across functions, therapeutic target areas and research and development projects that are in line with the Company’s long-term company-wide strategic goals. Consistent with this decision-making process, the CEO uses consolidated financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. Operating expenses are used to monitor budget versus actual results. The review of budgeted versus actual results is used in assessing performance of the segment. All the Company’s long-lived assets are held in the United States and all the Company’s revenues are primarily related to TLANDO. The following table is representative of the significant expense categories regularly provided to the CODM when managing the Company’s single reporting segment. A reconciliation to the consolidated net loss for the three and six months ended June 30, 2026 and 2025 is included at the bottom of the table below. Schedule of Significant Expense Categories 2026 2025 2026 2025 Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Total revenues $ 190,099 $ 622,849 $ 309,496 $ 716,713 Program expenses (1) Lead clinical candidate (1) 1,040,859 1,042,929 2,798,028 1,049,621 Other research and development programs (1) 17,155 155,415 13,894 176,388 Non-program expenses (2) 873,833 735,511 1,861,478 1,736,128 Personnel costs 1,042,353 1,028,142 2,204,264 2,112,907 Stock-based compensation 58,145 65,205 123,543 136,207 Total segment operating income (loss) ( 2,842,246 ) ( 2,404,353 ) ( 6,691,711 ) ( 4,494,538 ) Other income (loss) (3) 219,651 198,637 397,222 423,949 Net income (loss) $ ( 2,622,595 ) $ ( 2,205,716 ) $ ( 6,294,489 ) $ ( 4,070,589 ) (1) Includes external research and development expenses. (2) Includes general and administrative expenses, information technology, infrastructure, facilities, intellectual property, and legal and professional fees. (3) Includes interest income and income tax expense. 20