Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 05, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-36357 | ||
Entity Registrant Name | LIPOCINE INC. | ||
Entity Central Index Key | 0001535955 | ||
Entity Tax Identification Number | 99-0370688 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 675 Arapeen Drive | ||
Entity Address, Address Line Two | Suite 202 | ||
Entity Address, City or Town | Salt Lake City | ||
Entity Address, State or Province | UT | ||
Entity Address, Postal Zip Code | 84108 | ||
City Area Code | 801 | ||
Local Phone Number | 994-7383 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | LPCN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 25.6 | ||
Entity Common Stock, Shares Outstanding | 5,315,830 | ||
Documents Incorporated by Reference [Text Block] | None | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Firm ID | 270 | ||
Auditor Name | Tanner LLC | ||
Auditor Location | Salt Lake City, Utah |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 4,771,758 | $ 3,148,496 |
Marketable investment securities | 17,263,788 | 29,381,410 |
Accrued interest income | 52,254 | 80,427 |
Contract asset - current portion | 579,428 | |
Prepaid and other current assets | 773,424 | 945,319 |
Total current assets | 22,861,224 | 34,135,080 |
Contract asset - non-current portion | 3,252,500 | |
Property and equipment, net of accumulated depreciation of $1,182,191 and $1,153,530 respectively | 116,095 | 131,589 |
Other assets | 23,753 | 23,753 |
Total assets | 23,001,072 | 37,542,922 |
Current liabilities: | ||
Accounts payable | 1,395,977 | 600,388 |
Accrued expenses | 1,218,486 | 1,077,738 |
Warrant liability - current portion | 17,166 | |
Total current liabilities | 2,631,629 | 1,678,126 |
Warrant liability | 229,856 | |
Total liabilities | 2,631,629 | 1,907,982 |
Commitments and contingencies (notes 8, 9 and 11) | ||
Stockholders’ equity: | ||
Common stock, par value $0.0001 per share, 200,000,000 shares authorized; 5,316,166 and 5,235,166 issued and 5,315,830 and 5,234,830 outstanding | 8,860 | 8,852 |
Additional paid-in capital | 220,171,250 | 219,112,164 |
Treasury stock at cost, 336 shares | (40,712) | (40,712) |
Accumulated other comprehensive gain (loss) | 7,259 | (20,321) |
Accumulated deficit | (199,777,214) | (183,425,043) |
Total stockholders’ equity | 20,369,443 | 35,634,940 |
Total liabilities and stockholders’ equity | $ 23,001,072 | $ 37,542,922 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Accumulated depreciation | $ 1,182,191 | $ 1,153,530 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 5,316,166 | 5,235,166 |
Common stock, shares outstanding | 5,315,830 | 5,234,830 |
Treasury stock, shares | 336 | 336 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenues: | ||
License revenue | $ 109,987 | $ 500,000 |
Minimum guaranteed royalties revenue (reversal of variable consideration) | (2,960,805) | |
Total revenues (reversal of variable consideration), net | (2,850,818) | 500,000 |
Operating expenses: | ||
Research and development | 10,175,251 | 8,556,888 |
General and administrative | 4,904,888 | 4,062,487 |
Total operating expenses | 15,080,139 | 12,619,375 |
Operating loss | (17,930,957) | (12,119,375) |
Other income (expense): | ||
Interest and investment income | 1,366,940 | 572,578 |
Interest expense | (27,098) | |
Unrealized gain on warrant liability | 212,690 | 565,940 |
Gain on litigation settlement liability | 250,000 | |
Total other income, net | 1,579,630 | 1,361,420 |
Loss before income tax expense | (16,351,327) | (10,757,955) |
Income tax expense | (755) | (681) |
Net loss | (16,352,082) | (10,758,636) |
Issuance of Series B preferred stock dividend | (89) | |
Net loss attributable to common shareholders Net loss attributable to common shareholders | $ (16,352,171) | $ (10,758,636) |
Basic loss per share attributable to common stock | $ (3.10) | $ (2.06) |
Weighted average common shares outstanding, basic | 5,269,671 | 5,231,681 |
Diluted loss per share attributable to common stock | $ (3.14) | $ (2.15) |
Weighted average common shares outstanding, diluted | 5,269,671 | 5,256,169 |
Comprehensive loss: | ||
Net unrealized gain (loss) on available-for-sale securities | $ 27,580 | $ (2,305) |
Comprehensive loss | $ (16,324,502) | $ (10,760,941) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Preferred Stock [Member] Series B Preferred Stock [Member] | Common Stock [Member] | Treasury Stock, Common [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balances, value at Dec. 31, 2021 | $ 8,830 | $ (40,712) | $ 218,286,323 | $ (18,016) | $ (172,666,407) | $ 45,570,018 | |
Mezzanine equity, balance, value at Dec. 31, 2021 | |||||||
Balance, shares at Dec. 31, 2021 | 5,221,883 | 336 | |||||
Net loss | (10,758,636) | (10,758,636) | |||||
Unrealized net gain on marketable investment securities | (2,305) | (2,305) | |||||
Stock-based compensation | 636,140 | 636,140 | |||||
Option exercises | $ 22 | 211,401 | 211,423 | ||||
Option exercises, shares | 12,947 | ||||||
Costs associated with ATM Offering | (21,700) | (21,700) | |||||
Balances, value at Dec. 31, 2022 | $ 8,852 | $ (40,712) | 219,112,164 | (20,321) | (183,425,043) | 35,634,940 | |
Mezzanine equity, balance, value at Dec. 31, 2022 | |||||||
Balance, shares at Dec. 31, 2022 | 5,234,830 | 336 | |||||
Mezzanine equity, balance, shares at Dec. 31, 2022 | |||||||
Net loss | (16,352,082) | (16,352,082) | |||||
Unrealized net gain on marketable investment securities | 27,580 | 27,580 | |||||
Stock-based compensation | 654,438 | 654,438 | |||||
Mezzanine equity, Issuance of Series B preferred stock dividend, value | $ 9 | ||||||
Mezzanine equity, Issuance of Series B preferred stock dividend, shares | 88,511 | ||||||
Mezzanine equity, Redemption of Series B preferred stock, value | $ (9) | ||||||
Mezzanine equity, Redemption of Series B preferred stock, shares | (88,511) | ||||||
Issuance of Series B preferred stock dividend | 80 | 80 | |||||
Redemption of Series B preferred stock | 9 | (89) | (80) | ||||
Common stock sold through ATM offering | $ 8 | 404,559 | 404,567 | ||||
Common stock sold through ATM offering, shares | 81,000 | ||||||
Balances, value at Dec. 31, 2023 | $ 8,860 | $ (40,712) | $ 220,171,250 | $ 7,259 | $ (199,777,214) | $ 20,369,443 | |
Mezzanine equity, balance, value at Dec. 31, 2023 | |||||||
Balance, shares at Dec. 31, 2023 | 5,315,830 | 336 | |||||
Mezzanine equity, balance, shares at Dec. 31, 2023 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (16,352,082) | $ (10,758,636) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation expense | 28,661 | 9,453 |
Stock-based compensation expense | 654,438 | 636,140 |
Non-cash interest expense | 5,842 | |
Non-cash gain on change in fair value of warrant liability | (212,690) | (565,940) |
Gain on settlement of litigation liability | (250,000) | |
Amortization of discounts on marketable investment securities | (952,651) | (122,048) |
Write off of contract asset due to variable consideration revenue reversal | 2,960,805 | |
Changes in operating assets and liabilities: | ||
Accrued interest income | 28,173 | 166,826 |
Contract asset | 709,933 | 218,072 |
Prepaid and other current assets | 333,085 | 569,146 |
Accounts payable | 795,589 | (688,954) |
Accrued expenses | 140,748 | 61,280 |
Litigation settlement liability | (1,250,000) | |
Cash used in operating activities | (11,865,991) | (11,968,819) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (13,167) | (133,831) |
Purchases of marketable investment securities | (22,902,147) | (45,074,462) |
Maturities of marketable investment securities | 36,000,000 | 59,502,000 |
Cash provided by investing activities | 13,084,686 | 14,293,707 |
Cash flows from financing activities: | ||
Debt repayments | (1,666,667) | |
End of loan payment | (650,000) | |
Net proceeds from sale of common stock through ATM | 404,567 | (21,700) |
Proceeds from stock option exercises | 211,423 | |
Cash provided by (used in) financing activities | 404,567 | (2,126,944) |
Net increase in cash and cash equivalents | 1,623,262 | 197,944 |
Cash and cash equivalents at beginning of period | 3,148,496 | 2,950,552 |
Cash and cash equivalents at end of period | 4,771,758 | 3,148,496 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 21,256 | |
Income taxes paid | 225 | 200 |
Supplemental disclosure of non-cash investing and financing activity: | ||
Net unrealized gain (loss) on available-for-sale securities | 27,580 | (2,305) |
Accrued final payment charge on debt | 5,842 | |
Issuance of Series B preferred stock | $ 89 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure [Table] | ||
Net Income (Loss) Attributable to Parent | $ (16,352,082) | $ (10,758,636) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Description of Business | (1) Description of Business Lipocine Inc. (“Lipocine” or the “Company”), a clinical-stage biopharmaceutical company focused on central nervous system (“CNS”) disorders, is engaged in research and development for the delivery of drugs using its proprietary delivery technology. The Company’s principal operation is to provide oral delivery solutions for existing drugs. Lipocine develops its own drug candidates or it develops drug candidates on behalf of or in collaboration with corporate partners. The Company has funded operating costs primarily through collaborative license, milestone and research arrangements, through federal grants, through the sale of equity securities and through debt. The Company is incorporated under the laws of the State of Delaware. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies (a) Use of Estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“US GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include those related to the timing and amount of revenue recognized from licensing agreements, stock-based compensation; income tax uncertainties; the fair value of the warrant liability and the useful lives of property and equipment. (b) Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities to the Company of three months or less to be cash equivalents. Although the Company may deposit its cash and cash equivalents with multiple financial institutions, its deposits, at times, may exceed federally insured limits. Cash and cash equivalents were $ 4.8 3.1 (c) Receivables Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company maintains an allowance for doubtful accounts for estimated losses. In establishing the allowance, management considers historical losses adjusted to take into account current market conditions and their customers’ financial condition, the amount of receivables in dispute, and the current receivables aging and current payment patterns. The Company had no write-offs in 2023 and 2022 and the Company did not record an allowance for doubtful accounts as of December 31, 2023 and 2022 as there were no accounts receivable outstanding. The Company does not have any off-balance-sheet credit exposure related to its customers. (d) Revenue Recognition The Company generates most of its revenue from license and royalty arrangements. At the 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 or 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. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) Disaggregation of Revenue Schedule of Disaggregation of Revenue Type of Revenue 2023 2022 License $ 109,987 $ 500,000 Minimum guaranteed royalties revenue (reversal of variable consideration) (2,960,805 ) - Revenue $ (2,850,818 ) $ 500,000 Under Topic 606, all revenue has been recognized as point in time for the years ended December 31, 2023 and 2022. See Note 4 for a description of the license agreement with Antares Pharma, Inc. (the “Antares License Agreement”). See Note 12 for a description of the agreement with Spriaso. License Fees Royalties. Contract Assets Contract assets consist of minimum royalty revenue earned in relation to the license agreement but not yet payable based on the terms of the contract. On October 2, 2023, the Company received notice from Antares of Antares’ termination of the Antares License Agreement which stated that the Antares License Agreement will terminate effective January 31, 2024. The Company received approximately $ 902,000 710,000 192,000 3.0 zero 3,832,000 Revenue Concentration A major partner is considered to be one that comprises more than 10 3.0 500,000 100 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) (e) Property and Equipment Property and equipment are recorded at cost, less accumulated depreciation. Maintenance and repairs that do not extend the life or improve the asset are expensed in the year incurred. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which are five years three years seven years (f) Accounting for Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets held and used is measured by a comparison of the carrying amount of an asset to future net cash flows (undiscounted) expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets held for sale are reported at the lower of the carrying amount, or fair value, less costs to sell. (g) Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is provided against net deferred tax assets if, based upon the available evidence, it is more likely than not that some or all of the net deferred tax assets will not be realized. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50 percent (h) 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 of directors 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, in the past 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. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) 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, nonemployees 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 that has been expensed in the statements of operations amounted to $ 654,000 and $ 636,000 for the years ended December 31, 2023 and 2022, allocated as follows: Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs Years Ended December 31, 2023 2022 Research and development $ 358,352 $ 338,018 General and administrative 296,086 298,122 $ 654,438 $ 636,140 The Company issued 26,467 74,334 Key assumptions used in the determination of the fair value of stock options granted are as follows: Expected Term Share-Based Payment, Risk-Free Interest Rate Expected Dividend Expected Volatility LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) For options granted in 2023 and 2022, 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 2023 2022 Expected term 5.73 5.82 Risk-free interest rate 3.73 % 3.06 % Expected dividend yield — — Expected volatility 98.97 % 99.31 % FASB Accounting Standards Codification (“ASC”) 718, Stock Compensation, As of December 31, 2023, there was $ 455,000 1.4 6.19 11.50 (i) 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. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) 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 at December 31, 2023 and 2022: Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis Fair value measurements at reporting date using December 31, 2023 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 4,695,491 $ 4,695,491 $ - $ - Government treasury bills 14,281,104 14,281,104 - - US. Government agency securities 2,982,684 - 2,982,684 - $ 21,959,279 $ 18,976,595 $ 2,982,684 $ - Liabilities: Warrant liability $ 17,166 $ - $ - $ 17,166 $ 21,976,445 $ 18,976,595 $ 2,982,684 $ 17,166 Fair value measurements at reporting date using Deember 31, 2022 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,694,434 $ 2,694,434 $ - $ - Government treasury bills 5,959,000 5,959,000 - - Commercial paper 14,586,930 - 14,586,930 - Corporate bonds and notes 5,454,690 - 5,454,690 - U.S. government agency securities 3,380,790 - 3,380,790 - $ 32,075,844 $ 8,653,434 $ 23,422,410 $ - Liabilities: Warrant liability $ 229,856 $ - $ - $ 229,856 $ 32,305,700 $ 8,653,434 $ 23,422,410 $ 229,856 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) 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 bonds and notes: The Company uses a third-party pricing service to value these investments. United States bonds and notes are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices for identical assets and reportable trades. Corporate bonds, notes, and commercial paper: The Company uses a third-party pricing service to value these investments. Corporate bonds, notes and commercial paper are classified within Level 2 of the fair value hierarchy because they are valued using broker/dealer quotes, bids and offers, benchmark yields and credit spreads and other observable inputs. Warrant liability: The warrant liability (which relates to warrants to purchase shares of common stock) is marked-to-market each reporting period with the change in fair value recorded to other income (expense) in the accompanying statements of operations until the warrants are exercised, expire or other facts and circumstances lead the warrant liability to be reclassified to stockholders’ equity. The fair value of the warrant liability is estimated using a Black-Scholes option-pricing model. The significant assumptions used in preparing the option pricing model for valuing the warrant liability as of December 31, 2023, include (i) volatility of 100 4.79 8.50 2.79 0.9 100 4.41 8.50 6.77 1.9 The Company’s accounting policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, Level 2 or Level 3 for the years ended December 31, 2023 and December 31, 2022. (j) Earnings (Loss) per Share Basic earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted earnings (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. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) The following table sets forth the computation of basic and diluted earnings (loss) per share of common stock for the years ended December 31, 2023 and 2022. Schedule of Computation of Basic and Diluted Earnings (Loss) Per Share of Common Stock 2023 2022 Years Ended December 31, 2023 2022 Basic loss per share attributable to common stock: Numerator Net loss $ (16,352,171 ) $ (10,758,636 ) Denominator Weighted avg. common shares outstanding 5,269,671 5,231,681 Basic loss per share attributable to common stock $ (3.10 ) $ (2.06 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (16,352,171 ) $ (10,758,636 ) Effect of dilutive securities on net loss: Common stock warrants 212,690 565,940 Total net loss for purpose of calculating diluted net loss per common share $ (16,564,861 ) $ (11,324,576 ) Denominator Weighted avg. common shares outstanding 5,269,671 5,231,681 Weighted average effect of dilutive securities: Common stock warrants - 24,488 Total shares for purpose of calculating diluted net loss per common share 5,269,671 5,256,169 Diluted loss per share attributable to common stock $ (3.14 ) $ (2.15 ) The computation of diluted earnings per share for the years ended December 31, 2023 and 2022 does not include the following stock options or warrants to purchase shares in the computation of diluted earnings per share because these instruments were antidilutive: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share December 31, 2023 2022 Stock options 262,247 277,225 Warrants 49,433 49,433 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) (k) Segment Information The Company is a single reportable segment engaged in research and development for the delivery of drugs using its proprietary delivery technology. Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The chief operating decision maker made such decisions and assessed performance at the company level, as one segment. (l) Principles of Consolidation The consolidated financial statements include the accounts of the Company and all subsidiaries. The Company eliminates all intercompany accounts and transactions in consolidation. |
Marketable Investment Securitie
Marketable Investment Securities | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Investment Securities | (3) 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 at December 31, 2023 and 2022 were as follows: Schedule of Available for Sale Securities December 31, 2023 Amortized Cost Gross unrealized holding gains Gross unrealized holding losses Aggregate fair value Government treasury bills $ 14,272,530 $ 8,574 $ - $ 14,281,104 U.S. government agency securities 2,983,999 - (1,315 ) 2,982,684 $ 17,256,529 $ 8,574 $ (1,315 ) $ 17,263,788 December 31, 2022 Amortized Cost Gross unrealized holding gains Gross unrealized holding losses Aggregate fair value Government treasury bills $ 5,973,087 $ - $ (14,087 ) $ 5,959,000 Commercial paper 20,052,505 - (10,885 ) 20,041,620 U.S. government agency securities 3,376,139 4,651 - 3,380,790 $ 29,401,731 $ 4,651 $ (24,972 ) $ 29,381,410 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (3) Marketable Investment Securities - (continued) Maturities of debt securities classified as available-for-sale securities at December 31, 2023 are as follows: Schedule of Maturities of Debt Securities Classified as Available-for-Sale Securities December 31, 2023 Amortized Cost Aggregate fair value Due within one year $ 17,256,529 $ 17,263,788 $ 17,256,529 $ 17,263,788 There were no no 36.0 59.5 no |
Contractual Agreements
Contractual Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Contractual Agreements | |
Contractual Agreements | (4) Contractual Agreements (a) Abbott Products, Inc. On March 29, 2012, the Company terminated its collaborative agreement with Solvay Pharmaceuticals, Inc. (later acquired by Abbott Products, Inc.) 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% 1.0 50% 34,000 12,000 (b) Antares Pharma, Inc. On October 14, 2021, the Company entered into a license agreement (“License Agreement”) with Antares Pharma, Inc. (“Antares”) pursuant to which the Company granted to Antares an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize, upon final approval of TLANDO® from the U.S. Food and Drug Administration (“FDA”), 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. TLANDO received FDA approval on March 29, 2022. Upon execution of the Antares License Agreement, Antares paid to the Company an initial payment of $ 11.0 5.0 160.0 20% LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (4) Contractual Agreements – (continued) Pharmaceuticals Inc. (Verity). See Note 4(c) for a description of the Verity License Agreement. Upon termination of the Antares License Agreement, all rights and licenses granted by the Company to Antares under the Antares License Agreement will terminate and all rights in TLANDO will be transferred to the Company’s new licensing partner, Verity. Under the Antares License Agreement, the Company retained development and commercialization rights in the rest of the world, and with respect to applications outside of the Field inside or outside the United States. The License Agreement also provided Antares with an option, exercisable on or before March 31, 2022, to license TLANDO XR (LPCN 1111), the Company’s potential once-daily oral product candidate for testosterone replacement therapy. On April 1, 2022, the Company entered into the First Amendment to the License Agreement (the “Amendment”), pursuant to which the License Agreement was amended to extend the deadline by which Antares was to exercise its option to license TLANDO XR to June 30, 2022. As consideration for the Company agreeing to enter into the Amendment, in April 2022 Antares paid the Company a non-refundable cash fee of $ 500,000 3.0 500,000 (c) Verity Pharmaceuticals, Inc. On January 12, 2024, the Company entered into a License Agreement (the “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 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 License Agreement also provides GSL with a license to develop and commercialize TLANDO XR, the Company’s potential once-daily oral product candidate for testosterone replacement therapy. The Company retains development and commercialization rights outside of the United States and Canada, and with respect to applications outside of the Field inside or outside the United States and Canada. Upon execution of the License Agreement, GSL agreed to pay the Company a license fee of $ 11.0 2.5 5.0 2.5 1.0 259.0 12% 18% Pursuant to the terms of the 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 United States and Canada, while the Company is generally responsible for expenses relating to development activities outside of the Field and/or the United States and Canada. (d) Contract Research and Development The Company has entered into agreements with various contract organizations that conduct preclinical, clinical, analytical and manufacturing development work on behalf of the Company as well as a number of independent contractors, primarily clinical researchers, who serve as advisors to the Company. The Company incurred expenses of $ 6.7 5.6 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 |
Loan and Security Agreement
Loan and Security Agreement | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Loan and Security Agreement | (5) Loan and Security Agreement Silicon Valley Bank Loan On January 5, 2018, the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Silicon Valley Bank (“SVB”) pursuant to which SVB agreed to lend the Company $ 10.0 The principal borrowed under the Loan and Security Agreement bore interest at a rate equal to the Prime Rate, as reported in the money rates section of The Wall Street Journal or any successor publication representing the rate of interest per annum then in effect, plus one percent per annum, which interest was payable monthly. June 1, 2022 650,000 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | (6) Property and Equipment Property and equipment consisted of the following: Schedule of Property and Equipment 2023 2022 Years Ended December 31, 2023 2022 Computer equipment and software $ 66,830 $ 53,663 Lab and office equipment 1,180,052 1,180,052 Furniture and fixtures 51,404 51,404 Property and equipment, gross 1,298,286 1,285,119 Less accumulated depreciation (1,182,191 ) (1,153,530 ) Property and equipment, net $ 116,095 $ 131,589 Depreciation expense for the years ended December 31, 2023 and 2022 was approximately $ 29,000 9,500 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (7) Income Taxes (a) Income Tax Expense Income tax expense consists of: Schedule of Income Tax Expense 2023 2022 December 31, 2023 2022 U.S. federal $ - $ - State and local 755 681 Deferred - - Total $ 755 $ 681 (b) Tax Rate Reconciliation Income tax expense was $ 755 681 21% Schedule of Pretax Income from Continuing Operations 2023 2022 December 31, 2023 2022 Computed “expected” tax expense (benefit) $ (3,433,893 ) $ (2,259,272 ) Increase (reduction) in income taxes resulting from: Change in valuation allowance 3,619,564 2,529,547 State and local income taxes, net of federal income tax benefit 596 538 Stock expense 319,214 314,186 Research and development tax credits (434,858 ) (422,495 ) Orphan drug tax credit (26,245 ) (42,976 ) Warrant Liability (44,665 ) (118,847 ) Other, net 1,042 - Total $ 755 $ 681 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (7) Income Taxes – (continued) (c) Significant Components of Deferred Taxes The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2023 and 2022 are presented below: Schedule of Deferred Tax Assets and Liabilities 2023 2022 December 31, 2023 2022 Deferred tax assets: Stock-based compensation $ 1,188,535 $ 1,428,167 Net operating loss carryforwards 35,108,766 35,595,940 Employee benefits 45,592 44,602 Research and development tax credits 6,032,559 5,491,805 Orphan drug tax credits 1,274,204 1,240,982 Plant and equipment - - Sec. 174 Expenses 3,945,862 1,997,787 Other deductible temporary differences 167,371 69,273 Total gross deferred tax assets 47,762,889 45,868,556 Net deferred tax assets $ 47,762,889 $ 45,868,556 Deferred tax liabilities: Plant and equipment (7,227 ) (9,052 ) Total gross deferred tax liabilities (7,227 ) (9,052 ) Net deferred tax liabilities $ (7,227 ) $ (9,052 ) Deferred tax asset/deferred tax liability 47,755,662 45,859,504 Valuation allowance (47,755,662 ) (45,859,504 ) Net deferred tax asset $ - $ - The valuation allowance for deferred tax assets as of December 31, 2023 and 2022 was $ 47.8 45.9 1.9 2.9 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (7) Income Taxes – (continued) During the year ended December 31, 2013, the Company experienced a change in ownership, as defined by the Internal Revenue Code, as amended (the “Code”) under Section 382. A change of ownership occurs when ownership of a company increases by more than 50 percentage points over a three-year testing period of certain stockholders. As a result of this ownership change, we determined that our annual limitation on the utilization of our federal net operating loss (“NOL”) and credit carryforwards is approximately $ 1.1 9.8 3.3 1.2 As of December 31, 2023, we had NOL and research and development credit carryforwards for U.S. federal income tax reporting purposes of approximately $ 138.6 4.4 Approximately $33.7 million of the NOL will expire between 2024 and 2034 and $52.4 million of the NOL will expire 2035 through 2037 expire in 2033 through 2043 1.3 We also have state NOL and research and development credit carry forwards of approximately $ 128.9 1.7 expire in 2024 through 2038 The Company’s federal and state income tax returns for December 31, 2020 through 2023 are open tax years. A reconciliation of the beginning and ending amount of total unrecognized tax contingencies, excluding interest and penalties, for the years ended December 31, 2023 and 2022 are as follows: Schedule of Reconciliation of the Beginning and Ending Amount of Total Unrecognized Tax Contingencies, Excluding Interest and Penalties December 31, 2023 2022 Balance, beginning of year $ - $ - Balance, end of year $ - $ - LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Leases | (8) Leases The Company has a non-cancelable operating lease for office space and laboratory facilities in Salt Lake City, Utah. On January 24, 2024, the term of the lease has been extended through February 28, 2025. Future minimum lease payments under the non-cancelable operating lease as of December 31, 2023 are: Schedule of Future Minimum Rental Payments for Operating Leases Operating leases Year ending December 31: 2024 $ 366,290 2025 61,346 Total minimum lease payments $ 427,636 The Company’s rent expense was $ 355,000 341,000 |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | (9) Stockholders’ Equity On May 1, 2023, at the 2023 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split at a ratio not less than 1-for-5 and not more than 1-for-20, with the exact ration to be set within that range at the discretion of the Board without further approval or authorization from stockholders. On May 10, 2023, the Company’s Board approved a reverse stock split of 1-for-17 All common stock share data and per share price data of the Company reflect the reverse stock split effective May 11, 2023. On June 8, 2022, at the 2022 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of the Company’s common stock, par value $ 0.0001 100,000,000 200,000,000 (a) Issuance of Common Stock On March 6, 2017, the Company entered into a sales agreement (“Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) 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. The Company currently has registered up to $ 50.0 3.0% The Company is not obligated to make any sales of its common stock under the Sales Agreement. The offering of common stock pursuant to the Sales Agreement will terminate upon the termination of the Sales Agreement as permitted therein. The Company and Cantor may each terminate the Sales Agreement at any time upon ten days’ prior notice. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (9) Stockholders’ Equity – (continued) As of December 31, 2023, we had sold an aggregate of 964,711 34.52 33.3 32.1 81,000 5.36 405,000 24,000 40.8 5.3 (b) Series B Preferred Stock On March 7, 2023, the Board of the Company declared a dividend of one one-thousandth (1/1,000 th 0.0001 The dividend was based on the number of shares of outstanding common stock on March 24, 2023, and resulted in 88,511 Each whole share of Series B Preferred Stock entitled the holder thereof to 1,000,000 votes per share, and each fraction of a share of Series B Preferred Stock had a ratable number of votes. Thus, each one-thousandth of a share of Series B Preferred Stock was entitled to 1,000 votes. All shares of Series B Preferred Stock that were not present in person or by proxy at the 2023 annual meeting as of immediately prior to the opening of the polls (the “Initial Redemption Time”) were automatically redeemed by the Company without further action on the part of the Company or the holder of shares of Series B Preferred Stock (the “Initial Redemption”). The remaining shares of Series B Preferred Stock that were not redeemed pursuant to the Initial Redemption were redeemed automatically upon the effectiveness of the amendment to the Certificate of Incorporation implementing the Reverse Stock Split (the “Subsequent Redemption”). Each “beneficial owner” (as such terms are defined in the Certificate of Designation with respect to the Series B Preferred Stock) of shares of Series B Preferred Stock redeemed in the redemptions described above has the right to receive an amount equal to $0.01 in cash for each ten whole shares of Series B Preferred Stock that were “beneficially owned” by the beneficial owner as of immediately prior to the applicable redemption time and redeemed pursuant to such redemption, payable upon receipt by the Company of a written request submitted by the applicable beneficial owner to the corporate secretary of the Company following the applicable redemption time. The Series B Preferred Stock was not convertible into, or exchangeable for, shares of any other class or series of stock or other securities of the Company. The Series B Preferred Stock had no stated maturity and was not subject to any sinking fund. The Series B Preferred Stock was not subject to any restriction on the redemption or repurchase of shares by the Company while there is any arrearage in the payment of dividends or sinking fund installments. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (9) Stockholders’ Equity – (continued) The Company was not solely in control of the redemption of the shares of Series B Preferred Stock prior to the annual meeting of stockholders since the holders had the option of deciding whether to vote in respect of the above-described Reverse Stock Split, which determined whether a given holder’s shares of Series B Preferred Stock was redeemed in the Initial Redemption or the Subsequent Redemption. Since the redemption of the Series B Preferred Stock was not solely in the control of the Company, the shares of Series B Preferred Stock were classified within the mezzanine equity in the Company’s unaudited consolidated statement of stockholder’s equity. Upon issuance, the shares of Series B Preferred Stock were measured at redemption value. As of June 30, 2023, all shares of Series B Preferred Stock had been redeemed by the Company. The foregoing description of the Series B Preferred Stock does not purport to be complete and is qualified in its entirety by reference to the Certificate of Designation, which is filed as Exhibit 3.2 to the Form 8-K filed with the SEC on March 10, 2023. (c) Rights Agreement On November 13, 2015, the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent, entered into a Rights Agreement. Also on November 12, 2015, the board of directors 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 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. 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 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (9) Stockholders’ Equity – (continued) (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 15,994 74,817 145,405 145,405 189,522 189,522 336,582 ten 336,582 48,422 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, 2022 277,225 $ 38.44 Options granted 26,467 6.19 Options exercised - - Options forfeited (7,352 ) 6.91 Options cancelled (34,093 ) 52.72 Balance at December 31, 2023 262,247 34.21 Options exercisable at December 31, 2023 194,228 42.72 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (9) Stockholders’ Equity – (continued) The following table summarizes information about stock options outstanding and exercisable at December 31, 2023: Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable Options outstanding Options exercisable Number outstanding Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value Number exerciseable Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value 262,247 6.60 $ 34.21 $ - 194,228 5.84 $ 42.72 $ - The intrinsic value for stock options is defined as the difference between the current market value and the exercise price. The total intrinsic value of stock options exercised during the years ended December 31, 2023 and 2022, was $ 0 173,000 0 12,947 (e) Common Stock Warrants The Company accounts for its common stock warrants under ASC 480, Distinguishing Liabilities from Equity As of December 31, 2023 and 2022, the Company had 64,362 Schedule of Fair Value of Warrants December 31, 2023 December 31, 2022 November 18, 2019 Expected life in years 0.88 1.88 5.00 Risk-free interest rate 4.79 % 4.41 % 1.63 % Dividend yield — — — Volatility 100.00 % 100.00 % 224.47 % Stock price $ 2.79 $ 6.77 $ 6.89 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (9) Stockholders’ Equity – (continued) During the years ended December 31, 2023 and 2022, the Company recorded a non-cash gain of $ 213,000 566,000 Schedule of Reconciliation of Warrant Liability Warrant Liability Balance at December 31, 2022 $ 229,856 Change in fair value of common stock warrants (212,690 ) Balance at December 31, 2023 $ 17,166 Additionally, in the February 2020 Offering, the Company issued 296,593 49,433 The following table summarizes the number of common stock warrants outstanding and the weighted average exercise price: Schedule of Number of Warrants Outstanding and the Weighted Average Exercise Price Warrants Weighted Average Exercise Price Outstanding at December 31, 2022 113,795 $ 8.72 Issued - - Exercised - - Expired - - Cancelled - - Forfeited - - Balance at December 31, 2023 113,795 $ 8.72 During the years ended December 31, 2023 and 2022, zero The following table summarizes information about common stock warrants outstanding at December 31, 2023: Schedule of Common Stock Warrants Outstanding Warrants outstanding Number exercisable Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value 113,795 1.00 $ 8.72 $ - LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
401(k) Plan | (10) 401(k) Plan On January 1, 2002, the Company adopted a tax qualified employee savings and retirement plan (the “401(k) Plan”) covering eligible employees. Pursuant to the 401(k) Plan, employees may elect to reduce current compensation by a percentage of eligible compensation, not to exceed legal limits, and contribute the amount of such reduction to the 401(k) Plan. Beginning April 1, 2014, the 401(k) Plan was amended to require matching contributions to the 401(k) Plan by the Company on behalf of the participants of 100 102,000 94,000 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (11) 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. On April 2, 2019, the Company filed a lawsuit against Clarus in the United States District Court for the District of Delaware alleging that Clarus’s JATENZO® product infringes six of Lipocine’s issued U.S. patents: 9,034,858; 9,205,057; 9,480,690; 9,757,390; 6,569,463; and 6,923,988. However, on February 11, 2020, the Company voluntarily dismissed allegations of patent infringement for expired U.S. Patent Nos. 6,569,463 and 6,923,988 in an effort to streamline the issues and associated costs for dispute. Clarus answered the complaint and asserted counterclaims of non-infringement and invalidity. The Company answered Clarus’s counterclaims on April 29, 2019. The Court held a scheduling conference on August 15, 2019, a claim construction hearing on February 11, 2020, and a summary judgment hearing on January 15, 2021. In May 2021, the Court granted Clarus’ motion for Summary Judgment, finding the asserted claims of Lipocine’s U.S. patents 9,034,858; 9,205,057; 9,480,690; and 9,757,390 invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112. Clarus still had remaining claims before the Court. On July 13, 2021, the Company entered into the Global Agreement with Clarus which resolved all outstanding claims of this litigation as well as the on-going United States Patent and Trademark Office (“USPTO”) Interference No. 106,128 between the parties. Under the terms of the Global Agreement, the Company agreed to pay Clarus $ 4.0 2.5 1.0 500,000 1,250,000 On November 14, 2019, the Company and certain of our officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v. Lipocine Inc. et al LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (11) Commitments and Contingencies (continued) Management does not currently believe that any other matter, individually or in the aggregate, will 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 indemnifications provisions. Additionally, the Company has indemnified its directors and officers to the maximum extent permitted under the laws of the State of Delaware. |
Agreement with Spriaso, LLC
Agreement with Spriaso, LLC | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Agreement with Spriaso, LLC | (12) 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 10.0 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; 110,000 0 Consolidations |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | (13) Subsequent Events On January 12, 2024, the Company entered into a License Agreement with Verity Pharmaceuticals, Inc. for the commercialization of TLANDO® in the U.S. and for the development and commercialization rights to TLANDO XR in Canada as described in Note 4(c). |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates | (a) Use of Estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“US GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include those related to the timing and amount of revenue recognized from licensing agreements, stock-based compensation; income tax uncertainties; the fair value of the warrant liability and the useful lives of property and equipment. |
Cash and Cash Equivalents | (b) Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities to the Company of three months or less to be cash equivalents. Although the Company may deposit its cash and cash equivalents with multiple financial institutions, its deposits, at times, may exceed federally insured limits. Cash and cash equivalents were $ 4.8 3.1 |
Receivables | (c) Receivables Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company maintains an allowance for doubtful accounts for estimated losses. In establishing the allowance, management considers historical losses adjusted to take into account current market conditions and their customers’ financial condition, the amount of receivables in dispute, and the current receivables aging and current payment patterns. The Company had no write-offs in 2023 and 2022 and the Company did not record an allowance for doubtful accounts as of December 31, 2023 and 2022 as there were no accounts receivable outstanding. The Company does not have any off-balance-sheet credit exposure related to its customers. |
Revenue Recognition | (d) Revenue Recognition The Company generates most of its revenue from license and royalty arrangements. At the 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 or 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. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) Disaggregation of Revenue Schedule of Disaggregation of Revenue Type of Revenue 2023 2022 License $ 109,987 $ 500,000 Minimum guaranteed royalties revenue (reversal of variable consideration) (2,960,805 ) - Revenue $ (2,850,818 ) $ 500,000 Under Topic 606, all revenue has been recognized as point in time for the years ended December 31, 2023 and 2022. See Note 4 for a description of the license agreement with Antares Pharma, Inc. (the “Antares License Agreement”). See Note 12 for a description of the agreement with Spriaso. License Fees Royalties. Contract Assets Contract assets consist of minimum royalty revenue earned in relation to the license agreement but not yet payable based on the terms of the contract. On October 2, 2023, the Company received notice from Antares of Antares’ termination of the Antares License Agreement which stated that the Antares License Agreement will terminate effective January 31, 2024. The Company received approximately $ 902,000 710,000 192,000 3.0 zero 3,832,000 Revenue Concentration A major partner is considered to be one that comprises more than 10 3.0 500,000 100 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) |
Property and Equipment | (e) Property and Equipment Property and equipment are recorded at cost, less accumulated depreciation. Maintenance and repairs that do not extend the life or improve the asset are expensed in the year incurred. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which are five years three years seven years |
Accounting for Impairment of Long-Lived Assets | (f) Accounting for Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets held and used is measured by a comparison of the carrying amount of an asset to future net cash flows (undiscounted) expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets held for sale are reported at the lower of the carrying amount, or fair value, less costs to sell. |
Income Taxes | (g) Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is provided against net deferred tax assets if, based upon the available evidence, it is more likely than not that some or all of the net deferred tax assets will not be realized. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50 percent |
Share Based Payments | (h) 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 of directors 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, in the past 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. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) 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, nonemployees 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 that has been expensed in the statements of operations amounted to $ 654,000 and $ 636,000 for the years ended December 31, 2023 and 2022, allocated as follows: Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs Years Ended December 31, 2023 2022 Research and development $ 358,352 $ 338,018 General and administrative 296,086 298,122 $ 654,438 $ 636,140 The Company issued 26,467 74,334 Key assumptions used in the determination of the fair value of stock options granted are as follows: Expected Term Share-Based Payment, Risk-Free Interest Rate Expected Dividend Expected Volatility LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) For options granted in 2023 and 2022, 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 2023 2022 Expected term 5.73 5.82 Risk-free interest rate 3.73 % 3.06 % Expected dividend yield — — Expected volatility 98.97 % 99.31 % FASB Accounting Standards Codification (“ASC”) 718, Stock Compensation, As of December 31, 2023, there was $ 455,000 1.4 6.19 11.50 |
Fair Value | (i) 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. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) 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 at December 31, 2023 and 2022: Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis Fair value measurements at reporting date using December 31, 2023 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 4,695,491 $ 4,695,491 $ - $ - Government treasury bills 14,281,104 14,281,104 - - US. Government agency securities 2,982,684 - 2,982,684 - $ 21,959,279 $ 18,976,595 $ 2,982,684 $ - Liabilities: Warrant liability $ 17,166 $ - $ - $ 17,166 $ 21,976,445 $ 18,976,595 $ 2,982,684 $ 17,166 Fair value measurements at reporting date using Deember 31, 2022 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,694,434 $ 2,694,434 $ - $ - Government treasury bills 5,959,000 5,959,000 - - Commercial paper 14,586,930 - 14,586,930 - Corporate bonds and notes 5,454,690 - 5,454,690 - U.S. government agency securities 3,380,790 - 3,380,790 - $ 32,075,844 $ 8,653,434 $ 23,422,410 $ - Liabilities: Warrant liability $ 229,856 $ - $ - $ 229,856 $ 32,305,700 $ 8,653,434 $ 23,422,410 $ 229,856 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) 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 bonds and notes: The Company uses a third-party pricing service to value these investments. United States bonds and notes are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices for identical assets and reportable trades. Corporate bonds, notes, and commercial paper: The Company uses a third-party pricing service to value these investments. Corporate bonds, notes and commercial paper are classified within Level 2 of the fair value hierarchy because they are valued using broker/dealer quotes, bids and offers, benchmark yields and credit spreads and other observable inputs. Warrant liability: The warrant liability (which relates to warrants to purchase shares of common stock) is marked-to-market each reporting period with the change in fair value recorded to other income (expense) in the accompanying statements of operations until the warrants are exercised, expire or other facts and circumstances lead the warrant liability to be reclassified to stockholders’ equity. The fair value of the warrant liability is estimated using a Black-Scholes option-pricing model. The significant assumptions used in preparing the option pricing model for valuing the warrant liability as of December 31, 2023, include (i) volatility of 100 4.79 8.50 2.79 0.9 100 4.41 8.50 6.77 1.9 The Company’s accounting policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, Level 2 or Level 3 for the years ended December 31, 2023 and December 31, 2022. |
Earnings (Loss) per Share | (j) Earnings (Loss) per Share Basic earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted earnings (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. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) The following table sets forth the computation of basic and diluted earnings (loss) per share of common stock for the years ended December 31, 2023 and 2022. Schedule of Computation of Basic and Diluted Earnings (Loss) Per Share of Common Stock 2023 2022 Years Ended December 31, 2023 2022 Basic loss per share attributable to common stock: Numerator Net loss $ (16,352,171 ) $ (10,758,636 ) Denominator Weighted avg. common shares outstanding 5,269,671 5,231,681 Basic loss per share attributable to common stock $ (3.10 ) $ (2.06 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (16,352,171 ) $ (10,758,636 ) Effect of dilutive securities on net loss: Common stock warrants 212,690 565,940 Total net loss for purpose of calculating diluted net loss per common share $ (16,564,861 ) $ (11,324,576 ) Denominator Weighted avg. common shares outstanding 5,269,671 5,231,681 Weighted average effect of dilutive securities: Common stock warrants - 24,488 Total shares for purpose of calculating diluted net loss per common share 5,269,671 5,256,169 Diluted loss per share attributable to common stock $ (3.14 ) $ (2.15 ) The computation of diluted earnings per share for the years ended December 31, 2023 and 2022 does not include the following stock options or warrants to purchase shares in the computation of diluted earnings per share because these instruments were antidilutive: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share December 31, 2023 2022 Stock options 262,247 277,225 Warrants 49,433 49,433 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2023 and 2022 (2) Summary of Significant Accounting Policies – (continued) |
Segment Information | (k) Segment Information The Company is a single reportable segment engaged in research and development for the delivery of drugs using its proprietary delivery technology. Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The chief operating decision maker made such decisions and assessed performance at the company level, as one segment. |
Principles of Consolidation | (l) Principles of Consolidation The consolidated financial statements include the accounts of the Company and all subsidiaries. The Company eliminates all intercompany accounts and transactions in consolidation. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Disaggregation of Revenue | Disaggregation of Revenue Schedule of Disaggregation of Revenue Type of Revenue 2023 2022 License $ 109,987 $ 500,000 Minimum guaranteed royalties revenue (reversal of variable consideration) (2,960,805 ) - Revenue $ (2,850,818 ) $ 500,000 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs Years Ended December 31, 2023 2022 Research and development $ 358,352 $ 338,018 General and administrative 296,086 298,122 $ 654,438 $ 636,140 |
Schedule of Key Assumption of Fair Value of Stock Options Granted | For options granted in 2023 and 2022, 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 2023 2022 Expected term 5.73 5.82 Risk-free interest rate 3.73 % 3.06 % Expected dividend yield — — Expected volatility 98.97 % 99.31 % |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis Fair value measurements at reporting date using December 31, 2023 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 4,695,491 $ 4,695,491 $ - $ - Government treasury bills 14,281,104 14,281,104 - - US. Government agency securities 2,982,684 - 2,982,684 - $ 21,959,279 $ 18,976,595 $ 2,982,684 $ - Liabilities: Warrant liability $ 17,166 $ - $ - $ 17,166 $ 21,976,445 $ 18,976,595 $ 2,982,684 $ 17,166 Fair value measurements at reporting date using Deember 31, 2022 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,694,434 $ 2,694,434 $ - $ - Government treasury bills 5,959,000 5,959,000 - - Commercial paper 14,586,930 - 14,586,930 - Corporate bonds and notes 5,454,690 - 5,454,690 - U.S. government agency securities 3,380,790 - 3,380,790 - $ 32,075,844 $ 8,653,434 $ 23,422,410 $ - Liabilities: Warrant liability $ 229,856 $ - $ - $ 229,856 $ 32,305,700 $ 8,653,434 $ 23,422,410 $ 229,856 |
Schedule of Computation of Basic and Diluted Earnings (Loss) Per Share of Common Stock | The following table sets forth the computation of basic and diluted earnings (loss) per share of common stock for the years ended December 31, 2023 and 2022. Schedule of Computation of Basic and Diluted Earnings (Loss) Per Share of Common Stock 2023 2022 Years Ended December 31, 2023 2022 Basic loss per share attributable to common stock: Numerator Net loss $ (16,352,171 ) $ (10,758,636 ) Denominator Weighted avg. common shares outstanding 5,269,671 5,231,681 Basic loss per share attributable to common stock $ (3.10 ) $ (2.06 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (16,352,171 ) $ (10,758,636 ) Effect of dilutive securities on net loss: Common stock warrants 212,690 565,940 Total net loss for purpose of calculating diluted net loss per common share $ (16,564,861 ) $ (11,324,576 ) Denominator Weighted avg. common shares outstanding 5,269,671 5,231,681 Weighted average effect of dilutive securities: Common stock warrants - 24,488 Total shares for purpose of calculating diluted net loss per common share 5,269,671 5,256,169 Diluted loss per share attributable to common stock $ (3.14 ) $ (2.15 ) |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | The computation of diluted earnings per share for the years ended December 31, 2023 and 2022 does not include the following stock options or warrants to purchase shares in the computation of diluted earnings per share because these instruments were antidilutive: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share December 31, 2023 2022 Stock options 262,247 277,225 Warrants 49,433 49,433 |
Marketable Investment Securit_2
Marketable Investment Securities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available for Sale Securities | Schedule of Available for Sale Securities December 31, 2023 Amortized Cost Gross unrealized holding gains Gross unrealized holding losses Aggregate fair value Government treasury bills $ 14,272,530 $ 8,574 $ - $ 14,281,104 U.S. government agency securities 2,983,999 - (1,315 ) 2,982,684 $ 17,256,529 $ 8,574 $ (1,315 ) $ 17,263,788 December 31, 2022 Amortized Cost Gross unrealized holding gains Gross unrealized holding losses Aggregate fair value Government treasury bills $ 5,973,087 $ - $ (14,087 ) $ 5,959,000 Commercial paper 20,052,505 - (10,885 ) 20,041,620 U.S. government agency securities 3,376,139 4,651 - 3,380,790 $ 29,401,731 $ 4,651 $ (24,972 ) $ 29,381,410 |
Schedule of Maturities of Debt Securities Classified as Available-for-Sale Securities | Maturities of debt securities classified as available-for-sale securities at December 31, 2023 are as follows: Schedule of Maturities of Debt Securities Classified as Available-for-Sale Securities December 31, 2023 Amortized Cost Aggregate fair value Due within one year $ 17,256,529 $ 17,263,788 $ 17,256,529 $ 17,263,788 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following: Schedule of Property and Equipment 2023 2022 Years Ended December 31, 2023 2022 Computer equipment and software $ 66,830 $ 53,663 Lab and office equipment 1,180,052 1,180,052 Furniture and fixtures 51,404 51,404 Property and equipment, gross 1,298,286 1,285,119 Less accumulated depreciation (1,182,191 ) (1,153,530 ) Property and equipment, net $ 116,095 $ 131,589 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Tax Expense | Income tax expense consists of: Schedule of Income Tax Expense 2023 2022 December 31, 2023 2022 U.S. federal $ - $ - State and local 755 681 Deferred - - Total $ 755 $ 681 |
Schedule of Pretax Income from Continuing Operations | Schedule of Pretax Income from Continuing Operations 2023 2022 December 31, 2023 2022 Computed “expected” tax expense (benefit) $ (3,433,893 ) $ (2,259,272 ) Increase (reduction) in income taxes resulting from: Change in valuation allowance 3,619,564 2,529,547 State and local income taxes, net of federal income tax benefit 596 538 Stock expense 319,214 314,186 Research and development tax credits (434,858 ) (422,495 ) Orphan drug tax credit (26,245 ) (42,976 ) Warrant Liability (44,665 ) (118,847 ) Other, net 1,042 - Total $ 755 $ 681 |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2023 and 2022 are presented below: Schedule of Deferred Tax Assets and Liabilities 2023 2022 December 31, 2023 2022 Deferred tax assets: Stock-based compensation $ 1,188,535 $ 1,428,167 Net operating loss carryforwards 35,108,766 35,595,940 Employee benefits 45,592 44,602 Research and development tax credits 6,032,559 5,491,805 Orphan drug tax credits 1,274,204 1,240,982 Plant and equipment - - Sec. 174 Expenses 3,945,862 1,997,787 Other deductible temporary differences 167,371 69,273 Total gross deferred tax assets 47,762,889 45,868,556 Net deferred tax assets $ 47,762,889 $ 45,868,556 Deferred tax liabilities: Plant and equipment (7,227 ) (9,052 ) Total gross deferred tax liabilities (7,227 ) (9,052 ) Net deferred tax liabilities $ (7,227 ) $ (9,052 ) Deferred tax asset/deferred tax liability 47,755,662 45,859,504 Valuation allowance (47,755,662 ) (45,859,504 ) Net deferred tax asset $ - $ - |
Schedule of Reconciliation of the Beginning and Ending Amount of Total Unrecognized Tax Contingencies, Excluding Interest and Penalties | A reconciliation of the beginning and ending amount of total unrecognized tax contingencies, excluding interest and penalties, for the years ended December 31, 2023 and 2022 are as follows: Schedule of Reconciliation of the Beginning and Ending Amount of Total Unrecognized Tax Contingencies, Excluding Interest and Penalties December 31, 2023 2022 Balance, beginning of year $ - $ - Balance, end of year $ - $ - |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Schedule of Future Minimum Rental Payments for Operating Leases | Future minimum lease payments under the non-cancelable operating lease as of December 31, 2023 are: Schedule of Future Minimum Rental Payments for Operating Leases Operating leases Year ending December 31: 2024 $ 366,290 2025 61,346 Total minimum lease payments $ 427,636 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Stock Option Activity | 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, 2022 277,225 $ 38.44 Options granted 26,467 6.19 Options exercised - - Options forfeited (7,352 ) 6.91 Options cancelled (34,093 ) 52.72 Balance at December 31, 2023 262,247 34.21 Options exercisable at December 31, 2023 194,228 42.72 |
Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable | The following table summarizes information about stock options outstanding and exercisable at December 31, 2023: Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable Options outstanding Options exercisable Number outstanding Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value Number exerciseable Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value 262,247 6.60 $ 34.21 $ - 194,228 5.84 $ 42.72 $ - |
Schedule of Fair Value of Warrants | Schedule of Fair Value of Warrants December 31, 2023 December 31, 2022 November 18, 2019 Expected life in years 0.88 1.88 5.00 Risk-free interest rate 4.79 % 4.41 % 1.63 % Dividend yield — — — Volatility 100.00 % 100.00 % 224.47 % Stock price $ 2.79 $ 6.77 $ 6.89 |
Schedule of Reconciliation of Warrant Liability | Schedule of Reconciliation of Warrant Liability Warrant Liability Balance at December 31, 2022 $ 229,856 Change in fair value of common stock warrants (212,690 ) Balance at December 31, 2023 $ 17,166 |
Schedule of Number of Warrants Outstanding and the Weighted Average Exercise Price | The following table summarizes the number of common stock warrants outstanding and the weighted average exercise price: Schedule of Number of Warrants Outstanding and the Weighted Average Exercise Price Warrants Weighted Average Exercise Price Outstanding at December 31, 2022 113,795 $ 8.72 Issued - - Exercised - - Expired - - Cancelled - - Forfeited - - Balance at December 31, 2023 113,795 $ 8.72 |
Schedule of Common Stock Warrants Outstanding | The following table summarizes information about common stock warrants outstanding at December 31, 2023: Schedule of Common Stock Warrants Outstanding Warrants outstanding Number exercisable Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value 113,795 1.00 $ 8.72 $ - |
Schedule of Disaggregation of R
Schedule of Disaggregation of Revenue (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Product Information [Line Items] | ||
Revenue | $ (2,850,818) | $ 500,000 |
License [Member] | ||
Product Information [Line Items] | ||
Revenue | 109,987 | 500,000 |
Minimum Guaranteed Royalties [Member] | ||
Product Information [Line Items] | ||
Revenue | $ (2,960,805) |
Schedule of Employee Service Sh
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based payment arrangement, expense | $ 654,438 | $ 636,140 |
Research and Development Expense [Member] | ||
Share-based payment arrangement, expense | 358,352 | 338,018 |
General and Administrative Expense [Member] | ||
Share-based payment arrangement, expense | $ 296,086 | $ 298,122 |
Schedule of Key Assumption of F
Schedule of Key Assumption of Fair Value of Stock Options Granted (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Expected term | 5 years 8 months 23 days | 5 years 9 months 25 days |
Risk-free interest rate | 3.73% | 3.06% |
Expected dividend yield | 0% | 0% |
Expected volatility | 98.97% | 99.31% |
Schedule of Fair Value, Assets
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | $ 21,959,279 | $ 32,075,844 |
Fair value of assets and liabilities | 21,976,445 | 32,305,700 |
US Government Corporations and Agencies Securities [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 2,982,684 | 3,380,790 |
Warrant [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Liabilities, fair value disclosure | 17,166 | 229,856 |
Corporate Bonds and Notes [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 5,454,690 | |
Fair Value, Inputs, Level 1 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 18,976,595 | 8,653,434 |
Fair value of assets and liabilities | 18,976,595 | 8,653,434 |
Fair Value, Inputs, Level 1 [Member] | US Government Corporations and Agencies Securities [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | ||
Fair Value, Inputs, Level 1 [Member] | Warrant [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Liabilities, fair value disclosure | ||
Fair Value, Inputs, Level 1 [Member] | Corporate Bonds and Notes [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | ||
Fair Value, Inputs, Level 2 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 2,982,684 | 23,422,410 |
Fair value of assets and liabilities | 2,982,684 | 23,422,410 |
Fair Value, Inputs, Level 2 [Member] | US Government Corporations and Agencies Securities [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 2,982,684 | 3,380,790 |
Fair Value, Inputs, Level 2 [Member] | Warrant [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Liabilities, fair value disclosure | ||
Fair Value, Inputs, Level 2 [Member] | Corporate Bonds and Notes [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 5,454,690 | |
Fair Value, Inputs, Level 3 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | ||
Fair value of assets and liabilities | 17,166 | 229,856 |
Fair Value, Inputs, Level 3 [Member] | US Government Corporations and Agencies Securities [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | ||
Fair Value, Inputs, Level 3 [Member] | Warrant [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Liabilities, fair value disclosure | 17,166 | 229,856 |
Fair Value, Inputs, Level 3 [Member] | Corporate Bonds and Notes [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | ||
Money Market Funds [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 4,695,491 | 2,694,434 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 4,695,491 | 2,694,434 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | ||
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | ||
US Treasury Securities [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 14,281,104 | 5,959,000 |
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 14,281,104 | 5,959,000 |
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | ||
US Treasury Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | ||
Commercial Paper [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 14,586,930 | |
Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | ||
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value | 14,586,930 | |
Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, fair value |
Schedule of Computation of Basi
Schedule of Computation of Basic and Diluted Earnings (Loss) Per Share of Common Stock (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Net loss | $ (16,352,171) | $ (10,758,636) |
Weighted avg. common shares outstanding | 5,269,671 | 5,231,681 |
Basic loss per share attributable to common stock | $ (3.10) | $ (2.06) |
Effect of dilutive securities on net loss: | ||
Common stock warrants | $ 212,690 | $ 565,940 |
Total net loss for purpose of calculating diluted net loss per common share | $ (16,564,861) | $ (11,324,576) |
Weighted average effect of dilutive securities: | ||
Common stock warrants | 24,488 | |
Total shares for purpose of calculating diluted net loss per common share | 5,269,671 | 5,256,169 |
Diluted loss per share attributable to common stock | $ (3.14) | $ (2.15) |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Warrant [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 49,433 | 49,433 |
Share-Based Payment Arrangement, Option [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 262,247 | 277,225 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Product Information [Line Items] | ||
Cash and cash equivalents | $ 4,800,000 | $ 3,100,000 |
Revenues | $ (2,850,818) | 500,000 |
Income tax examination likelihood description | greater than 50 percent | |
Share-based payment arrangement, expense | $ 654,438 | $ 636,140 |
Unrecognized compensation cost | $ 455,000 | |
Weighted average period of stock option plan | 1 year 4 months 24 days | |
Weighted average fair value of share-based compensation | $ 6.19 | $ 11.50 |
Volatility rate | 98.97% | 99.31% |
Risk free interest rate | 3.73% | 3.06% |
Expected life | 5 years 8 months 23 days | 5 years 9 months 25 days |
Warrant [Member] | ||
Product Information [Line Items] | ||
Volatility rate | 100% | 100% |
Risk free interest rate | 4.79% | 4.41% |
strike price | $ 8.50 | $ 8.50 |
Fair value of common stock | $ 2.79 | $ 6.77 |
Expected life | 10 months 24 days | 1 year 10 months 24 days |
Share-Based Payment Arrangement, Option [Member] | ||
Product Information [Line Items] | ||
Number of shares issued | 26,467 | 74,334 |
Office Equipment [Member] | ||
Product Information [Line Items] | ||
Estimated useful lives | 5 years | |
Computer Equipment [Member] | ||
Product Information [Line Items] | ||
Estimated useful lives | 3 years | |
Furniture and Fixtures [Member] | ||
Product Information [Line Items] | ||
Estimated useful lives | 7 years | |
Major Customer [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||
Product Information [Line Items] | ||
Concentration risk, percentage | 10% | |
One Major Customer [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||
Product Information [Line Items] | ||
Concentration risk, percentage | 100% | |
License Agreement [Member] | ||
Product Information [Line Items] | ||
Payments for royalty | $ 902,000 | |
Contract asset | 710,000 | |
Imputed interest receivable | 192,000 | |
Antares License Agreement [Member] | ||
Product Information [Line Items] | ||
Contract asset | 0 | $ 3,832,000 |
Non-cash revenue reversal of variable consideration | $ 3,000,000 | |
Revenues | $ 500,000 |
Schedule of Available for Sale
Schedule of Available for Sale Securities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 17,256,529 | $ 29,401,731 |
Gross unrealized holding gains | 8,574 | 4,651 |
Gross unrealized holding losses | (1,315) | (24,972) |
Aggregate fair value | 17,263,788 | 29,381,410 |
US Treasury Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 14,272,530 | 5,973,087 |
Gross unrealized holding gains | 8,574 | |
Gross unrealized holding losses | (14,087) | |
Aggregate fair value | 14,281,104 | 5,959,000 |
U S Government Agency Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 2,983,999 | 3,376,139 |
Gross unrealized holding gains | 4,651 | |
Gross unrealized holding losses | (1,315) | |
Aggregate fair value | $ 2,982,684 | 3,380,790 |
Corporate Bonds Notes and Commercial Paper [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 20,052,505 | |
Gross unrealized holding gains | ||
Gross unrealized holding losses | (10,885) | |
Aggregate fair value | $ 20,041,620 |
Schedule of Maturities of Debt
Schedule of Maturities of Debt Securities Classified as Available-for-Sale Securities (Details) | Dec. 31, 2023 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Due within one year, Amortized Cost | $ 17,256,529 |
Due within one year, Aggregate fair value | 17,263,788 |
Total maturities of debt securities classified as available-for-sale securities, Amortized Cost | 17,256,529 |
Total maturities of debt securities classified as available-for-sale securities, Aggregate fair value | $ 17,263,788 |
Marketable Investment Securit_3
Marketable Investment Securities (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | ||
Sales of marketable investment securities | $ 0 | $ 0 |
Realized gains or losses | 0 | 0 |
Matured marketable investment securities | 36,000,000 | 59,500,000 |
Other-than-temporary impairments | $ 0 | $ 0 |
Contractual Agreements (Details
Contractual Agreements (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||
Jan. 01, 2026 | Jan. 01, 2025 | Feb. 01, 2024 | Jan. 12, 2024 | Jan. 12, 2024 | Oct. 14, 2021 | Mar. 29, 2012 | Apr. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Contract research and development expenses | $ 6,700,000 | $ 5,600,000 | ||||||||
Royalty Agreement Terms [Member] | Abbott Products, Inc. [Member] | ||||||||||
Percentage of net sales | 1% | |||||||||
Royalties, commitment amount | $ 1,000,000 | |||||||||
Percentage of royalties reduction based upon product launch | 50% | |||||||||
Royalty expense | 34,000 | 12,000 | ||||||||
License Agreement [Member] | ||||||||||
License fee | $ 11,000,000 | |||||||||
Royalty payments percentage | 20% | |||||||||
License Agreement [Member] | Maximum [Member] | ||||||||||
Milestone revenue to be received | $ 160,000,000 | |||||||||
License Agreement [Member] | Forecast [Member] | ||||||||||
Initial payment | $ 5,000,000 | $ 5,000,000 | ||||||||
License Agreement [Member] | Antares Pharma Inc [Member] | ||||||||||
Reversal of variable consideration revenue | $ 500,000 | $ 3,000,000 | $ 500,000 | |||||||
License Agreement [Member] | Gordon Silver Limited [Member] | ||||||||||
Milestone payment | $ 259,000,000 | |||||||||
License Agreement [Member] | Gordon Silver Limited [Member] | Subsequent Event [Member] | ||||||||||
License fee | $ 5,000,000 | $ 11,000,000 | ||||||||
Initial payment | $ 2,500,000 | |||||||||
License Agreement [Member] | Gordon Silver Limited [Member] | Maximum [Member] | ||||||||||
Royalty payments percentage | 18% | |||||||||
License Agreement [Member] | Gordon Silver Limited [Member] | Minimum [Member] | ||||||||||
Royalty payments percentage | 12% | |||||||||
License Agreement [Member] | Gordon Silver Limited [Member] | Forecast [Member] | ||||||||||
License fee | $ 1,000,000 | $ 2,500,000 |
Loan and Security Agreement (De
Loan and Security Agreement (Details Narrative) - Loan and Security Agreement [Member] - Silicon Valley Bank [Member] | Jan. 05, 2018 USD ($) |
Line of Credit Facility [Line Items] | |
Aggregate amount | $ 10,000,000 |
Debt instrument description | The principal borrowed under the Loan and Security Agreement bore interest at a rate equal to the Prime Rate, as reported in the money rates section of The Wall Street Journal or any successor publication representing the rate of interest per annum then in effect, plus one percent per annum, which interest was payable monthly. |
Debt instrument, maturity date | Jun. 01, 2022 |
Debt instrument, balloon payment to be paid | $ 650,000 |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,298,286 | $ 1,285,119 |
Less accumulated depreciation | (1,182,191) | (1,153,530) |
Property and equipment, net | 116,095 | 131,589 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 66,830 | 53,663 |
Lab and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,180,052 | 1,180,052 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 51,404 | $ 51,404 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expenses | $ 29,000 | $ 9,500 |
Schedule of Income Tax Expense
Schedule of Income Tax Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal | ||
State and local | 755 | 681 |
Deferred | ||
Total | $ 755 | $ 681 |
Schedule of Pretax Income from
Schedule of Pretax Income from Continuing Operations (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Computed “expected” tax expense (benefit) | $ (3,433,893) | $ (2,259,272) |
Change in valuation allowance | 3,619,564 | 2,529,547 |
State and local income taxes, net of federal income tax benefit | 596 | 538 |
Stock expense | 319,214 | 314,186 |
Research and development tax credits | (434,858) | (422,495) |
Orphan drug tax credit | (26,245) | (42,976) |
Warrant Liability | (44,665) | (118,847) |
Other, net | 1,042 | |
Total | $ 755 | $ 681 |
Schedule of Deferred Tax Assets
Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Abstract] | ||
Stock-based compensation | $ 1,188,535 | $ 1,428,167 |
Net operating loss carryforwards | 35,108,766 | 35,595,940 |
Employee benefits | 45,592 | 44,602 |
Research and development tax credits | 6,032,559 | 5,491,805 |
Orphan drug tax credits | 1,274,204 | 1,240,982 |
Plant and equipment | ||
Sec. 174 Expenses | 3,945,862 | 1,997,787 |
Other deductible temporary differences | 167,371 | 69,273 |
Total gross deferred tax assets | 47,762,889 | 45,868,556 |
Net deferred tax assets | 47,762,889 | 45,868,556 |
Plant and equipment | (7,227) | (9,052) |
Total gross deferred tax liabilities | (7,227) | (9,052) |
Net deferred tax liabilities | (7,227) | (9,052) |
Deferred tax asset/deferred tax liability | 47,755,662 | 45,859,504 |
Valuation allowance | (47,755,662) | (45,859,504) |
Net deferred tax asset |
Schedule of Reconciliation of t
Schedule of Reconciliation of the Beginning and Ending Amount of Total Unrecognized Tax Contingencies, Excluding Interest and Penalties (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Abstract] | ||
Balance, beginning of year | ||
Balance, end of year |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Income tax expense (benefit) | $ 755 | $ 681 |
Federal income tax rate | 21% | 21% |
Deferred tax assets, valuation allowance | $ 47,755,662 | $ 45,859,504 |
Valuation allowance increase | 1,900,000 | $ 2,900,000 |
Operating loss carry forwards | 1,100,000 | |
Operating loss carry forwards pre-ownership change amount | 9,800,000 | |
Operating loss forgive pre-ownership change amount | 3,300,000 | |
Operating loss carry forwards pre-ownership change amount | 1,200,000 | |
Operating loss carryforwards | 138,600,000 | |
Tax credit carryforward amount | $ 4,400,000 | |
Operating loss carry forwards expiration date | Approximately $33.7 million of the NOL will expire between 2024 and 2034 and $52.4 million of the NOL will expire 2035 through 2037. Pursuant to the Tax Cuts and Jobs Act of 2017, NOL’s generated in 2018 and subsequent years have an unlimited carryforward therefore the 2023, 2022, 2020, 2019 and 2018 NOL of $52.5 million can be carried forward indefinitely. The research and development credits will begin to expire in 2033 through 2043. | |
Us Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforward, description | expire 2035 through 2037 | |
Us Federal [Member] | Research and Development Expense [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforward, description | expire in 2033 through 2043 | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 128,900,000 | |
Tax credit carryforward amount | $ 1,700,000 | |
Operating loss carry forwards expiration date | approximately $128.9 million and $1.7 million, respectively. The Company’s state NOL of $31.2 million will expire between 2024 and 2029, and $97.7 million will expire in 2030 through 2037. | |
State and Local Jurisdiction [Member] | Research and Development Expense [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforward amount | $ 1,300,000 | |
Tax credit carryforward, description | expire in 2024 through 2038 |
Schedule of Future Minimum Rent
Schedule of Future Minimum Rental Payments for Operating Leases (Details) | Dec. 31, 2023 USD ($) |
Leases | |
2024 | $ 366,290 |
2025 | 61,346 |
Total minimum lease payments | $ 427,636 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Leases | ||
Operating leases, rent expense | $ 355,000 | $ 341,000 |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Option Indexed to Issuer's Equity [Line Items] | ||
Number of shares, ending balance | 262,247 | |
Weighted average exercise price, ending balance | $ 34.21 | |
Number of shares, options exercisable | 194,228 | |
Weighted average exercise price, options exercisable | $ 42.72 | |
Share-Based Payment Arrangement, Option [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Number of shares, beginning balance | 277,225 | |
Weighted average exercise price, beginning balance | $ 38.44 | |
Number of shares, Options granted | 26,467 | |
Weighted average exercise price, Options granted | $ 6.19 | |
Number of shares, Options exercised | (12,947) | |
Weighted average exercise price, Options exercised | ||
Number of shares, Options forfeited | (7,352) | |
Weighted average exercise price, Options forfeited | $ 6.91 | |
Number of shares, Options cancelled | (34,093) | |
Weighted average exercise price, Options cancelled | $ 52.72 | |
Number of shares, ending balance | 262,247 | 277,225 |
Weighted average exercise price, ending balance | $ 34.21 | $ 38.44 |
Number of shares, options exercisable | 194,228 | |
Weighted average exercise price, options exercisable | $ 42.72 |
Schedule of Share-based Compens
Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Equity [Abstract] | |
Number of options outstanding | shares | 262,247 |
Options outstanding, Weighted average remaining contractual life (Years) | 6 years 7 months 6 days |
Options outstanding, Weighted average exercise price | $ / shares | $ 34.21 |
Options outstanding, Aggregate intrinsic value | $ | |
Number of options exercisable | shares | 194,228 |
Options exercisable, Weighted average remaining contractual life (Years) | 5 years 10 months 2 days |
Options exercisable, Weighted average exercise price | $ / shares | $ 42.72 |
Options exercisable, Aggregate intrinsic value | $ |
Schedule of Fair Value of Warra
Schedule of Fair Value of Warrants (Details) - $ / shares | 12 Months Ended | ||
Nov. 18, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Expected life in years | 5 years 8 months 23 days | 5 years 9 months 25 days | |
Risk-free interest rate | 3.73% | 3.06% | |
Dividend yield | 0% | 0% | |
Volatility | 98.97% | 99.31% | |
Warrant [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Expected life in years | 10 months 24 days | 1 year 10 months 24 days | |
Risk-free interest rate | 4.79% | 4.41% | |
Volatility | 100% | 100% | |
Stock price | $ 2.79 | $ 6.77 | |
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Warrant [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Expected life in years | 5 years | 10 months 17 days | 1 year 10 months 17 days |
Risk-free interest rate | 1.63% | 4.79% | 4.41% |
Dividend yield | |||
Volatility | 224.47% | 100% | 100% |
Stock price | $ 6.89 | $ 2.79 | $ 6.77 |
Schedule of Reconciliation of W
Schedule of Reconciliation of Warrant Liability (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity [Abstract] | ||
Balance at December 31, 2022 | $ 229,856 | |
Change in fair value of common stock warrants | (212,690) | $ (565,940) |
Balance at December 31, 2023 | $ 17,166 | $ 229,856 |
Schedule of Number of Warrants
Schedule of Number of Warrants Outstanding and the Weighted Average Exercise Price (Details) - Warrant [Member] | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
Warrants Outstanding, Beginning | shares | 113,795 |
Weighted Average Exercise Price, Outstanding, Beginning | $ / shares | $ 8.72 |
Warrants, Issued | shares | |
Weighted Average Exercise Price, Issued | $ / shares | |
Warrants, Exercised | shares | |
Weighted Average Exercise Price, Exercised | $ / shares | |
Warrants, Expired | shares | |
Weighted Average Exercise Price, Expired | $ / shares | |
Warrants, Cancelled | shares | |
Weighted Average Exercise Price, Cancelled | $ / shares | |
Warrants, Forfeited | shares | |
Weighted Average Exercise Price, Forfeited | $ / shares | |
Warrants Outstanding, Ending | shares | 113,795 |
Weighted Average Exercise Price, Outstanding, Ending | $ / shares | $ 8.72 |
Schedule of Common Stock Warran
Schedule of Common Stock Warrants Outstanding (Details) - Warrant [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of warrants exercisable, shares | 113,795 | 113,795 |
Warrants outstanding, Weighted average remaining contractual life | 1 year | |
Warrants outstanding, Weighted average exercise price | $ 8.72 | $ 8.72 |
Warrants outstanding, Aggregate intrinsic value |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 12 Months Ended | |||||||||||||
Dec. 31, 2023 | May 10, 2023 | Mar. 24, 2023 | Mar. 06, 2017 | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 07, 2023 | Jun. 08, 2022 | Jun. 07, 2022 | Jun. 30, 2020 | Jun. 30, 2018 | Jun. 30, 2016 | Nov. 13, 2015 | Apr. 30, 2014 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Reverse stock split, description | reverse stock split of 1-for-17 | |||||||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | |||||||||||
Fair value of shares issued during the period | $ 404,567 | |||||||||||||
Net proceeds from common stock offering | $ 404,567 | $ (21,700) | ||||||||||||
Preferred stock redemption price | $ 0.001 | $ 0.001 | $ 63.96 | |||||||||||
Intrinsic value of option exercise | ||||||||||||||
Non-cash loss on change in fair value of warrant liability | $ (212,690) | $ (565,940) | ||||||||||||
November 2019 Offering [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Warrants outstanding | 64,362 | 64,362 | 64,362 | |||||||||||
Non-cash loss on change in fair value of warrant liability | $ 213,000 | $ 566,000 | ||||||||||||
February 2020 Offering [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Warrants outstanding | 49,433 | 49,433 | ||||||||||||
Issued | 296,593 | |||||||||||||
Exercised | 0 | 0 | ||||||||||||
Share-Based Payment Arrangement, Option [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Intrinsic value of option exercise | $ 0 | $ 0 | $ 173,000 | |||||||||||
Option exercises, shares | 12,947 | |||||||||||||
Stock Incentive Plan 2014 [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized | 336,582 | 336,582 | 58,823 | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 48,422 | 48,422 | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period | 10 years | |||||||||||||
2011 Equity Incentive Plan [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 15,994 | |||||||||||||
Series B Preferred Stock [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Preferred stock, stated par value | $ 0.0001 | |||||||||||||
Preferred stock, shares issued | 88,511 | |||||||||||||
Preferred stock voting rights, description | Each whole share of Series B Preferred Stock entitled the holder thereof to 1,000,000 votes per share, and each fraction of a share of Series B Preferred Stock had a ratable number of votes. Thus, each one-thousandth of a share of Series B Preferred Stock was entitled to 1,000 votes. | |||||||||||||
Preferred stock redemption terms | Each “beneficial owner” (as such terms are defined in the Certificate of Designation with respect to the Series B Preferred Stock) of shares of Series B Preferred Stock redeemed in the redemptions described above has the right to receive an amount equal to $0.01 in cash for each ten whole shares of Series B Preferred Stock that were “beneficially owned” by the beneficial owner as of immediately prior to the applicable redemption time and redeemed pursuant to such redemption, payable upon receipt by the Company of a written request submitted by the applicable beneficial owner to the corporate secretary of the Company following the applicable redemption time. | |||||||||||||
Maximum [Member] | Stock Incentive Plan 2014 [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized | 336,582 | 189,522 | 145,405 | |||||||||||
Minimum [Member] | Stock Incentive Plan 2014 [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized | 189,522 | 145,405 | 74,817 | |||||||||||
Common Stock [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Fair value of shares issued during the period | $ 8 | |||||||||||||
Stock issued during period, shares, new issues | 81,000 | |||||||||||||
Option exercises, shares | 12,947 | |||||||||||||
Sales Agreement [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Percentage of gross proceeds on sale of shares | 3% | |||||||||||||
Stock issued during period, shares, new issues | 964,711 | |||||||||||||
Shares issued, price per share | $ 34.52 | $ 34.52 | ||||||||||||
Proceeds from issuance of common stock, gross | $ 33,300,000 | |||||||||||||
Net proceeds from common stock offering | 32,100,000 | |||||||||||||
Proceeds from available for sale | 40,800,000 | |||||||||||||
Sales Agreement [Member] | Maximum [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Proceeds from available for sale | $ 5,300,000 | |||||||||||||
Sales Agreement [Member] | Common Stock [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Stock issued during period, shares, new issues | 81,000 | |||||||||||||
Net proceeds from common stock offering | $ 24,000 | |||||||||||||
Proceeds from Issuance of Sale | $ 405,000 | |||||||||||||
Sales Agreement [Member] | Common Stock [Member] | Weighted Average [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Shares issued, price per share | $ 5.36 | $ 5.36 | ||||||||||||
Sales Agreement [Member] | Cantor Fitzgerald & Co. [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Fair value of shares issued during the period | $ 50,000,000 | |||||||||||||
Revision of Prior Period, Adjustment [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Common stock, par value | $ 0.0001 | |||||||||||||
Common stock, shares authorized | 200,000,000 | 100,000,000 |
401(k) Plan (Details Narrative)
401(k) Plan (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Employer matching contribution percent | 100% | |
Contribution plan cost | $ 102,000 | $ 94,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - Global Agreement [Member] - USD ($) | Jul. 13, 2023 | Jul. 13, 2022 | Apr. 29, 2022 | Apr. 02, 2019 |
May 2022 [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Litigation settlement | $ 1,250,000 | |||
Clarus Therapeutics Inc [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Litigation settlement | $ 500,000 | $ 1,000,000 | $ 4,000,000 | |
Clarus Therapeutics Inc [Member] | Immediately [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Litigation settlement | $ 2,500,000 |
Agreement with Spriaso, LLC (De
Agreement with Spriaso, LLC (Details Narrative) - Spriaso LLC[Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
License and Service Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Percentage of royalty | 20% | |
Proceeds from contributions from affiliates | $ 10,000,000 | |
Agreement description | 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; | |
Service Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Licensing revenue | $ 110,000 | $ 0 |