Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 07, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2021 | ||
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 | $ 120.5 | ||
Entity Common Stock, Shares Outstanding | 88,290,650 | ||
Documents Incorporated By Reference | Portions of the registrant’s definitive Proxy Statement for its 2021 Annual Meeting of Stockholders are incorporated by reference into Part III of this Form 10-K | ||
ICFR Auditor Attestation 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, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 2,950,552 | $ 19,217,382 |
Restricted cash | 5,000,000 | |
Marketable investment securities | 41,667,405 | 449,992 |
Accrued interest income | 247,253 | 391 |
Prepaid and other current assets | 1,514,465 | 661,258 |
Total current assets | 46,379,675 | 25,329,023 |
Marketable investment securities | 2,021,800 | |
Contract asset | 4,050,000 | |
Property and equipment, net of accumulated depreciation of $1,144,077 and $1,143,697 respectively | 7,211 | |
Other assets | 23,753 | 23,753 |
Total assets | 52,482,439 | 25,352,776 |
Current liabilities: | ||
Accounts payable | 1,289,342 | 1,597,220 |
Accrued expenses | 1,016,458 | 1,653,178 |
Debt - current portion | 2,310,825 | 3,333,333 |
Litigation settlement liability - current portion | 1,000,000 | |
Total current liabilities | 5,616,625 | 6,583,731 |
Debt - non-current portion | 2,257,075 | |
Warrant liability | 795,796 | 1,170,051 |
Litigation settlement liability - non-current portion | 500,000 | |
Total liabilities | 6,912,421 | 10,010,857 |
Commitments and contingencies (notes 5, 8 and 11) | ||
Stockholders’ equity: | ||
Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized; zero issued and outstanding | ||
Common stock, par value $0.0001 per share, 100,000,000 shares authorized; 88,296,360 and 70,041,967 issued and 88,290,650 and 70,036,257 outstanding | 8,830 | 7,005 |
Additional paid-in capital | 218,286,323 | 187,407,634 |
Treasury stock at cost, 5,710 shares | (40,712) | (40,712) |
Accumulated other comprehensive loss | (18,016) | |
Accumulated deficit | (172,666,407) | (172,032,008) |
Total stockholders’ equity | 45,570,018 | 15,341,919 |
Total liabilities and stockholders’ equity | $ 52,482,439 | $ 25,352,776 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Accumulated Depreciation, Depletion and Amortization, Property, Plant, and Equipment (in dollars) | $ 1,144,077 | $ 1,143,697 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 88,296,360 | 70,041,967 |
Common stock, shares outstanding | 88,290,650 | 70,036,257 |
Treasury stock, shares | 5,710 | 5,710 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
Revenues | $ 16,140,838 | |
Operating expenses: | ||
Research and development | 7,665,559 | 9,748,469 |
General and administrative | 5,329,776 | 8,247,795 |
Total operating expenses | 12,995,335 | 17,996,264 |
Operating income (loss) | 3,145,503 | (17,996,264) |
Other income (expense) | ||
Interest and investment income | 67,700 | 75,650 |
Interest expense | (203,292) | (386,618) |
Gain on extinguishment of debt | 234,802 | |
Unrealized gain (loss) on warrant liability | 355,890 | (2,892,189) |
Litigation settlement | (4,000,000) | |
Total other expense, net | (3,779,702) | (2,968,355) |
Loss before income tax expense | (634,199) | (20,964,619) |
Income tax expense | (200) | (200) |
Net loss | $ (634,399) | $ (20,964,819) |
Basic loss per share attributable to common stock | $ (0.01) | $ (0.38) |
Weighted average common shares outstanding, | 86,934,618 | 55,688,085 |
Diluted loss per share attributable to common stock | $ (0.01) | $ (0.38) |
Weighted average common shares outstanding, diluted | 86,934,618 | 55,688,085 |
Comprehensive loss: | ||
Net loss | $ (634,399) | $ (20,964,819) |
Unrealized net gain (loss) on available-for-sale securities | (18,016) | 38 |
Comprehensive loss | $ (652,415) | $ (20,964,781) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Common Stock [Member] | Treasury Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 3,766 | $ (40,712) | $ 157,391,969 | $ (38) | $ (151,067,189) | $ 6,287,796 |
Balance, shares at Dec. 31, 2019 | 37,649,465 | 5,710 | ||||
Net loss | (20,964,819) | (20,964,819) | ||||
Unrealized net loss on marketable investment securities | 38 | 38 | ||||
Common stock sold through equity offering | $ 1,008 | 5,652,132 | 5,653,140 | |||
Common stock sold through equity offering, shares | 10,084,034 | |||||
Common stock issued for warrant exercises | $ 1,510 | 7,673,366 | 7,674,876 | |||
Common stock issued for warrant exercises, shares | 15,097,651 | |||||
Stock-based compensation | 1,373,182 | 1,373,182 | ||||
Settlement of warrant liability on warrant exercises | 6,313,338 | 6,313,338 | ||||
Vesting of restricted stock units | $ 63 | (63) | ||||
Vesting of restricted stock units, shares | 628,807 | |||||
Common stock sold through ATM offering | $ 658 | 9,003,710 | 9,004,368 | |||
Common stock sold through ATM offering, shares | 6,576,300 | |||||
Ending balance, value at Dec. 31, 2020 | $ 7,005 | $ (40,712) | 187,407,634 | (172,032,008) | 15,341,919 | |
Balance, shares at Dec. 31, 2020 | 70,036,257 | 5,710 | ||||
Net loss | (634,399) | (634,399) | ||||
Unrealized net loss on marketable investment securities | (18,016) | (18,016) | ||||
Common stock sold through equity offering | $ 1,643 | 26,838,814 | 26,840,457 | |||
Common stock sold through equity offering, shares | 16,428,571 | |||||
Common stock issued for warrant exercises | $ 1 | 4,999 | 5,000 | |||
Common stock issued for warrant exercises, shares | 10,000 | |||||
Stock-based compensation | 603,946 | 603,946 | ||||
Settlement of warrant liability on warrant exercises | 18,365 | 18,365 | ||||
Common stock sold through ATM offering | $ 181 | 3,405,872 | 3,406,053 | |||
Common stock sold through ATM offering, shares | 1,811,238 | |||||
Option exercises | 6,693 | 6,693 | ||||
Option exercises, shares | 4,584 | |||||
Ending balance, value at Dec. 31, 2021 | $ 8,830 | $ (40,712) | $ 218,286,323 | $ (18,016) | $ (172,666,407) | $ 45,570,018 |
Balance, shares at Dec. 31, 2021 | 88,290,650 | 5,710 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (634,399) | $ (20,964,819) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation expense | 380 | 3,554 |
Stock-based compensation expense | 603,946 | 1,373,182 |
Non-cash interest expense | 53,750 | 109,335 |
Non-cash gain on extinguishment of debt | (234,802) | |
Non-cash loss (gain) on change in fair value of warrant liability | (355,890) | 2,892,189 |
Amortization of premium/discount on marketable investment securities | 515,577 | (2,616) |
Changes in operating assets and liabilities: | ||
Accrued interest income | (246,862) | 16,131 |
Prepaid and other current assets | (4,903,207) | (115,371) |
Accounts payable | (307,878) | 414,979 |
Accrued expenses | (636,720) | 1,205,140 |
Litigation settlement liability | 1,500,000 | |
Cash used in operating activities | (4,411,303) | (15,303,098) |
Cash flows from investing activities: | ||
Purchases of fixed assets | (7,591) | |
Purchases of marketable investment securities | (48,422,806) | (6,315,297) |
Maturities of marketable investment securities | 4,650,000 | 10,208,000 |
Cash provided by (used in) investing activities | (43,780,397) | 3,892,703 |
Cash flows from financing activities: | ||
Proceeds from debt | 233,537 | |
Debt repayments | (3,333,333) | (1,666,667) |
Proceeds from stock option exercises | 6,693 | |
Proceeds from sale of common stock sold in equity offering | 26,840,457 | 5,653,140 |
Proceeds from exercise of warrants | 5,000 | 7,674,876 |
Net proceeds from sale of common stock through ATM | 3,406,053 | 9,004,368 |
Cash provided by financing activities | 26,924,870 | 20,899,254 |
Net increase (decrease) in cash and cash equivalents | (21,266,830) | 9,488,859 |
Cash, cash equivalents and restricted cash at beginning of period | 24,217,382 | 14,728,523 |
Cash, cash equivalents and restricted cash at end of period | 2,950,552 | 24,217,382 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 149,543 | 276,019 |
Income taxes paid | 200 | 200 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Settlement of warrant liability on warrant exercises | 18,365 | 6,313,338 |
Unrealized net gain (loss) on marketable investment securities | (18,016) | 38 |
Accrued final payment charge on debt | $ 53,750 | $ 109,335 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | (1) Description of Business Lipocine Inc. (“Lipocine” or the “Company”), a clinical-stage biopharmaceutical company focused on metabolic and endocrine 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, 2021 | |
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 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 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 $ 3.0 19.2 (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 2021 and 2020 and the Company did not record an allowance for doubtful accounts as of December 31, 2021 and 2020 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 inception of each contract, the Company identifies the goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company reassess 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, 2021 and 2020 (2) Summary of Significant Accounting Policies – (continued) Disaggregation of Revenue Schedule of Disaggregation of Revenue Type of Revenue Licensing $ 11,000,000 Sales-based royalties 54,994 Minimum guaranteed royalties 4,050,000 Materials 1,035,844 Revenue $ 16,140,838 Under Topic 606, all revenue has been recognized as point in time for the year ended December 31, 2021. See Note 4 for a description of the license agreement with Antares Pharma, Inc. 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. The contract asset as of December 31, 2021 is related to the Antares License Agreement. Revenue Concentration A major customer is considered to be one that comprises more than 10 99.7 no LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (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 likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest and penalties related to unrecognized tax benefits as a component of its income tax expense. (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, 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, 2021 and 2020 (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 $ 604,000 1.4 Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs Year Ended 2021 2020 Research and development $ 280,186 $ 583,212 General and administrative 323,760 789,970 $ 603,946 $ 1,373,182 The Company issued 1,106,000 1,360,000 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, 2021 and 2020 (2) Summary of Significant Accounting Policies – (continued) For options granted in 2021 and 2020, 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 2021 2020 Expected term 5.83 5.83 Risk-free interest rate 1.04 % 0.93 % Expected dividend yield — — Expected volatility 102.18 % 100.32 % FASB Accounting Standards Codification (“ASC”) 718, Stock Compensation, As of December 31, 2021, there was $ 1.4 2.3 0.97 0.72 (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, 2021 and 2020 (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, 2021 and 2020: Schedule of Fair Value, Assets Measured on Recurring Basis December 31, Fair value measurements at reporting date using 2021 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,089,751 $ 2,089,751 $ - $ - Government treasury bills 5,515,920 5,515,920 - - Commercial paper 15,385,634 - 15,385,634 - Corporate bonds and notes 22,787,651 - 22,787,651 - $ 45,778,956 $ 7,605,671 $ 38,173,285 $ - Liabilities: Warrant liability $ 795,796 - - 795,796 $ 46,574,752 $ 7,605,671 $ 38,173,285 $ 795,796 December 31, Fair value measurements at reporting date using 2020 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 18,399,585 $ 18,399,585 $ - $ - Commercial paper 449,992 - 449,992 - $ 18,849,577 $ 18,399,585 $ 449,992 $ - Liabilities: Warrant liability $ 1,170,051 - - 1,170,051 $ 20,019,628 $ 18,399,585 $ 449,992 $ 1,170,051 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (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, 2021, include (i) volatility of 100 %, (ii) risk free interest rate of 0.97 %, (iii) strike price of $ 0.50, (iv) fair value of common stock of $ .99 , and (v) expected life of 2.9 years. The significant assumptions used in preparing the option pricing model for valuing the warrant liability as of December 31, 2020, include (i) volatility of 100 %, (ii) risk free interest rate of 0.27 %, (iii) strike price of $ 0.50 , (iv) fair value of common stock of $ 1.36 , and (v) expected life of 3.9 years. 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, 2021 and 2020. (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, 2021 and 2020 (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, 2021 and 2020. Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock Year Ended December 31, 2021 2020 Basic loss per share attributable to common stock: Numerator Net loss $ (634,399 ) $ (20,964,819 ) Denominator Weighted avg. common shares outstanding 86,934,618 55,688,085 Basic loss per share attributable to common stock $ (0.01 ) $ (0.38 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (634,399 ) $ (20,964,819 ) Denominator Weighted avg. common shares outstanding 86,934,618 55,688,085 Diluted loss per share attributable to common stock $ (0.01 ) $ (0.38 ) The computation of diluted earnings per share for the years ended December 31, 2021 and 2020 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, 2021 2020 Stock options 4,551,205 3,564,458 Warrants 1,934,366 1,944,366 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (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, 2021 | |
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, 2021 and 2020 were as follows: Schedule of Available-for-Sale Securities December 31, 2021 Amortized Cost Gross unrealized holding gains Gross unrealized holding losses Aggregate fair value Government treasury bills $ 5,526,122 $ - $ (10,202 ) $ 5,515,920 Corporate bonds, notes and commercial paper 38,181,099 - (7,814 ) 38,173,285 $ 43,707,221 $ - $ (18,016 ) $ 43,689,205 December 31, 2020 Amortized Cost Gross unrealized holding gains Gross unrealized holding losses Aggregate fair value Commercial paper $ 449,992 - - $ 449,992 $ 449,992 $ - $ - $ 449,992 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (3) Marketable Investment Securities - (continued) Maturities of debt securities classified as available-for-sale securities at December 31, 2021 are as follows: Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities December 31, 2021 Amortized Cost Aggregate fair value Due within one year $ 41,680,635 $ 41,667,405 Due after one year through two years 2,026,586 2,021,800 $ 43,707,221 $ 43,689,205 There were no no 4.7 10.2 no |
Contractual Agreements
Contractual Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Health Care Organizations [Abstract] | |
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 (b) Ant ares 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. The Antares License Agreement also provides Antares with an option, exercisable on or before March 31, 2022, to license TLANDO XR, the Company’s potential once-daily oral product candidate for testosterone replacement therapy. Upon execution of the Antares License Agreement, Antares paid to the Company an initial payment of $ 11.0 5.0 160.0 20 4.0 35.0 20 16.1 million and zero during the years ended December 31, 2021 and 2020. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (4) Contractual Agreements – (continued) (c) 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 $ 4.9 6.8 |
Loan and Security Agreement
Loan and Security Agreement | 12 Months Ended |
Dec. 31, 2021 | |
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 bears 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 ( 4.25 June 1, 2022 650,000 644,000 In connection with the Loan and Security Agreement, the Company granted to SVB a security interest in substantially all of the Company’s assets now owned or hereafter acquired, excluding intellectual property and certain other assets. On September 9, 2021, SVB consented to the Antares Licensing Agreement which among other things provides Antares a license to certain intellectual property as well as assigns Antares the TLANDO® trademark. In addition, as TLANDO was not approved by the United States Food and Drug Administration (“FDA”) prior to May 31, 2018, the Company maintained $ 5.0 While any amounts are outstanding under the Loan and Security Agreement, the Company is subject to a number of affirmative and negative covenants, including covenants regarding dispositions of property, business combinations or acquisitions, incurrence of additional indebtedness and transactions with affiliates, among other customary covenants. The credit facility also includes events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus 5.0 100,000 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (5) Loan and Security Agreement – (continued) Future maturities of principal payments on the Loan and Security Agreement at December 31, 2021 (excluding accrued final payment fee) are as follows: Schedule of Maturities of Debt Years Ending December 31, Amount (in thousands) 2022 1,667 Thereafter — $ 1,667 Payroll Protection Program Loan In April 2020, the Company was granted a loan from SVB in the aggregate amount of $ 233,537 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | (6) Property and Equipment Property and equipment consisted of the following: Schedule of Property and Equipment December 31, 2021 December 31, 2020 Computer equipment and software $ 43,361 $ 43,361 Lab and office equipment 1,056,523 1,048,932 Furniture and fixtures 51,404 51,404 Property, and equipment, gross 1,151,288 1,143,697 Less accumulated depreciation (1,144,077 ) (1,143,697 ) Property, and equipment, net $ 7,211 $ - Depreciation expense for the years ended December 31, 2021 and 2020 was approximately $ 400 4,000 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (7) Income Taxes (a) Income Tax Expense Income tax expense consists of: Schedule of Income Tax Expense December 31, 2021 2020 U.S. federal $ - $ - State and local 200 200 Deferred - - Total $ 200 $ 200 (b) Tax Rate Reconciliation Income tax expense was $ 200 200 21 Schedule of Pretax Income from Continuing Operations December 31, 2021 2020 Computed “expected” tax benefit $ (133,182 ) $ (4,402,570 ) Increase (reduction) in income taxes resulting from: Change in valuation allowance 476,431 4,248,002 State and local income taxes, net of federal income tax benefit 158 158 Stock expense 97,697 86,209 Research and development tax credits (352,163 ) (485,254 ) Orphan drug tax credit (14,025 ) (4,797 ) Warrant liability (74,737 ) 607,360 Other, net 21 (48,908 ) Total $ 200 $ 200 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (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, 2021 and 2020 are presented below. Schedule of Deferred Tax Assets and Liabilities December 31, 2021 2020 Deferred tax assets: Stock-based compensation $ 1,687,480 $ 1,651,482 Net operating loss carryforwards 34,759,890 35,102,326 Employee benefits 56,009 54,108 Research and development tax credits 4,935,609 4,472,003 Orphan drug tax credits 1,186,582 1,168,828 Plant and equipment - 959 Other deductible tempory differences 394,636 5,386 Total gross deferred tax assets 43,020,206 42,455,092 Deferred tax assets: Plant and equipment (1,871 ) - Total gross deferred tax liabilities (1,871 ) - Net deferred tax liabilities $ (1,871 ) $ - Deferred tax asset/deferred tax liability 43,018,335 42,455,092 Less valuation allowance (43,018,335 ) (42,455,092 ) Net deferred tax assets $ - $ - The valuation allowance for deferred tax assets as of December 31, 2021 and 2020 was $ 43.0 42.5 0.5 5.2 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (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 20.2 5.5 1.2 As of December 31, 2021, we had NOL and research and development credit carryforwards for U.S. federal income tax reporting purposes of approximately $ 135.6 3.5 Approximately $24.6 million of the NOL will expire between 2023 and 2033 and $70.8 million of the NOL will expire 2034 through 2037 expire in 2033 through 2041 1.2 We also have state NOL and research and development credit carry forwards of approximately $ 127.1 1.4 expire in 2023 through 2035 The Company’s federal and state income tax returns for December 31, 2018 through 2021 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, 2021 and 2020 are as follows: Schedule of Reconciliation of the Beginning and Ending Amount of Total Unrecognized Tax Contingencies, Excluding Interest and Penalties December 31, 2021 2020 Balance, beginning of year - $ - Balance, end of year - $ - |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Leases | (8) Leases On August 6, 2004, the Company assumed a non-cancelable operating lease for office space and laboratory facilities in Salt Lake City, Utah. On May 6, 2014, the Company modified and extended the lease through February 28, 2018, on February 8, 2018, the Company extended the lease through February 28, 2019, on January 2, 2019, the Company extended the lease through February 29, 2020, on February 24, 2020, the Company extended the lease through February 28, 2021, on March 3, 2021, the Company extended the lease through February 28, 2022 and on January 24, 2022, the Company extended the lease through February 28, 2023. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (8) Leases – (continued) Future minimum lease payments under non-cancelable operating leases as of December 31, 2021 are: Schedule of Future Minimum Rental Payments for Operating Leases Operating leases Year ending December 31: 2022 $ 341,429 2023 $ 57,273 Total minimum lease payments $ 398,702 The Company’s rent expense was $ 330,000 |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders’ Equity | (9) Stockholders’ Equity (a) Issuance of Common Stock On January 28, 2021, the Company completed a public offering of securities registered under an effective registration statement filed pursuant to the Securities Act of 1933, as amended (“January 2021 Offering”). The gross proceeds from the January 2021 Offering were approximately $ 28.7 1.9 16,428,571 On February 27, 2020, the Company completed a registered direct offering of securities registered under an effective registration statement filed pursuant to the Securities Act of 1933, as amended (“February 2020 Offering”). The gross proceeds from the February 2020 Offering were approximately $ 6.0 347,000 10,084,034 0.595 0.53 On November 18, 2019, the Company completed a public offering of securities registered under an effective registration statement filed pursuant to the Securities Act of 1933, as amended (“November 2019 Offering”). The gross proceeds from the November 2019 Offering were approximately $ 6.0 404,000 10,450,000 1,550,000 0.50 0.4999 .0001 0.50 768,000 4.8 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (9) Stockholders’ Equity – (continued) On March 6, 2017, the Company entered into the 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 shares of the Company’s common stock sold under the Sales Agreement are sold and issued pursuant to the Registration Statement on Form S-3 (File No. 333-250072) (the “Form S-3”), which was previously declared effective by the Securities and Exchange Commission, and the related prospectus and one or more prospectus supplements. The Company is not obligated to make any sales of its common stock under the 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. As of December 31, 2021, we had sold an aggregate of 15,023,073 shares at a weighted-average sales price of $ 2.19 per share under the Sales Agreement for aggregate gross proceeds of $ 32.9 million and net proceeds of $ 31.7 million, after deducting sales agent commission and discounts and our other offering costs. During the year ended December 31, 2021, the Company sold 1,811,238 shares of our common stock pursuant to the current Registration Statement on Form S-3 (File No. 333-250072) at a weighted-average sales price of $ 1.95 per share, resulting in net proceeds of approximately $ 3.4 million under the Sales Agreement which is net of $ 112,000 in expenses. During the year ended December 31, 2020, the Company sold 3,746,300 shares of our common stock pursuant to the current Registration Statement on Form S-3 (File No. 333-250072) at a weighted average sales price of $ 1.41 per share, in net proceeds of approximately $ 5.1 million under the Sales Agreement which is net of $ 148,000 in expenses. Additionally, during the year ended December 31, 2020, the Company sold 2,830,000 shares of our common stock pursuant to the prior Registration Statement on Form S-3 (File No. 333-220942) at a weighted average sales price of $ 1.43 per share under the ATM for aggregate gross proceeds of $ 3.9 million which is net of $ 165,000 in expenses. As of December 31, 2021, the Company had $ 41.2 million available for sale under the Sales Agreement. (b) 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 per one-thousandth share (the “Purchase Price”). The Rights will generally become exercisable upon the earlier to occur of (i) 10 business days following a public announcement that a person or group of affiliated or associated persons has become an Acquiring Person (as defined below) or (ii) 10 business days (or such later date as may be determined by action of the board of directors prior to such time as any person or group of affiliated or associated persons becomes an Acquiring Person) following the commencement of, or announcement of an intention to make, a tender offer or exchange offer the consummation of which would result in the beneficial ownership by a person or group of 15% or more of the outstanding common stock of the Company. Except in certain situations, a person or group of affiliated or associated persons becomes an “Acquiring Person” upon acquiring beneficial ownership of 15% or more of the outstanding shares of common stock of the Company. LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (9) Stockholders’ Equity – (continued) 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 (c) 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 1,000,000 271,906 1,271,906 2,471,906 2,471,906 3,221,906 3,221,906 5,721,906 ten-year 5,721,906 857,459 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (9) Stockholders’ Equity – (continued) 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, 2020 3,564,458 $ 3.36 Options granted 1,105,500 1.23 Options exercised (4,584 ) 1.46 Options forfeited - - Options cancelled (114,169 ) 4.51 Balance at December 31, 2021 4,551,205 2.82 Options exercisable at December 31, 2021 2,799,979 3.84 The following table summarizes information about stock options outstanding and exercisable at December 31, 2021: 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 4,551,205 6.66 $ 2.82 $ 315,330 2,799,979 5.01 $ 3.84 $ 201,966 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, 2021 and 2020 was $ 2,000 zero 4,584 zero LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (9) Stockholders’ Equity – (continued) (d) Common Stock Warrants The Company accounts for its common stock warrants under ASC 480, Distinguishing Liabilities from Equity As of December 31, 2021, the Company had 1,094,030 Schedule of Fair Value of Warrants December 31, 2021 December 31, 2020 December 31, 2019 November 18, 2019 Expected life in years 2.88 3.88 4.88 5.00 Risk-free interest rate 0.97 % 0.27 % 1.69 % 1.63 % Dividend yield — — — — Volatility 100.00 % 100.00 % 225.93 % 224.47 % Stock price $ 0.99 $ 1.36 $ 0.39 $ 0.41 During the year ended December 31, 2021, the Company recorded a non-cash gain of $ 356,000 from the change in fair value of the November 2019 Offering warrants and during the year ended December 31, 2020, the Company recorded a non-cash loss of $ 2.9 million from the change in fair value of the November 2019 Offering warrants. The following table is a reconciliation of the warrant liability measured at fair value using level 3 inputs: Schedule of Reconciliation of Warrant Liability Warrant Liability Balance at December 31, 2020 $ 1,170,051 Settlement of liabilty on warrant exercise (18,365 ) Change in fair value of common stock warrants (355,890 ) Balance at December 31, 2021 $ 795,796 Additionally, in the February 2020 Offering, the Company issued 5,042,017 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (9) Stockholders’ Equity – (continued) 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, 2020 1,944,366 $ 0.51 Issued - - Exercised (10,000 ) 0.50 Expired - - Cancelled - - Forfeited - - Balance at December 31, 2021 1,934,366 $ 0.51 During the years ended December 31, 2021 and 2020, 10,000 15.1 5,000 7.7 The following table summarizes information about common stock warrants outstanding at December 31, 2021: Warrants outstanding Number exercisable Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value 1,934,366 3.00 $ 0.51 $ 922,629 |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2021 | |
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 81,000 and $ 67,000 , respectively, to the 401(k) Plan during the years ended December 31, 2021 and 2020 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
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 million payable as follows: $ 2.5 million immediately, $ 1.0 million on July 13, 2022 and $ 500,000 on July 13, 2023. No future royalties are owing from either party. On July 15, 2021, the Court dismissed with prejudice the Company’s claims and Clarus’ counterclaims. 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 1.25 million. The Company filed a motion to dismiss this class action lawsuit on July 24, 2020. In response, the plaintiffs filed their response to the motion to dismiss the class action lawsuit on September 22, 2020, and the Company filed its reply to the motion to dismiss on October 22, 2020. A hearing on the motion to dismiss occurred on January 12, 2022. The Company intends to vigorously defend ourselves against these allegations and have not recorded a liability related to this shareholder class action lawsuit as the outcome is not probable nor can an estimate be made of loss, if any. On March 13, 2020, the Company filed U.S. patent application serial number 16/818,779 (the “Lipocine ‘779 Application”) with the USPTO. On October 16 and November 3, 2020, the Company filed suggestions for interference with the USPTO requesting that a patent interference be declared between the Lipocine ‘779 Application and US patent application serial number 16/656,178 to Clarus Therapeutics, Inc. (the “Clarus ‘178 Application”). Pursuant to our request, the Patent Trial and Appeal Board (“PTAB”) at the USPTO declared the interference on January 4, 2021 to ultimately determine, as between the Company and Clarus, who is entitled to the claimed subject matter. The interference number is 106,128, and we were initially declared Senior Party. A conference call with the PTAB was held on January 25, 2021 to discuss proposed motions. On February 1, 2021, the PTAB issued an order authorizing certain motions and setting the schedule for the preliminary motions phase. On July 13, 2021, the Company entered into the Global Agreement with Clarus to resolve interference No. 106,128 among other items. On July 26, 2021, the PTAB granted the Company’s request for adverse judgment in interference No. 106,128 in accordance with the Global Agreement. Beyond Solomon Abady v. Lipocine Inc. et al LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (11) Commitments and Contingencies (continued) 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, 2021 | |
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; 55,000 and zero , respectively, in royalty revenue from Spriaso. Spriaso filed its first NDA and as an affiliated entity of the Company, it used up the one-time waiver for user fees for a small business submitting its first human drug application to the FDA. Spriaso is considered a variable interest entity under the FASB ASC Topic 810-10, Consolidations |
Accounting Pronouncements
Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Changes and Error Corrections [Abstract] | |
Accounting Pronouncements | (13) Accounting Pronouncements Accounting Pronouncements Issued Not Yet Adopted In 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments However, in October 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses, Derivatives and Hedging, and Leases: Effective Dates . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Use of Estimates | (a) Use of Estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles 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 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 $ 3.0 19.2 |
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 2021 and 2020 and the Company did not record an allowance for doubtful accounts as of December 31, 2021 and 2020 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 inception of each contract, the Company identifies the goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company reassess 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, 2021 and 2020 (2) Summary of Significant Accounting Policies – (continued) Disaggregation of Revenue Schedule of Disaggregation of Revenue Type of Revenue Licensing $ 11,000,000 Sales-based royalties 54,994 Minimum guaranteed royalties 4,050,000 Materials 1,035,844 Revenue $ 16,140,838 Under Topic 606, all revenue has been recognized as point in time for the year ended December 31, 2021. See Note 4 for a description of the license agreement with Antares Pharma, Inc. 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. The contract asset as of December 31, 2021 is related to the Antares License Agreement. Revenue Concentration A major customer is considered to be one that comprises more than 10 99.7 no LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (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 likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest and penalties related to unrecognized tax benefits as a component of its income tax expense. |
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, 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, 2021 and 2020 (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 $ 604,000 1.4 Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs Year Ended 2021 2020 Research and development $ 280,186 $ 583,212 General and administrative 323,760 789,970 $ 603,946 $ 1,373,182 The Company issued 1,106,000 1,360,000 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, 2021 and 2020 (2) Summary of Significant Accounting Policies – (continued) For options granted in 2021 and 2020, 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 2021 2020 Expected term 5.83 5.83 Risk-free interest rate 1.04 % 0.93 % Expected dividend yield — — Expected volatility 102.18 % 100.32 % FASB Accounting Standards Codification (“ASC”) 718, Stock Compensation, As of December 31, 2021, there was $ 1.4 2.3 0.97 0.72 |
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, 2021 and 2020 (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, 2021 and 2020: Schedule of Fair Value, Assets Measured on Recurring Basis December 31, Fair value measurements at reporting date using 2021 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,089,751 $ 2,089,751 $ - $ - Government treasury bills 5,515,920 5,515,920 - - Commercial paper 15,385,634 - 15,385,634 - Corporate bonds and notes 22,787,651 - 22,787,651 - $ 45,778,956 $ 7,605,671 $ 38,173,285 $ - Liabilities: Warrant liability $ 795,796 - - 795,796 $ 46,574,752 $ 7,605,671 $ 38,173,285 $ 795,796 December 31, Fair value measurements at reporting date using 2020 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 18,399,585 $ 18,399,585 $ - $ - Commercial paper 449,992 - 449,992 - $ 18,849,577 $ 18,399,585 $ 449,992 $ - Liabilities: Warrant liability $ 1,170,051 - - 1,170,051 $ 20,019,628 $ 18,399,585 $ 449,992 $ 1,170,051 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (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, 2021, include (i) volatility of 100 %, (ii) risk free interest rate of 0.97 %, (iii) strike price of $ 0.50, (iv) fair value of common stock of $ .99 , and (v) expected life of 2.9 years. The significant assumptions used in preparing the option pricing model for valuing the warrant liability as of December 31, 2020, include (i) volatility of 100 %, (ii) risk free interest rate of 0.27 %, (iii) strike price of $ 0.50 , (iv) fair value of common stock of $ 1.36 , and (v) expected life of 3.9 years. 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, 2021 and 2020. |
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, 2021 and 2020 (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, 2021 and 2020. Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock Year Ended December 31, 2021 2020 Basic loss per share attributable to common stock: Numerator Net loss $ (634,399 ) $ (20,964,819 ) Denominator Weighted avg. common shares outstanding 86,934,618 55,688,085 Basic loss per share attributable to common stock $ (0.01 ) $ (0.38 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (634,399 ) $ (20,964,819 ) Denominator Weighted avg. common shares outstanding 86,934,618 55,688,085 Diluted loss per share attributable to common stock $ (0.01 ) $ (0.38 ) The computation of diluted earnings per share for the years ended December 31, 2021 and 2020 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, 2021 2020 Stock options 4,551,205 3,564,458 Warrants 1,934,366 1,944,366 LIPOCINE INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2021 and 2020 (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, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Disaggregation of Revenue | Disaggregation of Revenue Schedule of Disaggregation of Revenue Type of Revenue Licensing $ 11,000,000 Sales-based royalties 54,994 Minimum guaranteed royalties 4,050,000 Materials 1,035,844 Revenue $ 16,140,838 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs Year Ended 2021 2020 Research and development $ 280,186 $ 583,212 General and administrative 323,760 789,970 $ 603,946 $ 1,373,182 |
Schedule of Key Assumption of Fair Value of Stock Options Granted | For options granted in 2021 and 2020, 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 2021 2020 Expected term 5.83 5.83 Risk-free interest rate 1.04 % 0.93 % Expected dividend yield — — Expected volatility 102.18 % 100.32 % |
Schedule of Fair Value, Assets Measured on Recurring Basis | Schedule of Fair Value, Assets Measured on Recurring Basis December 31, Fair value measurements at reporting date using 2021 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,089,751 $ 2,089,751 $ - $ - Government treasury bills 5,515,920 5,515,920 - - Commercial paper 15,385,634 - 15,385,634 - Corporate bonds and notes 22,787,651 - 22,787,651 - $ 45,778,956 $ 7,605,671 $ 38,173,285 $ - Liabilities: Warrant liability $ 795,796 - - 795,796 $ 46,574,752 $ 7,605,671 $ 38,173,285 $ 795,796 December 31, Fair value measurements at reporting date using 2020 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 18,399,585 $ 18,399,585 $ - $ - Commercial paper 449,992 - 449,992 - $ 18,849,577 $ 18,399,585 $ 449,992 $ - Liabilities: Warrant liability $ 1,170,051 - - 1,170,051 $ 20,019,628 $ 18,399,585 $ 449,992 $ 1,170,051 |
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, 2021 and 2020. Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock Year Ended December 31, 2021 2020 Basic loss per share attributable to common stock: Numerator Net loss $ (634,399 ) $ (20,964,819 ) Denominator Weighted avg. common shares outstanding 86,934,618 55,688,085 Basic loss per share attributable to common stock $ (0.01 ) $ (0.38 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (634,399 ) $ (20,964,819 ) Denominator Weighted avg. common shares outstanding 86,934,618 55,688,085 Diluted loss per share attributable to common stock $ (0.01 ) $ (0.38 ) |
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, 2021 and 2020 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, 2021 2020 Stock options 4,551,205 3,564,458 Warrants 1,934,366 1,944,366 |
Marketable Investment Securit_2
Marketable Investment Securities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-Sale Securities | Schedule of Available-for-Sale Securities December 31, 2021 Amortized Cost Gross unrealized holding gains Gross unrealized holding losses Aggregate fair value Government treasury bills $ 5,526,122 $ - $ (10,202 ) $ 5,515,920 Corporate bonds, notes and commercial paper 38,181,099 - (7,814 ) 38,173,285 $ 43,707,221 $ - $ (18,016 ) $ 43,689,205 December 31, 2020 Amortized Cost Gross unrealized holding gains Gross unrealized holding losses Aggregate fair value Commercial paper $ 449,992 - - $ 449,992 $ 449,992 $ - $ - $ 449,992 |
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, 2021 are as follows: Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities December 31, 2021 Amortized Cost Aggregate fair value Due within one year $ 41,680,635 $ 41,667,405 Due after one year through two years 2,026,586 2,021,800 $ 43,707,221 $ 43,689,205 |
Loan and Security Agreement (Ta
Loan and Security Agreement (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Maturities of Debt | Future maturities of principal payments on the Loan and Security Agreement at December 31, 2021 (excluding accrued final payment fee) are as follows: Schedule of Maturities of Debt Years Ending December 31, Amount (in thousands) 2022 1,667 Thereafter — $ 1,667 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following: Schedule of Property and Equipment December 31, 2021 December 31, 2020 Computer equipment and software $ 43,361 $ 43,361 Lab and office equipment 1,056,523 1,048,932 Furniture and fixtures 51,404 51,404 Property, and equipment, gross 1,151,288 1,143,697 Less accumulated depreciation (1,144,077 ) (1,143,697 ) Property, and equipment, net $ 7,211 $ - |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Tax Expense | Income tax expense consists of: Schedule of Income Tax Expense December 31, 2021 2020 U.S. federal $ - $ - State and local 200 200 Deferred - - Total $ 200 $ 200 |
Schedule of Pretax Income from Continuing Operations | Schedule of Pretax Income from Continuing Operations December 31, 2021 2020 Computed “expected” tax benefit $ (133,182 ) $ (4,402,570 ) Increase (reduction) in income taxes resulting from: Change in valuation allowance 476,431 4,248,002 State and local income taxes, net of federal income tax benefit 158 158 Stock expense 97,697 86,209 Research and development tax credits (352,163 ) (485,254 ) Orphan drug tax credit (14,025 ) (4,797 ) Warrant liability (74,737 ) 607,360 Other, net 21 (48,908 ) Total $ 200 $ 200 |
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, 2021 and 2020 are presented below. Schedule of Deferred Tax Assets and Liabilities December 31, 2021 2020 Deferred tax assets: Stock-based compensation $ 1,687,480 $ 1,651,482 Net operating loss carryforwards 34,759,890 35,102,326 Employee benefits 56,009 54,108 Research and development tax credits 4,935,609 4,472,003 Orphan drug tax credits 1,186,582 1,168,828 Plant and equipment - 959 Other deductible tempory differences 394,636 5,386 Total gross deferred tax assets 43,020,206 42,455,092 Deferred tax assets: Plant and equipment (1,871 ) - Total gross deferred tax liabilities (1,871 ) - Net deferred tax liabilities $ (1,871 ) $ - Deferred tax asset/deferred tax liability 43,018,335 42,455,092 Less valuation allowance (43,018,335 ) (42,455,092 ) Net deferred tax assets $ - $ - |
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, 2021 and 2020 are as follows: Schedule of Reconciliation of the Beginning and Ending Amount of Total Unrecognized Tax Contingencies, Excluding Interest and Penalties December 31, 2021 2020 Balance, beginning of year - $ - Balance, end of year - $ - |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Schedule of Future Minimum Rental Payments for Operating Leases | Future minimum lease payments under non-cancelable operating leases as of December 31, 2021 are: Schedule of Future Minimum Rental Payments for Operating Leases Operating leases Year ending December 31: 2022 $ 341,429 2023 $ 57,273 Total minimum lease payments $ 398,702 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2020 3,564,458 $ 3.36 Options granted 1,105,500 1.23 Options exercised (4,584 ) 1.46 Options forfeited - - Options cancelled (114,169 ) 4.51 Balance at December 31, 2021 4,551,205 2.82 Options exercisable at December 31, 2021 2,799,979 3.84 |
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, 2021: 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 4,551,205 6.66 $ 2.82 $ 315,330 2,799,979 5.01 $ 3.84 $ 201,966 Warrants outstanding Number exercisable Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value 1,934,366 3.00 $ 0.51 $ 922,629 |
Schedule of Fair Value of Warrants | Schedule of Fair Value of Warrants December 31, 2021 December 31, 2020 December 31, 2019 November 18, 2019 Expected life in years 2.88 3.88 4.88 5.00 Risk-free interest rate 0.97 % 0.27 % 1.69 % 1.63 % Dividend yield — — — — Volatility 100.00 % 100.00 % 225.93 % 224.47 % Stock price $ 0.99 $ 1.36 $ 0.39 $ 0.41 |
Schedule of Reconciliation of Warrant Liability | Schedule of Reconciliation of Warrant Liability Warrant Liability Balance at December 31, 2020 $ 1,170,051 Settlement of liabilty on warrant exercise (18,365 ) Change in fair value of common stock warrants (355,890 ) Balance at December 31, 2021 $ 795,796 |
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, 2020 1,944,366 $ 0.51 Issued - - Exercised (10,000 ) 0.50 Expired - - Cancelled - - Forfeited - - Balance at December 31, 2021 1,934,366 $ 0.51 |
Schedule of Disaggregation of R
Schedule of Disaggregation of Revenue (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Product Information [Line Items] | ||
Revenue | $ 16,140,838 | |
License [Member] | ||
Product Information [Line Items] | ||
Revenue | 11,000,000 | |
Sales-based royalties [Member] | ||
Product Information [Line Items] | ||
Revenue | 54,994 | |
Minimum guaranteed royalties [Member] | ||
Product Information [Line Items] | ||
Revenue | 4,050,000 | |
Materials [Member] | ||
Product Information [Line Items] | ||
Revenue | $ 1,035,844 |
Schedule of Employee Service Sh
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expense | $ 603,946 | $ 1,373,182 |
Research and Development Expense [Member] | ||
Share-based Payment Arrangement, Expense | 280,186 | 583,212 |
General and Administrative Expense [Member] | ||
Share-based Payment Arrangement, Expense | $ 323,760 | $ 789,970 |
Schedule of Key Assumption of F
Schedule of Key Assumption of Fair Value of Stock Options Granted (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounting Policies [Abstract] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years 9 months 29 days | 5 years 9 months 29 days |
Risk-free interest rate | 1.04% | 0.93% |
Expected dividend yield | 0.00% | 0.00% |
Expected volatility | 102.18% | 100.32% |
Schedule of Fair Value, Assets
Schedule of Fair Value, Assets Measured on Recurring Basis (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | $ 45,778,956 | $ 18,849,577 |
Financial and Nonfinancial Liabilities, Fair Value Disclosure | 46,574,752 | 20,019,628 |
Corporate Bonds and Notes [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | 22,787,651 | |
Warrant [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Financial and Nonfinancial Liabilities, Fair Value Disclosure | 795,796 | 1,170,051 |
Fair Value, Inputs, Level 1 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | 7,605,671 | 18,399,585 |
Financial and Nonfinancial Liabilities, Fair Value Disclosure | 7,605,671 | 18,399,585 |
Fair Value, Inputs, Level 1 [Member] | Corporate Bonds and Notes [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | ||
Fair Value, Inputs, Level 1 [Member] | Warrant [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Financial and Nonfinancial Liabilities, Fair Value Disclosure | ||
Fair Value, Inputs, Level 2 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | 38,173,285 | 449,992 |
Financial and Nonfinancial Liabilities, Fair Value Disclosure | 38,173,285 | 449,992 |
Fair Value, Inputs, Level 2 [Member] | Corporate Bonds and Notes [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | 22,787,651 | |
Fair Value, Inputs, Level 2 [Member] | Warrant [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Financial and Nonfinancial Liabilities, Fair Value Disclosure | ||
Fair Value, Inputs, Level 3 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | ||
Financial and Nonfinancial Liabilities, Fair Value Disclosure | 795,796 | 1,170,051 |
Fair Value, Inputs, Level 3 [Member] | Corporate Bonds and Notes [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | ||
Fair Value, Inputs, Level 3 [Member] | Warrant [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Financial and Nonfinancial Liabilities, Fair Value Disclosure | 795,796 | 1,170,051 |
Money Market Funds [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | 2,089,751 | 18,399,585 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | 2,089,751 | 18,399,585 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | ||
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | ||
US Treasury Securities [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | 5,515,920 | |
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | 5,515,920 | |
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | ||
US Treasury Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | ||
Commercial Paper [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | 15,385,634 | 449,992 |
Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | ||
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure | 15,385,634 | 449,992 |
Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Assets, Fair Value Disclosure |
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, 2021 | Dec. 31, 2020 | |
Accounting Policies [Abstract] | ||
Net loss | $ (634,399) | $ (20,964,819) |
Weighted avg. common shares outstanding | 86,934,618 | 55,688,085 |
Basic loss per share attributable to common stock | $ (0.01) | $ (0.38) |
Net loss | $ (634,399) | $ (20,964,819) |
Weighted avg. common shares outstanding | 86,934,618 | 55,688,085 |
Diluted loss per share attributable to common stock | $ (0.01) | $ (0.38) |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Warrant [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Warrants | 1,934,366 | 1,944,366 |
Share-based Payment Arrangement, Option [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Warrants | 4,551,205 | 3,564,458 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Product Information [Line Items] | |||
Cash Equivalents, at Carrying Value | $ 19,200,000 | $ 3,000,000 | $ 19,200,000 |
Total revenues | $ 0 | ||
Stock-based compensation cost | 603,946 | $ 1,373,182 | |
Unrecognized compensation cost | $ 1,400,000 | ||
Weighted average period of stock option plan | 2 years 3 months 18 days | ||
Weighted average fair value of share-based compensation | $ 0.97 | $ 0.72 | |
Volatility rate | 102.18% | 100.32% | |
Risk free interest rate | 1.04% | 0.93% | |
Expected life | 5 years 9 months 29 days | 5 years 9 months 29 days | |
Warrant [Member] | |||
Product Information [Line Items] | |||
Volatility rate | 100.00% | 100.00% | |
Risk free interest rate | 0.97% | 0.27% | |
strike price | $ 0.50 | $ 0.50 | $ 0.50 |
Fair value of common stock | $ 1.36 | $ 0.99 | $ 1.36 |
Expected life | 2 years 10 months 24 days | 3 years 10 months 24 days | |
Share-based Payment Arrangement, Option [Member] | |||
Product Information [Line Items] | |||
Number of stock options issued | 1,106,000 | 1,360,000 | |
Office Equipment [Member] | |||
Product Information [Line Items] | |||
Property, Plant and Equipment, Useful Life | 5 years | ||
Computer equipment and software [Member] | |||
Product Information [Line Items] | |||
Property, Plant and Equipment, Useful Life | 3 years | ||
Furniture and Fixtures [Member] | |||
Product Information [Line Items] | |||
Property, Plant and Equipment, Useful Life | 7 years | ||
Major Customer [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | |||
Product Information [Line Items] | |||
Percentage of total revenue | 10.00% | ||
One major customer [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | |||
Product Information [Line Items] | |||
Percentage of total revenue | 99.70% |
Schedule of Available-for-Sale
Schedule of Available-for-Sale Securities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 43,707,221 | $ 449,992 |
Gross unrealized holding gains | ||
Gross unrealized holding losses | (18,016) | |
Aggregate fair value | 43,689,205 | 449,992 |
US Treasury Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 5,526,122 | |
Gross unrealized holding gains | ||
Gross unrealized holding losses | (10,202) | |
Aggregate fair value | 5,515,920 | |
Corporate Bonds Notes And Commercial Paper [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 38,181,099 | |
Gross unrealized holding gains | ||
Gross unrealized holding losses | (7,814) | |
Aggregate fair value | $ 38,173,285 | |
Commercial Paper [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 449,992 | |
Gross unrealized holding gains | ||
Gross unrealized holding losses | ||
Aggregate fair value | $ 449,992 |
Schedule of Maturities of Debt
Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities (Details) | Dec. 31, 2021USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Due within one year | $ 41,680,635 |
Due within one year | 41,667,405 |
Due after one year through two years | 2,026,586 |
Due after one year through two years | 2,021,800 |
Total maturities of debt securities classified as available-for-sale securities, amortized cost | 43,707,221 |
Total maturities of debt securities classified as available-for-sale securities, fair value | $ 43,689,205 |
Marketable Investment Securit_3
Marketable Investment Securities (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | ||
Proceeds from Sale of Held-to-maturity Securities | $ 0 | $ 0 |
Debt and Equity Securities, Realized Gain (Loss) | 0 | 0 |
Matured marketable investment securities | 4,700,000 | 10,200,000 |
Other than temporary impairments | $ 0 | $ 0 |
Contractual Agreements (Details
Contractual Agreements (Details Narrative) - USD ($) | Jan. 01, 2026 | Jan. 01, 2025 | Oct. 14, 2021 | Mar. 29, 2012 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Malpractice Insurance [Line Items] | |||||||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 0 | ||||||
Contract research and development expenses | $ 4,900,000 | $ 6,800,000 | |||||
Collaborative Arrangement [Member] | Abbott Products Inc [Member] | |||||||
Malpractice Insurance [Line Items] | |||||||
Percentage of net sales | 1.00% | ||||||
Royalties, commitment amount | $ 1,000,000 | ||||||
Percentage of royalties reduction based upon product launch | 50.00% | ||||||
License Agreement [Member] | |||||||
Malpractice Insurance [Line Items] | |||||||
License fee | $ 11,000,000 | ||||||
Percentage of royalty payment | 20.00% | ||||||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 16,100,000 | $ 0 | |||||
License Agreement [Member] | Maximum [Member] | |||||||
Malpractice Insurance [Line Items] | |||||||
Sales milestone | $ 160,000,000 | ||||||
License Agreement [Member] | Subsequent Event [Member] | Forecast [Member] | |||||||
Malpractice Insurance [Line Items] | |||||||
Potential license fees from a licensee | $ 5,000,000 | $ 5,000,000 | |||||
License Agreement [Member] | TLANDO XR [Member] | |||||||
Malpractice Insurance [Line Items] | |||||||
License fee | 4,000,000 | ||||||
Clinical and development milestones | $ 35,000,000 |
Schedule of Maturities of Deb_2
Schedule of Maturities of Debt (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Debt Disclosure [Abstract] | |
2022 | $ 1,667 |
Thereafter | |
Total | $ 1,667 |
Loan and Security Agreement (De
Loan and Security Agreement (Details Narrative) - USD ($) | Jan. 05, 2018 | Apr. 30, 2020 | Dec. 31, 2021 | Sep. 09, 2021 |
Loan And Security Agreement [Member] | Silicon Valley Bank [Member] | ||||
Short-term Debt [Line Items] | ||||
Aggregate amount | $ 10,000,000 | |||
Debt Instrument, Interest Rate, Basis for Effective Rate | The principal borrowed under the Loan and Security Agreement bears 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 (4.25% as of December 31, 2021), which interest is payable monthly | |||
Interest rate | 4.25% | |||
Debt Instrument, Maturity Date | Jun. 1, 2022 | |||
Debt instrument, balloon payment to be paid | $ 650,000 | |||
Debt instrument, increase in amount | $ 644,000 | |||
Cash collateral for borrowed securities | $ 5,000,000 | |||
Debt Instrument, Restrictive Covenants | While any amounts are outstanding under the Loan and Security Agreement, the Company is subject to a number of affirmative and negative covenants, including covenants regarding dispositions of property, business combinations or acquisitions, incurrence of additional indebtedness and transactions with affiliates, among other customary covenants. The credit facility also includes events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus 5.0% and would provide SVB, as collateral agent, with the right to exercise remedies against the Company and the collateral securing the credit facility, including foreclosure against the property securing the credit facilities, including its cash. | |||
Debt instrument, basis spread on interest rate for debt default | 5.00% | |||
Debt instrument, minimum amount considered for insolvency | $ 100,000 | |||
Payroll Protection Program Loan [Member] | ||||
Short-term Debt [Line Items] | ||||
Proceeds from loans | $ 233,537 |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property, and equipment, gross | $ 1,151,288 | $ 1,143,697 |
Less accumulated depreciation | (1,144,077) | (1,143,697) |
Property, and equipment, net | 7,211 | |
Computer equipment and software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, and equipment, gross | 43,361 | 43,361 |
Lab and office equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, and equipment, gross | 1,056,523 | 1,048,932 |
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, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expenses | $ 400 | $ 4,000 |
Schedule of Income Tax Expense
Schedule of Income Tax Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal | ||
State and local | 200 | 200 |
Deferred | ||
Total | $ 200 | $ 200 |
Schedule of Pretax Income from
Schedule of Pretax Income from Continuing Operations (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Computed “expected” tax benefit | $ (133,182) | $ (4,402,570) |
Change in valuation allowance | 476,431 | 4,248,002 |
State and local income taxes, net of federal income tax benefit | 158 | 158 |
Stock expense | 97,697 | 86,209 |
Research and development tax credits | (352,163) | (485,254) |
Orphan drug tax credit | (14,025) | (4,797) |
Warrant liability | (74,737) | 607,360 |
Other, net | 21 | (48,908) |
Total | $ 200 | $ 200 |
Schedule of Deferred Tax Assets
Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Income Tax Disclosure [Abstract] | ||
Stock-based compensation | $ 1,687,480 | $ 1,651,482 |
Net operating loss carryforwards | 34,759,890 | 35,102,326 |
Employee benefits | 56,009 | 54,108 |
Research and development tax credits | 4,935,609 | 4,472,003 |
Orphan drug tax credits | 1,186,582 | 1,168,828 |
Plant and equipment | 959 | |
Other deductible tempory differences | 394,636 | 5,386 |
Total gross deferred tax assets | 43,020,206 | 42,455,092 |
Plant and equipment | (1,871) | |
Total gross deferred tax liabilities | (1,871) | |
Net deferred tax liabilities | (1,871) | |
Deferred tax asset/deferred tax liability | 43,018,335 | 42,455,092 |
Less valuation allowance | (43,018,335) | (42,455,092) |
Net deferred tax assets |
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 ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Income Tax Disclosure [Abstract] | ||
Balance, beginning of year | ||
Balance, end of year |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards [Line Items] | ||
Income Tax Expense (Benefit) | $ 200 | $ 200 |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 21.00% |
Deferred Tax Assets, Valuation Allowance | $ 43,018,335 | $ 42,455,092 |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 500,000 | $ 5,200,000 |
Operating Loss Carry forwards Limitations On Use Amount | 1,100,000 | |
Operating Loss Carry forwards Pre-ownership Change Amount | 20,200,000 | |
Operating Loss Forgive Pre-ownership Change Amount | 5,500,000 | |
Tax Credit Carryforward Pre-ownership Change Amount | 1,200,000 | |
Operating Loss Carryforwards | 135,600,000 | |
Tax Credit Carryforward, Amount | $ 3,500,000 | |
Operating Loss Carry forwards Expiration Date1 | Approximately $24.6 million of the NOL will expire between 2023 and 2033 and $70.8 million of the NOL will expire 2034 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 2020, 2019 and 2018 NOL of $40.2 million can be carried forward indefinitely. The research and development credits will begin to expire in 2033 through 2041. | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating Loss Carryforwards | $ 127,100,000 | |
Tax Credit Carryforward, Amount | $ 1,400,000 | |
Operating Loss Carry forwards Expiration Date1 | approximately $127.1 million and $1.4 million, respectively. None of the Company’s state NOL expires in 2022, $34.8 million expires between 2022 and 2029, and $92.3 million will expire in 2030 through 2036 | |
Tax Credit Carryforward, Description | expire in 2023 through 2035 | |
Research and Development Expense [Member] | State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax Credit Carryforward, Amount | $ 1,200,000 | |
Tax Credit Carryforward, Description | expire 2034 through 2037 | |
Research and Development Expense [Member] | Us Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax Credit Carryforward, Description | expire in 2033 through 2041 |
Schedule of Future Minimum Rent
Schedule of Future Minimum Rental Payments for Operating Leases (Details) | Dec. 31, 2021USD ($) |
Leases | |
2022 | $ 341,429 |
2023 | 57,273 |
Total minimum lease payments | $ 398,702 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Leases | ||
Operating Leases, Rent Expense | $ 330,000 | $ 330,000 |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Option Indexed to Issuer's Equity [Line Items] | ||
Number of shares, Balance at end of the period (in shares) | 4,551,205 | |
Weighted average exercise price, Balance at end of the period (in dollars per share) | $ 2.82 | |
Number of shares, Options exercisable (in shares) | 2,799,979 | |
Weighted average exercise price, Options exercisable (in dollars per share) | $ 3.84 | |
Share-based Payment Arrangement, Option [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Number of shares, Balance at beginning of the period (in shares) | 3,564,458 | |
Weighted average exercise price, Balance at beginning of the period (in dollars per share) | $ 3.36 | |
Number of shares, Options granted (in shares) | 1,105,500 | |
Weighted average exercise price, Options granted (in dollars per share) | $ 1.23 | |
Number of shares, Options exercised (in shares) | (4,584) | 0 |
Weighted average exercise price, Options exercised (in dollars per share) | $ 1.46 | |
Number of shares, Options forfeited (in shares) | ||
Weighted average exercise price, Options forfeited (in dollars per share) | ||
Number of shares, Options cancelled (in shares) | (114,169) | |
Weighted average exercise price, Options cancelled (in dollars per share) | $ 4.51 | |
Number of shares, Balance at end of the period (in shares) | 4,551,205 | 3,564,458 |
Weighted average exercise price, Balance at end of the period (in dollars per share) | $ 2.82 | $ 3.36 |
Number of shares, Options exercisable (in shares) | 2,799,979 | |
Weighted average exercise price, Options exercisable (in dollars per share) | $ 3.84 |
Schedule of Share-based Compens
Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of options outstanding, shares | 4,551,205 | |
Options outstanding, Weighted average remaining contractual life (Years) | 6 years 7 months 28 days | |
Options outstanding, Weighted average exercise price (in dollars per share) | $ 2.82 | |
Options outstanding, Aggregate intrinsic value | $ 315,330 | |
Number of options exercisable | 2,799,979 | |
Options exercisable, Weighted average remaining contractual life (Years) | 5 years 3 days | |
Options exercisable, Weighted average exercise price | $ 3.84 | |
Options exercisable, Aggregate intrinsic value | $ 201,966 | |
Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of warrants exercisable, shares | 1,934,366 | 1,944,366 |
Weighted average remaining contractual life | 3 years | |
Weighted average exercise price, per share | $ 0.51 | $ 0.51 |
Aggregate intrinsic value | $ 922,629 |
Schedule of Fair Value of Warra
Schedule of Fair Value of Warrants (Details) - $ / shares | Nov. 18, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Subsidiary, Sale of Stock [Line Items] | ||||
Expected life in years | 5 years 9 months 29 days | 5 years 9 months 29 days | ||
Risk-free interest rate | 1.04% | 0.93% | ||
Dividend yield | 0.00% | 0.00% | ||
Volatility | 102.18% | 100.32% | ||
Warrant [Member] | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Expected life in years | 2 years 10 months 24 days | 3 years 10 months 24 days | ||
Risk-free interest rate | 0.97% | 0.27% | ||
Volatility | 100.00% | 100.00% | ||
Stock price | $ 0.99 | $ 1.36 | ||
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Warrant [Member] | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Expected life in years | 5 years | 2 years 10 months 17 days | 3 years 10 months 17 days | 4 years 10 months 17 days |
Risk-free interest rate | 1.63% | 0.97% | 0.27% | 1.69% |
Dividend yield | ||||
Volatility | 224.47% | 100.00% | 100.00% | 225.93% |
Stock price | $ 0.41 | $ 0.99 | $ 1.36 | $ 0.39 |
Schedule of Reconciliation of W
Schedule of Reconciliation of Warrant Liability (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Equity [Abstract] | ||
Balance at December 31, 2020 | $ 1,170,051 | |
Settlement of liabilty on warrant exercise | (18,365) | |
Change in fair value of common stock warrants | (355,890) | $ 2,892,189 |
Balance at December 31, 2021 | $ 795,796 | $ 1,170,051 |
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, 2021$ / sharesshares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
Warrants Outstanding, Beginning | shares | 1,944,366 |
Weighted Average Exercise Price, Outstanding, Beginning | $ / shares | $ 0.51 |
Warrants, Issued | shares | |
Weighted Average Exercise Price, Issued | $ / shares | |
Warrants, Exercised | shares | (10,000) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 0.50 |
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 | 1,934,366 |
Weighted Average Exercise Price, Outstanding, Ending | $ / shares | $ 0.51 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | Jan. 28, 2021 | Feb. 27, 2020 | Nov. 18, 2019 | Mar. 06, 2017 | Nov. 13, 2015 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Jun. 30, 2018 | Jun. 30, 2016 | Apr. 30, 2014 |
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock sold through ATM offering | $ 3,406,053 | $ 9,004,368 | |||||||||
[custom:SharesAvailableForFutureIssuance-0] | $ 41,200,000 | ||||||||||
[custom:ClassOfWarrantsOrRightRedemptionPriceOfWarrantsOrRights] | $ 63.96 | $ 0.001 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 315,330 | ||||||||||
Fair Value Adjustment of Warrants | (355,890) | 2,892,189 | |||||||||
Net proceeds from exercise of warrants | 5,000 | 7,674,876 | |||||||||
Share-based Payment Arrangement, Option [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 2,000 | $ 0 | |||||||||
Share-based compensation arrangement by share-based payment award, options, exercises in period | 4,584 | 0 | |||||||||
Stock Incentive Plan 2014 [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 5,721,906 | 1,000,000 | |||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 857,459 | ||||||||||
Contractual life | 10 years | ||||||||||
Stock Incentive Plan 2014 [Member] | Minimum [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 3,221,906 | 2,471,906 | 1,271,906 | ||||||||
Stock Incentive Plan 2014 [Member] | Maximum [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 5,721,906 | 3,221,906 | 2,471,906 | ||||||||
2011 Equity Incentive Plan [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 271,906 | ||||||||||
Common Stock [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Number of shares issued | 1,811,238 | 6,576,300 | |||||||||
Common stock sold through ATM offering | $ 181 | $ 658 | |||||||||
Share-based compensation arrangement by share-based payment award, options, exercises in period | 4,584 | ||||||||||
Common Stock Warrant [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Exercised | 10,000 | 15,100,000 | |||||||||
Net proceeds from exercise of warrants | $ 5,000 | $ 7,700,000 | |||||||||
Sales Agreement [Member] | Cantor [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock sold through ATM offering | $ 500,000 | ||||||||||
Percentage of gross proceeds on sale of shares | 3.00% | ||||||||||
January 2021 Offering [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock gross | $ 28,700,000 | ||||||||||
Payment of stock issuance costs | $ 1,900,000 | ||||||||||
Number of shares issued | 16,428,571 | ||||||||||
February 2020 Offering [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock gross | $ 6,000,000 | ||||||||||
Payment of stock issuance costs | $ 347,000 | ||||||||||
Issued | 5,042,017 | ||||||||||
February 2020 Offering [Member] | Class A Unit [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Number of shares issued | 10,084,034 | ||||||||||
Share issued exercise price per share | $ 0.595 | ||||||||||
February 2020 Offering [Member] | Common Stock [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Share issued exercise price per share | $ 0.53 | ||||||||||
November 2019 Offering [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock gross | $ 6,000,000 | ||||||||||
Payment of stock issuance costs | $ 404,000 | ||||||||||
Warrants outstanding | 1,094,030 | ||||||||||
Fair Value Adjustment of Warrants | $ 356,000 | 2,900,000 | |||||||||
November 2019 Offering [Member] | Class A Unit [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Number of shares issued | 10,450,000 | ||||||||||
November 2019 Offering [Member] | Common Stock [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Share issued exercise price per share | $ 0.50 | ||||||||||
Common stock sold through ATM offering | $ 768,000 | ||||||||||
November 2019 Offering [Member] | Class B Units [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Number of shares issued | 1,550,000 | ||||||||||
Share issued exercise price per share | $ 0.4999 | ||||||||||
November 2019 Offering [Member] | Pre Funded Warrants [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Share issued exercise price per share | 0.0001 | ||||||||||
Warrant exercise price per share | $ 0.50 | ||||||||||
November 2019 Offering [Member] | Additional Paid-in Capital [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock sold through ATM offering | $ 4,800,000 | ||||||||||
ATM Market Offering [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock gross | $ 32,900,000 | ||||||||||
Number of shares issued | 15,023,073 | ||||||||||
Share issued exercise price per share | $ 2.19 | ||||||||||
Proceeds from Issuance or Sale of Equity | $ 31,700,000 | ||||||||||
ATM Market Offering [Member] | Sales Agreement [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Payment of stock issuance costs | $ 112,000 | $ 148,000 | |||||||||
Number of shares issued | 1,811,238 | 3,746,300 | |||||||||
Share issued exercise price per share | $ 1.95 | $ 1.41 | |||||||||
ATM Market Offering [Member] | Sale Agreement [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Proceeds from Issuance or Sale of Equity | $ 3,400,000 | $ 5,100,000 | |||||||||
ATM Market Offering [Member] | Sale Agreement [Member] | Common Stock [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock gross | 3,900,000 | ||||||||||
Payment of stock issuance costs | $ 165,000 | ||||||||||
Number of shares issued | 2,830,000 | ||||||||||
Share issued exercise price per share | $ 1.43 |
401(k) Plan (Details Narrative)
401(k) Plan (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Retirement Benefits [Abstract] | ||
Employer matching contribution percent | 100.00% | |
Defined Contribution Plan, Cost | $ 81,000 | $ 67,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | Jul. 13, 2023 | Jul. 13, 2022 | Apr. 02, 2019 | Nov. 14, 2019 |
[custom:RetentionPayables-0] | $ 1,250,000 | |||
Global Agreement [Member] | ||||
Litigation Settlement, Amount Awarded to Other Party | $ 4,000,000 | |||
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | ||||
Litigation Settlement, Amount Awarded to Other Party | $ 2,500,000 | |||
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | Forecast [Member] | ||||
Litigation Settlement, Amount Awarded to Other Party | $ 500,000 | $ 1,000,000 |
Agreement with Spriaso, LLC (De
Agreement with Spriaso, LLC (Details Narrative) - Spriaso LLC[Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
License Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Percentage of royalty | 20.00% | |
Proceeds from Contributions from Affiliates | $ 10,000,000 | |
Service Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
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; | |
Proceeds from reimbursements | $ 55,000 | $ 0 |