Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 03, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2022 | |
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 $0.0001 per share | |
Trading Symbol | LPCN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 88,510,791 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 4,981,193 | $ 2,950,552 |
Marketable investment securities | 32,414,473 | 41,667,405 |
Accrued interest income | 80,411 | 247,253 |
Prepaid and other current assets | 603,546 | 1,514,465 |
Total current assets | 38,079,623 | 46,379,675 |
Marketable investment securities | 2,021,800 | |
Contract asset | 4,050,000 | 4,050,000 |
Property and equipment, net of accumulated depreciation of $1,148,374 and $1,144,077 | 40,013 | 7,211 |
Other assets | 23,753 | 23,753 |
Total assets | 42,193,389 | 52,482,439 |
Current liabilities: | ||
Accounts payable | 814,004 | 1,289,342 |
Accrued expenses | 899,301 | 1,016,458 |
Debt - current portion | 2,310,825 | |
Litigation settlement liability - current portion | 1,000,000 | |
Total current liabilities | 1,713,305 | 5,616,625 |
Warrant liability | 590,339 | 795,796 |
Litigation settlement liability - non-current portion | 500,000 | |
Total liabilities | 2,303,644 | 6,912,421 |
Commitments and contingencies (notes 6, 8, 9 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, 200,000,000 shares authorized; 88,504,834 and 88,296,360 issued and 88,499,124 and 88,290,650 outstanding | 8,850 | 8,829 |
Additional paid-in capital | 218,792,479 | 218,286,324 |
Treasury stock at cost, 5,710 shares | (40,712) | (40,712) |
Accumulated other comprehensive loss | (84,907) | (18,016) |
Accumulated deficit | (178,785,965) | (172,666,407) |
Total stockholders’ equity | 39,889,745 | 45,570,018 |
Total liabilities and stockholders’ equity | $ 42,193,389 | $ 52,482,439 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Accumulated depreciation | $ 1,148,374 | $ 1,144,077 |
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 | 200,000,000 | 200,000,000 |
Common stock, shares issued | 88,504,834 | 88,296,360 |
Common stock, shares outstanding | 88,499,124 | 88,290,650 |
Treasury stock, shares | 5,710 | 5,710 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenues [Abstract] | ||||
Revenues: | $ 500,000 | $ 500,000 | ||
Operating expenses: | ||||
Research and development | 2,898,012 | 1,464,687 | 4,785,965 | 3,045,228 |
General and administrative | 1,129,519 | 1,525,592 | 2,373,205 | 3,059,544 |
Total operating expenses | 4,027,531 | 2,990,279 | 7,159,170 | 6,104,772 |
Operating loss | (3,527,531) | (2,990,279) | (6,659,170) | (6,104,772) |
Other income (expense): | ||||
Interest and investment income | 69,877 | 17,344 | 111,453 | 27,993 |
Interest expense | (7,568) | (57,428) | (27,098) | (126,401) |
Unrealized gain on warrant liability | 583,445 | 221,322 | 205,457 | 26,257 |
Gain (loss) litigation settlement liability | 250,000 | (4,000,000) | 250,000 | (4,000,000) |
Total other income (expense), net | 895,754 | (3,818,762) | 539,812 | (4,072,151) |
Loss before income tax expense | (2,631,777) | (6,809,041) | (6,119,358) | (10,176,923) |
Income tax expense | (200) | (200) | ||
Net loss | $ (2,631,777) | $ (6,809,041) | $ (6,119,558) | $ (10,177,123) |
Basic loss per share attributable to common stock | $ (0.03) | $ (0.08) | $ (0.07) | $ (0.12) |
Weighted average common shares outstanding, basic | 88,499,067 | 88,290,650 | 88,404,999 | 85,556,110 |
Diluted loss per share attributable to common stock | $ (0.04) | $ (0.08) | $ (0.07) | $ (0.12) |
Weighted average common shares outstanding, diluted | 88,998,515 | 88,998,292 | 88,987,800 | 86,294,935 |
Comprehensive loss: | ||||
Net loss | $ (2,631,777) | $ (6,809,041) | $ (6,119,558) | $ (10,177,123) |
Net unrealized gain (loss) on available-for-sale securities | (17,491) | 22,273 | (66,891) | (186) |
Comprehensive loss | $ (2,649,268) | $ (6,786,768) | $ (6,186,449) | $ (10,177,309) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - 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, 2020 | $ 7,005 | $ (40,712) | $ 187,407,634 | $ (172,032,008) | $ 15,341,919 | |
Beginning balance, shares at Dec. 31, 2020 | 70,036,257 | 5,710 | ||||
Net loss | (10,177,123) | (10,177,123) | ||||
Unrealized net gain (loss) on marketable investment securities | (186) | (186) | ||||
Stock-based compensation | 294,313 | 294,313 | ||||
Option exercises | 6,693 | 6,693 | ||||
Option exercises, shares | 4,584 | |||||
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 | |||||
Settlement of warrant liability on warrant exercises | 18,365 | 18,365 | ||||
Common stock sold through ATM offering | $ 181 | 3,415,934 | 3,416,115 | |||
Common stock sold through ATM offering, shares | 1,811,238 | |||||
Ending balance, value at Jun. 30, 2021 | $ 8,830 | $ (40,712) | 217,986,752 | (186) | (182,209,131) | 35,745,553 |
Ending balance, shares at Jun. 30, 2021 | 88,290,650 | 5,710 | ||||
Beginning balance, value at Mar. 31, 2021 | $ 8,830 | $ (40,712) | 217,845,280 | (22,459) | (175,400,090) | 42,390,849 |
Beginning balance, shares at Mar. 31, 2021 | 88,290,650 | 5,710 | ||||
Net loss | (6,809,041) | (6,809,041) | ||||
Unrealized net gain (loss) on marketable investment securities | 22,273 | 22,273 | ||||
Stock-based compensation | 146,747 | 146,747 | ||||
Costs associated with ATM offering | (5,275) | (5,275) | ||||
Ending balance, value at Jun. 30, 2021 | $ 8,830 | $ (40,712) | 217,986,752 | (186) | (182,209,131) | 35,745,553 |
Ending balance, shares at Jun. 30, 2021 | 88,290,650 | 5,710 | ||||
Beginning balance, value at Dec. 31, 2021 | $ 8,829 | $ (40,712) | 218,286,324 | (18,016) | (172,666,407) | 45,570,018 |
Beginning balance, shares at Dec. 31, 2021 | 88,290,650 | 5,710 | ||||
Net loss | (6,119,558) | (6,119,558) | ||||
Unrealized net gain (loss) on marketable investment securities | (66,891) | (66,891) | ||||
Stock-based compensation | 310,597 | 310,597 | ||||
Costs associated with ATM offering | (10,500) | (10,500) | ||||
Option exercises | $ 21 | 206,058 | 206,079 | |||
Option exercises, shares | 208,474 | |||||
Ending balance, value at Jun. 30, 2022 | $ 8,850 | $ (40,712) | 218,792,479 | (84,907) | (178,785,965) | 39,889,745 |
Ending balance, shares at Jun. 30, 2022 | 88,499,124 | 5,710 | ||||
Beginning balance, value at Mar. 31, 2022 | $ 8,850 | $ (40,712) | 218,663,319 | (67,416) | (176,154,188) | 42,409,853 |
Beginning balance, shares at Mar. 31, 2022 | 88,498,924 | 5,710 | ||||
Net loss | (2,631,777) | (2,631,777) | ||||
Unrealized net gain (loss) on marketable investment securities | (17,491) | (17,491) | ||||
Stock-based compensation | 139,569 | 139,569 | ||||
Costs associated with ATM offering | (10,500) | (10,500) | ||||
Option exercises | 91 | 91 | ||||
Option exercises, shares | 200 | |||||
Ending balance, value at Jun. 30, 2022 | $ 8,850 | $ (40,712) | $ 218,792,479 | $ (84,907) | $ (178,785,965) | $ 39,889,745 |
Ending balance, shares at Jun. 30, 2022 | 88,499,124 | 5,710 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (6,119,558) | $ (10,177,123) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation expense | 4,297 | |
Stock-based compensation expense | 310,597 | 294,313 |
Non-cash interest expense | 5,842 | 33,886 |
Non-cash gain on change in fair value of warrant liability | (205,457) | (26,257) |
Amortization of premium on marketable investment securities | 87,282 | 203,958 |
Changes in operating assets and liabilities: | ||
Accrued interest income | 166,842 | (232,177) |
Prepaid and other current assets | 910,919 | 378,078 |
Accounts payable | (475,338) | (690,744) |
Accrued expenses | (117,157) | (208,990) |
Litigation settlement liability | (1,250,000) | 4,000,000 |
Gain on extinguishment of litigation settlement liability | (250,000) | |
Cash used in operating activities | (6,931,731) | (6,425,056) |
Cash flows from investing activities: | ||
Purchase of fixed assets | (37,099) | |
Purchases of marketable investment securities | (22,681,441) | (35,876,211) |
Maturities of marketable investment securities | 33,802,000 | 450,000 |
Cash provided by (used in) investing activities | 11,083,460 | (35,426,211) |
Cash flows from financing activities: | ||
Debt repayments | (1,666,667) | (1,666,667) |
End of loan payment | (650,000) | |
Net proceeds from common stock offering | 26,840,457 | |
Proceeds from (costs associated with) ATM | (10,500) | 3,416,115 |
Proceeds from stock option exercises | 206,079 | 6,693 |
Net proceeds from exercise of warrants | 5,000 | |
Cash provided by (used in) financing activities | (2,121,088) | 28,601,598 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 2,030,641 | (13,249,669) |
Cash, cash equivalents, and restricted cash at beginning of period | 2,950,552 | 24,217,382 |
Cash, cash equivalents, and restricted cash at end of period | 4,981,193 | 10,967,713 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 21,256 | 92,515 |
Income taxes paid | 200 | 200 |
Supplemental disclosure of non-cash investing and financing activity: | ||
Settlement of warrant liability on warrant exercises | 18,365 | |
Net unrealized loss on available-for-sale securities | (66,891) | (186) |
Accrued final payment charge on debt | $ 5,842 | $ 33,886 |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | (1) Basis of Presentation The accompanying unaudited condensed consolidated financial statements included herein have been prepared by Lipocine Inc. (“Lipocine” or the “Company”) in accordance with the rules and regulations of the United States Securities and Exchange Commission (“SEC”). The unaudited condensed consolidated financial statements are comprised of the financial statements of Lipocine and its subsidiaries, collectively referred to as the Company. In management’s opinion, the interim financial data presented includes all adjustments (consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by U.S. generally accepted accounting principles (“U.S. GAAP”) has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2022. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021. The preparation of the unaudited condensed consolidated financial statements requires management to make estimates and assumptions relating to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with U.S. GAAP. Actual results could differ from these estimates. The Company believes that its existing capital resources, together with interest thereon, will be sufficient to meet its projected operating requirements through at least June 30, 2023 which includes an on-going clinical study for LPCN 1148 and compliance with regulatory requirements. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could utilize its available capital resources sooner than it currently expects if additional activities are performed by the Company including clinical studies for LPCN 1148, LPCN 1144, LPCN 1111, LPCN1107, LPCN 1154 and LPCN 2101. While the Company believes it has sufficient liquidity and capital resources to fund our projected operating requirements through at least June 30, 2023, the Company will need to raise additional capital at some point through the equity or debt markets or via out-licensing activities, before or after June 30, 2023, to support its operations. If the Company is unsuccessful in raising additional capital, its ability to continue as a going concern may become a risk. Further, the Company’s operating plan may change, and the Company may need additional funds to meet operational needs and capital requirements for product development, regulatory compliance and clinical trial activities sooner than planned. In addition, the Company’s capital resources may be consumed more rapidly if it pursues additional clinical studies for LPCN 1148, LPCN 1144, LPCN 1111, LPCN 1107, LPCN 1154 and LPCN 2101. Conversely, the Company’s capital resources could last longer if it reduces expenses, reduces the number of activities currently contemplated under our operating plan, terminates, modifies the design or suspends on-going clinical studies or terminates or settles any on-going litigation activities. |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | (2) Revenue The Company generates most of its revenue from license and royalty arrangements. At inception of each contract, the Company identifies the goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company 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. See Note 8 for a description of the license agreement with Antares Pharma, Inc. (“Antares”). See Note 12 for a description of the agreement with Spriaso. License Fees Royalties Contract Assets. 235,000 Revenue Concentration. 10 % of the Company’s total revenues. The Company recognized license revenue of $ 500,000 zero 100 |
Earnings (Loss) per Share
Earnings (Loss) per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Earnings (Loss) per Share | (3) 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. The following table sets forth the computation of basic and diluted earnings (loss) per share of common stock for the three and six months ended June 30, 2022 and 2021: Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock 2022 2021 2022 2021 Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Basic loss per share attributable to common stock: Numerator Net loss $ (2,631,777 ) $ (6,809,041 ) $ (6,119,558 ) $ (10,177,123 ) Denominator Weighted avg. common shares outstanding 88,499,067 88,290,650 88,404,999 85,556,110 Basic loss per share attributable to common stock $ (0.03 ) $ (0.08 ) $ (0.07 ) $ (0.12 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (2,631,777 ) $ (6,809,041 ) $ (6,119,558 ) $ (10,177,123 ) Effect of dilutive securities on net loss: Common stock warrants 583,445 221,322 205,457 26,257 Total net loss for purpose of calculating diluted net loss per common share $ (3,215,222 ) $ (7,030,363 ) $ (6,325,015 ) $ (10,203,380 ) Denominator Weighted avg. common shares outstanding 88,499,067 88,290,650 88,404,999 85,556,110 Weighted average effect of dilutive securities: Common stock warrants 499,448 697,642 582,801 738,825 Total shares for purpose of calculating diluted net loss per common share 88,998,515 88,988,292 88,987,800 86,294,935 Diluted loss per share attributable to common stock $ (0.04 ) $ (0.08 ) $ (0.07 ) $ (0.12 ) The computation of diluted loss per share for the three and six months ended June 30, 2022 and 2021 does not include the following stock options and warrants to purchase shares of common stock in the computation of diluted loss per share because these instruments were antidilutive: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share June 30, 2022 2021 Stock options 4,026,882 3,915,790 Warrants 840,336 840,336 |
Marketable Investment Securitie
Marketable Investment Securities | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Investment Securities | (4) Marketable Investment Securities The Company has classified its marketable investment securities as available-for-sale securities, all of which are debt securities. These securities are carried at fair value with unrealized holding gains and losses, net of the related tax effect, included in accumulated other comprehensive income (loss) in stockholders’ equity until realized. Gains and losses on investment security transactions are reported on the specific-identification method. Dividend income is recognized on the ex-dividend date and interest income is recognized on an accrual basis. The amortized cost, gross unrealized holding gains, gross unrealized holding losses, and fair value for available-for-sale securities by major security type and class of security at June 30, 2022 and December 31, 2021 were as follows: Schedule of Available-for-Sale Securities June 30, 2022 Amortized Cost Gross unrealized holding gains Gross unrealized holding losses Aggregate fair value Government treasury bills $ 9,514,989 $ - $ (50,974 ) $ 9,464,015 Corporate bonds, notes and commercial paper 22,984,391 - (33,933 ) 22,950,458 $ 32,499,380 $ - $ (84,907 ) $ 32,414,473 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 Commercial paper 38,181,099 - (7,814 ) 38,173,285 $ 43,707,221 $ - $ (18,016 ) $ 43,689,205 Maturities of debt securities classified as available-for-sale securities at June 30, 2022 are as follows: Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities June 30, 2022 Amortized Cost Aggregate fair value Due within one year $ 32,499,380 $ 32,414,473 $ 32,499,380 $ 32,414,473 There were no no 8.6 0 33.8 450,000 no |
Fair Value
Fair Value | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value | (5) Fair Value The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: ● Level 1 Inputs: Quoted prices for identical instruments in active markets. ● Level 2 Inputs: Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-derived valuation in which all significant inputs and significant value drivers are observable in active markets. ● Level 3 Inputs: Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. 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 June 30, 2022 and December 31, 2021: Schedule of Fair Value, Assets Measured on Recurring Basis Fair value measurements at reporting date using June 30, 2022 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 4,753,610 $ 4,753,610 $ - $ - Government treasury bills 9,464,015 9,464,015 - - Commercial paper 17,157,364 - 17,157,364 - Corporate bonds and notes 5,793,094 - 5,793,094 - $ 37,168,083 $ 14,217,625 $ 22,950,458 $ - Liabilities: Warrant liability $ 590,339 - - 590,339 $ 37,758,422 $ 14,217,625 $ 22,950,458 $ 590,339 Fair value measurements at reporting date using December 31, 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 The following methods and assumptions were used to determine the fair value of each class of assets and liabilities recorded at fair value in the balance sheets: Cash equivalents: Cash equivalents primarily consist of highly-rated money market funds and treasury bills with original maturities to the Company of three months or less and are purchased daily at par value with specified yield rates. Cash equivalents related to money market funds and treasury bills are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices or broker or dealer quotations for similar assets. Government treasury bills: The Company uses a third-party pricing service to value these investments. United States treasury bills are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets for identical assets and reportable trades. 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 June 30, 2022, include (i) volatility of 100.0 2.99 0.50 0.80 2.38 100.0 0.97 0.50 0.99 2.88 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 three and six months ended June 30, 2022. |
Loan and Security Agreements an
Loan and Security Agreements and Other Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Loan and Security Agreements and Other Liabilities | (6) Loan and Security Agreements and Other Liabilities Silicon Valley Bank Loan On January 5, 2018, the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Silicon Valley Bank (“SVB”) pursuant to which SVB agreed to lend the Company $ 10.0 The principal borrowed under the Loan and Security Agreement bore interest at a rate equal to the Prime Rate, as reported in the money rates section of The Wall Street Journal or any successor publication representing the rate of interest per annum then in effect, plus one percent per annum, which interest was payable monthly. June 1, 2022 650,000 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (7) Income Taxes The tax provision for interim periods is determined using an estimate of the Company’s effective tax rate for the full year adjusted for discrete items, if any, that are taken into account in the relevant period. Each quarter the Company updates its estimate of the annual effective tax rate, and if the estimated tax rate changes, the Company makes a cumulative adjustment. At June 30, 2022 and December 31, 2021, the Company had a full valuation allowance against its deferred tax assets, net of expected reversals of existing deferred tax liabilities, as it believes it is more likely than not that these benefits will not be realized. |
Contractual Agreements
Contractual Agreements | 6 Months Ended |
Jun. 30, 2022 | |
Health Care Organizations [Abstract] | |
Contractual Agreements | (8) 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 17,000 (b) Antares Pharma, Inc. On October 14, 2021, the Company entered into a license agreement (“License Agreement”) with Antares Pharma, Inc. (“Antares”) pursuant to which the Company granted to Antares an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize, upon final approval of TLANDO® from the U.S. Food and Drug Administration (“FDA”), the Company’s TLANDO product with respect to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, as indicated in NDA No. 208088, treatment of Klinefelter syndrome, and pediatric indications relating to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (the “Field”), in each case within the United States. The Antares License Agreement also provided Antares with an option, exercisable on or before March 31, 2022, to license TLANDO XR (LPCN 1111), the Company’s potential once-daily oral product candidate for testosterone replacement therapy. On April 1, 2022, the Company entered into the First Amendment to the License Agreement (the “Amendment”), pursuant to which the License Agreement was amended to extend the deadline by which Antares shall exercise its option to license TLANDO XR to June 30, 2022. As consideration for the Company agreeing to enter into the Amendment, in April 2022 Antares paid the Company a non-refundable cash fee of $ 500,000 11.0 5.0 160.0 20 500,000 zero On May 24, 2022, Halozyme Therapeutics completed an acquisition of Antares Pharma Inc. through the merger of a wholly owned subsidiary of Halozyme with and into Antares, with Antares continuing as the surviving corporation and becoming a wholly owned subsidiary of Halozyme. (c) Contract Research and Development The Company has entered into agreements with various contract organizations that conduct pre-clinical, clinical, analytical and manufacturing development work on behalf of the Company as well as a number of independent contractors and primarily clinical researchers who serve as advisors to the Company. The Company incurred expenses of $ 2.1 786,000 3.2 1.7 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases | |
Leases | (9) Leases The Company has a non-cancelable operating lease for office space and laboratory facilities in Salt Lake City, Utah. The term of the lease has been extended through February 28, 2023. Future minimum lease payments under non-cancelable operating leases as of June 30, 2022 are: Schedule of Future Minimum Rental Payments for Operating Leases Operating leases Year ending December 31: 2022 $ 171,819 2023 57,273 Total minimum lease payments $ 229,092 The Company’s rent expense was $ 86,000 83,000 170,000 165,000 |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity | (10) Stockholders’ Equity On June 8, 2022, at the 2022 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of the Company’s common stock, par value $ 0.0001 100,000,000 200,000,000 (a) Issuance of Common Stock On 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 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 June 30, 2022, the Company had sold an aggregate of 15,023,073 2.19 32.9 31.7 zero 1,811,238 1.95 3.4 112,000 41.2 (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 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) 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. The Company uses the Black-Scholes model to compute the estimated fair value of stock option awards. Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of the Company’s common stock price, (ii) the periods of time over which employees and members of the board of directors are expected to hold their options prior to exercise (expected term), (iii) expected dividend yield on the Common Stock, and (iv) risk-free interest rates. Stock-based compensation expense also includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Stock-based compensation cost that has been expensed in the statements of operations amounted to approximately $ 140,000 147,000 311,000 294,000 Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs Three Months Ended Six Months Ended 2022 2021 2022 2021 Research and development $ 63,021 $ 69,483 $ 142,673 $ 136,369 General and administrative 76,548 77,264 167,924 157,944 $ 139,569 $ 146,747 $ 310,597 $ 294,313 The Company issued 171,500 504,000 66,000 376,000 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 For options granted during the six months ended June 30, 2022 and 2021, 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 2022 2021 Expected term 5.77 5.70 Risk-free interest rate 1.93 % 0.52 % Expected dividend yield — — Expected volatility 101.67 % 95.52 % FASB ASC 718, Stock Compensation, As of June 30, 2022, there was $ 1.1 2.0 (d) Stock Option Plan In April 2014, the board of directors adopted the 2014 Stock and Incentive Plan (“2014 Plan”) subject to shareholder approval which was received in June 2014. The 2014 Plan provides for the granting of nonqualified and incentive stock options, stock appreciation rights, restricted stock units, restricted stock and dividend equivalents. An aggregate of 1,000,000 271,906 1,271,906 2,471,906 2,471,906 3,221,906 3,221,906 5,721,906 ten 5,721,906 1,265,308 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, 2021 4,551,205 $ 2.82 Options granted 504,000 1.06 Options exercised (208,474 ) 0.99 Options forfeited (488,747 ) 1.16 Options cancelled (331,102 ) 5.69 Balance at June 30, 2022 4,026,882 2.65 Options exercisable at June 30, 2022 2,629,346 3.47 The following table summarizes information about stock options outstanding and exercisable at June 30, 2022: 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 4,026,882 6.26 $ 2.65 $ 152,241 2,629,346 4.72 $ 3.47 $ 123,331 The intrinsic value for stock options is defined as the difference between the current market value and the exercise price. There were 200 208,474 zero 4,584 (e) Common Stock Warrants The Company accounts for its common stock warrants under ASC 480, Distinguishing Liabilities from Equity As of June 30, 2022, the Company had 1,094,030 Schedule of Fair Value of Warrants June 30, 2022 December 31, 2021 Expected life in years 2.38 2.88 Risk-free interest rate 2.99 % 0.97 % Dividend yield — — Volatility 100.00 % 100.00 % Stock price $ 0.80 $ 0.99 During the three and six months ended June 30, 2022, the Company recorded a non-cash gain of $ 583,445 205,457 221,000 26,000 Schedule of Reconciliation of Warrant Liability Warrant Liability Balance at December 31, 2021 $ 795,796 Settlement of liability on warrant exercise - Change in fair value of common stock warrants (205,457 ) Balance at June 30, 2022 $ 590,339 Additionally, in the February 2020 Offering, the Company issued 5,042,017 840,336 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, 2021 1,934,366 $ 0.51 Issued - - Exercised - - Expired - - Cancelled - - Forfeited - - Balance at June 30, 2022 1,934,366 $ 0.51 During the three and six months ended June 30, 2022, no zero 10,000 5,000 The following table summarizes information about common stock warrants outstanding at June 30, 2022: Warrants outstanding Number exercisable Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value 1,934,366 2.50 $ 0.51 $ 555,100 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
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 has answered the complaint and asserted counterclaims of non-infringement, inequitable conduct 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 counterclaims before the Court. On July 13, 2021, Clarus and the Company entered into a global settlement agreement (“Global Agreement’) which resolved all outstanding claims of this litigation as well as the on-going United States Patent and Trademark Office (“USPTO”) Interference No. 106,128 between the parties. Under the terms of the Global Agreement, the Company agreed to pay Clarus $ 4.0 2.5 1.0 500,000 1,250,000 On November 14, 2019, the Company and certain of its officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v. Lipocine Inc. et al 1.25 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, Lipocine 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 the Company’s 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 the Company was 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, Clarus and the Company entered into the Global Agreement 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., 2:19-cv-00906-PM matter, management does not currently believe that any other matter, individually or in the aggregate, will have a material adverse effect on our financial condition, liquidity or results of operations. Guarantees and Indemnifications In the ordinary course of business, the Company enters into agreements, such as lease agreements, licensing agreements, clinical trial agreements, and certain services agreements, containing standard guarantee and / or indemnification provisions. Additionally, the Company has indemnified its directors and officers to the maximum extent permitted under the laws of the State of Delaware. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | (12) Related Party Transactions Spriaso, LLC Service Agreement The Company has a license and a services agreement with Spriaso, LLC (“Spriaso”), a related-party that is majority-owned by certain current and former directors of Lipocine Inc. and their affiliates. Under the license agreement, the Company assigned and transferred to Spriaso all of the Company’s rights, title and interest in its intellectual property to develop products for the cough and cold field. In addition, Spriaso received all rights and obligations under the Company’s product development agreement with a third-party. In exchange, the Company will receive a royalty of 20 percent of the net proceeds received by Spriaso, up to a maximum of $ 10.0 million. Spriaso also granted back to the Company an exclusive license to such intellectual property to develop products outside of the cough and cold field. The Company also agreed to continue providing up to 10 percent of the services of certain employees to Spriaso for a period of time. The agreement to provide services expired in 2021; however, it may be extended upon written agreement of Spriaso and the Company. The Company did not receive any reimbursements from Spriaso for the three and six months ended June 30, 2022 and 2021, respectively. Additionally, during the three and six months ended June 30, 2022 and 2021, the Company did not receive any royalty revenue from Spriaso. Spriaso filed its first NDA and as an affiliated entity of the Company, and used up the one-time waiver for user fees for a small business submitting its first new drug application to the FDA. Spriaso is considered a variable interest entity under the FASB ASC Topic 810-10, Consolidations |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Changes and Error Corrections [Abstract] | |
Recent Accounting Pronouncements | (13) Recent 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 . |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
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 three and six months ended June 30, 2022 and 2021: Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock 2022 2021 2022 2021 Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Basic loss per share attributable to common stock: Numerator Net loss $ (2,631,777 ) $ (6,809,041 ) $ (6,119,558 ) $ (10,177,123 ) Denominator Weighted avg. common shares outstanding 88,499,067 88,290,650 88,404,999 85,556,110 Basic loss per share attributable to common stock $ (0.03 ) $ (0.08 ) $ (0.07 ) $ (0.12 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (2,631,777 ) $ (6,809,041 ) $ (6,119,558 ) $ (10,177,123 ) Effect of dilutive securities on net loss: Common stock warrants 583,445 221,322 205,457 26,257 Total net loss for purpose of calculating diluted net loss per common share $ (3,215,222 ) $ (7,030,363 ) $ (6,325,015 ) $ (10,203,380 ) Denominator Weighted avg. common shares outstanding 88,499,067 88,290,650 88,404,999 85,556,110 Weighted average effect of dilutive securities: Common stock warrants 499,448 697,642 582,801 738,825 Total shares for purpose of calculating diluted net loss per common share 88,998,515 88,988,292 88,987,800 86,294,935 Diluted loss per share attributable to common stock $ (0.04 ) $ (0.08 ) $ (0.07 ) $ (0.12 ) |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | The computation of diluted loss per share for the three and six months ended June 30, 2022 and 2021 does not include the following stock options and warrants to purchase shares of common stock in the computation of diluted loss per share because these instruments were antidilutive: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share June 30, 2022 2021 Stock options 4,026,882 3,915,790 Warrants 840,336 840,336 |
Marketable Investment Securit_2
Marketable Investment Securities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-Sale Securities | Schedule of Available-for-Sale Securities June 30, 2022 Amortized Cost Gross unrealized holding gains Gross unrealized holding losses Aggregate fair value Government treasury bills $ 9,514,989 $ - $ (50,974 ) $ 9,464,015 Corporate bonds, notes and commercial paper 22,984,391 - (33,933 ) 22,950,458 $ 32,499,380 $ - $ (84,907 ) $ 32,414,473 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 Commercial paper 38,181,099 - (7,814 ) 38,173,285 $ 43,707,221 $ - $ (18,016 ) $ 43,689,205 |
Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities | Maturities of debt securities classified as available-for-sale securities at June 30, 2022 are as follows: Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities June 30, 2022 Amortized Cost Aggregate fair value Due within one year $ 32,499,380 $ 32,414,473 $ 32,499,380 $ 32,414,473 |
Fair Value (Tables)
Fair Value (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets Measured on Recurring Basis | Schedule of Fair Value, Assets Measured on Recurring Basis Fair value measurements at reporting date using June 30, 2022 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 4,753,610 $ 4,753,610 $ - $ - Government treasury bills 9,464,015 9,464,015 - - Commercial paper 17,157,364 - 17,157,364 - Corporate bonds and notes 5,793,094 - 5,793,094 - $ 37,168,083 $ 14,217,625 $ 22,950,458 $ - Liabilities: Warrant liability $ 590,339 - - 590,339 $ 37,758,422 $ 14,217,625 $ 22,950,458 $ 590,339 Fair value measurements at reporting date using December 31, 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 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases | |
Schedule of Future Minimum Rental Payments for Operating Leases | Future minimum lease payments under non-cancelable operating leases as of June 30, 2022 are: Schedule of Future Minimum Rental Payments for Operating Leases Operating leases Year ending December 31: 2022 $ 171,819 2023 57,273 Total minimum lease payments $ 229,092 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs Three Months Ended Six Months Ended 2022 2021 2022 2021 Research and development $ 63,021 $ 69,483 $ 142,673 $ 136,369 General and administrative 76,548 77,264 167,924 157,944 $ 139,569 $ 146,747 $ 310,597 $ 294,313 |
Schedule of Key Assumption of Fair Value of Stock Options Granted | For options granted during the six months ended June 30, 2022 and 2021, 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 2022 2021 Expected term 5.77 5.70 Risk-free interest rate 1.93 % 0.52 % Expected dividend yield — — Expected volatility 101.67 % 95.52 % |
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, 2021 4,551,205 $ 2.82 Options granted 504,000 1.06 Options exercised (208,474 ) 0.99 Options forfeited (488,747 ) 1.16 Options cancelled (331,102 ) 5.69 Balance at June 30, 2022 4,026,882 2.65 Options exercisable at June 30, 2022 2,629,346 3.47 |
Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable | The following table summarizes information about stock options outstanding and exercisable at June 30, 2022: 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 4,026,882 6.26 $ 2.65 $ 152,241 2,629,346 4.72 $ 3.47 $ 123,331 Warrants outstanding Number exercisable Weighted average remaining contractual life (Years) Weighted average exercise price Aggregate intrinsic value 1,934,366 2.50 $ 0.51 $ 555,100 |
Schedule of Fair Value of Warrants | Schedule of Fair Value of Warrants June 30, 2022 December 31, 2021 Expected life in years 2.38 2.88 Risk-free interest rate 2.99 % 0.97 % Dividend yield — — Volatility 100.00 % 100.00 % Stock price $ 0.80 $ 0.99 |
Schedule of Reconciliation of Warrant Liability | Schedule of Reconciliation of Warrant Liability Warrant Liability Balance at December 31, 2021 $ 795,796 Settlement of liability on warrant exercise - Change in fair value of common stock warrants (205,457 ) Balance at June 30, 2022 $ 590,339 |
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, 2021 1,934,366 $ 0.51 Issued - - Exercised - - Expired - - Cancelled - - Forfeited - - Balance at June 30, 2022 1,934,366 $ 0.51 |
Revenue (Details Narrative)
Revenue (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Research revenue | $ 500,000 | $ 500,000 | ||
Major Customer [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Concentration Risk, Percentage | 10% | |||
Antares [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Concentration Risk, Percentage | 100% | |||
License Agreement [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Payments for royalty | $ 235,000 | |||
Research revenue | $ 500,000 | $ 0 | $ 500,000 | $ 0 |
Schedule of Computation of Basi
Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (2,631,777) | $ (6,809,041) | $ (6,119,558) | $ (10,177,123) |
Weighted avg. common shares outstanding | 88,499,067 | 88,290,650 | 88,404,999 | 85,556,110 |
Basic loss per share attributable to common stock | $ (0.03) | $ (0.08) | $ (0.07) | $ (0.12) |
Common stock warrants | $ 583,445 | $ 221,322 | $ 205,457 | $ 26,257 |
Total net loss for purpose of calculating diluted net loss per common share | $ (3,215,222) | $ (7,030,363) | $ (6,325,015) | $ (10,203,380) |
Common stock warrants | 499,448 | 697,642 | 582,801 | 738,825 |
Total shares for purpose of calculating diluted net loss per common share | 88,998,515 | 88,988,292 | 88,987,800 | 86,294,935 |
Diluted loss per share attributable to common stock | $ (0.04) | $ (0.08) | $ (0.07) | $ (0.12) |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Warrant [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 840,336 | 840,336 |
Share-Based Payment Arrangement, Option [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 4,026,882 | 3,915,790 |
Schedule of Available-for-Sale
Schedule of Available-for-Sale Securities (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Marketable Securities [Line Items] | ||
Amortized cost | $ 32,499,380 | $ 43,707,221 |
Gross unrealized holding gains | ||
Gross unrealized holding losses | (84,907) | (18,016) |
Aggregate fair value | 32,414,473 | 43,689,205 |
US Treasury Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized cost | 9,514,989 | 5,526,122 |
Gross unrealized holding gains | ||
Gross unrealized holding losses | (50,974) | (10,202) |
Aggregate fair value | 9,464,015 | 5,515,920 |
Corporate Bonds Notes and Commercial Paper [Member] | ||
Marketable Securities [Line Items] | ||
Amortized cost | 22,984,391 | 38,181,099 |
Gross unrealized holding gains | ||
Gross unrealized holding losses | (33,933) | (7,814) |
Aggregate fair value | $ 22,950,458 | $ 38,173,285 |
Schedule of Maturities of Debt
Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities (Details) | Jun. 30, 2022 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Due within one year, Amortized Cost | $ 32,499,380 |
Due within one year, Aggregate fair value | 32,414,473 |
Total maturities of debt securities classified as available-for-sale securities, amortized cost | 32,499,380 |
Total maturities of debt securities classified as available-for-sale securities, fair value | $ 32,414,473 |
Marketable Investment Securit_3
Marketable Investment Securities (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Proceeds from sale of Held-to-maturity securities | $ 0 | $ 0 | $ 0 | $ 0 |
Realized gain (loss) | 0 | 0 | 0 | 0 |
Matured marketable investment securities | 8,600,000 | 0 | 33,800,000 | 450,000 |
Other than temporary impairments | $ 0 | $ 0 | $ 0 | $ 0 |
Schedule of Fair Value, Assets
Schedule of Fair Value, Assets Measured on Recurring Basis (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | $ 37,168,083 | $ 45,778,956 |
Liabilities, fair value | 37,758,422 | 46,574,752 |
Corporate Bonds and Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 5,793,094 | 22,787,651 |
Warrant [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities, fair value | 590,339 | 795,796 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 14,217,625 | 7,605,671 |
Liabilities, fair value | 14,217,625 | 7,605,671 |
Fair Value, Inputs, Level 1 [Member] | Corporate Bonds and Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | ||
Fair Value, Inputs, Level 1 [Member] | Warrant [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities, fair value | ||
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 22,950,458 | 38,173,285 |
Liabilities, fair value | 22,950,458 | 38,173,285 |
Fair Value, Inputs, Level 2 [Member] | Corporate Bonds and Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 5,793,094 | 22,787,651 |
Fair Value, Inputs, Level 2 [Member] | Warrant [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities, fair value | ||
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | ||
Liabilities, fair value | 590,339 | 795,796 |
Fair Value, Inputs, Level 3 [Member] | Corporate Bonds and Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | ||
Fair Value, Inputs, Level 3 [Member] | Warrant [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities, fair value | 590,339 | 795,796 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 4,753,610 | 2,089,751 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 4,753,610 | 2,089,751 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | ||
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | ||
US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 9,464,015 | 5,515,920 |
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 9,464,015 | 5,515,920 |
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | ||
US Treasury Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | ||
Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 17,157,364 | 15,385,634 |
Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | ||
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 17,157,364 | 15,385,634 |
Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value |
Fair Value (Details Narrative)
Fair Value (Details Narrative) - $ / shares | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Expected volatility | 101.67% | 95.52% | |
Risk-free interest rate | 1.93% | 0.52% | |
Expected term | 5 years 9 months 7 days | 5 years 8 months 12 days | |
Warrant [Member] | |||
Expected volatility | 100% | 100% | |
Risk-free interest rate | 2.99% | 0.97% | |
Strike price | $ 0.50 | $ 0.50 | |
Fair value of common stock | $ 0.80 | $ 0.99 | |
Expected term | 2 years 4 months 17 days | 2 years 10 months 17 days |
Loan and Security Agreements _2
Loan and Security Agreements and Other Liabilities (Details Narrative) - Loan and Security Agreement [Member] - Silicon Valley Bank [Member] | Jan. 05, 2018 USD ($) |
Short-Term Debt [Line Items] | |
Aggregate amount | $ 10,000,000 |
Debt instrument description | The principal borrowed under the Loan and Security Agreement bore interest at a rate equal to the Prime Rate, as reported in the money rates section of The Wall Street Journal or any successor publication representing the rate of interest per annum then in effect, plus one percent per annum, which interest was payable monthly. |
Debt instrument, maturity date | Jun. 01, 2022 |
Debt instrument, balloon payment to be paid | $ 650,000 |
Contractual Agreements (Details
Contractual Agreements (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Oct. 14, 2021 | Mar. 29, 2012 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
ContractualAgreementsLineItems [Line Items] | ||||||
Revenue | $ 500,000 | $ 500,000 | ||||
Contract research and development expenses | 2,100,000 | 786,000 | 3,200,000 | 1,700,000 | ||
Collaborative Arrangement [Member] | Abbott Products Inc [Member] | ||||||
ContractualAgreementsLineItems [Line Items] | ||||||
Percentage of net sales | 1% | |||||
Royalties, commitment amount | $ 1,000,000 | |||||
Percentage of royalties reduction based upon product launch | 50% | |||||
Royalty expense | 17,000 | 17,000 | ||||
License Agreement [Member] | ||||||
ContractualAgreementsLineItems [Line Items] | ||||||
Cash fee | $ 500,000 | |||||
License fee | $ 11,000,000 | |||||
Percentage of royalty payment | 20% | |||||
Revenue | $ 500,000 | $ 0 | 500,000 | $ 0 | ||
License Agreement [Member] | Maximum [Member] | ||||||
ContractualAgreementsLineItems [Line Items] | ||||||
Sales milestone | $ 160,000,000 | |||||
License Agreement [Member] | January 1, 2025 [Member] | ||||||
ContractualAgreementsLineItems [Line Items] | ||||||
Payments will be made for license fees | 5,000,000 | |||||
License Agreement [Member] | January 1, 2026 [Member] | ||||||
ContractualAgreementsLineItems [Line Items] | ||||||
Payments will be made for license fees | $ 5,000,000 |
Schedule of Future Minimum Rent
Schedule of Future Minimum Rental Payments for Operating Leases (Details) | Jun. 30, 2022 USD ($) |
Leases | |
2022 | $ 171,819 |
2023 | 57,273 |
Total minimum lease payments | $ 229,092 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Leases | ||||
Rent expense | $ 86,000 | $ 83,000 | $ 170,000 | $ 165,000 |
Schedule of Employee Service Sh
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Allocated share based compensation expense | $ 139,569 | $ 146,747 | $ 310,597 | $ 294,313 |
Research and Development Expense [Member] | ||||
Allocated share based compensation expense | 63,021 | 69,483 | 142,673 | 136,369 |
General and Administrative Expense [Member] | ||||
Allocated share based compensation expense | $ 76,548 | $ 77,264 | $ 167,924 | $ 157,944 |
Schedule of Key Assumption of F
Schedule of Key Assumption of Fair Value of Stock Options Granted (Details) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Equity [Abstract] | ||
Expected term | 5 years 9 months 7 days | 5 years 8 months 12 days |
Risk-free interest rate | 1.93% | 0.52% |
Expected dividend yield | ||
Expected volatility | 101.67% | 95.52% |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Option Indexed to Issuer's Equity [Line Items] | ||||
Number of shares, Balance at end of the period (in shares) | 4,026,882 | 4,026,882 | ||
Weighted average exercise price, Balance at end of the period (in dollars per share) | $ 2.65 | $ 2.65 | ||
Number of shares, Options exercisable (in shares) | 2,629,346 | 2,629,346 | ||
Weighted average exercise price, Options exercisable (in dollars per share) | $ 3.47 | $ 3.47 | ||
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) | 4,551,205 | |||
Weighted average exercise price, Balance at beginning of the period (in dollars per share) | $ 2.82 | |||
Number of shares, Options granted (in shares) | 171,500 | 66,000 | 504,000 | 376,000 |
Weighted average exercise price, Options granted (in dollars per share) | $ 1.06 | |||
Number of shares, Options exercised (in shares) | (200) | 0 | (208,474) | (4,584) |
Weighted average exercise price, Options exercised (in dollars per share) | $ 0.99 | |||
Number of shares, Options forfeited (in shares) | (488,747) | |||
Weighted average exercise price, Options forfeited (in dollars per share) | $ 1.16 | |||
Number of shares, Options cancelled (in shares) | (331,102) | |||
Weighted average exercise price, Options cancelled (in dollars per share) | $ 5.69 | |||
Number of shares, Balance at end of the period (in shares) | 4,026,882 | 4,026,882 | ||
Weighted average exercise price, Balance at end of the period (in dollars per share) | $ 2.65 | $ 2.65 | ||
Number of shares, Options exercisable (in shares) | 2,629,346 | 2,629,346 | ||
Weighted average exercise price, Options exercisable (in dollars per share) | $ 3.47 | $ 3.47 |
Schedule of Share-based Compens
Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of options outstanding, shares | 4,026,882 | |
Options outstanding, Weighted average remaining contractual life (Years) | 6 years 3 months 3 days | |
Options outstanding, Weighted average exercise price (in dollars per share) | $ 2.65 | |
Options outstanding, Aggregate intrinsic value | $ 152,241 | |
Number of options exercisable | 2,629,346 | |
Options exercisable, Weighted average remaining contractual life (Years) | 4 years 8 months 19 days | |
Options exercisable, Weighted average exercise price | $ 3.47 | |
Options exercisable, Aggregate intrinsic value | $ 123,331 | |
Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of warrants exercisable, shares | 1,934,366 | 1,934,366 |
Weighted average remaining contractual life | 2 years 6 months | |
Weighted average exercise price, per share | $ 0.51 | $ 0.51 |
Aggregate intrinsic value | $ 555,100 |
Schedule of Fair Value of Warra
Schedule of Fair Value of Warrants (Details) - $ / shares | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | |||
Expected life in years | 5 years 9 months 7 days | 5 years 8 months 12 days | |
Risk-free interest rate | 1.93% | 0.52% | |
Dividend yield | |||
Volatility | 101.67% | 95.52% | |
Warrant [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Expected life in years | 2 years 4 months 17 days | 2 years 10 months 17 days | |
Risk-free interest rate | 2.99% | 0.97% | |
Volatility | 100% | 100% | |
Stock price | $ 0.80 | $ 0.99 | |
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Warrant [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Expected life in years | 2 years 4 months 17 days | 2 years 10 months 17 days | |
Risk-free interest rate | 2.99% | 0.97% | |
Dividend yield | |||
Volatility | 100% | 100% | |
Stock price | $ 0.80 | $ 0.99 |
Schedule of Reconciliation of W
Schedule of Reconciliation of Warrant Liability (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Equity [Abstract] | ||
Balance at December 31, 2021 | $ 795,796 | |
Settlement of liability on warrant exercise | ||
Change in fair value of common stock warrants | (205,457) | $ (26,257) |
Balance at June 30, 2022 | $ 590,339 |
Schedule of Number of Warrants
Schedule of Number of Warrants Outstanding and the Weighted Average Exercise Price (Details) - Warrant [Member] | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
Warrants Outstanding, Beginning | shares | 1,934,366 |
Weighted Average Exercise Price, Outstanding, Beginning | $ / shares | $ 0.51 |
Warrants, Issued | shares | |
Weighted Average Exercise Price, Issued | $ / shares | |
Warrants, Exercised | shares | |
Weighted Average Exercise Price, Exercised | $ / shares | |
Warrants, Expired | shares | |
Weighted Average Exercise Price, Expired | $ / shares | |
Warrants, Cancelled | shares | |
Weighted Average Exercise Price, Cancelled | $ / shares | |
Warrants, Forfeited | shares | |
Weighted Average Exercise Price, Forfeited | $ / shares | |
Warrants Outstanding, Ending | shares | 1,934,366 |
Weighted Average Exercise Price, Outstanding, Ending | $ / shares | $ 0.51 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||||||||||
Jan. 28, 2021 | Feb. 27, 2020 | Nov. 18, 2019 | Mar. 06, 2017 | Nov. 13, 2015 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 08, 2022 | Jun. 07, 2022 | Dec. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2018 | Jun. 30, 2016 | Apr. 30, 2014 | |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | |||||||||||||
Warrants exercise price | $ 0.50 | |||||||||||||||
Fair value of shares issued during the period | $ 3,416,115 | |||||||||||||||
Net proceeds from common stock offering | 26,840,457 | |||||||||||||||
Class of warrant or right, redemption price of warrants or rights | $ 63.96 | $ 0.001 | ||||||||||||||
Stock-based compensation expense | $ 139,569 | $ 146,747 | $ 310,597 | 294,313 | ||||||||||||
Unrecognized compensation cost | 1,100,000 | $ 1,100,000 | ||||||||||||||
Share based payment arrangement, nonvested award, cost not yet recognized, period for recognition | 2 years | |||||||||||||||
Non-cash loss on change in fair value of warrant liability | $ (205,457) | (26,257) | ||||||||||||||
Warrants outstanding | $ 590,339 | 590,339 | $ 795,796 | |||||||||||||
Net proceeds from exercise of warrants | $ 5,000 | |||||||||||||||
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 | 5,721,906 | 1,000,000 | |||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 1,265,308 | 1,265,308 | ||||||||||||||
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 | |||||||||||||||
Share-Based Payment Arrangement, Option [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Share-based compensation arrangement by share-based payment award, options issued | 171,500 | 66,000 | 504,000 | 376,000 | ||||||||||||
Option exercises, shares | 200 | 0 | 208,474 | 4,584 | ||||||||||||
Sales Agreement [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Percentage of gross proceeds on sale of shares | 3% | |||||||||||||||
Sales Agreement [Member] | Cantor [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Fair value of shares issued during the period | $ 50,000,000 | |||||||||||||||
Warrant [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Issued | ||||||||||||||||
Exercised | ||||||||||||||||
Net proceeds from exercise of warrants | $ 5,000 | |||||||||||||||
January 2021 Offering [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Proceeds from issuance of common stock, gross | $ 28,700,000 | |||||||||||||||
Agent fees and other offering expenses | $ 1,900,000 | |||||||||||||||
Stock issued during period, shares, new issues | 16,428,571 | |||||||||||||||
February 2020 Offering [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Proceeds from issuance of common stock, gross | $ 6,000,000 | |||||||||||||||
Agent fees and other offering expenses | $ 347,000 | |||||||||||||||
Issued | 5,042,017 | |||||||||||||||
Warrants outstanding | $ 840,336 | $ 840,336 | ||||||||||||||
Exercised | 0 | 0 | 0 | 10,000 | ||||||||||||
February 2020 Offering [Member] | Class A Unit [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Stock issued during period, shares, new issues | 10,084,034 | |||||||||||||||
Shares issued, price per share | $ 0.595 | |||||||||||||||
February 2020 Offering [Member] | Common Stock [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Warrants exercise price | $ 0.53 | |||||||||||||||
November 2019 Offering [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Proceeds from issuance of common stock, gross | $ 6,000,000 | |||||||||||||||
Agent fees and other offering expenses | 404,000 | |||||||||||||||
Warrants outstanding | 1,094,030 | 1,094,030 | ||||||||||||||
Non-cash loss on change in fair value of warrant liability | $ 583,445 | $ 221,000 | $ 205,457 | $ 26,000 | ||||||||||||
November 2019 Offering [Member] | Warrant [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Fair value of shares issued during the period | $ 4,800,000 | |||||||||||||||
November 2019 Offering [Member] | Class A Unit [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Stock issued during period, shares, new issues | 10,450,000 | |||||||||||||||
Shares issued, price per share | $ 0.50 | |||||||||||||||
November 2019 Offering [Member] | Class B Units [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Stock issued during period, shares, new issues | 1,550,000 | |||||||||||||||
Shares issued, price per share | $ 0.4999 | |||||||||||||||
November 2019 Offering [Member] | Pre Funded Warrants [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Warrants exercise price | $ 0.0001 | |||||||||||||||
November 2019 Offering [Member] | Common Stock and Additional Paid in Capital [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Fair value of shares issued during the period | $ 768,000 | |||||||||||||||
At Market Offering [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Proceeds from issuance of common stock, gross | $ 32,900,000 | |||||||||||||||
Stock issued during period, shares, new issues | 15,023,073 | |||||||||||||||
Shares issued, price per share | $ 2.19 | $ 2.19 | ||||||||||||||
Net proceeds from common stock offering | $ 31,700,000 | |||||||||||||||
At Market Offering [Member] | Sales Agreement [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Proceeds from issuance of common stock, gross | $ 3,400,000 | |||||||||||||||
Stock issued during period, shares, new issues | 0 | 1,811,238 | ||||||||||||||
Shares issued, price per share | $ 1.95 | $ 1.95 | ||||||||||||||
Net proceeds from common stock offering | $ 112,000 | |||||||||||||||
Accredited Investors [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Proceeds from issuance of common stock, gross | $ 41,200,000 | |||||||||||||||
Revision of Prior Period, Adjustment [Member] | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Common stock, par value | $ 0.0001 | |||||||||||||||
Common stock, shares authorized | 200,000,000 | 100,000,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | 6 Months Ended | ||||||
Jul. 13, 2023 | Jul. 13, 2022 | Apr. 29, 2022 | Apr. 02, 2019 | Jun. 30, 2022 | Jun. 30, 2021 | Nov. 14, 2019 | |
Litigation settlement | $ 250,000 | ||||||
Retention payable | $ 1,250,000 | ||||||
Global Agreement [Member] | May 2022 [Member] | |||||||
Litigation settlement | $ 1,250,000 | ||||||
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | |||||||
Litigation settlement | $ 4,000,000 | ||||||
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | Forecast [Member] | |||||||
Litigation settlement | $ 500,000 | ||||||
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | Subsequent Event [Member] | |||||||
Litigation settlement | $ 1,000,000 | ||||||
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | Immediately [Member] | |||||||
Litigation settlement | $ 2,500,000 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - License and Service Agreement [Member] - Spriaso LLC [Member] $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Percentage of royalty | 20% |
Proceeds from Contributions from Affiliates | $ 10 |
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; |