Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 08, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-36357 | |
Entity Registrant Name | LIPOCINE INC. | |
Entity Central Index Key | 0001535955 | |
Entity Tax Identification Number | 99-0370688 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 675 Arapeen Drive | |
Entity Address, Address Line Two | Suite 202 | |
Entity Address, City or Town | Salt Lake City | |
Entity Address, State or Province | UT | |
Entity Address, Postal Zip Code | 84108 | |
City Area Code | 801 | |
Local Phone Number | 994-7383 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | LPCN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 5,315,830 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 5,014,695 | $ 3,148,496 |
Marketable investment securities | 20,775,275 | 29,381,410 |
Accrued interest income | 24,230 | 80,427 |
Contract asset - current portion | 579,428 | 579,428 |
Prepaid and other current assets | 690,900 | 945,319 |
Total current assets | 27,084,528 | 34,135,080 |
Contract asset - non-current portion | 3,252,500 | 3,252,500 |
Property and equipment, net of accumulated depreciation of $1,166,441 and $1,153,530 respectively | 122,679 | 131,589 |
Other assets | 23,753 | 23,753 |
Total assets | 30,483,460 | 37,542,922 |
Current liabilities: | ||
Accounts payable | 517,587 | 600,388 |
Accrued expenses | 1,309,595 | 1,077,738 |
Total current liabilities | 1,827,182 | 1,678,126 |
Warrant liability | 104,267 | 229,856 |
Total liabilities | 1,931,449 | 1,907,982 |
Commitments and contingencies (notes 6, 8, 9 and 11) | ||
Stockholders’ equity: | ||
Common stock, par value $0.0001 per share, 200,000,000 shares authorized; 5,235,166 issued and 5,234,830 outstanding | 8,852 | 8,852 |
Additional paid-in capital | 219,443,674 | 219,112,164 |
Treasury stock at cost, 336 shares | (40,712) | (40,712) |
Accumulated other comprehensive loss | (15,812) | (20,321) |
Accumulated deficit | (190,843,991) | (183,425,043) |
Total stockholders’ equity | 28,552,011 | 35,634,940 |
Total liabilities and stockholders’ equity | $ 30,483,460 | $ 37,542,922 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Accumulated depreciation | $ 1,166,441 | $ 1,153,530 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 5,235,166 | 5,235,166 |
Common stock, shares outstanding | 5,234,830 | 5,234,830 |
Treasury stock, shares | 336 | 336 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Statement [Abstract] | ||||
Revenues: | $ 500,000 | $ 54,990 | $ 500,000 | |
Operating expenses: | ||||
Research and development | 2,515,211 | 2,898,012 | 5,621,521 | 4,785,965 |
General and administrative | 1,440,394 | 1,129,519 | 2,727,708 | 2,373,205 |
Total operating expenses | 3,955,605 | 4,027,531 | 8,349,229 | 7,159,170 |
Operating loss | (3,955,605) | (3,527,531) | (8,294,239) | (6,659,170) |
Other income (expense): | ||||
Interest and investment income | 379,521 | 69,877 | 749,991 | 111,453 |
Interest expense | (7,568) | (27,098) | ||
Unrealized gain on warrant liability | 27,455 | 583,445 | 125,589 | 205,457 |
Gain on litigation settlement liability | 250,000 | 250,000 | ||
Total other income, net | 406,976 | 895,754 | 875,580 | 539,812 |
Loss before income tax expense | (3,548,629) | (2,631,777) | (7,418,659) | (6,119,358) |
Income tax expense | (200) | (200) | ||
Net loss | (3,548,629) | (2,631,777) | (7,418,859) | (6,119,558) |
Issuance of Series B preferred stock dividend | (89) | |||
Net loss attributable to common shareholders | $ (3,548,629) | $ (2,631,777) | $ (7,418,948) | $ (6,119,558) |
Basic loss per share attributable to common stock | $ (0.68) | $ (0.50) | $ (1.42) | $ (1.17) |
Weighted average common shares outstanding, basic | 5,234,830 | 5,234,141 | 5,234,830 | 5,228,608 |
Diluted loss per share attributable to common stock | $ (0.68) | $ (0.61) | $ (1.44) | $ (1.20) |
Weighted average common shares outstanding, diluted | 5,234,830 | 5,263,389 | 5,234,830 | 5,262,993 |
Comprehensive loss: | ||||
Net unrealized gain (loss) on available-for-sale securities | $ (19,053) | $ (17,491) | $ 4,509 | $ (66,891) |
Comprehensive loss | $ (3,567,682) | $ (2,649,268) | $ (7,414,350) | $ (6,186,449) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) | Preferred Stock [Member] Series B Preferred Stock [Member] | Common Stock [Member] | Treasury Stock, Common [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balances at Dec. 31, 2021 | $ 8,829 | $ (40,712) | $ 218,286,324 | $ (18,016) | $ (172,666,407) | $ 45,570,018 | |
Balances, shares at Dec. 31, 2021 | 5,221,883 | 336 | |||||
Net loss | (6,119,558) | (6,119,558) | |||||
Unrealized net gain on marketable investment securities | (66,891) | (66,891) | |||||
Stock-based compensation | 310,597 | 310,597 | |||||
Option exercises | $ 21 | 206,058 | 206,079 | ||||
Option exercises, shares | 12,261 | ||||||
Costs associated with ATM Offering | (10,500) | (10,500) | |||||
Balances at Jun. 30, 2022 | $ 8,850 | $ (40,712) | 218,792,479 | (84,907) | (178,785,965) | 39,889,745 | |
Balances, shares at Jun. 30, 2022 | 5,234,144 | 336 | |||||
Balances at Mar. 31, 2022 | $ 8,850 | $ (40,712) | 218,663,319 | (67,416) | (176,154,188) | 42,409,853 | |
Balances, shares at Mar. 31, 2022 | 5,234,132 | 336 | |||||
Net loss | (2,631,777) | (2,631,777) | |||||
Unrealized net gain on marketable investment securities | (17,491) | (17,491) | |||||
Stock-based compensation | 139,569 | 139,569 | |||||
Option exercises | 91 | 91 | |||||
Option exercises, shares | 12 | ||||||
Costs associated with ATM Offering | (10,500) | (10,500) | |||||
Balances at Jun. 30, 2022 | $ 8,850 | $ (40,712) | 218,792,479 | (84,907) | (178,785,965) | 39,889,745 | |
Balances, shares at Jun. 30, 2022 | 5,234,144 | 336 | |||||
Balances at Dec. 31, 2022 | $ 8,852 | $ (40,712) | 219,112,164 | (20,321) | (183,425,043) | 35,634,940 | |
Balances, shares at Dec. 31, 2022 | 5,234,830 | 336 | |||||
Net loss | (7,418,859) | (7,418,859) | |||||
Unrealized net gain on marketable investment securities | 4,509 | 4,509 | |||||
Stock-based compensation | 342,637 | 342,637 | |||||
Costs associated with ATM Offering | (11,216) | (11,216) | |||||
Redemption of Series B preferred stock | $ (9) | 9 | |||||
Redemption of Series B preferred stock, shares | (88,511) | ||||||
Issuance of Series B preferred stock dividend | $ 9 | 80 | (89) | ||||
Issuance of Series B preferred stock dividend, shares | 88,511 | ||||||
Balances at Jun. 30, 2023 | $ 8,852 | $ (40,712) | 219,443,674 | (15,812) | (190,843,991) | 28,552,011 | |
Balances, shares at Jun. 30, 2023 | 5,234,830 | 336 | |||||
Balances at Mar. 31, 2023 | $ 9 | $ 8,852 | $ (40,712) | 219,284,000 | 3,241 | (187,295,362) | 31,960,028 |
Balances, shares at Mar. 31, 2023 | 88,511 | 5,234,830 | 336 | ||||
Net loss | (3,548,629) | (3,548,629) | |||||
Unrealized net gain on marketable investment securities | (19,053) | (19,053) | |||||
Stock-based compensation | 164,865 | 164,865 | |||||
Costs associated with ATM Offering | (5,200) | (5,200) | |||||
Redemption of Series B preferred stock | $ (9) | 9 | |||||
Redemption of Series B preferred stock, shares | (88,511) | ||||||
Balances at Jun. 30, 2023 | $ 8,852 | $ (40,712) | $ 219,443,674 | $ (15,812) | $ (190,843,991) | $ 28,552,011 | |
Balances, shares at Jun. 30, 2023 | 5,234,830 | 336 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (7,418,859) | $ (6,119,558) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation expense | 12,910 | 4,297 |
Stock-based compensation expense | 342,637 | 310,597 |
Non-cash interest expense | 5,842 | |
Non-cash gain on change in fair value of warrant liability | (125,589) | (205,457) |
Amortization of premium (discounts) on marketable investment securities | (508,425) | 87,282 |
Changes in operating assets and liabilities: | ||
Accrued interest income | 56,197 | 166,842 |
Prepaid and other current assets | 254,419 | 910,919 |
Accounts payable | (82,801) | (475,338) |
Accrued expenses | 231,857 | (117,157) |
Litigation settlement liability | (1,250,000) | |
Gain on extinguishment of litigation settlement liability | (250,000) | |
Cash used in operating activities | (7,237,654) | (6,931,731) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (4,000) | (37,099) |
Purchases of marketable investment securities | (8,780,931) | (22,681,441) |
Maturities of marketable investment securities | 17,900,000 | 33,802,000 |
Cash provided by investing activities | 9,115,069 | 11,083,460 |
Cash flows from financing activities: | ||
Debt repayments | (1,666,667) | |
End of loan payment | (650,000) | |
Costs associated with ATM Offering | (11,216) | (10,500) |
Proceeds from stock option exercises | 206,079 | |
Cash used in financing activities | (11,216) | (2,121,088) |
Net increase in cash and cash equivalents | 1,866,199 | 2,030,641 |
Cash and cash equivalents at beginning of period | 3,148,496 | 2,950,552 |
Cash and cash equivalents at end of period | 5,014,695 | 4,981,193 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 21,256 | |
Income taxes paid | 656 | 200 |
Supplemental disclosure of non-cash investing and financing activity: | ||
Net unrealized gain (loss) on available-for-sale securities | 4,509 | (66,891) |
Accrued final payment charge on debt | 5,842 | |
Issuance of Series B preferred stock dividend | $ 89 |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2023. 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, 2022. The preparation of the unaudited condensed consolidated financial statements requires management to make estimates and assumptions relating to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with U.S. GAAP. Actual results could differ from these estimates. The Company believes that its existing capital resources, together with interest thereon, will be sufficient to meet its projected operating requirements through at least August 10, 2024 which includes an on-going clinical study for LPCN 1148 in the management of decompensated cirrhosis, a confirmatory pivotal pharmacokinetic (“PK”) study for LPCN 1154 in Postpartum Depression (“PPD”), 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 1154, LPCN 1144 for non-cirrhotic non-alcoholic steatohepatitis (“NASH”), LPCN 1111 an oral TRT product with the potential for once daily dosing, LPCN 1107 for the prevention of recurrent preterm birth, and LPCN 2101 for epilepsy. While the Company believes it has sufficient liquidity and capital resources to fund our projected operating requirements through at least August 10, 2024, the Company will need to raise additional capital at some point through the equity or debt markets or via out-licensing activities to support its operations. If the Company is unsuccessful in raising additional capital, its ability to continue as a going concern will become a risk. Further, the Company’s operating plan may change, and the Company may need additional funds to meet operational needs and capital requirements for product development, regulatory compliance and clinical trial activities sooner than planned. In addition, the Company’s capital resources may be consumed more rapidly if it pursues additional clinical studies for LPCN 1148, LPCN 1144, LPCN 1111, LPCN 1107, LPCN 1154 and LPCN 2101. Conversely, the Company’s capital resources could last longer if the Company reduces expenses, reduces the number of activities currently contemplated under its operating plan, or terminates, modifies the design or suspends on-going clinical studies. On May 10, 2023, at the 2023 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split at a ratio not less than 1-for-5 and not more than 1-for-20, with the exact ratio to be set within that range at the discretion of the Company’s board of directors (the “Board”) without further approval or authorization from our stockholders in order to achieve a minimum bid price of $1.00 per share for a minimum of 10 consecutive trading days, as required for continuous listing of the common stock on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). On May 10, 2023, the Company’s Board approved a reverse stock split ratio of 1-for-17 The accompanying consolidated financial statements and notes to consolidated financial statements give retroactive effect to the reverse stock split for all periods presented. The reverse stock split did not change the number of authorized shares of common stock or its par value. |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2023 | |
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 reassesses its reserves for variable consideration at each reporting date and makes adjustments, if necessary, which may affect revenue and earnings in periods in which any such changes become known. See Note 8 for a description of the license agreement with Antares Pharma, Inc. (“Antares”). See Note 12 for a description of the agreement with Spriaso, a related party. License Fees Royalties. Contract Assets Contract assets consist of minimum royalty revenue earned in relation to the license agreement but not yet due based on the terms of the contract. The contract asset as of June 30, 2023 is related to the Antares License Agreement. The contract asset was reduced by approximately $ 218,000 579,000 Revenue Concentration A major partner is considered to be one that comprises more than 10 0 500,000 55,000 500,000 100 100 |
Earnings (Loss) per Share
Earnings (Loss) per Share | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 and 2022: Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Basic loss per share attributable to common stock: Numerator Net loss $ (3,548,629 ) $ (2,631,777 ) $ (7,418,859 ) $ (6,119,558 ) Denominator Weighted avg. common shares outstanding 5,234,830 5,234,141 5,234,830 5,228,608 Basic loss per share attributable to common stock $ (0.68 ) $ (0.50 ) $ (1.42 ) $ (1.17 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (3,548,629 ) $ (2,631,777 ) $ (7,418,859 ) $ (6,119,558 ) Effect of dilutive securities on net loss: Common stock warrants 27,455 583,445 125,589 205,457 Total net loss for purpose of calculating diluted net loss per common share $ (3,576,084 ) $ (3,215,222 ) $ (7,544,448 ) $ (6,325,015 ) Denominator Weighted avg. common shares outstanding 5,234,830 5,234,141 5,234,830 5,228,608 Weighted average effect of dilutive securities: Common stock warrants - 29,248 - 34,385 Total shares for purpose of calculating diluted net loss per common share 5,234,830 5,263,389 5,234,830 5,262,993 Diluted loss per share attributable to common stock $ (0.68 ) $ (0.61 ) $ (1.44 ) $ (1.20 ) The computation of diluted loss per share for the three and six months ended June 30, 2023 and 2022 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, 2023 2022 Stock options 264,150 236,822 Warrants 49,433 49,433 |
Marketable Investment Securitie
Marketable Investment Securities | 6 Months Ended |
Jun. 30, 2023 | |
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 as of June 30, 2023, and December 31, 2022, were as follows: Schedule of Available for Sale Securities June 30, 2023 Amortized Gross Gross Aggregate Government treasury bills $ 2,360,569 $ - $ (2,937 ) $ 2,357,632 Corporate bonds, notes and commercial paper 9,703,495 - (6,102 ) 9,697,393 U.S. government agency securities 8,727,023 - (6,773 ) 8,720,250 $ 20,791,087 $ - $ (15,812 ) $ 20,775,275 December 31, 2022 Amortized Gross Gross Aggregate Government treasury bills $ 5,973,087 $ - $ (14,087 ) $ 5,959,000 Commercial paper 20,052,505 - (10,885 ) 20,041,620 U.S. government agency securities 3,376,139 4,651 - 3,380,790 $ 29,401,731 $ 4,651 $ (24,972 ) $ 29,381,410 Maturities of debt securities classified as available-for-sale securities as of June 30, 2023, are as follows: Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities June 30, 2023 Amortized Aggregate Due within one year $ 20,791,087 $ 20,775,275 $ 20,791,087 $ 20,775,275 There were no no 5.9 8.6 17.9 33.8 no |
Fair Value
Fair Value | 6 Months Ended |
Jun. 30, 2023 | |
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 as of June 30, 2023 and December 31, 2022: Schedule of Fair Value, Assets Measured on Recurring Basis Fair value measurements at reporting date using June 30, 2023 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 4,897,774 $ 4,897,774 $ - $ - Government treasury bills 2,357,632 2,357,632 - - Commercial paper 7,339,702 - 7,339,702 - Corporate bonds and notes 2,357,691 - 2,357,691 - US. Government agency securities 8,720,250 - 8,720,250 - $ 25,673,049 $ 7,255,406 $ 18,417,643 $ - Liabilities: Warrant liability $ 104,267 $ - $ - $ 104,267 $ 25,777,316 $ 7,255,406 $ 18,417,643 $ 104,267 Fair value measurements at reporting date using December 31, 2022 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,694,434 $ 2,694,434 $ - $ - Government treasury bills 5,959,000 5,959,000 - - Commercial paper 14,586,930 - 14,586,930 - Corporate bonds and notes 5,454,690 - 5,454,690 - U.S. government agency securities 3,380,790 - 3,380,790 - $ 32,075,844 $ 8,653,434 $ 23,422,410 $ - Liabilities: Warrant liability $ 229,856 $ - $ - $ 229,856 $ 32,305,700 $ 8,653,434 $ 23,422,410 $ 229,856 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, commercial paper and U.S. government agency securities: The Company uses a third-party pricing service to value these investments. Corporate bonds, notes and commercial paper and U.S. government agency securities 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, 2023, include (i) volatility of 100 5.25 8.50 5.04 1.4 100 4.41 8.50 6.77 1.9 The Company’s accounting policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, Level 2, or Level 3 for the three and six months ended June 30, 2023. |
Loan and Security Agreements
Loan and Security Agreements | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Loan and Security Agreements | (6) Loan and Security Agreements 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, 2023 | |
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, 2023 and December 31, 2022, 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, 2023 | |
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 9,000 17,000 13,000 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 New Drug Application (“NDA”) No. 208088, treatment of Klinefelter syndrome, and pediatric indications relating to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (the “Field”), in each case within the United States. TLANDO received FDA approval on March 29, 2022. Upon execution of the Antares License Agreement, Antares paid the Company an initial payment of $ 11.0 5.0 160.0 20 The Company retains development and commercialization rights in the rest of the world, and with respect to applications outside of the Field inside or outside the United States. Antares also purchased certain existing inventory of licensed product from the Company. Finally, pursuant to the terms of the Antares License Agreement, Antares is generally responsible for expenses relating to the development (including the conduct of any clinical trials) and commercialization of TLANDO in the Field in the United States, while the Company is generally responsible for expenses relating to development activities outside of the Field and/or 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 was to exercise its option to license TLANDO XR to June 30, 2022. As consideration for the Company agreeing to enter into the Amendment, in April 2022 Antares paid the Company a non-refundable cash fee of $ 500,000 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. The Company did not recognize any revenue under the Antares Licensing Agreement during the three or six months ended June 30, 2023 or 2022. (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 $ 1.7 2.1 3.8 3.2 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
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, 2024. Future minimum lease payments under the non-cancelable operating lease as of June 30, 2023 are: Schedule of Future Minimum Rental Payments for Operating Leases Operating leases Year ending December 31: 2023 $ 178,678 2024 59,559 Total minimum lease payments $ 238,237 The Company’s rent expense was $ 89,000 86,000 176,000 170,000 |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | (10) Stockholders’ Equity On May 10, 2023, at the 2023 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split at a ratio not less than 1-for-5 and not more than 1-for-20, with the exact ratio to be set within that range at the discretion of the Board without further approval or authorization from our stockholders. On May 10, 2023, the Company’s Board approved a reverse stock split ratio of 1-for-17 All common stock share data and per share price data of the Company reflect the reverse stock split effective May 11, 2023. On June 8, 2022, at the 2022 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of the Company’s common stock, par value $ 0.0001 100,000,000 200,000,000 (a) Issuance of Common Stock On March 6, 2017, the Company entered into 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, 2023, the Company had sold an aggregate of 883,711 37.23 32.9 31.7 41.2 15.7 (b) Series B Preferred Stock On March 7, 2023, the Board of the Company declared a dividend of one one-thousandth (1/1,000 th 0.0001 The dividend was based on the number of shares of outstanding common stock on March 24, 2023, and resulted in 88,511 Each whole share of Series B Preferred Stock entitled the holder thereof to 1,000,000 votes per share, and each fraction of a share of Series B Preferred Stock had a ratable number of votes. Thus, each one-thousandth of a share of Series B Preferred Stock was entitled to 1,000 votes. shares of Common Stock at a ratio determined in accordance with the terms of such amendment (the “Reverse Stock Split”), and (ii) any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split (the “Adjournment Proposal”) All shares of Series B Preferred Stock that were not present in person or by proxy at the 2023 annual meeting as of immediately prior to the opening of the polls (the “Initial Redemption Time”) were automatically redeemed by the Company without further action on the part of the Company or the holder of shares of Series B Preferred Stock (the “Initial Redemption”). The remaining shares of Series B Preferred Stock that were not redeemed pursuant to the Initial Redemption were redeemed automatically upon the effectiveness of the amendment to the Certificate of Incorporation implementing the Reverse Stock Split (the “Subsequent Redemption”). As of June 30, 2023, all shares of Series B Preferred Stock have been redeemed by the Company. Each “beneficial owner” (as such terms are defined in the Certificate of Designation with respect to the Series B Preferred Stock) of shares of Series B Preferred Stock redeemed in the redemptions described above has the right to receive an amount equal to $0.01 in cash for each ten whole shares of Series B Preferred Stock that were “beneficially owned” by the beneficial owner as of immediately prior to the applicable redemption time and redeemed pursuant to such redemption, payable upon receipt by the Company of a written request submitted by the applicable beneficial owner to the corporate secretary of the Company following the applicable redemption time. The Series B Preferred Stock was not convertible into, or exchangeable for, shares of any other class or series of stock or other securities of the Company. The Series B Preferred Stock had no stated maturity and was not subject to any sinking fund. The Series B Preferred Stock was not subject to any restriction on the redemption or repurchase of shares by the Company while there is any arrearage in the payment of dividends or sinking fund installments. The Company was not solely in control of the redemption of the shares of Series B Preferred Stock prior to the annual meeting of stockholders since the holders had the option of deciding whether to vote in respect of the above-described Reverse Stock Split, which determined whether a given holder’s shares of Series B Preferred Stock was redeemed in the Initial Redemption or the Subsequent Redemption. Since the redemption of the Series B Preferred Stock was not solely in the control of the Company, the shares of Series B Preferred Stock were classified within the mezzanine equity in the Company’s unaudited consolidated statement of stockholder’s equity. Upon issuance, the shares of Series B Preferred Stock were measured at redemption value. As of June 30, 2023, all shares of Series B Preferred Stock have been redeemed by the Company. The foregoing description of the Series B Preferred Stock does not purport to be complete and is qualified in its entirety by reference to the Certificate of Designation, which is filed as Exhibit 3.2 to the Form 8-K filed with the SEC on March 10, 2023. (c) Rights Agreement On November 13, 2015, the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent, entered into a Rights Agreement. Also on November 12, 2015, the Board of 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 (d) Share-Based Payments The Company recognizes stock-based compensation expense for grants of stock option awards, restricted stock units and restricted stock under the Company’s Incentive Plan to employees, nonemployees and nonemployee members of the Company’s Board based on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award’s requisite service period. In addition, the Company has granted performance-based stock option awards and restricted stock units, which vest based upon the Company satisfying certain performance conditions. Potential compensation cost, measured on the grant date, related to these performance options will be recognized only if, and when, the Company estimates that these options or units will vest, which is based on whether the Company considers the performance conditions to be probable of attainment. The Company’s estimates of the number of performance-based options or units that will vest will be revised, if necessary, in subsequent periods. The Company uses the Black-Scholes model to compute the estimated fair value of stock option awards. Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of the Company’s common stock price, (ii) the periods of time over which employees and members of the board of directors are expected to hold their options prior to exercise (expected term), (iii) expected dividend yield on the Common Stock, and (iv) risk-free interest rates. Stock-based compensation expense also includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Stock-based compensation cost that has been expensed in the statements of operations amounted to approximately $ 165,000 140,000 343,000 311,000 Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs 2023 2022 2023 2022 Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development $ 83,229 $ 63,021 $ 178,742 $ 142,673 General and administrative 81,636 76,548 163,895 167,924 Total $ 164,865 $ 139,569 $ 342,637 $ 310,597 The Company issued 8,820 26,467 10,086 29,643 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, 2023 and 2022, the Company calculated the fair value of each option grant on the respective dates of grant using the following weighted average assumptions: Schedule of Key Assumption of Fair Value of Stock Options Granted 2023 2022 Expected term 5.73 5.77 Risk-free interest rate 3.73 % 1.93 % Expected dividend yield — — Expected volatility 98.97 % 101.67 % FASB ASC 718, Stock Compensation, As of June 30, 2023, there was approximately $ 766,000 1.64 (e) Stock Option Plan In April 2014, the Board adopted the 2014 Stock and Incentive Plan (“2014 Plan”) subject to shareholder approval which was received in June 2014. The 2014 Plan provides for the granting of nonqualified and incentive stock options, stock appreciation rights, restricted stock units, restricted stock and dividend equivalents. An aggregate of 58,823 15,994 74,817 145,405 145,405 189,522 189,522 336,582 ten 336,582 46,519 A summary of stock option activity is as follows: Schedule of Stock Option Activity Outstanding stock options Number of Weighted average Balance at December 31, 2022 277,225 $ 38.44 Options granted 26,467 6.19 Options exercised - - Options forfeited (7,352 ) 6.91 Options cancelled (32,190 ) 47.77 Balance at June 30, 2023 264,150 34.95 Options exercisable at June 30, 2023 167,770 48.55 The following table summarizes information about stock options outstanding and exercisable at June 30, 2023: Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable Options outstanding Options exercisable Number Weighted Weighted Aggregate Number Weighted Weighted Aggregate 264,150 7.06 $ 34.95 $ 4,586 167,770 5.88 $ 48.55 $ - The intrinsic value for stock options is defined as the difference between the current market value and the exercise price. There were 0 12 0 12,261 (f) Common Stock Warrants The Company accounts for its common stock warrants under ASC 480, Distinguishing Liabilities from Equity As of June 30, 2023, the Company had 64,362 June 30, 2023 December 31, 2022 Expected life in years 1.38 1.88 Risk-free interest rate 5.25 % 4.41 % Dividend yield — — Volatility 100.00 % 100.00 % Stock price $ 5.04 $ 6.77 During the three and six months ended June 30, 2023, the Company recorded non-cash gains of approximately $ 27,000 126,000 583,000 205,000 Schedule of Reconciliation of Warrant Liability Warrant Liability Balance at December 31, 2022 $ 229,856 Settlement of liability on warrant exercise - Change in fair value of common stock warrants (125,589 ) Balance at June 30, 2023 $ 104,267 Additionally, in the February 2020 Offering, the Company issued 296,593 49,433 The following table summarizes the number of common stock warrants outstanding and the weighted average exercise price: Schedule of Number of Warrants Outstanding and the Weighted Average Exercise Price Warrants Weighted Average Outstanding at December 31, 2022 113,795 $ 8.72 Issued - - Exercised - - Expired - - Cancelled - - Forfeited - - Balance at June 30, 2023 113,795 $ 8.72 There were no The following table summarizes information about common stock warrants outstanding at June 30, 2023: Schedule of Common Stock Warrants Outstanding Warrants outstanding Number exercisable Weighted average Weighted average Aggregate intrinsic 113,795 1.51 $ 8.72 $ - |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (11) Commitments and Contingencies Litigation The Company is involved in various lawsuits, claims and other legal matters from time to time that arise in the ordinary course of conducting business. The Company records a liability when a particular contingency is probable and estimable. On April 2, 2019, the Company filed a lawsuit against Clarus in the United States District Court for the District of Delaware alleging that Clarus’s JATENZO® product infringes six of Lipocine’s issued U.S. patents: 9,034,858; 9,205,057; 9,480,690; 9,757,390; 6,569,463; and 6,923,988. However, on February 11, 2020, the Company voluntarily dismissed allegations of patent infringement for expired U.S. Patent Nos. 6,569,463 and 6,923,988 in an effort to streamline the issues and associated costs for dispute. Clarus answered the complaint and asserted counterclaims of non-infringement and invalidity. The Company answered Clarus’s counterclaims on April 29, 2019. The Court held a scheduling conference on August 15, 2019, a claim construction hearing on February 11, 2020, and a summary judgment hearing on January 15, 2021. In May 2021, the Court granted Clarus’ motion for Summary Judgment, finding the asserted claims of Lipocine’s U.S. patents 9,034,858; 9,205,057; 9,480,690; and 9,757,390 invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112. Clarus still had remaining claims before the Court. On July 13, 2021, the Company entered into the Global Agreement (the “Global Agreement”) with Clarus which resolved all outstanding claims of this litigation as well as the on-going United States Patent and Trademark Office (“USPTO”) Interference No. 106,128 between the parties. Under the terms of the Global Agreement, the Company agreed to pay Clarus $ 4.0 2.5 1.0 500,000 1,250,000 On November 14, 2019, the Company and certain of its officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v. Lipocine Inc. et al., 2:19-cv-00906-PMW, filed in the United District Court for the District of Utah. The complaint alleges that the defendants made false and/or misleading statements and/or failed to disclose that the Company’s filing of the NDA for TLANDO to the FDA contained deficiencies and as a result the defendants’ statements about our business and operations were false and misleading and/or lacked a reasonable basis in violation of federal securities laws. The lawsuit sought certification as a class action (for a purported class of purchasers of the Company’s securities from March 27, 2019 through November 8, 2019), compensatory damages in an unspecified amount, and unspecified equitable or injunctive relief. The Company has insurance that covers claims of this nature. The retention amount payable by the Company under its policy is $ 1.25 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. |
Agreement with Spriaso, LLC
Agreement with Spriaso, LLC | 6 Months Ended |
Jun. 30, 2023 | |
Related Party Transactions [Abstract] | |
Agreement with Spriaso, LLC | (12) Agreement with Spriaso, LLC The Company has a license and a services agreement with Spriaso, a related-party that is majority-owned by certain current and former directors of Lipocine Inc. and their affiliates. Under the license agreement, the Company assigned and transferred to Spriaso all of the Company’s rights, title and interest in its intellectual property to develop products for the cough and cold field. In addition, Spriaso received all rights and obligations under the Company’s product development agreement with a third-party. In exchange, the Company will receive a royalty of 20 10.0 The Company also agreed to continue providing up to 10 percent of the services of certain employees to Spriaso for a period of time. The agreement to provide services expired in 2021; 0 55,000 0 |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 and 2022: Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Basic loss per share attributable to common stock: Numerator Net loss $ (3,548,629 ) $ (2,631,777 ) $ (7,418,859 ) $ (6,119,558 ) Denominator Weighted avg. common shares outstanding 5,234,830 5,234,141 5,234,830 5,228,608 Basic loss per share attributable to common stock $ (0.68 ) $ (0.50 ) $ (1.42 ) $ (1.17 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (3,548,629 ) $ (2,631,777 ) $ (7,418,859 ) $ (6,119,558 ) Effect of dilutive securities on net loss: Common stock warrants 27,455 583,445 125,589 205,457 Total net loss for purpose of calculating diluted net loss per common share $ (3,576,084 ) $ (3,215,222 ) $ (7,544,448 ) $ (6,325,015 ) Denominator Weighted avg. common shares outstanding 5,234,830 5,234,141 5,234,830 5,228,608 Weighted average effect of dilutive securities: Common stock warrants - 29,248 - 34,385 Total shares for purpose of calculating diluted net loss per common share 5,234,830 5,263,389 5,234,830 5,262,993 Diluted loss per share attributable to common stock $ (0.68 ) $ (0.61 ) $ (1.44 ) $ (1.20 ) |
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, 2023 and 2022 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, 2023 2022 Stock options 264,150 236,822 Warrants 49,433 49,433 |
Marketable Investment Securit_2
Marketable Investment Securities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available for Sale Securities | Schedule of Available for Sale Securities June 30, 2023 Amortized Gross Gross Aggregate Government treasury bills $ 2,360,569 $ - $ (2,937 ) $ 2,357,632 Corporate bonds, notes and commercial paper 9,703,495 - (6,102 ) 9,697,393 U.S. government agency securities 8,727,023 - (6,773 ) 8,720,250 $ 20,791,087 $ - $ (15,812 ) $ 20,775,275 December 31, 2022 Amortized Gross Gross Aggregate Government treasury bills $ 5,973,087 $ - $ (14,087 ) $ 5,959,000 Commercial paper 20,052,505 - (10,885 ) 20,041,620 U.S. government agency securities 3,376,139 4,651 - 3,380,790 $ 29,401,731 $ 4,651 $ (24,972 ) $ 29,381,410 |
Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities | Maturities of debt securities classified as available-for-sale securities as of June 30, 2023, are as follows: Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities June 30, 2023 Amortized Aggregate Due within one year $ 20,791,087 $ 20,775,275 $ 20,791,087 $ 20,775,275 |
Fair Value (Tables)
Fair Value (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 4,897,774 $ 4,897,774 $ - $ - Government treasury bills 2,357,632 2,357,632 - - Commercial paper 7,339,702 - 7,339,702 - Corporate bonds and notes 2,357,691 - 2,357,691 - US. Government agency securities 8,720,250 - 8,720,250 - $ 25,673,049 $ 7,255,406 $ 18,417,643 $ - Liabilities: Warrant liability $ 104,267 $ - $ - $ 104,267 $ 25,777,316 $ 7,255,406 $ 18,417,643 $ 104,267 Fair value measurements at reporting date using December 31, 2022 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,694,434 $ 2,694,434 $ - $ - Government treasury bills 5,959,000 5,959,000 - - Commercial paper 14,586,930 - 14,586,930 - Corporate bonds and notes 5,454,690 - 5,454,690 - U.S. government agency securities 3,380,790 - 3,380,790 - $ 32,075,844 $ 8,653,434 $ 23,422,410 $ - Liabilities: Warrant liability $ 229,856 $ - $ - $ 229,856 $ 32,305,700 $ 8,653,434 $ 23,422,410 $ 229,856 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | Future minimum lease payments under the non-cancelable operating lease as of June 30, 2023 are: Schedule of Future Minimum Rental Payments for Operating Leases Operating leases Year ending December 31: 2023 $ 178,678 2024 59,559 Total minimum lease payments $ 238,237 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 2023 2022 2023 2022 Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development $ 83,229 $ 63,021 $ 178,742 $ 142,673 General and administrative 81,636 76,548 163,895 167,924 Total $ 164,865 $ 139,569 $ 342,637 $ 310,597 |
Schedule of Key Assumption of Fair Value of Stock Options Granted | For options granted during the six months ended June 30, 2023 and 2022, the Company calculated the fair value of each option grant on the respective dates of grant using the following weighted average assumptions: Schedule of Key Assumption of Fair Value of Stock Options Granted 2023 2022 Expected term 5.73 5.77 Risk-free interest rate 3.73 % 1.93 % Expected dividend yield — — Expected volatility 98.97 % 101.67 % June 30, 2023 December 31, 2022 Expected life in years 1.38 1.88 Risk-free interest rate 5.25 % 4.41 % Dividend yield — — Volatility 100.00 % 100.00 % Stock price $ 5.04 $ 6.77 |
Schedule of Stock Option Activity | A summary of stock option activity is as follows: Schedule of Stock Option Activity Outstanding stock options Number of Weighted average Balance at December 31, 2022 277,225 $ 38.44 Options granted 26,467 6.19 Options exercised - - Options forfeited (7,352 ) 6.91 Options cancelled (32,190 ) 47.77 Balance at June 30, 2023 264,150 34.95 Options exercisable at June 30, 2023 167,770 48.55 |
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, 2023: Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable Options outstanding Options exercisable Number Weighted Weighted Aggregate Number Weighted Weighted Aggregate 264,150 7.06 $ 34.95 $ 4,586 167,770 5.88 $ 48.55 $ - |
Schedule of Reconciliation of Warrant Liability | Schedule of Reconciliation of Warrant Liability Warrant Liability Balance at December 31, 2022 $ 229,856 Settlement of liability on warrant exercise - Change in fair value of common stock warrants (125,589 ) Balance at June 30, 2023 $ 104,267 |
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 Outstanding at December 31, 2022 113,795 $ 8.72 Issued - - Exercised - - Expired - - Cancelled - - Forfeited - - Balance at June 30, 2023 113,795 $ 8.72 |
Schedule of Common Stock Warrants Outstanding | The following table summarizes information about common stock warrants outstanding at June 30, 2023: Schedule of Common Stock Warrants Outstanding Warrants outstanding Number exercisable Weighted average Weighted average Aggregate intrinsic 113,795 1.51 $ 8.72 $ - |
Basis of Presentation (Details
Basis of Presentation (Details Narrative) | May 10, 2023 |
Accounting Policies [Abstract] | |
Reverse stock split, description | reverse stock split ratio of 1-for-17 |
Revenue (Details Narrative)
Revenue (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||||||
Revenue | $ 500,000 | $ 54,990 | $ 500,000 | |||
Major Customer [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Concentration Risk, Percentage | 10% | |||||
Spriaso [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Concentration Risk, Percentage | 100% | |||||
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 | $ 218,000 | |||||
License Agreement [Member] | Forecast [Member] | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Payments for royalty | $ 579,000 |
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, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (3,548,629) | $ (2,631,777) | $ (7,418,859) | $ (6,119,558) |
Weighted avg. common shares outstanding | 5,234,830 | 5,234,141 | 5,234,830 | 5,228,608 |
Basic loss per share attributable to common stock | $ (0.68) | $ (0.50) | $ (1.42) | $ (1.17) |
Effect of dilutive securities on net loss: | ||||
Common stock warrants | $ 27,455 | $ 583,445 | $ 125,589 | $ 205,457 |
Total net loss for purpose of calculating diluted net loss per common share | $ (3,576,084) | $ (3,215,222) | $ (7,544,448) | $ (6,325,015) |
Weighted average effect of dilutive securities: | ||||
Common stock warrants | 29,248 | 34,385 | ||
Total shares for purpose of calculating diluted net loss per common share | 5,234,830 | 5,263,389 | 5,234,830 | 5,262,993 |
Diluted loss per share attributable to common stock | $ (0.68) | $ (0.61) | $ (1.44) | $ (1.20) |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Warrant [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 49,433 | 49,433 |
Share-Based Payment Arrangement, Option [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 264,150 | 236,822 |
Schedule of Available for Sale
Schedule of Available for Sale Securities (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 20,791,087 | $ 29,401,731 |
Gross unrealized holding gains | 4,651 | |
Gross unrealized holding losses | (15,812) | (24,972) |
Aggregate fair value | 20,775,275 | 29,381,410 |
US Treasury Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 2,360,569 | 5,973,087 |
Gross unrealized holding gains | ||
Gross unrealized holding losses | (2,937) | (14,087) |
Aggregate fair value | 2,357,632 | 5,959,000 |
Corporate Bonds Notes and Commercial Paper [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 9,703,495 | 20,052,505 |
Gross unrealized holding gains | ||
Gross unrealized holding losses | (6,102) | (10,885) |
Aggregate fair value | 9,697,393 | 20,041,620 |
U S Government Agency Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 8,727,023 | 3,376,139 |
Gross unrealized holding gains | 4,651 | |
Gross unrealized holding losses | (6,773) | |
Aggregate fair value | $ 8,720,250 | $ 3,380,790 |
Schedule of Maturities of Debt
Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities (Details) | Jun. 30, 2023 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Due within one year, Amortized Cost | $ 20,791,087 |
Due within one year, Aggregate fair value | 20,775,275 |
Total maturities of debt securities classified as available-for-sale securities, Amortized Cost | 20,791,087 |
Total maturities of debt securities classified as available-for-sale securities, Aggregate fair value | $ 20,775,275 |
Marketable Investment Securit_3
Marketable Investment Securities (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Sales of marketable investment securities | $ 0 | $ 0 | ||
Realized gains or losses | 0 | 0 | ||
Matured marketable investment securities | $ 5,900,000 | $ 8,600,000 | 17,900,000 | 33,800,000 |
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, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | $ 25,673,049 | $ 32,075,844 |
Fair value net asset liability | 25,777,316 | 32,305,700 |
Corporate Bonds and Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 2,357,691 | 5,454,690 |
Warrant [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities, fair value | 104,267 | 229,856 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 7,255,406 | 8,653,434 |
Fair value net asset liability | 7,255,406 | 8,653,434 |
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 | 18,417,643 | 23,422,410 |
Fair value net asset liability | 18,417,643 | 23,422,410 |
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 | 2,357,691 | 5,454,690 |
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 | ||
Fair value net asset liability | 104,267 | 229,856 |
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 | 104,267 | 229,856 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 4,897,774 | 2,694,434 |
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 | 4,897,774 | 2,694,434 |
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 | 2,357,632 | 5,959,000 |
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 | 2,357,632 | 5,959,000 |
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 | 7,339,702 | 14,586,930 |
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 | 7,339,702 | 14,586,930 |
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 | ||
US Government Corporations and Agencies Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 8,720,250 | 3,380,790 |
US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | ||
US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value | 8,720,250 | 3,380,790 |
US Government Corporations and Agencies Securities [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) - Warrant [Member] | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 $ / shares | Dec. 31, 2022 $ / shares | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of common stock | $ 5.04 | $ 6.77 |
Measurement Input, Price Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 100 | 100 |
Measurement Input, Risk Free Interest Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 5.25 | 4.41 |
Measurement Input, Share Price [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 8.50 | 8.50 |
Measurement Input, Expected Term [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input, term | 1 year 4 months 24 days | 1 year 10 months 24 days |
Loan and Security Agreements (D
Loan and Security Agreements (Details Narrative) - Loan and Security Agreement [Member] - Silicon Valley Bank [Member] | Jan. 05, 2018 USD ($) |
Line of Credit Facility [Line Items] | |
Aggregate amount | $ 10,000,000 |
Debt instrument description | The principal borrowed under the Loan and Security Agreement bore interest at a rate equal to the Prime Rate, as reported in the money rates section of The Wall Street Journal or any successor publication representing the rate of interest per annum then in effect, plus one percent per annum, which interest was payable monthly. |
Debt instrument, maturity date | Jun. 01, 2022 |
Debt instrument, balloon payment to be paid | $ 650,000 |
Contractual Agreements (Details
Contractual Agreements (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Jan. 01, 2026 | Jan. 01, 2025 | Oct. 14, 2021 | Mar. 29, 2012 | Apr. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Contract research and development expenses | $ 1,700,000 | $ 2,100,000 | $ 3,800,000 | $ 3,200,000 | |||||
Collaborative Agreement [Member] | Abbott Products, Inc. [Member] | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Percentage of net sales | 1% | ||||||||
Royalties, commitment amount | $ 1,000,000 | ||||||||
Percentage of royalties reduction based upon product launch | 50% | ||||||||
Royalty expense | $ 9,000 | $ 17,000 | $ 13,000 | $ 17,000 | |||||
License Agreement [Member] | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
License fee | $ 11,000,000 | ||||||||
Royalty payments rates | 20% | ||||||||
Non-refundable cash fee | $ 500,000 | ||||||||
License Agreement [Member] | Maximum [Member] | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone revenue to be received | $ 160,000,000 | ||||||||
License Agreement [Member] | Forecast [Member] | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Payments to be made for license fees | $ 5,000,000 | $ 5,000,000 |
Schedule of Future Minimum Rent
Schedule of Future Minimum Rental Payments for Operating Leases (Details) | Jun. 30, 2023 USD ($) |
Lessee, Operating Lease, Description [Abstract] | |
2023 | $ 178,678 |
2024 | 59,559 |
Total minimum lease payments | $ 238,237 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Leases [Abstract] | ||||
Rent expense | $ 89,000 | $ 86,000 | $ 176,000 | $ 170,000 |
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, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Total | $ 164,865 | $ 139,569 | $ 342,637 | $ 310,597 |
Research and Development Expense [Member] | ||||
Total | 83,229 | 63,021 | 178,742 | 142,673 |
General and Administrative Expense [Member] | ||||
Total | $ 81,636 | $ 76,548 | $ 163,895 | $ 167,924 |
Schedule of Key Assumption of F
Schedule of Key Assumption of Fair Value of Stock Options Granted (Details) | 6 Months Ended | ||
Jun. 30, 2023 $ / shares | Jun. 30, 2022 | Dec. 31, 2022 $ / shares | |
Subsidiary, Sale of Stock [Line Items] | |||
Expected term | 5 years 8 months 23 days | 5 years 9 months 7 days | |
Risk-free interest rate | 3.73% | 1.93% | |
Expected dividend yield | |||
Expected volatility | 98.97% | 101.67% | |
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Measurement Input, Expected Term [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Expected life in years | 1 year 4 months 17 days | 1 year 10 months 17 days | |
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Warrants measurement input | 5.25 | 4.41 | |
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Measurement Input, Expected Dividend Rate [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Warrants measurement input | |||
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Measurement Input, Option Volatility [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Warrants measurement input | 100 | 100 | |
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Measurement Input, Share Price [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Stock price | $ 5.04 | $ 6.77 |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Option Indexed to Issuer's Equity [Line Items] | ||||
Number of shares, ending balance | 264,150 | 264,150 | ||
Weighted average exercise price, Balance | $ 34.95 | $ 34.95 | ||
Number of shares, options exercisable | 167,770 | 167,770 | ||
Weighted average exercise price, options exercisable | $ 48.55 | $ 48.55 | ||
Share-Based Payment Arrangement, Option [Member] | ||||
Option Indexed to Issuer's Equity [Line Items] | ||||
Number of shares, beginning balance | 277,225 | |||
Weighted average exercise price, ending balance | $ 38.44 | |||
Number of shares, Options granted | 8,820 | 10,086 | 26,467 | 29,643 |
Weighted average exercise price, Options granted | $ 6.19 | |||
Number of shares, Options exercised | 0 | (12) | (12,261) | |
Weighted average exercise price, Options exercised | ||||
Number of shares, Options forfeited | (7,352) | |||
Weighted average exercise price, Options forfeited | $ 6.91 | |||
Number of shares, Options cancelled | (32,190) | |||
Weighted average exercise price, Options cancelled | $ 47.77 | |||
Number of shares, ending balance | 264,150 | 264,150 | ||
Weighted average exercise price, Balance | $ 34.95 | $ 34.95 | ||
Number of shares, options exercisable | 167,770 | 167,770 | ||
Weighted average exercise price, options exercisable | $ 48.55 | $ 48.55 |
Schedule of Share-based Compens
Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable (Details) | 6 Months Ended |
Jun. 30, 2023 USD ($) $ / shares shares | |
Equity [Abstract] | |
Number of options outstanding | shares | 264,150 |
Options outstanding, Weighted average remaining contractual life (Years) | 7 years 21 days |
Options outstanding, Weighted average exercise price | $ / shares | $ 34.95 |
Options outstanding, Aggregate intrinsic value | $ | $ 4,586 |
Number of options exercisable | shares | 167,770 |
Options exercisable, Weighted average remaining contractual life (Years) | 5 years 10 months 17 days |
Options exercisable, Weighted average exercise price | $ / shares | $ 48.55 |
Options exercisable, Aggregate intrinsic value | $ |
Schedule of Reconciliation of W
Schedule of Reconciliation of Warrant Liability (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Equity [Abstract] | ||
Balance at December 31, 2022 | $ 229,856 | |
Settlement of liability on warrant exercise | ||
Change in fair value of common stock warrants | (125,589) | $ (205,457) |
Balance at June 30, 2023 | $ 104,267 |
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, 2023 $ / shares shares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
Warrants Outstanding, Beginning | shares | 113,795 |
Weighted Average Exercise Price, Outstanding, Beginning | $ / shares | $ 8.72 |
Warrants, Issued | shares | |
Weighted Average Exercise Price, Issued | $ / shares | |
Warrants, Exercised | shares | |
Weighted Average Exercise Price, Exercised | $ / shares | |
Warrants, Expired | shares | |
Weighted Average Exercise Price, Expired | $ / shares | |
Warrants, Cancelled | shares | |
Weighted Average Exercise Price, Cancelled | $ / shares | |
Warrants, Forfeited | shares | |
Weighted Average Exercise Price, Forfeited | $ / shares | |
Warrants Outstanding, Ending | shares | 113,795 |
Weighted Average Exercise Price, Outstanding, Ending | $ / shares | $ 8.72 |
Schedule of Common Stock Warran
Schedule of Common Stock Warrants Outstanding (Details) - Warrant [Member] - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Dec. 31, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of warrants exercisable, shares | 113,795 | 113,795 |
Weighted average remaining contractual life | 1 year 6 months 3 days | |
Weighted average exercise price, per share | $ 8.72 | $ 8.72 |
Aggregate intrinsic value |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||||||||||||||
Jun. 30, 2023 | May 10, 2023 | Mar. 24, 2023 | Mar. 06, 2017 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Mar. 07, 2023 | Dec. 31, 2022 | Jun. 08, 2022 | Jun. 07, 2022 | Jun. 30, 2020 | Jun. 30, 2018 | Jun. 30, 2016 | Nov. 13, 2015 | Apr. 30, 2014 | |
Class of Stock [Line Items] | |||||||||||||||||
Reverse stock split, description | reverse stock split ratio of 1-for-17 | ||||||||||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | 200,000,000 | |||||||||||||
Preferred stock redemption price | $ 0.001 | $ 0.001 | $ 0.001 | $ 63.96 | |||||||||||||
Stock-based compensation expense | $ 164,865 | $ 139,569 | $ 342,637 | $ 310,597 | |||||||||||||
Unrecognized compensation cost | $ 766,000 | $ 766,000 | $ 766,000 | ||||||||||||||
Share based payment arrangement, nonvested award, cost not yet recognized, period for recognition | 1 year 7 months 20 days | ||||||||||||||||
Non-cash loss on change in fair value of warrant liability | $ (125,589) | (205,457) | |||||||||||||||
November 2019 Offering [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Warrants outstanding | 64,362 | 64,362 | 64,362 | ||||||||||||||
Non-cash loss on change in fair value of warrant liability | $ 27,000 | $ 583,000 | $ 126,000 | $ 205,000 | |||||||||||||
February 2020 Offering [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Warrants outstanding | 49,433 | 49,433 | 49,433 | 49,433 | 49,433 | ||||||||||||
Warrants, Issued | 296,593 | ||||||||||||||||
Common stock warrants exercised | 0 | 0 | 0 | ||||||||||||||
Stock Incentive Plan 2014 [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 336,582 | 336,582 | 336,582 | 58,823 | |||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 46,519 | 46,519 | 46,519 | ||||||||||||||
Contractual life | 10 years | ||||||||||||||||
2011 Equity Incentive Plan [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 15,994 | ||||||||||||||||
Share-Based Payment Arrangement, Option [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Number of shares, Options granted (in shares) | 8,820 | 10,086 | 26,467 | 29,643 | |||||||||||||
Option exercises, shares | 0 | 12 | 12,261 | ||||||||||||||
Series B Preferred Stock [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Preferred stock, stated par value | $ 0.0001 | ||||||||||||||||
Preferred stock, shares issued | 88,511 | ||||||||||||||||
Preferred stock voting rights, description | Each whole share of Series B Preferred Stock entitled the holder thereof to 1,000,000 votes per share, and each fraction of a share of Series B Preferred Stock had a ratable number of votes. Thus, each one-thousandth of a share of Series B Preferred Stock was entitled to 1,000 votes. | ||||||||||||||||
Preferred stock redemption terms | Each “beneficial owner” (as such terms are defined in the Certificate of Designation with respect to the Series B Preferred Stock) of shares of Series B Preferred Stock redeemed in the redemptions described above has the right to receive an amount equal to $0.01 in cash for each ten whole shares of Series B Preferred Stock that were “beneficially owned” by the beneficial owner as of immediately prior to the applicable redemption time and redeemed pursuant to such redemption, payable upon receipt by the Company of a written request submitted by the applicable beneficial owner to the corporate secretary of the Company following the applicable redemption time. | ||||||||||||||||
Maximum [Member] | Stock Incentive Plan 2014 [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 336,582 | 189,522 | 145,405 | ||||||||||||||
Minimum [Member] | Stock Incentive Plan 2014 [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 189,522 | 145,405 | 74,817 | ||||||||||||||
Sales Agreement [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Percentage of gross proceeds on sale of shares | 3% | ||||||||||||||||
Stock issued during period, shares, new issues | 883,711 | ||||||||||||||||
Shares issued, price per share | $ 37.23 | $ 37.23 | $ 37.23 | ||||||||||||||
Proceeds from issuance of common stock, gross | $ 32,900,000 | ||||||||||||||||
Net proceeds from common stock offering | 31,700,000 | ||||||||||||||||
Proceeds from available for sale | 41,200,000 | ||||||||||||||||
Sales Agreement [Member] | Maximum [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Proceeds from available for sale | $ 15,700,000 | ||||||||||||||||
Sales Agreement [Member] | Cantor Fitzgerald & Co. [Member] | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Fair value of shares issued during the period | $ 50,000,000 | ||||||||||||||||
Revision of Prior Period, Adjustment [Member] | |||||||||||||||||
Class 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 | Nov. 14, 2019 | Apr. 02, 2019 | Jun. 30, 2023 | Jun. 30, 2022 | |
Litigation settlement | $ 250,000 | ||||||
Payments for legal settlements | $ 1,250,000 | ||||||
Global Agreement [Member] | May 2022 [Member] | |||||||
Litigation settlement | $ 1,250,000 | ||||||
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | |||||||
Litigation settlement | $ 1,000,000 | $ 4,000,000 | |||||
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | Forecast [Member] | |||||||
Litigation settlement | $ 500,000 | ||||||
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | Immediately [Member] | |||||||
Litigation settlement | $ 2,500,000 |
Agreement with Spriaso, LLC (De
Agreement with Spriaso, LLC (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Licensing revenue | $ 500,000 | $ 54,990 | $ 500,000 | |
License and Service Agreement [Member] | Spriaso LLC [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Percentage of royalty | 20% | |||
Proceeds from contributions from affiliates | $ 10,000,000 | |||
Agreement description | The Company also agreed to continue providing up to 10 percent of the services of certain employees to Spriaso for a period of time. The agreement to provide services expired in 2021; | |||
Service Agreement [Member] | Spriaso LLC [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Licensing revenue | $ 0 | $ 0 | $ 55,000 | $ 0 |