Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 21, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-39531 | ||
Entity Registrant Name | Processa Pharmaceuticals, Inc. | ||
Entity Central Index Key | 0001533743 | ||
Entity Tax Identification Number | 45-1539785 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 7380 Coca Cola Drive | ||
Entity Address, Address Line Two | Suite 106 | ||
Entity Address, City or Town | Hanover | ||
Entity Address, State or Province | MD | ||
Entity Address, Postal Zip Code | 21076 | ||
City Area Code | 443 | ||
Local Phone Number | 776-3133 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | PCSA | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 10.2 | ||
Entity Common Stock, Shares Outstanding | 2,855,981 | ||
Documents Incorporated by Reference [Text Block] | Portions of the Proxy Statement for the registrant’s 2024 Annual Meeting of Stockholders (the “Proxy Statement”) to be filed within 120 days of the end of the fiscal year ended December 31, 2023 are incorporated by reference into Part III hereof. Except with respect to information specifically incorporated by reference in this Form 10-K, the Proxy Statement is not deemed to be filed as a part hereof | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Firm ID | 6143 | ||
Auditor Name | BD & Company, Inc | ||
Auditor Location | Owings Mills, MD |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current Assets | ||
Cash and cash equivalents | $ 4,706,197 | $ 6,503,595 |
Prepaid expenses and other | 926,300 | 1,883,134 |
Total Current Assets | 5,632,497 | 8,386,729 |
Property and Equipment, net | 2,554 | |
Other Assets | ||
Operating lease right-of-use assets, net | 146,057 | 227,587 |
Other | 5,535 | 5,535 |
Total Other Assets | 151,592 | 233,122 |
Total Assets | 5,786,643 | 8,619,851 |
Current Liabilities | ||
Current maturities of operating lease liability | 83,649 | 78,896 |
Accounts payable | 311,617 | 327,548 |
Due to licensor | 189,000 | 189,000 |
Due to related parties | 39 | 51 |
Accrued expenses | 146,274 | 403,061 |
Total Current Liabilities | 730,579 | 998,556 |
Non-current Liabilities | ||
Non-current operating lease liability | 66,905 | 150,554 |
Total Liabilities | 797,484 | 1,149,110 |
Commitments and Contingencies | ||
Stockholders’ Equity | ||
Common stock, par value $0.0001, 100,000,000 shares authorized; 1,291,000 issued and 1,286,000 outstanding at December 31, 2023 and 806,774 issued and 801,774 outstanding at December 31, 2022 | 129 | 80 |
Additional paid-in capital | 80,658,111 | 72,018,222 |
Treasury stock | (300,000) | (300,000) |
Accumulated deficit | (75,369,081) | (64,247,561) |
Total Stockholders’ Equity | 4,989,159 | 7,470,741 |
Total Liabilities and Stockholders’ Equity | $ 5,786,643 | $ 8,619,851 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Jun. 27, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | |||
Common stock, par value | $ 0.0001 | $ 0.0001 | |
Common stock, shares authorized | 100,000,000 | 100,000,000 | 50,000,000 |
Common stock, shares issued | 1,291,000 | 806,774 | |
Common stock, shares outstanding | 1,286,000 | 801,774 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Expenses | ||
Research and development expenses | $ 5,799,518 | $ 11,494,230 |
General and administrative expenses | 5,657,543 | 8,763,058 |
Impairment of intangible asset | 7,268,143 | |
Operating Loss | (11,457,061) | (27,525,431) |
Other Income (Expense) | ||
Interest income, net | 335,541 | 101,202 |
Net Operating Loss Before Income Tax Benefit | (11,121,520) | (27,424,229) |
Income Tax Benefit | ||
Net Loss | $ (11,121,520) | $ (27,424,229) |
Net Loss Per Common Share - Basic | $ (8.48) | $ (34.05) |
Net Loss Per Common Share - Diluted | $ (8.48) | $ (34.05) |
Weighted Average Common Shares Used to Compute Net Loss Per Common Shares - Basic | 1,311,572 | 805,477 |
Weighted Average Common Shares Used to Compute Net Loss Per Common Shares - Diluted | 1,311,572 | 805,477 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock, Common [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2021 | $ 79 | $ 62,308,353 | $ (36,823,332) | $ 25,485,100 | |
Balance. shares at Dec. 31, 2021 | 785,512 | ||||
Acquisition of treasury stock | $ (300,000) | (300,000) | |||
Acquisition of treasury stock, shares | (5,000) | ||||
Stock-based compensation | $ 1 | 8,948,712 | 8,948,713 | ||
Stock-based compensation, shares | 11,890 | ||||
Shares issued in connection with the Purchase Agreement with Lincoln Park | $ 1 | 449,999 | 450,000 | ||
Shares issued in connection with the Purchase Agreement with Lincoln Park, shares | 6,181 | ||||
Shares issued in connection with license agreement | 400,000 | 400,000 | |||
Shares issued in connection with license agreement, shares | 5,000 | ||||
Shares withheld to pay income taxes on stock-based compensation | $ (1) | (88,842) | (88,843) | ||
Shares withheld to pay income taxes on stock-based compensation, shares | (1,809) | ||||
Net loss | (27,424,229) | (27,424,229) | |||
Balance at Dec. 31, 2022 | $ 80 | 72,018,222 | $ (300,000) | (64,247,561) | 7,470,741 |
Balance. shares at Dec. 31, 2022 | 806,774 | (5,000) | |||
Stock-based compensation | $ 1 | 1,060,338 | 1,060,339 | ||
Stock-based compensation, shares | 6,945 | ||||
Net loss | (11,121,520) | (11,121,520) | |||
Shares issued in connection with capital raises, net of transaction costs | $ 42 | 6,352,035 | 6,352,077 | ||
Shares issued in connection with capital raises, net of transaction costs, shares | 421,611 | ||||
Warrant granted in connection with a consulting agreement | 1,310,875 | 1,310,875 | |||
Settlement of stock award | (52,746) | (52,746) | |||
Other | $ 6 | (30,613) | (30,607) | ||
Other, shares | 55,670 | ||||
Balance at Dec. 31, 2023 | $ 129 | $ 80,658,111 | $ (300,000) | $ (75,369,081) | $ 4,989,159 |
Balance. shares at Dec. 31, 2023 | 1,291,000 | (5,000) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash Flows From Operating Activities | ||
Net Loss | $ (11,121,520) | $ (27,424,229) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 222 | |
Non-cash lease expense for right-of-use assets | 81,530 | 85,518 |
Non-cash milestone expense in connection with license agreement | 189,000 | |
Amortization of debt issuance costs | 115,613 | |
Amortization of intangible asset | 788,495 | |
Impairment of intangible asset | 7,268,143 | |
Stock-based compensation | 1,060,339 | 8,828,713 |
Warrants issued to purchase 158,007 shares of common stock | 1,310,875 | |
Net changes in operating assets and liabilities: | ||
Prepaid expenses and other | 956,834 | 210,549 |
Operating lease liability | (78,896) | (87,937) |
Accounts payable | (15,931) | 108,643 |
Due (from) to related parties | (12) | (1,721) |
Other receivables | 70,274 | |
Accrued expenses | (256,787) | 243,796 |
Net cash (used in) operating activities | (8,063,346) | (9,605,143) |
Cash Flows From Investing Activities | ||
Purchase of property and equipment | (2,776) | |
Net cash (used in) provided by investing activities | (2,776) | |
Cash Flows From Financing Activities | ||
Net proceeds from issuance of stock | 6,321,470 | |
Shares withheld to pay taxes on stock-based compensation | (88,843) | |
Settlement of stock award | (52,746) | |
Acquisition of treasury stock | (300,000) | |
Net cash (used in) provided by financing activities | 6,268,724 | (388,843) |
Net (Decrease) Increase in Cash and Cash Equivalents | (1,797,398) | (9,993,986) |
Cash and Cash Equivalents - Beginning of Year | 6,503,595 | 16,497,581 |
Cash and Cash Equivalents - End of Year | 4,706,197 | 6,503,595 |
Supplemental Cash Flow Information: | ||
Cash paid for interest | ||
Cash paid for income taxes | ||
Non-Cash Financing Activities | ||
Issuance of 880 shares of common stock in satisfaction of accrued director fees | 120,000 | |
Issuance of 5,000 shares of common stock in connection with a licensing agreement which had previously been recorded as a due to licensor | 400,000 | |
Issuance of 6,181 shares of common stock in connection with the Purchase Agreement with Lincoln Park | 450,000 | |
Right-of-use asset obtained in exchange for operating lease liability | (238,924) | |
Operating lease liability | 238,924 | |
Net |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) | 12 Months Ended |
Dec. 31, 2022 shares | |
Common Stock [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Shares issued in satisfaction of accrued director fees | 880 |
Shares issued in connection with license agreement | 5,000 |
Shares issued in connection with the Purchase Agreement with Lincoln Park | 6,181 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure [Table] | ||
Net Income (Loss) Attributable to Parent | $ (11,121,520) | $ (27,424,229) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual [Table] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Organization
Organization | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Note 1 – Organization Organization We are a clinical-stage biopharmaceutical company focused on incorporating our Regulatory Science Approach into the development of our Next Generation Chemotherapy (NGC) drugs to improve the safety and efficacy of cancer treatment. Our NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution while maintaining the well-known and established existing mechanisms of killing the cancer cells. By modifying the NGC drugs in this manner, we believe our three NGC treatments will provide improved safety-efficacy profiles when compared to their currently marketed counterparts. On January 22, 2024, we filed a Certificate of Amendment to our Certificate of Incorporation, as amended with the Secretary of State of Delaware that effected a 1-for-20 reverse stock split 0.0001 24,706,474 1,291,000 24,606,474 1,286,000 100,000,000 Liquidity Our consolidated financial statements have been prepared on a going concern basis, which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. We have incurred losses since inception, currently devoting substantially all of our efforts toward research and development of our next generation chemotherapy drug product candidates, including conducting clinical trials and providing general and administrative support for these operations, and have an accumulated deficit of $ 75.4 11.1 8.1 We have financed our operations primarily through public equity issuances, including an offering we closed on January 30, 2024 where we sold 476,000 1,079,555 1,555,555 6.3 million, after deducting placement agent fees and offering-related expenses (see Note 13 for additional details). Simultaneously with the closing of the sale, the pre-funded warrants were exercised in exchange for 1,079,555 At December 31, 2023, we had cash and cash equivalents totaling $ 4.7 million. Together with the $ 6.3 million net proceeds we raised in January 2024, and based on our current business plans, we believe these funds will satisfy our capital needs into early 2025. Our ability to execute our longer-term operating plans, including future preclinical studies and clinical trials for our portfolio of drugs depend on our ability to obtain additional funding from the sale of equity and/or debt securities, a strategic transaction or other funding transactions. We plan to raise additional funds in the future through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements, but will only do so if the terms are acceptable to us. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or planned future clinical trial plans, or research and development programs. This may also cause us to not meet obligations contained in certain of our license agreements and put these assets at risk. To the extent that we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. There can be no assurance that future funding will be available when needed. Absent additional funding, we believe that our cash and cash equivalents will not be sufficient to fund our operations for a period of one year or more after the date that these consolidated financial statements are available to be issued based on the timing and amount of our projected net loss from continuing operations and cash to be used in operating activities during that period of time. As a result, substantial doubt exists about our ability to continue as a going concern within one year after the date that these consolidated financial statements are available to be issued. The accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded assets, or the amounts and classification of liabilities that might be different should we be unable to continue as a going concern based on the outcome of these uncertainties described above. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Note 2 – Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (the “SEC”), and reflect all of our activities, including those of our wholly-owned subsidiary. All material intercompany accounts and transactions have been eliminated in consolidation. Operating results for the year ended December 31, 2023 are not necessarily indicative of future results. Use of Estimates In preparing our consolidated financial statements and related disclosures in conformity with GAAP and pursuant to the rules and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the consolidated financial statements and accompanying notes. Estimates are used for, but not limited to stock-based compensation, intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable, actual results could differ materially from those estimates and could impact future results of operations and cash flows. Cash and Cash Equivalents Cash and cash equivalents include cash on hand and money market funds. We consider all highly liquid investments maturing within three months from the date of purchase as cash equivalents. Property and Equipment Property is stated at cost, less accumulated depreciation. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Expenditures for maintenance and routine repairs are charged to expense as incurred. Depreciation is recognized on a straight-line basis over the estimated useful lives of the assets, which generally range from 3 5 Intangible Assets Intangible assets acquired individually or with a group of other assets from others (other than in a business combination) are recognized at cost, including transaction costs, and allocated to the individual assets acquired based on relative fair values and no goodwill is recognized. Cost is measured based on cash consideration paid. If consideration given is in the form of non-cash assets, liabilities incurred, or equity interests issued, measurement of cost is based on either the fair value of the consideration given or the fair value of the assets (or net assets) acquired, whichever is more evident and more reliably measurable. Costs of internally developing, maintaining or restoring intangible assets that are not specifically identifiable, have indeterminate lives or are inherent in a continuing business are expensed as incurred. Intangible assets purchased from others for use in research and development activities and that have alternative future uses (in research and development projects or otherwise) are capitalized in accordance with ASC Topic 350, Intangibles – Goodwill and Other. Intangibles with a finite useful life are amortized using the straight-line method unless the pattern in which the economic benefits of the intangible assets are consumed or used up are reliably determinable. The useful life is the best estimate of the period over which the asset is expected to contribute directly or indirectly to our future cash flow. The useful life is based on the duration of the expected use of the asset by us and the legal, regulatory or contractual provisions that constrain the useful life and future cash flows of the asset, including regulatory acceptance and approval, obsolescence, demand, competition and other economic factors. We evaluate the remaining useful life of intangible assets each reporting period to determine whether any revision to the remaining useful life is required. If the remaining useful life is changed, the remaining carrying amount of the intangible asset will be amortized prospectively over the revised remaining useful life. If an income approach is used to measure the fair value of an intangible asset, we consider the period of expected cash flows used to measure the fair value of the intangible asset, adjusted as appropriate for company-specific factors discussed above, to determine the useful life for amortization purposes. If no regulatory, contractual, competitive, economic or other factors limit the useful life of the intangible to us, the useful life is considered indefinite. Intangibles with an indefinite useful life are not amortized until its useful life is determined to be no longer indefinite. If the useful life is determined to be finite, the intangible is tested for impairment and the carrying amount is amortized over the remaining useful life in accordance with intangibles subject to amortization. Indefinite-lived intangibles are tested for impairment annually and more frequently if events or circumstances indicate that it is more-likely-than-not that the asset is impaired. Impairment of Long-Lived Assets and Intangibles Other Than Goodwill We account for the impairment of long-lived assets in accordance with ASC 360 , Property, Plant and Equipment Intangibles – Goodwill and Other, 7.3 million during the year ended December 31, 2022 (see Note 8). Fair Value Measurements and Disclosure We apply ASC 820, Fair Value Measurements and Disclosures Fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows: Level 1 – Quoted market prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity can access at the measurement date. Level 2 – Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. Fair value determined using models or other valuation methodologies. Level 3 – Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data. Fair value is determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where there is little market activity for the asset or liability. The asset’s or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to the fair value measurement. Our policy is to recognize transfers between levels of the fair value hierarchy in the period the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, 2, or 3 during the periods presented. Stock-based Compensation We measure compensation expense for stock options and other stock awards in accordance with ASC 718, Compensation—Stock Compensation For awards that contain performance vesting conditions, we do not recognize compensation expense until achieving the performance condition is probable. We estimate the fair value of stock option and warrant grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. We value restricted stock awards (RSAs) and restricted stock units (RSUs) based on the closing share price of our common stock on the date of grant. Stock-based compensation costs are recorded as general and administrative or research and development costs in the statements of operations based upon the underlying individual’s or entity’s role. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by employees or consultants who receive these awards, and subsequent events are not indicative of the reasonableness of our original estimates of fair value. We account for forfeitures in the period in which they occur, rather than estimate expected forfeitures. Net Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted average common stock outstanding (which excludes unvested RSAs) and vested, but unissued RSUs. Diluted loss per share is computed by dividing our net loss available to common shareholders by the diluted weighted average number of shares of common stock outstanding during the period. Since we have experienced a net loss for all periods presented, basic and diluted net loss per share are the same. As such, diluted loss per share for the years ended December 31, 2023 and 2022 excludes the impact of potentially dilutive common shares related to outstanding stock options, unvested restricted stock awards (RSAs), unvested RSUs and purchase warrants. Our diluted net loss per share for the years ended December 31, 2023 and 2022 excluded 296,326 128,943 Segments We operate in one Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable and accounts payable approximate their fair value because of the short-term maturity of these instruments. Research and development Research and development costs are expensed as incurred and consist of direct and overhead-related expenses related primarily to clinical trials, including development personnel salaries and related costs. Research and development costs totaled $ 5,799,518 11,494,230 Income Taxes We account for income taxes in accordance with ASC Topic 740, Income Taxes. 7.4 We recognize the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. Our policy is to record interest and penalties related to income taxes as part of its income tax provision. As of December 31, 2023, we had no Recent Accounting Pronouncements From time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”). We have implemented all new accounting pronouncements that are in effect and that may impact our financial statements. We have considered all recent accounting pronouncements issued since the last audit of our consolidated financial statements. We believe that these recent pronouncements will not have a material effect on our consolidated financial statements. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation | Note 3 - Stock-based Compensation T he Processa Pharmaceuticals Inc. 2019 Omnibus Equity Incentive Plan (the “2019 Plan”) allows us to make grants of stock options, restricted and unrestricted stock and other stock-based awards to employees, including our executive officers, consultants and directors. The 2019 Plan originally provided for the aggregate issuance of 150,000 150,000 300,000 27,326 Stock Compensation Expense We recorded stock-based compensation expense for the years ended December 31, 2023 and 2022 as follows: Schedule of Stock-based Compensation Expense 2023 2022 Year Ended 2023 2022 Research and development $ 363,956 $ 2,895,653 General and administrative 2,007,258 5,933,060 Total $ 2,371,214 $ 8,828,713 No tax benefits were attributed to the stock-based compensation expense because a valuation allowance was maintained for all net deferred tax assets relating to this expense. Stock Options The following table summarizes our stock option activity during the years ended December 31, 2022 and 2023: Schedule of Stock Option Activity Total options Outstanding Weighted average exercise price Weighted average remaining contractual life (in years) Outstanding as of January 1, 2022 8,943 $ 341.34 Options granted - Forfeited - Outstanding as of December 31, 2022 8,943 341.34 2.6 Options granted - Forfeited or expired (1,951 ) 257.28 Outstanding and exercisable as of December 31, 2023 6,992 $ 364.72 2.1 No forfeiture rate was applied to these stock options. The aggregate intrinsic value of outstanding options, all of which are exercisable, was $ 0 No stock options were exercised during the years ended December 31, 2023 or 2022 and there is no unamortized expense at either December 31, 2023 or 2022 since the options are fully vested. Restricted Stock Awards The following table summarizes our restricted stock award (RSA) activity during the years ended December 31, 2022 and 2023: Schedule of Restricted Stock Awards (“RSAs”) Activity Number of Weighted- Unvested as of January 1, 2022 4,555 $ 157.81 Granted 9,358 74.27 Forfeited (1,676 ) 110.62 Vested and issued (9,142 ) 100.88 Unvested as of December 31, 2022 3,095 94.44 Granted 10,750 14.59 Forfeited (1,250 ) 133.00 Cancelled (2,555 ) 22.13 Vested and issued (8,790 ) 24.44 Unvested as of December 31, 2023 1,250 $ 9.26 As of December 31, 2023, unrecognized stock-based compensation expense for RSAs of $ 5,825 On January 1, 2023, we granted RSAs totaling 4,500 1,305 On July 14, 2023, we granted RSAs totaling 6,250 3,750 RSAs for up to 2,500 shares of common stock are subject to regaining Nasdaq compliance, with RSAs for only 1,250 shares of common stock vesting if we regain Nasdaq compliance through a reverse stock split. Because we effected a reverse stock-split on January 22, 2024 (which we have retroactively applied to all share counts reported in this Annual Report on Form 10-K) and regained Nasdaq compliance on February 2, 2024. Effective December 31, 2023, we cancelled the RSAs for 1,250 shares of common stock that will not vest. 1,250 72,733 Restricted Stock Units The following table summarizes our restricted stock unit (RSU) activity during the years ended December 31, 2022 and 2023: Schedule of Restricted Stock Units (“RSUs”) Activity Number of Weighted- Outstanding at January 1, 2022 22,008 $ 155.29 Granted 121,439 61.50 Forfeited (3,431 ) 101.73 Cancelled (1,876 ) 171.58 Issued (2,399 ) 79.07 Outstanding at December 31, 2022 135,741 73.81 Granted 116,078 14.18 Forfeited (12,296 ) 21.69 Cancelled (16,801 ) 71.36 Outstanding at December 31, 2023 222,722 45.82 Vested and unissued (115,145 ) 71.90 Unvested at December 31, 2023 107,577 $ 17.90 As of December 31, 2023, unrecognized stock-based compensation expense for RSUs of $ 839,121 1.49 442,024 During the year ended December 31, 2023, we granted RSUs related to the future issuance of 76,078 On August 8, 2023, we also granted RSUs related to the future issuance of 40,000 20,000 20,000 10,000 10,000,000 10,000 10,000,000 Holders of our vested RSUs will be issued shares of our common stock upon the satisfaction of the distribution restrictions contained in their Restricted Stock Unit Award Agreement. The distribution restrictions are typically different (longer) than the vesting schedule, imposing an additional restriction on the holder. Unlike RSAs, while employees may hold fully vested RSUs, the individual does not hold any shares or have any rights of a shareholder until the distribution restrictions are met. Upon distribution to the employee, each RSU converts into one share of our common stock. The RSUs contain dividend equivalent rights. On January 1, 2024, we granted RSUs totaling $ 1.3 30.00 42,149 Warrants The following table summarizes our warrant activity during the years ended December 31, 2022 and 2023. Schedule of Warrants Activity Total warrants outstanding Weighted average exercise price Weighted average remaining contractual life (in years) Outstanding as of January 1, 2022 15,190 $ 213.22 Expired (907 ) 343.28 Outstanding as of December 31, 2022 14,283 205.01 0.9 Granted 173,007 19.27 Expired (6,783 ) 266.96 Not exercisable (7,500 ) 7.40 Outstanding and exercisable as of December 31, 2023 173,007 $ 25.41 2.2 In February 2023, we amended our financial consulting agreement with Spartan by extending the term until February 10, 2024. We compensated Spartan for financial consulting services provided under the amendment by granting warrants to purchase 158,007 20.40 April 17, 2026 15,000 7,500 7.40 November 18, 2025 We used the Black-Scholes option pricing model to calculate the grant date fair value of the two warrants with the following assumptions: Schedule of Stock Option Warrant Valuation Assumption Average risk-free rate of interest 4.32 4.88 % Expected term (years) 2.00 3.00 Expected stock price volatility 82.85 108.47 % Dividend yield 0 % |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 4 – Stockholders’ Equity Preferred Stock There were no Common Stock Increase in Our Authorized Number of Shares Subsequent to receiving shareholder approval on June 27, 2023, we amended our Certificate of Incorporation to increase the number of authorized shares of our common stock from 50,000,000 100,000,000 100,000,000 Financings During the year ended December 31, 2023, we issued 421,611 ● ATM Offering 28,483 shares at an average price of $ 24.40 per share for aggregate gross proceeds of $ 693,000 (net proceeds of $ 672,000 ) prior to deducting sales commissions. ● Lincoln Park Capital Fund, LLC Purchase Agreement – During the year ended December 31, 2023, we sold 2,500 shares at an average price of $ 21.60 per share for aggregate gross proceeds of $ 54,000 under the purchase agreement with Lincoln Park. ● Registered Direct Offering – 390,628 shares of common stock at a purchase price of $ 16.00 per share for gross proceeds of $ 6.3 million (net proceeds of $ 5.6 million). We paid the placement agent, Spartan Capital Securities, LLC, (“Spartan”) a cash fee of 8.0 60,000 158,007 20.40 During the year ended December 31, 2022, we had the following activity: ● On March 23, 2022, we entered into the Purchase Agreement with Lincoln Park, pursuant to which Lincoln Park has committed to purchase shares of our common stock, subject to the terms and conditions in the Purchase Agreement. We issued 6,181 shares of common stock (valued at $ 450,000 ) to Lincoln Park as a commitment fee in connection with entering into the Purchase Agreement and agreed to reimburse Lincoln Park $ 25,000 for fees incurred in connection with the Purchase Agreement. Concurrent with entering into the Purchase Agreement, we also entered into a registration rights agreement with Lincoln Park (the “Registration Rights Agreement”), pursuant to which we agreed to take certain actions relating to the registration under the Securities Act of 1933, as amended, of the offer and sale of the shares of common stock available for issuance under the Purchase Agreement. We have the right to present Lincoln Park with a purchase notice (a “Regular Purchase Notice”), directing Lincoln Park to purchase up to 1,250 1.00 3,750 120.00 150,000 1,250,000 The aggregate number of shares that we can issue to Lincoln Park under the Purchase Agreement may not exceed 157,122 19.99 9.99 We may terminate the Purchase Agreement at any time, at our sole discretion, without any cost or penalty, by giving one business day notice to Lincoln Park to terminate the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the common stock. There are no limitations on use of proceeds, financial or business covenants, restrictions on future financings (other than restrictions on our ability to enter into variable rate transactions described in the Purchase Agreement), rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. We may deliver Purchase Notices under the Purchase Agreement, subject to market conditions, and in light of our capital needs from time to time and under the limitations contained in the Purchase Agreement. Any proceeds that we receive under the Purchase Agreement are expected to be used for working capital and general corporate purposes. ● We issued 5,000 ● Also, during the year ended December 31, 2022, 1,809 911 Treasury Stock - Repurchase of Shares from Aposense, Ltd. On March 29, 2022, we purchased 5,000 300,000 and are holding these shares as treasury stock until they are reissued or retired at the discretion of our Board of Directors. |
Net Loss per Share of Common St
Net Loss per Share of Common Stock | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss per Share of Common Stock | Note 5 – Net Loss per Share of Common Stock Basic net loss per share is computed by dividing net loss by the weighted average common stock outstanding (which excludes unvested RSAs) and vested, but unissued RSUs. Diluted net loss per share is computed by dividing net loss by the diluted weighted average common stock outstanding, which includes potentially dilutive effect of stock options, unvested RSAs, unvested RSUs and warrants. The treasury-stock method is used to determine the dilutive effect of our stock options and warrants grants. Since we experienced a loss for both periods presented, basic and diluted net loss per share are the same and, as they would have an anti-dilutive impact on diluted net loss per share, any dilutive common shares outstanding were excluded from the computation shown below. The computation of net loss per share for the year ended December 31, 2023 and 2022 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2023 2022 Basic and diluted net loss per share: Net loss available to common shareholders $ (11,121,520 ) $ (27,424,229 ) Weighted-average number of common shares-basic and diluted 1,311,572 805,477 Basic and diluted net loss per share $ (8.48 ) $ (34.05 ) 2023 2022 Weighted-average number of common shares outstanding – basic and diluted 1,186,952 786,461 Weighted-average number of vested RSUs– basic and diluted 124,619 19,016 Weighted-average number of common shares-basic and diluted 1,311,572 805,477 As described in Note 3, we issued various equity instruments during the years ended December 31, 2023 and 2022 which impact our EPS calculation. All granted RSAs are considered issued and outstanding for purposes of our financial statements. Unvested RSAs are included as dilutive securities, but are excluded from our denominator of basic EPS. At December 31, 2023 and 2022, 1,250 3,095 107,577 102,623 The outstanding stock options, unvested RSAs, unvested RSUs and warrants to purchase common stock were excluded from the computation of diluted net loss per share as their effect would have been anti-dilutive for the periods presented below: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share 2023 2022 Stock options, unvested RSAs, unvested RSUs and purchase warrants 296,326 128,943 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Leases | Note 6 – Leases We lease our office space under an operating lease agreement. This lease does not have significant rent escalation, concessions, leasehold improvement incentives, or other build-out clauses. Further, the lease does not contain contingent rent provisions. Our office space lease includes both lease (e.g., fixed payments including rent, taxes, and insurance costs) and non-lease components (e.g., common-area or other maintenance costs), which are accounted for as a single lease component as we have elected the practical expedient to group lease and non-lease components for all leases. We also lease office equipment under an operating lease. Our leases do not provide an implicit rate and, as such, we have used our incremental borrowing rate of 8 Lease costs included in our consolidated statements of operations totaled $ 97,000 Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases Remaining lease term (years) for our office lease 1.8 Remaining lease term (years) for our equipment lease 0.3 Weighted average remaining lease term (years) for our facility and equipment leases 1.7 Weighted average discount rate for our facility and equipment leases 8.0 % Annual lease liabilities for all operating leases were as follows as of December 31, 2023: Schedule of Annual Lease Liabilities for all Operating Leases 2024 $ 92,389 2025 70,040 Total lease payments 162,429 Less: Interest (11,875 ) Present value of lease liabilities 150,554 Less: current maturities (83,649 ) Non-current lease liability $ 66,905 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2023 | |
License Agreements | |
License Agreements | Note 7 – License Agreements Elion Oncology, Inc. On August 23, 2020, we entered into a condition precedent License Agreement with Elion Oncology (“Elion License Agreement”), pursuant to which we acquired an exclusive license to develop, manufacture and commercialize PCS6422 globally. As part of the Elion License Agreement, we agreed to issue to Elion 5,000 shares of our common stock on each of the first and second anniversary dates of the Elion License Agreement. On May 17, 2022, we amended the third Milestone Event of Section 6.4 of our License Agreement with Elion Oncology, Inc. changing the third Milestone Event from “1 st 189,000 5,000 We are required to use commercially reasonable efforts, at our sole cost and expense to research, develop and commercialize products in one or more countries, including dosing a first patient with a product in a Phase 2 or 3 clinical trial within 48 months from when we entered into the License Agreement. We are currently on track to dose our first patient in a Phase 2 clinical trial on or before October 2, 2024. Either party may terminate the agreement in the event of a material breach of the agreement that has not been cured following written notice and a 90-day opportunity to cure such breach (which is shortened to 15 days for a payment breach). Ocuphire Pharma, Inc. On June 16, 2021, we executed a License Agreement with Ocuphire Pharma, Inc. (“Ocuphire Agreement”) under which we received a license to research, develop and commercialize PCS3117 globally, excluding the Republic of Singapore, China, Hong Kong, Macau and Taiwan 2,235 shares of our common stock to Ocuphire, a cash payment of $ 200,000 and assumed $ 66,583 in certain liabilities. Additional consideration includes future development and regulatory milestones payments to Ocuphire upon our achievement of certain defined clinical milestones, such as dosing a patient in pivotal trials and receiving marketing authorization by a regulatory authority in the United States or another country. In addition, we are required to pay Ocuphire one-time sales milestone payments based on the achievement during a calendar year of the highest annual Net Sales for products made and pay royalties based on annual Net Sales, as defined in the Ocuphire Agreement. We are required to use commercially reasonable efforts, at our sole cost and expense to oversee such commercialization efforts, to research, develop and commercialize products in one or more countries, including meeting specific diligence milestones that consist of: (i) first patient administered drug in a Clinical Trial of a Product prior to June 16, 2024 and (ii) first patient administered drug in a Pivotal Clinical Trial of a Product or first patient administered drug in a Clinical Trial for a Second Indication of a Product prior to June 16, 2026. We are currently in discussions with Ocuphire to extend these deadlines. Aposense, Ltd. On May 24, 2020, we entered into a condition precedent License Agreement with Aposense, Ltd. (“Aposense License Agreement”), pursuant to which we were granted Aposense’s patent rights and Know-How to develop and commercialize their next generation irinotecan cancer drug, PCS11T. The Aposense License Agreement provides us with an exclusive worldwide license (excluding China), to research, develop and commercialize products comprising or containing PCS11T. The license grant was conditioned on the following being satisfied within nine months of May 24, 2020 (or the Aposense License Agreement shall terminate): (i) our closing of an equity financing and successful up-listing to Nasdaq and (ii) Aposense obtaining the approval of the Israel Innovation Authority for the consummation of the transactions contemplated by the Aposense License Agreement. On October 6, 2020, all conditions were satisfied, resulting in the addition of PCS11T to our portfolio, and we issued 31,250 shares of our common stock to Aposense. As additional consideration, we will pay Aposense development and regulatory milestone payments (up to $ 3.0 Yuhan Corporation On August 19, 2020, we entered into a License Agreement with Yuhan Corporation (“Yuhan License Agreement”), pursuant to which we acquired an exclusive license to develop, manufacture and commercialize PCS12852 globally, excluding South Korea. 25,000 shares of common stock. As additional consideration, we will pay Yuhan development and regulatory milestone payments (a portion of which are payable in shares of our common stock based on the volume weighted average trading price during the period prior to such achievement and a portion of which are payable in cash) upon the achievement of certain milestones, based on a Yuhan affiliate purchasing 37,500 shares of common stock for $ 3,000,000 in our October 2020 underwritten public offering. The milestones primarily consist of dosing a patient in pivotal trials or having a drug indication approved by a regulatory authority in the United States or another country. In addition, we must pay Yuhan one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. We are also required to split any milestone payments received with Yuhan based on any sub-license agreement we may enter. We are required to use commercially reasonable efforts, at our sole cost and expense, in conjunction with a joint Processa-Yuhan Board to oversee such commercialization efforts, to research, develop and commercialize products in one or more countries, including meeting specific diligence milestones that consist of: (i) preparing a first draft of the product development plan within 90 days; (ii) requesting an FDA pre-IND meeting for a product within 6 months; (iii) dosing a first patient in a Phase 2A clinical trial with a product within 24 months; and (iv) dosing a first patient with a product in a Phase 2B clinical trial, Phase 3 clinical trial or other pivotal clinical trial with a product by August 19, 2024. CoNCERT Pharmaceuticals, Inc. On March 19, 2018, Promet, Processa and CoNCERT amended the CoNCERT Agreement executed in October 2017. The Amendment assigned the CONCERT Agreement to us and we exercised the exclusive option for the PCS499 compound in exchange for CoNCERT receiving, in part, $ 8.0 million of our common stock that was held by Promet ( 14,931 shares), for the benefit of Processa in satisfaction of the obligation due for the exclusive license for PCS499 acquired by us. Promet contributed the payment of the obligation due for the exclusive license to us without consideration paid to them. As a result of the transaction, we recognized an exclusive license intangible asset with a fair value of $ 8.0 million and an offsetting increase in additional paid-in capital resulting from the exchange. We fully impaired the intangible asset in 2022. We are required to pay CoNCERT royalties, on a product–by-product basis, on future worldwide net sales, or pay a percentage of any sublicense revenue, as described in the License Agreement with CoNCERT. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Note 8 - Intangible Assets Our gross intangible assets consisted primarily of costs we capitalized related to the acquisition of license rights to PCS499 from CoNCERT Pharmaceuticals. Inc. (“CoNCERT”) for shares of our common stock that had an issue date fair value of $ 8.0 1,782 3,037,147 1,782 Income Taxes Research and Development Intangible assets at December 31, 2023 and 2022 consisted of the following: Summary of Intangible Assets 2023 2022 Gross intangible assets $ - $ 11,059,429 Less: accumulated amortization - (3,791,286 ) Less: impairment of intangible asset - (7,268,143 ) Total intangible assets, net $ - $ - Amortization expense was $ 788,495 for the year ended December 31, 2022 and is included within research and development expense in the accompanying consolidated statements of operations. We did not have a similar expense during the year ended December 31, 2023. At December 31, 2022, following the difficulty we experienced to enroll patients in our Phase 2B clinical trial in PCS499, we terminated the trial for uNL. We recognized an impairment for remaining book value of the intangible asset of $ 7.3 million, thereby reducing the value of our intangible asset to zero. Our assessment was based on the uncertainty of determining whether we will be able to out-license PCS499 or enter a partnering/collaborating arrangement for its future development. We believe the rarity of the disease, along with other factors, makes enrollment not feasible for us due to time and cost constraints. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 9 - Income Taxes We have incurred net operating losses since inception. At December 31, 2023 and 2022, we had available federal and state net operating loss carryforwards of $ 28.6 24.0 29.3 2037 20 Pursuant to Code Sec. 382 of the Internal Revenue Code (“the Code”), the utilization of our net operating loss carryforwards could be limited as a result of a cumulative change in stock ownership of more than 50% over a three-year period. We have not completed a Sec. 382 study and as such our net operating loss carryforwards may be subject to such limitation. A reconciliation of our effective income tax rate and statutory income tax rate for the years ended December 31, 2023 and 2022 is as follows: Schedule of Effective Income Tax Rate Reconciliation 2023 2022 Year Ended December 31, 2023 2022 Federal statutory income tax rate 21.00 % 21.00 % State tax rate, net 5.77 % 5.72 % Permanent differences (0.25 )% (0.55 )% Federal orphan drug tax credit 1.41 % 0.93 % Deferred tax asset valuation allowance (27.93 )% (27.10 )% Effective income tax rate 0.00 % 0.00 % The significant components of our deferred tax assets and liabilities for Federal and state income taxes consisted of the following: Schedule of Deferred Tax Assets and Liabilities 2023 2022 December 31, 2023 2022 Deferred tax assets: Non-current: Net operating loss carry forward – Federal $ 6,012,941 $ 5,048,175 Net operating loss carry forward – State 1,672,436 1,431,839 Stock compensation expense 3,453,799 2,590,890 Depreciation and other 999 976 Purchased in-process R&D 2,500,562 2,494,829 Federal orphan drug credits 1,202,955 1,046,539 Capitalized research and development costs 2,795,379 1,929,462 Start-up expenditures and amortization - - Total non-current deferred tax assets 17,639,071 14,542,710 Valuation allowance for deferred tax assets (17,639,071 ) (14,542,710 ) Total deferred tax assets - - Deferred Tax Liabilities: Non-current: Intangible asset - - Total non-current deferred tax liabilities - - Total deferred tax asset (liability) $ - $ - Beginning in 2022, the Tax Cuts and Jobs Act of 2017 (TCJA) eliminated the option to deduct research and development expenditures in the current year and requires taxpayers to amortize them over five or fifteen years pursuant to IRC Section 174. During 2023 and 2022, for income tax purposes, we capitalized approximately $ 3.2 7.2 In 2022, as part of an evaluation of our tax attributes, we recharacterized approximately $ 7.4 The valuation allowance generally reflects limitations on our ability to use the tax attributes and reduces the value of such attributes to the more-likely-than-not realizable amount. We assessed the available positive and negative evidence to estimate if sufficient taxable income will be generated to use the existing net deferred tax assets. Based on a weighing of the objectively verifiable negative evidence primarily in the form of cumulative operating losses, we believe that it is not more-likely-than-not that the deferred tax assets will be realized and, accordingly, a full valuation allowance has been established. The valuation allowance increased by $ 3.1 7.4 We recognize potential liabilities for uncertain tax positions using a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more-likely-than-not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon settlement. We have not recorded any uncertain tax positions. As of December 31, 2023 and 2022, we had no We file U.S. Federal income tax returns, as well as state tax returns for California, Florida and Maryland. There are currently no income tax examinations underway for these jurisdictions. However, tax years from and including 2017 remain open for examination by federal and state income tax authorities. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 10 – Related Party Transactions CorLyst, LLC (“CorLyst”) reimburses us for shared costs related to payroll, health insurance and rent based on actual costs incurred, which are recognized as a reduction of our general and administrative operating expenses in our consolidated statements of operations. We recorded $ 112,000 124,000 No |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 11 – Commitments and Contingencies Purchase Obligations We enter contracts in the normal course of business with contract research organizations and subcontractors to further develop our products. The contracts are cancellable, with varying provisions regarding termination. If we terminated a cancellable contract with a specific vendor, we would only be obligated for products or services that we received as of the effective date of the termination and any applicable cancellation fees. As of December 31, 2023, we are contractually obligated to pay up to approximately $ 1.4 |
Concentration of Credit Risk
Concentration of Credit Risk | 12 Months Ended |
Dec. 31, 2023 | |
Risks and Uncertainties [Abstract] | |
Concentration of Credit Risk | Note 12 – Concentration of Credit Risk Financial instruments that potentially subject us to significant concentration of credit risk consist primarily of our cash and cash equivalents. We utilize only well-established banks and financial institutions with high credit ratings. Balances on deposit are insured by the Federal Deposit Insurance Corporation (FDIC) up to specified limits. Total cash held by our banks at December 31, 2023, exceeded FDIC limits. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 13 – Subsequent Events On January 30, 2024, we sold, pursuant to securities purchase agreements (the “Purchase Agreement”), 476,000 1,079,555 1,555,555 4.50 five years 4.50 4.4999 0.0001 1,079,555 7.0 6.3 62,222 5.625 February 1, 2027 |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (the “SEC”), and reflect all of our activities, including those of our wholly-owned subsidiary. All material intercompany accounts and transactions have been eliminated in consolidation. Operating results for the year ended December 31, 2023 are not necessarily indicative of future results. |
Use of Estimates | Use of Estimates In preparing our consolidated financial statements and related disclosures in conformity with GAAP and pursuant to the rules and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the consolidated financial statements and accompanying notes. Estimates are used for, but not limited to stock-based compensation, intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable, actual results could differ materially from those estimates and could impact future results of operations and cash flows. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include cash on hand and money market funds. We consider all highly liquid investments maturing within three months from the date of purchase as cash equivalents. |
Property and Equipment | Property and Equipment Property is stated at cost, less accumulated depreciation. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Expenditures for maintenance and routine repairs are charged to expense as incurred. Depreciation is recognized on a straight-line basis over the estimated useful lives of the assets, which generally range from 3 5 |
Intangible Assets | Intangible Assets Intangible assets acquired individually or with a group of other assets from others (other than in a business combination) are recognized at cost, including transaction costs, and allocated to the individual assets acquired based on relative fair values and no goodwill is recognized. Cost is measured based on cash consideration paid. If consideration given is in the form of non-cash assets, liabilities incurred, or equity interests issued, measurement of cost is based on either the fair value of the consideration given or the fair value of the assets (or net assets) acquired, whichever is more evident and more reliably measurable. Costs of internally developing, maintaining or restoring intangible assets that are not specifically identifiable, have indeterminate lives or are inherent in a continuing business are expensed as incurred. Intangible assets purchased from others for use in research and development activities and that have alternative future uses (in research and development projects or otherwise) are capitalized in accordance with ASC Topic 350, Intangibles – Goodwill and Other. Intangibles with a finite useful life are amortized using the straight-line method unless the pattern in which the economic benefits of the intangible assets are consumed or used up are reliably determinable. The useful life is the best estimate of the period over which the asset is expected to contribute directly or indirectly to our future cash flow. The useful life is based on the duration of the expected use of the asset by us and the legal, regulatory or contractual provisions that constrain the useful life and future cash flows of the asset, including regulatory acceptance and approval, obsolescence, demand, competition and other economic factors. We evaluate the remaining useful life of intangible assets each reporting period to determine whether any revision to the remaining useful life is required. If the remaining useful life is changed, the remaining carrying amount of the intangible asset will be amortized prospectively over the revised remaining useful life. If an income approach is used to measure the fair value of an intangible asset, we consider the period of expected cash flows used to measure the fair value of the intangible asset, adjusted as appropriate for company-specific factors discussed above, to determine the useful life for amortization purposes. If no regulatory, contractual, competitive, economic or other factors limit the useful life of the intangible to us, the useful life is considered indefinite. Intangibles with an indefinite useful life are not amortized until its useful life is determined to be no longer indefinite. If the useful life is determined to be finite, the intangible is tested for impairment and the carrying amount is amortized over the remaining useful life in accordance with intangibles subject to amortization. Indefinite-lived intangibles are tested for impairment annually and more frequently if events or circumstances indicate that it is more-likely-than-not that the asset is impaired. |
Impairment of Long-Lived Assets and Intangibles Other Than Goodwill | Impairment of Long-Lived Assets and Intangibles Other Than Goodwill We account for the impairment of long-lived assets in accordance with ASC 360 , Property, Plant and Equipment Intangibles – Goodwill and Other, 7.3 million during the year ended December 31, 2022 (see Note 8). |
Fair Value Measurements and Disclosure | Fair Value Measurements and Disclosure We apply ASC 820, Fair Value Measurements and Disclosures Fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows: Level 1 – Quoted market prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity can access at the measurement date. Level 2 – Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. Fair value determined using models or other valuation methodologies. Level 3 – Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data. Fair value is determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where there is little market activity for the asset or liability. The asset’s or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to the fair value measurement. Our policy is to recognize transfers between levels of the fair value hierarchy in the period the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, 2, or 3 during the periods presented. |
Stock-based Compensation | Stock-based Compensation We measure compensation expense for stock options and other stock awards in accordance with ASC 718, Compensation—Stock Compensation For awards that contain performance vesting conditions, we do not recognize compensation expense until achieving the performance condition is probable. We estimate the fair value of stock option and warrant grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. We value restricted stock awards (RSAs) and restricted stock units (RSUs) based on the closing share price of our common stock on the date of grant. Stock-based compensation costs are recorded as general and administrative or research and development costs in the statements of operations based upon the underlying individual’s or entity’s role. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by employees or consultants who receive these awards, and subsequent events are not indicative of the reasonableness of our original estimates of fair value. We account for forfeitures in the period in which they occur, rather than estimate expected forfeitures. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted average common stock outstanding (which excludes unvested RSAs) and vested, but unissued RSUs. Diluted loss per share is computed by dividing our net loss available to common shareholders by the diluted weighted average number of shares of common stock outstanding during the period. Since we have experienced a net loss for all periods presented, basic and diluted net loss per share are the same. As such, diluted loss per share for the years ended December 31, 2023 and 2022 excludes the impact of potentially dilutive common shares related to outstanding stock options, unvested restricted stock awards (RSAs), unvested RSUs and purchase warrants. Our diluted net loss per share for the years ended December 31, 2023 and 2022 excluded 296,326 128,943 |
Segments | Segments We operate in one |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable and accounts payable approximate their fair value because of the short-term maturity of these instruments. |
Research and development | Research and development Research and development costs are expensed as incurred and consist of direct and overhead-related expenses related primarily to clinical trials, including development personnel salaries and related costs. Research and development costs totaled $ 5,799,518 11,494,230 |
Income Taxes | Income Taxes We account for income taxes in accordance with ASC Topic 740, Income Taxes. 7.4 We recognize the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. Our policy is to record interest and penalties related to income taxes as part of its income tax provision. As of December 31, 2023, we had no |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”). We have implemented all new accounting pronouncements that are in effect and that may impact our financial statements. We have considered all recent accounting pronouncements issued since the last audit of our consolidated financial statements. We believe that these recent pronouncements will not have a material effect on our consolidated financial statements. |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Stock-based Compensation Expense | We recorded stock-based compensation expense for the years ended December 31, 2023 and 2022 as follows: Schedule of Stock-based Compensation Expense 2023 2022 Year Ended 2023 2022 Research and development $ 363,956 $ 2,895,653 General and administrative 2,007,258 5,933,060 Total $ 2,371,214 $ 8,828,713 |
Schedule of Restricted Stock Awards (“RSAs”) Activity | The following table summarizes our restricted stock award (RSA) activity during the years ended December 31, 2022 and 2023: Schedule of Restricted Stock Awards (“RSAs”) Activity Number of Weighted- Unvested as of January 1, 2022 4,555 $ 157.81 Granted 9,358 74.27 Forfeited (1,676 ) 110.62 Vested and issued (9,142 ) 100.88 Unvested as of December 31, 2022 3,095 94.44 Granted 10,750 14.59 Forfeited (1,250 ) 133.00 Cancelled (2,555 ) 22.13 Vested and issued (8,790 ) 24.44 Unvested as of December 31, 2023 1,250 $ 9.26 |
Schedule of Restricted Stock Units (“RSUs”) Activity | The following table summarizes our restricted stock unit (RSU) activity during the years ended December 31, 2022 and 2023: Schedule of Restricted Stock Units (“RSUs”) Activity Number of Weighted- Outstanding at January 1, 2022 22,008 $ 155.29 Granted 121,439 61.50 Forfeited (3,431 ) 101.73 Cancelled (1,876 ) 171.58 Issued (2,399 ) 79.07 Outstanding at December 31, 2022 135,741 73.81 Granted 116,078 14.18 Forfeited (12,296 ) 21.69 Cancelled (16,801 ) 71.36 Outstanding at December 31, 2023 222,722 45.82 Vested and unissued (115,145 ) 71.90 Unvested at December 31, 2023 107,577 $ 17.90 |
Schedule of Warrants Activity | The following table summarizes our warrant activity during the years ended December 31, 2022 and 2023. Schedule of Warrants Activity Total warrants outstanding Weighted average exercise price Weighted average remaining contractual life (in years) Outstanding as of January 1, 2022 15,190 $ 213.22 Expired (907 ) 343.28 Outstanding as of December 31, 2022 14,283 205.01 0.9 Granted 173,007 19.27 Expired (6,783 ) 266.96 Not exercisable (7,500 ) 7.40 Outstanding and exercisable as of December 31, 2023 173,007 $ 25.41 2.2 |
Warrant [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Stock Option Warrant Valuation Assumption | We used the Black-Scholes option pricing model to calculate the grant date fair value of the two warrants with the following assumptions: Schedule of Stock Option Warrant Valuation Assumption Average risk-free rate of interest 4.32 4.88 % Expected term (years) 2.00 3.00 Expected stock price volatility 82.85 108.47 % Dividend yield 0 % |
Share-Based Payment Arrangement, Option [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Stock Option Activity | The following table summarizes our stock option activity during the years ended December 31, 2022 and 2023: Schedule of Stock Option Activity Total options Outstanding Weighted average exercise price Weighted average remaining contractual life (in years) Outstanding as of January 1, 2022 8,943 $ 341.34 Options granted - Forfeited - Outstanding as of December 31, 2022 8,943 341.34 2.6 Options granted - Forfeited or expired (1,951 ) 257.28 Outstanding and exercisable as of December 31, 2023 6,992 $ 364.72 2.1 |
Net Loss per Share of Common _2
Net Loss per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share Basic and Diluted | The computation of net loss per share for the year ended December 31, 2023 and 2022 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2023 2022 Basic and diluted net loss per share: Net loss available to common shareholders $ (11,121,520 ) $ (27,424,229 ) Weighted-average number of common shares-basic and diluted 1,311,572 805,477 Basic and diluted net loss per share $ (8.48 ) $ (34.05 ) 2023 2022 Weighted-average number of common shares outstanding – basic and diluted 1,186,952 786,461 Weighted-average number of vested RSUs– basic and diluted 124,619 19,016 Weighted-average number of common shares-basic and diluted 1,311,572 805,477 |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | The outstanding stock options, unvested RSAs, unvested RSUs and warrants to purchase common stock were excluded from the computation of diluted net loss per share as their effect would have been anti-dilutive for the periods presented below: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share 2023 2022 Stock options, unvested RSAs, unvested RSUs and purchase warrants 296,326 128,943 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases | Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases Remaining lease term (years) for our office lease 1.8 Remaining lease term (years) for our equipment lease 0.3 Weighted average remaining lease term (years) for our facility and equipment leases 1.7 Weighted average discount rate for our facility and equipment leases 8.0 % |
Schedule of Annual Lease Liabilities for all Operating Leases | Annual lease liabilities for all operating leases were as follows as of December 31, 2023: Schedule of Annual Lease Liabilities for all Operating Leases 2024 $ 92,389 2025 70,040 Total lease payments 162,429 Less: Interest (11,875 ) Present value of lease liabilities 150,554 Less: current maturities (83,649 ) Non-current lease liability $ 66,905 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Intangible Assets | Intangible assets at December 31, 2023 and 2022 consisted of the following: Summary of Intangible Assets 2023 2022 Gross intangible assets $ - $ 11,059,429 Less: accumulated amortization - (3,791,286 ) Less: impairment of intangible asset - (7,268,143 ) Total intangible assets, net $ - $ - |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of our effective income tax rate and statutory income tax rate for the years ended December 31, 2023 and 2022 is as follows: Schedule of Effective Income Tax Rate Reconciliation 2023 2022 Year Ended December 31, 2023 2022 Federal statutory income tax rate 21.00 % 21.00 % State tax rate, net 5.77 % 5.72 % Permanent differences (0.25 )% (0.55 )% Federal orphan drug tax credit 1.41 % 0.93 % Deferred tax asset valuation allowance (27.93 )% (27.10 )% Effective income tax rate 0.00 % 0.00 % |
Schedule of Deferred Tax Assets and Liabilities | The significant components of our deferred tax assets and liabilities for Federal and state income taxes consisted of the following: Schedule of Deferred Tax Assets and Liabilities 2023 2022 December 31, 2023 2022 Deferred tax assets: Non-current: Net operating loss carry forward – Federal $ 6,012,941 $ 5,048,175 Net operating loss carry forward – State 1,672,436 1,431,839 Stock compensation expense 3,453,799 2,590,890 Depreciation and other 999 976 Purchased in-process R&D 2,500,562 2,494,829 Federal orphan drug credits 1,202,955 1,046,539 Capitalized research and development costs 2,795,379 1,929,462 Start-up expenditures and amortization - - Total non-current deferred tax assets 17,639,071 14,542,710 Valuation allowance for deferred tax assets (17,639,071 ) (14,542,710 ) Total deferred tax assets - - Deferred Tax Liabilities: Non-current: Intangible asset - - Total non-current deferred tax liabilities - - Total deferred tax asset (liability) $ - $ - |
Organization (Details Narrative
Organization (Details Narrative) - USD ($) | 12 Months Ended | |||||
Jan. 30, 2024 | Jan. 22, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | Jan. 21, 2024 | Jun. 27, 2023 | |
OrganizationLineItems [Line Items] | ||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | ||||
Common stock shares issued | 1,291,000 | 806,774 | ||||
Common stock shares outstanding | 1,286,000 | 801,774 | ||||
Common stock shares authorized | 100,000,000 | 50,000,000 | 100,000,000 | |||
Accumulated deficit | $ 75,369,081 | $ 64,247,561 | ||||
Net loss | 11,121,520 | 27,424,229 | ||||
Net cash used in operating activities | 8,063,346 | 9,605,143 | ||||
Net proceeds | 6,321,470 | |||||
Cash and cash equivalents | $ 4,706,197 | $ 6,503,595 | ||||
Subsequent Event [Member] | ||||||
OrganizationLineItems [Line Items] | ||||||
Reverse stock split | 1-for-20 reverse stock split | |||||
Common stock, par value | $ 0.0001 | |||||
Common stock shares issued | 1,291,000 | 24,706,474 | ||||
Common stock shares outstanding | 1,286,000 | 24,606,474 | ||||
Common stock shares authorized | 100,000,000 | |||||
Number of shares, sold | 476,000 | |||||
Net proceeds | $ 6,300,000 | |||||
Subsequent Event [Member] | Pre-Funded Warrants [Member] | ||||||
OrganizationLineItems [Line Items] | ||||||
Warrants to purchase | 1,079,555 | |||||
Warrants, exercised | 1,079,555 | |||||
Subsequent Event [Member] | Warrant [Member] | ||||||
OrganizationLineItems [Line Items] | ||||||
Warrants to purchase | 1,555,555 |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Details Narrative) | 12 Months Ended | |
Dec. 31, 2023 USD ($) Segments shares | Dec. 31, 2022 USD ($) shares | |
Accounting Policies [Line Items] | ||
Impairment of Intangible Assets, Indefinite-Lived (Excluding Goodwill) | $ 7,268,143 | |
Antidilutive securities excluded from computation of earnings per share | shares | 296,326 | 128,943 |
Number of operating segments | Segments | 1 | |
Research and development costs | $ 5,799,518 | $ 11,494,230 |
Operating loss carry forwards | $ 7,400,000 | |
Unrecognized tax benefits | $ 0 | |
Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives of property plant and equipment | 3 years | |
Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives of property plant and equipment | 5 years |
Schedule of Stock-based Compens
Schedule of Stock-based Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 2,371,214 | $ 8,828,713 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | 363,956 | 2,895,653 |
General and Administrative Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 2,007,258 | $ 5,933,060 |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Options outstanding, beginning balance | 8,943 | 8,943 |
Weighted average exercise price, beginning balance | $ 341.34 | $ 341.34 |
Options, granted | ||
Options, forfeited | (1,951) | |
Weighted average remaining contractual term, ending | 2 years 7 months 6 days | |
Weighted average exercise price, forfeited | $ 257.28 | |
Options outstanding and exercisable, ending balance | 6,992 | 8,943 |
Weighted average exercise price, ending balance | $ 364.72 | |
Weighted average remaining contractual term, ending | 2 years 1 month 6 days |
Schedule of Restricted Stock Aw
Schedule of Restricted Stock Awards (“RSAs”) Activity (Details) - Restricted Stock [Member] - $ / shares | 12 Months Ended | ||
Mar. 08, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Number of restricted stock, shares outstanding | 3,095 | 4,555 | |
Weighted-average grant-date fair value per share, Beginning balance | $ 94.44 | $ 157.81 | |
Number of shares, granted | 10,750 | 9,358 | |
Weighted-average grant-date fair value per share, granted | $ 14.59 | $ 74.27 | |
Number of shares, forfeited | (1,250) | (1,676) | |
Weighted-average grant-date fair value per share, forfeited | $ 133 | $ 110.62 | |
Number of shares, vested and issued | (8,790) | (9,142) | |
Weighted-average grant-date fair value per share, vested and issued | $ 24.44 | $ 100.88 | |
Number of shares, cancelled | (1,305) | (2,555) | |
Weighted-average grant-date fair value per share, cancelled | $ 22.13 | ||
Number of restricted stock, shares outstanding | 1,250 | 3,095 | |
Weighted-average grant-date fair value per share, outstanding | $ 9.26 | $ 94.44 |
Schedule of Restricted Stock Un
Schedule of Restricted Stock Units (“RSUs”) Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | ||
Aug. 08, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Number of shares, Beginning balance | 135,741 | 22,008 | |
Weighted-average grant-date fair value per share, Beginning balance | $ 73.81 | $ 155.29 | |
Number of shares, granted | 40,000 | 116,078 | 121,439 |
Weighted-average grant-date fair value per share, granted | $ 14.18 | $ 61.50 | |
Number of shares, forfeited | (12,296) | (3,431) | |
Weighted-average grant-date fair value per share, forfeited | $ 21.69 | $ 101.73 | |
Number of shares, cancelled | (16,801) | (1,876) | |
Weighted-average grant-date fair value per share, cancelled | $ 71.36 | $ 171.58 | |
Number of shares, issued | (2,399) | ||
Weighted-average grant-date fair value per share, shares issued | $ 79.07 | ||
Number of shares, ending balance | 222,722 | 135,741 | |
Weighted-average grant-date fair value per share, ending balance | $ 45.82 | $ 73.81 | |
Number of shares, vested and unissued | (115,145) | ||
Weighted-average grant-date fair value per share, vested and unissued | $ 71.90 | ||
Number of restricted stock, shares outstanding | 107,577 | 102,623 | |
Weighted-average grant-date fair value per share, outstanding | $ 17.90 |
Schedule of Warrants Activity (
Schedule of Warrants Activity (Details) - Warrant [Member] - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Warrants outstanding, ending balance | 14,283 | 15,190 |
Weighted average exercise price, beginning balance | 205.01 | 213.22 |
Warrants outstanding, expired | (6,783) | (907) |
Weighted average exercise price, expired | 266.96 | 343.28 |
Weighted average remaining contractual term, ending | 2 years 2 months 12 days | 10 months 24 days |
Warrants outstanding, granted | 173,007 | |
Weighted average exercise price, granted | 19.27 | |
Warrants outstanding, not exercisable | (7,500) | |
Weighted average exercise price, not exercisable | 7.40 | |
Warrants outstanding, ending balance | 173,007 | |
Weighted average exercise price, ending balance | 25.41 | 205.01 |
Schedule of Stock Option Warran
Schedule of Stock Option Warrant Valuation Assumption (Details) - Warrant [Member] | Dec. 31, 2023 |
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, measurement input | 0.0432 |
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, measurement input | 0.0488 |
Measurement Input, Expected Term [Member] | Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected term (years) | 2 years |
Measurement Input, Expected Term [Member] | Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected term (years) | 3 years |
Measurement Input, Option Volatility [Member] | Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, measurement input | 0.8285 |
Measurement Input, Option Volatility [Member] | Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, measurement input | 1.0847 |
Measurement Input, Expected Dividend Rate [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, measurement input | 0 |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) - USD ($) | 12 Months Ended | ||||||||||
Jan. 01, 2024 | Nov. 18, 2023 | Aug. 31, 2023 | Aug. 08, 2023 | Jul. 14, 2023 | Mar. 08, 2023 | Jan. 01, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Apr. 17, 2023 | Jul. 10, 2022 | |
Consulting Agreement [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Warrant, exercisable | 7,500 | ||||||||||
Warrant exercise price | $ 7.40 | ||||||||||
Warrant expiration date | Nov. 18, 2025 | ||||||||||
Warrants, granted | 15,000 | ||||||||||
Consulting Agreement [Member] | Spartan Capital Securites LLC [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Warrant, exercisable | 158,007 | ||||||||||
Warrant exercise price | $ 20.40 | ||||||||||
Warrant expiration date | Apr. 17, 2026 | ||||||||||
Share-Based Payment Arrangement, Option [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Aggregate intrinsic value of outstanding options | $ 0 | $ 0 | |||||||||
Stock option exercised | 0 | 0 | |||||||||
Restricted Stock [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Unrecognized share based compensation expense | $ 5,825 | ||||||||||
Number of shares, granted | 10,750 | 9,358 | |||||||||
Number of shares, cancelled | 1,305 | 2,555 | |||||||||
Number of shares, vested and issued | 8,790 | 9,142 | |||||||||
Restricted stock award description | RSAs for up to 2,500 shares of common stock are subject to regaining Nasdaq compliance, with RSAs for only 1,250 shares of common stock vesting if we regain Nasdaq compliance through a reverse stock split. Because we effected a reverse stock-split on January 22, 2024 (which we have retroactively applied to all share counts reported in this Annual Report on Form 10-K) and regained Nasdaq compliance on February 2, 2024. Effective December 31, 2023, we cancelled the RSAs for 1,250 shares of common stock that will not vest. | ||||||||||
Number of shares, forfeited | 1,250 | 1,676 | |||||||||
Restricted Stock [Member] | Three Directors [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Number of shares, granted | 4,500 | ||||||||||
Restricted Stock [Member] | Consultant [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Number of shares, granted | 6,250 | ||||||||||
Number of shares, vested and issued | 3,750 | ||||||||||
Restricted Stock [Member] | Chief Operating Officer [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Number of shares, forfeited | 1,250 | ||||||||||
Recognized stock compensation expense reversed | $ 72,733 | ||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Unrecognized share based compensation expense | $ 839,121 | ||||||||||
Number of shares, granted | 40,000 | 116,078 | 121,439 | ||||||||
Number of shares, cancelled | 16,801 | 1,876 | |||||||||
Number of shares, forfeited | 12,296 | 3,431 | |||||||||
Weighted average period for recognition | 1 year 5 months 26 days | ||||||||||
Unrecognized restricted stock expense | $ 442,024 | ||||||||||
Restricted Stock Units (RSUs) [Member] | Base Compensation [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Number of shares, granted | 76,078 | ||||||||||
Service Based RSU [Member] | Chief Executive Officer [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Number of shares, granted | 20,000 | ||||||||||
First Performance Based RSU [Member] | Chief Executive Officer [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Number of shares, granted | 10,000 | ||||||||||
Performance vesting criteria | $ 10,000,000 | ||||||||||
Second Performance Based RSU [Member] | Chief Executive Officer [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Number of shares, granted | 10,000 | ||||||||||
Performance vesting criteria | $ 10,000,000 | ||||||||||
2019 Plan [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Maximum equity available for issuance | 300,000 | 300,000 | 150,000 | ||||||||
Shares available for future grants | 27,326 | ||||||||||
2019 Plan [Member] | Original [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Maximum equity available for issuance | 150,000 | ||||||||||
2019 Omnibus Incentive Plan [Member] | Subsequent Event [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Restricted stock award grant, value | $ 1,300,000 | ||||||||||
Restricted stock award share price | $ 30 | ||||||||||
2019 Omnibus Incentive Plan [Member] | Subsequent Event [Member] | Maximum [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Restricted stock award grant, shares | 42,149 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 12 Months Ended | ||||||||
Feb. 14, 2023 | Mar. 29, 2022 | Mar. 23, 2022 | Oct. 06, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Nov. 18, 2023 | Jun. 27, 2023 | Apr. 17, 2023 | |
Class of Stock [Line Items] | |||||||||
Preferred stock, shares issued | 0 | 0 | |||||||
Preferred stock, shares outstanding | 0 | 0 | |||||||
Authorized shares of common stock | 100,000,000 | 50,000,000 | 100,000,000 | ||||||
Proceeds from Issuance of Common Stock | $ 6,321,470 | ||||||||
Share issued value | $ (30,607) | ||||||||
Repurchase of common stock value | $ 300,000 | ||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares, forfeited | 12,296 | 3,431 | |||||||
Restricted Stock Units (RSUs) [Member] | Federal, State and Local [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares, forfeited | 1,809 | ||||||||
Restricted Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares, forfeited | 1,250 | 1,676 | |||||||
Director [Member] | Restricted Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares, forfeited | 911 | ||||||||
Aposense, Ltd. [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Number of repurchase of common stock, shares | 5,000 | ||||||||
Repurchase of common stock value | $ 300,000 | ||||||||
Sales Agreement [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Stock issued | 28,483 | ||||||||
Share price | $ 24.40 | ||||||||
Gross proceeds from issuance of common stock | $ 693,000 | ||||||||
Proceeds from Issuance of Common Stock | $ 672,000 | ||||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Stock issued | 2,500 | ||||||||
Share price | $ 21.60 | ||||||||
Gross proceeds from issuance of common stock | $ 54,000 | ||||||||
Reimbursement fees | $ 25,000 | ||||||||
Number of shares issued | 6,181 | ||||||||
Number of common stock issued on commitment fees, value | $ 450,000 | ||||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | Maximum [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Share price | $ 120 | ||||||||
Number of common stock shares in regular purchase | 1,250 | ||||||||
Number of common stock shares exceeding regular purchase | 3,750 | ||||||||
Share issued value | $ 150,000 | ||||||||
Daily maximum committed purchase obligations, value | $ 1,250,000 | ||||||||
Maximum number of shares sold | 157,122 | ||||||||
Nasdaq's exchange cap percent | 19.99% | ||||||||
Beneficial ownership limitation percentage | 9.99% | ||||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | Minimum [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Minimum closing sale price | $ 1 | ||||||||
Securities Purchase Agreement [Member] | Registered Direct Offering [Member] | Accredited Investor [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Stock issued | 390,628 | ||||||||
Share price | $ 16 | ||||||||
Gross proceeds from issuance of common stock | $ 6,300,000 | ||||||||
Proceeds from Issuance of Common Stock | $ 5,600,000 | ||||||||
Securities Purchase Agreement [Member] | Registered Direct Offering [Member] | Placement Agent [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Cash fee percentage | 8% | ||||||||
Reimbursement fees | $ 60,000 | ||||||||
Consulting Agreement [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Purchase of warrants, shares | 7,500 | ||||||||
Warrant exercise price | $ 7.40 | ||||||||
Consulting Agreement [Member] | Spartan Capital Securites LLC [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Purchase of warrants, shares | 158,007 | ||||||||
Warrant exercise price | $ 20.40 | ||||||||
License Agreement [Member] | Elion Oncology [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Shares issued in connection with license agreement | 5,000 | ||||||||
License Agreement [Member] | Aposense, Ltd. [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Shares issued in connection with license agreement | 31,250 | ||||||||
Common Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Stock issued | 421,611 | ||||||||
Number of shares issued | 6,181 | ||||||||
Share issued value | $ 6 | ||||||||
Shares issued in connection with license agreement | 5,000 | ||||||||
Repurchase of common stock value |
Schedule of Net Loss Per Share
Schedule of Net Loss Per Share Basic and Diluted (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Net loss available to common shareholders | $ (11,121,520) | $ (27,424,229) |
Weighted average number of common shares-basic | 1,311,572 | 805,477 |
Weighted average number of common shares-diluted | 1,311,572 | 805,477 |
Basic net loss per share | $ (8.48) | $ (34.05) |
Diluted net loss per share | $ (8.48) | $ (34.05) |
Restricted Stock Units (RSUs) [Member] | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Weighted average number of common shares-basic | 124,619 | 19,016 |
Weighted average number of common shares-diluted | 124,619 | 19,016 |
Common Stock [Member] | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Weighted average number of common shares-basic | 1,186,952 | 786,461 |
Weighted average number of common shares-diluted | 1,186,952 | 786,461 |
Net Loss per Share of Common _3
Net Loss per Share of Common Stock (Details Narrative) - shares | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Restricted Stock [Member] | |||
Shares unvested | 1,250 | 3,095 | 4,555 |
Restricted Stock Units (RSUs) [Member] | |||
Shares unvested | 107,577 | 102,623 |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Stock options, unvested RSAs, unvested RSUs and purchase warrants | 296,326 | 128,943 |
Schedule of Weighted Average Re
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases (Details) | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | |
Weighted average remaining lease term (years) for our facility and equipment leases | 1 year 8 months 12 days |
Weighted average discount rate for our facility and equipment leases | 8% |
Facility Lease [Member] | |
Property, Plant and Equipment [Line Items] | |
Remaining lease term (years) | 1 year 9 months 18 days |
Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Remaining lease term (years) | 3 months 18 days |
Schedule of Annual Lease Liabil
Schedule of Annual Lease Liabilities for all Operating Leases (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Leases | ||
2024 | $ 92,389 | |
2025 | 70,040 | |
Total lease payments | 162,429 | |
Less: Interest | (11,875) | |
Present value of lease liabilities | 150,554 | |
Less: current maturities | (83,649) | $ (78,896) |
Non-current lease liability | $ 66,905 | $ 150,554 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Leases | ||
Operating lease borrowing rate | 8% | |
Lease cost | $ 97,000 | $ 97,000 |
License Agreements (Details Nar
License Agreements (Details Narrative) - USD ($) | 12 Months Ended | ||||||||||
May 17, 2022 | Jun. 16, 2021 | Oct. 06, 2020 | Aug. 23, 2020 | Aug. 19, 2020 | Mar. 19, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | Jan. 25, 2024 | Jan. 22, 2024 | Jan. 21, 2024 | |
Common stock, shares issued | 1,291,000 | 806,774 | |||||||||
Stock Issued During Period, Value, New Issues | $ 6,352,077 | ||||||||||
CoNCERT Pharmaceuticals, Inc [Member] | License Rights [Member] | |||||||||||
Stock Issued During Period, Shares, Acquisitions | 14,931 | ||||||||||
Stock Issued During Period, Value, New Issues | $ 8,000,000 | ||||||||||
Subsequent Event [Member] | |||||||||||
Common stock, shares issued | 1,291,000 | 24,706,474 | |||||||||
License Agreement [Member] | Subsequent Event [Member] | |||||||||||
Common stock, shares issued | 5,000 | ||||||||||
License Agreement [Member] | Elion Oncology [Member] | |||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 5,000 | ||||||||||
Expense and related liability | $ 189,000 | ||||||||||
Performance of milestone conditions, description | including dosing a first patient with a product in a Phase 2 or 3 clinical trial within 48 months from when we entered into the License Agreement. We are currently on track to dose our first patient in a Phase 2 clinical trial on or before October 2, 2024. Either party may terminate the agreement in the event of a material breach of the agreement that has not been cured following written notice and a 90-day opportunity to cure such breach (which is shortened to 15 days for a payment breach). | ||||||||||
Stock Issued During Period, Shares, Acquisitions | 5,000 | ||||||||||
License Agreement [Member] | Elion Oncology [Member] | First Milestone [Member] | |||||||||||
Milestone payment description | shares of our common stock on each of the first and second anniversary dates of the Elion License Agreement. | ||||||||||
License Agreement [Member] | Ocuphire Pharma Inc [Member] | |||||||||||
Stock Issued During Period, Shares, Acquisitions | 2,235 | ||||||||||
Cash paid under license agreement | $ 200,000 | ||||||||||
Liabilities Assumed | $ 66,583 | ||||||||||
License Agreement [Member] | Aposense, Ltd. [Member] | |||||||||||
Stock Issued During Period, Shares, Acquisitions | 31,250 | ||||||||||
Milestone payments, description | As additional consideration, we will pay Aposense development and regulatory milestone payments (up to $3.0 million per milestone) upon the achievement of certain milestones, which primarily consist of having a drug indication approved by a regulatory authority in the United States or another country. In addition, we will pay Aposense one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. We are also required to split any sales milestone payments or royalties we receive with Aposense based on any sub-license agreement we may enter. | ||||||||||
License Agreement [Member] | Aposense, Ltd. [Member] | Maximum [Member] | |||||||||||
Development and regulatory milestone payments | $ 3,000,000 | ||||||||||
License Agreement [Member] | Yuhan Corporation [Member] | |||||||||||
Performance of milestone conditions, description | specific diligence milestones that consist of: (i) preparing a first draft of the product development plan within 90 days; (ii) requesting an FDA pre-IND meeting for a product within 6 months; (iii) dosing a first patient in a Phase 2A clinical trial with a product within 24 months; and (iv) dosing a first patient with a product in a Phase 2B clinical trial, Phase 3 clinical trial or other pivotal clinical trial with a product by August 19, 2024. | ||||||||||
Stock Issued During Period, Shares, Acquisitions | 25,000 | ||||||||||
Milestone payments, description | In addition, we must pay Yuhan one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. We are also required to split any milestone payments received with Yuhan based on any sub-license agreement we may enter. | ||||||||||
License Agreement [Member] | Yuhan Affiliate [Member] | Underwritten Public Offering [Member] | October 2020 [Member] | |||||||||||
Shares issued in connection with our 2020 offering | 37,500 | ||||||||||
Proceeds from offering | $ 3,000,000 |
Summary of Intangible Assets (D
Summary of Intangible Assets (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Gross intangible assets | $ 11,059,429 | |
Less: accumulated amortization | (3,791,286) | |
Less: impairment of intangible asset | (7,268,143) | |
Total intangible assets, net |
Intangible Assets (Details Narr
Intangible Assets (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||
Recognition of deferred tax liability | ||
Amortization of Intangible Assets | 788,495 | |
Impairment of Intangible Assets, Indefinite-Lived (Excluding Goodwill) | $ 7,268,143 | |
License Rights [Member] | CoNCERT Pharmaceuticals, Inc [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Purchase price | 8,000,000 | |
Transaction cost | 1,782 | |
Recognition of deferred tax liability | 3,037,147 | |
Intangible asset, tax basis | $ 1,782 |
Schedule of Effective Income Ta
Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21% | 21% |
State tax rate, net | 5.77% | 5.72% |
Permanent differences | (0.25%) | (0.55%) |
Federal orphan drug tax credit | 1.41% | 0.93% |
Deferred tax asset valuation allowance | (27.93%) | (27.10%) |
Effective income tax rate | 0% | 0% |
Schedule of Deferred Tax Assets
Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carry forward – Federal | $ 6,012,941 | $ 5,048,175 |
Net operating loss carry forward – State | 1,672,436 | 1,431,839 |
Stock compensation expense | 3,453,799 | 2,590,890 |
Depreciation and other | 999 | 976 |
Purchased in-process R&D | 2,500,562 | 2,494,829 |
Federal orphan drug credits | 1,202,955 | 1,046,539 |
Capitalized research and development costs | 2,795,379 | 1,929,462 |
Start-up expenditures and amortization | ||
Total non-current deferred tax assets | 17,639,071 | 14,542,710 |
Valuation allowance for deferred tax assets | (17,639,071) | (14,542,710) |
Total deferred tax assets | ||
Intangible asset | ||
Total non-current deferred tax liabilities | ||
Total deferred tax asset (liability) |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Deferred tax assets, capital loss carryforwards | $ 28,600,000 | $ 24,000,000 |
Net operating loss carryforwards | 7,400,000 | |
Net operating loss carryforward, expiration date | 2037 | |
Net operating loss carryforward term | 20 years | |
Income tax examination description | Pursuant to Code Sec. 382 of the Internal Revenue Code (“the Code”), the utilization of our net operating loss carryforwards could be limited as a result of a cumulative change in stock ownership of more than 50% over a three-year period. We have not completed a Sec. 382 study and as such our net operating loss carryforwards may be subject to such limitation. | |
Valuation allowance deferred tax asset | $ 3,100,000 | 7,400,000 |
Penalties and interest expense | 0 | 0 |
Research and Development Expense [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Capitalized research and development net of amortization | $ 3,200,000 | 7,200,000 |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 29,300,000 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - CorLyst, LLC [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | ||
Rent and other costs reimbursements received | $ 112,000 | $ 124,000 |
Due from related parties | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) $ in Millions | Dec. 31, 2023 USD ($) |
CROs [Member] | |
Defined Benefit Plan Disclosure [Line Items] | |
Purchase obligation | $ 1.4 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | 12 Months Ended | ||
Jan. 30, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Subsequent Event [Line Items] | |||
Net proceeds | $ 6,321,470 | ||
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Number of shares, sold | 476,000 | ||
Net proceeds | $ 6,300,000 | ||
Subsequent Event [Member] | Pre-Funded Warrants [Member] | |||
Subsequent Event [Line Items] | |||
Warrants to purchase | 1,079,555 | ||
Warrants, exercised | 1,079,555 | ||
Subsequent Event [Member] | Warrant [Member] | |||
Subsequent Event [Line Items] | |||
Warrants to purchase | 1,555,555 | ||
Subsequent Event [Member] | Purchase Agreement [Member] | |||
Subsequent Event [Line Items] | |||
Number of shares, sold | 476,000 | ||
Warrant exercise price | $ 4.50 | ||
Gross proceeds | $ 7,000,000 | ||
Net proceeds | $ 6,300,000 | ||
Subsequent Event [Member] | Purchase Agreement [Member] | Placement Agent [Member] | |||
Subsequent Event [Line Items] | |||
Warrant exercise price | $ 5.625 | ||
Warrants to purchase | 62,222 | ||
Warrants, maturity date | Feb. 01, 2027 | ||
Subsequent Event [Member] | Purchase Agreement [Member] | Pre-Funded Warrants [Member] | |||
Subsequent Event [Line Items] | |||
Warrants to purchase | 1,079,555 | ||
Warrant exercise price | $ 0.0001 | ||
Warrants, price per share | $ 4.4999 | ||
Warrants, exercised | 1,079,555 | ||
Subsequent Event [Member] | Purchase Agreement [Member] | Warrant [Member] | |||
Subsequent Event [Line Items] | |||
Warrants to purchase | 1,555,555 | ||
Warrant exercise price | $ 4.50 | ||
Warrants, exercisable term | 5 years |