Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 01, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Period Focus | Q3 | |
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, $0.0001 par value per share | |
Trading Symbol | PCSA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 24,631,474 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current Assets | ||
Cash and cash equivalents | $ 6,860,672 | $ 6,503,595 |
Prepaid expenses and other | 1,046,790 | 1,883,134 |
Total Current Assets | 7,907,462 | 8,386,729 |
Property and Equipment, net | 2,694 | |
Other Assets | ||
Operating lease right-of-use assets, net | 167,035 | 227,587 |
Security deposit | 5,535 | 5,535 |
Total Other Assets | 172,570 | 233,122 |
Total Assets | 8,082,726 | 8,619,851 |
Current Liabilities | ||
Current maturities of operating lease liability | 82,744 | 78,896 |
Accounts payable | 346,299 | 327,548 |
Due to licensor | 189,000 | 189,000 |
Due to related parties | 5,791 | 51 |
Accrued expenses | 202,236 | 403,061 |
Total Current Liabilities | 826,070 | 998,556 |
Non-current Liabilities | ||
Non-current operating lease liability | 88,777 | 150,554 |
Total Liabilities | 914,847 | 1,149,110 |
Commitments and Contingencies | ||
Stockholders’ Equity | ||
Common stock, par value $0.0001, 100,000,000 shares authorized: 24,731,474 issued and 24,631,474 outstanding at September 30, 2023, and 16,135,400 issued and 16,035,400 outstanding at December 31, 2022 | 2,473 | 1,614 |
Additional paid-in capital | 80,429,556 | 72,016,688 |
Treasury stock at cost — 100,000 shares at September 30, 2023 and December 31, 2022 | (300,000) | (300,000) |
Accumulated deficit | (72,964,150) | (64,247,561) |
Total Stockholders’ Equity | 7,167,879 | 7,470,741 |
Total Liabilities and Stockholders’ Equity | $ 8,082,726 | $ 8,619,851 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 50,000,000 |
Common stock, shares issued | 24,731,474 | 16,135,400 |
Common stock, shares outstanding | 24,631,474 | 16,035,400 |
Treasury stock shares | 100,000 | 100,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Expenses | ||||
Research and development | $ 1,151,740 | $ 3,136,838 | $ 4,478,793 | $ 8,319,907 |
General and administrative | 1,015,872 | 2,920,280 | 4,508,818 | 6,137,674 |
Operating Loss | (2,167,612) | (6,057,118) | (8,987,611) | (14,457,581) |
Other Income (Expense) | ||||
Interest income, net | 85,661 | 36,708 | 271,022 | 45,672 |
Net Loss | $ (2,081,951) | $ (6,020,410) | $ (8,716,589) | $ (14,411,909) |
Net Loss per Common Share - Basic | $ (0.08) | $ (0.37) | $ (0.34) | $ (0.90) |
Net Loss per Common Share - Diluted | $ (0.08) | $ (0.37) | $ (0.34) | $ (0.90) |
Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Basic | 27,002,908 | 16,200,222 | 25,585,222 | 15,991,653 |
Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Diluted | 27,002,908 | 16,200,222 | 25,585,222 | 15,991,653 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock, Common [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2021 | $ 1,571 | $ 62,306,861 | $ (36,823,332) | $ 25,485,100 | |
Balance. shares at Dec. 31, 2021 | 15,710,246 | ||||
Stock-based compensation | $ 10 | 828,887 | 828,897 | ||
Stock-based compensation, shares | 103,670 | ||||
Acquisition of treasury stock | $ (300,000) | (300,000) | |||
Acquisition of treasury stock, shares | (100,000) | ||||
Shares issued in connection with purchase agreement | $ 12 | 449,988 | 450,000 | ||
Shares issued in connection with purchase agreement, shares | 123,609 | ||||
Net loss | (3,227,131) | (3,227,131) | |||
Balance at Mar. 31, 2022 | $ 1,593 | 63,585,736 | $ (300,000) | (40,050,463) | 23,236,866 |
Balance. shares at Mar. 31, 2022 | 15,937,525 | (100,000) | |||
Balance at Dec. 31, 2021 | $ 1,571 | 62,306,861 | (36,823,332) | 25,485,100 | |
Balance. shares at Dec. 31, 2021 | 15,710,246 | ||||
Net loss | (14,411,909) | ||||
Balance at Sep. 30, 2022 | $ 1,600 | 68,773,666 | $ (300,000) | (51,235,241) | 17,240,025 |
Balance. shares at Sep. 30, 2022 | 15,995,087 | (100,000) | |||
Balance at Mar. 31, 2022 | $ 1,593 | 63,585,736 | $ (300,000) | (40,050,463) | 23,236,866 |
Balance. shares at Mar. 31, 2022 | 15,937,525 | (100,000) | |||
Stock-based compensation | $ (1) | 2,009,370 | 2,009,369 | ||
Stock-based compensation, shares | (18,208) | ||||
Net loss | (5,164,368) | (5,164,368) | |||
Balance at Jun. 30, 2022 | $ 1,592 | 65,595,106 | $ (300,000) | (45,214,831) | 20,081,867 |
Balance. shares at Jun. 30, 2022 | 15,919,317 | (100,000) | |||
Stock-based compensation | $ 9 | 3,213,806 | 3,213,815 | ||
Stock-based compensation, shares | 86,888 | ||||
Net loss | (6,020,410) | (6,020,410) | |||
Shares withheld to pay income taxes on stock-based compensation | $ (1) | (35,246) | (35,247) | ||
Shares withheld to pay income taxes on stock-based compensation, shares | (11,118) | ||||
Balance at Sep. 30, 2022 | $ 1,600 | 68,773,666 | $ (300,000) | (51,235,241) | 17,240,025 |
Balance. shares at Sep. 30, 2022 | 15,995,087 | (100,000) | |||
Balance at Dec. 31, 2022 | $ 1,614 | 72,016,688 | $ (300,000) | (64,247,561) | 7,470,741 |
Balance. shares at Dec. 31, 2022 | 16,135,400 | (100,000) | |||
Stock-based compensation | $ 6 | 341,498 | 341,504 | ||
Stock-based compensation, shares | 63,882 | ||||
Net loss | (4,022,073) | (4,022,073) | |||
Shares issued in connection with capital raises, net of transaction costs | $ 843 | 6,351,234 | 6,352,077 | ||
Shares issued in connection with capital raises, net of transaction costs, shares | 8,432,192 | ||||
Balance at Mar. 31, 2023 | $ 2,463 | 78,709,420 | $ (300,000) | (68,269,634) | 10,142,249 |
Balance. shares at Mar. 31, 2023 | 24,631,474 | (100,000) | |||
Balance at Dec. 31, 2022 | $ 1,614 | 72,016,688 | $ (300,000) | (64,247,561) | 7,470,741 |
Balance. shares at Dec. 31, 2022 | 16,135,400 | (100,000) | |||
Net loss | (8,716,589) | ||||
Shares issued in connection with capital raises, net of transaction costs, shares | 8,432,192 | ||||
Balance at Sep. 30, 2023 | $ 2,473 | 80,429,556 | $ (300,000) | (72,964,150) | 7,167,879 |
Balance. shares at Sep. 30, 2023 | 24,731,474 | (100,000) | |||
Balance at Mar. 31, 2023 | $ 2,463 | 78,709,420 | $ (300,000) | (68,269,634) | 10,142,249 |
Balance. shares at Mar. 31, 2023 | 24,631,474 | (100,000) | |||
Stock-based compensation | 319,123 | 319,123 | |||
Net loss | (2,612,565) | (2,612,565) | |||
Warrant granted in connection with a consulting agreement | 1,310,875 | 1,310,875 | |||
Balance at Jun. 30, 2023 | $ 2,463 | 80,339,418 | $ (300,000) | (70,882,199) | 9,159,682 |
Balance. shares at Jun. 30, 2023 | 24,631,474 | (100,000) | |||
Net loss | (2,081,951) | (2,081,951) | |||
Stock-based compensation, net of forfeitures | $ 10 | 142,884 | 142,894 | ||
Stock-based compensation, net of forfeitures, shares | 100,000 | ||||
Settlement of stock award | (52,746) | (52,746) | |||
Balance at Sep. 30, 2023 | $ 2,473 | $ 80,429,556 | $ (300,000) | $ (72,964,150) | $ 7,167,879 |
Balance. shares at Sep. 30, 2023 | 24,731,474 | (100,000) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash Flows From Operating Activities | ||
Net loss | $ (8,716,589) | $ (14,411,909) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 82 | |
Lease expense for right-of-use assets | 60,552 | 66,126 |
Milestone expense in connection with license agreement | 189,000 | |
Amortization of issuance costs | 78,113 | |
Amortization of intangible asset | 591,372 | |
Stock-based compensation | 803,521 | 6,052,081 |
Warrants issued to purchase 3,160,130 shares of common stock in connection with a consulting agreement | 1,310,875 | |
Net changes in operating assets and liabilities: | ||
Prepaid expenses and other | 836,344 | 299,074 |
Operating lease liability | (57,929) | (69,420) |
Accounts payable | 18,751 | 92,161 |
Due (from) to related parties | 5,740 | (1,772) |
Other receivables | 70,274 | |
Accrued expenses | (200,825) | (62,858) |
Net cash used in operating activities | (5,939,478) | (7,107,758) |
Cash Flows From Investing Activities | ||
Purchase of property and equipment | (2,776) | |
Net cash used in investing activities | (2,776) | |
Cash Flows From Financing Activities | ||
Net proceeds from common stock issued | 6,352,077 | (35,247) |
Settlement of stock award | (52,746) | |
Acquisition of treasury stock | (300,000) | |
Net cash provided by (used in) financing activities | 6,299,331 | (335,247) |
Net Increase (Decrease) in Cash | 357,077 | (7,443,005) |
Cash and Cash Equivalents – Beginning of Period | 6,503,595 | 16,497,581 |
Cash and Cash Equivalents – End of Period | 6,860,672 | 9,054,574 |
Non-Cash Financing Activities | ||
Issuance of 123,609 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 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) (Parenthetical) | 9 Months Ended |
Sep. 30, 2022 shares | |
Purchase Agreement [Member] | Common Stock [Member] | Lincoln Park Capital Fund LLC [Member] | |
Shares issued in connection with the Purchase Agreement with Lincoln Park | 123,609 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure [Table] | ||||||||
Net Income (Loss) Attributable to Parent | $ (2,081,951) | $ (2,612,565) | $ (4,022,073) | $ (6,020,410) | $ (5,164,368) | $ (3,227,131) | $ (8,716,589) | $ (14,411,909) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2023 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Organization and Summary of Significant Accounting Policies | Note 1 – Organization and Summary of Significant Accounting Policies 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. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of our financial position and of the results of operations and cash flows for the periods presented. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC. The results of operations for the interim periods shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. Going Concern and Management’s Plans We have incurred losses since inception, devoting substantially all of our efforts toward research and development, and have an accumulated deficit of $ 73.0 8.7 5.9 During the nine months ended September 30, 2023, we raised gross proceeds of $ 7.0 6.4 8,432,192 Our condensed consolidated financial statements have been prepared using U.S. GAAP and are based on the assumption that we will continue as a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. We face certain risks and uncertainties that are present in many emerging pharmaceutical companies regarding product development, limited working capital, recurring losses and negative cash flow from operations, future profitability, ability to obtain future capital, protection of patents, technologies and property rights, competition, rapid technological change, navigating the domestic and major foreign markets’ regulatory and clinical environment, recruiting and retaining key personnel, dependence on third party manufacturing organizations, third party collaboration and licensing agreements, lack of sales and marketing activities. We currently have no customers or pharmaceutical products to sell or distribute. These risks and other factors raise substantial doubt about our ability to continue as a going concern. At September 30, 2023, we had cash and cash equivalents totaling $ 6.9 We had no We are hoping to raise additional funds in late 2023 or early 2024, but will only do so if the terms are acceptable to us. Additional funding may not be available to us on acceptable terms, or at all. 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 diligence obligations contained in certain of our license agreements and put these assets at risk. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. 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, making capital expenditures or declaring dividends. Uncertainty concerning our ability to continue as a going concern may hinder our ability to obtain future financing. Continued operations and our ability to continue as a going concern are dependent on our ability to obtain additional funding in the future and thereafter, and no assurances can be given that such funding will be available at all, in a sufficient amount, or on reasonable terms. Without additional funds from debt or equity financing, sales of assets, sales or out-licenses of intellectual property or technologies, or other transactions providing funds, we will rapidly exhaust our resources, be unable to meet diligence obligations in license agreements, and be unable to continue operations. 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 condensed 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 condensed consolidated financial statements are available to be issued. The accompanying condensed 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. Use of Estimates In preparing our condensed consolidated financial statements and related disclosures in conformity with U.S. GAAP and pursuant to the rules and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Estimates are used for, but not limited to preclinical and clinical trial expenses, 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. Income Taxes We account for income taxes in accordance with ASC Topic 740, Income Taxes. Under ACS 740-270 Income Taxes – Interim Reporting 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 September 30, 2023, exceeded FDIC limits. 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 condensed consolidated financial statements. We have evaluated recently issued accounting pronouncements and determined that there is no material impact on our condensed consolidated financial position or results of operations. |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 2 – 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 During the nine months ended September 30, 2023, we issued 8,432,192 ATM Offering On February 5, 2023, in connection with our Registered Direct Offering discussed below, we terminated our ATM and suspended the Sales Agreement with Oppenheimer & Co. Inc., but we expect to reinstate it in the future. During the nine months ended September 30, 2023, we sold 569,648 shares at an average price of $ 1.22 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 On March 23, 2022, we entered into a purchase agreement 15.0 1.00 50,000 1.08 54,000 Registered Direct Offering On February 14, 2023, we closed a registered direct offering (the “Offering”) for the sale of 7,812,544 shares of common stock at a purchase price of $ 0.80 per share for gross proceeds of $ 6.3 million (net proceeds of $ 5.6 million). We paid the Placement Agent (“Spartan Capital” or “Spartan”) a cash fee of 8.0 60,000 3,160,130 1.02 three years |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation | Note 3 - Stock-based Compensation On June 19, 2019, our stockholders approved, and we adopted the Processa Pharmaceuticals Inc. 2019 Omnibus Equity Incentive Plan (the “2019 Plan”). The 2019 Plan allows us, under the direction of our Board of Directors or a committee thereof, 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 provides for the aggregate issuance of 6,000,000 467,735 Stock Compensation Expense We recorded stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022 as follows: Schedule of Stock-based Compensation Expense 2023 2022 2023 2022 Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 76,626 $ 1,067,613 $ 286,152 $ 1,945,113 General and administrative 66,268 2,146,202 517,369 4,106,968 Total $ 142,894 $ 3,213,815 $ 803,521 $ 6,052,081 During the nine months ended September 30, 2023, we also recorded an expense of $ 1.3 Stock Options During the nine months ended September 30, 2023, stock options to purchase 36,885 141,611 18.22 2.4 years. Restricted Stock Awards Activity with respect to our Restricted Stock Awards (RSAs) during the nine months ended September 30, 2023 was as follows: Schedule of Restricted Stock Awards (“RSAs”) Activity Number of Weighted- Outstanding at January 1, 2023 61,888 $ 4.72 Granted 215,000 0.73 Forfeited (25,000 ) 6.65 Cancelled (26,118 ) 1.72 Issued (150,770 ) 1.35 Outstanding and unvested at September 30, 2023 75,000 $ 0.46 On January 1, 2023, we granted RSAs totaling 90,000 26,118 On July 14, 2023 , 125,000 50,000 resignation 25,000 73,000 At September 30, 2023, unrecognized stock-based compensation expense of $ 30,000 for RSAs representing 75,000 shares of common stock is expected to be recognized over a weighted average period of 0.41 years. The weighted-average grant-date fair value of RSAs granted during the nine months ended September 30, 2022 was $ 7.74 . Restricted Stock Units Activity with respect to our Restricted Stock Units (“RSUs”) during the nine months ended September 30, 2023 was as follows: Schedule of Restricted Stock Units (“RSUs”) Activity Number of Weighted- Outstanding at January 1, 2023 2,713,977 $ 3.69 Granted 2,273,328 0.72 Forfeited (144,478 ) 1.48 Cancelled (335,960 ) 3.57 Outstanding at September 30, 2023 4,506,867 2.30 Vested and unissued 2,291,923 3.58 Unvested at September 30, 2023 2,214,944 $ 0.97 On August 8, 2023, Mr. George Ng was appointed as our Chief Executive Officer and as a Board Director. In addition to cash compensation, the Compensation Committee awarded 800,000 400,000 400,000 200,000 10,000,000 200,000 10,000,000 436,043 38,000 At September 30, 2023, unrecognized stock-based compensation expense of $ 1.1 1.4 441,000 3.11 Holders of our vested RSUs have our promise to issue shares of our common stock upon meeting the distribution restrictions contained in their Restricted Stock Unit Award Agreement. The distribution restrictions are different (longer) than the vesting schedule, imposing an additional restriction on the holder. Unlike RSAs, while certain 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. Warrants During the nine months ended September 30, 2023, we granted warrants to purchase a total of 3,160,130 . The warrants were issued and exercisable on April 17, 2023 with an exercise price of $ 1.02 1,310,875 3,366,480 shares with a weighted average exercise price of $ 1.61 2.3 years. At September 30, 2023, we did not have any unrecognized stock-based compensation expense related to our granted stock purchase warrants. |
Net Loss per Share of Common St
Net Loss per Share of Common Stock | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss per Share of Common Stock | Note 4 – Net Loss per Share of Common Stock Net Loss Per Share Basic net loss per share is computed by dividing our net loss available to common shareholders by the weighted average number of shares of common stock outstanding (which excludes unvested RSAs and includes vested RSUs) during the period. 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 (which includes the potentially dilutive effect of stock options, unvested RSAs, unvested RSUs and warrants) during the period. Since we 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 three- and nine-month periods ended September 30, 2023 and 2022 excludes the impact of potentially dilutive common shares since those shares would have an anti-dilutive effect on net loss per share. The computation of net loss per share for the three- and nine-month periods ended September 30, 2023 and 2022 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2023 2022 2023 2022 Three Months Ended Nine Months Ended 2023 2022 2023 2022 Basic and diluted net loss per share: Net loss available to common stockholders $ (2,081,951 ) $ (6,020,410 ) $ (8,716,589 ) $ (14,411,909 ) Weighted average number of common shares-basic and diluted 27,002,908 16,200,222 25,585,222 15,991,653 Basic and diluted net loss per share $ (0.08 ) $ (0.37 ) $ (0.34 ) $ (0.90 ) Our diluted net loss per share for the three- and nine-month periods ended September 30, 2023 and 2022 excluded 5,798,035 2,760,527 |
Operating Leases
Operating Leases | 9 Months Ended |
Sep. 30, 2023 | |
Operating Leases | |
Operating Leases | Note 5 – Operating 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 condensed consolidated statements of operations totaled $ 24,000 73,000 Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases Remaining lease term (years) for our facility lease 2.0 Remaining lease term (years) for our equipment lease 0.5 Weighted average remaining lease term (years) for our facility and equipment leases 2.0 Weighted average discount rate for our facility and equipment leases 8.0 % Annual lease liabilities for all operating leases were as follows at September 30, 2023: Schedule of Annual Lease Liabilities for all Operating Leases 2023 $ 24,109 2024 92,356 2025 70,040 Total lease payments 186,505 Less: Interest (14,984 ) Present value of lease liabilities 171,521 Less: current maturities (82,744 ) Non-current lease liability $ 88,777 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 6 – 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 condensed consolidated statements of operations. We recorded $ 89,980 94,642 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 7 – Commitments and Contingencies Purchase Obligations We enter into 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 September 30, 2023, we are contractually obligated to pay up to approximately $ 1.8 |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
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. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of our financial position and of the results of operations and cash flows for the periods presented. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC. The results of operations for the interim periods shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. |
Going Concern and Management’s Plans | Going Concern and Management’s Plans We have incurred losses since inception, devoting substantially all of our efforts toward research and development, and have an accumulated deficit of $ 73.0 8.7 5.9 During the nine months ended September 30, 2023, we raised gross proceeds of $ 7.0 6.4 8,432,192 Our condensed consolidated financial statements have been prepared using U.S. GAAP and are based on the assumption that we will continue as a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. We face certain risks and uncertainties that are present in many emerging pharmaceutical companies regarding product development, limited working capital, recurring losses and negative cash flow from operations, future profitability, ability to obtain future capital, protection of patents, technologies and property rights, competition, rapid technological change, navigating the domestic and major foreign markets’ regulatory and clinical environment, recruiting and retaining key personnel, dependence on third party manufacturing organizations, third party collaboration and licensing agreements, lack of sales and marketing activities. We currently have no customers or pharmaceutical products to sell or distribute. These risks and other factors raise substantial doubt about our ability to continue as a going concern. At September 30, 2023, we had cash and cash equivalents totaling $ 6.9 We had no We are hoping to raise additional funds in late 2023 or early 2024, but will only do so if the terms are acceptable to us. Additional funding may not be available to us on acceptable terms, or at all. 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 diligence obligations contained in certain of our license agreements and put these assets at risk. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. 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, making capital expenditures or declaring dividends. Uncertainty concerning our ability to continue as a going concern may hinder our ability to obtain future financing. Continued operations and our ability to continue as a going concern are dependent on our ability to obtain additional funding in the future and thereafter, and no assurances can be given that such funding will be available at all, in a sufficient amount, or on reasonable terms. Without additional funds from debt or equity financing, sales of assets, sales or out-licenses of intellectual property or technologies, or other transactions providing funds, we will rapidly exhaust our resources, be unable to meet diligence obligations in license agreements, and be unable to continue operations. 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 condensed 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 condensed consolidated financial statements are available to be issued. The accompanying condensed 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. |
Use of Estimates | Use of Estimates In preparing our condensed consolidated financial statements and related disclosures in conformity with U.S. GAAP and pursuant to the rules and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Estimates are used for, but not limited to preclinical and clinical trial expenses, 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. |
Income Taxes | Income Taxes We account for income taxes in accordance with ASC Topic 740, Income Taxes. Under ACS 740-270 Income Taxes – Interim Reporting |
Concentration of Credit Risk | 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 September 30, 2023, exceeded FDIC limits. |
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 condensed consolidated financial statements. We have evaluated recently issued accounting pronouncements and determined that there is no material impact on our condensed consolidated financial position or results of operations. |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expense | We recorded stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022 as follows: Schedule of Stock-based Compensation Expense 2023 2022 2023 2022 Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 76,626 $ 1,067,613 $ 286,152 $ 1,945,113 General and administrative 66,268 2,146,202 517,369 4,106,968 Total $ 142,894 $ 3,213,815 $ 803,521 $ 6,052,081 |
Schedule of Restricted Stock Awards (“RSAs”) Activity | Activity with respect to our Restricted Stock Awards (RSAs) during the nine months ended September 30, 2023 was as follows: Schedule of Restricted Stock Awards (“RSAs”) Activity Number of Weighted- Outstanding at January 1, 2023 61,888 $ 4.72 Granted 215,000 0.73 Forfeited (25,000 ) 6.65 Cancelled (26,118 ) 1.72 Issued (150,770 ) 1.35 Outstanding and unvested at September 30, 2023 75,000 $ 0.46 |
Schedule of Restricted Stock Units (“RSUs”) Activity | Activity with respect to our Restricted Stock Units (“RSUs”) during the nine months ended September 30, 2023 was as follows: Schedule of Restricted Stock Units (“RSUs”) Activity Number of Weighted- Outstanding at January 1, 2023 2,713,977 $ 3.69 Granted 2,273,328 0.72 Forfeited (144,478 ) 1.48 Cancelled (335,960 ) 3.57 Outstanding at September 30, 2023 4,506,867 2.30 Vested and unissued 2,291,923 3.58 Unvested at September 30, 2023 2,214,944 $ 0.97 |
Net Loss per Share of Common _2
Net Loss per Share of Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share Basic and Diluted | The computation of net loss per share for the three- and nine-month periods ended September 30, 2023 and 2022 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2023 2022 2023 2022 Three Months Ended Nine Months Ended 2023 2022 2023 2022 Basic and diluted net loss per share: Net loss available to common stockholders $ (2,081,951 ) $ (6,020,410 ) $ (8,716,589 ) $ (14,411,909 ) Weighted average number of common shares-basic and diluted 27,002,908 16,200,222 25,585,222 15,991,653 Basic and diluted net loss per share $ (0.08 ) $ (0.37 ) $ (0.34 ) $ (0.90 ) |
Operating Leases (Tables)
Operating Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Operating 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 facility lease 2.0 Remaining lease term (years) for our equipment lease 0.5 Weighted average remaining lease term (years) for our facility and equipment leases 2.0 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 at September 30, 2023: Schedule of Annual Lease Liabilities for all Operating Leases 2023 $ 24,109 2024 92,356 2025 70,040 Total lease payments 186,505 Less: Interest (14,984 ) Present value of lease liabilities 171,521 Less: current maturities (82,744 ) Non-current lease liability $ 88,777 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | |||||||||
Accumulated deficit | $ 72,964,150 | $ 72,964,150 | $ 64,247,561 | ||||||
Net loss | 2,081,951 | $ 2,612,565 | $ 4,022,073 | $ 6,020,410 | $ 5,164,368 | $ 3,227,131 | 8,716,589 | $ 14,411,909 | |
Net cash used in operating activities | 5,939,478 | 7,107,758 | |||||||
Proceeds from sale of common stock | 7,000,000 | ||||||||
Net proceeds from common stock issued | $ 6,352,077 | $ (35,247) | |||||||
Sale of common stock, shares | 8,432,192 | ||||||||
Cash and cash equivalents | $ 6,860,672 | $ 6,860,672 | $ 6,503,595 | ||||||
Revenue | $ 0 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Feb. 14, 2023 | Mar. 23, 2022 | Mar. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Jun. 27, 2023 | Apr. 17, 2023 | Dec. 31, 2022 | |
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 | 100,000,000 | 50,000,000 | |||||
Gross proceeds | $ 6,352,077 | $ (35,247) | ||||||
Sales Agreement [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Average shares sold | 569,648 | |||||||
Average share price | $ 1.22 | |||||||
Gross proceeds from issuance of common stock | $ 693,000 | |||||||
Gross proceeds | $ 672,000 | |||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Average shares sold | 50,000 | |||||||
Average share price | $ 1.08 | |||||||
Gross proceeds | $ 54,000 | |||||||
Threshold price | $ 1 | |||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | Maximum [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Commitment to purchase common stock | $ 15,000,000 | |||||||
Securities Purchase Agreement [Member] | Registered Direct Offering [Member] | Accredited Investor [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Average shares sold | 7,812,544 | |||||||
Average share price | $ 0.80 | |||||||
Gross proceeds from issuance of common stock | $ 6,300,000 | |||||||
Gross proceeds | $ 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] | Spartan Capital Securites LLC [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants to purchase common stock, shares | 3,160,130 | |||||||
Warrant exercise price | $ 1.02 | |||||||
Warrant term | 3 years | |||||||
Common Stock [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Average shares sold | 8,432,192 | 8,432,192 |
Schedule of Stock-based Compens
Schedule of Stock-based Compensation Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | $ 142,894 | $ 3,213,815 | $ 803,521 | $ 6,052,081 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | 76,626 | 1,067,613 | 286,152 | 1,945,113 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | $ 66,268 | $ 2,146,202 | $ 517,369 | $ 4,106,968 |
Schedule of Restricted Stock Aw
Schedule of Restricted Stock Awards (“RSAs”) Activity (Details) - Restricted Stock [Member] - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of restricted stock, shares outstanding | 61,888 | |
Weighted-average grant-date fair value per share, outstanding | $ 4.72 | |
Number of shares, granted | 215,000 | |
Weighted-average grant-date fair value per share, granted | $ 0.73 | $ 7.74 |
Number of shares, forfeited | (25,000) | |
Weighted-average grant-date fair value per share, forfeited | $ 6.65 | |
Number of shares, cancelled | (26,118) | |
Weighted-average grant-date fair value per share, cancelled | $ 1.72 | |
Number of shares, vested and issued | (150,770) | |
Weighted-average grant-date fair value per share, vested and issued | $ 1.35 | |
Number of restricted stock shares outstanding | 75,000 | |
Weighted-average grant-date fair value per share, outstanding | $ 0.46 |
Schedule of Restricted Stock Un
Schedule of Restricted Stock Units (“RSUs”) Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 9 Months Ended | ||
Aug. 08, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Number of shares, Beginning balance | 2,713,977 | ||
Weighted-average grant-date fair value per share, Beginning balance | $ 3.69 | ||
Number of shares, granted | 800,000 | 2,273,328 | |
Weighted-average grant-date fair value per share, awarded | $ 0.72 | $ 3.11 | |
Number of shares, forfeited | (144,478) | ||
Weighted-average grant-date fair value per share, forfeited | $ 1.48 | ||
Number of shares, cancelled | (335,960) | ||
Weighted-average grant-date fair value per share, cancelled | $ 3.57 | ||
Number of shares, Ending balance | 4,506,867 | ||
Weighted-average grant-date fair value per share, Ending balance | $ 2.30 | ||
Number of shares, vested and unissued | 2,291,923 | ||
Weighted-average grant-date fair value per share, vested and unissued | $ 3.58 | ||
Number of restricted stock shares outstanding | 2,214,944 | ||
Weighted-average grant-date fair value per share, outstanding | $ 0.97 |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||||
Aug. 31, 2023 | Aug. 08, 2023 | Jul. 14, 2023 | Feb. 14, 2023 | Jan. 01, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Warrants issued in connection with consulting agreement | $ 1,310,875 | |||||||||
General and administrative expense | $ 1,015,872 | $ 2,920,280 | $ 4,508,818 | $ 6,137,674 | ||||||
Warrant [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Warrants issued in connection with consulting agreement | $ 1,300,000 | |||||||||
Weighted average exercise price | $ 1.02 | $ 1.61 | $ 1.61 | |||||||
Warrants to purchase shares | 3,366,480 | 3,366,480 | ||||||||
Weighted average remaining contractual life | 2 years 3 months 18 days | |||||||||
Warrant [Member] | Consultant [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Warrants granted | 3,160,130 | |||||||||
General and administrative expense | $ 1,310,875 | |||||||||
Share-Based Payment Arrangement, Option [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Options, forfeited | 36,885 | |||||||||
Options exercisable, shares | 141,611 | 141,611 | ||||||||
Options exercisable weighted average exercise price | $ 18.22 | $ 18.22 | ||||||||
Exercisable weighted average remaining contractual term | 2 years 4 months 24 days | |||||||||
Restricted Stock [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Number of shares, granted | 215,000 | |||||||||
Number of shares, cancelled | 26,118 | |||||||||
Number of shares, vested and issued | 150,770 | |||||||||
Number of shares, forfeited | 25,000 | |||||||||
Unrecognized share based compensation expense | $ 30,000 | $ 30,000 | ||||||||
Number of shares expected to recoginzed | 75,000 | 75,000 | ||||||||
Weighted average period for recognition | 4 months 28 days | |||||||||
Weighted-average grant-date fair value per share | $ 0.73 | $ 7.74 | ||||||||
Restricted Stock [Member] | Three Directors [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Number of shares, granted | 90,000 | |||||||||
Restricted Stock [Member] | Consultant [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Number of shares, granted | 125,000 | |||||||||
Number of shares, vested and issued | 50,000 | |||||||||
Restricted Stock [Member] | Chief Operating Officer [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Number of shares, forfeited | 25,000 | |||||||||
Recognized stock compensation expense reversed | $ 73,000 | |||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Number of shares, granted | 800,000 | 2,273,328 | ||||||||
Number of shares, cancelled | 335,960 | |||||||||
Number of shares, forfeited | 144,478 | |||||||||
Recognized stock compensation expense reversed | $ 38,000 | |||||||||
Unrecognized share based compensation expense | $ 1,100,000 | $ 1,100,000 | ||||||||
Weighted average period for recognition | 1 year 4 months 24 days | |||||||||
Weighted-average grant-date fair value per share | $ 0.72 | $ 3.11 | ||||||||
Number of shares forfeited and cancelled | 436,043 | |||||||||
Unrecognized restricted stock expense | $ 441,000 | |||||||||
Service Based RSU [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Number of shares, granted | 400,000 | |||||||||
First Performance Based R S U [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Number of shares, granted | 200,000 | |||||||||
Performance vesting criteria | $ 10,000,000 | |||||||||
Second Performance Based R S U [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Number of shares, granted | 200,000 | |||||||||
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 | 6,000,000 | 6,000,000 | ||||||||
Shares available for future grants | 467,735 | 467,735 |
Schedule of Net Loss Per Share
Schedule of Net Loss Per Share Basic and Diluted (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Earnings Per Share [Abstract] | ||||||||
Net loss available to common stockholders | $ (2,081,951) | $ (2,612,565) | $ (4,022,073) | $ (6,020,410) | $ (5,164,368) | $ (3,227,131) | $ (8,716,589) | $ (14,411,909) |
Weighted average number of common shares-basic | 27,002,908 | 16,200,222 | 25,585,222 | 15,991,653 | ||||
Weighted average number of common shares-diluted | 27,002,908 | 16,200,222 | 25,585,222 | 15,991,653 | ||||
Basic net loss per share | $ (0.08) | $ (0.37) | $ (0.34) | $ (0.90) | ||||
Diluted net loss per share | $ (0.08) | $ (0.37) | $ (0.34) | $ (0.90) |
Net Loss per Share of Common _3
Net Loss per Share of Common Stock (Details Narrative) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Earnings Per Share [Abstract] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 5,798,035 | 2,760,527 |
Schedule of Weighted Average Re
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases (Details) | Sep. 30, 2023 |
Property, Plant and Equipment [Line Items] | |
Weighted average remaining lease term (years) for our facility and equipment leases | 2 years |
Weighted average discount rate for our facility and equipment leases | 8% |
Facility Lease [Member] | |
Property, Plant and Equipment [Line Items] | |
Remaining lease term (years) | 2 years |
Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Remaining lease term (years) | 6 months |
Schedule of Annual Lease Liabil
Schedule of Annual Lease Liabilities for all Operating Leases (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Operating Leases | ||
2023 | $ 24,109 | |
2024 | 92,356 | |
2025 | 70,040 | |
Total lease payments | 186,505 | |
Less: Interest | (14,984) | |
Present value of lease liabilities | 171,521 | |
Less: current maturities | (82,744) | $ (78,896) |
Non-current lease liability | $ 88,777 | $ 150,554 |
Operating Leases (Details Narra
Operating Leases (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Leases | ||||
Operating lease borrowing rate | 8% | 8% | ||
Lease cost | $ 24,000 | $ 24,000 | $ 73,000 | $ 73,000 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CorLyst, LLC [Member] | ||
Related Party Transaction [Line Items] | ||
Rent and other costs reimbursements received | $ 89,980 | $ 94,642 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) $ in Millions | Sep. 30, 2023 USD ($) |
CROs [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Purchase obligation | $ 1.8 |