Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | May 09, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Period Focus | Q1 | |
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, $0.0001 par value per share | |
Trading Symbol | PCSA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 24,531,474 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current Assets | ||
Cash and cash equivalents | $ 10,741,602 | $ 6,503,595 |
Prepaid expenses and other | 1,477,519 | 1,883,134 |
Total Current Assets | 12,219,121 | 8,386,729 |
Property and Equipment, net | ||
Other Assets | ||
Operating lease right-of-use assets, net of accumulated amortization | 207,787 | 227,587 |
Security deposit | 5,535 | 5,535 |
Total Other Assets | 213,322 | 233,122 |
Total Assets | 12,432,443 | 8,619,851 |
Current Liabilities | ||
Current maturities of operating lease liability | 81,166 | 78,896 |
Accounts payable | 316,709 | 327,548 |
Due to licensor | 189,000 | 189,000 |
Due to related parties | $ 51 | |
Other Liability, Current, Related and Nonrelated Party Status [Extensible Enumeration] | Related Party [Member] | |
Accrued expenses | 1,573,961 | $ 403,061 |
Total Current Liabilities | 2,160,836 | 998,556 |
Non-current Liabilities | ||
Non-current operating lease liability | 129,358 | 150,554 |
Total Liabilities | 2,290,194 | 1,149,110 |
Commitments and Contingencies | ||
Stockholders’ Equity | ||
Common stock, par value $0.0001, 50,000,000 shares authorized: 24,631,474 issued and 24,531,474 outstanding at March 31, 2023 and 16,135,400 issued and 16,035,400 outstanding at December 31, 2022 | 2,463 | 1,614 |
Additional paid-in capital | 78,709,420 | 72,016,688 |
Treasury stock at cost — 100,000 shares at March 31, 2023 and December 31, 2022 | (300,000) | (300,000) |
Accumulated deficit | (68,269,634) | (64,247,561) |
Total Stockholders’ Equity | 10,142,249 | 7,470,741 |
Total Liabilities and Stockholders’ Equity | $ 12,432,443 | $ 8,619,851 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 24,631,474 | 16,135,400 |
Common stock, shares outstanding | 24,531,474 | 16,035,400 |
Treasury stock shares | 100,000 | 100,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating Expenses | ||
Research and development expenses | $ 1,627,480 | $ 2,043,984 |
General and administrative expenses | 2,478,055 | 1,184,730 |
Operating Loss | (4,105,535) | (3,228,714) |
Other Income (Expense), net | 83,462 | 1,583 |
Net Operating Loss Before Income Tax Benefit | (4,022,073) | (3,227,131) |
Income Tax Benefit | ||
Net Loss | $ (4,022,073) | $ (3,227,131) |
Net Loss Per Common Share - Basic and Diluted | $ (0.18) | $ (0.20) |
Weighted Average Common Shares Used to Compute Net Loss Per Common Shares - Basic and Diluted | 22,770,789 | 15,831,118 |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Changes in Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock, Common [Member] | Retained Earnings [Member] | Total |
Beginning balance, value 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 | 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) | |||
Beginning balance, value 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) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash Flows From Operating Activities | ||
Net loss | $ (4,022,073) | $ (3,227,131) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash lease expense for right-of-use assets | 19,800 | 22,559 |
Amortization of issuance costs | 3,113 | |
Amortization of intangible asset | 197,124 | |
Stock-based compensation | 341,504 | 828,897 |
Recording of warrant to be 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 | 405,615 | 216,717 |
Operating lease liability | (18,926) | (23,195) |
Accounts payable | (10,839) | 97,187 |
Due (from) to related parties | (51) | (1,772) |
Other receivables | 70,274 | |
Accrued expenses | (139,975) | 13,301 |
Net cash used in operating activities | (2,114,070) | (1,802,926) |
Cash Flows From Financing Activities | ||
Net proceeds from common stock issued | 6,352,077 | |
Acquisition of treasury stock | (300,000) | |
Net cash provided by (used in) financing activities | 6,352,077 | (300,000) |
Net Increase (Decrease) in Cash | 4,238,007 | (2,102,926) |
Cash and Cash Equivalents – Beginning of Period | 6,503,595 | 16,497,581 |
Cash and Cash Equivalents – End of Period | 10,741,602 | 14,394,655 |
Non-Cash Financing Activities | ||
Issuance of 123,609 shares of common stock in connection with the Purchase Agreement with Lincoln Park | $ 450,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) (Parenthetical) | 3 Months Ended |
Mar. 31, 2022 shares | |
Common Stock [Member] | |
Shares issued in connection with the Purchase Agreement with Lincoln Park | 123,609 |
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 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 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. Liquidity We have incurred losses since inception, devoting substantially all of our efforts toward research and development, and have an accumulated deficit of $ 68.3 million 4.0 million We had no During the three months ended March 31, 2023, we raised gross proceeds of $ 7.0 6.4 8,432,192 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 March 31, 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 consolidated financial position or results of operations. |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 2 – Stockholders’ Equity Preferred Stock There were no Common Stock During the three months ended March 31, 2023, we issued 8,432,192 ATM Offering On August 20, 2021, we entered into the Sales Agreement with Oppenheimer & Co. Inc. (the “Sales Agent”) under which we may issue and sell up to $ 30.0 569,648 1.22 693,000 672,000 Lincoln Park Capital Fund, LLC Purchase Agreement On March 23, 2022, we entered into the Purchase Agreement with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to $ 15.0 , including that the closing sale price of the common stock on the purchase date is not below a threshold price of $ 1.00 50,000 1.08 54,000 Registered Direct Offering On February 14, 2023, we closed a registered direct offering (the “Offering”) of 7,812,544 shares of common stock at a purchase price of $ 0.80 per share for gross proceeds of $ 6.3 of 5.6 The Purchase Agreement provides that, subject to certain exceptions, until the earlier of (i) 90 days after the closing of the Offering or (ii) the trading day following the date that our common stock’s closing price exceeds $2.00 for a period of 10 consecutive trading days , . We paid the Placement Agent a cash fee of 8.0 % of the gross proceeds from the Offering, excluding proceeds received from our insiders, and reimbursed the Placement Agent for legal fees of $ 60,000 . The engagement agreement with the Placement Agent requires us to indemnify the Placement Agent and certain of its affiliates against certain customary liabilities. On February 14, 2023, we amended our consulting agreement with Spartan originally entered into on August 24, 2022, extending the term of the consulting agreement until February 10, 2024. As compensation for services under the agreement, on April 17, 2023, we granted Spartan a 3,160,130 shares of our common stock with an exercise price of $ 1.02 . The warrant will expire three years from the date of issuance and contains both call and cashless exercise provisions. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 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 1,394,122 Stock Compensation Expense We recorded stock-based compensation expense for the three month ended March 31, 2023 and 2022 as follows: Schedule of Stock-based Compensation Expense 2023 2022 Research and development $ 99,621 $ 191,875 General and administrative 241,883 637,022 Total $ 341,504 $ 828,897 At March 31, 2023, we recorded an expense and related accrued liability of $ 1.3 , which is not included in the table above Stock Options During the three months ended March 31, 2023, 36,885 141,611 18.22 2.9 At March 31, 2023, we did not have any unrecognized stock-based compensation expense related to our granted stock options. Restricted Stock Awards Activity with respect to our Restricted Stock Awards (RSAs) during the three months ended March 31, 2023 was as follows: Schedule of Restricted Stock Awards (“RSAs”) Activity Number of shares Weighted- Outstanding at January 1, 2023 61,888 $ 4.72 Granted 90,000 1.10 Cancelled (26,118 ) 1.72 Outstanding and unvested at March 31, 2023 125,770 $ 2.75 On January 1, 2023, we granted RSAs totaling 90,000 of their compensation on a retroactive basis, 26,118 At March 31, 2023, the total unrecognized stock-based compensation expense related to the outstanding and unvested RSAs was $ 163,100 , which is expected to be recognized over a weighted average period of 0.5 years. Restricted Stock Units Activity with respect to our Restricted Stock Units (“RSUs”) during the three months ended March 31, 2023 was as follows: Schedule of Restricted Stock Units (“RSUs”) Activity Number of shares Weighted- Outstanding at January 1, 2023 2,713,977 $ 3.69 Granted 966,503 1.10 Outstanding at March 31, 2023 3,680,480 3.01 Vested and unissued 2,585,247 3.50 Unvested at March 31, 2023 1,095,233 $ 1.86 At March 31, 2023, unrecognized stock-based compensation expense of $ 1.2 million 2.1 322,000 Holders of our vested RSUs have our promise to issue shares of our common stock upon meeting the Warrants During the three months ended March 31, 2023, we agreed to grant a warrant to purchase a total of 3,160,130 . The warrant was issued and exercisable on April 17, 2023 with an exercise price of $ 1.02 1,310,875 At March 31, 2023, we had outstanding stock purchase warrants, including the warrant issued on April 17, 2023, for the purchase of 3,366,480 shares with a weighted average exercise price of $ 1.61 2.8 206,350 exercisable will be exercisable At March 31, 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 | 3 Months Ended |
Mar. 31, 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 both periods presented, basic and diluted net loss per share are the same. As such, diluted loss per share for the three months ended March 31, 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 months ended March 31, 2023 and 2022 was as follows: Schedule of Net Loss Per Share Basic and Dilute 2023 2022 Three months ended March 31, 2023 2022 Basic and diluted net loss per share: Net loss available to common stockholders $ (4,022,073 ) $ (3,227,131 ) Weighted average number of common shares-basic and diluted 22,770,789 15,831,118 Basic and diluted net loss per share $ (0.18 ) $ (0.20 ) Our diluted net loss per share for the three months ended March 31, 2023 and 2022 excluded 4,729,094 3,160,130 795,342 |
Operating Leases
Operating Leases | 3 Months Ended |
Mar. 31, 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 $ 22,461 21,918 Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases Remaining lease term (years) for our facility lease 2.5 Remaining lease term (years) for our equipment lease 1.0 Weighted average remaining lease term (years) for our facility and equipment leases 2.5 Weighted average discount rate for our facility and equipment leases 8.0 % Annual lease liabilities for all operating leases were as follows at March 31, 2023: Schedule of Annual Lease Liabilities for all Operating Leases 2023 $ 70,600 2024 92,356 2025 70,040 Total lease payments 232,996 Less: Interest (22,472 ) Present value of lease liabilities 210,524 Less: current maturities (81,166 ) Non-current lease liability $ 129,358 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 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 being reimbursed in our condensed consolidated statement of operations. We recorded $ 30,205 31,262 No |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 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 (CROs) and subcontractors to further develop our products. The contracts are cancelable, with varying provisions regarding termination. If we terminated a cancelable contract with a specific vendor, we would only be obligated for products or services that we received at the effective date of the termination and any applicable cancellation fees. At March 31, 2023, we are contractually obligated to pay up to $ 3.0 |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 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. |
Liquidity | Liquidity We have incurred losses since inception, devoting substantially all of our efforts toward research and development, and have an accumulated deficit of $ 68.3 million 4.0 million We had no During the three months ended March 31, 2023, we raised gross proceeds of $ 7.0 6.4 8,432,192 |
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 March 31, 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 consolidated financial position or results of operations. |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expense | We recorded stock-based compensation expense for the three month ended March 31, 2023 and 2022 as follows: Schedule of Stock-based Compensation Expense 2023 2022 Research and development $ 99,621 $ 191,875 General and administrative 241,883 637,022 Total $ 341,504 $ 828,897 |
Schedule of Restricted Stock Awards (“RSAs”) Activity | Activity with respect to our Restricted Stock Awards (RSAs) during the three months ended March 31, 2023 was as follows: Schedule of Restricted Stock Awards (“RSAs”) Activity Number of shares Weighted- Outstanding at January 1, 2023 61,888 $ 4.72 Granted 90,000 1.10 Cancelled (26,118 ) 1.72 Outstanding and unvested at March 31, 2023 125,770 $ 2.75 |
Schedule of Restricted Stock Units (“RSUs”) Activity | Activity with respect to our Restricted Stock Units (“RSUs”) during the three months ended March 31, 2023 was as follows: Schedule of Restricted Stock Units (“RSUs”) Activity Number of shares Weighted- Outstanding at January 1, 2023 2,713,977 $ 3.69 Granted 966,503 1.10 Outstanding at March 31, 2023 3,680,480 3.01 Vested and unissued 2,585,247 3.50 Unvested at March 31, 2023 1,095,233 $ 1.86 |
Net Loss per Share of Common _2
Net Loss per Share of Common Stock (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share Basic and Dilute | The computation of net loss per share for the three months ended March 31, 2023 and 2022 was as follows: Schedule of Net Loss Per Share Basic and Dilute 2023 2022 Three months ended March 31, 2023 2022 Basic and diluted net loss per share: Net loss available to common stockholders $ (4,022,073 ) $ (3,227,131 ) Weighted average number of common shares-basic and diluted 22,770,789 15,831,118 Basic and diluted net loss per share $ (0.18 ) $ (0.20 ) |
Operating Leases (Tables)
Operating Leases (Tables) | 3 Months Ended |
Mar. 31, 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 2.5 Remaining lease term (years) for our equipment lease 1.0 Weighted average remaining lease term (years) for our facility and equipment leases 2.5 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 March 31, 2023: Schedule of Annual Lease Liabilities for all Operating Leases 2023 $ 70,600 2024 92,356 2025 70,040 Total lease payments 232,996 Less: Interest (22,472 ) Present value of lease liabilities 210,524 Less: current maturities (81,166 ) Non-current lease liability $ 129,358 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | |||
Accumulated deficit | $ 68,269,634 | $ 64,247,561 | |
Net loss | 4,022,073 | $ 3,227,131 | |
Revenue | 0 | ||
Proceeds from sale of common stock | 7,000,000 | ||
Net proceeds from sale of stock | $ 6,352,077 | ||
Sale of common stock, shares | 8,432,192 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 3 Months Ended | ||||||
Feb. 09, 2023 | Mar. 23, 2022 | Aug. 20, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Apr. 17, 2023 | Dec. 31, 2022 | |
Class of Stock [Line Items] | |||||||
Preferred stock, shares issued | 0 | 0 | |||||
Preferred stock, shares outstanding | 0 | 0 | |||||
Net proceeds from common stock | $ 6,352,077 | ||||||
Sales Agreement [Member] | |||||||
Class of Stock [Line Items] | |||||||
Number of shares issued | 569,648 | ||||||
Shares Issued, Price Per Share | $ 1.22 | ||||||
Gross proceeds from common stock | $ 693,000 | ||||||
Net proceeds from common stock | $ 672,000 | ||||||
Sales Agreement [Member] | Maximum [Member] | |||||||
Class of Stock [Line Items] | |||||||
Maximum value to be sold at the market offering | $ 30,000,000 | ||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | |||||||
Class of Stock [Line Items] | |||||||
Number of shares issued | 50,000 | ||||||
Shares Issued, Price Per Share | $ 1.08 | ||||||
Net proceeds from common stock | $ 54,000 | ||||||
Threshold price | $ 1 | ||||||
Purchase Agreement [Member] | Maximum [Member] | Lincoln Park Capital Fund LLC [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] | |||||||
Number of shares issued | 7,812,544 | ||||||
Shares Issued, Price Per Share | $ 0.80 | ||||||
Gross proceeds from common stock | $ 6,300,000 | ||||||
Net proceeds from common stock | $ 5,600,000 | ||||||
Restrictions to issue stock | The Purchase Agreement provides that, subject to certain exceptions, until the earlier of (i) 90 days after the closing of the Offering or (ii) the trading day following the date that our common stock’s closing price exceeds $2.00 for a period of 10 consecutive trading days | ||||||
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] | |||||||
Number of shares issued | 8,432,192 |
Schedule of Stock-based Compens
Schedule of Stock-based Compensation Expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 341,504 | $ 828,897 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | 99,621 | 191,875 |
General and Administrative Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 241,883 | $ 637,022 |
Schedule of Restricted Stock Aw
Schedule of Restricted Stock Awards (“RSAs”) Activity (Details) - Restricted Stock [Member] | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of restricted stock, shares outstanding | shares | 61,888 |
Weighted-average grant-date fair value per share, outstanding | $ / shares | $ 4.72 |
Number of shares, granted | shares | 90,000 |
Weighted-average grant-date fair value per share, awarded | $ / shares | $ 1.10 |
Number of shares, cancelled | shares | (26,118) |
Weighted-average grant-date fair value per share, cancelled | $ / shares | $ 1.72 |
Number of restricted stock shares outstanding | shares | 125,770 |
Weighted-average grant-date fair value per share, outstanding | $ / shares | $ 2.75 |
Schedule of Restricted Stock Un
Schedule of Restricted Stock Units (“RSUs”) Activity (Details) - Restricted Stock Units (RSUs) [Member] | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of shares, Beginning balance | shares | 2,713,977 |
Weighted-average grant-date fair value per share, Beginning balance | $ / shares | $ 3.69 |
Number of shares, awarded | shares | 966,503 |
Weighted-average grant-date fair value per share, awarded | $ / shares | $ 1.10 |
Number of shares, Ending balance | shares | 3,680,480 |
Weighted-average grant-date fair value per share, Ending balance | $ / shares | $ 3.01 |
Number of shares, vested and unissued | shares | 2,585,247 |
Weighted-average grant-date fair value per share, vested and unissued | $ / shares | $ 3.50 |
Number of restricted stock shares outstanding | shares | 1,095,233 |
Weighted-average grant-date fair value per share, outstanding | $ / shares | $ 1.86 |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) - USD ($) | 3 Months Ended | ||||
Feb. 14, 2023 | Jan. 01, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Expenses and accrued liabilities | $ 1,573,961 | $ 403,061 | |||
General and administrative expense | 2,478,055 | $ 1,184,730 | |||
Warrant [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Expenses and accrued liabilities | $ 1,300,000 | ||||
Weighted average exercise price | $ 1.02 | $ 1.61 | |||
Warrants to purchase shares | 3,366,480 | ||||
Weighted average remaining contractual life | 2 years 9 months 18 days | ||||
Number of warrant exercisable shares | 206,350 | ||||
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 | ||||
Options exercisable weighted average exercise price | $ 18.22 | ||||
Exercisable weighted average remaining contractual term | 2 years 10 months 24 days | ||||
Restricted Stock [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of shares, granted | 90,000 | ||||
Number of shares, cancelled | 26,118 | ||||
Unrecognized share based compensation expense | $ 163,100 | ||||
Weighted average period for recognition | 6 months | ||||
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 Units (RSUs) [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of shares, granted | 966,503 | ||||
Unrecognized share based compensation expense | $ 1,200,000 | ||||
Weighted average period for recognition | 2 years 1 month 6 days | ||||
Unrecognized restricted stock expense | $ 322,000 | ||||
2019 Plan [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Maximum equity available for issuance | 6,000,000 | ||||
Shares available for future grants | 1,394,122 |
Schedule of Net Loss Per Share
Schedule of Net Loss Per Share Basic and Dilute (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Net loss available to common stockholders | $ (4,022,073) | $ (3,227,131) |
Weighted average number of common shares-basic and diluted | 22,770,789 | 15,831,118 |
Basic and diluted net loss per share | $ (0.18) | $ (0.20) |
Net Loss per Share of Common _3
Net Loss per Share of Common Stock (Details Narrative) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 4,729,094 | 795,342 |
Committed Warrant [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Antidilutive securities including from computation of earnings per share, amount | 3,160,130 |
Schedule of Weighted Average Re
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases (Details) | Mar. 31, 2023 |
Property, Plant and Equipment [Line Items] | |
Weighted average remaining lease term (years) for our facility and equipment leases | 2 years 6 months |
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 6 months |
Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Remaining lease term (years) | 1 year |
Schedule of Annual Lease Liabil
Schedule of Annual Lease Liabilities for all Operating Leases (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Operating Leases | ||
2023 | $ 70,600 | |
2024 | 92,356 | |
2025 | 70,040 | |
Total lease payments | 232,996 | |
Less: Interest | (22,472) | |
Present value of lease liabilities | 210,524 | |
Less: current maturities | (81,166) | $ (78,896) |
Non-current lease liability | $ 129,358 | $ 150,554 |
Operating Leases (Details Narra
Operating Leases (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating Leases | ||
Operating lease borrowing rate | 8% | |
Lease cost | $ 22,461 | $ 21,918 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - CorLyst, LLC [Member] - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Related Party Transaction [Line Items] | ||
Rent and other costs reimbursements received | $ 30,205 | $ 31,262 |
Related Party [Member] | ||
Related Party Transaction [Line Items] | ||
Due from related parties | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) $ in Millions | Mar. 31, 2023 USD ($) |
Agreements [Member] | Contract Research Organizations [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Purchase obligation | $ 3 |