Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | May 10, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2024 | |
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, $0.0001 par value per share | |
Trading Symbol | PCSA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 2,858,007 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Current Assets | ||
Cash and cash equivalents | $ 8,920,363 | $ 4,706,197 |
Due from related parties | 22,295 | |
Prepaid expenses and other | 857,635 | 926,300 |
Total Current Assets | 9,800,293 | 5,632,497 |
Property and Equipment, net | 2,415 | 2,554 |
Other Assets | ||
Lease right-of-use assets, net of accumulated amortization | 136,489 | 146,057 |
Security deposit | 5,535 | 5,535 |
Total Other Assets | 142,024 | 151,592 |
Total Assets | 9,944,732 | 5,786,643 |
Current Liabilities | ||
Current maturities of lease liabilities | 89,680 | 83,649 |
Accounts payable | 455,368 | 311,617 |
Due to licensor | 189,000 | |
Due to related parties | 39 | |
Accrued expenses | 465,618 | 146,274 |
Total Current Liabilities | 1,010,666 | 730,579 |
Non-current Liabilities | ||
Non-current lease liabilities | 50,700 | 66,905 |
Total Liabilities | 1,061,366 | 797,484 |
Commitments and Contingencies | ||
Stockholders’ Equity | ||
Common stock, par value $0.0001, 100,000,000 shares authorized: 2,860,981 issued and 2,855,981 outstanding at March 31, 2024 and 1,291,000 issued and 1,286,000 outstanding at December 31, 2023 | 286 | 129 |
Additional paid-in capital | 87,278,542 | 80,658,111 |
Treasury stock at cost — 5,000 shares at March 31, 2024 and December 31, 2023 | (300,000) | (300,000) |
Accumulated deficit | (78,095,462) | (75,369,081) |
Total Stockholders’ Equity | 8,883,366 | 4,989,159 |
Total Liabilities and Stockholders’ Equity | $ 9,944,732 | $ 5,786,643 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 2,860,981 | 1,291,000 |
Common stock, shares outstanding | 2,855,981 | 1,286,000 |
Treasury stock shares | 5,000 | 5,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating Expenses | ||
Research and development expenses | $ 1,539,070 | $ 1,627,480 |
General and administrative expenses | 1,270,528 | 2,478,055 |
Operating Loss | (2,809,598) | (4,105,535) |
Other Income (Expense), net | 83,217 | 83,462 |
Net Loss | $ (2,726,381) | $ (4,022,073) |
Net Loss Per Common Share - Basic | $ (1.11) | $ (3.53) |
Net Loss Per Common Share - Diluted | $ (1.11) | $ (3.53) |
Weighted Average Common Shares Used to Compute Net Loss Per Common Shares - Basic | 2,466,523 | 1,138,573 |
Weighted Average Common Shares Used to Compute Net Loss Per Common Shares - Diluted | 2,466,523 | 1,138,573 |
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 |
Balance at Dec. 31, 2022 | $ 80 | $ 72,018,222 | $ (300,000) | $ (64,247,561) | $ 7,470,741 |
Balance. shares at Dec. 31, 2022 | 806,774 | (5,000) | |||
Stock-based compensation | $ 1 | 341,503 | 341,504 | ||
Stock-based compensation, shares | 3,195 | ||||
Shares issued in connection with capital raise, net of transaction costs | $ 42 | 6,352,035 | 6,352,077 | ||
Shares issued in connection with capital raises, net of transaction costs, shares | 421,611 | ||||
Net loss | (4,022,073) | (4,022,073) | |||
Balance at Mar. 31, 2023 | $ 123 | 78,711,760 | $ (300,000) | (68,269,634) | 10,142,249 |
Balance. shares at Mar. 31, 2023 | 1,231,580 | (5,000) | |||
Balance at Dec. 31, 2023 | $ 129 | 80,658,111 | $ (300,000) | (75,369,081) | 4,989,159 |
Balance. shares at Dec. 31, 2023 | 1,291,000 | (5,000) | |||
Stock-based compensation | $ 1 | 167,642 | 167,643 | ||
Stock-based compensation, shares | 13,176 | ||||
Shares issued in connection with capital raise, net of transaction costs | $ 156 | 6,282,274 | 6,282,430 | ||
Shares issued in connection with capital raises, net of transaction costs, shares | 1,555,555 | ||||
Net loss | (2,726,381) | (2,726,381) | |||
Shares issued in connection with license agreement | $ 1 | 188,999 | 189,000 | ||
Shares issued in connection with license agreement, shares | 5,000 | ||||
Settlement of stock award | (8,561) | (8,561) | |||
Shares withheld to pay income taxes on stock-based compensation | $ (1) | (9,923) | (9,924) | ||
Shares withheld to pay income taxes on stock-based compensation, shares | (3,750) | ||||
Balance at Mar. 31, 2024 | $ 286 | $ 87,278,542 | $ (300,000) | $ (78,095,462) | $ 8,883,366 |
Balance. shares at Mar. 31, 2024 | 2,860,981 | (5,000) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash Flows From Operating Activities | ||
Net loss | $ (2,726,381) | $ (4,022,073) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 139 | |
Non-cash lease expense for right-of-use assets | 21,372 | 19,800 |
Stock-based compensation | 167,643 | 341,504 |
Recording of warrant to be issued to purchase 158,007 shares of common stock in connection with a consulting agreement | 1,310,875 | |
Net changes in operating assets and liabilities: | ||
Prepaid expenses and other | 68,665 | 405,615 |
Operating lease liability | (21,083) | (18,926) |
Accounts payable | 143,751 | (10,839) |
Due (from) related parties | (22,334) | (51) |
Accrued expenses | 319,344 | (139,975) |
Net cash used in operating activities | (2,048,884) | (2,114,070) |
Cash Flows From Financing Activities | ||
Net proceeds from issuance of stock | 6,282,430 | 6,352,077 |
Shares withheld to pay taxes on stock-based compensation | (9,924) | |
Settlement of stock award | (8,561) | |
Payment of finance lease obligation | (895) | |
Net cash provided by financing activities | 6,263,050 | 6,352,077 |
Net Increase in Cash | 4,214,166 | 4,238,007 |
Cash and Cash Equivalents – Beginning of Period | 4,706,197 | 6,503,595 |
Cash and Cash Equivalents – End of Period | 8,920,363 | 10,741,602 |
Non-Cash Financing Activities | ||
Issuance of 5,000 shares of common stock in connection with a licensing agreement which had previously been recorded as a due to licensor | 189,000 | |
Right-of-use asset | 11,804 | |
Financing lease liability | (11,804) | |
Net |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) (Parenthetical) | 3 Months Ended |
Mar. 31, 2024 shares | |
Common Stock [Member] | |
Shares issued in connection with license agreement | 5,000 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure [Table] | ||
Net Income (Loss) | $ (2,726,381) | $ (4,022,073) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b51 Arr Adopted Flag | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b51 Arr Trmntd Flag | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
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. On January 22, 2024, we filed a Certificate of Amendment to our Certificate of Incorporation, as amended with the Secretary of State of Delaware that effected a 1-for-20 reverse stock split 0.0001 24,706,474 1,291,000 24,606,474 1,286,000 100,000,000 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, 2023, 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 Our condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. We have incurred losses since inception, are currently devoting substantially all of our efforts toward research and development of our NGC drug product candidates, including conducting clinical trials and providing general and administrative support for these operations, and have an accumulated deficit of $ 78.1 million at March 31, 2024. During the three months ended March 31, 2024, we generated a net loss of $ 2.7 million and used $ 2.0 million in net cash for operating activities from continuing operations. To date, none of our drug candidates have been approved for sale, and therefore we have not generated any product revenue and do not expect positive cash flow from operations in the foreseeable future. We have financed our operations primarily through public equity issuances, including an offering we closed on January 30, 2024 where we sold 476,000 shares of our common stock, pre-funded warrants to purchase up to 1,079,555 shares of our common stock, and warrants for the purchase of up to 1,555,555 shares of our common stock for net proceeds of $ 6.3 , after deducting placement agent fees and offering-related expenses. Simultaneously with the closing of the sale, the pre-funded warrants were exercised in exchange for 1,079,555 shares of our common stock. We will continue to be dependent upon equity and/or debt financing until we are able to generate positive cash flows from its operations. At March 31, 2024, we had cash and cash equivalents totaling $ 8.9 , including the of rial We plan to raise additional funds in the future through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements, but will only do so if the terms are acceptable to us. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or planned future clinical trial plans, or research and development programs. This may also cause us to not meet obligations contained in certain of our license agreements and put these assets at risk. To the extent that we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. There can be no assurance that future funding will be available when needed. Absent additional funding, we believe that our cash and cash equivalents will not be sufficient to fund our operations for a period of one year or more after the date that these condensed condensed condensed 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, 2024, 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 | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 2 – Stockholders’ Equity Preferred Stock There were no Common Stock During the three months ended March 31, 2024, we issued the following shares of common stock. ● On January 22, 2024, we issued 6,203 2,373 ● On January 25, 2024, we issued 5,000 , Inc. (“Elion”) ● On January 30, 2024, we sold, pursuant to securities purchase agreements (the “Purchase Agreement”), 476,000 shares of common stock, pre-funded warrants to purchase up to 1,079,555 shares of common stock in lieu of shares of common stock (the “Pre-Funded Warrants”), and warrants to purchase up to 1,555,555 shares of our common stock (the “Common Warrants’) pursuant to a public offering (the “Offering”). The Common Warrants have an exercise price of $ 4.50 , are immediately exercisable and will remain exercisable until the date that is five years after their original issuance. The Shares were offered at a combined public offering price of $ 4.50 per share and accompanying Common Warrant and $ 4.4999 per Pre-Funded Warrant and accompanying Common Warrant. The Pre-Funded Warrants had an exercise price of $ 0.0001 and were exercised in full simultaneously with the closing of the Offering in exchange for 1,079,555 shares of our common stock. Gross proceeds in connection with the Offering were $ 7.0 million. We received $ 6.3 in net proceeds from the Offering, after deducting the fees of the placement agent and other offering-related expenses. We also issued to the placement agent warrants to purchase 62,222 shares of common stock, exercisable at $ 5.625 per share that expire on February 1, 2027 . ● On February 5, 2024, we issued 1,250 ● On March 5, 2024, we issued 3,223 1,377 for During the three months ended March 31, 2023, we issued 421,611 ● ATM Offering 28,483 24.40 693,000 672,000 ● Lincoln Park Capital Fund, LLC Purchase Agreement – During the three months ended March 31 2,500 21.60 54,000 ● Registered Direct Offering – Registered Direct 390,628 16.00 6.3 5.6 We paid the placement agent, Spartan Capital Securities, LLC, (“Spartan”) a cash fee of 8.0 Registered Direct 60,000 158,007 20.40 |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation | Note 3 - Stock-based Compensation On June 19, 2019, our stockholders approved, and we adopted , 300,000 35,508 Stock Compensation Expense We recorded stock-based compensation expense for the three month ended March 31, 2024 and 2023 as follows: Schedule of Stock-based Compensation Expense 2024 2023 Research and development $ 31,121 $ 99,621 General and administrative 136,522 241,883 Total $ 167,643 $ 341,504 Stock Options No 6,992 364.72 1.9 At March 31, 2024, we did not have any unrecognized stock-based compensation expense related to our granted stock options. Restricted Stock Awards During the three months ended March 31, 2024, we vested 1,250 estricted Stock Awards (“R ”) 9.26 no Restricted Stock Units Activity with respect to our Restricted Stock Units (“RSUs”) during the three months ended March 31, 2024 was as follows: Schedule of Restricted Stock Units (“RSUs”) Activity Number of Weighted- Outstanding at January 1, 2024 222,722 $ 45.82 Granted - - Forfeited (7,290 ) 63.91 Issued (9,426 ) 102.68 Outstanding at March 31, 2024 206,006 42.58 Vested and unissued 124,529 59.75 Unvested at March 31, 2024 81,477 $ 16.33 On January 1, 2024, we granted RSUs for the future issuance of no more than 39,202 shares of our common stock, contingent upon receiving shareholder approval to increase the number of shares available under our 2019 Omnibus Incentive Plan (“Incentive Plan”) at our annual shareholder meeting in June 2024. The number of shares to be issued under the RSUs will be based on the greater of: (i) $ 30.00 per share or (ii) the closing price per share on the day we receive shareholder approval to increase the number of shares available under the Incentive Plan. At March 31, 2024, unrecognized stock-based compensation expense of $ 723,000 1.4 420,000 Holders of our vested RSUs will be issued Warrants During the three months ended March 31, 2024, other than warrants to purchase 1,617,777 shares of common stock as part of our public offering (see Note 2), we did not grant any warrants to purchase shares of our common stock and warrants to purchase 5,000 15,000 shares of our common stock in exchange for a payment of $ 10,000 . At March 31, 2024, we had outstanding stock purchase warrants for the purchase of 1,778,284 shares with a weighted average exercise price of $ 6.1 7 and a weighted average remaining contractual life of 4. 5 years. All the outstanding stock purchase warrants are exercisable at March 31, 2024. W e did not have any unrecognized stock-based compensation expense related to our granted stock purchase warrants at March 31, 2024. |
Net Loss per Share of Common St
Net Loss per Share of Common Stock | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 and 2023 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, 2024 and 2023 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2024 2023 Three months ended March 31, 2024 2023 Basic and diluted net loss per share: Net loss available to common stockholders $ (2,726,381 ) $ (4,022,073 ) Weighted average number of common shares-basic and diluted 2,466,523 1,138,573 Basic and diluted net loss per share $ (1.11 ) $ (3.53 ) 2024 2023 Weighted-average number of common shares outstanding – basic and diluted 2,331,867 1,010,410 Weighted-average number of vested RSUs– basic and diluted 134,657 128,164 Weighted-average number of common shares-basic and diluted 2,466,523 1,138,573 Our diluted net loss per share for the three months ended March 31, 2024 and 2023 excluded 1,866,753 236,496 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2024 | |
Leases | |
Leases | Note 5 – 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 a financing 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 Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating and Financing Leases Remaining lease term (years) for our facility lease 1.5 Remaining lease term (years) for our equipment lease 1.8 Weighted average discount rate for our facility and equipment leases 8.0 % Annual lease liabilities for the operating lease were as follows at March 31, 2024: Schedule of Annual Lease Liabilities for all Operating Leases 2024 $ 68,247 2025 70,040 Total lease payments 138,287 Less: Interest (8,816 ) Present value of lease liabilities 129,471 Less: current maturities (84,878 ) Non-current lease liability $ 44,593 Annual lease liabilities for the financing lease were as follows at March 31, 2024: Schedule of Annual Lease Liabilities for all Financing Leases 2024 $ 4,849 2025 6,820 2026 488 Total lease payments 12,157 Less: Interest (1,248 ) Present value of lease liabilities 10,909 Less: current maturities (4,802 ) Non-current lease liability $ 6,107 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2024 | |
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 $ 23,000 30,000 22,295 no |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024, we are contractually obligated to pay up to $ 984,000 |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
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. On January 22, 2024, we filed a Certificate of Amendment to our Certificate of Incorporation, as amended with the Secretary of State of Delaware that effected a 1-for-20 reverse stock split 0.0001 24,706,474 1,291,000 24,606,474 1,286,000 100,000,000 |
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, 2023, 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 Our condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. We have incurred losses since inception, are currently devoting substantially all of our efforts toward research and development of our NGC drug product candidates, including conducting clinical trials and providing general and administrative support for these operations, and have an accumulated deficit of $ 78.1 million at March 31, 2024. During the three months ended March 31, 2024, we generated a net loss of $ 2.7 million and used $ 2.0 million in net cash for operating activities from continuing operations. To date, none of our drug candidates have been approved for sale, and therefore we have not generated any product revenue and do not expect positive cash flow from operations in the foreseeable future. We have financed our operations primarily through public equity issuances, including an offering we closed on January 30, 2024 where we sold 476,000 shares of our common stock, pre-funded warrants to purchase up to 1,079,555 shares of our common stock, and warrants for the purchase of up to 1,555,555 shares of our common stock for net proceeds of $ 6.3 , after deducting placement agent fees and offering-related expenses. Simultaneously with the closing of the sale, the pre-funded warrants were exercised in exchange for 1,079,555 shares of our common stock. We will continue to be dependent upon equity and/or debt financing until we are able to generate positive cash flows from its operations. At March 31, 2024, we had cash and cash equivalents totaling $ 8.9 , including the of rial We plan to raise additional funds in the future through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements, but will only do so if the terms are acceptable to us. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or planned future clinical trial plans, or research and development programs. This may also cause us to not meet obligations contained in certain of our license agreements and put these assets at risk. To the extent that we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. There can be no assurance that future funding will be available when needed. Absent additional funding, we believe that our cash and cash equivalents will not be sufficient to fund our operations for a period of one year or more after the date that these condensed condensed condensed |
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, 2024, 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) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expense | We recorded stock-based compensation expense for the three month ended March 31, 2024 and 2023 as follows: Schedule of Stock-based Compensation Expense 2024 2023 Research and development $ 31,121 $ 99,621 General and administrative 136,522 241,883 Total $ 167,643 $ 341,504 |
Schedule of Restricted Stock Units (“RSUs”) Activity | Activity with respect to our Restricted Stock Units (“RSUs”) during the three months ended March 31, 2024 was as follows: Schedule of Restricted Stock Units (“RSUs”) Activity Number of Weighted- Outstanding at January 1, 2024 222,722 $ 45.82 Granted - - Forfeited (7,290 ) 63.91 Issued (9,426 ) 102.68 Outstanding at March 31, 2024 206,006 42.58 Vested and unissued 124,529 59.75 Unvested at March 31, 2024 81,477 $ 16.33 |
Net Loss per Share of Common _2
Net Loss per Share of Common Stock (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share Basic and Diluted | The computation of net loss per share for the three months ended March 31, 2024 and 2023 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2024 2023 Three months ended March 31, 2024 2023 Basic and diluted net loss per share: Net loss available to common stockholders $ (2,726,381 ) $ (4,022,073 ) Weighted average number of common shares-basic and diluted 2,466,523 1,138,573 Basic and diluted net loss per share $ (1.11 ) $ (3.53 ) 2024 2023 Weighted-average number of common shares outstanding – basic and diluted 2,331,867 1,010,410 Weighted-average number of vested RSUs– basic and diluted 134,657 128,164 Weighted-average number of common shares-basic and diluted 2,466,523 1,138,573 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases | |
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating and Financing Leases | Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating and Financing Leases Remaining lease term (years) for our facility lease 1.5 Remaining lease term (years) for our equipment lease 1.8 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 the operating lease were as follows at March 31, 2024: Schedule of Annual Lease Liabilities for all Operating Leases 2024 $ 68,247 2025 70,040 Total lease payments 138,287 Less: Interest (8,816 ) Present value of lease liabilities 129,471 Less: current maturities (84,878 ) Non-current lease liability $ 44,593 |
Schedule of Annual Lease Liabilities for all Financing Leases | Annual lease liabilities for the financing lease were as follows at March 31, 2024: Schedule of Annual Lease Liabilities for all Financing Leases 2024 $ 4,849 2025 6,820 2026 488 Total lease payments 12,157 Less: Interest (1,248 ) Present value of lease liabilities 10,909 Less: current maturities (4,802 ) Non-current lease liability $ 6,107 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | |||||
Jan. 30, 2024 | Jan. 22, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Jan. 21, 2024 | Dec. 31, 2023 | |
OrganizationLineItems [Line Items] | ||||||
Reverse stock split | 1-for-20 reverse stock split | |||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Common stock shares issued | 1,291,000 | 2,860,981 | 24,706,474 | 1,291,000 | ||
Common stock shares outstanding | 1,286,000 | 2,855,981 | 24,606,474 | 1,286,000 | ||
Common stock shares authorized | 100,000,000 | 100,000,000 | 100,000,000 | |||
Accumulated deficit | $ 78,095,462 | $ 75,369,081 | ||||
Net loss | 2,726,381 | $ 4,022,073 | ||||
Net cash for operating activities from continuing operations | 2,048,884 | 2,114,070 | ||||
Net proceeds | $ 6,300,000 | 6,282,430 | $ 6,352,077 | |||
Cash and cash equivalents | $ 8,920,363 | $ 4,706,197 | ||||
Purchase Agreement [Member] | ||||||
OrganizationLineItems [Line Items] | ||||||
Number of shares sold | 476,000 | |||||
Net proceeds | $ 6,300,000 | |||||
Purchase Agreement [Member] | Warrant [Member] | ||||||
OrganizationLineItems [Line Items] | ||||||
Warrants to purchase shares | 1,555,555 | 1,617,777 | ||||
Purchase Agreement [Member] | Pre-Funded Warrants [Member] | ||||||
OrganizationLineItems [Line Items] | ||||||
Warrants to purchase shares | 1,079,555 | |||||
Warrant exercised | 1,079,555 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 3 Months Ended | |||||||||
Mar. 05, 2024 | Feb. 05, 2024 | Jan. 30, 2024 | Jan. 25, 2024 | Jan. 22, 2024 | Feb. 14, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Apr. 17, 2023 | |
Class of Stock [Line Items] | ||||||||||
Preferred stock, shares issued | 0 | 0 | ||||||||
Preferred stock, shares outstanding | 0 | 0 | ||||||||
Stock withheld for income taxes | 1,377 | 2,373 | ||||||||
Net proceeds | $ 6,300,000 | $ 6,282,430 | $ 6,352,077 | |||||||
Common Stock [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued | 1,555,555 | 421,611 | ||||||||
Purchase Agreement [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued | 476,000 | |||||||||
Gross proceeds from issuance of common stock | $ 7,000,000 | |||||||||
Net proceeds | $ 6,300,000 | |||||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued | 2,500 | |||||||||
Share price | $ 21.60 | |||||||||
Gross proceeds from issuance of common stock | $ 54,000 | |||||||||
Purchase Agreement [Member] | Placement Agent [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Warrant exercise price | $ 5.625 | |||||||||
Warrants to purchase shares | 62,222 | |||||||||
Warrant expire date | Feb. 01, 2027 | |||||||||
Purchase Agreement [Member] | Warrant [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Warrants to purchase common stock, shares | 1,555,555 | 1,617,777 | ||||||||
Warrant exercise price | $ 4.50 | |||||||||
Warrant term | 5 years | |||||||||
Purchase Agreement [Member] | Pre-Funded Warrants [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Warrants to purchase common stock, shares | 1,079,555 | |||||||||
Warrant exercise price | $ 0.0001 | |||||||||
Share price | $ 4.4999 | |||||||||
Warrant exercised | 1,079,555 | |||||||||
Sales Agreement [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued | 28,483 | |||||||||
Share price | $ 24.40 | |||||||||
Gross proceeds from issuance of common stock | $ 693,000 | |||||||||
Net proceeds | $ 672,000 | |||||||||
Securities Purchase Agreement [Member] | Registered Direct Offering [Member] | Accredited Investor [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued | 390,628 | |||||||||
Share price | $ 16 | |||||||||
Gross proceeds from issuance of common stock | $ 6,300,000 | |||||||||
Net 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 | 158,007 | 158,007 | ||||||||
Warrant exercise price | $ 20.40 | |||||||||
Five Executive Officers and One Employee [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued | 6,203 | |||||||||
Elion Oncology [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued | 5,000 | |||||||||
Consultant [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued | 1,250 | |||||||||
Former Employee [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued | 3,223 |
Schedule of Stock-based Compens
Schedule of Stock-based Compensation Expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 167,643 | $ 341,504 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | 31,121 | 99,621 |
General and Administrative Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 136,522 | $ 241,883 |
Schedule of Restricted Stock Un
Schedule of Restricted Stock Units (“RSUs”) Activity (Details) - Restricted Stock Units (RSUs) [Member] | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of shares, Beginning balance | shares | 222,722 |
Weighted-average grant-date fair value per share, Beginning balance | $ / shares | $ 45.82 |
Number of shares, granted | shares | |
Weighted-average grant-date fair value per share, granted | $ / shares | |
Number of shares, forfeited | shares | (7,290) |
Weighted-average grant-date fair value per share, forfeited | $ / shares | $ 63.91 |
Number of shares, issued | shares | (9,426) |
Weighted-average grant-date fair value per share, shares issued | $ / shares | $ 102.68 |
Number of shares, ending balance | shares | 206,006 |
Weighted-average grant-date fair value per share, ending balance | $ / shares | $ 42.58 |
Number of shares, vested and unissued | shares | 124,529 |
Weighted-average grant-date fair value per share, vested and unissued | $ / shares | $ 59.75 |
Number of shares, unvested | shares | 81,477 |
Weighted-average grant-date fair value per share, unvested | $ / shares | $ 16.33 |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) - USD ($) | 3 Months Ended | ||||
Jan. 01, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Jan. 30, 2024 | Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Payments for settlement of stock awards | $ 8,561 | ||||
Purchase Agreement [Member] | Warrant [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Warrants to purchase shares | 1,617,777 | 1,555,555 | |||
Weighted average exercise price | $ 4.50 | ||||
Consulting Agreement [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Warrants, expired | 5,000 | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Forfeitures | 15,000 | ||||
Payments for settlement of stock awards | $ 10,000 | ||||
Share-Based Payment Arrangement, Option [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Options, forfeited | 0 | ||||
Options exercisable, shares | 6,992 | ||||
Options exercisable weighted average exercise price | $ 364.72 | ||||
Exercisable weighted average remaining contractual term | 1 year 10 months 24 days | ||||
Restricted Stock [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of shares, vested | 1,250 | ||||
Weighted-average grant-date fair value per share, shares vested | $ 9.26 | ||||
Number of shares, outstanding | 0 | ||||
Restricted Stock Units (RSUs) [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of shares, outstanding | 206,006 | 222,722 | |||
Number of shares, granted | |||||
Unrecognized share based compensation expense | $ 723,000 | ||||
Weighted average period for recognition | 1 year 4 months 24 days | ||||
Unrecognized restricted stock expense | $ 420,000 | ||||
Restricted Stock Units (RSUs) [Member] | Maximum [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of shares, granted | 39,202 | ||||
Share Price | $ 30 | ||||
Warrant [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Warrants to purchase shares | 1,778,284 | ||||
Weighted average exercise price | $ 6.1 | ||||
Weighted average remaining contractual life | 4 years 6 months | ||||
2019 Plan [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Maximum equity available for issuance | 300,000 | ||||
Shares available for future grants | 35,508 |
Schedule of Net Loss Per Share
Schedule of Net Loss Per Share Basic and Diluted (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Net loss available to common stockholders | $ (2,726,381) | $ (4,022,073) |
Weighted average number of common shares-basic | 2,466,523 | 1,138,573 |
Weighted average number of common shares-diluted | 2,466,523 | 1,138,573 |
Basic net loss per share | $ (1.11) | $ (3.53) |
Diluted net loss per share | $ (1.11) | $ (3.53) |
Restricted Stock Units (RSUs) [Member] | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Weighted average number of common shares-basic | 134,657 | 128,164 |
Weighted average number of common shares-diluted | 134,657 | 128,164 |
Common Stock [Member] | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Weighted average number of common shares-basic | 2,331,867 | 1,010,410 |
Weighted average number of common shares-diluted | 2,331,867 | 1,010,410 |
Net Loss per Share of Common _3
Net Loss per Share of Common Stock (Details Narrative) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Earnings Per Share [Abstract] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,866,753 | 236,496 |
Schedule of Weighted Average Re
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating and Financing Leases (Details) | Mar. 31, 2024 |
Property, Plant and Equipment [Line Items] | |
Weighted average discount rate for our facility and equipment leases | 8% |
Facility Lease [Member] | |
Property, Plant and Equipment [Line Items] | |
Remaining lease term (years) | 1 year 6 months |
Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Remaining lease term (years) | 1 year 9 months 18 days |
Schedule of Annual Lease Liabil
Schedule of Annual Lease Liabilities for all Operating Leases (Details) | Mar. 31, 2024 USD ($) |
Leases | |
2024 | $ 68,247 |
2025 | 70,040 |
Total lease payments | 138,287 |
Less: Interest | (8,816) |
Present value of lease liabilities | 129,471 |
Less: current maturities | (84,878) |
Non-current lease liability | $ 44,593 |
Schedule of Annual Lease Liab_2
Schedule of Annual Lease Liabilities for all Financing Leases (Details) | Mar. 31, 2024 USD ($) |
Leases | |
2024 | $ 4,849 |
2025 | 6,820 |
2026 | 488 |
Total lease payments | 12,157 |
Less: Interest | (1,248) |
Present value of lease liabilities | 10,909 |
Less: current maturities | (4,802) |
Non-current lease liability | $ 6,107 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Leases | ||
Operating and financing lease borrowing rate | 8% | |
Lease cost | $ 22,461 | $ 22,461 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Related Party Transaction [Line Items] | |||
Due from related parties | $ 22,295 | ||
CorLyst, LLC [Member] | |||
Related Party Transaction [Line Items] | |||
Rent and other costs reimbursements received | 23,000 | $ 30,000 | |
Due from related parties | $ 22,295 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) | Mar. 31, 2024 USD ($) |
CROs [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Purchase obligation | $ 984,000 |