Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 27, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-39531 | ||
Entity Registrant Name | Processa Pharmaceuticals, Inc. | ||
Entity Central Index Key | 0001533743 | ||
Entity Tax Identification Number | 45-1539785 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 7380 Coca Cola Drive | ||
Entity Address, Address Line Two | Suite 106 | ||
Entity Address, City or Town | Hanover | ||
Entity Address, State or Province | MD | ||
Entity Address, Postal Zip Code | 21076 | ||
City Area Code | (443) | ||
Local Phone Number | 776-3133 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | PCSA | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 33.8 | ||
Entity Common Stock, Shares Outstanding | 24,557,592 | ||
Documents Incorporated by Reference | Portions of the Proxy Statement for the registrant’s 2023 Annual Meeting of Stockholders (the “Proxy Statement”) to be filed within 120 days of the end of the fiscal year ended December 31, 2022 are incorporated by reference into Part III hereof. Except with respect to information specifically incorporated by reference in this Form 10-K, the Proxy Statement is not deemed to be filed as a part hereof | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Firm ID | 6143 | ||
Auditor Location | Owings Mills, MD | ||
Auditor Name | BD & Company, Inc |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current Assets | ||
Cash and cash equivalents | $ 6,503,595 | $ 16,497,581 |
Due from tax agencies | 70,274 | |
Prepaid expenses and other | 1,883,134 | 1,759,296 |
Total Current Assets | 8,386,729 | 18,327,151 |
Other Assets | ||
Operating lease right-of-use assets, net | 227,587 | 74,181 |
Intangible assets, net | 8,056,638 | |
Other | 5,535 | 5,535 |
Total Other Assets | 233,122 | 8,136,354 |
Total Assets | 8,619,851 | 26,463,505 |
Current Liabilities | ||
Current maturities of operating lease liability | 78,896 | 71,078 |
Accounts payable | 327,548 | 218,905 |
Due to licensor | 189,000 | 400,000 |
Due to related parties | 51 | 1,772 |
Accrued expenses | 403,061 | 279,265 |
Total Current Liabilities | 998,556 | 971,020 |
Non-current Liabilities | ||
Non-current operating lease liability | 150,554 | 7,385 |
Total Liabilities | 1,149,110 | 978,405 |
Commitments and Contingencies | ||
Stockholders’ Equity | ||
Common stock, par value $0.0001, 50,000,000 shares authorized; 16,135,400 issued and 16,035,400 outstanding at December 31, 2022 and 15,710,246 issued and outstanding at December 31, 2021 | 1,614 | 1,571 |
Additional paid-in capital | 72,016,688 | 62,306,861 |
Treasury stock | (300,000) | |
Accumulated deficit | (64,247,561) | (36,823,332) |
Total Stockholders’ Equity | 7,470,741 | 25,485,100 |
Total Liabilities and Stockholders’ Equity | $ 8,619,851 | $ 26,463,505 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 50,000,000 | 30,000,000 |
Common stock, shares issued | 16,135,400 | 15,710,246 |
Common stock, shares outstanding | 16,035,400 | 15,710,246 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Expenses | ||
Research and development expenses | $ 11,494,230 | $ 6,878,021 |
Acquisition of in-process research and development | 566,583 | |
General and administrative expenses | 8,763,058 | 4,688,939 |
Impairment of intangible asset | 7,268,143 | |
Operating Loss | (27,525,431) | (12,133,543) |
Other Income (Expense) | ||
Forgiveness of Payroll Protection Program loan and related accrued interest | 163,771 | |
Interest income, net | 101,202 | 11,627 |
Net Operating Loss Before Income Tax Benefit | (27,424,229) | (11,958,145) |
Income Tax Benefit | 530,611 | |
Net Loss | $ (27,424,229) | $ (11,427,534) |
Net Loss Per Common Share - Basic and Diluted | $ (1.70) | $ (0.75) |
Weighted Average Common Shares Used to Compute Net Loss Per Common Shares - Basic and Diluted | 16,109,291 | 15,319,463 |
Consolidated Statement of Chang
Consolidated Statement of Changes in Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2020 | $ 1,419 | $ 48,333,857 | $ (25,395,798) | $ 22,939,478 | |
Beginning balance, shares at Dec. 31, 2020 | 14,181,734 | ||||
Stock-based compensation | $ 5 | 3,288,010 | 3,288,015 | ||
Stock-Based compensation, shares | 50,270 | ||||
Shares issued in private placement, net of transaction costs | $ 132 | 9,875,418 | 9,875,550 | ||
Shares issued in private placement, net of transaction costs, shares | 1,321,132 | ||||
Shares issued in connection with license agreement | $ 14 | 699,986 | 700,000 | ||
Shares issued in connection with license agreement, shares | 144,689 | ||||
Shares withheld to pay income taxes on stock-based compensation | $ (1) | (64,395) | (64,396) | ||
Shares withheld to pay income taxes on stock-based compensation, shares | (9,176) | ||||
Shares issued in ATM purchase, net of transaction costs | $ 2 | 173,985 | 173,987 | ||
Shares issued in ATM purchases, net of transaction costs, shares | 21,597 | ||||
Net loss | (11,427,534) | (11,427,534) | |||
Ending balance, value at Dec. 31, 2021 | $ 1,571 | 62,306,861 | (36,823,332) | 25,485,100 | |
Ending balance, shares at Dec. 31, 2021 | 15,710,246 | ||||
Stock-based compensation | $ 24 | 8,948,689 | 8,948,713 | ||
Stock-Based compensation, shares | 237,690 | ||||
Shares issued in connection with license agreement | $ 10 | 399,990 | 400,000 | ||
Shares issued in connection with license agreement, shares | 100,000 | ||||
Shares withheld to pay income taxes on stock-based compensation | $ (3) | (88,840) | (88,843) | ||
Shares withheld to pay income taxes on stock-based compensation, shares | (36,145) | ||||
Net loss | (27,424,229) | (27,424,229) | |||
Acquisition of treasury stock | $ (300,000) | (300,000) | |||
Acquisition of treasury stock, shares | (100,000) | ||||
Shares issued in connection with the Purchase Agreement with Lincoln Park | $ 12 | 449,988 | 450,000 | ||
Shares issued in connection with the Purchase Agreement with Lincoln Park, shares | 123,609 | ||||
Ending balance, value at Dec. 31, 2022 | $ 1,614 | $ 72,016,688 | $ (300,000) | $ (64,247,561) | $ 7,470,741 |
Ending balance, shares at Dec. 31, 2022 | 16,135,400 | (100,000) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash Flows From Operating Activities | ||
Net Loss | $ (27,424,229) | $ (11,427,534) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 484 | |
Non-cash lease expense for right-of-use assets | 85,518 | 84,377 |
Non-cash milestone expense in connection with license agreement | 189,000 | |
Non-cash acquisition of in-process research and development | 300,000 | |
Amortization of debt issuance costs | 115,613 | |
Amortization of intangible asset | 788,495 | 790,488 |
Impairment of intangible asset | 7,268,143 | |
Deferred income tax (benefit) expense | (530,611) | |
Stock-based compensation | 8,828,713 | 3,408,015 |
Forgiveness of Payroll Protection Program loan and related accrued interest | (163,771) | |
Net changes in operating assets and liabilities: | ||
Prepaid expenses and other | 210,549 | (1,018,095) |
Operating lease liability | (87,937) | (87,200) |
Accounts payable | 108,643 | (101,789) |
Due (from) to related parties | (1,721) | 86,644 |
Other receivables | 70,274 | 6,750 |
Accrued expenses | 243,796 | (65,049) |
Net cash (used in) operating activities | (9,605,143) | (8,717,291) |
Cash Flows From Financing Activities | ||
Net proceeds from common stock sold | 10,049,537 | |
Shares withheld to pay taxes on stock-based compensation | (88,843) | (64,396) |
Acquisition of treasury stock | (300,000) | |
Other | (186,493) | |
Net cash (used in) provided by financing activities | (388,843) | 9,798,648 |
Net (Decrease) Increase in Cash and Cash Equivalents | (9,993,986) | 1,081,357 |
Cash and Cash Equivalents - Beginning of Year | 16,497,581 | 15,416,224 |
Cash and Cash Equivalents - End of Year | 6,503,595 | 16,497,581 |
Supplemental Cash Flow Information: | ||
Cash paid for interest | ||
Cash paid for income taxes | ||
Non-Cash Financing Activities | ||
Issuance of 17,572 shares of common stock in satisfaction of accrued director fees | 120,000 | |
Issuance of 123,609 shares of common stock in connection with the Purchase Agreement with Lincoln Park | 450,000 | |
Issuance of 100,000 shares of common stock in connection with a licensing agreement which had previously been recorded as a due to licensor | 400,000 | 400,000 |
Right-of-use asset obtained in exchange for operating lease liability | (238,924) | |
Operating lease liability | 238,924 | |
Net |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | ||
Shares issued in connection with the Purchase Agreement with Lincoln Park | 123,609 | |
Common Stock [Member] | ||
Shares issued in satisfaction of accrued director fees | 17,572 | |
Shares issued in connection with the Purchase Agreement with Lincoln Park | 123,609 | |
Shares issued in connection with license agreement | 100,000 | 144,689 |
Common Stock [Member] | Licensing Agreement [Member] | ||
Shares issued in connection with license agreement | 100,000 | 100,000 |
Organization and Description of
Organization and Description of the Business | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Organization and Description of the Business | Note 1 – Organization and Description of the Business Business Activities and Organization We are a clinical-stage biopharmaceutical company focused on utilizing the Processa Regulatory Science Approach including the principles associated with FDA’s Project Optimus Oncology initiative and the related FDA Draft Guidance, in the development of NGC oncology drug products. Our mission is to provide better treatment options than those that presently exist by extending a patient’s survival and/or improving a patient’s quality of life. This is achieved by taking FDA-approved, widely used oncology drugs or the cancer killing metabolites of these drugs and altering how they are metabolized and/or distributed in the body, including how they are distributed to the actual cancer cells. The three NGC treatments in our pipeline are as follows: ● NGC-Capecitabine is a combination of PCS6422 and capecitabine. NGC-Capecitabine alters the metabolism of capecitabine without having any clinically meaningful biological effect itself. In clinical trials, NGC-Capecitabine has a safety profile different than capecitabine when administered by itself. Side effects, such as Hand-Foot Syndrome (HFS) and cardiotoxicity that typically occur in 50-70% of patients treated with capecitabine and caused by specific capecitabine metabolites that are not formed to any extent with NGC-Capecitabine, do not appear to be side effects associated with NGC-Capecitabine. These types of toxicities can result in decreased doses, interrupted doses, or discontinuation of treatment with capecitabine. In addition, NGC-Capecitabine has been found to be greater than 50 times more potent than capecitabine based on the systemic exposure of the capecitabine metabolite 5-FU, which is metabolized to the cancer-killing metabolites. Like capecitabine, NGC-Capecitabine could be used to treat patients with various cancers, such as metastatic colorectal, gastrointestinal, breast and pancreatic. We estimate at least 200,000 patients in the United States were diagnosed in 2022 with metastatic colorectal, gastrointestinal, breast, and pancreatic cancers. In mid-April of 2023, we are scheduled to begin discussions with the FDA regarding the design of our Phase 2B trial and Project Optimus in order to initiate the Phase 2B trial in the second half of 2023. ● NGC-Gemcitabine (also identified as PCS3117) is an oral analog of gemcitabine that is converted to its active metabolite by a different enzyme system than gemcitabine resulting in a positive response in gemcitabine patients as well as some gemcitabine treatment-resistant patients. Like gemcitabine, NGC-Gemcitabine could be used to treat patients with various cancers such as pancreatic, lung, ovarian, and breast. We estimate at least 275,000 patients in the United States were diagnosed in 2022 with pancreatic, lung, ovarian, and breast cancer. We plan to meet with the FDA in 2023 to discuss potential study designs including implementation of Project Optimus initiative as part of the design, and then submit the Phase 2B protocol to the Investigational New Drug (IND Application) in the second half of 2023. ● NGC-Irinotecan (also identified as PCS11T) is a prodrug of the active metabolite of irinotecan (SN-38). The chemical structure of NGC-Irinotecan influences the uptake of the drug into cancer cells, resulting in more NGC-Irinotecan entering cancer cells than normal cells in mice. These levels were significantly greater than those seen with irinotecan, resulting in lower doses of NGC-Irinotecan having greater efficacy than irinotecan and improved safety in animal models. Like irinotecan, NGC-Irinotecan could be used to treat patients with various cancers such as lung, colorectal, gastrointestinal, and pancreatic cancer. We estimate at least 200,000 patients in the United States were diagnosed in 2022 with lung, colorectal, gastrointestinal, and pancreatic cancer. We plan to conduct IND-enabling and toxicology studies in 2023 and 2024. Historically, much of oncology drug development has searched for a new or different way to treat cancer. Our approach is to modify and improve three different, currently approved, and widely used chemotherapy treatments so that the human body handles these NGC treatments differently than their presently approved counterpart drugs while the cancer killing mechanism of action remains the same. FDA’s Project Optimus Oncology initiative and Oncology Guidance recommends that the dose-response (both safety and efficacy) relationships be evaluated for all oncology drugs. We have begun this process for our NGC treatments. To date, we have found that our NGC treatments are likely to have a better safety-efficacy profile than the current widely used marketed counterpart drugs, not only potentially making the development and approval process more efficient, but also differentiating our NGC treatments from the existing treatment. We believe our NGC treatments have the potential to extend the survival and/or quality of life for more patients diagnosed with cancer while decreasing the number of patients who are required to dose adjust or discontinue treatment because of side effects or lack of response. As part of our shift in priority, including the allocation of resources to NGC drugs, we suspended further enrollment in the PCS499 trial for uNL. We are evaluating options to monetize both PCS12852 and PCS499. The clinical study findings for PCS12852 were positive in gastroparesis patients and there were no safety concerns noted during the conduct of either study. Recent Financings Registered Direct Offering On February 9, 2023, we entered into a securities purchase agreement (the “Purchase Agreement”) relating to the issuance and sale of shares of common stock pursuant to a registered direct offering (the “Offering”) with certain accredited investors (the “Investors”). The Investors purchased approximately $ 6.3 7,812,544 0.80 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 neither we nor our subsidiary will issue or enter into any agreement to issue or announce the issuance or proposed issuance of any shares of common stock or common stock equivalents. The net proceeds from the Offering, after deducting the fees of the Placement Agent, Spartan Capital Securities, LLC (“Spartan”), and the estimated offering expenses, were approximately $ 5.7 The common stock was offered and sold pursuant to our Registration Statement on Form S-3 (Registration No. 333-257558) previously filed with the Securities and Exchange Commission and declared effective on July 9, 2021, the base prospectus included therein and the related prospectus supplement dated February 9, 2023. We paid the Placement Agent a cash fee of 8.0 60,000 3,160,130 1.02 three years At-the-Market Transactions On August 20, 2021, we entered into an equity distribution agreement (the “Sales Agreement”) with Oppenheimer & Co. Inc. (the “Sales Agent”) under which we may issue and sell in a registered “at-the-market” offering shares of our common stock having an aggregate offering price of up to $ 30.0 3.0 On February 3, 2023, we sold 569,648 672,393 21,597 174,000 Equity Line of Credit Transactions On March 23, 2022, we entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park has committed to purchase up to $ 15.0 million of shares (the “Purchase Shares”) of our common stock, subject to the terms and conditions in the Purchase Agreement. We issued 123,609 shares of common stock (valued at $ 450,000 ) to Lincoln Park as a commitment fee in connection with entering into the Purchase Agreement and reimbursed Lincoln Park $ 25,000 for fees incurred in connection with the Purchase Agreement. Concurrently with entering into the Purchase Agreement, we also entered into a registration rights agreement with Lincoln Park (the “Registration Rights Agreement”), pursuant to which we agreed to take certain actions relating to the registration under the Securities Act of 1933, as amended, of the offer and sale of the shares of common stock available for issuance under the Purchase Agreement. We did not draw on our Equity Line of Credit with Lincoln Park in 2022. In January 2023, we sold Lincoln Park 50,000 54,000 Impairment of PCS499 In-process Research and Development Asset In February 2023, we suspended further enrollment in our PCS499 trial for uNL due to difficulties we encountered in enrolling our PCS499 trial for uNL. As a result, we recognized a non-cash expense of $ 7.3 |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Note 2 – Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (the “SEC”), and reflect all of our activities, including those of our wholly-owned subsidiary. All material intercompany accounts and transactions have been eliminated in consolidation. Liquidity We have incurred losses since inception, devoting substantially all of our efforts toward moving the drugs in our pipeline through the regulatory process and other research and development activities, and have an accumulated deficit of approximately $ 64.2 million as of December 31, 2022. During the year ended December 31, 2022, we generated a net loss of approximately $ 27.4 million, of which $ 17.4 million represented non-cash expenses. Net cash used in our operating activities during the year ended December 31, 2022 was approximately $ 9.6 million. We expect to continue to generate operating losses and negative cash flow from operations for the foreseeable future. Based on our current plans, we believe our current cash balances along with net proceeds of $ 6.4 We had no Use of Estimates In preparing our consolidated financial statements and related disclosures in conformity with GAAP and pursuant to the rules and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the consolidated financial statements and accompanying notes. Estimates are used for, but not limited to: stock-based compensation, intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable, actual results could differ materially from those estimates and could impact future results of operations and cash flows. Cash and Cash Equivalents Cash and cash equivalents include cash on hand and money market funds. We consider all highly liquid investments with a maturity at the date of purchase of three months or less to be cash equivalents. Property and Equipment Property is stated at cost, less accumulated depreciation. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Expenditures for maintenance and routine repairs are charged to expense as incurred. Depreciation is recognized on a straight-line basis over the estimated useful lives of the assets, which generally range from 3 5 Intangible Assets Intangible assets acquired individually or with a group of other assets from others (other than in a business combination) are recognized at cost, including transaction costs, and allocated to the individual assets acquired based on relative fair values and no goodwill is recognized. Cost is measured based on cash consideration paid. If consideration given is in the form of non-cash assets, liabilities incurred, or equity interests issued, measurement of cost is based on either the fair value of the consideration given or the fair value of the assets (or net assets) acquired, whichever is more clearly evident and more reliably measurable. Costs of internally developing, maintaining or restoring intangible assets that are not specifically identifiable, have indeterminate lives or are inherent in a continuing business are expensed as incurred. Intangible assets purchased from others for use in research and development activities and that have alternative future uses (in research and development projects or otherwise) are capitalized in accordance with ASC Topic 350, Intangibles – Goodwill and Other. Intangibles with a finite useful life are amortized using the straight-line method unless the pattern in which the economic benefits of the intangible assets are consumed or used up are reliably determinable. The useful life is the best estimate of the period over which the asset is expected to contribute directly or indirectly to our future cash flows. The useful life is based on the duration of the expected use of the asset by us and the legal, regulatory or contractual provisions that constrain the useful life and future cash flows of the asset, including regulatory acceptance and approval, obsolescence, demand, competition and other economic factors. We evaluate the remaining useful life of intangible assets each reporting period to determine whether any revision to the remaining useful life is required. If the remaining useful life is changed, the remaining carrying amount of the intangible asset will be amortized prospectively over the revised remaining useful life. If an income approach is used to measure the fair value of an intangible asset, we consider the period of expected cash flows used to measure the fair value of the intangible asset, adjusted as appropriate for company-specific factors discussed above, to determine the useful life for amortization purposes. If no regulatory, contractual, competitive, economic or other factors limit the useful life of the intangible to us, the useful life is considered indefinite. Intangibles with an indefinite useful life are not amortized until its useful life is determined to be no longer indefinite. If the useful life is determined to be finite, the intangible is tested for impairment and the carrying amount is amortized over the remaining useful life in accordance with intangibles subject to amortization. Indefinite-lived intangibles are tested for impairment annually and more frequently if events or circumstances indicate that it is more-likely-than-not that the asset is impaired. Impairment of Long-Lived Assets and Intangibles Other Than Goodwill We account for the impairment of long-lived assets in accordance with ASC 360 , Property, Plant and Equipment Intangibles – Goodwill and Other, 7.3 No Fair Value Measurements and Disclosure We apply ASC 820, Fair Value Measurements and Disclosures Fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows: Level 1 – Quoted market prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 – Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. Fair value determined through the use of models or other valuation methodologies. Level 3 – Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data. Fair value is determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where there is little market activity for the asset or liability. The asset’s or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to the fair value measurement. Our policy is to recognize transfers between levels of the fair value hierarchy in the period the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, 2, or 3 during the periods presented. Stock-based Compensation We measure compensation expense for stock options and other stock awards in accordance with ASC 718, Compensation—Stock Compensation For awards that contain performance vesting conditions, we do not recognize compensation expense until achieving the performance condition is probable. We estimate the fair value of stock option and warrant grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. We value restricted stock awards (RSAs) and restricted stock units (RSUs) based on the closing share price on the date of grant. Stock-based compensation costs are recorded as general and administrative or research and development costs in the statements of operations based upon the underlying individual’s or consultant’s role. When evaluating the assumptions required for the Black-Scholes model, we recognized that our previous volatility computation was based on a basket of peer companies, which was no longer representative of the actual measure of the distribution of returns of our common stock and began using our Company’s historical closing stock prices for awards granted after September 1, 2021. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by employees or consultants who receive these awards, and subsequent events are not indicative of the reasonableness of our original estimates of fair value. We account for forfeitures in the period in which they occur, rather than estimate expected forfeitures. Net Loss Per Share Basic 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 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 outstanding during the period. Since we experienced a net loss for all periods presented, basic and diluted net loss per share are the same. As such, diluted loss per share for the years ended December 31, 2022 and 2021 excludes the impact of potentially dilutive common shares related to outstanding stock options, unvested restricted stock awards (RSAs), unvested restricted stock units (RSUs) and purchase warrants. Our diluted net loss per share for the years ended December 31, 2022 and 2021 excluded 2,577,910 822,430 As noted above, we amended our consulting agreement with Spartan, extending the term of the consulting agreement until February 10, 2024. We will compensate Spartan for financial consulting services provided under the amendment by granting Spartan warrants to purchase 3,160,130 1.02 2.6 three years Segments We operate in one Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable and accounts payable approximate their fair value because of the short-term maturity of these instruments. Research and development Research and development costs are expensed as incurred and consisted of direct and overhead-related expenses related primarily to clinical trials, development personnel salaries and related costs. Research and development costs totaled $ 11,494,230 6,878,021 Income Taxes We account for income taxes in accordance with ASC Topic 740, Income Taxes. 7.4 We recognize the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. Our policy is to record interest and penalties related to income taxes as part of its income tax provision. As of December 31, 2022, we had no Recent Accounting Pronouncements From time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”). We have implemented all new accounting pronouncements that are in effect and that may impact our financial statements. We have considered all recent accounting pronouncements issued since the last audit of our consolidated financial statements. We believe that these recent pronouncements will not have a material effect on our consolidated financial statements. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Note 3 - Intangible Assets Our gross intangible assets consisted primarily of costs we capitalized related to the acquisition of license rights to PCS499 from CoNCERT Pharmaceuticals. Inc. (“CoNCERT”) for shares of our common stock that had an issue date fair value of $ 8 1,782 3,037,147 1,782 Income Taxes Research and Development Intangible assets at December 31, 2022 and 2021 consisted of the following: Summary of Intangible Assets 2022 2021 Gross intangible assets $ 11,059,429 $ 11,059,429 Less: accumulated amortization (3,791,286 ) (3,002,791 ) Less: impairment of intangible asset (7,268,143 ) - Total intangible assets, net $ - $ 8,056,638 Amortization expense was $ 788,495 790,488 We review amounts previously capitalized for impairment whenever events or changes in circumstances indicate to us that the carrying value of the assets might not be recoverable. In May 2021, we enrolled our first patient in our Phase 2B trial for the treatment of ulcerative NL with PCS499. Although we initiated a number of recruitment programs to increase the enrollment of patients in this study, we were only able to recruit four patients by December 31, 2022. We have experienced extremely slow enrollment in the study given the extreme rarity of the condition (rarer than reported in the literature), the impact of COVID-19, and the reluctance of patients to be in a clinical study. We will complete the study for those currently enrolled, but in February 2023, we suspended further enrollment in the PCS499 trial for uNL, effectively terminating the trial. At December 31, 2022, as a result of our decision to halt future enrollment and terminate our PCS499 clinical trial for uNL, we recognized an impairment for remaining book value of the intangible asset of $ 7.3 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 4 - Income Taxes We have incurred net operating losses since inception. At December 31, 2022 and 2021, we had available federal and state net operating loss carryforwards of $ 24.0 12.5 23.7 2037 20 Pursuant to Code Sec. 382 of the Internal Revenue Code (“the Code”), the utilization of our net operating loss carryforwards could be limited as a result of a cumulative change in stock ownership of more than 50% over a three-year period. We have not completed a Sec. 382 study and as such our net operating loss carryforwards may be subject to such limitation. Our provision (benefit) for income taxes for the years ended December 31, 2022 and 2021 was as follows: Schedule of Provision for Income Taxes 2022 2021 Year Ended December 31, 2022 2021 Current: Federal $ - $ - State - - Total deferred tax benefit - - Deferred: Federal (5,887,151 ) (2,853,937 ) State (1,567,560 ) (624,844 ) Total deferred tax benefit (7,454,711 ) (3,478,781 ) Valuation allowance 7,454,711 2,948,170 Net deferred tax benefit - (530,611 ) Total tax provision (benefit) $ - $ (530,611 ) A deferred tax liability was recorded on March 19, 2018 when we received CoNCERT’s license and Know-How in exchange for our common stock that had been issued in an Internal Revenue Code Section 351 Transaction. The Section 351 Transaction treats the acquisition of the license and Know-How for stock as a tax-free exchange. As a result, under ASC 740-10-25-51 Income Taxes 3,037,147 11,038,929 1,782 We recorded the benefit of net operating losses in our consolidated financial statements to the extent possible as a reduction in the deferred tax liability created by the future financial statement amortization of the intangible asset from the acquired CoNCERT license and Know-How prior to its full impairment at December 31, 2022. For the year ended December 31, 2021, we recorded a federal income tax benefit of $ 530,611 A reconciliation of our effective income tax rate and statutory income tax rate for the years ended December 31, 2022 and 2021 is as follows: Schedule of Effective Income Tax Rate Reconciliation 2022 2021 Year Ended December 31, 2022 2021 Federal statutory income tax rate 21.00 % 21.00 % State tax rate, net 5.72 % 5.23 % Permanent differences (0.55 )% (0.18 )% Federal orphan drug tax credit 0.93 % 3.04 % Deferred tax asset valuation allowance (27.10 )% (24.65 )% Effective income tax rate 0.00 % 4.44 % The significant components of our deferred tax assets and liabilities for Federal and state income taxes consisted of the following: Schedule of Deferred Tax Assets and Liabilities 2022 2021 December 31, 2022 2021 Deferred tax assets: Non-current: Net operating loss carry forward – Federal $ 5,048,175 $ 2,615,518 Net operating loss carry forward – State 1,431,839 760,897 Stock compensation expense 2,590,890 593,365 Depreciation and other 976 13,200 Purchased in-process R&D 2,494,829 2,481,070 Federal orphan drug credits 1,046,539 791,151 Capitalized research and development costs 1,929,462 - Start-up expenditures and amortization - 1,978,418 Total non-current deferred tax assets 14,542,710 9,233,619 Valuation allowance for deferred tax assets (14,542,710 ) (7,087,999 ) Total deferred tax assets - 2,145,620 Deferred Tax Liabilities: Non-current: Intangible asset - (2,145,620 ) Total non-current deferred tax liabilities - (2,145,620 ) Total deferred tax asset (liability) $ - $ - Beginning in 2022, the Tax Cuts and Jobs Act of 2017 (TCJA) eliminated the option to deduct research and development expenditures in the current year and requires taxpayers to amortize them over five or fifteen years pursuant to IRC Section 174. During 2022, for income tax purposes, we capitalized approximately $ 7.2 In 2022, as part of an evaluation of our tax attributes, we recharacterized approximately $ 7.4 The valuation allowance generally reflects limitations on our ability to use the tax attributes and reduces the value of such attributes to the more-likely-than-not realizable amount. We assessed the available positive and negative evidence to estimate if sufficient taxable income will be generated to use the existing net deferred tax assets. Based on a weighting of the objectively verifiable negative evidence primarily in the form of cumulative operating losses, we believe that it is not more likely than not that the deferred tax assets will be realized and, accordingly, a full valuation allowance has been established. The valuation allowance increased by $ 7.4 2.9 We recognize potential liabilities for uncertain tax positions using a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. We have not recorded any uncertain tax positions. As of December 31, 2022 and 2021, we had no We file U.S. Federal income tax returns, as well as state tax returns for California, Florida and Maryland. There are currently no income tax examinations underway for these jurisdictions. However, tax years from and including 2017 remain open for examination by federal and state income tax authorities. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation | Note 5 - Stock-based Compensation T he Processa Pharmaceuticals Inc. 2019 Omnibus Equity Incentive Plan (the “2019 Plan”) allows us to make grants of stock options, restricted and unrestricted stock and other stock-based awards to employees, including our executive officers, consultants and directors. The 2019 Plan originally provided for the aggregate issuance of 3,000,000 3,000,000 6,000,000 2,387,622 Stock Compensation Expense We recorded stock-based compensation expense for the years ended December 31, 2022 and 2021 as follows: Schedule of Stock-based Compensation Expense 2022 2021 Year Ended 2022 2021 Research and development $ 2,895,653 $ 809,839 General and administrative 5,933,060 2,598,176 Total $ 8,828,713 $ 3,408,015 No tax benefits were attributed to the stock-based compensation expense because a valuation allowance was maintained for all net deferred tax assets relating to this expense. Stock Options We did no 30,000 The fair value of the stock option grant was estimated using the Black-Scholes option-pricing model at the date of grant. The expected volatility of stock options granted on or after September 1, 2021 will be calculated using the Company’s historical closing stock prices. The expected term of our stock options was determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that we have never paid cash dividends and do not expect to pay any cash dividends in the foreseeable future. The fair value of the option award granted during the year ended December 31, 2021 was estimated using the following assumptions: Schedule of Stock Option Valuation Assumption Average risk-free rate of interest 1.85 % Expected term (years) 2 Expected stock price volatility 81.77 % Dividend yield 0 % The following table summarizes our stock option activity during the years ended December 31, 2022 and 2021: Schedule of Stock Option Activity Total options Outstanding Weighted average exercise price Weighted average remaining contractual life (in years) Outstanding as of January 1, 2021 152,806 $ 18.11 Options granted 30,000 11.70 1.2 Forfeited (4,310 ) 16.80 Outstanding as of December 31, 2021 178,496 17.07 3.6 Options granted - - Forfeited - - Outstanding and exercisable as of December 31, 2022 178,496 $ 17.07 2.6 The weighted average grant-date fair value per share of options granted during the year ended December 31, 2021 was $ 5.23 1,910,240 1,659,909 No Restricted Stock Awards Activity in our Restricted Stock Awards (“RSAs”) during the years Schedule of Restricted Stock Awards (“RSAs”) Activity Number of Weighted- Unvested as of January 1, 2021 122,782 $ 8.04 Granted 37,500 6.65 Vested and issued (58,467 ) 7.90 Forfeited (10,706 ) 6.54 Unvested as of December 31, 2021 91,109 7.74 Granted 187,058 3.71 Vested and Issued (182,790 ) 5.04 Forfeited (33,489 ) 5.53 Unvested as of December 31, 2022 61,888 $ 4.72 As of December 31, 2022, unrecognized stock-based compensation expense of approximately $ 199,000 During the year ended December 31, 2022, we granted RSAs related to the future issuance of 187,058 ● RSAs for 59,766 196,500 ● RSAs for 109,720 -2023 378,000 54,624 ● 17,572 120,000 On May 31, 2022, one of our directors did not seek reelection and forfeited RSAs for 18,208 shares of our common stock related to their 2022 service. On January 1, 2023, we awarded RSAs for 90,000 Restricted Stock Units Activity in our Restricted Stock Units (“RSUs”) during the years Schedule of Restricted Stock Units (“RSUs”) Activity Number of Weighted- Outstanding at January 1, 2021 - - Granted 457,593 $ 7.75 Forfeited (4,000 ) 8.61 Issued (14,000 ) 7.12 Cancelled - - Outstanding at December 31, 2021 439,593 7.76 Granted 2,428,285 3.08 Forfeited (68,539 ) 5.09 Issued (47,976 ) 3.95 Cancelled (37,386 ) 8.61 Outstanding at December 31, 2022 2,713,977 3.69 Vested and unissued (662,069 ) 4.54 Unvested at December 31, 2022 2,051,908 $ 3.42 As of December 31, 2022, unrecognized stock-based compensation expense of approximately $ 472,000 1.7 320,000 During the year ended December 31, 2022, we granted RSUs related to the future issuance of 417,073 ursuant to agreements with our Executive team and certain other employees where a portion of their base compensation was paid in RSUs . The value of an RSU award was based on the average share price of the month services were provided. 5.00 On April 1, 2022, we also granted RSUs for 1,979,818 shares of our common stock which vest on January 1, 2023 and are subject to distribution requirements before any shares of common stock are issued. The RSUs had a fair value of $ 6.2 million, which was fully recognized in stock-based compensation expense during the year ended December 31, 2022. Holders of our vested RSUs will be issued shares of our common stock upon the satisfaction of the distribution restrictions contained in their Restricted Stock Unit Award Agreement. The distribution restrictions are typically different (longer) than the vesting schedule, imposing an additional restriction on the holder. Unlike RSAs, while employees may hold fully vested RSUs, the individual does not hold any shares or have any rights of a shareholder until the distribution restrictions are met. Upon distribution to the employee, each RSU converts into one share of our common stock. The RSUs contain dividend equivalent rights. On June 1, 2022, in connection with the termination of a long-term employee, we accelerated the vesting of 62,940 90,228 On January 1, 2023, we awarded RSUs for 966,503 shares to employees , of Warrants No stock purchase warrants were granted and 18,107 285,618 10.25 0.9 The following table summarizes our warrant activity during the years ended December 31, 2022 and 2021. Schedule of Warrants Activity Total warrants outstanding Weighted average exercise price Weighted average remaining contractual life (in years) Outstanding as of January 1, 2021 534,674 $ 18.34 Warrants granted 229,268 8.09 Forfeited (460,217 ) 18.31 Outstanding as of December 31, 2021 303,725 18.34 1.5 Warrants granted - - Forfeited (18,107 ) 17.16 Outstanding and exercisable as of December 31, 2022 285,618 $ 10.25 0.9 Our outstanding warrants expire at various dates through September 1, 2024. In January 2021, we issued a warrant for the purchase of 100,000 321,158 May 2022, we extended the expiration date of this warrant by one year to January 11, 2024 33,000 of incremental expense , based on an expected volatility of 84.39 7.18 In September 2021, we also issued a warrant for the purchase of 50,000 139,900 September 1, 2024 8.00 We used the Black-Scholes option pricing model to calculate the grant date fair value of the two warrants with the following assumptions: Schedule of Stock Option Warrant Valuation Assumption Average risk-free rate of interest 0.42 1.85 % Expected term (years) 2.00 3.00 Expected stock price volatility 74.48 81.77 % Dividend yield 0 % We recognize expense based on the fair value of the warrants over their service or vesting periods and recorded $ 103,374 391,108 In February 2021, we also issued warrants for the purchase of 79,268 1,321,132 9.30 February 16, 2023 In February 2023, we amended our financial consulting agreement with Spartan by extending the term until February 10, 2024. We will compensate Spartan for financial consulting services provided under the amendment by granting warrants to purchase 3,160,130 1.02 three years |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 6 – Stockholders’ Equity On January 1, 2022, we amended our Certificate of Incorporation to increase the number of authorized shares of our common stock from 30,000,000 50,000,000 50,000,000 Preferred Stock There were no Common Stock Subsequent to December 31, 2022, we raised gross proceeds of $ 7.0 8,432,192 ● In January 2023, we sold 50,000 shares at an average price of $ 1.08 per share for an aggregate gross proceedings of $ 54,000 through the Purchase Agreement we entered into with Lincoln Park Capital in March 2022. We did not sell any shares to Lincoln Park under the Purchase Agreement during the year ended December 31, 2022. ● On February 3, 2023, we sold 569,648 1.22 693,000 30.0 ● On February 14, 2023, we closed on a registered direct offering for the sale of 7,812,544 0.80 6.3 5.7 During the year ended December 31, 2022, we had the following activity: ● On March 23, 2022, we entered into the Purchase Agreement with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to $ 15.0 123,609 450,000 25,000 We have the right to present Lincoln Park with a purchase notice (a “Regular Purchase Notice”), directing Lincoln Park to purchase up to 25,000 of $ 1.00 75,000 1,250,000 The aggregate number of shares that we can issue to Lincoln Park under the Purchase Agreement may not exceed 3,142,430 19.99 9.99 We may terminate the Purchase Agreement at any time, at our sole discretion, without any cost or penalty, by giving one business day notice to Lincoln Park to terminate the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the common stock. There are no limitations on use of proceeds, financial or business covenants, restrictions on future financings (other than restrictions on our ability to enter into variable rate transactions described in the Purchase Agreement), rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. We may deliver Purchase Notices under the Purchase Agreement, subject to market conditions, and in light of our capital needs from time to time and under the limitations contained in the Purchase Agreement. Any proceeds that we receive under the Purchase Agreement are expected to be used for working capital and general corporate purposes. ● We issued 100,000 ● Also, during the year ended December 31, 2022, 36,145 to pay for federal, state and local income taxes and an additional 18,208 During the year ended December 31, 2021, we had the following activity: ● On February 24, 2021, we sold in a private placement 1,321,132 10.2 9.9 79,268 9.30 February 16, 2023 ● On June 8, 2021, we granted 37,500 ● On June 16, 2021, we issued 44,689 ● On August 20, 2021, we entered into an equity distribution agreement (the “Sales Agreement”) with Oppenheimer & Co. Inc. (the “Sales Agent”) under which we may issue and sell in a registered “at-the-market” offering shares of our common stock having an aggregate offering price of up to $ 30.0 21,597 8.33 ● On October 6, 2021, we also issued 100,000 ● We granted 17,800 180,000 17,800 14,300 ● During the year ended December 31, 2021, 9,176 to pay for federal, state and local income taxes and an additional 1,530 Treasury Stock - Repurchase of Shares from Aposense, Ltd. On March 29, 2022, we purchased 100,000 300,000 and are holding these shares as treasury stock until they are reissued or retired at the discretion of our Board of Directors. |
Net Loss per Share of Common St
Net Loss per Share of Common Stock | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Share of Common Stock | Note 7 – Net Loss per Share of Common Stock Basic net loss per share is computed by dividing net loss by the weighted average common stock outstanding (which excludes unvested RSAs) and vested RSUs. Diluted net loss per share is computed by dividing net loss by the diluted weighted average common stock outstanding, which includes potentially dilutive effect of stock options, unvested RSAs, unvested RSUs and warrants. Since we experienced a loss for both periods presented, basic and diluted net loss per share are the same and, as they would have an anti-dilutive impact on diluted net loss per share, any dilutive common shares outstanding were excluded from the computation shown below. The computation of net loss per share for the year ended December 31, 2022 and 2021 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2022 2021 Basic and diluted net loss per share: Net loss available to common shareholders $ (27,424,229 ) $ (11,427,534 ) Weighted-average number of common shares-basic and diluted 16,109,291 15,319,463 Basic and diluted net loss per share $ (1.70 ) $ (0.75 ) As described in Note 5, we issued various equity instruments during the years ended December 31, 2022 and 2021 which impact our EPS calculation. All granted RSAs are considered issued and outstanding for purposes of our financial statements. Unvested RSAs are included as dilutive securities, but are excluded from our denominator of basic EPS. At December 31, 2022 and 2021, 61,888 91,109 2,051,908 249,100 The outstanding stock options, unvested RSAs, unvested RSUs and warrants to purchase common stock were excluded from the computation of diluted net loss per share as their effect would have been anti-dilutive for the periods presented below: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share 2022 2021 Stock options, unvested RSAs, unvested RSUs and purchase warrants 2,577,910 822,430 The calculation of potentially dilutive securities at December 31, 2022 excludes the 1,056,503 3,160,130 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
Leases | Note 8 – Leases We lease our office space under an operating lease agreement, which was renewed on October 3, 2022 and its effects were recorded as of September 30, 2022. This lease does not have significant rent escalation, concessions, leasehold improvement incentives, or other build-out clauses. Further, the lease does not contain contingent rent provisions. Our office space lease includes both lease (e.g., fixed payments including rent, taxes, and insurance costs) and non-lease components (e.g., common-area or other maintenance costs), which are accounted for as a single lease component as we have elected the practical expedient to group lease and non-lease components for all leases. We also lease office equipment under an operating lease. Our leases do not provide an implicit rate and, as such, we have used our incremental borrowing rate of 8 Lease costs included in our consolidated statements of operations totaled $ 96,785 94,263 Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases Remaining lease term (years) for our office lease 2.8 Remaining lease term (years) for our equipment lease 1.3 Weighted average remaining lease term (years) for our facility and equipment leases 2.7 Weighted average discount rate for our facility and equipment leases 8.0 % Annual lease liabilities for all operating leases were as follows as of December 31, 2022: Schedule of Annual Lease Liabilities for all Operating Leases 2023 $ 93,845 2024 92,356 2025 70,040 Total lease payments 256,241 Less: Interest (26,791 ) Present value of lease liabilities 229,450 Less: current maturities (78,896 ) Non-current lease liability $ 150,554 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2022 | |
License Agreements | |
License Agreements | Note 9 – License Agreements Elion Oncology, Inc. On August 23, 2020, we entered into a condition precedent License Agreement with Elion Oncology (“Elion License Agreement”), pursuant to which we acquired an exclusive license to develop, manufacture and commercialize PCS6422 globally. The grant of license was conditioned on the following being satisfied by October 30, 2020: (i) our closing on an equity financing of at least $15 million in gross proceeds and (ii) successful up-listing to Nasdaq. On October 6, 2020, all conditions were satisfied, resulting in the addition of PCS6422 to our portfolio, and we paid $ 100,000 825,000 Such shares were subject to a lock-up, with 50% of such shares released from such lock-up after six months and the remaining 25% tranches were released following 9 months and 12 months, respectively As part of the Elion License Agreement, we agreed to issue to Elion 100,000 shares of our common stock on each of the first and second anniversary dates of the Elion License Agreement, which we fulfilled on October 5, 2021 and 2022, respectively. As additional consideration, we will pay Elion development and regulatory milestone payments (a portion of which are payable in shares of our common stock and a portion of which are payable in cash) upon the achievement of certain milestones, which include FDA or other regulatory approval and dosing a patient . In addition, we must pay Elion one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. We are also required to split any milestone payments received with Elion based on any sub-license agreement we may enter into. On May 17, 2022, we amended the third Milestone Event of Section 6.4 of our License Agreement with Elion Oncology, Inc. changing the third Milestone Event from “1 st 189,000 We are required to use commercially reasonable efforts, at our sole cost and expense to research, develop and commercialize products in one or more countries, including meeting specific diligence milestones that consist of: (i) dosing a first patient in a Phase 1B clinical trial with a product within 12 months; and (ii) dosing a first patient with a product in a Phase 2 or 3 clinical trial within 48 months. Either party may terminate the agreement in the event of a material breach of the agreement that has not been cured following written notice and a 90-day opportunity to cure such breach (which is shortened to 15 days for a payment breach). Ocuphire Pharma, Inc. On June 16, 2021, we executed a License Agreement with Ocuphire Pharma, Inc. (“Ocuphire Agreement”) under which we received a license to research, develop and commercialize PCS3117 (formerly RX-3117) globally, excluding the Republic of Singapore, China, Hong Kong, Macau and Taiwan As consideration for the Ocuphire Agreement, we issued 44,689 200,000 66,583 We are required to use commercially reasonable efforts, at our sole cost and expense to oversee such commercialization efforts, to research, develop and commercialize products in one or more countries, including meeting specific diligence milestones that consist of: (i) first patient administered drug in a Clinical Trial of a Product prior to June 16, 2024 and (ii) first patient administered drug in a Pivotal Clinical Trial of a Product or first patient administered drug in a Clinical Trial for a Second Indication of a Product prior to June 16, 2026. Either party may terminate the agreement in the event of a material breach of the agreement that has not been cured following written notice and a 120-day opportunity to cure such breach. Aposense, Ltd. On May 24, 2020, we entered into a condition precedent License Agreement with Aposense, Ltd. (“Aposense License Agreement”), pursuant to which we were granted Aposense’s patent rights and Know-How to develop and commercialize their next generation irinotecan cancer drug, PCS11T (formerly known as ATT-11T). The Aposense License Agreement provides us with an exclusive worldwide license (excluding China), to research, develop and commercialize products comprising or containing PCS11T. The grant of license was conditioned on the following being satisfied within nine months of May 24, 2020 (or the Aposense License Agreement shall terminate): (i) our closing of an equity financing and successful up-listing to Nasdaq and (ii) Aposense obtaining the approval of the Israel Innovation Authority for the consummation of the transactions contemplated by the Aposense License Agreement. On October 6, 2020, all conditions were satisfied, resulting in the addition of PCS11T to our portfolio, and we issued 625,000 Such shares were subject to a lock-up, with 40% of such shares released from such lock-up after six months and the remaining two 30% tranches were released upon completion of the next two subsequent quarters As additional consideration, we will pay Aposense development and regulatory milestone payments (up to $ 3.0 Yuhan Corporation On August 19, 2020, we entered into a License Agreement with Yuhan Corporation (“Yuhan License Agreement”), pursuant to which we acquired an exclusive license to develop, manufacture and commercialize PCS12852 (formerly known as YH12852) globally, excluding South Korea. As consideration for the Yuhan License Agreement and related Share Issuance Agreement, we issued to Yuhan 500,000 750,000 3,000,000 In addition, we must pay Yuhan one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. We are also required to split any milestone payments received with Yuhan based on any sub-license agreement we may enter into We are required to use commercially reasonable efforts, at our sole cost and expense, in conjunction with a joint Processa-Yuhan Board to oversee such commercialization efforts, to research, develop and commercialize products in one or more countries, including meeting specific diligence milestones that consist of: (i) preparing a first draft of the product development plan within 90 days; (ii) requesting an FDA pre-IND meeting for a product within 6 months; (iii) dosing a first patient in a Phase 2A clinical trial with a product within 24 months; and (iv) dosing a first patient with a product in a Phase 2B clinical trial, Phase 3 clinical trial or other pivotal clinical trial with a product within 48 months CoNCERT Pharmaceuticals, Inc. On March 19, 2018, Promet, Processa and CoNCERT amended the CoNCERT Agreement executed in October 2017. The Amendment assigned the CONCERT Agreement to us and we exercised the exclusive option for the PCS499 compound in exchange for CoNCERT receiving, in part, $ 8 .0 million of our common stock that was held by Promet ( 298,615 shares at $ 26.79 per share), for the benefit of Processa in satisfaction of the obligation due for the exclusive license for PCS499 acquired by us. Promet contributed the payment of the obligation due for the exclusive license to us without consideration paid to them. As a result of the transaction, we recognized an exclusive license intangible asset with a fair value of $ 8.0 million and an offsetting increase in additional paid-in capital resulting from the exchange. We estimated the fair value of the common stock issued based on the market approach and CoNCERT’s requirement to receive shares valued at $ 8.0 We are required to pay CoNCERT royalties, on a product–by-product basis, on future worldwide net sales, or pay a percentage of any sublicense revenue, as described in the License Agreement with CoNCERT. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 10 – Related Party Transactions CorLyst, LLC (“CorLyst”) reimburses us for shared costs related to payroll, health insurance and rent based on actual costs incurred, which are recognized as a reduction of our general and administrative operating expenses in our consolidated statement of operations. We recorded $ 124,497 126,324 No 1,772 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 11 – Commitments and Contingencies Purchase Obligations We enter into contracts in the normal course of business with contract research organizations and subcontractors to further develop our products. The contracts are cancellable, with varying provisions regarding termination. If we terminated a cancellable contract with a specific vendor, we would only be obligated for products or services that we received as of the effective date of the termination and any applicable cancellation fees. As of December 31, 2022, we are contractually obligated to pay up to approximately $ 3.6 1.1 |
Concentration of Credit Risk
Concentration of Credit Risk | 12 Months Ended |
Dec. 31, 2022 | |
Risks and Uncertainties [Abstract] | |
Concentration of Credit Risk | Note 12 – Concentration of Credit Risk Financial instruments that potentially subject us to significant concentration of credit risk consist primarily of our cash and cash equivalents. We utilize only well-established banks and financial institutions with high credit ratings. Balances on deposit are insured by the Federal Deposit Insurance Corporation (FDIC) up to specified limits. Total cash held by our banks at December 31, 2022, exceeded FDIC limits. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (the “SEC”), and reflect all of our activities, including those of our wholly-owned subsidiary. All material intercompany accounts and transactions have been eliminated in consolidation. |
Liquidity | Liquidity We have incurred losses since inception, devoting substantially all of our efforts toward moving the drugs in our pipeline through the regulatory process and other research and development activities, and have an accumulated deficit of approximately $ 64.2 million as of December 31, 2022. During the year ended December 31, 2022, we generated a net loss of approximately $ 27.4 million, of which $ 17.4 million represented non-cash expenses. Net cash used in our operating activities during the year ended December 31, 2022 was approximately $ 9.6 million. We expect to continue to generate operating losses and negative cash flow from operations for the foreseeable future. Based on our current plans, we believe our current cash balances along with net proceeds of $ 6.4 We had no |
Use of Estimates | Use of Estimates In preparing our consolidated financial statements and related disclosures in conformity with GAAP and pursuant to the rules and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the consolidated financial statements and accompanying notes. Estimates are used for, but not limited to: stock-based compensation, intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable, actual results could differ materially from those estimates and could impact future results of operations and cash flows. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include cash on hand and money market funds. We consider all highly liquid investments with a maturity at the date of purchase of three months or less to be cash equivalents. |
Property and Equipment | Property and Equipment Property is stated at cost, less accumulated depreciation. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Expenditures for maintenance and routine repairs are charged to expense as incurred. Depreciation is recognized on a straight-line basis over the estimated useful lives of the assets, which generally range from 3 5 |
Intangible Assets | Intangible Assets Intangible assets acquired individually or with a group of other assets from others (other than in a business combination) are recognized at cost, including transaction costs, and allocated to the individual assets acquired based on relative fair values and no goodwill is recognized. Cost is measured based on cash consideration paid. If consideration given is in the form of non-cash assets, liabilities incurred, or equity interests issued, measurement of cost is based on either the fair value of the consideration given or the fair value of the assets (or net assets) acquired, whichever is more clearly evident and more reliably measurable. Costs of internally developing, maintaining or restoring intangible assets that are not specifically identifiable, have indeterminate lives or are inherent in a continuing business are expensed as incurred. Intangible assets purchased from others for use in research and development activities and that have alternative future uses (in research and development projects or otherwise) are capitalized in accordance with ASC Topic 350, Intangibles – Goodwill and Other. Intangibles with a finite useful life are amortized using the straight-line method unless the pattern in which the economic benefits of the intangible assets are consumed or used up are reliably determinable. The useful life is the best estimate of the period over which the asset is expected to contribute directly or indirectly to our future cash flows. The useful life is based on the duration of the expected use of the asset by us and the legal, regulatory or contractual provisions that constrain the useful life and future cash flows of the asset, including regulatory acceptance and approval, obsolescence, demand, competition and other economic factors. We evaluate the remaining useful life of intangible assets each reporting period to determine whether any revision to the remaining useful life is required. If the remaining useful life is changed, the remaining carrying amount of the intangible asset will be amortized prospectively over the revised remaining useful life. If an income approach is used to measure the fair value of an intangible asset, we consider the period of expected cash flows used to measure the fair value of the intangible asset, adjusted as appropriate for company-specific factors discussed above, to determine the useful life for amortization purposes. If no regulatory, contractual, competitive, economic or other factors limit the useful life of the intangible to us, the useful life is considered indefinite. Intangibles with an indefinite useful life are not amortized until its useful life is determined to be no longer indefinite. If the useful life is determined to be finite, the intangible is tested for impairment and the carrying amount is amortized over the remaining useful life in accordance with intangibles subject to amortization. Indefinite-lived intangibles are tested for impairment annually and more frequently if events or circumstances indicate that it is more-likely-than-not that the asset is impaired. |
Impairment of Long-Lived Assets and Intangibles Other Than Goodwill | Impairment of Long-Lived Assets and Intangibles Other Than Goodwill We account for the impairment of long-lived assets in accordance with ASC 360 , Property, Plant and Equipment Intangibles – Goodwill and Other, 7.3 No |
Fair Value Measurements and Disclosure | Fair Value Measurements and Disclosure We apply ASC 820, Fair Value Measurements and Disclosures Fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows: Level 1 – Quoted market prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 – Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. Fair value determined through the use of models or other valuation methodologies. Level 3 – Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data. Fair value is determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where there is little market activity for the asset or liability. The asset’s or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to the fair value measurement. Our policy is to recognize transfers between levels of the fair value hierarchy in the period the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, 2, or 3 during the periods presented. |
Stock-based Compensation | Stock-based Compensation We measure compensation expense for stock options and other stock awards in accordance with ASC 718, Compensation—Stock Compensation For awards that contain performance vesting conditions, we do not recognize compensation expense until achieving the performance condition is probable. We estimate the fair value of stock option and warrant grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. We value restricted stock awards (RSAs) and restricted stock units (RSUs) based on the closing share price on the date of grant. Stock-based compensation costs are recorded as general and administrative or research and development costs in the statements of operations based upon the underlying individual’s or consultant’s role. When evaluating the assumptions required for the Black-Scholes model, we recognized that our previous volatility computation was based on a basket of peer companies, which was no longer representative of the actual measure of the distribution of returns of our common stock and began using our Company’s historical closing stock prices for awards granted after September 1, 2021. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by employees or consultants who receive these awards, and subsequent events are not indicative of the reasonableness of our original estimates of fair value. We account for forfeitures in the period in which they occur, rather than estimate expected forfeitures. |
Net Loss Per Share | Net Loss Per Share Basic 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 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 outstanding during the period. Since we experienced a net loss for all periods presented, basic and diluted net loss per share are the same. As such, diluted loss per share for the years ended December 31, 2022 and 2021 excludes the impact of potentially dilutive common shares related to outstanding stock options, unvested restricted stock awards (RSAs), unvested restricted stock units (RSUs) and purchase warrants. Our diluted net loss per share for the years ended December 31, 2022 and 2021 excluded 2,577,910 822,430 As noted above, we amended our consulting agreement with Spartan, extending the term of the consulting agreement until February 10, 2024. We will compensate Spartan for financial consulting services provided under the amendment by granting Spartan warrants to purchase 3,160,130 1.02 2.6 three years |
Segments | Segments We operate in one |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable and accounts payable approximate their fair value because of the short-term maturity of these instruments. |
Research and development | Research and development Research and development costs are expensed as incurred and consisted of direct and overhead-related expenses related primarily to clinical trials, development personnel salaries and related costs. Research and development costs totaled $ 11,494,230 6,878,021 |
Income Taxes | Income Taxes We account for income taxes in accordance with ASC Topic 740, Income Taxes. 7.4 We recognize the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. Our policy is to record interest and penalties related to income taxes as part of its income tax provision. As of December 31, 2022, we had no |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”). We have implemented all new accounting pronouncements that are in effect and that may impact our financial statements. We have considered all recent accounting pronouncements issued since the last audit of our consolidated financial statements. We believe that these recent pronouncements will not have a material effect on our consolidated financial statements. |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Intangible Assets | Intangible assets at December 31, 2022 and 2021 consisted of the following: Summary of Intangible Assets 2022 2021 Gross intangible assets $ 11,059,429 $ 11,059,429 Less: accumulated amortization (3,791,286 ) (3,002,791 ) Less: impairment of intangible asset (7,268,143 ) - Total intangible assets, net $ - $ 8,056,638 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Income Taxes | Our provision (benefit) for income taxes for the years ended December 31, 2022 and 2021 was as follows: Schedule of Provision for Income Taxes 2022 2021 Year Ended December 31, 2022 2021 Current: Federal $ - $ - State - - Total deferred tax benefit - - Deferred: Federal (5,887,151 ) (2,853,937 ) State (1,567,560 ) (624,844 ) Total deferred tax benefit (7,454,711 ) (3,478,781 ) Valuation allowance 7,454,711 2,948,170 Net deferred tax benefit - (530,611 ) Total tax provision (benefit) $ - $ (530,611 ) |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of our effective income tax rate and statutory income tax rate for the years ended December 31, 2022 and 2021 is as follows: Schedule of Effective Income Tax Rate Reconciliation 2022 2021 Year Ended December 31, 2022 2021 Federal statutory income tax rate 21.00 % 21.00 % State tax rate, net 5.72 % 5.23 % Permanent differences (0.55 )% (0.18 )% Federal orphan drug tax credit 0.93 % 3.04 % Deferred tax asset valuation allowance (27.10 )% (24.65 )% Effective income tax rate 0.00 % 4.44 % |
Schedule of Deferred Tax Assets and Liabilities | The significant components of our deferred tax assets and liabilities for Federal and state income taxes consisted of the following: Schedule of Deferred Tax Assets and Liabilities 2022 2021 December 31, 2022 2021 Deferred tax assets: Non-current: Net operating loss carry forward – Federal $ 5,048,175 $ 2,615,518 Net operating loss carry forward – State 1,431,839 760,897 Stock compensation expense 2,590,890 593,365 Depreciation and other 976 13,200 Purchased in-process R&D 2,494,829 2,481,070 Federal orphan drug credits 1,046,539 791,151 Capitalized research and development costs 1,929,462 - Start-up expenditures and amortization - 1,978,418 Total non-current deferred tax assets 14,542,710 9,233,619 Valuation allowance for deferred tax assets (14,542,710 ) (7,087,999 ) Total deferred tax assets - 2,145,620 Deferred Tax Liabilities: Non-current: Intangible asset - (2,145,620 ) Total non-current deferred tax liabilities - (2,145,620 ) Total deferred tax asset (liability) $ - $ - |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Stock-based Compensation Expense | We recorded stock-based compensation expense for the years ended December 31, 2022 and 2021 as follows: Schedule of Stock-based Compensation Expense 2022 2021 Year Ended 2022 2021 Research and development $ 2,895,653 $ 809,839 General and administrative 5,933,060 2,598,176 Total $ 8,828,713 $ 3,408,015 |
Schedule of Stock Option Activity | The following table summarizes our stock option activity during the years ended December 31, 2022 and 2021: Schedule of Stock Option Activity Total options Outstanding Weighted average exercise price Weighted average remaining contractual life (in years) Outstanding as of January 1, 2021 152,806 $ 18.11 Options granted 30,000 11.70 1.2 Forfeited (4,310 ) 16.80 Outstanding as of December 31, 2021 178,496 17.07 3.6 Options granted - - Forfeited - - Outstanding and exercisable as of December 31, 2022 178,496 $ 17.07 2.6 |
Schedule of Restricted Stock Awards (“RSAs”) Activity | Activity in our Restricted Stock Awards (“RSAs”) during the years Schedule of Restricted Stock Awards (“RSAs”) Activity Number of Weighted- Unvested as of January 1, 2021 122,782 $ 8.04 Granted 37,500 6.65 Vested and issued (58,467 ) 7.90 Forfeited (10,706 ) 6.54 Unvested as of December 31, 2021 91,109 7.74 Granted 187,058 3.71 Vested and Issued (182,790 ) 5.04 Forfeited (33,489 ) 5.53 Unvested as of December 31, 2022 61,888 $ 4.72 |
Schedule of Restricted Stock Units (“RSUs”) Activity | Activity in our Restricted Stock Units (“RSUs”) during the years Schedule of Restricted Stock Units (“RSUs”) Activity Number of Weighted- Outstanding at January 1, 2021 - - Granted 457,593 $ 7.75 Forfeited (4,000 ) 8.61 Issued (14,000 ) 7.12 Cancelled - - Outstanding at December 31, 2021 439,593 7.76 Granted 2,428,285 3.08 Forfeited (68,539 ) 5.09 Issued (47,976 ) 3.95 Cancelled (37,386 ) 8.61 Outstanding at December 31, 2022 2,713,977 3.69 Vested and unissued (662,069 ) 4.54 Unvested at December 31, 2022 2,051,908 $ 3.42 |
Schedule of Warrants Activity | The following table summarizes our warrant activity during the years ended December 31, 2022 and 2021. Schedule of Warrants Activity Total warrants outstanding Weighted average exercise price Weighted average remaining contractual life (in years) Outstanding as of January 1, 2021 534,674 $ 18.34 Warrants granted 229,268 8.09 Forfeited (460,217 ) 18.31 Outstanding as of December 31, 2021 303,725 18.34 1.5 Warrants granted - - Forfeited (18,107 ) 17.16 Outstanding and exercisable as of December 31, 2022 285,618 $ 10.25 0.9 |
Warrant [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Stock Option Warrant Valuation Assumption | We used the Black-Scholes option pricing model to calculate the grant date fair value of the two warrants with the following assumptions: Schedule of Stock Option Warrant Valuation Assumption Average risk-free rate of interest 0.42 1.85 % Expected term (years) 2.00 3.00 Expected stock price volatility 74.48 81.77 % Dividend yield 0 % |
Share-Based Payment Arrangement, Option [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Stock Option Warrant Valuation Assumption | The fair value of the option award granted during the year ended December 31, 2021 was estimated using the following assumptions: Schedule of Stock Option Valuation Assumption Average risk-free rate of interest 1.85 % Expected term (years) 2 Expected stock price volatility 81.77 % Dividend yield 0 % |
Net Loss per Share of Common _2
Net Loss per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share Basic and Diluted | The computation of net loss per share for the year ended December 31, 2022 and 2021 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2022 2021 Basic and diluted net loss per share: Net loss available to common shareholders $ (27,424,229 ) $ (11,427,534 ) Weighted-average number of common shares-basic and diluted 16,109,291 15,319,463 Basic and diluted net loss per share $ (1.70 ) $ (0.75 ) |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | The outstanding stock options, unvested RSAs, unvested RSUs and warrants to purchase common stock were excluded from the computation of diluted net loss per share as their effect would have been anti-dilutive for the periods presented below: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share 2022 2021 Stock options, unvested RSAs, unvested RSUs and purchase warrants 2,577,910 822,430 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases | Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases Remaining lease term (years) for our office lease 2.8 Remaining lease term (years) for our equipment lease 1.3 Weighted average remaining lease term (years) for our facility and equipment leases 2.7 Weighted average discount rate for our facility and equipment leases 8.0 % |
Schedule of Annual Lease Liabilities for all Operating Leases | Annual lease liabilities for all operating leases were as follows as of December 31, 2022: Schedule of Annual Lease Liabilities for all Operating Leases 2023 $ 93,845 2024 92,356 2025 70,040 Total lease payments 256,241 Less: Interest (26,791 ) Present value of lease liabilities 229,450 Less: current maturities (78,896 ) Non-current lease liability $ 150,554 |
Organization and Description _2
Organization and Description of the Business (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||
Feb. 14, 2023 | Feb. 09, 2023 | Feb. 03, 2023 | Mar. 23, 2022 | Aug. 20, 2021 | Jan. 31, 2023 | Mar. 25, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Apr. 12, 2023 | |
Proceeds from issuance of stock | $ 6,400,000 | |||||||||
Impairment of Intangible Assets, Indefinite-Lived (Excluding Goodwill) | 7,268,143 | |||||||||
In Process Research and Development [Member] | ||||||||||
Impairment of Intangible Assets, Indefinite-Lived (Excluding Goodwill) | $ 7,300,000 | |||||||||
Consulting Agreement [Member] | Spartan Capital Securites LLC [Member] | Forecast [Member] | ||||||||||
Warrants issued to purchase common stock | 3,160,130 | |||||||||
Warrants exercise price | $ 1.02 | |||||||||
Warrants term | 3 years | |||||||||
Sales Agreement [Member] | ||||||||||
Shares issued during period | 21,597 | |||||||||
Price per share | $ 8.33 | |||||||||
Proceeds from issuance of stock | $ 174,000 | |||||||||
Transaction costs, percentage | 3% | |||||||||
Sales Agreement [Member] | Maximum [Member] | ||||||||||
Maximum number of shares to be sold at the market offering | $ 30,000,000 | |||||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | ||||||||||
Reimbursement fees | $ 25,000 | |||||||||
Shares issued in connection with the Purchase Agreement with Lincoln Park, shares | 123,609 | |||||||||
Number of common stock issued on commitment fees, value | $ 450,000 | |||||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | Maximum [Member] | ||||||||||
Maximum commitment to purchase common stock value | $ 15,000,000 | |||||||||
Subsequent Event [Member] | ||||||||||
Shares issued during period | 8,432,192 | |||||||||
Proceeds from issuance of stock | $ 7,000,000 | |||||||||
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Registered Direct Offering [Member] | Spartan Capital Securites LLC [Member] | ||||||||||
Proceeds from issuance of stock | $ 5,700,000 | |||||||||
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Registered Direct Offering [Member] | Accredited Investor [Member] | ||||||||||
Gross proceeds from issuance of stock | $ 6,300,000 | |||||||||
Shares issued during period | 7,812,544 | |||||||||
Price per share | $ 0.80 | |||||||||
Agreement conditions | 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 neither we nor our subsidiary will issue or enter into any agreement to issue or announce the issuance or proposed issuance of any shares of common stock or common stock equivalents. | |||||||||
Proceeds from issuance of stock | $ 5,700,000 | |||||||||
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Registered Direct Offering [Member] | Placement Agent [Member] | ||||||||||
Transaction costs, percentage | 8% | |||||||||
Reimbursement fees | $ 60,000 | |||||||||
Subsequent Event [Member] | ATM Offering [Member] | ||||||||||
Shares issued during period | 569,648 | |||||||||
Proceeds from issuance of stock | $ 672,393 | |||||||||
Subsequent Event [Member] | Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | ||||||||||
Shares issued during period | 50,000 | |||||||||
Price per share | $ 1.08 | |||||||||
Proceeds from issuance of stock | $ 54,000 |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Details Narrative) | 12 Months Ended | ||
Dec. 31, 2022 USD ($) Segment shares | Dec. 31, 2021 USD ($) shares | Apr. 12, 2023 $ / shares shares | |
AccountingPoliciesLineItems [Line Items] | |||
Accumulated deficit | $ 64,247,561 | $ 36,823,332 | |
Net income loss | 27,424,229 | 11,427,534 | |
Non-cash expenses | 17,400,000 | ||
Net cash used in operating activities | 9,605,143 | 8,717,291 | |
Proceeds from issuance of stock | 6,400,000 | ||
Revenue | 0 | ||
Impairment loss of long-lived assets and intangibles other than goodwill | $ 7,268,143 | ||
Antidilutive securities excluded from computation of earnings per share | shares | 2,577,910 | 822,430 | |
Number of operating segments | Segment | 1 | ||
Research and development costs | $ 11,494,230 | $ 6,878,021 | |
Operating loss carry forwards | 7,400,000 | ||
Unrecognized tax benefits | $ 0 | ||
Forecast [Member] | Consulting Agreement [Member] | Spartan Capital Securites LLC [Member] | |||
AccountingPoliciesLineItems [Line Items] | |||
Warrants issued to purchase common stock | shares | 3,160,130 | ||
Warrants exercise price | $ / shares | $ 1.02 | ||
Warrants term | 3 years | ||
Minimum [Member] | |||
AccountingPoliciesLineItems [Line Items] | |||
Estimated useful lives of property plant and equipment | 3 years | ||
Maximum [Member] | |||
AccountingPoliciesLineItems [Line Items] | |||
Estimated useful lives of property plant and equipment | 5 years |
Summary of Intangible Assets (D
Summary of Intangible Assets (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Gross intangible assets | $ 11,059,429 | $ 11,059,429 |
Less: accumulated amortization | (3,791,286) | (3,002,791) |
Less: impairment of intangible asset | (7,268,143) | |
Total intangible assets, net | $ 8,056,638 |
Intangible Assets (Details Narr
Intangible Assets (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||
Recognition of deferred tax liability | ||
Amortization expense | 788,495 | 790,488 |
Impairment of intangible asset | 7,268,143 | |
License Rights [Member] | CoNCERT Pharmaceuticals, Inc [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Purchase price | 8,000,000 | |
Transaction cost | 1,782 | |
Recognition of deferred tax liability | 3,037,147 | |
Intangible asset, tax basis | $ 1,782 |
Schedule of Provision for Incom
Schedule of Provision for Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Federal | ||
State | ||
Total deferred tax benefit | ||
Federal | (5,887,151) | (2,853,937) |
State | (1,567,560) | (624,844) |
Total deferred tax benefit | (7,454,711) | (3,478,781) |
Valuation allowance | 7,454,711 | 2,948,170 |
Net deferred tax benefit | (530,611) | |
Total tax provision (benefit) | $ (530,611) |
Schedule of Effective Income Ta
Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21% | 21% |
State tax rate, net | 5.72% | 5.23% |
Permanent differences | (0.55%) | (0.18%) |
Federal orphan drug tax credit | 0.93% | 3.04% |
Deferred tax asset valuation allowance | (27.10%) | (24.65%) |
Effective income tax rate | 0% | 4.44% |
Schedule of Deferred Tax Assets
Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carry forward – Federal | $ 5,048,175 | $ 2,615,518 |
Net operating loss carry forward – State | 1,431,839 | 760,897 |
Stock compensation expense | 2,590,890 | 593,365 |
Depreciation and other | 976 | 13,200 |
Purchased in-process R&D | 2,494,829 | 2,481,070 |
Federal orphan drug credits | 1,046,539 | 791,151 |
Capitalized research and development costs | 1,929,462 | |
Start-up expenditures and amortization | 1,978,418 | |
Total non-current deferred tax assets | 14,542,710 | 9,233,619 |
Valuation allowance for deferred tax assets | (14,542,710) | (7,087,999) |
Total deferred tax assets | 2,145,620 | |
Intangible asset | (2,145,620) | |
Total non-current deferred tax liabilities | (2,145,620) | |
Total deferred tax asset (liability) |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Mar. 19, 2018 | |
Operating Loss Carryforwards [Line Items] | |||
Deferred tax assets, capital loss carryforwards | $ 24,000,000 | $ 12,500,000 | |
Net operating loss carryforwards | $ 7,400,000 | ||
Net operating loss carryforward, expiration date | 2037 | ||
Net operating loss carryforward term | 20 years | ||
Income tax examination description | Pursuant to Code Sec. 382 of the Internal Revenue Code (“the Code”), the utilization of our net operating loss carryforwards could be limited as a result of a cumulative change in stock ownership of more than 50% over a three-year period. We have not completed a Sec. 382 study and as such our net operating loss carryforwards may be subject to such limitation. | ||
Deferred tax liability, intangible assets | 2,145,620 | ||
Income tax expense benefit | 530,611 | ||
Capitalized research and development costs | 1,929,462 | ||
Valuation allowance deferred tax asset | 7,400,000 | 2,900,000 | |
penalties and interest expense | 0 | $ 0 | |
Research and Development Expense [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Capitalized research and development costs | 7,200,000 | ||
License Rights [Member] | CoNCERT Pharmaceuticals, Inc [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Deferred tax liabilities | $ 3,037,147 | ||
Deferred tax liability, intangible assets | 11,038,929 | ||
Deferred tax liability, expenses | $ 1,782 | ||
Domestic Tax Authority [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 23,700,000 |
Schedule of Stock-based Compens
Schedule of Stock-based Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total | $ 8,828,713 | $ 3,408,015 |
Research and Development Expense [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total | 2,895,653 | 809,839 |
General and Administrative Expense [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total | $ 5,933,060 | $ 2,598,176 |
Schedule of Stock Option Valuat
Schedule of Stock Option Valuation Assumption (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Share-Based Payment Arrangement [Abstract] | |
Average risk-free rate of interest | 1.85% |
Expected term (years) | 2 years |
Expected stock price volatility | 81.77% |
Dividend yield | 0% |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement [Abstract] | ||
Options outstanding, beginning balance | 178,496 | 152,806 |
Weighted average exercise price, beginning balance | $ 17.07 | $ 18.11 |
Options, granted | 30,000 | |
Weighted average exercise price, granted | $ 11.70 | |
Weighted average remaining contractual term, Options granted | 1 year 2 months 12 days | |
Options, forfeited | (4,310) | |
Weighted average exercise price, forfeited | $ 16.80 | |
Weighted average remaining contractual term, ending | 3 years 7 months 6 days | |
Options outstanding, ending balance | 178,496 | |
Weighted average exercise price, ending balance | $ 17.07 | |
Weighted average remaining contractual term, ending | 2 years 7 months 6 days |
Schedule of Restricted Stock Aw
Schedule of Restricted Stock Awards (“RSAs”) Activity (Details) - Restricted Stock [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of restricted stock, shares outstanding | 91,109 | 122,782 |
Weighted-average grant-date fair value per share, outstanding | $ 7.74 | $ 8.04 |
Number of shares, granted | 187,058 | 37,500 |
Weighted-average grant-date fair value per share, granted | $ 3.71 | $ 6.65 |
Number of shares, vested and issued | (182,790) | (58,467) |
Weighted-average grant-date fair value per share, vested and issued | $ 5.04 | $ 7.90 |
Number of shares, forfeited | (33,489) | (10,706) |
Weighted-average grant-date fair value per share, forfeited | $ 5.53 | $ 6.54 |
Number of restricted stock shares outstanding | 61,888 | 91,109 |
Weighted-average grant-date fair value per share, outstanding | $ 4.72 | $ 7.74 |
Schedule of Restricted Stock Un
Schedule of Restricted Stock Units (“RSUs”) Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | ||
Apr. 01, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Number of shares, Beginning balance | 439,593 | ||
Weighted-average grant-date fair value per share, Beginning balance | $ 7.76 | ||
Number of shares, granted | 1,979,818 | 2,428,285 | 457,593 |
Weighted-average grant-date fair value per share, granted | $ 3.08 | $ 7.75 | |
Number of shares, forfeited | (68,539) | (4,000) | |
Weighted-average grant-date fair value per share, forfeited | $ 5.09 | $ 8.61 | |
Number of shares, issued | (47,976) | (14,000) | |
Weighted-average grant-date fair value per share, shares issued | $ 3.95 | $ 7.12 | |
Number of shares, cancelled | (37,386) | ||
Weighted-average grant-date fair value per share, cancelled | $ 8.61 | ||
Number of shares, ending balance | 2,713,977 | 439,593 | |
Weighted-average grant-date fair value per share, ending balance | $ 3.69 | $ 7.76 | |
Number of shares, vested and unissued | (662,069) | ||
Weighted-average grant-date fair value per share, vested and unissued | $ 4.54 | ||
Number of shares, unvested | 2,051,908 | 249,100 | |
Weighted-average grant-date fair value per share, unvested | $ 3.42 |
Schedule of Warrants Activity (
Schedule of Warrants Activity (Details) - Warrant [Member] - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Warrants outstanding, beginning balance | 303,725 | 534,674 |
Weighted average exercise price, beginning balance | 18.34 | 18.34 |
Warrants granted | 229,268 | |
Weighted average exercise price, warrants granted | 8.09 | |
Warrants, forfeited | (18,107) | (460,217) |
Weighted average exercise price, warrants forfeited | 17.16 | 18.31 |
Weighted average remaining contractual term, ending | 1 year 6 months | |
Warrants outstanding, ending balance | 285,618 | |
Weighted average exercise price, ending balance | 10.25 | |
Weighted average remaining contractual term, ending | 10 months 24 days |
Schedule of Stock Option Warran
Schedule of Stock Option Warrant Valuation Assumption (Details) - Warrant [Member] | Dec. 31, 2022 |
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, measurement input | 0.0042 |
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, measurement input | 0.0185 |
Measurement Input, Expected Term [Member] | Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected term (years) | 2 years |
Measurement Input, Expected Term [Member] | Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected term (years) | 3 years |
Measurement Input, Option Volatility [Member] | Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, measurement input | 0.7448 |
Measurement Input, Option Volatility [Member] | Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, measurement input | 0.8177 |
Measurement Input, Expected Dividend Rate [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, measurement input | 0 |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) | 3 Months Ended | 12 Months Ended | |||||||||||
Jan. 01, 2023 shares | Jul. 10, 2022 shares | Jun. 02, 2022 USD ($) shares | May 31, 2022 shares | Apr. 01, 2022 USD ($) shares | Feb. 24, 2021 $ / shares shares | Mar. 25, 2023 shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Apr. 12, 2023 $ / shares shares | Jul. 11, 2022 shares | Sep. 01, 2021 USD ($) $ / shares shares | Jan. 31, 2021 USD ($) shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Options, granted | 30,000 | ||||||||||||
Share based compensation | $ | $ 8,828,713 | $ 3,408,015 | |||||||||||
Private Placement [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Shares issued during period, shares | 1,321,132 | ||||||||||||
Private Placement [Member] | Placement Agent [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Warrants issued to purchase common stock | 79,268 | ||||||||||||
Warrants exercise price | $ / shares | $ 9.30 | ||||||||||||
Warrant expiration date | Feb. 16, 2023 | ||||||||||||
Consulting Agreement [Member] | Forecast [Member] | Spartan Capital Securites LLC [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Warrants issued to purchase common stock | 3,160,130 | ||||||||||||
Warrants exercise price | $ / shares | $ 1.02 | ||||||||||||
Warrants term | 3 years | ||||||||||||
Common Stock [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Shares issued during period, shares | 1,321,132 | ||||||||||||
Subsequent Event [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Shares issued during period, shares | 8,432,192 | ||||||||||||
Consultants [Member] | Common Stock [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Share based compensation granted in period | 17,800 | ||||||||||||
Share-Based Payment Arrangement, Option [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Options, granted | 30,000 | ||||||||||||
Weighted average grant-date fair value | $ / shares | $ 5.23 | ||||||||||||
Aggregate fair value of stock options vested | $ | $ 1,910,240 | $ 1,659,909 | |||||||||||
Options, exercised | 0 | 0 | |||||||||||
Restricted Stock [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Unrecognized share based compensation expense | $ | $ 199,000 | ||||||||||||
Share based compensation granted in period | 187,058 | 37,500 | |||||||||||
RSAs vested and issued | 182,790 | 58,467 | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Forfeited in Period | 33,489 | 10,706 | |||||||||||
Restricted Stock [Member] | Consultants [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Share based compensation granted in period | 59,766 | ||||||||||||
Share based compensation | $ | $ 196,500 | ||||||||||||
Restricted Stock [Member] | Directors [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Share based compensation granted in period | 109,720 | ||||||||||||
Share based compensation granted in period, fair value | $ | $ 378,000 | ||||||||||||
RSAs vested and issued | 54,624 | ||||||||||||
Shares of common stock issued | 17,572 | ||||||||||||
Directors' fees | $ | $ 120,000 | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Forfeited in Period | 18,208 | ||||||||||||
Restricted Stock [Member] | Directors [Member] | Subsequent Event [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
RSAs vested and issued | 90,000 | ||||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Unrecognized share based compensation expense | $ | $ 472,000 | ||||||||||||
Share based compensation granted in period | 1,979,818 | 2,428,285 | 457,593 | ||||||||||
Share based compensation granted in period, fair value | $ | $ 6,200,000 | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Forfeited in Period | 68,539 | 4,000 | |||||||||||
Weighted average period for recognition | 1 year 8 months 12 days | ||||||||||||
Unrecognized restricted stock expense | $ | $ 320,000 | ||||||||||||
Minimum price per share of equity compensation | $ / shares | $ 5 | ||||||||||||
Restricted Stock Units (RSUs) [Member] | Base Compensation [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Share based compensation granted in period | 417,073 | ||||||||||||
Restricted Stock Units (RSUs) [Member] | Common Stock [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Share based compensation granted in period | 17,800 | ||||||||||||
Accelerated vesting, shares | 62,940 | ||||||||||||
Share based compensation costs | $ | $ 90,228 | ||||||||||||
Shares issued during period, shares | 14,300 | ||||||||||||
Warrant [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Share based compensation | $ | $ 103,374 | $ 391,108 | |||||||||||
Warrants granted | 229,268 | ||||||||||||
Warrants, forfeited | 18,107 | 460,217 | |||||||||||
Warrants issued to purchase common stock | 285,618 | ||||||||||||
Warrants exercise price | $ / shares | $ 10.25 | ||||||||||||
Weighted average remaining contractual life | 10 months 24 days | ||||||||||||
Warrant [Member] | Consultant [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Warrants issued to purchase common stock | 50,000 | 100,000 | |||||||||||
Warrants exercise price | $ / shares | $ 7.18 | $ 8 | |||||||||||
Fair value of warrants issued | $ | $ 139,900 | $ 321,158 | |||||||||||
Warrant expiration date | Jan. 11, 2024 | Sep. 01, 2024 | |||||||||||
Warrants modification expense recognized | $ | $ 33,000 | ||||||||||||
Warrant [Member] | Consultant [Member] | Measurement Input, Price Volatility [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.8439 | ||||||||||||
2019 Plan [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
maximum equity available for issuance | 6,000,000 | ||||||||||||
Increase in equity available for issuance under the plan | 3,000,000 | ||||||||||||
Shares available for future grants | 2,387,622 | ||||||||||||
2019 Plan [Member] | Original [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
maximum equity available for issuance | 3,000,000 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||||
Feb. 14, 2023 | Feb. 03, 2023 | Apr. 01, 2022 | Mar. 29, 2022 | Mar. 23, 2022 | Aug. 20, 2021 | Jun. 16, 2021 | Jun. 08, 2021 | Feb. 24, 2021 | Oct. 06, 2020 | Jan. 31, 2023 | Mar. 25, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Jan. 01, 2022 | |
Class of Stock [Line Items] | |||||||||||||||
Common stock, shares authorized | 50,000,000 | 30,000,000 | 50,000,000 | ||||||||||||
Preferred stock, shares issued | 0 | 0 | |||||||||||||
Preferred stock, shares outstanding | 0 | 0 | |||||||||||||
Proceeds from issuance of stock | $ 6,400,000 | ||||||||||||||
Shares issued in private placement, net of transaction costs, value | $ 9,875,550 | ||||||||||||||
Repurchase of common stock value | $ 300,000 | ||||||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Number of shares, forfeited | 68,539 | 4,000 | |||||||||||||
Number of shares, granted | 1,979,818 | 2,428,285 | 457,593 | ||||||||||||
Restricted Stock Units (RSUs) [Member] | Federal, State and Local [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Number of shares, forfeited | 36,145 | ||||||||||||||
Restricted Stock [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Number of shares, forfeited | 33,489 | 10,706 | |||||||||||||
Number of shares, granted | 187,058 | 37,500 | |||||||||||||
Restricted Stock [Member] | Employment Termination [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Number of shares, forfeited | 1,530 | ||||||||||||||
Restricted Stock [Member] | Federal, State and Local [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Number of shares, forfeited | 9,176 | ||||||||||||||
Common Stock [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Shares issued during period | 1,321,132 | ||||||||||||||
Shares issued in connection with the Purchase Agreement with Lincoln Park | 123,609 | ||||||||||||||
Shares issued in connection with license agreement | 100,000 | 144,689 | |||||||||||||
Shares issued in private placement, net of transaction costs, value | $ 132 | ||||||||||||||
Repurchase of common stock value | |||||||||||||||
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Shares issued during period | 14,300 | ||||||||||||||
Number of shares, granted | 17,800 | ||||||||||||||
Director [Member] | Restricted Stock [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Number of shares, forfeited | 18,208 | ||||||||||||||
Employees [Member] | Restricted Stock [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Number of shares, granted | 37,500 | ||||||||||||||
Consultants [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Options and warrants granted | 180,000 | ||||||||||||||
Consultants [Member] | Restricted Stock [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Number of shares, granted | 59,766 | ||||||||||||||
Consultants [Member] | Common Stock [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Number of shares, granted | 17,800 | ||||||||||||||
Aposense, Ltd. [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Number of repurchase of common stock, shares | 100,000 | ||||||||||||||
Repurchase of common stock value | $ 300,000 | ||||||||||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Shares issued in connection with the Purchase Agreement with Lincoln Park | 123,609 | 123,609 | |||||||||||||
Number of common stock issued on commitment fees, value | $ 450,000 | ||||||||||||||
Reimbursement fees | 25,000 | ||||||||||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | Maximum [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Commitment to purchase common stock | $ 15,000,000 | ||||||||||||||
Number of common stock shares in regular purchase | 25,000 | ||||||||||||||
Number of common stock shares exceeding regular purchase | 75,000 | ||||||||||||||
Daily maximum committed purchase obligations, value | $ 1,250,000 | ||||||||||||||
Maximum number of shares sold | 3,142,430 | ||||||||||||||
Nasdaq's exchange cap percent | 19.99% | ||||||||||||||
Beneficial ownership limitation percentage | 9.99% | ||||||||||||||
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | Minimum [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Minimum closing sale price | $ 1 | ||||||||||||||
Sales Agreement [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Proceeds from issuance of stock | $ 174,000 | ||||||||||||||
Shares issued during period | 21,597 | ||||||||||||||
Price per share | $ 8.33 | ||||||||||||||
Sales Agreement [Member] | Maximum [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Maximum number of shares to be sold at the market offering | $ 30,000,000 | ||||||||||||||
License Agreement [Member] | Elion Oncology [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Shares issued in connection with license agreement | 825,000 | 100,000 | 100,000 | ||||||||||||
License Agreement [Member] | Ocuphire Pharma Inc [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Shares issued in connection with license agreement | 44,689 | ||||||||||||||
License Agreement [Member] | Aposense, Ltd. [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Shares issued in connection with license agreement | 625,000 | ||||||||||||||
Private Placement [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Shares issued during period | 1,321,132 | ||||||||||||||
Gross proceeds from issuance of common stock | $ 10,200,000 | ||||||||||||||
Shares issued in private placement, net of transaction costs, value | $ 9,900,000 | ||||||||||||||
Private Placement [Member] | Placement Agent [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Warrants issued to purchase common stock | 79,268 | ||||||||||||||
Warrants exercise price | $ 9.30 | ||||||||||||||
Warrant expiration date | Feb. 16, 2023 | ||||||||||||||
Subsequent Event [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Proceeds from issuance of stock | $ 7,000,000 | ||||||||||||||
Shares issued during period | 8,432,192 | ||||||||||||||
Subsequent Event [Member] | Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Proceeds from issuance of stock | $ 54,000 | ||||||||||||||
Shares issued during period | 50,000 | ||||||||||||||
Price per share | $ 1.08 | ||||||||||||||
Subsequent Event [Member] | Sales Agreement [Member] | Oppenheimer & Co. Inc, [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Proceeds from issuance of stock | $ 693,000 | ||||||||||||||
Shares issued during period | 569,648 | ||||||||||||||
Price per share | $ 1.22 | ||||||||||||||
Subsequent Event [Member] | Sales Agreement [Member] | Oppenheimer & Co. Inc, [Member] | Maximum [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Maximum number of shares to be sold at the market offering | $ 30,000,000 | ||||||||||||||
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Registered Direct Offering [Member] | Accredited Investor [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Proceeds from issuance of stock | $ 5,700,000 | ||||||||||||||
Shares issued during period | 7,812,544 | ||||||||||||||
Price per share | $ 0.80 | ||||||||||||||
Gross proceeds from issuance of common stock | $ 6,300,000 | ||||||||||||||
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Registered Direct Offering [Member] | Accredited Investor [Member] | Common Stock [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Gross proceeds from issuance of common stock | $ 6,300,000 |
Schedule of Net Loss Per Share
Schedule of Net Loss Per Share Basic and Diluted (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Net loss available to common shareholders | $ (27,424,229) | $ (11,427,534) |
Weighted-average number of common shares-basic and diluted | 16,109,291 | 15,319,463 |
Basic and diluted net loss per share | $ (1.70) | $ (0.75) |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Stock options, unvested RSAs, unvested RSUs and purchase warrants | 2,577,910 | 822,430 |
Net Loss per Share of Common _3
Net Loss per Share of Common Stock (Details Narrative) - shares | 12 Months Ended | |||||
Jan. 01, 2023 | Apr. 01, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Apr. 12, 2023 | Dec. 31, 2020 | |
Forecast [Member] | Consulting Agreement [Member] | Spartan Capital Securites LLC [Member] | ||||||
Warrants issued to purchase common stock | 3,160,130 | |||||
Restricted Stock [Member] | ||||||
Shares unvested | 61,888 | 91,109 | 122,782 | |||
Number of shares, granted | 187,058 | 37,500 | ||||
Restricted Stock Units (RSUs) [Member] | ||||||
Shares unvested | 2,051,908 | 249,100 | ||||
Number of shares, granted | 1,979,818 | 2,428,285 | 457,593 | |||
Restricted Stock [Member] and Restricted Stock Units (RSUs) [Member] | Subsequent Event [Member] | ||||||
Number of shares, granted | 1,056,503 |
Schedule of Weighted Average Re
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases (Details) | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | |
Weighted average remaining lease term (years) for our facility and equipment leases | 2 years 8 months 12 days |
Weighted average discount rate for our facility and equipment leases | 8% |
Office Building [Member] | |
Property, Plant and Equipment [Line Items] | |
Remaining lease term (years) | 2 years 9 months 18 days |
Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Remaining lease term (years) | 1 year 3 months 18 days |
Schedule of Annual Lease Liabil
Schedule of Annual Lease Liabilities for all Operating Leases (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Leases | ||
2023 | $ 93,845 | |
2024 | 92,356 | |
2025 | 70,040 | |
Total lease payments | 256,241 | |
Less: Interest | (26,791) | |
Present value of lease liabilities | 229,450 | |
Less: current maturities | (78,896) | $ (71,078) |
Non-current lease liability | $ 150,554 | $ 7,385 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leases | ||
Operating lease borrowing rate | 8% | |
Lease cost | $ 96,785 | $ 94,263 |
License Agreements (Details Nar
License Agreements (Details Narrative) - USD ($) | 12 Months Ended | |||||||
May 17, 2022 | Jun. 16, 2021 | Oct. 06, 2020 | Aug. 23, 2020 | Aug. 19, 2020 | Mar. 19, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Issued During Period, Value, New Issues | $ 9,875,550 | |||||||
CoNCERT Pharmaceuticals, Inc [Member] | License Rights [Member] | ||||||||
Shares issued in connection with license agreement | 298,615 | |||||||
Stock Issued During Period, Value, New Issues | $ 8,000,000 | |||||||
Business Acquisition, Share Price | $ 26.79 | |||||||
License Agreement [Member] | Elion Oncology [Member] | ||||||||
Conditions for grant of license, description | The grant of license was conditioned on the following being satisfied by October 30, 2020: (i) our closing on an equity financing of at least $15 million in gross proceeds and (ii) successful up-listing to Nasdaq. | |||||||
Cash paid under license agreement | $ 100,000 | |||||||
Shares issued in connection with license agreement | 825,000 | 100,000 | 100,000 | |||||
Common stock, lock-up description | Such shares were subject to a lock-up, with 50% of such shares released from such lock-up after six months and the remaining 25% tranches were released following 9 months and 12 months, respectively | |||||||
Common Stock, Capital Shares Reserved for Future Issuance | 100,000 | |||||||
Milestone payments, description | As additional consideration, we will pay Elion development and regulatory milestone payments (a portion of which are payable in shares of our common stock and a portion of which are payable in cash) upon the achievement of certain milestones, which include FDA or other regulatory approval and dosing a patient | |||||||
Expense and related liability | $ 189,000 | |||||||
Performance of milestone conditions, description | specific diligence milestones that consist of: (i) dosing a first patient in a Phase 1B clinical trial with a product within 12 months; and (ii) dosing a first patient with a product in a Phase 2 or 3 clinical trial within 48 months. Either party may terminate the agreement in the event of a material breach of the agreement that has not been cured following written notice and a 90-day opportunity to cure such breach (which is shortened to 15 days for a payment breach). | |||||||
License Agreement [Member] | Elion Oncology [Member] | First Milestone [Member] | ||||||||
Milestone payment description | shares of our common stock on each of the first and second anniversary dates of the Elion License Agreement, which we fulfilled on October 5, 2021 and 2022, respectively. | |||||||
License Agreement [Member] | Ocuphire Pharma Inc [Member] | ||||||||
Cash paid under license agreement | $ 200,000 | |||||||
Shares issued in connection with license agreement | 44,689 | |||||||
Liabilities assumed | $ 66,583 | |||||||
License Agreement [Member] | Aposense, Ltd. [Member] | ||||||||
Shares issued in connection with license agreement | 625,000 | |||||||
Common stock, lock-up description | Such shares were subject to a lock-up, with 40% of such shares released from such lock-up after six months and the remaining two 30% tranches were released upon completion of the next two subsequent quarters | |||||||
Milestone payments, description | As additional consideration, we will pay Aposense development and regulatory milestone payments (up to $3.0 million per milestone) upon the achievement of certain milestones, which primarily consist of having a drug indication approved by a regulatory authority in the United States or another country. In addition, we will pay Aposense one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. We are also required to split any sales milestone payments or royalties we receive with Aposense based on any sub-license agreement we may enter into | |||||||
License Agreement [Member] | Aposense, Ltd. [Member] | Maximum [Member] | ||||||||
Development and regulatory milestone payments | $ 3,000,000 | |||||||
License Agreement [Member] | Yuhan Corporation [Member] | ||||||||
Shares issued in connection with license agreement | 500,000 | |||||||
Milestone payments, description | In addition, we must pay Yuhan one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. We are also required to split any milestone payments received with Yuhan based on any sub-license agreement we may enter into | |||||||
Performance of milestone conditions, description | specific diligence milestones that consist of: (i) preparing a first draft of the product development plan within 90 days; (ii) requesting an FDA pre-IND meeting for a product within 6 months; (iii) dosing a first patient in a Phase 2A clinical trial with a product within 24 months; and (iv) dosing a first patient with a product in a Phase 2B clinical trial, Phase 3 clinical trial or other pivotal clinical trial with a product within 48 months | |||||||
License Agreement [Member] | Yuhan Affiliate [Member] | Underwritten Public Offering [Member] | October 2020 [Member] | ||||||||
Shares issued in connection with our 2020 offering | 750,000 | |||||||
Proceeds from offering | $ 3,000,000 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - CorLyst, LLC [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Rent and other costs reimbursements received | $ 124,497 | $ 126,324 |
Due from related parties | $ 0 | 0 |
Prepaid reimbursements related parties | $ 1,772 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - Contract Research Organizations [Member] $ in Millions | Dec. 31, 2022 USD ($) |
Agreements [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Purchase obligation | $ 3.6 |
PCS499 Clinical Trial [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Purchase obligation | $ 1.1 |