Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 02, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-39531 | |
Entity Registrant Name | Processa Pharmaceuticals, Inc. | |
Entity Central Index Key | 0001533743 | |
Entity Tax Identification Number | 45-1539785 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 7380 Coca Cola Drive | |
Entity Address, Address Line Two | Suite 106 | |
Entity Address, City or Town | Hanover | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 21076 | |
City Area Code | (443) | |
Local Phone Number | 776-3133 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | PCSA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 15,604,605 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Current Assets | ||
Cash and cash equivalents | $ 20,831,195 | $ 15,416,224 |
Due from related party | 154,730 | |
Due from tax agencies | 70,274 | 77,024 |
Prepaid expenses and other | 1,664,257 | 554,708 |
Total Current Assets | 22,565,726 | 16,202,686 |
Property and Equipment, net | 484 | |
Other Assets | ||
Operating lease right-of-use assets, net of accumulated amortization | 117,236 | 158,558 |
Intangible assets, net of accumulated amortization | 8,449,462 | 8,847,126 |
Security deposit | 5,535 | 5,535 |
Total Other Assets | 8,572,233 | 9,011,219 |
Total Assets | 31,137,959 | 25,214,389 |
Current Liabilities | ||
Note payable – Paycheck Protection Program, current portion | 117,574 | |
Current maturities of operating lease liability | 92,447 | 87,200 |
Accrued interest | 950 | |
Accounts payable | 287,878 | 320,694 |
Due to licensor | 400,000 | 400,000 |
Due to related parties | 11,742 | 69,858 |
Accrued expenses | 369,110 | 224,676 |
Total Current Liabilities | 1,161,177 | 1,220,952 |
Non-current Liabilities | ||
Note payable – Paycheck Protection Program | 44,885 | |
Non-current operating lease liability | 30,896 | 78,463 |
Non-current due to licensor | 400,000 | 400,000 |
Net deferred tax liability | 304,194 | 530,611 |
Total Liabilities | 1,896,267 | 2,274,911 |
Commitments and Contingencies | ||
Stockholders’ Equity | ||
Common stock, par value $0.0001, 30,000,000 shares authorized: 15,604,605 and 14,187,984 issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 1,560 | 1,419 |
Additional paid-in capital | 59,892,453 | 48,333,857 |
Accumulated deficit | (30,652,321) | (25,395,798) |
Total Stockholders’ Equity | 29,241,692 | 22,939,478 |
Total Liabilities and Stockholders’ Equity | $ 31,137,959 | $ 25,214,389 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 30,000,000 | 30,000,000 |
Common stock, shares issued | 15,604,605 | 14,187,984 |
Common stock, shares outstanding | 15,604,605 | 14,187,984 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Operating Expenses | ||||
Research and development expenses | $ 1,614,954 | $ 427,109 | $ 3,086,401 | $ 928,855 |
Acquisition of in-process research and development | 515,630 | 515,630 | ||
General and administrative expenses | 1,329,213 | 374,878 | 2,051,073 | 859,255 |
Operating Loss | (3,459,797) | (801,987) | (5,653,104) | (1,788,110) |
Other Income (Expense) | ||||
Forgiveness of PPP loan and related accrued interest | 163,771 | 163,771 | ||
Interest expense | (19,280) | (362) | (36,450) | |
Interest income | 1,814 | 18 | 6,755 | 846 |
Net Operating Loss Before Income Tax Benefit | (3,294,212) | (821,249) | (5,482,940) | (1,823,714) |
Income Tax Benefit | 137,169 | 87,835 | 226,417 | 215,964 |
Net Loss | $ (3,157,043) | $ (733,414) | $ (5,256,523) | $ (1,607,750) |
Net Loss per Common Share - Basic and Diluted | $ (0.20) | $ (0.13) | $ (0.35) | $ (0.29) |
Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Basic and Diluted | 15,406,363 | 5,515,566 | 14,997,303 | 5,515,566 |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Changes in Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Stock Dividend Payable [Member] | Retained Earnings [Member] | Total |
Beginning balance at Dec. 31, 2019 | $ 549 | $ 18,994,008 | $ 3 | $ (10,982,010) | $ 8,012,550 |
Beginning balance, shares at Dec. 31, 2019 | 5,486,595 | ||||
Stock-based compensation | 98,663 | 98,663 | |||
Stock-based compensation, shares | |||||
Transaction costs related to anticipated 2020 offering | (2,806) | (2,806) | |||
Net loss | (874,336) | (874,336) | |||
Ending balance at Mar. 31, 2020 | $ 549 | 19,089,865 | 3 | (11,856,346) | 7,234,071 |
Ending balance, shares at Mar. 31, 2020 | 5,486,595 | ||||
Beginning balance at Dec. 31, 2019 | $ 549 | 18,994,008 | 3 | (10,982,010) | 8,012,550 |
Beginning balance, shares at Dec. 31, 2019 | 5,486,595 | ||||
Net loss | (1,607,750) | ||||
Ending balance at Jun. 30, 2020 | $ 552 | 19,182,228 | (12,589,760) | 6,593,020 | |
Ending balance, shares at Jun. 30, 2020 | 5,515,566 | ||||
Beginning balance at Mar. 31, 2020 | $ 549 | 19,089,865 | 3 | (11,856,346) | 7,234,071 |
Beginning balance, shares at Mar. 31, 2020 | 5,486,595 | ||||
Stock-based compensation | 93,869 | 93,869 | |||
Stock-based compensation, shares | |||||
Stock dividend distributed due to full-ratchet anti-dilution adjustment | $ 3 | (3) | |||
Stock dividend distributed due to full-ratchet anti-dilution adjustment, shares | 28,971 | ||||
Transaction costs related to anticipated 2020 offering | (1,506) | (1,506) | |||
Net loss | (733,414) | (733,414) | |||
Ending balance at Jun. 30, 2020 | $ 552 | 19,182,228 | (12,589,760) | 6,593,020 | |
Ending balance, shares at Jun. 30, 2020 | 5,515,566 | ||||
Beginning balance at Dec. 31, 2020 | $ 1,419 | 48,333,857 | (25,395,798) | 22,939,478 | |
Beginning balance, shares at Dec. 31, 2020 | 14,187,984 | ||||
Stock-based compensation | $ 1 | 620,590 | 620,591 | ||
Stock-based compensation, shares | 12,500 | ||||
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 | ||||
Net loss | (2,099,480) | (2,099,480) | |||
Ending balance at Mar. 31, 2021 | $ 1,552 | 58,829,865 | (27,495,278) | 31,336,139 | |
Ending balance, shares at Mar. 31, 2021 | 15,521,616 | ||||
Beginning balance at Dec. 31, 2020 | $ 1,419 | 48,333,857 | (25,395,798) | 22,939,478 | |
Beginning balance, shares at Dec. 31, 2020 | 14,187,984 | ||||
Shares issued in private placement, net of transaction costs | 446,477 | ||||
Net loss | (5,256,523) | ||||
Ending balance at Jun. 30, 2021 | $ 1,560 | 59,892,453 | (30,652,321) | 29,241,692 | |
Ending balance, shares at Jun. 30, 2021 | 15,604,605 | ||||
Beginning balance at Mar. 31, 2021 | $ 1,552 | 58,829,865 | (27,495,278) | 31,336,139 | |
Beginning balance, shares at Mar. 31, 2021 | 15,521,616 | ||||
Stock-based compensation | $ 4 | 762,592 | 762,596 | ||
Stock-based compensation, shares | 38,300 | ||||
Shares issued in connection with license agreement | $ 4 | 299,996 | 300,000 | ||
Shares issued in connection with license agreement, shares | 44,689 | ||||
Net loss | (3,157,043) | (3,157,043) | |||
Ending balance at Jun. 30, 2021 | $ 1,560 | $ 59,892,453 | $ (30,652,321) | $ 29,241,692 | |
Ending balance, shares at Jun. 30, 2021 | 15,604,605 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash Flows From Operating Activities | ||
Net loss | $ (5,256,523) | $ (1,607,750) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 484 | 4,223 |
Non-cash lease expense for right-of-use assets | 41,322 | 39,483 |
Non-cash acquisition of in-process research and development | 300,000 | |
Amortization of debt issuance costs | 2,140 | |
Amortization of intangible asset | 397,664 | 397,664 |
Deferred income tax benefit | (226,417) | (215,964) |
Stock-based compensation | 1,173,622 | 192,532 |
Forgiveness of PPP loan and related accrued interest | (163,771) | |
Net changes in operating assets and liabilities: | ||
Prepaid expenses and other | (876,899) | 217,923 |
Operating lease liability | (42,320) | (38,820) |
Accrued interest | 362 | 36,581 |
Accounts payable | (32,816) | (2,241) |
Due (from) to related parties | 96,614 | (26,813) |
Other receivables | 6,750 | |
Accrued expenses | 144,434 | 104,013 |
Net cash used in operating activities | (4,437,494) | (897,029) |
Cash Flows From Financing Activities | ||
Net proceeds from private placement | 9,875,550 | |
Borrowings on line of credit payable from related party | 500,000 | |
Proceeds received from our Paycheck Protection Program note payable | 162,459 | |
Other | (23,085) | (4,312) |
Net cash provided by financing activities | 9,852,465 | 658,147 |
Net Increase (Decrease) in Cash | 5,414,971 | (238,882) |
Cash and Cash Equivalents – Beginning of Period | 15,416,224 | 691,536 |
Cash and Cash Equivalents – End of Period | $ 20,831,195 | $ 452,654 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Organization and Summary of Significant Accounting Policies | Note 1 – Organization and Summary of Significant Accounting Policies Business Activities and Organization We are a clinical-stage biopharmaceutical company focused on the development of drug products that are intended to provide treatment for patients who have a high unmet medical need condition that effects survival or the patient’s quality of life and for which few or no treatment options currently exist. We currently have five drugs: four in various stages of clinical development (PCS499, PCS12852, PCS3117, and PCS6422) and one in nonclinical development (PCS11T). We group our drugs into non-oncology (PCS499 and PCS12852) and oncology (PCS3117, PCS6422 and PCS11T). A summary of each of our five drugs is provided below: ● Our most advanced product candidate, PCS499, is an oral tablet that is a deuterated analog of one of the major metabolites of pentoxifylline (PTX or Trental®). We completed a Phase 2A trial for PCS499 in patients with ulcerative and non-ulcerative necrobiosis lipoidica (NL) in late 2020, and in May 2021 we enrolled the first patient in our Phase 2B trial for the treatment of ulcerative NL. We expect to complete our interim analysis of the Phase 2B trial in the first half of 2022; complete the trial in the second half of 2022; and, depending on the results, begin a pivotal Phase 3 trial in 2023. ● PCS12852 is a highly specific and potent 5HT4 agonist which has already been evaluated in clinical studies in South Korea for gastric emptying and gastrointestinal motility. We are planning on submitting an IND application in the third quarter of 2021 for the treatment of gastroparesis based on our pre-IND communications with the FDA. We anticipate beginning to enroll patients for a Phase 2A trial in the first half of 2022, with expected completion in the first half of 2023. ● PCS3117, which we licensed in June 2021, is a cytosine analog, similar to gemcitabine (Gemzar®) but different enough in chemical structure that some patients are more likely to respond to PCS3117 than gemcitabine. We are developing potential biomarkers to predict which patients are more likely to respond to PCS3117 than gemcitabine and other chemotherapy agents to provide a more targeted, precision medicine approach to the treatment of pancreatic and/or non-small cell lung cancer. Over the next 6-12 months, we will be developing and refining these biomarker assays for use in our clinical trials, which should be completed in the first half of 2022. We anticipate validating our approach and confirming our hypothesis in a planned Phase 2B study expected to start in the second half of 2022 and, depending on the results, conducting a Phase 3 pivotal trial in 2023-2024. ● PCS6422 is an orally administered irreversible enzyme inhibitor administered in combination with capecitabine. On August 2 2021, we enrolled the first patient in our Phase 1B dose-escalation maximum tolerated dose trial in patients with advanced refractory gastrointestinal (GI) tract tumors. We anticipate completing an interim cohort analysis in the fourth quarter of 2021; determine the maximum tolerated dose (MTD) in the second half of 2022; and, depending on the results, begin a pivotal Phase 2B/3 trial in 2023-2024. ● Our only non-clinical asset is PCS11T, an analog of SN38 (SN38 being the active metabolite of irinotecan) and a next generation irinotecan drug for multiple types of cancers. PCS11T is presently in the IND pre-clinical toxicology stage. We hope to submit an IND in the second half of 2022 or first half of 2023, followed by a Phase 1B maximum tolerated dose trial. Impact of COVID-19 The extent of the impact of the COVID-19 pandemic on our business, operations and development timelines and plans remains uncertain, and will depend on certain developments, including the duration of the outbreak and its impact on our development activities, planned clinical trial enrollment, future trial sites, contract research organizations (CROs), third-party manufacturers, and other third parties with whom we do business, as well as its impact on regulatory authorities and our key scientific and management personnel. Although we modified our operations and practices in 2020 due to the COVID-19 pandemic and to comply with federal, state and local requirements, our business, operations and development timelines were not materially adversely affected. However, the extent to which the COVID-19 pandemic may affect our business, operations and development timelines and plans in the future, including the resulting impact on our expenditures and capital needs, remains uncertain. In addition, a recession or market correction resulting from the spread of the coronavirus could materially affect the value of our common stock. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the U.S. Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the SEC. The results of operations for the interim periods shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. Liquidity We have incurred losses since inception, devoting substantially all of our efforts toward research and development, and have an accumulated deficit of approximately $ 30.7 million at June 30, 2021. During the six months ended June 30, 2021, we generated a net loss of approximately $ 5.3 million and we expect to continue to generate operating losses and negative cash flow from operations for the foreseeable future. However, we believe our cash balance at June 30, 2021 is adequate to fund our budgeted operations well into 2023. Our ability to execute our longer-term operating plans, including unplanned future clinical trials for our portfolio of drugs depend on our ability to obtain additional funding from the sale of equity and/or debt securities, a strategic transaction or other funding transactions. We plan to continue to actively pursue financing alternatives, but there can be no assurance that we will obtain the necessary funding in the future when necessary. We had no Use of Estimates In preparing our condensed consolidated financial statements and related disclosures in conformity with U.S. GAAP and pursuant to the rules and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Estimates are used for, but not limited to preclinical and clinical trial expenses, stock-based compensation, intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable, actual results could differ materially from those estimates and could impact future results of operations and cash flows. 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, no Stock-based Compensation Stock-based compensation expense is based on the grant-date fair value estimated in accordance with the provisions of ASC 718, Compensation-Stock Compensation Stock-based compensation awards during the six months ended June 30, 2021 consisted of the following: Stock Based Compensation Awards Employee and Director stock-based compensation $ 956,004 Stock-based compensation paid to consultants for services rendered and to be rendered 427,183 Stock-based compensation paid 1,383,187 Total amount included in prepaid expenses (312,293 ) Less amortization of prepaid expenses 102,728 Total stock-based compensation for the six months ended June 30, 2021 $ 1,173,622 At June 30, 2021, $ 209,565 of stock-based compensation paid to consultants for services is included in our prepaid expense and is being amortized over the contract period of one year as services are expected to be provided. 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 and vested RSUs during the period. Diluted loss per share is computed by dividing our net loss available to common shareholders by the diluted weighted average number of shares of common stock during the period. Since we experienced a net loss for both periods presented, basic and diluted net loss per share are the same. As such, diluted loss per share for the six months ended June 30, 2021 and 2020 excludes the impact of potentially dilutive common shares related to outstanding stock options, unvested restricted stock awards (RSAs), unvested restricted stock units (RSUs) and warrants and, in 2020, the conversion of our 2019 Senior Notes and related party line of credit (LOC) since those shares would have an anti-dilutive effect on loss per share. Our diluted net loss per share for the six months ended June 30, 2021 and 2020 excluded 709,954 and 797,964 , respectively, of potentially dilutive common shares, respectively, related to outstanding stock options, unvested RSAs, unvested RSUs and warrants and, in 2020, the conversion of our Senior Notes and related party LOC since those shares would have had an anti-dilutive effect on loss per share during the periods then ended. Recent Accounting Pronouncements From time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”). We have implemented all new accounting pronouncements that are in effect and that may impact our condensed consolidated financial statements. We have evaluated recently issued accounting pronouncements and determined that there is no material impact on our financial position or results of operations. |
License Agreement with Ocuphire
License Agreement with Ocuphire Pharma, Inc | 6 Months Ended |
Jun. 30, 2021 | |
License Agreement With Ocuphire Pharma Inc | |
License Agreement with Ocuphire Pharma, Inc | Note 2 – License Agreement with Ocuphire Pharma, Inc On June 16, 2021, we executed a License Agreement with Ocuphire Pharma, Inc. (“Ocuphire Agreement”) under which provided us with 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 shares of our common stock to Ocuphire, a cash payment of $ 200,000 and assumed certain liabilities. Additional consideration includes future development and regulatory milestones payments to Ocuphire upon our achievement of certain defined clinical milestones , such as dosing a patient in pivotal trials and receiving marketing authorization by a regulatory authority in the United States or another country. In addition, we are required to pay Ocuphire one-time sales milestone payments based on the achievement during a calendar year of the highest annual Net Sales for products made and pay royalties based on annual Net Sales, as defined in the Ocuphire Agreement. We are required to use commercially reasonable efforts, at our sole cost and expense to oversee such commercialization efforts, to research, develop and commercialize products in one or more countries, including meeting specific diligence milestones that consist of: (i) first patient administered drug in a Clinical Trial of a Product prior to June 16, 2024; and (ii) first patient administered drug in a Pivotal Clinical Trial of a Product or first patient administered drug in a Clinical Trial for a Second Indication of a Product prior to June 16, 2026. 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 |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 3 – Property and Equipment Property and equipment at June 30, 2021 and December 31, 2020 consisted of the following: Schedule of Property and Equipment June 30, 2021 December 31, 2020 Software $ 19,740 $ 19,740 Office equipment 9,327 9,327 Total Cost 29,067 29,067 Less: accumulated depreciation 29,067 28,583 Property and equipment, net $ - $ 484 |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Note 4 – Intangible Assets Intangible assets at June 30, 2021 and December 31, 2020 consisted of the following: Summary of Intangible Assets June 30, 2021 December 31, 2020 Gross intangible assets $ 11,059,429 $ 11,059,429 Less: accumulated amortization (2,609,967 ) (2,212,303 ) Total intangible assets, net $ 8,449,462 $ 8,847,126 Amortization expense was $ 397,664 790,000 788,000 The capitalized costs for the license rights to PCS499 included the $ 8 1,782 3,037,147 1,782 Income Taxes Research and Development |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 5 – Income Taxes We account for income taxes in accordance with ASC Topic 740, Income Taxes. A deferred tax liability was recorded on March 19, 2018 when Processa received CoNCERT’s license and “Know-How” in exchange for Processa stock that had been issued in the 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 Under ACS 740-270 Income Taxes – Interim Reporting |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | Note 6 – Stock-based Compensation We recorded $ 1,173,622 and $ 192,532 of stock-based compensation expense for the six months ended June 30, 2021 and 2020, respectively. During the six months ended June 30, 2021, we awarded the following equity instruments: Equity Instruments Awarded Award Type Number of Shares Awarded Number of Shares Vested Restricted stock awards – employee 37,500 - Restricted stock units – employees 114,551 62,551 Restricted stock units – consultants 17,800 13,300 Stock options – consultant 30,000 7,500 Warrants – consultant 100,000 100,000 We valued the RSAs and RSUs based on the closing share price on the date of grant. The fair values of the stock options and warrants granted were estimated using the Black-Scholes option pricing model at the date of grant. The RSUs, stock options and warrants issued to consultants were for services provided in 2021. Of the awards granted to consultants, 12,500 RSUs and 100,000 warrants vested upon grant but represent services that will be provided over a one-year service period. As such, at June 30, 2021, we recognized $ 209,565 related to these awards as a prepaid expense for the portion of services the consultant has yet to provide. We did not grant any awards during the same period in 2020. At June 30, 2021, we had the following awards outstanding related to stock-based compensation: Stock-based Compensation Awards Outstanding Award Type Amount Outstanding Amount Vested Amount Unvested Restricted stock awards 350,556 190,274 160,282 Restricted stock units 132,351 75,851 56,500 Stock Options 182,806 130,588 52,218 Warrants 100,000 100,000 - The weighted average exercise price of stock options and warrants outstanding at June 30, 2021 was $ 17.06 7.18 310,365 February 16, 2023 210,365 |
Paycheck Protection Program Loa
Paycheck Protection Program Loan | 6 Months Ended |
Jun. 30, 2021 | |
Paycheck Protection Program Loan | |
Paycheck Protection Program Loan | Note 7 – Paycheck Protection Program Loan In May 2020, we entered into a $ 162,459 Paycheck Protection Promissory Note (the “PPP Loan”) with the Bank of America. The PPP Loan was made under, and is subject to the terms and conditions of, the PPP which was established under the CARES Act and is administered by the U.S. Small Business Administration. The current term of the loan is two years with a maturity date of May 5, 2022 , and it contains a favorable fixed annual interest rate of 1.00 %. Payments of principal and interest on the PPP Loan were deferred for the first six months of the term of the PPP Loan until November 5, 2020. Principal and interest are payable monthly and may be prepaid by us at any time prior to maturity with no prepayment penalties. Under the terms of the CARES Act, recipients can apply for and receive forgiveness for all, or a portion, of the loan granted under the PPP. Such forgiveness will be determined, subject to limitations, based on the use of loan proceeds for certain permissible purposes as set forth in the PPP, including, but not limited to, payroll costs, mortgage interest, rent or utility costs, and on the maintenance of employee and compensation levels during a certain time period following the funding of the PPP Loan. We used the entire proceeds of our PPP Loan for payroll costs and applied for full forgiveness on January 18, 2021. On February 11, 2021, Bank of America submitted a decision to the Small Business Administration that the full amount should be forgiven. |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 8 – Stockholders’ Equity During the six months ended June 30, 2021 we granted a total of 17,800 100,000 446,477 209,565 d. We also granted 37,500 On February 24, 2021, we sold in a private placement 1,321,132 10.2 9.9 79,268 9.30 February 24, 2023 On June 16, 2021, we issued 44,689 shares of our common stock to Ocuphire Pharma, Inc. pursuant to the agreement we entered into with them (see Note 2). There were no |
Net Loss per Share of Common St
Net Loss per Share of Common Stock | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss per Share of Common Stock | Note 9 – Net Loss per Share of Common Stock Basic net loss per share is computed by dividing net loss by the weighted average common shares outstanding and vested RSUs. Diluted net loss per share is computed by dividing net loss by the weighted average common shares outstanding, which includes potentially dilutive effect of stock options, unvested RSAs, unvested RSUs, warrants and senior convertible notes. Since we experienced a loss for all periods presented, any dilutive common shares outstanding were excluded from the computation as shown below, as they would have an anti-dilutive impact on diluted net loss per share. The treasury-stock method is used to determine the dilutive effect of our stock options and warrants, and the if-converted method is used to determine the dilutive effect of the Senior Notes. The computation of net loss per share for the three and six months ended June 30, 2021 and 2020 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2021 2020 2021 2020 Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Basic and diluted net loss per share: Net loss $ (3,157,043 ) $ (733,414 ) $ (5,256,523 ) $ (1,607,750 ) Weighted average number of common shares-basic and diluted 15,406,363 5,515,566 14,997,303 5,515,566 Basic and diluted net loss per share $ (0.20 ) $ (0.13 ) $ (0.35 ) $ (0.29 ) The following potentially dilutive securities were excluded from the computation of diluted net loss per share as their effect would have been anti-dilutive for the periods presented. Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share Six months ended June 30, 2021 2020 Stock options, unvested RSAs, unvested RSUs and purchase warrants 709,954 704,003 Senior convertible notes and convertible related party LOC, plus related accrued interest - 93,961 |
Operating Leases
Operating Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Operating Leases | Note 10 – Operating Leases We lease our office space under an operating lease agreement. This lease does not have significant rent escalation, concessions, leasehold improvement incentives, or other build-out clauses. Further, the lease does not contain contingent rent provisions. We also lease office equipment under an operating lease. 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. Our leases do not provide an implicit rate and, as such, we have used our incremental borrowing rate of 8% Lease costs included in our condensed consolidated statements of operations totaled $ 21,801 23,995 45,831 48,201 Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases Weighted average remaining lease term (years) for our facility and equipment leases 1.44 Weighted average discount rate for our facility and equipment leases 8.00 % Maturities of our lease liabilities for all operating leases were as follows as of June 30, 2021: Schedule of Maturities of Lease Liabilities for all Operating Leases 2021 $ 48,777 2022 75,969 2023 6,228 2024 1,557 Total lease payments 132,531 Less: Interest (9,188 ) Present value of lease liabilities 123,343 Less: current maturities (92,447 ) Non-current lease liability $ 30,896 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 11 – Related Party Transactions A shareholder, CorLyst, LLC, reimburses us for shared costs related to payroll, health care insurance and rent based on actual costs incurred, which are recognized as a reduction of our general and administrative operating expenses in our condensed consolidated statement of operations. In September 2020, CorLyst prepaid shared expenses to us for the fourth quarter of 2020 through the July 2021. At June 30, 2021, we recognized $ 11,742 in prepaid reimbursements as due to related parties in the accompanying condensed consolidated balance sheet. At June 30, 2020, we had $ 500,000 No amounts were due from CorLyst at June 30, 2021 and December 31, 2020. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 12 – 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 and complete our clinical trials. 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. We are contractually obligated to pay up to approximately $ 4.1 million of future services under the agreements with the CROs, but our actual contractual obligations will vary depending on the progress and results of the clinical trials. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Business Activities and Organization | Business Activities and Organization We are a clinical-stage biopharmaceutical company focused on the development of drug products that are intended to provide treatment for patients who have a high unmet medical need condition that effects survival or the patient’s quality of life and for which few or no treatment options currently exist. We currently have five drugs: four in various stages of clinical development (PCS499, PCS12852, PCS3117, and PCS6422) and one in nonclinical development (PCS11T). We group our drugs into non-oncology (PCS499 and PCS12852) and oncology (PCS3117, PCS6422 and PCS11T). A summary of each of our five drugs is provided below: ● Our most advanced product candidate, PCS499, is an oral tablet that is a deuterated analog of one of the major metabolites of pentoxifylline (PTX or Trental®). We completed a Phase 2A trial for PCS499 in patients with ulcerative and non-ulcerative necrobiosis lipoidica (NL) in late 2020, and in May 2021 we enrolled the first patient in our Phase 2B trial for the treatment of ulcerative NL. We expect to complete our interim analysis of the Phase 2B trial in the first half of 2022; complete the trial in the second half of 2022; and, depending on the results, begin a pivotal Phase 3 trial in 2023. ● PCS12852 is a highly specific and potent 5HT4 agonist which has already been evaluated in clinical studies in South Korea for gastric emptying and gastrointestinal motility. We are planning on submitting an IND application in the third quarter of 2021 for the treatment of gastroparesis based on our pre-IND communications with the FDA. We anticipate beginning to enroll patients for a Phase 2A trial in the first half of 2022, with expected completion in the first half of 2023. ● PCS3117, which we licensed in June 2021, is a cytosine analog, similar to gemcitabine (Gemzar®) but different enough in chemical structure that some patients are more likely to respond to PCS3117 than gemcitabine. We are developing potential biomarkers to predict which patients are more likely to respond to PCS3117 than gemcitabine and other chemotherapy agents to provide a more targeted, precision medicine approach to the treatment of pancreatic and/or non-small cell lung cancer. Over the next 6-12 months, we will be developing and refining these biomarker assays for use in our clinical trials, which should be completed in the first half of 2022. We anticipate validating our approach and confirming our hypothesis in a planned Phase 2B study expected to start in the second half of 2022 and, depending on the results, conducting a Phase 3 pivotal trial in 2023-2024. ● PCS6422 is an orally administered irreversible enzyme inhibitor administered in combination with capecitabine. On August 2 2021, we enrolled the first patient in our Phase 1B dose-escalation maximum tolerated dose trial in patients with advanced refractory gastrointestinal (GI) tract tumors. We anticipate completing an interim cohort analysis in the fourth quarter of 2021; determine the maximum tolerated dose (MTD) in the second half of 2022; and, depending on the results, begin a pivotal Phase 2B/3 trial in 2023-2024. ● Our only non-clinical asset is PCS11T, an analog of SN38 (SN38 being the active metabolite of irinotecan) and a next generation irinotecan drug for multiple types of cancers. PCS11T is presently in the IND pre-clinical toxicology stage. We hope to submit an IND in the second half of 2022 or first half of 2023, followed by a Phase 1B maximum tolerated dose trial. |
Impact of COVID-19 | Impact of COVID-19 The extent of the impact of the COVID-19 pandemic on our business, operations and development timelines and plans remains uncertain, and will depend on certain developments, including the duration of the outbreak and its impact on our development activities, planned clinical trial enrollment, future trial sites, contract research organizations (CROs), third-party manufacturers, and other third parties with whom we do business, as well as its impact on regulatory authorities and our key scientific and management personnel. Although we modified our operations and practices in 2020 due to the COVID-19 pandemic and to comply with federal, state and local requirements, our business, operations and development timelines were not materially adversely affected. However, the extent to which the COVID-19 pandemic may affect our business, operations and development timelines and plans in the future, including the resulting impact on our expenditures and capital needs, remains uncertain. In addition, a recession or market correction resulting from the spread of the coronavirus could materially affect the value of our common stock. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the U.S. Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the SEC. The results of operations for the interim periods shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. |
Liquidity | Liquidity We have incurred losses since inception, devoting substantially all of our efforts toward research and development, and have an accumulated deficit of approximately $ 30.7 million at June 30, 2021. During the six months ended June 30, 2021, we generated a net loss of approximately $ 5.3 million and we expect to continue to generate operating losses and negative cash flow from operations for the foreseeable future. However, we believe our cash balance at June 30, 2021 is adequate to fund our budgeted operations well into 2023. Our ability to execute our longer-term operating plans, including unplanned future clinical trials for our portfolio of drugs depend on our ability to obtain additional funding from the sale of equity and/or debt securities, a strategic transaction or other funding transactions. We plan to continue to actively pursue financing alternatives, but there can be no assurance that we will obtain the necessary funding in the future when necessary. We had no |
Use of Estimates | Use of Estimates In preparing our condensed consolidated financial statements and related disclosures in conformity with U.S. GAAP and pursuant to the rules and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Estimates are used for, but not limited to preclinical and clinical trial expenses, stock-based compensation, intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable, actual results could differ materially from those estimates and could impact future results of operations and cash flows. |
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, no |
Stock-based Compensation | Stock-based Compensation Stock-based compensation expense is based on the grant-date fair value estimated in accordance with the provisions of ASC 718, Compensation-Stock Compensation Stock-based compensation awards during the six months ended June 30, 2021 consisted of the following: Stock Based Compensation Awards Employee and Director stock-based compensation $ 956,004 Stock-based compensation paid to consultants for services rendered and to be rendered 427,183 Stock-based compensation paid 1,383,187 Total amount included in prepaid expenses (312,293 ) Less amortization of prepaid expenses 102,728 Total stock-based compensation for the six months ended June 30, 2021 $ 1,173,622 At June 30, 2021, $ 209,565 of stock-based compensation paid to consultants for services is included in our prepaid expense and is being amortized over the contract period of one year as services are expected to be provided. |
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 and vested RSUs during the period. Diluted loss per share is computed by dividing our net loss available to common shareholders by the diluted weighted average number of shares of common stock during the period. Since we experienced a net loss for both periods presented, basic and diluted net loss per share are the same. As such, diluted loss per share for the six months ended June 30, 2021 and 2020 excludes the impact of potentially dilutive common shares related to outstanding stock options, unvested restricted stock awards (RSAs), unvested restricted stock units (RSUs) and warrants and, in 2020, the conversion of our 2019 Senior Notes and related party line of credit (LOC) since those shares would have an anti-dilutive effect on loss per share. Our diluted net loss per share for the six months ended June 30, 2021 and 2020 excluded 709,954 and 797,964 , respectively, of potentially dilutive common shares, respectively, related to outstanding stock options, unvested RSAs, unvested RSUs and warrants and, in 2020, the conversion of our Senior Notes and related party LOC since those shares would have had an anti-dilutive effect on loss per share during the periods then ended. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”). We have implemented all new accounting pronouncements that are in effect and that may impact our condensed consolidated financial statements. We have evaluated recently issued accounting pronouncements and determined that there is no material impact on our financial position or results of operations. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Stock Based Compensation Awards | Stock-based compensation awards during the six months ended June 30, 2021 consisted of the following: Stock Based Compensation Awards Employee and Director stock-based compensation $ 956,004 Stock-based compensation paid to consultants for services rendered and to be rendered 427,183 Stock-based compensation paid 1,383,187 Total amount included in prepaid expenses (312,293 ) Less amortization of prepaid expenses 102,728 Total stock-based compensation for the six months ended June 30, 2021 $ 1,173,622 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment at June 30, 2021 and December 31, 2020 consisted of the following: Schedule of Property and Equipment June 30, 2021 December 31, 2020 Software $ 19,740 $ 19,740 Office equipment 9,327 9,327 Total Cost 29,067 29,067 Less: accumulated depreciation 29,067 28,583 Property and equipment, net $ - $ 484 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Intangible Assets | Intangible assets at June 30, 2021 and December 31, 2020 consisted of the following: Summary of Intangible Assets June 30, 2021 December 31, 2020 Gross intangible assets $ 11,059,429 $ 11,059,429 Less: accumulated amortization (2,609,967 ) (2,212,303 ) Total intangible assets, net $ 8,449,462 $ 8,847,126 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Equity Instruments Awarded | Equity Instruments Awarded Award Type Number of Shares Awarded Number of Shares Vested Restricted stock awards – employee 37,500 - Restricted stock units – employees 114,551 62,551 Restricted stock units – consultants 17,800 13,300 Stock options – consultant 30,000 7,500 Warrants – consultant 100,000 100,000 |
Stock-based Compensation Awards Outstanding | At June 30, 2021, we had the following awards outstanding related to stock-based compensation: Stock-based Compensation Awards Outstanding Award Type Amount Outstanding Amount Vested Amount Unvested Restricted stock awards 350,556 190,274 160,282 Restricted stock units 132,351 75,851 56,500 Stock Options 182,806 130,588 52,218 Warrants 100,000 100,000 - |
Net Loss per Share of Common _2
Net Loss per Share of Common Stock (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share Basic and Diluted | The computation of net loss per share for the three and six months ended June 30, 2021 and 2020 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2021 2020 2021 2020 Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Basic and diluted net loss per share: Net loss $ (3,157,043 ) $ (733,414 ) $ (5,256,523 ) $ (1,607,750 ) Weighted average number of common shares-basic and diluted 15,406,363 5,515,566 14,997,303 5,515,566 Basic and diluted net loss per share $ (0.20 ) $ (0.13 ) $ (0.35 ) $ (0.29 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share Six months ended June 30, 2021 2020 Stock options, unvested RSAs, unvested RSUs and purchase warrants 709,954 704,003 Senior convertible notes and convertible related party LOC, plus related accrued interest - 93,961 |
Operating Leases (Tables)
Operating Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
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 Weighted average remaining lease term (years) for our facility and equipment leases 1.44 Weighted average discount rate for our facility and equipment leases 8.00 % |
Schedule of Maturities of Lease Liabilities for all Operating Leases | Maturities of our lease liabilities for all operating leases were as follows as of June 30, 2021: Schedule of Maturities of Lease Liabilities for all Operating Leases 2021 $ 48,777 2022 75,969 2023 6,228 2024 1,557 Total lease payments 132,531 Less: Interest (9,188 ) Present value of lease liabilities 123,343 Less: current maturities (92,447 ) Non-current lease liability $ 30,896 |
Stock Based Compensation Awards
Stock Based Compensation Awards (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Accounting Policies [Abstract] | ||
Employee and Director stock-based compensation | $ 956,004 | |
Stock-based compensation paid to consultants for services rendered and to be rendered | 427,183 | |
Stock-based compensation paid | 1,383,187 | |
Total amount included in prepaid expenses | (312,293) | |
Less amortization of prepaid expenses | 102,728 | |
Total stock-based compensation for the six months ended June 30, 2021 | $ 1,173,622 | $ 192,532 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | |||||||
Retained Earnings (Accumulated Deficit) | $ 30,652,321 | $ 30,652,321 | $ 25,395,798 | ||||
Net Income (Loss) Attributable to Parent | $ 3,157,043 | $ 2,099,480 | $ 733,414 | $ 874,336 | 5,256,523 | $ 1,607,750 | |
Revenue | 0 | ||||||
Impairment loss of long-lived assets and intangibles other than goodwill | 0 | $ 0 | |||||
Share-based Payment Arrangement, Expense | $ (312,293) | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 709,954 | 797,964 | |||||
Consultants [Member] | |||||||
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | |||||||
Share-based Payment Arrangement, Expense | $ 209,565 |
License Agreement with Ocuphi_2
License Agreement with Ocuphire Pharma, Inc (Details Narrative) - License Agreement [Member] - Ocuphire Pharma Inc [Member] | Jun. 16, 2021USD ($)shares |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Stock Issued During Period, Shares, New Issues | shares | 44,689 |
Cash paid under license agreement | $ | $ 200,000 |
Milestone payments, description | Additional consideration includes future development and regulatory milestones payments to Ocuphire upon our achievement of certain defined clinical milestones |
Performance of milestone conditions, description | 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 |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Total Cost | $ 29,067 | $ 29,067 |
Less: accumulated depreciation | 29,067 | 28,583 |
Property and equipment, net | 484 | |
Software Development [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total Cost | 19,740 | 19,740 |
Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total Cost | $ 9,327 | $ 9,327 |
Summary of Intangible Assets (D
Summary of Intangible Assets (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Gross intangible assets | $ 11,059,429 | $ 11,059,429 |
Less: accumulated amortization | (2,609,967) | (2,212,303) |
Total intangible assets, net | $ 8,449,462 | $ 8,847,126 |
Intangible Assets (Details Narr
Intangible Assets (Details Narrative) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Finite-Lived Intangible Assets [Line Items] | ||
Amortization expense | $ 397,664 | $ 397,664 |
Future amortization expense | 790,000 | |
Future amortization expense, annual periods thereafter | 788,000 | |
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 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - CoNCERT Pharmaceuticals, Inc [Member] - License Rights [Member] | Mar. 19, 2018USD ($) |
Entity Listings [Line Items] | |
Deferred tax liability | $ 3,037,147 |
Intangible assets, financial reporting basis | 11,038,929 |
Intangible assets, tax basis | $ 1,782 |
Equity Instruments Awarded (Det
Equity Instruments Awarded (Details) | 6 Months Ended |
Jun. 30, 2021shares | |
Equity Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares vested | 130,588 |
Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares vested | 75,851 |
Employees [Member] | Restricted Stock [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares awarded | 37,500 |
Number of shares vested | |
Employees [Member] | Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares awarded | 114,551 |
Number of shares vested | 62,551 |
Consultants [Member] | Warrant [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares awarded | 100,000 |
Number of shares vested | 100,000 |
Consultants [Member] | Equity Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares awarded | 30,000 |
Number of shares vested | 7,500 |
Consultants [Member] | Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares awarded | 17,800 |
Number of shares vested | 13,300 |
Stock-based Compensation Awards
Stock-based Compensation Awards Outstanding (Details) | 6 Months Ended |
Jun. 30, 2021shares | |
Warrant [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of warrants outstanding | 100,000 |
Number of warrants vested | 100,000 |
Number of warrants unvested | |
Equity Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of stock options outstanding | 182,806 |
Number of stock options vested | 130,588 |
Number of stock options unvested | 52,218 |
Restricted Stock Awards [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of restricted stock outstanding | 350,556 |
Number of restricted stock vested | 190,274 |
Number of restricted stock unvested | 160,282 |
Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of restricted stock outstanding | 132,351 |
Number of restricted stock vested | 75,851 |
Number of restricted stock unvested | 56,500 |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Payment Arrangement, Noncash Expense | $ 1,173,622 | $ 192,532 |
Allocated share based compensation expense | $ (312,293) | |
Weighted average exercise price of stock price | $ 17.06 | |
Weighted average exercise price of warrants | $ 7.18 | |
Number of warrants | 310,365 | |
Warrants maturity date | Feb. 16, 2023 | |
PIPE Transactions [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of warrants | 210,365 | |
Warrant [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of warrants vested | 100,000 | |
Restricted Stock Units (RSUs) [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of restricted stock vested | 75,851 | |
Consultant [Member] | Restricted Stock Units (RSUs) [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of restricted stock vested | 12,500 | |
Consultants [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share based compensation expense | $ 209,565 | |
Consultants [Member] | Warrant [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of warrants vested | 100,000 | |
Consultants [Member] | Restricted Stock Units (RSUs) [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of restricted stock vested | 13,300 |
Paycheck Protection Program L_2
Paycheck Protection Program Loan (Details Narrative) - Paycheck Protection Program [Member] | 1 Months Ended |
May 31, 2020USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Proceeds from Loans | $ 162,459 |
Debt Instrument, Maturity Date | May 5, 2022 |
Debt Instrument, Interest Rate, Stated Percentage | 1.00% |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | Jun. 16, 2021 | Feb. 24, 2021 | Mar. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 |
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | ||||||
Number of common stock granted | 17,800 | |||||
Number of warrant issued | 100,000 | |||||
Value of common stock issued during period | $ 9,875,550 | $ 446,477 | ||||
Prepaid expenses | 209,565 | |||||
Proceeds from issuance of private placement | $ 9,875,550 | |||||
Warrants exercisable | $ 7.18 | |||||
Warrants expire date | Feb. 16, 2023 | |||||
Preferred Stock, Shares Outstanding | 0 | 0 | ||||
Private Placement [Member] | ||||||
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | ||||||
Value of common stock issued during period | $ 10,200,000 | |||||
Stock Issued During Period, Shares, New Issues | 1,321,132 | |||||
Proceeds from issuance of private placement | $ 9,900,000 | |||||
License Agreement [Member] | Ocuphire Pharma Inc [Member] | ||||||
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 44,689 | |||||
Employees [Member] | Restricted Stock [Member] | ||||||
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | ||||||
Number of restricted shares granted | 37,500 | |||||
Placement Agent [Member] | Private Placement [Member] | ||||||
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | ||||||
Number of warrant issued | 79,268 | |||||
Warrants exercisable | $ 9.30 | |||||
Warrants expire date | Feb. 24, 2023 |
Schedule of Net Loss Per Share
Schedule of Net Loss Per Share Basic and Diluted (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Earnings Per Share [Abstract] | ||||||
Net loss | $ (3,157,043) | $ (2,099,480) | $ (733,414) | $ (874,336) | $ (5,256,523) | $ (1,607,750) |
Weighted average number of common shares-basic and diluted | 15,406,363 | 5,515,566 | 14,997,303 | 5,515,566 | ||
Basic and diluted net loss per share | $ (0.20) | $ (0.13) | $ (0.35) | $ (0.29) |
Schedule of Antidilutive Securi
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 709,954 | 797,964 |
Stock Options and Purchase Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 709,954 | 704,003 |
Senior Convertible Notes and Convertible Related-Party Line of Credit [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 93,961 |
Schedule of Weighted Average Re
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases (Details) | Jun. 30, 2021 |
Leases [Abstract] | |
Weighted average remaining lease term (years) for our facility and equipment leases | 1 year 5 months 8 days |
Weighted average discount rate for our facility and equipment leases | 8.00% |
Schedule of Maturities of Lease
Schedule of Maturities of Lease Liabilities for all Operating Leases (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2021 | $ 48,777 | |
2022 | 75,969 | |
2023 | 6,228 | |
2024 | 1,557 | |
Total lease payments | 132,531 | |
Less: Interest | (9,188) | |
Present value of lease liabilities | 123,343 | |
Less: current maturities | (92,447) | $ (87,200) |
Non-current lease liability | $ 30,896 | $ 78,463 |
Operating Leases (Details Narra
Operating Leases (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Leases [Abstract] | ||||
Operating leases incremental borrowing rate | 8.00% | 8.00% | ||
Lease costs | $ 21,801 | $ 23,995 | $ 45,831 | $ 48,201 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Entity Listings [Line Items] | ||
Due to related parties | $ 11,742 | $ 69,858 |
Amount due from related parties | 154,730 | |
Senior Convertible Notes and Convertible Related-Party Line of Credit [Member] | ||
Entity Listings [Line Items] | ||
Outstanding amount | 500,000 | |
CorLyst, LLC [Member] | ||
Entity Listings [Line Items] | ||
Due to related parties | 11,742 | |
Amount due from related parties | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) $ in Millions | Jun. 30, 2021USD ($) |
Agreements [Member] | Contract Research Organizations [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Purchase Obligation | $ 4.1 |