Document and Entity Information
Document and Entity Information | 6 Months Ended |
Jun. 30, 2020 | |
Cover [Abstract] | |
Entity Registrant Name | Processa Pharmaceuticals, Inc. |
Entity Central Index Key | 0001533743 |
Document Type | S-1/A |
Amendment Flag | true |
Amendment Description | Amendment No. 3 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business Flag | true |
Entity Emerging Growth Company | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Current Assets | |||
Cash and cash equivalents | $ 452,654 | $ 691,536 | $ 1,740,961 |
Due from related party | 26,497 | 21,583 | |
Prepaid expenses and other | 97,682 | 315,605 | 257,832 |
Total Current Assets | 576,833 | 1,007,141 | 2,020,376 |
Property and Equipment | |||
Software | 19,740 | 19,740 | |
Office equipment | 9,327 | 9,327 | |
Total Cost | 29,067 | 29,067 | |
Less: accumulated depreciation | 20,137 | 11,692 | |
Property and equipment, net | 4,707 | 8,930 | 17,375 |
Other Assets | |||
Operating lease right-of-use assets, net of accumulated amortization | 179,591 | 219,074 | |
Intangible assets, net of accumulated amortization | 9,244,790 | 9,642,454 | 10,437,782 |
Security deposit | 5,535 | 5,535 | 5,535 |
Total Other Assets | 9,429,916 | 9,867,063 | 10,443,317 |
Total Assets | 10,011,456 | 10,883,134 | 12,481,068 |
Current Liabilities | |||
Senior convertible notes, net of debt issuance costs | 804,643 | 802,503 | 230,000 |
Line of credit payable - related party | 500,000 | ||
Note payable - Paycheck Protection Program, current portion | 72,203 | ||
Current maturities of operating lease liability | 71,967 | 77,992 | |
Accrued interest | 58,483 | 21,902 | 20,343 |
Accounts payable | 73,371 | 75,612 | 292,102 |
Due to related parties | 316 | ||
Accrued expenses | 317,252 | 213,239 | 103,259 |
Total Current Liabilities | 1,897,919 | 1,191,564 | 645,704 |
Non-current Liabilities | |||
Note payable - Paycheck Protection Program | 90,256 | ||
Non-current operating lease liability | 114,595 | 147,390 | |
Net deferred tax liability | 1,315,666 | 1,531,630 | 2,134,346 |
Total Liabilities | 3,418,436 | 2,870,584 | 2,780,050 |
Commitments and Contingencies | |||
Stockholders' Equity | |||
Common stock, par value $0.0001, 30,000,000 ,100,000,000 and 350,000,000 shares authorized; 5,514,447, 5,486,476 and 5,525,009 issued and outstading at June 30, 2020, December 31, 2019 and December 31, 2018, respectively | 552 | 549 | 552 |
Additional paid-in capital | 19,182,228 | 18,994,008 | 19,124,600 |
Common stock deemed dividend payable: 28,971 shares at par value | 3 | ||
Stock subscription receivable | (1,800,000) | ||
Accumulated deficit | (12,589,760) | (10,982,010) | (7,624,134) |
Total Stockholders' Equity | 6,593,020 | 8,012,550 | 9,701,018 |
Total Liabilities and Stockholders' Equity | $ 10,011,456 | $ 10,883,134 | $ 12,481,068 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | |||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 30,000,000 | 100,000,000 | |
Common stock, shares issued | 5,514,447 | 5,486,476 | 5,525,009 |
Common stock, shares outstanding | 5,514,447 | 5,486,476 | 5,525,009 |
Common stock, shares deemed dividend payable | 28,971 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating Expenses | ||||||
Research and development expenses | $ 427,109 | $ 726,904 | $ 928,855 | $ 1,211,655 | $ 2,320,573 | $ 3,085,317 |
General and administrative expenses | 374,878 | 410,072 | 859,255 | 807,837 | 1,614,909 | 1,439,623 |
Total operating expenses | 801,987 | 1,136,976 | 1,788,110 | 2,019,492 | ||
Operating Loss | (801,987) | (1,136,976) | (1,788,110) | (2,019,492) | (3,935,482) | (4,524,940) |
Other Income (Expense) | ||||||
Interest expense | (19,280) | (6,102) | (36,450) | (10,702) | (36,658) | (161,205) |
Interest income | 18 | 3,398 | 846 | 9,383 | 11,548 | 18,297 |
Total other income (expense) | (19,262) | (2,704) | (35,604) | (1,319) | ||
Net Operating Loss Before Income Tax Benefit | (821,249) | (1,139,680) | (1,823,714) | (2,020,811) | (3,960,592) | (4,667,848) |
Income Tax Benefit | 87,835 | 170,602 | 215,964 | 300,901 | 602,716 | 902,801 |
Net Loss | $ (733,414) | $ (969,078) | $ (1,607,750) | $ (1,719,910) | $ (3,357,876) | $ (3,765,047) |
Net Loss per Common Stock - Basic and Diluted | $ (0.13) | $ (0.18) | $ (0.29) | $ (0.31) | $ (0.70) | $ (0.71) |
Weighted Average Common Stock Used to Compute Net Loss Applicable to Common Stock - Basic and Diluted | 5,515,447 | 5,525,009 | 5,515,447 | 5,525,009 | 5,525,635 | 5,332,141 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-In Capital [Member] | Subscription Receivable [Member] | Common Stock Dividend Payable [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 504 | $ 4,231,746 | $ (3,859,087) | $ 373,163 | ||
Balance, shares at Dec. 31, 2017 | 5,039,033 | |||||
Recognize the fair value of exclusive license intangible asset acquired from CoNCERT in exchange for 298,615 common stock of Processa held by Promet | 8,000,000 | 8,000,000 | ||||
Conversion of Senior convertible notes and accrued interest for common stock and stock purchase warrants | $ 17 | 2,312,592 | 2,312,609 | |||
Conversion of Senior convertible notes and accrued interest for common stock and stock purchase warrants, shares | 172,327 | |||||
Issuance of common stock units for cash, net of costs of $308,830 | $ 20 | 2,874,667 | 2,874,687 | |||
Issuance of common stock units for cash, net of costs of $308,830, shares | 200,369 | |||||
Issuance of common stock units for a future research funding commitment, net of costs of $168,457 | $ 11 | 1,631,532 | (1,800,000) | (168,457) | ||
Issuance of common stock units for a future research funding commitment, net of costs of $168,457, shares | 113,280 | |||||
Stock-based compensation | 74,063 | 74,063 | ||||
Net loss | (3,765,047) | (3,765,047) | ||||
Balance at Dec. 31, 2018 | $ 552 | 19,124,600 | (1,800,000) | (7,624,134) | 9,701,018 | |
Balance, shares at Dec. 31, 2018 | 5,525,009 | |||||
Stock-based compensation | 58,559 | 58,559 | ||||
Payments made directly by investor for clinical trial costs | 115,000 | 115,000 | ||||
Net loss | (750,832) | (750,832) | ||||
Balance at Mar. 31, 2019 | $ 552 | 19,183,159 | (1,685,000) | (8,374,966) | 9,123,745 | |
Balance, shares at Mar. 31, 2019 | 5,525,009 | |||||
Balance at Dec. 31, 2018 | $ 552 | 19,124,600 | (1,800,000) | (7,624,134) | 9,701,018 | |
Balance, shares at Dec. 31, 2018 | 5,525,009 | |||||
Net loss | (1,719,910) | |||||
Balance at Jun. 30, 2019 | $ 552 | 19,249,635 | (1,404,073) | (9,344,044) | 8,502,070 | |
Balance, shares at Jun. 30, 2019 | 5,525,009 | |||||
Balance at Dec. 31, 2018 | $ 552 | 19,124,600 | (1,800,000) | (7,624,134) | 9,701,018 | |
Balance, shares at Dec. 31, 2018 | 5,525,009 | |||||
Conversion of Senior convertible notes and accrued interest for common stock and stock purchase warrants | $ 2 | 258,928 | 258,930 | |||
Conversion of Senior convertible notes and accrued interest for common stock and stock purchase warrants, shares | 18,107 | |||||
Stock-based compensation | 510,478 | 510,478 | ||||
Payments made directly by investor for clinical trial costs | 900,000 | 900,000 | ||||
Pledged shares of common stock forfeited upon revised research funding commitment | $ (5) | (899,995) | 900,000 | |||
Pledged shares of common stock forfeited upon revised research funding commitment, shares | (56,640) | |||||
Deemed stock dividend due to full ratchet anti-dilution adjustment | (3) | 3 | ||||
Net loss | (3,357,876) | (3,357,876) | ||||
Balance at Dec. 31, 2019 | $ 549 | 18,994,008 | 3 | (10,982,010) | 8,012,550 | |
Balance, shares at Dec. 31, 2019 | 5,486,476 | |||||
Balance at Mar. 31, 2019 | $ 552 | 19,183,159 | (1,685,000) | (8,374,966) | 9,123,745 | |
Balance, shares at Mar. 31, 2019 | 5,525,009 | |||||
Stock-based compensation | 66,476 | 66,476 | ||||
Payments made directly by investor for clinical trial costs | 280,927 | 280,927 | ||||
Net loss | (969,078) | (969,078) | ||||
Balance at Jun. 30, 2019 | $ 552 | 19,249,635 | (1,404,073) | (9,344,044) | 8,502,070 | |
Balance, shares at Jun. 30, 2019 | 5,525,009 | |||||
Balance at Dec. 31, 2019 | $ 549 | 18,994,008 | 3 | (10,982,010) | 8,012,550 | |
Balance, shares at Dec. 31, 2019 | 5,486,476 | |||||
Stock-based compensation | 98,663 | 98,663 | ||||
Transaction costs related to anticipated 2020 offering | (2,806) | (2,806) | ||||
Net loss | (874,336) | (874,336) | ||||
Balance at Mar. 31, 2020 | $ 549 | 19,089,865 | 3 | (11,856,346) | 7,234,071 | |
Balance, shares at Mar. 31, 2020 | 5,486,476 | |||||
Balance at Dec. 31, 2019 | $ 549 | 18,994,008 | 3 | (10,982,010) | 8,012,550 | |
Balance, shares at Dec. 31, 2019 | 5,486,476 | |||||
Net loss | (1,607,750) | |||||
Balance at Jun. 30, 2020 | $ 552 | 19,182,228 | (12,589,760) | 6,593,020 | ||
Balance, shares at Jun. 30, 2020 | 5,515,447 | |||||
Balance at Mar. 31, 2020 | $ 549 | 19,089,865 | 3 | (11,856,346) | 7,234,071 | |
Balance, shares at Mar. 31, 2020 | 5,486,476 | |||||
Stock-based compensation | 93,869 | 93,869 | ||||
Transaction costs related to anticipated 2020 offering | (1,506) | (1,506) | ||||
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 | |||||
Net loss | (733,414) | (733,414) | ||||
Balance at Jun. 30, 2020 | $ 552 | $ 19,182,228 | $ (12,589,760) | $ 6,593,020 | ||
Balance, shares at Jun. 30, 2020 | 5,515,447 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) | 12 Months Ended |
Dec. 31, 2018USD ($)shares | |
Statement of Stockholders' Equity [Abstract] | |
Common stock, shares exchanged | shares | 298,615 |
Conversion of senior convertible notes, costs | $ 82,502 |
Issuance of common stock units for cash, cost | 308,830 |
Issuance of common stock units for a future research funding commitment, cost | $ 168,457 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash Flows From Operating Activities | ||||
Net loss | $ (1,607,750) | $ (1,719,910) | $ (3,357,876) | $ (3,765,047) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation | 4,223 | 4,223 | 8,445 | 8,445 |
Non-cash lease expense for right-of-use assets | 39,483 | 36,282 | 74,124 | |
Amortization of debt issuance costs | 2,140 | 1,783 | 67,069 | |
Amortization of intangible asset | 397,664 | 397,664 | 795,328 | 621,647 |
Deferred income tax (benefit) expense | (215,964) | (300,901) | (602,716) | (902,801) |
Stock-based compensation | 192,532 | 125,035 | 510,478 | 74,063 |
Net changes in operating assets and liabilities: | ||||
Prepaid expenses and other | 217,923 | (10,090) | (57,773) | (216,386) |
Operating lease liability | (38,820) | (38,940) | (77,779) | |
Accrued interest | 36,581 | 8,587 | 30,489 | 94,122 |
Accounts payable | (2,241) | (148,751) | (216,490) | 241,416 |
Due (from) to related parties | (26,813) | 22,919 | 21,899 | 40,690 |
Accrued expenses | 104,013 | 208,979 | 119,943 | 28,868 |
Net cash used in operating activities | (897,029) | (1,414,903) | (2,750,145) | (3,707,914) |
Cash Flows From Investing Activities | ||||
Purchase of software license | (20,500) | |||
Purchase of intangible asset | (1,782) | |||
Net cash (used in) investing activities | (22,282) | |||
Cash Flows From Financing Activities | ||||
Net proceeds from issuance of stock | 2,874,687 | |||
Proceeds from issuance of senior convertible notes | ||||
Proceeds received in satisfaction of stock subscription receivable | 395,927 | 900,000 | ||
Borrowings on line of credit payable from related party | 500,000 | |||
Proceeds received from our Paycheck Protection Program note payable | 162,459 | |||
Transaction costs related to anticipated 2020 offering | (4,312) | |||
Transaction costs incurred on senior convertible notes | (4,280) | (82,502) | ||
Payment of placement agent and legal fees associated with clinical funding commitment | (168,457) | |||
Net cash (used in) provided by financing activities | 658,147 | 395,927 | 1,700,720 | 2,623,728 |
Net Decrease in Cash | (238,882) | (1,018,976) | (1,049,425) | (1,106,468) |
Cash and Cash Equivalents - Beginning of Period | 691,536 | 1,740,961 | 1,740,961 | 2,847,429 |
Cash and Cash Equivalents - End of Period | 452,654 | 721,985 | 691,536 | 1,740,961 |
Supplemental Cash Flow Information: | ||||
Cash paid for interest | ||||
Cash paid for income taxes | ||||
Non-Cash Investing and Financing Activities | ||||
Right-of-use asset obtained in exchange for operating lease liability | (293,198) | (293,198) | ||
Reduction in deferred lease liability | (9,963) | (9,963) | ||
Operating lease liability | 303,161 | 303,161 | ||
Net | ||||
Issuance of 28,971 shares of common stock due to triggering, in December 2019, the full ratchet anti-dilution provision of common stock sold in our 2018 Private Placement Transactions | $ 3 | |||
Recognize the exclusive license intangible asset acquired from CoNCERT | (11,037,147) | |||
Recognize deferred tax liability for basis difference of Intangible asset | 3,037,147 | |||
Recognize additional paid-in capital for consideration paid from the transfer of 298,615 common stock of Processa released by Promet to CoNCERT for Processa | 8,000,000 | |||
Cash paid for intangible asset acquired from CoNCERT | ||||
Conversion of $230,000 and $2,350,000, respectively, of Senior Convertible Debt and related accrued interest of $28,930 and $114,333, respectively, into 18,107 and 172,327 shares, respectively, of common stock and warrants | 258,930 | 2,464,333 | ||
Common stock and stock purchase warrants (forfeited)/issued in connection with a clinical trial funding commitment | $ (900,000) | $ 1,800,000 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Statement of Cash Flows [Abstract] | ||
Common stock, shares transferred | 298,615 | |
Conversion of senior convertible debt, value | $ 230,000 | $ 2,350,000 |
Accrued interest | $ 28,930 | $ 114,333 |
Accrued interest converted into shares of common stock and warrants | 18,107 | 172,327 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | Note 1 – Organization and Summary of Significant Accounting Policies Business Activities and Organization Processa is a clinical stage biopharmaceutical company focused on the development of drug products that are intended to improve the survival and/or quality of life for patients who have a high unmet medical need condition. Within this group of pharmaceutical products, we currently are developing one product for multiple indications (i.e., the use of a drug to treat a particular disease) and will begin developing our newly acquired drugs (PCS11T and PCS100) once adequate funding has been obtained. We continue searching for additional products for our portfolio that meet our criteria. PCS499 Our lead product, PCS499, is an oral tablet that is a deuterated analog of one of the major metabolites of pentoxifylline (PTX or Trental ® The degeneration of tissue occurring at the NL lesion site may be caused by a number of pathophysiological changes which has made it extremely difficult to develop effective treatments for this condition. PCS499 may provide a solution since PCS499 and its metabolites affect a number of the biological pathways which could contribute to the pathophysiology associated with NL. On June 18, 2018, the FDA granted orphan-drug designation for PCS499 for the treatment of NL. On September 28, 2018, the IND for PCS499 in NL was made effective by the FDA, such that we could move forward with a Phase 2A trial multicenter, open-label prospective trial designed to determine the safety and tolerability of PCS499 in patients with NL. The first enrolled NL patient in this Phase 2A clinical trial was dosed on January 29, 2019 and the study completed enrollment on August 23, 2019. The main objective of the trial was to evaluate the safety and tolerability of PCS499 in patients with NL and to use the collected safety and efficacy data to design future clinical trials. Based on toxicology studies and healthy human volunteer studies, Processa and the FDA agreed that a PCS499 dose of 1.8 grams/day would be the highest dose administered to NL patients in this Phase 2A trial. As anticipated, the PCS499 dose of 1.8 grams/day, 50% greater than the maximum tolerated dose of PTX, appeared to be well tolerated with no serious adverse events reported. All adverse events reported in the study were mild in severity. As expected, gastrointestinal symptoms were the most noted adverse events and reported in four patients, all of which were mild in severity and resolved within 1-2 weeks of starting dosing. Two patients presenting with more severe ulcerated NL had ulcers for more than two months prior to dosing. At baseline, the reference ulcer in one of the two patients measured 3.5 cm 2 2 On March 25, 2020, we met with the FDA and discussed the clinical program, as well as the nonclinical and clinical pharmacology plans to support the submission of the PCS499 New Drug Application (NDA) in the U.S. for the treatment of ulcers in NL patients. With input from the FDA we will be designing the next trial as a randomized, placebo-controlled trial to evaluate the ability of PCS499 to completely close ulcers in patients with NL. We initially planned to begin recruiting for the randomized, placebo-controlled trial in the fourth quarter 2020, but we now expect to begin recruiting patients in 20201 due to the ongoing COVID-19 pandemic. This PCS499 NL study will be a randomized, placebo-controlled Phase 2B study to better understand the potential response of NL patients on drug and on placebo. After obtaining the results from this Phase 2B study, we expect to meet with FDA to discuss our Phase 2B drug and placebo response findings while further discussing the next steps to obtain approval. PCS11T On May 24, 2020, we entered into a condition precedent License Agreement (the “Aposense Agreement”) with Aposense, Ltd., (“Aposense”), pursuant to which we were granted a contingent license in Aposense’s patent rights and know-how to develop and commercialize their next generation irinotecan cancer drug, PCS11T (formerly known as ATT-11T). Granting of the license is conditioned on the following being satisfied within 9 months of May 24, 2020 (or the Aposense 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 Agreement. PCS11T is a novel lipophilic anti-cancer pro-drug that is being developed for the treatment of the same solid tumors as prescribed for irinotecan. This pro-drug is a conjugate of a specific proprietary Aposense molecule connected to SN-38, the active metabolite of irinotecan. The proprietary molecule in PCS11T has been designed to allow PCS11T to bind to cell membranes to form an inactive pro-drug depot on the cell with SN-38 preferentially accumulating in the membrane of tumors cells and the tumor core. This unique characteristic is expected to make the therapeutic window of PCS11T wider than all other irinotecan products such that the antitumor effect of PCS11T will occur at a much lower dose with a milder adverse effect profile than irinotecan. Irinotecan serves as a water-soluble pro-drug of SN-38, with SN-38 being significantly more potent as a topoisomerase I inhibitor than irinotecan. Despite the widespread use of commercially marketed irinotecan products in the treatment of metastatic colorectal cancer and other cancers resulting in peak annual sales of approximately $1.1 billion, irinotecan has a narrow therapeutic window and includes an FDA “Black Box” warning for both neutropenia and severe diarrhea. Its adverse effects include diarrhea, neutropenia, leucopenia, lymphocytopenia, and anemia, which are major impediments to optimal dosing for efficacy since the dose must often be reduced with repeated treatment cycles. There is, therefore, a substantial unmet need to overcome the limitations of the current commercially marketed irinotecan products, improving efficacy and reducing the severity of treatment emergent adverse events. The potential wider therapeutic window of PCS11T will likely lead to more patients responding with less side effects when on PCS11T compared to other irinotecan products. Pre-clinical studies conducted to date showed that that PCS11T has an efficacy advantage over Irinotecan as demonstrated by tumor eradication at much lower doses than irinotecan across various tumor xenograft models. PCS11T produced a marked, dose-related sustained tumor growth inhibition (TGI) in all the evaluated models. TGI in these models was significantly improved in comparison to irinotecan. Tumor regression was also observed in several models. PCS11T does not affect acetyl choline esterase (AChE) activity in human and rat plasma in vitro, which would suggest that PCS11T will show an improved safety profile, unlike irinotecan which is known for its cholinergic related side-effects. Prior to the License Agreement, Aposense had met with the FDA at a Pre-IND meeting. At that meeting, agreement was reached related to the necessary manufacturing and toxicological study requirements for filing the IND and the subsequent design of the Phase 1B study for PCS11T in the treatment of solid tumors. Depending upon our available funds, we are currently planning to manufacture the product at a GMP facility, conduct the required toxicological studies required to file the IND and initiate the Phase 1B study in oncology patients with solid tumors in late 2021. PCS100 On August 29, 2019, we entered into an exclusive license agreement with Akashi Therapeutics, Inc. (“Akashi”) to develop and commercialize an anti-fibrotic, anti-inflammatory drug, PCS100, which also promotes healthy muscle fiber regeneration. In previous clinical trials in Duchenne Muscular Dystrophy (DMD), PCS100 showed promising improvement in the muscle strength of non-ambulant pediatric patients. Although the FDA placed a clinical hold on the DMD trial after a serious adverse event in a pediatric patient, the FDA has removed the drug off clinical hold and defined how PCS100 can resume clinical trials in DMD. Once we have obtained adequate funding, we plan to develop PCS100 in rare adult fibrotic related diseases such as focal segmental glomerulosclerosis, idiopathic pulmonary fibrosis or Scleroderma. At the present time we are evaluating the potential GMP manufacturing facilities and the potential indications for PCS100. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of 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, 2019, as filed with the SEC. The results of operations for the interim periods shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. Going Concern and Management’s Plans Our condensed consolidated financial statements have been prepared using U.S. GAAP and are based on the assumption that we will continue as a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. We face certain risks and uncertainties that are present in many emerging pharmaceutical company regarding product development and commercialization, limited working capital, recurring losses and negative cash flow from operations, future profitability, ability to obtain future capital, protection of patents, technologies and property rights, competition, rapid technological change, navigating the domestic and major foreign markets’ regulatory and clinical environment, recruiting and retaining key personnel, dependence on third party manufacturing organizations, third party collaboration and licensing agreements, lack of sales and marketing activities. We currently have no customers or pharmaceutical products to sell or distribute. These risks and other factors raise substantial doubt about our ability to continue as a going concern. We have relied primarily on private placements with a small group of accredited investors to finance our business and operations. As described in more detail below, we entered into two line of credit agreements last year with related parties providing a revolving commitment of an aggregate of up to $1.4 million. We have not had any revenue since our inception. We are looking at ways to add a revenue stream to offset some of our expenses but do not currently have any revenue under contract or any immediate sales prospects. At June 30, 2020, we had an accumulated deficit of $12.6 million, and during the six months ended June 30, 2020, we incurred a net loss of $1,607,750 and used $897,029 in net cash from operating activities from continuing operations. At June 30, 2020, we had cash and cash equivalents totaling $452,654. On September 20, 2019, we entered into two separate Line of Credit Agreements (“LOC Agreements”) to borrow up to $700,000 with current stockholders and related parties: DKBK Enterprises, LLC (“DKBK”) and CorLyst, LLC (“CorLyst”) ($1.4 million total). Under the LOC Agreements, all funds borrowed bear an 8% annual interest rate. The lenders have the right to convert all or any portion of the debt and interest into shares of our common stock. Our Chief Executive Officer (CEO) is also the CEO and Managing Member of both lenders. DKBK directly holds 16,166 shares of our common stock, less than 1% of our outstanding common stock, and CorLyst beneficially owns 1,095,649 shares, representing 19.8% of our outstanding common stock. In April and June 2020, we drew $500,000 under the LOC Agreement with DKBK. On July 21, 2020, we drew an additional $200,000, bringing the total amount drawn under the LOC Agreement with DKBK to $700,000. In December 2019, we closed our bridge financing and issued $805,000 of 2019 Senior Notes to accredited investors. In order to preserve cash, in August 2019 we began delaying some cash outflows, primarily through the deferred payment of certain salaries ($210,800 has been included in accrued expenses at June 30, 2020) until such time as we have raised sufficient funding. In May 2020, we entered into a promissory note in favor of the Bank of America under the Small Business Administration Paycheck Protection Program of the Coronavirus Aid, Relief and Economic Security Act of 2020 (the “CARES Act”) for a $162,459 loan (“the PPP Loan”). We plan to use the loan proceeds for payroll costs, rent and utilities in accordance with the relevant terms and conditions of the CARES Act. We have begun the process of raising capital in an underwritten public offering, however, we have faced delays due to the global pandemic caused by the novel coronavirus, COVID-19. Based on our current plan, we will need to raise additional capital to fund our future operations. While we believe our current resources are adequate to complete the closeout of our current Phase 2A trial for NL, we do not currently have resources to conduct other future trials, such as the Phase 2B clinical trial approved by the FDA, or to develop our other drug candidates without raising additional capital. We believe that our existing cash and LOC Agreements will enable us to fund our operating expenses and capital expenditure requirements through the end of 2020. Additional funding may not be available to us on acceptable terms, or at all. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or future clinical trial plans, or research and development programs. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. To the extent that we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Uncertainty concerning our ability to continue as a going concern may hinder our ability to obtain future financing. Continued operations and our ability to continue as a going concern are dependent on our ability to obtain additional funding in the future and thereafter, and no assurances can be given that such funding will be available at all, in a sufficient amount, or on reasonable terms. Without additional funds from debt or equity financing, sales of assets, sales or out-licenses of intellectual property or technologies, or other transactions providing funds, we will rapidly exhaust our resources and be unable to continue operations. Absent additional funding, we believe that our cash and cash equivalents will not be sufficient to fund our operations for a period of one year or more after the date that these condensed consolidated financial statements are available to be issued based on the timing and amount of our projected net loss from continuing operations and cash to be used in operating activities during that period of time. As a result, substantial doubt exists about our ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are available to be issued. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded assets, or the amounts and classification of liabilities that might be different should we be unable to continue as a going concern based on the outcome of these uncertainties described above. Use of Estimates In preparing our condensed consolidated financial statements and related disclosures in conformity with 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, determining the fair value of acquired assets and assumed liabilities, intangible assets, 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, 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 Net Loss Per Share Basic loss per share is computed by dividing our net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the year. Diluted loss per share is computed by dividing our net loss available to common stockholders 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, 2020 and 2019 excludes the impact of 740,899 and 719,083 potentially dilutive common stock, respectively, related to outstanding stock options and warrants and the conversion of our 2017 and 2019 Senior Notes since those shares would have an anti-dilutive effect on loss per share. 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 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 Description of
Organization and Description of the Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of the Business | Note 1 – Organization and Description of the Business Processa Pharmaceuticals, Inc. (“Processa” or “the Company”) is an emerging clinical stage biopharmaceutical company focused on the development of drug products that are intended to provide treatment for and improve the survival and/or quality of life of patients who have a high unmet medical need condition or who have no alternative treatment. Within this group of pharmaceutical products, we currently are developing one product for multiple indications (i.e., the use of a drug to treat a particular disease), will begin developing a newly acquired drug once adequate funding has been obtained, and are searching for additional products for our portfolio. PCS499 Our lead product, PCS499, is an oral tablet that is a deuterated analog of the major metabolites of pentoxifylline (Trental ® The degeneration of tissue occurring at the NL lesion site may be caused by a number of pathophysiological changes, which has made it extremely difficult to develop effective treatments for this condition. PCS499 may provide a solution since PCS499 and its metabolites affect a number of biological pathways, several of which could contribute to the pathophysiology associated with NL. On June 18, 2018, the FDA granted orphan-drug designation to PCS499 for the treatment of NL. On September 28, 2018, the IND for PCS499 in NL was made effective by the FDA, such that we could move forward with the Phase 2A safety and dose tolerability trial. We dosed our first NL patient in this Phase 2A clinical trial on January 29, 2019 and completed enrollment on August 23, 2019. The main objective of the trial is to evaluate the safety and tolerability of PCS499 in patients with NL and to use the collected safety and efficacy data to design future clinical trials. Based on toxicology studies and healthy human volunteer studies, Processa and the FDA agreed that a PCS499 dose of 1.8 grams/day would be the highest dose administered to NL patients in this Phase 2 trial. As anticipated, the PCS499 dose of 1.8 grams/day, 50% greater than the maximum tolerated dose of PTX, appeared to be well tolerated with no serious adverse events reported. To date, nine of the patients dosed at 1.8 grams/day have reported only mild adverse events related to the treatment, which occurred mostly in the first month of treatment and were quickly resolved. As expected, gastrointestinal or CNS adverse events were reported most often. We have a meeting scheduled with the FDA in March 2020 to further discuss the development of PCS499, including a future clinical trial. PCS100 On August 29, 2019, we entered into an exclusive license agreement with Akashi Therapeutics, Inc. (“Akashi”) to develop and commercialize an anti-fibrotic, anti-inflammatory drug, PCS100, which also promotes healthy muscle fiber regeneration. In previous clinical trials in Duchenne Muscular Dystrophy (DMD), PCS100 showed promising improvement in the muscle strength of non-ambulant pediatric patients. Although the FDA placed a clinical hold on the DMD trial after a serious adverse event in a pediatric patient, the FDA has removed the clinical hold and defined how PCS100 can resume clinical trials in DMD. Once we have obtained adequate funding, we plan to develop PCS100 in rare adult fibrotic related diseases such as focal segmental glomerulosclerosis, idiopathic pulmonary fibrosis or Scleroderma. |
Going Concern and Management's
Going Concern and Management's Plans | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Going Concern and Management's Plans | Note 2 – Going Concern and Management’s Plans Our consolidated financial statements are prepared using U.S. GAAP and are based on the assumption that we will continue as a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. We face certain risks and uncertainties regarding product development and commercialization, limited working capital, recurring losses and negative cash flow from operations, future profitability, ability to obtain future capital, protection of patents, technologies and property rights, competition, rapid technological change, navigating the domestic and major foreign markets’ regulatory and clinical environment, recruiting and retaining key personnel, dependence on third party manufacturing organizations, third party collaboration and licensing agreements, lack of sales and marketing activities and having no customers or pharmaceutical products to sell or distribute. These risks and other factors raised substantial doubt about our ability to continue as a going concern as of the date of the filing of this Annual Report on Form 10-K for the year ended December 31, 2019. We have relied on private placements with a small group of accredited investors to finance our business and operations. We have not had any revenue since our inception, and we do not currently have any revenue under contract or any immediate sales prospects. As of December 31, 2019, we had an accumulated deficit of approximately $11.0 million. For the year ended December 31, 2019, we incurred a net loss from continuing operations of approximately $3.4 million and used approximately $2.8 million in net cash from operating activities. We expect our operating costs to be substantial as we incur costs related to the clinical trials for our product candidates and that we will operate at a loss for the foreseeable future. On September 20, 2019, we entered into two separate LOC Agreements (“LOC Agreements”) with DKBK Enterprises, LLC (“DKBK”) and CorLyst, LLC (“CorLyst”, and, together with DKBK, collectively, “Lenders”), both related parties, which provide a revolving commitment of up to $700,000 each ($1.4 million total). Under the LOC Agreements, all funds borrowed bear interest at an annual rate of 8%. The promissory notes issued in connection with the LOC Agreements provide that the Lenders have the right to convert all or any portion of the principal and accrued and unpaid interest into our common stock on the same terms as our 2019 Senior Convertible Notes. Therefore, the Lenders may convert the outstanding debt under the LOC Agreements into our common stock at a conversion price equal to the lower of (i) $14.28 per share, (ii) a price per share equal to a 10% discount to the pre-money valuation of an equity sale of the Company’s common stock for cash, or (iii) at an adjusted price; all as more particularly described in the 2019 Senior Convertible Notes. Our CEO is also the CEO and Managing Member of both Lenders. CorLyst beneficially owns 996,376 shares of Processa common stock, representing approximately 17.8% of the Company’s outstanding shares of voting capital stock. We have not drawn any amounts under these LOC agreements as of February 28, 2020. In connection with the LOC Agreements, we amended the existing pledge agreement with PoC Capital on September 30, 2019 to reduce the committed funds from $1.8 million to $900,000, which has been paid in full as of December 31, 2019. As part of the original pledge agreement, we issued 113,280 shares of common stock and 113,280 warrants to purchase shares of common stock to PoC Capital but held 56,640 shares and 56,640 warrants as collateral until certain payment milestones were met. PoC Capital forfeited the pledged collateral in the amended agreement. The forfeited shares and warrants have been returned to us. In December 2019, we closed our bridge financing and issued $805,000 of the 2019 Senior Notes to accredited investors (see Note 7). We have also delayed some of our cash outflows, primarily through the deferred payment of salaries ($122,175, which has been accrued and included in accrued expenses at December 31, 2019) until such time as we have raised sufficient funding. Based on our current plan, we will need to raise additional capital to fund our future operations. While we believe our current resources are adequate to complete our current Phase 2A trial for NL, we do not currently have resources to conduct other future trials or develop PCS100 without raising additional capital. As noted above, the timing and extent of our spending will depend on the costs associated with, and the results of our Phase 2A trial for NL. Our anticipated spending and our cash flow needs could change significantly as the trial progresses. There may be costs we incur during our trial that we do not currently anticipate in order to complete the trial, requiring us to need additional capital sooner than currently expected. The additional funding may not be available to us on acceptable terms, or at all. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or future clinical trials, or research and development programs. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. To the extent that we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Uncertainty concerning our ability to continue as a going concern may hinder our ability to obtain future financing. Continued operations and our ability to continue as a going concern are dependent on our ability to obtain additional funding in the future and thereafter, and no assurances can be given that such funding will be available at all, in a sufficient amount, or on reasonable terms. Without additional funds from debt or equity financing, sales of assets, sales or out-licenses of intellectual property or technologies, or other transactions providing funds, we will rapidly exhaust our resources and be unable to continue operations. Absent additional funding, we believe that our cash and cash equivalents will not be sufficient to fund our operations for a period of one year or more after the date that these condensed consolidated financial statements are available to be issued based on the timing and amount of our projected net loss from continuing operations and cash to be used in operating activities during that period of time. As a result, substantial doubt exists about our ability to continue as a going concern as of the date of the filing of the Annual Report on Form 10-K for the year ended December 31, 2019. The accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded assets, or the amounts and classification of liabilities that might be different should we be unable to continue as a going concern based on the outcome of these uncertainties described above. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Note 3 – 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. We have reclassified certain immaterial prior year amounts to conform to our current year presentation. The reclassification of prior period amounts had no effect on previously reported net income, stockholders’ equity or cash flows. On December 23, 2019, we effected a 1-for-7 reverse stock split, reducing the number of the Company’s common stock outstanding on that date from 38,404,530 shares to 5,486,476 shares. The number of authorized shares of common stock remained unchanged at 100,000,000 shares and the number of authorized shares of preferred stock remained unchanged at 1,000,000 shares. Additionally, the conversion price of our 2019 Senior Notes, the exercise price of all then outstanding options and warrants, and the number of shares reserved for future issuance pursuant to our equity compensation plans were all adjusted proportionately in connection with the reverse stock split. All share and per share amounts and conversion and exercise prices presented herein have been adjusted retroactively to reflect this change. Use of Estimates In preparing our 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 consolidated financial statements and accompanying notes. Estimates are used for, but not limited to stock-based compensation, determining the fair value of acquired assets and assumed liabilities, intangible assets, 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 to 5 years. We amortize leasehold improvements over the shorter of the estimated useful life of the asset or the term of the related lease. Upon retirement or disposition of assets, the costs and related accumulated depreciation are removed from the accounts with the resulting net gain or loss, if any, reflected in the consolidated statement of operations. 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, 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 expense is based on the grant-date fair value estimated in accordance with the provisions of ASC 718, Compensation-Stock Compensation Net Loss Per Share Basic loss per share is computed by dividing our net loss available to common stockholders 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 stockholders by the diluted weighted average number of shares of common stock 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, 2019 and 2018 excludes the impact of potentially dilutive common stock related to outstanding stock options and warrants and the conversion of our 2017 and 2019 Senior Notes since those shares would have an anti-dilutive effect on loss per share. As more fully described in Note 11, we have determined the sale of the 2019 Senior Notes in late 2019 triggered the full ratchet anti-dilution provision of the common stock we sold in 2018 Private Placement Transactions. For purposes of computing our basic and diluted EPS, we increased our net loss available for common stockholders by the fair value of the additional shares to be issued since they did not affect all our common stockholders equally and there are no contingencies related to the issuance of these shares. We also included the related shares which will be issued in 2020 in our weighted number of shares of common stock outstanding. Our diluted net loss per share for the years ended December 31, 2019 and 2018 excluded 715,452, and 588,586 of potentially dilutive common stock, respectively, related to the conversion of our Senior Notes and outstanding stock options and warrants since those shares would have had an anti-dilutive effect on loss per share during the years then ended. Segments We operate in one segment. Management uses one measurement of profitability and does not segregate its business for internal reporting. All our assets are located within the United States. Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and the senior convertible notes approximate fair value because of the short-term maturity of these instruments, including the mandatory conversion of the Senior Notes into our common stock upon meeting certain conditions. Debt Issuance Costs We recognized the debt issuance costs incurred related to our 2017 and 2019 Senior Notes as a reduction of the carrying amount of the 2017 and 2019 Senior Notes on the face of the consolidated balance sheet. The debt issuance costs are amortized to interest expense using the straight-line method over the term of the 2019 Senior Notes and the interest method over the term of the 2017 Senior Notes. Research and development Research and development costs are expensed as incurred and consisted of direct and overhead-related expenses. Research and development costs totaled $2,320,573 and $3,085,317 for the years ended December 31, 2019 and 2018, respectively. Expenditures to acquire technologies, including licenses, which are utilized in research and development and that have no alternative future use are expensed when incurred. Technology we develop for use in our products is expensed as incurred until technological feasibility has been established after which it is capitalized and depreciated. No research and development costs were capitalized during the years ended December 31, 2019 and 2018. Income Taxes As a result of our reverse acquisition merger, there was an ownership change as defined by Internal Revenue Code Section 382. Prior to the closing of the transaction, Promet was treated as a partnership for federal income tax purposes and thus was not subject to income taxes at the entity level, and no provision or liability for income taxes has been included in the consolidated financial statements through October 4, 2017. In addition, Promet determined that it was not required to record a liability related to uncertain tax positions as a result of the requirements of ASC 740-10-25 Income Taxes We account for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, we recognize the tax benefit from an uncertain tax position only if it is more-likely-than-not that the tax position will be sustained upon examination by the taxing authorities, based on the technical merits of the position. Estimated interest and penalties related to uncertain tax positions are included as a component of interest expense and general and administrative expense, respectively. We had no unrecognized tax benefits or uncertain tax positions for any periods presented. On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (“TCJA”) was signed into law. In December 2017, the SEC issued Staff Accounting Bulletin 118 (“SAB 118”) to provide clarification in implementing the TCJA when registrants do not have the necessary information available to complete the accounting for an element of the TCJA in the period of its enactment. SAB 118 provides for tax amounts to be classified as provisional and subject to remeasurement for up to one year from the enactment date for such elements when the accounting effect is not complete but can be reasonably estimated. We considered our estimates of the tax effects of the TCJA on the components of our tax provision to be reasonable and no provisional estimates subject to remeasurement were necessary to complete the accounting. We file U.S. federal income and California and Maryland state tax returns. There are currently no income tax examinations underway for these jurisdictions. However, tax years from and including 2016 remain open for examination by federal and state income tax authorities. 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 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. Recently adopted accounting pronouncements In July 2017, the FASB issued Accounting Standards Update 2017-11 (ASU 2017-11), which allows companies to exclude a down round feature when determining whether a financial instrument is considered indexed to the entity’s own stock. As a result, financial instruments with round down features are no longer classified as liabilities and embedded conversion options with down round features are no longer bifurcated. For equity-classified freestanding financial instruments, such as warrants, an entity will treat the value of the effect of the round down, when triggered, as a dividend and a reduction of income available to common stockholders in computing basic earnings per share. The guidance in ASU 2017-11 is effective for fiscal year beginning after December 15, 2018, and interim periods within those fiscal years. We early adopted ASU 2017-11 effective January 1, 2018 without a material impact on our consolidated financial statements. On January 1, 2019, we adopted Accounting Standards Codification (ASC) 842, Leases The adoption of the new guidance did not have a material impact on the consolidated statement of operations. For further details regarding the adoption of this standard, see Note 12, “Operating Leases.” |
Acquisition
Acquisition | 12 Months Ended |
Dec. 31, 2019 | |
Business Combinations [Abstract] | |
Acquisition | Note 4 – Acquisition On October 4, 2017, in exchange for 90 percent or 4,535,121 shares of our common stock, we acquired the net assets of Promet, totaling $1,017,342, in a transaction that was accounted for as a reverse acquisition in accordance with ASC 805-40-45, Business Combinations - Reverse Acquisitions The transaction was considered a capital transaction in substance. Accordingly, for accounting purposes, it was assumed that Promet issued shares to Heatwurx at fair value, net of the assets and liabilities assumed from Heatwurx as shown below, which were recognized as a reduction of additional paid-in-capital at closing of the reverse merger. The net recognized value of Heatwurx identifiable assets and liabilities included the following: Cash $ 6,280 Accounts payable (26,098 ) Accrued expenses (17,932 ) Net liabilities assumed $ (37,750 ) Our consolidated financial statements present the financial position (with a retrospective adjustment to Promet’s legal capital to reflect our pre-merger capital structure) and operations of Promet prior to October 4, 2017, and of the combined company from October 4, 2017 forward. The assets and liabilities of Promet are recognized and measured at their historical carrying amounts. The accumulated deficit and other equity balances of Promet have been carried forward and adjusted to reflect our legal shares and par value with the difference allocated to additional paid-in capital. Promet incurred acquisition-related transaction costs of $58,763, which are included in general and administrative expense, a component of operating expenses in the consolidated statements of operations. Earnings per share (“EPS”) is calculated using our equity structure, including the equity interests issued to Promet in the asset acquisition transaction. Prior to the reverse acquisition, EPS was based on Promet’s net income and weighted average common stock outstanding that were received in the asset purchase transaction. Subsequent to the reverse acquisition, EPS is based on the weighted actual number of common stock outstanding during that period (see Note 11). |
Intangible Assets
Intangible Assets | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Intangible Assets | Note 2 – Intangible Assets Intangible assets at June 30, 2020 and December 31, 2019 consisted of the following: June 30, 2020 December 31, 2019 Gross intangible assets $ 11,059,429 $ 11,059,429 Less: accumulated amortization (1,814,639 ) (1,416,975 ) Total intangible assets, net $ 9,244,790 $ 9,642,454 Amortization expense was $397,664 for the six months ended June 30, 2020 and 2019 and is included within research and development expense in the accompanying condensed consolidated statements of operations. Our estimated amortization expense for the next year will be approximately $795,000 per year and for annual periods thereafter approximately $788,000 per year. The capitalized costs for the license rights to PCS499 included the $8 million purchase price, $1,782 in transaction costs and $3,037,147 associated with the initial recognition of an offsetting deferred tax liability related to the acquired temporary difference for an asset purchased that is not a business combination and has a tax basis of $1,782 in accordance with ASC 740-10-25-51 Income Taxes Research and Development | Note 5 - Intangible Assets Intangible assets at December 31, 2019 consisted of the capitalized costs of $20,500 for a purchased software license and $11,038,929 associated with our exercise of the option to acquire the exclusive license from CoNCERT related to patent rights and know-how to develop and commercialize compounds and products for PCS499 and each metabolite thereof and the related income tax effects. The capitalized costs for the license rights to PCS499 include $8 million purchase price, $1,782 in transaction costs and $3,037,147 associated with the initial recognition of an offsetting deferred tax liability related to the acquired temporary difference for an asset purchased that is not a business combination and has a tax basis of $1,782 in accordance with ASC 740-10-25-51 Income Taxes Research and Development Acquisition of the CoNCERT License 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 million of our common stock that was held by Promet (298,615 shares at $26.79 per share) and for the benefit of Processa in satisfaction of the obligation due for the exclusive license for PCS499 acquired by us. There was no change in the total shares issued and outstanding of 5,039,033. 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 million and an offsetting increase in additional paid-in capital resulting from the exchange. The CoNCERT Agreement provides us with an exclusive (including to CoNCERT) royalty-bearing license to CoNCERT’s patent rights and know-how to develop, manufacture, use, sub-license and commercialize compounds (PCS499 and each metabolite thereof) and pharmaceutical products with such compounds worldwide. We are required to pay CoNCERT royalties, on a product by product basis, on worldwide net sales, as follows: ● 4% of the net sales of the portion less than or equal to $100 million; ● 5% of the net sales of the portion greater than $100 million and less than or equal to $500 million; ● 6% of the net sales of the portion greater than $500 million and less than or equal to $1.0 billion; and ● 10% of the net sales of the portion greater than $1 billion if such sales are made by us or our affiliates. With respect to net sales made by us or any of our affiliates, we will pay 10% of net sales and with respect to sales by our sublicensee, we will pay the greater of (i) 6% or (ii) 50% of all payment received by us with respect to such sublicensee. We will also pay 15% of any sublicense revenue earned by us for a period equivalent to the royalty term (as defined in the CoNCERT Agreement) until the earliest of (a) our raising $8 million of gross proceeds and (b) CoNCERT being able to sell its shares of our common stock without restrictions pursuant to the terms of the amended Agreement. All other terms of the CONCERT Agreement remained unchanged. 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 million. The market approach was based on the final negotiated number of shares of stock determined on a volume weighted average price of our common stock over a 45 day period preceding the mid-February 2018 finalized negotiation of the modification to the option and license agreement with CoNCERT, an unrelated third party, for the exclusive license rights to PCS499. The total cost recognized for the exclusive license acquired represents the allocated fair value related to the stock transferred to CoNCERT plus the recognition of the deferred tax liability related to the acquired temporary difference and the transaction costs incurred to complete the transaction as discussed above. Our intangible assets consist of the following at December 31, 2019: License Rights Software December 31, to PCS499 License 2019 Gross intangible assets $ 11,038,929 $ 20,500 $ 11,059,429 Less: accumulated amortization (1,405,301 ) (11,674 ) (1,416,975 ) Total intangible assets, net $ 9,633,628 $ 8,826 $ 9,642,454 Our intangible assets consist of the following at December 31, 2018: License Rights Software December 31, to PCS499 License 2018 Gross intangible assets $ 11,038,929 $ 20,500 $ 11,059,429 Less: accumulated amortization (616,807 ) (4,840 ) (621,647 ) Total intangible assets, net $ 10,422,122 $ 15,660 $ 10,437,782 Amortization expense was $795,328 and $621,647 for the years ended December 31, 2019 and 2018 and is included within research and development expense in the accompanying consolidated statements of operations. As of December 31, 2019, estimated amortization expense for the next year will be approximately $795,000 and approximately $788,000 per year for annual periods thereafter. |
License Agreement for PCS100
License Agreement for PCS100 | 12 Months Ended |
Dec. 31, 2019 | |
License Agreement For PCS100Abstract | |
License Agreement for PCS100 | Note 6 – License Agreement for PCS100 On August 29, 2019, we entered into an exclusive license agreement with Akashi to develop and commercialize an anti-fibrotic, anti-inflammatory drug, PCS100, which also promotes healthy muscle fiber regeneration. In previous clinical trials in Duchenne Muscular Dystrophy (DMD), PCS100 showed promising improvement in the muscle strength of non-ambulant pediatric patients. Although the FDA placed a clinical hold on the DMD trial after a serious adverse event in a pediatric patient, the FDA has removed the clinical hold and defined how PCS100 can resume clinical trials in DMD. Once we have obtained adequate funding, we plan to develop PCS100 in rare adult fibrotic related diseases such as focal segmental glomerulosclerosis, idiopathic pulmonary fibrosis or Scleroderma. The Akashi Agreement provides us with a worldwide license to research, develop, make and commercialize products comprising or containing PCS100. As partial consideration for the license, we paid $10,000 to Akashi upon full execution of the license agreement. This upfront payment was expensed as a research and development cost. As additional consideration, we will pay Akashi 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 must pay Akashi 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. Due to the early stage of PCS100, it is not possible to determine if any of the development or sales milestones will be achieved and no amounts have been accrued related to these contingent payments. We are also required to split any milestone payments we receive with Akashi based on any sub-license agreement we may enter into. 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) requesting a meeting with the FDA for a first indication within 18 months of the date of the agreement, (ii) submitting an IND for a drug indication on or before June 30, 2022 and (iii) initiating a Phase 1 or 2 trial for a drug indication on or before December 30, 2022. Either party may terminate the agreement in the event of a material breach of the license agreement that has not been cured following written notice and a 60-day opportunity to cure such breach (which is shortened to 15 days for a payment breach). |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Notes Payable | Note 7 – Notes Payable Line of Credit Agreements On September 20, 2019, we entered into two separate LOC Agreements (“LOC Agreements”) with DKBK Enterprises, LLC (“DKBK”) and CorLyst, LLC (“CorLyst”, and, together with DKBK, collectively, “Lenders”), both related parties, which provide a revolving commitment of up to $700,000 each ($1.4 million total). Under the LOC Agreements, all funds borrowed bear interest at an annual rate of 8%. The promissory notes issued in connection with the LOC Agreements provide that the Lenders have the right to convert all or any portion of the principal and accrued and unpaid interest into our common stock on the same terms as are our 2019 Senior Convertible Notes. Therefore, the Lenders may convert the outstanding debt under the LOC Agreements into our common stock at a conversion price equal to the lower of (i) $14.28 per share, (ii) a price per share equal to a 10% discount to the pre-money valuation of an equity sale of the Company’s common stock for cash, or (iii) at an adjusted price; all as more particularly described in the 2019 Senior Convertible Notes. Our Chief Executive Officer (CEO) is also the CEO and Managing Member of both Lenders. CorLyst beneficially owns 996,376 shares of Processa common stock, representing approximately 17.8% of the Company’s outstanding shares of voting capital stock at December 31, 2019. We have not drawn any amounts under these LOC Agreements as of February 28, 2020. Senior Convertible Notes The balance of our Senior Convertible Notes at December 31, 2019 and 2018 was as follows: 2019 2018 2019 Senior Notes $ 805,000 $ - 2017 Senior Notes - 230,000 Less: Unamortized debt issuance costs (2,497 ) - Balance 802,503 230,000 Current portion (802,503 ) (230,000 ) Long term portion $ - $ - Interest expense totaled $36,658 and $161,205 for the years ended December 31, 2019 and 2018, respectively. Included in interest expense is the amortization of the related debt issuance costs of $1,783, and $67,069 for the years ended December 31, 2019 and 2018, respectively. The Senior Notes and related accrued interest are classified as current liabilities in our consolidated balance sheets. 2019 Senior Notes During the fourth quarter of 2019, accredited investors purchased $805,000 of 8% Senior Convertible Notes (“2019 Senior Notes”) from us. For every $1,000 principal amount purchased, the note holders received 70 warrants to purchase our common stock. As a result, we granted 56,350 warrants to purchase our common stock at an exercise price of $19.04, which expire on December 19, 2023. The 2019 Senior Notes bear interest at 8% per year and if converted, the interest is payable in kind (in common stock). The 2019 Senior Notes mature on December 15, 2020. The 2019 Senior Notes are convertible by the holder upon (i) completion of listing our common stock on either the Nasdaq Capital Market or the New York Stock Exchange or if we raise at least $14 million, prior to December 15, 2020, the maturity date of the 2019 Senior Notes, in one or more qualified financings. If the 2019 Senior Notes are not paid or converted prior to their maturity date, the principal and any accrued interest will be automatically or mandatorily converted into our common stock. The 2019 Senior Notes, plus any accrued interest is convertible into shares of our common stock at a conversion price equal to the lower of (i) $14.28 per share or (ii) a price per share equal to a 10% discount to the pre-money valuation of an equity sale of the Company’s common stock for cash, as defined in the 2019 Senior Note agreement, occurring after the closing of the 2019 Senior Note financing. The 2019 Senior Notes provide the holders with (a) the option of receiving 110% of principal plus accrued interest in the event there is a change of control prior to conversion of the 2019 Senior Notes; (b) weighted-average anti-dilution protection in event of any sale of securities at a net consideration per share that is less than the applicable conversion price per share to the holder until we have raised an additional $14 million from the sale of certain securities; and (c) certain preemptive rights pro rata to their respective interests through December 31, 2021. The 2019 Senior Notes contains negative covenants that do not permit us to incur additional indebtedness or liens on property or assets owned, repurchase common stock, pay dividends, or enter into any transaction with affiliates of ours that would require disclosure in a public filing with the Securities and Exchange Commission. Upon an event of default, the outstanding principal amount of the Senior Notes, plus accrued but unpaid interest and other amounts owing in respect thereof through the date of acceleration, shall become immediately due and payable in cash at the holder’s election, if not cured within the cure period. We incurred $4,280 in debt issuance costs related to the 2019 Senior Notes. The debt issuance costs are amortized to interest expense using straight line amortization over the term of the 2019 Senior Notes. 2017 Senior Notes In October and November of 2017, certain entities affiliated with current stockholders and other accredited investors purchased $2.58 million of our 8% Senior Convertible Notes (“2017 Senior Notes”) in a bridge financing undertaken by us to support our operations. The 2017 Senior Notes bore interest at 8% per year. On May 25, 2018, pursuant to the mandatory and automatic conversion provisions of the Senior Notes, we converted $2,350,000 of the $2,580,000 outstanding Senior Notes, along with accrued interest of $114,333 into 172,327 shares of our common stock (at a conversion price of $14.30 per share) and issued to the debt holders warrants to purchase a total of 172,327 shares of common stock, exercisable for three years at an exercise price of $17.16. We also incurred costs totaling $82,502 related to our contractual obligations to file a resale registration statement related to this transaction with the SEC. 2017 Senior Notes totaling $230,000 held by Canadian investors remained outstanding at December 31, 2018. Although qualifying for automatic and mandatory conversion, they could not be converted until the Alberta Securities Commission released us from a cease trade order (which predated our merger with Heatwurx) and permitted us to issue common stock units (consisting of shares of our common stock and stock purchase warrants) to these Canadian investors. In June 2019, the Alberta Securities Commission released the cease trade order and assessed us a $10,000 fine, which was expensed. On July 2, 2019, we converted the remaining principal and related accrued interest of $28,930 into 18,107 shares of common stock and issued warrants to purchase 18,107 shares of common stock. We evaluated the warrants issued in this transaction and determined they should be classified as equity. We incurred $154,800 in debt issuance costs on the 2017 Senior Notes in connection with a payment to the placement agent, which was reported as a reduction of the carrying amount of the 2017 Senior Notes on the face of the consolidated balance sheets. The debt issuance costs were amortized to interest expense using the effective interest rate method over the term of the Senior Convertible Notes. The effective interest rate on the 2017 Senior Notes was 7.72% before debt issuance costs, since no payments of interest are due until maturity and 13.96% including the debt issuance costs based on the repayment terms of the 2017 Senior Notes. |
Income Taxes
Income Taxes | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Income Taxes | Note 3 – 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 we 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 Under ACS 740-270 Income Taxes – Interim Reporting | Note 9 – 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 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 During the years ended December 31, 2019 and 2018, we incurred net operating losses of $3,960,592 and $4,667,848, respectively. We did not record any income tax benefit for the $1,205,811 ($331,809 tax effected) and $1,356,840 ($373,368 tax effected) of general and administrative expenses treated as deferred start-up expenditures for tax purposes for the years ended December 31, 2019 and 2018, respectively. We did not record any income tax benefit for the $283,189 of federal orphan drug tax credits for the year ended December 31, 2019. Additionally, we did not record any income tax benefit in 2017 for the $259,049 ($71,284 tax effected) of tax losses incurred in 2017 which resulted in tax loss carryforwards. The benefit was recognized in 2018 in the calculation of the valuation allowance. The 2017 net operating loss carry forwards are available for application against future taxable income for 20 years expiring in 2037. Tax losses incurred after December 31, 2017 have an indefinite carry forward period. However, the tax loss incurred after December 31, 2017 and carried forward can only offset 80 percent of future taxable income in any one year, with any excess losses being carried forward indefinitely. We have recorded the benefit of our 2019 and 2018 net operating losses in our consolidated financial statements 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.” The benefit associated with the net operating loss carry forward will more-likely-than-not go unrealized unless future operations are successful except for their offset against the deferred tax liability created by the acquired CoNCERT license and “Know-How.” For the years ended December 31, 2019 and 2018, we recorded a federal income tax benefit of $602,716 and $902,801, respectively, as a result of offsetting our deferred tax liability by the deferred tax assets resulting from our net operating losses and the income tax effect of the intangible asset amortization for financial statement purposes. Our provision (benefit) for income taxes for the years ended December 31, 2019 and 2018 was as follows: Year Ended December 31, 2019 2018 Current: Federal $ - $ - State - - Total deferred tax benefit - - Deferred: Federal (1,037,267 ) (940,510 ) State (234,033 ) (292,047 ) Total deferred tax benefit (1,271,300 ) (1,232,557 ) Valuation allowance 668,584 329,756 Net deferred tax benefit (602,716 ) (902,801 ) Total tax provision (benefit) $ (602,716 ) $ (902,801 ) A reconciliation of our effective income tax rate and statutory income tax rate for the years ended December 31, 2019 and 2018 is as follows: Year Ended December 31, 2019 2018 Federal statutory income tax rate 21.00 % 21.00 % State tax rate, net 3.60 % 4.58 % Permanent differences (1.96 )% (0.90 )% Federal orphan drug tax credit 7.15 % - % Deferred tax asset valuation allowance (14.57 )% (5.33 )% Effective income tax rate 15.22 % 19.35 % On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (“TCJA”) was signed into law. Among its provisions, the TCJA reduces the statutory U.S. Corporate income tax rate from 34% to 21% effective January 1, 2018. The TCJA includes provisions that, in certain instances, impose U.S. income tax liabilities on future earnings of foreign subsidiaries and limit the deductibility of future interest expenses. The TCJA also provides for accelerated deductions of certain capital expenditures made after September 27, 2017 through bonus depreciation and an indefinite tax loss carryforward period for losses incurred after December 31, 2017. However, these tax-loss carry forwards can only offset 80 percent of future taxable income in any one year, with respect to any excess continuing to be carried forward indefinitely. Losses incurred prior to January 1, 2018 continue to carry forward for twenty years. The application of the TCJA may change due to regulations subsequently issued by the U.S. Treasury Department. We applied the guidance in SAB 118 when accounting for the enactment-date effects of the TCJA in 2018 and throughout 2019. At December 31, 2019 and 2018, we had available federal net operating loss carryforwards of approximately $4.1 million and $2.7 million, respectively. The federal net operating loss generated in 2019 and 2018 of $1.4 million and $2.4 million, respectively, will carry forward indefinitely and be available to offset up to 80% of future taxable income each year. Net operating losses generated prior to 2018 will expire 2037. We are evaluating our qualified research expenditures for the federal orphan drug credit and the federal and state credit for increasing research activities to offset potential future tax liabilities. The federal research and development tax credits have a 20-year carryforward period. We have not recognized any deferred tax assets related to research and development tax credits as of December 31, 2019 or 2018. We also have available state net operating loss carryforwards of approximately $4.1 million and $2.7 million as of December 31, 2019 and 2018, respectively, which expire 2037. All federal and state net operating loss and credit carryforwards listed above are reflected after the reduction for amounts effectively eliminated under Section 382. We do not recognize other deferred income tax assets at this time because the realization of the assets is not more-likely-than-not that they will be realized. As of December 31, 2019 and 2018, we had deferred start-up expenditures and other deductible expenses for both federal and state income tax purposes of $6,977,317 and $4,369,700, respectively. The benefit associated with the amortization of the deferred start-up expenditures and other deductible expenses will more-likely-than-not go unrealized unless future operations are successful. Since the success of future operations is indeterminable, the potential benefits resulting from these deferred tax assets have not been recorded in our consolidated financial statements. The significant components of our deferred tax assets and liabilities for Federal and state income taxes consisted of the following: December 31, 2019 2018 Deferred tax assets: Non-current: Net operating loss carry forward – Federal $ 854,196 $ 559,817 Net operating loss carry forward – State 265,106 173,743 Deferred rent - 2,742 Stock option expense 72,504 20,380 Depreciation 8,753 4,549 Federal orphan drug credits 283,189 - Start-up expenditures and amortization 800,681 468,872 Total non-current deferred tax assets 2,284,429 1,230,103 Valuation allowance for deferred tax assets (1,165,126 ) (496,542 ) Total deferred tax assets 1,119,303 733,561 Deferred Tax Liabilities: Non-current: Intangible asset (2,650,933 ) (2,867,907 ) Total non-current deferred tax liabilities (2,650,933 ) (2,867,907 ) Total deferred tax asset (liability) $ (1,531,630 ) $ (2,134,346 ) The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, the projected future taxable income and tax planning strategies in making this assessment. Based on management’s analysis, a reserve has been established against the deferred tax assets related to deferred start-up expenditures and other deductible expenses. The change in the valuation allowance in 2019 and 2018 was $668,584 and $329,755, respectively. Our total deferred tax asset as of December 31, 2019 and 2018 include $2,909,715 ($800,681 tax effected) and $1,703,904 ($468,872 tax effected) of general and administrative expenses treated as deferred start-up expenditures for tax purposes, respectively, $4,067,602 ($1,119,302 tax effected) and $2,665,796 ($733,560 tax effected) of tax losses resulting in tax loss carryforwards as of the same periods and $283,189 of federal orphan drug tax credits as of December 31, 2019. We have had no revenues and recognized cumulative loses since inception. Due to the uncertainty regarding future profitability and recognition of taxable income to utilize the amortization of deferred start-up expenditures, federal orphan drug tax credits and the tax loss carryforwards, except for its offset against the deferred tax liability created by our acquisition of the CoNCERT license, a valuation allowance against any potential deferred tax assets has been recognized for the years ended December 31, 2019 and 2018. 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. We are subject to taxation in the United States and state jurisdictions where applicable. There are currently no income tax examinations underway for these jurisdictions. However, tax years from and including 2016 remain open for examination by federal and state income tax authorities. |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | ||
Stock-based Compensation | Note 4 – Stock-based Compensation We did not grant any stock options to our employees or non-employees during the six months ended June 30, 2020. During the six months ended June 30, 2019, we granted 129,919 stock options to employees and non-employees under the 2019 Omnibus Incentive Plan. At June 30, 2020, we had outstanding options to purchase 169,329 shares of our common stock of which options for the purchase of 56,853 shares of our common stock were vested. We recorded $192,532 and $125,035 of stock-based compensation expense for the six months ended June 30, 2020 and 2019, respectively. | Note 10 - Stock-based Compensation On June 19, 2019, our stockholders approved and we adopted the Processa Pharmaceuticals Inc. 2019 Omnibus Equity Incentive Plan (the “Omnibus Plan”) and we terminated our prior equity incentive compensation plan, the Heatwurx, Inc. 2011 Amended and Restated Equity Plan (the “2011 Plan”). The Omnibus Plan allows us, under the direction of our Board of Directors or a committee thereof, to make grants of stock options, restricted and unrestricted stock and other stock-based awards to employees, including our executive officers, consultants and directors. An aggregate of 500,000 shares of our common stock, adjusted for the one for seven reverse stock split completed on December 23, 2019, were initially available for issuance under the Omnibus Plan. Shares available under the Omnibus Plan may be authorized but unissued shares, shares purchased on the open market or treasury shares. On June 20, 2019, our Board of Directors granted stock options for the purchase of 129,919 shares of our common stock to employees. The stock options awarded contained either service or performance vesting conditions, as described below, have a contractual term of five years and an exercise price equal to the closing price of our common stock on the OTCQB on the date of grant of $16.80. We granted 54,915 stock options to employees and non-employees during the year ended December 31, 2018. Stock options representing the purchase of 65,148 shares of common stock (of the 129,919 stock options granted on June 20, 2019) contained service vesting conditions. The service condition related solely to employees rendering service over a three-year period. These awards vest one-third on the first anniversary of the grant date, and then vest ratably over the remaining twenty-four months, 1/36 th Stock options representing the purchase of 64,771 shares of common stock (of the 129,919 stock options granted on June 20, 2019) vest upon meeting the following performance criteria: (i) 12,958 shares vest when we in-license one new or additional drug; (ii) 12,958 shares vest when our current Phase 2A clinical trial for PCS499 is complete; and (iii) 38,855 shares vest when we up-list from the OTCQB to either the Nasdaq or NYSE markets. We are recognizing compensation cost for the awards related to completion of our current clinical trial and for in-licensing a new drug. The clinical trial is progressing as planned with no significant adverse events, is fully enrolled, and fully funded. Management does not foresee any reasons why this study will not be completed as planned and believes it is probable that this performance condition will be met in mid-2020. On August 29, 2019, we reached a license agreement with Akashi Therapeutics for PCS100 and as such, the performance condition related to the award for in-licensing one new or additional drug has been met. As for the last award with performance conditions related to up-listing on Nasdaq or NYSE markets, management has determined that until we complete the performance related condition, it is not probable to conclude the performance condition will be achieved. As such, no stock-based compensation expense is being recorded for those awards. We recorded $510,478 and $74,063 of stock-based compensation expense for the years ended December 31, 2019 and 2018, respectively. The allocation of stock-based compensation expense between research and development and general and administrative expense was as follows: Year ended December 31, 2019 2018 Research and Development $ 113,239 $ - General and Administrative 397,239 74,063 Total $ 510,478 $ 74,063 During the year ended December 31, 2018, there was one grant for the purchase of 7,143 shares of our common stock outstanding under the 2011 Plan. We also granted non-qualified stock options outside of the Plan for a total of 47,772 shares of common stock. An option for the purchase of 45,200 shares of common stock vests over a four-year term and an option for the purchase of 2,572 shares of common stock vests over one-year term. Stock option granted in 2018 all have a maximum contractual term of ten years. Vesting is subject to the holder’s continuous service with us. The fair value of each stock option grants was estimated using the Black-Scholes option-pricing model at the date of grant. We lack company-specific historical and implied volatility information and therefore, determined our expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expect to continue to do so until such time as it has adequate historical data regarding the volatility of our own traded stock price. Due to the lack of historical exercise history, 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 our option awards granted during the year ended December 31, 2019 and 2018 was estimated using the following assumptions: 2019 2018 Average risk-free rate of interest 1.85 % 3.09 % Expected term (years) 3.75 to 5.00 5.00 to 6.25 Expected stock price volatility 81.77 % 85.31 % Dividend yield 0 % 0 % The following table summarizes our stock option activity for the years ended December 31, 2019 and 2018: Total options Outstanding Weighted average exercise price Weighted average remaining contractual life (in years) Outstanding as of January 1, 2018 - - - Options granted 54,915 20.45 9.8 Exercised - - - Forfeited - - - Outstanding as of December 31, 2018 54,915 $ 20.45 9.8 Options granted 129,919 16.80 4.5 Exercised - - - Forfeited (7,872 ) 16.80 4.5 Outstanding as of December 31, 2019 176,962 17.93 5.8 Exercisable (vested) at December 31, 2019 29,655 18.53 6.9 The weighted average grant date fair value per share of options granted during the year ended December 31, 2019 and 2018 was between $9.88 and $15.10. No forfeiture rate was applied to these stock options. No tax benefits were attributed to the stock-based compensation expense because a valuation allowance was maintained for all net deferred tax assets. As of December 31, 2019, there was $1,450,684 of total unrecognized compensation expense, related to the unvested stock options which are expected to be recognized over a weighted average period of 5.82 years. |
2019 Senior 8% Convertible Note
2019 Senior 8% Convertible Notes Payable | 6 Months Ended |
Jun. 30, 2020 | |
Debt Disclosure [Abstract] | |
2019 Senior 8% Convertible Notes Payable | Note 5 – 2019 Senior 8% Convertible Notes Payable During the fourth quarter of 2019, accredited investors purchased $805,000 of 8% Senior Convertible Notes (“2019 Senior Notes”) from us. For every $1,000 principal amount purchased, the note holders received 70 warrants to purchase our common stock. As a result, we granted 56,350 warrants to purchase our common stock at an exercise price of $19.04, which expire on December 19, 2023. The 2019 Senior Notes bear interest at 8% per year and if converted, the interest is payable in kind (in common stock). The 2019 Senior Notes mature on December 15, 2020. At June 30, 2020 and December 31, 2019, we had $805,000 of 2019 Senior Notes outstanding. The 2019 Senior Notes are convertible by the holder upon (i) completion of listing our common stock on either the Nasdaq Capital Market or the New York Stock Exchange or if we raise at least $14 million, prior to December 15, 2020, the maturity date of the 2019 Senior Notes, in one or more qualified financings. If the 2019 Senior Notes are not paid or converted prior to their maturity date, the principal and any accrued interest will be automatically or mandatorily converted into our common stock. The 2019 Senior Notes, plus any accrued interest, is convertible into shares of our common stock at a conversion price equal to the lower of (i) $14.28 per share or (ii) a price per share equal to a 10% discount to the pre-money valuation of an equity sale of the Company’s common stock for cash, as defined in the 2019 Senior Note agreement, occurring after the closing of the 2019 Senior Note financing. The 2019 Senior Notes provide the holders with (a) the option of receiving 110% of principal plus accrued interest in the event there is a change of control prior to conversion of the 2019 Senior Notes; (b) weighted-average anti-dilution protection in event of any sale of securities at a net consideration per share that is less than the applicable conversion price per share to the holder until we have raised an additional $14 million from the sale of certain securities; and (c) certain preemptive rights pro rata to their respective interests through December 31, 2021. The 2019 Senior Notes contains negative covenants that do not permit us to incur additional indebtedness or liens on property or assets owned, repurchase common stock, pay dividends, or enter into any transaction with affiliates of ours that would require disclosure in a public filing with the Securities and Exchange Commission. Upon an event of default, the outstanding principal amount of the Senior Notes, plus accrued but unpaid interest and other amounts owing in respect thereof through the date of acceleration, shall become immediately due and payable in cash at the holder’s election, if not cured within the cure period. We incurred $4,280 in debt issuance costs related to the 2019 Senior Notes. The debt issuance costs are amortized to interest expense using straight line amortization over the term of the 2019 Senior Notes. |
Related Party Line of Credit Ag
Related Party Line of Credit Agreements | 6 Months Ended |
Jun. 30, 2020 | |
Controlling interest, description | |
Related Party Line of Credit Agreements | Note 6 – Related Party Line of Credit Agreements On September 20, 2019, we entered into two separate LOC Agreements (“LOC Agreements”) with DKBK Enterprises, LLC (“DKBK”) and CorLyst, LLC (“CorLyst”, and, together with DKBK, collectively, “Lenders”), both related parties, which provide a revolving commitment of up to $700,000 each ($1.4 million total). Under the LOC Agreements, all funds borrowed bear interest at an annual rate of 8%. The promissory notes issued in connection with the LOC Agreements provide that the Lenders have the right to convert all or any portion of the principal and accrued and unpaid interest into our common stock on the same terms as our 2019 Senior Convertible Notes. Therefore, the Lenders may convert the outstanding debt under the LOC Agreements into our common stock at a conversion price equal to the lower of (i) $14.28 per share, (ii) a price per share equal to a 10% discount to the pre-money valuation of an equity sale of the Company’s common stock for cash, or (iii) at an adjusted price; all as more particularly described in the 2019 Senior Convertible Notes. Our Chief Executive Officer (CEO) is also the CEO and Managing Member of both lenders. DKBK directly holds 16,166 shares of our common stock, representing less than 1% of our outstanding common stock, and CorLyst beneficially owns 1,095,649 shares of our common stock, representing 19.8% of our outstanding common stock at June 30, 2020. In April and June 2020, we drew $500,000 under the LOC Agreement with DKBK. On July 21, 2020, we drew an additional $200,000, bringing the total amount drawn under the LOC Agreement with DKBK to $700,000. |
Paycheck Protection Program Loa
Paycheck Protection Program Loan | 6 Months Ended |
Jun. 30, 2020 | |
Percentage of common stock holdings | |
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 terms 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 is 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 (collectively, “Qualifying Expenses”), and on the maintenance of employee and compensation levels during a certain time period following the funding of the PPP Loan. We have used the proceeds of our PPP Loan for payroll costs. However, no assurance is provided that we will be able to obtain forgiveness of the PPP Loan in whole or in part. As of June 30, 2020, $72,203 of the total $162,459 PPP-related debt is classified as a current liability on our condensed consolidated balances sheets. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Equity [Abstract] | ||
Stockholders' Equity | Note 8 – Stockholders’ Equity On September 30, 2019, our Pledge Agreement with PoC Capital was amended to reduce the committed funds under this Agreement from $1.8 million to $900,000, which was paid in full as of December 31, 2019. As part of the Pledge Agreement amendment, PoC Capital forfeited the pledged collateral (56,640 shares of our common stock and warrants to purchase 56,640 shares of our common stock) in the amended agreement. The forfeited shares of our common stock and stock purchase warrants have been returned to us. We determined the sale of the 2019 Senior Notes in late 2019 which are convertible into common stock at a conversion rate of $14.28 per share, triggered the full ratchet anti-dilution provision of common stock we sold in our 2018 Private Placement Transactions. As a result, those stockholders were entitled to 28,971 shares of common stock in the fourth quarter of 2019, which we issued on June 18, 2020. We accounted for these shares at December 31, 2019 as a deemed dividend payable at their par value. On June 25, 2020, we amended our Certificate of Incorporation reducing the number of authorized shares of our common stock from 100,000,000 to 30,000,000. We believe 100,000,000 authorized shares of common stock was disproportionately large in relation to the Company’s outstanding common stock and our anticipated future needs, and the reduction will reduce our future Delaware franchise tax. We have not had any sales of our preferred stock since we were incorporated on March 29, 2011 and there were no issued or outstanding shares of preferred stock at June 30, 2020 or December 31, 2019. | Note 8 – Stockholders’ Equity In August 2019, we amended our certificate of incorporation, reducing the authorized number of shares of our preferred stock from 10,000,000 to 1,000,000 and our common stock from 350,000,000 to 100,000,000. We have not had any sales of our preferred stock since we were incorporated on March 29, 2011 and there were no issued or outstanding shares of preferred stock at December 31, 2019 or 2018. 2019 Private Placement Transactions During 2019 we amended our Pledge Agreement with PoC Capital to reduce the committed funds from $1.8 million to $900,000, which has been paid in full as of December 31, 2019. As part of the original Pledge Agreement, we issued 113,280 shares of common stock and 113,280 warrants to purchase shares of common stock to PoC Capital but held 56,640 shares and 56,640 warrants as collateral until certain payment milestones were met. PoC Capital forfeited the pledged collateral in the amended agreement (see below). The forfeited shares and warrants have been returned to us. 2018 Private Placement Transactions Between May 15, 2018 and June 29, 2018, we sold an aggregate of 200,369 units in a private placement transaction at a purchase price equal to $15.89 per unit for gross proceeds of approximately $3.2 million. Each unit consisted of one share of our common stock and a warrant to purchase one share of our common stock for $19.07, subject to adjustment thereunder for a period of three years. We paid $167,526 to our placement agent and issued placement agent warrants to purchase up to 12,021 shares of common stock, with a three-year term, at an exercise price equal to $19.07. We also incurred costs totaling $141,304 related to this transaction and our contractual obligation to file a resale registration statement related to the PIPE transaction with the SEC. The issuance costs were charged against additional paid in capital. On May 25, 2018, we entered into an Agreement with PoC Capital, LLC (“PoC”), where PoC agreed to finance $1,800,000 in study costs associated with certain clinical studies, including our Phase 2A study to evaluate the safety, tolerability, efficacy and pharmacodynamics of PCS499 in patients with Necrosis Lipoidica in exchange for 113,280 shares of our common stock and a warrant for the purchase of 113,280 shares of common stock with an exercise price of $19.07, expiring on July 29, 2021. We paid $108,000 to our placement agent and issued our placement agent warrants to purchase 6,797 shares of common stock, with a three-year term, at an exercise price equal to $19.07. We also incurred costs totaling $60,457 related to this transaction and our contractual obligation to file a resale registration statement related to this transaction with the SEC. The issuance costs were charged against additional paid in capital. As part of this transaction, we also entered into a Pledge Agreement with PoC, under which we received a security interest for 56,640 common stock units, or half the shares and warrants we issued to PoC, to hold as collateral. The Pledge Agreement with PoC Capital was amended on September 30, 2019 to reduce the committed funds from $1.8 million to $900,000, which has been paid in full as of December 31, 2019. As part of the Pledge Agreement amendment, PoC Capital forfeited the pledged collateral in the amended agreement. The forfeited shares and warrants have been returned to us. We initially recorded the full amount of the commitment, $1.8 million, as a subscription receivable and reduced the subscription receivable in the period PoC made payments to our CRO or to us. We evaluated the warrants issued in the 2018 Private Placement Transactions and determined they should be classified as equity. The common stock, but not the warrants, issued for the 2018 Private Placement Transactions and the conversion of the 2017 Senior Notes have, subject to certain customary exceptions, full ratchet anti-dilution protection. Until we have issued equity securities or securities convertible into equity securities for a total of an additional $20 million in cash or assets, including the proceeds from the exercise of the warrants issued above, in the event we issue additional equity securities or securities convertible into equity securities at a purchase price less than $15.89 per share of common stock, the above purchase prices shall be adjusted and new shares of common stock issued as if the purchase price was such lower amount (or, if such additional securities are issued without consideration, to a price equal to $0.01 per share). We have determined the sale of 2019 Senior Notes, which are convertible into common stock at a conversion rate of $14.28 triggered the full ratchet anti-dilution provision of the common stock we sold in 2018 Private Placement Transactions described above. As a result, those stockholders were entitled to 28,971 shares of common stock in the fourth quarter of 2019. We will issue 28,971 shares of common stock to those stockholders in 2020. We determined the value of these shares to be $506,993 based on a price per share of $17.50, which represents the closing price per share on October 18, 2019, the last day investors had to rescind their investment. We recorded the triggering of the full ratchet anti-dilution provision as a deemed dividend payable at December 31, 2019 in our statement of changes in stockholders’ equity at par value due to the fact that we have a retained deficit and are receiving no additional consideration for these shares. |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
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 stock outstanding. Diluted net loss per share is computed by dividing net loss by the weighted average common stock outstanding, which includes potentially dilutive effect of stock options, warrants and senior convertible notes. Since we experienced a loss for both periods presented, including any dilutive common stock outstanding would have an anti-dilutive impact on diluted net loss per share, and as shown below were excluded from the computation. The treasury-stock method is used to determine the dilutive effect of our stock options and warrants grants, 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 six months ended June 30, 2020 and 2019 was as follows: Six months ended June 30, 2020 2019 Basic and diluted net loss per share: Net loss $ (1,607,750 ) $ (1,719,910 ) Weighted average number of common stock-basic and diluted 5,515,447 5,524,895 Basic and diluted net loss per share $ (0.29 ) $ (0.31 ) The following potentially dilutive securities were excluded from the computation of diluted net income per share as their effect would have been anti-dilutive for the periods presented. 2020 2019 Stock options and purchase warrants 646,938 700,976 Senior convertible notes and LOC, plus related accrued interest 93,961 18,107 740,899 719,083 | Note 11 – 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. Diluted net loss per share is computed by dividing net loss by the weighted average common stock outstanding without the impact of potential dilutive common stock outstanding because 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 grants, and the if-converted method is used to determine the dilutive effect of the 2017 and 2019 Senior Notes. The computation of net loss per share for the year ended December 31, 2019 and 2018 was as follows: 2019 2018 Basic and diluted net loss per share: Net loss $ (3,357,876 ) $ (3,765,047 ) Deemed dividend related to the triggering of the full ratchet anti-dilution provision at fair value (506,993 ) - Net loss available to common stockholders (3,864,869 ) (3,765,047 ) Weighted-average number of common stock-basic and diluted 5,525,635 5,332,141 Basic and diluted net loss per share $ (0.70 ) $ (0.71 ) We have determined the sale of the 2019 Senior Notes in late 2019, which are convertible into common stock at a conversion rate of $14.28 per share triggered the full ratchet anti-dilution provision of the common stock we sold in 2018 Private Placement Transactions (see Note 8). As a result, those stockholders were entitled to 28,971 shares of common stock in the fourth quarter of 2019. We will issue 28,971 shares of common stock to these stockholders in 2020. We determined the value of these shares at $506,993 based on a price per share of $17.50 which represents the closing price per share on October 18, 2019, the last day investors had to rescind their investment. For purposes of computing our basic and diluted EPS, we increased our net loss available for common stockholders by the fair value of the additional shares to be issued since they did not affect all our common stockholders equally and there are no contingencies related to the issuance of these shares. We also included these shares in our weighted number of shares of common stock outstanding. Triggering the full ratchet anti-dilution provision increased our basic and diluted net loss per share by $0.09 per share, from $(0.61) to $(0.70). The outstanding options and warrants to purchase common stock and the shares issuable under the 2017 and 2019 Senior Notes were excluded from the computation of diluted net income per share as their effect would have been anti-dilutive for the periods are presented below: 2019 2018 Stock options and purchase warrants 654,569 571,055 Senior convertible notes 60,883 17,531 |
Leases
Leases | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | ||
Leases | Note 10 – 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% in determining the present value of the lease payments based on the information available at the lease commencement date. Lease costs included in our condensed consolidated statement of operations totaled $23,995 and $24,729 for the three months ended June 30, 2020 and 2019, respectively, and $48,201 and $49,302 for the six months ended June 30, 2020 and 2019, respectively. The weighted average remaining lease terms and discount rate for our operating leases were as follows at June 30, 2020: Weighted average remaining lease term (years) for our facility and equipment leases 2.23 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, 2020: 2020 $ 45,869 2021 90,495 2022 69,741 Total lease payments 206,105 Less: Interest (19,543 ) Present value of lease liabilities 186,562 Less: current maturities (71,967 ) Non-current lease liability $ 114,595 | Note 12 - 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% in determining the present value of the lease payments based on the information available at the lease commencement date. Lease costs included in our consolidated statement of operations totaled $98,020 and $88,237 for the years ended December 31, 2019 and 2018, respectively. The weighted average remaining lease terms and discount rate for our operating leases were as follows at December 31, 2019: 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 % Maturities of our lease liabilities for all operating leases were as follows as of December 31, 2019: 2020 $ 92,603 2021 90,495 2022 69,741 Total lease payments 252,839 Less: Interest (27,457 ) Present value of lease liabilities 225,382 Less: current maturities (77,992 ) Non-current lease liability $ 147,390 |
License Agreement with Aposense
License Agreement with Aposense, Ltd. | 6 Months Ended |
Jun. 30, 2020 | |
Unamortized Debt Issuance Cost [Member] | |
License Agreement with Aposense, Ltd. | Note 11 – License Agreement with Aposense, Ltd. On May 24, 2020 we executed a condition precedent License Agreement (“Aposense Agreement”) with Aposense under which they will provide us with an exclusive worldwide license (excluding China) to research, develop and commercialize products comprising or containing PCS11T. The grant of license is conditioned on the following being satisfied within 9 months of May 24, 2020 (or the Aposense 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 Agreement. Within five business days of satisfying the conditions, we must issue Aposense a number of shares of common stock determined by dividing $2.5 million by the price per share paid by such investors in equity financing. Such shares will be subject to a lock-up, with 40% of such shares released from such lock up after six months and the remaining two 30% tranches to be 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 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 must 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 milestone payments we receive with Aposense based on any sub-license agreement we may enter into. 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) submitting an IND for a drug indication within 30 months following the satisfaction of the license conditions above; (ii) dosing of a first patient with a product within 42 months following the satisfaction of the license conditions above; (iii) dosing of a first patient with a product in a pivotal clinical trial within 72 months following the satisfaction of the license conditions above and (iv) an NDA submission within 120 months following the satisfaction of the license conditions above. Either party may terminate the Aposense Agreement in the event of a material breach of the license 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). |
Related Party Transactions
Related Party Transactions | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Related Party Transactions [Abstract] | ||
Related Party Transactions | Note 12 – Related Party Transactions CorLyst 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 being reimbursed in our condensed consolidated statement of operations. We recorded $25,928 and $52,464 of reimbursements during the six months ended June 30, 2020 and 2019, respectively. Amounts due from CorLyst at June 30, 2020 and December 31, 2019 were $24,713 and $0, respectively. At June 30, 2020, we also had approximately $1,700 due from certain employees for health insurance contributions. We did not have comparable a similar receivable at December 31, 2019. | Note 13 – Related Party Transactions A stockholder, 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 consolidated statements of operations. Reimbursable expenses from CorLyst totaled $103,047 and $107,402 for rent and other costs during the years ended December 31, 2019 and 2018, respectively. Amounts due from related parties at December 31, 2019 and 2018 were $0 and $21,583, respectively. As described further in Note 7, we also entered into two separate Line of Credit Agreements with CorLyst, LLC and DKBK Enterprises, LLC, both related parties, on September 20, 2019. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Commitments and Contingencies | Note 13 – 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 a contract with a specific vendor were to be terminated, 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 had no purchase obligations at June 30, 2020. | Note 14 – 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 a contract with a specific vendor were to be terminated, 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 had a purchase obligation of approximately $0 and $35,000 at December 31, 2019 and 2018, respectively. Due to the contingent nature of the amounts and timing of the payments, we have excluded our agreement with the CRO with whom we have contracted to conduct our Phase 2A clinical trial for NL. We were contractually obligated for up to approximately $487,000 of future services under the agreement, but our actual contractual obligations will vary depending on the progress and results of the clinical trial. |
Concentration of Credit Risk
Concentration of Credit Risk | 12 Months Ended |
Dec. 31, 2019 | |
Risks and Uncertainties [Abstract] | |
Concentration of Credit Risk | Note 15 – Concentration of Credit Risk We maintain cash accounts in two commercial banks. Balances on deposit are insured by the Federal Deposit Insurance Corporation (FDIC) up to specified limits. Total cash held by one bank was $691,536 at December 31, 2019, which exceed FDIC limits. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Business Activities and Organization | Business Activities and Organization Processa is a clinical stage biopharmaceutical company focused on the development of drug products that are intended to improve the survival and/or quality of life for patients who have a high unmet medical need condition. Within this group of pharmaceutical products, we currently are developing one product for multiple indications (i.e., the use of a drug to treat a particular disease) and will begin developing our newly acquired drugs (PCS11T and PCS100) once adequate funding has been obtained. We continue searching for additional products for our portfolio that meet our criteria. PCS499 Our lead product, PCS499, is an oral tablet that is a deuterated analog of one of the major metabolites of pentoxifylline (PTX or Trental ® The degeneration of tissue occurring at the NL lesion site may be caused by a number of pathophysiological changes which has made it extremely difficult to develop effective treatments for this condition. PCS499 may provide a solution since PCS499 and its metabolites affect a number of the biological pathways which could contribute to the pathophysiology associated with NL. On June 18, 2018, the FDA granted orphan-drug designation for PCS499 for the treatment of NL. On September 28, 2018, the IND for PCS499 in NL was made effective by the FDA, such that we could move forward with a Phase 2A trial multicenter, open-label prospective trial designed to determine the safety and tolerability of PCS499 in patients with NL. The first enrolled NL patient in this Phase 2A clinical trial was dosed on January 29, 2019 and the study completed enrollment on August 23, 2019. The main objective of the trial was to evaluate the safety and tolerability of PCS499 in patients with NL and to use the collected safety and efficacy data to design future clinical trials. Based on toxicology studies and healthy human volunteer studies, Processa and the FDA agreed that a PCS499 dose of 1.8 grams/day would be the highest dose administered to NL patients in this Phase 2A trial. As anticipated, the PCS499 dose of 1.8 grams/day, 50% greater than the maximum tolerated dose of PTX, appeared to be well tolerated with no serious adverse events reported. All adverse events reported in the study were mild in severity. As expected, gastrointestinal symptoms were the most noted adverse events and reported in four patients, all of which were mild in severity and resolved within 1-2 weeks of starting dosing. Two patients presenting with more severe ulcerated NL had ulcers for more than two months prior to dosing. At baseline, the reference ulcer in one of the two patients measured 3.5 cm 2 2 On March 25, 2020, we met with the FDA and discussed the clinical program, as well as the nonclinical and clinical pharmacology plans to support the submission of the PCS499 New Drug Application (NDA) in the U.S. for the treatment of ulcers in NL patients. With input from the FDA we will be designing the next trial as a randomized, placebo-controlled trial to evaluate the ability of PCS499 to completely close ulcers in patients with NL. We initially planned to begin recruiting for the randomized, placebo-controlled trial in the fourth quarter 2020, but we now expect to begin recruiting patients in 20201 due to the ongoing COVID-19 pandemic. This PCS499 NL study will be a randomized, placebo-controlled Phase 2B study to better understand the potential response of NL patients on drug and on placebo. After obtaining the results from this Phase 2B study, we expect to meet with FDA to discuss our Phase 2B drug and placebo response findings while further discussing the next steps to obtain approval. PCS11T On May 24, 2020, we entered into a condition precedent License Agreement (the “Aposense Agreement”) with Aposense, Ltd., (“Aposense”), pursuant to which we were granted a contingent license in Aposense’s patent rights and know-how to develop and commercialize their next generation irinotecan cancer drug, PCS11T (formerly known as ATT-11T). Granting of the license is conditioned on the following being satisfied within 9 months of May 24, 2020 (or the Aposense 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 Agreement. PCS11T is a novel lipophilic anti-cancer pro-drug that is being developed for the treatment of the same solid tumors as prescribed for irinotecan. This pro-drug is a conjugate of a specific proprietary Aposense molecule connected to SN-38, the active metabolite of irinotecan. The proprietary molecule in PCS11T has been designed to allow PCS11T to bind to cell membranes to form an inactive pro-drug depot on the cell with SN-38 preferentially accumulating in the membrane of tumors cells and the tumor core. This unique characteristic is expected to make the therapeutic window of PCS11T wider than all other irinotecan products such that the antitumor effect of PCS11T will occur at a much lower dose with a milder adverse effect profile than irinotecan. Irinotecan serves as a water-soluble pro-drug of SN-38, with SN-38 being significantly more potent as a topoisomerase I inhibitor than irinotecan. Despite the widespread use of commercially marketed irinotecan products in the treatment of metastatic colorectal cancer and other cancers resulting in peak annual sales of approximately $1.1 billion, irinotecan has a narrow therapeutic window and includes an FDA “Black Box” warning for both neutropenia and severe diarrhea. Its adverse effects include diarrhea, neutropenia, leucopenia, lymphocytopenia, and anemia, which are major impediments to optimal dosing for efficacy since the dose must often be reduced with repeated treatment cycles. There is, therefore, a substantial unmet need to overcome the limitations of the current commercially marketed irinotecan products, improving efficacy and reducing the severity of treatment emergent adverse events. The potential wider therapeutic window of PCS11T will likely lead to more patients responding with less side effects when on PCS11T compared to other irinotecan products. Pre-clinical studies conducted to date showed that that PCS11T has an efficacy advantage over Irinotecan as demonstrated by tumor eradication at much lower doses than irinotecan across various tumor xenograft models. PCS11T produced a marked, dose-related sustained tumor growth inhibition (TGI) in all the evaluated models. TGI in these models was significantly improved in comparison to irinotecan. Tumor regression was also observed in several models. PCS11T does not affect acetyl choline esterase (AChE) activity in human and rat plasma in vitro, which would suggest that PCS11T will show an improved safety profile, unlike irinotecan which is known for its cholinergic related side-effects. Prior to the License Agreement, Aposense had met with the FDA at a Pre-IND meeting. At that meeting, agreement was reached related to the necessary manufacturing and toxicological study requirements for filing the IND and the subsequent design of the Phase 1B study for PCS11T in the treatment of solid tumors. Depending upon our available funds, we are currently planning to manufacture the product at a GMP facility, conduct the required toxicological studies required to file the IND and initiate the Phase 1B study in oncology patients with solid tumors in late 2021. PCS100 On August 29, 2019, we entered into an exclusive license agreement with Akashi Therapeutics, Inc. (“Akashi”) to develop and commercialize an anti-fibrotic, anti-inflammatory drug, PCS100, which also promotes healthy muscle fiber regeneration. In previous clinical trials in Duchenne Muscular Dystrophy (DMD), PCS100 showed promising improvement in the muscle strength of non-ambulant pediatric patients. Although the FDA placed a clinical hold on the DMD trial after a serious adverse event in a pediatric patient, the FDA has removed the drug off clinical hold and defined how PCS100 can resume clinical trials in DMD. Once we have obtained adequate funding, we plan to develop PCS100 in rare adult fibrotic related diseases such as focal segmental glomerulosclerosis, idiopathic pulmonary fibrosis or Scleroderma. At the present time we are evaluating the potential GMP manufacturing facilities and the potential indications for PCS100. | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of 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, 2019, 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. | 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. We have reclassified certain immaterial prior year amounts to conform to our current year presentation. The reclassification of prior period amounts had no effect on previously reported net income, stockholders’ equity or cash flows. On December 23, 2019, we effected a 1-for-7 reverse stock split, reducing the number of the Company’s common stock outstanding on that date from 38,404,530 shares to 5,486,476 shares. The number of authorized shares of common stock remained unchanged at 100,000,000 shares and the number of authorized shares of preferred stock remained unchanged at 1,000,000 shares. Additionally, the conversion price of our 2019 Senior Notes, the exercise price of all then outstanding options and warrants, and the number of shares reserved for future issuance pursuant to our equity compensation plans were all adjusted proportionately in connection with the reverse stock split. All share and per share amounts and conversion and exercise prices presented herein have been adjusted retroactively to reflect this change. |
Going Concern and Management's Plans | Going Concern and Management’s Plans Our condensed consolidated financial statements have been prepared using U.S. GAAP and are based on the assumption that we will continue as a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. We face certain risks and uncertainties that are present in many emerging pharmaceutical company regarding product development and commercialization, limited working capital, recurring losses and negative cash flow from operations, future profitability, ability to obtain future capital, protection of patents, technologies and property rights, competition, rapid technological change, navigating the domestic and major foreign markets’ regulatory and clinical environment, recruiting and retaining key personnel, dependence on third party manufacturing organizations, third party collaboration and licensing agreements, lack of sales and marketing activities. We currently have no customers or pharmaceutical products to sell or distribute. These risks and other factors raise substantial doubt about our ability to continue as a going concern. We have relied primarily on private placements with a small group of accredited investors to finance our business and operations. As described in more detail below, we entered into two line of credit agreements last year with related parties providing a revolving commitment of an aggregate of up to $1.4 million. We have not had any revenue since our inception. We are looking at ways to add a revenue stream to offset some of our expenses but do not currently have any revenue under contract or any immediate sales prospects. At June 30, 2020, we had an accumulated deficit of $12.6 million, and during the six months ended June 30, 2020, we incurred a net loss of $1,607,750 and used $897,029 in net cash from operating activities from continuing operations. At June 30, 2020, we had cash and cash equivalents totaling $452,654. On September 20, 2019, we entered into two separate Line of Credit Agreements (“LOC Agreements”) to borrow up to $700,000 with current stockholders and related parties: DKBK Enterprises, LLC (“DKBK”) and CorLyst, LLC (“CorLyst”) ($1.4 million total). Under the LOC Agreements, all funds borrowed bear an 8% annual interest rate. The lenders have the right to convert all or any portion of the debt and interest into shares of our common stock. Our Chief Executive Officer (CEO) is also the CEO and Managing Member of both lenders. DKBK directly holds 16,166 shares of our common stock, less than 1% of our outstanding common stock, and CorLyst beneficially owns 1,095,649 shares, representing 19.8% of our outstanding common stock. In April and June 2020, we drew $500,000 under the LOC Agreement with DKBK. On July 21, 2020, we drew an additional $200,000, bringing the total amount drawn under the LOC Agreement with DKBK to $700,000. In December 2019, we closed our bridge financing and issued $805,000 of 2019 Senior Notes to accredited investors. In order to preserve cash, in August 2019 we began delaying some cash outflows, primarily through the deferred payment of certain salaries ($210,800 has been included in accrued expenses at June 30, 2020) until such time as we have raised sufficient funding. In May 2020, we entered into a promissory note in favor of the Bank of America under the Small Business Administration Paycheck Protection Program of the Coronavirus Aid, Relief and Economic Security Act of 2020 (the “CARES Act”) for a $162,459 loan (“the PPP Loan”). We plan to use the loan proceeds for payroll costs, rent and utilities in accordance with the relevant terms and conditions of the CARES Act. We have begun the process of raising capital in an underwritten public offering, however, we have faced delays due to the global pandemic caused by the novel coronavirus, COVID-19. Based on our current plan, we will need to raise additional capital to fund our future operations. While we believe our current resources are adequate to complete the closeout of our current Phase 2A trial for NL, we do not currently have resources to conduct other future trials, such as the Phase 2B clinical trial approved by the FDA, or to develop our other drug candidates without raising additional capital. We believe that our existing cash and LOC Agreements will enable us to fund our operating expenses and capital expenditure requirements through the end of 2020. Additional funding may not be available to us on acceptable terms, or at all. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or future clinical trial plans, or research and development programs. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. To the extent that we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Uncertainty concerning our ability to continue as a going concern may hinder our ability to obtain future financing. Continued operations and our ability to continue as a going concern are dependent on our ability to obtain additional funding in the future and thereafter, and no assurances can be given that such funding will be available at all, in a sufficient amount, or on reasonable terms. Without additional funds from debt or equity financing, sales of assets, sales or out-licenses of intellectual property or technologies, or other transactions providing funds, we will rapidly exhaust our resources and be unable to continue operations. Absent additional funding, we believe that our cash and cash equivalents will not be sufficient to fund our operations for a period of one year or more after the date that these condensed consolidated financial statements are available to be issued based on the timing and amount of our projected net loss from continuing operations and cash to be used in operating activities during that period of time. As a result, substantial doubt exists about our ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are available to be issued. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded assets, or the amounts and classification of liabilities that might be different should we be unable to continue as a going concern based on the outcome of these uncertainties described above. | |
Use of Estimates | Use of Estimates In preparing our condensed consolidated financial statements and related disclosures in conformity with 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, determining the fair value of acquired assets and assumed liabilities, intangible assets, 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. | Use of Estimates In preparing our 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 consolidated financial statements and accompanying notes. Estimates are used for, but not limited to stock-based compensation, determining the fair value of acquired assets and assumed liabilities, intangible assets, 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 to 5 years. We amortize leasehold improvements over the shorter of the estimated useful life of the asset or the term of the related lease. Upon retirement or disposition of assets, the costs and related accumulated depreciation are removed from the accounts with the resulting net gain or loss, if any, reflected in the consolidated statement of operations. | |
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. | 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, | 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, |
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 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 Stock-based compensation expense is based on the grant-date fair value estimated in accordance with the provisions of ASC 718, Compensation-Stock Compensation |
Net Loss Per Share | Net Loss Per Share Basic loss per share is computed by dividing our net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the year. Diluted loss per share is computed by dividing our net loss available to common stockholders 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, 2020 and 2019 excludes the impact of 740,899 and 719,083 potentially dilutive common stock, respectively, related to outstanding stock options and warrants and the conversion of our 2017 and 2019 Senior Notes since those shares would have an anti-dilutive effect on loss per share. | Net Loss Per Share Basic loss per share is computed by dividing our net loss available to common stockholders 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 stockholders by the diluted weighted average number of shares of common stock 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, 2019 and 2018 excludes the impact of potentially dilutive common stock related to outstanding stock options and warrants and the conversion of our 2017 and 2019 Senior Notes since those shares would have an anti-dilutive effect on loss per share. As more fully described in Note 11, we have determined the sale of the 2019 Senior Notes in late 2019 triggered the full ratchet anti-dilution provision of the common stock we sold in 2018 Private Placement Transactions. For purposes of computing our basic and diluted EPS, we increased our net loss available for common stockholders by the fair value of the additional shares to be issued since they did not affect all our common stockholders equally and there are no contingencies related to the issuance of these shares. We also included the related shares which will be issued in 2020 in our weighted number of shares of common stock outstanding. Our diluted net loss per share for the years ended December 31, 2019 and 2018 excluded 715,452, and 588,586 of potentially dilutive common stock, respectively, related to the conversion of our Senior Notes and outstanding stock options and warrants since those shares would have had an anti-dilutive effect on loss per share during the years then ended. |
Segments | Segments We operate in one segment. Management uses one measurement of profitability and does not segregate its business for internal reporting. All our assets are located within the United States. | |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and the senior convertible notes approximate fair value because of the short-term maturity of these instruments, including the mandatory conversion of the Senior Notes into our common stock upon meeting certain conditions. | |
Debt Issuance Costs | Debt Issuance Costs We recognized the debt issuance costs incurred related to our 2017 and 2019 Senior Notes as a reduction of the carrying amount of the 2017 and 2019 Senior Notes on the face of the consolidated balance sheet. The debt issuance costs are amortized to interest expense using the straight-line method over the term of the 2019 Senior Notes and the interest method over the term of the 2017 Senior Notes. | |
Research and Development | Research and development Research and development costs are expensed as incurred and consisted of direct and overhead-related expenses. Research and development costs totaled $2,320,573 and $3,085,317 for the years ended December 31, 2019 and 2018, respectively. Expenditures to acquire technologies, including licenses, which are utilized in research and development and that have no alternative future use are expensed when incurred. Technology we develop for use in our products is expensed as incurred until technological feasibility has been established after which it is capitalized and depreciated. No research and development costs were capitalized during the years ended December 31, 2019 and 2018. | |
Income Taxes | Income Taxes As a result of our reverse acquisition merger, there was an ownership change as defined by Internal Revenue Code Section 382. Prior to the closing of the transaction, Promet was treated as a partnership for federal income tax purposes and thus was not subject to income taxes at the entity level, and no provision or liability for income taxes has been included in the consolidated financial statements through October 4, 2017. In addition, Promet determined that it was not required to record a liability related to uncertain tax positions as a result of the requirements of ASC 740-10-25 Income Taxes We account for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, we recognize the tax benefit from an uncertain tax position only if it is more-likely-than-not that the tax position will be sustained upon examination by the taxing authorities, based on the technical merits of the position. Estimated interest and penalties related to uncertain tax positions are included as a component of interest expense and general and administrative expense, respectively. We had no unrecognized tax benefits or uncertain tax positions for any periods presented. On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (“TCJA”) was signed into law. In December 2017, the SEC issued Staff Accounting Bulletin 118 (“SAB 118”) to provide clarification in implementing the TCJA when registrants do not have the necessary information available to complete the accounting for an element of the TCJA in the period of its enactment. SAB 118 provides for tax amounts to be classified as provisional and subject to remeasurement for up to one year from the enactment date for such elements when the accounting effect is not complete but can be reasonably estimated. We considered our estimates of the tax effects of the TCJA on the components of our tax provision to be reasonable and no provisional estimates subject to remeasurement were necessary to complete the accounting. We file U.S. federal income and California and Maryland state tax returns. There are currently no income tax examinations underway for these jurisdictions. However, tax years from and including 2016 remain open for examination by federal and state income tax authorities. | |
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 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. | 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 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. |
Recently Adopted Accounting Pronouncements | Recently adopted accounting pronouncements In July 2017, the FASB issued Accounting Standards Update 2017-11 (ASU 2017-11), which allows companies to exclude a down round feature when determining whether a financial instrument is considered indexed to the entity’s own stock. As a result, financial instruments with round down features are no longer classified as liabilities and embedded conversion options with down round features are no longer bifurcated. For equity-classified freestanding financial instruments, such as warrants, an entity will treat the value of the effect of the round down, when triggered, as a dividend and a reduction of income available to common stockholders in computing basic earnings per share. The guidance in ASU 2017-11 is effective for fiscal year beginning after December 15, 2018, and interim periods within those fiscal years. We early adopted ASU 2017-11 effective January 1, 2018 without a material impact on our consolidated financial statements. On January 1, 2019, we adopted Accounting Standards Codification (ASC) 842, Leases The adoption of the new guidance did not have a material impact on the consolidated statement of operations. For further details regarding the adoption of this standard, see Note 12, “Operating Leases.” |
Acquisition (Tables)
Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Business Combinations [Abstract] | |
Schedule of Identifiable Assets and Liabilities | The net recognized value of Heatwurx identifiable assets and liabilities included the following: Cash $ 6,280 Accounts payable (26,098 ) Accrued expenses (17,932 ) Net liabilities assumed $ (37,750 ) |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Summary of Intangible Assets | Intangible assets at June 30, 2020 and December 31, 2019 consisted of the following: June 30, 2020 December 31, 2019 Gross intangible assets $ 11,059,429 $ 11,059,429 Less: accumulated amortization (1,814,639 ) (1,416,975 ) Total intangible assets, net $ 9,244,790 $ 9,642,454 | Our intangible assets consist of the following at December 31, 2019: License Rights Software December 31, to PCS499 License 2019 Gross intangible assets $ 11,038,929 $ 20,500 $ 11,059,429 Less: accumulated amortization (1,405,301 ) (11,674 ) (1,416,975 ) Total intangible assets, net $ 9,633,628 $ 8,826 $ 9,642,454 Our intangible assets consist of the following at December 31, 2018: License Rights Software December 31, to PCS499 License 2018 Gross intangible assets $ 11,038,929 $ 20,500 $ 11,059,429 Less: accumulated amortization (616,807 ) (4,840 ) (621,647 ) Total intangible assets, net $ 10,422,122 $ 15,660 $ 10,437,782 |
Notes Payable (Tables)
Notes Payable (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Senior Convertible Notes | The balance of our Senior Convertible Notes at December 31, 2019 and 2018 was as follows: 2019 2018 2019 Senior Notes $ 805,000 $ - 2017 Senior Notes - 230,000 Less: Unamortized debt issuance costs (2,497 ) - Balance 802,503 230,000 Current portion (802,503 ) (230,000 ) Long term portion $ - $ - |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Income Taxes | Our provision (benefit) for income taxes for the years ended December 31, 2019 and 2018 was as follows: Year Ended December 31, 2019 2018 Current: Federal $ - $ - State - - Total deferred tax benefit - - Deferred: Federal (1,037,267 ) (940,510 ) State (234,033 ) (292,047 ) Total deferred tax benefit (1,271,300 ) (1,232,557 ) Valuation allowance 668,584 329,756 Net deferred tax benefit (602,716 ) (902,801 ) Total tax provision (benefit) $ (602,716 ) $ (902,801 ) |
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, 2019 and 2018 is as follows: Year Ended December 31, 2019 2018 Federal statutory income tax rate 21.00 % 21.00 % State tax rate, net 3.60 % 4.58 % Permanent differences (1.96 )% (0.90 )% Federal orphan drug tax credit 7.15 % - % Deferred tax asset valuation allowance (14.57 )% (5.33 )% Effective income tax rate 15.22 % 19.35 % |
Schedule of Deferred Tax Assets | The significant components of our deferred tax assets and liabilities for Federal and state income taxes consisted of the following: December 31, 2019 2018 Deferred tax assets: Non-current: Net operating loss carry forward – Federal $ 854,196 $ 559,817 Net operating loss carry forward – State 265,106 173,743 Deferred rent - 2,742 Stock option expense 72,504 20,380 Depreciation 8,753 4,549 Federal orphan drug credits 283,189 - Start-up expenditures and amortization 800,681 468,872 Total non-current deferred tax assets 2,284,429 1,230,103 Valuation allowance for deferred tax assets (1,165,126 ) (496,542 ) Total deferred tax assets 1,119,303 733,561 Deferred Tax Liabilities: Non-current: Intangible asset (2,650,933 ) (2,867,907 ) Total non-current deferred tax liabilities (2,650,933 ) (2,867,907 ) Total deferred tax asset (liability) $ (1,531,630 ) $ (2,134,346 ) |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Allocation of Stock-based Compensation Expense | The allocation of stock-based compensation expense between research and development and general and administrative expense was as follows: Year ended December 31, 2019 2018 Research and Development $ 113,239 $ - General and Administrative 397,239 74,063 Total $ 510,478 $ 74,063 |
Schedule of Stock Option Valuation Assumption | The fair value of our option awards granted during the year ended December 31, 2019 and 2018 was estimated using the following assumptions: 2019 2018 Average risk-free rate of interest 1.85 % 3.09 % Expected term (years) 3.75 to 5.00 5.00 to 6.25 Expected stock price volatility 81.77 % 85.31 % Dividend yield 0 % 0 % |
Schedule of Stock Option | The following table summarizes our stock option activity for the years ended December 31, 2019 and 2018: Total options Outstanding Weighted average exercise price Weighted average remaining contractual life (in years) Outstanding as of January 1, 2018 - - - Options granted 54,915 20.45 9.8 Exercised - - - Forfeited - - - Outstanding as of December 31, 2018 54,915 $ 20.45 9.8 Options granted 129,919 16.80 4.5 Exercised - - - Forfeited (7,872 ) 16.80 4.5 Outstanding as of December 31, 2019 176,962 17.93 5.8 Exercisable (vested) at December 31, 2019 29,655 18.53 6.9 |
Leases (Tables)
Leases (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | ||
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases | The weighted average remaining lease terms and discount rate for our operating leases were as follows at June 30, 2020: Weighted average remaining lease term (years) for our facility and equipment leases 2.23 Weighted average discount rate for our facility and equipment leases 8.00 % | The weighted average remaining lease terms and discount rate for our operating leases were as follows at December 31, 2019: 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 % |
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, 2020: 2020 $ 45,869 2021 90,495 2022 69,741 Total lease payments 206,105 Less: Interest (19,543 ) Present value of lease liabilities 186,562 Less: current maturities (71,967 ) Non-current lease liability $ 114,595 | Maturities of our lease liabilities for all operating leases were as follows as of December 31, 2019: 2020 $ 92,603 2021 90,495 2022 69,741 Total lease payments 252,839 Less: Interest (27,457 ) Present value of lease liabilities 225,382 Less: current maturities (77,992 ) Non-current lease liability $ 147,390 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Earnings Per Share [Abstract] | ||
Schedule of Net Loss Per Share Basic and Diluted | The computation of net loss per share for the six months ended June 30, 2020 and 2019 was as follows: Six months ended June 30, 2020 2019 Basic and diluted net loss per share: Net loss $ (1,607,750 ) $ (1,719,910 ) Weighted average number of common stock-basic and diluted 5,515,447 5,524,895 Basic and diluted net loss per share $ (0.29 ) $ (0.31 ) | The computation of net loss per share for the year ended December 31, 2019 and 2018 was as follows: 2019 2018 Basic and diluted net loss per share: Net loss $ (3,357,876 ) $ (3,765,047 ) Deemed dividend related to the triggering of the full ratchet anti-dilution provision at fair value (506,993 ) - Net loss available to common stockholders (3,864,869 ) (3,765,047 ) Weighted-average number of common stock-basic and diluted 5,525,635 5,332,141 Basic and diluted net loss per share $ (0.70 ) $ (0.71 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities were excluded from the computation of diluted net income per share as their effect would have been anti-dilutive for the periods presented. 2020 2019 Stock options and purchase warrants 646,938 700,976 Senior convertible notes and LOC, plus related accrued interest 93,961 18,107 740,899 719,083 | The outstanding options and warrants to purchase common stock and the shares issuable under the 2017 and 2019 Senior Notes were excluded from the computation of diluted net income per share as their effect would have been anti-dilutive for the periods are presented below: 2019 2018 Stock options and purchase warrants 654,569 571,055 Senior convertible notes 60,883 17,531 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Details Narrative) - USD ($) | Jul. 21, 2020 | Dec. 31, 2019 | Sep. 20, 2019 | May 31, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Accumulated deficit | $ (10,982,010) | $ (12,589,760) | $ (12,589,760) | $ (10,982,010) | $ (7,624,134) | |||||||
Net loss | (733,414) | $ (874,336) | $ (969,078) | $ (750,832) | (1,607,750) | $ (1,719,910) | (3,357,876) | (3,765,047) | ||||
Net cash used in operating activities | (897,029) | $ (1,414,903) | (2,750,145) | (3,707,914) | ||||||||
Cash and cash equivalents | 691,536 | 452,654 | 452,654 | 691,536 | 1,740,961 | |||||||
Proceeds from sale of convertible notes | ||||||||||||
Accrued salary | 122,175 | $ 210,800 | $ 210,800 | $ 122,175 | ||||||||
Potentially dilutive common shares | 740,899 | 719,083 | 715,452 | 588,586 | ||||||||
2019 Senior Notes [Member] | ||||||||||||
Proceeds from sale of convertible notes | 805,000 | $ 805,000 | ||||||||||
DKBK Enterprises, LLC [Member] | ||||||||||||
Number of common stock shares owned | 16,166 | |||||||||||
DKBK Enterprises, LLC [Member] | Maximum [Member] | ||||||||||||
Outstanding shares of common stock percentage | 1.00% | 1.00% | ||||||||||
Corlyst [Member] | ||||||||||||
Outstanding shares of common stock percentage | 19.80% | 19.80% | ||||||||||
Number of common stock shares owned | 1,095,649 | |||||||||||
Two LOC Agreements [Member] | Related Parties [Member] | ||||||||||||
Revolving line of credit commitment | $ 1,400,000 | $ 1,400,000 | ||||||||||
Two LOC Agreements [Member] | Lenders [Member] | ||||||||||||
Revolving line of credit commitment | $ 1,400,000 | |||||||||||
Line of credit, interest percentage | 8.00% | |||||||||||
LOC Agreements [Member] | DKBK Enterprises, LLC [Member] | ||||||||||||
Revolving line of credit commitment | $ 700,000 | |||||||||||
Line of credit, additional drawn value | $ 500,000 | $ 500,000 | ||||||||||
LOC Agreements [Member] | DKBK Enterprises, LLC [Member] | Subsequent Event [Member] | ||||||||||||
Line of credit, additional drawn value | $ 200,000 | |||||||||||
Line of credit, total drawn value | $ 700,000 | |||||||||||
LOC Agreements [Member] | CorLyst, LLC [Member] | ||||||||||||
Revolving line of credit commitment | $ 700,000 | |||||||||||
PPP Loan [Member] | ||||||||||||
Proceeds from loans | $ 162,459 |
Going Concern and Management'_2
Going Concern and Management's Plans (Details Narrative) (10-K) - USD ($) | Dec. 31, 2019 | Sep. 30, 2019 | Sep. 20, 2019 | May 25, 2018 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Accumulated deficit | $ (10,982,010) | $ (12,589,760) | $ (12,589,760) | $ (10,982,010) | $ (7,624,134) | |||||||
Net loss | (733,414) | $ (874,336) | $ (969,078) | $ (750,832) | (1,607,750) | $ (1,719,910) | (3,357,876) | (3,765,047) | ||||
Net cash used in operating activities | (897,029) | $ (1,414,903) | $ (2,750,145) | (3,707,914) | ||||||||
Debt instrument, conversion price per share | $ 14.28 | $ 14.28 | ||||||||||
Warrants to purchase shares of common stock | 56,350 | 56,350 | ||||||||||
Proceeds from sale of convertible notes | ||||||||||||
Accrued salary | $ 122,175 | $ 210,800 | $ 210,800 | $ 122,175 | ||||||||
2019 Senior Notes [Member] | ||||||||||||
Warrants to purchase shares of common stock | 70 | 70 | ||||||||||
Debt instrument purchase for warrants, description | For every $1,000 principal amount purchased, the note holders received 70 warrants to purchase our common stock. | |||||||||||
Proceeds from sale of convertible notes | $ 805,000 | $ 805,000 | ||||||||||
Accredited Investors [Member] | 2019 Senior Notes [Member] | ||||||||||||
Proceeds from sale of convertible notes | $ 805,000 | |||||||||||
Two LOC Agreements [Member] | Lenders [Member] | ||||||||||||
Maximum revolving line of credit | $ 1,400,000 | |||||||||||
Line of credit, interest percentage | 8.00% | |||||||||||
Debt instrument, conversion price per share | $ 14.28 | |||||||||||
Debt instrument, conversion terms | Under the LOC Agreements, all funds borrowed bear interest at an annual rate of 8%. The promissory notes issued in connection with the LOC Agreements provide that the Lenders have the right to convert all or any portion of the principal and accrued and unpaid interest into our common stock on the same terms as our 2019 Senior Convertible Notes. Therefore, the Lenders may convert the outstanding debt under the LOC Agreements into our common stock at a conversion price equal to the lower of (i) $14.28 per share, (ii) a price per share equal to a 10% discount to the pre-money valuation of an equity sale of the Company's common stock for cash, or (iii) at an adjusted price; all as more particularly described in the 2019 Senior Convertible Notes. Our CEO is also the CEO and Managing Member of both Lenders. CorLyst beneficially owns 996,376 shares of Processa common stock, representing approximately 17.8% of the Company's outstanding shares of voting capital stock. | |||||||||||
LOC Agreements [Member] | DKBK Enterprises, LLC [Member] | ||||||||||||
Maximum revolving line of credit | $ 700,000 | |||||||||||
Warrants to purchase shares of common stock | 805 | |||||||||||
LOC Agreements [Member] | CorLyst, LLC [Member] | ||||||||||||
Maximum revolving line of credit | $ 700,000 | |||||||||||
Common stock beneficially owned, shares | 996,376 | |||||||||||
Equity method investment, ownership percentage | 17.80% | |||||||||||
Pledge Agreement [Member] | PoC Capital [Member] | ||||||||||||
Maximum revolving line of credit | $ 900,000 | $ 1,800,000 | ||||||||||
Common stock, forfeited | 56,640 | |||||||||||
Warrants, forfeited | 56,640 | |||||||||||
PoC Capital, LLC [Member] | ||||||||||||
Number of common stock issued | 113,280 | |||||||||||
Warrants to purchase shares of common stock | 113,280 |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Details Narrative) (10-K) - USD ($) | Dec. 23, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Jun. 25, 2020 | Jun. 24, 2020 | Aug. 08, 2019 | Aug. 07, 2019 | Jan. 02, 2019 | Mar. 19, 2018 | Oct. 04, 2017 |
Reverse stock split, description | 1-for-7 reverse stock split | |||||||||||||
Common stock, shares outstanding | 38,404,530 | 5,514,447 | 5,514,447 | 5,486,476 | 5,525,009 | 5,039,033 | 5,039,033 | |||||||
Common stock, shares authorized | 30,000,000 | 30,000,000 | 100,000,000 | 30,000,000 | 100,000,000 | 100,000,000 | 350,000,000 | |||||||
Preferred stock, shares authorized | 1,000,000 | 10,000,000 | 1,000,000 | |||||||||||
Potentially dilutive common shares | 740,899 | 719,083 | 715,452 | 588,586 | ||||||||||
Research and development costs | $ 427,109 | $ 726,904 | $ 928,855 | $ 1,211,655 | $ 2,320,573 | $ 3,085,317 | ||||||||
Right of use asset | 179,591 | 179,591 | 219,074 | |||||||||||
Lease obligations | $ 114,595 | $ 114,595 | $ 147,390 | |||||||||||
Accounting Standards Update 2016-02 [Member] | ||||||||||||||
Right of use asset | $ 293,198 | |||||||||||||
Lease obligations | $ 303,161 | |||||||||||||
Minimum [Member] | ||||||||||||||
Estimated useful lives of property plant and equipment | 3 years | |||||||||||||
Maximum [Member] | ||||||||||||||
Estimated useful lives of property plant and equipment | 5 years |
Acquisition (Details Narrative)
Acquisition (Details Narrative) (10-K) - USD ($) | Oct. 04, 2017 | Dec. 31, 2018 | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 23, 2019 | Mar. 19, 2018 |
Number of shares issued in exchange for license agreement | 298,615 | |||||
Common stock shares issued | 5,039,033 | 5,525,009 | 5,514,447 | 5,486,476 | 5,039,033 | |
Common stock shares outstanding | 5,039,033 | 5,525,009 | 5,514,447 | 5,486,476 | 38,404,530 | 5,039,033 |
Promet Therapeutics LLC [Member] | ||||||
Business acquisition exchange percentage | 90.00% | |||||
Number of shares issued in exchange for net assets | 4,535,121 | |||||
Business acquisition acquired value | $ 1,017,342 | |||||
Equity ownership percentage | 84.00% | |||||
Percentage of common stock holdings held for others | 6.00% | |||||
Voting interest | 90.00% | |||||
Promet Therapeutics LLC [Member] | General and Administrative [Member] | ||||||
Acquisition related transaction costs | $ 58,763 |
Acquisition - Schedule of Ident
Acquisition - Schedule of Identifiable Assets and Liabilities (Details) (10-K) | Oct. 04, 2017USD ($) |
Business Combinations [Abstract] | |
Cash | $ 6,280 |
Accounts payable | (26,098) |
Accrued expenses | (17,932) |
Net liabilities assumed | $ (37,750) |
Intangible Assets (Details Narr
Intangible Assets (Details Narrative) - USD ($) | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Mar. 19, 2018 | |
Amortization expense | $ 397,664 | $ 397,664 | $ 795,328 | $ 621,647 | |
Future amortization expense, year one | 795,000 | 795,000 | |||
Future amortization expense, thereafter | $ 788,000 | $ 788,000 | |||
CoNCERT Pharmaceuticals, Inc [Member] | |||||
Recognition of deferred tax liability | $ 3,037,147 | ||||
Intangible asset, tax basis | 1,782 | ||||
CoNCERT Pharmaceuticals, Inc [Member] | License Rights [Member] | |||||
Purchase price | 8,000,000 | ||||
Transaction cost | 1,782 | ||||
Recognition of deferred tax liability | 3,037,147 | ||||
Intangible asset, tax basis | $ 1,782 |
Intangible Assets (Details Na_2
Intangible Assets (Details Narrative) (10-K) - USD ($) | Mar. 19, 2018 | Oct. 04, 2017 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 23, 2019 |
Number of shares acquired in exchange for common stock | 298,615 | ||||||
Common stock shares issued | 5,039,033 | 5,039,033 | 5,514,447 | 5,486,476 | 5,525,009 | ||
Common stock shares outstanding | 5,039,033 | 5,039,033 | 5,514,447 | 5,486,476 | 5,525,009 | 38,404,530 | |
Amortization expense | $ 397,664 | $ 397,664 | $ 795,328 | $ 621,647 | |||
Future amortization expense, year one | 795,000 | 795,000 | |||||
Future amortization expense, thereafter | $ 788,000 | 788,000 | |||||
Product Concentration Risk [Member] | Sub License [Member] | |||||||
Sales percentage | 10.00% | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | |||||||
Capitalized cost | $ 11,038,929 | ||||||
Recognition of deferred tax liability | 3,037,147 | ||||||
Intangible asset, tax basis | $ 1,782 | ||||||
Number of shares acquired in exchange for common stock | 298,615 | ||||||
Shares acquired price per share | $ 26.79 | ||||||
Fair value of intangible asset received in exchange for common stock | $ 8,000,000 | ||||||
Sublicense royalty percentage | 15.00% | ||||||
Sales percentage description | We will pay the greater of (i) 6% or (ii) 50% of all payment received by us with respect to such sublicencee. We will also pay 15% of any sublicense revenue earned by us for a period equivalent to the royalty term (as defined in the CoNCERT Agreement) until the earliest of (a) our raising $8 million of gross proceeds and (b) CoNCERT being able to sell its shares of our common stock without restrictions pursuant to the terms of the amended Agreement. | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | Category 1 [Member] | Maximum [Member] | |||||||
Amount of sales limit | $ 100,000,000 | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | Category 1 [Member] | Product Concentration Risk [Member] | |||||||
Sales percentage | 4.00% | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | Category 2 [Member] | Maximum [Member] | |||||||
Amount of sales limit | $ 500,000,000 | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | Category 2 [Member] | Minimum [Member] | |||||||
Amount of sales limit | $ 100,000,000 | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | Category 2 [Member] | Product Concentration Risk [Member] | |||||||
Sales percentage | 5.00% | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | Category 3 [Member] | Maximum [Member] | |||||||
Amount of sales limit | $ 1,000,000,000 | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | Category 3 [Member] | Minimum [Member] | |||||||
Amount of sales limit | $ 500,000,000 | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | Category 3 [Member] | Product Concentration Risk [Member] | |||||||
Sales percentage | 6.00% | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | Category 4 [Member] | Minimum [Member] | |||||||
Amount of sales limit | $ 1,000,000,000 | ||||||
CoNCERT Pharmaceuticals, Inc [Member] | Category 4 [Member] | Product Concentration Risk [Member] | |||||||
Sales percentage | 10.00% | ||||||
Software License [Member] | |||||||
Capitalized cost | $ 20,500 |
Intangible Assets - Summary of
Intangible Assets - Summary of Intangible Assets (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Gross intangible assets | $ 11,059,429 | $ 11,059,429 | $ 11,059,429 |
Less: accumulated amortization | (1,814,639) | (1,416,975) | (621,647) |
Total intangible assets, net | $ 9,244,790 | $ 9,642,454 | $ 10,437,782 |
Intangible Assets - Summary o_2
Intangible Assets - Summary of Intangible Assets (Details) (10-K) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Gross intangible assets | $ 11,059,429 | $ 11,059,429 | $ 11,059,429 |
Less: Accumulated amortization | (1,814,639) | (1,416,975) | (621,647) |
Total intangible assets, net | $ 9,244,790 | 9,642,454 | 10,437,782 |
License Rights To PCS 499 [Member] | |||
Gross intangible assets | 11,038,929 | 11,038,929 | |
Less: Accumulated amortization | (1,405,301) | (616,807) | |
Total intangible assets, net | 9,633,628 | 10,422,122 | |
Software License [Member] | |||
Gross intangible assets | 20,500 | 20,500 | |
Less: Accumulated amortization | (11,674) | (4,840) | |
Total intangible assets, net | $ 8,826 | $ 15,660 |
License Agreement for PCS100 (D
License Agreement for PCS100 (Details Narrative) (10-K) - USD ($) | Aug. 29, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Research and development cost | $ 427,109 | $ 726,904 | $ 928,855 | $ 1,211,655 | $ 2,320,573 | $ 3,085,317 | |
License Agreement [Member] | Akashi [Member] | |||||||
Research and development cost | $ 10,000 | ||||||
Maximum payment per milestone | $ 3,000,000 | ||||||
Milestone payments description | As additional consideration, we will pay Akashi development and regulatory milestone payments (up to $3.0 million per milestone) upon the achievement of certain milestones, which primarily consist of having a drug indication approved by a regulatory authority in the United States or another country. In addition, we must pay Akashi one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. Due to the early stage of PCS100, it is not possible to determine if any of the development or sales milestones will be achieved and no amounts have been accrued related to these contingent payments. We are also required to split any milestone payments we receive with Akashi based on any sub-license agreement we may enter into. |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) (10-K) - USD ($) | Dec. 31, 2019 | Sep. 20, 2019 | Jul. 02, 2019 | May 25, 2018 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2017 |
Debt conversion price per share | $ 14.28 | $ 14.28 | |||||||||
Interest expense | $ 19,280 | $ 6,102 | $ 36,450 | $ 10,702 | $ 36,658 | $ 161,205 | |||||
Amortization of debt issuance costs | 2,140 | $ 1,783 | 67,069 | ||||||||
Proceeds from sale of convertible notes | |||||||||||
Warrants to purchase shares of common stock | 56,350 | 56,350 | |||||||||
Senior convertible notes, outstanding | $ 805,000 | 805,000 | 805,000 | $ 805,000 | |||||||
Accrued interest | $ 21,902 | $ 58,483 | $ 58,483 | $ 21,902 | 20,343 | ||||||
2019 Senior Notes [Member] | |||||||||||
Discount percentage | 10.00% | 10.00% | |||||||||
Debt interest rate | 8.00% | 8.00% | |||||||||
Debt issuance costs | $ 4,280 | $ 4,280 | |||||||||
Proceeds from sale of convertible notes | 805,000 | 805,000 | |||||||||
Debt principal amount | $ 1,000 | $ 1,000 | |||||||||
Warrants to purchase shares of common stock | 70 | 70 | |||||||||
Warrants exercise price | $ 19.04 | $ 19.04 | |||||||||
Debt maturity date | Dec. 15, 2020 | Dec. 15, 2020 | |||||||||
Warrant expiration date | Dec. 19, 2023 | Dec. 19, 2023 | |||||||||
Senior convertible notes, outstanding | $ 805,000 | $ 805,000 | |||||||||
Debt instrument purchase for warrants, description | For every $1,000 principal amount purchased, the note holders received 70 warrants to purchase our common stock. | ||||||||||
Accredited Investors [Member] | 2019 Senior Notes [Member] | |||||||||||
Proceeds from sale of convertible notes | $ 805,000 | ||||||||||
Accredited Investors [Member] | 2017 Senior Notes [Member] | |||||||||||
Debt conversion price per share | $ 14.30 | ||||||||||
Debt interest rate | 8.00% | ||||||||||
Debt issuance costs | $ 154,800 | ||||||||||
Warrants to purchase shares of common stock | 172,327 | ||||||||||
Warrants exercise price | $ 17.16 | ||||||||||
Senior convertible notes, outstanding | $ 2,580,000 | ||||||||||
Conversion of senior notes | $ 2,350,000 | ||||||||||
Accrued interest | $ 114,333 | ||||||||||
Number of common stock issued | 172,327 | ||||||||||
Warrants exercise term | 3 years | ||||||||||
Debt effective interest rate, before debt issuance costs | 7.72% | ||||||||||
Debt effective interest rate, including debt issuance costs | 13.96% | ||||||||||
Canadian Investors [Member] | 2017 Senior Notes [Member] | |||||||||||
Warrants to purchase shares of common stock | 18,107 | ||||||||||
Warrants exercise price | $ 17.16 | ||||||||||
Senior convertible notes, outstanding | $ 230,000 | ||||||||||
Cease trade order fine | $ 10,000 | ||||||||||
Conversion of senior notes | 230,000 | ||||||||||
Accrued interest | $ 28,930 | ||||||||||
Number of common stock issued | 18,107 | ||||||||||
Warrants exercise term | 3 years | ||||||||||
LOC Agreements [Member] | DKBK Enterprises, LLC [Member] | |||||||||||
Revolving line of credit commitment | $ 700,000 | ||||||||||
Warrants to purchase shares of common stock | 805 | ||||||||||
LOC Agreements [Member] | CorLyst, LLC [Member] | |||||||||||
Revolving line of credit commitment | $ 700,000 | ||||||||||
Two LOC Agreements [Member] | Lenders [Member] | |||||||||||
Revolving line of credit commitment | $ 1,400,000 | ||||||||||
Line of credit annual interest rate | 8.00% | ||||||||||
Debt conversion price per share | $ 14.28 | ||||||||||
Discount percentage | 10.00% |
Notes Payable - Schedule of Sen
Notes Payable - Schedule of Senior Convertible Notes (Details) (10-K) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Senior Notes | $ 805,000 | $ 805,000 | |
Balance | $ 804,643 | 802,503 | $ 230,000 |
Senior Convertible Notes [Member] | |||
Less: Unamortized debt issuance costs | (2,497) | ||
Balance | 802,503 | 230,000 | |
Current portion | (802,503) | (230,000) | |
Long term portion | |||
2019 Senior Notes [Member] | |||
Senior Notes | 805,000 | ||
2017 Senior Notes [Member] | |||
Senior Notes | $ 230,000 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) | Mar. 19, 2018USD ($) |
Income Tax Disclosure [Abstract] | |
Deferred tax liability | $ 3,037,147 |
Intangible assets, financial reporting basis | 11,038,929 |
Intangible assets, tax basis | $ 1,782 |
Income Taxes (Details Narrati_2
Income Taxes (Details Narrative) (10-K) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Mar. 19, 2018 | |
Deferred tax liability | $ 3,037,147 | |||||||
Intangible assets, financial reporting basis | 11,038,929 | |||||||
Intangible assets, tax basis | $ 1,782 | |||||||
Net operating loss before income tax benefit | $ (821,249) | $ (1,139,680) | $ (1,823,714) | $ (2,020,811) | $ (3,960,592) | $ (4,667,848) | ||
Income tax benefit | $ (87,835) | $ (170,602) | $ (215,964) | $ (300,901) | $ (602,716) | (902,801) | $ 259,049 | |
Income tax effected rate amount | $ 71,284 | |||||||
Net operating loss carryforward term | P20Y | |||||||
Net operating loss carryforward, expiration date | 2037 | |||||||
Federal net operating loss carryforward | $ 854,196 | 559,817 | ||||||
Change in valuation of allowance | 668,584 | 329,755 | ||||||
Deferred tax asset, start-up expenditures | 2,909,715 | 1,703,904 | ||||||
Deferred tax asset, loss carryforwards | 4,067,602 | 2,665,796 | ||||||
Deferred tax asset, start-up expenditures, tax effected | 800,681 | 468,872 | ||||||
Deferred tax asset, loss carryforwards, tax effected | 1,119,302 | $ 733,560 | ||||||
Tax Cuts and Jobs Act [Member] | ||||||||
Income tax description | On December 22, 2017, the Tax Cuts and Jobs Act of 2017 ("TCJA") was signed into law. Among its provisions, the TCJA reduces the statutory U.S. Corporate income tax rate from 34% to 21% effective January 1, 2018. | |||||||
Federal [Member] | ||||||||
Net operating loss carryforward | 1,400,000 | $ 2,400,000 | ||||||
Federal net operating loss carryforward | 4,100,000 | 2,700,000 | ||||||
Deferred tax loss carryforward | 6,977,317 | 4,369,700 | ||||||
Orphan Drug [Member] | ||||||||
Income tax benefit | 283,189 | |||||||
Deferred tax loss carryforward | 283,189 | |||||||
General and Administrative [Member] | ||||||||
Income tax benefit | 1,205,811 | 1,356,840 | ||||||
Income tax effected rate amount | $ 331,809 | $ 373,368 |
Income Taxes - Schedule of Prov
Income Taxes - Schedule of Provision for Income Taxes (Details) (10-K) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||||||
Current, Federal | |||||||
Current, State | |||||||
Total current | |||||||
Deferred, Federal | (1,037,267) | (940,510) | |||||
Deferred, State | (234,033) | (292,047) | |||||
Total deferred tax benefit | (1,271,300) | (1,232,557) | |||||
Valuation allowance | 668,584 | 329,756 | |||||
Net deferred tax benefit | (602,716) | (902,801) | |||||
Total tax provision (benefit) | $ (87,835) | $ (170,602) | $ (215,964) | $ (300,901) | $ (602,716) | $ (902,801) | $ 259,049 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) (10-K) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21.00% | 21.00% |
State tax rate, net | 3.60% | 4.58% |
Permanent differences | (1.96%) | (0.90%) |
Federal orphan drug tax credit | 7.15% | 0.00% |
Deferred tax asset valuation allowance | (14.57%) | (5.33%) |
Effective income tax rate | 15.22% | 19.35% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets (Details) (10-K) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carry forward - Federal | $ 854,196 | $ 559,817 |
Net operating loss carry forward - State | 265,106 | 173,743 |
Deferred rent | 2,742 | |
Stock option expense | 72,504 | 20,380 |
Depreciation | 8,753 | 4,549 |
Federal orphan drug credits | 283,189 | |
Start-up expenditures and amortization | 800,681 | 468,872 |
Total non-current deferred tax assets | 2,284,429 | 1,230,103 |
Valuation allowance for deferred tax assets | (1,165,126) | (496,542) |
Total deferred tax assets | 1,119,303 | 733,561 |
Intangible asset | (2,650,933) | (2,867,907) |
Total non-current deferred tax liabilities | (2,650,933) | (2,867,907) |
Total deferred tax asset (liability) | $ (1,531,630) | $ (2,134,346) |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of stock option granted to employees or non-employees | 129,919 | 54,915 | ||
Number of option to purchase shares | 169,329 | |||
Purchase of common stock shares vested | 56,853 | |||
Stock-based compensation expense | $ 192,532 | $ 125,035 | $ 510,478 | $ 74,063 |
Employees and Non-Employees [Member] | ||||
Number of stock option granted to employees or non-employees | 129,919 | 54,915 |
Stock-based Compensation (Det_2
Stock-based Compensation (Details Narrative) (10-K) - USD ($) | Dec. 23, 2019 | Jun. 20, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Reverse stock split, description | 1-for-7 reverse stock split | ||||||
Number of stock option granted | 129,919 | 54,915 | |||||
Stock option contractual term | 5 years 9 months 18 days | 9 years 9 months 18 days | |||||
Weighted average exercise price | $ 17.93 | $ 20.45 | |||||
Stock-based compensation expense | $ 510,478 | $ 74,063 | |||||
Number of option purchase shares | 169,329 | ||||||
Unrecognized compensation expense | $ 1,450,684 | ||||||
Unvested stock options expected to be recognized over a weighted average period | 5 years 9 months 25 days | ||||||
Minimum [Member] | |||||||
Fair value per share, weighted average | $ 9.88 | $ 9.88 | |||||
Maximum [Member] | |||||||
Fair value per share, weighted average | $ 15.10 | $ 15.10 | |||||
Non Qualified Stock Options [Member] | |||||||
Number of stock option granted | 47,772 | ||||||
Non Qualified Stock Options [Member] | Vested Option One [Member] | |||||||
Number of option purchase shares | 45,200 | ||||||
Options vesting period | 4 years | ||||||
Non Qualified Stock Options [Member] | Vested Option Two [Member] | |||||||
Number of option purchase shares | 2,572 | ||||||
Options vesting period | 1 year | ||||||
Employees [Member] | |||||||
Number of stock option granted | 129,919 | ||||||
Stock option contractual term | 5 years | ||||||
Weighted average exercise price | $ 16.80 | ||||||
Employees [Member] | Performance Shares [Member] | |||||||
Number of stock option granted | 64,771 | ||||||
Employees [Member] | Tranche One [Member] | Service Vesting [Member] | |||||||
Number of stock option granted | 65,148 | ||||||
Stock option contractual term | 3 years | ||||||
Employees [Member] | Tranche One [Member] | In-license a new or additional drug [Member] | |||||||
Number of stock option granted | 12,958 | ||||||
Employees [Member] | Tranche Two [Member] | Phase 2a trial for PCS-499 Complete [Member] | |||||||
Number of stock option granted | 12,958 | ||||||
Employees [Member] | Tranche Three [Member] | Up-List From The OCTQB [Member] | |||||||
Number of stock option granted | 38,855 | ||||||
Employees and Non-Employees [Member] | |||||||
Number of stock option granted | 129,919 | 54,915 | |||||
Omnibus Plan [Member] | |||||||
Number of shares available for issuance | 500,000 | ||||||
Reverse stock split, description | one for seven reverse stock split | ||||||
2011 Plan [Member] | |||||||
Number of option purchase shares | 7,143 |
Stock-based Compensation - Sche
Stock-based Compensation - Schedule of Allocation of Stock-based Compensation Expense (Details) (10-K) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Allocation of stock-based compensation expense | $ 510,478 | $ 74,063 |
Research and Development [Member] | ||
Allocation of stock-based compensation expense | 113,239 | |
General and Administrative [Member] | ||
Allocation of stock-based compensation expense | $ 397,239 | $ 74,063 |
Stock-based Compensation - Sc_2
Stock-based Compensation - Schedule of Stock Option Valuation Assumption (Details) (10-K) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Average risk-free rate of interest | 1.85% | 3.09% |
Expected stock price volatility | 81.77% | 85.31% |
Dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Expected term (years) | 3 years 9 months | 5 years |
Maximum [Member] | ||
Expected term (years) | 5 years | 6 years 2 months 30 days |
Stock-based Compensation - Sc_3
Stock-based Compensation - Schedule of Stock Option (Details) (10-K) - $ / shares | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement [Abstract] | |||
Total options Outstanding, Beginning Balance | 176,962 | 54,915 | |
Total options Outstanding, Granted | 129,919 | 54,915 | |
Total options Outstanding, Exercised | |||
Total options Outstanding, Forfeited | (7,872) | ||
Total options Outstanding, Ending Balance | 176,962 | 54,915 | |
Total options Outstanding, Exercisable (vested) | 29,655 | ||
Weighted average exercise price, Beginning balance | $ 17.93 | $ 20.45 | |
Weighted average exercise price, Granted | 16.80 | 20.45 | |
Weighted average exercise price, Exercised | |||
Weighted average exercise price, Forfeited | 16.80 | ||
Weighted average exercise price, Ending balance | 17.93 | $ 20.45 | |
Weighted average exercise price, Exercisable (vested) | $ 18.53 | ||
Weighted average remaining contractual life (in years), Beginning | 9 years 9 months 18 days | 9 years 9 months 18 days | |
Weighted average remaining contractual life (in years), Granted | 4 years 6 months | ||
Weighted average remaining contractual life (in years), Forfeited | 4 years 6 months | ||
Weighted average remaining contractual life (in years), Ending | 5 years 9 months 18 days | 9 years 9 months 18 days | |
Weighted average remaining contractual life (in years), Exercisable (vested) | 6 years 10 months 25 days |
2019 Senior 8% Convertible No_2
2019 Senior 8% Convertible Notes Payable (Details Narrative) - USD ($) | Dec. 31, 2019 | Dec. 31, 2019 | Jun. 30, 2020 |
Senior convertible notes, outstanding | $ 805,000 | $ 805,000 | $ 805,000 |
Warrants to purchase shares of common stock | 56,350 | 56,350 | |
2019 Senior Notes [Member] | |||
Senior convertible notes, outstanding | $ 805,000 | $ 805,000 | |
Debt interest rate | 8.00% | 8.00% | |
Debt principal amount | $ 1,000 | $ 1,000 | |
Warrants to purchase shares of common stock | 70 | 70 | |
Warrants exercise price | $ 19.04 | $ 19.04 | |
Debt maturity date | Dec. 15, 2020 | Dec. 15, 2020 | |
Debt conversion price, description | The 2019 Senior Notes, plus any accrued interest, is convertible into shares of our common stock at a conversion price equal to the lower of (i) $14.28 per share or (ii) a price per share equal to a 10% discount to the pre-money valuation of a Qualified Financing or an Equity State Transaction, both as defined in the 2019 Senior Note agreement, occurring after the closing of the 2019 Senior Note financing. | ||
Discount percentage | 10.00% | 10.00% | |
Debt issuance costs | $ 4,280 | $ 4,280 | |
2019 Senior Notes [Member] | Warrant [Member] | |||
Warrants to purchase shares of common stock | 56,350 | 56,350 | |
Warrants exercise price | $ 19.04 | $ 19.04 |
Related Party Line of Credit _2
Related Party Line of Credit Agreements (Details Narrative) - USD ($) | Jul. 21, 2020 | Sep. 20, 2019 | Jun. 30, 2020 | Jun. 30, 2020 | Dec. 31, 2019 |
Debt conversion price per share | $ 14.28 | ||||
DKBK Enterprises, LLC [Member] | |||||
Number of common stock shares owned | 16,166 | ||||
DKBK Enterprises, LLC [Member] | Maximum [Member] | |||||
Outstanding shares percentage owned | 1.00% | 1.00% | |||
Corlyst [Member] | |||||
Number of common stock shares owned | 1,095,649 | ||||
Outstanding shares percentage owned | 19.80% | 19.80% | |||
LOC Agreements [Member] | DKBK Enterprises, LLC [Member] | |||||
Revolving line of credit commitment | $ 700,000 | ||||
Line of credit, additional drawn value | $ 500,000 | $ 500,000 | |||
LOC Agreements [Member] | DKBK Enterprises, LLC [Member] | Subsequent Event [Member] | |||||
Line of credit, additional drawn value | $ 200,000 | ||||
Line of credit, drawn value | $ 700,000 | ||||
LOC Agreements [Member] | CorLyst, LLC [Member] | |||||
Revolving line of credit commitment | 700,000 | ||||
Two LOC Agreements [Member] | Lenders [Member] | |||||
Revolving line of credit commitment | $ 1,400,000 | ||||
Line of credit annual interest rate | 8.00% | ||||
Debt conversion price per share | $ 14.28 | ||||
Discount percentage | 10.00% |
Paycheck Protection Program L_2
Paycheck Protection Program Loan (Details Narrative) - USD ($) | 1 Months Ended | ||
May 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | |
Note payable, current portion | $ 72,203 | ||
PPP Loan [Member] | |||
Proceeds from loans | $ 162,459 | ||
Debt interest rate | 1.00% | ||
Debt maturity date | May 5, 2022 | ||
Note payable, current portion | $ 72,203 |
Stockholders' Equity (Details N
Stockholders' Equity (Details Narrative) - USD ($) | Jun. 18, 2020 | Sep. 30, 2019 | Jun. 30, 2020 | Jun. 25, 2020 | Jun. 24, 2020 | Dec. 31, 2019 | Aug. 08, 2019 | Aug. 07, 2019 |
Debt conversion price per share | $ 14.28 | |||||||
Common stock, shares authorized | 30,000,000 | 30,000,000 | 100,000,000 | 100,000,000 | 100,000,000 | 350,000,000 | ||
Preferred stock, shares issued | ||||||||
Preferred stock, shares outstanding | ||||||||
Pledge Agreement with PoC [Member] | ||||||||
Reduced clinical trial funding commitment | $ 900,000 | |||||||
Number of pledged shares forfeited | 56,640 | |||||||
Warrants to purchase common stock, forfeited | 56,640 | |||||||
2018 Private Placement Transactions [Member] | ||||||||
Debt conversion price per share | $ 14.28 | |||||||
Number of common stock issued | 28,971 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details Narrative) (10-K) - USD ($) | Jun. 18, 2020 | Sep. 30, 2019 | May 25, 2018 | Jun. 29, 2018 | Dec. 31, 2019 | Jun. 30, 2020 | Jun. 25, 2020 | Jun. 24, 2020 | Aug. 08, 2019 | Aug. 07, 2019 |
Preferred stock, shares authorized | 1,000,000 | 10,000,000 | 1,000,000 | |||||||
Common stock, shares authorized | 100,000,000 | 30,000,000 | 30,000,000 | 100,000,000 | 100,000,000 | 350,000,000 | ||||
Warrants to purchase common stock | 56,350 | |||||||||
Debt conversion price per share | $ 14.28 | |||||||||
PoC Capital, LLC [Member] | ||||||||||
Number of common stock issued | 113,280 | |||||||||
Warrants to purchase common stock | 113,280 | |||||||||
Number of common stock, forfeited | 56,640 | |||||||||
Warrants to purchase common stock, forfeited | 56,640 | |||||||||
Purchase price per unit | $ 15.89 | |||||||||
Warrant exercise price per share | $ 19.07 | |||||||||
Amount paid to placement agent | $ 108,000 | |||||||||
Issued placement agent warrants to purchase shares | 6,797 | |||||||||
Warrant term | 3 years | |||||||||
Transaction costs incurred | $ 60,457 | |||||||||
Clinical trial funding commitment | $ 900,000 | $ 1,800,000 | ||||||||
2018 Private Placement Transactions [Member] | ||||||||||
Number of common stock issued | 28,971 | |||||||||
Number of units sold | 200,369 | |||||||||
Purchase price per unit | $ 15.89 | |||||||||
Gross proceeds from unit sold | $ 3,200,000 | |||||||||
Warrant exercise price per share | $ 19.07 | |||||||||
Amount paid to placement agent | $ 167,526 | |||||||||
Issued placement agent warrants to purchase shares | 12,021 | |||||||||
Warrant term | 3 years | |||||||||
Transaction costs incurred | $ 141,304 | |||||||||
Debt conversion price per share | $ 14.28 | |||||||||
Sale of stock price per share | $ 17.50 | |||||||||
Number of common stock to be issued | 28,971 | |||||||||
Number of common stock to be issued, value | $ 506,993 | |||||||||
Pledge Agreement with PoC [Member] | ||||||||||
Number of common stock, pledged | 56,640 | |||||||||
Warrants to purchase common stock, pledged | 56,640 |
Net Loss Per Share of Common _3
Net Loss Per Share of Common Stock (Details Narrative) (10-K) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Debt conversion price per share | $ 14.28 | |||||
Reduction in basic and diluted net loss per share | 0.09 | |||||
Original net loss per common stock - basic and diluted | (0.61) | |||||
Net loss per common stock - basic and diluted | $ (0.13) | $ (0.18) | $ (0.29) | $ (0.31) | $ (0.70) | $ (0.71) |
2018 Private Placement Transactions [Member] | ||||||
Debt conversion price per share | $ 14.28 | $ 14.28 | ||||
Number of common stock to be issued | 28,971 | |||||
Number of common stock to be issued, value | $ 506,993 | |||||
Shares issued price per share | $ 17.50 |
Net Loss Per Share of Common _4
Net Loss Per Share of Common Stock - Schedule of Net Loss Per Share Basic and Diluted (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Earnings Per Share [Abstract] | ||||||||
Net loss | $ (733,414) | $ (874,336) | $ (969,078) | $ (750,832) | $ (1,607,750) | $ (1,719,910) | $ (3,357,876) | $ (3,765,047) |
Weighted average number of common shares-basic and diluted | 5,515,447 | 5,525,009 | 5,515,447 | 5,525,009 | 5,525,635 | 5,332,141 | ||
Basic and diluted net loss per share | $ (0.13) | $ (0.18) | $ (0.29) | $ (0.31) | $ (0.70) | $ (0.71) |
Net Loss Per Share of Common _5
Net Loss Per Share of Common Stock - Schedule of Net Loss Per Share Basic and Diluted (Details) (10-K) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Earnings Per Share [Abstract] | ||||||||
Net loss | $ (733,414) | $ (874,336) | $ (969,078) | $ (750,832) | $ (1,607,750) | $ (1,719,910) | $ (3,357,876) | $ (3,765,047) |
Deemed dividend related to the triggering of the full ratchet anti-dilution provision at fair value | (506,993) | |||||||
Net loss available to common stockholders | $ (3,864,869) | $ (3,765,047) | ||||||
Weighted average number of common stock-basic and diluted | 5,515,447 | 5,525,009 | 5,515,447 | 5,525,009 | 5,525,635 | 5,332,141 | ||
Basic and diluted net loss per share | $ (0.13) | $ (0.18) | $ (0.29) | $ (0.31) | $ (0.70) | $ (0.71) |
Net Loss Per Share of Common _6
Net Loss Per Share of Common Stock - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive securities excluded from computation of earnings per share | 740,899 | 719,083 | 715,452 | 588,586 |
Stock Options and Purchase Warrants [Member] | ||||
Antidilutive securities excluded from computation of earnings per share | 646,938 | 700,976 | 654,569 | 571,055 |
Senior Convertible Notes and LOC, Plus Related Accrued Interest [Member] | ||||
Antidilutive securities excluded from computation of earnings per share | 93,961 | 18,107 |
Net Loss Per Share of Common _7
Net Loss Per Share of Common Stock - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) (10-K) - shares | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive securities excluded from computation of earnings per share | 740,899 | 719,083 | 715,452 | 588,586 |
Stock Options and Purchase Warrants [Member] | ||||
Antidilutive securities excluded from computation of earnings per share | 646,938 | 700,976 | 654,569 | 571,055 |
Senior Convertible Notes [Member] | ||||
Antidilutive securities excluded from computation of earnings per share | 60,883 | 17,531 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Leases [Abstract] | ||||||
Operating leases incremental borrowing rate | 8.00% | 8.00% | 8.00% | |||
Lease costs | $ 23,995 | $ 24,729 | $ 48,201 | $ 49,302 | $ 98,020 | $ 88,237 |
Leases (Details Narrative) (10-
Leases (Details Narrative) (10-K) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Leases [Abstract] | ||||||
Operating leases incremental borrowing rate | 8.00% | 8.00% | 8.00% | |||
Lease costs | $ 23,995 | $ 24,729 | $ 48,201 | $ 49,302 | $ 98,020 | $ 88,237 |
Leases - Schedule of Weighted A
Leases - Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases (Details) | Jun. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Weighted average remaining lease term (years) for our facility and equipment leases | 2 years 2 months 23 days | 2 years 8 months 12 days |
Weighted average discount rate for our facility and equipment leases | 8.00% | 8.00% |
Leases - Schedule of Weighted_2
Leases - Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases (Details) (10-K) | Jun. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Weighted average remaining lease term (years) for our facility and equipment leases | 2 years 2 months 23 days | 2 years 8 months 12 days |
Weighted average discount rate for our facility and equipment leases | 8.00% | 8.00% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities for All Operating Leases (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Leases [Abstract] | |||
2020 | $ 45,869 | ||
2021 | 90,495 | $ 90,495 | |
2022 | 69,741 | 69,741 | |
Total lease payments | 206,105 | 252,839 | |
Less: Interest | (19,543) | (27,457) | |
Present value of lease liabilities | 186,562 | 225,382 | |
Less: current maturities | (71,967) | (77,992) | |
Non-current lease liability | $ 114,595 | $ 147,390 |
Leases - Schedule of Maturiti_2
Leases - Schedule of Maturities of Lease Liabilities for All Operating Leases (Details) (10-K) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Leases [Abstract] | |||
2020 | $ 92,603 | ||
2021 | $ 90,495 | 90,495 | |
2022 | 69,741 | 69,741 | |
Total lease payments | 206,105 | 252,839 | |
Less: Interest | (19,543) | (27,457) | |
Present value of lease liabilities | 186,562 | 225,382 | |
Less: current maturities | (71,967) | (77,992) | |
Non-current lease liability | $ 114,595 | $ 147,390 |
License Agreement with Aposen_2
License Agreement with Aposense, Ltd. (Details Narrative) - License Agreement [Member] - Aposense, Ltd. [Member] | May 24, 2020USD ($) |
Common stock, lock-up description | Within five business days of satisfying the conditions, we must issue Aposense a number of shares of common stock determined by dividing $2.5 million by the price per share paid by such investors in equity financing. Such shares will be subject to a lock-up, with 40% of such shares released from such lock up after six months and the remaining two 30% tranches to be released upon completion of the next two subsequent quarters. |
Milestone payments, description | In addition, we must 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 milestone payments we receive with Aposense based on any sub-license agreement we may enter into. |
Performance of milestone conditions, description | Specific diligence milestones that consist of (i) submitting an IND for a drug indication within 30 months following the satisfaction of the license conditions above; (ii) dosing of a first patient with a product within 42 months following the satisfaction of the license conditions above; (iii) dosing of a first patient with a product in a pivotal clinical trial within 72 months following the satisfaction of the license conditions above and (iv) an NDA submission within 120 months following the satisfaction of the license conditions above. |
Maximum [Member] | |
Development and regulatory milestone payments | $ 3,000,000 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Amount due from related parties | $ 26,497 | $ 21,583 | ||
Due from employees for health insurance contributions | 1,700 | |||
CorLyst, LLC [Member] | ||||
Reimbursable expenses | 25,928 | $ 52,464 | 103,047 | 107,402 |
Amount due from related parties | $ 24,713 | $ 0 | $ 21,583 |
Related Party Transactions (D_2
Related Party Transactions (Details Narrative) (10-K) - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Amount due from related parties | $ 26,497 | $ 21,583 | ||
CorLyst, LLC [Member] | ||||
Reimbursable expenses | 25,928 | $ 52,464 | 103,047 | 107,402 |
Amount due from related parties | $ 24,713 | $ 0 | $ 21,583 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Commitments and Contingencies Disclosure [Abstract] | |||
Purchase obligations | $ 0 | $ 35,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) (10-K) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Commitments and Contingencies Disclosure [Abstract] | |||
Purchase obligations | $ 0 | $ 35,000 | |
Contractual obligation | $ 487,000 |
Concentration of Credit Risk (D
Concentration of Credit Risk (Details Narrative) (10-K) | Dec. 31, 2019USD ($) |
Risks and Uncertainties [Abstract] | |
Cash exceeds FDIC limits | $ 691,536 |